WO2023124541A1

WO2023124541A1 - Valve repair device capable of secondary clamping

Info

Publication number: WO2023124541A1
Application number: PCT/CN2022/130085
Authority: WO
Inventors: 严新火; 江巍
Original assignee: 杭州德晋医疗科技有限公司
Priority date: 2021-12-30
Filing date: 2022-11-04
Publication date: 2023-07-06
Also published as: CN116407343A

Abstract

A valve repair device (100) capable of secondary clamping, comprising a push catheter (10), a clamp assembly (20), and a pre-clamping assembly (30). The clamp assembly (20) comprises a clamp push rod (21) movably mounted in the push catheter (10) in a penetrating manner, and a proximal clamp (22) and a distal clamp (23) that can be relatively opened and closed. The pre-clamping assembly (30) comprises an upper clamping member (31) and a lower clamping member (32); the upper clamping member (31) comprises an upper push rod (311) and an upper clamping portion (312) provided at a distal end of the upper push rod (311); the lower clamping member (32) comprises a lower push rod (321) and a lower clamping portion (322) provided at a distal end of the lower push rod (321). The valve repair device (100) has a working state. In the working state, the upper clamping portion (312) is provided with a first clamping surface (3121), and the lower clamping portion (322) is provided with a second clamping surface (3221); the first clamping surface (3121) works in conjunction with the second clamping surface (3221) to clamp a valve leaflet (1), and the proximal clamp (22) works in conjunction with the distal clamp (23) to clamp the valve leaflet (1) again. The range of a ratio of the area of the first clamping surface (3121) to the area of the valve leaflet (1) is [1/6-1). The range of a ratio of the area of the second clamping surface (3221) to the area of the valve leaflet (1) is [1/6-1). The valve leaflet (1) can be prevented from folding, and the effect of an operation is ensured.

Description

Secondary clamping valve repair device

This application claims the priority of the Chinese patent application with the application number 202111661072.7 and the application title "Secondary Clamping Valve Repair Device" submitted to the China Patent Office on December 30, 2021, the entire contents of which are incorporated by reference in In this application.

technical field

The present application relates to the technical field of medical devices, in particular to a valve repair device capable of secondary clamping.

Background technique

Heart valves such as the mitral and tricuspid valves are one-way "valves" between the atria and ventricles, ensuring that blood can only flow from the atria to the ventricles. When the chordae of the heart valve become diseased or ruptured, it will cause valvular insufficiency, trigger mitral regurgitation or tricuspid regurgitation, and cause blood to flow back from the ventricle to the atrium, causing a series of pathological changes and clinical symptoms of the heart. In severe cases it can lead to heart failure.

Among them, the mitral valve includes two leaflets, an anterior leaflet and a posterior leaflet, and the tricuspid valve includes three leaflets, an anterior leaflet, a septal leaflet, and a posterior leaflet. The valve leaflet includes a rough zone and a zona pellucida. The rough zone is located on the edge of the valve leaflet and is the apposition surface of the valve leaflet. The structure is thicker; the zona pellucida is located above the rough zone and the structure is thinner.

There is an existing suture implanter for the treatment of valvular insufficiency. The suture implanter clamps the valve leaflets through two chucks first, and then inserts sutures on the rough belt at the edge of the valve leaflets. Realize the treatment of heart valve insufficiency. Because the capture surface area of the suture implanter for capturing the leaflets is too small and the leaflets will swing up and down during heart activity, when the two chucks clamp the leaflets, it is necessary to rely on the front top leaflets of the instrument to clamp the leaflets hold. However, this method of operation has the risk of inaccurate clamping of the leaflets or even excessive clamping, which may cause leaflets to fold and accumulate. Too close to the zona pellucida will not only cause the suture to be subjected to excessive leaflet apposition force, which will affect the life of the suture; moreover, because the thickness of the zona pellucida is thin, the anchoring force on the suture is small, and the risk of suture falling off is relatively high. big.

Contents of the invention

In order to solve the above technical problems, the present application provides a valve repair device capable of secondary clamping, which can avoid leaflet folding by secondary clamping, so that the suture can be stably and accurately implanted into the The rough band located at the edge of the valve leaflet ensures the safety and reliability of the suture implantation position, improves the life of the suture, and at the same time makes the suture not easy to fall off, ensuring the effect of the operation.

The present application provides a valve repair device capable of secondary clamping, which includes a pushing catheter, a clip assembly and a pre-clamp assembly. The chuck assembly includes a chuck push rod that is movably installed in the push catheter and a proximal chuck and a distal chuck that can be opened and closed relatively. The proximal chuck is arranged at the far end of the push catheter, and the distal chuck is arranged Distal end of collet push rod. The pre-clamping assembly includes an upper clamping part and a lower clamping part. The upper clamping part includes an upper push rod that is movably worn in the push conduit and an upper clamping part located at the far end of the upper push rod. The lower clamping part includes The lower push rod installed in the pushing catheter and the lower clamping part arranged at the far end of the lower push rod are movable. The valve repair device has a working state. In the working state, the upper clamping part and the lower clamping part are located outside the distal end of the push catheter, the upper clamping part has a first clamping surface, and the lower clamping part has a second clamping surface. The first clamping surface cooperates with the second clamping surface to clamp the leaflet, and the proximal chuck cooperates with the distal chuck to clamp the leaflet again. Wherein, the ratio range of the area of the first clamping surface to the area of the leaflet is [1/6-1); the range of the ratio of the area of the second clamping surface to the area of the leaflet is [1/6-1).

In the valve repair device provided by the present application, the chuck assembly and the pre-clamp assembly are delivered to the vicinity of the valve through the push catheter; then the first clamping surface of the upper clamping part and the second clamping surface of the lower clamping part The leaflets are pre-clamped, and then the proximal chuck and the distal chuck are used to clamp the valve leaflets for the second time by operating the chuck push rod installed in the push catheter. When the proximal chuck and the distal chuck clamp After the valve leaflet is held, suture implantation can be performed on the valve leaflet to achieve the treatment of heart valve insufficiency. Since the area ratio ranges of the first clamping surface and the second clamping surface to the leaflet are both [1/6-1), when the first clamping surface and the second clamping surface clamp the leaflet, the leaflet can be Fully flattened to avoid folding and stacking of the leaflets, so as to ensure that the leaflets remain flat after the proximal and distal chucks clamp the leaflets again, thereby ensuring that the sutures can be stably and accurately implanted in the valve. The rough belt at the edge of the leaflet ensures the safety and reliability of the suture implantation position, avoids the suture from being subjected to a large leaflet apposition force, and improves the life of the suture; The thread can be subject to a greater anchoring force, so that the suture is not easy to fall off, which ensures the effect of the operation.

Description of drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings that need to be used in the embodiments. Apparently, the drawings in the following description are some embodiments of the present application, which are common to those skilled in the art. Technical personnel can also obtain other drawings based on these drawings without paying creative work.

FIG. 1 is a schematic perspective view of a valve repair device capable of secondary clamping provided in an embodiment of the present application in a working state.

Fig. 2 is an enlarged view of part II in Fig. 1 .

Fig. 3 is a schematic perspective view of the valve repair device in Fig. 1 in a delivery state.

FIG. 4 is an enlarged view of part IV in FIG. 3 .

FIG. 5 is an exploded perspective view of the three-dimensional structure of the valve repair device in FIG. 1 .

Fig. 6 is a schematic perspective view of the pre-clamping assembly in Fig. 5 .

Fig. 7 is a schematic perspective view of the three-dimensional structure of the pushing catheter and the proximal chuck in Fig. 5 .

Fig. 8 is a schematic perspective view of the three-dimensional structure of Fig. 7 omitting the proximal chuck.

FIG. 9 is a schematic perspective view of another valve repair device provided in an embodiment of the present application when the proximal chuck, the pushing catheter and the distal chuck are in a delivery state.

Fig. 10 is a top view of the valve leaflet clamped by the valve repair device in Fig. 1 .

Fig. 11 is a top view of another valve repair device clamped by an embodiment of the present application.

Fig. 12 is a top view of another valve repair device clamped by an embodiment of the present application.

FIG. 13 is a partial structural schematic view of the valve leaflet clamped by the upper clamping part and the lower clamping part in FIG. 5 .

Fig. 14 is another perspective view of the pushing catheter and the proximal chuck in Fig. 5 .

Fig. 15 is an enlarged view of part XV in Fig. 14 .

Fig. 16 is a schematic perspective view of the assembly of the pushing catheter, the proximal chuck and the pre-clamping assembly in Fig. 5 .

FIG. 17 is an enlarged view of part XVII in FIG. 16 .

Fig. 18 is a three-dimensional schematic diagram of the assembly of the pushing catheter, the pre-clamping component and the handle component (housing and sealing structure omitted) in Fig. 5 .

Fig. 19 is a sectional view along XIX-XIX of Fig. 18 .

FIG. 20 is an exploded perspective view of the three-dimensional structure of the first stop ring, the upper connection knob, the second stop ring and the lower connection knob in FIG. 18 .

Fig. 21 is a perspective view of the assembly of the pushing catheter and the connecting structure in Fig. 18 .

Fig. 22 is an exploded perspective view of the three-dimensional structure of the push catheter and the connecting structure in Fig. 18 .

Fig. 23 is a partial cross-sectional view along the axial direction of the assembled valve repair device of Fig. 5 .

Fig. 24 is an enlarged view of part XXIV in Fig. 23 .

Fig. 25 is a schematic perspective view of the three-dimensional structure of the suture assembly provided by the embodiment of the present application.

Fig. 26 is an enlarged view of part XXV in Fig. 5 .

27 to 33 are schematic diagrams of the process of implanting sutures in the anterior leaflet of the mitral valve by the valve repair device provided by the embodiment of the present application; wherein, FIG. 31 is an enlarged view of part XXXI in FIG. 30 .

Detailed ways

The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the application, not all of them. Based on the implementation manners in this application, all other implementation manners obtained by persons of ordinary skill in the art without making creative efforts belong to the scope of protection of this application.

In addition, the following descriptions of the various embodiments refer to the attached drawings to illustrate specific embodiments that the application can be used to implement. The directional terms mentioned in this application, such as "upper", "lower", "front", "rear", "left", "right", "inner", "outer", "side", etc., only is to refer to the direction of the attached drawings. Therefore, the direction terms used are for better and clearer description and understanding of the present application, rather than indicating or implying that the referred device or element must have a specific orientation, and must have a specific orientation. construction and operation, therefore should not be construed as limiting the application.

Orientation definition: For clarity of description, the end close to the operator is referred to as the "proximal end" and the end far away from the operator is referred to as the "distal end" during the operation. The direction of the connecting line of the end center; the radial direction refers to the direction perpendicular to the axial direction; the connection between "part A" and "part B" can be the direct contact connection between "part A" and "part B", or the connection between "part A" and "part B" "Part B" is indirectly connected through "Part C". The above definitions are only for the convenience of expression, and should not be understood as limitations on the present application.

Please refer to FIG. 1 and FIG. 33 together. The embodiment of the present application provides a valve repair device 100 that can be clamped twice. The valve repair device 100 can perform interventional treatment for mitral valve regurgitation or tricuspid valve regurgitation through the apical approach. The following will take the valve repair device 100 for interventional treatment of mitral valve regurgitation as an example to describe in detail. When the valve repair device 100 is used, the valve repair device 100 passes through the orifice of the mitral valve to pre-clamp one of the valve leaflets, clamps again, and then implants sutures 201 on the valve leaflet 1 to relieve or eliminate mitral valve damage. valve regurgitation. The suture 201 can be used as an artificial chord to replace the diseased or broken chord in the patient's heart; or a plurality of sutures 201 can be fixed to each other to achieve edge-to-edge repair of the mitral valve. It should be noted that the leaflet 1 of the mitral valve includes an anterior leaflet 1b and a posterior leaflet 1a, and the leaflet of the tricuspid valve includes an anterior leaflet, a septal leaflet and a posterior leaflet. The orifice of the mitral valve refers to the space between the anterior leaflet 1b and the posterior leaflet 1a.

Please refer to FIG. 1 to FIG. 12 together. The secondary clamping valve repair device 100 provided by the embodiment of the present application includes a pushing catheter 10 , a clip assembly 20 and a pre-clamping assembly 30 . The chuck assembly 20 includes a chuck push rod 21 movably installed in the push catheter 10 and a proximal chuck 22 and a distal chuck 23 that can be opened and closed relatively. The proximal chuck 22 is arranged at the distal end of the push catheter 10 , The distal chuck 23 is located at the distal end of the chuck push rod 21 . The pre-clamping assembly 30 includes an upper clamping part 31 and a lower clamping part 32, and the upper clamping part 31 includes an upper push rod 311 which is movably worn in the push catheter 10 and an upper clamping rod located at the far end of the upper push rod 311. part 312 , the lower clamping part 32 includes a lower push rod 321 movably mounted in the pushing catheter 10 and a lower clamping part 322 arranged at the distal end of the lower push rod 321 . The valve repair device 100 has a working state. In the working state, the upper clamping part 312 and the lower clamping part 322 are located outside the distal end of the pushing catheter 10. The upper clamping part 312 has a first clamping surface 3121, and the lower clamping part 312 has a first clamping surface 3121. The part 322 has a second clamping surface 3221, the first clamping surface 3121 cooperates with the second clamping surface 3221 to clamp the valve leaflet 1, and the proximal clamp 22 cooperates with the distal clamp 23 to clamp the valve leaflet 1 again . Wherein, the ratio range of the area of the first clamping surface 3121 to the area of the leaflet 1 is [1/6-1); the ratio range of the area of the second clamping surface 3221 to the area of the leaflet 1 is [1/6 -1).

The above-mentioned valve repair device 100 transports the chuck assembly 20 and the pre-clamp assembly 30 to the vicinity of the valve through the pushing catheter 10; The holding surface 3221 pre-clamps the valve leaflet 1, and then the proximal chuck 22 and the distal chuck 23 perform secondary clamping on the valve leaflet 1 by operating the chuck push rod 11 mounted in the push catheter 10, After the valve leaflet 1 is clamped by the proximal clamp 22 and the distal clamp 23 , the valve leaflet 1 can be implanted with sutures 201 to achieve the treatment of heart valve insufficiency. Since the area ratio ranges of the first clamping surface 3121 and the second clamping surface 3221 to the leaflet 1 are both [1/6-1), the first clamping surface 3121 and the second clamping surface 3221 clamp the leaflet 1 At this time, the valve leaflet 1 can be completely flattened to avoid the folding and accumulation of the valve leaflet 1, so as to ensure that the valve leaflet 1 remains flattened after the proximal chuck 22 and the distal chuck 23 clamp the valve leaflet 1 again, thereby ensuring The suture 201 can be stably and accurately implanted into the rough belt at the edge of the leaflet 1, ensuring that the implantation position of the suture 201 is safe and reliable, preventing the suture 201 from being subject to a large leaflet apposition force, and improving the suture 201. and because the thickness of the rough belt is relatively thick, the suture 201 implanted in the rough belt can be subject to a greater anchoring force, so that the suture 201 is not easy to fall off, ensuring the effect of the operation.

It should be noted that, taking the ratio of the area of the first clamping surface 3121 to the area of the leaflet 1 as an example, the range of the ratio is [1/6-1), which means that the area of the first clamping surface 3121 and the area of the leaflet 1 The ratio of the areas of the leaves 1 can be 1/6, or any value greater than 1/6 and less than 1. Preferably, the ratio range of the area of the first clamping surface 3121 to the area of the leaflet 1 and the ratio range of the area of the second clamping surface 3221 to the area of the leaflet 1 are both [1/4-4/5], More preferably, the ratio range is [1/3-4/5], such as 1/2, so that the first clamping surface 3121 and the second clamping surface 3221 are easy to clamp the leaflet 1 and the leaflet 1 is flattened better. The area of the valve leaflet 1 can be obtained by taking the average value of multiple samples. Due to the different leaflet areas of the mitral valve and tricuspid valve, the area of the first clamping surface 3121 and the area of the second clamping surface 3221 are set for different leaflets 1; implant sutures in different leaflets 1 201. Valve repair devices 100 with different specifications can be selected in a targeted manner.

In this application, the distal surface of the proximal clamp 22 cooperates with the proximal surface of the distal clamp 23 to clamp the leaflet 1 again. Optionally, the distal surface of the proximal clamp 22 is parallel to the proximal surface of the distal clamp 23, so as to ensure that when the proximal clamp 22 and the distal clamp 23 clamp the leaflet 1, the The distal surface and the proximal surface of the distal chuck 23 have a larger contact area with the valve leaflet 1 , which is beneficial for the proximal chuck 22 and the distal chuck 23 to clamp the valve leaflet 1 . In one example, the proximal surface of the distal collet 23 is inclined from the collet push rod 21 to the distal end, and the distal surface of the proximal collet 22 is parallel to the proximal surface of the distal collet 23 .

It should be noted that, in the present application, in the working state, the upper clamping part 312 is located on the distal side of the lower clamping part 322, and the first clamping surface 3121 is the direction where the upper clamping part 312 faces the lower clamping part 322. The second clamping surface 3221 is the surface of the lower clamping part 322 facing the upper clamping part 312 . The following is based on this description. The "first", "second" and so on are only for convenience of description, and should not be regarded as limitations on the present application.

Please refer to FIG. 1 to FIG. 6 together. In some embodiments, the upper clamping portion 312 and the lower clamping portion 322 are made of materials with shape memory function. Valve repair device 100 also has a delivery state. In the delivery state, the upper clamping part 312 and the lower clamping part 322 are compressed and deformed and at least partially accommodated in the push catheter 10; The lower clamping part 312 is bent relative to the upper push rod 311, the lower clamping part 322 passes through the pushing catheter 10 and unfolded, the lower clamping part 322 is bent relative to the lower push rod 321, and the upper clamping part 312 and the lower clamping part 322 are located between the distal chuck 23 and the pushing catheter 10 .

It can be understood that both the upper clamping part 312 and the lower clamping part 322 are made of materials with shape memory function, and the upper clamping part 312 and the lower clamping part 322 can keep flattened when they are not subjected to external force (such as As shown in Figure 2), it can be deformed and reduced in volume when subjected to external force (as shown in Figure 4). Therefore, the size of the upper clamping part 312 and the lower clamping part 322 can be designed larger to ensure that the areas of the first clamping surface 3121 and the second clamping surface 3221 in the working state are sufficiently large. In this way, when the first clamping surface 3121 and the second clamping surface 3221 clamp the leaflet 1 (as shown in FIG. 10 ), the two can complete the flattening of the leaflet 1 to avoid folding and stacking of the leaflet 1 . In the working state, the upper clamping part 312 and the lower clamping part 322 are bent radially away from the chuck push rod 21 relative to the upper push rod 311 and the lower push rod 321 (as shown in FIG. 2 ). On the one hand Interference between the upper clamping part 312 and the lower clamping part 322 and the chuck push rod 21 can be avoided, thereby avoiding the situation that the upper clamping part 312 and the lower clamping part 322 cannot be fully expanded due to the obstruction of the chuck push rod 21; On the other hand, since the upper clamping part 312 and the lower clamping part 322 are bent in the same direction relative to the upper push rod 311 and the lower push rod 321, the projection of the upper clamping part 312 and the lower clamping part 322 in the radial direction Having a larger overlapping area or substantially overlapping is beneficial for the upper clamping part 312 and the lower clamping part 322 to clamp the leaflet 1 . Materials with shape memory function can be selected from Ti-Ni-based shape-memory alloys, copper-based shape-memory alloys, iron-based shape-memory alloys, shape-memory polymers, etc., such as nickel-titanium alloys, which are not limited in this application.

When the valve repair device 100 is in the delivery state, the proximal clamp 22 and the distal clamp 23 are in a closed state. Since the upper clamping part 312 and the lower clamping part 322 are compressed and deformed and at least partially accommodated in the pushing catheter 10, the valve The cross-sectional area of the repair device 100 in the radial direction is small; on the one hand, it is beneficial to reduce the size of the surgical trauma caused by the delivery of the valve repair device 100, which is conducive to postoperative rehabilitation of the patient; on the other hand, it is beneficial to avoid the valve repair device 100 from passing through The leaflet 1 of the mitral valve is compressed (as shown in FIG. 10 ) and the leaflet 1 is damaged. After the valve repair device 100 passes through the orifice of the mitral valve, the valve repair device 100 is converted from the delivery state to the working state. The chuck push rod 21 drives the distal chuck 23 to move distally and is in an open state with the proximal chuck 22 . The upper push rod 311 drives the upper clamping part 312 to pass through the distal end of the push catheter 10, and the upper clamping part 312 is bent and unfolded relative to the upper push rod 311 under the action of its own shape memory function; the lower push rod 321 drives All the lower clamping part 322 passes through the distal end of the push catheter 10, and the lower clamping part 322 is bent and unfolded relative to the lower push rod 321 under the action of its own shape memory function; the first clamping surface 3121 is connected with the second clamping surface The holding surface 3221 cooperates to clamp the valve leaflet 1 , and the proximal clamp 22 and the distal clamp 23 cooperate to clamp the valve leaflet 1 again.

5 to 8, in some embodiments, the pushing catheter 10 includes a main body section 11, and the pushing catheter 10 is provided with a push rod cavity 12 and a pushing cavity 111 passing through the opposite ends of the main body section 11 in the axial direction. The rod 21 is movably mounted in the push rod chamber 12 , and the upper push rod 311 and the lower push rod 321 are movably mounted in the push chamber 111 . Further, the push chamber 111 includes an upper push chamber 1111 and a lower push chamber 1112, the upper push chamber 1111 is closer to the push rod chamber 12 than the lower push chamber 1112, the upper push rod 311 is movably mounted in the upper push chamber 1111, and the lower push chamber 1111 is movable. The push rod 311 is movably installed in the lower push cavity 1112 .

It can be understood that since the collet push rod 21, the upper push rod 311 and the lower push rod 321 are movable and respectively installed in different inner cavities of the push catheter 10, it is possible to avoid the collet push rod 21, the upper push rod 311 and the lower push rod 321 Friction or collision occurs when moving in the pushing conduit 10 , ensuring the smoothness of axial movement of the collet push rod 21 , the upper push rod 311 and the lower push rod 321 . In other embodiments, the upper push rod 311 and the lower push rod 321 can also be movably mounted in a push chamber 111 .

In the example shown in FIG. 5 to FIG. 8 , in the working state, both the upper clamping part 312 and the lower clamping part 322 are non-closed ring structures, and the number of the upper push rods 311 and the lower push rods 321 is two. Two opposite ends of the upper clamping portion 312 are respectively connected to the distal ends of the two upper push rods 311 , and opposite ends of the lower clamping portion 322 are respectively connected to the distal ends of the two lower push rods 321 . The upper clamping part 312 forms a stable non-closed ring structure by connecting with the two upper push rods 311 , and the lower clamping part 322 forms a stable non-closed ring structure by connecting with the two lower push rods 321 . The non-closed ring structure can be a non-closed circular ring, a non-closed elliptical ring, a non-closed square ring, a non-closed rectangular ring, etc. The application does not specifically limit the shapes of the upper clamping part 312 and the lower clamping part 322 . It should be noted that the shapes of the upper clamping portion 312 and the lower clamping portion 322 may be the same or different.

Correspondingly, there are two upper push cavities 1111 and lower push cavities 1112, the two upper push cavities 1111 are respectively located on both sides of the push rod cavity 12, and the two lower push cavities 1112 are respectively located on both sides of the push rod cavity 12 . The two upper push rods 311 are movably installed in the two upper push cavities 1111 respectively; the two lower push rods 321 are respectively movably installed in the two lower push cavities 1112 . When the valve repair device 100 is switched from the working state to the delivery state, the two upper push rods 311 are respectively moved axially and proximally in the two upper push chambers 1111 synchronously, which can drive the opposite ends of the upper clamping part 312 along the Move axially toward the proximal end and penetrate into the two upper pushing chambers 1111 respectively until the upper clamping part 312 abuts against the pushing catheter 10 or the proximal chuck 22 and tightens; The pushing cavity 1112 is synchronously moved towards the proximal end in the axial direction, which can drive the opposite ends of the lower clamping part 322 to move towards the proximal end in the axial direction and respectively penetrate into the two lower pushing cavities 1112 until the lower clamping part 322 reaches the proximal end. Connect push catheter 10 or proximal chuck 22 to tighten. Therefore, when the valve repair device 100 is in the delivery state, most of the upper clamping part 312 and the lower clamping part 322 are accommodated in the pushing cavity 111, and a small part is exposed outside the distal end of the pushing cavity 111, that is, exposed to the pushing catheter 10. of the remote exterior.

In other embodiments, the upper push chamber 1111 and the lower push chamber 1112 located on the same side of the push rod chamber 12 can also communicate with each other, that is, the upper push rod 311 and the lower push rod 321 located on the same side of the push rod chamber 12 share one push chamber 111 .

Please refer to FIG. 4 and FIG. 7 , in some embodiments, the proximal clip 22 protrudes from the distal surface 112 of the main body section 11 , and the side wall 221 of the proximal clip 22 and the distal surface 112 of the main body section 11 An avoidance groove 222 is formed between them, and the avoidance groove 222 communicates with the upper pushing chamber 1111 and the lower pushing chamber 1112 . In the conveying state, the upper clamping part 312 is accommodated in the escape groove 222 and the upper pushing cavity 1111 , and the lower clamping part 322 is accommodated in the avoiding groove 222 and the lower pushing cavity 1112 . It can be understood that the proximal clamp 22 can be integrally formed with the pushing catheter 10 ; it can also be fixed with the pushing catheter 10 by welding, which is not limited in this application.

In the example of FIG. 7, the distal outlets of the two upper push cavities 1111 and the two lower push cavities 1112 are located on the distal surface 112 of the main body section 11, and the escape groove 222 communicates with the two upper push cavities 1111 and the two lower push cavities. Push cavity 1112. When the valve repair device 100 is in the delivery state, the proximal chuck 22 and the distal chuck 23 are in a closed state, the part of the upper clamping part 312 exposed outside the pushing catheter 10 is accommodated in the escape groove 222, and the lower clamping part 322 The portion exposed outside the pushing catheter 10 is accommodated in the escape groove 222 . At this time, the upper clamping portion 312 and the lower clamping portion 322 are partially located between the distal end surface of the pushing catheter 10 (ie, the distal end surface of the main body section 11 ) and the proximal end surface of the distal chuck 23 . The design of the escape groove 222 can prevent the upper clamping part 312 and the lower clamping part 322 from interfering with the closing of the proximal clamp 22 and the distal clamp 23, and the proximal clamp 22 and the distal clamp 23 can be relatively closed to almost There is no gap, so that the valve repair device 100 can form a whole with a smooth appearance, which is convenient to reduce the surgical trauma caused by pushing the valve repair device 100 .

In other embodiments, the escape groove 222 may not be provided, that is, the distal surface 112 of the main body section 11 is completely covered by the proximal clamping head 22 . The distal outlets of the two upper push cavities 1111 and the two lower push cavities 1112 are located on the distal side wall of the main body section 11, and the upper clamping portion 312 of the non-closed ring structure passes through the distal outlets of the upper push cavities 1111. The lower clamping part 322 of the non-closed ring structure passes through the distal outlet of the lower pushing chamber 1112 and is exposed to the pushing The distal end of the catheter 10 is external and coiled on the distal side wall of the main body section 11 .

Please refer to FIG. 2 , FIG. 4 and FIG. 9 , in some embodiments, when the valve repair device 100 is in the delivery state, the upper clamping part 312 and the lower clamping part 322 are sequentially stacked in the avoidance groove 222 in the axial direction, in other words , the lower clamping portion 322 is located between the upper clamping portion 312 and the distal end surface 112 of the main body section 11 in the axial direction. Compared with the design in which the upper clamping part 312 and the lower clamping part 322 accommodated in the escape groove 222 are arranged radially, this design reduces the radial dimension of the push catheter 10, thereby reducing the When the radial size of the valve repair device 100 is adjusted, it is more convenient to deliver the valve repair device 100 .

Optionally, when the upper clamping part 312 and the lower clamping part 322 are sequentially stacked in the avoidance groove 222 in the axial direction, the groove depth of the avoidance groove 222 (that is, the size of the avoidance groove 222 in the axial direction) is equal to or greater than that of the upper The sum of the dimensions of the clamping portion 312 and the lower clamping portion 322 in the axial direction.

In the example shown in FIG. 2 and FIG. 4 , the depth of the escape groove 222 is greater than the sum of the dimensions of the upper clamping portion 312 and the lower clamping portion 322 in the axial direction. When the valve repair device 100 in the working state clamps the valve leaflet 1 between the distal surface of the pushing catheter 10 and the proximal surface of the distal chuck 23 through the upper clamping part 312 and the lower clamping part 322 (as shown in the figure 10 ), the leaflet 1 presses against the distal surface of the proximal clamp 22 , and the surface of the upper clamping portion 312 away from the lower clamping portion 322 is substantially flush with the distal surface of the proximal clamp 22 . At this time, the upper clamping part 312 and the lower clamping part 322 clamp the leaflet 1 to completely flatten it. In this way, when the proximal clamp 22 and the distal clamp 23 clamp the valve leaflet 1 again, the upper clamping part 312 is prevented from interfering with the secondary clamping of the distal clamp 23 and the proximal clamp 22 to the valve leaflet 1 , thereby avoiding the situation that the distal clamp 23 and the proximal clamp 22 cannot be closed due to the obstruction of the upper clamping portion 311 to clamp the leaflet 1 .

In the example shown in FIG. 9 , the depth of the escape groove 222 is equal to the sum of the dimensions of the upper clamping portion 312 and the lower clamping portion 322 in the axial direction. The proximal surface of the distal chuck 23 is provided with a relief groove 231 corresponding to the avoidance groove 222 . When the proximal chuck 22 and the distal chuck 23 are in a closed state, the relief groove 231 communicates with the escape groove 222 . Since the upper clamping part 312 and the lower clamping part 322 are accommodated in the escape groove 222, the sum of the dimensions of the two in the axial direction is equal to the groove depth of the avoidance groove 222, when the valve repair device 100 in the working state passes the upper clamp After the holding part 312 and the lower clamping part 322 clamp the leaflet 1 (as shown in FIG. 10 ) between the distal surface of the push catheter 10 and the proximal surface of the distal chuck 23, the leaflet 1 is pressed against the proximal surface. On the distal surface of the end clamp 22, the surface of the upper clamping portion 312 facing away from the lower clamping portion 322 will be farther away from the distal surface 112 of the main body section 11 than the distal surface of the proximal clamp 22. An avoidance groove 231 is designed on the proximal end surface, which can prevent the upper clamping part 312 from interfering with the re-clamping of the valve leaflet 1 by the distal chuck 23 and the proximal chuck 22 .

Please refer to FIG. 6 and FIG. 7 , in some embodiments, the proximal chuck 22 is provided with a push rod channel 223 passing through its opposite end surfaces in the axial direction and communicating with the push rod cavity 12 , and the chuck push rod 21 is axially The movable wear is installed in the push rod cavity 12 and the push rod channel 223 . The chuck push rod 21 moves axially in the push rod cavity 12 and the push rod channel 223 and can drive the distal chuck 23 to move axially, so that the proximal chuck 22 and the distal chuck 23 are relatively separated in the axial direction. combine. In this way, the clamp push rod 21 (as shown in Figure 2 ) can pass through the distal surface of the proximal clamp 22, ensuring that the distal clamp 23 and the proximal clamp 22 have a larger overlapping area or Basically overlapping, it is beneficial for the upper clamping part 312 and the lower clamping part 322 to clamp the leaflet 1 again (as shown in FIG. 10 ).

Please refer to FIG. 11 , in some embodiments, in the working state, the upper clamping part 312 and the lower clamping part 322 are both closed ring structures, and the number of the upper push rod 311 and the lower push rod 321 is one, and the upper The clamping portion 312 is connected to the distal end of the upper push rod 311 , and the lower clamping portion 322 is connected to the lower push rod 321 . In the delivery state, the upper clamping part 312 and the lower clamping part 322 can be fully accommodated in the push cavity 111 (as shown in Figure 7), that is, the upper clamping part 312 and the lower clamping part 322 can be completely accommodated in the push catheter 10 in. In the example of FIG. 11 , the pushing cavity 111 includes an upper pushing cavity 1111 and a lower pushing cavity 1112, the number of the upper pushing cavity 1111 and the lower pushing cavity 1112 is one, and the upper pushing cavity 1111 and the lower pushing cavity 1112 are located in the push rod cavity 12 on the same side. The upper push rod 311 is movably mounted in the upper push chamber 1111, and the lower push rod 321 is movably mounted in the lower push chamber 1112. Since the upper clamping part 312 and the lower clamping part 322 can be compressed and deformed, the upper clamping part 312 The upper push rod 311 can penetrate axially toward the proximal end and be completely accommodated in the upper push chamber 1111; the lower clamping part 322 can axially penetrate the lower push rod 321 toward the proximal end and be completely accommodated in the lower push chamber 1112 in. It can be understood that the upper clamping part 312 and the lower clamping part 322 are provided with an escape position, so as to prevent the upper clamping part 312 and the lower clamping part 322 from covering the proximal clamp 22 and the distal clamp 23, thereby affecting the proximal clamp. The secondary clamping of the valve leaflet 1 by the head 22 and the distal chuck 23 . In other embodiments, the upper pushing cavity 1111 and the lower pushing cavity 1112 may also be located at two sides of the push rod cavity 12 .

It should be noted that, one of the upper clamping portion 312 and the lower clamping portion 322 may also be a closed loop structure, and the other may be an open loop structure, which is not limited in this application.

As shown in Figures 10 and 11, when both the upper clamping portion 312 and the lower clamping portion 322 are annular structures (annular structures include non-closed annular structures and closed annular structures), the first clamping surface 3121 The upper clamping part 312 of the finger faces the outer peripheral surface of the lower clamping part 322, the area of the first clamping surface 3121 is the outer peripheral surface area of the upper clamping part 312, and the second clamping surface 3221 refers to the lower clamping part 322 faces the outer peripheral surface of the upper clamping portion 312 , and the area of the second clamping surface 3221 refers to the outer peripheral surface area of the lower clamping portion 312 . Both the upper clamping part 312 and the lower clamping part 322 are annular structures, which can effectively save materials and reduce costs on the one hand; on the other hand, the upper clamping part 312 and the lower clamping part 322 are easy to deform and have a smaller volume after compression , which is beneficial for the upper clamping part 312 and the lower clamping part 322 to be accommodated in the pushing cavity 111 smoothly.

Please refer to Fig. 12. In some embodiments, in the working state, the upper clamping part 312 and the lower clamping part 322 are both sheet-like structures, and the number of the upper push rod 311 and the lower push rod 321 is one. The holding portion 312 is connected to the distal end of the upper push rod 311 , and the lower clamping portion 322 is connected to the distal end of the lower push rod 321 . In the delivery state, the upper clamping part 312 and the lower clamping part 322 can be fully accommodated in the push cavity 111 (as shown in Figure 7), that is, the upper clamping part 312 and the lower clamping part 322 can be completely accommodated in the push catheter 10 in. In the example of FIG. 12 , the push cavity 111 includes an upper push cavity 1111 and a lower push cavity 1112, the number of the upper push cavity 1111 and the lower push cavity 1112 is one, and the upper push cavity 1111 and the lower push cavity 1112 are located in the push rod cavity 12 on the same side. The upper push rod 311 is movably mounted in the upper push chamber 1111 , and the lower push rod 321 is movably mounted in the lower push chamber 1112 . Since both the upper clamping part 312 and the lower clamping part 322 can be compressed and deformed, the upper clamping part 312 can be inserted into the proximal end along the axial direction with the upper push rod 311 and completely accommodated in the upper pushing cavity 1111; the lower clamping part 322 can be axially inserted into the proximal end along with the lower push rod 321 and completely accommodated in the lower push cavity 1112 . It can be understood that the upper clamping part 312 and the lower clamping part 322 are provided with an escape position, so as to prevent the upper clamping part 312 and the lower clamping part 322 from covering the proximal clamp 22 and the distal clamp 23, thereby affecting the proximal clamp. The secondary clamping of the valve leaflet 1 by the head 22 and the distal chuck 23 . In other embodiments, the upper pushing cavity 1111 and the lower pushing cavity 1112 may also be located at two sides of the push rod cavity 12 .

It should be noted that, one of the upper clamping part 312 and the lower clamping part 322 may be a ring structure, and the other may be a sheet structure, which is not limited in this application.

As shown in FIGS. 10 to 12 , in the working state, the area of the first clamping surface 3121 of the upper clamping portion 312 is larger than the area of the second clamping surface 3221 of the lower clamping portion 322 . In this way, when the upper clamping part 312 and the lower clamping part 322 clamp the leaflet 1, the second clamping surface 3221 can be covered by the first clamping surface 3121, further ensuring that the upper clamping part 312 and the lower clamping part 322 There is sufficient clamping force when the leaflet 1 is clamped, so that the leaflet 1 can be clamped more stably and the leaflet 1 after clamping can be in a better flattened state. In addition, the lower clamping part 322 also plays a role of lifting the leaflet 1, so that the upper clamping part 312 and the lower clamping part 322 can easily clamp the leaflet 1 to ensure that the leaflet 1 is flattened.

When the upper clamping part 312 and the lower clamping part 322 are non-closed ring structures, since the area of the first clamping surface 3121 of the upper clamping part 312 is greater than the area of the second clamping surface 3221 of the lower clamping part 322 , when the upper clamping part 312 and the lower clamping part 322 clamp the leaflet 1, the lower clamping part 322 can press the leaflet 1 into and fix it in the upper clamping part 312, so that the upper clamping part 312 and the lower clamping part The clamping portion 322 can clamp the leaflet 1 more stably.

Please refer to FIG. 13 , in some embodiments, in the working state, there is an angle α between the first clamping surface 3121 and the second clamping surface 3221, and the angle range of the angle α is (0°, 30°] In this way, the upper clamping part 312 and the lower clamping part 322 have sufficient clamping force when clamping the leaflet 1 to ensure that the leaflet 1 is fully flattened after being clamped. In the example of Fig. 13, in In the working state, the upper push rod 311 extends axially, and the upper clamping part 312 is perpendicular to the upper push rod 311, that is, the first clamping surface 3121 of the upper clamping part 312 is perpendicular to the axial direction; the lower push rod 321 extends along the axial direction. The lower clamping part 322 is inclined towards the distal end relative to the lower push rod 321, that is, the second clamping surface 3221 of the lower clamping part 322 has an included angle with the radial direction. Thus, the first clamping surface 3121 and the second clamping surface 3121 There is an angle α between the clamping surfaces 3221 .

It should be noted that the angle range of the angle α between the first clamping surface 3121 and the second clamping surface 3221 is (0°, 30°], which means that the angle α can be 30°, or greater than Any degree between 0° and less than 30°. Preferably, the range of angle α is [5°, 10°].

In other embodiments, the lower clamping portion 322 may also be perpendicular to the lower push rod 321 , and the upper clamping portion 312 is inclined toward the proximal end relative to the upper push rod 311 . Alternatively, the upper clamping portion 312 is inclined toward the proximal end relative to the upper push rod 311 , and the lower clamping portion 322 is inclined toward the distal end relative to the lower push rod 321 . Of course, the first clamping surface 3121 and the second clamping surface 3221 can also be arranged in parallel; for example, the upper clamping part 312 is perpendicular to the upper push rod 311 , and the lower clamping part 322 is perpendicular to the lower push rod 321 .

Please refer to FIGS. 14 to 17 together. In some embodiments, the pusher catheter 10 further includes a connection section 13 connected to the proximal end of the main body section 11 , and the push rod cavity 12 penetrates to the proximal surface of the connection section 13 in the axial direction. , the connecting section 13 is provided with a guide groove 131 communicating with the push cavity 111, the guide groove 131 has an opening extending in the axial direction, the upper clamping member 31 also includes an upper operating member 313 connected to the proximal end of the upper push rod 311, and the lower clamping The member 32 also includes a lower operating member 323 connected to the proximal end of the lower push rod 321 . The upper operating member 313 and the lower operating member 323 are disposed in the guide groove 131 and partially exposed to the outside of the pushing catheter 10 from the opening of the guide groove 131 . In this way, the operator can control the upper push rod 311 and the lower push rod 321 to move axially in the push cavity 111 by controlling the upper operating member 313 and the lower operating member 323 to move axially in the guide groove 131 outside the push catheter 10 . To move to, and then control the upper clamping part 312 and the lower clamping part 322 to be accommodated in the pushing cavity 111 or control the upper clamping part 312 and the lower clamping part 322 to go out of the pushing cavity 111 for clamping operation. Moreover, due to the limitation of the opening of the guide groove 131, the upper push rod 311 and the lower push rod 321 will not rotate when they move axially in the push cavity 111, ensuring that the upper clamping portion passing out from the far end of the push cavity 111 312 and the lower clamping part 322 will not shift, which is beneficial to the clamping of the upper clamping part 312 and the lower clamping part 322, thereby avoiding secondary adjustments to the upper clamping part 312 and the lower clamping part 322, reducing Difficulty of the operation.

It should be noted that, since the push rod cavity 12 penetrates through the proximal end surface of the connecting section 13 in the axial direction, the proximal end of the chuck push rod 21 (as shown in FIG. 10) through the proximal end.

Further, the guide groove 131 includes an upper guide groove 1311 and a lower guide groove 1312 extending axially, the upper guide groove 1311 communicates with the upper push chamber 1111, and the upper push rod 311 is movably mounted in the upper push chamber 1111 and the upper guide groove 1311 , the upper operating part 313 is located in the upper guide groove 1311 and is exposed to the outside of the push catheter 10 from the opening of the upper guide groove 1311; the lower guide groove 1312 communicates with the lower push cavity 1112, and the lower push rod 321 is movable and installed in the lower push cavity 1112 And in the lower guiding groove 1312 , the lower operating member 323 is disposed in the lower guiding groove 1312 and exposed to the outside of the pushing catheter 10 from the opening of the lower guiding groove 1312 . In this way, since the upper operating member 313 and the lower operating member 323 move axially in the upper guide groove 313 and the lower guide groove 323 respectively, on the one hand, avoid friction or collision when the upper operating member 313 and the lower operating member 323 move axially. , to ensure the smoothness of the axial movement of the upper operating member 313 and the lower operating member 323; on the other hand, the axial size of the pushing catheter 10 is effectively reduced, and the size of the valve repair device 100 (as shown in FIG. 1 ) is further reduced. It facilitates the miniaturization design of the valve repair device 100 .

In the examples shown in Figures 14 to 17, since the upper clamping part 312 and the lower clamping part 322 are non-closed ring structures in the working state, the upper push rod 311, the lower push rod 321, the upper push chamber 1111 and the lower push rod The number of push chambers 1112 is two, the two upper push chambers 1111 are located on both sides of the push rod chamber 12, the two lower push chambers 1112 are located on both sides of the push rod chamber 12, and the two upper push chambers 1111 are compared to The two lower push cavities 1112 are closer to the push rod cavity 12 . Therefore, the number of the upper guide groove 1311 and the lower guide groove 1312 is also two. The two upper guide grooves 1311 are respectively located on both sides of the push rod chamber 12, and communicate with the two upper push chambers 1111 respectively; The cavity 1111 is connected, and the two upper guide slots 1311 are closer to the push rod cavity 12 than the two lower guide slots 1312 .

There is one upper operating member 313 and one lower operating member 323 , the proximal ends of the two upper push rods 311 are connected to the upper operating member 313 , and the proximal ends of the two lower push rods 313 are connected to the lower operating member 323 . Both the upper operating part 313 and the lower operating part 323 are semicircular and fit to the connecting section 13 , and the axial projections of the upper operating part 313 and the lower operating part 323 on the proximal surface of the connecting section 13 do not overlap. In this way, friction or collision between the upper operating member 313 and the lower operating member 323 when moving axially in the guide groove 131 is further avoided, and the smooth axial movement of the upper operating member 313 and the lower operating member 323 is further ensured. The present application does not specifically limit the shapes of the upper operating member 313 and the lower operating member 323 , which may also be in other shapes, such as semi-ellipse, and the shapes of the upper operating member 313 and the lower operating member 323 may also be different.

Further, the guide groove 131 extends axially to the proximal end surface of the connecting section 13 . In the examples shown in FIG. 14 to FIG. 17 , the upper guide groove 1311 and the lower guide groove 1312 respectively penetrate to the proximal end surface of the connecting section 13 along the axial direction. In this way, when the pre-clamping assembly 30 (as shown in FIG. 5 ) is installed in the push catheter 10, the upper push rod 311 can be movably installed in the upper push cavity 1111, and the proximal end of the upper push rod 311 can pass through the upper push rod 1111. The guide groove 1311 passes through the proximal end of the connecting section 13; then the upper operating member 313 is installed on the proximal end of the upper push rod 311, and the upper operating member 313 is axially pushed toward the distal end until the upper operating member 313 penetrates the upper guide groove 1311 is partly exposed from the opening of the upper guide groove 1311, so that the upper clamping part 31 is installed on the pushing conduit 10; similarly, the lower clamping part 32 is installed in the pushing conduit 10, which is convenient for assembly and reduces the assembly time.

In other embodiments, the number of the upper operating member 313 and the lower operating member 323 can also be two, the proximal end of each upper push rod 311 is connected to one upper operating member 313, and the proximal end of each lower push rod 313 is connected to the upper operating member 313. A lower operating member 323 is connected. Certainly, the number of the upper operating member 313 and the lower operating member 323 may also be different; for example, the number of the upper operating member 313 is one, and the number of the lower operating member 323 is two.

In other embodiments, the upper guide groove 1311 and the lower guide groove 1312 located on the same side of the push rod cavity 12 can communicate with each other, that is, the upper operating part 313 and the lower operating part 323 located on the same side of the push rod cavity 12 share a guide groove 131, The upper push rod 311 and the lower push rod 321 located on the same side of the push rod cavity 12 are movably mounted in the same guide groove 131 .

In other embodiments, the number of guide grooves 131 can also be one, that is, the guide grooves 131 penetrate the peripheral wall of the connecting section 13 in the radial direction and communicate with the two upper push cavities 1111 and the two lower push cavities 1112, so that the guide grooves 131 There are two openings in the radial direction. The upper operating part 313 is partially exposed to the outside of the push conduit 10 from an opening of the guide groove 131; the lower operating part 323 is partially exposed to the outside of the push conduit 10 from the other opening of the guide groove 131, and the two lower push rods 321 and the upper operation Both the member 313 and the lower operating member 323 are movably fitted in the same guide groove 131 .

Please refer to FIG. 1 and FIG. 17 to FIG. 20 together. In some embodiments, the valve repair device 100 further includes a handle assembly 40, and the handle assembly 40 includes an upper connection knob 41 and a lower connection knob 42 sleeved on the connection section 13, The upper connecting knob 41 is threaded to the upper operating member 313 , and the lower connecting knob 42 is threaded to the lower operating member 323 . In this way, the operator can respectively control the axial movement of the upper operating member 313 and the lower operating member 323 by turning the upper connection knob 41 and the lower connection knob 42 respectively, and the operation is simple.

17 to 20, the upper operating part 313 and the lower operating part 323 are provided with external threads, and the external threads are respectively exposed to the push conduit 10 through the opening of the upper guide groove 1111 and the opening of the lower guide groove 1112. external. The upper connection knob 41 and the lower connection knob 42 are respectively provided with internal thread holes corresponding to the external threads. The internally threaded hole of the upper connecting knob 41 is connected with the external thread of the upper operating part 313, and the internally threaded hole of the lower connecting knob 42 is connected with the external thread of the lower operating part 323, so that the two can be controlled synchronously by turning the upper connecting knob 41. The upper push rod 311 moves in the axial direction to control the upper clamping part 321 to move in the axial direction; by turning the lower connection knob 42, the two lower push rods 321 can be synchronously controlled to move in the axial direction to control the lower clamping part 322 to move in the axial direction. axial movement.

It should be noted that when the upper clamping part 312 and the lower clamping part 312 clamp the valve leaflet 1, the upper clamping part 312 is farther away from the proximal end than the lower clamping part 322, and the upper connecting knob 41 is farther away from the proximal end than the lower connecting knob 41. 42 should be further away from the proximal end of the pushing catheter 10 in the axial direction, which is beneficial to reduce the axial dimension of the upper clamping member 311, save materials and reduce costs.

Please refer to FIG. 1 and FIG. 17 to FIG. 20 , in some embodiments, the handle assembly 40 further includes a first stop ring 43 , a second stop ring 44 and a third stop ring fixedly sleeved on the connecting section 13 451 , the upper connection knob 41 is axially limited between the first stop ring 43 and the second stop ring 44 , and the lower connection knob 42 is axially limited between the second stop ring 44 and the third stop ring 45 . In this way, it is ensured that the upper connecting knob 41 and the lower connecting knob 42 can only rotate but not move axially, so that the upper operating member 313 and the lower operating member 323 can be controlled axially by rotating the upper connecting knob 41 and the lower connecting knob 42 respectively. move.

In the example shown in Fig. 1 and Fig. 17 to Fig. 20, the first stop ring 43 is fixedly set on the connection position between the connecting section 13 and the main body section 11, the connecting section 13 is provided with a card slot 132, and the second stop ring 44 is set in the card slot 132 . Specifically, the second stop ring 44 includes a detachable first stop part 441 and a second stop part 442, the first stop part 441 is provided with a through hole, and the second stop part 442 is provided with a hole suitable for the through hole. When assembling the protruding column, first snap the first stop part 441 into the slot 132, and then insert the protruding post of the second stop part 442 into the through hole of the first stop part 441, so that the second stop part 441 The second stop ring 44 is set in the card groove 132, and the second stop ring 44 is fixed axially relative to the connecting section 13 through the limit of the card groove 132; in addition, the detachable first stop part 441 and the second stop part Part 442 is easy to disassemble. It should be noted that the axial distance between the second stop ring 44 and the first stop ring 43 is adapted to the axial length of the upper connecting knob 41 . The third stop ring 451 is sleeved on the proximal end of the connecting section 13, and the axial distance between the second stop ring 44 and the third stop ring 451 is adapted to the axial length of the lower connection knob 42 for the upper connection. The knob 41 and the lower connecting knob 42 are axially limited.

Please refer to Fig. 5, Fig. 21 and Fig. 22 together, the handle assembly 40 (as shown in Fig. 1 ) also includes a connection structure 45 and a housing 46 fixedly connected with the connection structure 45, the connection structure 45 includes the third stop The ring 451, the proximal end of the connecting section 13 is passed through the connecting structure 45, the chuck assembly 20 also includes a chuck operating member 24 connected to the proximal end of the chuck push rod 21, and the chuck operating member 24 is arranged on the housing 46 . In this way, the pushing catheter 10 is integrally connected with the casing 46 through the connecting structure 45 . The design of the housing 46 is convenient for the operator to hold, thereby facilitating the operator to operate the valve repair device 100 . The design of the collet operating member 24 is convenient for the operator to control the axial movement of the collet push rod 21 , thereby facilitating the relative opening and closing of the proximal collet 22 and the distal collet 23 .

Please refer to Fig. 21 and Fig. 22, in some embodiments, the connecting structure 45 includes a first connecting part 452 and a second connecting part 453, the third stop ring 451 is arranged at the distal end of the first connecting part 452, and the first connecting part 452 The piece 452 is provided with a matching groove 4521 axially penetrating through its opposite end surfaces, the second connecting piece 453 is provided with an installation groove 4531 axially penetrating its opposite end surfaces, and the proximal end of the connecting section 452 is fixedly mounted in the matching groove 4521 Among them, the first connecting piece 452 is fixedly mounted in the installation groove 4531 , and the housing 46 is fixedly sleeved outside the second connecting piece 453 .

It can be understood that the shell 46 is fixedly sleeved outside the second connecting piece 453, the first connecting piece 452 is fixedly inserted into the installation groove 4531 of the second connecting piece 453, and the first connecting piece 452 is connected to the shell through the second connecting piece 453. The body 46 is fixed; the proximal end of the connecting section 452 is fixed and fitted in the matching groove 4521 of the first connecting piece 452, and the proximal end of the connecting section 452 is fixed with the housing 46 through the first connecting piece 452, so that the pushing catheter 10 can pass through the connection Structure 45 is connected to housing 46 . At this time, the third stop ring 451 is axially fixed relative to the connecting section 13 .

In the example shown in Fig. 21 and Fig. 22, the fitting groove 4521 extends axially and runs through the opposite end surfaces of the third stop ring 451, and a plurality of bosses 4522 are arranged in the fitting groove 4521, and the plurality of bosses 4522 can be arranged along the shaft. Slide one by one and engage in the two upper guide grooves 1311 and the two lower guide grooves 1312, so that the proximal end of the connecting section 13 can be fixedly mounted in the third stop ring 451 and the first connecting piece 452, and the structure Simple and low processing cost.

Furthermore, when the first connecting piece 452 is fixedly installed in the installation groove 4531, and the proximal end of the connecting section 13 is fixedly installed in the matching groove 4521 of the first connecting piece 452, the proximal surface of the connecting section 13, the first The proximal end surface of the connecting piece 452 and the proximal end surface of the second connecting piece 453 are substantially flush, so as to prevent the slender piece installed in each lumen of the pushing catheter, such as the clamping push rod, from hanging in the air and becoming unstable.

Referring to FIG. 5 , FIG. 23 and FIG. 24 , in some embodiments, the housing 46 includes an upper housing 461 and a lower housing 462 that are detachably closed. After the pushing catheter 10 is assembled with the connecting structure 45 , the housing 46 is fixedly sleeved outside the second connecting member 453 . The collet push rod 21 passes through the proximal end surface of the connecting section 13, the proximal end of the collet push rod 21 is located in the housing 46, and the collet operating part 24 arranged at the proximal end of the collet push rod 21 passes through radially The housing 46 can move axially on the housing 46 . When the operator holds the housing 46, the axial movement of the chuck push rod 21 can be controlled by axially sliding the chuck operating member 24 outside the housing 46, which is simple and convenient to operate. In addition, the detachable design of the upper shell 461 and the lower shell 462 is convenient for assembly and disassembly.

Please refer to FIG. 5, FIG. 7, FIG. 8 and FIG. 25 together. In some embodiments, the valve repair device 100 further includes a puncture assembly 50, and the puncture assembly 50 includes a puncture push rod 51 and a The puncture needle 52 disposed at the distal end of the puncture push rod 51 can be connected with the suture 201 , and the puncture needle 52 is used to puncture the leaflet 1 (as shown in FIG. 10 ) to implant the suture 201 into the leaflet 1 .

It can be understood that after the proximal chuck 22 and the distal chuck 23 clamp the valve leaflet 1 again, the puncture needle 52 can puncture the valve leaflet 1 and connect with the suture 201, and the puncture push rod 61 can drive the suture 201 to be implanted. leaflet 1.

Further, the pushing catheter 10 is provided with a puncture cavity 113 axially penetrating through its opposite two ends, and the proximal chuck 22 is provided with a puncture channel 224 axially penetrating its opposite two surfaces, the puncture cavity 113 and the puncture channel 224 are one by one Corresponding to the communication, the puncture push rod 51 is movably installed in the puncture cavity 113 and the puncture channel 224 . The puncture push rod 51 can drive the puncture needle 52 to pass through the distal surface of the proximal chuck 22 from the puncture channel 224 to puncture the leaflet 1, and then connect with the suture 201, and drive the suture 201 to implant the leaflet 1, It is ensured that the puncture needle 52 can stably puncture the leaflet 1 .

Referring to FIG. 5 , FIG. 10 , FIG. 25 and FIG. 26 , the embodiment of the present application also provides a suture assembly 200 , which includes the above-mentioned suture 201 and sleeve 202 . The suture 201 includes a first end 2011 and a second end 2012, the first end 2011 and/or the second end 2012 are fixedly connected to the sleeve 202, the suture 201 is accommodated in the chuck push rod 21 and the distal chuck 23, The sleeve 202 is accommodated in the distal clamp 23 , and the sleeve 202 is used for fixed connection with the puncture needle 52 . In this way, after the proximal chuck 22 and the distal chuck 23 clamp the leaflet 1 again, push the puncture push rod 51 toward the distal end to drive the puncture needle 52 to puncture the leaflet 1 and then connect the sleeve 202, so that the puncture needle 52 connects the seam thread 201 , at this time, withdrawing the puncture push rod 51 toward the proximal end can drive the puncture needle 52 to retreat, and then drive the sleeve 202 to pass through the leaflet 1 , thereby implanting the suture 201 into the leaflet 1 . Since the puncture needle 52 and the suture 201 form a stable and reliable indirect connection through the sleeve 202, the suture 201 is not easy to be separated from the puncture needle 52, and the operator can quickly and easily pull the end or both ends of the suture 201 connected to the sleeve 202. A suture 201 is implanted on the valve leaflet 1 to a predetermined position.

In the example shown in Fig. 5 and Fig. 25, the first end 2011 and the second end 2012 of the suture 201 are provided with a sleeve 202, correspondingly, the puncture push rod 51, the puncture needle 52, the puncture cavity 113 and the puncture channel 224 The number is two, the two puncture needles 52 are respectively arranged at the distal ends of the two puncture push rods 51, the two puncture cavities 113 are respectively connected with the two puncture channels 24 axially, and each puncture push rod 51 is movably mounted on the In a puncture cavity 113 and a puncture channel 24 . The two sleeves 202 correspond to the two puncture needles 52 one by one.

Please refer to FIG. 26 , the chuck push rod 21 is provided with a through suture channel 211 along its axial direction. The distal chuck 23 is provided with two suture receiving holes (not shown in the figure) and two sleeve holes 232 penetrating through its proximal end surface. The two suture receiving holes are connected with the suture channel 211. The barrel holes 232 are in axial communication with the two suture receiving holes respectively. The suture 201 is accommodated in the suture channel 211 and the two suture receiving holes, that is, the suture 201 is accommodated in the chuck push rod 21 and the distal chuck 23 . The two sleeves 202 arranged at the first end 2011 and the second end 2012 are respectively accommodated in the two sleeve holes 232, that is, the two sleeves 202 are both accommodated in the distal chuck 23, and the sleeve 202 is used for The end connected to the puncture needle 52 (that is, the end away from the suture 201 ) faces the proximal clamp 22 .

Optionally, the sleeve 202 and the puncture needle 52 may also be fixedly connected by methods including but not limited to threaded connection, bonding, rough surface friction connection, interference fit and the like. The first end 2011 and the second end 2012 of the suture 201 can be fixedly connected to the sleeve 202 by means including but not limited to knotting, winding, welding, bonding, snapping and the like. The material of the suture 201 may be a polymer material compatible with the human body or a relatively soft metal material. Preferably, the suture 201 implanted in the human body is made of polymer materials such as PET (polyethylene terephthalate, Polyethylene Glycol Terephthalate), e-PTFE (expanded polytetrafluoroethylene, Expanded PTFE).

Please refer to FIG. 5, FIG. 7 and FIG. 31 together. In some embodiments, the valve repair device 100 further includes a support assembly 60, and the support assembly 60 includes a support arm 61 that is movably worn in the push catheter 10 and is located on the support arm. 61 a support member 62 at the far end. The support member 62 is made of elastic and/or flexible material, the support arm 61 is used to drive the support member 62 to pass through the distal side wall of the pushing catheter 10 , and the support member 62 is used to support the leaflet 1 . The support 62 can stabilize the pulsating leaflet 1, greatly reduce the range of motion of the leaflet 1, ensure that the upper clamping part 312 and the lower clamping part 322 can stably pre-clamp the leaflet 1, and ensure that the proximal clamping The head 22 and the distal chuck 23 can stably clamp the leaflet 1 for a second time, thereby ensuring that the valve repair device 100 can treat mitral valve regurgitation stably and reliably.

In the examples shown in FIG. 5 , FIG. 7 and FIG. 31 , the pushing catheter 10 is axially provided with a support arm lumen 114 penetrating through its distal end surface. The support arm cavity 114 includes a support member outlet 1141 , and the support member outlet 1141 is provided on the distal side wall of the main body section 11 , that is, the support member outlet 1141 is provided on the distal side wall of the push catheter 10 . The support arm 61 is movably installed in the support arm cavity 114 , that is, the support arm 61 is movably installed in the pushing catheter 10 . Since the support member 62 is made of elastic and/or flexible material, the support member 62 can be compressed and deformed, and the support member 62 can be compressed and accommodated in the support arm cavity 114 . The axial movement of the support arm 61 toward the distal end drives the support member 62 accommodated in the support arm cavity 114 to pass through the support member outlet 1141 , that is, the support member 62 passes through the distal side wall of the pushing catheter 10 . The support member 62 stretches under its own elastic action, the volume of the support member 62 becomes larger, and its contact area with the leaflet 1 increases, so that the leaflet 1 can be stably supported to stabilize the beating leaflet 1, The range of motion of the leaflet 1 is greatly reduced, ensuring that the proximal chuck 22 and the distal chuck 22 can clamp the leaflet stably and reliably. It can be understood that the support member 62 made of elastic and/or flexible material can adapt to the anatomical structure of the leaflet 1 and the range of motion of the leaflet 1, so as to prevent the leaflet 1 from being damaged by the support member 62.

Preferably, the support member 62 is made of a material with a shape memory function, and the material with a shape memory function can be selected from Ti-Ni-based shape memory alloys, copper-based shape memory alloys, iron-based shape memory alloys, and shape-memory polymers. etc., such as nickel-titanium alloy, the present application does not make any limitation on this. In the example of FIG. 31 , the support member 62 is a mesh balloon braided by a plurality of nickel-titanium wires. In other embodiments, the support member 62 can also be extended into a columnar shape, a nest shape, an oblate shape, a disk shape and other closed structures capable of supporting the valve leaflet 1, which are not specifically limited in this application.

Please refer to FIG. 5, FIG. 7, FIG. 8 and FIG. 25 together. In some embodiments, the valve repair device 100 further includes a probe assembly 70, and the probe assembly 70 includes at least one probe 71, and the probe 71 is movable In the pushing catheter 10, the proximal chuck 22 is provided with a probe passage 225, the distal chuck 23 is provided with a probe receiving hole 233 opposite to the probe passage 225, and the distal chuck 23 and the proximal chuck 22 are closed. , the distal end of the probe 71 can protrude from the probe channel 225 and be accommodated in the probe receiving hole 233 .

In this way, when the valve leaflet 1 (as shown in FIG. 10 ) is not clamped between the proximal clamp 22 and the distal clamp 23 and closed, the probe 71 can pass through the proximal clamp from the probe passage 225 axially. The head 22 is accommodated in the probe accommodation hole 233 . When the valve leaflet 1 is clamped between the proximal chuck 22 and the distal chuck 23, and the leaflet edge 1 is in contact with the chuck push rod 21, the distal end of the probe 71 is drawn from the proximal end of the proximal chuck 22. After the end surface passes through, it will be blocked by the leaflet 1 and cannot continue to advance to the distal end, which shows that the clamping effect of the leaflet 1 is better. At this time, the puncture assembly 50 can be operated to puncture the leaflet 1 to implant the suture 201 (as shown in FIG. 26 ) into the leaflet 1 . Moreover, the distal end of the probe 71 is blocked by the leaflet 1 and cannot enter the probe receiving hole 233 , which also indicates that the position between the edge of the leaflet 1 and the suture 201 is relatively fixed, which improves the reliability of the implantation of the suture 201 . The clamping effect of the leaflet 1 can be effectively detected by the probe 71, and the structure of the probe 71 is simple and easy to operate.

Further, the pushing catheter 10 is provided with a probe lumen 115 extending axially through its proximal and distal surfaces. The probe channel 225 runs through the opposite end surfaces of the proximal chuck 22 in the axial direction and communicates with the probe cavity 115 in the axial direction. The central axes of the probe channel 225 and the probe cavity 115 are collinear, that is, the probe receiving hole 233 is opposite to the probe channel 225 . The probe 71 is movably installed in the probe chamber 115 and the probe channel 225 , and can extend out from the probe channel 225 and be accommodated in the probe receiving hole 233 . Therefore, the probe 71 can be movably worn in the pushing catheter 10 .

In the examples shown in FIG. 5 , FIG. 7 , FIG. 8 and FIG. 25 , there are two probes 71 , and the two probes 71 extend along the axial direction and are arranged side by side relative to the axial direction. Correspondingly, there are two probe cavities 115, probe passages 225, and probe receiving holes 233, and the two probe cavities 115 are in axial communication with the two probe passages 225, and each probe receiving hole 233 The central axis of a probe chamber 115 and the central axis of a probe channel 225 are collinear. Each probe 71 is movably mounted in a probe cavity 115 and a probe channel 225 , and can protrude from the probe channel 225 to be accommodated in a probe receiving hole 233 . In other embodiments, the number of probes 71 can be one, or more, such as three, four, etc.; One, three or four, etc., the present application does not limit this.

Referring to FIG. 5 , FIG. 23 and FIG. 24 , in some embodiments, the handle assembly 40 (as shown in FIG. 1 ) further includes a sealing structure 47 disposed between the second connecting member 453 and the housing 46 . The sealing structure 47 includes a sealing tube 471 , a fixed sleeve 472 , a sealing gasket 473 and a sealing nut 474 . The sealing tube 471 is sleeved on the proximal end of the second connecting piece 453, the fixed sleeve 472 is fixedly sleeved on the distal end of the second connecting piece 453, and the distal end of the sealing tube 471 is threadedly connected to the proximal end of the fixing sleeve 472, so that The sealing tube 471 is sealed and fixedly connected to the second connecting member 453 . The lumen of the sealing tube 471 communicates with each lumen of the pushing catheter 10 . The sealing tube 471 is accommodated in the casing 46 and fixedly connected with the upper casing 461 and the lower casing 462 , and the casing 46 is fixedly sleeved outside the second connecting member 453 through the sealing tube 471 .

The proximal inner cavity of the sealing tube 471 is provided with a receiving groove 4711 , and the sealing gasket 473 is accommodated in the receiving groove 4711 . The sealing nut 474 is screwed to the proximal end of the sealing tube 471 , and the sealing nut 474 presses against the sealing gasket 473 so that the sealing gasket 473 is fixed in the receiving groove 4711 . The sealing gasket 473 is used to seal the proximal opening of the sealing tube 471 . Since the sealing tube 471 has a certain axial length, there is a distance between the sealing gasket 473 and the proximal end surface of the pushing catheter 10 .

The sealing gasket 473 is provided with a plurality of through holes, and the plurality of through holes communicate with each lumen of the pushing catheter 10 one by one. The collet push rod 21 , the puncture push rod 51 , the support arm 61 , and the probe 71 , which pass through the proximal end surface of the push catheter 10 , can penetrate into the inner cavity of the sealing tube 471 , and are movably installed in the sealing gasket 473 . in a through hole. Due to the deformability of the sealing gasket, there will be no gap between the chuck push rod 21, the puncture push rod 51, the support arm 61, the probe 71 and the through hole of the sealing gasket 473, so as to ensure the tightness of the sealing tube 471 . It should be noted that the sealing gasket 473 may be a flexible silicone gasket or other flexible gaskets made of other materials, which is not limited in this application.

As shown in Figure 5, the sealing tube 471 is provided with an exhaust joint 4712 connected to its inner cavity, and the exhaust joint 4712 is used to connect an exhaust pipe (not shown in the figure) to empty each push catheter 10 by filling it with liquid such as physiological saline. The air in the inner cavity can avoid air embolism caused by entering the venous system with the blood circulation of the human body after the valve repair device 100 enters the human body, so as to ensure the safety of the operation.

Please refer to Fig. 2, Fig. 5 and Fig. 26 to Fig. 33 together. Taking the implantation of suture 201 through the apex of the anterior leaflet 1b of the mitral valve leaflet 1 as an example, the valve repair provided by the embodiment of the present application will be described. The process of using the device 100.

S1. Referring to FIG. 27 , the valve repair device 100 in the delivery state is introduced into the left ventricle 2 along the apical puncture port, and then enters the left atrium 3 through the mitral valve orifice.

S2. Please refer to FIG. 28, push the chuck operating member 24 toward the distal end in the axial direction, and drive the distal chuck 23 to move toward the distal end, so that the distal chuck 23 and the proximal chuck are in an open state; then, move the The support member 62 passes through the distal side wall of the push catheter 10, and the support member 62 is fully unfolded; then the upper connecting knob 41 is rotated, and the upper clamping part 312 is completely passed through and unfolded from the distal end of the push catheter 10; then, continue Turn the upper connecting knob 41 , and the upper clamping part 312 moves distally until the distal surface of the upper clamping part 312 is flush with the proximal surface of the distal chuck 23 .

S3. Referring to FIG. 29 , the valve repair device 100 is withdrawn until the support member 62 supports the anterior leaflet 1b for leaflet positioning and support.

S4, please refer to Fig. 30 and Fig. 31, turn the lower connection knob 42, pass the lower clamping part 322 from the distal end of the push catheter 10 and unfold it; then, continue to rotate the lower connection knob 42 until the lower clamping part 322 Fully expand and close to the front leaflet 1b to reposition the leaflet 1.

S5. Please refer to Figure 31 and Figure 32, turn the upper connection knob 42, and the upper clamping part 312 moves towards the proximal end until the upper clamping part 312 and the lower clamping part 322 clamp the front leaf 1b, at this time, the front leaf 1b Completely flattened into a horizontal state; then, retract the chuck operating part 24 toward the proximal end in the axial direction, and drive the distal chuck 23 to move toward the proximal end until the distal chuck 23 and the proximal chuck 22 are clamped again. Leaf 1b.

S6, please refer to Fig. 2, the operation probe 71 passes through the distal surface of the proximal chuck 22, and the probe 71 detects whether the anterior lobe 1b has been clamped by the distal chuck 23 and the proximal chuck 22, if If not clamped, repeat step S5 until the probe 71 detects that the anterior leaflet 1b has been clamped by the distal chuck 23 and the proximal chuck 22, and proceed to step S7; if it has been clamped, directly proceed to step S7 .

S7. Referring to Fig. 2, Fig. 5, Fig. 26 and Fig. 33, push the puncture push rod 51 to move toward the distal end, so that the puncture needle 52 is connected to the sleeve 202 accommodated in the distal chuck 23 after piercing the front leaf 1b , the puncture needle 52 forms a connection with the suture 201 through the sleeve 202; then, the retreating puncture push rod 51 moves toward the proximal end, so that the suture 201 connected with the puncture needle 52 moves toward the proximal end and passes through the front leaf 1b, the slit The wire 201 is implanted in the anterior lobe 1b.

S8. Please refer to Fig. 31 to Fig. 33, push the collet operating part 24 toward the distal end in the axial direction, so that the distal collet 23 and the proximal clamping 22 are in an open state, and the proximal collet 22 and the distal collet 23 no longer clamp the anterior leaflet 1b; then, turn the upper connection knob 41, the upper clamping part 312 moves toward the distal end, and the upper clamping part 312 and the lower clamping part 322 no longer clamp the anterior leaflet 1b; then withdraw the valve Repair device 100 below the papillary muscle; then, turn the upper connection knob 41 and the lower connection knob 42, so that the upper clamping part 312 and the lower clamping part 322 are accommodated in the pushing catheter 10; then, the operating support 62 is self-supporting The outlet 1141 is accommodated in the pushing catheter 10; then the chuck operating member 24 is retracted axially toward the proximal end until the proximal chuck 22 and the distal chuck 23 are in a closed state; finally, the valve repair device 100 is withdrawn from the left The ventricle 2 is out of the body, and the suture 201 is left in the left ventricle 3 as an artificial chord to replace the broken or diseased chord to treat mitral valve regurgitation.

In the description of this specification, descriptions referring to the terms "one embodiment", "some embodiments", "exemplary embodiments", "examples", "specific examples", or "some examples" etc. mean that the embodiments are combined Specific features, structures, materials, or characteristics described in or examples are included in at least one embodiment or example of the present application. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the described specific features, structures, materials or characteristics may be combined in any suitable manner in any one or more embodiments or examples.

Although the embodiments of the present application have been shown and described, those skilled in the art can understand that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principle and spirit of the present application. The scope of the application is defined by the claims and their equivalents.

Claims

A valve repair device capable of secondary clamping, characterized in that it comprises:

push catheter;

A chuck assembly, the chuck assembly includes a chuck push rod movably mounted in the push catheter and a proximal chuck and a distal chuck that can be opened and closed relatively, the proximal chuck is arranged on the Pushing the distal end of the catheter, the distal chuck is located at the distal end of the chuck push rod; and

A pre-clamping component, the pre-clamping component includes an upper clamping part and a lower clamping part, the upper clamping part includes an upper push rod that is movably worn in the push guide tube and is located on the upper push rod The upper clamping part at the distal end, the lower clamping part includes a lower push rod that is movably worn in the pushing catheter and a lower clamping part that is arranged at the distal end of the lower push rod;

The valve repair device has a working state, and in the working state, the upper clamping part and the lower clamping part are located outside the distal end of the pushing catheter, and the upper clamping part has a first clip The lower clamping part has a second clamping surface, the first clamping surface cooperates with the second clamping surface to clamp the leaflet, the proximal clamping head and the distal clamping The head cooperates to clamp the valve leaflet again;

Wherein, the ratio range of the area of the first clamping surface to the area of the leaflet is [1/6-1); the ratio range of the area of the second clamping surface to the area of the leaflet is [1/6-1).
The valve repair device capable of secondary clamping according to claim 1, wherein, in the working state, the lower clamping part is located between the upper clamping part and the pushing catheter, and the The area of the first clamping surface is greater than the area of the second clamping surface.
The valve repair device capable of secondary clamping according to claim 1, characterized in that, in the working state, there is an angle between the first clamping surface and the second clamping surface, so The angle range of the included angle is (0°, 30°].
The valve repair device capable of secondary clamping according to claim 1, characterized in that, in the working state, the upper clamping part is a sheet structure or a ring structure, and the lower clamping part is Sheet structure or ring structure.
The valve repair device that can be clamped twice according to claim 1, wherein the upper clamping part and the lower clamping part are made of materials with shape memory function, and the valve repair device also has delivery status;

In the conveying state, the upper clamping part and the lower clamping part are compressed and deformed and at least partially accommodated in the pushing catheter;

In the working state, the upper clamping part passes through the pushing conduit and unfolds, the upper clamping part bends relative to the upper push rod, and the lower clamping part passes through the pushing tube completely. The catheter is unfolded, the lower clamping part is bent relative to the lower push rod, and the upper clamping part and the lower clamping part are both located between the distal chuck and the pushing catheter.
The valve repair device capable of secondary clamping according to claim 5, wherein the pushing catheter comprises a main body section, and the pushing catheter is provided with a push rod cavity axially penetrating through opposite end surfaces of the main body section As well as a pushing chamber, the chuck push rod is movably mounted in the push rod chamber, and the upper push rod and the lower push rod are movably mounted in the push chamber.
The valve repair device capable of secondary clamping according to claim 6, wherein the pushing cavity includes an upper pushing cavity and a lower pushing cavity, and the upper pushing cavity is closer to the lower pushing cavity than the lower pushing cavity. The push rod chamber, the upper push rod is movably mounted in the upper push chamber, and the lower push rod is movably mounted in the lower push chamber.
The valve repair device capable of secondary clamping according to claim 7, wherein both the upper clamping part and the lower clamping part are non-closed ring structures, and the upper pushing chamber and the There are two lower push chambers, two upper push rods and two lower push rods, two upper push chambers are located on both sides of the push rod chamber, and two The lower push chambers are respectively located on both sides of the push rod chamber, and the two upper push rods are respectively movably mounted in the two upper push chambers, and the opposite ends of the upper clamping part are respectively connected to two The far ends of the upper push rods and the two lower push rods are movable respectively in the two lower push chambers, and the opposite ends of the lower clamping part are respectively connected to the far ends of the two lower push rods. end.
The valve repair device capable of secondary clamping according to claim 8, wherein the proximal chuck protrudes from the distal surface of the main body section, and the side wall of the proximal chuck is in contact with the An avoidance groove is formed between the distal end surfaces of the main body section, and the avoidance groove communicates with the upper pushing cavity and the lower pushing cavity, and in the conveying state, the upper clamping part is accommodated in the avoiding groove and In the upper pushing chamber, the lower clamping portion is accommodated in the escape groove and the lower pushing chamber.
The valve repair device capable of secondary clamping according to claim 9, wherein the proximal surface of the distal chuck is provided with an escape groove corresponding to the avoidance groove, and the proximal chuck is in contact with the escape groove. When the distal chuck is in a closed state, the escape groove communicates with the avoidance groove.
The re-clampable valve repair device according to any one of claims 6 to 10, wherein the pushing catheter further includes a connecting section connected to the proximal end of the main body section, and the pushing rod cavity Axially penetrates to the proximal end surface of the connecting section, the connecting section is provided with a guide groove communicating with the pushing cavity, the guide groove has an opening extending in the axial direction, and the upper clamping part also includes a connection The upper operating part at the proximal end of the upper push rod, the lower clamping part also includes a lower operating part connected to the proximal end of the lower push rod, the upper operating part and the lower operating part are arranged on the The guide groove is partly exposed to the outside of the pushing conduit through the opening.
The valve repair device that can be clamped twice according to claim 11, wherein the valve repair device further includes a handle assembly, and the handle assembly includes an upper connection knob and a lower connection sleeve sleeved on the connecting section. a knob, the upper connecting knob is threaded to the upper operating part, and the lower connecting knob is threaded to the lower operating part.
The valve repair device capable of secondary clamping according to claim 12, wherein the handle assembly further comprises a first stop ring, a second stop ring and a second stop ring fixedly sleeved on the connecting section. Three stop rings, the upper connection knob is axially limited between the first stop ring and the second stop ring, and the lower connection knob is axially limited between the second stop ring and the second stop ring. Between the third stop ring.
The valve repair device capable of secondary clamping according to claim 13, wherein the handle assembly further includes a connection structure and a housing fixedly connected to the connection structure, and the connection structure includes the third The stop ring, the proximal end of the connecting section is installed in the connecting structure, the chuck assembly also includes a chuck operating part connected to the proximal end of the chuck push rod, and the chuck operating part is set on the housing.
The valve repair device capable of secondary clamping according to claim 14, wherein the connecting structure includes a first connecting piece and a second connecting piece, and the third stop ring is arranged on the first connecting piece. The far end of the piece, the first connecting piece is provided with a matching groove axially penetrating through its opposite two ends, and the second connecting piece is provided with an installation groove axially penetrating its opposite two surfaces, the connecting section The proximal end is fixedly installed in the matching groove, the first connecting piece is fixedly installed in the installation groove, and the housing is fixedly sleeved outside the second connecting piece.
The valve repair device that can be clamped twice according to claim 1, wherein the valve repair device further includes a puncture component, the puncture component includes a puncture push rod that is movably mounted in the push catheter and A puncture needle is provided at the distal end of the puncture push rod, the puncture needle can be connected with a suture, and the puncture needle is used to puncture the leaflet so as to implant the suture into the leaflet.
The secondary clampable valve repair device according to claim 1 or 16, characterized in that, the valve repair device further comprises a support assembly, and the support assembly includes a support arm movably mounted in the push catheter and a support member arranged at the distal end of the support arm, the support member is made of elastic and/or flexible material, and the support arm is used to drive the support member to pass through the distal side wall of the push catheter , the support member is used to support the leaflet.
The valve repair device capable of secondary clamping according to claim 1, wherein the valve repair device further comprises a probe assembly, the probe assembly includes at least one probe, and the probe is movable In the push catheter, the proximal clamp is provided with a probe channel, the distal clamp is provided with a probe receiving hole opposite to the probe channel, and the distal clamp is connected to the proximal When the end clip is closed, the distal end of the probe can protrude from the probe channel and be accommodated in the probe receiving hole.