CN116158894A - Valve prosthesis conveying device and valve prosthesis system - Google Patents

Abstract

The embodiment of the application relates to the technical field of medical devices, in particular to a conveying device of a valve prosthesis, which comprises: a sheath, a catheter assembly, and an inner core assembly; the sheath tube is sleeved at the distal end of the inner core assembly and fixedly connected with the inner core assembly, and is used for binding the valve prosthesis in a compressed state; the catheter assembly is movably sleeved on the inner core assembly, the distal end of the catheter assembly is positioned in the sheath tube, and the distal end of the catheter assembly is used for loading the valve prosthesis in a compressed state; the conveying device is configured to: the inner core assembly is urged to move the sheath distally relative to the catheter assembly to release the valve prosthesis in a compressed state. The valve prosthesis conveying device and the valve prosthesis system can convey the valve prosthesis with a special structure to a target position of a human body and release the valve prosthesis.

Description

Valve prosthesis conveying device and valve prosthesis system

Technical Field

The embodiment of the application relates to the technical field of medical devices, in particular to a conveying device of a valve prosthesis and a valve prosthesis system.

Background

Mitral insufficiency (Mitral Regurgitation: MR) is the most common valve disorder, with a incidence of about 1.7% in the general population. Severe MR will severely impair cardiac function, increase the risk of heart failure, severely threatening health and longevity.

The main treatment modality for traditional severe MR patients is mitral valve repair/replacement under extracorporeal circulation, i.e. repair of the mitral valve by open chest surgery or replacement of the native mitral valve with a prosthetic valve prosthesis. The mitral valve repair/replacement technology under the extracorporeal circulation is mature, the effect is definite, but the risk is high and the death rate is high for the aged, the patients with serious cardiac insufficiency or serious complications, and the treatment mode is not easy to adopt.

Transcatheter mitral valve replacement (Transcatheter Mitral Valve Replacement, TMVR) is a minimally invasive valve replacement technique emerging in recent years. The technology conveys the valve prosthesis to a target position through a cardiac apex or femoral artery and the like, then releases the valve to realize the replacement of the native mitral valve, thereby avoiding the traumatic operation such as sternal cleavage, extracorporeal circulation and the like. Therefore, TMVR has low risk, less trauma and fast healing, provides treatment opportunities for replacement valves for advanced high-risk MR patients, reduces the degree of regurgitation and avoids heart failure, thereby benefiting advanced high-risk MR patients.

However, the existing delivery devices for delivering valve prostheses have a number of problems, such as being not applicable to delivering valve prostheses having particular configurations (e.g., having an epitaxial connector structure, a double stent structure). Accordingly, there is a need to provide a new valve prosthesis delivery device and valve prosthesis system.

Disclosure of Invention

It is an aim of embodiments of the present application to provide a delivery device and a valve prosthesis system for delivering and releasing a valve prosthesis having a specific structure to a target site of the human body.

To solve the above-mentioned problems, embodiments of the present application provide a delivery device for a valve prosthesis, including: a sheath, a catheter assembly, and an inner core assembly; the sheath tube is sleeved at the far end of the inner core assembly and fixedly connected with the inner core assembly, and the sheath tube is used for binding the valve prosthesis in a compressed state; the catheter assembly is movably sleeved on the inner core assembly, the distal end of the catheter assembly is positioned in the sheath tube, and the distal end of the catheter assembly is used for loading the valve prosthesis in a compressed state; the delivery device is configured to: the inner core assembly is urged to move the sheath distally relative to the catheter assembly to release the valve prosthesis in a compressed state.

In addition, embodiments of the present application also provide a valve prosthesis system, comprising: the valve prosthesis and the conveying device are sleeved on the catheter assembly in a compressed state, and one part of the valve prosthesis is positioned in the sheath tube, and the other part of the valve prosthesis is positioned outside the sheath tube.

The embodiment of the application provides a delivery device of valve prosthesis and valve prosthesis system, includes: a sheath, a catheter assembly, and an inner core assembly; the sheath tube is sleeved at the far end of the inner core assembly and fixedly connected with the inner core assembly, and the sheath tube is used for binding the valve prosthesis in a compressed state; the catheter assembly is movably sleeved on the inner core assembly, the distal end of the catheter assembly is positioned in the sheath tube, and the distal end of the catheter assembly is used for loading the valve prosthesis in a compressed state; the delivery device is configured to: the inner core assembly is urged to move the sheath distally relative to the catheter assembly to release the valve prosthesis in a compressed state. In this way, after the valve prosthesis loaded on the distal end of the catheter assembly is delivered to a target position of a human body (i.e. a position where the valve prosthesis is required to be released in the human body) by using the delivery device, the inner core assembly can be driven to drive the sheath tube to move distally relative to the catheter assembly so as to release the valve prosthesis in a compressed state, so that interference between the sheath tube and a special structure (such as an epitaxial connector structure and a double-layer bracket structure) of the valve prosthesis in the process of releasing the valve prosthesis by using the delivery device can be avoided, and further, the valve prosthesis with the special structure is delivered to the target position of the human body and released.

In addition, the catheter assembly includes: the valve prosthesis comprises a sleeve and a guide block fixed with the distal end of the sleeve, wherein the sleeve and the guide block are sleeved on the inner core assembly, the distal end of the sleeve is used for loading the valve prosthesis in a compressed state, and the guide block is accommodated in the sheath tube and used for guiding the sleeve to axially move.

In addition, the conveying device further comprises: a handle assembly axially relatively stationary with the core assembly or fixed with a proximal end of the core assembly, the handle assembly for driving movement of the core assembly; the catheter assembly is located between the distal end of the core assembly and the handle assembly.

In addition, the handle assembly includes: a housing for gripping by an operator, and a collet secured to the housing for securing or maintaining axially relative stationary relation to the proximal end of the core assembly.

In addition, the shell is of a hollow structure, a groove is formed in the shell, the clamping head is clamped in the groove, and the clamping head is sleeved and fixed at the proximal end of the inner core assembly.

In addition, the catheter assembly includes: the valve prosthesis comprises a middle steel tube and a wire guide tube fixed at the proximal end of the middle steel tube, wherein the middle steel tube and the wire guide tube are sleeved on the inner core assembly, the distal end of the middle steel tube is used for loading the valve prosthesis in a compressed state, the wire guide tube is positioned at the proximal end of the sheath tube, a first cavity which penetrates through the wire guide tube axially is formed in the circumferential direction of the wire guide tube, and the first cavity is used for accommodating a guide wire.

In addition, the guide wire tube is provided with a second cavity which penetrates through the guide wire tube in the axial direction, and the proximal end part of the middle steel tube is accommodated in the second cavity and fixed with the guide wire tube.

In addition, the inner core assembly comprises an inner core tube and an inner steel tube, the inner core tube is located at the distal end of the inner steel tube, at least part of the distal end of the inner core tube is accommodated in the sheath tube, and the diameter of the inner core tube is smaller than that of the inner steel tube.

In addition, the valve prosthesis comprises: the connecting piece is positioned outside the sheath tube and extends from the proximal end to the distal end of the main body part.

In addition, the valve prosthesis further comprises: at least one support for positioning outside of the native leaflet or chordae tendineae, constraining radial expansion of the body portion to grip the native leaflet or chordae tendineae with the body portion; the connector is connected with the support to connect the support with the main body.

In addition, the supporting piece is a hollow elastic piece and is arc-shaped in a natural state, and a general closed loop is formed by the connecting piece; the connecting piece comprises two hollow short rods and a connecting body connected with the main body part and the two short rods; the number of the supporting pieces is the same as that of the connecting pieces, and two ends of each supporting piece are respectively sleeved on one short rod.

In addition, the valve prosthesis system further comprises: a guide wire; the catheter assembly includes: the guide wire tube is circumferentially provided with at least two first channels penetrating axially, and the first channels are used for accommodating guide wires; one guide wire is matched with the two first cavities, the two short rods and one supporting piece, and the guide wire is used for guiding the two short rods to be sleeved with one supporting piece.

Drawings

Fig. 1 is a schematic view of a conveying device according to a first embodiment of the present disclosure;

FIG. 2 is a schematic view of the portion A of FIG. 1 in partial enlarged view and with the sheath in perspective;

FIG. 3 is a schematic view of a sheath and core assembly according to an embodiment of the present disclosure;

FIG. 4 is a schematic view of a partial structure of a catheter assembly according to an embodiment of the present application;

FIG. 5 is a cross-sectional view of a housing structure according to an embodiment of the present disclosure after being disassembled;

FIG. 6 is a schematic view of a partial structure of a guidewire tube according to an embodiment of the present disclosure;

FIG. 7 is a schematic view of a distal portion of a valve prosthesis system provided in accordance with a second embodiment of the present application;

FIG. 8 is a cross-sectional view of a distal portion of a valve prosthesis system provided in accordance with a second embodiment of the present application;

FIG. 9 is a schematic view of a main body portion and a connector of a valve prosthesis according to a second embodiment of the present disclosure;

fig. 10 is a schematic view of a support for a valve prosthesis according to a second embodiment of the present application.

Detailed Description

Those of ordinary skill in the art will understand that in various embodiments of the present application, numerous technical details are set forth in order to provide a better understanding of the present application. However, the technical means claimed in the present application can be realized based on various changes and modifications of the following embodiments.

In various embodiments of the present application, "proximal" refers to the end that is closer to the operator, farther from the patient; accordingly, "distal" refers to the end that is closer to the patient, farther from the operator.

The embodiment of the application provides a delivery device of valve prosthesis and valve prosthesis system, includes: a sheath, a catheter assembly, and an inner core assembly; the sheath tube is sleeved at the distal end of the inner core assembly and fixedly connected with the inner core assembly, and is used for binding the valve prosthesis in a compressed state; the catheter assembly is movably sleeved on the inner core assembly, the distal end of the catheter assembly is positioned in the sheath tube, and the distal end of the catheter assembly is used for loading the valve prosthesis in a compressed state; the conveying device is configured to: the inner core assembly is urged to move the sheath distally relative to the catheter assembly to release the valve prosthesis in a compressed state. In this way, after the valve prosthesis loaded on the distal end of the catheter assembly is conveyed to the target position of the human body by the conveying device, the inner core assembly can be driven to drive the sheath tube to move distally relative to the catheter assembly so as to release the valve prosthesis in a compressed state, so that interference between the sheath tube and a special structure (such as an epitaxial connector structure and a double-layer bracket structure) of the valve prosthesis in the process of releasing the valve prosthesis by the conveying device can be avoided, and further, the valve prosthesis with the special structure is conveyed to the target position of the human body and released.

The valve prosthesis comprises a compressed state and a released state, the radial dimension of at least a portion of the valve prosthesis in the compressed state being smaller than the radial dimension of the valve prosthesis in the released state. When the valve prosthesis is required to be conveyed to a target position of a human body, the valve prosthesis is required to be set into a compressed state; after the valve prosthesis is delivered to the target position of the human body, the valve prosthesis is required to be converted into a release state from a compression state by a balloon or a self-expansion mode, so as to realize fixation with the native valve.

For the purposes of making the objects, technical solutions and advantages of the embodiments of the present application more apparent, the following detailed description of each embodiment of the present application will be given with reference to the accompanying drawings.

Referring to fig. 1 and 2, a valve prosthesis delivery device 100 according to an embodiment of the present application includes: sheath 110, catheter assembly 120, and core assembly 130; sheath 110 is sleeved on the distal end of inner core assembly 130, and sheath 110 is fixedly connected with inner core assembly 130, sheath 110 is used for binding the valve prosthesis in a compressed state; the catheter assembly 120 is movably sleeved on the core assembly 130, and the distal end of the catheter assembly 120 is positioned in the sheath 110, and the distal end of the catheter assembly 120 is used for loading the valve prosthesis in a compressed state; the conveying apparatus 100 is configured to: the inner core assembly 130 is urged to move the sheath 110 distally relative to the catheter assembly 120 to release the valve prosthesis in a compressed state.

During operation, the valve prosthesis is compressed and then loaded at the distal end of the catheter assembly 120, the sheath 110 is constrained to the valve prosthesis in a compressed state, and then the valve prosthesis is conveyed to a target position of a human body through a route such as the apex of the heart or the atrial septum by using the conveying device 100 provided by the embodiment of the application; after the delivery device 100 is used to deliver the valve prosthesis to the target site of the human body, the inner core assembly 130 is driven to move the sheath 110 distally relative to the catheter assembly 120 so that the valve prosthesis is released from the sheath 110, thereby releasing the valve prosthesis with a specific structure. Among them, valve prostheses with special structures are for example those with epitaxial connectors, double-layered stents.

With continued reference to fig. 1 and 2, and with concurrent reference to fig. 3, in this embodiment, the core assembly 130 includes: the core member 131. The core member 131 is fixedly coupled to the sheath 110 such that the core member 131 drives the sheath 110 to move distally.

Further, the core assembly 130 further includes: a guide head 132, the guide head 132 being located at the distal end of the core member 131 for assisting the sheath 110 and the valve prosthesis to reach a target position for release of the valve prosthesis.

Specifically, the cross section of the guide head 132 provided in this embodiment is circular arc. It should be noted that, in other embodiments, the cross section of the guide head may not be circular, for example: in an alternative embodiment, the guide head is conical in cross-section; in another alternative embodiment, the guide head is spindle-shaped in cross-section.

In this embodiment, the guide head 132 is made of PEBAX material (PEBAX: polyether amide block copolymer) to avoid the guide head 132 from puncturing a heart or a human tissue organ such as a human tissue blood vessel during the process of delivering the valve prosthesis to a target site of a human body by the delivery device 100. It should be noted that, in other alternative embodiments, the guide head 132 may be made of other materials, such as: TPU materials (TPU: thermoplastic polyurethane elastomer) and the like.

Guide head 132 also serves to secure sheath 110 to core assembly 130. In this embodiment, the distal end of sheath 110 is secured to guide head 132 of inner core assembly 130.

Preferably, the sheath 110 is sleeved on the guide head 132, and the sheath 110 is fixed with the guide head 132. As such, the guide head 132 may also support the lumen of the sheath 110. Specifically, the proximal end of the guide head 132 includes a fixation portion that is positioned within the sheath 110 and is fixed with the sheath 110. The fixing part and the sheath 110 can be in interference fit or bonded by biocompatible glue to realize the fixed connection of the two. Further, the outer diameter of the fixing portion is smaller than the outer diameter of the rest of the guide head 132, and the outer diameter of the sheath tube 110 is smaller than or equal to the outer diameter of the rest of the guide head 132, so that the connection portion between the sheath tube 110 and the guide head 132 and the rest of the guide head 132 are smoother, and the sheath tube 110 is prevented from scraping the vessel wall and the ventricular atrial wall when entering into tissue organs such as a human blood vessel and a heart. In addition, the securing portion forms an abutment shoulder with the remainder of the guide head 132 that can prevent distal movement of the sheath 110 relative to the guide head 132.

In this embodiment, sheath 110 is made of a thermoplastic material. Specifically, the sheath 110 provided in this embodiment is made of polypropylene. It should be noted that, in other alternative embodiments, the sheath 110 may be made of a polypropylene material, such as: in an alternative embodiment, sheath 110 is made of polyvinyl chloride material.

Referring to fig. 1 to 3 together, it is preferable that the core member 131 includes a core tube 133 and an inner steel tube 134, the core tube 133 is located at a distal end of the inner steel tube 134, at least a portion of the distal end of the core tube 133 is accommodated in the sheath tube 110, and a diameter of the core tube 133 is smaller than a diameter of the inner steel tube 134.

In this way, the use of the inner steel tube 134 having a larger diameter as the proximal end of the core member 131 ensures that the proximal end of the core member 131 is not deformed when the core member 131 is driven or even when the core assembly 130 is moved distally.

In this embodiment, the proximal end of the inner core tube 133 is fixed to the distal end of the inner steel tube 134. In an alternative embodiment, the inner core tube 133 is integrally formed with the inner steel tube 134.

With continued reference to fig. 1 and 2, and with concurrent reference to fig. 4, in this embodiment, the catheter assembly 120 includes: sleeve 121 and guide 122 secured to the distal end of sleeve 121, sleeve 121 and guide 122 being both sleeved on core assembly 130, the distal end of sleeve 121 being for loading the valve prosthesis in a compressed state, guide 122 being received in sheath 110 and for guiding axial movement of sleeve 121.

Specifically, in this embodiment, the proximal end of guide 122 is fixedly coupled to the distal end of cannula 121, the distal end of guide 122 is a free end, and guide 122 is axially movably inserted into sheath 110. Further, guide 122 includes a distal guide portion and a proximal support portion. Wherein, the outer diameter of the guiding part is increased from the far to the near until the guiding part is equivalent to the outer diameter of the supporting part; the outer diameter of the support is slightly smaller than the inner diameter of sleeve 121 to allow guide 122 to move freely within sheath 110. The guiding part can be in a shape of a round table, a spherical crown, a hemispherical shape and the like. As such, insertion of guide 122 into sheath 110 is facilitated when sheath 110 is required to capture the valve prosthesis after loading the valve prosthesis onto the distal end of sleeve 121.

In addition, the catheter assembly 120 further includes: a tab (not shown) at the distal end of the sleeve 121 for removably loading the valve prosthesis at the distal end of the sleeve 121 to prevent undesired axial movement of the valve prosthesis. The specific shape of the hanger is not particularly limited in this embodiment.

With further reference to fig. 1, 4 and 6, the sleeve 121 preferably comprises: the middle steel tube 123 and the wire guide tube 124 fixed at the proximal end of the middle steel tube 123 are sleeved on the inner core assembly 130, the distal end of the middle steel tube 123 is used for loading the valve prosthesis in a compressed state, the wire guide tube 124 is circumferentially provided with a first cavity 125 penetrating axially, and the first cavity 125 is used for accommodating a guide wire. During delivery, the valve prosthesis in a compressed state is loaded on the distal end of the middle steel tube 123, and the valve prosthesis and the middle steel tube 123 are fixed and do not move relatively; when the valve prosthesis is released, the sheath 110 no longer constrains the valve prosthesis, either self-expanding or by balloon expansion out of the fixation of the middle steel tube 123. Alternatively, the guidewire tube 124 may be circumferentially provided with a plurality of first lumens 125 extending axially therethrough for passage of a guidewire. Thus, the problem that the guide wires in the traditional conveying system are contained in the inner tube, and the inner tube cannot provide a channel for a plurality of guide wires to pass through due to the limitation of the size is solved, so that the guide wires can realize more functions besides the functions of the traditional guide conveying device.

Furthermore, in the present embodiment, before the core assembly 130 and the catheter assembly 120 in the delivery device 100 are moved in the human body, the guide wire passing through the first lumen 125 is guided to a target position along a natural lumen, a blood vessel or a planned path of an organ of the human body under the guidance of an X-ray, a CT (computed tomography), an ultrasound or the like detection device, and then the core assembly 130 and the catheter assembly 120 are further guided to the target position along the guide wire.

Further, the guide wire tube 124 is provided with a second lumen 126 extending axially therethrough, and a proximal end portion of the middle steel tube 123 is received in the second lumen 126 and secured to the guide wire tube 124. Since the proximal end portion of the middle steel tube 123 is accommodated in the second lumen 126, the outer diameter of the middle steel tube 123 is smaller than the diameter of the second lumen 126, i.e., the outer diameter of the middle steel tube 123 is smaller than the outer diameter of the guide wire tube 124. In this way, the valve prosthesis is loaded by adopting the distal end of the middle steel pipe 123 with smaller outer diameter, so that the containing space between the middle steel pipe 123 and the sheath pipe 110 is larger when the distal end of the middle steel pipe 123 is placed in the sheath pipe 110, thereby being convenient for containing the valve prosthesis with larger size or reducing the compression difficulty of the valve prosthesis; on the other hand, the diameter of the guide wire tube 124 is slightly larger, so that more guide wires can be arranged, the conveying device can have more functions, the release of the valve prosthesis with a special structure is realized, and the types and the quantity of instruments required in the conveying and release processes of the valve prosthesis are reduced.

In this embodiment, catheter assembly 120 is further provided with a seal (not shown) positioned between the proximal end of middle steel tube 123 and guidewire tube 124 to sealingly secure the proximal end of middle steel tube 123 to guidewire tube 124. In other alternative embodiments, a seal may not be provided, so long as the proximal end of the middle steel tube 123 may be fixed to the guide wire tube 124.

Further, the guide wire 124 is made of a material having a low surface friction coefficient. For example, the guide wire tube 124 is made of PEEK (PEEK: polyetheretherketone), PTFE (PTFE: polytetrafluoroethylene), or the like. In this manner, frictional resistance experienced by the guidewire tube 124 may be reduced when the guidewire tube is moved.

With continued reference to fig. 1 and 3, in this embodiment, the conveying apparatus 100 further includes: a handle assembly 140, the handle assembly 140 being axially relatively stationary with the core assembly 130 or fixed with the proximal end of the core assembly 130, the handle assembly 140 being adapted to drive movement of the core assembly 130; catheter assembly 120 is located between the distal end of core assembly 130 and handle assembly 140.

Thus, when an operator uses the delivery device 100 to deliver the valve prosthesis to a target site in the human body, the operator can operate the handle assembly 140, and the handle assembly 140 moves distally to drive the inner core assembly 130 to move distally, so as to drive the sheath 110 fixed to the distal end of the inner core assembly 130 to move distally relative to the catheter assembly 120, thereby releasing the valve prosthesis in a compressed state.

More specifically, to ensure that sheath 110 moves distally relative to catheter assembly 120 without displacing the valve prosthesis loaded on catheter assembly 120, catheter assembly 120 may be secured in place when the operator actuates distal movement of inner core assembly 130 to release the valve prosthesis. To immobilize the catheter assembly 120, the catheter assembly 120 may be fixed on other positioning devices, or an operator may hold the catheter assembly 120 while manipulating the handle assembly 140 and keep the catheter assembly 120 immobilized as the core assembly 130 is moved distally.

In this embodiment, the handle assembly 140 is fixed to the proximal end of the core member 131 of the core assembly 130. In an alternative embodiment, the handle assembly 140 is rotatably provided on the core member 131 in the circumferential direction of the core member 131, and the handle assembly 140 is held axially relatively stationary with the core member 131 of the core assembly 130. Thus, the handle assembly 140 and the core member 131 can rotate relatively, so that when the handle assembly 140 is rotated by misoperation, the rotation is not transmitted to the sheath 110, and further, the valve prosthesis is prevented from being kinked.

With continued reference to fig. 1 and 3, and with concurrent reference to fig. 5, further, the handle assembly 140 includes: a housing 141 and a collet 142 secured to the housing 141, the housing 141 for an operator to grasp to manipulate the core assembly 130, the collet 142 for securing the housing 141 to the proximal end of the core assembly 130 or to remain axially relatively stationary.

Thus, after the operator delivers the valve prosthesis to the target site of the human body using the delivery device 100, the housing 141 is grasped and the housing 141 is moved distally to drive the core assembly 130 distally via the collet 142 to drive the sheath 110, which is secured to the distal end of the core assembly 130, distally relative to the catheter assembly 120, thereby releasing the valve prosthesis.

Specifically, the casing 141 has a hollow structure, a groove 143 is provided in the casing 141, the collet 142 is clamped or rotatably provided in the groove 143, and the collet 142 is sleeved and fixed on the proximal end of the core member 131. In this way, the housing 141 and the proximal end of the core member 131 can be fixed or held axially relatively stationary by the collet 142. In addition, since the case 141 is of a hollow structure, it is possible to increase the volume of the case 141 to increase the area of the case 141 held by the operator and to ensure that the weight of the case 141 is light to facilitate the operator's operation.

Further, the groove 143 is an annular groove, the outer edge of the collet 142 is stepped, the collet 142 has a first body 144 and a second body 145 connected to the first body 144, the outer diameter of the first body 144 is larger than that of the second body 145, the first body 144 is clamped in the groove 143 to fix the collet 142 and the housing at least axially, and the first body 144 and the second body 145 are both sleeved at the proximal end of the core member 131 and fixed to the core member 131. In this manner, the contact area of collet 142 with core assembly 130 may be increased by second body 145, thereby increasing the stability of the fixation of collet 142 with core assembly 130. In another alternative embodiment, the collet 142 is a bearing, the outer race of which is fixedly received in the groove 143, and the inner race of which is fixedly coupled to the proximal end of the core member 131.

More specifically, in the present embodiment, the housing 141 is a hollow structure that is penetrated axially, and the core assembly 130 passes through the housing 141 and continues to extend toward the proximal end of the delivery device 100, that is, a portion of the proximal end of the core assembly 130 is located in the hollow structure of the housing 141 and a portion is located outside the proximal end of the housing 141.

With continued reference to fig. 1-6, and with simultaneous reference to fig. 7-10. A second embodiment of the present application provides a valve prosthesis system, comprising: delivery device 100 and valve prosthesis 200. Wherein the conveying device 100 includes: sheath 110, catheter assembly 120, and core assembly 130; sheath 110 is sleeved on the distal end of core assembly 130, and sheath 110 is fixedly connected with core assembly 130, sheath 110 is used for binding valve prosthesis 200 in a compressed state; the catheter assembly 120 is movably sleeved on the inner core assembly 130, and the distal end of the catheter assembly 120 is positioned in the sheath 110, and the distal end of the catheter assembly 120 is loaded with the valve prosthesis 200 in a compressed state; the conveying apparatus 100 is configured to: the inner core assembly 130 is urged to move the sheath 110 distally relative to the catheter assembly 120 to release the valve prosthesis 200 in a compressed state; the valve prosthesis 200 in a compressed state is sleeved on the catheter assembly 120, and one part of the valve prosthesis 200 is positioned inside the sheath 110, and the other part is positioned outside the sheath 110.

In fact, the delivery device 100 included in the valve prosthesis system provided in the second embodiment of the present application is the same as the delivery device provided in the first embodiment, so the delivery device 100 included in the valve prosthesis system provided in the second embodiment of the present application has the same beneficial effects as the delivery device provided in the first embodiment, and is not described herein.

Preferably, the valve prosthesis 200 includes a main body portion 210 and at least one connector 220 secured to a proximal end of the main body portion 210, the main body portion 210 being positioned within the sheath 110, the connector 220 being positioned outside the sheath 110 and extending distally from the proximal end of the main body portion 210.

Specifically, after the valve prosthesis 200 is implanted, the distal end of the valve prosthesis 200 is closer to the atrial side and the proximal end of the valve prosthesis 200 is closer to the ventricular side. When loaded, valve prosthesis 200 is disposed at the proximal end of sheath 110, body portion 210 is positioned within sheath 110, and connector 220 is positioned outside of sheath 110. In this manner, after delivery of the valve prosthesis 200 to the target site of the human body using the delivery device 100, the inner core assembly 130 is actuated to move the sheath 110 distally relative to the catheter assembly 120 so that the valve prosthesis 200 is gradually released until the valve prosthesis 200 is completely released from the tether of the sheath 110. In this process, since the connector 220 is located outside the sheath 110 and at the proximal end of the sheath 110, the conventional delivery device can cause the sheath fixedly connected to the outer tube assembly (similar to the catheter assembly of the present embodiment) to interfere with the connector 220 of the valve prosthesis 200, resulting in undesired displacement of the valve prosthesis, while the sheath 110, which is fixedly connected to the inner core assembly, in the delivery device of the present embodiment moves distally relative to the catheter assembly 120, the sheath 110 does not interfere with the connector 220 of the valve prosthesis 200, thereby ensuring that the valve prosthesis does not undesirably displace when released.

Further, the valve prosthesis 200 further comprises: at least one support 230, the support 230 is configured to be disposed outside of the native leaflet or chordae tendineae, and to constrain radial expansion of the body portion 210 to co-clamp the native leaflet or chordae tendineae with the body portion 210. The connection member 220 is connected with the support member 230 to connect the support member 230 with the body portion 210.

Still further, the supporting member 230 is a hollow elastic member and is arc-shaped in a natural state, and forms a substantially closed loop through the connecting member 220. Here, a substantially closed loop should be understood in a broad sense, as long as the arrangement of the plurality of supports 230 in the circumferential direction of the body portion 210 can bind the expansion of the body portion 210 in the radial direction, and should not be construed in a narrow sense as the plurality of supports 230 must extend one revolution in the circumferential direction.

Accordingly, the connection member 220 includes two hollow short bars 221 and a connection body 222 connected to both the main body portion 210 and the short bars 221. The number of the supporting members 230 is the same as the number of the connecting members 220. Both ends of the supporting member 230 are respectively sleeved on a short rod 221. The two ends of the supporting member 230 are respectively sleeved on a short rod 221, which may be that the two ends of the supporting member 230 are respectively sleeved on a short rod 221 of different connecting members 220, or that the two ends of the supporting member 230 are respectively sleeved on a short rod 221 of the same connecting member 220. In this way, the support 230 can be connected to the body 210 and can bind the expansion of the body 210 in the radial direction. Obviously, the outside diameter of the stub 221 needs to be smaller than the inside diameter of the support 230. In order to reinforce the relative positional relationship between the two short bars 221 of each link 220, the link 220 further includes a reinforcement body 223, and both ends of the reinforcement body 223 are fixedly connected to one short bar 221, respectively.

In the present embodiment, the number of the supporting pieces 230 is two. The supports 230 are semicircular in shape in nature, and the two supports 230 form a generally circular shape. After implantation of the valve prosthesis, the support 230 is located outside of the native leaflets or chords, the body portion 210 is located inside of the native leaflets or chords, and the body portion 210 is subjected to radial forces of the support 230. In other alternative embodiments, the number of supports 230 is one, and the supports 230 form a substantially circular shape in the natural state. In further alternative embodiments, the number of supports 230 is three, four or more, and the supports 230 are semi-circular with a smaller arc in nature.

In this embodiment, the valve prosthesis system further comprises: a guide wire 300; catheter assembly 120 of delivery device 100 includes: the guide wire tube 124, the guide wire tube 124 is circumferentially provided with at least two first cavities 125 penetrating axially, the first cavities 125 are used for accommodating the guide wires 300; a guide wire 300 is engaged with the two first lumens 125, the two stubs 221, and a support 230, and the guide wire 300 is used to guide the two stubs 221 to be engaged with the support 230. The guide wire 300 is used, on the one hand, for delivering the valve prosthesis 200 along the path of the guide wire 300 to the target site, as described in the above embodiments, and, on the other hand, for cooperating with the two first lumens 125, the two short bars 221 and a support 230, such that both ends of the support 230 are respectively sleeved with one short bar 221.

The method of operation of the valve prosthesis delivery system of the present embodiment will be exemplarily explained below taking as an example a valve prosthesis delivery system formed by a delivery device 100 having two guide wires 300, two support members 230 and four first lumens 125.

In performing a procedure with the valve prosthesis system, a guidewire 300 is first delivered to the body through a first lumen 125 until the distal end of the guidewire 300 reaches the vicinity of the mitral valve and the guidewire 300 is wrapped around the native mitral valve leaflet from one side; then delivering the capture device (not shown) to the body through the other first lumen 125, capturing the distal end of the guidewire 300, and extending the guidewire 300 out of the body through the other first lumen 125 where the capture device is located; in accordance with the previous steps, another guidewire 300 is passed into the body through one first lumen 125 and around the mitral valve native leaflets from the other side, and out of the body through the other first lumen 125.

Then, each of the support members 230 is inserted into a guide wire 300, and the support members 230 are delivered to the mitral valve native valve She Waice along the path of the guide wire 300, for example, the support members 230 may be pushed to the mitral valve native valve She Waice by a pushing device (not shown); withdrawing the delivery device 100, leaving the support 230 and the portion of the guide wire 300 located in the body, compressively loading the main body portion 210 of the valve prosthesis 200 in the distal end of the catheter assembly 120, the core assembly 130 bringing the proximal end of the sheath 110 into proximity with and restraining the main body portion 210 of the valve prosthesis 200, the connectors 220 of the valve prosthesis 200 being located outside the sheath 110, passing both ends of the guide wire 300 through the stubs 221 of the different connectors 220, respectively; the valve prosthesis 200 is delivered to the vicinity of the mitral valve and the end of the support 230 is sleeved with the short shaft 221 of the connector 220, and then the guide wire 300 is withdrawn, and the support 230 is restored to its natural state, forming a substantially closed loop. Wherein, when the end of the supporting member 230 is sleeved with the short bar 221 of the connecting member 220, since one end of the guide wire 300 is positioned in one of the first cavity 125 and the short bar 221 and the other end is positioned in the other of the first cavity 125 and the other short bar 221, and the space between the two ends of the guide wire 300 is positioned in the supporting member 230, when the short bar 221 is moved distally by the delivery device 100, the two short bars 221 can be moved along the path of the guide wire 300 to ensure that the two short bars 221 can be aligned with the one end of the supporting member 230, respectively, thereby facilitating the sleeve connection of the end of the supporting member 230 with the short bar 221 of the connecting member 220.

Finally, the valve prosthesis 200 is adjusted in position and posture to the proper posture, and then the inner core assembly 130 drives the sheath 110 to move distally, releasing the body portion 210 of the valve prosthesis 200, the body portion 210 expanding and being restrained by the support 230. At this point, the valve prosthesis 200 and the native leaflets are better fixedly attached under the combined action of the support 230 and the expanded body portion 210.

In this embodiment, when the core assembly 130 drives the sheath 110 to move distally to release the main body 210 of the valve prosthesis 200, the sheath 110 moves distally relative to the catheter assembly 120, and the connector 220 of the valve prosthesis 200 is located at the proximal end of the valve prosthesis 200, and the connector 220 extends from the proximal end of the main body 210 to the distal end of the main body 210. Thus, interference of the sheath 110 with the connector 220 of the valve prosthesis 200 during release of the valve prosthesis by the delivery device 100 may be avoided; after the valve prosthesis 200 is detached from the sheath 110, the valve prosthesis 200 loaded at the distal end of the catheter assembly 120 may be transitioned from the compressed state to the released state by means of a balloon or self-expanding, or the like. Wherein the valve prosthesis 200 in a compressed state is fixed and does not move relative to the catheter assembly 120 when the valve prosthesis 200 is loaded on the distal end of the catheter assembly 120; and when the valve prosthesis 200 is in the released state, the valve prosthesis 200 is disengaged from the fixation of the catheter assembly 120. At this point, the catheter assembly 120 may be moved relative to the valve prosthesis. On the other hand, in the whole conveying process, the first channels 125 penetrating axially are provided in the circumferential direction of the guide wire tube 124 for the guide wire 300 to pass through, so that the problem that the guide wire 300 is accommodated in the inner tube in the conventional conveying system, and the inner tube cannot provide a plurality of channels for the guide wire 300 to pass through due to the limitation of the size is solved, and further, the guide wire 300 can realize more functions besides those of the conventional guiding conveying device.

It will be understood by those of ordinary skill in the art that the foregoing embodiments are specific examples of implementing the present application and that various changes in form and details may be made therein without departing from the spirit and scope of the present application. Various changes and modifications may be made by one skilled in the art without departing from the spirit and scope of the invention, and the scope of the invention shall be defined by the appended claims.

Claims (13)

1. A delivery device for a valve prosthesis, comprising:

a sheath, a catheter assembly, and an inner core assembly;

the sheath tube is sleeved at the far end of the inner core assembly and fixedly connected with the inner core assembly, and the sheath tube is used for binding the valve prosthesis in a compressed state;

the catheter assembly is movably sleeved on the inner core assembly, the distal end of the catheter assembly is positioned in the sheath tube, and the distal end of the catheter assembly is used for loading the valve prosthesis in a compressed state;

the delivery device is configured to: the inner core assembly is urged to move the sheath distally relative to the catheter assembly to release the valve prosthesis in a compressed state.

2. The delivery device of claim 1, wherein the catheter assembly comprises: the valve prosthesis comprises a sleeve and a guide block fixed with the distal end of the sleeve, wherein the sleeve and the guide block are sleeved on the inner core assembly, the distal end of the sleeve is used for loading the valve prosthesis in a compressed state, and the guide block is accommodated in the sheath tube and used for guiding the sleeve to axially move.

3. The delivery device of claim 1, further comprising: a handle assembly axially relatively stationary with the core assembly or fixed with a proximal end of the core assembly, the handle assembly for driving movement of the core assembly; the catheter assembly is located between the distal end of the core assembly and the handle assembly.

4. A delivery device as claimed in claim 3, wherein the handle assembly comprises: a housing for gripping by an operator, and a collet secured to the housing for securing or maintaining axially relative stationary relation to the proximal end of the core assembly.

5. The delivery device of claim 4, wherein the housing is hollow, a recess is provided in the housing, the collet is snapped into the recess, and the collet is sleeved and secured to the proximal end of the core assembly.

6. The delivery device of claim 1, wherein the catheter assembly comprises: the valve prosthesis comprises a middle steel tube and a wire guide tube fixed at the proximal end of the middle steel tube, wherein the middle steel tube and the wire guide tube are sleeved on the inner core assembly, the distal end of the middle steel tube is used for loading the valve prosthesis in a compressed state, the wire guide tube is positioned at the proximal end of the sheath tube, a first cavity which penetrates through the wire guide tube axially is formed in the circumferential direction of the wire guide tube, and the first cavity is used for accommodating a guide wire.

7. The delivery device of claim 6, wherein the guidewire tube is provided with a second lumen extending axially therethrough, and wherein the proximal portion of the middle steel tube is received within the second lumen and secured to the guidewire tube.

8. The delivery device of claim 1, wherein the inner core assembly comprises an inner core tube and an inner steel tube, the inner core tube is located at a distal end of the inner steel tube, at least a portion of the distal end of the inner core tube is received in the sheath tube, and a diameter of the inner core tube is smaller than a diameter of the inner steel tube.

9. A valve prosthesis system, comprising: valve prosthesis and delivery device according to claim 1, wherein the valve prosthesis is placed over the catheter assembly in a compressed state, and wherein a portion of the valve prosthesis is located inside the sheath and another portion is located outside the sheath.

10. The valve prosthesis system of claim 9, wherein the valve prosthesis comprises: the connecting piece is positioned outside the sheath tube and extends from the proximal end to the distal end of the main body part.

11. The valve prosthesis system of claim 10, wherein the valve prosthesis further comprises: at least one support for positioning outside of the native leaflet or chordae tendineae, constraining radial expansion of the body portion to grip the native leaflet or chordae tendineae with the body portion; the connector is connected with the support to connect the support with the main body.

12. The valve prosthesis system of claim 11, wherein the support member is a hollow elastic member and is arcuate in nature and forms a substantially closed loop with the connection member; the connecting piece comprises two hollow short rods and a connecting body connected with the main body part and the two short rods; the number of the supporting pieces is the same as that of the connecting pieces, and two ends of each supporting piece are respectively sleeved on one short rod.

13. The valve prosthesis system of claim 12, further comprising: a guide wire; the catheter assembly includes: the guide wire tube is circumferentially provided with at least two first channels penetrating axially, and the first channels are used for accommodating guide wires; one guide wire is matched with the two first cavities, the two short rods and one supporting piece, and the guide wire is used for guiding the two short rods to be sleeved with one supporting piece.

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