Valve repair system

Abstract

The application provides a valve repair system. A pre-clamping device in the valve repair system comprises a delivery shaft and a clamping assembly. The delivery shaft is provided with an axial delivery cavity and a receiving cavity. The delivery cavity penetrates through opposite ends of the delivery shaft, and the receiving cavity penetrates through the distal end of the delivery shaft. The delivery cavity is used to movably install a suture implant device. The clamping assembly comprises an upper clamping member and a lower clamping member. The upper clamping member comprises an upper clamping push rod movably installed in the receiving cavity and an upper clamping portion arranged at the distal end of the upper clamping push rod. The lower clamping member comprises a lower clamping push rod movably installed in the receiving cavity and a lower clamping portion arranged at the distal end of the lower clamping push rod. The pre-clamping device has a working state. In the working state, the upper clamping portion and the lower clamping portion are located outside the receiving cavity. The upper clamping portion has a first clamping surface, and the lower clamping portion has a second clamping surface. The first clamping surface cooperates with the second clamping surface to clamp a valve leaflet. The area ratio of the first clamping surface and the second clamping surface to the valve leaflet is greater than or equal to 1 / 6 and less than 1.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and in particular relates to a valve repair system. 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 two 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 system. The pre-clamping device in this valve repair system can stably capture the valve leaflets, enabling the suture implantation device to stably and accurately implant the suture into the rough band located at the edge of the valve leaflet. This ensures the safe and reliable implantation position of the suture, improves the lifespan of the suture, and makes the suture less prone to falling out, thus guaranteeing the surgical outcome.

[0006] This invention first provides a pre-clamping device, which includes a conveying shaft and a clamping assembly. The conveying shaft has a conveying cavity and a receiving cavity extending axially. The conveying cavity extends through opposite ends of the conveying shaft, and the receiving cavity extends through the distal end of the conveying shaft. The conveying cavity is used to move the suture implantation device. The clamping assembly includes an upper clamping member and a lower clamping member. The upper clamping member includes an upper clamping push rod that is movably inserted into the receiving cavity and an upper clamping portion located at the distal end of the upper clamping push rod. The lower clamping member includes a lower clamping push rod that is movably inserted into the receiving cavity and a lower clamping portion located at the distal end of the lower clamping push rod. The pre-clamping device has a working state. In the working state, the upper clamping portion and the lower clamping portion are located outside the receiving cavity. 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 leaflet. The ratio of the area of ​​the first clamping surface to the area of ​​the leaflet and the ratio of the area of ​​the second clamping surface to the area of ​​the leaflet are both greater than or equal to 1 / 6 and less than 1.

[0007] The present invention also provides a valve repair system, which includes the aforementioned pre-clamping device and suture implantation device. The suture implantation device includes a pushing assembly and a clamping assembly. The pushing assembly includes a pushing catheter movably inserted into a delivery cavity. The clamping assembly includes a clamping rod movably inserted into the pushing catheter, and a proximal clamp and a distal clamp that open and close relative to each other along the axial direction. The proximal clamp is located at the distal end of the pushing catheter or at the distal end face of the pushing catheter as a proximal clamp, and the distal clamp is located at the distal end of the clamping rod. After the upper clamping part and the lower clamping part clamp the leaflet, the proximal clamp and the distal clamp clamp the leaflet again.

[0008] The pre-clamping device and valve repair system provided by this invention pre-clamp the valve leaflets using a first clamping surface of the upper clamping part and a second clamping surface of the lower clamping part. Then, a suture implantation device inserted into the delivery cavity is used to implant sutures onto the valve leaflets to treat valvular regurgitation. Since 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, the first and second clamping surfaces can completely flatten the valve leaflets when clamping them, preventing folding and stacking. This allows the suture implantation device to stably and accurately implant the suture into the rough band located at the edge of the valve leaflet, ensuring a safe and reliable suture implantation position, avoiding excessive valve leaflet clamping force on the suture, and improving suture lifespan. Furthermore, due to the relatively thick rough band, the suture implanted there experiences greater anchoring force, making it less prone to suture dislodgement and ensuring the effectiveness of the surgery. Attached Figure Description

[0009] 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.

[0010] Figure 1 This is a three-dimensional structural diagram of the valve repair system provided in an embodiment of the present invention.

[0011] Figure 2 yes Figure 1 A three-dimensional structural diagram of the pre-clamping device in operation.

[0012] Figure 3 yes Figure 2 Enlarged view of Part III.

[0013] Figure 4 yes Figure 1 A three-dimensional structural diagram of the pre-clamping device in the conveying state.

[0014] Figure 5 yes Figure 4 A magnified view of the middle V section.

[0015] Figure 6 yes Figure 1 An exploded three-dimensional diagram of the pre-clamping device in operation.

[0016] Figure 7 yes Figure 6 Enlarged view of section VII.

[0017] Figure 8 yes Figure 1 A top view of the pre-clamping device clamping the leaflet.

[0018] Figure 9 This is a top view of another pre-clamping device provided in an embodiment of the present invention, which clamps the leaflet.

[0019] Figure 10 This is a top view of another pre-clamping device for clamping leaflets provided in an embodiment of the present invention.

[0020] Figure 11 This is a top view of another pre-clamping device provided in an embodiment of the present invention clamping a leaflet.

[0021] Figure 12 yes Figure 2 A partial structural diagram of the upper and lower clamping components clamping the leaflets (leaflets omitted).

[0022] Figure 13 yes Figure 6A three-dimensional structural diagram of the assembled conveyor shaft, clamping assembly, and guide assembly.

[0023] Figure 14 yes Figure 13 A three-dimensional structural diagram of the central conveyor shaft.

[0024] Figure 15 yes Figure 13 A three-dimensional structural diagram of the guide component.

[0025] Figure 16 yes Figure 13 A three-dimensional structural diagram of the clamping component.

[0026] Figure 17 yes Figure 6 A schematic diagram of the three-dimensional structure after the clamping component and the guiding component are assembled.

[0027] Figure 18 yes Figure 17 Enlarged view of section XVIII.

[0028] Figure 19 yes Figure 6 A three-dimensional structural diagram of the assembled conveyor shaft, clamping assembly, guide assembly, and handle assembly (omitting the first, second, and third knobs).

[0029] Figure 20 yes Figure 19 A three-dimensional structural diagram of the middle shell.

[0030] Figure 21 yes Figure 1 A three-dimensional structural diagram of the central suture implantation device.

[0031] Figure 22 yes Figure 21 A schematic diagram of the three-dimensional structure.

[0032] Figure 23 yes Figure 22 Enlarged view of section XXIII.

[0033] Figure 24 This is a three-dimensional structural diagram of the connection between the suture and the sleeve provided in an embodiment of the present invention.

[0034] Figures 25 to 33 This is a schematic diagram of the process of implanting a suture in the posterior leaflet of the mitral valve via the apical approach of the valve repair system provided by this invention. Detailed Implementation

[0035] 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.

[0036] 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.

[0037] 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 central axis of component A refers to the geometric center line of component A; component A can be directly connected to component B, or indirectly connected through component C. The above definitions are for ease of description only and should not be construed as limiting the invention.

[0038] Please refer to the following: Figure 1 , Figure 30 and Figure 33 This invention provides a valve repair system 1000, which can be accessed via the apex of the heart to perform interventional treatment for mitral or tricuspid regurgitation. The following detailed description uses the valve repair system 1000 for mitral regurgitation interventional treatment as an example. The valve repair system 1000 includes a pre-clamping device 100 and a suture implantation device 200. When using the valve repair system 1000, the pre-clamping device 100 passes through the orifice of the mitral valve to pre-clamp one of the leaflets 1. After the pre-clamping device 100 clamps the leaflet 1, the suture implantation device 200 implants a suture 80 onto the leaflet 1. The suture 80 can serve as an artificial chordae tendineae to replace diseased or ruptured chordae tendineae in the patient's heart; or multiple sutures 80 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.

[0039] Please refer to the following: Figures 1 to 11The pre-clamping device 100 provided in this embodiment of the invention includes a conveying shaft 10 and a clamping assembly 20. The conveying shaft 10 is provided with a conveying cavity 11 and a receiving cavity 12 extending axially. The conveying cavity 11 passes through both ends of the conveying shaft 10, and the receiving cavity 12 passes through the distal end of the conveying shaft 10. The conveying cavity 11 is used to movably insert the suture implantation device 200. The clamping assembly 20 includes an upper clamping member 21 and a lower clamping member 22. The upper clamping member 21 includes an upper clamping push rod 211 movably inserted into the receiving cavity 12 and an upper clamping portion 212 disposed at the distal end of the upper clamping push rod 211. The lower clamping member 22 includes a lower clamping push rod 221 movably inserted into the receiving cavity 12 and a lower clamping portion 222 disposed at the distal end of the lower clamping push rod 221. The pre-clamping device 100 is in a working state. In the working state, the upper clamping part 212 and the lower clamping part 222 are located outside the receiving cavity 12. The upper clamping part 212 has a first clamping surface 2121 and the lower clamping part 222 has a second clamping surface 2221. The first clamping surface 2121 and the second clamping surface 2221 cooperate to clamp the leaflet 1. The ratio of the area of ​​the first clamping surface 2121 to the area of ​​the leaflet 1 and the ratio of the area of ​​the second clamping surface 2221 to the area of ​​the leaflet 1 are both greater than or equal to 1 / 6 and less than 1.

[0040] The aforementioned pre-clamping device 100, by moving the upper clamping push rod 211 and the lower clamping push rod 221, can drive the first clamping surface 2121 of the upper clamping part 212 and the second clamping surface 2221 of the lower clamping part 222 to move relative to each other, thereby pre-clamping the leaflet 1. Then, by operating the suture implantation device 200 inserted into the delivery cavity 11, a suture 80 (e.g., ...) is implanted onto the leaflet 1. Figure 33 As shown, this device is used to treat valvular regurgitation. Since the ratio of the area of ​​the first clamping surface 2121 to the area of ​​the leaflet 1 and the ratio of the area of ​​the second clamping surface 2221 to the area of ​​the leaflet 1 are both greater than or equal to 1 / 6 and less than 1, the areas of the first clamping surface 2121 and the second clamping surface 2221 are relatively large. When the first clamping surface 2121 and the second clamping surface 2221 clamp the leaflet 1, they can completely flatten the leaflet 1, avoiding folding and stacking. Therefore, the suture implantation device 200 can stably and accurately implant the suture 80 into the rough band located at the edge of the leaflet 1, ensuring a safe and reliable implantation position for the suture 80, avoiding excessive leaflet clamping force on the suture 80, and improving the lifespan of the suture 80. Moreover, because the rough band is relatively thick, the suture 80 implanted in the rough band can receive a greater anchoring force, thus the suture 80 is less likely to fall out, ensuring the effectiveness of the surgery.

[0041] It should be noted that, taking the ratio of the area of ​​the first clamping surface 2121 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 2121 to the area of ​​the leaflet 1 can be 1 / 6, or any value greater than 1 / 6 and less than 1. Preferably, the ratio of the area of ​​the first clamping surface 2121 to the area of ​​the leaflet 1 and the ratio of the area of ​​the second clamping surface 2221 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 ratio is greater than or equal to 1 / 3 and less than or equal to 4 / 5, for example, 1 / 2, which makes it easier for the first clamping surface 2121 and the second clamping surface 2221 to clamp the leaflet 1 and improves 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 2121 and the second clamping surface 2221 of the pre-clamping device 100 are set for different leaflets 1; when sutures 80 are implanted in different leaflets 1, different specifications of pre-clamping devices 100 can be selected accordingly.

[0042] In addition, such as Figure 1 and Figure 27 As shown, the pre-clamping device 100 also acts as an outer sheath for the suture implantation device 200. The suture implantation device 200 can directly pass through the delivery cavity 11 of the pre-clamping device 100 to the distal end of the delivery shaft 10 and implant the suture 80 on the leaflet 1. This avoids the suture implantation device 200 from puncturing the ventricular wall 2 again and causing secondary damage to the ventricular wall 2. It also avoids the suture implantation device 200 from rubbing back and forth on the ventricular wall 2 and causing damage to the ventricular wall 2.

[0043] In this invention, in the working state, the upper clamping portion 212 is located at the distal end of the lower clamping portion 222. The first clamping surface 2121 is the surface of the upper clamping portion 212 facing the lower clamping portion 222, and the second clamping surface 2221 is the surface of the lower clamping portion 222 facing the upper clamping portion 212. The following description is based on this. The terms "first," "second," etc., are merely for ease of description and should not be considered as limitations on the invention.

[0044] Please refer to the following: Figures 2 to 6 In some embodiments, the upper clamping portion 212 and the lower clamping portion 222 are made of a material with shape memory function. The pre-clamping device 100 also has a conveying state. In the conveying state, the upper clamping portion 212 and the lower clamping portion 222 are compressed and deformed and at least partially housed in the receiving cavity 12. In the working state, the upper clamping portion 212 extends out of the receiving cavity 12 and unfolds, and the upper clamping portion 212 bends relative to the upper clamping push rod 211; the lower clamping portion 222 extends out of the receiving cavity 12 and unfolds, and the lower clamping portion 222 bends relative to the lower clamping push rod 221.

[0045] It is understood that both the upper clamping part 212 and the lower clamping part 222 are made of materials with shape memory function. After the upper clamping part 212 and the lower clamping part 222 are shaped, they can remain flat when not subjected to external force (e.g., Figure 3 As shown), it can deform and shrink in volume when subjected to external forces (such as...). Figure 5 (As shown). Therefore, the dimensions of the upper clamping portion 212 and the lower clamping portion 222 can be designed to be relatively large, ensuring that the areas of the first clamping surface 2121 and the second clamping surface 2221 are sufficiently large in the working state. Thus, when the first clamping surface 2121 and the second clamping surface 2221 clamp the leaflet 1 (as shown), Figure 8 When (as shown), both can flatten the leaflet 1, preventing it from folding and piling up. In the working state, the upper clamping part 212 and the lower clamping part 222 bend in the same direction relative to the upper clamping push rod 211 and the lower clamping push rod 221, respectively (as shown). Figure 3 As shown, the upper clamping part 212 and the lower clamping part 222 have a large overlapping area or are basically overlapping in the radial direction, which is beneficial for the upper clamping part 212 and the lower clamping part 222 to clamp the leaflet 1. 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 limit the material in any way.

[0046] When the pre-clamping device 100 is in the delivery state, due to the compression deformation of the upper clamping part 212 and the lower clamping part 222 and their at least partial containment in the receiving cavity 12, the cross-sectional area of ​​the pre-clamping device 100 in the radial direction is relatively small. This is beneficial in two ways: firstly, it reduces the size of the surgical trauma caused by delivering the pre-clamping device 100, which is beneficial for the patient's postoperative recovery; secondly, it helps to prevent the pre-clamping device 100 from passing through the orifice of the mitral valve (e.g., Figure 25 When the space between the anterior leaflet 1b and the posterior leaflet 1a is shown, it compresses the leaflet 1 and thus affects the leaflet 1 (as shown). Figure 8 (As shown) damage. After the pre-clamping device 100 passes through the orifice of the mitral valve, the pre-clamping device 100 changes from the conveying state to the working state. The upper clamping push rod 211 drives the upper clamping part 212 to pass through the distal end of the receiving cavity 12. Under the action of its own shape memory function, the upper clamping part 212 bends and unfolds relative to the upper clamping push rod 211; the lower clamping push rod 221 drives the lower clamping part 222 to pass through the distal end of the receiving cavity 12. Under the action of its own shape memory function, the lower clamping part 222 bends and unfolds relative to the upper clamping push rod 211; the first clamping surface 2121 and the second clamping surface 2221 cooperate to clamp the leaflet 1.

[0047] Please see Figure 7 and Figure 8In some embodiments, both the upper clamping portion 212 and the lower clamping portion 222 are non-closed ring structures in the working state. There are two upper clamping push rods 211 and two lower clamping push rods 221. The two upper clamping push rods 211 are respectively a first upper clamping push rod 2111 and a second upper clamping push rod 2112, and the two lower clamping push rods 221 are respectively a first lower clamping push rod 2211 and a second lower clamping push rod 2212. The opposite ends of the upper clamping portion 212 are respectively connected to the distal ends of the first upper clamping push rod 2111 and the second upper clamping push rod 2112, and the opposite ends of the lower clamping portion 222 are respectively connected to the distal ends of the first lower clamping push rod 2211 and the second lower clamping push rod 2212. The upper clamping portion 212 forms a stable non-closed ring structure through its connection with the first upper clamping push rod 2111 and the second upper clamping push rod 2112. Similarly, the lower clamping portion 222 forms a stable non-closed ring structure through its connection with the first lower clamping push rod 2211 and the second lower clamping push rod 2212. 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 212 and the lower clamping portion 222. It should be noted that the shapes of the upper clamping portion 212 and the lower clamping portion 222 can be the same or different.

[0048] Correspondingly, there are two receiving cavities 12. The central axis of the conveying cavity 11 is coaxial with the central axis of the conveying shaft 10, and the two receiving cavities 12 are located on both sides of the conveying cavity 11. The two receiving cavities 12 are a first receiving cavity 121 and a second receiving cavity 122. A first upper clamping push rod 2111 is movably inserted into the first receiving cavity 121, and a second upper clamping push rod 2112 is movably inserted into the second receiving cavity 122; a first lower clamping push rod 2211 is movably inserted into the first receiving cavity 121, and a second lower clamping push rod 2212 is movably inserted into the second receiving cavity 122.

[0049] Since the first receiving cavity 121 and the second receiving cavity 122 are located on both sides of the transport cavity 11, the extended line of the central axis of the transport cavity 11 passes through the opening of the upper clamping part 212 and the opening of the lower clamping part 222, as shown... Figure 1 As shown, when the suture implantation device 200 passes through the far end of the conveying shaft 10 from the conveying chamber 11, the suture implantation device 200 is located between the two ends of the upper clamping part 212 and the two ends of the lower clamping part 222, so as to avoid the upper clamping part 212 and the lower clamping part 222 interfering with the suture implantation device 200 and ensure that the suture implantation device 200 can stably perform the suture implantation operation.

[0050] When the pre-clamping device 100 switches from the working state to the conveying state, the first upper clamping push rod 2111 and the second upper clamping push rod 2112 move axially toward the proximal end in the first receiving cavity 121 and the second receiving cavity 122, respectively, causing the opposite ends of the upper clamping part 212 to move axially toward the proximal end and enter the first receiving cavity 121 and the second receiving cavity 122, respectively, until the upper clamping part 212 presses against the distal end of the conveying shaft 10 and tightens; the first lower clamping push rod 2211 and the second lower clamping push rod 2212 move axially toward the proximal end in the first receiving cavity 121 and the second receiving cavity 122, respectively, causing the opposite ends of the lower clamping part 222 to move axially toward the proximal end and enter the first receiving cavity 121 and the second receiving cavity 122, respectively, until the lower clamping part 222 presses against the distal end of the conveying shaft 10 and tightens. Therefore, when the pre-clamping device 100 is in the conveying state, the upper clamping part 212 and the lower clamping part 222 are mostly housed in the receiving cavity 12, and a small part is exposed outside the far end of the conveying shaft 10.

[0051] Furthermore, please refer to the following: Figures 5 to 8 The pre-clamping device 100 further includes a guiding assembly, which includes two guide members 30, namely a first guide member 31 and a second guide member 32. Both the first guide member 31 and the second guide member 32 have two axially extending pushing cavities, namely an upper pushing cavity and a lower pushing cavity. Specifically, the first guide member 31 has a first upper pushing cavity 311 and a first lower pushing cavity 312 arranged radially, and the second guide member 32 has a second upper pushing cavity 321 and a second lower pushing cavity 322 arranged radially. The first guide member 31 is movably inserted into the first receiving cavity 121, and the second guide member 32 is movably inserted into the second receiving cavity 122. The first upper clamping push rod 2111 is movably inserted into the first upper pushing cavity 311 of the first guide 31, and the second upper clamping push rod 2112 is movably inserted into the second upper pushing cavity 321 of the second guide 32; the first lower clamping push rod 2211 is movably inserted into the first lower pushing cavity 312 of the first guide 31, and the second lower clamping push rod 2212 is movably inserted into the second lower pushing cavity 322 of the second guide 32.

[0052] When the pre-clamping device 100 is in the conveying state, the first guide 31 is housed in the first receiving cavity 121, the first upper clamping push rod 2111 is housed in the first upper pushing cavity 311 of the first guide 31 and thus in the first receiving cavity 121, and the first lower clamping push rod 2211 is housed in the first lower pushing cavity 312 of the first guide 31 and thus in the first receiving cavity 121; the second guide 32 is housed in the second receiving cavity 122, the second upper clamping push rod 2112 is housed in the second upper pushing cavity 321 of the second guide 32, and the second lower clamping push rod 2212 is housed in the second lower pushing cavity 322 of the second guide 32 and thus in the second receiving cavity 122. When the pre-clamping device 100 is in operation, the first guide 31 and the second guide 32 can move axially and pass through the distal ends of the first receiving cavity 121 and the second receiving cavity 122 respectively, moving away from the distal end of the conveying shaft 10; the first upper clamping push rod 2111 and the second upper clamping push rod 2112 pass through the first upper pushing cavity 311 and the second upper pushing cavity 321 respectively and move axially toward the distal end, driving the upper clamping part 212 to pass through; the first lower clamping push rod and the second upper clamping push rod 2112 pass through the first upper pushing cavity 311 and the second upper pushing cavity 321 respectively and move axially toward the distal end, driving the lower clamping part 222 to pass through, so that the upper clamping part 212 and the lower clamping part 222 can clamp the leaflet 1 at a position spaced a certain distance from the distal end face of the conveying shaft 10.

[0053] In this way, when the upper clamping part 212 and the lower clamping part 222 clamp the leaflet 1, it can not only prevent the leaflet 1 from being too close to the far end face of the conveying shaft 10 and blocking the far end opening of the conveying cavity 11, thus affecting the suture implantation device 200 from passing through the far end of the conveying cavity 11; but also reserve adjustment space for the suture implantation device 200 that passes through the far end of the conveying cavity 11 to move in the axial direction, so as to facilitate the adjustment of the suture implantation device 200 and perform suture implantation operation on the leaflet 1.

[0054] Furthermore, since the first upper clamping push rod 2111, the second upper clamping push rod 2112, the first lower clamping push rod 2211, and the second lower clamping push rod 2212 are respectively movably mounted in different pushing cavities, friction or collision can be avoided when the first upper clamping push rod 2111 and the first lower clamping push rod 2211 move in the first receiving cavity 121, and friction or collision can be avoided when the second upper clamping push rod 2112 and the second lower clamping push rod 2212 move in the second receiving cavity 122, ensuring that the first upper clamping push rod 2111, the first lower clamping push rod 2211, the second upper clamping push rod 2112, and the second lower clamping push rod 2212 move smoothly along the axial direction.

[0055] Optionally, the radial cross-sectional shape of the first receiving cavity 121 and the second receiving cavity 122 is non-circular, and the first guide 31 is adapted to the first receiving cavity 121 and the second guide 32 is adapted to the second receiving cavity 122 (e.g., Figure 5 (As shown). In this way, the first guide 31 and the second guide 32 can only move axially and cannot rotate in the first receiving cavity 121 and the second receiving cavity 122. This ensures that when the upper clamping part 212 and the lower clamping part 222 pass through the first guide 31 and the second guide 32, the projections of the first clamping surface 2121 and the second clamping surface 2221 are basically coincident, avoiding secondary adjustments to the upper clamping part 212 and the lower clamping part 222 and reducing the difficulty of the surgical operation.

[0056] Please see Figure 9 In some embodiments, the distal end face of the delivery shaft 10 is further provided with a receiving groove 13 connecting the two receiving cavities 12. In the delivery state, the upper clamping part 212 and the lower clamping part 222 are received in the two receiving cavities 12 and the receiving groove 13. In this way, when the pre-clamping device 100 is in the delivery state, the upper clamping part 212 and the lower clamping part 222 are prevented from being exposed outside the delivery shaft 10, which is aesthetically pleasing and simple. Moreover, during the process of the pre-clamping device 100 delivering to the leaflet 1, the upper clamping part 212 and the lower clamping part 222 are prevented from rubbing against the heart tissue, thus avoiding damage to the heart tissue. It should be noted that since the receiving groove 13 is provided on the distal end face of the delivery shaft 10 and connects the receiving cavities 12 on both sides of the delivery cavity 11, the receiving groove 13 is also connected to the delivery cavity 11.

[0057] In other embodiments, both the first guide 31 and the second guide 32 are provided with a pushing cavity. For example, the first upper clamping push rod 2111 and the second upper clamping push rod 2112 are movably inserted into the pushing cavity of the first guide 31, and the first lower clamping push rod 2211 and the second lower clamping push rod 2212 are movably inserted into the pushing cavity of the second guide 32.

[0058] In other embodiments, the guide assembly can be omitted, and the number of receiving cavities 12 can be four. For example, there are two first receiving cavities 121 and two second receiving cavities 122, with the two first receiving cavities 121 arranged radially and the two second receiving cavities 122 arranged radially. The first upper clamping push rod 2111 and the second upper clamping push rod 2112 are respectively movably inserted into the two first receiving cavities 121, and the first lower clamping push rod 2211 and the second lower clamping push rod 2212 are respectively movably inserted into the two second receiving cavities 12. That is, the first upper clamping push rod 2111, the second upper clamping push rod 2112, the first lower clamping push rod 2211, and the second lower clamping push rod 2212 are respectively movably inserted into different receiving cavities 12.

[0059] Please see Figure 10In some embodiments, in the working state, both the upper clamping part 212 and the lower clamping part 222 are closed ring structures. There is one upper clamping push rod 211 and one lower clamping push rod 221. The upper clamping part 212 is connected to the distal end of the upper clamping push rod 211, and the lower clamping part 222 is connected to the distal end of the lower clamping push rod 221. In the conveying state, both the upper clamping part 212 and the lower clamping part 222 can be completely housed within the receiving cavity 12. Figure 10 In the example, there is one receiving cavity 12 and one guide 30. The guide 30 is movably inserted into the receiving cavity 12. The guide 30 has two pushing cavities extending axially. The upper clamping push rod 211 is movably inserted into one pushing cavity of the guide 30, and the lower clamping push rod 221 is movably inserted into the other pushing cavity of the guide 30. When the upper clamping push rod 211 and the lower clamping push rod 221 move axially towards the proximal end in the two pushing cavities respectively, since both the upper clamping part 212 and the lower clamping part 222 can be compressed and deformed, both the upper clamping part 212 and the lower clamping part 222 can be inserted axially towards the proximal end and completely received in the two pushing cavities, that is, the upper clamping part 212 and the lower clamping part 222 are received in the same receiving cavity 12. It can be understood that the upper clamping part 212 and the lower clamping part 222 are provided with clearances to avoid the upper clamping part 212 and the lower clamping part 222 from obstructing the delivery cavity 11. In other embodiments, the guide 30 may be omitted, and the number of receiving cavities 12 may be two. The two receiving cavities 12 are located on both sides of the transport cavity 11; of course, the two receiving cavities 12 may also be located on the same side of the transport cavity 11. The upper clamping push rod 211 and the lower clamping push rod 221 are respectively movably inserted into the two receiving cavities 12, and the upper clamping part 212 and the lower clamping part 222 can be completely received in the two receiving cavities 12 respectively.

[0060] It should be noted that the upper clamping part 212 and the lower clamping part 222 may be either a closed ring structure or a non-closed ring structure, and the present invention does not limit this.

[0061] like Figure 8 and Figure 10As shown, when both the upper clamping portion 212 and the lower clamping portion 222 are annular structures (annular structures include non-closed annular structures and closed annular structures), the first clamping surface 2121 refers to the outer peripheral surface of the upper clamping portion 212 facing the lower clamping portion 222, and the area of ​​the first clamping surface 2121 is the area of ​​the outer peripheral surface of the upper clamping portion 212. The second clamping surface 2221 refers to the outer peripheral surface of the lower clamping portion 222 facing the upper clamping portion 212, and the area of ​​the second clamping surface 2221 refers to the area of ​​the outer peripheral surface of the lower clamping portion 222. The annular structure of both the upper clamping portion 212 and the lower clamping portion 222 effectively saves materials and reduces costs. Furthermore, the upper clamping portion 212 and the lower clamping portion 222 are easily deformable and have a small compressed volume, which facilitates the smooth reception of the upper clamping portion 212 and the lower clamping portion 222 within the receiving cavity 12.

[0062] Please see Figure 11 In some embodiments, in the working state, both the upper clamping part 212 and the lower clamping part 222 are sheet-like structures. There is one upper clamping push rod 211 and one lower clamping push rod 221. The upper clamping part 212 is connected to the distal end of the upper clamping push rod 211, and the lower clamping part 222 is connected to the distal end of the lower clamping push rod 221. In the transport state, both the upper clamping part 212 and the lower clamping part 222 can be completely housed within the receiving cavity 12. Figure 11 In this example, there are two receiving cavities 12, located on opposite sides of the transport cavity 11. The upper clamping push rod 211 and the lower clamping push rod 221 are movably inserted into the two receiving cavities 12. When the upper clamping push rod 211 and the lower clamping push rod 221 move axially towards the proximal end within the two receiving cavities 12, due to the compressibility of the upper clamping portion 212 and the lower clamping portion 222, both can be inserted axially towards the proximal end and completely contained within the two receiving cavities 12. It is understood that the upper clamping portion 212 and the lower clamping portion 222 are provided with clearances to prevent them from obstructing the transport cavity 11. In other embodiments, the two receiving cavities 12 may also be located on the same side of the transport cavity 11.

[0063] It should be noted that the upper clamping part 212 and the lower clamping part 222 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.

[0064] like Figures 8 to 11As shown, in some embodiments, in the working state, the area of ​​the first clamping surface 2121 of the upper clamping portion 212 is larger than the area of ​​the second clamping surface 2221 of the lower clamping portion 222. Thus, when the upper clamping portion 212 and the lower clamping portion 222 clamp the leaflet 1, the second clamping surface 2221 can be covered by the first clamping surface 2121, further ensuring sufficient clamping force when the upper clamping portion 212 and the lower clamping portion 222 clamp the leaflet 1, thereby clamping the leaflet 1 more stably and allowing the clamped leaflet 1 to be in a better flattened state. Furthermore, the lower clamping portion 222 also supports the leaflet 1, making it easier for the upper clamping portion 212 and the lower clamping portion 222 to clamp the leaflet 1, ensuring that the leaflet 1 is flattened.

[0065] When both the upper clamping part 212 and the lower clamping part 222 are non-closed ring structures, since the area of ​​the first clamping surface 2121 of the upper clamping part 212 is larger than the area of ​​the second clamping surface 2221 of the lower clamping part 222, when the upper clamping part 212 and the lower clamping part 222 clamp the leaflet 1, the lower clamping part 222 can press the leaflet 1 into and fix it in the upper clamping part 212, so that the upper clamping part 212 and the lower clamping part 222 can clamp the leaflet 1 more stably.

[0066] Please see Figure 12 In some embodiments, during operation, an angle α exists between the first clamping surface 2121 and the second clamping surface 2221, where the angle α is greater than 0° and less than or equal to 30°. This ensures that the upper clamping portion 212 and the lower clamping portion 222 have sufficient clamping force when clamping the leaflet 1, guaranteeing that the leaflet 1 is fully flattened after being clamped. Figure 12 In the example, in the working state, the lower clamping push rod 221 extends axially, and the lower clamping portion 222 is perpendicular to the lower clamping push rod 221, that is, the second clamping surface 2221 of the lower clamping portion 222 is perpendicular to the axial direction; the upper clamping push rod 211 extends axially, and the upper clamping portion 212 is inclined towards the proximal end relative to the upper clamping push rod 211, that is, the first clamping surface 2121 of the upper clamping portion 212 has an angle with the radial direction. Therefore, there is an angle α between the first clamping surface 2121 and the second clamping surface 2221.

[0067] It should be noted that the included angle α between the first clamping surface 2121 and the second clamping surface 2221 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°.

[0068] In other embodiments, the upper clamping portion 212 may be perpendicular to the upper clamping push rod 211, and the lower clamping portion 222 may be inclined distally relative to the lower clamping push rod 221. Alternatively, the upper clamping portion 212 may be inclined proximally relative to the upper clamping push rod 211, and the lower clamping portion 222 may be inclined distally relative to the lower clamping push rod 221. Of course, the first clamping surface 2121 and the second clamping surface 2221 may also be arranged parallel to each other; for example, the upper clamping portion 212 may be perpendicular to the upper clamping push rod 211, and the lower clamping portion 222 may be perpendicular to the lower clamping push rod 221.

[0069] Please refer to the following: Figures 13 to 15 In some embodiments, the conveyor shaft 10 includes a main body segment 14 and a connecting segment 15 connecting the proximal end of the main body segment 14. A receiving cavity 12 extends to the junction of the main body segment 14 and the connecting segment 15. The connecting segment 15 has a guide groove 151 communicating with the receiving cavity 12, and the guide groove 151 has an axially extending opening 1511. The guiding assembly also includes a guiding actuation member 33 connected to the proximal end of the guide member 30. The guiding actuation member 33 is disposed in the guide groove 151 and partially protrudes from the opening 1511 outside the conveyor shaft 10. Thus, by controlling the axial movement of the guide member 30 within the receiving cavity 12, the operator can control the axial movement of the guide member 30 within the guide groove 151 by controlling the axial movement of the guiding actuation member 33 from outside the conveyor shaft 10. Furthermore, due to the restriction of the opening 1511, the guide 30 will not rotate when it moves axially in the receiving cavity 12, ensuring that the upper clamping part 212 and the lower clamping part 222 that extend from the distal end of the guide 30 will not shift. This facilitates the clamping of the upper clamping part 212 and the lower clamping part 222, thereby avoiding the need for secondary adjustments to the upper clamping part 212 and the lower clamping part 222 and reducing the difficulty of the surgical operation.

[0070] Please refer to the following: Figure 13 , Figure 14 as well as Figure 16In some embodiments, the upper clamping member 21 further includes an upper operating member 213 connected to the proximal end of the upper clamping push rod 211, and the lower clamping member 22 further includes a lower operating member 223 connected to the proximal end of the lower clamping push rod 221. The upper operating member 213 is disposed in the guide groove 151 and partially protrudes from the opening 1511 outside the conveying shaft 10, and the lower operating member 223 is disposed in the guide groove 151 and partially protrudes from the opening 1511 outside the conveying shaft 10. In this way, by controlling the upper operating member 213 and the lower operating member 223 to move axially in the guide groove 151 from outside the conveying shaft 10, the operator can control the upper clamping push rod 211 and the lower clamping push rod 221 to move axially in the receiving cavity 12, thereby controlling the upper clamping part 212 and the lower clamping part 222 to be received in the receiving cavity 12 or controlling the upper clamping part 212 and the lower clamping part 222 to protrude from the receiving cavity 12 for clamping operation. Furthermore, due to the restriction of the opening 1511, the upper clamping push rod 211 and the lower clamping push rod 221 will not rotate when moving axially in the receiving cavity 12, ensuring that the upper clamping part 212 and the lower clamping part 222 that pass through the distal end of the receiving cavity 12 will not deviate, which is beneficial to the clamping of the upper clamping part 212 and the lower clamping part 222, thereby avoiding secondary adjustments to the upper clamping part 212 and the lower clamping part 222 and reducing the difficulty of the surgical operation.

[0071] exist Figures 13 to 18 In the illustrated embodiment, since both the upper clamping portion 212 and the lower clamping portion 222 are non-closed ring structures in the working state, the upper clamping push rod 211 includes a first upper clamping push rod 2111 and a second upper clamping push rod 2112, and the lower clamping push rod 221 includes a first lower clamping push rod 2211 and a second lower clamping push rod 2212. Correspondingly, the receiving cavity 12 includes a first receiving cavity 121 and a second receiving cavity 122, and the guiding assembly includes a first guide member 31 and a second guide member 32. The first guide member 31 includes a first upper pushing cavity 311 and a first lower pushing cavity 312, and the second guide member 32 includes a second upper pushing cavity 321 and a second lower pushing cavity 322. The first guide 31 is movably inserted into the first receiving cavity 121, and the second guide 32 is movably inserted into the second receiving cavity 122; the first upper clamping push rod 2111 is movably inserted into the first upper pushing cavity 311, and the second upper clamping push rod 2112 is movably inserted into the second upper pushing cavity 321; the first lower clamping push rod 2211 is movably inserted into the first lower pushing cavity 312, and the second lower clamping push rod 2212 is movably inserted into the second lower pushing cavity 322. The guide groove 151 radially penetrates both sides of the connecting section 15 and communicates with the first receiving cavity 121 and the second receiving cavity 122, so that the guide groove 151 has two opposing openings 1511 in the radial direction.

[0072] Therefore, there are two guide operation members 33, namely a first guide operation member 331 and a second guide operation member 332. The first guide operation member 331 is located at the proximal end of the first guide member 31, and the second guide operation member 332 is located at the proximal end of the second guide member 32. Both the first guide operation member 331 and the second guide operation member 332 are located in the guide groove 151 and protrude from the outside of the conveyor shaft 10 through the two openings 1511 of the guide groove 151, so that the first guide operation member 331 and the second guide operation member 332 can move axially in the guide groove 151 respectively. In addition, the first upper pushing cavity 311 and the first lower pushing cavity 312 of the first guide member 31 pass through the first guide operation member 331 axially, and the second upper pushing cavity 321 and the second lower pushing cavity 322 of the second guide member 32 pass through the second guide operation member 332 axially. Thus, the first upper clamping push rod 2111, which is movably inserted into the first upper pushing cavity 311, can exit from the proximal end of the first guiding operating member 331; the first lower clamping push rod 2211, which is movably inserted into the first lower pushing cavity 312, can exit from the proximal end of the first guiding operating member 331; the second upper clamping push rod 2112, which is movably inserted into the second upper pushing cavity 321, can exit from the proximal end of the second guiding operating member 332; and the second lower clamping push rod 2212, which is movably inserted into the second lower pushing cavity 322, can exit from the proximal end of the second guiding operating member 332. This facilitates the operator's control of the axial movement of the first upper clamping push rod 2111, the second upper clamping push rod 2112, the first lower clamping push rod 2211, and the second lower clamping push rod 2212.

[0073] There are two upper operating components 213, namely a first upper operating component 2131 and a second upper operating component 2132. The first upper operating component 2131 is located near the first upper clamping push rod 2111, and the second upper operating component 2132 is located near the second upper clamping push rod 2112. Both the first upper operating component 2131 and the second upper operating component 2132 are located in the guide groove 151 and protrude from the outside of the conveyor shaft 10 through the two openings 1511 of the guide groove 151, so that the first upper operating component 2131 and the second upper operating component 2132 can move axially in the guide groove 151 respectively. In addition, the first upper operating member 2131 is provided with a first connecting hole 2133 through its opposite ends along the axial direction. The central axis of the first connecting hole 2133 is collinear with the central axis of the first lower pushing cavity 312. The second upper operating member 2132 is provided with a second connecting hole 2134 through its opposite ends along the axial direction. The central axis of the second connecting hole 2134 is collinear with the central axis of the second lower pushing cavity 322. Thus, the first lower clamping push rod 2211 and the second lower clamping push rod 2212 can respectively pass through the proximal ends of the first upper operating member 2131 and the second upper operating member 2132, which facilitates the operator to control the axial movement of the first lower clamping push rod 2211 and the second lower clamping push rod 2212.

[0074] There are two lower operating components 223, namely a first lower operating component 2231 and a second lower operating component 2232. The first lower operating component 2231 is located near the first lower clamping push rod 2211, and the second lower operating component 2232 is located near the second lower clamping push rod 2212. Both the first lower operating component 2231 and the second lower operating component 2232 are located in the guide groove 151 and protrude from the outside of the conveyor shaft 10 through the two openings 1511 of the guide groove 151, so that the first lower operating component 2231 and the second lower operating component 2232 can move axially in the guide groove 151 respectively.

[0075] Furthermore, the conveyor shaft 10 is provided with four axially spaced bosses at the connecting section 15 to divide the connecting section 15 into a first part 152, a second part 153, and a third part 154. Specifically, the multiple bosses, from the distal end to the proximal end, include a first boss 16, a second boss 17, a third boss 18, and a fourth boss 19. The first part 152 is located between the first boss 16 and the second boss 17, the second part 153 is located between the second boss 17 and the third boss 18, and the third part 154 is located between the third boss 18 and the fourth boss 19. The first guide operating member 331 and the second guide operating member 332 move axially in the first part 152, the first upper operating member 2131 and the second upper operating member 2132 move axially in the second part 153, and the first lower operating member 2231 and the second lower operating member 2232 move axially in the third part 154. In this way, the limiting effect of the first boss 16, the second boss 17, the third boss 18, and the fourth boss 19 prevents the guide operating member 33, the upper operating member 213, and the lower operating member 223 from colliding and affecting the clamping operation of the upper clamping part 212 and the lower clamping part 222 when they move axially. Moreover, the presence of the first boss 16 and the fourth boss 19 also prevents the guide operating member 33, the upper operating member 213, and the lower operating member 223 from disengaging from the conveyor shaft 10.

[0076] In other embodiments, there may be two guide grooves 151, which are located on both sides of the connecting section 15 and are not connected to the conveying cavity 11. The two guide grooves 151 are respectively connected to the first receiving cavity 121 and the second receiving cavity 122, and each guide groove 151 has an opening 1511 extending axially.

[0077] Please refer to the following: Figure 6 , Figure 13 , Figure 19 as well as Figure 20The pre-clamping device 100 also includes a handle assembly 40, which includes a housing 41. A connecting section 15 is housed within the housing 41. The housing 41 has a slotted hole 411 corresponding to the opening 1511, through which the guide operating member 33, the upper operating member 213, and the lower operating member 223 protrude from the outside of the housing 41. The design of the housing 41 facilitates the operator's grip, thereby facilitating the operation of the pre-clamping device 100. Furthermore, the design of the slotted hole 411 allows the operator to control the axial movement of the guide operating member 33, the upper operating member 213, and the lower operating member 223 from outside the housing 41.

[0078] Specifically, the housing 41 includes a first housing 412, a second housing 413, and a third housing 414. The first housing 412 and the second housing 413 are matched and fastened together to form a hollow inner cavity and a strip-shaped hole 411. The third housing 414 is placed over the proximal ends of the first housing 412 and the second housing 413, and limits the first housing 412 and the second housing 413 by the third housing 414, preventing the matched and fastened first housing 412 and the second housing 413 from disengaging, and ensuring the stability of the connection between the first housing 412 and the second housing 413. The first housing 412 is provided with a plurality of first grooves (not shown in the figure) corresponding to the first boss 16, the second boss 17, the third boss 18, and the fourth boss 19. The second housing 413 is provided with a plurality of second grooves 4131 (e.g., ...) corresponding to the first boss 16, the second boss 17, the third boss 18, and the fourth boss 19. Figure 6 As shown, when the connecting section 15 is housed in the housing 41, the first boss 16, the second boss 17, the third boss 18 and the fourth boss 19 are respectively engaged between the corresponding first groove and the corresponding second groove 4131.

[0079] Since the guide groove 151 has two opposing openings 1511 in the radial direction, and the strip hole 411 penetrates radially through opposite sides of the housing 41, the strip hole 411 corresponds to the two openings 1511 of the guide groove 151. Thus, the first guide operating member 331, the second guide operating member 332, the first upper operating member 2131, the second upper operating member 2132, the first lower operating member 2231, and the second lower operating member 2232 can protrude from the strip hole 411 onto the outside of the housing 41. Therefore, the operator can control the axial movement of the first guide operating member 331, the second guide operating member 332, the first upper operating member 2131, the second upper operating member 2132, the first lower operating member 2231, and the second lower operating member 2232 from outside the housing 41.

[0080] Please refer to the following: Figure 2 , Figure 6 , Figure 13 as well as Figure 19The handle assembly 40 also includes a first knob 42, a second knob 43, and a third knob 44 fitted onto the housing 41. The first knob 42 is threadedly connected to the guide operating member 33, the second knob 43 is threadedly connected to the upper operating member 213, and the third knob 44 is threadedly connected to the lower operating member 223. Thus, by rotating the first knob 42, the second knob 43, and the third knob 44 respectively, the operator can control the axial movement of the guide operating member 33, the upper operating member 213, and the lower operating member 223, making operation simple.

[0081] In the illustrated embodiment, the first guide operating member 331, the second guide operating member 332, the first upper operating member 2131, the second upper operating member 2132, the first lower operating member 2231, and the second lower operating member 2232 are all provided with external threads. These external threads are exposed outside the housing 41 through the opening 1511 of the guide groove 151 and the strip-shaped hole 411. The first knob 42, the second knob 43, and the third knob 44 are respectively provided with internal threads corresponding to the external threads. The internal thread of the first knob 42 engages with the external threads of the first guide operating member 331 and the second guide operating member 332. By rotating the first knob 42, the first guide operating member 331 and the second guide operating member 332 can be moved axially synchronously, thereby synchronously controlling the axial movement of the first guide member 31 and the second guide member 32. The internal thread of the second knob 43 engages with the external threads of the first upper operating member 2131 and the second upper operating member 2132. By rotating the second knob 43, the first upper operating member 2131 and the second upper operating member 2132 can be moved axially synchronously, thereby synchronously controlling the first upper clamping push rod 2111 and the second upper clamping push rod 2112 to move axially, thus controlling the upper clamping part 212 to move axially. The internal thread of the third knob 44 engages with the external threads of the first lower operating member 2231 and the second lower operating member 2232. By rotating the third knob 44, the first lower operating member 2231 and the second lower operating member 2232 can be moved axially synchronously, thereby synchronously controlling the first lower clamping push rod 2211 and the second lower clamping push rod 2212 to move axially, thus controlling the lower clamping part 222 to move axially. Thus, by rotating the first knob 42, the second knob 43, and the third knob 44, the upper clamping part 212 and the lower clamping part 222 can be controlled to perform clamping operations at a position away from the far end face of the conveying shaft 10.

[0082] Please see Figure 6 and Figure 19The housing 41 has a first stop boss 415 at its distal end and a second stop boss 416 at its proximal end. The handle assembly 40 also includes a first stop ring 45 and a second stop ring 46 sleeved on the housing 41. The first knob 42 is axially limited between the first stop boss 415 and the first stop ring 45, the second knob 43 is axially limited between the first stop ring 45 and the second stop ring 46, and the third knob 44 is axially limited between the second stop ring 46 and the second stop boss 416. This ensures that the first knob 42, the second knob 43, and the third knob 44 can only rotate and cannot move axially, so that by rotating the first knob 42, the second knob 43, and the third knob 44, the guide operating member 33, the upper operating member 213, and the lower operating member 223 can be controlled to move axially, respectively. It should be noted that, in the axial direction, the position of the first stop ring 45 on the housing 41 corresponds to the position of the second boss 17 on the connecting section 15, the position of the second stop ring 46 on the housing 41 corresponds to the position of the third boss 18 on the connecting section 15, and the third housing 414 acts as the second stop boss 416.

[0083] The following describes the suture implantation device 200 (e.g. Figure 21 (As shown) will be explained in detail.

[0084] Please refer to the following: Figure 1 , Figure 2 , Figure 21 , Figure 22 as well as Figure 30 The suture implantation device 200 includes a pushing assembly 50 and a clamping assembly 60. The pushing assembly 50 includes a pushing catheter 51 movably inserted into the delivery chamber 11. The clamping assembly 60 includes a clamping rod 61 movably inserted into the pushing catheter 51, and a proximal clamp 62 and a distal clamp 63 that open and close relative to each other along the axial direction. The proximal clamp 62 is located at the distal end of the pushing catheter 51 or on the distal end face of the pushing catheter 51, and the distal clamp 63 is located at the distal end of the clamping rod 61. After the upper clamping part 212 and the lower clamping part 222 of the pre-clamping device 100 clamp the leaflet 1, the proximal clamp 62 and the distal clamp 63 of the suture implantation device 200 clamp the leaflet 1 again.

[0085] It is understandable that when the upper clamping part 212 and the lower clamping part 222 clamp the leaflet 1, the leaflet 1 is in a flattened state. Pushing and pulling the clamping rod 61 can control the relative opening and closing of the proximal clamp 62 and the distal clamp 63 of the suture implantation device 200 to clamp the leaflet 1 again, thereby stabilizing the clamping of the leaflet 1. This is beneficial for implanting the suture 80 on the leaflet 1 and ensures that the suture 80 is implanted stably and accurately into the rough band located at the edge of the leaflet 1.

[0086] In this invention, the delivery catheter 51 is a tubular body with a certain axial length, and has multiple through lumens extending along its axial direction, the lumens being separated from each other. Optionally, the delivery catheter 51 can be a one-piece molded multi-lumen tube, or it can be formed by fitting an outer tube and an inner tube together. In some embodiments, a proximal clamp 62 can be provided separately, and the proximal clamp 62 can be fused, bonded, or welded to the distal end of the delivery catheter 51. The proximal clamp 62 has multiple channels corresponding to the various lumens of the delivery catheter 51. Of course, the distal end face of the delivery catheter 51 can also be used as the proximal clamp 62. The shapes of the proximal clamp 62 and the distal clamp 63 should match the shape of the delivery catheter 51 to form a smooth whole, facilitating delivery and reducing damage to patient tissues during delivery.

[0087] Please refer to the following: Figure 22 as well as Figure 31 In some embodiments, the suture implantation device 200 further includes a puncture assembly 70. The puncture assembly 70 includes a puncture push rod 71 movably inserted into the push catheter 51 and a puncture needle 72 disposed at the distal end of the puncture push rod 71. The puncture needle 72 can be connected to the suture 80. The puncture assembly 70 is used to puncture the leaflet 1 to implant the suture 80 into the leaflet 1.

[0088] It is understandable that after the proximal clamp 62 and distal clamp 63 of the suture implantation device 200 clamp the leaflet 1 again, the puncture needle 72 punctures the leaflet 1 and connects with the suture 80. Pulling the puncture push rod 71 can drive the suture 80 to be implanted into the leaflet 1.

[0089] Please see Figure 22 , Figure 23 and Figure 24 In this invention, the suture 80 includes a first end 81 and a second end 82. A sleeve 83 is fixedly connected to the first end 81 and / or the second end 82. The suture 80 is housed in a clamping rod 61 and a distal clamp 63. The sleeve 83 is housed in the distal clamp 63 and is used to be fixedly connected to the puncture needle 72. Thus, when the proximal clamp 62 and the distal clamp 63 clamp the leaflet 1 again, pushing the puncture push rod 71 distally drives the puncture needle 72 to puncture the leaflet 1 and connect to the sleeve 83, thereby connecting the puncture needle 72 to the suture 80. At this time, withdrawing the puncture push rod 71 proximally can drive the puncture needle 72 to withdraw, thereby driving the sleeve 83 to pass through the leaflet 1, thus implanting the suture 80 into the leaflet 1. Since the puncture needle 72 and the suture 80 form a stable and reliable indirect connection through the sleeve 83, the suture 80 is not easy to detach from the puncture needle 72. The operator can easily and quickly pull one or both ends of the suture 80 connected to the sleeve 83 to the predetermined position and implant the suture 80 on the leaflet 1.

[0090] In the illustrated embodiment, both the first end 81 and the second end 82 of the suture 80 are provided with sleeves 83. Correspondingly, there are two puncture push rods 71 ​​and two puncture needles 72, with the two puncture needles 72 respectively located at the distal ends of the two puncture push rods 71. The two sleeves 83 correspond one-to-one with the two puncture needles 72. Specifically, the clamping rod 61 has a through suture channel 611 along its axial direction. The distal clamp 63 has two suture receiving cavities 631 that penetrate its proximal end face, and both suture receiving cavities 631 are connected to the suture channel 611. The distal clamp 63 also has two sleeve cavities 632 that penetrate its proximal end face, and the two sleeve cavities 632 are axially connected to the two suture receiving cavities 631 respectively. The suture 80 is housed in the suture channel 611 and the two suture receiving cavities 631, that is, the suture 80 is housed in the clamping rod 61 and the distal clamp 63. The two sleeves 83 located at the first end 81 and the second end 82 are respectively housed in the two sleeve cavities 632, that is, both sleeves 83 are housed in the distal clamp 63, and the end of the sleeve 83 used to connect with the puncture needle 72 (i.e. the end away from the suture 80) faces the proximal clamp 62.

[0091] Optionally, the sleeve 83 and the puncture needle 72 can be fixedly connected by means including but not limited to snap-fit ​​connection, threaded connection, bonding, rough surface friction connection, interference fit, etc. The first end 81 and the second end 82 of the suture 80 can be fixedly connected to the sleeve 83 by means including but not limited to knotting, wrapping, welding, bonding, snap-fit, etc. The material of the suture 80 can be a biocompatible polymer material or a relatively soft metal material, etc. Preferably, the suture 80 implanted in the human body is a polymer material such as PET (polyethylene terephthalate) or e-PTFE (expanded polytetrafluoroethylene).

[0092] In some embodiments, the pushing component 50 further includes a pushing handle 52 located at the distal end of the pushing catheter 51. The pushing handle 52 is used to manipulate the suture implantation device 200 to push distally or retract proximally. Thus, the presence of the pushing handle 52 facilitates the operator's grip on the suture implantation device 200, making operation easier and improving surgical efficiency.

[0093] Please refer to the following: Figure 1 , Figure 2 , Figure 6 as well as Figures 25 to 33 The following example illustrates the use of the valve repair system 1000 provided in this embodiment of the invention, using transapical suture implantation of the posterior leaflet 1a of the mitral valve.

[0094] S1, please refer to the following: Figure 2 , Figure 6 , Figure 25 and Figure 26 The pre-clamping device 100, in its delivery state, is introduced into the left ventricle 3 through the apical puncture site, and then passes through the mitral valve orifice into the left atrium 4. When the distal end of the pre-clamping device 100 crosses the mitral valve, the first knob 42 is rotated to push the guides 30 (first guide 31 and second guide 32) out a certain length from the distal end of the delivery shaft 10; then the second knob 43 and the third knob 44 are rotated to push the upper clamping part 212 and the lower clamping part 222 out from the distal ends of the first guide 31 and the second guide 32. The upper clamping part 212 and the lower clamping part 222 unfold due to their own shape memory function. At this time, the pre-clamping device 100 is in the working state.

[0095] S2, please refer to Figure 1 and Figure 27 The suture implantation device 200 is guided into the delivery cavity 11 of the delivery shaft 10 of the pre-clamping device 100 until the distal clamp 63 and proximal clamp 62 of the suture implantation device 200 are exposed from the distal end of the delivery shaft 10. At this time, the proximal clamp 62 and the distal clamp 63 are located between the upper clamping part 212 and the lower clamping part 222, and there is a certain distance between the upper clamping part 212 and the lower clamping part 222 and the distal end of the delivery shaft 10.

[0096] S3, please refer to it as well. Figure 28 and Figure 29 The pre-clamping device 100 is retracted as a whole until the lower clamping part 222 abuts against the posterior leaf 1a to position the posterior leaf 1a under the flap; then, the suture implantation device 200 is operated so that the distal clamp 63 and the proximal clamp 62 of the suture implantation device 200 are separated, and the distal end face of the proximal clamp 62 is basically parallel to the lower clamping part 222; the second knob 43 is rotated so that the upper clamping part 212 moves towards the proximal end until the upper clamping part 212 and the lower clamping part 222 clamp the posterior leaf 1a. At this time, the posterior leaf 1a is completely flattened and in a horizontal state.

[0097] S4, please refer to it as well. Figure 1 , Figure 30 and Figure 31 The distal clamp 63 and proximal clamp 62 of the suture implantation device 200 are opened and closed relative to each other to clamp the posterior leaf 1a again; the puncture push rod 71 is pushed to move distally, so that the puncture needle 72 punctures the posterior leaf 1a and connects with the sleeve 83 housed in the distal clamp 63. At this time, the puncture needle 72 is connected with the suture 80; then, the puncture push rod 71 is retracted to move proximally, so that the suture 80 connected with the puncture needle 72 moves proximally and passes through the posterior leaf 1a, and the suture 80 is implanted in the posterior leaf 1a.

[0098] S5, please refer to it as well. Figure 1 , Figure 2 , Figure 6 , Figure 32 and Figure 33 After the suture 80 is implanted, the second knob 43 is turned so that the upper clamping part 212 moves distally. At this time, the upper clamping part 212 and the lower clamping part 222 no longer clamp the posterior leaf 1a. Then, the suture implantation device 200 is operated so that the distal clamp 63 and the proximal clamp 62 no longer clamp the posterior leaf 1a, and the suture implantation device 200 is retracted into the delivery cavity 11 of the delivery shaft 10 of the pre-clamping device 100. Next, the pre-clamping device 100 is retracted below the papillary muscle. At this time, the first knob 42, the second knob 43 and the third knob 44 are turned so that the upper clamping part 212, the lower clamping part 222, the first guide 31 and the second guide 32 are all received in the delivery shaft 10. Finally, the pre-clamping device 100 is retracted until the pre-clamping device 100 is withdrawn from the left ventricle 3 to the outside of the body. At this point, both the pre-clamping device 100 and the suture implantation device 200 are removed from the heart; the suture 80 is left in the left ventricle 3 as an artificial chordae tendineae to replace the broken or diseased chordae tendineae, in order to treat mitral regurgitation.

[0099] In the description of this specification, references to terms such as "some embodiments," "illustrative embodiments," "examples," "specific examples," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. 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.

[0100] Although embodiments of the invention have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. A valve repair system, characterized in that, include: Pre-clamping device and suture implantation device; The pre-clamping device includes a conveying shaft and a clamping assembly. The conveying shaft is provided with a conveying cavity and a receiving cavity extending along the axial direction. The conveying cavity passes through the opposite ends of the conveying shaft, and the receiving cavity passes through the distal end of the conveying shaft. The conveying cavity is used for the movable suture implantation device. The clamping assembly includes an upper clamping member and a lower clamping member. The upper clamping member includes an upper clamping push rod that is movably inserted into the receiving cavity and an upper clamping part located at the distal end of the upper clamping push rod. The lower clamping member includes a lower clamping push rod that is movably inserted into the receiving cavity and a lower clamping part located at the distal end of the lower clamping push rod. The pre-clamping device is used to pre-clamp the leaflet. The pre-clamping device has a working state in which the upper clamping part and the lower clamping part are located outside the receiving cavity. 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 pre-clamp the leaflet. The ratio of the area of ​​the first clamping surface to the area of ​​the leaflet and the ratio of the area of ​​the second clamping surface to the area of ​​the leaflet are both greater than or equal to 1 / 6 and less than 1. After the pre-clamping device clamps the leaflet, the suture implantation device clamps the leaflet again and implants a suture onto the leaflet. The suture implantation device includes a pushing component and a clamping component. The pushing component includes a pushing catheter that is movably inserted into the delivery cavity. The clamping component includes a clamping rod that is movably inserted into the pushing catheter, and a proximal clamp and a distal clamp that open and close relative to each other along the axial direction. The proximal clamp is located at the distal end of the pushing catheter or at the distal end face of the pushing catheter as the proximal clamp. The distal clamp is located at the distal end of the clamping rod. After the upper clamping part and the lower clamping part clamp the leaflet, the proximal clamp and the distal clamp clamp the leaflet again.

2. The valve repair system 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 pre-clamping device also has a conveying state; In the conveying state, the upper clamping part and the lower clamping part are compressed and deformed and at least partially housed in the receiving cavity; In the working state, the upper clamping part extends out of the receiving cavity and unfolds, the upper clamping part bends relative to the upper clamping push rod, the lower clamping part extends out of the receiving cavity and unfolds, and the lower clamping part bends relative to the lower clamping push rod.

3. The valve repair system according to claim 1 or 2, characterized in that, In the operating state, the area of ​​the first clamping surface is greater than the area of ​​the second clamping surface.

4. The valve repair system according to claim 1 or 2, 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°.

5. The valve repair system according to claim 1 or 2, 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.

6. The valve repair system according to claim 2, characterized in that, The pre-clamping device further includes a guide assembly, which includes a guide member that is axially movably inserted into the receiving cavity. The guide member has a push cavity extending axially, and the upper clamping push rod and the lower clamping push rod are movably inserted into the push cavity.

7. The valve repair system according to claim 6, characterized in that, In the working state, both the upper clamping part and the lower clamping part are non-closed ring structures. There are two upper clamping push rods and two lower clamping push rods. The two opposite ends of the upper clamping part are respectively connected to the far ends of the two upper clamping push rods, and the two opposite ends of the lower clamping part are respectively connected to the far ends of the two lower clamping push rods.

8. The valve repair system according to claim 7, characterized in that, The number of receiving cavities and guide members are both two. The central axis of the conveying cavity is coaxial with the central axis of the conveying shaft. The two receiving cavities are located on both sides of the conveying cavity. The two guide members are movably installed in the two receiving cavities. Each guide member has two pushing cavities, which are an upper pushing cavity and a lower pushing cavity. The two upper clamping push rods are movably installed in the upper pushing cavities of the two guide members, and the two lower clamping push rods are movably installed in the lower pushing cavities of the two guide members.

9. The valve repair system according to claim 7, characterized in that, The number of receiving cavities is two, and the far end face of the conveying shaft is also provided with a storage groove connecting the two receiving cavities. In the conveying state, the upper clamping part and the lower clamping part are received in the two receiving cavities and the storage groove.

10. The valve repair system according to any one of claims 6 to 9, characterized in that, The conveying shaft includes a main body section and a connecting section connecting the proximal end of the main body section. The receiving cavity extends to the connection between the main body section and the connecting section. The connecting section is provided with a guide groove communicating with the receiving cavity. The guide groove has an opening extending axially. The guiding assembly also includes a guiding operating member connected to the proximal end of the guide member. The guiding operating member is disposed in the guide groove and partially exposed outside the conveying shaft from the opening.

11. The valve repair system according to claim 10, characterized in that, The upper clamping member further includes an upper operating member connected to the proximal end of the upper clamping push rod, and the lower clamping member further includes a lower operating member connected to the proximal end of the lower clamping push rod. The upper operating member is disposed in the guide groove and partially exposed outside the conveying shaft from the opening, and the lower operating member is disposed in the guide groove and partially exposed outside the conveying shaft from the opening.

12. The valve repair system according to claim 11, characterized in that, The pre-clamping device further includes a handle assembly, which includes a housing. The connecting section is housed in the housing. The housing has a strip-shaped hole corresponding to the opening. The guide operating member, the upper operating member, and the lower operating member protrude from the strip-shaped hole outside the housing.

13. The valve repair system according to claim 12, characterized in that, The handle assembly further includes a first knob, a second knob, and a third knob sleeved on the housing. The first knob is threaded to the guide operating member, the second knob is threaded to the upper operating member, and the third knob is threaded to the lower operating member.

14. The valve repair system according to claim 13, characterized in that, The housing has a first stop boss at its distal end and a second stop boss at its proximal end. The handle assembly also includes a first stop ring and a second stop ring fixedly sleeved on the housing. The first knob is axially limited between the first stop boss and the first stop ring, the second knob is axially limited between the first stop ring and the second stop ring, and the third knob is axially limited between the second stop ring and the second stop boss.

15. The valve repair system according to claim 1, characterized in that, The suture implantation device further includes a puncture assembly, which 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 can be connected to a suture, and the puncture assembly is used to puncture the leaflet to implant the suture into the leaflet.

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