CA3114776A1 - Steerable electrosurgical puncture device - Google Patents

Abstract

A puncturing device configured to create a puncture in a tissue having a maneuverable distal portion which is connected to a distal tip. A handle with an actuation mechanism is at the proximal portion of the puncturing device. The maneuverable distal portion is coupled to the actuation mechanism, where upon actuation of the actuation mechanism manipulates the maneuverable distal portion, thereby manipulating the distal tip of the puncturing device.

Description

Steerable Electrosurgical Puncture Device TECHNICAL FIELD
The disclosure relates to a steerable puncturing device configured to create a puncture in a tissue.
BACKGROUND OF THE ART
[0001] Certain medical procedures require the use of a medical device that can create punctures or channels through tissues of the heart. Specifically, puncturing the septum of a heart creates a direct route to the left atrium where numerous cardiology procedures take place. One such device that gains access to the left atrium is a transseptal puncturing device which, in some devices, delivers radiofrequency energy from a generator into the tissue to create the perforation. The user positions the puncturing device at a target location on the fossa ovalis located on the septum of the heart and turns the generator on to begin delivering energy to the target location. The delivery of radiofrequency energy to a tissue results in vaporization of the intracellular fluid of the cells which are in contact with the energy delivery device. Ultimately, this results in a void, hole, or channel at the target tissue site.

[0002] As the field of electrophysiology and interventional cardiology has developed, site-specific transseptal punctures have proven to be beneficial for completing various interventions on the left side of the heart, such as pulmonary vein isolation, left atrial appendage closure, and mitral valve repair.

[0003] Pulmonary vein isolation is used to treat atrial fibrillation which is an abnormal heart rhythm due to incorrect electrical impulses being fired. Atrial fibrillation results in the atria from contracting or effectively squeezing blood to the ventricles.
The incorrect electrical impulses tend to originate in the pulmonary veins; therefore, the goal of pulmonary vein isolation is to scar the tissue where the irregular signals are coming from.
Since the pulmonary veins are posterior structures in the left atrium, the specific location of the transseptal puncture on the fossa ovalis allow surgeons to create an optimal pathway for the catheters used during this procedure. Specifically, a puncture positioned more Date Recue/Date Received 2021-04-13 anteriorly on the fossa ovalis provides the most favourable approach. This site-specific puncture allows for a more efficient procedure.

[0004] Patient's with atrial fibrillation have an increased risk of forming blood clots;
in many cases, these clots are formed in the left atrial appendage which is a small, pouch-like sac in the left atrium, although it is unclear what function, if any, the left atrial appendage is performs. Blood will clot within the pouch and get released into the cardiovascular system. In order to prevent the buildup of blood, the left atrial appendage is closed using a variety of methods, some of which involve accessing the left atrium via a transseptal puncture. Since the left atrial appendage is located posteriorly, the positioning of the transseptal puncture may be used to aid in the delivery of the device into the atrium, allowing for a more efficient and effective procedure. More specifically, the puncture is ideally positioned more posteriorly on the fossa ovalis.

[0005] A site specific transseptal puncture is also beneficial for mitral valve repairs in order to treat mitral valve regurgitation. Mitral valve regurgitation occurs when the mitral valve leaflets do not close completely, resulting in blood flowing backwards or leaking into the atrium causing increased blood volume and pressure in the left atrium, which in severe cases, may lead to fluid build-up in the lungs. A mitral valve repair involves placing a clip within the mitral valve that clips together a portion of the leaflet. Proper positioning of the clip is important during this procedure. A site-specific transseptal puncture facilitates in positioning of the mitral clip, such that it enables the clip to reach the middle of the mitral valve; a puncture positioned posterior and slightly superior on the fossa ovalis is optimal.

[0006] In light of the advantages of site-specific puncturing during a transseptal puncture, there exists a need to provide a novel puncturing device to provide users with the ability to precisely control the distal tip (i.e., puncturing portion) of the device.
SUMMARY OF THE INVENTION
Date Recue/Date Received 2021-04-13

[0007] In one broad aspect of the invention, a puncturing device configured to create a puncture in a tissue comprises an elongate member having a proximal portion and a maneuverable distal portion. The proximal portion of the puncture device has a handle with an actuation mechanism. The maneuverable distal portion is connected to a distal tip which is configured to puncture tissue. The maneuverable distal portion is coupled to the actuation mechanism such that actuation of the actuation mechanism manipulates the distal portion of the puncturing device which manipulates the distal tip of the puncturing device.

[0008] As a feature of this aspect, the maneuverable distal portion may comprise a ball and socket joint. In some embodiments, the puncturing device may comprise at least one pull wire which is connected to the ball of the ball and socket joint and extends the length of the puncturing device such that the at least one pull wire is coupled to the actuation mechanism. In an alternative embodiment, the puncturing device may comprise a hydraulic system. The ball of the ball and socket joint may have at least one projection while the socket may have at least one hydraulic element such that the hydraulic element interacts with the projection. The hydraulic element may be a piston or an inflatable balloon which is connected to a lumen where fluid may be injected into, causing the hydraulic element to interact with the projection.

[0009] In another feature, the maneuverable distal portion comprises a plurality of cut-outs and at least one pull wire, connected to the distal portion, distal the plurality of cut-outs, and extending the length of the puncturing device such that the at least one pull wire is coupled to the actuation mechanism. In some embodiments, the plurality of cut-outs may comprise at least one of c-cuts, spiral shaped cuts, interrupted spiral cuts, interlocking cuts, and dove-tail cuts.

[0010] In another feature, the maneuverable distal portion comprises an inner tube with an inner tube cut-out portion and an outer tube with an outer tube cut-out portion. The inner tube cut-out portion and the outer tube cut-out portion align, reducing the stiffness of the distal portion, causing the distal portion to bias towards a direction. In some embodiments, Date Recue/Date Received 2021-04-13 the inner tube is coupled to the actuation mechanism, such that the inner tube is rotatable relative to the outer tube. In an alternative embodiment, the outer tube is coupled to the actuation mechanism, such that the outer tube is rotatable relative to the inner tube. In another embodiment, the inner tube and the outer tube may, both, be coupled to the actuation mechanism such that the inner tube and outer tube are rotatable.

[0011] In a further broad aspect, embodiments of the present invention comprise an assembly configured to create a puncture in tissue, comprising a dilator having a proximal portion and a distal portion with a lumen extending therebetween. The lumen in the proximal portion may have a larger diameter than the lumen in the distal portion, forming a shoulder. The puncturing device includes a proximal portion and a distal portion, ending in a distal tip. Forward pressure on the proximal portion of the puncturing device results in the puncturing device interacting with the shoulder of the dilator, creating a pivot point, deflecting the distal tip of the puncturing device. In some embodiments, the dilator may comprise a securing mechanism at the proximal portion, whereby the securing mechanism secures the puncturing device in a desired position. In some embodiments, the securing mechanism may be a thumb screw, a hemostasis valve, or may be a Tuohy-Borst adapter.

[0012] An exemplary method of accessing the left atrium of a patient using the present invention may include the following steps:
(i) gaining access to a vasculature;
(ii) advancing the steerable puncturing device to a target location of a septum of the heart;
(iii) manipulating the maneuverable distal portion of the puncturing device such that a distal tip, configured to puncture the septum, is at a desired position on the target location; and (iv) puncturing at the desired position on the target location, creating a site-specific puncture.
Date Recue/Date Received 2021-04-13 BRIEF DESCRIPTION OF THE DRAWING

[0013] In order that the invention may be readily understood, embodiments of the invention are illustrated by way of examples in the accompanying figures, in which:

[0014] Fig. 1 is an illustration of an exemplary system for a transseptal puncture.

[0015] Fig. 2a is an illustration of a cross-sectional view of a puncturing device with a maneuverable distal portion comprising of a ball and socket joint.

[0016] Fig. 2b is an illustration of a cross-sectional view of a puncturing device comprising a ball and socket joint with pull wires welded to the ball.

[0017] Fig. 2c is an illustration of a perspective view of the puncturing device comprising a ball and socket joint with pull wires welded directly to the ball.

[0018] Fig. 2d is an illustration of a top view of the puncturing device comprising a ball and socket joint with pull wires.

[0019] Fig. 3 is an illustration of cross-sectional view of a puncturing device with a ball and socket joint, movable using a hydraulic mechanism.

[0020] Fig. 4 is an illustration of a cross-sectional view of a puncturing device with a maneuverable distal portion where the distal portion comprises a plurality of cut-outs.

[0021] Fig. 5a is an illustration of a cross-sectional view of a puncturing device with a maneuverable distal portion where the distal portion comprises concentric tubes in a balanced configuration.

[0022] Fig. 5b is an illustration of a cross-sectional view taken along the line 5b in Fig.
5a, illustrating a balanced configuration.
Date Recue/Date Received 2021-04-13

[0023] Fig. 5c is an illustration of a cross-sectional view of a puncturing device with a maneuverable distal portion where the distal portion comprises concentric tubes in a biased configuration.

[0024] Fig. 5d is an illustration of a cross-sectional view taken along the line 5c in Fig.
5c, illustrating a biased configuration.

[0025] Fig. 6a is an illustration of a cross-sectional view of a dilator and a puncturing device where the dilator comprises a shoulder.

[0026] Fig. 6b is an illustration of a cross-sectional view of a dilator and a puncturing device where the puncturing device pivots as it interacts with the shoulder of the dilator.
DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS

[0027] Transseptal puncture is a routine procedure used to gain access to the left side of the heart. A transseptal puncture creates a pathway from the right atrium to the left atrium via the fossa ovalis, located on the septum. As the field of electrophysiology and interventional cardiology has evolved, the importance of site-specific transseptal punctures has emerged. Site-specific transseptal punctures have optimized various interventions such as pulmonary vein isolations, left atrial appendage closures, and mitral valve repairs. Thus, there exists a need for a steerable puncturing device which provides users with the ability to precisely control the puncturing portion such that site-specific transseptal punctures may be performed.

[0028] The inventors of the present invention have discovered systems and methods that attempt to overcome the limitations associated with prior art systems.
Specifically, the invention relates to a steerable puncturing device and method for creating a perforation in the atrial septum while using the curvature of the distal portion of the device to automatically stop the delivery of energy to the atrial septum upon completion of the puncture.
Date Recue/Date Received 2021-04-13

[0029] With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of certain embodiments of the present invention only. Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways.
Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

[0030] Figure 1 illustrates an embodiment of an exemplary system 100 that may be used during a transseptal puncture. The system 100 comprises a puncturing device 110, a dilator 120, a sheath 130, and an energy generator 140. The puncturing device 110, is configured to deliver energy to the tissue via an energy delivery device 112 positioned at the distal tip 114. The proximal portion of the puncturing device 110 ends in a handle 116 which connects to the generator 140 via a connector cable 150. The puncturing device 110 comprises a distal portion 118 which may be manipulated to allow users to control the position of the energy delivery device 112 on the fossa ovalis. The manipulation of the distal portion 118 may come from the puncturing device 110 itself, or it may be manipulated as it interacts with ancillary devices such as the dilator 120 or sheath 130.

[0031] An exemplary method of accessing the left atrium of a patient using the present invention may include the following steps:
(i) Gaining access to the vasculature, for example through the femoral vein or subclavian vein.
(ii) Advancing the puncturing device 110 and assembly (i.e., dilator 120 and sheath 130) to the target location of the fossa ovalis on the atrial septum.
Date Recue/Date Received 2021-04-13 (iii) Depending on the intervention being performed on the left side of the heart, the user may now manipulate the distal portion 118 of the puncturing device 110 to create a site-specific transseptal puncture on the fossa ovalis. For example, a mitral valve repair may involve a puncture which is posterior and slightly superior.
(iv) Once the user is satisfied with the puncture site, energy is delivered from the generator to the puncture device; the energy travels along the length of the puncture device 110 and is delivered to the tissue from the energy deliver device. This creates a pathway from the right atrium to the left atrium of the heart.

[0032] In one embodiment, the distal portion 118 may be controlled by the puncturing device 110 itself. For example, as seen in Figure 2a, the distal portion 118 of the puncturing device 110 may be constructed as a ball-and-socket joint 210. The ball-and-socket joint 210 may be manipulated through various means which will be discussed below. The puncturing device 110 comprises an elongate member which is coated in an insulative material 222 from the proximal portion (not show) to the distal portion 118, leaving an exposed distal tip in the form of an energy delivery device 112.
The puncturing device 110 may further include a lumen 216 extending the length of the puncturing device 110; in some embodiments, the ball 212 may include a lumen 217 which leads to outlet ports 218 to allow for the injection or aspiration of fluids during the procedure.

[0033] Figure 2b illustrates a cross-sectional view of the puncture device 110 including a ball-and-socket joint 210 which can be manipulated by pull wires 224. The pull wires 224 may be directly connected to the ball 212, extending along the length of the puncturing device 110 such that they may be controlled by the handle 116. For example, the handle 116 may comprise a system which converts a rotation to linear movement (not shown). Some mechanisms which may be employed can be found in current steerable medical devices, such as steerable sheaths. In some embodiments, this may be in the form Date Recue/Date Received 2021-04-13 of an actuator with one or more pull wires 224, and a means for deflecting the pull wires 224 by translating the actuation of the actuator into movement of the pull wires 224. The distal end of the pull wires 224 are coupled to the distal portion 118 of the puncturing device 110, such as coupled the ball 212. The pull wires 224 may be coupled to the ball 212 through welding. The proximal end (not shown) of the pull wires 242 are coupled to the means for deflecting the pull wires 242. In one embodiment, the actuator located on the handle 116 may comprise a rotational knob, whose rotational movement is converted into linear movement via a sliding assembly; in other words, the rotational knob is coupled to the linear sliding assembly which moves within the housing of the handle 116.
Rotating the knob will move the slide assembly such that the linear movement of the slide assembly is converted into deflection of the distal portion 118 via the pull wires 242.
Further details of this mechanism are disclosed in application number PCT/IB2017/058137 publication number W02018/116162, and are incorporated herein.

[0034] The ball 212, at the distal portion 219 of the puncture device 110, may be contained between extended arms 215, as shown in Figure 2c. The arms 215 act as the socket 214 of the ball-and-socket joint. Figure 2d illustrates a top view of the distal portion 219 of the puncture device 110. In this embodiment, the pull wires (not shown) which attach to the ball 212 can be inserted through the holes 225, where they may then extend the length of the puncture device 110 and connect to the control system to allow for actuation. In some embodiments, the holes 225 may be positioned in an alternating fashion between the extended arms 215 of the socket 214.

[0035] In alternative embodiments, the distal portion 118 may be manipulated using hydraulics. With reference now to Figure 3, the ball 212 may comprise at least two extension arms 310 positioned on opposite sides of the ball 212. The socket 214 comprises at least two inflatable features 312, positioned such that the inflatable features 312 may push against the extension arms 310, rotating the ball 212, which in turn rotates the distal portion 118. The inflatable features 312 are each connected to a lumen 314 that extends the length of the puncturing device 110. At the proximal end of the puncturing device, the Date Recue/Date Received 2021-04-13 handle 116 comprises a port (not shown) which connects to each lumen 314. A
fluid, such as saline may be injected into the lumen 314 via the port at the handle 116, this will cause the inflatable feature 312 to expand distally, pushing the extension arm 310 upwards which will cause the ball 212 to rotate. Similarly, if the fluid is withdrawn from the lumen 314, the inflatable feature 312 will deflate, causing the extension arm 310 to move downwards, as there is no longer a force pushing against it. The inflatable feature 312 may be a semi-compliant balloon or a piston such that when pressure is applied, the balloon or piston will expand to push against the extension arms 310, similarly when pressure is removed, the balloon or piston may deflate or retract.

[0036] The puncturing device 110 may be constructed of an electrically conductive material to provide the energy delivery device 112 with energy, creating a puncture at the target location. The puncturing device 110 may be composed of stainless steels, copper, titanium, and nickel-titanium alloys (for example, Nitinol ), amongst others.
Energy is delivered from the generator to the handle 116 of the puncturing device; the energy then travels along the conductive body to the energy delivery device at the distal tip and to the tissue. The ball 212 and socket 214 may be constructed of an electrically conductive material as well, with an electrically conductive lubricant provided between the ball 212 and socket 214 to ensure smooth movement of the distal portion 118. The shaft of the puncturing device 110 may be coated in an electrically insulating material to ensure energy is delivered to the energy delivery device 112 at the distal tip 114. The layer of insulation 222 may be one of many biocompatible dielectric materials, including, but not limited to, polytetrafluoroethylene (PTFE, Teflon ), parylene, polyimides, polyethylene, terephthalate (PET), polyether block amide (PEBAX ), and polyetheretherketone (PEEKTm), or any combinations thereof. The portion of the ball 212 not in contact with the socket may be coated in electrically insulating material, up to the distal portion 118 of the puncturing device, with an exposed distal tip 114, forming the energy delivery device 112.

[0037] Figure 4 illustrates an alternative embodiment of a puncturing device with a maneuverable distal portion 118. The distal portion 118 comprises a plurality of cuts 410 Date Recue/Date Received 2021-04-13 through its sidewall which may be made by various means, including laser cutting, into the electrically conductive elongate member. These cuts in the distal portion will create a portion of increased flexibility. Different configuration of cuts are possible, including c-cuts, spiral shaped cuts, interrupted spiral cuts, interlocking cuts, and dove-tail cuts. In some embodiments, the puncturing device 110 may be composed of stainless steels, copper, titanium, and nickel-titanium alloys (for example, Nitinol ), amongst others. The puncturing device 110 may comprise a layer of insulation 222 which may be one of many biocompatible dielectric materials, including, but not limited to, polytetrafluoroethylene (PTEEõ Teflon ), parylene, polyimides, polyethylene, terephthalate (PET), polyether block amide (PEBAX ), and polyetheretherketone (PEEKTm), or any combinations thereof In an alternative embodiment, the distal portion 118 may comprise of different kinds of tubing such as PEEK braids, woven plastics, or flexible plastics in order to provide flexibility instead of providing laser cuts in the distal portion 118. In these embodiments, the distal portion 118 may further comprise pull wires 224 which may be welded directly to the puncturing device 110, distal to the plurality of cuts 410. In an alternative embodiment, an o-ring may be connected to pull wires (not shown). The pull wires 224 may be operably coupled to an actuator in the handle to provide the user with the ability to control and manipulate the distal portion 118 of the puncturing device 110.
The handle may comprise a system which converts a rotation to linear movement (not shown).
Some mechanisms which may be employed can be found in current steerable medical devices, such as steerable sheaths. In some embodiments, this may be in the form of an actuator with one or more pull wires 224, and a means for deflecting the pull wires 224 by translating the actuation of the actuator into movement of the pull wires 224.
The distal end of the pull wires 224 are coupled to the distal portion 118 of the puncturing device 110, such as coupled to an o-ring or directly welded to the puncturing device 110.
The proximal end of the pull wires 224 are coupled to the means for deflecting the pull wires 224. In one embodiment, the actuator located on the handle may comprise a rotational knob, whose rotational movement is converted into linear movement via a sliding assembly;
in other words, the rotational knob is coupled to the linear sliding assembly which moves within Date Recue/Date Received 2021-04-13 the housing of the handle. Rotating the knob will move the slide assembly such that the linear movement of the slide assembly is converted into deflection of the distal portion 118 via the pull wires 224. In an alternative embodiment, this actuation method may be coupled with shape memory properties of the material to provide even more curvature to the needle.
For example, shape memory properties may be activated by using body temperature or bi-metallic stripes to control the macro-curvature of the needle, using pull-wires to provide the micro-movement of the distal tip.

[0038] With reference to Figure 5a ¨ 5d, an alternative embodiment of the present invention may comprise a puncturing device 110 comprising concentric tubes in order to .. control the curvature of the distal portion 118. The puncture device 110 comprises an inner tube 514 and an outer tube 512 which surrounds the inner tube 514. In some embodiments the inner 514 and outer tubes 512 are comprised of a conductive, biocompatible, material which is covered in a layer of insulation 222. For example, the inner 514 and outer tube 512 may be composed of stainless steels, copper, titanium, and nickel-titanium alloys (for example, Nitinol ), amongst others. The layer of insulation 222 may be one of many biocompatible dielectric materials, including, but not limited to, polytetrafluoroethylene (PTFE, Teflon ), parylene, polyimides, polyethylene, terephthalate (PET), polyether block amide (PEBAX ), and polyetheretherketone (PEEKTm), or any combinations thereof. The inner 514 and outer tube 512 each comprise a cut-out portion 510 located in the distal portion 518 of the puncture device 110. In some embodiments, the inner tube 514 ends in a puncturing tip which may comprise an energy delivery device 112. The inner tube 514 may comprise an inner lumen 516 which extends from the proximal portion of the device to the distal portion 118, ending in outlets 218 at the distal tip. In some embodiments, the inner tube 514 is rotatable within the outer tube 512. The inner tube 514 may be coupled to an actuation mechanism at the proximal end of the puncturing device 110. For example, this actuation mechanism may comprise a rotatable knob which, upon rotation, rotates the inner tube 514. In alternative embodiments, the outer tube 512 may be rotatable relative to the inner tube 514. In this embodiment, the outer tube 512 may be coupled to the actuation mechanism. In even further embodiments, both the inner tube 514 Date Recue/Date Received 2021-04-13 and outer tube 512 may be rotatable, independent of one another. Figure 5a illustrates the puncture device 110 in a balanced configuration, that is when the cut-out section 510 has the inner 514 and outer tube 512 are opposing one another, this can be seen in Figure 5b which illustrates the cross-sectional view of the cut-out portion. This configuration provides the distal portion 118 of the puncturing device 110 to have increased stiffness and allows the distal portion 118 be substantially straight. Figure 5c illustrates the puncture device 110 in a biased configuration, when the cut-out section 510 of both the inner 514 and outer tube 512 are aligned; a cross-sectional view of the cut-out portion 510 can be seen in Figure 5d. In this configuration, the stiffness of the distal portion 118 is decreased, which results in the distal portion 118 being curved such that the side of the puncturing device 110 which has the aligned cut-out 510 is in compression.

[0039] In some embodiments, ancillary devices may be used to manipulate and control the direction of the puncturing device. In one embodiment, the dilator 120 may comprise a shoulder 610 along the lumen within the distal portion 612 of the dilator. The shoulder 610 is created by decreasing the lumen 630 from a larger diameter to a smaller diameter, as illustrated in Figure 6a ¨ 6b. The dilator 120 may be comprised of a harder material, such as high-density polyethylene (HDPE) or a softer material, for example polyurethane or polyether block amide. The puncturing device 110 may be constructed from an electrically conductive material to provide the pathway for energy to be delivered from the generator to the distal tip (e.g., energy delivery device 112) of the puncturing device 110. The puncturing device 110, as seen in Figure 6a, is an elongate member comprised of materials such as stainless steels, copper, titanium, and nickel-titanium alloys (for example, Nitinol ), amongst others. This provides the puncturing device 110 with flexibility such that it can bend easily but still return to the original shape. The puncturing device 110 may further comprise a layer of insulation 222 which terminates at an energy delivery device 112 at the distal tip. In one embodiment, the puncturing device 110 may further include a lumen 216 which runs from the proximal end to the distal end, terminating at outlet ports 218. At the proximal end, the lumen 216 may connect to a side port to enable injection, withdrawal, or aspiration of fluids. The distal portion of the puncturing device 110 Date Recue/Date Received 2021-04-13 comprises a taper 620 as the diameter moves from a larger diameter to a smaller diameter.
With reference now to Figure 6b, the taper 620 of the puncturing device 110 interacts with the shoulder 610 of the dilator 120 to create a fulcrum or a pivot point;
during this interaction, the puncturing device 110 pivots and deflects, allowing the user to manipulate the puncturing tip 112. The more forward force applied to the puncturing device 110, the more the distal tip 112 will pivot. In some embodiments, at the proximal portion of the dilator 120, a mechanism may be provided to secure the puncturing device 110 in place once the correct pivot or deflection position has been achieved. This may comprise some type of mechanism to cinch the proximal end of the puncturing device 110, for example a thumb screw mechanism, hemostasis valve, or Tuohy-Borst adapter.

[0040] The embodiments of the invention described above are intended to be exemplary only. The scope of the invention is therefore intended to be limited solely by the scope of the appended claims.

[0041] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.

[0042] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or Date Recue/Date Received 2021-04-13 identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.
Date Recue/Date Received 2021-04-13

Claims (3)

We claim:
1) A puncturing device configured to create a puncture in a tissue comprising, an elongate member having a proximal portion and a maneuverable distal portion;
the proximal portion comprising a handle having an actuation mechanism;
the maneuverable distal portion connected to a distal tip configured to

1 0 puncture the tissue; and, the maneuverable distal portion coupled to the actuation mechanism;
whereby actuation of the actuation mechanism manipulates the maneuverable distal portion, thereby manipulating the distal tip of the puncturing device.
2) The puncturing device of claim 1, wherein the maneuverable distal portion comprises a ball and socket joint.

3) The puncturing device of claim 2, wherein at least one pull wire is connected to a ball of the ball and socket joint and extends a length of the puncturing device such that the at least one pull wire is coupled to the actuation mechanism.
2 5 4) The puncturing device of claim 1, wherein the actuation mechanism comprises a hydraulics system.
5) The puncturing device of claim 4, wherein a ball of the ball and socket joint comprises at least one projection and a socket of the ball and socket joint 3 0 comprises at least one hydraulic element that interacts with the at least one projection.
6) The puncturing device of claim 5, wherein the hydraulic element is a piston in a lumen whereby the piston extends and retracts from the lumen with the injection 3 5 of a fluid into the lumen.
7) The puncturing device of claim 5, wherein the hydraulic element is an inflatable balloon in a lumen, whereby the inflatable balloon inflates and deflates with the injection of a fluid into the lumen.

Date Recue/Date Received 2021-04-13 8) The puncturing device of claim 1, wherein the maneuverable distal portion comprises a plurality of cut-outs.
9) The puncturing device of claim 8, wherein at least one pull wire is connected to the distal portion, distal the plurality of cut-outs, and extend a length of the puncturing device such that the at least one pull wire is coupled to the actuation mechanism.
10) The puncturing device of claim 9, wherein the plurality of cut-outs comprises at least one of c-cuts, spiral shaped cuts, interrupted spiral cuts, interlocking cuts, and dove-tail cuts.
11) The puncturing device of claim 1, wherein the maneuverable distal portion comprises an inner tube comprising an inner tube cut-out portion and an outer tube comprising an outer tube cut-out portion.
12) The puncturing device of claim 11, wherein the inner tube cut-out portion and the outer tube cut-out portion align, thus reducing the stiffness of the distal portion, causing the distal portion to bias towards a direction.

13) The puncturing device of claim 12, wherein the inner tube is coupled to the actuation mechanism, such that the inner tube is rotatable relative to the outer tube.
2 5 14) The puncturing device of claim 12, wherein the outer tube is coupled to the actuation mechanism, such that the outer tube is rotatable relative to the inner tube.
15) The puncturing device of claim 12, wherein the outer tube and the inner tube are 3 0 coupled to the actuation mechanism, such that the outer tube and the inner tube are rotatable.
16) An assembly configured to create a puncture in a tissue comprising, a dilator having a proximal portion and a distal portion and a lumen 3 5 extending therebetween;
the lumen of the proximal portion of the dilator has a larger diameter than the lumen of the distal portion of the dilator, forming a shoulder; and, 4 0 a puncturing device having a proximal portion and a distal portion Date Recue/Date Received 2021-04-13 terminating in a distal tip;
whereby a forward pressure on the proximal portion of the puncturing device results the distal portion of the puncturing device to interact with the shoulder, creating a pivot point which results in a deflection of the distal tip;
17) The assembly of claim 16, wherein the dilator comprises a securing mechanism at the proximal portion whereby the securing mechanism secures the puncturing device in a desired position.
18) The assembly of claim 17, wherein the securing mechanism comprises a thumb screw mechanism.
19) The assembly of claim 17, wherein the securing mechanism comprises a hemostasis valve.
20) The assembly of claim 17, wherein the securing mechanism comprises a Tuohy-B orst adapter.

21) A method of accessing a left atrium of a heart using a steerable puncturing device comprising a maneuverable distal portion, the steps comprising, gaining access to a vasculature;

2 5 advancing the steerable puncturing device to a target location of a septum of the heart;
manipulating the maneuverable distal portion of the puncturing device such that a distal tip, configured to puncture the septum, is at a desired position on the target location; and

3 0 puncturing at the desired position on the target location, creating a site-specific puncture.
Date Recue/Date Received 2021-04-13