Valve clamping device and valve repairing system

Abstract

The invention discloses a valve clamping device and a valve repair system. The valve clamping device comprises a fixing base, a pair of clamping pieces, a driving assembly and a locking mechanism. The fixing base is provided with a hollow channel, and the pair of clamping pieces are hinged to the fixing base. The driving assembly is provided with a driving shaft, the driving shaft is movably inserted into the hollow channel, and the driving shaft moves in the axial direction to drive the clamping piece to be opened and closed relative to the fixing base so as to clamp the valve leaflet of the valve. The locking mechanism comprises a locking piece, a pushing piece and an unlocking piece, a locking hole is formed in the locking piece in the axial direction, the driving shaft is inserted into the locking hole in a penetrating mode, the pushing piece abuts against the locking piece, the locking piece is obliquely arranged in the fixing base, the edge of the locking hole is connected to the driving shaft in a clamped mode to be locked, and the locking piece is connected with the locking piece in a clamped mode. The unlocking piece strides across the locking piece, a gap is formed between the unlocking piece and the locking piece, and the unlocking piece drives the locking piece to move to unlock the driving shaft when being subjected to unlocking pulling force.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to a valve clamping device and a valve repair system. Background Art

[0002] Atrioventricular valves such as the mitral valve and the tricuspid valve are one-way valves in the heart. A normal and healthy atrioventricular valve can control the blood flow from the atrium to the ventricle, while preventing the blood from flowing from the ventricle to the atrium. For example, the mitral valve is a one-way valve located between the left atrium and the left ventricle of the heart, which can control the blood flow from the left atrium to the left ventricle, while preventing the blood from flowing from the left ventricle to the left atrium. Specifically, the mitral valve includes a pair of valve leaflets, namely the anterior leaflet and the posterior leaflet. When the edges of the anterior leaflet and the posterior leaflet are aligned, the mitral valve can be completely closed, preventing the blood from flowing from the left ventricle to the left atrium. When there are organic or functional changes in the valve leaflets or their related structures of the mitral valve, the anterior and posterior leaflets of the mitral valve do not align properly. As a result, when the left ventricle of the heart contracts, the mitral valve cannot be completely closed, causing the blood to flow back from the left ventricle to the left atrium, thereby triggering a series of pathophysiological changes, known as "mitral regurgitation".

[0003] Surgical procedures usually use surgical methods such as edge-to-edge suture of the valve to treat mitral regurgitation. However, such surgical procedures have defects such as complex surgical procedures, high surgical costs, high patient trauma, high risk of complications, long hospital stays, and painful patient recovery processes. The interventional valve clamping procedure refers to implanting a valve clamping device into the mitral valve to pull the two originally misaligned valve leaflets towards each other, reducing or eliminating the gap between the valve leaflets, thereby treating regurgitation.

[0004] The valve clamping device usually clamps the two valve leaflets of the valve with a pair of expandable or closable clamping members and then closes them, thereby pulling the two valve leaflets towards each other. The valve clamping devices of the prior art usually rely on the shape memory of the clamping members themselves or the screw self-locking of the drive shaft to maintain the closed state. However, such self-locking methods mainly rely on the shape memory of the material itself or the reliability of the screw, and the stability is poor. When the valve clamping device is repeatedly pulled by the pulsating valve leaflets without interruption or repeatedly washed by the high-speed flowing blood, the self-locking is likely to fail, causing the clamping members to accidentally spring open, resulting in the unilateral or bilateral detachment of the valve clamping device, leading to surgical failure or endangering the life and health of the patient. Summary of the Invention

[0005] In view of this, this application provides a valve clamping device and a valve repair system to solve the problems in the prior art.

[0006] On the one hand, an embodiment of the present application provides a valve clamping device, which includes: a fixed seat having a hollow channel; a pair of clamping members hinged to the fixed seat; a driving assembly having a driving shaft movably inserted into the hollow channel, the driving shaft moving axially to drive the clamping members to open and close relative to the fixed seat; a locking mechanism including a locking member, a pushing member and an unlocking member, the locking member axially defining a locking hole through which the driving shaft is inserted, the pushing member abutting against the locking member to incline the locking member in the fixed seat and cause the edge of the locking hole to be clamped to the driving shaft for locking, at least part of the unlocking member straddles the locking member and has a gap therebetween, and when the unlocking member is subjected to an unlocking pulling force, it drives the locking member to move to unlock the driving shaft.

[0007] In a preferred embodiment, the pair of clamping members are respectively and independently hinged to the fixed seat, and when the clamping members are unfolded relative to the fixed seat to the maximum extent, the extension lines of the contour edges of the pair of clamping members are symmetrically inverted V-shaped with respect to the center of the connection line of the hinge points of the pair of clamping members on the fixed seat.

[0008] In a preferred embodiment, the included angle A of the inverted V shape is less than or equal to 150 degrees, and the distance W between the perpendicular lines of the contour edges of the pair of clamping members is less than or equal to 9 mm.

[0009] In a preferred embodiment, the driving assembly further includes two connecting rods hinged to form a V shape, and the other end of each connecting rod is respectively connected to one of the clamping members, and the driving shaft is connected to the vertex of the V shape to drive the connecting rods and the clamping members to open and close.

[0010] In a preferred embodiment, the driving assembly further includes a base and two connecting rods hinged to the base, and the other end of each connecting rod is respectively connected to one of the clamping members, and the driving shaft is connected to the base to drive the connecting rods and the clamping members to open and close.

[0011] In a preferred embodiment, the fixed seat has a protruding hinge portion, the pair of clamping members are hinged to the hinge portion, the unlocking member leans against the hinge portion after straddling the locking member, when the unlocking member is subjected to a pulling force, the unlocking member clings to the bottom of the locking member and pulls the locking member to move to be close to horizontal, and the unlocking member is elastically deformed by the abutment of the hinge portion and has a tendency to straighten; after the pulling force is withdrawn, the unlocking member moves downward along the hinge portion and resumes its shape to restore the gap with the locking member.

[0012] In a preferred embodiment, the fixing seat includes a main body portion, the hinge portion includes two surfaces which are integrally protruded from the front and rear sides of the main body portion respectively, each of the clamping members spans the main body portion and is hinged to the two hinge portions, each of the hinge portions has an arc-shaped edge wall, and the unlocking member spans the locking member and extends to lean against the edge walls of the two hinge portions.

[0013] In a preferred embodiment, the fixing seat has an inner cavity with a boss, one end of the locking member abuts against the boss, and a gap is formed between the other end and the inner cavity of the fixing seat, and the unlocking member is a side-by-side structure formed by folding the wire loop, and the side-by-side structure spans the locking member and extends out of the inner cavity to lean against the edge walls of the two hinged parts.

[0014] In a preferred embodiment, the fixing seat has an inner cavity with a boss, one end of the locking member abuts against the boss, and the other end has a gap with the inner cavity of the fixing seat, and the unlocking member is a single structure formed by folding a wire loop, one side of the single structure spans over the locking member and extends to lean against one side edge wall of the two hinged parts, and the other side of the single structure spans over the boss and extends to lean against the other side edge wall of the two hinged parts.

[0015] In a preferred embodiment, the wire loop is formed by an elastic wire with two ends fixed together.

[0016] In a preferred embodiment, the push member includes an elastic bending portion, which abuts against the inner cavity of the fixed seat, and a limiting groove is provided on the side wall of the fixed seat. One end of the push member is limited in the limiting groove and presses the locking member on the boss, and the other end of the push member abuts against the locking member.

[0017] In a preferred embodiment, the valve clamping device also includes a clamping member, which includes a connecting seat and a pair of elastic clamping arms extending from the connecting seat, the elastic clamping arms cooperate with the clamping member to clamp the leaflets of the valve, and the connecting seat is provided with a slot on two opposite sides, and the fixing seat is provided with a clamping block protruding outward on two opposite sides, and the clamping block is inserted into the slot to fix the clamping member.

[0018] In a preferred embodiment, the push member has an elastic bending portion that pushes against the inner cavity of the fixing seat, and a limiting groove is provided on the side wall of the fixing seat. One end of the push member is limited in the limiting groove, and the other end pushes against the locking member.

[0019] In a preferred embodiment, the valve clamping device further includes an elastic clamping member, the elastic clamping member includes a connecting seat and a pair of clamping arms extending from the connecting seat, the clamping arms cooperate with the clamping members to clamp the valve leaflets, clamping grooves are formed on opposite sides of the connecting seat, and clamping blocks protrude outward from opposite sides of the fixing seat, and the clamping blocks are inserted into the clamping grooves to fix the elastic clamping member.

[0020] In a preferred embodiment, it further includes a support member and an elastic sealing member, the support member has a first end connected to the fixing seat, one end of the sealing member is connected to the first end of the support member, and the other end is freely suspended around the support member.

[0021] On the other hand, the present invention provides a valve clamping device, which includes: a fixing seat having a hollow channel and a protruding hinge portion; at least a pair of clamping members hinged to the hinge portion; at least a pair of clamping arms, the at least a pair of clamping arms and the at least a pair of clamping members respectively cooperate to clamp the valve leaflets; a driving assembly having a driving shaft movably inserted into the hollow channel of the fixing seat, the driving shaft moves axially to drive the clamping members to open and close relatively; a locking mechanism including a locking member, a pushing member and an unlocking member, the locking member is axially provided with a locking hole, the driving shaft is inserted through the locking hole, the pushing member abuts against the locking member to make the locking member inclined in the fixing seat, and the edge of the locking hole is clamped to the driving shaft to lock, at least part of the unlocking member straddles the locking member and leans against the hinge portion, the unlocking member is subjected to a pulling force and pulls the locking member to move towards being horizontal, so that the locking member releases the locking of the driving shaft, and the unlocking member is simultaneously abutted by the hinge portion to generate elastic deformation and has a tendency to straighten, after the pulling force is withdrawn, the unlocking member moves down along the hinge portion and restores its shape to restore the gap with the locking member.

[0022] In still another aspect, an embodiment of the present application provides a valve repair system, which includes the valve clamping device as described above and a delivery device for delivering the valve clamping device.

[0023] Compared with the prior art, the valve repair system of the present invention has a locking mechanism that can achieve mechanical control locking, and there is a gap between the unlocking member and the locking member in the natural state without being subjected to an unlocking pulling force. In the case of having a gap, it is not easy for the unlocking member to be accidentally touched and cause the locking mechanism to be unlocked. In a preferred solution, the unlocking member leans against a protruding hinged portion of the fixed seat, and when subjected to an unlocking pulling force, it generates an elastic deformation tending to straighten due to the abutment of the hinged portion. After the unlocking pulling force is withdrawn, the unlocking member tending to straighten will move downward along the hinged portion and restore its shape to restore the gap with the locking member. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only some embodiments of the present application. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0025] Figure 1 is a three-dimensional schematic diagram of a valve clamping device provided by the first embodiment of the present application.

[0026] Figure 2 is Figure 1 a three-dimensional schematic diagram of the clamping member of the valve clamping device being fully deployed and the clamping member being deployed.

[0027] Figure 3 is Figure 2 another perspective schematic diagram of the valve clamping device.

[0028] Figure 4 is Figure 1 a three-dimensional schematic diagram of the fixed seat of the valve clamping device.

[0029] Figure 5 is Figure 1 a three-dimensional schematic diagram of the assembled state of the fixed seat, the locking mechanism and the drive shaft of the valve clamping device.

[0030] Figure 6 is Figure 5 a front view schematic diagram.

[0031] Figure 7 is Figure 2 a state schematic diagram of the valve clamping device when the clamping member is not deployed.

[0032] Figure 8 is Figure 1 a three-dimensional schematic diagram of the clamping member of the valve clamping device.

[0033] Figure 9 isFigure 1 Schematic three-dimensional view of the unlocking member.

[0034] Figure 10 is Figure 5 Schematic view of the cooperation state of the unlocking member with the locking mechanism and the hinge part under the unlocking pulling force.

[0035] Figure 11 is Figure 10 Front schematic view.

[0036] Figure 12 is Figure 9 Schematic view of the change of the unlocking member before and after being subjected to the unlocking pulling force.

[0037] Figure 13 is Figure 7 Assembly schematic view of the fixed seat and the clamping member.

[0038] Figure 14 is Figure 1 Schematic view of the clamping leaflets of the valve clamping device.

[0039] Figure 15 is Figure 1 Schematic view of the valve clamping device implanted between two leaflets.

[0040] Figure 16 is Figure 15 Schematic view of implanting the valve clamping device in the marginal junction area on the basis of

[0041] Figure 17 Schematic three-dimensional view of the valve clamping device provided in the second embodiment of the present application.

[0042] Figure 18 is Figure 17 Schematic three-dimensional view of the unlocking member.

[0043] Figure 19 is Figure 18 Schematic three-dimensional view of the unlocking member installed on the locking mechanism and leaning against the edge of the hinge part of the fixed seat.

[0044] Figure 20 is Figure 19 Schematic view of the cooperation state of the unlocking member with the locking mechanism and the hinge part under the unlocking pulling force.

[0045] Figure 21 is Figure 18 Schematic view of the change of the unlocking member before and after being subjected to the unlocking pulling force.

[0046] Figure 22 Schematic structural view of the valve clamping device according to the third embodiment of the present application.

[0047] Figure 23It is a schematic diagram of the state when the valve repair system provided by the embodiment of the present invention is applied to the treatment of the mitral valve;

[0048] Figure 24 It is Figure 23 a schematic diagram of the state when the valve clamping device of closes and clamps the valve leaflets;

[0049] Figure 25 It is Figure 24 a schematic diagram of the state when the valve clamping device of is separated from the delivery device.

[0050] The following specific embodiments will further illustrate the present application in conjunction with the above-mentioned drawings. Specific Embodiments

[0051] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the scope of protection of the present application.

[0052] First of all, it should be noted that in the field of interventional medicine, along the delivery path of the instrument, the end of the instrument close to the operator is usually referred to as the proximal end, and the end of the instrument far from the operator is referred to as the distal end. Specifically, for the delivery device used to deliver and release the implantable device into the patient's body, the distal end refers to the end where the delivery device can be freely inserted into the animal or human body, and the proximal end refers to the end where the delivery device is operated by the user or machine. The direction of the rotation center axis of an object such as a cylinder or a tube is defined as the axial direction, the circumferential direction is the direction around the axis of a cylindrical object such as a cylinder or a tube (perpendicular to the axis and perpendicular to the cross-sectional radius at the same time), and the radial direction refers to the direction along the diameter or radius. Among them, the axial direction, the circumferential direction, and the radial direction together constitute three orthogonal directions of the cylindrical object. It should be noted that regardless of the "end" in words such as "proximal end", "distal end", "one end", "the other end", "the first end", "the second end", "the initial end", "the end", "both ends", "the free end", "the upper end", "the lower end", etc., it is not limited to the end head, the end point, or the end face, but also includes the part that extends a certain axial distance and / or radial distance on the component to which the end head, the end point, or the end face belongs from the end head, the end point, or the end face. The above definitions are only for the convenience of expression and should not be construed as a limitation to the present application.

[0053] It can be understood that the terms in the description, claims and the above-mentioned drawings of this application are only for describing specific embodiments and are not intended to limit this application. The terms "first", "second", etc. in the description, claims and the above-mentioned drawings of this application are used to distinguish different objects and are not used to describe a specific order. Unless otherwise clearly stated in the context, the singular forms "a" and "the" are also intended to include the plural forms. The term "comprising" and any variation thereof are intended to cover non-exclusive inclusion. In addition, this application can be implemented in many different forms and is not limited to the embodiments described below. The purpose of providing the following specific embodiments is to facilitate a clearer and more thorough understanding of the disclosed content of this application. The words indicating directions such as up, down, left, and right are only in terms of the positions of the shown structures in the corresponding drawings.

[0054] It should be noted that all the above-mentioned drawings are exemplary illustrations of this application and do not represent the actual size of the product. Also, the dimensional ratio relationships between components in the drawings are not used to limit the actual products of this application. The subsequent description in the specification is the preferred embodiment for implementing this application. However, the above description is for the purpose of explaining the general principles of this application and is not intended to limit the scope of this application. The protection scope of this application shall be determined by what is defined in the appended claims.

[0055] Please refer to Figures 1 to 8 , a valve clamping device 100 provided in the first embodiment of this application, which is used for treating mitral or tricuspid regurgitation, basically includes a fixed seat 10, a pair of clamping members 20, a driving assembly 30, and a locking mechanism 40.

[0056] Please see Figure 4 , the fixed seat 10 has an inner cavity 11 and a hollow channel 12, and the hollow channel 12 penetrates the upper and lower walls of the inner cavity 11 of the fixed seat 10. In this embodiment, the fixed seat 10 further has a protruding hinged portion 13, and the hinged portion 13 protrudes from the outer surface of the upper wall of the inner cavity 11 of the fixed seat 10.

[0057] The pair of clamping members 20 are hinged to the fixed seat 10. In this embodiment, the pair of clamping members 20 are hinged on the hinged portion 13, and the pair of clamping members 20 have their respective hinge points 131 and 132 on the hinged portion 13. In this way, as Figure 6As shown, since the pair of clamping members 20 have respective hinge points 131 and 132 on the hinge portion 13, compared with the mutual restriction caused by the pair of clamping members 20 sharing a hinge point, the pair of clamping members 20 can be unfolded to the maximum extent relative to the fixed seat 10. Thus, when the valve clamping device 100 is located in the left ventricle or the right ventricle, if it is necessary to adjust the implantation state, the pair of clamping members 20 can be unfolded to the maximum extent to reduce the overall outer diameter, and then the valve clamping device 100 is retracted from the ventricle to the atrium for re-implantation.

[0058] As Figure 7 shown, when the clamping member 20 is unfolded to the maximum extent relative to the fixed seat 10, the contour edges of the pair of clamping members 20 are in an inverted V shape symmetric about the center of the connecting line of the hinge points of the pair of clamping members on the fixed seat, and the included angle A of the inverted V shape is less than or equal to 150 degrees, that is, the pair of clamping members 20 can be unfolded to the maximum extent of 210 degrees relative to the fixed seat 10, and the distance W between the vertical lines of the contour edges of the pair of clamping members 20 is less than or equal to 9 mm. This dimension is beneficial for retracting the valve clamping device 100 from the narrow internal space of the heart.

[0059] See Figure 8 , specifically, each clamping member 20 is basically composed of a sheet body 22 and two spaced ribs 24 extending from the sheet body 22. The two ribs 24 of one clamping member 20 straddle the front and back sides of the fixed seat 10 and are respectively hinged to the fixed seat 10 at the end hinge points 24a by pins. Each clamping member 20 can be made of stainless steel.

[0060] The drive assembly 30 most basically includes a drive shaft 32. Please refer to Figure 5 , the drive shaft 32 is movably inserted into the hollow channel 12 of the fixed seat 10, and the drive shaft 32 moves axially to drive the clamping member 20 to open and close relative to the fixed seat 10 to clamp the valve leaflets. In this embodiment, please refer to Figure 2 again, since the fixed seat 10 is located in the middle of the valve clamping device 100, the drive assembly 30 further includes two connecting rods 33 and 34 respectively connected to the pair of clamping members 20. Thus, when the drive shaft 32 moves, the clamping member 20 is driven to open and close relative to the fixed seat 10. When the pair of clamping members 20 are opened relative to each other, the valve leaflets can be captured; when the pair of clamping members 20 are closed relative to each other, two adjacent valve leaflets can be clamped.

[0061] The two connecting rods 33, 34 are hinged to the same hinge point 35. The hinge point 35 can be a position on a base 36, and the base 36 is fixedly connected to the drive shaft 32. Hinging to the same hinge point 35 is beneficial for reducing the size of the base 36, thereby reducing the size of the entire valve clamping device 100.

[0062] In summary, in the valve clamping device 100, when the clamping member 20 is deployed to the maximum extent, it is in an inverted V shape in the minimum state. And because the two connecting rods 33, 34 are hinged to the same hinge point 35, the two connecting rods 33, 34 are in a V shape, also minimizing the space occupied by the two connecting rods 33, 34. The entire valve clamping device 100, whether in the fully deployed or closed state, is similar to a butterfly shape, being light and small, which is beneficial for the conveying state of the valve clamping device 100 when closing through the conveying device or the retracting state when deployed to the maximum as described above.

[0063] Please refer again to Figure 4 and Figure 5 、 Figure 6 , the locking mechanism 40 includes a locking member 42, a pushing member 43 and an unlocking member 44. The locking member 42 and the pushing member 43 are received in the inner cavity 11 of the fixed seat 10. The locking member 42 is axially provided with a locking hole 421, and the drive shaft 32 is inserted through the locking hole 421. The pushing member 43 abuts against the locking member 42, making the locking member 42 inclined in the fixed seat 10 and causing the edge of the locking hole 421 to be clamped to the drive shaft 32 for locking. The unlocking member 44 straddles the locking member 42 and is used to drive the locking member to move to unlock the drive shaft 32 when subjected to a pulling force (see the unlocking pulling force applied by the unlocking control wire 45 in Figure 17 ).

[0064] Specifically, the inner cavity 11 of the fixed seat 10 is provided with a boss 110. One end of the locking member 42 abuts against the boss 110, and there is a gap between the other end and the inner cavity 11 of the fixed seat 10, giving the locking member 42 room for movement. One end of the locking member 42 abutting against the boss 110 can be directly placed on the boss 110. Under the natural state pushing of the pushing member 43, the other end of the locking member 42 is lower than the end of the locking member 42 abutting against the boss 110. The locking hole 421 can be a smooth through hole, and the drive shaft 32 can be provided with a section of thread or a rough surface, so that the locking hole 421 can be clamped to the drive shaft 32 to lock the drive shaft 32, so that the clamping member 20 can be held in the required position, such as the position when closed.

[0065] The pushing member 43 includes an elastic bending portion 432. The bending portion 432 abuts against the upper wall of the inner cavity 11 of the fixing base 10. A limiting groove 112 is provided on the side wall of the fixing base 10. The limiting groove 112 is located above the boss 110. One end of the pushing member 43 is limited in one of the limiting grooves 112, and the locking member 42 is pressed against the boss 110. The other end of the pushing member 43 abuts against the locking member 42. The limiting groove 112 helps to fix the pushing member 43 at one end and prevent the pushing member 43 from slipping.

[0066] In this embodiment, limiting grooves 112 are provided on two opposite side walls of the fixing base 10. One of the limiting grooves 112 is used to limit the pushing member 43, and the other limiting groove 112 is empty. The empty limiting groove 112 can reduce the weight of the fixing base 10 and is symmetric with the other limiting groove 112, playing a role in facilitating processing.

[0067] Please refer to Figure 9 , the unlocking member 44 can be formed by fixing two ends of a thin wire with steel sleeves 442 to form a wire loop, and the wire loop can be pre-shaped by a certain bending to form a bending portion 444.

[0068] Please refer to Figures 5 - 6 and Figures 10 - 11 , the middle part of the unlocking member 44 crosses the locking member 42 in the inner cavity 11 of the fixing base 10. In the natural state without being subjected to a pulling force towards the proximal end, there is a certain gap B between the unlocking member 44 and the locking member 42. This gap B helps to prevent the unlocking member 44 from being in close contact with the locking member 42, and thus in some cases can prevent the unlocking member 44 from being accidentally touched and triggering the unlocking of the locking member 42. This gap B is preferably a length distance between 0.05 and 5 mm.

[0069] In one embodiment, the above-mentioned gap B can be determined by the pre-set position of the unlocking member 44, that is, a certain gap is left between the unlocking member 44 and the locking member 42 during pre-assembly. When an external force, such as an unlocking pulling force, is applied, the unlocking member 44 can move and press against the locking member 42, thereby driving the locking member 42 to move and unlock the drive shaft 32; when the unlocking pulling force disappears, the unlocking member 44, under the reaction force of the locking member 42, and due to its own elasticity and / or shape memory function, tends to restore its shape and restore the gap B with the locking member 42. The lowest position of the unlocking member 44 is on the surface of the inner cavity 11 of the fixed seat 10. However, usually, after the unlocking member 44 crosses the locking member 42, the pair of clamping members 20 are hinged to the surface of the fixed seat 10, and the unlocking member 44 passes through the gap between the two ribs 24 of the clamping member 20. The hinge point 131 of the clamping member 20, such as a hinge pin, forms a certain limit on the unlocking member 44, so that the unlocking member 44 will not slide down to the surface of the inner cavity 11 of the fixed seat 10.

[0070] Preferably, the unlocking member 44 includes a nickel-titanium wire, and the wire diameter can be between 0.07 and 0.25 mm. Since nickel-titanium has a shape memory function, it deforms when subjected to an unlocking pulling force, and after the unlocking pulling force is withdrawn, the unlocking member 44 tends to restore its original position and shape due to the shape memory function. In some modified embodiments, other metals such as stainless steel, or other shape memory alloys, or in the form of strips, bands, or rods can also be used.

[0071] In this embodiment, the above-mentioned gap B does not need to be reserved between the unlocking member 44 and the locking member 42 during assembly. Since the fixed seat 10 has a protruding hinge portion 13, the unlocking member 44 can lean against the hinge portion 13 after crossing the locking member 42. Due to the small size of the above-mentioned gap B, a gap can be generated after the assembly is completed.

[0072] When controlled by an unlocking pulling force, the unlocking member 13 presses against the bottom of the locking member 42 to generate a pulling force on the locking member 42, so that the locking member 42 unlocks the drive shaft 32. The unlocking member 13 is simultaneously abutted by the hinge portion 13, and a part of the bent portion 444, such as Figure 12 part C undergoes elastic deformation and has a tendency to straighten ( Figure 12 the arrow in Figures 5 - 6 indicates the change from the deformed state to the undeformed state), that is, the bending degree of the part of the unlocking member 44 that leans against the hinge portion 13 in the original natural state becomes smaller. After the unlocking pulling force is withdrawn, the unlocking member 44 with a reduced bending degree will move down along the hinge portion 13 to generate / restore the gap B with the locking member (see

[0073] In this embodiment, the unlocking member 44 is a side-by-side structure formed by folding a wire loop in half. This side-by-side structure straddles the bottom of the end of the locking member 42 away from the boss 110 and extends out of the fixing base 10 to lean against the hinge portions 13 on the front and rear sides of the fixing base 10. To make the unlocking member 44 fit the hinge portion 13 more closely, the periphery of the hinge portion 13 can be made into an arc shape.

[0074] Please refer to again Figure 1 , in this embodiment, the valve clamping device 100 further includes a blocking member 50. Both ends of the side-by-side structure formed by folding the wire loop of the unlocking member 44 extend into the blocking member 50 and are further detachably connected to the unlocking control wire 45 of the delivery device (see Figure 17 ). Since the unlocking member 44 is thin and deformable, the unlocking control wire 45 can be, for example, a polymer material wire or still a nitinol wire. When assembling the valve clamping device 100 with the delivery device (see Figure 23 ), the unlocking control wire 45 passes through both ends of the wire loop of the unlocking member 44. When the delivery device is separated from the valve clamping device 100, the unlocking control wire 45 can be withdrawn.

[0075] The blocking member 50 can fill the gap between the clamping members 20 to further prevent blood reflux in the mitral valve or tricuspid valve. The blocking member 50 includes a three-dimensional network structure made of a shape memory material. Thus, at different clamping angles of the clamping members 20, or rather different clamping forces, the blocking member 50 can adaptively deform to fit the gap between the valve leaflets with different anatomical structures, thereby adjusting the pulling degree of the valve clamping device 100 on the valve leaflets. Optionally, the blocking member 40 is formed by braiding shape memory function braided wires into a three-dimensional network structure; or, it is formed by cutting shape memory function rod materials or pipe materials into a three-dimensional network structure. Specifically, after being braided or cut, the shape memory material is heat-treated and shaped so that the blocking member 40 can have a specific shape. The blocking member 40 can be deformed when subjected to an external force, such as being squeezed by the clamping member 20, and tends to return to its original shape, thereby providing a supporting force for the clamping member 20. For example, for adjacent valve leaflets of the tricuspid valve with a large, thin, and fragile gap (which can be the anterior and posterior leaflets, anterior and septal leaflets, or posterior and septal leaflets of the tricuspid valve), the clamping member 20 can be closed at a larger clamping angle to avoid excessive stress on the valve leaflets and prevent the valve leaflets from being perforated or torn; for adjacent valve leaflets of the mitral valve (i.e., the anterior and posterior leaflets of the mitral valve), the clamping member 20 can be closed at a smaller clamping angle to provide a larger clamping force on the valve leaflets. Optionally, the three-dimensional network structure includes a plurality of meshes formed by the interweaving of multiple braided wires, and the mesh shape of each mesh is a polygon, for example, it can be but is not limited to a quadrilateral.

[0076] In this embodiment, please refer to Figure 5, one end of the fixed seat 10 extends out a hollow support member 16, the drive shaft 32 passes through the hollow channel 12 of the fixed seat 10 and extends into the support member 16. The proximal end of the support member 16 is used for detachably connecting with the delivery sheath of the delivery device (see Figure 23 ), and the drive shaft 32 is detachably connected with the drive mandrel of the delivery device (see Figure 23 ). One end of the plugging member 50 is fixed to the support member 16 through a steel sleeve 52, and one end of the plugging member 50 is open and freely suspended. Thus, when the plugging member 50 is subjected to a certain external force, such as the pulling effect of other components, or the upward pushing effect when the two clamping members 20 are closed, it will move to adjust its position.

[0077] In this embodiment, since both ends of the side-by-side structure formed by folding the wire loop of the unlocking member 44 extend into the plugging member 50, and the steel sleeve 442 of the unlocking member 44 also extends into the plugging member 50. When the unlocking member 44 is subjected to an unlocking pulling force, the steel sleeve 442 of the unlocking member 44 will pull the plugging member 50 to move upward. When the unlocking pulling force of the unlocking member 44 is withdrawn, the plugging member 50 will tend to restore its original shape due to its own elasticity, and give a reaction force to the steel sleeve 442 of the unlocking member 44 to make it move downward together, so that the unlocking member 44 moves downward and a certain gap is restored with the locking member 42. In this embodiment, due to the limitation of the plugging member 50, even without the limitation of the protruding hinge portion 13, the unlocking member 44 can leave a gap with the locking member 42.

[0078] In summary, due to the hinge point 131 of the clamping member 20, or the protruding hinge portion 13, or the limiting or restraining effect of the plugging member 50, a gap is left between the unlocking member 44 and the locking member 42.

[0079] During unlocking control, when the unlocking control wire 45 applies an unlocking pulling force towards the proximal end to the unlocking member 44, the unlocking member 44 pulls up the locking member 42 away from one end of the boss 110, so that the locking member 42 is lifted to a flat or nearly flat state against the biasing force of the pushing member 43, thereby releasing the clamping of the locking hole 421 on the drive shaft 32, and the drive shaft 32 is unlocked and can drive and control the clamping member 20. When the unlocking control wire 45 is separated from the unlocking member 44, the locking member 42 returns to an inclined state under the biasing force of the pushing member 43, so as to clamp and lock the drive shaft 32.

[0080] Please refer to Figure 13In this embodiment, the valve clamping device 100 also includes a clamping member 60, which includes a connecting seat 61 and a pair of elastic clamping arms 62 extending integrally from the connecting seat 61. The connecting seat 61 is provided with a card slot 612 on two opposite sides, and the fixing seat 10 is provided with a card block 15 protruding outward on two opposite sides. The card block 15 is inserted into the card slot 612 to fix the clamping member 60.

[0081] The clamping member 60 may be made of an elastic material or a material with shape memory function, and deforms when subjected to an external force. After the external force disappears, it tends to restore its original shape and position due to its elasticity or shape memory ability. Therefore, it can be tightened and gathered during the delivery process, and automatically opens again to capture the leaflets of the valve after being released. Common materials of the elastic clamping member 60 are, for example, nickel-titanium alloy. In this embodiment, the ends of the two elastic clamping arms 62 of the clamping member 60 are respectively provided with threading holes, and then the control wire of the delivery device is detachably passed through the threading holes, thereby controlling the opening and closing of the two clamping arms 62 relative to the fixing seat 10 or the clamping member 20.

[0082] like Figure 14 When clamping the two leaflets 80a, 80b of the valve, the leaflets 80a, 80b are clamped by the elastic clamping arm 62 (see Figure 13 ) and the clamping member 20. After the leaflet is properly clamped, the control line of the delivery device can be separated from the clamping arm 62.

[0083] In the valve clamping device 100 of the first embodiment, since the clamping member 20 is in an inverted V-shape at the smallest state when it is expanded to the maximum extent, and since the two connecting rods 33 and 34 are hinged to the same hinge point 35, the two connecting rods 33 and 34 are in a V-shaped state, and the space occupied by the two connecting rods 33 and 34 is minimized, the entire valve clamping device 100 has a butterfly shape of the smallest size whether it is expanded to the maximum extent or closed, and the valve clamping device 100 of the butterfly shape is conducive to the edge junction area of ​​the mitral valve MV (see Figures 15 - 16 ) to perform implantation in a small space. Figure 15 There is a leak 80c at the junction area, and a valve clip device 100 can be implanted (see Figure 16 ).

[0084] See also Figures 17 to 21 In the valve clamping device 200 of the second embodiment of the present invention, another unlocking member 44a is used. The shape and assembly of the unlocking member 44a are different from those of the unlocking member 44 of the first embodiment.

[0085] The unlocking member 44a is a folded wire loop, which is still formed by fixing a single elastic wire with steel sleeves 442a at both ends to form a wire loop. The difference from the unlocking member 44 is that: the unlocking member 44a is a single structure formed by folding the wire loop. One side 445a of this single structure crosses the side of the locking member 42 away from the boss 110 and extends to lean against one side edge wall of the two hinge parts 13, and the other side 445b of this single structure crosses the boss 110 and extends to lean against the other side edge walls of the front and rear hinge parts 13 of the fixed seat 10.

[0086] During the use operation, the unlocking control wire 45 of the conveying device still passes through both ends of the unlocking member 44a. When the unlocking control wire 45 applies an unlocking pulling force towards the proximal end of the doctor to the unlocking member 44a, since one end of the unlocking member 44a is on the boss 110, the unlocking member 44a can only pull up the locking member 42 on the side of the locking member 42 away from the boss 110, so that the locking member 42 is lifted to a flat or nearly flat state against the biasing force of the pushing member 43, and the locking of the locking member 42 to the drive shaft 32 is released. During the unlocking process, the part of the unlocking member 44a that is abutted by the hinge part 13, such as Figure 21 part C as shown, undergoes elastic deformation and tends to straighten. The Figure 21 arrow in this figure indicates the change of part C from before deformation to after deformation.

[0087] After the unlocking pulling force is withdrawn, the locking member 42 resumes tilting under the biasing force of the pushing member 43, so as to re-lock the locking member 42. At this time, the unlocking member 44a that is abutted by the hinge part 13 and tends to straighten moves down along the hinge part 13 and gradually resumes its shape and resumes the gap B with the locking member 42 (see Figure 19 ).

[0088] Please refer to Figure 22 , the third embodiment of the present invention provides a valve clamping device 300. The difference between the valve clamping device 300 and the valve clamping device 100 or 200 is that: the fixed seat 10a has no protruding hinge parts, the clamping members 20a are directly hinged to the surface of the fixed seat 10a through pins, and a pair of the clamping members 20a are hinged at the same hinge point 131a; in addition, the connecting rods 33a, 34a of the clamping members 20a are not hinged at the same hinge point, but are respectively hinged at both ends of the base 36a. Figure 22 The shown valve clamping device 300 adopts the aforementioned unlocking member 44. In some other embodiments, the valve clamping device 300 can also adopt the aforementioned unlocking member 44a.

[0089] On the surfaces of the valve clamping devices 100, 200, and 300, such as the surfaces of the clamping members and the surfaces of the elastic clamping members, a film (not shown in the figure) can be respectively covered. The film can be made of a polymer material with biocompatibility, antioxidant property, and anti-dissolution property, such as PET, ePTFE, polyester, PTFE, silicone resin, urethane, metal fiber, or other biocompatible polymers. In this application, PET material is preferably used. It can be understood that the film 18 made of a biocompatible material can promote the crawling of endothelial cells and can effectively reduce the rejection reaction caused by the direct contact of metal with biological tissues.

[0090] The valve clamping device of the present invention can be applied to the treatment of the regurgitation of heart valves, including the mitral valve or the tricuspid valve. Please refer to Figure 1 , Figures 23 to 25 For example, taking the repair process of the anterior leaf and posterior leaf of the mitral valve as an example, and taking the valve clamping device 100 as an example, the valve repair system of the present invention includes a valve clamping device 100 and a delivery device 500. The delivery device 500 includes a driving mandrel 520, a delivery sheath 540 sleeved outside the driving mandrel 520, and an operating handle (not shown in the figure) of the doctor at the proximal end. The driving mandrel 520 is detachably connected to the driving shaft 32 of the valve clamping device 100. The operation method of the valve repair of the present invention mainly includes the following steps:

[0091] By means of femoral vein puncture, the delivery sheath 540 is delivered to the left atrium through the inferior vena cava; then the driving mandrel 520 extends out of the delivery sheath 540, and the driving mandrel 520 controls the valve clamping device 100 to approach the anterior leaf and posterior leaf of the mitral valve; the driving mandrel 520 is delivered distally, and the driving mandrel 520 drives the driving shaft 32 (see Figure 1 ) to move, so as to drive the clamping member 20 (see Figure 1 ) to expand. At this time, the direction of the clamping member 20 is adjusted, and the relative position between the clamping member 20 and the anterior leaf and posterior leaf of the mitral valve can be observed through a medical imaging or imaging device, so that the clamping member 20 is substantially perpendicular to the free edges of the anterior leaf and posterior leaf; then the valve clamping device 100 is pushed to the left ventricle through the driving mandrel 520, and the valve clamping device 100 is placed under the anterior leaf and posterior leaf, and the clamping member 20 is continuously opened to the capture position; at the same time, the two elastic clamping arms 62 of the clamping member 60 are pulled (see Figure 1 ). At this time, a leaflet accommodation space is respectively formed between the two clamping arms 34 and the clamping member 20;

[0092] Release the elastic clamping arms 62 on both sides simultaneously or successively. The elastic clamping arms 62 cooperate with the clamping member 20 to capture the anterior leaf 80a and the posterior leaf 80b. When it is observed that the leaflets are not clamped in the proper position, pull the drive mandrel 520 proximally to drive the drive shaft 42, thereby driving the clamping member 20 to close, so that the anterior leaf and the posterior leaf are clamped between the elastic clamping arms 62 and the clamping member 20.

[0093] Release the threaded connection between the drive mandrel 520 and the drive shaft 50, and withdraw the drive mandrel 520. The connection between the valve clamping device 100 and the drive mandrel 520 is released. Then, withdraw the delivery device 500 together with the unlocking control line 45 (see Figure 17 ) and the control line of the elastic clamping member out of the body, obtaining the implanted state as shown in Figure 25 . The valve clamping device 100 pulls the anterior leaf and the posterior leaf of the mitral valve towards each other and clamps them, completing the edge-to-edge repair of the mitral valve.

[0094] The above valve repair system and valve clamping device are suitable for application in mitral or tricuspid valve clamping procedures. In addition to the above femoral vein - interatrial septum - atrium - ventricle path, it can also be the transapical approach. One or more valve clamping devices 100 can be implanted when treatment is needed.

[0095] In the treatment of the tricuspid valve, three pairs of clamping members and three pairs of clamping arms respectively cooperating with the three pairs of clamping members can also be provided on the valve clamping device. Thus, the clamping members and the clamping arms cooperate to clamp the anterior leaf, the posterior leaf, and the septal leaf of the tricuspid valve, and one valve clamping device can complete the treatment in one clamping.

[0096] The above has introduced the embodiments of the present application in detail. Specific examples are used in this article to elaborate on the principle and embodiments of the present application. The description of the above embodiments is only used to help understand the method and its core idea of the present application. At the same time, for those of ordinary skill in the art, according to the idea of the present application, there will be changes in the specific embodiments and application scopes. In summary, the content of this specification should not be construed as a limitation to the present application.

Claims

1. A valve clamping device, comprising: A fixing seat, wherein the fixing seat has a hollow passage; A pair of clamping members, the pair of clamping members are hinged to the fixing seat; A driving assembly, wherein the driving assembly has a driving shaft, the driving shaft is movably inserted into the hollow channel, and the driving shaft moves axially to drive the pair of clamping members to open and close relative to the fixing seat; as well as The locking mechanism comprises a locking piece, a pushing piece and an unlocking piece, wherein the locking piece has a locking hole axially arranged therein, the driving shaft is inserted into the locking hole, the pushing piece pushes against the locking piece so that the locking piece is tiltedly arranged in the fixing seat, and the edge of the locking hole is engaged with the driving shaft to be locked, at least part of the unlocking piece crosses over the locking piece and is separated from the locking piece by a gap, and when the unlocking piece is subjected to a pulling force, it drives the locking piece to move and unlocks the driving shaft.

2. The valve clamping device according to claim 1, characterized in that, The pair of clamps are independently hinged on the fixing seat, and when the clamps are unfolded to the maximum extent relative to the fixing seat, the extension lines of the contour edges of the pair of clamps are inverted V-shaped symmetry relative to the center of the line connecting the hinge points of the pair of clamps on the fixing seat.

3. The valve clamping device according to claim 2, characterized in that, The included angle A of the inverted V shape is less than or equal to 150 degrees, and the distance W between the vertical lines of the contour edges of the pair of clamping parts is less than or equal to 9 mm.

4. The valve clamping device according to claim 1, wherein, The driving assembly also includes two connecting rods hinged to each other in a V shape, the other end of each connecting rod is connected to a clamping piece, and the driving shaft is connected to the apex of the V shape to drive the connecting rod and the clamping piece to open and close.

5. The valve clamping device according to claim 1, wherein The driving assembly also includes a base and two connecting rods hinged on the base, the other end of each connecting rod is connected to a clamping piece, and the driving shaft is connected to the base to drive the connecting rod and the clamping piece to open and close.

6. The valve clamping device according to claim 1, wherein, The fixing seat has a protruding hinge portion, the pair of clamping parts are hinged to the hinge portion, the unlocking part crosses over the locking part and leans against the hinge portion, when the unlocking part is subjected to pulling force, the unlocking part is pressed against the bottom of the locking part and pulls the locking part to move to a level close to horizontal, and at the same time, the unlocking part is elastically deformed by the support of the hinge portion and has a tendency to straighten; after the pulling force is removed, the unlocking part moves down along the hinge portion and restores its shape to restore the gap with the locking part.

7. The valve clamping device according to claim 6, characterized in that, The fixing seat includes a main body portion, and the hinged portion includes two surfaces which are integrally protruded from the surfaces of the opposite front and rear sides of the main body portion, each of the clamping members spans the main body portion and is hinged to the two hinged portions, each of the hinged portions has an arc-shaped edge wall, and the unlocking member spans over the locking member and extends to lean against the edge walls of the two hinged portions.

8. The valve clamping device according to claim 7, characterized in that, The fixing seat has an inner cavity with a boss, one end of the locking piece abuts against the boss, and a gap is formed between the other end and the inner cavity of the fixing seat, and the unlocking piece is a side-by-side structure formed by folding the wire loop, which spans the locking piece and extends out of the inner cavity to lean against the edge walls of the two hinged parts.

9. The valve clamping device according to claim 7, characterized in that, The fixed seat has an inner cavity, a boss is arranged in the inner cavity, one end of the locking member abuts against the boss, and there is a gap between the other end and the inner cavity of the fixed seat. The unlocking member is a single structure formed by folding a wire loop in half. One side of the single structure straddles the locking member and extends to lean against one side edge wall of the two hinge parts, and the other side of the single structure straddles the boss and extends to lean against the other side edge wall of the two hinge parts.

10. The valve clamping device according to claim 8 or 9, characterized in that, The wire loop is formed by an elastic wire with both ends fixed together.

11. The valve clamping device according to claim 8 or 9, characterized in that, The pushing member includes an elastic bent portion, the bent portion abuts against the inner cavity of the fixed seat, a limiting groove is arranged on the side wall of the fixed seat, one end of the pushing member is limited in the limiting groove and presses the locking member against the boss, and the other end of the pushing member abuts against the locking member.

12. The valve clamping device according to claim 1, characterized in that, It further includes a clamping member, the clamping member includes a connecting seat and a pair of elastic clamping arms extending from the connecting seat, the elastic clamping arms cooperate with the clamping member to clamp the leaflets of the valve, clamping grooves are formed on two opposite sides of the connecting seat, and clamping blocks protruding outward are arranged on two opposite sides of the fixed seat, and the clamping blocks are inserted into the clamping grooves to fix the clamping member.

13. The valve clamping device according to claim 1, characterized in that, It further includes a support member and an elastic sealing member, the support member has a first end connected to the fixed seat, one end of the sealing member is connected to the first end of the support member, and the other end is freely suspended around the support member.

14. A valve clamping device, which comprises: A fixed seat, the fixed seat has a hollow channel and protruding hinge parts; At least one pair of clamping members, the at least one pair of clamping members are hinged to the hinge parts of the fixed seat; At least one pair of clamping arms, the at least one pair of clamping arms and the at least one pair of clamping members respectively cooperate to clamp the leaflets of the valve; A driving assembly, the driving assembly has a driving shaft, the driving shaft is movably inserted into the hollow channel of the fixed seat, and the driving shaft moves axially to drive the clamping members to open and close relative to the fixed seat; And A locking mechanism, the locking mechanism includes a locking member, a pushing member and an unlocking member. The locking member is axially provided with a locking hole, the driving shaft is inserted through the locking hole, the pushing member abuts against the locking member, so that the locking member is inclined and arranged in the fixed seat, and the edge of the locking hole is clamped to the driving shaft for locking. At least part of the unlocking member straddles the locking member and leans against the hinge part. The unlocking member is subjected to a pulling force and pulls the locking member to move to be close to horizontal, so that the locking member releases the locking of the driving shaft. At the same time, the unlocking member is abutted by the hinge part and elastically deformed to have a tendency to straighten. After the pulling force is withdrawn, the unlocking member moves downward along the hinge part and restores its shape to restore the gap with the locking member.

15. A valve repair system, which comprises the valve clamping device according to claim 1 or 14, and a delivery device for delivering the valve clamping device.

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