Valve leaflet fixing apparatus and valve repair system

Abstract

A valve leaflet fixing apparatus and a valve repair system. The valve leaflet fixing apparatus comprises a driving assembly (2), a pair of clamping arms (1), and fixing clamping pieces (3) in fit with the clamping arms (1). The driving assembly (2) comprises a base support (21), a driving shaft (22), and a connecting block (23). The base support (21) comprises a central cylinder (211). The central cylinder (211) is made of a rigid material. The driving shaft (22) is connected to the central cylinder (211) by means of self-locking threads. The clamping arms (1) are connected to the driving shaft (22) by means of the connecting block (23). The driving shaft (22) drives, by means of rotation, the clamping arms (1) to open and close relative to the base support (21). The cross section of the clamping arms (1) is of a U-shaped or "["-shaped structure. When the pair of clamping arms (1) is closed opposite to each other to be in fit with the fixing clamping pieces (3) to fix a valve leaflet, the central cylinder (211) abuts against the fixing clamping pieces (3) to provide support. The use of the valve leaflet fixing apparatus is beneficial to reducing damage to the valve leaflet and improving the reliability of fixing the valve leaflet, thereby improving the flexibility, efficiency, and safety of surgery.

Description

A leaflet fixation device and a valve repair system TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a leaflet fixation device and a valve repair system. BACKGROUND

[0002] Mitral regurgitation (MR) is a heart valve disease, the pathogenesis of which involves the failure of the mitral valve to completely close during cardiac systole, resulting in blood flowing from the left ventricle to the left atrium. This regurgitation can cause heart failure, pulmonary edema and other serious complications, and even life-threatening in severe cases. Despite the severity of MR, traditional surgical treatment has a high risk and recurrence rate, therefore, transcatheter mitral valve repair as a minimally invasive treatment has gradually become the preferred option for treating MR.

[0003] The existing valve clamping system is composed of a pair of controllable opening and closing clamping arms and a capture piece, which is used to capture and stabilize the leaflets of the mitral valve. After the valve clamp contacts the leaflet, the friction generated is the key factor to ensure that the valve clamp does not separate from the leaflet during blood flow impact and leaflet movement. In the prior art, the friction mainly depends on the protruding or serrated friction elements on the capture piece, the number of these friction elements is proportional to the friction, thereby affecting the fixation stability of the valve clamp clamping the valve. However, the increase or excessive sharpness of the friction elements can cause damage to the leaflet tissue, and in severe cases, perforation of the leaflet, especially in surgeries that require multiple captures and clamping of the leaflet, the damage to the leaflet by the barbs is higher. Secondly, for primary mitral regurgitation caused by wide leaflet lesions, the existing valve clamping system usually uses methods such as increasing the width of the clamping arm or designing an inflatable and expandable clamping arm. These methods can improve the treatment effect to a certain extent, but also increase the volume of the valve clamp, and cause greater damage to the leaflet. SUMMARY

[0004] To solve the problem of the leaflet fixation device of the valve repair system in the prior art being not firm and reliable in fixing the leaflet, and being prone to causing damage to the leaflet.

[0005] The present application provides a leaflet fixation device, comprising a driving assembly, a pair of clamping arms, and a fixed clamping piece cooperating with the clamping arms.

[0006] The driving assembly comprises a base support, a driving shaft and a connecting block; the base support comprises a center cylinder made of a rigid material; the driving shaft is connected to the center cylinder through a self-locking thread; the clamping arms are connected to the driving shaft through the connecting block, and the driving shaft drives the clamping arms to open and close relative to the base support by rotating;

[0007] The cross section of the clamping arm is U-shaped or "[ " shaped structure, when a pair of the clamping arms are closed and cooperate with the fixed clamping piece to fix the leaflet, the center tube abuts against the fixed clamping piece to provide support.

[0008] Further, the clamping arm comprises a bottom wall and two side walls, the included angle between the inner surface of the bottom wall and the inner surface of the side wall is obtuse, and the depth of the clamping arm is at least twice the thickness of the bottom wall.

[0009] Further, the fixed clamping piece comprises a friction surface, and the friction surface is provided with a groove or a convex structure with a smooth end.

[0010] Further, the ratio of the arc length of the fixed clamping piece to the shortest distance between the two side walls of the U-shaped or "[ " shaped structure of the clamping arm is in the range of 0.5 to 1.

[0011] Further, after a pair of the clamping arms are closed relative to the base support, the included angle between the two clamping arms is in the range of 0° to 60°.

[0012] Further, after a pair of the clamping arms are closed relative to the base support, the center axis of the two clamping arms after being closed is aligned with the center axis of the center tube.

[0013] Further, one end of the clamping arm extends to the side away from the inner surface thereof to form a first folded edge, and the included angle between the first folded edge and the inner surface of the clamping arm is obtuse.

[0014] Further, the end of the clamping arm connected to the connecting block is provided with a connecting section.

[0015] The inner surface of the clamping arm extends at least partially in the direction close to the center tube from the middle part to the direction of the first folded edge and the direction of the connecting section.

[0016] Further, the connecting section is provided with a guide sliding groove, and the base support is provided with a sliding groove driving member at least partially located in the guide sliding groove.

[0017] The centripetal side of the guide sliding groove on the connecting section is provided with a connecting shaft hole for connecting with the connecting block, and the connecting line of the connecting shaft hole and the sliding groove driving member is coplanar with the center axis of the center tube.

[0018] The application also provides a valve repair system, comprising a delivery device and the leaflet fixing device, and the delivery device comprises a delivery tube assembly, a transmission shaft and a clutch mechanism arranged in the delivery tube assembly.

[0019] The clutch mechanism comprises a clutch member and a connecting shaft arranged in the clutch member, the clutch member is detachably connected with the base support, and the connecting shaft is used for connecting the transmission shaft and the driving shaft, and a channel is arranged in the connecting shaft and communicates with the inner cavity of the transmission shaft and the central cavity of the driving shaft.

[0020] Further, a first clamping structure is arranged at one end of the connecting shaft connected with the driving shaft, a second clamping structure is arranged on the driving shaft, and the first clamping structure and the second clamping structure are clamped to limit the relative rotation between the connecting shaft and the driving shaft.

[0021] Further, the connecting shaft is arranged to be movable relative to the clutch member between a first position and a second position, the clutch member is separated from the base support when the connecting shaft moves from the first position to the second position, and the first clamping structure is separated from the second clamping structure.

[0022] Further, the clutch member comprises a fixed end and a clutch end, the clutch end comprises a first half-clamp and a second half-clamp which are connected with each other and can be separated relative to each other, and the first half-clamp and the second half-clamp are connected with the base support to limit the base support in the axial direction and the circumferential direction when the clutch member is in the engaged state.

[0023] The embodiment of the present application has the following beneficial effects:

[0024] The clamping arm of the present application has a U-shaped or “[”-shaped structure, and is closed under the driving of the driving shaft of the driving assembly. When the clamping arm is completely closed, the center tube is tightly wrapped between the apposed segments of the clamping arm, and the clamping arm and the fixed clamping piece together form a stable clamping space, which can stack more leaflet tissues and provide stronger extrusion force and higher static friction force. Compared with the traditional method of increasing friction force by using a piercing structure, the damage to the leaflets is greatly reduced, and the leaflets can be firmly fixed on the device. When treating a wider valve lesion, the number of leaflet fixation devices used is significantly reduced, and the surgical efficiency and safety are improved. The tight apposition of the clamping arm and the center tube, as well as the fixed clamping piece, together constitute a double fixation mechanism for the leaflets, and the center tube provides effective support force to the fixed clamping piece, effectively improving the reliability and stability of the fixation effect. The driving shaft and the center tube are connected through self-locking threads, which improves the power transmission efficiency. By adjusting the tightening degree of the transmission threads, the extrusion force on the leaflets can be accurately controlled, thereby realizing fine adjustment of the fixation force of the leaflets and improving the firmness of the leaflet clamping. Therefore, efficient and stable leaflet clamping in a small space is possible.

[0025] The application realizes efficient and stable fixation of the valve leaflet through the carefully designed driving assembly, the cooperatively working clamping arm and the fixed clamping piece, and the center tube support structure, solves the problems of large damage to the valve leaflet, insufficient clamping force and poor stability in the traditional fixation mode, and further improves the use performance and reliability of the whole device through structural optimization and integration.

[0026] The valve repair system of the application is connected with the valve leaflet fixation device through a reusable clutch mechanism, so that the valve leaflet fixation device can be flexibly withdrawn and recapture the valve leaflet during the fixation of the valve leaflet, thereby enhancing the flexibility and accuracy of the operation. In the process of capturing the valve leaflet, the clamping arm, the fixed clamping piece and the center tube are cooperatively used to form a stable clamping space. By adjusting the fastening degree of the transmission thread, the extrusion force on the valve leaflet is controlled, the inclusion range of the valve leaflet tissue is effectively expanded, stronger extrusion force and higher static friction force are ensured, thereby the potential damage to the valve leaflet tissue is minimized, the stability and reliability of the valve leaflet fixation are improved, and the operation flexibility and safety are improved. BRIEF DESCRIPTION OF DRAWINGS

[0027] In order to more clearly illustrate the technical solutions of the application, the following will briefly introduce the drawings needed to be used in the embodiments or prior art description. Obviously, the drawings in the following description are only some embodiments of the application, and other drawings can be obtained by those skilled in the art without creative labor.

[0028] Fig. 1 is a structural schematic view of the valve leaflet fixation device according to an embodiment of the application;

[0029] Fig. 2 is a structural schematic view of the valve leaflet fixation device fixing the heart valve leaflet according to an embodiment of the application;

[0030] Fig. 3 is a side schematic view of the valve leaflet fixation device fixing the heart valve leaflet according to an embodiment of the application;

[0031] Fig. 4 is a sectional view of the clamping arm according to an embodiment of the application;

[0032] Fig. 5 is a structural schematic view of the clamping arm in one embodiment of the application;

[0033] Fig. 6 is a structural schematic view of the clamping arm in another embodiment of the application;

[0034] Fig. 7 is a sectional view of the completely closed valve leaflet fixation device in the delivery tube assembly according to an embodiment of the application;

[0035] Fig. 8 is a sectional schematic view of the valve leaflet fixation device fixing the valve leaflet according to an embodiment of the application;

[0036] Fig. 9 is a side structural schematic view of the valve leaflet fixation device according to an embodiment of the application;

[0037] Fig. 10 is a schematic view of the position structure of the fixed clamping piece and the clamping arm in the embodiment of the application;

[0038] Fig. 11 is a schematic view of the structure of the fixed clamping piece in different embodiments of the application;

[0039] Fig. 12 is a trend chart of the clamping angle of the leaflet fixing device and the separation force of pulling the leaflet from the leaflet fixing device varying with the driving torque;

[0040] Fig. 13 is a schematic view of the structure of the valve repair system in the embodiment of the application;

[0041] Fig. 14 is a schematic view of the structure of the clutch in the embodiment of the application;

[0042] Fig. 15 is a schematic view of the connecting shaft in the embodiment of the application;

[0043] Fig. 16 is a schematic view of the connecting seat in the embodiment of the application;

[0044] Fig. 17 is a schematic view of the connecting state of the clutch mechanism and the leaflet fixing device in the embodiment of the application;

[0045] Fig. 18 is a schematic view of the separation state of the clutch mechanism and the leaflet fixing device in the embodiment of the application.

[0046] In the drawings, the reference signs correspond to: clamping arm 1, friction member 111, first folded edge 112, second folded edge 116, bottom wall 113, side wall 114, connecting section 12, guide sliding groove 121, connecting shaft hole 123, driving assembly 2, base bracket 21, clamping matching part 210, center cylinder 211, base hanging lug 213, driving shaft 22, second clamping structure 221, connecting block 23, sliding groove driving member 212, fixed clamping piece 3, friction surface 311, protruding structure 312, delivery pipe assembly 4, transmission shaft 41, leaflet 5, clutch mechanism 6, clutch member 61, fixed end 611, connecting hole 6111, clutch end 612, first half clamp 6121, second half clamp 6122, clamping part 6123, connecting shaft 62, boss section 621, first clamping structure 622, channel 623, connecting seat 63, connecting part 631, fixed hole 632, protective film layer 7. DETAILED DESCRIPTION

[0047] The technical solutions in the embodiments of the application will be clearly and completely described below with reference to the drawings in the embodiments of the application. Obviously, the described embodiments are only part of the embodiments of the application, rather than all the embodiments of the application. Based on the embodiments in the application, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the scope of protection of the application.

[0048] In the description of the present application, it needs to be understood that the terms "upper, lower, inner, outer, top, bottom" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or are directed to the components themselves in the vertical, perpendicular or gravity direction, only for the purpose of facilitating the description of the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application. The terms "first", "second" are only for the purpose of description, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the technical features indicated. Therefore, the features defined with "first", "second" can be explicitly or implicitly included one or more of the features.

[0049] Unless otherwise defined, the technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terms used herein are only for the purpose of describing specific embodiments and are not intended to limit the present application. The terms such as "part", "piece" and the like appearing in the present application can mean a single part or a combination of multiple parts. The terms such as "mounting", "setting", "connecting" and the like appearing in the present application should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can mean that one component is directly attached to another component, or it can mean that one component is attached to another component through an intermediate component, or it can mean that two elements are connected internally. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances. The features described in one embodiment herein can be applied to another embodiment alone or in combination with other features, unless the features are not applicable in the other embodiment or are otherwise stated.

[0050] The following describes a leaflet fixation device provided by an embodiment of the present application in combination with FIGS. 1-13. The leaflet fixation device is delivered to a designated location of a patient's heart in a catheter-based manner by a delivery device. The proximal end of the leaflet fixation device is detachably connected to the delivery device, and the leaflet fixation device can be accurately positioned near a heart valve that needs to be repaired by the delivery device. The leaflet fixation device can clamp the anterior leaflet and the posterior leaflet of the mitral valve. Through accurate operation, the clamping arms 1 and the fixation clamps 3 of the leaflet fixation device can be closed to clamp the two leaflets 5 together. The cooperation of the clamping arms 1, the fixation clamps 3 and the drive assembly 2 of the leaflet fixation device, and the friction force on the leaflets 5 make the leaflet fixation device not separate from the leaflets 5 during blood flow impact and leaflet movement, achieving stable fixation of the leaflets 5. After the leaflet fixation device clamps and fixes the anterior leaflet and the posterior leaflet of the mitral valve, the delivery device is separated from the leaflet fixation device, and the leaflet fixation device is implanted in the patient's body, achieving "edge-to-edge repair" of the mitral valve, thereby reducing or eliminating mitral regurgitation.

[0051] In some possible embodiments, the leaflet fixation device is covered with a protective film layer 7, which can be made of biocompatible material and can completely cover the leaflet fixation device to prevent tissue damage. After the leaflet fixation device is left in the heart as an implant, the protective film layer can protect the outer surface of the leaflet fixation device.

[0052] Specifically, the leaflet fixation device according to an embodiment of the present application, as shown in FIGS. 1-4, includes a driving assembly 2, a pair of clamping arms 1, and a fixing clamp 3 cooperating with the clamping arms 1.

[0053] The driving assembly 2 includes a base bracket 21, a driving shaft 22, and a connecting block 23. The base bracket 21 includes a center cylinder 211 made of rigid material. The driving shaft 22 is connected to the center cylinder 211 through self-locking threads. The clamping arms 1 are connected to the driving shaft 22 through the connecting block 23. The driving shaft 22 drives the clamping arms 1 to open and close relative to the base bracket 21 by rotating.

[0054] The clamping arms 1 have a U-shaped or “[”-shaped cross section. When the pair of clamping arms 1 are closed and cooperate with the fixing clamp 3 to fix the leaflet, the center cylinder 211 abuts against the fixing clamp 3 to provide support.

[0055] Specifically, the driving assembly 2 includes the base bracket 21. The pair of clamping arms 1 are arranged on both sides of the base bracket 21 and can be opened and closed. The fixing clamp 3 is arranged between the base bracket 21 and the clamping arms 1. The base bracket 21 includes the center cylinder 211. When the pair of clamping arms 1 are closed relative to the base bracket 21, the two clamping arms 1 are closed around the center cylinder 211. The driving assembly 2 further includes the driving shaft 22 and the connecting block 23. The driving shaft 22 is arranged in the center cylinder 211. In some possible embodiments, the center cylinder 211 is internally threaded. The driving shaft 22 is externally threaded and threadedly connected to the center cylinder 211. The connecting block 23 is arranged on the end of the driving shaft 22 away from the center cylinder 211. The clamping arms 1 are connected to the driving shaft 22 through the connecting block 23. The driving shaft 22 is used to rotate and drive the pair of clamping arms 1 to open and close.

[0056] Specifically, the connecting block 23 side includes a first mounting surface and a second mounting surface perpendicular to each other, the connecting block 23 is connected with the connecting segment 12 of the clamping arm 1 through the first mounting surface, and is connected with the fixed clamping piece 3 through the second mounting surface. When the connecting block 23 is driven by the driving shaft 22 to move in the axial direction of the driving shaft 22, the axial movement of the fixed clamping piece and the opening or closing of the clamping arm 1 are driven. During the process of clamping the valve leaf, through the threaded transmission structure between the center cylinder 211 and the driving shaft 22, the precise control of the valve leaf clamping process is realized, and the firmness of the valve leaf fixation is more significantly improved. With the continuous tightening of the transmission thread, the extrusion force on the valve leaf gradually increases, and at the same time the limit of the static friction force between the valve leaf and the valve leaf fixing device also rises synchronously, ensuring that the valve leaf can still maintain a stable fixed state under extreme conditions. The superiority of the threaded transmission connection lies in its force amplification characteristic. Compared with the traditional non-spiral transmission mode, the threaded transmission can convert a small torque input into a huge thrust or pull force through the principle of spiral transmission, thereby providing powerful power support for the movement of the clamping arm. This mechanism greatly reduces the dependence of the system on direct thrust or pull force, reduces the requirements for the structure and material strength of the system, and makes the entire system more flexible and efficient in design and manufacturing. Through the center cylinder 211, effective support force is provided for the clamping of the valve leaf by the fixed clamping piece 3 and the clamping arm 1, and the threaded transmission connection mechanism is adopted, so that efficient and stable valve leaf clamping in a limited space becomes possible.

[0057] Further, the driving shaft 22 is connected with the center cylinder 211 through self-locking thread, that is, the thread rise angle of the threaded transmission connection between the driving shaft 22 and the center cylinder is smaller than the friction angle. After the threaded transmission connection between the driving shaft 22 and the center cylinder 211 in the embodiment, because the matching threads have the same pitch and cross-sectional shape, the axial relative movement of the driving shaft 22 and the center cylinder 211 can be realized by rotating the driving shaft 22 or the center cylinder 211. Because the helical rise angle of the helical ring groove is smaller than the friction angle between the contact surfaces of the two helical grooves, when the driving shaft 22 and the center cylinder 211 are stopped, only the axial force is applied to the driving shaft 22 or the center cylinder 211, and the axial displacement of the driving shaft 22 or the center cylinder 211 does not occur, thereby realizing the self-locking function, so that the clamping arm 1 can be accurately stopped at any angle position through the threaded cooperation.

[0058] The cross section of the clamping arm 1 of the embodiment is U-shaped or "[ " shaped structure, distributed on both sides of the base support 21. The clamping arm 1 is closed under the drive of the drive shaft 22 of the drive assembly 2, and when the clamping arm 1 is completely closed, the center cylinder 211 is tightly wrapped between the closing segments of the clamping arm 1, and together with the clamping arm 1 and the fixed clamping piece 3, a stable clamping space is formed, which can effectively prevent the leaflet from slipping or shifting. The self-locking thread connection between the drive shaft and the center cylinder enables the clamping arm to accurately stay at any angle position, meeting the accurate control under different clamping requirements. The center cylinder adopts a rigid cylinder, which provides effective support for the clamping between the clamping arm and the fixed clamping piece, and provides additional reinforcement for the clamping force between the clamping arm 1 and the fixed clamping piece 3, significantly improving the stability and reliability of the clamping. With the gradual tightening of the thread, the extrusion force on the leaflet is gradually increased, improving the firmness of the fixation.

[0059] The embodiment realizes efficient and stable fixation of the leaflet through the carefully designed drive assembly, the cooperatively working clamping arm and fixed clamping piece, and the center cylinder 211 support structure, solves the problems of large damage to the leaflet, insufficient clamping force, poor stability and other problems in the traditional fixation method, and further improves the use performance and reliability of the whole device through structural optimization and integration.

[0060] Further, the clamping arm 1 includes a bottom wall 113 and two side walls 114, and the included angle between the inner surface of the bottom wall 113 and the inner surface of the side wall 114 is obtuse. The depth of the clamping arm 1 is at least twice the thickness of the bottom wall.

[0061] Specifically, the included angle λ between the inner surface of the bottom wall 113 and the inner surface of the side wall 114 of the clamping arm 1 is 110°-170°. Alternatively, the included angle λ can be 120°-150°; preferably, the included angle λ between the inner surface of the bottom wall 113 and the inner surface of the side wall 114 can be 120°, 125° or 130°. This makes it easier for the leaflet to enter the clamping arm 1 and better adhere to the bottom wall 113 and the two side walls 114, and the two side walls 114 of the clamping arm 1 have less tension between the leaflets to prevent damage to the leaflets.

[0062] In some possible embodiments, as shown in FIG. 4, the depth H of the clamping arm 1 is 2-6 times the thickness δ of the bottom wall. Alternatively, the depth H of the clamping arm 1 can be 3 times, 4 times, 5 times or 6 times the thickness δ of the bottom wall; preferably, the depth H of the clamping arm 1 is 3 times the thickness of the bottom wall.

[0063] The cross-section of the clamping arm 1 is designed as a U-shaped or “[”-shaped structure, which increases the contact area between the clamping arm 1 and the leaflet 5, provides more stable clamping effect, and reduces the pressure concentration on the leaflet 5 and the risk of damage. The depth of the clamping arm 1 is at least twice the thickness of the bottom 113, so that the clamping arm 1 can stack more leaflet tissue when fixing the leaflet 5, which is beneficial to handle wider valve lesions, and can reduce the number of valve fixing devices used.

[0064] In some possible embodiments, as shown in FIGS. 5 and 6, a plurality of friction elements 111 are arranged on the inner wall of the clamping arm 1. The friction elements 111 can be arranged as a plurality of protruding friction strips arranged side by side, a plurality of uniformly arranged protruding friction points, or a combination of friction strips and friction points. Further, the friction elements 111 can also be composed of a plurality of protrusions with different heights or shapes, forming a multi-stage friction structure to adapt to leaflets of different thicknesses. The arrangement of the friction elements 111 increases the friction between the clamping arm 1 and the leaflet, which helps to maintain the stability of clamping during blood flow impact and leaflet movement.

[0065] Further, after the pair of clamping arms 1 are closed relative to the base support 21, the included angle between the two clamping arms 1 is in the range of 0°-60°. In the embodiments of the present application, the clamping arm 1 is a symmetrical structure with the lengthwise center line as the axis. When the pair of clamping arms 1 are closed relative to each other, the included angle between the two clamping arms 1 is controlled in the range of 0°-60°, preferably in the range of 0°-20°, and the better the surrounding effect of the two clamping arms 1 on the center cylinder 211 after they are closed, the more stably the center cylinder 211 is fixed at the center position, ensuring the effective support of the center cylinder 211 on the outer side fixing clamping piece 3 and the leaflet, and effectively reducing the misalignment between the two leaflets during clamping, avoiding stress concentration and leaflet damage caused by misalignment, and ensuring the stability and durability of clamping.

[0066] Preferably, after the pair of clamping arms 1 are closed relative to the base support 21, the central axis of the two clamping arms 1 after they are closed is aligned with the central axis of the center cylinder 211. Specifically, as shown in FIG. 7, when the leaflet is not clamped, the two U-shaped or “[”-shaped structures can be completely closed in the cross-sectional view after the two clamping arms 1 are closed, the center cylinder 211 is completely surrounded at the center, forming a compact whole, optimizing the space utilization, and being beneficial to the delivery of the valve fixing device in the delivery tube assembly 4. FIG. 8 is a cross-sectional view of the valve fixing device fixing the leaflet. When the leaflet is clamped and fixed, the smaller the angle of the two clamping arms 1 after they are closed, the better the clamping effect on the leaflet, and the clamping stability of the leaflet is further improved.

[0067] In some possible embodiments, one end of the clamping arm 1 extends to a side away from the inner surface thereof to form a first fold 112, and the included angle between the first fold 112 and the inner surface of the clamping arm 1 is obtuse. Optionally, the included angle between the first fold 112 and the inner surface of the clamping arm 1 is 100°-160°. Further, it can be 120°-140°, preferably, the included angle between the first fold 112 and the inner surface of the clamping arm 1 can be 120°, 130°, 150° or 160°. The provision of the first fold 112 helps to guide the leaflet into the accommodation area of the clamping arm 1 during clamping of the leaflet, and provides additional support and fixing effect.

[0068] Further, the end of the clamping arm 1 connected with the connecting block 23 is provided with a connecting section 12 for connecting with the driving assembly. The inner surface of the clamping arm 1 extends at least partially towards the center tube 211 in the direction of the first fold 112 and the direction of the connecting section 12. Specifically, the part of the clamping arm 1 connected with the first fold 112 forms a first transition section, and the depth of the first transition section is smaller than the depth of the clamping arm 1, showing a gradually shrinking trend. Similarly, the part of the clamping arm 1 connected with the connecting section 12 forms a second transition section, and the depth of the second transition section is also smaller than the depth of the clamping arm 1. Overall, the clamping arm 1 adopts a structure design of large belly in the middle and appropriate shrinkage at both ends, so that the clamping arm 1 can accommodate more leaflet tissues when fixing the leaflet, and the shrinking trend from the clamping arm 1 to the first fold 112 makes the clamping arm more compact when closed, reducing the risk of leaflet slipping.

[0069] In some possible embodiments, one end of the clamping arm 1 extends to a side away from the inner surface thereof to form a first fold 112, and the included angle between the first fold 112 and the inner surface of the clamping arm 1 is obtuse. Optionally, the included angle between the first fold 112 and the inner surface of the clamping arm 1 is 100°-160°. Further, it can be 120°-140°, preferably, the included angle between the first fold 112 and the inner surface of the clamping arm 1 can be 120°, 130°, 150° or 160°. The provision of the first fold 112 helps to guide the leaflet into the accommodation area of the clamping arm 1 during clamping of the leaflet, and provides additional support and fixing effect.

[0070] Further, the connecting segment 12 is provided with a guide chute 121; the base support 21 is provided with a chute driving element 212 located at least partially in the guide chute 121; the centripetal side of the guide chute 121 of the connecting segment 12 is provided with a connecting shaft hole 123 for connecting with the connecting block 23, and the connecting line of the connecting shaft hole 123 and the chute driving element 212 is coplanar with the central axis of the central cylinder 211. Specifically, the base support 21 includes two base hanging ears 213 provided at the distal end of the central cylinder 211 and symmetrically arranged, and the chute driving element 212 is arranged on the base hanging ear 213. In the embodiment of the application, the cooperation of the guide chute 121 and the chute driving element 212 enables the opening and closing degree of the clamping arm 1 to be accurately controlled, thereby realizing accurate fixing of the valve; the parallelism of the connecting line of the connecting shaft hole and the chute driving element 212 with the central axis of the central cylinder 211 ensures the compactness of the entire device in the closed state, greatly reduces the volume of the distal end of the leaflet fixing device, is conducive to smooth delivery in the delivery tube assembly 4, and also reduces the potential damage to the patient.

[0071] The fixed clamping piece 3 is connected with the driving shaft 22 through the connecting block 23. The fixed clamping piece 3 is used to capture and fix the leaflet in cooperation with the clamping arm 1 under the control of the control element thereof, can more comprehensively clamp the leaflet, and improves the stability and reliability of clamping.

[0072] Further, as shown in FIG. 11, the fixed clamping piece 3 includes a friction surface 311, and the friction surface 311 is provided with a groove or a convex structure 312 with a smooth end portion. The design of the friction surface 311 helps to increase the friction between the fixed clamping piece 3 and the leaflet during the contact of the fixed clamping piece 3 with the leaflet, prevents the jumping phenomenon of the leaflet, and reduces the damage to the leaflet in the capturing process while ensuring sufficient clamping force.

[0073] In a possible implementation, the groove or the convex structure 312 on the friction surface 311 is uniformly arranged along the length direction of the fixed clamping piece 3. The friction force of the leaflet fixing device of the application to the leaflet not only comes from the friction surface 311 of the fixed clamping piece 3, but also mainly comes from the friction force caused by the extrusion of the clamping arm 1 and the central cylinder 211 to the leaflet. Due to the force amplification of the threaded transmission of the central cylinder 211 and the driving shaft 22, the leaflet is subjected to sufficient extrusion force, so that the fixing is more firm. Since the extrusion of the leaflet provides additional support for stabilizing the leaflet, the groove or the convex structure on the friction surface 311 can be appropriately reduced, and is designed as a structure with a smooth end portion, so that the damage to the leaflet is reduced. In addition, since the two leaflets are respectively fixed between the clamping arm 1 and the central cylinder 211 corresponding to the two leaflets, if one side of the leaflet falls off, it will not affect the fixation of the other side of the leaflet.

[0074] Further, the ratio of the arc length of the fixed clamping piece 3 to the shortest distance between the two side walls of the U-shaped or “[”-shaped structure of the clamping arm is in the range of 0.5-1. Alternatively, the ratio of the arc length of the fixed clamping piece 3 to the shortest distance between the two side walls of the U-shaped or “[”-shaped structure of the clamping arm 1 is in the range of 0.6-0.8. Preferably, it can be 0.6, 0.7 or 0.8. The reasonable ratio range of the arc length of the fixed clamping piece 3 to the shortest distance between the two side walls of the U-shaped or “[”-shaped structure of the clamping arm ensures that the fixed clamping piece 3 can closely fit the leaflet, increase the contact area with the leaflet, and more uniform clamping force, avoiding the phenomenon of slipping or displacement during clamping, so that the fixed clamping piece 3 can more effectively transfer the clamping force to the leaflet, thereby enhancing the firmness of clamping and improving the stability of clamping. Stable clamping force and uniform stress distribution help to reduce the wear and deformation of the leaflet and the clamping device, thereby prolonging the service life of the device.

[0075] The artificial valve leaflet with consistent mechanical properties is used to replace the biological valve leaflet to evaluate the performance of the valve leaflet fixing device. The single-layer thickness of the valve leaflet is 0.3±0.05mm, which is cut into a long strip with a width of 2cm by a blade, and then stacked and sutured to form an artificial valve with a thickness of 1.4-1.6mm. The artificial valve leaflet with appropriate length is placed on both sides of the unfolded clamping arm 1, and the valve leaflet fixing device is closed. The clamping angle of the valve leaflet fixing device is recorded using an image measuring instrument. The driving torque is provided to the threaded drive of the driving shaft, and the two clamping arms are closed. The size of the input torque is controlled using a torsion meter. After the valve leaflet is closed and in contact with the center cylinder, the input torque is continued until the specified size of the driving torque is reached. After the valve clamping is completed, a tensile test is performed on the screw test bench using a dynamometer (maximum load 50N, accuracy ±0.5%). The valve leaflet fixing device is fixed to one end of the tensile test bench using a clamp, and the artificial valve leaflet is fixed to the other end. Then, the sample is slowly vertically stretched, and the maximum value of the valve leaflet pulled off the valve leaflet fixing device, i.e. the separation force, is recorded. The separation force and clamping angle are tested under driving torques of 6N*mm, 11 N*mm, 16 N*mm, and 21 N*mm, respectively. In this experiment, 5 tests were performed under each driving torque condition, and 5 different sample individuals were used. The final trend of the valve leaflet fixing ability under driving torques of 6N*mm, 11 N*mm, 16 N*mm, and 21 N*mm is shown in FIG. 12, which is a trend graph of the clamping angle of the valve leaflet fixing device and the separation force of the valve leaflet pulled off the valve leaflet fixing device with the driving torque. The separation force is 9.72±1.33, 15.14±1.57, 19.48±2.62, and 22.33±1.38, respectively, and the clamping angle is CA: 21.38±1.74, 15.57±0.70, 12.93±0.71, and 10.88±1.15, respectively. It is obvious that the extrusion of the clamping arm and the center cylinder of the present application on the valve leaflet can improve the fixing ability of the valve leaflet fixing device on the valve leaflet, and as the driving torque increases, the clamping angle of the valve leaflet fixing device is smaller, and the extrusion degree on the valve leaflet is higher, resulting in the synchronous improvement of the fixing ability.

[0076] The clamping arm 1 of the embodiment adopts a U-shaped or "[ ]" shaped structure, and is closed under the driving of the driving shaft 22 of the driving assembly 2. When the clamping arm 1 is completely closed, the center tube 211 is tightly wrapped between the closing segments of the clamping arm 1, and together with the clamping arm 1 and the fixed clamping piece 3, a stable clamping space is formed, which can stack more leaflet tissues, provide stronger extrusion force and higher static friction force. Compared with the traditional method of increasing friction force by a piercing structure, the damage to the leaflets is greatly reduced, and the leaflets can be firmly fixed on the device. When treating a wider valve lesion, the number of leaflet fixation devices used is significantly reduced, and the operation efficiency and safety are improved. The tight closing of the clamping arm and the center tube, together with the fixed clamping piece, constitutes a double fixation mechanism for the leaflets, and the center tube provides effective support force to the fixed clamping piece, effectively improving the reliability and stability of the fixation effect. The driving shaft and the center tube are connected through self-locking screw transmission, which improves the power transmission efficiency. By adjusting the tightening degree of the transmission screw, the extrusion force on the leaflets can be accurately controlled, thereby realizing fine adjustment of the fixation force of the leaflets and improving the firmness of the leaflet clamping, so that efficient and stable leaflet clamping in a small space is possible.

[0077] As shown in FIGS. 13-18, the application also provides a valve repair system, which comprises a delivery device and a leaflet fixation device. The leaflet fixation device is loaded on the distal end of the delivery device and is delivered to a designated position in the heart by the delivery device.

[0078] The delivery device comprises a delivery tube assembly 4, a transmission shaft 41 arranged in the delivery tube assembly 4, and a clutch mechanism 6. The transmission shaft 41 is used to rotate to provide driving force for the leaflet fixation device and control the separation of the clutch mechanism 6 and the leaflet fixation device. The transmission shaft 41 of the embodiment is a rod-shaped body with an inner cavity or a hollow tubular body. The transmission shaft 41 is connected with the connecting shaft 62 of the clutch mechanism 6, and the rotation of the transmission shaft 41 drives the rotation of the connecting shaft 62. The axial pulling of the connecting shaft 62 can separate the connecting shaft 62 from the driving shaft 22.

[0079] One end of the clutch mechanism 6 is connected with the delivery tube assembly 4, and the other end is detachably connected with the leaflet fixation device. The clutch mechanism 6 comprises a clutch 61 and a connecting shaft 62 arranged in the clutch 61. The clutch 61 is detachably connected with the base support 21. The connecting shaft 62 is used to connect the transmission shaft 41 and the driving shaft 22, and the connecting shaft 62 is provided with a channel 623 which penetrates and communicates with the inner cavity of the transmission shaft 41 and the center cavity of the driving shaft 22.

[0080] Specifically, the clutch mechanism 6 comprises a clutch member 61, a connecting shaft 62 and a connecting seat 63, the connecting shaft 62 is arranged in the connecting seat 63 and the clutch member 61. The connecting seat 63 is used to connect the delivery tube assembly 4 and the clutch member 61, and the connecting seat 63 is provided with a cavity for the movement of the connecting shaft 62. The clutch member 61 is detachably connected with the base support 21, and the clutch member 61 comprises a fixed end 611 connected with the connecting seat 63 and a clutch end 612 detachably connected with the base support 21. When the delivery device drives the transmission shaft 41 and the connecting shaft 62 to move towards the proximal end, the clutch end 612 is opened and separated from the base support 21, so that the connecting shaft 62 is separated from the drive shaft 22. In the embodiment, when the clutch member 61 is separated from the base support 21, only the connecting shaft 62 needs to be pulled axially towards the proximal end, the clutch end 612 of the clutch member 61 sleeved on the outside of the connecting shaft 62 is opened and separated from the base support 21, the connecting shaft 62 is separated from the drive shaft 22, and the base support 21 remains stationary during the separation process. The separation process is stable, the separation steps are simple and fast, the clutch member can be reversibly deformed, the valve leaflet fixing device can be conveniently reloaded, and the delivery device can be reused.

[0081] Further, one end of the connecting shaft 62 connected with the drive shaft 22 is provided with a first clamping structure 622, and the drive shaft 22 is provided with a second clamping structure 221, and the first clamping structure 622 and the second clamping structure 221 can limit the relative rotation between the connecting shaft 62 and the drive shaft 22 when clamped. The connecting shaft 62 is arranged to be movable relative to the clutch member 61 between a first position and a second position, and when the connecting shaft 62 moves from the first position to the second position, the clutch member 61 is separated from the base support 21, and the first clamping structure 622 is separated from the second clamping structure 221. The connecting shaft 62 comprises a boss section 621, and when the connecting shaft 62 moves towards the proximal end from the first position, the boss section 621 on the connecting shaft 62 moves towards the proximal end, and when the boss section 621 completely escapes from the direct extrusion of the clutch member 61, the clutch member 61 is no longer subjected to external extrusion force. Because the clutch member 61 itself has good elasticity, the clutch member 61 restores its original natural open state.

[0082] Specifically, the end of the connecting seat 63 connected with the fixed end 611 is provided with a connecting part 631, which can be two symmetrical connecting ears. The connecting part 631 is provided with a fixing hole 632, and the connecting part 631 is connected with the fixed end 611 of the clutch part 61 through the fixing hole 632. The clutch part 61 includes the fixed end 611 and the clutch end 612. The fixed end 611 is connected with the connecting seat 63, and the clutch end 612 is detachably connected with the base support 21. The fixed end 611 is provided with a connecting hole 6111 corresponding to the fixing hole 632, so as to be connected with the connecting seat 63. The clutch end 612 includes a first half clamp 6121 and a second half clamp 6122 which are connected with each other and can be relatively separated. When the clutch part 61 is in the engaged state, the first half clamp 6121 and the second half clamp 6122 are connected with the base support 21, so as to limit the base support 21 in the axial and circumferential directions. The connecting hole 6111 on the side facing the clutch end 612 can be open, so as to facilitate the opening of the first half clamp 6121 and the second half clamp 6122 along the open gap.

[0083] In a possible implementation, the first half clamp 6121 and the second half clamp 6122 are each provided with a clamping part 6123, and the base support 21 is provided with a clamping matching part 210 corresponding to the clamping part 6123. The clamping part 6123 is connected with the clamping matching part 210, so as to limit the base support 21 in the axial and circumferential directions. When the transmission shaft 41 moves towards the proximal end, the clamping part 6123 is separated from the clamping matching part 210, so that the clutch part 61 is relatively separated from the base support 21.

[0084] In a possible implementation, the clutch part 61 can be made of an elastic material, and the fixed end 611 and the clutch end 612 are integrally formed. The first half clamp 6121 and the second half clamp 6122 are elastically connected at the fixed end, can be relatively opened or closed, and can be reversibly deformed, so that the clutch part 61 can be repeatedly used, and the delivery device can be repeatedly used. It should be noted that the clutch end 612 of the clutch part 61 is in an open state in a natural state without external force. At this time, the inner hole of the fixed end 611 is approximately elliptical. When the fixed end 611 is extruded to be circular by the pushing force of the connecting shaft 62 moving towards the proximal end, the fixed end 611 and the clutch end 612 are closed, and the opening is limited. Specifically, in actual application, after the release of the last set of leaflet fixing device, the delivery device is withdrawn, a new leaflet fixing device is aligned on the clutch part 61, and the transmission shaft 41 is pushed towards the distal end. The convex boss segment 621 of the connecting shaft 62 extrudes the port of the fixed end 611, so that the clutch end 612 is closed and connected with the base support 21, and the new leaflet fixing device is fixed.

[0085] The inner cavity of the transmission shaft 41, the channel 623 and the central cavity of the drive shaft 22 are communicated, so as to pass through the guide. In the case that the guide is not withdrawn, the delivery device can deliver and withdraw the leaflet fixing device along the delivery path established by the guide for multiple times.

[0086] The withdrawal process of the leaflet fixation device of the embodiment: the delivery tube assembly 4 and the transmission shaft 41 are synchronously pushed distally along the guide, under the observation of X-ray image or ultrasound image, it is determined that the open-close member 61 has contacted the base support 21; the delivery tube assembly 4 is kept stationary, and the transmission shaft 41 is synchronously pushed distally, thereby pushing the connecting shaft 62, the boss section 621 of the connecting shaft 62 extrudes the fixed end 611 of the open-close member 61, so that the open-close end 612 is closed, the open-close member 61 is connected with the base support 21, and at the same time, the connecting shaft 62 is also reconnected with the driving shaft 22, thereby withdrawing the leaflet fixation device, and further capturing the leaflet according to requirements, fixing the leaflet, until the repair is completed.

[0087] The valve repair system of the present application adopts a reusable open-close mechanism connected with the leaflet fixation device, so that the leaflet fixation device can be flexibly withdrawn and recapture the leaflet during the process of fixing the leaflet, thereby enhancing the flexibility and accuracy of operation. In the process of capturing the leaflet, the cooperation of the clamping arm, the fixing clamping piece and the center tube forms a stable clamping space. By adjusting the fastening degree of the transmission thread, the extrusion force on the leaflet is controlled, thereby effectively expanding the inclusion range of the leaflet tissue, ensuring stronger extrusion force and higher static friction force, thereby minimizing the potential damage to the leaflet tissue, improving the stability and reliability of the leaflet fixation, and improving the flexibility and safety of the operation.

[0088] Obviously, the above-described embodiments are only some of the embodiments of the present specification, not all. Based on the embodiments in the present specification, those skilled in the art can make other different forms of changes or modifications without creative labor, which should all fall within the protection scope of the present specification.

[0089] Other embodiments of the present specification will be readily apparent to those skilled in the art upon considering the specification and the practice of the embodiments disclosed herein. The present specification is intended to cover any variations, uses or adaptive changes of the present specification that follow the general principles of the present specification and include common knowledge or conventional technical means in the technical field not disclosed by the present specification. The specification and embodiments are only considered as exemplary, and the true scope and spirit of the present specification are indicated by the following claims.

[0090] It should be understood that the present specification is not limited to the precise structures described above and shown in the drawings, and various modifications and changes can be made without departing from its scope. The scope of the present specification is only limited by the appended claims.

Claims

1. A leaflet fixation device, comprising: The utility model relates to a kind of heart valve clamping devices, including drive assembly (2), a pair of clamping arms (1), and the fixed clamping piece that is matched with the clamping arm (1); The drive assembly (2) includes base support (21), drive shaft (22) and connecting block (23);The base support (21) includes center cylinder (211), and the center cylinder (211) is made of rigid material;The drive shaft (22) is connected with the center cylinder (211) by self-locking thread;The clamping arm (1) is connected with the drive shaft (22) by the connecting block (23), and the drive shaft (22) drives the clamping arm (1) to open and close relative to the base support (21) by rotating; The section of the clamping arm (1) is U-shaped or "[ "type structure, when a pair of the clamping arm (1) is closed and matched with the fixed clamping piece (3) to fix the leaflet, the center cylinder (211) is abutted with the fixed clamping piece (3) to provide support.

2. A leaflet fixation device according to claim 1, wherein, The clamping arm (1) includes a bottom wall (113) and two side walls (114), the included angle between the inner surface of the bottom wall (113) and the inner surface of the side wall (114) is obtuse, and the depth of the clamping arm (1) is at least twice the thickness of the bottom wall (113).

3. A leaflet fixation device according to claim 2, wherein, The fixed clamping piece (3) includes a friction surface (311), and the friction surface (311) is provided with a groove or a convex structure (312) with a smooth end.

4. The leaflet fixation device defined in claim 2, wherein, The ratio of the arc length of the fixed clamping piece (3) to the shortest distance between the two side walls of the U-shaped or "[ "type structure of the clamping arm (1) is in the range of 0.5-1.

5. The leaflet fixation device according to claim 1, wherein, After the pair of clamping arms (1) are closed relative to the base support (21), the included angle between the two clamping arms (1) is in the range of 0°-60°.

6. A leaflet fixation device according to claim 5, wherein, After the pair of clamping arms (1) are closed relative to the base support (21), the central axis of the two clamping arms (1) after closing is aligned with the central axis of the center cylinder (211).

7. The leaflet fixation device defined in claim 2, wherein, One end of the clamping arm (1) extends to the side away from the inner surface thereof to form a first folded edge (112), and the included angle between the first folded edge (112) and the inner surface of the clamping arm (1) is obtuse.

8. A leaflet fixation device according to claim 7, wherein, One end of the clamping arm (1) connected with the connecting block (23) is provided with a connecting segment (12). The inner surface of the clamping arm (1) extends in the direction of the first folded edge (112) and the direction of the connecting segment (12) towards the center cylinder (211) from the middle part.

9. A leaflet fixation device according to claim 8, wherein, The connecting segment (12) is provided with a guide sliding groove (121), and the base support (21) is provided with a sliding groove driving member (212) located at least partially in the guide sliding groove (121). The centripetal side of the guide sliding groove (121) of the connecting segment (12) is provided with a connecting shaft hole (123) for connecting with the connecting block (23), and the connecting line of the connecting shaft hole (123) and the sliding groove driving member (212) is coplanar with the central axis of the center cylinder (211).

10. A valve repair system characterized by, The delivery device comprises a delivery tube assembly (4), a transmission shaft (41) arranged in the delivery tube assembly (4), and a clutch mechanism (6); the clutch mechanism (6) comprises a clutch member (61) and a connecting shaft (62) arranged in the clutch member (61), the clutch member (61) is detachably connected with the base support (21); the connecting shaft (62) is used for connecting the transmission shaft (41) and the driving shaft (22), and the connecting shaft (62) is provided with a channel (623) penetrating through the inner cavity of the transmission shaft (41) and the central cavity of the driving shaft (22). The connecting shaft (62) is provided with a first clamping structure (622) at one end connected with the driving shaft (22), the driving shaft (22) is provided with a second clamping structure (221), and the first clamping structure (622) and the second clamping structure (221) are clamped to limit the relative rotation between the connecting shaft (62) and the driving shaft (22).

11. The valve repair system of claim 10, wherein, The connecting shaft (62) is arranged to be movable relative to the clutch member (61) between a first position and a second position, when the connecting shaft (62) moves from the first position to the second position, the clutch member (61) is separated from the base support (21), and the first clamping structure (622) is separated from the second clamping structure (221).

12. The valve repair system of claim 11, wherein, The clutch member (61) comprises a fixed end (611) and a clutch end (612), the clutch end (612) comprises a first half clamp (6121) and a second half clamp (6122) connected with each other and capable of being separated relative to each other, when the clutch member (61) is in the engaged state, the first half clamp (6121) and the second half clamp (6122) are connected with the base support (21) to limit the base support (21) in the axial and circumferential directions.

13. The valve repair system of Ciaim 10, wherein, ​

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