CN219579144U

CN219579144U - System for use with an object

Info

Publication number: CN219579144U
Application number: CN202223555582.9U
Authority: CN
Inventors: S·沙菲; R·Y·卡巴姆纳; B·P·墨菲; M·M·卡扎尔巴什; M·格雷罗; L·M·霍尔; E·绍连; E·W·海夫林; E·阿维夫; P·J-A·陈; E·R·狄克逊; A·N·拉森; O·科恩; T·肖厄姆; A·霍多斯; T·谢普斯; T·瑞克; Y·卡希尔; I·哈拉比; J·J·帕内利亚
Original assignee: Edwards Lifesciences Innovation Israel Ltd
Current assignee: Edwards Lifesciences Innovation Israel Ltd
Priority date: 2021-02-09
Filing date: 2022-02-08
Publication date: 2023-08-25
Anticipated expiration: 2032-02-08
Also published as: CN219579143U

Abstract

The present utility model relates to a system for use with an object. A system for use with a subject includes a catheter device. The catheter device includes a tube having a distal opening configured to be advanced to tissue of the subject. The catheter device also includes an extracorporeal unit coupled to the proximal portion of the tube. The system includes a series of anchors, each of the anchors including: a tissue engaging element and a head. Each of the anchors further includes a hub and an eyelet. The system may further include a tether passing through the eyelet of each of the anchors. The system may further include an anchor driver for each of the anchors configured to advance the anchor distally through the tube toward the distal opening and drive the tissue-engaging element into the tissue.

Description

System for use with an object

The present utility model is a divisional application of chinese patent application 2022202527599 entitled "system for use with a subject" with application day 2022, 2, 8.

Technical Field

The present utility model relates generally to the field of native heart valves, and in particular, to tissue anchors and related systems.

Background

Annuloplasty involves reshaping the tissue of the annulus. This can be done by pulling the tissue around the annulus into a new shape. Tissue anchors can be used to facilitate medical procedures, including annuloplasty, other tissue remodeling, and fixation of implants. In some cases, the tissue anchor may be used as a substitute for a suture. For example, the tissue anchor may be used for procedures that have no line of sight to the target.

Disclosure of Invention

This summary is intended to provide some examples and is not intended to limit the scope in any way. For example, any feature included in an example of this summary is not required by the claims unless the claims expressly state the feature. Moreover, the features, components, steps, concepts, etc. described in the examples of this summary and elsewhere in this disclosure may be combined in a variety of ways. Various features and steps described elsewhere in this disclosure may be included in examples summarized herein.

Some of the systems, devices, and techniques described herein, and applications thereof, include or are configured for use with implants that include a plurality of tissue anchors slidably coupled to a tether or retraction member or the like. The implant may be a tissue modifying implant that constricts tissue when the tether or the like is tensioned. The implant may be used with the heart of a subject/subject. For example, the implant may be an annuloplasty implant.

Some applications involve tissue anchors configured (e.g., shaped) to be slidable along a tether (e.g., wire, ribbon, rope, braid, shrink member, suture, etc.) when aligned (i.e., parallel or coaxial) with the tether and (ii) when oriented orthogonal to the tether. This is believed to facilitate, among other things, (i) advancement of the anchor along the tether while aligned with the tether during transcatheter delivery, and (ii) subsequent sliding of the tether relative to the anchor after implantation (e.g., when the tether is orthogonal to the anchor).

The tissue anchor may include (i) a tissue-engaging element, (ii) and a head at a proximal end of the tissue-engaging element. The head may define an aperture or other connector defining an aperture therethrough.

A variety of different tissue-engaging element configurations are possible for any of the various anchors described in this disclosure. In some applications, the tissue-engaging element may be shaped as a spiral having an axis, defining a central lumen along the axis, and configured to screw into tissue along the axis. In some applications, the tissue-engaging element may be pushed axially into the tissue, and in some cases, barbs or barb portions may be included to retain the tissue-engaging element in the tissue. In some applications, the tissue-engaging element may comprise a hook or a plurality of hooks. In some applications, the tissue-engaging element may comprise one or more of a clamp, a clip, a clamping device, a dart, a nail, a tine, or the like. Other tissue engaging elements or portions of anchors are also possible.

The eyelet may be arranged laterally from the axis of the tissue anchor. In some applications, the eyelet may rotate in a manner that facilitates smooth sliding along the tether (i) when the anchor is parallel to the tether and (ii) when the anchor is in an orthogonal orientation relative to the tether. Rotation of the eyelet allows the eyelet to define a respective clear, straight path through the aperture of the eyelet for the tether to pass through in each of these orientations of the anchor relative to the tether.

In some applications, one or more spacers or dividers (e.g., tubes, solid wall tubes, laser cut tubes, helical rods, springs, etc.) are threaded on the tether between the anchors. For some such applications, the eyelets define a flat face against which the spacer or divider may rest in order to provide a firm and stable spacing of the anchors and/or force distribution between the anchors.

In some applications, the tissue anchor includes a tissue-engaging element and a head. The anchor driver may engage the anchor at the head (e.g., reversibly attach to the head) and drive the tissue-engaging element into tissue. The tissue-engaging element may be the same as or similar to the other tissue-engaging elements described herein.

In some applications, catheter devices (e.g., implants including anchors threaded on tethers) for advancing and anchoring anchors are provided. The catheter device may include a tube and an extracorporeal unit, and a series of cartridges mounted on the extracorporeal unit may hold anchors so as to facilitate bringing each anchor in turn to a proximal opening of the tube for advancement through the tube by a driver. The extracorporeal unit may include a barrier that, along with the cartridge body, facilitates verification of engagement between the driver and the anchor, and impedes advancement of the anchor in the absence of such verification.

In some applications, the anchor includes a housing having a tissue-facing opening, and the tissue-engaging element is helical and stored within the housing such that when the tissue-facing opening faces tissue, rotation of the tissue-engaging element relative to the housing causes the tissue-engaging element to exit the housing helically via the tissue-facing opening and screw into the tissue. For some such applications, the tissue-engaging element is axially compressed within the housing and axially expands as it exits the tissue-facing opening.

In some applications, the tissue anchor includes a sharpened distal tip, a hollow body proximal to the tip, and a spring constrained within the hollow body. The tissue anchor is configured to be driven into tissue first such that the hollow body is disposed in the tissue, and then the spring is released such that it pushes the sharp end laterally out of the lateral port in the hollow body, further securing the anchoring of the anchor.

In some applications, the tissue anchors are delivered using a tool that includes a tube and a driver. The tool drives the distal opening of the tube into tissue, and the driver drives the tissue-engaging element of the anchor out of the opening and into the tissue while the opening remains submerged in the tissue.

In some applications, the tissue anchor has a head and a plurality of tissue-engaging elements configured to be driven linearly into tissue in which they move toward each other, pressing a tissue-facing side of the head against the tissue. The head may define a clamping portion such that movement of the tissue-engaging elements toward each other presses the clamping portion against the tissue. For some such applications, each tissue-engaging element defines a lateral barb, and the barbs may become exposed as the tissue-engaging elements are moved toward one another.

In some applications, the tether handling device is used to lock tension in the tether, for example, before the excess tether is cut and removed. For example, the tether handling device may include a clamp that clamps onto the tether. The tether handling device may also be configured to manage (e.g., move, limit, cover, and/or conceal) a remaining portion of the tether left after cutting, e.g., to reduce the likelihood of the cutting end damaging adjacent tissue.

In some applications, the tether steering device acts as a stop (or fastener) configured to lock onto the tether of a tissue modification implant that includes a plurality of anchors near the final tissue anchor of the tissue modification implant. When locked to the tether, the tether steering device is configured to limit movement of the tether relative to the final tissue anchor. Thus, if the tether handling device is locked to the tether after tension is applied to the tether, the tether handling device locks the tension in the tether.

Some applications relate to tensioners that include a spring and a restraint. The constraining member constrains the spring in an elastically deformed (i.e., strained) state, but is bioabsorbable at a given rate. Thus, after the constraint is decomposed in the body of the subject (e.g. after a predetermined duration after implantation), it stops constraining the spring and the spring moves away from its elastically deformed state, for example towards its rest state. The spring is coupled to at least one tether between the two anchors such that such movement of the spring pulls the tethers (e.g., applies tension to the tethers) pulling the anchors toward each other. This delayed application of tension to the tether is assumed to allow physiological processes (such as tissue restoration and growth) to enhance the anchoring of the anchor before increasing the tension to a degree that achieves the desired tissue adjustment when the tether is under a smaller amount of tension.

Some applications relate to anchor handling assemblies that may be used to transluminally de-anchor a tissue anchor from tissue of a subject and remove the anchor from the subject. Each of these anchor handling assemblies may include a sleeve and a tool. The distal end of the sleeve may be advanced over the head of the anchor, and then the jaws of the tool may be advanced within the sleeve and engaged with the anchor head of the anchor. The inner dimension of the distal portion of the sleeve may be such that it holds the jaws in a closed state, and the tool may be configured such that the jaws may lock to an interface of the anchor head when in the closed state, e.g., a snap fit. The tool may then de-anchor the anchor, which is then removed from the subject using the anchor handling assembly.

Some applications involve an anchor driver having a driver head that locks to a driver interface of the anchor by laterally moving a portion of the driver head and, for example, into a recess defined by the driver interface. For example, the fins may be pushed laterally by a rod extending distally between the fins. Alternatively, the cam of the driver head may be coupled to a distal portion of a rod that extends through the shaft of the driver, and the rod is eccentric relative to the shaft such that rotation of the shaft causes the cam to rotate and protrude laterally from the shaft.

In some applications, systems, devices, and techniques are described for use with an implant comprising a plurality of anchors threaded on a tether, whereby after anchoring the anchors to tissue, the anchors are added to the tether and anchored, or de-anchored and removed from between other anchors, from the tether. In some applications, a magnet is provided in the head of each anchor to facilitate navigation to the anchor. In some applications, the anchor head includes a shackle that facilitates this by allowing the tether to move laterally through the opening of the shackle without requiring axial passage of the tether, which would require the anchor head to instead include a conventional eyelet.

According to some applications, a system for use with a subject is provided, comprising a catheter device comprising a tube and an extracorporeal unit. The tube may have a distal opening configured to be transluminally advanced into the subject and a proximal end defining a proximal opening. The extracorporeal unit may be coupled to the proximal end of the tube and/or may define a deployment location. The extracorporeal unit may include a track leading to the deployed position, and/or a barrier movable between (i) a closed state in which the barrier obstructs the proximal opening, and (ii) an open state. In some applications, the rails are not used and the cartridge body can be moved into place by other means, such as, for example, attachment by hand, rotation into place, etc.

The system may also include a series of anchors.

In some applications, the system includes a series of cartridge bodies, each of which holds a respective anchor of the series of anchors and is coupled to the extracorporeal unit at a respective initial position of the series of initial positions. Each of the cartridge bodies can be configured to be movable along the track from the respective initial position to the deployed position (or otherwise movable to a deployed position, e.g., if no track is included) while remaining coupled to the extracorporeal unit, such that (i) in the deployed position the cartridge body holds the respective anchor opposite the proximal opening, and (ii) the barrier is in its closed state.

The system can further include an anchor driver configured, for each of the anchors, to (i) engage the anchor when the anchor is held opposite the proximal opening by the respective cartridge body in the deployed position, and (ii) apply a force to the anchor when engaged to the anchor that transitions the barrier to its open state. For each of the anchors, the anchor driver can be configured to push the anchor distally out of the respective cartridge body, through the proximal opening, and through the tube toward the distal opening while the barrier is held in its open state.

In some applications, the force is an engagement nuclear force that challenges engagement of the anchor by the anchor driver.

In some applications, the barrier is configured to move from its closed state to its open state by pivoting.

In some applications, the force is a proximal pulling force, and for each of the anchors, the anchor driver is configured to apply the proximal pulling force to the anchor when engaged with the anchor.

In some applications, the system is configured to define a threshold magnitude of the force, the barrier transitioning to the open state in response to the force only after the force exceeds the threshold magnitude.

In some applications, for each of the cartridge bodies, the cartridge body is configured to undergo a conformational change in response to the force, and the anchor driver is configured to transition the barrier to its open state by applying the force to the respective anchor to cause the conformational change.

In some applications, the barrier is biased toward being in its open state.

In some applications, the extracorporeal unit includes a spring-loaded displacement mechanism configured to transition the barrier to its open state in response to the force applied to the anchor by the anchor driver.

In some applications, each of the cartridge bodies is configured to lock to the extracorporeal unit upon reaching the deployment position.

In some applications, each of the cartridge bodies is shaped to be grasped by a human operator with a hand and configured to be moved by the operator with a hand along the track.

In some applications, the catheter device further comprises a port at the proximal opening of the tube. In some applications, the system further comprises a flush adapter comprising a fluid fitting, a nozzle, and a channel therebetween. In some applications, the flush adapter may be reversibly lockable to the extracorporeal unit in a flush position in which (i) the fluid fitting is accessible from outside the catheter device, and (ii) the nozzle is in fluid communication with the port such that fluid driven into the flush adapter via the fluid fitting is directed distally through the tube.

In some applications, in the irrigation position, the barrier is in its open state and the channel extends distally through the barrier.

In some applications, the flush position substantially coincides with the deployment position.

In some applications, the fluid fitting is a luer fitting.

In some applications, the port includes a sealing membrane, and for each of the anchors, the anchor driver is configured to advance the anchor distally through the membrane and into the tube.

In some applications, in the irrigation position, the nozzle is sealed proximally from the membrane with the port.

In some applications, the port has a tapered inner wall defining a lumen proximal to the membrane, the lumen of the port tapering distally toward the membrane.

In some applications, the nozzle is sized such that when the irrigation adapter is locked to the extracorporeal unit in the irrigation position, the nozzle seals against the tapered inner wall proximal to the membrane.

In some applications, the membrane is shaped to define a first aperture through the membrane, a second aperture through the membrane, and a closed slit connecting the first aperture and the second aperture.

In some applications, the first orifice is wider in diameter than the second orifice

In some applications, the first orifice is 3-10 times the second orifice.

In some applications, each of the anchors includes a tissue-engaging element. In some applications, each of the anchors includes a head including an eyelet. In some applications, the ports are arranged such that, for each of the cartridge bodies, when the cartridge body is in the deployed position and holds the respective anchor opposite the proximal opening: (i) The tissue-engaging element of the respective tissue anchor is aligned with the first aperture, thereby defining an anchor advancement axis from the respective tissue anchor through the first aperture and through the tube, and (ii) the aperture of the respective tissue anchor is aligned with the second aperture. The tissue-engaging element may be the same as or similar to the other tissue-engaging elements described herein.

In some applications, the system further comprises a platform, and the proximal end of the tube defines a longitudinal axis. In some applications, the extracorporeal unit is configured to be mounted on the platform in a manner that facilitates rotation of the extracorporeal unit about the longitudinal axis. In some applications, the extracorporeal unit is rotationally fixed to the tube such that rotation of the extracorporeal unit about the longitudinal axis rotates the tube.

In some applications, the system defines a series of discrete rotational orientations of the extracorporeal unit about the longitudinal axis, and the extracorporeal unit is configured to mount on the platform in a manner that facilitates orienting the extracorporeal unit in each of the discrete rotational orientations.

In some applications, the system further comprises at least one stop pin configured to secure the extracorporeal unit in each of the discrete rotational orientations.

In some applications, the at least one retaining pin is configured to secure the extracorporeal unit in each of the discrete rotational orientations by providing a snap fit of the extracorporeal unit in each of the discrete rotational orientations.

In some applications, the extracorporeal unit defines a series of recesses corresponding to the series of discrete rotational orientations. In some applications, the at least one retaining pin is configured to secure the extracorporeal unit on each of the discrete rotational orientations by protruding into a corresponding recess for each of the discrete rotational orientations.

In some applications, the system further comprises a bracket, the extracorporeal unit being configured to be mounted on the platform via a coupling between the bracket and the platform. In some applications, the extracorporeal unit is rotatably coupled to the bracket in a manner that facilitates rotation of the extracorporeal unit about the longitudinal axis. In some applications, the at least one stop pin is configured to secure the extracorporeal unit in each of the discrete rotational orientations by preventing rotation of the extracorporeal unit relative to the bracket when the extracorporeal unit is disposed in any of the discrete rotational orientations.

In some applications, the at least one retaining pin is spring loaded.

In some applications, for each of the cartridge bodies, the barrier is configured to transition to its closed state in response to movement of the cartridge body toward the deployed position.

In some applications, for each of the cartridge bodies, the barrier is configured to transition to its closed state in response to the cartridge body reaching the deployed position.

In some applications, for each of the cartridge bodies, the cartridge body is configured to urge the barrier toward its closed state upon the cartridge body reaching the deployed position.

In some applications, for each of the cartridge bodies, the cartridge body comprises a first component and a second component that (i) retains the respective anchor, (ii) defines a face that urges the barrier toward the closed state after the cartridge body reaches the deployed position, and (iii) is configured such that when the cartridge body is retained in the deployed position with the barrier in the closed state, application of the force to the respective anchor displaces the face such that the barrier responsively transitions to its open state.

In some applications, the cartridge body is configured such that when the cartridge body is held in the deployed position with the barrier in the closed state, application of the force to the respective anchors moves the facing proximally. In some applications, the barrier is configured to transition to the open state in response to the proximal-facing movement.

In some applications, the face is defined by the second component and the cartridge body is configured such that when the cartridge body is held in the deployed position with the barrier in the closed state, application of the force to the respective anchors displaces the face by sliding the second component relative to the first component.

In some applications, for each of the cartridge bodies, the cartridge body is coupled to the extracorporeal unit via a coupling between the first component and the extracorporeal unit.

In some applications, the second component is mounted inside the first component.

In some applications, the first component is shaped to be grasped by a human operator with a hand.

In some applications, each of the cartridge bodies is removable from the deployment position such that the deployment position empties for successive cartridge bodies in the series.

In some applications, each of the cartridge bodies is removable from the deployment position by removal from the extracorporeal unit.

In some applications, for each of the anchors, the anchor driver is configured to push the anchor distally out of the respective cartridge body, through the proximal opening, and through the tube toward the distal opening while the respective cartridge body is held in the deployed position.

In some applications, for each of the cartridge bodies, the cartridge body is configured such that the anchor driver prevents removal of the cartridge body from the deployed position when (i) the cartridge body is held at the deployed position and (ii) the anchor driver extends distally beyond the cartridge body and through the tube toward the distal opening.

In some applications, each of the anchors includes a tissue-engaging element and a head including an eyelet. In some applications, the system further comprises a tether (e.g., wire, ribbon, rope, braid, shrink member, suture, etc.) that passes through the eyelet of each of the anchors, has a proximal portion comprising a proximal end of the tether, and has a distal portion comprising a distal end of the tether. In some applications, the distal end of the tether may be advanced distally through the tube into the subject while the proximal end of the tether remains external to the subject. The tissue-engaging element may be the same as or similar to the other tissue-engaging elements described herein.

In some applications, the tube defines a lateral slit extending proximally from the distal end of the tube, and the lateral slit is sized to allow the tether, rather than the anchor, to exit the tube proximally from the distal end of the tube.

In some applications, the tube is shaped to define a narrowed entrance into the lateral slit, the narrowed entrance being configured to prevent, but not preclude, the tether from exiting the lateral slit distally through the narrowed entrance.

In some applications, the tube includes a tip frame that maintains the lateral slit and the narrowed entrance.

In some applications, the tip frame is resilient.

In some applications, for each of the anchors: (i) the tissue-engaging element defines a central longitudinal axis of the anchor, has a sharpened distal tip, and is configured to be driven into tissue of a subject, (ii) the head is coupled to a proximal end of the tissue-engaging element, and further comprises an interface configured to be reversibly engaged by the anchor driver, and (iii) the eyelet is mounted so as to be rotatable about the central longitudinal axis of the anchor.

In some applications, for each of the anchors, the eyelet: (i) defining an aperture and a sliding axis through the aperture, (ii) being laterally disposed from the central longitudinal axis of the anchor, thereby defining an eyelet axis orthogonal to the central longitudinal axis, and (iii) being mounted so as to be rotatable about the eyelet axis in a manner that constrains the sliding axis to be orthogonal to the eyelet axis.

In some applications, for each of the anchors, the eyelet: (i) defining an aperture and a sliding axis through the aperture, (ii) being laterally disposed from the central longitudinal axis of the anchor, and (iii) mounted so as to be pivotable about the central longitudinal axis while the sliding axis remains constrained to be orthogonal to the eyelet axis.

In some applications, the interface is disposed on the central longitudinal axis of the anchor.

In some applications, the tissue-engaging element is helical, defines the central longitudinal axis by extending in a helical fashion about and along the central longitudinal axis, and is configured to screw into the tissue of the subject.

In some applications, the head includes a collar surrounding the central longitudinal axis and rotatably coupled to the tissue-engaging element, and the eyelet is mounted on the collar and rotatable about the central longitudinal axis by rotation of the collar about the central longitudinal axis.

In some applications, the system further comprises a series of tubular spacers threaded on the tether alternating with the anchors.

In some applications, each of the spacers is resiliently flexible in terms of deflection.

In some applications, each of the spacers comprises a rigid ring at each end of the tubular spacer.

In some applications, each of the spacers resists axial compression.

In some applications, each of the spacers is defined by a spiral wire shaped as a coil.

In some applications, for each of the anchors, the anchor driver is configured to push the anchor distally out of the respective cartridge body, through the proximal opening, and through the tube toward the distal opening while the eyelet of the anchor remains threaded on the tether.

In some applications, the catheter device further comprises a port at the proximal opening of the tube, the port comprising a membrane. In some applications, the membrane is shaped to define a first aperture through the membrane, a second aperture through the membrane, and a closed slit connecting the first aperture and the second aperture. In some applications, the ports are arranged such that, for each of the anchors, the anchor driver is configured to push the anchor distally from the respective cartridge body and through the membrane, with the tissue engaging element passing through the first aperture and the tether extending through the second aperture.

In some applications, the catheter device further comprises a tensioner comprising a spring-loaded capstan coupled to the proximal portion of the tether and configured to maintain tension on the tether.

According to some applications, there is provided a method for use with a catheter device, the method comprising (i) transluminally advancing a distal portion of a tube of the catheter device to a heart of a subject, the catheter device comprising an extracorporeal unit coupled to a proximal end of the tube, a cartridge body coupled to the extracorporeal unit at an initial position and holding an anchor; and (ii) sliding the cartridge body along a track from the initial position to a deployed position in which the cartridge body holds the anchors opposite the proximal opening of the catheter, the extracorporeal unit including a barrier that obstructs the proximal opening. In some applications, the rails are not used and the cartridge body can be moved into place by other means, such as, for example, attachment by hand, rotation into place, etc.

The method may further include subsequently opening the barrier by applying a force to the anchor using an anchor driver engaged with the anchor.

The method may further include, after opening the barrier, pushing the anchor distally out of the cartridge body, through the proximal opening, and through the tube toward the distal portion of the tube using the anchor driver.

According to some applications, a system for use with a subject is provided, comprising a catheter device comprising a tube and an extracorporeal unit. The tube may have a proximal opening and a distal opening configured to be transluminally advanced into the subject. The extracorporeal unit may include a track leading to the deployed position, and/or a barrier movable between (i) a closed state in which the barrier obstructs the proximal opening, and (ii) an open state.

The system may further include a first cartridge body holding a first anchor and coupled to the extracorporeal unit and movable along the track from a first initial position to the deployed position while remaining coupled to the extracorporeal unit such that: (i) The first cartridge body holds the first anchor opposite the proximal opening, and (ii) the barrier in its closed state.

The system can further include a second cartridge body that retains a second anchor and is coupled to the extracorporeal unit and is movable along the track from a second initial position to the deployed position while remaining coupled to the extracorporeal unit such that (i) the second cartridge body retains the second anchor opposite the proximal opening and (ii) the barrier is in its closed state.

The system can further include an anchor driver that is (i) coupleable to the first anchor while the first anchor is held by the first cartridge body opposite the proximal opening, and/or (ii) configured to push the first anchor distally out of the first cartridge body, through the proximal opening, and through the tube when the barrier is in its open state. The anchor driver may then be coupleable to the second anchor while the second anchor is held by the second cartridge body opposite the proximal opening, and/or configured to push the second anchor distally out of the second cartridge body, through the proximal opening, and through the tube toward the first anchor when the barrier is in its open state.

In some applications, the driver is configured to, when: (i) the first cartridge body is in the deployed position, (ii) the barrier is in its open state, and (iii) the second cartridge body is held in the second initial position, pushing the first anchor distally out of the first cartridge body, through the proximal opening, and through the tube.

In some applications, each of the first cartridge body and the second cartridge body is configured to lock to the extracorporeal unit upon reaching the deployed position.

In some applications, each of the first cartridge body and the second cartridge body is shaped to be grasped by a human operator with a hand and configured to be moved along the track by the human operator with a hand.

In some applications, the rails are not used and the cartridge body can be moved into place by other means, such as, for example, attachment by hand, rotation into place, etc.

In some applications, each of the first cartridge body and the second cartridge body is removable from the deployed position by removal from the extracorporeal unit.

In some applications, the system further comprises a third cartridge body that holds a third anchor and is coupled to the extracorporeal unit and is movable along the track from a third initial position to a deployed position while remaining coupled to the extracorporeal unit such that the third cartridge body holds the third anchor opposite the proximal opening.

In some applications, the first anchor comprises a first tissue-engaging element and a first head comprising a first eyelet, and the second anchor comprises a second tissue-engaging element and a second head comprising a second eyelet. The first tissue-engaging element and the second tissue-engaging element may be the same or similar to other tissue-engaging elements described herein.

In some applications, the system further comprises a tether (e.g., wire, ribbon, rope, braid, shrink member, suture, etc.) passing through the first and second eyelets, the tether having a proximal portion comprising a proximal end of the tether and having a distal portion comprising a distal end of the tether, the distal end of the tether being distally advanceable through the tube into the subject while the proximal end of the tether remains external to the subject.

In some applications, the anchor driver is configured to push the first anchor distally out of the first cartridge body, through the proximal opening, and through the tube while the first eyelet of the first anchor remains threaded on the tether, and the anchor driver is configured to push the second anchor distally out of the second cartridge body, through the proximal opening, and through the tube while the second eyelet of the second anchor remains threaded on the tether.

In some applications, the catheter device further comprises a tensioning device configured to maintain tension on the tether during advancement of the first anchor and advancement of the second anchor.

In some applications, the tensioning device includes a spring and a spool coupled to the spring such that rotation of the spool in a first direction applies a stress to the spring, and the proximal portion of the tether is wound on the spool such that distal advancement of the distal portion of the tether through the tube rotates the spool in the first direction.

According to some applications, a system for use with a subject is provided, the system comprising a catheter device comprising a tube and an extracorporeal unit. The tube may have a distal opening configured to be advanced transluminally to tissue of the subject, and/or a proximal portion defining a longitudinal tube axis. The extracorporeal unit may be coupled to the proximal portion of the tube.

The system may further include a series of anchors, each of the anchors including (i) a tissue-engaging element, and/or a head coupled to the proximal end of the tissue-engaging element and including a hub and an eyelet. The tissue-engaging element may be the same as or similar to the other tissue-engaging elements described herein.

The system may further include a tether (e.g., wire, ribbon, rope, braid, shrink member, suture, etc.) that passes through the eyelet of each of the anchors.

The system may further include an anchor driver configured, for each of the anchors, to (i) engage the hub of the anchor, and/or (ii) advance the anchor distally through the tube toward the distal opening and drive the tissue engaging element into the tissue when engaged with the anchor.

The system may also include a platform. The system may define a series of discrete rotational orientations of the extracorporeal unit about the longitudinal tube axis. The extracorporeal unit is configured to be mounted on the platform in a manner that facilitates rotation of the extracorporeal unit about the longitudinal tube axis so as to be oriented in any of the discrete rotational orientations. The extracorporeal unit is rotatably fixed to the tube such that rotation of the extracorporeal unit about the longitudinal tube axis rotates the tube.

In some applications, the tether has a proximal end and a distal end, the distal end being distally advanceable through the tube into the subject while the proximal end of the tether remains external to the subject.

In some applications, the tube defines a lateral slit extending proximally from the distal end of the tube. In some applications, the lateral slit is sized to allow the tether, rather than the anchor, to exit the tube proximally and laterally from the distal end of the tube.

In some applications, the tube includes a tip frame that maintains the narrowing slit and the narrowing inlet.

In some applications, the tip frame is resilient.

In some applications, the at least one retaining pin is spring loaded.

In some applications, the system further comprises a bracket, the extracorporeal unit being configured to be mounted on the platform via a coupling between the bracket and the platform. In some applications, the extracorporeal unit is rotatably coupled to the stent in a manner that facilitates rotation of the extracorporeal unit about the longitudinal tube axis. In some applications, the at least one stop pin is configured to secure the extracorporeal unit in each of the discrete rotational orientations by preventing rotation of the extracorporeal unit relative to the bracket when the extracorporeal unit is disposed in any of the discrete rotational orientations.

In some applications, each of the spacers resists axial compression.

In some applications, for each of the anchors: (i) The tissue-engaging element defines a central longitudinal anchor axis of the anchor, and (ii) the eyelet is mounted so as to be rotatable about the central longitudinal anchor axis.

In some applications, for each of the anchors, the eyelet: (i) defining an aperture and a sliding axis through the aperture, (ii) being laterally disposed from the central longitudinal anchor axis, thereby defining an eyelet axis orthogonal to the central longitudinal anchor axis, and (iii) being mounted so as to be rotatable about the eyelet axis in a manner that constrains the sliding axis to be orthogonal to the eyelet axis.

In some applications, for each of the anchors, the eyelet: (i) defining an aperture and a sliding axis through the aperture, (ii) being laterally disposed from the central longitudinal anchor axis, and (iii) being mounted so as to be pivotable about the central longitudinal anchor axis while the sliding axis remains constrained to be orthogonal to the eyelet axis.

In some applications, the tissue-engaging element is helical, defines the central longitudinal anchor axis by extending in a helical fashion about and along the central longitudinal anchor axis, and is configured to screw into the tissue of the subject.

According to some applications, a system for use with a subject is provided, the system comprising a catheter device comprising a tube and an extracorporeal unit coupled to a proximal portion of the tube. The tube may have a distal opening configured to be transluminally advanced to tissue of the subject. The proximal portion of the tube may define a longitudinal tube axis.

The system may define a series of discrete rotational orientations of the extracorporeal unit about the longitudinal tube axis.

The system may include a platform on which the extracorporeal unit is configured to be mounted in a manner that facilitates rotation of the extracorporeal unit about the longitudinal tube axis so as to be oriented in any of the discrete rotational orientations.

The extracorporeal unit is rotatably fixed to the tube such that rotation of the extracorporeal unit about the longitudinal tube axis rotates the tube.

In some applications, the system further comprises a series of anchors, each of the anchors being advanceable through the tube and comprising a tissue-engaging element and a head coupled to the proximal end of the tissue-engaging element. The tissue-engaging element may be the same as or similar to the other tissue-engaging elements described herein.

In some applications, the head of each of the anchors includes a hub and an eyelet, and the system further includes a tether (e.g., wire, strand, band, rope, braid, shrink member, suture, etc.) that passes through the eyelet of each of the anchors.

In some applications, the system further comprises an anchor driver for each of the anchors, the anchor driver configured to engage the hub of the anchor and, when engaged with the anchor, advance the anchor distally through the tube toward the distal opening and drive the tissue engaging element into the tissue.

According to some applications, a method for use with a heart of a subject is provided, the method comprising transluminally advancing a distal portion of a tube of a catheter device of a system to the heart. The catheter device includes an extracorporeal unit coupled to the proximal portion of the tube, the proximal portion of the tube defining a longitudinal tube axis. In some applications, the system further includes a series of anchors, a tether (e.g., wire, ribbon, rope, braid, shrink member, suture, etc.) passing through the eyelets of each of the anchors, an anchor driver, and a platform.

In some applications, the extracorporeal unit is mounted on the platform in a manner that defines a series of discrete rotational orientations of the extracorporeal unit about the longitudinal tube axis.

In some applications, the method includes, when the extracorporeal unit is in a first one of the discrete rotational orientations, and using an anchor driver, advancing a first anchor in the series distally through the tube toward the distal opening, and anchoring the first anchor to a first site of tissue of the heart

In some applications, the method includes subsequently rotating the tube by a predetermined rotation angle by rotating the extracorporeal unit to a second of the discrete rotational orientations.

In some applications, the method includes, subsequently, while the extracorporeal unit remains in the second one of the discrete rotational orientations, and using the anchor driver, advancing a second anchor in the series distally through the tube toward the distal opening and over and along the tether, and anchoring the second anchor to a second site of tissue of the heart.

In some applications, the method further comprises subsequently pulling the first anchor and the second anchor toward each other by applying tension to the tether.

According to some applications, a system for use with a subject is provided, the system comprising a catheter device comprising a tube and an extracorporeal unit. The tube may have (i) a proximal portion including a proximal end, (ii) a distal portion configured to be transluminally advanced to tissue of the subject, and (iii) an intermediate portion extending between the proximal portion and the distal portion. The extracorporeal unit may be coupled to the proximal portion of the tube. The distal portion of the tube may define a lumen, a distal opening, and a lateral slit extending proximally from the distal opening. The distal portion of the tube may be rotatably coupled to the intermediate portion such that the lateral slit may swivel around the lumen.

The system may further include a series of anchors, each of the anchors including (i) a tissue-engaging element, and (ii) a head coupled to the proximal end of the tissue-engaging element and including a hub and an eyelet.

The system may further include an anchor driver for each of the anchors, the anchor driver configured to (i) engage the hub of the anchor and/or, when engaged with the anchor, advance the anchor distally through the tube toward the distal portion and drive the tissue engagement element into the tissue.

Each of the anchors may be sized to be pushed distally out of the lumen via the distal opening by the anchor driver. The lateral slit may be sized to allow the tether, but not the anchor, to exit the lumen laterally through the slit.

In some applications, the distal portion is shaped to define a narrowed entrance into the lateral slit, the narrowed entrance being configured to prevent, but not preclude, the tether from exiting the lateral slit distally through the narrowed entrance.

In some applications, each of the spacers resists axial compression.

According to some applications, a system and/or apparatus is provided that includes a tissue anchor including a helical tissue-engaging element and a head. The tissue-engaging element may have a proximal turn and a distal turn defining a sharpened distal tip. The tissue-engaging element may extend helically about a central anchor axis of the tissue anchor. The head may include a core, a flange, and/or a cap. The core may be disposed on the central longitudinal axis. The flange may be secured to the core and may have a proximally facing surface. The proximal turn of the tissue-engaging element may be located on the proximally-facing surface of the flange. The cap may be secured to the core in a manner that secures the tissue-engaging element to the head by clamping the proximal turn on the proximally-facing surface of the flange.

In some applications, the cap is secured to the core via complementary threads defined by the cap and the core.

In some applications, the flange is a first flange, the cap is shaped to define a second flange, and the cap is secured to the core in a manner that secures the tissue-engaging element to the head by sandwiching the proximal turn between the second flange and the proximally-facing surface of the first flange.

In some applications, the flange is shaped such that the proximally facing surface is inclined relative to the central anchor axis.

In some applications, the flange is shaped such that the proximally facing surface defines a partial spiral.

In some applications, the tissue-engaging element has a second turn distal next to the proximal turn, and the flange is disposed between the proximal turn and the second turn.

In some applications, the flange protrudes laterally beyond the core.

In some applications, the flange protrudes radially beyond the core.

In some applications, the device further comprises a washer, and the cap is secured to the core in a manner that secures the tissue-engaging element to the head by sandwiching the proximal turn between the washer and the proximally-facing surface of the flange.

In some applications, the proximal turn has a recess therein, the washer is shaped to define a protrusion, and the cap is secured to the core in a manner that secures the tissue-engaging element to the head by sandwiching the proximal turn between the washer and the proximally-facing surface of the flange, with the protrusion disposed in the recess.

In some applications, the core is shaped as a post and the cap is shaped to define a cavity in which the post is disposed.

In some applications, the head further comprises: (i) A collar disposed axially between the flange and the cap, surrounding and rotatable about the post, and (ii) an eyelet mounted on the collar and rotatable about the central anchor axis by rotation of the collar about the post.

In some applications, the cap defines a tubular wall defining the cavity, and the tubular wall is coaxially disposed between the post and the collar.

In some applications, the cap is secured to the core in a manner that secures the tissue-engaging element to the head by sandwiching the proximal turn between a distal end of the tubular wall and the proximally-facing surface of the flange.

According to some applications, a method for manufacturing a tissue anchor is provided, the anchor comprising a head and a helical tissue-engaging element, the method comprising placing a proximal turn of the helical tissue-engaging element on a proximally-facing surface of a flange of the head. In some applications, the head includes a core disposed on a central anchor axis of the tissue anchor, and the tissue-engaging element extends helically around the central anchor axis and has distal turns defining a sharpened distal tip. In some applications, the method includes clamping the proximal turn on the proximally facing surface of the flange by securing a cap to the core.

In some applications, securing the cap to the core includes screwing the cap onto the core.

In some applications, the flange is a first flange, the cap is shaped to define a second flange, and clamping the proximal turn on the proximally facing surface of the flange includes clamping the proximal turn between the second flange and the proximally facing surface of the first flange.

In some applications, clamping the proximal turn on the proximally facing surface of the flange includes clamping the proximal turn between a washer and the proximally facing surface of the flange by securing the cap to the core.

In some applications, the proximal turn has a recess therein, the washer is shaped to define a protrusion, and sandwiching the proximal turn between the washer and the proximally facing surface of the flange includes sandwiching the proximal turn between the washer and the proximally facing surface of the flange by securing the cap to the core such that the protrusion is disposed in the recess.

In some applications, the core is shaped as a post, the cap is shaped to define a cavity, and securing the cap to the core includes positioning the post in the cavity.

In some applications, the method further comprises axially positioning a collar between the flange and the cap such that the collar encircles the post and is rotatable about the post, the collar having an eyelet mounted thereon such that the eyelet is rotatable about the central anchor axis by rotation of the collar about the post.

In some applications, the cap defines a tubular wall defining the cavity, and securing the cap to the core includes coaxially positioning the tubular wall between the post and the collar.

In some applications, clamping the proximal turn on the proximally facing surface of the flange by securing a cap to the core includes clamping the proximal turn between a distal end of the tubular wall and the proximally facing surface of the flange by securing a cap to the core.

According to some applications, a system for use with a subject is provided, the system comprising a catheter device comprising a tube and an extracorporeal unit. The tube may have (i) a proximal portion including a proximal end, and (ii) a distal portion configured to be transluminally advanced to tissue of the subject. The extracorporeal unit may be coupled to the proximal portion of the tube.

The system may also include a fluoroscopic guide including a tab having a tip, a root, and a middle portion extending between the tip and the root.

At the root, the tab may be pivotably coupled to the distal portion of the tube in a manner that the tab is deflectable relative to the tube between (i) a retracted state in which the tab is substantially parallel to the tube and (ii) an extended state in which the tab extends laterally from the tube.

The intermediate portion may be radiopaque and flexible such that squeezing on the intermediate portion changes the curvature of the intermediate portion.

The fluoroscopic guide may further comprise a control rod extending from the distal portion of the tube to the tip of the tab such that (i) advancement of the control rod deflects the tab toward the extended state by pushing on the tip of the tab, and/or (ii) retraction of the control rod deflects the tab toward the retracted state by pulling on the tip of the tab.

In some applications, the fluoroscopic guide is configured such that advancement of the control rod deflects the tab toward the extended state by pushing the tip of the tab distally.

In some applications, the fluoroscopic guide is configured such that retraction of the control rod deflects the tab toward the extended state by pulling the tip of the tab proximally.

In some applications, the system further comprises an anchor and an anchor driver configured to advance the anchor distally through the tube toward the distal portion and drive the anchor into the tissue.

In some applications, the control rod extends from the extracorporeal unit along the tube to an exit point where the control rod extends from the tube to the tip of the fin.

In some applications, in the retracted state, the tip of the tab is disposed against the distal portion of the tube.

In some applications, in the retracted state, the tip of the airfoil is disposed proximally from the root of the airfoil.

In some applications, in the extended state, the fins extend from the tube to the end side.

In some applications, the distal portion of the tube includes a distal end of the tube, and the root of the tab is pivotably coupled to the distal portion of the tube at the distal end of the tube.

In some applications, the control rod is flexible such that advancement of the control rod to deflect the tab toward the extended state causes lateral deflection of the control rod away from the distal portion of the tube.

In some applications, the tab is pivotably coupled to the distal portion of the tube such that an angle of the tab between the retracted state and the extended state ranges from 80-160 degrees.

In some applications, the tab is pivotably coupled to the distal portion of the tube such that the angle of the tab between the retracted state and the extended state ranges from 90-140 degrees.

In some applications, the tab is pivotably coupled to the distal portion of the tube such that the angle of the tab between the retracted state and the extended state ranges from 100-130 degrees.

In some applications, in the extended state, the fins are disposed at 80-160 degrees relative to the tube.

In some applications, in the extended state, the fins are disposed at 90-140 degrees relative to the tube.

In some applications, in the extended state, the fins are disposed at 100-130 degrees relative to the tube.

According to some applications, a method is provided that includes transluminally advancing a distal portion of a tube of a catheter device to a heart of a subject, the catheter device including a fluoroscopic guide. In some applications, the fluoroscopic guide includes a tab having: (i) a tip, (ii) a root at which the fin is pivotably coupled to the distal portion of the tube, and (iii) a flexible intermediate portion extending between the tip and the root. In some applications, the fluoroscopic guide further comprises a control rod extending from the distal portion of the tube to the tip of the tab.

In some applications, the method further comprises placing the distal end of the tube against a tissue site of the heart near a valve of the heart. In some applications, the method includes deflecting the fins toward their extended state within the heart by advancing the control rod such that the control rod pushes the tips of the fins away from the tube.

In some applications, the method includes fluoroscopically observing a curvature of the intermediate portion while the distal end of the tube is held against the tissue site and the tab is held in its extended state.

In some applications, the method includes, in response to the observing, determining whether to drive an anchor into the tissue site.

In some applications, the method includes, in response to the determination, driving the anchor into the tissue site.

In some applications, deflecting the tab toward the extended state includes deflecting the tab toward the extended state by advancing the lever such that the lever pushes the tip of the tab distally.

In some applications, fluoroscopically observing the curvature includes fluoroscopically observing oscillations of the curvature.

In some applications, the catheter device includes an extracorporeal unit coupled to a proximal portion of the tube, and the control rod extends from the extracorporeal unit along the tube to an exit point at which the control rod extends from the tube to the tip of the fin. In some applications, the method includes deflecting the tab toward the extended state by pushing the lever includes deflecting the tab toward its extended state by pushing the lever from the extracorporeal unit.

In some applications, transluminally advancing the distal portion of the tube includes transluminally advancing the distal portion of the tube when the tab is in a retracted state in which the tip of the tab is disposed against the distal portion of the tube.

In some applications, transluminally advancing the distal portion of the tube includes transluminally advancing the distal portion of the tube when the fin is in a retracted state in which the tip of the fin is disposed proximally from the root of the fin.

In some applications, in the extended state, the fins extend from the tube to the end side, and deflecting the fins toward the extended state includes deflecting the fins toward the extended state in which the fins extend from the tube to the end side.

In some applications, the distal portion of the tube comprises a distal end of the tube, the root of the tab is pivotably coupled to the distal portion of the tube at a pivot point at the distal end of the tube, and deflecting the tab toward the extended state comprises deflecting the tab about the pivot point at the distal portion of the tube.

In some applications, the control rod is flexible, and advancing the control rod includes advancing the control rod such that the control rod laterally flexes away from the distal portion of the tube and pushes the tip of the tab away from the distal portion of the tube.

In some applications, the method further comprises, after the observing, deflecting the tab toward its retracted state by retracting the control lever such that the control lever pulls the tip of the tab toward the tube.

In some applications, deflecting the tab toward the retracted state includes deflecting the tab toward the retracted state by retracting the lever such that the lever pulls the tip of the tab proximally.

In some applications, the tissue site is a site on an annulus of the valve, and placing the distal end of the tube against the tissue site includes placing the distal end of the tube against the site on the annulus of the valve.

In some applications, deflecting the tab toward the extended state includes deflecting the tab toward the extended state such that the middle portion of the tab is pressed against a hinge of the valve where a leaflet of the valve is connected to the annulus.

In some applications, the method further comprises pressing the middle portion of the flap against a hinge of the valve where a leaflet of the valve is connected to the annulus.

In some applications, deflecting the airfoil toward the extended state includes deflecting the airfoil 80-160 degrees.

In some applications, deflecting the airfoil toward the extended state includes deflecting the airfoil 90-140 degrees.

In some applications, deflecting the airfoil toward the extended state includes deflecting the airfoil 100-130 degrees.

In some applications, in the extended state, the fins are disposed at 80-160 degrees relative to the tube, and deflecting the fins toward the extended state includes deflecting the fins such that the fins are disposed at 80-160 degrees relative to the tube.

In some applications, in the extended state, the fins are disposed at 90-140 degrees relative to the tube, and deflecting the fins toward the extended state includes deflecting the fins such that the fins are disposed at 90-140 degrees relative to the tube.

In some applications, in the extended state, the fins are disposed at 100-130 degrees relative to the tube, and deflecting the fins toward the extended state includes deflecting the fins such that the fins are disposed at 100-130 degrees relative to the tube.

According to some applications, there is provided a system and/or apparatus comprising an anchor for use with tissue of a subject, the anchor comprising: a housing having a tissue facing side defining a tissue facing opening from an interior of the housing to an exterior of the housing; and a tissue-engaging element shaped to define a helix having a plurality of turns about an axis and having a distal tip. The tissue-engaging element may be disposed within the housing (and may be axially compressible) and positioned such that rotation of the tissue-engaging element about the axis advances the spiral distally out of the tissue-facing opening. The tissue-engaging element may be configured to screw into the tissue and anchor the housing to the tissue, the tissue-facing side serving as a head of the anchor.

In some applications, the distal tip is sharpened.

In some applications, the anchor is configured such that screwing the tissue-engaging element into the tissue presses the tissue-facing side against the tissue.

In some applications, the housing side defines a clamping portion on the tissue facing side such that screwing the tissue engaging element into the tissue presses the clamping portion against the tissue.

In some applications, the anchor is configured such that screwing the tissue-engaging element into the tissue moves a proximal portion of the tissue-engaging element toward the tissue-facing side.

In some applications, the housing further has a driver side opposite the tissue facing side and defining a driver opening providing access to the interface from outside the housing, and the anchor is configured such that screwing the tissue engaging element into tissue moves the proximal portion of the tissue engaging element away from the driver side.

In some applications, the housing further has a driver side opposite the tissue facing side and defining a driver opening providing access to the interface from outside the housing, and the housing is configured to automatically retract when the spiral is distally fed out of the tissue facing opening such that the driver side follows the proximal portion of the tissue engaging element toward the tissue facing side.

In some applications, the anchor is configured such that screwing the tissue-engaging element into the tissue sandwiches the tissue-facing side between the tissue and the proximal portion of the tissue-engaging element.

In some applications, the tissue-engaging elements are configured such that when the spirals are fed out of the tissue-facing opening, the proximal portions of the spirals progressively expand axially as they are disposed outside the housing.

In some applications, when the spiral is disposed entirely within the housing, the spiral has a compressed pitch and a portion of the spiral disposed outside the housing has an expanded pitch that is at least twice the compressed pitch.

In some applications, the anchor includes an interface at a proximal portion of the tissue-engaging element, and the housing further has a driver side defining a driver opening from inside the housing to outside the housing, the driver opening providing access to the interface.

In some applications, the anchor is configured such that screwing the tissue-engaging element into the tissue moves the interface away from the driver side and toward the tissue-facing side.

In some applications, the anchor is configured such that screwing the tissue-engaging element into the tissue sandwiches the tissue-facing side between the tissue and the interface.

In some applications, the interface is rotationally locked with the spiral of the tissue-engaging element.

In some applications, the driver opening is disposed in front of the interface.

In some applications, the interface is visible through the driver opening.

In some applications, the interface includes a rod transverse to the axis and parallel to the driver opening.

In some applications, the driver side is opposite the tissue facing side.

In some applications, the system and/or apparatus further includes a driver having a driver head at a distal portion of the driver, the driver head sized to access the interface from outside the housing via the driver opening and configured to engage the interface and rotate the tissue-engaging element by applying torque to the interface.

In some applications, the driver head has an introduced state and a locked state; the anchor head is shaped to define a proximal opening through which the driver head may access the interface when the driver head is in the introduced state, and the anchor driver is configured to lock the driver head to the interface by laterally moving a portion of the driver head to transition the driver head to the locked state.

In some applications, the anchor driver includes a flexible shaft and a rod extending through the shaft, the anchor head is disposed at a distal end of the shaft, and the rod is configured to transition the driver head to the locked state by applying a force to the driver head.

In some applications, the driver head includes fins and the stem is configured to transition the driver head to the locked state by pushing distally between the fins such that the stem pushes the fins radially outward such that the fins lock to the interface.

In some applications, the fins are configured to lock to the interface via a friction fit when pushed radially outward by the stem.

In some applications, the driver head includes a cam, the lever is coupled to the cam, and is configured to transition the driver head to the locked state by rotating the cam such that at least a portion of the cam protrudes laterally.

In some applications, the rod is eccentric with respect to the shaft.

In some applications, the lever is eccentric with respect to the cam.

In some applications, in the introduced state, the cam is flush with the shaft.

In some applications, the anchor driver has a longitudinal axis defined by the shaft, and the shaft and the cam are circular in transverse cross-section.

In some applications, the interface is shaped to define a plurality of recesses, each recess being sized to receive the cam as the cam protrudes laterally.

According to some applications, there is provided a system and/or apparatus comprising a tissue anchor for use with an anchor driver, the tissue anchor comprising: a tissue-engaging element defining a central longitudinal axis of the anchor, having a sharpened distal tip, and configured to be driven into tissue of a subject; and an anchor head coupled to the proximal end of the tissue-engaging element. The anchor head may include a hub configured to be reversibly engaged by the anchor driver and an eyelet. The aperture defines an aperture and a sliding axis through the aperture and may be disposed laterally from the central longitudinal axis, thereby defining an aperture axis orthogonal to the central longitudinal axis. The eyelet may be mounted such that the eyelet is rotatable about the eyelet axis in a manner that constrains the sliding axis to be orthogonal to the eyelet axis.

In some applications, the eyelet is mounted such that the eyelet is pivotable about the central longitudinal axis while the sliding axis remains constrained to be orthogonal to the eyelet axis.

In some applications, the anchor head includes a collar surrounding the central longitudinal axis and rotatably coupled to the tissue-engaging element, and the eyelet is mounted on the collar and rotatable about the central longitudinal axis by rotation of the collar about the central longitudinal axis.

In some applications, the eyelet defines a flange disposed inside the collar, and a stem extending laterally through the collar and coupling the flange to the aperture.

In some applications, the collar is a closed collar defining a groove that supports the core pin.

In some applications, the collar is an open collar having free ends that together support the core pin.

In some applications, the aperture is shaped to define a first planar face and a second planar face, the aperture extending from the first planar face through the aperture to the second planar face, and the second planar face being opposite the first planar face.

In some applications, the systems and/or devices include an implant including the anchor and a tether (e.g., wire, ribbon, rope, braid, shrink member, suture, etc.) passing through the aperture.

In some applications, the first planar face is parallel to the aperture axis.

In some applications, the first planar face is orthogonal to the sliding axis.

In some applications, the first planar surface is parallel to the second planar surface.

In some applications, the aperture has an inner surface defining the aperture between the first planar face and the second planar face such that a narrowest portion of the aperture is intermediate the first planar face and the second planar face.

In some applications, the aperture defines the inner surface of the aperture as a hyperboloid.

In some applications, the eyelet defines the inner surface of the eyelet as a catenary surface.

In some applications, the anchor is a first anchor of the implant, the implant may further include a second anchor and a spacer or separator (e.g., rod, tube, solid wall tube, laser cut tube, coil, spring, etc.), the spacer or separator being tubular with two spacer ends and a lumen therebetween, and the spacer being threaded over the tether between the first anchor and the second anchor, wherein the tether passes through the spacer lumen.

In some applications, the spacer is resiliently flexible in terms of deflection.

In some applications, the spacer is generally not axially compressible.

In some applications, the spacer is defined by a helical wire shaped into a coil defining the spacer lumen.

In some applications, the spacer is configured to limit proximity between the first anchor and the second anchor.

In some applications, for each of the anchors, the eyelet is shaped to define two planar faces, the aperture extends through the eyelet between the planar faces, and the spacer is threaded on the tether between the first anchor and the second anchor such that one of the spacer ends faces one of the planar faces of the eyelet of the first anchor and the other of the spacer ends faces one of the planar faces of the eyelet of the second anchor, and each of the spacer ends is sized to abut flush against the planar face it faces.

In some applications, the system and/or apparatus further comprises the anchor driver.

In some applications, the anchor driver has a driver head having an introduced state and a locked state, the anchor head is shaped to define a proximal opening through which the driver head may access the interface when the driver head is in the introduced state, and the anchor driver is configured to lock the driver head to the interface by laterally moving a portion of the driver head to transition the driver head to the locked state.

In some applications, the driver head includes fins, and the stem is configured to transition the driver head to the locked state by pushing distally between the fins such that the stem pushes the fins radially outward such that the fins lock to the interface.

In some applications, the rod is eccentric with respect to the shaft.

In some applications, the lever is eccentric with respect to the cam.

In some applications, in the introduced state, the cam is flush with the shaft.

In some applications, the system and/or apparatus includes a delivery tool that includes the anchor driver and a percutaneously advanceable tube, and the anchor driver and the anchor are slidable through the tube when the anchor driver is engaged with the anchor.

In some applications, the tube defines an internal channel having a keyhole-shaped orthogonal cross-section defining a primary channel region and a secondary channel region, the primary channel region having a larger cross-sectional area than the secondary channel region, and the anchor is slidable through the channel, wherein the tissue engaging element slides tightly through the primary channel region and the eyelet slides tightly through the secondary channel region.

In some applications, the system and/or apparatus includes an implant including a tether and a tissue anchor, and the eyelet is shaped to facilitate simultaneous (i) tight sliding of the eyelet through a secondary channel region and (ii) smooth sliding of the eyelet over the tether when the tether is disposed within the secondary channel region and parallel to the central longitudinal axis.

In some applications, the anchor may be pushed out of a distal end of the tube, the tube defining a lateral slit extending proximally from the distal end of the tube, the slit being adjacent the secondary channel region, and the slit allowing the tether to exit the tube proximally from the distal end of the tube instead of the anchor.

In some applications, the systems and/or devices include an implant including a tether (e.g., wire, strand, ribbon, rope, braid, constriction member, suture, etc.) and the tissue anchor, and the eyelet is shaped to (i) facilitate smooth sliding of the tether through the aperture when the tether is parallel to the central longitudinal axis and (ii) when the tether is oriented orthogonal to the central longitudinal axis.

In some applications, the tether has a thickness and the narrowest portion of the aperture has a width no more than twice the thickness of the tether.

In some applications, the narrowest portion of the aperture is no more than 50% wider than the thickness of the tether.

In some applications, the narrowest portion of the aperture is no more than 20% wider than the thickness of the tether.

According to some applications, a system and/or apparatus is provided that includes an implant for use in a heart of a subject, the implant including a first anchor, a second anchor, at least one tether (e.g., wire, ribbon, rope, braid, constriction member, suture, etc.) coupling the first anchor to the second anchor, and a tensioner coupled to the at least one tether between the first anchor and the second anchor.

In some applications, the tensioner comprises a spring; and a restraining member that restrains the spring in an elastically deformed shape of the spring.

In some applications, the constraint is bioabsorbable such that after implantation of the implant within the heart, the decomposition of the constraint releases the spring from the constraint, and the spring is configured to automatically move away from the elastically deformed state toward the second shape upon release from the constraint.

In some applications, the coupling of the spring to the at least one tether is such that the movement of the spring away from the elastically deformed state toward the second shape pulls the first anchor and the second anchor toward each other via the at least one tether.

In some applications, the constraint comprises a suture. In some applications, the constraint comprises a strap.

In some applications, the constraint comprises a spacer or separator.

In some applications, the constraint constrains the spring by holding portions of the spring together.

In some applications, the constraint constrains the spring by keeping portions of the spring apart from each other.

In some applications, the first anchor is a tissue piercing anchor. In some applications, the first anchor is a clip.

In some applications, the spring is a tension spring. In some applications, the spring has a coiled configuration.

In some applications, the spring defines a cell, and movement of the spring away from the elastically deformed state toward the second shape includes the cell becoming smaller in a first dimension and larger in a second direction.

In some applications, the spring is a shortening spring (foreshortening spring), and movement of the spring away from the elastically deformed state toward the second shape includes shortening of the spring.

In some applications, the at least one tether (e.g., wire, ribbon, rope, braid, constriction member, suture, etc.) defines a path from the first anchor to the second anchor via the spring, and the coupling of the spring to the at least one tether is such that movement of the spring away from the elastically deformed state toward the second shape pulls the first anchor and the second anchor toward each other by introducing a meander to the path of the at least one tether.

In some applications, the constraint is a first constraint, the tensioner further comprises a second constraint, and the second constraint is configured to limit movement of the spring away from the elastically deformed state after release of the spring from the first constraint, thereby imposing a limit on pulling of the first and second anchors toward each other.

In some applications, the second constraint is bioabsorbable such that decomposition of the second constraint releases the spring from the second constraint, allowing the spring to further pull the first anchor and the second anchor toward each other beyond the limit.

In some applications, the first constraint is bioabsorbable at a first rate such that release of the spring from the first constraint occurs after a first duration of time after implantation of the implant into the heart, and the second constraint is bioabsorbable at a second rate such that release of the spring from the second constraint occurs after a second duration of time after implantation of the implant into the heart, the second duration of time being longer than the first duration of time.

In some applications, the first rate is such that the first duration is between 1 and 3 months.

In some applications, the second rate is such that the second duration is between 3 months and 1 year.

In some applications, the implant is an annuloplasty structure, the first and second anchors are configured to be driven into tissue of an annulus of a valve of the heart, and the implant is configured to reshape the annulus by pulling the first and second anchors toward each other.

In some applications, the at least one tether is a first at least one tether, the tensioner is a first tensioner, and the implant further comprises: a third anchor, a second at least one tether coupled to the third anchor, and a second tensioner coupled to the second at least one tether.

In some applications, the second at least one tether couples the third anchor to the second anchor, and the second tensioner is coupled to the second at least one tether between the third anchor and the second anchor.

In some applications, the at least one tether comprises: a first tether, the first tether tethering the first anchor to a first portion of the spring; and a second tether, the second tether being different from the first tether, and the second tether tethers the second anchor to a second portion of the spring, the first tether and the second tether thereby coupling the first anchor to the second anchor via the spring.

In some applications, the inter-part distance between the first and second parts is smaller in the second state than in the elastically deformed state.

According to some applications, there is provided a system and/or apparatus comprising an anchor for use with tissue of a subject, the anchor comprising: a sharp distal tip; a hollow body proximal to the distal tip; and a spring. The hollow body may be shaped to define a chamber, a sidewall surrounding the chamber, and one or more (e.g., two) ports in the sidewall. An anchor axis of the anchor may pass through the chamber and the tip. The spring may include an elongated element having one or more (e.g., two) ends, and the elongated element may define a loop therebetween. Typically, the ring is disposed at least within the chamber. In some applications, the anchor has a first state in which the spring is constrained by the side walls, and the anchor is transitionable from the first state to a second state in which the spring (e.g., an elongate element thereof) projects laterally from the hollow body via respective ones of the ports under less strain relative to the first state. In the second state, the ends may be disposed farther from each other than in the first state.

In some applications, the end is sharp.

In some applications, in the first state, the end does not protrude laterally from the hollow body.

In some applications, the anchor is configured such that the loop becomes smaller when the anchor transitions from the first state to the second state.

In some applications, the anchor is configured such that the ring moves axially within the chamber when the anchor transitions from the first state to the second state.

In some applications, the anchor further includes a head defining a hub configured to be reversibly engaged by the anchor driver.

In some applications, the system and/or apparatus further comprises a tether (e.g., wire, strand, ribbon, rope, braid, shrink member, suture, etc.), and the head defines an eyelet threaded onto the tether.

In some applications, in the first state, the end is disposed distally from the ring.

In some applications, in the second state, the end is disposed distally from the ring.

In some applications, in the second state, the end is disposed proximally from the ring.

In some applications, the system and/or apparatus further comprises a retainer, and the hollow body is shaped to define at least one window in the sidewall, and the retainer is configured to retain the anchor in the first state by extending through the window and into the loop.

In some applications, in the first state, each of the ends is disposed at the respective port, the anchors are configured such that the ring moves axially within the chamber when the anchors transition from the first state to the second state, and the retainer is configured to retain the anchors in the first state by preventing the ring from moving axially within the chamber.

In some applications, the hollow body is shaped to define two windows in the sidewall, the two windows being opposite each other and rotationally offset from the two ports.

In some applications, the retainer extends through one of the windows, through the ring, and out of the other of the windows.

In some applications, a port axis passes through the two ports and the anchor axis, and a window axis passes through the two windows and the anchor axis and is orthogonal to the port axis.

In some applications, the window is axially offset from the port.

According to some applications, a system and/or apparatus for use with tissue of a heart of a subject is provided, the system and/or apparatus including a tool and an anchor. The tool may be advanced transluminally to the heart and may include a tube having a distal end defining an opening; and a driver extending through at least a portion of the tube. The anchor may be at least partially disposed within the tube and include the tissue-engaging element, the anchor configured to anchor to the tissue by driving the tissue-engaging element into the tissue. The driver may extend through at least a portion of the tube, wherein a distal end of the driver is reversibly engaged with the anchor within the tube. The tool may be configured to penetrate the distal end of the tube into the tissue while the anchor remains at least partially disposed within the tube such that the opening is submerged within the tissue. The driver may be configured to drive the tissue-engaging element out of the opening and into the tissue when the opening is disposed within the tissue. The tissue-engaging element may be the same as or similar to the other tissue-engaging elements described herein.

In some applications, the distal end is tapered.

In some applications, the distal end is sharp.

In some applications, the anchor is disposed entirely within the tube.

In some applications, the anchor further comprises a head, the driver being reversibly engaged with the anchor by being reversibly engaged with the head.

In some applications, the system and/or apparatus further comprises a tether (e.g., wire, strand, ribbon, rope, braid, shrink member, suture, etc.), and the anchor further comprises a head defining an aperture through which the tether passes.

In some applications, at least a portion of the tissue-engaging element is constrained by the tube and configured to automatically change shape within the tissue upon exiting the opening.

In some applications, the portion of the tissue-engaging element is a tine.

In some applications, the portion of the tissue-engaging element is a flange.

In some applications, the flange comprises a polymer.

In some applications, the flange includes a sheet and a self-expanding frame supporting the sheet.

In some applications, a distal tip of the tissue-engaging element is disposed outside of the opening, and the tool is configured to penetrate the distal end of the tube into the tissue when the distal tip is disposed outside of the opening such that the opening is submerged within the tissue.

In some applications, the tissue-engaging element is shaped to fit snugly within the opening such that the tissue-engaging element blocks the opening when the tool penetrates the distal end of the tube into the tissue.

In some applications, the distal tip is sharpened, and the distal tip of the tissue-engaging element and the distal end of the tube together define a tapered point, the distal tip being a distal portion of the tapered point, and the distal end of the tube being a proximal portion of the tapered point.

In some applications, the tube defines a channel having a central channel region and lateral channel regions, and the anchor includes a head and tines, the head being disposed in the central channel region and each of the tines being disposed in a respective lateral channel region such that within the channel, the anchor is axially slidable but prevented from rotating.

In some applications, the channel is wider at the central channel region than at the lateral channel regions.

In some applications, the opening is defined through the channel to the distal end of the tube, and the opening is shaped to shape the distal end of the tube to resemble a beak.

According to some applications, a system and/or apparatus for use with tissue of a heart of a subject is provided, the system and/or apparatus comprising a tissue anchor comprising a head and a plurality of tissue engaging elements. The head may have a tissue facing side shaped to define a plurality of clamping portions, and may also have an opposite side defining an aperture. The tissue-engaging element may be disposed laterally from the clamping portion. Each of the tissue-engaging elements typically has a sharpened tip, a delivery state in which the tissue-engaging element is configured to be driven linearly into the tissue until the clamping portion contacts the tissue, and a clamping state. The tissue-engaging elements may be collectively configured such that when the plurality of tissue-engaging elements are disposed within the tissue with the clamping portion contacting the tissue, transition of the tissue-engaging elements toward the clamped state causes the tips to face each other and press the clamping portion against the tissue. The tissue-engaging element may be the same as or similar to the other tissue-engaging elements described herein.

In some applications, the plurality of tissue-engaging elements are collectively configured such that when the plurality of tissue-engaging elements are disposed within the tissue with the clamping portion contacting the tissue, transition of the tissue-engaging elements toward the clamped state squeezes the tissue between the plurality of tissue-engaging elements.

In some applications, each of the tissue-engaging elements has a deflecting portion and a stationary portion connecting the deflecting portion to the head, both the deflecting portion and the stationary portion being configured to be driven linearly into the tissue when the tissue-engaging element is in the delivery state, and the tissue-engaging element being configured such that (i) the stationary portion remains stationary relative to the head and (ii) the deflecting portion deflects relative to the stationary portion and relative to the head when the tissue-engaging element transitions toward the clamped state.

In some applications, the system and/or apparatus includes an implant comprising: the tissue anchor and a tether (e.g., wire, ribbon, rope, braid, shrink member, suture, etc.) passing through the eyelet.

In some applications, in the delivery state, each of the tissue-engaging elements has a medial side and a lateral side, the medial side being closer to the other tissue-engaging elements than the lateral side, and each of the tissue-engaging elements is shaped to define barbs on the lateral side.

In some applications, each of the tissue-engaging elements is configured such that in the delivery state the barb is covered and in the gripping state the barb is exposed.

In some applications, for each of the tissue-engaging elements, the barb is defined by the stationary portion.

In some applications, for each of the tissue-engaging elements, the barb is defined by the deflecting portion.

According to some applications, a system and/or device for use with tissue of a heart of a subject is provided, the system and/or device comprising: an anchor; a tether (e.g., wire, ribbon, rope, braid, shrink member, suture, etc.) coupled to the anchor; a tether handling device; and (3) a tool. The anchor is configured to anchor to the tissue, wherein the tether extends proximally from the anchor.

In some applications, the tether handling device may include a housing shaped to define a channel therethrough through which the tether extends in a manner that facilitates the housing to slide distally through a lumen to the anchor along the tether and over the tether. The tether handling device may further include a clamp coupled to the housing and biased to clamp onto the tether within the channel in a manner that prevents the housing from sliding relative to the tether.

In some applications, the tether steering device may further include an arm extending proximally from the housing, and the arm may include: a conduit shaped to receive a portion of the tether proximally from the housing, and a lever coupling the conduit to the housing.

In some applications, the lever may be biased to place the conduit in an offset position relative to the channel. The tool may comprise a tube.

In some applications, the system and/or apparatus may have a delivery state in which the tool is coupled to the tether handling device, wherein the tube is disposed within the channel in a manner that resists gripping by the grip, and is disposed within the tube in a manner that constrains the tube in a coaxial position relative to the channel. In some applications, in the delivery state, the tool is configured to transluminally distally advance the tether steering device over and along the tether toward the anchor.

In some applications, the conduit has open lateral sides.

In some applications, the tether extends out of a proximal side of the housing and the lever is biased to place the conduit against the proximal side of the housing.

In some applications, the bias of the clamp is such that, without the tube disposed in the channel, the clamp automatically clamps onto the tether within the channel in a manner that prevents the housing from sliding relative to the tether.

In some applications, in the delivery state, the tube is disposed within the channel and within the tube by extending distally through the tube and into the channel.

In some applications, the system and/or apparatus may transition from the delivery state to an intermediate state by proximally retracting the tube out of the channel rather than out of the tube.

In some applications, in the intermediate state, the distal portion of the tube remains disposed within the housing.

In some applications, the tether has sufficient tensile strength relative to the bias of the lever such that, without the tube disposed in the conduit, the lever may be prevented from moving the conduit to the biased position by proximally tensioning the tether from the clamp.

In some applications, the system and/or apparatus further comprises a cutter that is advanceable over and along the tether, axially movable relative to the tube, and configured to cut the tether proximally from the conduit.

In some applications, cutting the tether proximally from the tube triggers the lever to move the tube to the offset position as the tether is tensioned proximally from the clamp.

In some applications, the cutter is configured to cut the tether proximally from the conduit in a manner that causes the remaining portion of the tether to protrude proximally from the conduit, and the arm is configured such that the lever moving the conduit to the offset position pulls the remaining portion of the tether into the conduit.

In some applications, the tube may slide within the cutter.

According to some applications, a system and/or apparatus for use with a tether is provided that includes a clamp, which may include a chuck and a spring. The chuck may include a sleeve and a collet. The chuck may have a longitudinal axis, the sleeve encircling the longitudinal axis. The sleeve may have a tapered inner surface. In some applications, the collet is disposed within the sleeve and is sized to receive the tether therethrough. In some applications, the spring may push the collet axially against the tapered inner surface such that the collet is compressed inboard of the sleeve.

In some applications, the sleeve and the collet are concentric with the longitudinal axis.

In some applications, the spring is concentric with the longitudinal axis.

In some applications, the spring is a compression spring.

In some applications, the spring is helical.

In some applications, the spring surrounds the longitudinal axis, and the clamp is configured to be threaded onto the tether such that the sleeve, collet, and spring surround the tether.

In some applications, the sleeve has opposing surfaces and the spring is maintained under compression between the opposing surfaces and the collet.

In some applications, the system and/or apparatus further comprises the tether, and the clamp is configured to receive the tether through the collet and the sleeve, and the spring urges the collet axially against the tapered inner surface by urging the collet in a first axial direction relative to the sleeve such that the collet clamps the tether, thereby preventing the tether from sliding through the collet at least in the first axial direction.

In some applications, the grip is configured to facilitate sliding of the tether through the collet in a second axial direction by moving the tether in a second axial direction opposite the first axial direction by the sleeve pushing the collet axially away from the tapered inner surface, thereby reducing grip of the tether by the collet.

In some applications, the sleeve has opposing surfaces that the spring applies opposing forces to when the collet is pushed axially.

In some applications, the system and/or apparatus further comprises a tether, and the clip has a proximal end and a distal end, the tapered inner surface tapers toward the distal end, the chuck facilitates sliding of the clip along the tether in a distal direction in which the distal end directs the proximal end, and the chuck prevents sliding of the clip along the tether in a proximal direction in which the proximal end directs the distal end.

In some applications, the system and/or apparatus further includes a sheath extending proximally from the sleeve and resiliently coupled to the sleeve in the following manner: the sheath is retractable distally over the sleeve by applying a distally directed force to the sheath, and the sheath automatically re-extends proximally in response to removal of the distally directed force.

In some applications, the sheath is rigid.

In some applications, the system and/or apparatus further comprises a tool comprising a cutter configured to: the sheath is retracted distally over the sleeve by applying the distally directed force to the sheath. In some applications, the tool is configured to tension the tether by applying a proximally directed force to the tether while maintaining the distally directed force on the sheath such that the tether slides proximally through the collet. In some applications, the tool is configured to then cut the tether proximally from the sleeve in a manner that leaves a residual portion of the tether protruding proximally from the sleeve, and remove the distally directed force such that the sheath automatically re-extends proximally and encases the residual portion of the tether.

In some applications, the tool is configured to cut the tether proximally from the sleeve in a manner that leaves a residual portion of the tether protruding proximally from the chuck.

In some applications, the spring is a first spring and the clip further includes a second spring disposed laterally from the sleeve and providing a resilient coupling of the sheath to the sleeve.

In some applications, the sleeve defines a flange extending laterally from the sleeve, and the second spring is a compression spring disposed laterally from the sleeve such that application of the distally directed force to the sheath compresses the spring against the flange.

In some applications, the second spring is a coil spring.

In some applications, the second spring surrounds the sleeve.

According to some applications, a system and/or apparatus is provided that includes an implant configured to be implanted in a heart of a subject, the implant including a tether (e.g., wire, ribbon, rope, braid, constriction member, suture, etc.); an anchor slidably coupled to the tether and configured to anchor the tether to tissue of the heart; a spring; and a constraint. The spring has a resting state and may be coupled to the tether in a manner that applies tension to the tether as the spring moves toward the resting state. In some applications, the constraint may be coupled to the spring in a manner that prevents the spring from moving toward the resting state. The constraint may include a material (e.g., a bioabsorbable material) configured to decompose within the heart, and may be configured such that decomposition of the material reduces resistance of the constraint to the spring.

In some applications, the spring is a helical coil spring.

In some applications, the constraint is configured such that after a threshold amount of decomposition of the constraint, the constraint no longer blocks the spring, and the material is configured such that the threshold amount of decomposition is reached between 1 day and 2 years after implantation of the implant in the heart.

In some applications, the material is configured such that the threshold amount of decomposition is reached between 15 days and 2 years after the implant is implanted in the heart.

In some applications, the material is configured such that the threshold amount of decomposition is reached between 15 days and 1 year after the implant is implanted in the heart.

In some applications, the material is configured such that the threshold amount of decomposition is reached between 15 days and 6 months after implantation of the implant in the heart.

In some applications, the material is configured such that the threshold amount of decomposition is reached between 1 and 3 months after implantation of the implant in the heart.

In some applications, the material is configured such that the threshold amount of decomposition is reached between 1 and 2 months after implantation of the implant in the heart.

In some applications, the constraint is a first constraint and is configured to have a first lifetime after implantation of the implant such that after expiration of the first lifetime, the first constraint no longer blocks the spring, and the implant further comprises a second constraint configured to have a second lifetime after implantation of the implant, the second lifetime being greater than the first lifetime.

In some applications, the second constraint is coupled to the spring in a manner that prevents the spring from moving toward the resting state, thereby configuring the system and/or apparatus such that, after implantation of the implant: (i) After the first life expires, the spring moves partially toward the resting state but remains blocked by the second constraint; and (ii) after the second life expires, the second constraint no longer blocks the spring and the spring moves further toward the resting state.

In some applications, the spring is a first spring and the implant further comprises a second spring having a stationary state and coupled to the tether in such a way that movement of the second spring toward the stationary state applies tension to the tether.

In some applications, the second constraint is coupled to the second spring in a manner that prevents the second spring from moving toward the rest state of the second spring, and is configured such that after the second life expires, the second constraint no longer prevents the second spring.

In some applications, the first constraint and the second constraint are configured such that the second lifetime is at least twice the first lifetime.

In some applications, the first constraint and the second constraint are configured such that the second lifetime is at least three times the first lifetime.

In some applications, the first and second constraints are configured such that the first lifetime is between 1 and 3 months and the second lifetime is between 3 months and 1 year.

In some applications, the first and second constraints are configured such that the first lifetime is between 1 and 3 months and the second lifetime is between 3 and 6 months.

In some applications, the first and second constraints are configured such that the first lifetime is between 1 and 2 months and the second lifetime is between 3 months and 1 year.

In some applications, the first and second constraints are configured such that the first lifetime is between 1 and 2 months and the second lifetime is between 3 and 6 months.

In some applications, the constraint is stretch resistant and is coupled to the spring in a manner that resists stretching by the constraint and movement of the spring toward the resting state.

In some applications, the constraining member is a tether that tethers one portion of the spring to another portion of the spring, thereby preventing the one portion of the spring from moving away from the other portion of the spring.

In some applications, the constraint is a tube in which the spring is disposed.

In some applications, the constraint is compression resistant and is coupled to the spring in a manner that resists movement of the spring toward the resting state by the constraint resisting compression.

In some applications, the constraint is an obstruction disposed between one portion of the spring and another portion of the spring, thereby preventing the one portion of the spring from moving toward the other portion of the spring.

In some applications, the spring is shaped to define a cell having a first dimension and a second dimension and is configured to move toward the resting state by contracting in the first dimension and expanding in the second dimension.

In some applications, the spring is longer in the first dimension than in the second dimension when stopped by the constraint.

In some applications, the cell is a first cell and the spring is shaped to further define a second cell.

According to some applications, a system and/or device for use with tissue of a heart of a subject is provided, the system and/or device comprising: an anchor and an anchor handling assembly. The anchors generally include a tissue-engaging element, which may have a sharpened distal tip, and which may be configured to anchor the anchor to the tissue by driving into the tissue. The anchor head is coupled to a proximal end of the tissue-engaging element and includes an interface. The anchor handling assembly may include a sleeve and a tool. The sleeve has a distal portion including a distal end of the sleeve, the distal portion being transluminally advanceable to the anchor anchored to the tissue. The distal end can be sized to fit snugly over the anchor head. The tissue-engaging element may be the same as or similar to the other tissue-engaging elements described herein.

In some applications, the tool includes a flexible shaft and a tool head coupled to a distal end of the flexible shaft. The tool head may include jaws biased to assume an open state and reversibly squeezable into a closed state. The tool head may be sized relative to an inner dimension of the distal portion of the sleeve, sized such that placement of the tool head in the distal portion of the sleeve squeezes the jaws into the closed state.

In some applications, the tool may be configured to: advancing the tool head distally through the sleeve to the distal portion, locking the jaws to the interface when the jaws remain in the closed state, and applying a de-anchoring force to the anchor head when the jaws remain locked to the interface.

In some applications, when the tool head is locked to the hub and the distal end of the sleeve is disposed snugly over the anchor head, the jaws may be unlocked from the hub by retracting the sleeve proximally relative to the anchor head and the tool head such that the distal portion of the sleeve ceases to squeeze the jaws into the closed state and the jaws automatically move apart.

In some applications, the tool is configured to lock the jaws to the interface by pushing the driver head against the anchor head while the jaws remain in the closed state.

In some applications, in the closed state, the jaws define a gap therebetween, and when held in the closed state, the jaws are configured to: (i) In response to pushing the jaws onto the interface with a distally directed force of magnitude, as the interface deflects the jaws apart, is locked to the interface by receiving the interface into the gap, and (ii) resists unlocking from the interface as the interface exits the gap, and pulls the jaws with a proximally directed force of insufficient magnitude to pull the jaws away from the interface.

In some applications, the sleeve has a middle portion proximal to the distal portion, and the middle portion is internally sized such that placement of the tool head in the middle portion of the sleeve does not squeeze the jaws into the closed state.

In some applications, the jaws and the interface are configured to define a snap fit, and the tool is configured to lock the jaws to the interface by snap fitting the jaws to the interface while the jaws remain in the closed state.

In some applications, the de-anchor force is a de-anchor torque, and the tool is configured to apply the de-anchor torque to the anchor head while the jaws remain locked to the interface.

According to some applications, a system and/or apparatus for use with a tether for tissue fixation along a heart of a subject is provided, the system and/or apparatus including an anchor and an anchor handling assembly. The anchor includes a tissue-engaging element and a head coupled to a proximal portion of the tissue-engaging element. The head may comprise a shackle having an opening that is reversibly openable. The anchor handling assembly is transluminally advanceable to the heart and includes a driver and a linking tool. The driver is configured to anchor the tissue-engaging element to the tissue. The linking tool may be configured to temporarily open the opening and pass the tether laterally through the opening within the heart.

In some applications, the linking tool is configured to slidably couple the anchor to the tether within the heart by temporarily opening the opening and passing the tether laterally through the opening and into the shackle.

In some applications, the driver is configured to drive the tissue-engaging element into the tissue by screwing the tissue-engaging element into the tissue.

In some applications, at the opening, the shackle includes a spring loaded door.

In some applications, the spring loaded door is a single door.

In some applications, the spring loaded door is a double door.

In some applications, the spring loaded door is configured to open inwardly but not outwardly.

In some applications, the linking tool is configured to detach the anchor from the tether within the heart by temporarily opening the opening and passing the tether laterally through the opening and out of the shackle.

In some applications, the head further comprises a magnet, and the tool is configured to magnetically attract to the magnet.

According to some applications, a method for use with tissue of a heart of a subject is provided, the method comprising transluminally securing a tether (e.g., wire, ribbon, rope, braid, constriction member, suture, etc.) along the tissue by anchoring a plurality of anchors to respective locations of the tissue such that the tether extends between and along the plurality of anchors, each of the plurality of anchors having a respective eyelet through which the tether passes.

In some applications, the method includes transluminally while the plurality of anchors remain anchored to the tissue: (i) Slidably coupling an additional anchor to the tether between two anchors of the plurality of anchors, and (ii) anchoring the additional anchor to the tissue.

In some applications, anchoring the additional anchor to the tissue includes anchoring the additional anchor to the tissue after slidably coupling the additional anchor to the tether.

In some applications, anchoring the additional anchor to the tissue includes anchoring the additional anchor to the tissue prior to slidably coupling the additional anchor to the tether.

In some applications, for each anchor of the plurality of anchors, anchoring the anchor to a respective site of the tissue includes driving a tissue-engaging element of the anchor into the respective site of the tissue.

In some applications, for each of the plurality of anchors, driving the tissue-engaging element of the anchor into the respective site of the tissue includes screwing the tissue-engaging element of the anchor into the respective site of the tissue.

In some applications, the method further comprises contracting the tissue by tensioning the tether.

In some applications, tensioning the tether includes tensioning the tether after anchoring the additional anchor to the tissue.

In some applications, tensioning the tether includes tensioning the tether prior to slidably coupling the additional anchor to the tether.

In some applications, the method further comprises slackening the tether after tensioning the tether and before slidably coupling the additional anchor to the tether.

In some applications, the method further comprises re-tensioning the tether after anchoring the additional anchor to the tissue.

In some applications, slidably coupling the additional anchor to the tether includes clamping the additional anchor to the tether.

In some applications, the additional anchor comprises a head comprising a shackle, and clamping the additional anchor to the tether comprises, after anchoring the additional anchor to the tissue, transluminally grasping the tether and laterally pressing the tether into the shackle such that the shackle is slidably coupled to the tether.

In some applications, the shackle is a snap shackle, and pressing the tether laterally into the shackle includes pressing the tether laterally into the snap shackle such that the tether snaps into the snap shackle.

The method(s) and steps described above may be performed on a living animal or on a simulation (e.g., on a cadaver, cadaver heart, simulator (e.g., having a body part, heart, tissue, etc. being simulated), etc.).

According to some applications, there is provided a method for use with tissue of a heart of a subject, the method comprising: transluminally securing a tether (e.g., wire, band, rope, braid, shrink member, suture, etc.) along tissue by anchoring a plurality of anchors to respective sites of the tissue such that the tether extends between and along the plurality of anchors, each of the plurality of anchors having a respective eyelet through which the tether passes; and transluminally separating one of the plurality of anchors from the tether from between two other of the plurality of anchors.

In some applications, the one anchor includes a tissue-engaging element having a sharpened distal tip and a head coupled to a proximal portion of the tissue-engaging element, the head includes a magnetic element, and the method further includes transluminally advancing a tool to the one anchor, facilitated by magnetic attraction between the tool and the magnetic element, and separating the one anchor from the tether includes separating the one anchor from the tether using the tool. The tissue-engaging element may be the same as or similar to the other tissue-engaging elements described herein.

In some applications, the method further comprises de-anchoring the one anchor from the tissue while two other anchors of the plurality of anchors remain anchored to the tissue.

In some applications, de-anchoring the one anchor from the tissue includes de-anchoring the one anchor from the tissue prior to de-anchoring the one anchor from the tether.

In some applications, de-anchoring the one anchor from the tissue includes de-anchoring the one anchor from the tissue after de-anchoring the one anchor from the tether.

In some applications, the tether is tensioned after the one anchor is separated from the tether.

In some applications, tensioning the tether includes tensioning the tether prior to decoupling the one anchor from the tether.

In some applications, the method further comprises relaxing the tether after tensioning the tether and before separating the one anchor from the tether.

In some applications, the method further comprises re-tensioning the tether after separating the one anchor from the tether.

In some applications, decoupling the one anchor from the tether includes decoupling the additional anchor from the tether.

In some applications, the one anchor comprises a head comprising a shackle, and disengaging the one anchor from the tether comprises transluminally opening the shackle.

According to some applications, a system and/or apparatus including a tissue anchor is provided. The anchor may include a tissue-engaging element defining a central longitudinal axis of the anchor, having a sharpened distal tip, and configured to be driven into tissue of a subject. The anchor may further include an anchor head coupled to the proximal end of the tissue-engaging element. The anchor head may include a bracket (stock), a ball joint, and an eyelet coupled to the bracket via the ball joint. The tissue-engaging element may be the same as or similar to the other tissue-engaging elements described herein.

In some applications, the ball joint is disposed on the central longitudinal axis.

In some applications, the anchor head defines an eyelet axis through the ball joint and the eyelet, and the ball joint allows the eyelet to move to a position in which the eyelet axis is orthogonal to the central longitudinal axis.

In some applications, the lugs are fixedly coupled to the tissue-engaging element.

In some applications, the aperture is disposed laterally from the central longitudinal axis.

In some applications, the ball joint is disposed laterally from the central longitudinal axis.

In some applications, the anchor head includes a collar surrounding the lug and rotatably coupled to the lug, and the ball joint is mounted on the collar such that the ball joint is rotatable about the central longitudinal axis by rotation of the collar about the lug.

In some applications, the lugs are disposed on the central longitudinal axis.

In some applications, the ball joint includes a socket and a support stud; the support stud defining a ball at a first end of the stud, the ball being disposed within the socket; and a second end of the stud defines the aperture.

The ball joint may define (i) a deflection ball sector within which the ball joint allows the support stud to deflect into any angular setting relative to the socket, and (ii) a deflection plane on which the ball joint allows the support stud to deflect beyond the deflection ball sector, beyond which the ball joint prevents the support stud from deflecting beyond the deflection ball sector.

In some applications, the yaw ball sector has a midpoint, and the ball joint is positioned such that the midpoint is located on the central longitudinal axis.

In some applications, the ball joint defines the yaw ball sector to have a solid angle of at least one steradian.

In some applications, the ball joint defines the solid angle as at least two steradians.

In some applications, the ball joint defines the solid angle as 2-5 steradians.

In some applications, the ball joint defines the solid angle as 3-5 steradians.

In some applications, the ball joint defines a planar deflection angle arc of at least 110 degrees on the deflection plane; and on the deflection plane, the ball joint allows the support stud to deflect beyond a boundary only within the plane deflection angle arc.

In some applications, the ball joint defines the planar deflection angle arc as at least 120 degrees.

In some applications, the ball joint defines the planar deflection angle arc as at least 140 degrees.

In some applications, the ball joint defines the planar deflection angle arc as at least 160 degrees.

In some applications, the ball joint defines the planar deflection angle arc as at least 180 degrees.

In some applications, the ball joint defines the planar deflection angle arc as at least 200 degrees.

In some applications, the ball joint defines the planar deflection angle arc as no greater than 180 degrees.

In some applications, the ball joint defines the planar deflection angle arc as no greater than 160 degrees.

In some applications, the ball joint defines the planar deflection angle arc as no greater than 140 degrees.

In some applications, the aperture is shaped to define a first face and a second face opposite the first face; and the aperture having an aperture defined by an inner surface of the aperture, the aperture extending between the first face and the second face, and a narrowest portion of the aperture being intermediate the first face and the second face.

In some applications, the inner surface of the eyelet is hyperboloid.

In some applications, the inner surface of the eyelet is a catenary surface.

In some applications, the system/device includes an implant that includes a tether (e.g., wire, ribbon, rope, braid, constriction member, suture, etc.) and the anchor, the eyelet being threaded onto the tether.

In some applications, the anchor is a first anchor of the implant; and the implant further comprises a second anchor, the eyelet of the second anchor being threaded onto the tether.

In some applications, the implant further comprises a spacer or divider that is tubular, having two spacer ends and a lumen therebetween; and the spacer is threaded over the tether between the first anchor and the second anchor, wherein the tether passes through the spacer lumen.

In some applications, the spacer resists axial compression.

In some applications, the eyelet defines an aperture therethrough, the eyelet is threaded onto the tether by the tether passing through the aperture, and the anchor head is configured to facilitate smooth sliding of the tether through the aperture (i) when the tether is parallel to the central longitudinal axis and (ii) when the tether is oriented orthogonal to the central longitudinal axis.

In some applications, the tether has a thickness and the narrowest portion of the aperture is no more than twice the thickness of the tether.

In some applications, the anchor head further comprises a driver interface, and the system/apparatus further comprises an anchor driver configured to reversibly engage the driver interface and, when engaged with the driver interface, to (i) transluminally advance the anchor into the tissue, and (ii) drive the tissue engaging element into the tissue.

In some applications, the system/apparatus includes a delivery tool comprising a percutaneously advanceable tube and the anchor driver; and the anchor driver is configured to transluminally advance the anchor to the tissue by sliding the anchor through the tube when engaged with the driver interface.

In some applications, the tube defines an interior channel having a cross-section defining a primary channel region and a secondary channel region; the primary channel region having a larger cross-sectional area than the secondary channel region; and the anchor is slidable through the channel, wherein the tissue-engaging element slides through the primary channel region and the eyelet slides through the secondary channel region.

According to some applications, a system and/or apparatus is provided that includes a tissue anchor including a tissue engaging element defining a central longitudinal axis of the anchor, having a sharpened distal tip, and configured to be driven into tissue of a subject, and an anchor head. The anchor head may include a lug coupled to a proximal end of the tissue-engaging element; a drive interface coupled to the rest; and an eyelet hingedly coupled to the bracket such that the eyelet is pivotable on the drive interface. The tissue-engaging element may be the same as or similar to the other tissue-engaging elements described herein.

In some applications, the lugs are fixedly coupled to the proximal end of the tissue-engaging element.

In some applications, the drive interface is fixedly coupled to the rest.

In some applications, the lugs are coupled to the proximal end of the tissue-engaging element and the driver interface in a manner that transfers torque from the driver interface to the tissue-engaging element.

In some applications, the eyelet may be positioned on the central longitudinal axis.

In some applications, the hinged coupling of the eyelet to the bracket is such that the eyelet is positionable on a first side of the driver interface and pivotable over the driver interface to a second side of the driver interface, the second side being opposite the first side.

In some applications, the hinge coupling of the eyelet to the bracket is such that the eyelet may pivot on the driver interface in an arc of greater than 180 degrees.

In some applications, the anchor head includes an arch defining at least a portion of the eyelet, the arch having two bottom ends, each of the bottom ends being hingedly coupled to the lugs at a respective hinge point opposite each other.

In some applications, the anchor head includes a collar surrounding the lug and rotatably coupled to the lug; and the eyelet is hingedly coupled to the bracket by each of the bottom ends being hingedly coupled to the collar at a respective one of the hinge points.

In some applications, at each of the hinge points, the collar defines a respective recess, and a respective bottom end is hingedly coupled to the collar by protruding into the recess.

In some applications, the eyelet is centrally disposed on the arch.

In some applications, the eyelet is disposed eccentrically on the arch.

In some applications, the spacer resists axial compression.

In some applications, the system/device further comprises an anchor driver configured to reversibly engage the driver interface and configured, when engaged with the driver interface, (i) transluminally advance the anchor to the tissue, and (ii) drive the tissue engaging element into the tissue.

According to some applications, a method is provided that includes transluminally advancing an elongate tool including a holder and a cutter to an implant coupled to a heart of a subject. The implant may include a tether (e.g., wire, ribbon, rope, braid, shrink member, suture, etc.) under tension and a stop that locks the tension in the tether by locking to a first portion of the tether. The method may further include securing the stop to the retainer; and when the stopper remains secured to the retainer and locked to the first portion of the tether: (i) Reducing the tension on the tether by cutting the tether with the cutter, and (ii) withdrawing the tool, the stop, and the first portion of the tether from the subject while leaving a second portion of the tether coupled to the heart.

In some applications, the implant includes an anchor coupled to the tether and anchored to the heart, and withdrawing the tool, the stop, and the first portion of the tether includes withdrawing the tool, the stop, and the first portion of the tether from the subject while leaving the anchor anchored to the heart.

In some applications, the retainer includes a chamber and an opening to the chamber, the cutter is disposed at the opening, and securing the stop includes advancing the stop through the cutter and the opening and into the chamber.

In some applications, securing the stopper includes using the cutter to prevent the stopper from exiting the chamber via the opening.

In some applications, using the cutter to prevent the stopper from exiting the chamber via the opening includes actuating the cutter to occlude the opening.

In some applications, actuating the cutter to occlude the opening includes moving a blade of the cutter to occlude the opening, and cutting the tether includes cutting the tether with the blade by further moving the blade of the cutter.

In some applications, the implant is disposed inside the heart, and transluminally advancing the elongate tool to the implant includes transluminally advancing the elongate tool to the implant disposed inside the heart.

In some applications, the implant is an annuloplasty implant coupled to an annulus of a valve of the heart, and transluminally advancing the elongate tool to the implant comprises transluminally advancing the elongate tool to the annuloplasty implant coupled to the annulus.

In some applications, the method further comprises, after relieving the tension on the tether, deploying a prosthetic valve within the annulus of the valve of the heart.

In some applications, the annuloplasty implant extends in a path at least partially surrounding the annulus and is coupled to the annulus at a plurality of locations along the path, and transluminally advancing the elongate tool to the implant comprises transluminally advancing the elongate tool to the annuloplasty implant extending in the path at least partially surrounding the annulus and being coupled to the annulus at the plurality of locations along the path.

In some applications, the implant includes an anchor slidably coupled to the tether and anchored to the heart, the stop to lock the tension in the tether by preventing the first portion of the tether from sliding relative to the anchor, and the transluminally advancing the elongate tool to the implant includes: the elongate tool is advanced transluminally to an implant comprising the anchor slidably coupled to the tether and anchored to the heart, the stop locking the tension in the tether by preventing the first portion of the tether from sliding relative to the anchor.

In some applications, the stop prevents the first portion of the tether from sliding relative to the anchor by the stop abutting the anchor, and transluminally advancing the elongate tool to the implant comprises transluminally advancing the elongate tool to the implant wherein the stop prevents the first portion of the tether from sliding relative to the anchor by the stop abutting the anchor.

In some applications, cutting the tether includes cutting the tether between the stop and the anchor.

In some applications, reducing the tension on the tether by cutting the tether includes cutting the tether such that the cutting forms a first cut end and a second cut end of the tether, and the second portion of the tether pulls the second cut end away from the cutter and past the anchor. Withdrawing the first portion of the tether may include withdrawing the first portion of the tether along with the first cutting end. Leaving the second portion of the tether may include leaving the second portion of the tether along with the second cut end.

In some applications, the anchor is a first anchor; the implant includes a second anchor slidably coupled to the tether and anchored to the heart; and cutting the tether includes cutting the tether such that the second portion of the tether pulls the second cut end away from the cutter, past the first anchor, but not past the second anchor.

In some applications, cutting the tether such that the second portion of the tether pulls the second cutting end away from the cutter and past the anchor includes cutting the tether such that the second portion of the tether separates the anchor from the tether by pulling the second cutting end away from the cutter and past the anchor.

In some applications, the anchor is slidably coupled to the tether by threading the anchor's eyelet onto the tether; and cutting the tether such that the second portion of the tether separates the anchor from the tether includes cutting the tether such that the second portion of the tether drills the anchor from the tether by pulling the second cutting end away from the cutter and through the eyelet.

According to some applications, a method is provided that includes transluminally advancing an elongate tool to a tether (e.g., wire, ribbon, rope, braid, constriction member, suture, etc.) that is under tension and disposed within a heart of a subject. The elongate tool may include a holder and a cutter. The method may further include securing a first portion of the tether to the retainer; and while the first portion of the tether remains secured to the retainer, (i) relieving the tension on the tether by cutting the tether with the cutter, thereby separating the first portion of the tether from the second portion of the tether, and (ii) withdrawing the tool and the first portion of the tether from the subject while leaving the second portion of the tether coupled to the heart.

In some applications, the first portion of the tether includes a knot that locks the tension in the tether, and withdrawing the first portion of the tether includes withdrawing the knot from the subject.

In some applications, the first portion of the tether has the stop locked thereto, the stop locks the tension in the tether, and withdrawing the first portion of the tether includes withdrawing the stop from the subject.

In some applications, the tether is coupled to an anchor that is anchored to a heart, and withdrawing the tool and the first portion of the tether includes withdrawing the tool and the first portion of the tether from the subject while leaving the anchor anchored to the heart.

According to some applications, a system and/or apparatus is provided that includes a tissue anchor including a swivel joint, a first arm, and a second arm, the swivel joint defining an articulation axis. The first arm may define a first coupling and a first hook that curves about and away from the hinge axis, terminating in a first tip, the bending of the first hook being in a first direction about the hinge axis. The second arm may be hingedly coupled to the first arm via the swivel joint and may define a second coupling and a second hook that curves about and away from the hinge axis, terminating in a second tip, the curvature of the second hook in a second direction about the hinge axis, the second direction being opposite the first direction.

The hinged coupling of the second arm to the first arm may be such that the anchor is transitionable between (i) an open state in which the first arm is in a first rotational position about the hinge axis and (ii) a closed state; the first and second hooks defining a space therebetween, the first and second tips defining a gap therebetween into the space, and the first and second couplings being separated from one another, the first arm being in a second rotational position about the hinge axis in the closed state; the gap is smaller than in the open state; and the first and second couplings engage one another, the engagement between the first and second couplings preventing the anchor from transitioning out of the closed state.

In some applications, for each of the first and second hooks, the radius of curvature of the hook increases with distance from the swivel joint.

In some applications, in the closed state, the first tip and the second tip face away from each other.

In some applications, the anchor further comprises a spring configured to bias the first arm about the articulation axis toward a given rotational position.

In some applications, the spring is configured to bias the lock toward the closed state.

In some applications, the spring is a torsion spring.

In some applications, the swivel joint includes a pin extending through the first arm and the second arm, and the torsion spring is mounted on the pin.

In some applications, the first arm defines a first beam; the second arm defines a second beam; and the swivel joint is disposed between the first beam and the first hook and between the second beam and the second hook such that the first arm is a class I lever whose fulcrum is the swivel joint.

In some applications, the anchor is a class I double lever whose fulcrum is the swivel joint.

In some applications, the anchor may be transitionable from the open state toward the closed state by driving the first beam about the articulation axis.

In some applications, the anchor may transition from the open state toward the closed state by increasing alignment between the first beam and the second beam.

In some applications, the first coupling is disposed on the first beam; the second coupling is disposed on the second beam; and the hinged coupling of the second arm to the first arm is such that the anchor may be transitioned to the closed state by aligning the first beam with the second beam such that the first coupling and the second coupling responsively engage one another.

In some applications, the first coupling includes a protrusion and the second coupling includes a recess.

According to some applications, a system and/or apparatus for use with tissue of a heart is provided, the system/apparatus including a tether (e.g., wire, ribbon, rope, braid, constriction member, suture, etc.) and a tissue anchor. The tissue anchor may include a stem, an arm, a hinge, and a head. The arm may be coupled to the distal end of the core via the hinge. The head may be coupled to a proximal portion of the core. The tether may be slidably coupled to the head. The core may have an intermediate portion between the distal end and the proximal portion.

The anchor may be anchored into the tissue by sequentially advancing the first side of the arm, the hinge, and the intermediate portion of the core into the tissue such that the core extends from the distal end and the hinge within the tissue to the proximal portion above the tissue. The arm may be pivotable within the tissue about the hinge such that the anchor is transitionable within the tissue toward a constrained state in which the arm extends laterally across the distal end of the core. The head may be configured to clamp the tissue between the arm and the head by moving distally along the stem toward the hinge.

In some applications, the system/device further comprises a hollow needle having a sharp tip and configured to penetrate into the tissue. The arm may be configured to be delivered into the tissue within the needle. The core may be biased to bend automatically upon deployment from the needle within the tissue. The needle may be configured to inhibit the bending of the core pin when the core pin is disposed within the needle.

In some applications, the arm has a second side, the hinge is coupled to the arm between the first side and the second side such that transition of the anchor toward the constrained state pivots the arm relative to the stem within the tissue such that the first side of the arm moves proximally relative to the stem and the second side of the arm moves distally relative to the stem.

In some applications, the anchor is configured to automatically transition toward the constrained state upon application of a proximal pulling force to the core when the arm is disposed within the tissue.

In some applications, the second side measured between the top end of the second side and the hinge is longer than the first side measured between the top end of the first side and the hinge.

In some applications, the second side has an eccentric tip.

In some applications, the eccentric tip is sharp.

In some applications, the first side has a centered apex.

In some applications, the centering tip is sharp.

In some applications, the system/device further comprises a retrieval line coupled to the second side in the following manner: wherein proximal pulling of the retrieval wire transitions the anchor away from the constrained state by pivoting the arm relative to the mandrel within the tissue such that the first side of the arm moves distally relative to the mandrel and the second side of the arm moves proximally relative to the mandrel.

In some applications, the system/device further comprises a tube distally advanceable over and along the retrieval line and the core, and the anchor is configured to be de-anchored from the tissue by pulling the retrieval line, the core, and the second side of the arm into the tube.

In some applications, the retrieval line is detachable from the anchor in vivo.

According to some applications, there is provided a method for implanting an implant into tissue of a heart of a subject, the method comprising introducing a tissue anchor into the subject, the tissue anchor comprising a stem, a head, an arm and a hinge, the head being coupled to a proximal portion of the stem, the arm being coupled to the stem via the hinge, the stem having an intermediate portion between a distal end and the proximal portion.

The method may further include transluminally advancing the anchor (e.g., wire, ribbon, rope, braid, constriction member, suture, etc.) along a tether toward the heart, wherein the head slides over the tether; and sequentially advancing the first side of the arm, the hinge, and the intermediate portion of the core into the tissue such that a proximal portion of the core extends over the tissue.

The method may further include transitioning the anchor within the tissue toward its constrained state by pivoting the arm about the hinge such that the arm extends laterally across the distal end of the core; and then sandwiching the tissue between the arm and the head by moving the head distally along the stem toward the hinge.

In some applications, the method further comprises advancing a needle having a sharpened tip into the tissue, and advancing the first end of the arm, the hinge, and the intermediate portion of the core rod into the tissue comprises sequentially advancing the first end of the arm, the hinge, and the intermediate portion of the core rod out of the needle and into the tissue.

In some applications, advancing the first side of the arm into the tissue includes advancing the first side of the arm into an annulus of an atrioventricular valve of the heart when the arm is disposed alongside the annulus substantially orthogonal to a coronary artery.

In some applications, pivoting the arm about the hinge includes pivoting the arm about the hinge such that the arm becomes substantially parallel with the coronary artery.

In some applications, the arm has a second side, the hinge is coupled to the arm between the first side and the second side, and transitioning the anchor toward the retaining state includes pivoting the arm relative to the stem within the tissue such that the first side of the arm moves proximally relative to the stem and the second side of the arm moves distally relative to the stem.

In some applications, pivoting the arm about the hinge includes pivoting the arm about the hinge when a retrieval line is coupled to the second side, and the method further includes subsequently separating the retrieval line from the anchor in vivo.

In some applications, pivoting the arm relative to the mandrel includes applying a proximal pulling force to the mandrel such that the anchor automatically transitions toward the constrained state.

In some applications, the second side measured between the tip of the second side and the hinge is longer than the first side measured between the tip of the first side and the hinge, and pivoting the arm relative to the core includes applying a proximal pulling force to the core such that interaction between the tissue and the longer second side pivots the arm relative to the core.

In some applications, the second side has an eccentric tip, and pivoting the arm relative to the core includes applying a proximal pulling force to the core such that interaction between the tissue and the eccentric tip side pivots the arm relative to the core.

In some applications, the first side of the arm has a centering tip, and advancing the first side of the arm into the tissue includes penetrating the tissue with the centering tip.

In some applications, the method further comprises (i) de-anchoring the anchor from the tissue by pivoting the arm relative to the mandrel by proximally pulling a retrieval wire coupled to the second side such that, within the tissue, the first side of the arm moves distally relative to the mandrel and the second side of the arm moves proximally relative to the mandrel; and (ii) subsequently, pulling the arm (first the second side) out of the tissue.

In some applications, the method further comprises advancing a tube over and along the retrieval line and the core, and pulling the arm out of the tissue comprises pulling the arm (first second side) into the tube and out of the tissue.

According to some applications, a system and/or apparatus for use with tissue of a heart of a subject is provided, the system/apparatus including an implant including a tether (e.g., wire, ribbon, rope, braid, constriction member, suture, etc.), a first anchor, and a second anchor. Each of the first anchor and the second anchor may include a head slidably coupled to the tether; and a tissue-engaging element configured to anchor the anchor and the tether to the tissue. The tissue-engaging element may be the same as or similar to the other tissue-engaging elements described herein.

In some applications, the system/apparatus may further include a tubular spacer or divider defining a lumen along a spacer axis and having (i) a primary region that is flexible in deflection; and (ii) a secondary region at each end of the primary region, the secondary region being less flexible than the primary region in terms of deflection, the lumen extending through the primary region and both secondary regions. The tubular spacer may be threaded onto the tether between the first anchor and the second anchor by the tether passing through the lumen.

In some applications, the primary region is resiliently flexible in terms of deflection.

In some applications, the primary region resists axial compression.

In some applications, each of the secondary regions is more resistant to axial compression than the primary region.

In some applications, each of the secondary regions is shorter than the primary region.

In some applications, the combined length of both of the secondary regions is shorter than the primary region.

In some applications, each of the secondary regions is 30% less in length than the primary region. In some applications, each of the secondary regions is 20% less in length than the primary region. In some applications, each of the secondary regions is 10% smaller in length than the primary region. In some applications, each of the secondary regions has a length of at least 2% of the primary region. In some applications, each of the secondary regions is at least 5% longer than the primary region.

In some applications, the spacer or separator comprises a helical coil extending along the main region.

In some applications, the helical coil comprises a wire coiled to form the helical coil, and the wire has a core comprising a radiopaque material.

In some applications, the wire comprises a cobalt chromium alloy and the core comprises platinum.

In some applications, the coil extends into the secondary region.

In some applications, the helical coil comprises a wire coiled to form the helical coil, the wire having a wire thickness, and in a rest state of the helical coil, the helical coil has a pitch of 1.4-2 times the wire thickness.

In some applications, the pitch of the helical coil is 1.6-1.8 times the wire thickness in the rest state.

In some applications, the spacer includes a rigid ring coupled to an end of the helical coil at each of the secondary regions.

In some applications, the helical coil comprises a wire coiled to form the helical coil, the wire having a wire thickness, and each of the loops having a length along the spacer axis that is at least twice the wire thickness.

In some applications, each of the loops is disposed at least partially inside the helical coil.

In some applications, each of the loops has a flange disposed outside of the helical coil, the flange providing a bearing surface configured to facilitate sliding of the tether thereagainst.

According to some applications, a system and/or apparatus for use with an object is provided, the system and/or apparatus comprising a delivery tool and a stopper. The delivery tool may be percutaneously advanceable into the subject and may have a lumen. The stopper may include: a first element comprising a first plate defining a first passage therethrough; a second element comprising a second plate defining a second passage therethrough; a torsion bar.

In some applications, the torsion bar may connect the first plate to the second plate in the following manner: wherein (i) the torsion bar biases the stop toward a clamped state in which the first and second passages are offset relative to one another, and (ii) the stop is sized such that when the stop is disposed in the cavity, the delivery tool retains the stop in an open state, the stop being transitionable to the open state by increasing stress on the torsion bar and alignment between the first and second passages.

In some applications, both the first passage and the second passage are parallel to the torsion bar in both the clamped state and the open state.

In some applications, the cavity is defined by an inner surface of the delivery tool; and the stopper is sized to be disposed within the cavity with the first and second plates disposed within the cavity, wherein the inner surface retains the stopper in the open state by pressing against the first and second plates.

In some applications, the inner surfaces that press against the first and second plates prevent torsional destressing of the torsion bar when the stop is disposed within the cavity; and the stop is configured to transition towards the clamped state by moving the first plate relative to the second plate by torsional destressing of the torsion bar in response to ejection from the cavity.

In some applications, in the open state of the stopper, the stopper defines a central longitudinal axis passing through a center of the first plate and a center of the second plate; and a transition of the stop toward the clamped state shifts the center of at least one of the first plate and the second plate relative to the central longitudinal axis.

In some applications, both the first passageway and the second passageway are parallel to the longitudinal axis in both the open state and the clamped state.

In some applications, in the clamped state, the first plate is not coaxial with the second plate.

In some applications, the delivery tool is a catheter.

In some applications, the system/device further comprises a tether (e.g., wire, ribbon, rope, braid, shrink member, suture, etc.); the alignment between the first passageway and the second passageway is sufficient for the tether to be slidable through the stopper when the stopper is in the open state; and when the tether is disposed past the stop, transitioning the stop to the clamped state clamps the tether within the stop, thereby preventing the tether from sliding past the stop.

In some applications, the system/device includes an implant including the tether, the implant is collapsible by applying tension to the tether, and in the clamped state of the stop, the stop is configured to lock tension in the tether by clamping the tether.

In some applications, in the open state of the stopper, the first and second elements are aligned relative to each other such that the stopper is cylindrical.

In some applications, in the clamped state, the first element is offset relative to the second element such that the stop is non-cylindrical.

The utility model will be more fully understood from the following detailed description of the application thereof, taken in conjunction with the accompanying drawings, in which:

drawings

FIGS. 1A-I, 2A-B, 3A-D, and 4A-B are schematic illustrations of examples of anchors, implants including anchors, systems including implants, and techniques for use therewith, according to some applications;

FIGS. 5A-D and 6A-C are schematic illustrations of an example anchor for use with tissue of a subject, according to some applications;

FIGS. 7A-C and 8A-C are schematic illustrations of an example anchor according to some applications;

FIGS. 9A-C and 10A-C are schematic illustrations of example anchors according to some applications;

FIGS. 11A-D and 12A-E are schematic illustrations of respective example systems according to some applications;

13-17 are schematic illustrations of respective example anchors according to some applications;

18A-C, 19A-D, 20A-C, and 21A-E are schematic illustrations of example tether handling systems according to some applications, each tether handling system including a respective tether handling device;

FIGS. 22A-B, 23A-B, and 24A-D are schematic illustrations of various example tensioners according to some applications;

FIGS. 25A-F and 26A-B are schematic illustrations of an example anchor handling assembly according to some applications;

27A-C and 28A-B are schematic illustrations of an example anchor handling assembly according to some applications;

29A-B and 30A-B are schematic illustrations of respective anchor systems according to some applications;

31A-B, 32A-B, 33A-B, 34A-C, and 35A-C are schematic illustrations of systems, devices, and techniques for adding and/or removing anchors to and/or from an implant according to some applications;

36A-B, 37A-D, 38A-B, 39A-C, 40A-D, 41 and 42 are schematic illustrations of various tissue anchors and techniques for use therewith according to some applications;

43A-C are schematic illustrations of tissue anchors and variants thereof according to some applications;

FIGS. 44A-E and 45A-E are schematic illustrations of tissue anchors and techniques for using the same according to some applications;

46A-C and 47A-C are schematic illustrations of example spacers according to some applications;

48A-E are schematic illustrations of a tether handling system according to some applications;

49A-D are schematic illustrations of at least some steps in a technique for use with an implant coupled to a heart of a subject, according to some applications;

FIGS. 50, 51, 52A-F, and 53A-E are schematic illustrations of systems for use with an object according to some applications;

FIGS. 54 and 55A-C are schematic illustrations of a flexible tube having a rotatable distal portion according to some applications;

FIGS. 56A-B and 57A-B are schematic illustrations of flush adapters according to some applications;

58A-C are schematic illustrations of a fluoroscopic guide according to some applications;

fig. 59A-B are schematic illustrations of anchors according to some applications.

Detailed Description

In the following description, various aspects of the present disclosure will be described. For purposes of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the various aspects of the present disclosure. However, it will also be apparent to one skilled in the art that the present disclosure may be practiced without the specific details presented herein. Furthermore, well-known features may be omitted or simplified in order not to obscure the present disclosure.

Throughout the specification, the same names are used to denote different embodiments of the elements. Applications of the devices, systems, and techniques described herein may include any variation in which one element is replaced by another like-named element, unless otherwise indicated. Furthermore, the presence or absence of different suffixes of the same reference numbers are used to represent different embodiments of the same elements throughout the figures. Applications of the devices, systems, and techniques described herein may include any variation in which one element is replaced by another element having the same reference number (whether or not indicated by a suffix) unless otherwise indicated. To avoid excessive clutter due to the many reference numerals and leads on a particular drawing, some elements are introduced via one or more drawings and are not explicitly identified in each subsequent drawing containing the element.

1A-I, 2A-B, 3A-D, and 4A-B, FIGS. 1A-I, 2A-B, 3A-D, and 4A-B are schematic illustrations of examples of a tissue anchor 120, an implant 110 including a tissue anchor, a system 100 including an implant, and techniques for use therewith, according to some applications. The system 100 is a tissue modification system and may be used to modify the size of tissue structures (e.g., soft tissue). For example, the system 100 can be an annuloplasty system, and the implant 110 can be an annuloplasty structure (e.g., an annuloplasty ring, an annuloplasty implant, etc.).

Fig. 1A shows an isometric view of anchor 120, fig. 1B shows an exploded view, fig. 1C and 1E show side and top views, respectively, and fig. 1D and 1F show longitudinal and transverse cross-sections, respectively.

Anchor 120 includes a tissue-engaging element 130 and a head 180. The tissue-engaging elements may be configured in a variety of ways and may be the same as or similar to other tissue-engaging elements described herein. In some applications, as shown in fig. 1A-1F, the tissue-engaging element has a proximal end 132, a distal end 134, and defines a central longitudinal axis ax1 of the anchor 120. At the distal end 134, the tissue-engaging element 130 has a sharp distal tip 138, and the tissue-engaging element is configured to be driven (e.g., screwed, pushed, etc.) into tissue (e.g., soft tissue) of a subject. In some applications, and as shown, tissue-engaging element 130 is helical and defines a central lumen along axis ax1. Alternatively, tissue-engaging element 130 may be another type of tissue-engaging element, such as a dart, a nail, a hook, a clip, a clamp, a clamping device, and/or as described below with reference to fig. 13-17. In some applications, the tissue-engaging element may be hook-shaped, straight, angled, and/or another configuration. In some applications, the tissue-engaging element may include barbs or barbed portions to retain the tissue-engaging element in tissue.

Tissue-engaging element 130 has a lateral width dl. For applications where tissue-engaging element 130 is helical, width d1 is the outer diameter of the helix. The head 180 is coupled to the proximal end 132 of the tissue-engaging element 130 and includes a driver interface 182 and an aperture 140 (or other connector) defining an aperture 146 therethrough. The driver interface 182 is configured to be reversibly engaged by the anchor driver 160 (fig. 3A). The driver 160 generally includes an elongated and flexible shaft 162, and a driver head 164 coupled to a distal end of the shaft. The driver head 164 is a component of the anchor driver 160 that reversibly engages the driver interface 182. The driver interface 182 may be coupled (e.g., fixedly coupled) to the tissue-engaging element 130. In some applications, and as shown, the interface 182 includes a stem 183 that may be transverse to the axis ax 1.

In some applications, and as shown, the driver interface 182 is disposed or centered on a central longitudinal axis ax1, and the eyelet 140 is disposed laterally (e.g., off-center) from the axis ax1, thereby defining an eyelet axis ax2 that is orthogonal to the axis ax 1. That is, aperture axis ax2 is an axis extending laterally through aperture 140 orthogonally from axis ax 1. The eyelet 140 is shaped to define a sliding axis ax3 along which a tether (e.g., wire, ribbon, rope, braid, shrink member, suture, etc.) may slide through the aperture 146. Typically, the sliding axis ax3 is transverse to the aperture 146. Typically, the sliding axis ax3 is the axis that provides the least resistance through the orifice 146.

Fig. 1G shows the eyelet 140 in a different rotational orientation relative to the axis ax 1. Fig. 1H shows the eyelet 140 in a different position about the axis ax 1. Fig. 1I shows various views of eyelet 140.

In some applications, the sliding axis ax3 may be defined relative to the aperture plane p1 of the eyelet 140. For such applications, the sliding axis ax3 may be transverse to the sliding axis ax3. The orifice plane p1 is a cross-sectional plane through the aperture 140 where the orifice 146 appears to be closed (see, e.g., frame F of fig. 1I, which is a cross-section on the orifice plane p 1). In general, the orifice plane p1 is the plane in which the orifice 146 has the smallest cross-sectional area (see, e.g., frames B and E of fig. 1I) among all possible cross-sections through the aperture 140 in which the orifice 146 appears to be closed. In some applications, in cross section on aperture plane p1, aperture 146 appears to be circular (see, e.g., frame F of fig. 1I). In some applications, the orifice plane p1 is angled and centrally and positioned relative to the aperture 140 so as to divide the aperture into two identical halves. In some applications, and as shown in FIG. 1I, the aperture axis ax2 lies on the aperture plane p 1.

In some applications, the aperture 140 is shaped to define two planar faces 148 between which the aperture 146 extends through the aperture, e.g., one face at each end of the aperture. In some applications, the faces 148 are parallel to one another. In some applications, at least one of the faces 148 is orthogonal to the sliding axis ax3 and/or parallel to the eyelet axis ax 2. As described in more detail below, the face 148 is shaped to facilitate interaction with a tubular spacer or separator (e.g., tube, solid wall tube, laser cut tube, spiral rod, spring, etc.).

In some applications, the narrowest portion of the orifice 146 is intermediate the planar faces 148. In some applications, the orifice plane p1 is intermediate and parallel to the planar face. Frames B and F of fig. 1I show the narrowest portion of the orifice 146 as being on plane p1, intermediate the planar faces 148.

In some applications, the inner surface of the eyelet 140 is catenary in shape. In some applications, the inner surface of the eyelet 140 is hyperbolic in shape. See, for example, frames B and E of fig. 1I.

As described in more detail below, eyelet 140 is configured to facilitate sliding of anchor 120 along (or through) the tether when the anchor is aligned with the tether (i.e., when axis axl is parallel to the tether). As also described in greater detail below, eyelet 140 is further configured to facilitate sliding of the anchor along (or through) the tether when the anchor is oriented orthogonal to the tether (i.e., when axis ax1 is orthogonal to the tether). This is achieved at least in part because the eyelet 140 is rotatable, for example, such that the sliding axis ax3 may be oriented parallel to the axis ax1 or orthogonal to the axis ax1 and generally any orientation therebetween. The eyelet 140 may be rotatably mounted in such a manner as to constrain the sliding axis ax3 to be orthogonal to the eyelet axis ax 2. The rotatability of the eyelet 140 is illustrated by fig. 1G, where each frame shows the eyelet in a different rotational orientation relative to axis ax1, and the left frame shows a rotational orientation where axis ax3 is parallel to axis ax 1.

In some applications, the mounting of the eyelet 140 also allows the eyelet to swivel about axis ax1 while axis ax3 remains constrained to be orthogonal to axis ax 2. This is illustrated by FIG. 1H, where each frame shows the eyelet 140 in a different position about the axis ax1 (interface 182 and tissue-engaging element 130 are in the same position in each frame). This configuration of the anchor 120 that enables rotation and swiveling of the eyelet 140 without deflection advantageously increases predictability and reduces wear on the tether, given that the anchor is loosely coupled with the eyelet (e.g., like a link in a chain).

In some applications, attachment of eyelet 140 is accomplished by head 180 including collar 184 (which may also be referred to as a ring) to which eyelet is rotatably attached. Collar 184 surrounds axis ax1 and is rotatable about axis ax1, for example, by being rotatably coupled to tissue-engaging element 130, such as by being rotatably coupled to another component of head 180 that is fixedly coupled to the tissue-engaging element. For example, collar 184 may be rotatably coupled to rest 128, rest 128 coupled (e.g., fixedly coupled) to tissue-engaging element 130, and rest 128 couples (e.g., fixedly coupled) the tissue-engaging element to interface 182, for example, in a manner that transfers torque from interface 182 to tissue-engaging element 130. The lugs 128 may be considered and/or may be referred to as mounts. The lugs 128 may be disposed on the central longitudinal axis ax 1.

As shown, the lugs 128 may be formed from two components fixedly coupled to each other: component 128' and component 128". Component 128 "may be fixedly attached to tissue-engaging element 130 and component 128'. For example, and as shown, the component 128 "may be shaped to define a core 129, and the component 128" may serve as a cap secured to (e.g., on) the core. The core 129 may be disposed on the axis ax 1. The component 128' may also define and/or function as at least a portion of the interface 182. Component 128' may be farther from tissue-engaging element 130 than component 128".

The rotatable coupling of collar 184 to lugs 128 may be facilitated by the collar surrounding the lugs and by the axial restraint of one or more flanges 122 defined by the lugs (e.g., proximal flange 122 'defined by component 128', and/or distal flange 122 "defined by component 128").

Alternatively or additionally, rotatable coupling of eyelet 140 to collar 184 may be facilitated by an eyelet defining flange 142 disposed intermediate collar 184 and stem 144 extending laterally beyond the collar and connecting flange 142 to the aperture of the eyelet. In some applications, these components thereby form a swivel joint between eyelet 140 and collar 184. Fig. 2A-B illustrate two examples of this aspect. Fig. 2A shows collar 184 as an open collar 184a having free ends 186 that together support core pin 144 (e.g., the free ends are bearing surfaces). Fig. 2B shows collar 184 as a closed collar 184B that defines a recess 188 that supports core pin 144 (e.g., the collar defines a bearing surface that defines at least a portion of the recess).

As described above, the anchor 120 (e.g., its eyelet 140) is configured to facilitate sliding of the anchor along the tether (or sliding of the tether through the anchor) when the anchor is aligned with the tether (e.g., when the axis ax1 is parallel with the tether). This is assumed to facilitate transcatheter advancement of the anchor 120 along the tether. As also described above, the anchor 120 (e.g., its eyelet 140) is configured to facilitate sliding of the anchor along the tether (or sliding of the tether through the anchor) when the anchor is oriented orthogonal to the tether (e.g., when the axis ax1 is orthogonal to the tether). This is assumed to be particularly useful for applications in which the tether is tensioned after implantation in order to adjust the anatomical dimensions, such as annuloplasty. Fig. 3A-D illustrate an application in which tissue 10 represents tissue of an annulus of a native heart valve, such as a mitral or tricuspid valve, and implant 110 is an annuloplasty structure comprising a tether 112 (e.g., wire, string, ribbon, rope, braid, constriction member, suture, etc.) and a plurality of anchors 120.

Fig. 3A-D illustrate a system 100 that includes an implant 110 and a delivery tool 150 for percutaneous (e.g., transluminal, such as trans-femoral) implantation of the implant. Tool 150 includes a flexible anchor driver 160, which anchor driver 160 is configured to reversibly engage driver hub 182 of anchor 120. Via such engagement, driver 160 is configured to drive (e.g., screw) tissue-engaging element 130 into tissue 10. In some applications, the tool 150 further includes a flexible tube 152 (e.g., transluminal catheter), and each anchor 120 engaged with the driver 160 can be advanced through the flexible tube 152 to the tissue to which the anchor is to be anchored.

In fig. 3A, three anchors 120 have been anchored to tissue 10, and a fourth anchor is within the distal portion of tube 152. The sliding of the tether 112 proximally through the first of the anchors to be anchored is prevented by the presence of the stop 114a locked to the tether. Each of these anchors is advanced through tube 152 in a delivery state in which tether 112 extends through aperture 146 of eyelet 140 when generally parallel to axis ax 1. This is illustrated in inserts a and B in fig. 3A.

After a given anchor 120 has been anchored to tissue 10, tether 112 becomes orthogonally oriented relative to the given anchor, e.g., parallel to the tissue, as the subsequent anchors are anchored to the same tissue. The eyelet 140 is responsively rotated such that the tether 112 may still obtain a clear straight path through the eyelet aperture 146 along the now rotating sliding axis ax 3. This is illustrated in illustration C.

After a desired number of anchors 120 have been anchored (e.g., as shown in fig. 3C), an adjustment tool 190 is introduced (e.g., on and along the proximal portion of tether 112) and used to facilitate tensioning of the tether. When tether 112 is pulled proximally, a reference force is provided by the tool and/or by tube 152 (e.g., against the last anchor to be anchored). For example, due to the presence of stop 114a, the distal end of tether 112 cannot slide out of (e.g., be secured to) the first anchor. Thus, tensioning of tether 112 pulls anchors 120 closer to each other, thereby contracting the tissue to which the anchors are anchored (fig. 3C-D). This is facilitated by the eyelet 140 providing a smooth sliding of the tether 112 through the aperture 146 when the tether is orthogonal to the anchor, as described above. Tension is locked into implant 110, such as by securing second stop 114b to tether 112 near the last anchor. The excess tether 112 may then be cut and removed from the subject. Fig. 3D shows the state of the implant 110 after the stop 114b has been secured to the tether 112 and the excess tether has been cut and withdrawn into the adjustment tool 190, the adjustment tool 190 being shown retracted out of the subject.

In some applications, the stop 114B represents (or may be replaced with) a tether handling device, such as the tether handling devices 410 or 460 described below (mutatis mutandis), and/or a retraction member covering device, and/or a fastener (mutatis mutandis) such as those described with reference to fig. 35A-46B of WO2021/084407 of Kasher et al, which are incorporated herein by reference.

For simplicity, fig. 3A, 3C and 3D show implant 110 in a linear configuration. However, for annuloplasty, the implant 110 is typically implanted in a curvilinear (or even complete) fashion around the annulus, such that the constriction reduces the size of the annulus, improving the engagement of the leaflets. Fig. 4A and 4B show an implant 110 that has been partially implanted around the annulus (fig. 4A) where the mitral valve 12 and the annulus (fig. 4B) where the tricuspid valve 14 are implanted, respectively.

As described above, in some applications, the eyelet 140 is mounted for rotation about the axis ax 1. Thus, this provides independence between the rotational position of the eyelet and the rotational position of the tissue-engaging element 130. Given the application in which the tissue-engaging element 130 is helical, this independence advantageously allows the tissue-engaging element to be threaded into tissue to the extent necessary for optimal anchoring, without requiring the anchor to end up in a particular rotational orientation. It is further assumed that this independence allows eyelet 140 (and tether 112) to be in an optimal position relative to axis ax1 of each anchor 120 for a given application, regardless of the type of tissue-engaging element 130 used. For example, for applications in which implant 110 is used for annuloplasty, anchor 120 is typically anchored in a curvilinear fashion around the annulus, and eyelet 140 and tether 112 are typically disposed on the inside of the curvilinear line relative to axis ax 1.

In some applications (e.g., as described below with reference to fig. 29A-30B), the driver head 164 has an introduced state and a locked state, the anchor head 180 may be shaped to define a proximal opening through which the driver head may access the interface 182 when the driver head is in the introduced state (e.g., but not in the locked state), and the anchor driver 160 may be configured to lock the driver head 164 to the interface 182 by: the driver head is converted to a locked state by laterally moving a portion of the driver head.

In some applications, and as shown, tube 152 is shaped to control the rotational position of eyelet 140 relative to axis ax1 and/or tissue-engaging element 130 during delivery and anchoring. For some such applications, the tube 152 defines an internal passage (e.g., lumen) 154 that defines a primary passage area 154a and a secondary passage area 154B (fig. 3B). The primary channel region 154a has a larger cross-sectional area than the secondary channel region 154 b. Anchor 120 is slidable through channel 154 with tissue-engaging element 130 slid (typically tightly) through primary channel region 154a and eyelet 140 slid (typically tightly) through secondary channel region 154b and along tether 112. Rotation of the tube 152 thereby controls the position of the eyelet 140 and thus the position of the tether 112 about the axis ax1 of each anchor. While driver interface 182 and tissue-engaging element 130 may rotate within tube 152 (e.g., during threading of the tissue-engaging element into tissue 10), collar 184 and eyelet 140 (and thus tether 112) remain stationary, thereby reducing the likelihood of the tether becoming entangled on the anchor, twisted, or entangled. In some applications, and as shown, the channel 154 has a keyhole-shaped orthogonal cross section.

To anchor 120, the anchor is pushed out of the distal end of tube 152 as driver 160 rotates driver interface 182 (and thus tissue-engaging element 130) relative to the tube and as secondary channel region 154b generally prevents collar 184 from rotating relative to the tube. In some applications, it may be advantageous to place the distal end of the tube against tissue 10 (or even press against tissue 10) during anchoring of the anchor, for example, as shown in fig. 3A. In some applications, the tube 152 defines a lateral slit 156 extending proximally from the distal end of the tube such that the slit is continuous with the distal opening of the tube. In some applications, the slit 156 is adjacent to the secondary channel region 154b (e.g., laterally outward from the secondary channel region 154 b) and allows the tether 112, rather than the anchor 120, to exit the tube 152 laterally proximally from the distal end of the tube. It is believed that this facilitates implantation of an implant (such as implant 110) comprising a plurality of anchors coupled to (e.g., threaded on) a tether (e.g., wire, rope, ribbon, rope, braid, shrink member, suture, etc.), for example, by allowing tether 112 to exit tube 152 without being clamped to tissue, and/or by reducing the likelihood of inadvertent entanglement of the tether while anchoring the anchor.

In some applications, the width of the narrowest portion of the aperture 146 is no more than twice the thickness of the tether 112. For example, the narrowest portion of the aperture 146 may be no more than 50% wider than the thickness of the tether 112, such as no more than 20% wider, such as no more than 5% wider.

It should be noted that the anchor 120 remains threaded onto the tether 112 throughout the implantation and after implantation, regardless of changes in the orientation of the tether relative to the anchor during implantation. It is hypothesized that this advantageously reduces the likelihood of anchor embolization.

In some applications, the implant 110 includes one or more spacers or dividers 170 threaded onto the tether 112, typically with each spacer disposed between two anchors 120. Each spacer 170 may be tubular defining two ends and a lumen therebetween through which tether 112 passes with the ends of the spacer facing planar face 148 of anchor 120, the spacer being disposed between planar faces 148 of anchor 120.

The spacer 170 is flexible in terms of deflection and in some applications is resiliently flexible-meaning that it can deflect laterally by application of force and will resiliently return toward its resting shape upon removal of the force. In some applications, and as shown, the resting shape is an open cylinder. Although resiliently flexible in terms of deflection, the spacer 170 resists axial compression. In some applications, the spacer 170 is generally not axially compressible, meaning that in its resting shape, the spacer is not axially compressible by a force of the magnitude to which the spacer will be subjected in its normal use.

In some applications, the spacer 170 includes (e.g., is defined by) a wire shaped as a helical coil defining a lumen of the spacer. For some such applications, the spacer 170 is initially axially compressible (typically while providing a degree of axial compression resistance), and then typically becomes axially incompressible once compressed to the point where adjacent turns of the coil contact one another. In some applications, in the resting state of the coil, the pitch of the coil is small enough that the coil appears to be substantially closed, e.g. tubular. For example, the pitch of the coil may be less than twice the wire thickness (e.g., 1.4-2 times the wire thickness, such as 1.6-1.8 times the wire thickness, such as 1.7 times the wire thickness). In some applications, in the resting state of the coil, the coil is a closed coil, i.e. each turn of the coil is in contact with its adjacent coil.

In some applications, the slit 156 is sized to allow the spacer 170 threaded on the tether 112 to exit the tube 152 laterally proximally from the distal end of the tube.

Spacer 170 is configured to limit proximity between anchors 120 (between which spacer 170 is disposed). That is, as tether 112 is tensioned and anchors 120 become closer to one another, once the limit defined by the length of the spacer is reached, those anchors between which spacer 170 is disposed are prevented from further approaching one another.

In some applications, and as shown in the inset of fig. 3D, the ends of the spacer 170 are sized to abut, flush against the planar face 148 of the anchor 120. It is assumed that this results in a stable configuration as the contraction of tether 112 presses flat face 148 against the end of spacer 170. For example, the flat and flush interface is assumed to provide the tether 112 with a continuous lumen through the spacer 170 and the eyelet 140 while reducing the likelihood of tension on the tether causing lateral sliding of the spacer relative to the adjacent eyelet.

In some applications, anchor 120 and/or implant 110 may be used in conjunction with devices, systems, and/or implanted using methods/techniques (mutatis mutandis) described in one or more of the following references, each of which is incorporated herein by reference in its entirety for all purposes:

U.S. patent application 14/437,373 to Sheps et al, 4/21, 2015, published as US2015/0272734 (now U.S. patent 9,949,828);

U.S. patent application 15/782,687 filed on 10/12 in 2017 to Iflag et al, published as US2018/0049875 (now U.S. patent 10,765,514);

U.S. patent application 16/534,875 filed on 7 at 8.2019 by Brauon et al, published as US2020/0015971 (now U.S. patent 11,123,191);

International patent application PCT/IL2019/050777 to Brauon et al, published as WO 2020/012381;

international patent application PCT/IB2020/060044 to Kasher et al, published as WO2021/084407;

U.S. patent application Ser. No. 17/145,258, filed by Kasher et al at 2021, 1/0145584, published as US2021/0145584; and

international patent application PCT/IB2021/058665 filed by Halabi et al at 2021, 9, 23.

Furthermore, the techniques, methods, steps, etc. described or suggested in the incorporated references that may be used with the applications herein may be performed on living animals or on non-living simulations (e.g., on cadavers, cadaveric hearts, simulators (e.g., of body parts, tissues, etc. that are being simulated), etc.).

Referring to fig. 5A-D and 6A-C, fig. 5A-D and 6A-C are schematic illustrations of an anchor 220 for use with tissue (e.g., soft tissue) of a subject according to some applications. Fig. 5A shows a cross-sectional view, fig. 5B shows a cross-sectional view, fig. 5C shows an exploded view, and fig. 5D shows a projection. In some applications, anchor 220 may be used in place of other anchors described herein, mutatis mutandis. For example, in some applications, anchor 220 may be used in place of anchor 120 of implant 110 described above, and although anchor 220 is not described as having an eyelet for simplicity, an eyelet (such as eyelet 140) may be added to anchor 220 for use in implant 110.

Referring also to fig. 7A-C and 8A-C, fig. 7A-C and 8A-C are schematic illustrations of variations of anchor 220 (anchors 220' and 220", respectively) according to some applications. These variants can be used as described for anchor 220, mutatis mutandis, and have the same components and functions as anchor 220, unless otherwise stated.

Anchor 220 includes a housing 222 and a tissue-engaging element 230. The housing 222 has a tissue facing side 224 defining a tissue facing opening 225 from the interior of the housing to the exterior of the housing. In some applications, tissue-engaging element 230 is shaped to define a helix having a plurality of turns about axis ax4 (e.g., the central longitudinal axis of anchor 220) and having a distal tip 238 that may be sharpened.

Anchor 220 may be provided with a tissue-engaging element 230, with tissue-engaging element 230 disposed within housing 222 and positioned such that rotation of the tissue-engaging element about axis ax4 spirals distally out of opening 225. The tissue-engaging element 230 is configured to screw into tissue and anchor the housing 222 to tissue, with the tissue-facing side 224 serving as the head of the anchor 220. Fig. 6A-C illustrate examples of anchoring anchors 220 to tissue 10 according to some applications. It is contemplated that anchor 220 advantageously conceals tissue-engaging element 230 until anchoring, thereby reducing the likelihood of inadvertent and/or premature engagement of tissue or equipment, for example, during advancement and/or positioning of the anchor.

In some applications, and as shown, tissue-engaging element 230 is axially compressed within housing 222. For such applications, as the spirals are fed out toward the tissue opening 225, the proximal portions of the spirals progressively automatically (e.g., elastically) axially expand (fig. 6A-C) as they are disposed outside of the housing 222, e.g., the tissue-engaging element 230 is a compression spring. For some such applications, the portion of the spiral that is disposed outside the housing has an expanded pitch that is at least twice the original compressed pitch of the spiral when the spiral is disposed entirely within the housing. It is assumed that such a configuration of tissue-engaging element 230 advantageously (i) facilitates storing a greater number of helical turns within a given size of housing 222 than would be possible with a rigid tissue-engaging element, and/or (ii)) facilitates the exit of distal tip 238 from facing tissue opening 225 upon rotation of the tissue-engaging element.

As shown in fig. 6A, tissue-facing side 224 may be placed against tissue prior to rotation of tissue-engaging element 230. In some applications, this placement facilitates screwing tissue-engaging element 230 into tissue by preventing rotation of the housing relative to the tissue by contact between the tissue and housing 222 such that rotation of the tissue-engaging element (e.g., relative to the tissue) is also relative to the rotation of the housing. Screwing tissue-engaging element 230 into tissue further presses tissue-facing side 224 against the tissue. Variant anchor 220 'has a housing 222', which housing 222 'defines a clamping portion 226 on a tissue-facing side 224' of the housing, which clamping portion 226, when pressed against tissue, facilitates screwing tissue-engaging element 230 into tissue by further preventing rotation of the housing relative to the tissue.

Anchor 220 includes a driver interface 228 at a proximal portion of tissue-engaging element 230. By interfacing with interface 228, anchor driver 210 (which may be the same or different than driver 160) may rotate tissue-engaging element 230 and drive the tissue-engaging element into tissue. In some applications, and as shown, interface 228 is rotationally locked with the screw of tissue-engaging element 230. In the example shown, interface 228 includes a rod that may be transverse to axis ax4 and may be defined by a proximal portion of tissue-engaging element 230. For example, a single piece of material (e.g., wire) may be shaped to define both the helix and the interface 228 of the tissue-engaging element 230. However, other configurations of drives and drive interfaces may be used, including those described elsewhere herein.

The housing 222 may have a driver side 234, which driver side 234 defines a driver opening 236 from the interior of the housing to the exterior of the housing, in some applications, to provide access to the interface 228. In some applications, and as shown, the driver opening 236 is disposed in front of the interface 228, and/or the interface is visible through the driver opening. For applications in which interface 228 includes a rod, the rod may be parallel to driver opening 236 (i.e., parallel to the plane in which the opening lies).

In some applications, and as shown, driver side 234 is opposite (e.g., parallel) to tissue facing side 224.

At the distal portion of anchor driver 210, the driver has a driver head 214, which driver head 214 is configured to engage interface 228 and rotate the tissue-engaging element by applying torque to the interface, e.g., as described for anchor 120, mutatis mutandis. In some applications, the driver head 214 is sized to access the interface 228 from outside the housing 222 via the driver opening 236.

As shown, anchor 220 may be configured such that screwing tissue-engaging element 230 into tissue moves interface 228 and/or the proximal portion of the tissue-engaging element toward tissue-facing side 224. As shown, this may ultimately result in sandwiching the tissue-facing side 224 between the tissue and the interface/proximal portion of the tissue-engaging element. In some applications, and as shown, this movement of the interface 228 and/or proximal portion of the tissue-engaging element is also movement away from the driver side 234. However, in the variant anchor 220 "shown in fig. 8A-C, the housing 222" of the anchor is resilient and configured to automatically contract as the spiral is distally fed out of the tissue-facing opening 225 such that the driver side 234 follows the interface/proximal portion of the tissue-engaging element toward the tissue-facing side 224.

Referring to fig. 9A-C and 10A-C, fig. 9A-C and 10A-C are schematic illustrations of a tissue anchor 240 according to some applications. In some applications, the anchor 240 may be used as a component of an implant, such as an implant comprising a plurality of anchors connected by tethers (e.g., wires, lines, ropes, straps, ropes, braids, constriction members, sutures, etc.). For example, anchors 240 may be used in implant 110 instead of anchors 120, mutatis mutandis. For this reason, the anchor 240 is shown to include an eyelet 242, which eyelet 242 may be similar (or identical), mutatis mutandis, to the eyelet 140 described above or to the eyelet described in WO2021/084407 by Kasher et al, which is incorporated herein by reference. In some applications, the anchor 240 may be used for other purposes and may not include an eyelet.

The anchor 240 includes a tissue-engaging element 241, the tissue-engaging element 241 having a sharpened distal tip 244 and a hollow body 246 proximal to the tip 244. Hollow body 246 is shaped to define a chamber 254 and a sidewall 256 surrounding the chamber. The central longitudinal axis ax5 of the anchor 240 generally passes through the chamber 254 and the tip 244. One or more (e.g., two) ports 258 are defined in the sidewall 256.

The anchor 240 (e.g., the tissue-engaging element 241 thereof) further includes a spring 260, the spring 260 generally including an elongated element 261 having two ends 262 and defining a loop 264 therebetween. A ring 264 may be disposed within the chamber 254. In some applications, the spring 260 is a helical torsion spring. In some applications, and as shown, end 262 is sharpened, for example, to facilitate its penetration through tissue 10.

In the first state of the anchor 240, the spring 260 is constrained (e.g., medially) by the sidewall 256, for example, as shown in fig. 9A, 9C, 10A, and 10B. As described in more detail below, the anchor 240 may transition from a first state to a second state in which the spring 260 (e.g., its elongate element 261) is under less strain relative to the first state and the ends 262 are disposed farther apart from each other (e.g., as shown in fig. 10C). In the second state, each of the ends 262 protrudes laterally from the hollow body 246 via the respective port 258. Typically, in the first state, the end does not protrude laterally from the hollow body.

In some applications, the anchor 240 has an anchor head 250, which anchor head 250 may include a driver interface 252, which driver interface 252 is configured to be reversibly engaged by an anchor driver 280. In some applications, the driver 280 may be identical to the driver 160 described above, mutatis mutandis.

Fig. 10A-C illustrate a typical use of the anchor 240. The anchor 240 can be delivered into the subject while the anchor is in its first state (fig. 10A) and advanced distally into the tissue 10, typically with a tip 244 piercing the tissue (fig. 10B). Such propulsion may be primarily axial, e.g., with little or no rotation. Once hollow body 246 (or at least port 258) is disposed within tissue 10, the anchor is transitioned to its second state such that end 262 projects laterally from hollow body 246 via port 258 and into tissue 10, thereby securing the anchor in the tissue (fig. 10C).

Due to the nature of the spring 260, in some applications, the loop 264 becomes smaller as the anchor 240 transitions from its first state to its second state.

In some applications, the ring 264 moves axially (e.g., distally) within the chamber 254 when the anchor 240 transitions from its first state to its second state, for example, as shown by the transition from fig. 10B to fig. 10C.

In some applications, and as shown, in the first state, the end 262 is disposed distally from the ring 264. Alternatively, in the first state, the end 262 may be disposed proximally from the ring 264. In some applications, and as shown, in the second state, tip 262 is disposed proximally from ring 264 (but outside of body 246). Alternatively, in the second state, the end 262 may be disposed distally from the ring 264.

In some applications, and as shown, spring 260 is biased to automatically transition the anchor to the second state. For such applications, to retain the anchor 240 in its first state (e.g., for transluminal delivery and/or insertion into tissue), the retainer 282 may be used. The retainer 282 may be coupled to the spring 260 in a manner that resists movement of the spring 260. In the example shown, to transition the anchor 240 from its first state to its second state, the loop 264 is moved distally within the chamber 254. Retainer 282 retains anchor 240 in its first state by preventing spring 260 (e.g., ring 264 thereof) from moving distally within the chamber, thereby preventing end 262 from sliding out of port 258.

In some applications, at least one window 266 is defined in the sidewall 256, and the retainer 282 is configured to retain the anchor 240 in the first state by extending through the window and into the loop 264. For example, and as shown, two windows 266 may be defined in the side wall 256, and the retainer may extend through one window, through the ring, and out the other window. For some such applications, the two windows may be opposite each other and rotationally offset from the two ports 258. For example, port axis ax6 through port 258 may be orthogonal to window axis ax7 through window 266. Axis ax6 and/or axis ax7 may intersect axis ax 5. In some applications, and as shown, window 266 is axially offset from port 258.

Referring to fig. 11A-D and 12A-E, fig. 11A-D and 12A-E are schematic illustrations of respective systems 300 and 320 according to some applications. System 300 includes a tissue anchor 302 and a tool 310, and system 320 includes a tissue anchor 322 and a tool 330. In some applications, anchor 302 and/or anchor 322 can each be used as part of an implant, such as an implant comprising multiple anchors connected by tethers (e.g., wires, lines, ropes, bands, ropes, braids, shrink members, sutures, etc.). For example, anchor 302 and/or anchor 322 can be used in implant 110 in place of anchor 120, mutatis mutandis. In this case, anchor 302 and/or anchor 322 (e.g., the head thereof) may include an eyelet. Anchor 302 is shown with head 303 including eyelet 304 and anchor 322 is shown without eyelet. In some applications, anchor 302 and/or anchor 322 may have an aperture similar (or identical) to aperture 140 described above or to the aperture described in WO2021/084407 by Kasher et al, which is incorporated herein by reference, mutatis mutandis. Alternatively, the anchor 240 may be used for other purposes and may not include an eyelet, as shown.

The tool 310 is advanceable to the heart and includes a tube 312 and a driver 314 extending through at least a portion of the tube. The driver 314 reversibly engages the head 303 of the anchor 302. For simplicity, this engagement is not described in detail herein, but in some applications it is as described for one or more of the other anchors and drivers described herein. Tube 312 has a distal end defining an opening 316. The anchor 302 includes a tissue-engaging element 306 and is configured to be anchored to tissue 10 by driving the tissue-engaging element into the tissue.

Tool 330 may be advanced to the heart and includes a tube 332 and a driver 334. The driver 334 reversibly engages the head 323 of the anchor 322. For simplicity, this engagement is not described in detail herein, but in some applications it is as described for one or more of the other anchors and drivers described herein. Tube 332 has a distal end defining an opening 336. Anchor 322 includes a tissue-engaging element 326 and is configured to be anchored to tissue 10 by driving the tissue-engaging element into the tissue.

For each of systems 300 and 320, the anchor is at least partially disposed within the tube during transluminal advancement, and/or immediately prior to anchoring the anchor. As shown, for system 300, anchor 302 can be disposed entirely within tube 312, and for system 320, at least a distal tip of anchor 322 (e.g., of tissue-engaging element 326) can be exposed from opening 336.

Each of the tools 310 and 330 is configured to penetrate the distal end of the respective tube into tissue 10 while the respective anchor remains at least partially disposed within the respective tube such that the opening is submerged within the tissue (fig. 11C and 12C).

Each of drivers 314 and 334 extends through at least a portion of its respective tube, with the distal end of the driver reversibly engaging a respective anchor within the tube. The driver is configured to drive the tissue-engaging elements of the respective anchors out of the openings of the respective tubes and into tissue 10 while the openings remain disposed within the tissue.

In some applications, and as shown, the distal ends of tubes 312 and 332 are tapered and/or sharpened.

In some applications, for each of systems 300 and 320, at least a portion of the tissue-engaging element is constrained by the tube (e.g., during transluminal advancement and/or immediately prior to anchoring the anchor) and configured to automatically change shape within the tissue upon exiting the opening. For example, the tissue-engaging element 306 of the anchor 302 includes one or more tines 308 that automatically deflect and/or bend (e.g., laterally) after exiting the opening 316, and the tissue-engaging element 326 of the anchor 322 includes one or more flanges that automatically deflect, expand and/or bend (e.g., laterally) after exiting the opening 336.

In some applications, the tines 308 are metallic, e.g., include a superelastic and/or shape memory material (such as nitinol). In some applications, flange 328 includes a sheet and a self-expanding frame that supports the sheet. In some applications, flange 328 (e.g., a sheet thereof) comprises a polymer.

In some applications, and as shown (e.g., in fig. 11A-B), the tube 312 defines a channel 313, the channel 313 having a central channel region 313a and lateral channel regions 313B, and houses the anchor 302, with the head of the anchor (in the example shown, the head of the anchor includes the eyelet 304) disposed in the central channel region, and each of the tines 308 disposed in a respective one of the lateral channel regions such that within the channel, the anchor is axially slidable but prevented from rotating. It is assumed that this provides similar advantages to those described as provided by the construction of the channels of the system 100, mutatis mutandis.

In some applications, and as shown, the channel 313 is wider at the central channel region 313a than at the lateral channel regions 313 b.

The opening 316 may be defined by a channel 313 to the distal end of the tube 312. In some applications, and as shown, the shape of the opening 316 (e.g., along with the taper of the distal end of the tube 312) shapes the distal end of the tube 312 to resemble a beak.

In some applications, system 320 is configured such that during transluminal advancement and/or immediately prior to anchoring, distal tip 329 of tissue-engaging element 326 of anchor 322 is disposed outside (e.g., distal) opening 336, and tool 330 is configured to penetrate the distal end of tube 332 into tissue 10 such that the opening is submerged within the tissue when the distal tip is disposed outside of the opening (fig. 12C). For such applications, anchor 322 (e.g., tissue-engaging element 326 thereof) is shaped to fit snugly within opening 336 such that when tool 330 penetrates the distal end of tube 332 into tissue 10, the anchor (e.g., tissue-engaging element thereof) blocks the opening. It is hypothesized that this configuration advantageously facilitates penetration of tissue 10 without entry into tube 332. For some such applications, and as shown, the distal tip 329 and the distal end of the tube 332 together define a taper point, the distal tip being the distal portion of the taper point, and the distal end of the tube being the proximal portion of the taper point. This configuration is assumed to promote smooth access to tissue 10.

13-17, FIGS. 13-17 are schematic illustrations of respective tissue anchors according to some applications. In some applications, these anchors may each be used as part of an implant, such as an implant comprising multiple anchors connected by tethers (e.g., wires, lines, ropes, bands, ropes, braids, constriction members, sutures, etc.). For example, these anchors can be used in implant 110 instead of anchor 120, mutatis mutandis. Each of these anchors has an eyelet, which is shown in fig. 13-17 as a simple loop, but may alternatively be similar (or identical) to the eyelet 140 described above or to the eyelet described in WO2021/084407 of Kasher et al (mutatis mutandis), which is incorporated herein by reference for all purposes. Alternatively, these anchors may be used for other purposes and may not include eyelets, as shown.

Fig. 13 shows a tissue anchor 350 comprising a head 351 and a plurality of tissue-engaging elements 352. The head 351 has a tissue facing side 353 and an opposite side 354 defining an aperture 355. The tissue-engaging elements 352 are laterally disposed from the head 351 and each have a sharp tip. In the delivery state of the anchor 350 (left frame), the tissue-engaging element 352 is configured to be driven linearly into the tissue 10 (middle frame). When the tissue-engaging element 352 is disposed within tissue, the transition of the anchor 350 (e.g., the tissue-engaging element thereof) toward the clamped state causes the tips to face each other and press the tissue-facing side 353 of the head 351 against the tissue (right frame).

14-17 illustrate a corresponding tissue anchor similar to anchor 350, with additional features of the tissue-facing side of the head of the anchor defining a grip. For these tissue anchors, the transition of the anchor towards its clamped state presses the clamping portion against the tissue.

Fig. 14 shows a tissue anchor 360 comprising a head 361 and a tissue-engaging element 362. Head 361 has a tissue-facing side 363 shaped to define a clamping portion 366 and an opposite side 364 defining an aperture 365. The tissue-engaging elements 362 are laterally disposed from the head 361 and each have a sharpened tip. In the delivery state of anchor 360 (left frame), tissue-engaging element 362 is configured to be driven linearly into tissue 10, e.g., such that clamping portion 366 contacts tissue (middle frame). When the tissue-engaging element 362 is disposed within tissue, the transition of the anchor 360 (e.g., the tissue-engaging element thereof) toward the clamped state causes the tips to face each other and press the clamping portion 366 against the tissue (right frame).

Fig. 15 shows a tissue anchor 370 comprising a head 371 and a tissue-engaging element 372. The head 371 has a tissue-facing side 373 shaped to define a clamping portion 376 and an opposite side 374 defining an aperture 375. Tissue-engaging elements 372 are disposed laterally from head 371 and each has a sharp tip. In the delivery state of anchor 370 (left frame), tissue-engaging element 372 is configured to be driven linearly into tissue 10, e.g., such that clamping portion 376 contacts tissue (middle frame). When the tissue-engaging element 372 is disposed within tissue, the transition of the anchor 370 (e.g., the tissue-engaging element thereof) toward the clamped state causes the tips to face each other and press the clamp 376 against the tissue (right frame).

Fig. 16 shows a tissue anchor 380 comprising a head 381 and a tissue-engaging element 382. The head 381 has a tissue facing side 383 shaped to define a clamping portion 386 and an opposite side 384 defining an aperture 385. Tissue-engaging element 382 is disposed laterally from head 381 and each has a sharpened tip. In the delivery state of anchor 380 (left frame), tissue-engaging element 382 is configured to be driven linearly into tissue 10, e.g., such that clamping portion 386 contacts tissue (middle frame). When tissue-engaging element 382 is disposed within tissue, transition of anchor 380 (e.g., its tissue-engaging element) toward the clamped state causes the tips to face each other and press clamping portion 386 against the tissue (right frame).

Fig. 17 shows a tissue anchor 390 comprising a head 391 and a tissue-engaging element 392. The head 391 has a tissue facing side 393 shaped to define a clamping portion 396 and an opposite side 394 defining an aperture 395. Tissue-engaging elements 392 are disposed laterally from head 391 and each has a sharpened tip. In the delivery state of anchor 390 (left frame), tissue-engaging element 392 is configured to be driven linearly into tissue 10, e.g., such that clamping portion 396 contacts tissue (middle frame). When tissue-engaging element 392 is disposed within tissue, the transition of anchor 390 (e.g., the tissue-engaging element thereof) toward the clamped state causes the tips to face each other and press clamping portion 396 against the tissue (right frame).

Reference is again made to fig. 13-17. In some applications, the transition of the tissue-engaging element toward the clamped state squeezes tissue between the plurality of tissue-engaging elements.

Reference is again made to fig. 13-17. In some applications (e.g., as shown for anchor 380), each of the tissue-engaging elements has a deflecting portion and a stationary portion connecting the deflecting portion to the head, both of which are configured to be driven linearly into tissue when the tissue-engaging element is in a delivery state. For such applications, the tissue-engaging element may be configured such that when the tissue-engaging element transitions toward the clamped state, (i) the stationary portion remains stationary relative to the head, and (ii) the deflecting portion deflects relative to the stationary portion and relative to the head.

Reference is again made to fig. 13-17. In some applications (e.g., as shown for anchors 360, 370, and 380), each of the tissue-engaging elements has a medial side and a lateral side, the medial side is closer to the other tissue-engaging elements than the lateral side (at least in the delivery state), and each of the tissue-engaging elements is shaped to define barbs (367, 377, 387) on the lateral side. For some such applications (e.g., as shown for anchor 360), in the delivery state, the barb is covered (e.g., by another portion of the tissue-engaging element) and in the gripping state, the barb is exposed. For some such applications in which the tissue-engaging element additionally has a stationary portion and a deflecting portion, the barbs may be defined by the stationary portion. For other such applications, the barbs may be defined by a deflecting segment.

Referring now to FIGS. 18A-C, 19A-D, 20A-C, and 21A-E, FIGS. 18A-C, 19A-D, 20A-C, and 21A-E are schematic illustrations of tether handling systems 400 and 450, each including a respective tether handling device 410, 460, according to some applications. Tethers are used in a variety of medical procedures, including as sutures and/or as components of implants. It is often necessary to lock or secure such tethers at some point in the procedure. In the above example of tether 112 of implant 110, a stop (e.g., stop 114 b) is used for this purpose. For example, each of the tether steering devices 410 and 460 may be used to secure a tether, such as tether 112, in lieu of stop 114b and/or for similar purposes in the implants described in WO2021/084407 to Kasher et al, which is incorporated herein by reference for all purposes.

Furthermore, each of the tether handling devices 410 and 460 may also be used in applications in which the tether is to be severed (e.g., as described with respect to the system 100) by being configured to manage a remaining portion of the tether, e.g., by moving, restraining, covering, and/or covering it. This is assumed to be particularly advantageous for applications in which the cut end of the tether is hard and/or sharp, so as to reduce the likelihood that the hard and/or sharp cut end will damage adjacent tissue.

In some applications, for the system 100 described above (and other similar systems), such locking and manipulation of the tether 112 is performed after the final anchor of the implant has been implanted. In fig. 19A-D and 21A-E, the final anchor is represented by a block indicated by reference numeral 120 f. The block may schematically represent the head of the final anchor, or a component of the head (such as an eyelet).

Fig. 18A-C and 19A-D illustrate a system 400 including a tether steering device 410, for example, for use with system 100 in place of stop 114 b. Fig. 18A shows a projection, fig. 18B shows an exploded view, and fig. 18C shows a cross section.

The device 410 includes a housing 412, the housing 412 being shaped to define a passage 414 therethrough. The device 410 further includes a clamp 416, the clamp 416 being coupled to the housing 412 and biased to clamp onto the tether 112 within the channel 414 in a manner that prevents the housing (and locking device as a whole) from sliding relative to the tether.

In some applications, the device 410 further includes an arm 420 extending proximally from the housing 412. The arm 420 may include a conduit 422 shaped to receive a portion of the tether proximally from the housing. The conduit 422 may be circumferentially closed or, as shown, may have open lateral sides. The arm 420 may also include a lever 424, the lever 424 coupling the conduit 422 to the housing 412 and being biased to place the conduit in an offset position relative to the channel 414. An example of such offset positions is shown in fig. 19D, described below.

The system 400 also includes a tool 430, the tool 430 including a tube 432. Fig. 18A and 19A illustrate a delivery state of the system 400 in which the tool 430 is coupled to the device 410. In the delivery state, tube 432 is (i) disposed within channel 414 in a manner that prevents clamping of clamp 416, and (ii) disposed within tube 422 in a manner that constrains the tube in a coaxial position relative to the channel (i.e., despite the bias of lever 424). For example, and as shown, tube 432 may extend distally through conduit 422 and into channel 414.

It should be noted that in this context, the term "coaxial" (including in the specification and claims) means that the tether 112 may extend between the channel 414 and the conduit 422 while remaining substantially straight.

After final anchor 120f has been anchored, tether 112 remains proximally extending from the final anchor. In the delivery state, device 410 is transluminally slid distally over tether 112 and along tether 112 toward anchor 120f, with the tether extending through channel 414 (fig. 19A). In some applications, tether 112 passes through channel 414 after final anchor 120f has been implanted, and the anchor driver for anchoring the final anchor has been withdrawn. In some applications, tool 430 includes a pusher member (e.g., pusher) 438 that reversibly engages device 410 (e.g., housing 412 thereof) and is used to transluminally slide device 410 over tether 112 and along tether 112 toward anchor 120 f. The tube 432 may be disposed laterally from the pusher member 438, or through the pusher member (as shown).

In some applications, once device 410 is disposed at anchor 120f, in order to contract the tissue to which implant 110 is anchored, tension may be applied to tether 112 by pulling the tether (e.g., from outside the subject) as a reference force is provided by device 410 against anchor 120f (e.g., device 410 is pushed against anchor 120f by pushing member 438). Tension is then locked into implant 110 by securing device 410 to tether 112, by retracting tube 432 out of channel 414 until it no longer blocks grip 416 and the grip thereby automatically grips onto the tether (fig. 19B).

Once the tube 432 has been fully retracted (e.g., out of the tube 422), the tether 112 is typically cut at a location proximal to the tube 422 (fig. 19C). The final release of the arm 420 triggers the lever 424 to move the conduit 422 to an offset position relative to the channel 414 (fig. 19C-D). It should be noted that in this context, the term "offset" (including in the specification and claims) means that the tether 112 must be bent in order for the tether to extend between the channel 414 and the conduit 422. In some applications, and as shown, lever 424 is biased to place conduit 422 against the proximal side of housing 412.

Cutting of tether 112 may be performed using cutter 434, which cutter 434 may be part of tool 430. Cutter 434 may be advanceable on tether 112 and along tether 112 and axially movable relative to tube 432 (e.g., advanceable on tube 432 and along tube 432), e.g., slidable within the cutter. The advancement member 438 is shown as having been removed prior to advancement of the cutter 434 (or at least prior to cutting of the tether 112), but in some applications the cutter 434 may be advanced through the advancement member 438.

In some applications, the system 400 is configured to have an intermediate state in which the tube 432 has been retracted from the channel 414, but not from the conduit 422. For some such applications, in the intermediate state, the distal portion of tube 432 remains disposed within housing 412, e.g., proximal to channel 414 and/or clip 416. In the intermediate state, the tube 432 no longer blocks the clamp 416, and the clamp thereby automatically clamps onto the tether 112. Fig. 19B shows an example of such an intermediate state.

In some applications, the bias of tether 112 relative to lever 424 has sufficient tensile strength that tension on tether 112 proximally from grip 416 may prevent the lever from moving conduit 422 to the biased position even in the absence of tube 432. However, this tension is relieved upon cutting of tether 112, and trigger lever 424 moves conduit 422 to the offset position as described above.

Cutting of the tether 112 typically leaves a residual portion of the tether. For example, and as shown, cutting tether 112 proximally from conduit 422 may leave a residual portion of the tether protruding proximally from the conduit. The arm 420 is configured such that movement of the conduit 422 to the offset position moves the residual portion of the tether 112 toward the housing 412, e.g., restrains the residual portion in proximity to the housing. In some applications, the final curved shape of the residual portion of the tether 112 means that the residual portion is pulled into the conduit 422 such that the end of the tether is within the conduit.

Figures 20A-C and 21A-E illustrate a system 450 that includes a tether steering device 460, for example, for use with the system 100 in place of the stop 114 b. The system 450 may be used for purposes similar to the system 400, mutatis mutandis. Fig. 20A shows a projection of the device 460, fig. 20B shows an exploded view, and fig. 20C shows a cross section. The system 450 also typically includes a tool 480 described below.

The device 460 includes a clamp 462, the clamp 462 including a chuck 464 and a spring 472. Chuck 464 has a longitudinal axis ax8 and includes a sleeve 466 and a collet 470. The sleeve 466 is shown as comprising two discrete sub-components secured together. In fig. 20B only, these sub-components are labeled 466a and 466B. In some applications, the entire sleeve 466 is made of a single integral member (e.g., a single piece of stock). The clamp 470 is shown as comprising two discrete sub-components. However, the collet 470 may alternatively comprise three or more sub-components. Further, the sub-components of the collet 470 may not be discrete, e.g., they may be movable (e.g., flexible) portions integrated into a unitary member, e.g., made from a single piece of stock.

In some applications, the sleeve 466 surrounds an axis ax8 (e.g., defining the axis ax8 as the longitudinal axis of the chuck 464) and has a tapered inner surface 468. The collet 470 may be disposed within the sleeve 466 and sized to receive a tether (such as the tether 112) therethrough (e.g., sized to define a passage therethrough). The spring 472 pushes the collet 470 axially against the surface 468 such that the collet is compressed inboard by the sleeve 466 (e.g., by the surface 468 thereof). When the tether 112 is present within the collet 470, such squeezing of the collet causes the collet to clamp onto the tether, thereby preventing the tether from sliding through the collet in at least one axial direction. The axial direction may be distally (in fig. 21A-E, this is to the right relative to the collet 470). Typically, this axial direction is the same axial direction that the spring 472 pushes the collet 470 axially against the surface 468 (which is the rightward direction relative to the sleeve 466 in fig. 21A-E).

In some applications, the inner surface of the collet 470 is roughened or knurled to facilitate gripping of the tether 112.

In some applications, and as shown, the sleeve 466 and the collet 470 are concentric with the axis ax 8. Spring 472 may also be concentric with axis ax8 as shown.

In some applications, the spring 472 is a compression spring, such as a helical compression spring, as shown. For some such applications, and as shown, the spring 472 encircles the axis ax8, and the device 460 is configured to be threaded onto the tether such that the sleeve 466, collet 470, and spring encircle the tether.

In some applications, and as shown, the sleeve 466 has an opposing surface 469, and the spring 472 is maintained in a compressed state between the opposing surface and the collet 470 (e.g., in a relaxed state of the spring, the spring is longer than the distance between the opposing surface and the collet). That is, for such applications, the spring 472 applies an opposing force to the surface 469 as the collet 470 is pushed axially against the surface 468.

21A-E illustrate steps in an example procedure for using the system 450 according to some applications. The device 460 is threaded onto the tether 112 (fig. 21A). This may be performed after the final anchor 120f has been anchored to the tissue. Tool 480 (e.g., tubular member 482 thereof) is used to push device 460 distally on cable 112 and along cable 112 toward final anchor 120f (fig. 21B-C). Once the device 460 is in contact with the final anchor 120f, the tool 480 provides a reference force against the final anchor via the device 460 to facilitate tensioning of the tether 112 as the tether is pulled proximally (fig. 21C). Once the desired degree of tension (or desired degree of tissue contraction) is reached, the tether 112 is cut proximally from the clamp 462 using the cutter 484 and the tool 480 is removed from the subject (FIGS. 21D-E). The grip 462 maintains tension on the tether 112 by preventing the tether from moving relative to the grip. Cutter 484 may be a component of tool 480 that is disposed within tubular member 482, for example. The cutter 484 may be axially fixedly positioned (e.g., as shown) relative to the tubular member 482, or may be axially movable within the tubular member.

In some applications, and as shown, the grip 462 is configured to prevent the tether 112 from sliding through the collet 470 only in a first axial direction and to facilitate sliding of the tether through the collet 470 in an opposite second axial direction (to the left in fig. 21A-E). It is assumed that this advantageously avoids the need to actively unlock and/or lock the clamp 462. For example, and as shown in fig. 21B-C, pushing the grip 462 distally along the tether 112 moves the tether proximally through the grip (e.g., through its sleeve 466) such that the tether pushes the collet 470 axially away from the surface 468 (and against the spring 472), thereby releasing/reducing the clamping of the tether by the collet, and allowing the tether to slide proximally through the grip. This urging of the collet 470 is represented by the small gap between the collet and the surface 468 in the illustration of fig. 21C, wherein the tether 112 moves proximally relative to the clamp 462 (e.g., as compared to the illustration of fig. 21A, wherein the tether is fixed relative to the clamp).

As described above, the grip 462 (e.g., the chuck 464 thereof) facilitates unidirectional sliding of the device 460 along the tether 112. To facilitate the techniques described above, the device 460 may be threaded onto the tether 112 in an orientation in which the one-way is distal (i.e., such that the grip 462 (e.g., the device 460 as a whole) is slidable distally along the tether but prevented from sliding proximally along the tether). This orientation thus defines grip 462 as having a proximal end 463p and a distal end 463d, which may slide distally along cord 112, with the distal end guiding the proximal end. Surface 468 generally tapers toward distal end 463 d.

As described with reference to system 400, cutting of tether 112 may leave, with the necessary modifications, a residual portion of the tether protruding proximally from, for example, chuck 464. Also as described above, it is assumed that it is advantageous to move, restrain, cover and/or conceal the remaining portion of the tether. In some applications, the device 460 includes a sheath 474 that is resiliently coupled to the sleeve 466. In the rest state, the sheath 474 extends proximally from the sleeve 466 (fig. 21A). The resilient coupling of the sheath 474 to the sleeve 466 is such that (i) by applying a distally directed force to the sheath, the sheath can be retracted distally on the sleeve, and (ii) the sheath automatically re-extends proximally in response to removal of the distally directed force. In some applications, the sheath is rigid, at least in terms of deflection.

In some applications, the tool 480 is configured to provide such distally directed force, for example, when the device 460 is pushed distally along the tether 112. For example, at least a distal portion of the tool 480 (e.g., the tubular member 482 thereof) may be sized to contact the sheath 474 in a manner that causes the sheath to be retracted distally by the tool pushing the device 460 distally (fig. 21B-C). For some such applications, and as shown, the sheath 474 is retracted sufficiently such that the tool 480 (e.g., the tubular member 482 thereof) contacts the sleeve 466.

In some applications, and as shown, the cutter 484 cuts the tether 112 as the sheath 474 is retracted distally (fig. 21D) so that upon withdrawal of the tool 480 (and thereby removal of distally directed force applied to the sheath by the tool), the sheath automatically re-extends proximally and encases the remaining portion of the tether (fig. 21E).

In some applications, the resilient coupling of the sheath 474 to the sleeve 466 is provided by a spring 476, e.g., the spring 472 is a collet spring, and the spring 476 is a sheath spring. The spring 476 may be laterally disposed from the sleeve 466, e.g., surrounding the sleeve. As shown, the spring 476 may be a coil spring. The spring 476 may be a compression spring mounted such that when a distally directed force is applied to the sheath 474 and the sheath is responsively retracted over the sleeve 466, the spring 476 is pressed against a flange 478 extending laterally from the sleeve 466.

As shown, spring 476 may be sufficiently weak (e.g., have a sufficiently low spring constant) relative to spring 472 such that jacket 474 is fully retracted (e.g., tool 480 contacts sleeve 466) during distal advancement of device 460 along cord 112. Alternatively, the spring 476 may be sufficiently strong (e.g., have a sufficiently high spring rate) relative to the spring 472 to urge the device 460 along the tether 112 without fully retracting the sheath 474. For example, sheath 474 may be further retracted when anchor 120f prevents further distal advancement of device 460.

22A-B, 23A-B, and 24A-D, FIGS. 22A-B, 23A-B, and 24A-D are schematic illustrations of various tensioners according to some applications. Fig. 22A-B illustrate tensioner 500, fig. 23A-B illustrate tensioner 530, and fig. 24A-D illustrate tensioner 560.

A tissue modifying implant (such as implant 110 described above) including a tether (e.g., wire, rope, ribbon, rope, braid, shrink member, suture, etc.) that is tensioned to cause tissue shrinkage may exert a force on the tissue at the location where the tether is anchored to the tissue (e.g., at the location where the tissue anchor is anchored). It is assumed that in some applications it is advantageous to delay the application of at least some tension to the tether, e.g., so that tissue recovery and/or growth after anchoring may enhance anchoring, thereby reducing the likelihood of de-anchoring or other detrimental events occurring before (or after) a desired final amount of tether tensioning and tissue contraction has been achieved.

Although tensioners 500, 530 and 560 are described herein for use with implant 110, it should be noted that the scope of the present disclosure includes the use of these tensioners in other contexts, such as with other tissue modifying implants, mutatis mutandis. Similarly, while the tensioner is shown as being used with anchor 120 (which is a tissue piercing anchor), it should be noted that the tensioner may alternatively or additionally be used with clips or other types of anchors, mutatis mutandis.

Each of tensioners 500, 530, and 560 is configured to be coupled to at least one tether (e.g., tether 112) between two anchors (e.g., anchors 120) and includes a spring and a constraint that constrains the spring in an elastically deformed shape. The constraint is bioabsorbable such that, after implantation of the implant within the heart, decomposition of the constraint releases the spring from the constraint. The spring is configured to automatically move away from the elastically deformed state toward a second shape (e.g., a relaxed or resting shape) upon release from the constraint. The coupling of the spring to the tether is such that movement of the spring away from the elastically deformed state toward the second shape pulls the two anchors toward each other via the tether. That is, the dissolution of the constraint allows the spring to apply tension to the tether, pulling the anchors toward each other. Tensioners 500, 530, and 560 can thus be considered delay tensioners. Typically, when the implant is implanted (e.g., during the same procedure), a degree of tension is applied to the tether and additional tension is applied by the spring after the constraint breaks down. It should be noted that the spring may not actually reach its second shape due to the tension on the tether 112.

According to some applications, there is provided an implant comprising: a first anchor; a second anchor; and at least one tether coupling the first anchor to the second anchor. A tensioner may also be coupled to at least one tether between the first anchor and the second anchor and may include a spring and a restraint that restrains the spring in an elastically deformed shape of the spring.

In some applications, the constraint is bioabsorbable such that, after implantation of the implant within the heart, the decomposition of the constraint releases the spring from the constraint. In some applications, the spring is configured to automatically move away from the elastically deformed state toward the second shape upon release from the constraint. In some applications, the coupling of the spring to the at least one tether is such that the movement of the spring away from the elastically deformed state toward the second shape pulls the first anchor and the second anchor toward each other via the at least one tether.

In some applications, there is provided an implant comprising: a tether, an anchor slidably coupled to the tether and configured to anchor the tether to tissue of the heart, a spring having a stationary state and coupled to the tether in a manner that applies tension to the tether as the spring moves toward the stationary state, and a constraint.

In some applications, the constraint is coupled to the spring in a manner that prevents the spring from moving toward the resting state. In some applications, the constraint comprises a material configured to decompose within the heart, and is configured such that the decomposition of the material reduces resistance of the constraint to the spring.

Fig. 22A-B illustrate an example of a tensioner in the form of tensioner 500 according to some applications. Tensioner 500 is shown as part of modified implant 110, modified implant 110 being assigned reference numeral 110'. Tensioner 500 includes a spring 510 and a constraint 520. Fig. 22A shows implant 110' immediately after implantation, with spring 510 in its elastically deformed state. Fig. 22B shows implant 110' at a later time after constraint 520 is disassembled and spring 510 is moved toward its second shape.

The springs 510 are compression springs and may have a honeycomb structure, i.e., define one or more cells 512. As the spring 510 moves (i.e., collapses) away from its elastically deformed state toward its second shape, the cell 512 may become smaller in a first dimension (horizontally in fig. 22A-B) and larger in a second direction (vertically in fig. 22A-B). In some applications, the spring 510 is longer in a first dimension than in a second dimension when in its elastically deformed state. For some such applications, in its second state, the spring 510 is shorter in the first dimension than in the second dimension. It should be noted that the spring 510 is (or functions as) an extension spring.

In fig. 22A-B, tether 112 is shown as actually comprising a plurality of discrete tethers connected to one another via tensioners 500. For each tensioner 500, one of the discrete tethers is coupled to the first portion 516 'of the spring 510 and the other of the discrete tethers is coupled to the second portion 516' of the spring. The inter-part distance d2 between the first portion 516' and the second portion 516″ is smaller in the second state than in the elastically deformed state. Thus, in some applications, a first tether tethers a first anchor to a first portion of the spring; a second tether, different from the first tether, tethers the second anchor to a second portion of the spring; and the first and second tethers thereby couple the first anchor to the second anchor via the spring.

In some applications, the constraint 520 constrains the spring 510 by holding portions of the spring together. It should be noted that in this context, the term "together" (including the specification and claims) refers to preventing parts of a spring from moving away from each other—including variants in which parts of the spring are held in contact with each other and variants in which they are held together but not in contact with each other. The constraint 520 may be stretch resistant and may include a tether (e.g., wire, strand, rope, ribbon, rope, braid, shrink member, suture, etc.), strap, or loop, e.g., an element having a tensile strength. In some applications, and as shown, the spring 510 may have an eyelet 514 or other similar feature such as a notch, and the restraint 520 is coupled to the spring via the eyelet 514 or other similar feature such as a notch, and/or is prevented from moving relative to the spring. For example, and as shown, the constraint 520 may pass through the eyelet 514. Other eyelets or similar features may be present on portions 516' and 516″ to facilitate coupling tether 112 thereto.

Fig. 23A-B illustrate examples of tensioners in the form of tensioner 530 according to some applications. Tensioner 530 includes spring 540 and constraint 550. Fig. 23A shows tensioner 530 with spring 540 in its elastically deformed state. Fig. 23B shows tensioner 530 after constraint 550 is disassembled and spring 540 is moved toward its second shape.

Spring 540 is similar to spring 510, but generally defines at least two units 542, e.g., three or more units.

In some applications, the constraint 550 constrains the spring 540 by holding portions of the spring together. For example, and as shown, the constraint 520 may comprise a tube. However, the constraint 550 may alternatively comprise a suture, strap, or loop, for example, as described with respect to the tensioner 500.

In fig. 23A-B, tether 112 is shown as actually comprising a plurality of discrete tethers connected to respective portions of spring 540, e.g., as described above for tensioner 500, mutatis mutandis.

Fig. 24A-B illustrate examples of tensioners in the form of tensioners 560 according to some applications. Tensioner 560 includes a spring 570 and a plurality of constraints 580a, 580b, and 580c. Fig. 24A shows the tensioner 560 with the spring 570 in an elastically deformed state. Fig. 24B-C illustrate tensioner 560 progressively moving toward its second shape after successive decomposition of constraints 580a, 580B, and 580C.

The spring 570 may be a tension spring. For example, and as shown, the spring 570 may have a coiled structure, such as a helical coil.

In some applications, the constraint 580 constrains the springs 570 apart from one another by retaining portions of the springs. For example, and as shown, each of the constraints 580 may include one or more spacers or dividers 582. Each spacer 582 may be compression resistant and may hold adjacent portions (e.g., turns) of the spring 570 apart from one another. The constraint 580 is shown as having a comb-like structure with the spacers 582 connected to each other in series. However, the restraints 580 and/or the spacers 582, mutatis mutandis, may be differently shaped, e.g., depending on the shape and type of the springs 570.

For each of the tensioners 500, 530 and 560, the lifetime of at least one of the tensioners' constraints (which depends on the rate of bio-adsorption/decomposition of the constraint) is between 1 day and 2 years (e.g. between 15 days and 2 years, such as between 15 days and 1 year, such as between 15 days and 6 months, such as between 1 and 3 months, such as between 1 and 2 months) after implantation of the implant within the heart.

For each of tensioners 500, 530 and 560, the lifetime of at least one of the tensioner's constraints may be between 1 day and 2 years (e.g., between 15 days and 2 years, such as between 15 days and 1 year, such as between 15 days and 6 months, such as between 1 and 3 months, such as between 1 and 2 months) after implantation of the implant within the heart.

Each of the constraints 580 is configured to reach a threshold amount of decomposition after a respective period of time after implantation in the heart, and once the threshold is reached, the constraints no longer stop their respective springs. This is in fact the lifetime of a given constraint. The restraints 580 may be configured to have different lifetimes in order to gradually release the springs 570 (e.g., release respective portions of the springs in an interleaved manner) to gradually (e.g., in an interleaved manner) increase the tension on the tether over time. That is, after each life time expires, the spring 570 moves partially toward a resting state, but remains blocked by the remaining constraint(s) 580. This is represented in fig. 24A-D as constraint 580a with the shortest lifetime (whose expiration is represented in fig. 24B), constraint 580B with the next shortest lifetime (whose expiration is represented in fig. 24C), and constraint 580C with the longest lifetime (whose expiration is represented in fig. 24D).

A similar effect can be achieved by using multiple tensioners 500 or 530 mutatis mutandis. For example, the constraints of each tensioner 500 or 530 used may have different lifetimes. Alternatively or additionally, a given tensioner may have multiple constraints, each constraint having a different life. For example, tensioner 530 may include one constraint 550 per unit 542 of spring 540, or tensioners 500 and 530 may include multiple constraints per unit.

For tensioners having multiple restraints, the restraint with the shortest lifetime may be referred to as a first restraint of the tensioner and the restraint with the longer lifetime may be referred to as a second restraint of the tensioner. In some applications, the lifetime of the second constraint is at least twice (e.g., at least three times) the lifetime of the first constraint. In some applications, the lifetime of the first constraint is between 1 and 3 months (e.g., between 1 and 2 months) and the lifetime of the second constraint is between 3 months and 1 year (e.g., between 3 and 6 months).

As described above, each of the tensioners 500, 530 and 560 is described as being used with a tether by which in practice comprises a plurality of discrete tethers connected to each other via the tensioner. However, alternatively, in some applications, each of the tensioners may be used with a complete, continuous tether. For such applications, the tensioner is coupled to the tether such that movement of the spring away from the elastically deformed state toward the second shape introduces a tortuosity into the path taken by the tether. For some such applications, the tether may pass through a portion of the tensioner. It is hypothesized that such a configuration may advantageously facilitate sliding of the tensioner along the tether, for example, during implantation and/or during initial retraction of the implant.

In some applications, one or more of the tensioners described herein are mounted on the head of the tissue anchor.

Referring now to fig. 25A-F and 26A-B, fig. 25A-F and 26A-B are schematic illustrations of an anchor handling assembly 600 according to some applications. The assembly 600 may be particularly useful for de-anchoring and removing the anchors 120 during implantation of the implant 110, for example, after identifying that a given anchor has been sub-optimally anchored. The assembly 600 is described as being used with the anchors 120 of the implant 110, but it should be noted that the scope includes use of the assembly 600 with other anchors mutatis mutandis.

Anchor handling assembly 600 includes sleeve 610 and tool 620. Sleeve 610 has a distal portion 612 that includes a distal end 614 of the sleeve.

Fig. 25A shows implant 110 during its implantation, wherein three anchors 120 have been anchored to tissue 10. If it is determined that the leftmost anchor, which is the most recently anchored anchor, should be de-anchored and removed, the distal portion 612 of the sleeve 610 is advanced transluminally to the anchor and past the anchor head 180 of the anchor (fig. 25B-C). Distal end 614 of sleeve 610 is sized to fit snugly over anchor head 180.

Tool 620 includes a flexible shaft 622 and a tool head 624, tool head 624 coupled to the distal end of the shaft and including jaws 626. The jaws 626 are biased to assume an open state and are reversibly squeezable into a closed state.

While the distal end 614 remains disposed on the anchor head 180, the tool head 624 is advanced distally through the sleeve 610 to the distal portion 612 (fig. 25D). The jaws 626 are sized relative to the inner dimension of the distal portion 612 of the sleeve 610 such that placement of the tool head 624 in the distal portion of the sleeve squeezes the jaws into a closed condition. While the jaws 626 remain in the closed state, they are locked to the interface 182 (e.g., the stem 183 thereof), e.g., by further distally advancing the tool head 624, thereby pushing the tool head 624 against the anchor head 180 (fig. 25E), e.g., such that the interface (e.g., the stem 183 thereof) is received into the gap between the jaws.

In some applications, the jaws 626 and the interface 182 are configured to define a snap fit, and the assembly 600 (e.g., the tool 620 thereof) is configured to lock the jaws to the interface while the jaws are held in a closed state by snap fitting the jaws to the interface.

In some applications, the assembly 600 is configured such that when the tool head 624 is disposed in the distal portion 612, the jaws 626 prevent unlocking from the interface 182, e.g., such that a pulling force required to remove the driver head from the interface is greater than a pushing force required to lock the jaws to the interface (e.g., the jaws may be unlocked from the interface). That is, while remaining in the closed state, the jaws are configured to (i) lock into the interface by (i) receiving the interface into the gap in response to (e.g., momentarily) pushing the jaws onto the interface with the jaws deflected apart by the interface with a distally directed force of magnitude; (ii) Preventing unlocking from the interface as it leaves the gap, wherein pulling the jaws with a proximally directed force of magnitude is insufficient to pull the jaws away from the interface.

While the jaws 626 remain locked to the hub 182, the tool 620 is used to apply a deagglomeration force to the anchor head 180, e.g., torque in a rotational direction opposite to that previously used to implant the anchor (fig. 25F). In some applications, and as shown, when anchor 120 is de-anchored, tool 620 and sleeve 610 are proximally retracted in unison, thereby maintaining jaws 626 in a closed state.

Tool 620 (e.g., its jaws 626) may be unlocked from interface 182 by proximally retracting sleeve 610 relative to anchor head 180 and tool head 624 such that the distal portion of the sleeve ceases to squeeze the jaws into a closed state and the jaws (which may be exposed from the sleeve) automatically move apart (fig. 26A). The tool 620 (or the assembly 600 as a whole) may then be retracted (fig. 26B). In some applications, the unlocking may be performed upon determining that the anchor should not actually be de-anchored or that there is a suboptimal condition for de-anchoring. In some applications, and if the assembly 600 is used for initial anchoring of an anchor, rather than for de-anchoring, unlocking may be performed.

In some applications, sleeve 610 has a middle portion 618, the middle portion 618 being proximal to the distal portion 612, and the middle portion 618 being internally sized such that placement of the tool head 624 therein does not squeeze the jaws 626 into a closed state. Thus, in some applications, the jaws 626 are squeezed into their closed state by distally advancing the tool head 624 from the intermediate portion 618 into the distal portion 612.

Referring now to fig. 27A-C and 28A-B, fig. 27A-C and 28A-B are schematic illustrations of an anchor handling assembly 600' according to some applications. The anchor handling assembly 600' includes corresponding components similar to the assembly 600 and has the same overall function, but is constructed slightly differently. For example, the jaws 626 'of the assembly 600' are longer, curved than the jaws 626 of the assembly 600, and may be more flexible than the jaws 626 of the assembly 600. Fig. 27A-C illustrate steps in use of the assembly 600' that are identical to those shown in fig. 25D-F for the assembly 600, mutatis mutandis. Fig. 28A-B illustrate steps in use of the assembly 600', which are identical to those shown in fig. 26A-B for the assembly 600, mutatis mutandis.

29A-B and 30A-B, FIGS. 29A-B and 30A-B are schematic illustrations of anchor systems 630 and 660 according to some applications. Fig. 29A-B illustrate an anchor system 630 including a tissue anchor 640 and an anchor driver 650 for use therewith, and fig. 30A-B illustrate an anchor system 660 including a tissue anchor 670 and an anchor driver 680 for use therewith. Systems 630 and 660 may be used with the systems, devices, and techniques described elsewhere herein, for example, by replacing anchors (or anchor heads thereof) and anchor drivers (or driver heads thereof), mutatis mutandis. For example, anchor drivers 650 and 680 may be used to de-anchor and remove anchors 640 and 670, respectively, and/or to deliver and anchor anchors.

Anchor 640 includes a tissue-engaging element 642 and an anchor head 644. The anchor driver 650 includes a flexible shaft 652 and a driver head 654 disposed at a distal end of the shaft. Anchor 670 includes a tissue-engaging element 672 and an anchor head 674. The anchor driver 680 includes a flexible shaft 682 and a driver head 684 disposed at a distal end of the shaft.

In some applications, for each of systems 630 and 660: the anchor head has a driver interface 646 or 676; the driver head has an introduced state (fig. 29A and 30A) and a locked state (fig. 29B and 30B); the anchor head is shaped to define a proximal opening 645 or 675 through which the driver head can access the driver interface when the driver head is in the introduced state; and the anchor driver is configured to lock the driver head to the interface by laterally moving a portion of the driver head to transition the driver head to a locked state.

In some applications, for each of the systems 630 and 660, the anchor driver includes a rod 656 or 686 extending through the shaft and configured to transition the driver head to the locked state by applying a force to the driver head.

For the system 630, the driver head 654 includes a cam 658 coupled to a lever 656, and the lever is configured to transition the driver head 654 to its locked state by rotating the cam such that at least a portion of the cam protrudes laterally. In some applications, and as shown, this is achieved by the rod 656 being eccentric with respect to the shaft 652 and/or with respect to the cam 658.

In some applications, the cam 658 does not protrude laterally at all (e.g., the cam is flush with the shaft 652) in the introduced state.

In some applications, the shaft 652 and/or the cam 658 are circular in transverse cross-section relative to the longitudinal axis of the shaft 652.

In some applications, and as shown, interface 646 is shaped to define a plurality of recesses 648, each recess sized to receive cam 658 when cam 658 is laterally protruding. This enables driver 650 to engage anchor 640 in multiple rotational orientations of the driver relative to the anchor.

For the system 660, the driver head 684 includes fins 688, and the rod 686 is configured to transition the driver head 684 to its locked state by pushing distally between the fins such that the rod pushes the fins radially outward such that the fins lock to the interface 676. The fins 688 may be configured to lock to the interface 676 via a friction fit when pushed radially outward by the rod 686. In some applications, and as shown, the interface 676 may be shaped to define a frustoconical chamber 678 (e.g., where its wider base is farther from the opening 675 than its narrower base). The driver 680 can generally engage the anchor 670 in any rotational orientation of the driver relative to the anchor.

Referring now to FIGS. 31A-B, 32A-B, 33A-B, 34A-C, and 35A-C, FIGS. 31A-B, 32A-B, 33A-B, 34A-C, and 35A-C are schematic illustrations of systems, devices, and techniques for use at a heart valve according to some applications. The anchor removal is described above (e.g., with reference to fig. 25A-27C). It should be noted that for a tissue modifying implant (such as implant 110) that includes multiple anchors coupled to (e.g., threaded on) a tether, only the anchor that was recently anchored may be possible to de-anchor/remove. For example, if it is desired to leave the most recently anchored anchor in place, the most recently anchored anchor may prevent the de-anchored anchor (e.g., the more distal anchor) from being removed (e.g., slid proximally along the tether). Similar challenges may exist in delivering/anchoring additional anchors. That is, the nature of such implants may limit the addition of anchors to a distal to proximal order and/or may limit the subtraction of anchors to a proximal to distal order.

Fig. 31A shows a scenario where 5 anchors 120 of implant 110 have been anchored to tissue 10 of the annulus of mitral valve 12 but tensioning of tether 112 reshapes the annulus to sub-optimally leave a regurgitation site 16 where the leaflets of the valve do not coapt. Fig. 31B shows that additional anchors 120x have been coupled (e.g., slidably coupled) to tether 112 between previously anchored anchors and anchored to tissue, thereby further reshaping the annulus such that the regurgitant site is reduced (e.g., eliminated). That is, fig. 31A-B illustrate that the addition of anchor 120x is independent of the order from distal to proximal.

Fig. 32A shows a scenario where several anchors 120 of an implant 110 have been anchored to the tissue 10 of the annulus of the mitral valve 12 but the tensioning of the tether 112 reshapes the annulus in a manner that results in undesired deformation of the valve. Fig. 32B shows that one of these anchors (labeled 120y in fig. 32A) has been de-anchored from between the previously anchored anchors and separated from tether 112, thereby reducing (e.g., eliminating) deformation. That is, fig. 32A-B illustrate that the deduction of anchor 120y is independent of the order from proximal to distal.

33A-B, 34A-C, and 35A-C illustrate systems and/or devices configured to facilitate such order independent techniques. One of the challenges in adding or subtracting anchors in a sequence-independent manner is navigating the tool to the correct location. For example, to access a recently anchored anchor, it is possible to advance a tool along tether 112, such as shown in fig. 25A-F. However, it may be difficult to use this technique in order to access more distal anchors, for example, because the recently anchored anchors may impede advancement of the tool along the tether. Each of the anchors described with reference to fig. 33A-35C, mutatis mutandis, may be used instead of one or more of the anchors described with reference to fig. 31A-32B.

Fig. 33A and 33B illustrate embodiments 700a and 700B, respectively, of a tissue anchor 700, the tissue anchor 700 having an anchor head 702 including one or more magnets 704. The anchor head 702a of the anchor 700a includes a plurality of magnets 704a, for example, distributed circumferentially around the anchor head. The anchor head 702b of the anchor 700b includes a magnet 704b that may be centrally located, such as disc-shaped or annular-shaped. The anchor 700 is configured to facilitate navigation of the tool to the anchor (e.g., to anchors other than the most recently anchored anchor) without the need to advance the tool along the tether. Magnet(s) 704 may reduce the required navigation accuracy, e.g., once the tool has been navigated within a threshold proximity of the anchor, the tool is pulled by 704 into engagement with anchor 702.

Fig. 34A-C illustrate a system 710 including a tissue anchor 712 and an anchor handling assembly 730 according to some applications. According to some applications, anchor 712 has an anchor head 714 that includes a shackle 716. The shackle 716 has a reversibly openable opening 718 through which a tether (e.g., tether 112) may laterally pass (fig. 34A-B) via the reversibly openable opening 718 by temporarily opening the opening, e.g., to slidably couple the anchor to the tether (fig. 34C). Alternatively or additionally, the shackle 716 may be configured to facilitate separation of the tether from the anchor, mutatis mutandis. It should be noted that in this context, the term "lateral" (including the description and claims) is intended to distinguish between such passage of the tether into the shackle (which may and often does occur in the case of approaching the end of the tether) and passage of the tether into a conventional eyelet (which may be considered to be axially movable).

In some applications, at opening 718, shackle 716 includes a spring loaded door 720 (e.g., shackle 716 is a snap shackle). The gate 720 is shown as a single gate, but may alternatively be a double gate. In some applications, the door 720 is configured to open inwardly rather than outwardly.

The anchor handling assembly 730 also typically includes a linking tool 732.

In some applications, tool 732 is configured to temporarily open opening 718 within the heart and pass tether 112 laterally through the opening and into shackle 716, thereby slidably coupling tether 112 to anchor 712 (e.g., to achieve the results described with reference to fig. 31A-B). For example, the tool 732 may include (i) an actuator 734, the actuator 734 configured to actuate the door 720 to open it (e.g., by pushing against the door), and/or (ii) a limb 736, the limb 736 configured to move the tether 112 through the open door and into the shackle 716. In some applications, anchor handling assembly 730 further includes a driver 740, driver 740 configured to anchor the anchor by driving the tissue-engaging element into tissue (e.g., by applying torque to head 714 (e.g., to shackle 716)). 34A-C, the tissue is not shown for simplicity, but is still depicted as if the coupling of tether 112 to the anchor is performed immediately after anchor 712 has been anchored, i.e., immediately after the anchor has been anchored. However, it should be understood that the scope includes coupling the tether 112 to the anchor prior to anchoring the anchor, mutatis mutandis. Further, although driver 740 is shown as being coaxial with link tool 732, the driver and link tool may be parallel to each other or may be independent of each other.

In some applications, tool 732 is configured to temporarily open opening 718 within the heart and to laterally pass tether 112 through the opening and out of shackle 716, thereby separating tether 112 from anchor 712 (e.g., to achieve the results described with reference to fig. 32A-B). For example, the limb 736 may be configured to move the tether 112 through the open door 718 and out of the shackle 716. In some applications, driver 740 is configured to de-anchor (e.g., unscrew) the anchor, for example, by applying torque to head 714 (e.g., to shackle 716). It should be understood that the scope includes separating tether 112 from the anchor, either before or after the anchor is de-anchored, mutatis mutandis.

It should be noted that for clarity, fig. 34A-B and 35A-B show tether 112 as a single point, which is similar to a cross-section through the tether.

According to some applications, there is provided a method comprising: (i) Transluminally securing a tether along tissue by anchoring a plurality of anchors to respective locations of the tissue such that the tether extends between and along the plurality of anchors, each of the plurality of anchors having a respective eyelet through which the tether passes; and (ii) slidably coupling an additional anchor to the tether via a lumen between two of the plurality of anchors while the plurality of anchors remain anchored to the tissue, and anchoring the additional anchor to the tissue.

Thus, according to some applications, there is also provided a method comprising: (i) Transluminally securing a tether along tissue by anchoring a plurality of anchors to respective locations of the tissue such that the tether extends between and along the plurality of anchors, each of the plurality of anchors having a respective eyelet through which the tether passes; and (ii) transluminally separating one of the plurality of anchors from the tether from between two other of the plurality of anchors.

Fig. 35A-C illustrate a system 750 including a tissue anchor 752 and an anchor handling assembly 770, according to some applications. According to some applications, anchor 752 has an anchor head 754 that includes a shackle 756. The hook ring 756 has a reversibly openable opening 758 through which a tether (e.g., tether 112) may laterally pass (fig. 34A-B) by temporarily opening the opening via the reversibly openable opening 758, e.g., to slidably couple the anchor to the tether (fig. 34C). Alternatively or additionally, hook ring 756 can be configured to facilitate separation of the tether from the anchor, mutatis mutandis.

In some applications, hook ring 756 is configured to facilitate the clamping of a tether into and/or out of the hook ring. For example, the catch ring 756 may be a snap ring that momentarily opens to snap into the ring when the tether is pressed laterally into and through the opening 758.

Anchor handling assembly 770 also typically includes a linking tool 772.

In some applications, tool 772 is configured to temporarily open opening 758 within the heart and pass tether 112 laterally through the opening and into hook ring 756, thereby slidably coupling tether 112 to anchor 752 (e.g., to achieve the results described with reference to fig. 31A-B). For example, and as shown, tool 772 may press tether 112 laterally into and through opening 758, wherein the opening momentarily opens as the tether passes through. In some applications, anchor handling assembly 770 also includes a driver 780, driver 780 configured to anchor the anchor by driving the tissue-engaging element into tissue (e.g., by applying torque to head 754 (e.g., to hook ring 756). 35A-C do not show tissue for simplicity, but are still drawn as if performed immediately after anchor 712 has been anchored, i.e., the coupling of tether 112 to the anchor is performed immediately after the anchor has been anchored. However, it should be understood that the scope includes coupling the tether 112 to the anchor prior to anchoring the anchor, mutatis mutandis. Further, although driver 780 is shown as being coaxial with link tool 772, the driver and link tool may be parallel to each other or may be independent of each other.

In some applications, tool 772 is configured to temporarily open opening 758 within the heart and laterally pass tether 112 through the opening and out of hook ring 756, thereby separating tether 112 from anchor 752 (e.g., to achieve the results described with reference to fig. 32A-B). For example, tool 772 may pull tether 112 laterally into and through opening 758, which momentarily opens as the tether passes on its way out of hook ring 756. In some applications, driver 780 is configured to de-anchor (e.g., unscrew) the anchor, for example, by applying torque to head 754 (e.g., to shackle 756). It should be understood that the scope includes separating tether 112 from the anchor, either before or after the anchor is de-anchored, mutatis mutandis.

Reference is again made to fig. 31A-B. In some applications, tether 112 is tensioned prior to adding additional anchors 120x, for example, because the need to add an anchor is determined only when the tether is tensioned. For some such applications, tether 112 is relaxed after being tensioned (e.g., after determining the need for additional anchors) and before adding anchors 120 x. The tether 112 may then be re-tensioned after the additional anchors are added.

Reference is again made to fig. 32A-B. In some applications, tether 112 is tensioned prior to removing anchor 120y, for example, because the need to remove the anchor is determined only when the tether is tensioned. For some such applications, tether 112 is relaxed after being tensioned (e.g., after determining the need to remove the anchor) and before removing anchor 120 y. The tether 112 may then be re-tensioned after the anchor is removed.

Referring now to FIGS. 36A-B, 37A-D, 38A-B, 39A-C, 40A-D, 41 and 42, FIGS. 36A-B, 37A-D, 38A-B, 39A-C, 40A-D, 41 and 42 are schematic illustrations of various tissue anchors and techniques for use therewith according to some applications. Each of these anchors and their components may be as described for anchor 120 and its like-named components, mutatis mutandis, unless otherwise stated. Furthermore, each of these anchors, mutatis mutandis, may be used as a component of an implant further comprising a tether, for example as described above. For example, each of these anchors may include a tissue-engaging element and a head including an eyelet and a driver interface coupled (e.g., fixedly coupled) to the tissue-engaging element. The tissue-engaging element may be the same as or similar to the other tissue-engaging elements described herein.

Similar to anchors 120, each of these anchors may be configured to facilitate smooth sliding of the tether through the aperture of the eyelet if: (i) When the tether is parallel to the central longitudinal axis of the anchor (e.g., during delivery to the heart) and (ii) when the tether is oriented orthogonal to the central longitudinal axis (e.g., after the anchor has been anchored to the tissue of the heart). In some applications, the eyelet may be turned or rotated about the central longitudinal axis of the anchor, for example, due to being mounted on a rotatable collar, for example, similar to as described for anchor 120, mutatis mutandis. The eyelet may be deflectable relative to a central longitudinal axis of the anchor, as described in more detail below.

For each of these anchors, the head of the anchor may include a driver interface configured to be reversibly engaged by an anchor driver that advances and anchors the anchor, e.g., as described above for the other anchors. The driver interface may be disposed on or concentric with the central longitudinal axis of the anchor.

Fig. 36A-B illustrate a tissue anchor 800 including an anchor head 802, the anchor head 802 including an eyelet 810, the eyelet 810 being laterally disposed, i.e., eccentric, from a central longitudinal axis ax9 of the anchor 800, similar to the eyelet 140 of the anchor 120. However, while eyelet 140 of anchor 120 is individually rotatably coupled to collar 184 (e.g., with a swivel joint therebetween), eyelet 810 is coupled to collar 808 of anchor 800 via ball joint 812. In addition to allowing rotation of eyelet 810 (e.g., similar to a swivel joint between eyelet 140 and collar 184), ball joint 812 also allows deflection of the eyelet relative to collar 808 and relative to the anchor axis ax 9. The additional degrees of freedom provided by this configuration for eyelet 810 is assumed to advantageously allow the eyelet to assume an optimal orientation when tether 112 is tensioned, e.g., depending on the relative positions of the other anchors of the implant, thereby facilitating smooth sliding of the tether through the eyelet. It is further hypothesized that this configuration increases predictability of the implant and reduces wear on the tether as compared to anchors to which the eyelet is loosely coupled (e.g., links in a chain).

Fig. 37A-D illustrate a tissue anchor 820, similar to anchor 800, the tissue anchor 820 including an anchor head 822, the anchor head 822 including an eyelet 830, the eyelet 830 being coupled via a ball joint 832. However, ball joint 812 of anchor 800 is laterally disposed (i.e., eccentric) from the central longitudinal axis of the anchor, and ball joint 832 (e.g., ball 835 thereof) is disposed on central longitudinal axis ax10 of anchor 820. Fig. 38A-B illustrate an anchor 820 used as a component of an implant, for example, similar to that described above with reference to fig. 3A-D for anchor 120 of implant 110, mutatis mutandis.

Anchor 800 is shown to include tissue-engaging element 130 as described above, and anchor 820 is shown to include tissue-engaging element 241 as described above. However, it should be understood that other combinations of anchor heads and tissue-engaging elements are possible and contemplated throughout this patent application. For example, the tissue-engaging element 130 of anchor 800 can be replaced with tissue-engaging element 241, mutatis mutandis.

Thus, each of anchors 800 and 820 includes: (i) A tissue-engaging element defining a central longitudinal axis of the anchor, having a sharpened distal tip, and configured to be driven into tissue of a subject; (ii) An anchor head coupled to the proximal end of the tissue-engaging element. The anchor head includes lugs (e.g., lugs 804 of anchor 800 and lugs 824 of anchor 820, each of which may be as described for other anchors above, mutatis mutandis), ball joints, and eyelets coupled to the lugs via the ball joints.

For the anchor head of each of anchors 800 and 820, the eyelet axis (eyelet axis 811 for head 802 of anchor 800 and eyelet axis 831 for head 822 of anchor 820) passes through the center of the ball joint and the center of the eyelet, and the ball joint generally allows the eyelet to move laterally, e.g., from the center longitudinal axis of the anchor, to a position where the eyelet axis is orthogonal to the center longitudinal axis, e.g., for transluminal delivery. For example, in such a configuration, the anchor may be advanced through the tube 152 with the tissue-engaging element of the anchor sliding through the primary channel region 154a and the eyelet of the anchor sliding through the secondary channel region 154b, e.g., as similarly described above for the anchor 120, mutatis mutandis.

The ball joint 812 includes a socket 814 and a support stud 816, the support stud 816 defining a ball 815 at a first end of the support stud, the ball being disposed within the socket. The other end of the support stud 816 defines (or is coupled to) an eyelet 810. Similarly, the ball joint 832 includes a socket 834 and a support stud 836, the support stud 836 defining a ball 835 at a first end of the support stud, the ball being disposed within the socket. The other end of the support stud 836 defines (or is coupled to) the eyelet 830.

Similar to ball joints known in the art, each of ball joints 812 and 832 allows its support stud to deflect to any angular setting within a given deflection ball sector. The deflection ball sector may be defined by the support stud being blocked by the rim of the socket, for example, by a given amount of deflection from the angle of the midpoint of the deflection ball sector. In some applications, the yaw ball segment has a solid angle of at least one steradian (e.g., at least two steradians, e.g., 2-5 steradians, such as 3-5 steradians). In some applications, to retain the ball in the socket, the socket is larger than hemispherical such that the solid angle of the deflected ball sector is less than 2pi steradians (e.g., less than 6 steradians, such as less than 5 steradians).

Fig. 37B and 37D illustrate a deflection ball sector 839 of the ball joint 832. In some applications, and as shown, the midpoint of the deflection sphere sector 839 is located on the central longitudinal axis ax10 of the anchor 820.

In some applications, and as shown, the ball joint 832 (e.g., its socket 834) allows the support stud 836 to deflect beyond the limits of the deflection ball sector 839 (e.g., to a greater magnitude of angular deflection from the midpoint of the deflection ball sector 839) on a particular deflection plane 838. This may be provided by the edges of the socket 834 defining a recess 837 into which the support stud 836 may enter. On the deflection plane 838, the ball joint 832 thus defines a planar deflection angle arc 821 within which the support stud 836 can be deflected planarly, and the planar deflection angle arc 821 extends beyond the limits of the deflection ball sector. In some applications, planar deflection angle arc 821 is at least 110 degrees (e.g., at least 120 degrees, e.g., at least 140 degrees, e.g., at least 160 degrees, e.g., at least 180 degrees, such as at least 200 degrees). In some applications, planar deflection angle arc 821 is no greater than 200 degrees (e.g., no greater than 180 degrees, e.g., no greater than 160 degrees, such as no greater than 140 degrees).

Similar to that described above for eyelet 140, the narrowest portion of the aperture of eyelet 810 and/or eyelet 830 may be intermediate the opposite faces of the eyelet. In some applications, the inner surface of eyelet 810 and/or eyelet 830 is hyperboloid in shape. In some applications, the inner surface of eyelet 810 and/or eyelet 830 is catenary in shape.

Fig. 38A-B illustrate steps in implantation of an implant including a plurality of tissue anchors 820 slidably coupled to tether 112 (e.g., threaded onto tether 112) according to some applications. The implant is similar to implant 110 described above, but includes a plurality of anchors 820 instead of anchors 120, and fig. 40A-B are similar to fig. 3A-B, mutatis mutandis. Although fig. 38A-B illustrate an implant that does not include a spacer threaded onto tether 112 between anchors 820, a spacer or separator such as those described elsewhere herein may be used. The anchor 800 can be used in the same manner, mutatis mutandis.

38A-B, the eyelet can be laterally deflected from axis ax10 such that anchor 820 can be advanced transluminally along tether 112, for example, through a tube (such as tube 152). For example, aperture axis 831 can be orthogonal to axis ax10.

In some applications, and similar to the aperture of eyelet 140 of anchor 120, the width of the apertures of eyelets 810 and 830 may not be more than twice the thickness of the tether (e.g., not more than 50% wider than the thickness of the tether, such as not more than 20% wider than the thickness of the tether).

Fig. 39A-C illustrate various views of a tissue anchor 840, and fig. 40A-D illustrate at least some steps in the implantation of an implant including a plurality of such tissue anchors slidably coupled to a tether 112 (e.g., threaded onto the tether 112), according to some applications. The implant is similar to implant 110 described above, but includes a plurality of anchors 840 instead of anchors 120, and fig. 40A-D are similar to fig. 3A-D, mutatis mutandis. Anchor 840 includes an anchor head 842, anchor head 842 including a bracket 844, a driver interface 843, and eyelet 850. The lugs 844 are coupled (e.g., fixedly coupled) to the proximal end of the tissue-engaging element (tissue-engaging element 130, in the example shown) of the anchor 840 and are coupled (e.g., fixedly coupled) to the driver interface 843, for example, in a manner that transfers torque from the interface 843 to the tissue-engaging element.

Eyelet 850 is hingedly coupled to bracket 844 such that eyelet may be pivoted over interface 843, e.g., such that eyelet may be positioned on a first side of the drive interface and may be pivoted over the drive interface to a second, opposite side of the drive interface, opposite the first side. The pivoting may also allow eyelet 850 to be positioned on the central longitudinal axis ax11 of anchor 840. The pivoting of eyelet 850 is illustrated in fig. 39B-C. Although fig. 39B-C illustrate a pivot of approximately 100 degrees, the hinged coupling may be such that eyelet 850 may pivot through an arc of up to 180 degrees or even greater than 180 degrees.

In some applications, eyelet 850 is also rotatably coupled to bracket 844 (e.g., collar 848 coupled to head 842 via an eyelet), and the collar is rotatably coupled to the bracket, and thus rotatable about axis ax 11.

In some applications, and as shown, head 842 includes arch 851 and has two bottom ends 855. For some such applications, arch 851 defines at least a portion of eyelet 850. The hinged coupling of eyelet 850 to bracket 844 may be accomplished by hingedly coupling bottom end 855 to bracket 844 at respective hinge points opposite each other. For applications in which head 842 includes collar 808, and as shown, the hinged coupling of eyelet 850 to bracket 844 may be accomplished by hingedly coupling bottom end 855 to the collar at a hinge point. For example, and as shown, collar 808 may define a recess at each hinge point, and the respective bottom ends are hingedly coupled to the collar by protruding into the recess.

Thus, coupling of eyelet 850 allows for (i) deflection of eyelet relative to axis ax11, and (ii) rotation/swivel about axis ax 11.

Anchor 840 is shown as being a majority of arch 851 being part of eyelet 850 such that in at least some orientations of the eyelet, interface 843 is disposed within eyelet 850. Fig. 41 and 42 illustrate a variation of an anchor 840 in which an eyelet is provided on an arch in a manner that spaces the eyelet from the anchor interface of the anchor. Fig. 41 shows a variation 840 'of an anchor 840 comprising a eyelet 850', the eyelet 850 'being centrally disposed on an arch 851', e.g., such that in at least one orientation the eyelet is positionable on a central longitudinal axis of the anchor. Fig. 42 shows a variation 840 "of an anchor 840 comprising a eyelet 850", the eyelet 850 "being arranged eccentrically to an arch 851", for example such that in any possible orientation of the eyelet, the eyelet is lateral from the central longitudinal axis of the anchor.

As shown in fig. 40A-B, eyelet 850 may be laterally deflected from axis ax11 such that anchor 840 may be advanced transluminally along tether 112, for example through tube 852, such as by using driver 160 or another driver. For example, arch 851 may be orthogonal to axis ax11 and/or the eyelet axis through eyelet 850 and the hinge point may be orthogonal to axis ax11. Tube 852 may be similar or identical to tube 152 described above.

Fig. 40C shows five anchors 840 that have been anchored, with tether 112 extending through eyelet 850 of each anchor and proximally out of the subject. Fig. 40D shows tether 112 having been tensioned and stop 114b has been advanced and locked to the tether to lock the tension in the tether, e.g., as described for implant 110, mutatis mutandis.

Head 842 allows the eyelet to be moved laterally, e.g., from the central longitudinal axis of the anchor, to a position where the eyelet axis is orthogonal to the central longitudinal axis, such as for transluminal delivery. For example, in such a configuration, the anchor may be advanced through the tube 852 with the tissue-engaging element of the anchor sliding through the primary passage region of the tube and the eyelet of the anchor sliding through the secondary passage region of the tube, e.g., as similarly described above for anchor 120, mutatis mutandis.

Although fig. 40A-D illustrate an implant that does not include a spacer threaded onto tether 112 between anchors 840, a spacer or separator such as those described elsewhere herein may be used.

Referring to fig. 43A-C, fig. 43A-C are schematic illustrations of a tissue anchor 870 and variants 870' thereof according to some applications. The anchor 870 may be used as an anchor for an implant comprising a tether, for example, as described above for other anchors, mutatis mutandis.

As with the other anchors described herein, anchor 870 may be delivered, for example, transluminally to the heart of a subject. The anchor 870 includes two arms 872 (e.g., a first arm 872a and a second arm 872 b) that are hinged to each other at a swivel joint 874 defining a hinge axis ax12. Swivel joint 874 generally includes a pin 875 extending through each arm 872. Each arm 872 may be rigid. Each arm 872 defines a coupling 876 and a hook 878, e.g., arm 872a defines a first coupling 876a and a first hook 878a, and arm 872b defines a second coupling 876b and a second hook 878b. Each hook 878 curves about and away from the hinge axis ax12, terminating in a respective tip 879 (i.e., first and second tips 879a, 879 b), and the respective tip 879 may be sharpened. The hooks 878 bend in opposite directions about the hinge axis ax12. In some applications, hooks 878 lie in respective planes that are parallel to each other and orthogonal to hinge axis ax12.

Anchor 870 may transition between an open state (e.g., as shown in fig. 43A) and a closed state (e.g., as shown in fig. 43B). In the open state, the arm 872a is in a first rotational position about the hinge axis ax12, and the hooks 878a and 878b define a space 880 therebetween, with the tips 879a and 879b defining a gap 882 therebetween into the space. For example, hooks 878 may define respective concave surfaces facing each other, and space 880 includes two concave surfaces. In the closed state, the arm 872a is in a second rotational position about the hinge axis ax12, and the gap 882 is smaller than in the open state. For example, and as shown in fig. 43B, there may be virtually no gap between hooks 878 into space 880, thereby forming space 880 as an aperture of an eyelet defined by hooks 878.

Although the preceding paragraphs describe the open and closed states with respect to the rotational position of the arm 872a about the hinge axis ax12, these positions are relative to the arm 872 b. That is, in the open state, the arms 872a and 872b are in a first rotational juxtaposition about the hinge axis ax12, and in the closed state, the arms 872a and 872b are in a second rotational juxtaposition about the hinge axis. In some applications, the transition of the anchor 870 toward the closed state involves rotating the two arms 872 about the articulation axis ax12 (e.g., relative to another component, such as an anchor driver for advancing and actuating the anchor). However, in some applications, the transition of anchor 870 toward the closed state involves rotating only one of arms 872.

In the open state, the tips 879 may face in substantially the same direction as each other, e.g., to facilitate penetration of the hooks 878 into tissue. After the tip 879 has penetrated into the tissue, the anchor 870 may transition toward the closed state, and this transition typically advances the hook 878 further into the tissue. In general, the hooks 878 thereby act as tissue-engaging elements 871 of the anchor 870.

In some applications, and as shown, in the closed state, the tips 879 face away from each other.

In the open state, the couplers 876a and 876b are disengaged from each other, and in the closed state, the couplers are engaged with each other. This engagement prevents the anchor 870 from transitioning out of the closed state, thereby preventing the anchor from becoming de-anchored from the tissue. In some applications, one of the couplers 876 (in the example shown, coupler 876 b) includes a protrusion, and the other (in the example shown, coupler 876 a) includes a recess, with the couplers engaging each other by the protrusion protruding into the recess. In some applications, the couplings 876 are configured to automatically engage one another when aligned with one another. For example, and as shown, the arms 872 may be sufficiently close to each other along the axis ax12 such that the protrusions of the coupling 876b snap into the recesses of the coupling 876a when the couplings are aligned.

In some applications, each arm 872 defines a respective beam 884 (e.g., arm 872a defines beam 884a, and arm 872b defines beam 884 b). For some such applications, and as shown, a swivel 874 is disposed between the beam and the hook of each arm 872 (e.g., a pin 875 extends between the beam and the hook through each arm) such that each arm is a class I lever whose fulcrum is a swivel, and thus such that anchor 870 is thus a class I double lever whose fulcrum is a swivel. For some such applications, anchor 870 may be transitioned from an open state to a closed state by driving one or both beams 884 about hinge axis ax 12. That is, for some such applications, anchor 870 may be actuated by applying a force to one or both beams 884 (e.g., by an anchor driver engaging beams 884).

For applications in which each arm 872 defines a respective beam 884, transitioning the anchor 870 toward its closed state can be accomplished by increasing the alignment between the beams. For example, and as shown, the coupling 876 can be provided on the beam 884, and the hinged coupling between the arms 872 can be such that the anchor 870 can be transitioned to a closed state by aligning the beams with one another such that the couplings responsively engage one another.

In some applications, and as shown, the radius of curvature of each hook 878 increases with distance from swivel joint 874. Thus, in some applications, the curvature of each hook 878 may be considered to be generally helical, but less than 1 full turn (e.g., less than half a full turn). It is assumed that such a shape is advantageous compared to a hook having a more rounded curve, for example by improving the anchoring, such as by reducing the pulling force applied to the anchor to a rotation of the arm 872 about the swivel 874.

The variation 870' (fig. 43C) may be identical to the anchor 870, unless otherwise noted. In contrast to anchor 870, variant 870' further includes a spring 886, which spring 886 is configured to bias at least one of arms 872 toward a respective given rotational position about hinge axis ax 12. In the example shown, the spring 886 is configured to bias the anchor toward the closed state. In some applications, the spring 886 and the coupler 876 cooperate such that sufficient force must be applied to overcome the engagement of the spring and coupler in order to return the anchor toward its open state. The spring 886 may be coupled to the two arms 872, for example by connecting each end of the spring to a respective one of the arms (such as by protruding through an aperture in the arm, for example as shown). In some applications, and as shown, a spring 886 is connected to a hook 878 of each arm, e.g., as shown. Alternatively, a spring 886 may be connected to the beam 884 of each arm.

In some applications, the spring 886 is a torsion spring. For some such applications, and as shown, the spring 886 is mounted on the pin 875', the pin 875' may be identical to the pin 875 except that it houses the spring, for example by the pin 875' being longer and/or including additional flanges that retain the spring.

44A-E and 45A-E, FIGS. 44A-E and 45A-E are schematic illustrations of tissue anchors 900 and 920 and techniques for use thereof according to some applications. Each of the tissue anchors 900 and 920 includes a core (core 902 for anchor 900 and core 922 for anchor 920), an arm (arm 904 for anchor 900 and arm 924 for anchor 920) and a hinge (hinge 906 for anchor 900 and hinge 926 for anchor 920), the arms being coupled to the core via the hinge-typically at a distal portion (e.g., distal end) of the core. The core further has a proximal portion and an intermediate portion between the proximal portion and the distal portion. Each of the arms 904 and 924 has a first side (first side 904a for arm 904 and first side 924a for arm 924) and a second side (second side 904b for arm 904 and second side 924b for arm 924). The arm may be coupled to the hinge such that the hinge is disposed between the first side and the second side of the arm, e.g., a position of the hinge defines the first side and the second side of the arm.

For each of anchors 900 and 920, the anchor can be anchored into tissue (tissue 10) by sequentially advancing a first side of the arm (i.e., the first side of the arm serves as a forearm), the hinge, and an intermediate portion of the core into the tissue such that the core extends from the distal end of the core and the hinge (which is within the tissue) to a proximal portion of the core above the tissue, as shown, for example, in fig. 44A (for anchor 900) and fig. 45A (for anchor 920). The anchor 920 (e.g., the arms 924 thereof) may be advanced into tissue within a hollow needle 930 having a sharpened tip configured to penetrate into tissue. The anchor 900 (e.g., its arms 904) may be configured to be driven (e.g., exposed) directly into tissue without a hollow needle. To facilitate this, the first side 904a of the arm 904 may therefore have a sharpened tip 908. The tip 908 may be centered to facilitate straight advancement of the arm 904 through tissue. In some applications, the second side 904b is longer (e.g., 5-50% longer, such as 5-30% longer, such as 10-30% longer) than the first side 904a, which may alternatively or additionally facilitate straight advancement of the arms 904 through tissue by imparting positive longitudinal stability to the arms 904 in the distal direction.

Within the tissue, each of the arms 904 and 924 can pivot about a respective hinge such that the respective anchor can transition toward a constrained state in which the arms extend laterally across the core, for example, as shown in fig. 44B (for anchor 900) and fig. 45B (for anchor 920). In the constrained state, the arms prevent withdrawal of the anchor from the tissue. Thus, each of anchors 900 and 920 can be considered to include a tissue-engaging element that includes an arm and typically also includes at least a portion of a core. During pivoting of the arm, a first side of the arm moves proximally relative to the stem and a second side of the arm moves distally relative to the stem. Such pivoting may be accomplished by pulling the mandrel of the anchor proximally (i.e., applying a proximal pulling force to the mandrel of the anchor), for example, as if the anchor were removed from the tissue, wherein the arms automatically deflect in response to the pulling. To facilitate this behavior in the anchor 900, the second side 904B of the arm 904 may have a sharpened tip 910, which sharpened tip 910 may be eccentric (as shown) such that in response to initial movement of the anchor 900 proximally through tissue, the tip 910 pulls to one side, causing pivoting of the arm 904 (fig. 44B). For applications in which the second side 904b is longer than the first side 904a, this may alternatively or additionally facilitate pivoting of the arm 904 in response to initial proximal movement of the anchor 900 through tissue, for example by imparting negative longitudinal stability to the arm 904 in a proximal direction.

Anchor 920 is shown with another feature that facilitates pivoting of the arm (arm 924) in response to initial movement of the anchor proximally through tissue. When deployed in tissue from the needle 930, the core 922 is biased to bend automatically (fig. 45B), wherein the needle is configured to resist bending of the core when the core is disposed in the needle. For example, the core 922 may include an elastic or shape memory material. Bending of the core 922 upon deployment may move the core laterally relative to the arm 924, creating a gap between the core and the second side 924b of the arm. Upon initial movement of anchor 920 proximally through tissue, the tissue resists second side 624b, causing arm 924 to pivot responsively.

In some applications, each of anchors 900 and 920 further includes a head coupled to the stem of the anchor (e.g., to a proximal portion of the stem). The head 912 of anchor 900 is shown in fig. 44E, and it should be understood that a similar arrangement is possible for anchor 920, mutatis mutandis. The head 912 may represent or include features of the head of one or more of the other anchors described herein. Optionally, the head of one or more of the other anchors described herein may be modified to include features of the head 912.

Fig. 44E illustrates an application in which anchor 900 is used as a component of implant 901 similar to implant 110. For such applications, the head 912 may be slidably coupled to the tether 112 (e.g., threaded onto the tether 112). The head 912 is configured to move distally along the shaft 902 toward the hinge 906 such that the tissue 10 is sandwiched between the head and the arms 904. This is hypothesized to advantageously stabilize the anchor within the tissue and improve the anchoring. It is further assumed that the mobility of the head 912 along the shaft 902 may be hemodynamically advantageous, for example, because the head and tether 112 are closer to the surface of the tissue 10.

Although fig. 44E shows the implant 901 being used at the mitral valve 12, it should be noted that the implant may be used at other locations, such as other heart valves, e.g., tricuspid valves.

In some applications, and as shown, the retrieval line 914 is coupled to the second side of the arm in the following manner: wherein proximal pulling of the retrieval wire transitions the anchor away from the constrained state by pivoting the arm relative to the stem such that a first side of the arm moves distally relative to the stem and a second side of the arm moves proximally relative to the stem (i.e., toward a state in which the anchor initially enters tissue). The retrieval line 914 typically provides the operator with the option of de-anchoring the anchor 900 or the anchor 920, for example, if the anchor location or anchoring is determined to be suboptimal.

44C-D illustrate a retrieval line 914, the retrieval line 914 coupled to the second side 904b of the arm 904 for facilitating de-anchoring of the anchor 900. Proximal pulling (i.e., tensioning) of the retrieval wire 914 transitions the anchor 900 away from its constrained state by pivoting the arm relative to the mandrel 902 such that the first side 904a moves distally relative to the mandrel and the second side 904b moves proximally relative to the mandrel (fig. 44C). Subsequently, and generally while tension is maintained on the retrieval line 914, the anchor 900 is withdrawn from the tissue, such as by pulling the core 902 proximally (fig. 44D). 44D-E illustrate a similar procedure for anchor 920 except that needle 930 (or another tube) may be advanced distally over and along retrieval line 914 and core 922, and the withdrawal of the anchor may include pulling at least a second side 924b of the retrieval line, core and arm 924 into the needle (or another tube). In some applications, advancement of the needle 930 (or other tube) over the core bar 922 and along the core bar 922 realigns the core bar.

After determining that the anchor has been optimally anchored, the retrieval line 914 may be separated from the anchor and withdrawn from the subject, thereby deploying the anchor in the tissue. For example, the retrieval wire 914 may be looped through an aperture in the second side of the arm and may be separated from the anchor by unlocking the loop. However, it should be understood that other reversible couplings may be used.

According to some applications, there is provided a method for implanting an implant into tissue of a heart of a subject, the method comprising: (i) Introducing a tissue anchor into a subject, the tissue anchor comprising a core, a head, an arm, and a hinge, the head coupled to a proximal portion of the core, the arm coupled to the core via the hinge, the core having an intermediate portion between a distal end and the proximal portion, and (ii) transluminally advancing the anchor along a tether toward the heart, wherein the head slides over the tether.

In some applications, the method includes sequentially advancing the first side of the arm, the hinge, and the intermediate portion of the core into the tissue such that a proximal portion of the core extends over the tissue.

In some applications, the method includes transitioning the anchor within the tissue toward a constrained state by pivoting the arm about the hinge such that the arm extends laterally across the distal end of the core.

In some applications, the method includes subsequently sandwiching the tissue between the arm and the head by moving the head distally along the stem toward the hinge.

For applications in which anchors 900 or 920 are used as part of an annuloplasty implant (e.g., an implant similar to implant 110), the anchors may be driven into the annulus of the heart valve being treated. For both the mitral valve and the tricuspid valve, the coronary arteries are disposed within the atrial wall upstream of the valve, near the annulus of the valve, e.g., alongside at least a portion of the atrium. When anchoring an anchor (e.g., an anchor of an annuloplasty implant) to the annulus, it is desirable to avoid the coronary arteries. Anchors 900 and 920 are assumed to be advantageously advanceable into the annulus when the arms of the anchors are substantially orthogonal to the coronary arteries, with the narrowing of the anchors in this state facilitating avoidance of the coronary arteries. In some applications, the anchors are rotationally oriented such that when transitioned to the constrained state, the arms become substantially parallel with the coronary arteries. Whereby even when the anchor is thus widened, it avoids the coronary arteries. This is shown in fig. 45E, where the anchors 900 of the implant 901 are anchored to the annulus (tissue 10) of the mitral valve 12, with the arms 904 of each anchor being substantially parallel to the left coronary artery 7.

Referring now to fig. 46A-C and 47A-C, fig. 46A-C and 47A-C are schematic illustrations of spacers or dividers 170' and 170 "according to some applications. The spacers or dividers 170' and 170 "are variants of the spacers or dividers 170 described above and may be used as described above for the spacers or dividers 170. Each of the spacers or dividers 170' and 170 "includes a wire 940, which wire 940 is a helical coil shaped to define a lumen 942 of the spacer or divider. In some applications, and as shown, in the resting state of the coil, the pitch d3 of the coil is small enough that the coil appears to be substantially closed, e.g., tubular. For example, the pitch d3 may be less than twice the thickness d4 of the wire (e.g., 1.4-2 times the thickness of the wire, such as 1.6-1.8 times the thickness of the wire, such as 1.7 times the thickness of the wire)). In some applications, in the resting state of the coil, the coil is a closed coil, i.e. each turn of the coil is in contact with its adjacent coil.

The spacers or dividers 170' and 170 "are flexible in terms of deflection and are typically resiliently flexible, i.e., they can deflect laterally by the application of force and will resiliently return toward their resting shape upon removal of the force. In some applications, starting in its rest state, the spacers or partitions 170' and 170 "are initially axially compressible (while providing a degree of axial compression resistance), and then typically become axially incompressible once compressed to the point where adjacent turns of the coil contact one another.

Each of the spacers or partitions 170' and 170 "has a primary region 944 and a secondary region 946 at each end of the primary region. The major regions of the spacers or dividers 170' and 170 "may be identical to each other and thus common reference numeral 944 is provided. The minor regions of the spacers or dividers 170' are not necessarily identical to those of the spacers or dividers 170 "and thus the minor regions of the spacers or dividers 170' and 170" have been further provided with the respective reference numerals 946' and 946".

In some applications, and as shown, the spacing, flexibility, and compressibility characteristics described above for the spacers or dividers 170' and 170 "apply only to the primary region 944, and the secondary region 946 has one or more characteristics that are different from the primary region. For example, the secondary region 946 may be less flexible in deflection than the primary region 946 and/or less axially compressible than the primary region 946. In some applications, this reduced flexibility and/or compressibility is due, at least in part, to the pitch of the coils of wire 940 being smaller in secondary region 946 than in primary region 944, for example as shown. Alternatively or additionally, the reduced flexibility and/or compressibility is due, at least in part, to the spacer or separator including a loop 948 (for separator or separator 170') or 950 (for separator or separator 170 ") coupled to wire 940 at each secondary region.

The primary and secondary regions 944 and 946 are axial regions, i.e., the length of a given region refers to the length of the region along the axis ax 13. In some applications, each secondary region 946 may be shorter than the primary region 944 for a given spacer or separator 170' or 170 ". Furthermore, for a given spacer or divider 170' or 170", the combined length of the two secondary regions 946 may be shorter than the primary region 944. In some applications, for a given spacer or separator 170' or 170", the length of each secondary region 946 is less than 30% (e.g., less than 20%, e.g., less than 10%) of the primary region, and/or at least 2% (e.g., at least 5%) of the primary region. For example, the length of each secondary region 946 may be 5-10% of the primary region 944.

Rings 948 and 950 may be rigid and may be formed from a single piece of raw material. Loops 948 and 950 may be disposed inside the coil of wire 940 (e.g., as shown), but may be disposed around the outside of the coil in some applications. Rings 948 and 950 may be coupled to wire 940 by welding, brazing, adhering, and/or an interference fit.

In some applications, each of rings 948 and 950 has a length along axis ax13 that is greater than wire thickness d4 (e.g., at least twice wire thickness d 4). In some applications, the loop extends through at least two turns of the coil of wire 940. In some applications, each ring 948 or 950 may be shorter than the primary region 944 for a given spacer or separator 170' or 170 ". Furthermore, in some applications, the combined length of the two rings 948 or 950 may be shorter than the primary region 944 for a given spacer or separator 170' or 170 ". In some applications, for a given spacer or separator 170' or 170", the length of each loop 948 or 950 is less than 30% (e.g., less than 20%, e.g., less than 10%) of the primary region 944, and/or greater than 2% (e.g., greater than 5%) of the primary region 944. For example, the length of each loop 948 or 950 may be 5-10% of the primary region 944.

Loops 948 and 950 are assumed to improve the interaction of spacers or spacers 170' and 170 "with the anchors of the implant with which they are used. For example, when used with an implant 110 that includes an anchor 120, the implant loops 948 and 950 may stably abut, flush against the planar face 148 of the eyelet 140 of the anchor 120 as they contract. It is further hypothesized that rings 948 and 950 may reduce the likelihood that the spacer or a portion of the spacer (e.g., a portion of the helical coil) is compressed medially and pulled into the eyelet of the implant anchor as the implant is contracted.

In some applications, loops 948 and 950 cover the ends of the turns of wire 940, thereby reducing the likelihood of tether 112 entering between turns of the turns.

Although ring 948 may be a simple ring, ring 950 typically has a flange 952 at its end. In some applications, flange 952 facilitates coupling of ring 950 to a coil of wire 940. In some applications, flange 952 provides a rim 954 for a spacer or divider 170", the rim 954 having a radius of curvature greater than that which would be provided in the absence of ring 950 (e.g., than that which would be provided by wire 940 alone). Such a larger radius of curvature is assumed to give the rim 954 an advantage as a bearing surface against which the tether 112 may slide, e.g., due to reduced likelihood of the rim engaging the tether and/or damaging the tether.

In some applications, loop 950 may be asymmetrically shaped so that its shape matches the shape of the coil of wire 940, e.g., so as to facilitate coupling therebetween. This is visible in the illustrations of fig. 47A and 47C, wherein the height of flange 952 is different at different circumferential positions about axis ax13 in order to accommodate the terminal turns of the coil of wire 940.

In some applications, the location of the rings 948 and 950 inside the coil of wire 940 reduces the diameter of lumen 942 at the secondary region 946. It is hypothesized that in some applications, this reduced diameter advantageously biases the tether 112 toward the central longitudinal axis ax13 of the spacer or separator, thereby reducing the likelihood of undesired interactions between the tether and the coils of the wire 940.

It should be noted that although rings 948 and 950 have been named "rings," they may have a greater length than shown in the figures and thus may be described as tubes in some applications.

Rings 948 and 950 may comprise cobalt chrome. Wire 940 may include cobalt chrome. In some applications, and as shown, wire 940 has a core 941, core 941 including a radiopaque material such as platinum. For example, wire 940 may include a drawn fill tube. The final radiopacity of the core 941 is assumed to facilitate fluoroscopic guidance of the implant (e.g., implant 110) implantation and/or retraction. For example, the fluoroscopically visible length of the spacer or separator 170' or 170″ may be used as a reference for spacing the anchors apart during anchoring, and/or an indication of the extent of contraction of the implant.

Referring now to fig. 48A-E, fig. 48A-E are schematic illustrations of a tether steering system 970 according to some applications. The system 970 includes a stop 971 and generally also includes a tool 976 for use with the stop. Tethers are used in a variety of medical procedures, including as sutures and/or as components of implants. It is often necessary to lock or secure such tethers at some point in the procedure. In the above example of tether 112 of implant 110, a stop (e.g., stop 114 b) is used for this purpose. For example, the stop 971 may be used to secure a tether, such as the tether 112, in place of the stop 114b and/or for similar purposes in the implant described in WO2021/084407 to Kasher et al, which is incorporated herein by reference for all purposes.

In some applications, for the system 100 described above (and other similar systems), this locking of the tether 112 is performed after the final anchor of the implant has been implanted. In fig. 48D-E, the final anchor is represented by a portion of the tissue anchor indicated by reference numeral 978.

Fig. 48A-E illustrate a system 970 that includes a stop 971, e.g., stop 971 is used in place of stop 114b with system 100. Fig. 48A shows an exploded view of the stopper, fig. 48B shows a perspective view of the stopper in both an open state ("a") and a clamped state ("B"), fig. 48C shows an end view of the stopper in both an open state ("a") and a clamped state ("B"), and fig. 48D-E show the stopper in an open state (fig. 48D) delivered using the tool 976 and transitioning to a clamped state (fig. 48E) after delivery from the delivery tool.

The stopper 971 includes a first member 971a and a second member 971b. Each of these elements includes at least one plate, and typically includes a plurality of plates rigidly coupled to one another. For example, the first element 971a includes a main plate 973a and one or more auxiliary plates 975a, and the second element 971b includes a main plate 973b and one or more auxiliary plates 975b.

Each plate of the element 971a defines a respective passageway 974a therethrough. For applications in which the element 971a includes a plurality of plates that each define a respective passageway 974a, the plurality of passageways 974a may be aligned with one another, for example as shown. Similarly, each plate of element 971b defines a respective passageway 974b therethrough. For applications where the element 971b includes multiple plates that each define a respective passageway 974b, the multiple passageways 974b may be aligned with one another, for example as shown.

In at least some states of the stop 971, the two elements are arranged such that the passages 974a and 974b together define a channel 974 through the stop. The stop 971 may be configured to be threaded onto the tether 112, with the tether extending through the passage 974.

For applications in which each of the elements 971a and 971b includes multiple plates, they may be coupled with auxiliary plates interposed with each other, for example as shown.

The first element 971a may be coupled to the second element 971b via a torsion bar 972 in such a way that the torsion bar biases the stopper toward a clamped state of the stopper (the term "clamped state" is explained below). In the clamped state, the first passageway 974a and the second passageway 974b are offset relative to one another. This biasing may be achieved by fixedly attaching (e.g., welding, brazing, or adhering) the torsion bar 972 to the primary plate 973a of the first element 971a and the primary plate 973b of the second element 971b (e.g., in such a manner that the two plates are biased to be positioned offset from one another).

While the torsion bar 972 biases the stop 971 toward its clamped state, the stop can be transitioned to an "open state" (the term "open state" is explained below) by increasing the stress on the torsion bar such that the torsion bar twists about itself (i.e., about the torsion bar's central longitudinal axis ax 14) such that the alignment between the passages 974a and 974b increases. In the open state of the stopper 971, the tether 112 may slide through the channel 974.

In some applications, the tool 976 defines a cavity 977 for holding the stop 971 in an open state. In some applications, the tool 976 is a delivery tool (e.g., a catheter or sheath) for delivering the stop 971 toward the heart of the subject, and at least a portion of the delivery tool defines a lumen. In some applications, the stop 971 is sized such that when the stop is disposed within the cavity, the tool maintains the stop in an open state. This may be achieved by the cavity being sufficiently narrow that the walls of the cavity 977 press against the first element 971a (e.g., at least the primary plate 973a thereof) and the second element 971b (e.g., at least the primary plate 973b thereof) to force the two elements into alignment with respect to one another. Transitioning the stop 971 to its open state twists the torsion bar 972 (i.e., increases torsional stress on the torsion bar 972). In some applications, the stopper 971 is transitioned to its open state by introducing the stopper into the cavity 977.

In some applications, tether 112 is adapted to extend from within the heart (where the tether may be part of an implant (e.g., implant 110)), through a delivery tool, and out of the subject. For some such applications, the stop 971 may be advanced transluminally within the tool 976 on the tether 112 and along the tether 112 toward the heart of the subject while the stop is worn on the tether and maintained in an open state.

In some applications, the lumen 977 is a lumen extending through the delivery tool, and the stop 971 is slidable through the lumen and over and along the tether toward the heart. Optionally, the tool 976 advances the cavity 977 toward the heart, with the stop 971 disposed in the cavity (e.g., stationary within the cavity).

The torsional stress of the torsion bar 972 in the open state is such that the ejection of the stop 971 from the cavity 977 of the tool 976 (e.g., out of the distal portion of the delivery tool and into the heart of the subject) transitions the stop toward the clamped state due to torsional decompression of the torsion bar (i.e., torsion bar twisting about the central longitudinal axis ax 14). This causes passages 974a and 974b to become less aligned with each other and thus clamp the tether within channel 974, as shown in the enlarged view of the stop in fig. 48E. That is, the offset between passages 974a and 974b is such that the tether is no longer slidable past the stop and, thus, the tether is essentially trapped within the stop.

In some applications, the torsional relief of torsion bar 972 as it is ejected from tool 976 is caused by the removal of the compression of elements 971a and 971b by the walls of cavity 977, such that torsion bar 972 becomes free to twist relief (at least in part), moving at least primary plates 973a and 973b relative to one another.

In some applications, and as shown, the first and second members 971a, 971b are adapted to fit together in unison, with the auxiliary plates interposed between each other. In some applications, the first element 971a is identical to the second element 971 b. In some applications, the first element 971a is a mirror image of the second element 971 b.

In some applications, in the open state of the stop 971, the two elements assume a cylindrical configuration, as shown in fig. 48B-C. In some applications, the cavity 977 has a generally circular cross-section such that the stop 971, which is held in an open state, can slide tightly through the cavity.

In some applications, the auxiliary plate 975a of the first element is offset relative to the auxiliary plate 975b of the second element 971b in the clamped state of the stop 971 such that the first and second elements are more non-uniformly mated together in the clamped state of the stop. For applications in which the stop 971 is cylindrical in its open state, the stop may become less cylindrical in its clamped state, for example, as shown by state "B" of 48B-C.

49A-D, FIGS. 49A-D are schematic illustrations of at least some steps in a technique for use with an implant coupled to a heart of a subject, according to some applications. In some applications, the technique is used with an implant that includes a tether that is locked under tension and may also include a plurality of anchors coupled to tissue of the heart and slidably coupled to the tether. For example, and as shown. As shown in fig. 49A-D, the technique may be performed on living animals or non-living simulations. Other examples of implants that may be used with the technique include implants or annuloplasty structures described in one or more of the following patent applications, each of which is incorporated herein by reference:

U.S. patent application 15/782,687 filed on 10/12 2017 to Iflag et al, published as US2018/0049875 (now U.S. patent 10,765,514);

U.S. patent application 16/534,875 filed on 7 at 8/2019 by Brauon et al, published as US2020/0015971 (now U.S. patent 11,123,191);

The technique may be used to relieve tension on an implant tether. For example, for applications in which the implant is an annuloplasty structure, at some time after implantation of the implant (e.g., after months or years), it may be determined that implantation of the prosthetic valve at the native heart valve has become advantageous or necessary, for example, due to further deterioration of the native heart valve. For some such applications, the annuloplasty structure and/or the contracted annulus contracted by the annuloplasty structure may obstruct implantation of the prosthetic valve and/or may be detrimental to the implanted prosthetic valve. It is therefore hypothesized that in some applications it may be advantageous to relieve the tension on the tether of the implant, e.g., to allow the native heart valve to relax and/or re-expand prior to implantation of the prosthetic valve.

Fig. 49A shows an implant 110 implanted at the mitral valve 12, for example, as described above. In implant 110, tension may be locked in tether 112 by stop 114b, typically by locking the stop to first portion 112' of the tether, e.g., preventing the first portion of the tether from sliding relative to at least one anchor 120, such as by the stop abutting the anchor.

As described above, implant 110 may or may not include a spacer or divider 170. For clarity, the implant 110 is shown without the spacer or spacers in 49A-D. 49A-D may be used with implants that include a spacer or separator such as those described herein, as well as implants that do not include a spacer or separator.

Fig. 49A shows implant 110 that has been implanted at valve 12, e.g., as described above. Fig. 49 may be similar to fig. 4A. At some time after implantation of the implant 110 (e.g., when it is determined that implantation of the prosthetic valve has become advantageous or necessary), an elongate tool 960 comprising a retainer 961 and a cutter 962 is advanced to the implant (fig. 49B). A stop (in this case, stop 114 b) that locks tension in the tether is secured to the retainer 961. For example, and as shown, the retainer 961 may include a cavity 966, and the stopper may be secured to the retainer by advancing the stopper through an opening of the retainer (e.g., a distal opening) and into the cavity (e.g., by advancing the opening over the stopper) (insert a of fig. 49B). Further, a cutter 962 may be provided at the opening and a stop may pass through the opening and past the cutter into the chamber 966, for example, as shown. Cutter 962 (e.g., its blade) may prevent stopper 114B from re-exiting the chamber via the opening, particularly after the cutter has been actuated (insert B of fig. 49B). In the example shown, the cutter 962 is actuated by pulling one or more pull wires 963 such that sliding of the tapered surfaces relative to each other causes the cutter to move. For example, the tapered surface 964 may be fixed to the pull wire 963, and the tapered surface 965 may be fixed to the cutter 962 (e.g., a blade thereof), and upon pulling the pull wire 963, the surface 965 may slide relative to the surface 964 and toward the tether 112. However, other cutters and their actuation mechanisms may be used.

Sufficient actuation of cutter 962 cuts tether 112, thereby relieving tension on the tether (panel B of fig. 49B). In some applications, and as shown, the tether is cut between stop 114b and the anchor 120 to which the stop abuts. For some such applications, this is accomplished by advancing the tool 960 until the distal portion of the tool abuts the anchor 120 (e.g., its eyelet), for example, as shown in insert a of fig. 49B. The cut forms a first cut end 116 'and a second cut end 116 "of the tether, the first cut end belonging to the first portion 112' of the tether and the second cut end belonging to the second portion 112" of the tether. In some applications, after cutting, the second portion 112 "of the tether pulls the second cut end 116" away from the cutter 962 and past the anchor 120 (e.g., out of the eyelet of the anchor through which the tether 112 has been passed), thereby relieving tension on the tether. In some applications, the second cutting end 116 "is pulled through only a subset of the anchors 120 (e.g., through only the first anchor, i.e., the anchor to which the stop abuts) and not through another subset of anchors (e.g., the second anchor), thereby remaining coupled to the other subset of anchors.

The tool 960, stop 114B, and first portion 112' may then be withdrawn from the subject, leaving the second portion 112 "of the tether coupled to the heart (fig. 49B, panel C). Fig. 49C shows the tether (e.g., the second portion 112 "thereof) having responsively become slack and the mitral valve 12 having been slack and expanded. Fig. 49D shows the prosthetic valve 968 that has been subsequently implanted at (e.g., in) the mitral valve.

According to some applications, there is provided a method comprising: an implant for transluminally advancing an elongate tool comprising a holder and a cutter to a heart coupled to a subject, the implant comprising: (i) A tether under tension, and ii) a stop that locks the tension in the tether by locking to a first portion of the tether. The method further includes securing the stop to the retainer.

In some applications, the method includes, while the stop remains secured to the retainer and locked to the first portion of the tether: (a) Reducing the tension on the tether by cutting the tether with the cutter; and (b) withdrawing the tool, the stop, and the first portion of the tether from the subject while leaving a second portion of the tether coupled to the heart.

Although in the examples described above the tension is locked in the tether of the implant by a stop, it should be noted that the technique is applicable to implants where tension is locked in the tether by other means, such as by a knot. Whether the tension is locked in the tether by a stop or by other means, the technique may include removing one portion of the cut tether from the subject, e.g., while leaving another portion of the tether coupled to the heart. For example, for a stop-locked implant, the portion of the cutting tether to which the stop is locked (e.g., the first portion 112' described above) may be removed from the subject; and for a knot-locked implant, the portion of the tether comprising the knot may be removed from the subject.

According to some applications, there is provided a method comprising: (i) transluminally advancing an elongate tool to a tether under tension and disposed within a heart of a subject, the elongate tool comprising a holder and a cutter, (ii) securing a first portion of the tether to the holder, and (iii) while the first portion of the tether remains secured to the holder, (a) decoupling the first portion of the tether from the second portion of the tether by cutting the tether with the cutter to relieve the tension on the tether; and (b) withdrawing the tool and the first portion of the tether from the subject while leaving the second portion of the tether coupled to the heart.

It should be noted that although the technique of fig. 49A-D is described as being used with a previously transluminal implant, in some applications the technique may be used with a previously surgically implanted implant.

Referring to FIGS. 50, 51, 52A-F, and 53A-E, FIGS. 50, 51, 52A-F, and 53A-E are schematic illustrations of a system 1000 for use with an object according to some applications. Fig. 50 shows an overview of a system 1000 including an implant and a delivery tool 1050.

In the description of the system 1000, the implant of the system is described and illustrated as implant 110 described in more detail above, for example, with reference to fig. 1A-4B. However, it should be understood that the system 1000 may include other implants (mutatis mutandis), for example, the delivery tool 1050 may be used to implant other implants (mutatis mutandis). For example, the system 1000 may include other implants including or anchored with a plurality of anchors, such as, but not limited to, implants and/or anchors described herein, and/or implants and/or anchors described in WO2021/084407 by Kasher et al, which is incorporated herein by reference (e.g., implants including a plurality of anchors slidably coupled to (e.g., threaded onto) a tether). Alternatively or additionally, delivery tool 1050 and/or components thereof may be used (mutatis mutandis) to facilitate implantation of an implant (e.g., an annuloplasty structure) described in WO2014/064694 to Sheps et al and/or WO2016/174669 to ifah et al, each of which is incorporated herein by reference. Further, and more generally, the system 1000 and/or techniques described for use therewith may be used in conjunction with one or more of the systems and/or techniques described in the references cited in this paragraph.

As described above, implant 110 includes a plurality of tissue anchors 120 and a tether 112 through which the tissue anchors are threaded. As described in more detail below, during implantation, only the distal portion of tether 112 remains implanted within the subject, while the proximal portion of the tether remains attached to delivery tool 1050. However, for simplicity, implant 110 is described herein as including a tether.

The tissue anchors 120 are distributed serially along the tether 112, and the delivery tool 1050 can be used to implant the implant 110 by an anchor driver 1060, the anchor driver 1060 being used to advance the anchors distally into the subject and anchor the anchors to the internal tissue of the subject for each anchor 120 in turn, e.g., as described above with reference to fig. 1A-4B. For example, and as shown, implant 110 may be an annuloplasty implant implanted by distributing anchors 120 around at least a portion of an annulus of a native heart valve of a subject, such as a mitral valve or tricuspid valve. Further, in some applications, the distal end of tether 112 may be advanced distally into the subject along with the first anchor, and the subsequent anchors may be advanced by sliding them distally along the tether.

Delivery tool 1050 includes an anchor driver 1060 and a catheter device 1070, catheter device 1070 including a flexible tube (e.g., catheter) 1072 configured to be advanced into a subject. In some applications, delivery tool 1050 may be used as delivery tool 150 described above (e.g., with reference to fig. 1A-4B). In some applications, tube 1072 may be used as, correspond to, and/or be replaced with tube 152 described above (e.g., with reference to fig. 1A-4B). In some applications, driver 1060 may be used as, correspond to, and/or be replaced with driver 160 or any other anchor driver described above.

For applications in which the implant 110 is an annuloplasty implant, and as shown, the tube 1072 may be a transluminal (e.g., trans-femoral) pusher catheter. In some applications, at the distal portion of the tube 1072, the tube defines a lateral slit 1056 extending proximally from the distal end of the tube such that the slit is continuous with the distal opening 1071 of the tube (fig. 51). In some applications, the slit 1056 is similar in structure and/or function to the slit 156 described above. For example, the slit 1056 allows the tether 112 and the usual spacer or separator 170, rather than the anchor 120, to exit the tube 1072 laterally proximally from the distal end of the tube. However, the slit 1056 is shaped to define a narrowed entrance 1058 into the lateral slit that is configured to, for example, prematurely and/or unintentionally prevent (but not exclude) the tether from distally exiting the lateral slit. In some applications, the tube 1072 includes a tip frame 1054 that maintains (e.g., supports) the lateral slit 1056, the narrowed entrance 1058, and/or the distal opening 1071. For some such applications, the tip frame 1054 is resilient, e.g., to deform in response to being pressed against tissue, thereby reducing the likelihood of damage to the tissue.

The apparatus 1070 also includes an extracorporeal unit (e.g., an extracorporeal control unit) 1074 configured to remain external to the body of the subject. In some applications, the extracorporeal unit 1074 defines or is coupled to a handle of the device 1070. In some applications, the in vitro unit 1074 shares one or more features with one or more of the in vitro units 1074, and 1474 described in international patent application PCT/IB2021/058665 to Halabi et al, filed 9 months 23 2021, which is incorporated herein by reference. Furthermore, the device 1070 may be used, mutatis mutandis, to facilitate implantation of any of the implants described in US2021/0145584 to Kasher et al, which is incorporated herein by reference.

A system/apparatus, such as a catheter device 1070, includes a series of cartridge bodies 1020 that each hold (e.g., support) a respective anchor 120. Fig. 50 and 52A illustrate an initial state of the device 1070 in which each of the cartridge bodies 1020 is coupled to the extracorporeal unit 1074 in a respective initial position. In some applications, the extracorporeal unit 1074 includes or defines one or more rails 1080 (e.g., grooves (as shown), rails, slots, etc.), and each cartridge body 1020 can be moved (e.g., slid, etc.) along the rails 1080 from a respective initial position of the cartridge body to a deployed position in which the cartridge body retains its tissue anchors 120 opposite the proximal openings 1073 of the tubes 1072 while remaining coupled to the extracorporeal unit. An example of such movement is shown in the transition between fig. 52A and 52B, wherein a first cartridge body 1020f (which holds a first anchor 120 f) is moved (e.g., slid) from its initial position (fig. 52A) to a deployed position (fig. 52B). This may be performed manually by an operator gripping the cartridge body with his hand. In some applications, no track is used and the cartridge body can be moved into place by other means, such as being individually attached in place by hand, rotated into place, etc.

As shown, movement from the initial position to the deployed position may include rotation of the cartridge body 1020 (e.g., about the proximal end of the catheter device 1070), such as performing a U-turn. Thus, each anchor 120 may be initially oriented with its tissue-engaging element 130 directed proximally relative to catheter device 1070 (fig. 52A), and subsequently oriented with its tissue-engaging element directed distally relative to the catheter device (fig. 52B). Further, the cartridge bodies 1020 are thus typically initially arranged in a "reverse" order, with the first cartridge body 1020f being the most proximal side of the cartridge body as a whole relative to the delivery tool 1050 (fig. 50 and 52A). Similarly, the distal end of tether 112 may initially be the most proximally located portion of the tether.

As described above, the first anchor 120f is prevented from sliding off the tether 112, for example by the stop 114a or by being fixedly attached to the tether. Thus, the first cartridge body 1020f carrying the first anchor 120f carries the distal end of the tether 112 with it to the deployed position (fig. 52B). In some applications, and as shown, this arrangement is facilitated by the device by an extracorporeal unit 1074, the extracorporeal unit 1074 including a support (e.g., sheave or pulley) 1078 (e.g., a proximal support) about which the tether 112 rotates. The rails 1080 guide each cartridge body from its initial position in which it performs a U-turn around the support 1078 to a deployed position.

Assuming the device 1070 is configured as described above, with the tether 112 extending proximally and then distally, it is advantageous to position the cartridge body 1020 in a manner that is particularly easily accessible to an operator. For example, it in turn allows each cartridge body 1020 (and anchors 120 therein) to be accessible at the proximal end of catheter device 1070 without being obstructed by subsequent cartridge bodies.

In some applications, each cartridge body 1020 is configured to lock to the extracorporeal unit 1074 upon reaching the deployed position. Such a configuration may be accomplished, for example, using a latch mechanism, for example, wherein the extracorporeal unit 1074 includes one or more latches 1082, and each cartridge body 1020 is correspondingly shaped to be locked by the one or more latches. The latches 1082 can be resilient or spring-loaded such that they flex instantaneously (e.g., outwardly) in response to arrival of the cartridge body 1020 and then lock to the cartridge body automatically (e.g., a snap fit) after the cartridge body is fully positioned in the deployed position.

The system 1000 is configured such that for each anchor 120, when its cartridge body 1020 is in the deployed position, the anchor driver 1060 in turn engages the anchor, pushing the anchor distally out of the cartridge body and through the tube 1072, and driving the anchor into tissue (e.g., tissue of the heart). This is shown in fig. 52E. However, in some applications, and as shown, the extracorporeal unit 1074 includes a barrier 1030, the barrier 1030 shielding the proximal opening 1073 in its closed state. In this context, "shielding" does not necessarily mean that the barrier 1030 completely covers the opening 1073. More specifically, as shown, "shielding" may mean that the barrier is an obstacle for the anchors 120 to exit the cartridge body 1020 and/or access tube 1072 via the proximal openings 1073, for example, by disposing the barrier directly between the anchors in the cartridge body and the proximal openings of the catheter. However, in some applications, the barrier 1030 may be configured to completely cover the opening 1073.

Each cartridge body 1020 is movable along track 1080 from its initial position to a deployed position such that in the deployed position the cartridge body holds the respective anchor opposite the proximal opening and barrier 1030 is in its closed state. In some applications, the barrier 1030 may be closed (e.g., manually and/or via a separate step) prior to the cartridge body being moved to the deployed position. In some applications, and as shown, the barrier 1030 is configured to transition to its closed state (fig. 52B) in response to movement of the cartridge body toward the deployed position (e.g., in response to the cartridge body reaching the deployed position). In the particular example shown, the cartridge body 1020 (e.g., the face 1021 defined thereby) is configured to urge the barrier 1030 into its closed state upon the cartridge body reaching the deployed position.

Once the cartridge body 1020 is in the deployed position, the anchor 120 is held against the proximal opening 1073 of the tube 1072 and the operator engages the anchor driver 1060 with the anchor-e.g., to the hub 182 of the head 180 of the anchor (fig. 52C). The anchor driver 1060 may include an elongated and flexible shaft 1062, a driver head 1064, and an actuation handle 1066, the driver head 1064 coupled to a distal end of the shaft, the actuation handle 1066 configured to reversibly engage the driver head with the anchor 120, for example, via a lever extending from the handle to the driver head. When driver 1060 is engaged with anchor 120, a force to transition barrier 1030 to the open state may be applied to the anchor by the driver (fig. 52D). The force may be an engagement nuclear force that challenges engagement of the anchor by the anchor driver. The system 1000 is configured to define a threshold magnitude of force such that the barrier transitions to the open state in response to the force only after the force exceeds the threshold magnitude. In the example shown, the threshold magnitude may be primarily defined by the configuration of each cartridge body 1020. However, it should be noted that the scope of the present disclosure includes other components of the system 1000 that help define the threshold magnitude. If anchor driver 1060 is sub-optimally engaged with anchor 120, it will separate from the anchor upon application of a force below a threshold magnitude and barrier 1030 will remain closed. To proceed further, the driver (or a new driver) must be reengaged with the anchor. Only after a force of a threshold magnitude or above is successfully applied to the anchor to verify engagement of the anchor, the barrier 1030 is opened, allowing the driver 1060 to advance the anchor 120 distally beyond the barrier and into and through the tube 1072. It is hypothesized that this configuration reduces the likelihood that the suboptimal engaged anchor will be inadvertently released prematurely from the driver 1060 within the tube 1072 or the subject's body (e.g., prior to anchoring in tissue) and/or that the driver cannot apply the force required to drive the anchor into tissue.

In the example shown, the force (e.g., the coaptation core force) is a proximal pulling force. However, it should be understood that the scope of the present disclosure includes the use of other forces, such as torque, mutatis mutandis.

In some applications, and as shown, the force (e.g., the coaptation nuclear force) applied to the anchor 120 by the driver 1060 transitions the barrier 1030 to its open state by causing a conformational change in the cartridge body 1020 (e.g., the barrier 1030), e.g., the barrier 1030 is configured to transition to its open state in response to the conformational change.

In some applications, and as shown, the barrier 1030 may be biased toward being in its open state (e.g., by a spring-loaded displacement mechanism, such as spring 1032).

In some applications in which (i) the barrier 1030 opens in response to a conformational change of the cartridge body 1020 and (ii) the barrier is biased toward opening, the cartridge body 1020 reaches the deployed position when in the first conformation applying a closing force to the barrier 1030 (fig. 52B), and the conformational change of the cartridge body caused by the engagement verification force lessens (e.g., removes) the closing force from the barrier, allowing the barrier to open (fig. 52D). In the example shown, the barrier 1030 is pivotally mounted (e.g., on pin 1034) and opens and closes by pivoting. In some applications, and as shown, the closing force is a distally directed pushing force exerted by the cartridge body 1020 (e.g., face 1021 thereof) against the barrier 1030 (e.g., leading edge 1031 thereof).

In some applications, and as shown, each cartridge body 1020 includes a first component 1022 and a second component 1024, e.g., each component is a respective unitary structure made from a single piece of material.

In some applications, and as shown, the cartridge body 1020 is coupled to the extracorporeal unit 1074 by a coupling between the first member 1022 and the extracorporeal unit (e.g., by the first member slidably engaging the rail 1080). In some applications, and as shown, the first member 1022 is shaped and/or positioned to be grasped by a human operator with a hand.

In some applications, and as shown, the second component 1024 holds (e.g., supports) the anchor 120. In some applications, and as shown, the second component 1024 is mounted inside the first component 1022.

In some applications, the conformational change described above includes relative movement between the components 1022 and 1024 such that the face 1021 is displaced, thereby alleviating the closing force. For example, and as shown, the conformational change may include the second component 1024 sliding proximally relative to the first component 1022, e.g., by proximally pulling by a proximally directed engagement core force applied to the anchor 120 by the driver 1060, thereby displacing the face 1021 proximally (fig. 52D). For such applications, face 1021 may be defined by second component 1024. For applications in which the second component 1024 is mounted inside the first component 1022 and retains the anchor 120, such proximal movement/displacement creates a distally facing recess 1026 in the cartridge body 1020 (e.g., within the first component in which the second component was previously located), and the barrier 1030 can move (e.g., pivot) into the recess 1026 as the barrier 1030 is returned toward its open state.

For applications in which the opening of the barrier is achieved by causing a conformational change in the cartridge body 1020, the threshold magnitude may be defined at least in part by the configuration of each cartridge body, such as resistance to the conformational change. For example, for applications in which the conformational change comprises relative movement between components of the cartridge body (e.g., between components 1022 and 1024), the threshold magnitude may be defined at least in part by the resistance of the cartridge body to movement between its components. For example, the components may be mated to have a particular degree of friction therebetween, and/or the cartridge body may define a ridge or fastener that can be overcome only by forces exceeding a threshold magnitude.

Once the barrier 1030 is open, the driver 1060 can be used to advance the anchor 120 distally beyond the barrier, through the opening 1073, into the tube 1072 (fig. 52E), and through the catheter to the tissue (e.g., to heart tissue), and anchor the anchor to the tissue. As shown, this can be performed while the cartridge body 1020 remains in the deployed position, for example, with the driver 1060 (e.g., its shaft 1062) extending through the cartridge body. After anchoring, driver 1060 may be disconnected from anchor 120 and withdrawn (fig. 52F).

As described above, because the first anchor 120f is prevented from sliding off the tether 112, the first cartridge body 1020f carrying the first anchor 120f carries the distal end of the tether 112 to the deployed position (fig. 52B). Similarly, advancement of the first anchor 120f advances the distal end of the tether 112 through the tube 1072 to the tissue and anchors the first anchor to anchor the distal end of the tether to the tissue. As the driver 1060 is withdrawn, the tether 112 remains extended through the tube 1072 (fig. 52F) such that the subsequent anchor 120 advances through the catheter including over the tether and slides the subsequent anchor along the tether toward the previously anchored anchor.

For each cartridge body 1020, once its anchors 120 have been anchored, the cartridge body can be removed from the deployed position, such that the deployed position is emptied for the successive cartridge body. In some applications, removal of the cartridge body 1020 is facilitated by actuating a release latch 1076 on the extracorporeal unit 1074. In some applications, removing the cartridge body from the deployed position involves completely removing the cartridge body from the extracorporeal unit 1074. This may be facilitated by the cartridge body 1020 being slidably coupled to the tether 112 only via the anchors 120 and thereby being separated from the tether as the anchors exit the cartridge body. In some applications, the removal of the cartridge body is performed after the driver 1060 has been withdrawn, and in some applications, the driver (e.g., its presence within the cartridge body) may prevent the removal of the cartridge body.

In some applications, the extracorporeal unit 1074 includes a tensioner 1084 (e.g., including a spring-loaded winch) that reduces slack on the tether 112 and/or generally manages the tether during implantation of the implant 110. The assumption advantageously reduces the likelihood that tether 112 becomes twisted or tangled or inadvertent engagement of the tether with the delivered anchor. Further assuming that a winch is used to reduce slack rather than the proximal end of the tether being manually pulled by a human operator, it advantageously provides greater control over the magnitude and consistency of the tension applied to the tether and may further advantageously reduce the number of human operators required. In some applications, tensioner 1084 is as described in International patent application PCT/IB2021/058665 to Halabi et al, 9.23, 2021, incorporated herein by reference. However, it should be noted that aspects of the system 1000 (such as, but not limited to, the cartridge body 1020 and the barrier 1030) may be used independently of the tensioner 1084 (or any tensioner). Accordingly, the scope of the present disclosure includes variations of system 1000 that do not include tensioner 1084, as well as variations that do not include any tensioner.

As shown, for applications in which a spacer or separator 170 (or variations thereof) is used (i.e., for applications in which the implant 110 includes a spacer or separator), they may be disposed at the extracorporeal unit 1074 prior to implantation, alternately threaded on the tether 112 with the anchors 120. In some applications, each cartridge body 1020 can hold one of the spacers, such as the spacer that will precede the anchor housed by the cartridge body (as shown), or the spacer that will follow the anchor housed by the cartridge body.

In some applications, a port 1086 is disposed at the proximal opening 1073 of the tube 1072. Port 1086 may have a reducer lumen that facilitates smooth advancement of anchor 120 into tube 1072.

Port 1086 may include a membrane 1088 that provides a hemostatic seal during an implantation procedure. The film 1088 may be formed of silicone. The material (e.g., silicone) forming the film 1088 may have a hardness of 38-42 (e.g., 40) shore a. The film 1088 may be about 1mm thick. The membrane 1088 may be oriented substantially transverse to the proximal end of the tube 1072.

The film 1088 may be shaped to define a first aperture 1090 and a second aperture 1092 connected by a closure slit 1094. In some applications, the first aperture 1090 is larger in diameter (e.g., at least two times, such as at least three times, such as 3-10 times, such as at least 4 times) than the second aperture 1092. For example, the diameter of the first aperture 1090 may be 1.5-2.5mm (e.g., 1.7-2.2mm, e.g., 1.8-2.0mm, such as 1.9 mm), while the diameter of the second aperture 1092 may be 0.2-0.7mm (e.g., 0.2-0.6mm, e.g., 0.3-0.5mm, such as 0.4 mm).

As shown, port 1086 (e.g., its membrane 1088) may be oriented such that first aperture 1090 is located on an axis along which the tissue-engaging elements of driver 1060 and anchor 120 advance. When the cartridge body 1020 is in the deployed position (fig. 52B), the tissue-engaging elements of its tissue anchor 120 can be aligned with the first aperture 1090, thereby defining an anchor advancement axis from the tissue anchor through the first aperture and through the tube 1072.

As also shown, the second aperture 1092 is generally located on an axis along which the tether 112 advances. Each anchor may be advanced through membrane 1088 with (i) its central longitudinal axis and/or tissue-engaging element aligned with first aperture 1090 and (ii) its eyelet threaded onto tether 112 aligned with second aperture 1092.

It should be noted that typically neither the aperture 1090 (and thus the anchor advancement axis) nor the aperture 1092 are centrally aligned with respect to the tube 1072. Instead, the center of the first aperture 1090 may be disposed on one side of the central axis of the catheter and the center of the second aperture 1092 may be disposed on an opposite side of the central axis of the catheter. However, for applications in which the first aperture 1090 is sufficiently large, the first aperture may overlap with (but still not be centered about) the central axis of the catheter.

As each anchor 120 passes distally through membrane 1088, slit 1094 and generally apertures 1090 and 1092 responsively momentarily open or widen, and then close or re-narrow behind the anchor.

In some applications, the aperture 1090 is sized to seal around the driver 1060 (e.g., its shaft 1062), and the driver 1060 may be narrower than the head of the anchor 120. For example, in some applications, the diameter of the aperture 1090 is 80-120% (e.g., 90-110%) of the thickness of the shaft 1062.

In some applications, aperture 1092 is sized to seal around tether 112, tether 112 being narrower than the eyelet of anchor 120. For example, in some applications, the diameter of aperture 1092 is 50-200% (e.g., 80-120%, such as 90-110%) of the thickness of tether 112.

As the driver 1060 is withdrawn proximally through the membrane 1088, the tether 112 generally remains extended through the second aperture 1092 (FIG. 52F).

The dual orifice configuration of the membrane 1088 is assumed to advantageously provide a better hemostatic seal for the implantation procedure than other configurations (e.g., a single larger orifice or slit). For example, during anchoring of anchor 120 (when tether 112 and shaft 1062 extend through membrane 1088), a slit 1094 disposed between the tether and the driver may be closed

With further reference to fig. 56A-B and 57A-B, fig. 56A-B and 57A-B are schematic illustrations of a flush adapter 1100 according to some applications. Flush adapter 1100 is an optional component of system 1000. 56A-B are perspective views of an irrigation adapter 1100, and FIGS. 57A-B are perspective and cross-sectional views, respectively, of an irrigation adapter locked to an extracorporeal unit 1074 of a catheter device 1070 of the system 1000, according to some applications.

Flush adapter 1100 may include a fluid fitting 1102 (which acts as an inlet), a nozzle 1104 (which acts as an outlet), and a channel 1106 therebetween. In some applications, the flush adapter 1100 may be reversibly locked to the extracorporeal unit 1074 in a flush position in which (i) the fitting 1102 is accessible from outside the catheter device 1070 and (ii) the nozzle 1104 is in fluid communication (e.g., sealed fluid communication) with the port 1086 such that fluid driven into the flush adapter via the fitting is directed distally through the tube 1072.

Typically, flushing the catheter device with a liquid, such as saline, may be performed prior to and/or during the transcatheter procedure, e.g., to ensure that the catheter device is clean (e.g., free of air or blood). However, in existing catheter devices, the flushing liquid may be introduced laterally, for example, at a point distal to the proximal end of the catheter. In contrast, the flush adapter 1100 is positioned at the proximal end of the tube 1072. Such proximal placement is assumed to be particularly advantageous for the system 1000, for example, in order to reduce the likelihood of irrigation liquid escaping from the proximal end of the tube 1072. For example, for applications in which the system 1000 includes a membrane 1088, at some point in the procedure, the orifice 1090 and/or orifice 1092 are open and unobstructed (see, e.g., fig. 52A-D), and thus, if irrigation fluid is introduced laterally at a point distal of the proximal opening 1073, the irrigation fluid may escape proximally rather than being forced distally through the tube 1072.

The locking of the flush adapter 1100 to the extracorporeal unit 1074 may be a snap fit, for example facilitated by a snap fit onto a corresponding component of the extracorporeal unit and may be manually squeezed by a user to remove the resilient wings 1110 of the flush adapter from the extracorporeal unit.

The fluid fitting 1102 may be a luer fitting, or any other suitable fitting to which a source of flushing liquid may be connected.

In some applications, and as shown, the irrigation position (i.e., the position in which the irrigation adapter 1100 is locked to the extracorporeal unit 1074) is coincident with the deployment position (i.e., the position in which the cartridge body 1020 is disposed so as to hold the anchor 120 opposite the proximal opening 1073 of the tube 1072). For example, the flush adapter may be coupled to substantially the same extracorporeal unit area as the cartridge body 1020 in its deployed position.

As shown in fig. 57B, even for applications in which (i) the cartridge body 1020 closes the barrier 1030 after reaching the deployed position and (ii) the flush position coincides with the deployed position, the flush adapter 1100 does not normally close the barrier after placement at the flush position. For example, and as shown, the adapter 1100 is shaped and sized such that the channel 1106 extends distally through the barrier 1030, for example, without the adapter pushing the barrier closed. Thus, nozzle 1104 may become disposed distally beyond barrier 1030 such that it is sealed with port 1086.

In some applications, and as shown, nozzle 1104 is sealed with a port 1086 proximal to membrane 1088. In some applications, and as shown, nozzle 1104 is sealed with a tapered inner wall of port 1086. The nozzle 1104 may include an O-ring 1108 or other seal that facilitates such sealing.

In some applications, if flushing is required after the anchoring of the first anchor 120F, and thus as the tether 112 extends through the port 1086, the nozzle 1104 (e.g., O-ring 1108) may temporarily clamp the tether against the tapered inner wall of the port, e.g., with the O-ring sealed against the tether.

With additional reference to fig. 53A-E, 54, and 55A-C, fig. 53A-E, 54, and 55A-C are schematic illustrations of apparatus and techniques for facilitating use of a catheter having a lateral slit, according to some applications. In some applications, when a tube (e.g., a catheter) is used to implant an implant (such as implant 110) in a curvilinear manner (such as along/around the annulus of a heart valve), the rotational orientation of the distal end of the tube may remain constant relative to the tissue as the tube moves around the curve. Thus, the rotational orientation of the distal end of the tube may change relative to the portion of the implant currently fixed to the tissue (e.g., relative to a tangent to the curve at that portion of the implant). This may be particularly important in some applications when the distal end of the tube has a lateral slit (e.g., lateral slit 156 or lateral slit 1056) and/or another feature that reduces rotational symmetry of the tube. For example, assuming that when anchors 120 other than the first anchor of the implant are placed, it is advantageous to orient the lateral slit to face the previous anchor so that tether 112 may extend cleanly through the lateral slit to the previous anchor, e.g., rather than rubbing against the sides of the lateral slit, and/or bending around the outside of the tube. However, if the rotational orientation of the distal end of the tube is to remain constant relative to the tissue as the implant is implanted around a curve, the orientation optimal for placement of the second anchor may be suboptimal for placement of the subsequent anchors. This can be understood, for example, by comparing fig. 53B with fig. 53D. When the second anchor is placed (fig. 53B), the lateral slit 1056 substantially faces the first anchor, and the tether 112 extends cleanly through the lateral slit and is in a generally straight line between the lateral slit and the first anchor. If the tube 1072 is held in the same orientation for placement of the final anchor (fig. 53D), the lateral slit 1056 will not face the previous anchor (penultimate anchor) but may face the anterior side of the valve.

Fig. 53A-D illustrate some steps of implanting implant 110 using catheter device 1070 of system 1000 according to some applications. In some applications, and as shown, the system 1000 (e.g., the catheter device 1070 thereof) is configured to accommodate (e.g., compensate for) the effects described in the previous paragraph. For example, and as shown, an extracorporeal unit 1074 that may be mounted on the platform 1002 may be mounted on the platform (e.g., via the bracket 1004) in a manner that facilitates rotation of the extracorporeal unit about a longitudinal axis ax15 defined by the proximal end of the tube 1072. The extracorporeal unit 1074 may be rotationally fixed to the tube 1072, and thus rotation of the extracorporeal unit about the longitudinal axis rotates the tube. This arrangement is assumed to facilitate rotation of the distal end of the tube 1072 to optimally orient the lateral slits 1056 depending on the position of each anchor 120 relative to the previous anchor. For example, in each of fig. 53B, 53C and 53D, the extracorporeal unit 1074 is in a different rotational orientation, and the lateral slits 1056 thus face in different directions, substantially towards the previous anchor at a time.

In some applications, the system 1000 defines a series of discrete rotational orientations about a longitudinal axis, wherein the extracorporeal unit 1074 is mounted (or configured to be mounted) on the platform 1002 in a manner that facilitates orienting the extracorporeal unit in each of the discrete rotational orientations. For example, and as shown, the system 1000 (e.g., platform 1002, extracorporeal unit 1074, or mount 1004) may include at least one stop pin 1006 (e.g., a spring-loaded stop pin) configured to secure the extracorporeal unit in each discrete rotational orientation, e.g., via a snap fit. For example, the system 1000 may also define a series of recesses 1008 corresponding to the series of discrete rotational orientations such that in each discrete rotational orientation, the detent pin 1006 protrudes into the corresponding recess, thereby preventing rotation out of the discrete rotational orientations. In the example shown, the recess 1008 is defined by an extracorporeal unit 1074 (e.g., by the exterior of the housing of the tensioner 1084), and the stop pin 1006 is a component of the bracket 1004 or is coupled to the bracket 1004.

As shown, the bracket 1004 may be axially slidably coupled to the platform 1002. The support 1004 may provide rotational coupling of the extracorporeal unit 1074 to the platform 1002 by being rotatably coupled to the outside of the body. Such rotatable coupling may be facilitated by a rotatable coupling between the bracket 1004 and the proximal portion of the tube 1072. For example, and as shown, the bracket 1004 may define one or more channels 1005 through which a proximal portion of the tube 1072 passes, e.g., defining a barrel hinge, wherein the proximal portion of the tube 1072 acts as a "pin" of the hinge and the portion(s) of the bracket 1004 defining the channel 1005 act as a "knuckle" of the hinge.

Fig. 53A shows the distal end of tube 1072 positioned for placement of first anchor 120f of implant 110. Fig. 53B shows that the first anchor 120f has been anchored and the distal end of the tube 1072 is positioned for placement of the second anchor. In fig. 53A and 53B, the extracorporeal unit 1074 is provided in the same discrete rotational orientation, with the stop pin 1006 protruding into the same recess 1008. Fig. 53C shows three anchors 120 having been anchored with a spacer or separator 170 disposed therebetween, and the distal end of tube 1072 positioned for placement of a fourth anchor. The extracorporeal unit 1074 has been rotated to the other of its discrete rotational orientations (with the retaining pin 1006 protruding into the other of the recesses 1008) so as to orient the distal end of the tube 1072 such that the lateral slit 1056 substantially faces the fourth anchor. Fig. 53D shows seven anchors 120 have been anchored with a spacer or separator 170 disposed therebetween, and the distal end of tube 1072 positioned for placement of an eighth anchor. The extracorporeal unit 1074 has been rotated into yet another of its discrete rotational orientations (with the retaining pin 1006 protruding into yet another of the recesses 1008) so as to orient the distal end of the tube 1072 such that the lateral slit 1056 substantially faces the eighth anchor. In the example shown, where the implant 110 is implanted along the posterior annulus of the mitral valve 12, with the first anchor 120f near the anterolateral commissure (e.g., in a counterclockwise curvilinear manner), the extracorporeal unit 1074 rotates counterclockwise as the implant is gradually implanted.

Fig. 53E shows implant 110 implantation has been completed and tether 112 has been tensioned so as to constrict the annulus of valve 12 and reduce regurgitation through the valve.

It should be noted that the features described with reference to fig. 53A-E may be applied to other catheter devices including, but not limited to, catheter devices that are not used for implantation of an implant, such as implant 110, catheter devices that do not include and/or are not used with a cartridge body, such as cartridge body 1020, and catheter devices that do not have a barrier, such as barrier 1030. According to some applications, a system is provided that includes a catheter device and a platform. The catheter device may include (1) a tube having (a) a distal opening configured to be transluminally advanced to tissue of a subject, and (b) a proximal portion defining a longitudinal tube axis, and (2) an extracorporeal unit coupled to the proximal portion of the tube. The system may define a series of discrete rotational orientations of the extracorporeal unit about the longitudinal tube axis, the extracorporeal unit being configured to be mounted on the platform in a manner that facilitates rotation of the extracorporeal unit about the longitudinal tube axis so as to be oriented in any of the discrete rotational orientations. For such applications, the extracorporeal unit is rotatably fixed to the tube such that rotation of the extracorporeal unit about the longitudinal tube axis rotates the tube.

For some such applications, the system further includes a series of anchors threaded on the tether by the tether passing through the eyelets of each of the anchors. For some such applications, the system further includes an anchor driver configured to engage the head of the anchor, advance the anchor distally through the tube toward a distal opening, and anchor the anchor to the tissue for each of the anchors.

Fig. 54 and 55A-C illustrate another approach in which a distal portion of a tube defining a lateral slit, for example, may be rotated relative to a more proximal portion of the tube, according to some applications. A typical flexible tube (e.g., catheter) 1072a is provided. Tube 1072a may be considered a variation of tube 1072 of system 1000 and/or tube 152 of system 100, as described above. Thus, in some applications, tube 1072 and/or tube 152 may be replaced with tube 1072a mutatis mutandis. The tube 1072a has a proximal portion (not shown) including a proximal end, a distal portion 1120, and an intermediate portion 1122 extending between the proximal and distal portions. The proximal and/or intermediate portions 1122 may be as described for tube 1072 and/or tube 152, mutatis mutandis. Further, the distal portion 1120 defines a lateral slit 1124, e.g., as described with respect to slit 156 and/or slit 1056, mutatis mutandis.

As with tubes 1072 and 152, tube 1072a defines a lumen therethrough through which an anchor (e.g., anchor 120) can be advanced. The distal portion 1120 is rotatably coupled to the middle portion 1122 such that the lateral slit 1124 may swivel around the lumen. For example, the tube 1072a may define a rotational support 1126, the distal portion 1120 being coupled to the intermediate portion 1122 via the rotational support 1126. Although the rotational support 1126 is shown as a snap-fit of the distal portion 1120 to a circumferential track defined by the intermediate portion 1122, the scope of the present disclosure alternatively or additionally includes the use of other support types, including but not limited to rolling element bearings (e.g., including ball bearings or roller bearings).

In some applications, and as shown, the lumen of tube 1072a defines a primary channel region 1128a and a smaller secondary channel region 1128b, e.g., such that an anchor (e.g., anchor 120) comprising a tissue engaging element and a lateral eyelet is slidable through the tube with its tissue engaging element passing through the primary channel region and its eyelet sliding through the secondary channel region, e.g., as described above, mutatis mutandis. However, for some such applications, the distinction between primary and secondary channel regions does not continue into the distal portion 1120. For example, and as shown, the substantially conical region 1130 of the lumen of the tube 1072a (e.g., at the distal portion of the intermediate portion 1122) may widen and/or round toward the distal portion 1120.

Fig. 55A-C illustrate steps for implanting the implant 110 using a catheter tool that includes a tube 1072 a. 53A-D, when the distal end of the tube is moved in a curvilinear manner (e.g., to implant 110 around the annulus of valve 12), the lateral slit is maintained via its revolution about the lumen of the tube to be directed generally toward the previously anchored anchor. However, for tube 1072a, such rotation is achieved by rotation of distal portion 1120 relative to intermediate portion 1122, e.g., in the absence of intermediate portion rotation. In some applications, such rotation is passive, e.g., the lateral slit 1124 is moved into/maintained in alignment by the tether 112, e.g., by the orientation/vector of the portion of the tether currently disposed between the previously anchored anchor and the lateral slit.

58A-C, FIGS. 58A-C are schematic illustrations of a fluoroscopic guide 1140 according to some applications. The guide 1140 is configured to facilitate positioning a distal end of a tube (e.g., a catheter) percutaneously (e.g., transluminally) against an annulus of a valve of a heart, e.g., to anchor an anchor into the annulus. In the example shown, the guide 1140 is used with a tube 1072b, and the tube 1072b may be considered a variation of the tube 1072 or the tube 152 with the guide 1140 added. However, the guide 1140 may be used with other tubes, mutatis mutandis. Similarly, although in the example shown the guide is used to position the distal end of tube 1072b against the annulus 18 of the mitral valve 12, it may be used with other heart valves.

Valve 12 is disposed between an atrium (e.g., left atrium) 6 and a ventricle (e.g., left ventricle) 8 of the heart, and includes leaflets 20, the root of each leaflet being attached to an annulus 18 of the valve. It is assumed that for some procedures, such as annuloplasty and/or implantation of an implant at valve 12, it is advantageous to drive one or more anchors into the tissue of the annulus, rather than into leaflets 20 or walls of atrium 6. Implantation of implant 110 is such a procedure. Thus, for such applications, it may be advantageous to position the end of the tube (via which the anchor will be anchored) close to the root of the leaflet rather than on the leaflet. The guide 1140 is configured to facilitate such positioning.

The guide 1140 includes a tab 1142 and at least one lever (e.g., exactly one, exactly two, or more than two levers) 1150. The tab 1142 has a tip 1144, a root 1148, and a middle portion 1146 extending between the tip and the root. At the root 1148, the tab 1142 is pivotably coupled to a distal portion of the tube 1072B (e.g., to the distal end of the tube) in a manner that the tab is deflectable relative to the tube between (i) a retracted state (fig. 58A) in which the tab is substantially parallel to the tube, and (ii) an extended state (fig. 58B) in which the tab extends laterally from the tube. The middle portion 1146 is radiopaque and flexible, e.g., such that squeezing on the middle portion changes its curvature. In some applications, the tab 1142 (e.g., the middle portion 1146 thereof) comprises a fabric with a radiopaque coating. In some applications, the fins 1142 (e.g., the central portion 1146 thereof) comprise a thin strip of flexible metal.

The lever 1150 extends from the distal portion of the tube to the tip 1144 of the tab 1142 such that (i) advancement of the lever deflects the tab toward the extended state by pushing the tip 1144 (e.g., distally) and (ii) retraction of the lever deflects the tab toward the retracted state by pulling the tip 1144 (e.g., proximally). In some applications, and as shown, the lever 1150 extends along the tube 1072b (e.g., from the extracorporeal unit 1074; not shown) to an exit point 1151 where the lever extends from the tube to the tip 1144 of the fin. As shown, the lever 1150 may be flexible enough that advancement of the lever to deflect the tab toward the extended state causes the lever to flex laterally away from the distal portion of the tube (fig. 58B).

In some applications, and as shown in fig. 58A, in the retracted state, the tip 1144 is disposed proximal of the root 1148 and/or against the distal portion of the tube 1072 b.

In some applications, and as shown in fig. 58B, in the extended state, the tab 1142 extends from the tube 1072B to the end side-at least in the absence of other forces on the tab.

In some applications, in the extended state, the fins 1142 are disposed at 80-160 degrees (e.g., at 90-140 degrees, such as at 100-130 degrees) relative to the tube.

In some applications, the pivotable coupling of the fin 1142 to the tube 1072b is such that the angular range of the fin between the retracted state and the extended state (i.e., the angle through which the fin passes) is 80-160 degrees (e.g., 90-40 degrees, such as 100-130 degrees) -at least in the absence of other forces on the fin.

Fig. 58C is a schematic illustration showing that the distal end (i.e., distal opening) of tube 1072b has been facilitated by guide 1140 to be optimally placed over annulus 18 of valve 12, according to some applications. In this position, the region of the middle portion 1146 of the tab 1142 closest to the root 1148 may be urged proximally by the annulus 18 (relative to the tube 1072 b), e.g., by the annulus preventing the region of the tab from being urged against the annulus. During ventricular systole (left frame of fig. 58C), the region of the middle portion 1146 closer to the tip 1144 may also be pushed proximally/upstream in response to ventricular pressure, but by the leaflet 20. However, during ventricular diastole (right frame of fig. 58C), as the leaflet 20 moves downstream, the region of the middle portion 1146 that is closer to the tip 1144 may move distally/downstream, for example, as the lever 1150 continues to exert a force on the tip. The curvature of the radiopaque tab 1142 provides a fluoroscopic indication of the optimality of the position of the distal end/opening of the tube 1072 b. For example, in some applications, the optimal positioning may be identified fluoroscopically by: the region of the middle portion 1146 of the fin 1142 closest to the root 1148 is (i) urged proximally (e.g., and held in a stable position), (ii) the tip 1144 oscillates upstream and downstream with the cardiac cycle, and/or (iii) the oscillation change in curvature of the middle portion 1146.

According to some applications, a method is provided that includes transluminally advancing a distal portion of a tube of a catheter device to a heart of a subject, the catheter device including a fluoroscopic guide. In some applications, the fluoroscopic guide includes a tab having: (i) a tip, (ii) a root at which the fin is pivotably coupled to the distal portion of the tube, and (iii) a flexible intermediate portion extending between the tip and the root. In some applications, the fluoroscopic guide includes a control rod extending from the distal portion of the tube to the tip of the tab.

In some applications, the method includes placing the distal end of the tube against a tissue site of the heart near a valve of the heart.

In some applications, the method includes deflecting the fins toward their extended state within the heart by advancing the control rod such that the control rod pushes the tips of the fins away from the tube.

In some applications, the method includes fluoroscopically observing a curvature of the intermediate portion while the distal end of the tube is held against the tissue site and the tab is held in its extended state. In some applications, the method includes, (i) determining, in response to the observing, whether to drive an anchor into the tissue site; and (ii) driving the anchor into the tissue site in response to the determination.

Referring now to fig. 59A-B, fig. 59A-B are schematic illustrations of an anchor 120a according to some applications. Anchor 120a is a variation of anchor 120 and may be used as described above for anchor 120. Anchor 120a differs from anchor 120 primarily in its method of manufacture. Tissue-engaging element 130 of anchor 120 (e.g., a proximal turn of the tissue-engaging element) may be welded or brazed to head 180 (e.g., to a distally-facing surface of flange 122 "thereof), for example, in a manner that fixedly couples the tissue-engaging element to interface 182. Anchor 120a has reduced reliance on welding and may actually not utilize welding at all.

Anchor 120a includes a tissue-engaging element 130a, the tissue-engaging element 130a being similar to tissue-engaging element 130 except that in some applications, proximal turns 131 of tissue-engaging element 130a may have notches 1164. Similar to anchor 120, anchor 120a includes a head 180a, head 180a including a core 129a, a flange 122a "secured to the core, and a cap 128a' defining a hub 182. However, tissue-engaging element 130a is secured to head 180a primarily by (i) proximal turn 131 being located on a proximally-facing surface 1166 of flange 122a "and (ii) cap 128a' being secured to core 129a in a manner sandwiching the proximal turn on the proximal surface of the flange. Flange 122a "may be disposed between proximal turn 131 and a second turn of tissue-engaging element 130a immediately proximal and distal.

Flange 122a "generally protrudes laterally (e.g., radially) beyond core 129a.

Flange 122a "may be shaped to receive proximal turn 131, e.g., by proximal surface 1166 being sloped with respect to axis ax16 and/or defining a groove complementary in shape to the proximal turn. For example, and as shown, flange 122a "may be shaped such that proximal surface 1166 and/or the grooves therein define a partial spiral.

In some applications, and as shown, anchor 120a (e.g., head 180a thereof) further includes a washer 1160, and proximal turn 131 is sandwiched between a proximal surface of flange 122a″ and the washer. For some such applications, the washer 1160 is shaped to define a protrusion 1162, which protrusion 1162 further secures the proximal turn 131 in place by being disposed in the recess 1164. Alternatively or additionally, another flange (e.g., defined by cap 128 a') may function similarly to gasket 1160.

In some applications, and as shown, core 129a is shaped as a post. In some applications, and as shown, cap 128a' is shaped to define a cavity in which the post is disposed. For example, the cap 128a' may define a tubular wall 1168, the tubular wall 1168 defining a cavity by surrounding the cavity. In some applications, securement of cap 128a' to core 129a is provided at least in part by such positioning of the post within the cavity. For some such applications, the post of core 129a defines external threads and the cap (e.g., tubular wall 1168 thereof) defines internal threads.

In some applications in which anchor 120a includes a washer 1160 and cap 128a' defines a tubular wall 1168, the sandwiching of proximal turn 131 between washer 1160 and flange 122a "may be facilitated by the tubular wall being long enough to extend distally over core 129a and push against the washer (i.e., the distal end of the tubular wall pushes against the washer).

In some applications, anchor 120a includes a collar and eyelet, e.g., as described above for other anchors. For such applications, the collar may surround the tubular wall 1168 such that the tubular wall is coaxially disposed between the collar and the core 129a (e.g., a post thereof). The collar may be freely rotatable, but may be axially constrained by a proximal flange 122a 'defined by cap 128 a'.

The fabrication technique provided that anchor 120a and its reduced welding may advantageously facilitate more efficient fabrication and/or may impart greater strength and/or longer post-implantation life to the anchor. According to some applications, there is provided a method for manufacturing a tissue anchor comprising a head and a helical tissue-engaging element, the method comprising (i) placing a proximal turn of the helical tissue-engaging element on a proximal surface of a flange of the head, the head comprising a core disposed on a central anchor axis of the tissue anchor, and the tissue-engaging element extending helically around the central anchor axis and having a distal turn defining a sharp distal tip, and (ii) clamping the proximal turn on the proximal surface of the flange by securing a cap to the core.

Referring again to fig. 1A-59B. Each tissue anchor disclosed herein is described as comprising a tissue-engaging element and a head. Although each tissue anchor is shown and/or described as having a particular tissue-engaging element in combination with a particular head, each head described herein may alternatively be combined with (i.e., coupled to) any tissue-engaging element described in any reference herein or above incorporated by reference. Similarly, each tissue-engaging element described herein may optionally be combined with (i.e., coupled to) any head described in any reference herein or herein above incorporated by reference. Furthermore, the advantageous features described herein for a particular head or for a particular tissue-engaging element may be utilized by including the features on another head or tissue-engaging element (including those described herein and those described in any of the references incorporated herein by application above).

Referring again to fig. 1A-59B. The tools disclosed herein are generally described with (or in the context of) a particular implant, a particular tissue anchor, and/or a particular anchor head. It should be noted that each such tool can be used with (or in the context of) other implants, other tissue anchors, and/or other anchor heads (including those described herein and those described in any of the references incorporated herein by application), mutatis mutandis. Furthermore, the advantageous features described herein for a particular tool may be utilized by including the features on another tool, including those described herein and those described in any of the references previously incorporated by reference.

The utility model is not limited to the examples specifically shown and described above. Instead, the scope of the present utility model includes both combinations and sub-combinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not in the prior art. Furthermore, the treatment techniques, methods, steps, etc. described or suggested herein or in the references incorporated herein may be performed on a living animal or on a non-living simulation (e.g., on a cadaver, cadaver heart, simulator (e.g., with the body part, tissue, etc. being simulated), etc.).

Example applications (some non-limiting examples of the concepts herein are listed below):

example 1. A system for use with an object, comprising: (a) a catheter device, the catheter device comprising: (i) A tube having a distal opening configured to be advanced transluminally into the subject and a proximal end defining a proximal opening, and (ii) an extracorporeal unit coupled to the proximal end of the tube, defining a deployment location, and including a track leading to the deployment location; (B) a series of anchors; (C) a series of cartridges, each of the cartridges: (i) holding a respective anchor in the series of anchors, (ii) coupled to the extracorporeal unit at a respective initial position in a series of initial positions, (iii) movable along the track from the respective initial position to the deployed position while remaining coupled to the extracorporeal unit, such that in the deployed position the cartridge body holds the respective anchor opposite the proximal opening; and (D) an anchor driver, for each of the anchors, configured to: (i) Engaging the anchor while the anchor is held opposite the proximal opening by the respective cartridge body in the deployed position, and (ii) pushing the anchor distally out of the respective cartridge body, through the proximal opening, and through the tube toward the distal opening.

Example 2 the system of example 1, wherein the extracorporeal unit comprises a barrier movable between a closed state in which the barrier obstructs the proximal opening and an open state, and wherein for each of the anchors, the anchor driver is configured to: (A) When the anchors are held opposite the proximal opening by the respective cartridge body in the deployed position: (i) Engaging the anchors, and (ii) applying a force to the anchors that transitions the barrier to the open state when engaged with the anchors, and (ii) pushing the anchors distally out of the respective cartridge body, through the proximal opening, and through the tube toward the distal opening while the barrier remains in the open state.

Example 3 the system of example 2, wherein the force is an engagement nuclear force that challenges engagement of the anchor by the anchor driver.

Example 4 the system of any one of examples 2-3, wherein the force is a proximal pulling force, and wherein for each of the anchors, the anchor driver is configured to apply the proximal pulling force to the anchor when engaged with the anchor.

Example 5 the system of any of examples 2-4, wherein the system is configured to define a threshold magnitude of the force, the barrier to transition to the open state in response to the force only after the force exceeds the threshold magnitude.

Example 6 the system of any one of examples 2-5, wherein, for each of the cartridge bodies, the cartridge body is configured to undergo a conformational change in response to the force, and the anchor driver is configured to transition the barrier to the open state by applying a force to the respective anchor to cause the conformational change.

Example 7 the system of any one of examples 2-6, wherein the barrier is biased toward being in the open state.

Example 8 the system of any of examples 2-7, wherein the extracorporeal unit includes a spring-loaded displacement mechanism configured to transition the barrier to the open state in response to the force applied to the anchor by the anchor driver.

Example 9 the system of any of examples 1-8, wherein each of the cartridge bodies is configured to lock to the extracorporeal unit upon reaching the deployed position.

Example 10 the system of any of examples 1-9, wherein each of the cartridge bodies is shaped to be grasped by a human operator with a hand and configured to be moved by the operator with a hand along the track.

Example 11 the system of any of examples 1-10, wherein the catheter device further comprises a port at the proximal opening of the tube, and the system further comprises a flush adapter that: (i) Comprises a fluid fitting, a nozzle, and a passageway therebetween, and (ii) is reversibly lockable to the extracorporeal unit in a flushing position in which the fluid fitting is accessible from outside the catheter device and the nozzle is in fluid communication with the port such that fluid driven into the flush adapter via the fluid fitting is directed distally through the tube.

Example 12 the system of example 11, wherein in the irrigation position, a barrier of the extracorporeal unit is in the open state and the channel extends distally past the barrier.

Example 13 the system of example 11, wherein the irrigation position substantially coincides with the deployment position.

Example 14 the system of example 11, wherein the fluid fitting is a luer fitting.

Example 15 the system of example 11, wherein the port comprises a sealing membrane, the anchor driver for each of the anchors configured to advance the anchor distally through the membrane and into the tube.

Example 16 the system of example 15, wherein in the irrigation position, the nozzle is sealed with the port proximal to the membrane.

Example 17 the system of example 16, wherein the port has a tapered inner wall defining a lumen proximal to the membrane, the lumen of the port tapering distally toward the membrane.

Example 18 the system of example 17, wherein the nozzle is sized such that when the irrigation adapter is locked to the extracorporeal unit at the irrigation position, the nozzle seals against the tapered inner wall proximal to the membrane.

Example 19 the system of example 15, wherein the membrane is shaped to define a first aperture through the membrane, a second aperture through the membrane, and a closed slit connecting the first aperture and the second aperture.

Example 20 the system of example 19, wherein the first orifice is wider in diameter than the second orifice

Example 21 the system of example 20, wherein the first aperture is 3-10 times the second aperture.

Example 22 the system of example 20, wherein (a) each of the anchors comprises a tissue-engaging element and a head comprising an aperture, and (B) the ports are arranged such that, for each of the cartridge bodies, when the cartridge body is in the deployed position and the respective anchor is held against the proximal opening: (i) The tissue-engaging element of the respective tissue anchor is aligned with the first aperture, thereby defining an anchor advancement axis from the respective tissue anchor through the first aperture and through the tube, and (ii) the aperture of the respective tissue anchor is aligned with the second aperture.

Example 23 the system of any of examples 1-22, wherein (i) the system further comprises a platform, (ii) the proximal end of the tube defines a longitudinal axis, (iii) the extracorporeal unit is configured to be mounted on the platform in a manner that facilitates rotation of the extracorporeal unit about the longitudinal axis, and (iv) the extracorporeal unit is rotationally fixed to the tube such that rotation of the extracorporeal unit about the longitudinal axis rotates the tube.

Example 24 the system of example 23, wherein the system defines a series of discrete rotational orientations of the extracorporeal unit about the longitudinal axis, and the extracorporeal unit is configured to mount on the platform in a manner that facilitates the extracorporeal unit in each of the discrete rotational orientations.

Example 25 the system of example 24, further comprising at least one stop pin configured to secure the extracorporeal unit in each of the discrete rotational orientations.

Example 26 the system of example 25, wherein the at least one retaining pin is configured to secure the extracorporeal unit in each of the discrete rotational orientations by providing a snap fit of the extracorporeal unit in each of the discrete rotational orientations.

Example 27 the system of example 25, wherein the extracorporeal unit defines a series of recesses corresponding to the series of discrete rotational orientations, and the at least one retaining pin is configured to secure the extracorporeal unit on each of the discrete rotational orientations by protruding into the corresponding recess for each of the discrete rotational orientations.

Example 28 the system of example 25, wherein (i) the system further comprises a bracket, the extracorporeal unit is configured to be mounted on the platform via a coupling between the bracket and the platform, (ii) the extracorporeal unit is rotatably coupled to the bracket in a manner that facilitates rotation of the extracorporeal unit about the longitudinal axis, and (iii) the at least one stop pin is configured to secure the extracorporeal unit on each of the discrete rotational orientations by preventing rotation of the extracorporeal unit relative to the bracket when the extracorporeal unit is disposed on any of the discrete rotational orientations.

Example 29 the system of example 25, wherein the at least one detent pin is spring loaded.

Example 30 the system of any of examples 1-29, wherein, for each of the cartridge bodies, the barrier of the extracorporeal unit is configured to transition to a closed state in response to movement of the cartridge body toward the deployed position.

Example 31 the system of example 30, wherein, for each of the cartridge bodies, the barrier is configured to transition to the closed state in response to the cartridge body reaching the deployed position.

Example 32 the system of example 31, wherein, for each of the cartridge bodies, the cartridge body is configured to push the barrier toward the closed state after the cartridge body reaches the deployed position.

Example 33 the system of example 32, wherein, for each of the cartridge bodies, (i) the cartridge body comprises a first component and a second component that retains the respective anchor, (ii) defines a face that urges the barrier toward the closed state upon the cartridge body reaching the deployed position, and (iii) is configured such that when the cartridge body is retained in the deployed position with the barrier in the closed state, a force is applied to the respective anchor to displace the face such that the barrier responsively transitions to the open state.

Example 34 the system of example 33, wherein the cartridge body is configured such that when the cartridge body remains in the deployed position with the barrier in the closed state, application of the force to the respective anchors causes the proximally-facing movement, and the barrier is configured to transition to the open state in response to the proximally-facing movement.

Example 35 the system of example 33, wherein the face is defined by the second component and the cartridge body is configured such that when the cartridge body is held in the deployed position with the barrier in the closed state, application of the force to the respective anchors displaces the face by sliding the second component relative to the first component.

Example 36 the system of example 33, wherein, for each of the cartridge bodies, the cartridge body is coupled to the extracorporeal unit via a coupling between the first component and the extracorporeal unit.

Example 37 the system of example 33, wherein the second component is mounted inside the first component.

Example 38 the system of example 37, wherein the first component is shaped to be grasped by a human operator with a hand.

Example 39 the system of example 1, wherein each of the cartridge bodies is removable from the deployment position such that the deployment position is empty for successive cartridge bodies in the series.

Example 40 the system of example 39, wherein each of the cartridge bodies is removable from the deployment position by removal from the extracorporeal unit.

Example 41 the system of any of examples 1-40, wherein for each of the anchors, the anchor driver is configured to push the anchor distally out of the respective cartridge body, through the proximal opening, and through the tube toward the distal opening while the respective cartridge body is held in the deployed position.

Example 42 the system of example 41, wherein, for each of the cartridge bodies, the cartridge body is configured such that the anchor driver prevents removal of the cartridge body from the deployed position when (i) the cartridge body is held in the deployed position and (ii) the anchor driver extends distally beyond the cartridge body and through the tube toward the distal opening.

Example 43 the system of any of examples 1-42, wherein each of the anchors comprises a tissue-engaging element and comprises a head comprising an eyelet, and the system further comprises a tether that: (i) passing through the eyelet of each of the anchors, (ii) having a proximal portion comprising a proximal end of the tether, and (iii) having a distal portion comprising a distal end of the tether, the distal end of the tether being distally advanceable through the tube into the subject while the proximal end of the tether remains external to the subject.

Example 44 the system of example 43, wherein the tube defines a lateral slit extending proximally from the distal end of the tube, and the lateral slit is sized to allow the tether, but not the anchor, to exit the tube proximally from the distal end of the tube.

Example 45 the system of example 44, wherein the tube is shaped to define a narrowed entrance into the lateral slit, the narrowed entrance configured to prevent, but not preclude, the tether from exiting the lateral slit distally via the narrowed entrance.

Example 46 the system of example 45, wherein the tube includes a tip frame that maintains the lateral slit and the narrowed entrance.

Example 47 the system of example 46, wherein the tip frame is resilient.

Example 48 the system of example 43, wherein, for each of the anchors: (i) the tissue-engaging element defines a central longitudinal axis of the anchor, has a sharpened distal tip, and is configured to be driven into tissue of the subject, (ii) the head is coupled to a proximal end of the tissue-engaging element, and further comprises an interface configured to be reversibly engaged by the anchor driver, and (iii) the eyelet is mounted so as to be pivotable about the central longitudinal axis of the anchor.

Example 49 the system of example 48, wherein, for each of the anchors, the eyelet: (i) defining an aperture and a sliding axis through the aperture, (ii) being laterally disposed from the central longitudinal axis of the anchor, thereby defining an eyelet axis orthogonal to the central longitudinal axis, and (iii) being mounted so as to be rotatable about the eyelet axis in a manner that constrains the sliding axis to be orthogonal to the eyelet axis.

Example 50 the system of example 48, wherein, for each of the anchors, the eyelet: (i) defining an aperture and a sliding axis through the aperture, (ii) being laterally disposed from the central longitudinal axis of the anchor, thereby defining an eyelet axis orthogonal to the central longitudinal axis, and (iii) being mounted so as to be pivotable about the central longitudinal axis while the sliding axis remains constrained to be orthogonal to the eyelet axis.

Example 51 the system of example 48, wherein the interface is disposed on the central longitudinal axis of the anchor.

Example 52 the system of example 48, wherein the tissue-engaging element is helical, defines the central longitudinal axis by extending in a helical manner about and along the central longitudinal axis, and is configured to screw into the tissue of the subject.

Example 53 the system of example 48, wherein the head includes a collar surrounding the central longitudinal axis and rotatably coupled to the tissue-engaging element, and wherein the eyelet is mounted on the collar and rotatable about the central longitudinal axis by rotation of the collar about the central longitudinal axis.

Example 54 the system of example 43, further comprising a series of tubular spacers threaded on the tether alternating with the anchors.

Example 55 the system of example 54, wherein each of the spacers is resiliently flexible in deflection.

Example 56 the system of example 55, wherein each of the spacers comprises a rigid ring at each end of the tubular spacer.

Example 57 the system of example 54, wherein each of the spacers resists axial compression.

Example 58 the system of example 54, wherein each of the spacers is defined by a spiral shaped as a coil.

Example 59 the system of example 43, wherein for each of the anchors, the anchor driver is configured to push the anchor distally out of the respective cartridge body, through the proximal opening, and through the tube toward the distal opening while the eyelet of the anchor remains threaded on the tether.

Example 60 the system of example 59, wherein: (i) the catheter device further comprises a port at the proximal opening of the tube, the port comprising a membrane, (ii) the membrane being shaped to define a first aperture through the membrane, a second aperture through the membrane, and a closing slit connecting the first aperture and the second aperture, and (iii) the port being arranged such that, for each of the anchors, the anchor driver is configured to push the anchor distally out of the respective cartridge body and through the membrane, wherein the tissue engaging element passes through the first aperture, and the tether extends through the second aperture.

Example 61, the system of example 43, wherein the catheter device further comprises a tensioner comprising a spring-loaded capstan coupled to the proximal portion of the tether and configured to maintain tension on the tether.

Example 62. A method for use with a catheter device, the method comprising: (i) Advancing a distal portion of a tube of the catheter device transluminally to a heart of a subject, the catheter device comprising an extracorporeal unit coupled to a proximal end of the tube, a cartridge body coupled to the extracorporeal unit at an initial position and holding an anchor; (ii) Sliding the cartridge body along a track from the initial position to a deployed position in which the cartridge body holds the anchors opposite the proximal opening of the tube, the extracorporeal unit including a barrier that obstructs the proximal opening; (iii) Subsequently, using an anchor driver engaged with the anchor, opening the barrier by applying a force to the anchor; and (iv) subsequently, using the anchor driver, pushing the anchor distally out of the cartridge body, through the proximal opening, and through the tube toward the distal portion of the tube.

Example 63. A system for use with an object, comprising: (a) a catheter device, the catheter device comprising: (i) A tube having a proximal opening and a distal opening, the distal opening configured to be transluminally advanced into the subject, and (ii) an extracorporeal unit comprising a track leading to a deployment location; (B) A first cartridge body holding a first anchor and coupled to the extracorporeal unit and movable along the track from a first initial position to the deployed position while remaining coupled to the extracorporeal unit such that the first cartridge body holds the first anchor opposite the proximal opening; (C) A second cartridge body holding a second anchor and coupled to the extracorporeal unit and movable along the track from a second initial position to the deployed position while remaining coupled to the extracorporeal unit such that the second cartridge body holds the second anchor opposite the proximal opening; and (D) an anchor driver, the anchor driver: (i) can be coupled to the first anchor while the first anchor is held by the first cartridge body opposite the proximal opening, (ii) configured to push the first anchor distally out of the first cartridge body, through the proximal opening, and through the tube, (iii) can then be coupled to the second anchor while the second anchor is held by the second cartridge body opposite the proximal opening, and (iv) configured to push the second anchor distally out of the second cartridge body, through the proximal opening, and through the tube toward the first anchor.

Example 64 the system of example 63, wherein the extracorporeal unit comprises a barrier movable between a closed state in which the barrier obstructs the proximal opening and an open state, and wherein the anchor driver: (i) Configured to push the first anchor distally out of the first cartridge body, through the proximal opening, and through the tube when coupled to the first anchor and when the barrier is in the open state, (ii) subsequently configured to push the second anchor distally out of the second cartridge body, through the proximal opening, and through the tube toward the first anchor when coupled to the second anchor and when the barrier is in the open state.

Example 65 the system of example 64, wherein the driver is configured to push the first anchor distally out of the first cartridge body, through the proximal opening, and through the tube when: (i) the first cartridge body is in the deployed position, (ii) the barrier is in the open state, and (iii) the second cartridge body is held in the second initial position.

Example 66 the system of any of examples 63-65, wherein each of the first cartridge body and the second cartridge body is configured to lock to the extracorporeal unit upon reaching the deployed position.

Example 67 the system of any of examples 63-66, wherein each of the first cartridge body and the second cartridge body is shaped to be grasped by a human operator with a hand and configured to be moved by the human operator with a hand along the track, and/or wherein each of the first cartridge body and the second cartridge body is removable from the deployed position by being removed from the extracorporeal unit.

Example 68 the system of any of examples 63-67, further comprising a third cartridge body that retains a third anchor and is coupled to the extracorporeal unit and is movable along the track from a third initial position to the deployed position while remaining coupled to the extracorporeal unit such that the third cartridge body retains the third anchor opposite the proximal opening.

Example 69 the system of any of examples 63-68, wherein the first anchor comprises a first tissue-engaging element and a first head comprising a first eyelet, and the second anchor comprises a second tissue-engaging element and a second head comprising a second eyelet.

Example 70 the system of example 69, further comprising a tether passing through the first aperture and the second aperture, the tether having a proximal portion including a proximal end of the tether and having a distal portion including a distal end of the tether, the distal end of the tether being distally advanceable through the tube into the subject while the proximal end of the tether remains external to the subject.

Example 71 the system of example 70, wherein the anchor driver is configured to push the first anchor distally out of the first cartridge body, through the proximal opening, and through the tube while the first eyelet of the first anchor remains threaded on the tether, and wherein the anchor driver is configured to push the second anchor distally out of the second cartridge body, through the proximal opening, and through the tube while the second eyelet of the second anchor remains threaded on the tether.

Example 72 the system of example 71, wherein the catheter device further comprises a tensioning device configured to maintain tension on the tether during advancement of the first anchor and advancement of the second anchor.

Example 73 the system of example 72, wherein the tensioning device includes a spring and a spool coupled to the spring such that rotation of the spool in a first direction applies a stress to the spring, and wherein the proximal portion of the tether is wound on the spool such that distal advancement of the distal portion of the tether through the tube rotates the spool in the first direction.

Example 74 a system for use with an object, the system comprising: (a) a catheter device, the catheter device comprising: (i) A tube having a distal opening and a proximal portion, the distal opening configured to be transluminally advanced to tissue of the subject, and (ii) an extracorporeal unit coupled to the proximal portion of the tube; (B) A series of anchors, each of the anchors comprising: (i) A tissue-engaging element, and (ii) a head coupled to a proximal end of the tissue-engaging element and comprising an interface and an aperture; (C) A tether passing through an eyelet of each of the anchors; and (D) an anchor driver, for each of the anchors, configured to: (i) Engaging the hub of the anchor, and (ii) when engaged with the anchor, advancing the anchor distally through the tube toward the distal opening and driving the tissue-engaging element into the tissue.

Example 75 the system of example 74, wherein: (i) the system defines a series of discrete rotational orientations of the extracorporeal unit about a longitudinal tube axis of the proximal portion of the tube, (ii) the extracorporeal unit is configured to be mounted on a platform in a manner that facilitates rotation of the extracorporeal unit about the longitudinal tube axis so as to be oriented in either of the discrete rotational orientations, and (iii) the extracorporeal unit is rotationally fixed to the tube such that rotation of the extracorporeal unit about the longitudinal tube axis rotates the tube.

Example 76 the system of any of examples 74-75, wherein the tube defines a lateral slit extending proximally from the distal opening of the tube, and the lateral slit is sized to allow the tether, but not the anchor, to exit the tube proximally and laterally from the distal opening of the tube.

Example 77 the system of example 76, wherein the tube is shaped to define a narrowed entrance into the lateral slit, the narrowed entrance configured to prevent, but not preclude, the tether from exiting the lateral slit distally via the narrowed entrance.

Example 78 the system of example 77, wherein the tube includes a tip frame that maintains the lateral slit and the narrowed entrance.

Example 79 the system of example 78, wherein the tip frame is resilient.

Example 80 the system of any of examples 74-79, further comprising at least one stop pin configured to secure the extracorporeal unit in each of the discrete rotational orientations.

Example 81 the system of example 80, wherein the at least one detent pin is spring loaded.

Example 82 the system of example 80, wherein the at least one retaining pin is configured to secure the extracorporeal unit in each of the discrete rotational orientations by providing a snap fit of the extracorporeal unit in each of the discrete rotational orientations.

Example 83 the system of example 80, wherein: (i) The extracorporeal unit defines a series of recesses corresponding to the series of discrete rotational orientations, and (ii) the at least one retaining pin is configured to secure the extracorporeal unit on each of the discrete rotational orientations by protruding into the corresponding recess for each of the discrete rotational orientations.

Example 84 the system of example 80, wherein: the system further includes (i) a bracket configured to be mounted on a platform via a coupling between the bracket and the platform, (ii) the extracorporeal unit rotatably coupled to the bracket in a manner that facilitates rotation of the extracorporeal unit about a longitudinal tube axis of the proximal portion of the tube, and (iii) the at least one stop pin configured to secure the extracorporeal unit in each of the discrete rotational orientations by preventing rotation of the extracorporeal unit relative to the bracket when the extracorporeal unit is disposed in any of the discrete rotational orientations.

Example 85 the system of any of examples 74-84, further comprising a series of tubular spacers threaded on the tether alternating with the anchors.

Example 86 the system of example 85, wherein each of the spacers is resiliently flexible in deflection.

Example 87 the system of any of examples 85-86, wherein each of the spacers comprises a rigid ring at each end of the tubular spacer.

The system of any of examples 88, wherein each of the spacers resists axial compression.

Example 89 the system of any of examples 85-88, wherein each of the spacers is defined by a spiral shaped as a coil.

The system of any of examples 74-89, wherein, for each of the anchors: (i) The tissue-engaging element defines a central longitudinal anchor axis of the anchor, and (ii) the eyelet is mounted so as to be rotatable about the central longitudinal anchor axis.

Example 91 the system of example 90, wherein, for each of the anchors, the eyelet: (i) Defining an aperture and a sliding axis through the aperture, (ii) laterally disposed from the central longitudinal anchor axis, thereby defining an eyelet axis orthogonal to the central longitudinal anchor axis, and (ii) mounted so as to be rotatable about the eyelet axis in a manner that constrains the sliding axis to be orthogonal to the eyelet axis.

Example 92 the system of example 90, wherein, for each of the anchors, the eyelet: (i) Defining an aperture and a sliding axis through the aperture, (ii) laterally disposed from the central longitudinal anchor axis, thereby defining an eyelet axis orthogonal to the central longitudinal axis, and (ii) mounted for swiveling about the central longitudinal anchor axis while the sliding axis remains constrained to be orthogonal to the eyelet axis.

Example 93 the system of example 90, wherein the interface is disposed on the central longitudinal axis of the anchor.

Example 94 the system of example 90, wherein the tissue-engaging element is helical, defines the central longitudinal anchor axis by extending in a helical manner about and along the central longitudinal anchor axis, and is configured to screw into the tissue of the subject.

Example 95. A system for use with an object, the system comprising: (a) a catheter device, the catheter device comprising: (i) A tube having a distal opening configured to be advanced transluminally to tissue of the subject and a proximal portion defining a longitudinal tube axis, and (ii) an extracorporeal unit coupled to the proximal portion of the tube; and (B) a platform; and wherein: (1) the system defines a series of discrete rotational orientations of the extracorporeal unit about the longitudinal tube axis, (2) the extracorporeal unit is configured to be mounted on the platform in a manner that facilitates rotation of the extracorporeal unit about the longitudinal tube axis so as to be oriented in either of the discrete rotational orientations, and (3) the extracorporeal unit is rotationally fixed to the tube such that rotation of the extracorporeal unit about the longitudinal tube axis rotates the tube.

Example 96 the system of example 95, further comprising a series of anchors, each of the anchors being advanceable through the tube and comprising: (i) A tissue-engaging element, and (ii) a head coupled to a proximal end of the tissue-engaging element.

Example 97 the system of example 96, wherein the head of each of the anchors includes a hub and an eyelet, and wherein the system further comprises a tether that passes through the eyelet of each of the anchors.

Example 98 the system of example 97, further comprising an anchor driver for each of the anchors, the anchor driver configured to engage the interface of the anchor and, when engaged with the anchor, advance the anchor distally through the tube toward the distal opening and drive the tissue-engaging element into the tissue.

Example 99. A method for use with a heart of a subject, the method comprising: (A) Advancing a distal portion of a tube of a catheter device of a system transluminally to the heart, the catheter device further comprising an extracorporeal unit coupled to a proximal portion of the tube, the proximal portion of the tube defining a longitudinal tube axis, and the system further comprising: (i) a series of anchors, (ii) a tether passing through an aperture of each of the anchors, (iii) an anchor driver, and (iv) a platform on which the extracorporeal unit is mounted in a manner defining a series of discrete rotational orientations of the extracorporeal unit about the longitudinal tube axis; (B) Advancing a first anchor in the series distally through the tube toward a distal opening of the tube and anchoring the first anchor to a first site of tissue of the heart when the extracorporeal unit is in a first one of the discrete rotational orientations and using an anchor driver; (C) Subsequently, rotating the tube by a predetermined rotation angle by rotating the extracorporeal unit into a second discrete rotational orientation of the discrete rotational orientations; and (D) subsequently, while the extracorporeal unit remains in the second one of the discrete rotational orientations, and using the anchor driver, advancing a second anchor in the series distally through the tube toward the distal opening and over and along the tether, and anchoring the second anchor to a second site of tissue of the heart.

Example 100 the method of example 99, further comprising subsequently pulling the first anchor and the second anchor toward each other by applying tension to the tether.

Example 101 a system for use with an object, the system comprising: (a) a catheter device, the catheter device comprising: (i) A tube having a proximal portion including a proximal end, a distal portion configured to be transluminally advanced to tissue of the subject, and an intermediate portion extending between the proximal portion and the distal portion, and (ii) an extracorporeal unit coupled to the proximal portion of the tube; (B) A series of anchors, each of the anchors comprising: (i) A tissue-engaging element, and (ii) a head coupled to a proximal end of the tissue-engaging element and comprising an interface and an aperture; (C) A tether passing through the eyelet of each of the anchors; (D) An anchor driver, for each of the anchors, the anchor driver configured to: (i) Engaging the hub of the anchor, and (ii) advancing the anchor distally through the tube toward the distal portion and driving the tissue engaging element into the tissue when engaged with the anchor; and wherein: (1) the distal portion defines a lumen, a distal opening, and a lateral slit extending proximally from the distal opening, (2) each of the anchors is sized to be pushed distally out of the lumen by the anchor driver via the distal opening, (3) the lateral slit is sized to allow the tether, but not the anchor, to exit the lumen laterally through the lateral slit, and (4) the distal portion is rotatably coupled to the intermediate portion such that the lateral slit is pivotable about the lumen.

Example 102 the system of example 101, wherein the distal portion is shaped to define a narrowed entrance into the lateral slit, the narrowed entrance configured to prevent, but not preclude, the tether from exiting the lateral slit distally via the narrowed entrance.

Example 103 the system of any of examples 101-102, wherein the tether has a proximal end and a distal end, the distal end being distally advanceable through the tube into the subject while the proximal end of the tether remains external to the subject.

Example 104 the system of any of examples 101-103, further comprising a series of tubular spacers threaded on the tether alternating with the anchors.

Example 105 the system of example 104, wherein each of the spacers is resiliently flexible in deflection.

Example 106 the system of example 105, wherein each of the spacers comprises a rigid ring at each end of the tubular spacer.

Example 107 the system of example 104, wherein each of the spacers resists axial compression.

Example 108 the system of example 104, wherein each of the spacers is defined by a spiral shaped as a coil.

Example 109 the system of any one of examples 101-108, wherein, for each of the anchors: (i) The tissue-engaging element defines a central longitudinal anchor axis of the anchor, and (ii) the eyelet is mounted so as to be rotatable about the central longitudinal anchor axis.

Example 110 the system of example 109, wherein, for each of the anchors, the eyelet: (i) defining an aperture and a sliding axis through the aperture, (ii) being laterally disposed from the central longitudinal anchor axis, thereby defining an eyelet axis orthogonal to the central longitudinal anchor axis, and (iii) being mounted so as to be rotatable about the eyelet axis in a manner that constrains the sliding axis to be orthogonal to the eyelet axis.

Example 111 the system of example 109, wherein, for each of the anchors, the eyelet: (i) defining an aperture and a sliding axis through the aperture, (ii) being laterally disposed from the central longitudinal anchor axis, thereby defining an eyelet axis orthogonal to the central longitudinal axis, and (iii) being mounted so as to be pivotable about the central longitudinal anchor axis while the sliding axis remains constrained to be orthogonal to the eyelet axis.

Example 112 the system of example 109, wherein the interface is disposed on the central longitudinal axis of the anchor.

Example 113 the system of example 109, wherein the tissue-engaging element is helical, defines the central longitudinal anchor axis by extending in a helical manner about and along the central longitudinal anchor axis, and is configured to screw into the tissue of the subject.

Example 114, a tissue anchor, comprising: (A) A helical tissue-engaging element, the helical tissue-engaging element: (i) Having a proximal turn and a distal turn defining a sharpened distal tip, and (ii) extending helically about a central anchor axis of the tissue anchor; and (B) a head, the head comprising: (i) A core disposed on the central longitudinal axis, and (ii) a flange secured to the core and having a proximally facing surface on which the proximal turns are located; and (iii) a cap secured to the core in a manner that secures the tissue-engaging element to the head by clamping the proximal turn on the proximally-facing surface of the flange.

Example 115 the tissue anchor of example 114, wherein the cap is secured to the core via complementary threads defined by the cap and the core.

Example 116 the tissue anchor of any one of examples 114-115, wherein the flange is a first flange, the cap is shaped to define a second flange, and the cap is secured to the core in a manner that secures the tissue-engaging element to the head by sandwiching the proximal turn between the second flange and the proximally-facing surface of the first flange.

Example 117 the tissue anchor of any of examples 114-116, wherein the flange is shaped such that the proximally-facing surface is inclined relative to the central anchor axis.

Example 118 the tissue anchor of any of examples 114-117, wherein the flange is shaped such that the proximally facing surface defines a partial spiral.

Example 119 the tissue anchor of any one of examples 114-118, wherein the tissue-engaging element has a second turn distal immediately adjacent the proximal turn, and wherein the flange is disposed between the proximal turn and the second turn.

Example 120 the tissue anchor of any one of examples 114-119, wherein the flange protrudes laterally beyond the core.

Example 121 the tissue anchor of any of examples 114-120, wherein the flange radially protrudes beyond the core.

Example 122 the tissue anchor of any of examples 114-121, further comprising a washer, and wherein the cap is secured to the core in a manner that secures the tissue-engaging element to the head by sandwiching the proximal turn between the washer and the proximally-facing surface of the flange.

Example 123 the tissue anchor of example 122, wherein the proximal turn has a recess therein, the washer is shaped to define a protrusion, and the cap is secured to the core in a manner that secures the tissue-engaging element to the head by sandwiching the proximal turn between the washer and the proximally-facing surface of the flange, wherein the protrusion is disposed in the recess.

Example 124 the tissue anchor of any of examples 114-123, wherein the core is shaped as a post and the cap is shaped to define a cavity in which the post is disposed.

Example 125 the tissue anchor of example 124, wherein the head further comprises: (i) A collar disposed axially between the flange and the cap, surrounding and rotatable about the post, and (ii) an eyelet mounted on the collar and rotatable about the central anchor axis by rotation of the collar about the post.

Example 126 the tissue anchor of example 125, wherein the cap defines a tubular wall defining the cavity, and the tubular wall is coaxially disposed between the post and the collar.

Example 127 the tissue anchor of example 126, wherein the cap is secured to the core in a manner that secures the tissue-engaging element to the head by sandwiching the proximal turn between a distal end of the tubular wall and the proximally-facing surface of the flange.

Example 128, a method for manufacturing a tissue anchor, the anchor comprising a head and a helical tissue-engaging element, the method comprising: (i) Placing a proximal turn of the helical tissue-engaging element on a proximally-facing surface of a flange of the head, the head comprising a core disposed on a central anchor axis of the tissue anchor, and the tissue-engaging element extending helically around the central anchor axis and having a distal turn defining a sharpened distal tip, and (ii) clamping the proximal turn on the proximally-facing surface of the flange by securing a cap to the core.

Example 129 the method of example 128, wherein securing the cap to the core comprises screwing the cap onto the core.

Example 130 the method of any of examples 128-129, wherein the flange is a first flange, the cap is shaped to define a second flange, and clamping the proximal turn on the proximally-facing surface of the flange includes clamping the proximal turn between the second flange and the proximally-facing surface of the first flange.

Example 131 the method of any of examples 128-130, wherein clamping the proximal turn on the proximally-facing surface of the flange comprises clamping the proximal turn between a gasket and the proximally-facing surface of the flange by securing the cap to the core.

Example 132 the method of example 131, wherein the proximal turn has a recess therein, the washer is shaped to define a protrusion, and sandwiching the proximal turn between the washer and the proximally facing surface of the flange comprises sandwiching the proximal turn between the washer and the proximally facing surface of the flange by securing the cap to the core such that the protrusion is disposed in the recess.

Example 133 the method of any of examples 128-132, wherein the core is shaped as a post, the cap is shaped to define a cavity, and securing the cap to the core comprises positioning the post in the cavity.

Example 134 the method of example 133, further comprising axially positioning a collar between the flange and the cap such that the collar surrounds the post and is rotatable about the post, the collar having an eyelet mounted thereon such that the eyelet is rotatable about the central anchor axis by rotation of the collar about the post.

Example 135 the method of example 134, wherein the cap defines a tubular wall defining the cavity, and wherein securing the cap to the core comprises coaxially positioning the tubular wall between the post and the collar.

Example 136 the method of example 135, wherein clamping the proximal turn on the proximally-facing surface of the flange by securing the cap to the core comprises clamping the proximal turn between a distal end of the tubular wall and the proximally-facing surface of the flange by securing the cap to the core.

Example 137 a system for use with a subject, the system comprising a catheter device comprising: (a) a tube having: (i) A proximal portion comprising a proximal end, and (ii) a distal portion configured to be transluminally advanced to tissue of the subject; (B) An extracorporeal unit coupled to the proximal portion of the tube; and (C) a fluoroscopic guide, the fluoroscopic guide comprising: (i) A fin having (a) a tip, (b) a root at which the fin is pivotably coupled to the distal portion of the tube in a manner that the fin is deflectable relative to the tube between a retracted state in which the fin is substantially parallel to the tube and an extended state in which the fin extends laterally from the tube, and (c) a middle portion extending between the tip and the root, the middle portion being: radiopaque and flexible such that squeezing on the intermediate portion changes the curvature of the intermediate portion, and (ii) a control rod extending from the distal portion of the tube to the tip of the tab such that: (a) Advancement of the lever deflects the tab toward the extended state by pushing the tip of the tab, and (b) retraction of the lever deflects the tab toward the retracted state by pulling the tip of the tab.

Example 138 the system of example 137, wherein the fluoroscopic guide is configured such that advancement of the control rod deflects the tab toward the extended state by pushing a tip of the tab distally.

Example 139 the system of any of examples 137-138, wherein the fluoroscopic guide is configured such that retraction of the control rod deflects the tab toward the extended state by pulling the tip of the tab proximally.

Example 140 the system of any of examples 137-139, further comprising an anchor and an anchor driver configured to advance the anchor distally through the tube toward the distal portion and drive the anchor into the tissue.

The system of any of examples 137-140, wherein the control rod extends from the extracorporeal unit along the tube to an exit point at which the control rod extends from the tube to the tip of the airfoil.

The system of any of examples 137-141, wherein in the retracted state, the tip of the tab is disposed against the distal portion of the tube.

Example 143 the system of any of examples 137-142, wherein in the retracted state, the tip of the airfoil is disposed proximally from the root of the airfoil.

The system of any of examples 137-143, wherein in the extended state, the fin extends from the tube to an end side.

The system of any of examples 137-144, wherein the distal portion of the tube comprises a distal end of the tube, and wherein the root of the tab is pivotably coupled to the distal portion of the tube at the distal end of the tube.

Example 146 the system of any of examples 137-145, wherein the control rod is flexible such that advancement of the control rod to deflect the tab toward the extended state causes the control rod to flex laterally away from the distal portion of the tube.

Example 147 the system of any of examples 137-146, wherein the tab is pivotably coupled to the distal portion of the tube such that an angular range of the tab between the retracted state and the extended state is 80-160 degrees.

Example 148, the system of example 147, wherein the tab is pivotably coupled to the distal portion of the tube such that the angular extent of the tab between the retracted state and the extended state is 90-140 degrees.

Example 149 the system of example 148, wherein the tab is pivotably coupled to the distal portion of the tube such that the angle of the tab between the retracted state and the extended state ranges from 100-130 degrees.

Example 150 the system of any of examples 137-149, wherein in the extended state, the fins are disposed at 80-160 degrees relative to the tube.

Example 151 the system of example 150, wherein in the extended state, the fins are disposed at 90-140 degrees relative to the tube.

Example 152 the system of example 151, wherein in the extended state, the fins are disposed at 100-130 degrees relative to the tube.

Example 153. A method comprising: (A) A distal portion of a tube of a catheter device is advanced transluminally to a heart of a subject, the catheter device comprising a fluoroscopic guide comprising: (i) a fin having: (a) a tip, (b) a root at which the tab is pivotably coupled to the distal portion of the tube, and (c) a flexible intermediate portion extending between the tip and the root, and (ii) a lever extending from the distal portion of the tube to the tip of the tab; (B) Placing a distal end of the tube against a tissue site of the heart near a valve of the heart; (C) Within the heart, deflecting the fins toward their extended state by advancing the control rod such that the control rod pushes the tips of the fins away from the tube; (D) Fluoroscopically observing a curvature of the intermediate portion while the distal end of the tube is held against the tissue site and the tab is held in the extended state; (E) Responsive to the observing, determining whether to drive an anchor into the tissue site; and (F) driving the anchor into the tissue site in response to the determination.

Example 154 the method of example 153, wherein deflecting the tab toward the extended state includes deflecting the tab toward the extended state by advancing the lever such that the lever pushes the tip of the tab distally.

Example 155 the method of any of examples 153-154, wherein fluoroscopically observing the curvature includes fluoroscopically observing oscillations of the curvature.

Example 156 the method of any one of examples 153-155, wherein: (i) the catheter device comprises an extracorporeal unit coupled to a proximal portion of the tube, (ii) the control rod extends from the extracorporeal unit along the tube to an exit point at which the control rod extends from the tube to the tip of the tab, and (iii) deflecting the tab toward the extended state by pushing the control rod comprises deflecting the tab toward its extended state by pushing the control rod from the extracorporeal unit.

Example 157 the method of any of examples 153-156, wherein transluminally advancing the distal portion of the tube comprises transluminally advancing the distal portion of the tube when the fin is in a retracted state in which the tip of the fin is disposed against the distal portion of the tube.

Example 158 the method of any of examples 153-157, wherein transluminally advancing the distal portion of the tube comprises transluminally advancing the distal portion of the tube when the fin is in a retracted state in which the tip of the fin is disposed proximally from the root of the fin.

Example 159 the method of any of examples 153-158, wherein in the extended state the fin extends from the tube to an end side, and wherein deflecting the fin toward the extended state comprises deflecting the fin toward the extended state in which the fin extends from the tube to an end side.

The method of any of examples 153-159, wherein the root portion of the tab is pivotably coupled to a distal portion of the tube at a pivot point at the distal end of the tube, and deflecting the tab toward the extended state includes deflecting the tab about the pivot point at the distal portion of the tube.

Example 161 the method of any of examples 153-160, wherein the control rod is flexible, and wherein advancing the control rod includes advancing the control rod such that the control rod laterally flexes away from the distal portion of the tube and pushes the tip of the tab away from the distal portion of the tube.

Example 162 the method of any of examples 153-161, further comprising, after the observing, deflecting the tab toward its retracted state by retracting the lever such that the lever pulls the tip of the tab toward the tube.

Example 163 the method of example 162, wherein deflecting the tab toward the retracted state comprises deflecting the tab toward the retracted state by retracting the lever such that the lever pulls the tip of the tab proximally.

Example 164 the method of any of examples 153-163, wherein the tissue site is a site on an annulus of the valve, and wherein placing the distal end of the tube against the tissue site comprises placing the distal end of the tube against the site on the annulus of the valve.

Example 165 the method of example 164, wherein deflecting the tab toward the extended state includes deflecting the tab toward the extended state such that the middle portion of the tab is pressed against a hinge of the valve at which a leaflet of the valve is connected to the annulus.

Example 166 the method of example 164, further comprising pressing the middle portion of the flap against a hinge of the valve at which a leaflet of the valve is connected to the annulus.

Example 167. The method of any of examples 153-166, wherein deflecting the airfoil toward the extended state includes deflecting the airfoil 80-160 degrees.

Example 168 the method of example 167, wherein deflecting the airfoil toward the extended state includes deflecting the airfoil 90-140 degrees.

Example 169. The method of example 168, wherein deflecting the airfoil toward the extended state includes deflecting the airfoil 100-130 degrees.

Example 170 the method of any of examples 153-169, wherein in the extended state the fins are disposed at 80-160 degrees relative to the tube, and wherein deflecting the fins toward the extended state comprises deflecting the fins such that the fins are disposed at 80-160 degrees relative to the tube.

Example 171 the method of example 170, wherein in the extended state the fins are disposed at 90-140 degrees relative to the tube, and wherein deflecting the fins toward the extended state comprises deflecting the fins such that the fins are disposed at 90-140 degrees relative to the tube.

Example 172 the method of example 171, wherein in the extended state the fins are disposed at 100-130 degrees relative to the tube, and wherein deflecting the fins toward the extended state comprises deflecting the fins such that the fins are disposed at 100-130 degrees relative to the tube.

Example 173 a system comprising an anchor for use with tissue of a subject, the anchor comprising: (A) A housing having a tissue facing side defining a tissue facing opening from an interior of the housing to an exterior of the housing; and (B) a tissue-engaging element, the tissue-engaging element: (i) Shaped to define a spiral having a plurality of turns about an axis, (ii) axially compressed within the housing, and positioned such that rotation of the tissue-engaging element about the axis advances the spiral distally out of the tissue-facing opening; and (iii) configured to screw into the tissue and anchor the housing to the tissue, the tissue facing side serving as an anchor head for the anchor.

Example 174 the system of example 173, wherein the distal tip of the tissue-engaging element is sharpened.

Example 175 the system of any of examples 173-174, wherein the anchor is configured such that screwing the tissue-engaging element into the tissue presses the tissue-facing side against the tissue.

Example 176 the system of example 175, wherein the housing side defines a clamping portion on the tissue-facing side such that screwing the tissue-engaging element into the tissue presses the clamping portion against the tissue.

Example 177 the system of any of examples 173-176, wherein the anchor is configured such that screwing the tissue-engaging element into the tissue moves a proximal portion of the tissue-engaging element toward the tissue-facing side.

Example 178 the system of example 177, wherein: (i) The housing also has a driver side opposite the tissue facing side and defining a driver opening providing access to the interface from outside the housing, and (ii) the anchor is configured such that screwing the tissue engaging element into tissue moves the proximal portion of the tissue engaging element away from the driver side.

Example 179 the system of example 177, wherein: (i) The housing also has a driver side opposite the tissue facing side and defining a driver opening providing access to the interface from outside the housing, and (ii) the housing is configured to automatically contract when the spiral is distally fed out of the tissue facing opening such that the driver side follows the proximal portion of the tissue engaging element toward the tissue facing side.

Example 180 the system of example 177, wherein the anchor is configured such that screwing the tissue-engaging element into the tissue sandwiches the tissue-facing side between the tissue and the proximal portion of the tissue-engaging element.

Example 181 the system of any of examples 173-180, wherein the tissue-engaging element is configured such that when the spirals are fed out of the tissue-facing opening, a proximal portion of the spirals progressively expand axially as they are disposed outside the housing.

Example 182 the system of example 181, wherein the spiral has a compressed pitch when the spiral is disposed entirely within the housing, and a portion of the spiral disposed outside the housing has an expanded pitch that is at least twice the compressed pitch.

Example 183 the system of any of examples 173-182, wherein: (i) The anchor includes an interface at a proximal portion of the tissue-engaging element, and (ii) the housing further has a driver side defining a driver opening from inside the housing to outside the housing, the driver opening providing access to the interface.

Example 184 the system of any of examples 173-183, wherein the anchor is configured such that screwing the tissue-engaging element into the tissue moves the interface away from the driver side and toward the tissue-facing side.

Example 185 the system of example 184, wherein the anchor is configured such that screwing the tissue-engaging element into the tissue sandwiches the tissue-facing side between the tissue and the interface.

Example 186 the system of example 183, wherein the interface is rotationally locked with the spiral of the tissue-engaging element.

Example 187 the system of example 183, wherein the driver opening is disposed in front of the interface.

Example 188 the system of example 183, wherein the interface is visible via the driver opening.

Example 189, the system of example 183, wherein the interface includes a rod transverse to the axis and parallel to the driver opening.

Example 190, the system of example 183, wherein the driver side is opposite the tissue facing side.

Example 191 the system of example 183, wherein the system further comprises a driver having a driver head at a distal portion of the driver, the driver head: (i) Is sized to access the interface from outside the housing via the driver opening, and (ii) is configured to engage the interface and rotate the tissue engagement element by applying torque to the interface.

Example 192 the system of example 191, wherein: (i) The driver head has an introduced state and a locked state; (ii) The anchor head is shaped to define a proximal opening through which the driver head is accessible to the hub when the driver head is in the introduced state, and (iii) the anchor driver is configured to lock the driver head to the hub by laterally moving a portion of the driver head to transition the driver head to the locked state.

Example 193 the system of example 192, wherein: (i) the anchor driver includes a flexible shaft and a stem extending through the shaft, (ii) the anchor head is disposed at a distal end of the shaft, and (iii) the stem is configured to transition the driver head to the locked state by applying a force to the driver head.

Example 194 the system of example 193, wherein the driver head comprises fins and the stem is configured to transition the driver head to the locked state by pushing distally between the fins such that the stem pushes the fins radially outward such that the fins lock to the interface.

Example 195 the system of example 194, wherein the fins are configured to lock to the interface via a friction fit when pushed radially outward by the stem.

The system of example 196, wherein the driver head includes a cam, the lever is coupled to the cam, and is configured to transition the driver head to the locked state by rotating the cam such that at least a portion of the cam protrudes laterally.

Example 197 the system of example 196, wherein the rod is eccentric relative to the shaft.

Example 198 the system of example 196, wherein the rod is eccentric relative to the cam.

Example 199 the system of example 196, wherein in the introduced state, the cam is flush with the shaft.

Example 200 the system of example 196, wherein the anchor driver has a longitudinal axis defined by the shaft, and wherein the shaft and the cam are circular in transverse cross-section.

Example 201 the system of example 196, wherein the interface is shaped to define a plurality of recesses, each recess sized to receive the cam when the cam protrudes laterally.

Example 202, an apparatus comprising a tissue anchor for use with an anchor driver, the anchor comprising: (A) A tissue-engaging element defining a central longitudinal axis of the anchor, having a sharpened distal tip, and configured to be driven into tissue of a subject; and (B) an anchor head coupled to the proximal end of the tissue-engaging element, the anchor head comprising: (i) An interface configured to be reversibly engaged by the anchor driver, and (ii) an eyelet defining an aperture and a sliding axis through the aperture, the eyelet being disposed laterally from the central longitudinal axis to define an eyelet axis orthogonal to the central longitudinal axis, and the eyelet being mounted such that the eyelet is rotatable about the eyelet axis in a manner that constrains the sliding axis to be orthogonal to the eyelet axis.

Example 203 the device of example 202, wherein the interface is disposed on the central longitudinal axis of the anchor.

Example 204 the apparatus of example 202, wherein the tissue-engaging element is helical, defines the central longitudinal axis by extending in a helical manner about and along the central longitudinal axis, and is configured to screw into the tissue of the subject.

Example 205 the apparatus of any of examples 202-204, wherein the eyelet is mounted such that the eyelet is pivotable about the central longitudinal axis while the sliding axis remains constrained to be orthogonal to the eyelet axis.

Example 206, the apparatus of example 205, wherein the anchor head includes a collar surrounding the central longitudinal axis and rotatably coupled to the tissue-engaging element, and wherein the eyelet is mounted on the collar and rotatable about the central longitudinal axis by rotation of the collar about the central longitudinal axis.

Example 207 the apparatus of example 206, wherein the aperture defines:

a flange provided inside the collar, and

A stem extends laterally through the collar and couples the flange to the aperture.

Example 208 the device of example 207, wherein the collar is a closed collar defining a groove supporting the stem.

Example 209 the apparatus of example 207, wherein the collar is an open collar having free ends that together support the core pin.

Example 210 the apparatus of any of examples 202-209, wherein the aperture is shaped to define a first planar face and a second planar face, the aperture extending from the first planar face through the aperture to the second planar face, and the second planar face being opposite the first planar face.

Example 211 the apparatus of example 210, wherein the apparatus comprises an implant comprising the anchor and a tether passing through the aperture.

Example 212 the apparatus of example 210, wherein the first planar face is parallel to the aperture axis.

Example 213 the apparatus of example 210, wherein the first planar face is orthogonal to the sliding axis.

Example 214 the apparatus of example 210, wherein the first planar surface is parallel to the second planar surface.

Example 215 the apparatus of example 210, wherein the aperture has an inner surface defining the aperture between the first planar surface and the second planar surface such that a narrowest portion of the aperture is intermediate the first planar surface and the second planar surface.

Example 216 the apparatus of example 215, wherein the aperture defines the inner surface of the aperture as a hyperboloid.

Example 217 the apparatus of example 215, wherein the eyelet defines the inner surface of the eyelet as a catenary surface.

Example 218 the apparatus of any one of examples 202-217, wherein the apparatus comprises an implant comprising the anchor and a tether passing through the aperture.

The apparatus of example 218, wherein the anchor is a first anchor of the implant, and the implant further comprises: (i) A second anchor, and (ii) a spacer, the spacer being tubular, having two spacer ends and a spacer lumen therebetween, wherein the spacer is threaded over the tether between the first anchor and the second anchor, wherein the tether passes through the spacer lumen.

Example 220 the apparatus of example 219, wherein the spacer is resiliently flexible in deflection.

Example 221 the apparatus of example 219, wherein the spacer resists axial compression.

Example 222, the apparatus of example 219, wherein the spacer is defined by a helical wire shaped to define a coil of the spacer lumen.

Example 223 the device of example 219, wherein the spacer is configured to limit proximity between the first anchor and the second anchor.

Example 224 the apparatus of example 219, wherein: (i) for each of the anchors, the eyelet is shaped to define two planar faces through which the aperture extends between the planar faces, (ii) the spacer is threaded on the tether between the first and second anchors such that one of the spacer ends faces one of the planar faces of the eyelet of the first anchor and the other of the spacer ends faces one of the planar faces of the eyelet of the second anchor, and (iii) each of the spacer ends is sized to abut flush against the planar face it faces.

Example 225 the device of any one of examples 202-224, further comprising an anchor driver.

Example 226 the apparatus of example 225, wherein: (i) the anchor driver has a driver head having an introduced state and a locked state, (ii) the anchor head is shaped to define a proximal opening through which the driver head can access the interface when the driver head is in the introduced state, and (iii) the anchor driver is configured to lock the driver head to the interface by laterally moving a portion of the driver head to transition the driver head to the locked state.

Example 227 the apparatus of example 226, wherein: (i) the anchor driver includes a flexible shaft and a stem extending through the shaft, (ii) the anchor head is disposed at a distal end of the shaft, and (iii) the stem is configured to transition the driver head to the locked state by applying a force to the driver head.

Example 228 the apparatus of example 227, wherein the driver head comprises fins, and the stem is configured to transition the driver head to the locked state by pushing distally between the fins such that the stem pushes the fins radially outward such that the fins lock to the interface.

Example 229 the apparatus of example 228, wherein the fins are configured to lock to the interface via a friction fit when pushed radially outward by the stem.

Example 230 the apparatus of example 227, wherein the driver head includes a cam, the lever is coupled to the cam, and is configured to transition the driver head to the locked state by rotating the cam such that at least a portion of the cam protrudes laterally.

Example 231 the apparatus of example 230, wherein the rod is eccentric relative to the shaft.

Example 232 the apparatus of example 230, wherein the rod is eccentric relative to the cam.

Example 233 the apparatus of example 230, wherein in the introduced state, the cam is flush with the shaft.

The apparatus of example 234, wherein the anchor driver has a longitudinal axis defined by the shaft, and wherein the shaft and the cam are circular in transverse cross-section.

Example 235 the apparatus of example 230, wherein the interface is shaped to define a plurality of recesses, each recess sized to receive the cam when the cam protrudes laterally.

The apparatus of any of examples 226-235, wherein: (i) The apparatus includes a delivery tool comprising the anchor driver and a percutaneously advanceable tube, and (ii) the anchor driver and the anchor are slidable through the tube when the anchor driver is engaged with the anchor.

Example 237 the apparatus of example 236, wherein: (i) the tube defines an internal passage having a keyhole-shaped orthogonal cross-section defining a primary passage area and a secondary passage area, (ii) the primary passage area has a larger cross-sectional area than the secondary passage area, and (iii) the anchor is slidable through the passage, wherein the tissue engaging element slides tightly through the primary passage area and the eyelet slides tightly through the secondary passage area.

Example 238 the apparatus of example 237, wherein: (A) The apparatus includes an implant including a tether and the tissue anchor, and (B) the eyelet is shaped to facilitate simultaneous (i) tight sliding of the eyelet through a secondary channel region and (ii) smooth sliding of the eyelet over the tether when the tether is disposed within the secondary channel region and parallel to the central longitudinal axis.

Example 239 the apparatus of example 238, wherein: (i) the anchor is pushable out of the distal end of the tube, (ii) the tube defines a lateral slit extending proximally from the distal end of the tube, (iii) the lateral slit is adjacent the secondary channel region, and (iv) the lateral slit allows a tether to exit the tube proximally from the distal end of the tube instead of the anchor.

Example 240 the device of example 239, wherein the tube is shaped to define a narrowed entrance into the lateral slit, the narrowed entrance configured to prevent, but not preclude, the tether from exiting the lateral slit distally via the narrowed entrance.

Example 241 the apparatus of example 240, wherein the tube includes a tip frame to maintain the narrowed slit and the narrowed entrance.

Example 242 the apparatus of example 241, wherein the tip frame is resilient.

Example 243 the apparatus of any one of examples 202-239, wherein: (A) The apparatus includes an implant including a tether and a tissue anchor, and (B) the eyelet is shaped to facilitate smooth sliding of the tether through the aperture (i) when the tether is parallel to the central longitudinal axis and (ii) when the tether is oriented orthogonal to the central longitudinal axis.

Example 244 the apparatus of example 243, wherein the tether has a thickness and the narrowest portion of the aperture has a width no more than twice the thickness of the tether.

Example 245 the apparatus of example 244, wherein the narrowest portion of the aperture is no more than 50% wider than a thickness of the tether.

Example 246 the apparatus of example 245, wherein the narrowest portion of the aperture is no more than 20% wider than a thickness of the tether.

Example 247 a system comprising an implant for use in a heart of a subject, the implant comprising: (a) a first anchor; (B) a second anchor; (C) At least one tether coupling the first anchor to the second anchor; and (D) a tensioner coupled to at least one tether between the first anchor and the second anchor, and comprising: (i) a spring; and (ii) a restraint that restrains the spring in an elastically deformed shape of the spring; and wherein: (1) the constraint is bioabsorbable such that after implantation of the implant within the heart, decomposition of the constraint releases the spring from the constraint, (2) the spring is configured to automatically move away from the elastically deformed state toward a second shape upon release from the constraint, and (3) the coupling of the spring to the at least one tether is such that the movement of the spring away from the elastically deformed state toward the second shape pulls the first anchor and the second anchor toward each other via the at least one tether.

Example 248 the system of example 247, wherein the constraint comprises a suture.

Example 249 the system of example 247, wherein the constraint comprises a strap.

Example 250 the system of example 247, wherein the constraint comprises a spacer.

Example 251. The system of example 247, wherein the restraint restrains the spring by holding portions of the spring together.

Example 252 the system of example 247, wherein the constraint constrains the spring by maintaining portions of the spring apart from each other.

Example 253. The system of example 247, wherein the first anchor is a tissue piercing anchor.

Example 254 the system of example 247, wherein the first anchor is a clip.

Example 255 the system of example 247, wherein the spring is an extension spring.

Example 256 the system of example 247, wherein the spring has a coiled configuration.

Example 257 the system of any one of examples 247-256, wherein the spring defines a cell, and movement of the spring away from the elastically deformed state toward the second shape includes the cell becoming smaller in a first dimension and larger in a second direction.

The system of any of examples 247 to 256, wherein the spring is a shortening spring and movement of the spring away from the elastically deformed state toward the second shape comprises shortening of the spring.

The system of any of examples 247 to 258, wherein: (i) The at least one tether defines a path from the first anchor to the second anchor via the spring, and (ii) the coupling of the spring to the at least one tether is such that movement of the spring away from the elastically deformed state toward the second shape pulls the first anchor and the second anchor toward each other by introducing a tortuosity into the path of the at least one tether.

Example 260 the system of any of examples 247-259, wherein: (i) the constraint is a first constraint, (ii) the tensioner further comprises a second constraint, (iii) the second constraint is configured to limit movement of the spring away from the elastically deformed state after release of the spring from the first constraint, thereby imposing a limit on pulling of the first and second anchors toward each other, (iv) the second constraint is bioabsorbable such that decomposition of the second constraint releases the spring from the second constraint, thereby allowing the spring to pull the first and second anchors further toward each other beyond the limit, (v) the first constraint is bioabsorbable at a first rate such that release of the spring from the first constraint occurs after a first duration of time after implantation of the implant into the heart, and (vi) the second constraint is bioabsorbable at a second rate such that release of the spring from the second constraint occurs after the second duration of time after implantation of the implant into the heart.

Example 261 the system of example 260, wherein the first rate is such that the first duration is between 1 and 3 months.

Example 262 the system of example 260, wherein the second rate is such that the second duration is between 3 months and 1 year.

The system of any of examples 263, wherein the implant is an annuloplasty structure, the first anchor and the second anchor are configured to be driven into tissue of an annulus of a valve of the heart, and the implant is configured to reshape the annulus by pulling the first anchor and the second anchor toward each other.

Example 264 the system of example 263, wherein: (i) the at least one tether is a first at least one tether, (ii) the tensioner is a first tensioner, and (iii) the implant further comprises: a third anchor, a second at least one tether coupled to the third anchor, and a second tensioner coupled to the second at least one tether.

Example 265 the system of example 264, wherein the second at least one tether couples the third anchor to the second anchor, and the second tensioner is coupled to the second at least one tether between the third anchor and the second anchor.

The system of any of examples 266, wherein the at least one tether comprises: (i) A first tether, the first tether tethering the first anchor to a first portion of the spring; and (ii) a second tether, the second tether being different from the first tether, and the second tether tethers the second anchor to a second portion of the spring, the first tether and the second tether thereby coupling the first anchor to the second anchor via the spring.

Example 267 the system of example 266, wherein a part-to-part distance between the first portion and the second portion is smaller in the second state than in the elastically deformed state.

Example 268. An apparatus comprising an anchor for use with tissue of a subject, the anchor comprising: (a) a sharpened distal tip; (B) A hollow body proximal to the distal tip and shaped to define: (i) a chamber, (ii) a sidewall surrounding the chamber, an anchor axis of the anchor passing through the chamber and the tip, and (iii) two ports in the sidewall; and (C) a spring comprising an elongated element having two ends and defining a loop therebetween, at least the loop being disposed within the chamber; and wherein the anchor: (1) Having a first state in which the spring is restrained by the side walls, and (2) is transitionable from the first state to a second state in which the elongate element is under less strain relative to the first state, and the ends are disposed farther from each other, each of the ends protruding laterally from the hollow body via a respective one of the ports.

Example 269 the device of example 268, wherein the end is sharp.

Example 270 the apparatus of example 268, wherein in the first state, the end does not protrude laterally from the hollow body.

Example 271 the device of any one of examples 268-270, wherein the anchor is configured such that the loop becomes smaller when the anchor transitions from the first state to the second state.

The device of any one of examples 268-270, wherein the anchor is configured such that the ring moves axially within the chamber when the anchor transitions from the first state to the second state.

Example 273 the device of any of examples 268-272, wherein the anchor further comprises a head defining an interface configured to be reversibly engaged by an anchor driver.

Example 274 the apparatus of example 273, further comprising a tether, wherein the head defines an eyelet threaded onto the tether.

Example 275 the apparatus of any one of examples 268-274, wherein in the first state, the end is disposed distally from the ring.

The apparatus of example 276, wherein in the second state, the end is disposed distally from the ring.

Example 277 the apparatus of example 275, wherein in the second state, the end is disposed proximally from the ring.

The apparatus of any of examples 268-277, further comprising a holder, wherein: (i) The hollow body is shaped to define at least one window in the sidewall, and (ii) the retainer is configured to retain the anchor in the first state by extending through the window and into the loop.

The apparatus of example 279, wherein: (i) in the first state, each of the ends is disposed at the respective port, (ii) the anchor is configured such that the ring moves axially within the chamber when the anchor transitions from the first state to the second state, and (iii) the retainer is configured to retain the anchor in the first state by preventing the ring from moving axially within the chamber.

Example 280 the apparatus of example 278, wherein the hollow body is shaped to define two windows in the sidewall, the two windows being opposite each other and rotationally offset from the two ports.

Example 281 the apparatus of example 280, wherein the retainer extends through one of the windows, through the ring, and out of the other of the windows.

Example 282 the apparatus of example 280, wherein: (i) A port axis passes through the two ports and the anchor axis, and (ii) a window axis passes through the two windows and the anchor axis and is orthogonal to the port axis.

Example 283 the apparatus of example 280, wherein the window is axially offset from the port.

Example 284 an apparatus for use with tissue of a heart of a subject, the apparatus comprising: (A) A tool transluminally advanceable to the heart and comprising a tube having a distal end defining an opening; and (B) an anchor disposed at least partially within the tube and comprising a tissue-engaging element, the anchor configured to anchor to the tissue by driving the tissue-engaging element into the tissue; and (C) a driver extending through at least a portion of the tube, a distal end of the driver reversibly engaging the anchor within the tube, the driver configured to drive the tissue-engaging element out of the opening and into the tissue when the opening is disposed within the tissue; and wherein: the tool is configured to penetrate the distal end of the tube into the tissue while the anchor remains at least partially disposed within the tube such that the opening is submerged within the tissue.

Example 285. The apparatus of example 284, wherein the distal end is tapered.

Example 286 the device of example 284, wherein the distal end is sharp.

Example 287, the apparatus of example 284, wherein the anchor is disposed entirely within the tube.

Example 288 the apparatus of example 284, wherein the anchor further comprises a head, the driver being reversibly engaged with the anchor by being reversibly engaged with the head.

The apparatus of any of examples 284-288, further comprising a tether, wherein the anchor further comprises a head defining an aperture through which the tether passes.

The apparatus of any of examples 284-289, wherein at least a portion of the tissue-engaging element is constrained by the tube and is configured to automatically change shape within the tissue upon exiting the opening.

Example 291 the apparatus of example 290, wherein the portion of the tissue-engaging element is a tine.

Example 292 the apparatus of example 290, wherein the portion of the tissue-engaging element is a flange.

Example 293 the apparatus of example 292, wherein the flange comprises a polymer.

Example 294 the apparatus of example 292, wherein the flange includes a sheet and a self-expanding frame supporting the sheet.

The apparatus of any of examples 284-294, wherein a distal tip of the tissue-engaging element is disposed outside the opening, and the tool is configured to penetrate the distal end of the tube into the tissue when the distal tip is disposed outside the opening such that the opening is submerged within the tissue.

Example 296 the apparatus of example 295, wherein the tissue-engaging element is shaped to fit snugly within the opening such that the tissue-engaging element blocks the opening when the tool penetrates the distal end of the tube into the tissue.

Example 297 the apparatus of example 295, wherein the distal tip is sharpened, and wherein the distal tip of the tissue-engaging element and the distal end of the tube together define a taper point, the distal tip being a distal portion of the taper point, and the distal end of the tube being a proximal portion of the taper point.

The apparatus of any one of examples 284-297, wherein: (i) The tube defining a channel having a central channel region and a lateral channel region; and (ii) the anchor comprises a head and tines, the head being disposed in the central channel region and each of the tines being disposed in a respective lateral channel region such that within the channel the anchor is axially slidable but prevented from rotating.

Example 299 the apparatus of example 298, wherein the channel is wider at the central channel region than at the lateral channel regions.

Example 300 the apparatus of example 298, wherein the opening is defined through the passageway to the distal end of the tube, and wherein the opening is shaped to shape the distal end of the tube to resemble a beak.

Example 301 a system for use with tissue of a heart of a subject, the system comprising a tissue anchor comprising: (a) a head, the head: (i) Having a tissue-facing side shaped to define a plurality of clamping portions, and (ii) an opposite side defining an aperture; and (B) a plurality of tissue-engaging elements disposed laterally from the clamping portion: (i) Each tissue-engaging element having a sharpened tip, (ii) each tissue-engaging element having: a delivery state in which the tissue-engaging elements are configured to be driven linearly into the tissue until the clamping portion contacts the tissue, and (iii) a clamping state in which the tissue-engaging elements are configured such that, when disposed within the tissue with the clamping portion contacting the tissue, transition of the tissue-engaging elements toward the clamping state causes the tips to face each other and to press the clamping portion against the tissue.

Example 302 the system of example 301, wherein the plurality of tissue-engaging elements are collectively configured such that, when the plurality of tissue-engaging elements are disposed within the tissue with the clamping portion contacting the tissue, transition of the tissue-engaging elements toward the clamped state squeezes the tissue between the plurality of tissue-engaging elements.

Example 303 the system of any one of examples 301-302, wherein each of the tissue-engaging elements has a deflecting portion and a stationary portion connecting the deflecting portion to the head, both the deflecting portion and the stationary portion configured to be driven linearly into the tissue when the tissue-engaging element is in the delivery state, and the tissue-engaging element is configured such that when the tissue-engaging element transitions toward the clamped state: (i) The stationary portion remains stationary relative to the head, and (ii) the deflecting portion deflects relative to the stationary portion and relative to the head.

Example 304 the system of any of examples 301-303, wherein the system comprises an implant comprising: (i) The tissue anchor, and (ii) a tether, the tether passing through the eyelet.

Example 305 the system of any one of examples 301-304, wherein: (i) In the delivery state, each of the tissue-engaging elements has a medial side and a lateral side, the medial side being closer to the other tissue-engaging elements than the lateral side; and (ii) each of the tissue-engaging elements is shaped to define barbs on the lateral sides.

Example 306 the system of example 305, wherein each of the tissue-engaging elements is configured such that in the delivery state the barb is covered and in the gripping state the barb is exposed.

The system of example 307, wherein each of the tissue-engaging elements has a deflecting portion and a stationary portion connecting the deflecting portion to the head, both the deflecting portion and the stationary portion configured to be driven linearly into the tissue when the tissue-engaging element is in the delivery state, and the tissue-engaging element is configured such that when the tissue-engaging element transitions toward the clamped state: (i) The stationary portion remains stationary relative to the head, and (ii) the deflecting portion deflects relative to the stationary portion and relative to the head.

Example 308 the system of example 307, wherein, for each of the tissue-engaging elements, the barb is defined by the stationary portion.

Example 309 the system of example 307, wherein, for each of the tissue-engaging elements, the barb is defined by the deflecting portion.

Example 310. A system for use with tissue of a heart of a subject, the system comprising: (a) an anchor; (B) A tether coupled to the anchor, the anchor configured to anchor to the tissue such that the tether extends proximally from the anchor; (C) A tether handling device comprising (i) a housing shaped to define a channel therethrough, the tether extending through the channel in a manner that facilitates the housing to slide distally transluminally over and along the tether to the anchor; (ii) A clamp coupled to the housing and biased to clamp onto the tether within the channel in a manner that prevents the housing from sliding relative to the tether; and (iii) an arm extending proximally from the housing, and comprising: a conduit shaped to receive a portion of the tether proximally from the housing, and a lever coupling the conduit to the housing and biased to place the conduit in an offset position relative to the channel; and (D) a tool comprising a tube; and wherein the system has a delivery state in which (1) the tool is coupled to the tether handling device, wherein the tube: (a) Is disposed within the channel in a manner that resists gripping by the grip, and (b) is disposed within the conduit in a manner that constrains the conduit in a coaxial position relative to the channel, and (2) is configured to transluminally advance the tether steering device over and along the tether toward the anchor.

Example 311 the system of example 310, wherein the duct has an open lateral side.

Example 312 the system of example 310, wherein the tether extends proximally of the housing, and wherein the lever is biased to place the conduit against the proximal side of the housing.

Example 313 the system of any of examples 310-312, wherein the bias of the clamp is such that, without the tube disposed in the channel, the clamp automatically clamps onto the tether within the channel in a manner that prevents the housing from sliding relative to the tether.

Example 314 the system of example 313, wherein in the delivery state, the tube is disposed within the channel and within the channel by extending distally through the channel and into the channel.

Example 315 the system of example 313, wherein the system is transitionable from the delivery state to an intermediate state by proximally retracting the tube out of the channel without out of the tube.

Example 316 the system of example 313, wherein in the intermediate state, the distal portion of the tube remains disposed within the housing.

Example 317 the system of any of examples 310-316, wherein the bias of the tether relative to the lever has sufficient tensile strength such that, without the tube disposed in the conduit, the lever may be prevented from moving the conduit to the biased position by proximally tensioning the tether from the clamp.

Example 318 the system of example 317, further comprising a cutter advanceable over and along the tether, axially movable relative to the tube, and configured to cut the tether proximally from the conduit.

Example 319 the system of example 318, wherein cutting the tether proximally from the conduit triggers the lever to move the conduit to the offset position as the tether is tensioned proximally from the clamp.

Example 320 the system of example 319, wherein: (i) The cutter is configured to cut the tether proximally from the conduit in a manner such that a residual portion of the tether protrudes proximally from the conduit, and (ii) the arm is configured such that the lever moving the conduit to the offset position pulls the residual portion of the tether into the conduit.

Example 321. The system of example 318, wherein the tube is slidable within the cutter.

Example 322 an apparatus for use with a tether, the apparatus comprising a clamp comprising: (A) A chuck, the chuck having a longitudinal axis, and comprising: (i) A sleeve surrounding the longitudinal axis and having a tapered inner surface, and (ii) a collet disposed within the sleeve and sized to receive the tether therethrough; and (B) a spring that pushes the collet axially against the tapered inner surface such that the collet is compressed inboard of the sleeve.

Example 323, the apparatus of example 322, wherein the sleeve and the collet are concentric with the longitudinal axis.

Example 324 the apparatus of example 323, wherein the spring is concentric with the longitudinal axis.

Example 325 the apparatus of any one of examples 322-324, wherein the spring is a compression spring.

Example 326 the apparatus of example 325, wherein the spring is helical.

The apparatus of example 327, wherein the spring surrounds the longitudinal axis, the clamp configured to be threaded onto the tether such that the sleeve, the collet, and the spring surround the tether.

Example 328 the apparatus of example 325, wherein the sleeve has opposing surfaces and the spring is maintained under compression between the opposing surfaces and the collet.

The apparatus of any of examples 322-328, further comprising the tether, wherein: (i) The grip is configured to receive the tether through the collet and the sleeve, and (ii) the spring urges the collet axially against the tapered inner surface by urging the collet in a first axial direction relative to the sleeve such that the collet grips the tether, thereby preventing the tether from sliding through the collet at least in the first axial direction.

Example 330 the apparatus of example 329, wherein the grip is configured to facilitate sliding of the tether through the collet in the second axial direction by moving the tether in a second axial direction opposite the first axial direction by pushing the collet axially away from the tapered inner surface through the sleeve, thereby reducing grip of the tether by the collet.

Example 331 the apparatus of any of examples 322-330, wherein the sleeve has opposing surfaces to which the spring applies opposing forces when the collet is axially pushed.

Example 332 the apparatus of example 331, further comprising a tether, wherein: (i) the grip has a proximal end and a distal end, the tapered inner surface tapering toward the distal end, (ii) the chuck facilitates sliding of the grip along the tether in a distal direction in which the distal end directs the proximal end, and (iii) the chuck prevents sliding of the grip along the tether in a proximal direction in which the proximal end directs the distal end.

Example 333 the device of example 332, further comprising a sheath extending proximally from the sleeve and resiliently coupled to the sleeve in the following manner: (i) The sheath is distally retractable over the sleeve by applying a distally directed force to the sheath, and (ii) the sheath automatically re-extends proximally in response to removal of the distally directed force.

Example 334 the device of example 333, wherein the sheath is rigid.

Example 335 the apparatus of example 333, further comprising a tool comprising a cutter, the tool configured to: (i) Retracting the sheath distally over the sleeve by applying the distally directed force to the sheath; (ii) While maintaining the distally directed force on the sheath: (a) Tensioning the tether by applying a proximally directed force to the tether such that the tether slides proximally through the collet, and (b) subsequently cutting the tether proximally from the sleeve in a manner that leaves a residual portion of the tether protruding proximally from the sleeve, and (iii) removing the distally directed force such that the sheath automatically re-extends proximally and encases the residual portion of the tether.

Example 336 the apparatus of example 335, wherein the tool is configured to cut the tether proximally from the sleeve in a manner that leaves a residual portion of the tether protruding proximally from the chuck.

Example 337 the apparatus of example 333, wherein the spring is a first spring, and wherein the clamp further comprises a second spring disposed laterally from the sleeve and providing a resilient coupling of the sheath to the sleeve.

Example 338 the apparatus of example 337, wherein: (i) The sleeve defines a flange extending laterally from the sleeve, and (ii) the second spring is a compression spring disposed laterally from the sleeve such that application of the distally directed force to the sheath compresses the spring against the flange.

Example 339 the apparatus of example 337, wherein the second spring is a coil spring.

Example 340 the apparatus of example 337, wherein the second spring surrounds the sleeve.

Example 341. A system comprising an implant configured to be implanted in a heart of a subject, the implant comprising: (a) a tether; (B) An anchor slidably coupled to the tether and configured to anchor the tether to tissue of the heart; (C) A spring having a resting state and coupled to the tether in a manner that applies tension to the tether as the spring moves toward the resting state; and (D) a constraint, the constraint: (i) coupled to the spring in a manner that resists movement of the spring toward the resting state, (ii) including a material configured to decompose within the heart, and (iii) configured such that decomposition of the material reduces the resistance of the restraint to the spring.

Example 342 the system of example 341, wherein the spring is a helical coil spring.

Example 343 the system of any one of examples 341-342, wherein: (i) The constraint is configured such that after a threshold amount of decomposition of the constraint, the constraint no longer blocks the spring, and (ii) the material is configured such that the threshold amount of decomposition is reached between 1 day and 2 years after implantation of the implant in the heart.

Example 344 the system of example 343, wherein the material is configured such that the threshold decomposition amount is reached between 15 days and 2 years after the implant is implanted in the heart.

Example 345 the system of example 344, wherein the material is configured such that the threshold decomposition amount is reached between 15 days and 1 year after the implant is implanted in the heart.

Example 346 the system of example 345, wherein the material is configured such that the threshold decomposition amount is reached between 15 days and 6 months after implantation of the implant in the heart.

Example 347 the system of example 346, wherein the material is configured such that the threshold decomposition amount is reached between 1 and 3 months after implantation of the implant in the heart.

Example 348 the system of example 347, wherein the material is configured such that the threshold decomposition amount is reached between 1 and 2 months after implantation of the implant in the heart.

Example 349 the system of any one of examples 341-348, wherein: (i) The constraint is a first constraint and is configured to have a first lifetime after implantation of the implant such that after expiration of the first lifetime, the first constraint no longer blocks the spring; and (ii) the implant further comprises a second constraint configured to have a second lifetime after implantation of the implant, the second lifetime being greater than the first lifetime.

Example 350, the system of example 349, wherein the second constraint is coupled to the spring in a manner that prevents the spring from moving toward the stationary state, such that the system is configured such that, after implantation of the implant: (i) After the first life expires, the spring moves partially toward the resting state but remains blocked by the second constraint; and (ii) after the second life expires, the second constraint no longer blocks the spring and the spring moves further toward the resting state.

Example 351, the system of example 349, wherein: (i) the spring is a first spring, (ii) the implant further comprises a second spring having a resting state and coupled to the tether in a manner that movement of the second spring toward the resting state applies tension to the tether, and (iii) the second constraint is coupled to the second spring in a manner that prevents movement of the second spring toward the resting state of the second spring, and is configured such that after expiration of the second lifetime, the second constraint no longer prevents the second spring.

Example 352 the system of example 349, wherein the first constraint and the second constraint are configured such that a second lifetime is at least twice the first lifetime.

Example 353 the system of example 349, wherein the first constraint and the second constraint are configured such that a second lifetime is at least three times the first lifetime.

Example 354 the system of example 349, wherein the first constraint and the second constraint are configured such that the first lifetime is between 1 and 3 months and the second lifetime is between 3 months and 1 year.

Example 355 the system of example 354, wherein the first constraint and the second constraint are configured such that the first lifetime is between 1 and 3 months and the second lifetime is between 3 and 6 months.

Example 356 the system of example 354, wherein the first constraint and the second constraint are configured such that the first lifetime is between 1 and 2 months and the second lifetime is between 3 months and 1 year.

Example 357 the system of example 356, wherein the first constraint and the second constraint are configured such that the first lifetime is between 1 and 2 months and the second lifetime is between 3 and 6 months.

Example 358 the system of any of examples 341-357, wherein the constraint is stretch resistant and is coupled to the spring in a manner that resists movement of the spring toward the resting state by the constraint resisting stretching.

Example 359 the system of example 358, wherein the restraint is a tether that tethers one portion of the spring to another portion of the spring, thereby preventing the one portion of the spring from moving away from the other portion of the spring.

Example 360 the system of example 358, wherein the constraint is a tube in which the spring is disposed.

Example 361 the system of any of examples 341-360, wherein the constraint is compression resistant and coupled to the spring in a manner that prevents the spring from moving toward the resting state by the constraint preventing compression.

Example 362 the system of example 361, wherein the constraint is an obstruction disposed between one portion of the spring and another portion of the spring, thereby preventing the one portion of the spring from moving toward the another portion of the spring.

Example 363 the system of any of examples 341-362, wherein the spring: (i) Is shaped to define a cell having a first dimension and a second dimension, and (i) is configured to move toward the resting state by contracting in the first dimension and expanding in the second dimension.

Example 364 the system of example 363, wherein the spring is longer in the first dimension than in the second dimension when blocked by the constraint.

Example 365 the system of example 363, wherein the cell is a first cell and the spring is shaped to further define a second cell.

Example 366 a system for use with tissue of a heart of a subject, the system comprising: (a) an anchor, the anchor comprising: (i) A tissue-engaging element having a sharpened distal tip and configured to anchor the anchor to the tissue by driving into the tissue; and (ii) an anchor head coupled to the proximal end of the tissue-engaging element and comprising a hub; and (B) an anchor handling assembly, the anchor handling assembly comprising: (i) A sleeve having a distal portion including a distal end of the sleeve, the distal portion being transluminally advanceable to the anchor anchored to the tissue, and the distal end being sized to fit snugly over the anchor head; and (ii) a tool comprising: (a) A flexible shaft, and (b) a tool head coupled to a distal end of the flexible shaft, comprising jaws biased to assume an open state and reversibly squeezable into a closed state, and sized relative to an inner dimension of the distal portion of the sleeve, such that placement of the tool head in the distal portion of the sleeve squeezes the jaws into the closed state; and wherein the tool is configured to: (1) advancing the tool head distally through the sleeve to the distal portion, (2) locking the jaws to the interface when the jaws remain in the closed state, and (3) applying a de-anchoring force to the anchor head when the jaws remain locked to the interface.

The system of example 367, wherein when the tool head is locked to the hub and the distal end of the sleeve is disposed snugly over the anchor head, the jaws may be unlocked from the hub by retracting the sleeve proximally relative to the anchor head and the tool head such that the distal portion of the sleeve ceases to squeeze the jaws into the closed state and the jaws automatically move apart.

Example 368 the system of example 366, wherein the tool is configured to lock the jaws to the interface by pushing the driver head against the anchor head while the jaws remain in the closed state.

Example 369 the system of any of examples 366-368, wherein: (i) In the closed state, the jaws define a gap therebetween; and (ii) when held in the closed state, the jaws are configured to: (a) In response to pushing the jaws onto the interface with a distally directed force of magnitude, being locked to the interface by receiving the interface into the gap as the interface deflects the jaws apart; and (b) preventing unlocking from the interface as a result of the interface exiting the gap, wherein pulling the jaws with a proximally directed force of the magnitude is insufficient to pull the jaws away from the interface.

The system of any of examples 366-369, wherein the sleeve has a middle portion proximal to the distal portion and the middle portion is internally sized such that placement of the tool head in the middle portion of the sleeve does not squeeze the jaws into the closed state.

The system of any of examples 371, wherein the jaws and the interface are configured to define a snap fit, and the tool is configured to lock the jaws to the interface by snap fitting the jaws to the interface while the jaws remain in the closed state.

Example 372 the system of any one of examples 366-371, wherein the de-anchor force is a de-anchor torque, and wherein the tool is configured to apply the de-anchor torque to the anchor head while the jaws remain locked to the interface.

Example 373. A system for use with a tether for tissue fixation along a heart of a subject, the system comprising: (a) an anchor, the anchor comprising: (i) A tissue-engaging element having a sharpened distal tip; and (ii) a head coupled to a proximal portion of the tissue-engaging element and comprising a shackle having an opening that can be reversibly opened; and (B) an anchor handling assembly transluminally advanceable to the heart, and comprising: (i) A driver configured to drive the tissue-engaging element into the tissue; and (ii) a linking tool configured to temporarily open the opening within the heart and to pass the tether laterally through the opening.

Example 374 the system of example 373, wherein the linking tool is configured to slidably couple the anchor to the tether within the heart by temporarily opening the opening and passing the tether laterally through the opening and into the shackle.

Example 375 the system of example 373, wherein the driver is configured to drive the tissue-engaging element into the tissue by screwing the tissue-engaging element into the tissue.

The system of any one of examples 373-375, wherein at the opening, the shackle comprises a spring loaded door.

Example 377 the system of example 376, wherein the spring-loaded door is a single door.

Example 378 the system of example 376, wherein the spring-loaded door is a double door.

Example 379 the system of example 376, wherein the spring-loaded door is configured to open inward but not open outward.

Example 380 the system of any one of examples 373-379, wherein the linking tool is configured to detach the anchor from the tether within the heart by temporarily opening the opening and passing the tether laterally through the opening and out of the shackle.

Example 381 the system of example 380, wherein the head further comprises a magnet, and wherein the tool is configured to magnetically attract to the magnet.

Example 382 a method for use with tissue of a heart of a subject, the method comprising: (i) Transluminally securing a tether along tissue by anchoring a plurality of anchors to respective locations of the tissue such that the tether extends between and along the plurality of anchors, each of the plurality of anchors having a respective eyelet through which the tether passes; and (ii) transluminally while the plurality of anchors remain anchored to the tissue: (a) Slidably coupling an additional anchor to the tether between two anchors of the plurality of anchors; and (b) anchoring the additional anchor to the tissue.

The method of example 382, wherein anchoring the additional anchor to the tissue comprises anchoring the additional anchor to the tissue after slidably coupling the additional anchor to the tether.

Example 384 the method of example 382, wherein anchoring the additional anchor to the tissue comprises anchoring the additional anchor to the tissue prior to slidably coupling the additional anchor to the tether.

The method of any of examples 382-384, wherein, for each of the plurality of anchors, anchoring the anchor to a respective site of the tissue comprises driving a tissue-engaging element of the anchor into the respective site of the tissue.

Example 386 the method of example 385, wherein, for each of the plurality of anchors, driving the tissue-engaging element of the anchor into the respective site of the tissue comprises screwing the tissue-engaging element of the anchor into the respective site of the tissue.

Example 387 the method of any one of examples 382-386, further comprising contracting the tissue by tensioning the tether.

The method of example 388, wherein tensioning the tether includes tensioning the tether after anchoring the additional anchor to the tissue.

Example 389 the method of example 387, wherein tensioning the tether includes tensioning the tether prior to slidably coupling the additional anchor to the tether.

Example 390 the method of example 389, further comprising slackening the tether after tensioning the tether and before slidably coupling the additional anchor to the tether.

Example 391 the method of example 390, further comprising re-tensioning the tether after anchoring the additional anchor to the tissue.

Example 392 the method of any of examples 382-391, wherein slidably coupling the additional anchor to the tether includes clamping the additional anchor to the tether.

The method of example 393, wherein the additional anchor comprises a head comprising a shackle, and wherein clamping the additional anchor to the tether comprises, after anchoring the additional anchor to the tissue, transluminally grasping the tether and laterally pressing the tether into the shackle such that the shackle is slidably coupled to the tether.

Example 394 the method of example 393, wherein the shackle is a snap shackle, and wherein pressing the tether laterally into the shackle comprises pressing the tether laterally into the snap shackle such that the tether snaps into the snap shackle.

Example 395, a method for use with tissue of a heart of a subject, the method comprising: (i) Transluminally securing a tether along tissue by anchoring a plurality of anchors to respective locations of the tissue such that the tether extends between and along the plurality of anchors, each of the plurality of anchors having a respective eyelet through which the tether passes; and (ii) transluminally separating one of the plurality of anchors from the tether from between two other of the plurality of anchors.

Example 396 the method of example 395, wherein: (i) The one anchor includes a tissue-engaging element having a sharpened distal tip and a head coupled to a proximal portion of the tissue-engaging element, the head including a magnetic element, and (ii) the method further includes transluminally advancing a tool to the one anchor facilitated by magnetic attraction between the tool and the magnetic element, wherein separating the one anchor from the tether includes separating the one anchor from the tether using the tool.

The method of any one of examples 395-396, further comprising de-anchoring the one anchor from the tissue while two other anchors of the plurality of anchors remain anchored to the tissue.

Example 398. The method of example 397, wherein de-anchoring the one anchor from the tissue comprises de-anchoring the one anchor from the tissue prior to de-anchoring the one anchor from the tether.

Example 399 the method of example 397, wherein de-anchoring the one anchor from the tissue comprises de-anchoring the one anchor from the tissue after de-anchoring the one anchor from the tether.

Example 400 the method of any of examples 395-399, wherein for each anchor of the plurality of anchors, anchoring the anchor to a respective site of the tissue comprises driving a tissue engaging element of the anchor into the respective site of the tissue.

Example 401 the method of example 400, wherein, for each of the plurality of anchors, driving the tissue-engaging element of the anchor into the respective site of the tissue includes screwing the tissue-engaging element of the anchor into the respective site of the tissue.

Example 402 the method of any one of examples 395-401, further comprising contracting the tissue by tensioning a tether.

Example 403, the method of example 402, wherein the tether is tensioned after the one anchor is separated from the tether.

Example 404 the method of example 402, wherein tensioning the tether includes tensioning the tether prior to decoupling the one anchor from the tether.

Example 405 the method of example 404, further comprising slackening the tether after tensioning the tether and before separating the one anchor from the tether.

Example 406 the method of example 405, further comprising re-tensioning the tether after separating the one anchor from the tether.

Example 407, the method of example 395, wherein separating the one anchor from the tether comprises disengaging the additional anchor from the tether.

Example 408 the method of example 407, wherein the one anchor comprises a head comprising a shackle, and wherein disengaging the one anchor from the tether comprises transluminally opening the shackle.

Example 409. An apparatus comprising a tissue anchor, the anchor comprising: (A) A tissue-engaging element defining a central longitudinal axis of the anchor, having a sharpened distal tip, and configured to be driven into tissue of a subject; and (B) an anchor head coupled to the proximal end of the tissue-engaging element, the anchor head comprising: (i) a bracket, (ii) a ball joint, and (iii) an eyelet coupled to the bracket via the ball joint.

Example 410 the apparatus of example 409, wherein the ball joint is disposed on the central longitudinal axis.

Example 411 the apparatus of any one of examples 409-410, wherein the anchor head defines an eyelet axis through the ball joint and the eyelet, and the ball joint allows the eyelet to move to a position in which the eyelet axis is orthogonal to the central longitudinal axis.

Example 412 the device of any one of examples 409-411, wherein the rest is fixedly coupled to the tissue engagement element.

The device of any of examples 409-412, wherein the tissue-engaging element is helical, defines the central longitudinal axis by extending in a helical fashion around and along the central longitudinal axis, and is configured to screw into the tissue of the subject.

Example 414 the apparatus of any of examples 409-413, wherein the aperture is disposed laterally from the central longitudinal axis.

Example 415, the apparatus of example 414, wherein the ball joint is disposed laterally from the central longitudinal axis.

Example 416 the apparatus of example 415, wherein the anchor head comprises a collar surrounding the lug and rotatably coupled to the lug, and wherein the ball joint is mounted on the collar such that the ball joint is revolvable about the central longitudinal axis by rotation of the collar about the lug.

Example 417 the apparatus of example 415, wherein the lugs are disposed on the central longitudinal axis.

Example 418 the apparatus of any one of examples 409-417, wherein: (i) the ball joint comprises a socket and a support stud, (ii) the support stud defines a ball at a first end of the stud, the ball being disposed within the socket, (iii) a second end of the stud defines the aperture, and (iv) the ball joint defines: (a) A deflection ball sector, the ball joint allowing the support stud to deflect within the deflection ball sector into any angular setting relative to the socket, and (b) a deflection plane, the ball joint allowing the support stud to deflect beyond the deflection ball sector on the deflection plane, beyond which the ball joint prevents the support stud from deflecting beyond the deflection ball sector.

Example 419 the apparatus of example 418, wherein the yaw ball sector has a midpoint, and the ball joint is positioned such that the midpoint is located on the central longitudinal axis.

Example 420 the apparatus of example 418, wherein the ball joint is disposed on the central longitudinal axis.

Example 421 the apparatus of example 418, wherein the ball joint defines the yaw ball sector to have a solid angle of at least one steradian.

Example 422 the apparatus of example 421, wherein the ball joint defines the solid angle as at least two steradians.

Example 423 the apparatus of example 422, wherein the ball joint defines the solid angle as 2-5 steradians.

Example 424 the apparatus of example 423, wherein the ball joint defines the solid angle as 3-5 steradians.

Example 425 the apparatus of example 418, wherein: (i) The ball joint defines a planar deflection angle arc of at least 110 degrees on the deflection plane, and (ii) the ball joint allows the support stud to deflect beyond a boundary only within the planar deflection angle arc on the deflection plane.

Example 426 the apparatus of example 425, wherein the ball joint defines the planar deflection angle arc as at least 120 degrees.

Example 427 the apparatus of example 426, wherein the ball joint defines the planar deflection angle arc as at least 140 degrees.

Example 428 the apparatus of example 427, wherein the ball joint defines the planar deflection angle arc as at least 160 degrees.

Example 429 the apparatus of example 428, wherein the ball joint defines the planar deflection angle arc as at least 180 degrees.

Example 430 the apparatus of example 429, wherein the ball joint defines the planar deflection angle arc as at least 200 degrees.

Example 431 the apparatus of example 425, wherein the ball joint defines the planar deflection angle arc to be no greater than 180 degrees.

Example 432 the apparatus of example 431, wherein the ball joint defines the planar deflection angle arc to be no greater than 160 degrees.

Example 433 the apparatus of example 432, wherein the ball joint defines the planar deflection angle arc to be no greater than 140 degrees.

Example 434 the apparatus of any one of examples 409-433, wherein: (i) The aperture is shaped to define a first face and a second face opposite the first face, and (ii) the aperture has an aperture defined by an inner surface of the aperture, the aperture extending between the first face and the second face, and a narrowest portion of the aperture being intermediate the first face and the second face.

Example 435 the apparatus of example 434, wherein the inner surface of the aperture is hyperboloid.

Example 436 the apparatus of example 434, wherein the inner surface of the eyelet is a catenary surface.

Example 437 the device of any one of examples 409-436, wherein the device comprises an implant comprising a tether and the anchor, the eyelet threaded onto the tether.

Example 438 the apparatus of example 437, wherein: (i) The anchor is a first anchor of the implant, and (ii) the implant further comprises a second anchor, the eyelet of which passes onto the tether.

Example 439 the apparatus of example 438, wherein: (i) The implant further includes a spacer that is tubular having two spacer ends and a lumen therebetween, and (ii) the spacer is threaded over the tether between the first anchor and the second anchor, wherein the tether passes through the spacer lumen.

Example 440, the apparatus of example 439, wherein the spacer is elastically flexible in deflection.

Example 441 the apparatus of example 439, wherein the spacer prevents axial compression.

Example 442 the apparatus of example 439, wherein the spacer is defined by a helical wire shaped to define a coil of the spacer lumen.

The apparatus of example 443, wherein the eyelet defines an aperture therethrough, the eyelet is threaded onto the tether by the tether passing through the aperture, and the anchor head is configured to facilitate smooth sliding of the tether through the aperture (i) when the tether is parallel to the central longitudinal axis and (ii) when the tether is oriented orthogonal to the central longitudinal axis.

Example 444 the device of example 443, wherein the tether has a thickness and a width of a narrowest portion of the aperture is no more than twice the thickness of the tether.

Example 445 the apparatus of example 444, wherein the narrowest portion of the aperture is no more than 50% wider than a thickness of the tether.

Example 446 the apparatus of example 445, wherein the narrowest portion of the aperture is no more than 20% wider than a thickness of the tether.

Example 447 the device of any of examples 409-446, wherein the anchor head further comprises a driver interface, and wherein the device further comprises an anchor driver configured to reversibly engage the driver interface and, when engaged with the driver interface, (i) transluminally advance the anchor to the tissue, and (ii) drive the tissue engaging element into the tissue.

Example 448 the device of example 447, wherein the interface is disposed on the central longitudinal axis of the anchor.

Example 449 the apparatus of example 447, wherein: (i) The apparatus includes a delivery tool comprising a percutaneously advanceable tube and the anchor driver, and (ii) the anchor driver is configured to transluminally advance the anchor to the tissue by sliding the anchor through the tube when engaged with the driver interface.

Example 450 the apparatus of example 449, wherein: (i) the tube defines an internal passage having a cross-section defining a primary passage region and a secondary passage region, (ii) the primary passage region has a larger cross-sectional area than the secondary passage region, and (iii) the anchor is slidable through the passage, with the tissue-engaging element sliding through the primary passage region and the eyelet sliding through the secondary passage region.

Example 451 an apparatus comprising a tissue anchor, the anchor comprising: (A) A tissue-engaging element defining a central longitudinal axis of the anchor, having a sharpened distal tip, and configured to be driven into tissue of a subject; and (B) an anchor head, the anchor head comprising: (i) a bracket coupled to a proximal end of the tissue-engaging element, (ii) a driver interface coupled to the bracket, and (iii) an eyelet hingedly coupled to the bracket such that the eyelet is pivotable on the driver interface.

Example 452 the apparatus of example 451, wherein the lug is fixedly coupled to the proximal end of the tissue-engaging element.

Example 453 the device of any of examples 451-452, wherein the drive interface is fixedly coupled to the rest.

Example 454 the device of any of examples 451-453, wherein the lug is coupled to the proximal end of the tissue-engaging element and the driver interface in a manner that transfers torque from the driver interface to the tissue-engaging element.

Example 455 the apparatus of any of examples 451-454, wherein the eyelet is positionable on the central longitudinal axis.

Example 456 the apparatus of any one of examples 451-455, wherein the hinge coupling of the eyelet to the bracket is such that the eyelet is positionable on a first side of the driver interface and pivotable over the driver interface to a second side of the driver interface, the second side opposite the first side.

Example 457 the apparatus of any of examples 451-456, wherein the hinge of the eyelet to the bracket is coupled such that the eyelet is pivotable on the drive interface in an arc greater than 180 degrees.

Example 458 the apparatus of any of examples 451-457, wherein the tissue-engaging element is helical, defines the central longitudinal axis by extending in a helical manner about and along the central longitudinal axis, and is configured to screw into the tissue of the subject.

Example 459 the apparatus of any one of examples 451-456, wherein the anchor head comprises an arch defining at least a portion of the eyelet, the arch having two bottom ends, each of the bottom ends being hingedly coupled to the rest at a respective hinge point opposite each other.

Example 460 the apparatus of example 459, wherein: (i) The anchor head includes a collar surrounding the lugs and rotatably coupled to the lugs, and (ii) the eyelet is hingedly coupled to the lugs by each of the bottom ends being hingedly coupled to the collar at a respective one of the hinge points.

Example 461 the apparatus of example 460, wherein at each of the hinge points, the collar defines a respective recess, and the respective bottom end is hingedly coupled to the collar by protruding into the recess.

Example 462 the apparatus of example 459, wherein the eyelet is centrally disposed on the arch.

Example 463 the apparatus of example 459, wherein the eyelet is eccentrically disposed on the arch.

Example 464 the device of any of examples 451-463, wherein the device includes an implant including a tether and the anchor, the eyelet being threaded onto the tether.

Example 465 the apparatus of example 464, wherein: (i) The anchor is a first anchor of the implant, and (ii) the implant further comprises a second anchor, the eyelet of which passes onto the tether.

Example 466 the apparatus of example 465, wherein: (i) The implant further includes a spacer that is tubular having two spacer ends and a lumen therebetween, and (ii) the spacer is threaded over the tether between the first anchor and the second anchor, wherein the tether passes through the spacer lumen.

Example 467 the device of example 466, wherein the spacer is resiliently flexible in deflection.

Example 468 the apparatus of example 466, wherein the spacer prevents axial compression.

Example 469 the device of example 466, wherein the spacer is defined by a helical wire shaped to define a coil of the spacer lumen.

Example 470 the apparatus of example 464, wherein the eyelet defines an aperture therethrough, the eyelet is threaded onto the tether by the tether passing through the aperture, and the anchor head is configured to facilitate smooth sliding of the tether through the aperture (i) when the tether is parallel to the central longitudinal axis and (ii) when the tether is oriented orthogonal to the central longitudinal axis.

Example 471 the device of any of examples 451-470, wherein the device further comprises an anchor driver configured to reversibly engage the driver interface and, when engaged with the driver interface, to (i) transluminally advance the anchor to the tissue, and (ii) drive the tissue engagement element into the tissue.

Example 472 the apparatus of example 471, wherein the interface is disposed on the central longitudinal axis of the anchor.

The apparatus of example 473, wherein: (i) The apparatus includes a delivery tool comprising a percutaneously advanceable tube and the anchor driver, and (ii) the anchor driver is configured to transluminally advance the anchor to the tissue by sliding the anchor through the tube when engaged with the driver interface.

Example 474. A method, comprising: (A) An implant for transluminally advancing an elongate tool comprising a holder and a cutter to a heart coupled to a subject, the implant comprising: (i) A tether under tension, and ii) a stop that locks the tension in the tether by locking to a first portion of the tether; (B) securing the stopper to the retainer; and (C) while the stop remains secured to the retainer and locked to the first portion of the tether: (i) Reducing the tension on the tether by cutting the tether with the cutter; and (ii) withdrawing the tool, the stop, and the first portion of the tether from the subject while leaving a second portion of the tether coupled to the heart.

Example 475 the method of example 474, wherein the implant includes an anchor coupled to the tether and anchored to the heart, and wherein withdrawing the tool, the stop, and the first portion of the tether includes withdrawing the tool, the stop, and the first portion of the tether from the subject while leaving the anchor anchored to the heart.

Example 476 the method of any of examples 474-475, wherein the retainer includes a chamber and an opening to the chamber, the cutter is disposed at the opening, and securing the stop includes advancing the stop through the cutter and the opening and into the chamber.

Example 477 the method of example 476, wherein securing the stopper includes using the cutter to prevent the stopper from exiting the chamber via the opening.

Example 478 the method of example 477, wherein using the cutter to prevent the stop from exiting the chamber via the opening comprises actuating the cutter to block the opening.

Example 479 the method of example 478, wherein actuating the cutter to occlude the opening comprises moving a blade of the cutter to occlude the opening, and wherein cutting the tether comprises cutting the tether with the blade by further moving the blade of the cutter.

Example 480 the method of any of examples 474-479, wherein the implant is disposed inside the heart, and transluminally advancing the elongate tool to the implant comprises transluminally advancing the elongate tool to the implant disposed inside the heart.

Example 481 the method of example 480, wherein the implant is an annuloplasty implant coupled to an annulus of a valve of the heart, and transluminally advancing the elongate tool to the implant comprises transluminally advancing the elongate tool to the annuloplasty implant coupled to the annulus.

Example 482. The method of example 481, further comprising, after relieving the tension on the tether, deploying a prosthetic valve within the annulus of the valve of the heart.

Example 483 the method of example 481, wherein the annuloplasty implant extends in a path at least partially surrounding the annulus and is coupled to the annulus at a plurality of locations along the path, and transluminally advancing the elongate tool to the implant comprises transluminally advancing the elongate tool to the annuloplasty implant extending in the path at least partially surrounding the annulus and being coupled to the annulus at the plurality of locations along the path.

The method of any of examples 484-483, wherein the implant includes an anchor slidably coupled to the tether and anchored to the heart, the stop to lock the tension in the tether by preventing the first portion of the tether from sliding relative to the anchor, and the transluminally advancing the elongate tool to the implant includes transluminally advancing the elongate tool to the implant including the anchor slidably coupled to the tether and anchored to the heart, the implant to lock the stop to the tension in the tether by preventing the first portion of the tether from sliding relative to the anchor.

The method of example 485, wherein the stop prevents the first portion of the tether from sliding relative to the anchor by the stop abutting the anchor, and transluminally advancing the elongate tool to the implant comprises transluminally advancing the elongate tool to the implant, wherein the stop prevents the first portion of the tether from sliding relative to the anchor by the stop abutting the anchor.

Example 486 the method of example 484, wherein cutting the tether includes cutting the tether between the stop and the anchor.

Example 487 the method of example 486, wherein: (i) relieving the tension on the tether by cutting the tether comprises cutting the tether such that the cutting forms a first cut end and a second cut end of the tether, and the second portion of the tether pulls the second cut end away from the cutter and past the anchor, (ii) withdrawing the first portion of the tether comprises withdrawing the first portion of the tether along with the first cut end, and (iii) leaving the second portion of the tether comprises leaving the second portion of the tether along with the second cut end.

Example 488 the method of example 487, wherein: (i) the anchor is a first anchor, (ii) the implant includes a second anchor slidably coupled to the tether and anchored to the heart, and (iii) cutting the tether includes cutting the tether such that the second portion of the tether pulls the second cutting end away from the cutter, past the first anchor, but not past the second anchor.

Example 489 the method of example 487, wherein cutting the tether such that the second portion of the tether pulls the second cut end away from the cutter and past the anchor includes cutting the tether such that the second portion of the tether separates the anchor from the tether by pulling the second cut end away from the cutter and past the anchor.

Example 490 the method of example 489, wherein: (i) The anchor is slidably coupled to the tether through an eyelet of the anchor threaded onto the tether, and (ii) cutting the tether such that the second portion of the tether separates the anchor from the tether includes cutting the tether such that the second portion of the tether drills out of the anchor from the tether by pulling the second cutting end away from the cutter and through the eyelet.

Example 491, a method, comprising: (A) Transluminally advancing an elongate tool to a tether under tension and disposed within a heart of a subject, the elongate tool comprising a holder and a cutter; (B) Securing a first portion of the tether to the retainer; and (C) while the first portion of the tether remains secured to the retainer: (i) Releasing the tension on the tether by cutting the tether with the cutter, thereby separating the first portion of the tether from the second portion of the tether; and (ii) withdrawing the tool and the first portion of the tether from the subject while leaving the second portion of the tether coupled to the heart.

Example 492 the method of example 491, wherein the first portion of the tether comprises a knot that locks the tension in the tether, and wherein withdrawing the first portion of the tether comprises withdrawing the knot from the subject.

Example 493 the method of example 491, wherein the first portion of the tether has the stop locked thereto, the stop locking the tension in the tether, and wherein withdrawing the first portion of the tether comprises withdrawing the stop from the subject.

The method of any of examples 491-493, wherein said tether is coupled to an anchor that is anchored to said heart, and wherein withdrawing said tool and said first portion of said tether comprises withdrawing said tool and said first portion of said tether from said subject while leaving said anchor anchored to said heart.

Example 495 an apparatus comprising a tissue anchor, the anchor comprising: (A) A swivel joint defining a hinge axis; (B) a first arm defining: (i) A first coupling, and (ii) a first hook, the first hook curving about and away from the hinge axis, terminating in a first tip, the curvature of the first hook being in a first direction about the hinge axis; and (C) a second arm hingedly coupled to the first arm via the swivel joint and defining: (i) A second coupling, and (ii) a second hook, the second hook curving about and away from the hinge axis, terminating in a second tip, the curvature of the second hook in a second direction about the hinge axis, the second direction being opposite the first direction; and wherein the articulation of the second arm to the first arm is coupled such that the anchor is transitionable between: (1) an open state in which: (a) The first arm is in a first rotational position about the hinge axis; (b) The first and second hooks defining a space therebetween, (c) the first and second tips defining a gap therebetween into the space, and (d) the first and second coupling members being separated from one another, and (2) a closed state in which: (a) The first arm is in a second rotational position about the hinge axis; (b) the gap is smaller than in the open state; and (c) the first and second couplings engage one another, the engagement between the first and second couplings preventing the anchor from transitioning out of the closed state.

Example 496 the apparatus of example 495, wherein, for each of the first hook and the second hook, a radius of curvature of the hook increases with distance from the swivel joint.

Example 497 the device of any one of examples 495-496, wherein in the closed state, the first tip and the second tip face away from each other.

The apparatus of any of examples 495-496, wherein the anchor further comprises a spring configured to bias the first arm about the articulation axis toward a given rotational position.

Example 499 the device of example 498, wherein said spring is configured to bias the lock toward said closed state.

Example 500 the apparatus of example 498, wherein said spring is a torsion spring.

Example 501 the apparatus of example 500, wherein the swivel joint includes a pin extending through the first arm and the second arm, and wherein the torsion spring is mounted on the pin.

Example 502 the apparatus of any one of examples 495-501, wherein: (I) the first arm defines a first beam, (ii) the second arm defines a second beam, and (iii) the swivel joint is disposed between the first beam and the first hook and between the second beam and the second hook such that the first arm is a class I lever whose fulcrum is the swivel joint.

Example 503 the apparatus of example 502, wherein the anchor is a class I double lever whose fulcrum is the swivel joint.

Example 504 the apparatus of example 502, wherein the anchor is transitionable from the open state toward the closed state by driving the first beam about the articulation axis.

Example 505 the apparatus of example 504, wherein the anchor is transitionable from the open state toward the closed state by increasing an alignment between the first beam and the second beam.

Example 506 the apparatus of example 505, wherein: (i) the first coupling is disposed on the first beam, (ii) the second coupling is disposed on the second beam, and (iii) the hinged coupling of the second arm to the first arm is such that the anchor is transitionable to the closed state by aligning the first beam with the second beam such that the first coupling and the second coupling responsively engage each other.

Example 507 the apparatus of example 506, wherein the first coupling includes a protrusion and the second coupling includes a recess.

Example 508, an apparatus for use with tissue of a heart, the apparatus comprising: (a) a tether; and (B) a tissue anchor, the tissue anchor comprising: (i) a core, (ii) an arm, (iii) a hinge, the arm being coupled to a distal end of the core via the hinge, and (iv) a head coupled to a proximal portion of the core, the tether being slidably coupled to the head, and the core having an intermediate portion between the distal end and the proximal portion; and wherein: the anchor may be anchored into the tissue by sequentially advancing a first side of the arm, the hinge, and the intermediate portion of the core into the tissue such that the core extends from the distal end within the tissue and the hinge to the proximal portion above the tissue, (2) the arm may be pivoted within the tissue about the hinge such that the anchor may transition within the tissue toward a constrained state in which the arm extends laterally across the distal end of the core, and (3) the head is configured to sandwich the tissue between the arm and the head by moving distally along the core toward the hinge.

Example 509 the apparatus of example 508, further comprising a hollow needle, wherein: (i) the needle has a sharpened tip configured to penetrate into the tissue, (ii) the arm is configured to be delivered into the tissue within the needle, (iii) the core is biased to bend automatically upon deployment from the needle within the tissue, and (iv) the needle is configured to prevent the bending of the core when the core is disposed within the needle.

Example 510 the device of any of examples 508-509, wherein the arm has a second side, the hinge is coupled to the arm between the first side and the second side such that transition of the anchor toward the constrained state pivots the arm relative to the stem within the tissue such that the first side of the arm moves proximally relative to the stem and the second side of the arm moves distally relative to the stem.

Example 511 the device of example 510, wherein the anchor is configured to automatically transition toward the constrained state upon application of a proximal pulling force to the core when the arm is disposed within the tissue.

Example 512 the apparatus of example 511, wherein the second side measured between a top end of the second side and the hinge is longer than the first side measured between a top end of the first side and the hinge.

Example 513 the apparatus of example 511, wherein the second side has an eccentric tip.

Example 514 the apparatus of example 513, wherein the eccentric tip is sharp.

Example 515 the device of example 513, wherein the first side has a centered top end.

Example 516 the apparatus of example 515, wherein the centering tip is sharp.

Example 517 the apparatus of example 510, further comprising a retrieval line coupled to the second side in a manner that: wherein proximal pulling of the retrieval wire transitions the anchor away from the constrained state by pivoting the arm relative to the mandrel within the tissue such that the first side of the arm moves distally relative to the mandrel and the second side of the arm moves proximally relative to the mandrel.

The device of example 518, further comprising a tube distally advanceable over and along the retrieval line and the core, and wherein the anchor is configured to be de-anchored from the tissue by pulling the retrieval line, the core, and the second side of the arm into the tube.

Example 519 the device of example 517, wherein the retrieval line is detachable from the anchor in vivo.

Example 520. A method for implanting an implant into tissue of a heart of a subject, the method comprising: (A) Introducing a tissue anchor into a subject, the tissue anchor comprising a core, a head, an arm, and a hinge, the head coupled to a proximal portion of the core, the arm coupled to the core via the hinge, the core having an intermediate portion between a distal end and the proximal portion, (B) transluminally advancing the anchor along a tether toward the heart, wherein the head slides on the tether; (C) Advancing the first side of the arm, the hinge, and the intermediate portion of the core sequentially into the tissue such that a proximal portion of the core extends over the tissue; (D) Transitioning the anchor within the tissue toward a constrained state by pivoting the arm about the hinge such that the arm extends laterally across the distal end of the core; and (E) subsequently sandwiching the tissue between the arm and the head by moving the head distally along the stem toward the hinge.

Example 521 the method of example 520, further comprising advancing a needle having a sharpened tip into the tissue, wherein advancing the first end of the arm, the hinge, and the intermediate portion of the core rod into the tissue comprises sequentially advancing the first end of the arm, the hinge, and the intermediate portion of the core rod out of the needle and into the tissue.

Example 522 the method of any of examples 520-521, wherein advancing the first side of the arm into the tissue comprises advancing the first side of the arm into an annulus of an atrioventricular valve of the heart when the arm is disposed alongside the annulus substantially orthogonal to a coronary artery.

Example 523 the method of example 522, wherein pivoting the arm about the hinge includes pivoting the arm about the hinge such that the arm becomes substantially parallel with the coronary artery.

The method of any of examples 520-523, wherein the arm has a second side, the hinge is coupled to the arm between the first side and the second side, and wherein transitioning the anchor toward the hold state includes pivoting the arm relative to the core rod within the tissue such that the first side of the arm moves proximally relative to the core rod and the second side of the arm moves distally relative to the core rod.

Example 525 the method of example 524, wherein pivoting the arm about the hinge includes pivoting the arm about the hinge when a retrieval line is coupled to the second side, and wherein the method further comprises subsequently separating the retrieval line from the anchor in vivo.

Example 526 the method of example 524, wherein pivoting the arm relative to the core includes applying a proximal pulling force to the core such that the anchor automatically transitions toward the constrained state.

Example 527 the method of example 526, wherein the second side measured between the tip of the second side and the hinge is longer than the first side measured between the tip of the first side and the hinge, and wherein pivoting the arm relative to the stem comprises applying a proximal pulling force to the stem such that interaction between the tissue and the longer second side pivots the arm relative to the stem.

Example 528 the method of example 526, wherein the second side has an eccentric tip, and wherein pivoting the arm relative to the mandrel comprises applying a proximal pulling force to the mandrel such that interaction between the tissue and the eccentric tip side pivots the arm relative to the mandrel.

Example 529 the method of example 528, wherein the first side of the arm has a centered tip, and wherein advancing the first side of the arm into the tissue comprises penetrating the tissue with the centered tip.

Example 530 the method of example 524, further comprising de-anchoring the anchor from the tissue by: (i) Pivoting the arm relative to the stem by pulling proximally on a retrieval wire coupled to the second side such that, within the tissue, the first side of the arm moves distally relative to the stem and the second side of the arm moves proximally relative to the stem; and (ii) subsequently, pulling the arm (first second side) out of the tissue.

Example 531 the method of example 530, further comprising advancing a tube over and along the retrieval line and the core bar, wherein pulling the arm out of the tissue comprises pulling the arm (first second side) into the tube and out of the tissue.

Example 532 an implant, comprising: (a) a tether; (B) A first anchor and a second anchor, each of the first anchor and the second anchor comprising: (i) A head slidably coupled to the tether, and (ii) a tissue-engaging element configured to anchor the anchor and the tether to the tissue; and (C) a tubular spacer defining a lumen along a spacer axis and having: (i) A primary region, the primary region being flexible in deflection; and (ii) a secondary region at each end of the primary region, the secondary region being less flexible than the primary region in terms of deflection, the lumen extending through the primary region and both secondary regions; and wherein the tubular spacer is threaded onto the tether between the first anchor and the second anchor by the tether passing through the lumen.

Example 533. The implant of example 532, wherein said primary region is elastically flexible in terms of deflection.

Example 534 the implant of any of examples 532-533, wherein the primary region resists axial compression.

Example 535 the implant of example 534, wherein each of the secondary regions is more resistant to axial compression than the primary region.

Example 536 the implant of any one of examples 532-535, wherein each of the secondary regions is shorter than the primary region.

Example 537 the implant of example 536, wherein the combined length of both of the secondary regions is shorter than the primary region.

Example 538 the implant of example 536, wherein each of the secondary regions is 30% less in length than the primary region.

Example 539 the implant of example 538, wherein each of the secondary regions is 20% less in length than the primary region.

Example 540 the implant of example 539, wherein each of the secondary regions is 10% smaller in length than the primary region.

Example 541 the implant of example 540, wherein each of the secondary regions has a length that is at least 2% of the primary region.

Example 542 the implant of example 540, wherein each of the secondary regions has a length that is at least 5% of the primary region.

Example 543 the implant of any one of examples 532-542, wherein the spacer comprises a helical coil extending along the main region.

Example 544 the implant of example 543, wherein the helical coil comprises a wire coiled to form the helical coil, and wherein the wire has a core comprising a radiopaque material.

Example 545 the implant of example 544, wherein the wire comprises a cobalt-chromium alloy, and wherein the core comprises platinum.

Example 546 the implant of example 543, wherein the coil extends into the secondary region.

Example 547 the implant of example 543, wherein the helical coil comprises a wire coiled to form the helical coil, the wire having a wire thickness, and wherein in a rest state of the helical coil, the helical coil has a pitch of 1.4-2 times the wire thickness.

Example 548 the implant of example 547, wherein in said at rest state said pitch of said helical coil is 1.6-1.8 times said wire thickness.

Example 549 the implant of example 543, wherein the spacer comprises a rigid ring coupled to the end of the helical coil at each of the secondary regions.

Example 550 the implant of example 549, wherein the helical coil comprises a wire coiled to form the helical coil, the wire having a wire thickness, and wherein each of the loops has a length along the spacer axis that is at least twice the wire thickness.

Example 551. The implant of example 549, wherein each of the loops is disposed at least partially inside the helical coil.

Example 552 the implant of example 549, wherein each of the rings has a flange disposed outside of the helical coil, the flange providing a bearing surface configured to facilitate sliding of the tether thereagainst.

Example 553 a system for use with an object, the system comprising: (A) A delivery tool percutaneously advanceable into the subject and having a lumen; and (B) a stopper, the stopper comprising: (i) A first element comprising a first plate defining a first passage therethrough; (ii) A second element comprising a second plate defining a second passage therethrough; and (iii) a torsion bar connecting the first plate to the second plate in the following manner: (a) The torsion bar biases the stop toward a clamped state in which the first and second passages are offset relative to one another, and (b) the stop is sized such that when the stop is disposed in the cavity, the delivery tool holds the stop in an open state to which the stop can be transitioned by increasing stress on the torsion bar and alignment between the first and second passages.

The system of example 554, wherein in both the clamped state and the open state, both the first passageway and the second passageway are parallel with the torsion bar.

Example 555 the system of any of examples 553-554, wherein: (i) The cavity is defined by an inner surface of the delivery tool, and (ii) the stop is sized to be disposed within the cavity in a manner that the first and second plates are disposed within the cavity, wherein the inner surface retains the stop in the open state by pressing against the first and second plates.

Example 556. The system of example 555, wherein: (i) The inner surface pressing against the first plate and the second state resists torsional destressing of the torsion bar when the stop is disposed within the cavity, and (ii) the stop is configured to transition toward the clamped state by torsional destressing of the torsion bar moving the first plate relative to the second plate in response to ejection from the cavity.

Example 557 the system of example 555, wherein: (i) In the open state of the stop, the stop defines a central longitudinal axis passing through a center of the first plate and a center of the second plate, and (ii) transition of the stop toward the clamped state shifts the center of at least one of the first plate and the second plate relative to the central longitudinal axis.

Example 558 the system of example 557, wherein in both the open state and the clamped state, the first passageway and the second passageway are both parallel to the longitudinal axis.

Example 559 the system of example 557, wherein in said clamped state, said first plate is not coaxial with said second plate.

Example 560. The system of example 557, wherein the delivery tool is a catheter.

Example 561 the system of any of examples 553-560, further comprising a tether, and wherein: (i) The alignment between the first passageway and the second passageway is sufficient for the tether to be slidable through the stopper when the stopper is in the open state, and (ii) the stopper transitions to the clamped state clamping the tether within the stopper when the tether is disposed past the stopper, thereby preventing the tether from sliding past the stopper.

Example 562 the system of example 561, wherein the system includes an implant including the tether, the implant being collapsible by applying tension to the tether, and wherein in the clamped state of the stop, the stop is configured to lock tension in the tether by clamping the tether.

The system of any of examples 553-562, wherein in the open state of the stop, the first element and the second element are aligned relative to one another such that the stop is cylindrical.

Example 564 the system of example 563, wherein in the clamped state, the first element is offset relative to the second element such that the stop is non-cylindrical.

Example 565, a system for use with an object, comprising: (a) a catheter device, the catheter device comprising: (i) A tube having a proximal opening and a distal opening, the distal opening configured to be transluminally advanced into the subject, and (ii) an extracorporeal unit comprising: a track leading to a deployed position, and a barrier movable between a closed state in which the barrier obstructs the proximal opening and an open state; (B) A first cartridge body holding a first anchor and coupled to the extracorporeal unit and movable along the track from a first initial position to the deployed position while remaining coupled to the extracorporeal unit such that: (i) The first cartridge body holds the first anchor opposite the proximal opening, and (ii) the barrier in the closed state; (C) A second cartridge body holding a second anchor and coupled to the extracorporeal unit and movable along the track from a second initial position to the deployed position while remaining coupled to the extracorporeal unit such that: (i) The second cartridge body holds the second anchor opposite the proximal opening, and (ii) the barrier in the closed state; and (D) an anchor driver, the anchor driver: (i) can be coupled to the first anchor while the first anchor is held by the first cartridge body opposite the proximal opening, (ii) can be configured to push the first anchor distally out of the first cartridge body, through the proximal opening, and through the tube when the barrier is in the open state, (iii) can then be coupled to the second anchor while the second anchor is held by the second cartridge body opposite the proximal opening, and (iv) can be configured to push the second anchor distally out of the second cartridge body, through the proximal opening, and through the tube toward the first anchor when the barrier is in the open state.

The system of example 565, wherein the driver is configured to push the first anchor distally out of the first cartridge body, through the proximal opening, and through the tube when: (i) the first cartridge body is in the deployed position, (ii) the barrier is in the open state, and (iii) the second cartridge body is held in the second initial position.

Example 567 the system of any of examples 565-566, wherein each of the first cartridge body and the second cartridge body is configured to lock to the extracorporeal unit upon reaching the deployed position.

The system of any of examples 565-567, wherein each of the first cartridge body and the second cartridge body is shaped to be grasped by a human operator with a hand and configured to be moved by the human operator with a hand along the track, and/or wherein each of the first cartridge body and the second cartridge body is removable from the deployed position by removal from the extracorporeal unit.

Example 569 the system of any of examples 565-568, further comprising a third cartridge body that holds a third anchor and is coupled to the extracorporeal unit and is movable along the track from a third initial position to the deployed position while remaining coupled to the extracorporeal unit such that the third cartridge body holds the third anchor opposite the proximal opening.

Example 570 the system of any of examples 565-569, wherein the first anchor comprises a first tissue-engaging element and a first head comprising a first eyelet, and the second anchor comprises a second tissue-engaging element and a second head comprising a second eyelet.

The system of example 571, further comprising a tether passing through the first aperture and the second aperture, the tether having a proximal portion including a proximal end of the tether and having a distal portion including a distal end of the tether, the distal end of the tether being distally advanceable through the tube into the subject while the proximal end of the tether remains external to the subject.

Example 572 the system of example 571, wherein the anchor driver is configured to push the first anchor distally out of the first cartridge body, through the proximal opening, and through the tube while the first aperture of the first anchor remains threaded on the tether, and wherein the anchor driver is configured to push the second anchor distally out of the second cartridge body, through the proximal opening, and through the tube while the second aperture of the second anchor remains threaded on the tether.

Example 573 the system of example 572, wherein the catheter device further comprises a tensioning device configured to maintain tension on the tether during advancement of the first anchor and advancement of the second anchor.

Example 574 the system of example 573, wherein the tensioning device comprises a spring and a spool coupled to the spring such that rotation of the spool in a first direction applies a stress to the spring, and wherein the proximal portion of the tether is wound around the spool such that distal advancement of the distal portion of the tether through the tube rotates the spool in the first direction.

Claims

1. A system for use with a subject, the system comprising an annuloplasty implant, the annuloplasty implant comprising:

a tether;

a series of anchors, each of the anchors comprising:

the head portion of the device is provided with a plurality of grooves,

a tissue-engaging element coupled to the head and extending away from the head to define a longitudinal axis of the anchor, an

An eyelet coupled to the head and disposed laterally from the longitudinal axis; and a stop secured to the tether in a manner that prevents sliding of the tether relative to the series of end anchors,

The annuloplasty implant is configured to be implanted along an annulus of a valve of the heart by screwing the tissue engagement element of each of the anchors into tissue of the annulus via torque applied to the head.

2. The system of claim 1, wherein for each of the anchors, the eyelet is pivotable over the head.

3. The system of claim 1, wherein for each of the anchors, the eyelet is metallic.

4. The system of claim 1, wherein for each of the anchors, the eyelet is rotatable about the head.

5. The system of claim 1, further comprising a driver that engages the head for each anchor in the series, the anchor being advanced transluminally to the heart and the tissue-engaging element being driven into the tissue by applying the torque to the head.

6. The system of claim 5, wherein for each of the anchors:

The tissue-engaging element extends distally away from the head,

the head defines an interface at a proximal side of the head, the driver is configured to engage the head at the interface, and

the eyelet is mounted on a collar that encircles the longitudinal axis between the hub and the tissue-engaging element.

7. The system of claim 5, wherein, for each of the anchors, the driver is configured to drive the tissue-engaging element into the tissue by applying the torque to the head without rotating the eyelet about the longitudinal axis.

8. The system of claim 1, wherein the annuloplasty implant further comprises a plurality of spacers threaded on the tether between the series of anchors and configured to prevent movement of the anchors toward each other along the tether.

9. The system of claim 8, wherein the spacer and the anchor alternate along the tether.

10. The system of claim 8, wherein each of the spacers is tubular.

11. The system of claim 8, wherein each of the spacers comprises a helical coil.

12. The system of claim 8, wherein each of the spacers is laterally flexible.

13. The system of claim 8, wherein each of the spacers is metallic.