Valve repair device with secondary clamping

Abstract

The application provides a twice clamping valve repair device, which comprises a pushing catheter, a chuck assembly and a pre-clamping assembly. The chuck assembly comprises a chuck push rod movably arranged in the pushing catheter, a proximal chuck and a distal chuck which can be opened and closed relative to each other. The pre-clamping assembly comprises an upper clamping piece and a lower clamping piece. The upper clamping piece comprises an upper push rod and an upper clamping part arranged at the distal end of the upper push rod. The lower clamping piece comprises a lower push rod and a lower clamping part arranged at the distal end of the lower push rod. The valve repair device has a working state. In the working state, the upper clamping part has a first clamping surface, the lower clamping part has a second clamping surface, the first clamping surface and the second clamping surface cooperate to clamp the valve leaflet, and the proximal chuck and the distal chuck cooperate to clamp the valve leaflet again. The ratio of the area of the first clamping surface to the area of the valve leaflet and the ratio of the area of the second clamping surface to the area of the valve leaflet are both greater than or equal to 1 / 6 and less than 1, so that the valve leaflet can be prevented from being folded and the effect of the operation can be ensured.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and in particular relates to a valve repair device that can be clamped twice. Background Technology

[0002] Heart valves, such as the mitral and tricuspid valves, are one-way valves between the atria and ventricles, ensuring that blood can flow only from the atria to the ventricles. When the chordae tendineae of the heart valves become diseased or ruptured, it can cause valvular insufficiency, leading to mitral or tricuspid regurgitation. This causes blood to flow back from the ventricles to the atria, resulting in a series of pathological changes and clinical symptoms in the heart, and in severe cases, heart failure.

[0003] The mitral valve consists of two leaflets: the anterior leaflet and the posterior leaflet. The tricuspid valve consists of three leaflets: the anterior leaflet, the septum, and the posterior leaflet. Each leaflet includes a ridge of roughness and a ridge of transparency. The ridge of roughness is located at the edge of the leaflet and is the occlusal surface of the leaflet; it is relatively thick. The ridge of transparency is located above the ridge of roughness and is relatively thin.

[0004] A suture implanter is available for treating valvular regurgitation. This implanter first clamps the leaflets with two clamps, then inserts a suture into the rough band at the leaflet edge, thus treating the valvular regurgitation. However, because the capture area of ​​the suture implanter for capturing the leaflets is too small and the leaflets swing up and down during cardiac activity, the clamps must rely on the front of the device to press against the leaflets to achieve proper clamping. This method carries risks such as inaccurate leaflet clamping or even excessive clamping leading to leaflet folding and stacking. The clamps can easily clamp the zona pellucida of the leaflets, causing the suture to be implanted too close to the zona pellucida. This not only results in excessive leaflet clamping force on the suture, affecting its lifespan, but also, due to the thinness of the zona pellucida, the anchoring force on the suture is weak, increasing the risk of suture dislodgement. Summary of the Invention

[0005] To address the aforementioned technical problems, this invention provides a valve repair device with secondary clamping capability. This device avoids valve leaflet folding through secondary clamping, allowing for stable and precise implantation of sutures into the rough band located at the edge of the valve leaflet. This ensures a safe and reliable suture implantation position, improves suture lifespan, and prevents sutures from falling out, thus guaranteeing the effectiveness of the surgery.

[0006] This invention provides a valve repair device with secondary clamping capability, comprising a delivery catheter, a clamp assembly, and a pre-clamping assembly. The clamp assembly includes a clamp push rod movably inserted into the delivery catheter and a proximal clamp and a distal clamp that can be opened and closed relative to each other. The proximal clamp is located at the distal end of the delivery catheter, and the distal clamp is located at the distal end of the clamp push rod. The pre-clamping assembly includes an upper clamping member and a lower clamping member. The upper clamping member includes an upper push rod movably inserted into the delivery catheter and an upper clamping portion located at the distal end of the upper push rod. The lower clamping member includes a lower push rod movably inserted into the delivery catheter and a lower clamping portion located at the distal end of the lower push rod. The valve repair device has a working state. In the working state, the upper clamping portion and the lower clamping portion are located outside the distal end of the delivery catheter. The upper clamping portion has a first clamping surface, and the lower clamping portion has a second clamping surface. The first clamping surface and the second clamping surface cooperate to clamp the valve leaflet, and the proximal clamp and the distal clamp cooperate to clamp the valve leaflet again. The ratio of the area of ​​the first clamping surface to the area of ​​the leaflet is greater than or equal to 1 / 6 and less than 1; the ratio of the area of ​​the second clamping surface to the area of ​​the leaflet is greater than or equal to 1 / 6 and less than 1.

[0007] The valve repair device provided by this invention delivers a clamp assembly and a pre-clamping assembly to the vicinity of the valve via a push catheter; then, the valve leaflet is pre-clamped by the first clamping surface of the upper clamping part and the second clamping surface of the lower clamping part; then, by operating the clamp push rod inserted in the push catheter, the proximal clamp and the distal clamp perform a secondary clamping of the valve leaflet; after the proximal clamp and the distal clamp clamp the valve leaflet, the valve leaflet can be sutured to achieve the treatment of valvular regurgitation. Since the area ratio of the first and second clamping surfaces to the leaflet is greater than or equal to 1 / 6 and less than 1, the first and second clamping surfaces can completely flatten the leaflet when clamping it, avoiding folding and stacking. This ensures that the leaflet remains flat after the proximal and distal clamps clamp it again, thus ensuring that the suture can be stably and accurately implanted into the rough band located at the edge of the leaflet. This ensures that the suture implantation position is safe and reliable, avoids the suture being subjected to large leaflet counterforce, and improves the suture's lifespan. Moreover, because the rough band is relatively thick, the suture implanted in the rough band can be subjected to a large anchoring force, making it less likely for the suture to fall out and ensuring the surgical effect. Attached Figure Description

[0008] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0009] Figure 1 This is a three-dimensional structural diagram of the valve repair device with secondary clamping capability provided in the embodiment of the present invention in its working state.

[0010] Figure 2 yes Figure 1 Enlarged view of Part II.

[0011] Figure 3 yes Figure 1 A three-dimensional structural diagram of the valve repair device in the delivery state.

[0012] Figure 4 yes Figure 3 Enlarged view of section IV.

[0013] Figure 5 yes Figure 1 A three-dimensional exploded view of the valve repair device.

[0014] Figure 6 yes Figure 5 A three-dimensional structural diagram of the pre-clamping component.

[0015] Figure 7 yes Figure 5 A three-dimensional structural diagram of the push catheter and the proximal clamp.

[0016] Figure 8 yes Figure 7 A three-dimensional structural diagram omitting the proximal clamp.

[0017] Figure 9 This is a three-dimensional structural diagram of the proximal clamp, the push catheter, and the distal clamp of another valve repair device provided in the embodiment of the present invention when it is in the delivery state.

[0018] Figure 10 yes Figure 1 A top view of the valve leaflet being held by the mid-valve repair device.

[0019] Figure 11 This is a top view of another valve repair device provided in an embodiment of the present invention, which holds the valve leaflet.

[0020] Figure 12 This is a top view of another valve repair device provided in an embodiment of the present invention, which clamps the valve leaflet.

[0021] Figure 13 yes Figure 5 A partial structural diagram of the upper and lower clamping components clamping the leaflets.

[0022] Figure 14 yes Figure 5 Another three-dimensional structural diagram of the push catheter and the proximal clamp.

[0023] Figure 15 yes Figure 14 Enlarged view of the XV section.

[0024] Figure 16 yes Figure 5 A three-dimensional structural diagram of the assembled push catheter, proximal clamp, and pre-clamping assembly.

[0025] Figure 17 yes Figure 16 An enlarged view of section XVII.

[0026] Figure 18 yes Figure 5 A three-dimensional structural diagram of the assembled push tube, pre-clamping assembly and handle assembly (excluding the housing and sealing structure).

[0027] Figure 19 yes Figure 18 A cross-sectional view along XIX-XIX.

[0028] Figure 20 yes Figure 18 An exploded view of the three-dimensional structure of the first stop ring, the upper connecting knob, the second stop ring, and the lower connecting knob.

[0029] Figure 21 yes Figure 18 A three-dimensional structural diagram of the push tube and connecting structure after assembly.

[0030] Figure 22 yes Figure 18 A three-dimensional exploded view of the push tube and connecting structure.

[0031] Figure 23 yes Figure 5 A partial axial cross-sectional view of the valve repair device after assembly.

[0032] Figure 24 yes Figure 23 Enlarged view of section XXIV.

[0033] Figure 25 This is a three-dimensional structural diagram of the suture assembly provided in an embodiment of the present invention.

[0034] Figure 26 yes Figure 5 Enlarged view of the XXV portion.

[0035] Figures 27 to 33 This is a schematic diagram illustrating the process of implanting a suture into the anterior leaflet of the mitral valve using the valve repair device provided in this embodiment of the invention; wherein, Figure 31 yes Figure 30 Enlarged view of section XXXI. Detailed Implementation

[0036] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0037] Furthermore, the following descriptions of various embodiments are based on the accompanying illustrations, illustrating specific implementations of the invention. Directional terms used in this invention, such as "up," "down," "front," "rear," "left," "right," "inner," "outer," and "side," are merely for reference to the accompanying illustrations. Therefore, the use of directional terms is for better and clearer explanation and understanding of the invention, and does not indicate or imply that the referred device or element must have a specific orientation, or be constructed and operated in a specific orientation; thus, it should not be construed as a limitation of the invention.

[0038] Orientation Definitions: For clarity, during the surgical procedure, the end closer to the operator is referred to as the "proximal end," and the end farther from the operator is referred to as the "distal end." Axial direction refers to the direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device; radial direction refers to the direction perpendicular to the axial direction; the connection between "Component A" and "Component B" can be a direct contact connection or an indirect connection via "Component C." The above definitions are for ease of description only and should not be construed as limiting the invention.

[0039] Please refer to the following: Figure 1 as well as Figure 33 This invention provides a valve repair device 100 capable of secondary clamping. The valve repair device 100 can be used for interventional treatment of mitral or tricuspid regurgitation via the apical approach. The following detailed description uses the valve repair device 100 for interventional treatment of mitral regurgitation as an example. When using the valve repair device 100, the device passes through the orifice of the mitral valve to pre-clamp one of the leaflets, then clamps it again, and then implants a suture 201 onto the leaflet 1 to reduce or eliminate mitral regurgitation. The suture 201 can serve as an artificial chordae tendineae to replace diseased or ruptured chordae tendineae in the patient's heart; or multiple sutures 201 can be fixed together 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 leaflets of the tricuspid valve include 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.

[0040] Please refer to the following: Figures 1 to 12The valve repair device 100 capable of secondary clamping provided in this embodiment of the invention includes a push catheter 10, a clamp assembly 20, and a pre-clamping assembly 30. The clamp assembly 20 includes a clamp push rod 21 movably inserted into the push catheter 10, and a proximal clamp 22 and a distal clamp 23 that can be opened and closed relative to each other. The proximal clamp 22 is located at the distal end of the push catheter 10, and the distal clamp 23 is located at the distal end of the clamp push rod 21. The pre-clamping assembly 30 includes an upper clamping member 31 and a lower clamping member 32. The upper clamping member 31 includes an upper push rod 311 movably inserted into the push catheter 10 and an upper clamping portion 312 located at the distal end of the upper push rod 311. The lower clamping member 32 includes a lower push rod 321 movably inserted into the push catheter 10 and a lower clamping portion 322 located 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 push catheter 10. The upper clamping part 312 has a first clamping surface 3121, and the lower clamping part 322 has a second clamping surface 3221. The first clamping surface 3121 and the second clamping surface 3221 cooperate to clamp the leaflet 1. The proximal clamp 22 and the distal clamp 23 cooperate to clamp the leaflet 1 again. The ratio of the area of ​​the first clamping surface 3121 to the area of ​​the leaflet 1 is greater than or equal to 1 / 6 and less than 1; the ratio of the area of ​​the second clamping surface 3221 to the area of ​​the leaflet 1 is greater than or equal to 1 / 6 and less than 1.

[0041] The valve repair device 100 described above delivers the clamp assembly 20 and the pre-clamping assembly 30 to the vicinity of the valve via the push catheter 10; then the leaflet 1 is pre-clamped by the first clamping surface 3121 of the upper clamping part 312 and the second clamping surface 3221 of the lower clamping part 322; then the proximal clamp 22 and the distal clamp 23 are used to clamp the leaflet 1 again by operating the clamp push rod 21 inserted in the push catheter 10. After the proximal clamp 22 and the distal clamp 23 clamp the leaflet 1, the suture 201 can be implanted into the leaflet 1 to achieve the treatment of valvular regurgitation. Since the area ratio of the first clamping surface 3121 and the second clamping surface 3221 to the leaflet 1 is greater than or equal to 1 / 6 and less than 1, when the first clamping surface 3121 and the second clamping surface 3221 clamp the leaflet 1, they can completely flatten the leaflet 1, avoiding the leaflet 1 from folding and piling up. This ensures that the leaflet 1 remains flat after the proximal clamp 22 and the distal clamp 23 clamp the leaflet 1 again, thereby ensuring that the suture 201 can be stably and accurately implanted into the rough band located at the edge of the leaflet 1. This ensures that the implantation position of the suture 201 is safe and reliable, avoids the suture 201 being subjected to a large leaflet counterforce, and improves the lifespan of the suture 201. Moreover, because the rough band is relatively thick, the suture 201 implanted in the rough band can be subjected to a large anchoring force, so the suture 201 is not easy to fall off, ensuring the effect of the surgery.

[0042] 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, a ratio greater than or equal to 1 / 6 and less than 1 means that the ratio of the area of ​​the first clamping surface 3121 to the area of ​​the leaflet 1 can be 1 / 6, or any value greater than 1 / 6 and less than 1. Preferably, the ratios of the area of ​​the first clamping surface 3121 to the area of ​​the leaflet 1 and the ratios of the area of ​​the second clamping surface 3221 to the area of ​​the leaflet 1 are both greater than or equal to 1 / 4 and less than or equal to 4 / 5. More preferably, the ratios of the area of ​​the first clamping surface 3121 to the area of ​​the leaflet 1 and the ratios of the area of ​​the second clamping surface 3221 to the area of ​​the leaflet 1 are both greater than or equal to 1 / 3 and less than or equal to 4 / 5, for example, 1 / 2, making it easier for the first clamping surface 3121 and the second clamping surface 3221 to clamp the leaflet 1 and improving the flattening effect of the leaflet 1. The area of ​​the leaflet 1 can be obtained by averaging multiple samples. Since the areas of the leaflets of the mitral and tricuspid valves are different, the areas of the first clamping surface 3121 and the second clamping surface 3221 are set for different leaflets 1; when sutures 201 are implanted in different leaflets 1, valve repair devices 100 of different specifications can be selected accordingly.

[0043] In this invention, the distal face of the proximal chuck 22 mates with the proximal face of the distal chuck 23 to clamp the leaflet 1 again. Optionally, the distal face of the proximal chuck 22 is parallel to the proximal face of the distal chuck 23, ensuring that when the proximal chuck 22 and the distal chuck 23 clamp the leaflet 1, the distal faces of the proximal chuck 22 and the proximal faces of the distal chuck 23 have a large contact area with the leaflet 1, which is beneficial for the proximal chuck 22 and the distal chuck 23 to clamp the leaflet 1. In one example, the proximal face of the distal chuck 23 is inclined distally from the chuck push rod 21, and the distal face of the proximal chuck 22 is parallel to the proximal face of the distal chuck 23.

[0044] It should be noted that, in the present invention, in the working state, the upper clamping part 312 is located at the distal end of the lower clamping part 322, the first clamping surface 3121 is the surface of the upper clamping part 312 facing the lower clamping part 322, and the second clamping surface 3221 is the surface of the lower clamping part 322 facing the upper clamping part 312. The following description is based on this. The terms "first," "second," etc., are merely for ease of description and should not be regarded as limitations on the present invention.

[0045] Please refer to the following: Figures 1 to 6In some embodiments, the upper clamping portion 312 and the lower clamping portion 322 are made of a shape memory material. The valve repair device 100 also has a delivery state. In the delivery state, the upper clamping portion 312 and the lower clamping portion 322 are compressed and deformed and at least partially housed in the push catheter 10; in the working state, the upper clamping portion 312 extends completely out of the push catheter 10 and unfolds, the upper clamping portion 312 bends relative to the upper push rod 311, the lower clamping portion 322 extends completely out of the push catheter 10 and unfolds, the lower clamping portion 322 bends relative to the lower push rod 321, and both the upper clamping portion 312 and the lower clamping portion 322 are located between the distal clamp 23 and the push catheter 10.

[0046] It is understandable that both the upper clamping part 312 and the lower clamping part 322 are made of materials with shape memory function. After the upper clamping part 312 and the lower clamping part 322 are shaped, they can remain flat when not subjected to external force (e.g., Figure 2 As shown), it can deform and shrink in volume when subjected to external forces (such as...). Figure 4 (As shown). Therefore, the dimensions of the upper clamping portion 312 and the lower clamping portion 322 can be designed to be relatively large, ensuring that the areas of the first clamping surface 3121 and the second clamping surface 3221 are sufficiently large in the working state. Thus, when the first clamping surface 3121 and the second clamping surface 3221 clamp the leaflet 1 (as shown), Figure 10 When (as shown), the two parts can flatten the leaflet 1, preventing the leaflet 1 from folding and piling up. In the working state, the upper clamping part 312 and the lower clamping part 322 bend radially away from the upper push rod 311 and the lower push rod 321 relative to the upper push rod 311 and the lower push rod 321 (as shown). Figure 2 As shown, this design avoids interference between the upper clamping part 312 and the lower clamping part 322 and the chuck push rod 21, thus preventing the upper clamping part 312 and the lower clamping part 322 from being unable to fully unfold due to the obstruction of the chuck push rod 21. Furthermore, since the upper clamping part 312 and the lower clamping part 322 bend in the same direction relative to the upper push rod 311 and the lower push rod 321, their radial projections have a large overlapping area or are essentially overlapping, which 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; this invention does not impose any limitations on these selections.

[0047] 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. Because the upper clamping portion 312 and the lower clamping portion 322 are compressed and deformed and at least partially housed within the delivery catheter 10, the valve repair device 100 has a smaller cross-sectional area in the radial direction. This is beneficial in two ways: firstly, it reduces the size of the surgical trauma caused by delivering the valve repair device 100, which is beneficial for the patient's postoperative recovery; secondly, it helps avoid compressing the leaflet 1 when the valve repair device 100 passes through the mitral valve orifice (e.g., ...). Figure 10 (As shown) This causes damage to the leaflet 1. After the valve repair device 100 passes through the orifice of the mitral valve, the valve repair device 100 changes from the delivery state to the working state. The clamp push rod 21 drives the distal clamp 23 to move distally and open with the proximal clamp 22. The upper push rod 311 drives the upper clamping part 312 to pass through the distal end of the push catheter 10. Under the action of its own shape memory function, the upper clamping part 312 bends and unfolds relative to the upper push rod 311; the lower push rod 321 drives the lower clamping part 322 to pass through the distal end of the push catheter 10. Under the action of its own shape memory function, the lower clamping part 322 bends and unfolds relative to the lower push rod 321; the first clamping surface 3121 and the second clamping surface 3221 cooperate to clamp the leaflet 1, and the proximal clamp 22 and the distal clamp 23 cooperate to clamp the leaflet 1 again.

[0048] Please see Figures 5 to 8 In some embodiments, the push conduit 10 includes a main body segment 11. The push conduit 10 is provided with a push rod cavity 12 and a push cavity 111 extending axially through opposite end faces of the main body segment 11. The clamp push rod 21 is movably inserted into the push rod cavity 12, and the upper push rod 311 and the lower push rod 321 are movably inserted into the push cavity 111. Further, the push cavity 111 includes an upper push cavity 1111 and a lower push cavity 1112. The upper push cavity 1111 is closer to the push rod cavity 12 than the lower push cavity 1112. The upper push rod 311 is movably inserted into the upper push cavity 1111, and the lower push rod 321 is movably inserted into the lower push cavity 1112.

[0049] It is understood that since the chuck push rod 21, the upper push rod 311, and the lower push rod 321 are respectively movably installed in different cavities of the push tube 10, friction or collision can be avoided when the chuck push rod 21, the upper push rod 311, and the lower push rod 321 move in the push tube 10, ensuring the smooth axial movement of the chuck 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 may also be movably installed in a single push cavity 111.

[0050] exist Figures 5 to 8In the example, during operation, both the upper clamping portion 312 and the lower clamping portion 322 are non-closed ring structures, and there are two upper push rods 311 and two lower push rods 321. The opposite ends of the upper clamping portion 312 are connected to the distal ends of the two upper push rods 311, and the opposite ends of the lower clamping portion 322 are connected to the distal ends of the two lower push rods 321. The upper clamping portion 312 forms a stable non-closed ring structure through its connection with the two upper push rods 311, and the lower clamping portion 322 forms a stable non-closed ring structure through its connection 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. This invention does not specifically limit the shapes of the upper clamping portion 312 and the lower clamping portion 322. It should be noted that the shapes of the upper clamping portion 312 and the lower clamping portion 322 can be the same or different.

[0051] Correspondingly, there are two upper pushing cavities 1111 and two lower pushing cavities 1112. The two upper pushing cavities 1111 are located on both sides of the push rod cavity 12, and the two lower pushing cavities 1112 are located on both sides of the push rod cavity 12. The two upper push rods 311 are movably inserted into the two upper pushing cavities 1111, and the two lower push rods 321 are movably inserted into the two lower pushing cavities 1112. When the valve repair device 100 switches from the working state to the delivery state, the two upper push rods 311 move synchronously along the axial direction towards the proximal end in the two upper push chambers 1111, which can drive the opposite ends of the upper clamping part 312 to move along the axial direction towards the proximal end and enter the two upper push chambers 1111 respectively, until the upper clamping part 312 abuts against the push catheter 10 or the proximal clamp 22 and tightens; the two lower push rods 321 move synchronously along the axial direction towards the proximal end in the two lower push chambers 1112, which can drive the opposite ends of the lower clamping part 322 to move along the axial direction towards the proximal end and enter the two lower push chambers 1112 respectively, until the lower clamping part 322 abuts against the push catheter 10 or the proximal clamp 22 and tightens. Therefore, when the valve repair device 100 is in the delivery state, the upper clamping part 312 and the lower clamping part 322 are mostly housed in the push cavity 111, and a small part is exposed outside the distal end of the push cavity 111, that is, outside the distal end of the push catheter 10.

[0052] In other embodiments, the upper push cavity 1111 and the lower push cavity 1112 located on the same side of the push rod cavity 12 can also be connected, that is, the upper push rod 311 and the lower push rod 321 located on the same side of the push rod cavity 12 share a push cavity 111.

[0053] Please see Figure 4 and Figure 7In some embodiments, the proximal chuck 22 protrudes from the distal surface 112 of the main body segment 11, and a clearance groove 222 is formed between the sidewall 221 of the proximal chuck 22 and the distal surface 112 of the main body segment 11. The clearance groove 222 connects the upper pushing cavity 1111 and the lower pushing cavity 1112. In the conveying state, the upper clamping part 312 is received in the clearance groove 222 and the upper pushing cavity 1111, and the lower clamping part 322 is received in the clearance groove 222 and the lower pushing cavity 1112. It is understood that the proximal chuck 22 can be integrally formed with the pushing guide tube 10; it can also be fixed with the pushing guide tube 10 by welding. This application is not limited to this.

[0054] exist Figure 7 In the example, the distal outlets of the two upper push chambers 1111 and the two lower push chambers 1112 are all located on the distal end face 112 of the main body segment 11, and the clearance groove 222 connects the two upper push chambers 1111 and the two lower push chambers 1112. When the valve repair device 100 is in the delivery state, the proximal clamp 22 and the distal clamp 23 are in the closed state, and the portion of the upper clamping part 312 exposed outside the push catheter 10 is received in the clearance groove 222, and the portion of the lower clamping part 322 exposed outside the push catheter 10 is received in the clearance groove 222. At this time, the upper clamping part 312 and the lower clamping part 322 are partially located between the distal end face of the push catheter 10 (i.e., the distal end face of the main body segment 11) and the proximal end face of the distal clamp 23. The design of the clearance groove 222 can prevent the upper clamping part 312 and the lower clamping part 322 from interfering with the closure of the proximal clamp 22 and the distal clamp 23. The proximal clamp 22 and the distal clamp 23 can be closed relative to each other to almost no gap, so that the valve repair device 100 can form a smooth whole, which makes it easier to reduce the surgical trauma caused by pushing the valve repair device 100.

[0055] In other embodiments, the clearance groove 222 may not be provided, that is, the distal end face 112 of the main body segment 11 is completely blocked by the proximal end clamp 22. The distal outlets of the two upper pushing chambers 1111 and the two lower pushing chambers 1112 are all located on the distal sidewall of the main body segment 11. The upper clamping part 312 of the non-closed ring structure protrudes from the distal outlet of the upper pushing chamber 1111 and is exposed outside the distal end of the pushing conduit 10 and coiled around the distal sidewall of the main body segment 11. The lower clamping part 322 of the non-closed ring structure protrudes from the distal outlet of the lower pushing chamber 1112 and is exposed outside the distal end of the pushing conduit 10 and coiled around the distal sidewall of the main body segment 11.

[0056] Please see Figure 2 , Figure 4 and Figure 9In some embodiments, when the valve repair device 100 is in the delivery state, the upper clamping portion 312 and the lower clamping portion 322 are stacked sequentially in the clearance groove 222 along the axial direction. In other words, the lower clamping portion 322 is located axially between the upper clamping portion 312 and the distal end face 112 of the main body segment 11. Compared with the design where the upper clamping portion 312 and the lower clamping portion 322 are arranged radially within the clearance groove 222, this design reduces the radial dimension of the delivery catheter 10, thereby reducing the radial dimension of the valve repair device 100 in the delivery state, and making it easier to deliver the valve repair device 100.

[0057] Optionally, when the upper clamping part 312 and the lower clamping part 322 are stacked sequentially in the relief groove 222 along the axial direction, the groove depth of the relief groove 222 (i.e., the axial dimension of the relief groove 222) is equal to or greater than the sum of the axial dimensions of the upper clamping part 312 and the lower clamping part 322.

[0058] exist Figure 2 and Figure 4 In the example, the depth of the clearance groove 222 is greater than the sum of the axial dimensions of the upper clamping part 312 and the lower clamping part 322. When the valve repair device 100 is in operation, it clamps the leaflet 1 between the distal end face of the push catheter 10 and the proximal end face of the distal clamp 23 via the upper clamping part 312 and the lower clamping part 322. Figure 10 (As shown) Afterwards, leaflet 1 is pressed against the distal surface of proximal clamp 22, and the surface of upper clamping part 312 facing away from lower clamping part 322 is basically flush with the distal surface of proximal clamp 22. At this time, upper clamping part 312 and lower clamping part 322 clamp leaflet 1 to completely flatten it. In this way, when proximal clamp 22 and distal clamp 23 clamp leaflet 1 again, upper clamping part 312 is prevented from interfering with the secondary clamping of leaflet 1 by distal clamp 23 and proximal clamp 22, thereby avoiding the situation where distal clamp 23 and proximal clamp 22 cannot close to clamp leaflet 1 due to obstruction by upper clamping part 312.

[0059] exist Figure 9 In the example, the depth of the clearance groove 222 is equal to the sum of the axial dimensions of the upper clamping part 312 and the lower clamping part 322. The proximal end face of the distal clamp 23 is provided with a clearance groove 231 corresponding to the clearance groove 222. When the proximal clamp 22 and the distal clamp 23 are in the closed state, the clearance groove 231 connects to the clearance groove 222. Since the sum of the axial dimensions of the upper clamping part 312 and the lower clamping part 322 is equal to the depth of the clearance groove 222 when they are housed in the clearance groove 222, the valve repair device 100, in its working state, clamps the leaflet 1 (e.g., ...) between the distal end face of the push catheter 10 and the proximal end face of the distal clamp 23 through the upper clamping part 312 and the lower clamping part 322. Figure 10(As shown) After that, the leaflet 1 is pressed against the distal surface of the proximal clamp 22. The surface of the upper clamping part 312 that is away from the lower clamping part 322 is further away from the distal surface 112 of the main body segment 11 than the distal surface of the proximal clamp 22. The proximal surface of the distal clamp is designed with a clearance groove 231 to prevent the upper clamping part 312 from interfering with the distal clamp 23 and the proximal clamp 22 in clamping the leaflet 1 again.

[0060] Please see Figure 6 and Figure 7 In some embodiments, the proximal chuck 22 is provided with a push rod channel 223 that extends axially through its opposite end faces and communicates with the push rod cavity 12. The chuck push rod 21 is axially movably inserted into the push rod cavity 12 and the push rod channel 223. The axial movement of the chuck push rod 21 in the push rod cavity 12 and the push rod channel 223 can drive the distal chuck 23 to move axially, so that the proximal chuck 22 and the distal chuck 23 open and close relative to each other in the axial direction. In this way, the chuck push rod 21 (e.g. Figure 2 (As shown) can extend from the distal end face of the proximal clamp 22, ensuring that the distal clamp 23 and the proximal clamp 22 have a large or nearly overlapping area in the radial direction, which is beneficial for the upper clamping part 312 and the lower clamping part 322 to clamp the leaflet 1 again (as shown). Figure 10 (As shown).

[0061] Please see Figure 11 In some embodiments, in the working state, both the upper clamping part 312 and the lower clamping part 322 are closed ring structures, and there is one upper push rod 311 and one lower push rod 321. The upper clamping part 312 is connected to the distal end of the upper push rod 311, and the lower clamping part 322 is connected to the lower push rod 321. In the conveying state, the upper clamping part 312 and the lower clamping part 322 can be completely accommodated in the pushing cavity 111 (e.g., Figure 7 As shown in the diagram, both the upper clamping part 312 and the lower clamping part 322 can be fully accommodated within the push-pull guide tube 10. Figure 11In the example, the pushing cavity 111 includes an upper pushing cavity 1111 and a lower pushing cavity 1112, with one upper pushing cavity 1111 and one lower pushing cavity 1112. The upper pushing cavity 1111 and the lower pushing cavity 1112 are located on the same side of the push rod cavity 12. The upper push rod 311 is movably inserted into the upper pushing cavity 1111, and the lower push rod 321 is movably inserted into the lower pushing cavity 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 axially towards the proximal end along the upper push rod 311 and completely accommodated in the upper pushing cavity 1111; the lower clamping part 322 can be inserted axially towards the proximal end along the lower push rod 321 and completely accommodated in the lower pushing cavity 1112. It is understood that the upper clamping part 312 and the lower clamping part 322 are provided with clearances to prevent the upper clamping part 312 and the lower clamping part 322 from obstructing the proximal clamp 22 and the distal clamp 23, thereby affecting the secondary clamping of the leaflet 1 by the proximal clamp 22 and the distal clamp 23. In other embodiments, the upper push cavity 1111 and the lower push cavity 1112 may also be located on both sides of the push rod cavity 12.

[0062] It should be noted that the upper clamping part 312 and the lower clamping part 322 may be either a closed ring structure or a non-closed ring structure, and the present invention does not limit this.

[0063] like Figure 10 and Figure 11 As shown, 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 refers to the outer peripheral surface of the lower clamping portion 322 facing the upper clamping portion 312, and the area of ​​the first clamping surface 3121 is the area of ​​the outer peripheral surface of the upper clamping portion 312. The second clamping surface 3221 refers to the outer peripheral surface of the upper clamping portion 312 facing the lower clamping portion 322, and the area of ​​the second clamping surface 3221 is the area of ​​the outer peripheral surface of the lower clamping portion 322. The annular structure of both the upper clamping portion 312 and the lower clamping portion 322 effectively saves materials and reduces costs. Furthermore, the upper clamping portion 312 and the lower clamping portion 322 are easily deformable and have a small compressed volume, which facilitates the smooth reception of the upper clamping portion 312 and the lower clamping portion 322 within the push cavity 111.

[0064] Please see Figure 12 In some embodiments, in the working state, both the upper clamping part 312 and the lower clamping part 322 are sheet-like structures, and there is one upper push rod 311 and one lower push rod 321. The upper clamping part 312 is connected to the distal end of the upper push rod 311, and the lower clamping part 322 is connected to the distal end of the lower push rod 321. In the conveying state, the upper clamping part 312 and the lower clamping part 322 can be completely accommodated in the push cavity 111 (e.g., Figure 7 As shown in the diagram, both the upper clamping part 312 and the lower clamping part 322 can be fully accommodated within the push-pull guide tube 10. Figure 12 In the example, the pushing cavity 111 includes an upper pushing cavity 1111 and a lower pushing cavity 1112, with one upper pushing cavity 1111 and one lower pushing cavity 1112. The upper pushing cavity 1111 and the lower pushing cavity 1112 are located on the same side of the push rod cavity 12. The upper push rod 311 is movably inserted into the upper pushing cavity 1111, and the lower push rod 321 is movably inserted into the lower pushing cavity 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 axially towards the proximal end along the upper push rod 311 and completely accommodated in the upper pushing cavity 1111; the lower clamping part 322 can be inserted axially towards the proximal end along the lower push rod 321 and completely accommodated in the lower pushing cavity 1112. It is understood that the upper clamping part 312 and the lower clamping part 322 are provided with clearances to prevent the upper clamping part 312 and the lower clamping part 322 from obstructing the proximal clamp 22 and the distal clamp 23, thereby affecting the secondary clamping of the leaflet 1 by the proximal clamp 22 and the distal clamp 23. In other embodiments, the upper push cavity 1111 and the lower push cavity 1112 may also be located on both sides of the push rod cavity 12.

[0065] It should be noted that the upper clamping part 312 and the lower clamping part 322 may also have one of them as a ring structure and the other as a sheet structure. The present invention does not impose any restrictions on this.

[0066] like Figures 10 to 12 As shown, in the working state, the area of ​​the first clamping surface 3121 of the upper clamping part 312 is larger than the area of ​​the second clamping surface 3221 of the lower clamping part 322. Thus, 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 sufficient clamping force when the upper clamping part 312 and the lower clamping part 322 clamp the leaflet 1. This allows for more stable clamping of the leaflet 1 and ensures that the clamped leaflet 1 is in a better flattened state. Furthermore, the lower clamping part 322 also supports the leaflet 1, making it easier for the upper clamping part 312 and the lower clamping part 322 to clamp the leaflet 1 and ensure that the leaflet 1 is flattened.

[0067] When both 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 larger 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 322 can clamp the leaflet 1 more stably.

[0068] Please see Figure 13In some embodiments, during operation, an angle α exists between the first clamping surface 3121 and the second clamping surface 3221, where the angle α is greater than 0° and less than or equal to 30°. This ensures that the upper clamping portion 312 and the lower clamping portion 322 have sufficient clamping force when clamping the leaflet 1, guaranteeing that the leaflet 1 is fully flattened after being clamped. Figure 13 In the example, during operation, the upper push rod 311 extends axially, and the upper clamping portion 312 is perpendicular to the upper push rod 311, meaning the first clamping surface 3121 of the upper clamping portion 312 is perpendicular to the axial direction; the lower push rod 321 extends axially, and the lower clamping portion 322 is inclined distally relative to the lower push rod 321, meaning the second clamping surface 3221 of the lower clamping portion 322 has an angle with the radial direction. Therefore, an angle α exists between the first clamping surface 3121 and the second clamping surface 3221.

[0069] It should be noted that the included angle α between the first clamping surface 3121 and the second clamping surface 3221 is greater than 0° and less than or equal to 30°, meaning that the included angle α can be 30°, or any degree greater than 0° and less than 30°. Preferably, the included angle α is greater than or equal to 5° and less than or equal to 10°.

[0070] In other embodiments, the lower clamping portion 322 may be perpendicular to the lower push rod 321, and the upper clamping portion 312 may be inclined proximally relative to the upper push rod 311. Alternatively, the upper clamping portion 312 may be inclined proximally relative to the upper push rod 311, and the lower clamping portion 322 may be inclined distally relative to the lower push rod 321. Of course, the first clamping surface 3121 and the second clamping surface 3221 may also be arranged parallel to each other; for example, the upper clamping portion 312 may be perpendicular to the upper push rod 311, and the lower clamping portion 322 may be perpendicular to the lower push rod 321.

[0071] Please refer to the following: Figures 14 to 17In some embodiments, the push catheter 10 further includes a connecting section 13 connected to the proximal end of the main body section 11. The push rod cavity 12 extends axially to the proximal end face of the connecting section 13. 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 axially. The upper clamping member 31 further includes an upper operating member 313 connected to the proximal end of the upper push rod 311. The lower clamping member 32 further 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 outside the push catheter 10 from the opening of the guide groove 131. In this way, by controlling the upper operating member 313 and the lower operating member 323 axially within the guide groove 131, the operator can control the upper push rod 311 and the lower push rod 321 to move axially within the push cavity 111. This allows the operator to control the upper clamping part 312 and the lower clamping part 322 to be received within the push cavity 111 or to extend out of the push cavity 111 for clamping operations. Moreover, due to the restriction of the opening of the guide groove 131, the upper push rod 311 and the lower push rod 321 will not rotate when moving axially within the push cavity 111, ensuring that the upper clamping part 312 and the lower clamping part 322 extending from the distal end of the push cavity 111 will not deviate. This facilitates 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 and reducing the difficulty of the surgical operation.

[0072] It should be noted that, since the push rod cavity 12 extends axially to the proximal end face of the connecting section 13, the chuck push rod 21 (such as...) Figure 5 The proximal end of the catheter (as shown) can pass through the proximal end of the connecting segment 13 (i.e., the proximal end of the push catheter 10).

[0073] Furthermore, the guide groove 131 includes an upper guide groove 1311 and a lower guide groove 1312 extending axially. The upper guide groove 1311 is connected to the upper push cavity 1111. The upper push rod 311 is movably inserted into the upper push cavity 1111 and the upper guide groove 1311. The upper operating member 313 is disposed in the upper guide groove 1311 and protrudes from the opening of the upper guide groove 1311 to the outside of the push conduit 10. The lower guide groove 1312 is connected to the lower push cavity 1112. The lower push rod 321 is movably inserted into the lower push cavity 1112 and the lower guide groove 1312. The lower operating member 323 is disposed in the lower guide groove 1312 and protrudes from the opening of the lower guide groove 1312 to the outside of the push conduit 10. In this way, since the upper operating member 313 and the lower operating member 323 move axially in the upper guide groove 1311 and the lower guide groove 1312 respectively, friction or collision between the upper operating member 313 and the lower operating member 323 during axial movement is avoided, ensuring the smoothness of axial movement of the upper operating member 313 and the lower operating member 323; on the other hand, the axial dimension of the push catheter 10 is effectively reduced, further reducing the size of the valve repair device 100 (e.g., Figure 1 The size (as shown) facilitates the miniaturization design of the valve repair device 100.

[0074] exist Figures 14 to 17 In the example, since both the upper clamping part 312 and the lower clamping part 322 are non-closed ring structures in the working state, there are two upper push rods 311, two lower push rods 321, two upper pushing chambers 1111, and two lower pushing chambers 1112. The two upper pushing chambers 1111 are located on both sides of the push rod cavity 12, and the two lower pushing chambers 1112 are located on both sides of the push rod cavity 12, with the two upper pushing chambers 1111 being closer to the push rod cavity 12 than the two lower pushing chambers 1112. Therefore, there are also two upper guide grooves 1311 and two lower guide grooves 1312. The two upper guide grooves 1311 are located on both sides of the push rod cavity 12 and communicate with the two upper pushing chambers 1111 respectively; the two lower guide grooves 1312 are located on both sides of the push rod cavity 12 and communicate with the two lower pushing chambers 1112 respectively, with the two upper guide grooves 1311 being closer to the push rod cavity 12 than the two lower guide grooves 1312.

[0075] 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 321 are connected to the lower operating member 323. Both the upper operating member 313 and the lower operating member 323 are semi-circular and adapted to the connecting section 13. The projections of the upper operating member 313 and the lower operating member 323 along the axial direction on the proximal end face of the connecting section 13 do not overlap. This further avoids friction or collision between the upper operating member 313 and the lower operating member 323 when they move axially in the guide groove 131, and further ensures smooth axial movement of the upper operating member 313 and the lower operating member 323. The present invention does not specifically limit the shape of the upper operating member 313 and the lower operating member 323; they can also be other shapes, such as semi-elliptical shapes, and the shapes of the upper operating member 313 and the lower operating member 323 can also be different.

[0076] Furthermore, the guide groove 131 extends axially to the near end face of the connecting section 13. Figures 14 to 17 In the example, the upper guide groove 1311 and the lower guide groove 1312 extend axially to the proximal end face of the connecting section 13, respectively. Thus, when the pre-clamping assembly 30 (such as...) is placed... Figure 5When the upper push rod 311 is installed in the push conduit 10 (as shown), it can first be movably inserted into the upper push cavity 1111. The proximal end of the upper push rod 311 can pass through the upper guide groove 1311 from the proximal end of the connecting section 13. Then, the upper operating member 313 is installed at the proximal end of the upper push rod 311, and the upper operating member 313 is pushed axially towards the distal end until the upper operating member 313 passes into the upper guide groove 1311 and is partially exposed from the opening of the upper guide groove 1311, so that the upper clamping member 31 is installed on the push conduit 10. Similarly, the lower clamping member 32 is installed in the push conduit 10, which facilitates assembly and reduces assembly time.

[0077] In other embodiments, the number of upper operating members 313 and lower operating members 323 may also be two, with the proximal end of each upper push rod 311 connected to one upper operating member 313 and the proximal end of each lower push rod 321 connected to one lower operating member 323. Of course, the number of upper operating members 313 and lower operating members 323 may also be different; for example, the number of upper operating members 313 may be one, and the number of lower operating members 323 may be two.

[0078] 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 be connected, that is, the upper operating member 313 and the lower operating member 323 located on the same side of the push rod cavity 12 share a guide groove 131, and the upper push rod 311 and the lower push rod 321 located on the same side of the push rod cavity 12 are movably inserted into the same guide groove 131.

[0079] In other embodiments, the number of guide grooves 131 may also be one, that is, the guide groove 131 penetrates the peripheral wall of the connecting section 13 radially and communicates with the two upper push chambers 1111 and the two lower push chambers 1112, so that the guide groove 131 has two openings in the radial direction. The upper operating member 313 partially protrudes from the outside of the push conduit 10 through one opening of the guide groove 131; the lower operating member 323 partially protrudes from the outside of the push conduit 10 through the other opening of the guide groove 131, and the two lower push rods 321, the upper operating member 313 and the lower operating member 323 are all movably mounted in the same guide groove 131.

[0080] Please refer to the following: Figure 1 as well as Figures 17 to 20 In some embodiments, the valve repair device 100 further includes a handle assembly 40, which includes an upper connecting knob 41 and a lower connecting knob 42 sleeved on the connecting section 13. The upper connecting knob 41 is threadedly connected to the upper operating member 313, and the lower connecting knob 42 is threadedly connected to the lower operating member 323. In this way, the operator can control the upper operating member 313 and the lower operating member 323 to move axially by rotating the upper connecting knob 41 and the lower connecting knob 42 respectively, making operation simple.

[0081] exist Figures 17 to 20In the example, both the upper operating member 313 and the lower operating member 323 are provided with external threads, which are exposed outside the push guide tube 10 through the openings of the upper guide groove 1311 and the lower guide groove 1312, respectively. The upper connecting knob 41 and the lower connecting knob 42 are respectively provided with internal threaded holes corresponding to the external threads. The internal threaded hole of the upper connecting knob 41 is engaged with the external thread of the upper operating member 313, and the internal threaded hole of the lower connecting knob 42 is engaged with the external thread of the lower operating member 323. Thus, by rotating the upper connecting knob 41, the two upper push rods 311 can be moved axially simultaneously to control the upper clamping part 312 to move axially; by rotating the lower connecting knob 42, the two lower push rods 321 can be moved axially simultaneously to control the lower clamping part 322 to move axially.

[0082] It should be noted that, since the upper clamping part 312 is further away from the proximal end than the lower clamping part 322 when clamping the leaflet 1, the upper clamping part 312 should be further away from the proximal end of the push tube 10 in the axial direction than the lower connecting knob 42. This is beneficial to reduce the axial dimension of the upper clamping part 31, save materials, and reduce costs.

[0083] Please see Figure 1 and Figures 17 to 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 451 fixedly sleeved on the connecting section 13. The upper connecting knob 41 is axially limited between the first stop ring 43 and the second stop ring 44, and the lower connecting knob 42 is axially limited between the second stop ring 44 and the third stop ring 451. This ensures that the upper connecting knob 41 and the lower connecting knob 42 can only rotate and cannot move axially, so that by rotating the upper connecting knob 41 and the lower connecting knob 42, the upper operating member 313 and the lower operating member 323 can be controlled to move axially, respectively.

[0084] exist Figure 1 and Figures 17 to 20In the example, the first stop ring 43 is fixedly fitted at the connection position between the connecting section 13 and the main body section 11. The connecting section 13 is provided with a slot 132, and the second stop ring 44 is fitted into the 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 protrusion that matches the through hole. During assembly, the first stop part 441 is first inserted into the slot 132, and then the protrusion of the second stop part 442 is embedded into the through hole of the first stop part 441, so that the second stop ring 44 is fitted into the slot 132. Through the limiting of the slot 132, the second stop ring 44 is axially fixed relative to the connecting section 13. In addition, the detachable first stop part 441 and second stop part 442 are easy to disassemble and assemble. 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 connecting knob 42 to axially limit the upper connecting knob 41 and the lower connecting knob 42.

[0085] Please refer to the following: Figure 5 , Figure 21 as well as Figure 22 Handle assembly 40 (e.g.) Figure 1 (As shown) It also includes a connecting structure 45 and a housing 46 fixedly connected to the connecting structure 45. The connecting structure 45 includes the third stop ring 451. The proximal end of the connecting segment 13 is inserted into the connecting structure 45. The clamp assembly 20 also includes a clamp operating member 24 connected to the proximal end of the clamp push rod 21. The clamp operating member 24 is disposed on the housing 46. In this way, the push catheter 10 is connected to the housing 46 as a whole through the connecting structure 45. The design of the housing 46 makes it easy for the operator to hold, and thus makes it easy for the operator to operate the valve repair device 100. The design of the clamp operating member 24 makes it easy for the operator to control the axial movement of the clamp push rod 21, and thus makes it easy to control the relative opening and closing of the proximal clamp 22 and the distal clamp 23.

[0086] Please see Figure 21 and Figure 22 In some embodiments, the connecting structure 45 includes a first connector 452 and a second connector 453. A third stop ring 451 is disposed at the distal end of the first connector 452. The first connector 452 is provided with a mating groove 4521 extending axially through its opposite end faces. The second connector 453 is provided with a mounting groove 4531 extending axially through its opposite end faces. The proximal end of the connecting segment 13 is fixedly inserted into the mating groove 4521. The first connector 452 is fixedly inserted into the mounting groove 4531. The housing 46 is fixedly sleeved on the outside of the second connector 453.

[0087] It can be understood that the housing 46 is fixedly sleeved on the outside of the second connector 453, and the first connector 452 is fixedly inserted into the mounting groove 4531 of the second connector 453. The first connector 452 is fixed to the housing 46 through the second connector 453. The proximal end of the connecting segment 13 is fixedly inserted into the mating groove 4521 of the first connector 452. The proximal end of the connecting segment 13 is fixed to the housing 46 through the first connector 452, so that the push tube 10 can be connected to the housing 46 through the connecting structure 45. At this time, the third stop ring 451 is axially fixed relative to the connecting segment 13.

[0088] exist Figure 21 and Figure 22 In the example, the mating groove 4521 extends axially and passes through the opposite end faces of the third stop ring 451. The mating groove 4521 is provided with multiple bosses 4522. The multiple bosses 4522 can slide and engage with the two upper guide grooves 1311 and the two lower guide grooves 1312 one by one along the axial direction. Thus, the proximal end of the connecting section 13 can be fixedly installed in the third stop ring 451 and the first connecting member 452. The structure is simple and the processing cost is low.

[0089] Furthermore, when the first connector 452 is fixedly inserted into the mounting groove 4531, and the proximal end of the connecting segment 13 is fixedly inserted into the mating groove 4521 of the first connector 452, the proximal end face of the connecting segment 13, the proximal end face of the first connector 452, and the proximal end face of the second connector 453 are basically flush, thus preventing slender parts such as the clamping push rod part inserted into the various cavities of the push catheter from being suspended and unstable.

[0090] Please see Figure 5 , Figure 23 and Figure 24 In some embodiments, the housing 46 includes a detachable and closable upper housing 461 and a lower housing 462. After the push conduit 10 is assembled with the connecting structure 45, the housing 46 is then fixedly sleeved onto the second connecting member 453. The chuck push rod 21 extends from the proximal end face of the connecting section 13, with the proximal end of the chuck push rod 21 located within the housing 46. The chuck operating member 24, located at the proximal end of the chuck push rod 21, extends radially out of the housing 46 and 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 sliding the chuck operating member 24 axially outside the housing 46. The operation is simple and convenient. In addition, the detachable design of the upper housing 461 and the lower housing 462 facilitates disassembly and assembly.

[0091] Please refer to the following: Figure 5 , Figure 7 , Figure 8 as well as Figure 25In some embodiments, the valve repair device 100 further includes a puncture assembly 50, which includes a puncture plunger 51 movably inserted into the push catheter 10 and a puncture needle 52 located at the distal end of the puncture plunger 51. The puncture needle 52 can be connected to a suture 201 and is used to puncture the valve leaflet 1 (e.g., Figure 10 (As shown) suture 201 is inserted into leaflet 1.

[0092] It is understandable that after the proximal clamp 22 and the distal clamp 23 clamp the leaflet 1 again, the puncture needle 52 can puncture the connection between the leaflet 1 and the suture 201, and pulling the puncture push rod 51 can drive the suture 201 to be implanted into the leaflet 1.

[0093] Furthermore, the push catheter 10 is provided with puncture cavities 113 extending axially through its opposite end faces, and the proximal clamp 22 is provided with puncture channels 224 extending axially through its opposite end faces. The puncture cavities 113 and puncture channels 224 are connected in a one-to-one correspondence. The puncture push rod 51 is movably inserted into the puncture cavities 113 and puncture channels 224. The puncture push rod 51 can drive the puncture needle 52 to pass through the puncture channel 224 and out of the distal end face of the proximal clamp 22 to puncture the leaflet 1, and then connect with the suture 201, driving the suture 201 to be implanted into the leaflet 1, ensuring that the puncture needle 52 can stably puncture the leaflet 1.

[0094] Please see Figure 5 , Figure 10 , Figure 25 and Figure 26 This invention also provides a suture assembly 200, which includes the suture 201 and sleeve 202 described above. The suture 201 includes a first end 2011 and a second end 2012, and the sleeve 202 is fixedly connected to the first end 2011 and / or the second end 2012. The suture 201 is housed in the chuck push rod 21 and the distal chuck 23, and the sleeve 202 is housed in the distal chuck 23. The sleeve 202 is used to be fixedly connected to the puncture needle 52. Thus, after the proximal clamp 22 and distal clamp 23 clamp the leaflet 1 again, pushing the puncture pusher 51 distally drives the puncture needle 52 to puncture the leaflet 1 and connect to the sleeve 202, thereby connecting the puncture needle 52 to the suture 201. At this time, withdrawing the puncture pusher 51 proximally will drive the puncture needle 52 to withdraw, thereby driving the sleeve 202 through the leaflet 1, thus 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 easily detached from the puncture needle 52. The operator can easily and quickly pull one or both ends of the suture 201 connected to the sleeve 202 to the predetermined position to implant the suture 201 into the leaflet 1.

[0095] exist Figure 5 and Figure 25In the example, both the first end 2011 and the second end 2012 of the suture 201 are provided with sleeves 202. Correspondingly, there are two puncture pushers 51, two puncture needles 52, two puncture chambers 113, and two puncture channels 224. The two puncture needles 52 are respectively located at the distal ends of the two puncture pushers 51. The two puncture chambers 113 are axially connected to the two puncture channels 224 respectively. Each puncture pusher 51 is movably inserted into one puncture chamber 113 and one puncture channel 224. The two sleeves 202 correspond one-to-one with the two puncture needles 52.

[0096] Please see Figure 26 The chuck push rod 21 has a through suture channel 211 along its axial direction. The distal chuck 23 has two suture receiving holes (not shown in the figure) and two sleeve holes 232 penetrating its proximal end face. Both suture receiving holes are connected to the suture channel 211, and the two sleeve holes 232 are axially connected to the two suture receiving holes respectively. The suture 201 is housed in the suture channel 211 and the two suture receiving holes, that is, the suture 201 is housed in the chuck push rod 21 and the distal chuck 23. The two sleeves 202, which are located at the first end 2011 and the second end 2012 respectively, are housed in the two sleeve holes 232, that is, both sleeves 202 are housed in the distal chuck 23. The end of the sleeve 202 that is connected to the puncture needle 52 (i.e., the end away from the suture 201) faces the proximal chuck 22.

[0097] Optionally, the sleeve 202 and the puncture needle 52 can also be fixedly connected by means including but not limited to threaded connection, bonding, rough surface friction connection, interference fit, etc. 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, wrapping, welding, bonding, snap-fit, etc. The material of the suture 201 can be a biocompatible polymer material or a relatively soft metal material, etc. Preferably, the suture 201 implanted in the human body is a polymer material such as PET (polyethylene terephthalate) or e-PTFE (expanded polytetrafluoroethylene).

[0098] Please refer to the following: Figure 5 , Figure 7 as well as Figure 31In some embodiments, the valve repair device 100 further includes a support assembly 60, which includes a support arm 61 movably inserted into the delivery catheter 10 and a support member 62 located at the distal end of the support arm 61. The support member 62 is made of an elastic and / or flexible material. The support arm 61 is used to drive the support member 62 through the distal sidewall of the delivery catheter 10, and the support member 62 is used to support the leaflet 1. The support member 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 clamp 22 and the distal clamp 23 can stably clamp the leaflet 1 again, thereby ensuring that the valve repair device 100 can stably and reliably treat mitral regurgitation.

[0099] exist Figure 5 , Figure 7 and Figure 31 In the example, the push conduit 10 has a support arm cavity 114 extending axially through its distal end face. The support arm cavity 114 includes a support outlet 1141, which is located on the distal sidewall of the main body section 11, i.e., the support outlet 1141 is located on the distal sidewall of the push conduit 10. The support arm 61 is movably inserted into the support arm cavity 114, i.e., the support arm 61 is movably inserted into the push conduit 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 housed in the support arm cavity 114. The axial movement of the support arm 61 distally causes the support member 62 housed in the support arm cavity 114 to exit from the support outlet 1141, i.e., the support member 62 exits from the distal sidewall of the push conduit 10. The support member 62 extends under its own elasticity, increasing its volume and thus its contact area with the leaflet 1. This provides stable support for the leaflet 1, stabilizing its pulsating motion and significantly reducing its range of motion. This ensures that the proximal clamp 22 and distal clamp 23 can reliably clamp the leaflet. It is understood that the support member 62, made of elastic and / or flexible material, can adapt to the anatomical structure and range of motion of the leaflet 1, preventing damage to the leaflet 1.

[0100] Preferably, the support member 62 is made of a material with shape memory function. The material 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. This invention does not impose any limitations on this. Figure 31 In the example, the support 62 is a mesh-like sac woven from multiple nickel-titanium wires. In other embodiments, the support 62 may also be extended into other closed structures that can support the leaflet 1, such as columnar, nest-like, flattened round, or disc-like structures, which are not specifically limited in this invention.

[0101] Please refer to the following: Figure 5 , Figure 7 , Figure 8 as well as Figure 25 In some embodiments, the valve repair device 100 further includes a probe assembly 70, which includes at least one probe 71. The probe 71 is movably inserted into the push catheter 10. The proximal clamp 22 is provided with a probe channel 225, and the distal clamp 23 is provided with a probe receiving hole 233 opposite to the probe channel 225. When the distal clamp 23 and the proximal clamp 22 are closed, the distal end of the probe 71 can extend from the probe channel 225 and be received in the probe receiving hole 233.

[0102] Thus, when there is no clamping leaflet 1 between the proximal clamp 22 and the distal clamp 23 (e.g.) Figure 10 When closed (as shown), the probe 71 can axially pass through the probe channel 225 and exit the proximal clamp 22, and be received in the probe receiving hole 233. When the leaflet 1 is clamped between the proximal clamp 22 and the distal clamp 23, and the leaflet edge 1 contacts the clamp push rod 21, the distal end of the probe 71, after passing through the proximal end face of the proximal clamp 22, will be blocked by the leaflet 1 and cannot continue to advance distally, indicating that the leaflet 1 has a good clamping effect. At this time, the puncture assembly 50 can be operated to puncture the leaflet 1 and insert the suture 201 (as shown). Figure 26 As shown, leaflet 1 is implanted. Furthermore, the distal end of probe 71 is blocked by leaflet 1 and cannot enter probe receiving hole 233, indicating that the position between the edge of leaflet 1 and suture 201 is relatively fixed, improving the reliability of suture 201 implantation. The clamping effect of leaflet 1 can be effectively detected through probe 71, and probe 71 has a simple structure and is easy to operate.

[0103] Furthermore, the delivery catheter 10 is provided with a probe cavity 115 extending axially through its proximal and distal faces. A probe channel 225 extends axially through the opposite end faces of the proximal clamp 22 and communicates axially with the probe cavity 115. A probe receiving hole 233 extends axially through the proximal face of the distal clamp 23, and its central axis is collinear with the central axes of the probe channel 225 and the probe cavity 115, i.e., the probe receiving hole 233 is opposite to the probe channel 225. The probe 71 is movably inserted into the probe cavity 115 and the probe channel 225, and can extend from the probe channel 225 and be received in the probe receiving hole 233. Therefore, the probe 71 can be movably inserted into the delivery catheter 10.

[0104] exist Figure 5 , Figure 7 , Figure 8 as well as Figure 25In the example, there are two probes 71, which extend axially and are arranged side by side relative to each other. Correspondingly, there are two probe cavities 115, two probe channels 225, and two probe receiving holes 233. The two probe cavities 115 are axially connected to the two probe channels 225, and the central axis of each probe receiving hole 233 is collinear with the central axis of one probe cavity 115 and one probe channel 225. Each probe 71 is movably inserted into one probe cavity 115 and one probe channel 225, and can extend from the probe channel 225 and be received in one probe receiving hole 233. In other embodiments, the number of probes 71 can be one, or more, such as three or four; correspondingly, the number of probe cavities 115, probe channels 225, and probe receiving holes 233 can also be one, three, or four, etc., and the present invention does not limit this.

[0105] Please see Figure 5 , Figure 23 and Figure 24 In some embodiments, the handle assembly 40 (e.g. Figure 1 (As shown) It also includes a sealing structure 47, which is disposed between the second connector 453 and the housing 46. The sealing structure 47 includes a sealing tube 471, a fixing sleeve 472, a sealing gasket 473, and a sealing nut 474. The sealing tube 471 is sleeved on the proximal end of the second connector 453, and the fixing sleeve 472 is fixedly sleeved on the distal end of the second connector 453. 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 connector 453. The inner cavity of the sealing tube 471 communicates with each inner cavity of the push conduit 10. The sealing tube 471 is housed in the housing 46 and is fixedly connected to the upper housing 461 and the lower housing 462. The housing 46 is fixedly sleeved on the outside of the second connector 453 through the sealing tube 471.

[0106] The proximal end of the sealing tube 471 has a receiving groove 4711, in which the sealing gasket 473 is housed. A sealing nut 474 is screwed onto the proximal end of the sealing tube 471, pressing against the sealing gasket 473 to fix it in the receiving groove 4711. The sealing gasket 473 seals the proximal opening of the sealing tube 471. Because the sealing tube 471 has a certain axial length, there is a gap between the sealing gasket 473 and the proximal face of the push guide tube 10.

[0107] The sealing gasket 473 has multiple through holes, each of which communicates with one of the inner cavities of the push tube 10. The clamp push rod 21, puncture push rod 51, support arm 61, and probe 71, extending from the proximal end face of the push tube 10, can penetrate into the inner cavity of the sealing tube 471 and movably pass through one of the through holes of the sealing gasket 473. Due to the deformability of the sealing gasket, there are no gaps between the clamp push rod 21, puncture push rod 51, support arm 61, probe 71 and the through hole of the sealing gasket 473, ensuring the sealing performance of the sealing tube 471. It should be noted that the sealing gasket 473 can be a flexible silicone gasket or other flexible gaskets made of other materials; this invention does not limit this.

[0108] like Figure 5 As shown, the sealing tube 471 is provided with an exhaust connector 4712 that connects to its inner cavity. The exhaust connector 4712 is used to connect to an exhaust pipe (not shown) to fill with saline or other liquids to vent the air in each inner cavity of the push catheter 10, so as to prevent air from entering the venous system with the blood circulation after the valve repair device 100 enters the human body and causing air embolism, thus ensuring the safety of the operation.

[0109] Please refer to the following: Figure 2 , Figure 5 as well as Figures 26 to 33 The following example illustrates the use of the valve repair device 100 provided in this embodiment of the invention by implanting a suture 201 through the apex of the mitral valve leaflet 1b.

[0110] S1, please refer to Figure 27 The valve repair device 100, which is in the delivery state, is introduced into the left ventricle 2 along the apical puncture site, and then passes through the mitral valve orifice into the left atrium 3.

[0111] S2, please refer to Figure 28 Push the chuck operating member 24 axially toward the distal end, causing 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, push the support member 62 through the distal side wall of the push guide tube 10, and the support member 62 is fully unfolded; then rotate the upper connecting knob 41 to push the upper clamping part 312 through the distal end of the push guide tube 10 and unfold it; then continue to rotate the upper connecting knob 41, and the upper clamping part 312 moves toward the distal end until the distal end surface of the upper clamping part 312 is flush with the proximal end surface of the distal chuck 23.

[0112] S3, please refer to Figure 29 The valve repair device 100 is then withdrawn until the support member 62 supports the anterior leaflet 1b for leaflet positioning and support.

[0113] S4, please refer to Figure 30 and Figure 31Turn the lower connection knob 42 to fully extend and unfold the lower clamping part 322 from the distal end of the push catheter 10; then, continue to turn the lower connection knob 42 until the lower clamping part 322 is fully unfolded and closely adheres to the anterior leaflet 1b, so as to perform secondary positioning of the leaflet 1.

[0114] S5, please refer to Figure 31 and Figure 32 Rotate the upper connecting knob 41, 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 is completely flattened and in a horizontal state. Then, retract the chuck operating member 24 along the axial direction towards the proximal end, driving the distal chuck 23 to move towards the proximal end until the distal chuck 23 and the proximal chuck 22 clamp the front leaf 1b again.

[0115] S6, please refer to Figure 2 The probe 71 extends from the distal end face of the proximal chuck 22 and detects whether the anterior leaf 1b has been clamped by the distal chuck 23 and the proximal chuck 22. If it has not been clamped, step S5 is repeated until the probe 71 detects that the anterior leaf 1b has been clamped by the distal chuck 23 and the proximal chuck 22, and then step S7 is entered; if it has been clamped, step S7 is entered directly.

[0116] S7, please refer to Figure 2 , Figure 5 , Figure 26 as well as Figure 33 The puncture pusher 51 is pushed to move distally, so that the puncture needle 52 punctures the anterior leaf 1b and connects with the sleeve 202 housed in the distal clamp 23. The puncture needle 52 is connected to the suture 201 through the sleeve 202. Then, the puncture pusher 51 is retracted to move proximally, so that the suture 201 connected to the puncture needle 52 moves proximally and passes through the anterior leaf 1b. The suture 201 is implanted in the anterior leaf 1b.

[0117] S8, please refer to Figures 31 to 33Push the chuck operating member 24 axially toward the distal end, so that the distal chuck 23 and the proximal chuck 22 are in an open state, and the proximal chuck 22 and the distal chuck 23 no longer clamp the anterior leaflet 1b; then, rotate the upper connecting knob 41, and the upper clamping part 312 moves distally, and the upper clamping part 312 and the lower clamping part 322 no longer clamp the anterior leaflet 1b; then retract the valve repair device 100 below the papillary muscle; then, rotate the upper connecting knob 41 and the lower connecting knob 42 to open the upper clamp The holding part 312 and the lower clamping part 322 are housed in the push catheter 10; then, the operating support 62 is housed in the push catheter 10 from the support outlet 1141; then the clamp operating part 24 is withdrawn axially towards the proximal end until the proximal clamp 22 and the distal clamp 23 are in a closed state; finally, the valve repair device 100 is withdrawn from the left ventricle 2 to the outside of the body, and the suture 201 is left in the left ventricle 2 as an artificial chordae tendineae to replace the broken or diseased chordae tendineae to treat mitral regurgitation.

[0118] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with an embodiment or example is included in at least one embodiment or example of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0119] Although embodiments of this application have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of this application, the scope of which is defined by the claims and their equivalents.

Claims

1. A valve repair device capable of secondary clamping, characterized in that, include: Pushing the conduit; A clamp assembly, comprising a clamp push rod movably inserted into the push tube and a proximal clamp and a distal clamp that can be opened and closed relative to each other, wherein the proximal clamp is located at the distal end of the push tube and the distal clamp is located at the distal end of the clamp push rod. A pre-clamping assembly, comprising an upper clamping member and a lower clamping member, wherein the upper clamping member comprises an upper push rod movably inserted into the push guide and an upper clamping portion disposed at the distal end of the upper push rod, and the lower clamping member comprises a lower push rod movably inserted into the push guide and a lower clamping portion disposed at the distal end of the lower push rod; as well as The puncture assembly includes a puncture push rod movably inserted into the push catheter and a puncture needle located at the distal end of the puncture push rod, the puncture needle being used to connect a suture. 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 and the second clamping surface cooperate to clamp the leaflet. The proximal clamp and the distal clamp cooperate to clamp the leaflet again. Wherein, the ratio of the area of ​​the first clamping surface to the area of ​​the leaflet is greater than or equal to 1 / 6 and less than 1; the ratio of the area of ​​the second clamping surface to the area of ​​the leaflet is greater than or equal to 1 / 6 and less than 1.

2. The valve repair device capable of secondary clamping according to claim 1, characterized in that, In the operating state, the lower clamping part is located between the upper clamping part and the push guide tube, and the area of ​​the first clamping surface is larger than the area of ​​the second clamping surface.

3. 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, and the angle is greater than 0° and less than or equal to 30°.

4. The valve repair device capable of secondary clamping according to claim 1, characterized in that, In the operating state, the upper clamping part is a sheet-like structure or a ring-like structure, and the lower clamping part is a sheet-like structure or a ring-like structure.

5. The valve repair device capable of secondary clamping according to claim 1, characterized in that, The upper clamping part and the lower clamping part are made of a material with shape memory function, and the valve repair device also has a delivery state; In the conveying state, the upper clamping portion and the lower clamping portion are compressed and deformed and at least partially housed in the push conduit; In the working state, the upper clamping part extends completely through the push guide and unfolds, the upper clamping part bends relative to the upper push rod, the lower clamping part extends completely through the push guide and unfolds, the lower clamping part bends relative to the lower push rod, and both the upper clamping part and the lower clamping part are located between the distal clamp and the push guide.

6. The valve repair device capable of secondary clamping according to claim 5, characterized in that, The push conduit includes a main body section, and the push conduit has a push rod cavity and a push cavity that extend axially through opposite end faces of the main body section. The clamp push rod is movably inserted into the push rod cavity, and the upper push rod and the lower push rod are movably inserted into the push cavity.

7. The valve repair device capable of secondary clamping according to claim 6, characterized in that, The pushing cavity includes an upper pushing cavity and a lower pushing cavity. The upper pushing cavity is closer to the push rod cavity than the lower pushing cavity. The upper push rod is movably inserted into the upper pushing cavity, and the lower push rod is movably inserted into the lower pushing cavity.

8. The valve repair device capable of secondary clamping according to claim 7, characterized in that, Both the upper clamping part and the lower clamping part are non-closed ring structures. There are two upper pushing cavities and two lower pushing cavities. There are two upper push rods and two lower push rods. The two upper pushing cavities are located on both sides of the push rod cavity, and the two lower pushing cavities are located on both sides of the push rod cavity. The two upper push rods are movably inserted into the two upper pushing cavities. The opposite ends of the upper clamping part are connected to the distal ends of the two upper push rods. The two lower push rods are movably inserted into the two lower pushing cavities, and the opposite ends of the lower clamping part are connected to the distal ends of the two lower push rods.

9. The valve repair device capable of secondary clamping according to claim 8, characterized in that, The proximal chuck protrudes from the distal surface of the main body segment. A clearance groove is formed between the sidewall of the proximal chuck and the distal surface of the main body segment. The clearance groove connects the upper pushing cavity and the lower pushing cavity. In the conveying state, the upper clamping part is received in the clearance groove and the upper pushing cavity, and the lower clamping part is received in the clearance groove and the lower pushing cavity.

10. The valve repair device capable of secondary clamping according to claim 9, characterized in that, The proximal end of the distal chuck is provided with a clearance groove corresponding to the clearance groove. When the proximal chuck and the distal chuck are in a closed state, the clearance groove is connected to the clearance groove.

11. The valve repair device capable of secondary clamping according to any one of claims 6 to 10, characterized in that, The push conduit further includes a connecting section connected to the proximal end of the main body section. The push rod cavity extends axially to the proximal end face of the connecting section. The connecting section is provided with a guide groove communicating with the push cavity. The guide groove has an opening extending axially. The upper clamping member further includes an upper operating member connected to the proximal end of the upper push rod. The lower clamping member further includes a lower operating member connected to the proximal end of the lower push rod. The upper operating member and the lower operating member are disposed in the guide groove and partially exposed outside the push conduit from the opening.

12. The valve repair device capable of secondary clamping according to claim 11, characterized in that, The valve repair device further includes a handle assembly, which includes an upper connecting knob and a lower connecting knob sleeved on the connecting section. The upper connecting knob is threaded to the upper operating member, and the lower connecting knob is threaded to the lower operating member.

13. The valve repair device capable of secondary clamping according to claim 12, characterized in that, The handle assembly further includes a first stop ring, a second stop ring, and a third stop ring fixedly sleeved on the connecting section. The upper connecting knob is axially limited between the first stop ring and the second stop ring, and the lower connecting knob is axially limited between the second stop ring and the third stop ring.

14. The valve repair device capable of secondary clamping according to claim 13, characterized in that, The handle assembly further includes a connecting structure and a housing fixedly connected to the connecting structure. The connecting structure includes the third stop ring, and the proximal end of the connecting segment is inserted into the connecting structure. The chuck assembly further includes a chuck operating member connected to the proximal end of the chuck push rod, and the chuck operating member is disposed on the housing.

15. The valve repair device capable of secondary clamping according to claim 14, characterized in that, The connection structure includes a first connector and a second connector. The third stop ring is located at the distal end of the first connector. The first connector has a mating groove extending axially through its opposite end faces. The second connector has an mounting groove extending axially through its opposite end faces. The proximal end of the connecting segment is fixedly inserted into the mating groove. The first connector is fixedly inserted into the mounting groove. The housing is fixedly sleeved on the outside of the second connector.

16. The valve repair device capable of secondary clamping according to claim 1, characterized in that, The valve repair device further includes a puncture assembly, which includes a puncture plunger movably inserted into the push catheter and a puncture needle located at the distal end of the puncture plunger. The puncture needle can be connected to a suture and is used to puncture the leaflet to implant the suture into the leaflet.

17. The valve repair device capable of secondary clamping according to claim 1 or 16, characterized in that, The valve repair device further includes a support assembly, which includes a support arm movably inserted into the push catheter and a support member disposed at the distal end of the support arm. The support member is made of elastic and / or flexible material. The support arm is used to drive the support member to pass through the distal sidewall of the push catheter, and the support member is used to support the valve leaflet.

18. The valve repair device capable of secondary clamping according to claim 1, characterized in that, The valve repair device further includes a probe assembly, which includes at least one probe that is movably inserted into the delivery catheter. The proximal clamp has a probe channel, and the distal clamp has a probe receiving hole opposite to the probe channel. When the distal clamp and the proximal clamp are closed, the distal end of the probe can extend from the probe channel and be received in the probe receiving hole.

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