CN115517815A

CN115517815A - Atrioventricular valve clamping device and atrioventricular valve clamping system

Info

Publication number: CN115517815A
Application number: CN202110713830.9A
Authority: CN
Inventors: 刘先宝; 王建安; 江巍; 张庭超
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2021-06-25
Filing date: 2021-06-25
Publication date: 2022-12-27

Abstract

The application provides an atrioventricular valve clamping device and atrioventricular valve clamping system that easily catches leaflet and improve leaflet clamping stability and reliability. The atrioventricular valve clamping device comprises a supporting member, an adjusting member, at least two clamping members, a driving assembly and at least one catching assembly. The adjusting piece is sleeved on the supporting piece; each clamping piece is arranged on the outer side of the adjusting piece, and one end of each clamping piece is rotatably connected to one end of the supporting piece; the driving assembly comprises an opening part and an elastic closing part, the opening part is connected with each clamping part and is used for driving the at least two clamping parts to open relative to the adjusting part, and the elastic closing part is connected with each clamping part and is used for enabling the at least two clamping parts to be automatically closed and keeping the at least two clamping parts closed relative to the adjusting part in a natural state; each capturing assembly comprises a capturing elastic sheet and a control line correspondingly connected with the capturing elastic sheet, one capturing elastic sheet is correspondingly arranged between one clamping piece and the adjusting piece, and the control line is used for controlling the corresponding capturing elastic sheet to be far away from or close to the corresponding clamping piece.

Description

Atrioventricular valve clamping device and atrioventricular valve clamping system

Technical Field

The application relates to the technical field of medical equipment, in particular to an atrioventricular valve clamping device and an atrioventricular valve clamping system.

Background

Atrioventricular valves, such as the mitral valve and the tricuspid valve, are one-way valves in the heart, and normal healthy atrioventricular valves can control the flow of blood from the atrium to the ventricle while avoiding the flow of blood from the ventricle to the atrium. For example: the mitral valve is a one-way valve located between the left atrium and the left ventricle of the heart, and can control the blood flow from the left atrium to the left ventricle, and simultaneously avoid the blood flow from the left ventricle to the left atrium; the tricuspid valve is a one-way valve located between the right atrium and right ventricle of the heart and controls the flow of blood from the right atrium to the right ventricle while preventing the flow of blood from the right ventricle to the right atrium.

The mitral valve includes an anterior leaflet and a posterior leaflet, and the tricuspid valve includes an anterior leaflet, a posterior leaflet, and a septal leaflet. Normally, when the left ventricle or the right ventricle contracts, the edges of any two adjacent valve leaflets of the mitral valve or the tricuspid valve are completely involuted, and blood is prevented from flowing from the ventricle to the atrium. If the leaflets or their associated structures undergo organic or functional changes, such as rupture of chordae tendineae, causing the adjacent leaflets of the mitral or tricuspid valve to coapt poorly, the mitral or tricuspid valve will not close completely when the left or right ventricle contracts, resulting in regurgitation of blood from the ventricle into the atrium, causing a series of pathophysiological changes known as "mitral regurgitation" or "tricuspid regurgitation".

Interventional valve clamping refers to the treatment of regurgitation by implanting a valve clamping device into the atrioventricular valve such as mitral valve, tricuspid valve, etc., and pulling the two leaflets that are otherwise poorly coaptated toward each other for edge-to-edge repair, thereby reducing or eliminating the leaflet gap. Referring to fig. 1, a conventional valve clamping device 100 uses a torsion spring 101 to automatically close two clamping arms 103 relative to an adjusting member 105, so as to clamp the valve between the clamping arms 103 and the adjusting member 105.

However, since any adjacent two leaflets of the mitral valve or the tricuspid valve are dynamic in the cardiac cycle, the above-mentioned conventional valve clamping device 100 needs to capture and clamp two leaflets at the same time at a correct and short moment, and there is a high possibility that the two clamp arms 103 are closed but the leaflets are not captured or the area for capturing and clamping the leaflets 300 is too small as shown in fig. 2, which not only has a high difficulty in capturing the leaflets, but also has poor stability and reliability in clamping the leaflets. In particular, the tricuspid valve is less visible under an image than the mitral valve, and it is more difficult to determine the correct, short moment that can capture two leaflets simultaneously, i.e., the leaflet capture is more difficult, and the leaflets of the tricuspid valve are thinner, which requires more stability and reliability for clamping the leaflets.

Disclosure of Invention

In order to solve the technical problem, the application provides an atrioventricular valve clamping device and atrioventricular valve clamping system, can enough catch the valve leaf relatively easily, has improved the stability and the reliability of centre gripping valve leaf simultaneously again.

In order to achieve the above object, one aspect of the present application provides an atrioventricular valve clamping device comprising a support member, an adjustment member, at least two clamping members, a driving assembly, and at least one catching assembly. The adjusting piece is sleeved on the supporting piece; the at least two clamping pieces are arranged on the outer side of the adjusting piece, and one end of each clamping piece is rotatably connected to one end of the supporting piece; the driving assembly comprises an opening piece and an elastic closing piece; the opening part is connected with each clamping part and is used for driving the at least two clamping parts to open relative to the adjusting part; the elastic closing part is connected with each clamping piece and is used for enabling the at least two clamping pieces to be automatically closed and to be kept closed relative to the adjusting piece in a natural state; each capture assembly comprises a capture elastic sheet and a control line correspondingly connected with the capture elastic sheet, the capture elastic sheet is correspondingly arranged between the clamping piece and the adjusting piece, and the control line is used for controlling the corresponding capture elastic sheet to be far away from or close to the corresponding clamping piece.

This application another aspect still provides an atrioventricular valve clamping system, including conveyor and foretell atrioventricular valve clamping device, conveyor with atrioventricular valve clamping device can dismantle the connection, conveyor is used for carrying atrioventricular valve clamping device and control drive assembly.

According to the atrioventricular valve clamping device and the atrioventricular valve clamping system, the catching elastic sheet is additionally arranged between the at least one clamping piece and the adjusting piece, the catching elastic sheet is correspondingly connected with the control line, the control line controls the corresponding catching elastic sheet to be matched with the corresponding clamping piece to realize single-side valve leaf catching, and then the elastic closing piece enables the at least two clamping pieces to be quickly and automatically closed, so that two valve leaves do not need to be simultaneously caught and clamped at one moment like the prior art, the difficulty of valve leaf catching is obviously reduced, and the valve leaf catching operation is relatively easy; moreover, through operating the control line and the corresponding capturing elastic sheet, the leaflet can be captured on one side easily when the area of the leaflet entering between the capturing elastic sheet and the corresponding clamping piece is large enough, so that the capturing and clamping area of the leaflet is increased, and the stability and the reliability of the final leaflet clamping are improved.

The atrioventricular valve clamping device and the atrioventricular valve clamping system are not limited to application in interventional mitral valve clamping or interventional tricuspid valve clamping. Because the ventricular valve clamping device and the atrioventricular valve clamping system are easier to capture the valve leaflets and can stably and reliably clamp the valve leaflets, the ventricular valve clamping device is particularly suitable for tricuspid valve clamping operation and treatment of tricuspid regurgitation.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required to be used in the embodiments are briefly described below, it is obvious that the drawings in the following description are some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings without creative efforts.

Fig. 1 and 2 are schematic structural views of a valve clamping device in the prior art.

Figure 3 is a front view of an atrioventricular valve clamping device provided in accordance with a first embodiment of the present application, connected to the distal end of a delivery device.

Fig. 4 is a perspective view of the atrioventricular valve clamping device of fig. 3, wherein the drive rod of the opening member is detachably connected to the spindle of the delivery device.

Fig. 5 is a front view of the support, the opener, and the mandrel of fig. 4.

Fig. 6 is a perspective view of the supporting member, the opening member and the mandrel of fig. 5.

Fig. 7 is an axial cross-sectional view of the adjustment member of fig. 4 in a natural state.

Fig. 8 is a perspective view of the clip of fig. 4.

Fig. 9 is a schematic perspective view of the catching shell fragment in fig. 4.

Fig. 10 is a front view of a partial structure of the atrioventricular valve clamping device of fig. 3.

Fig. 11 is a schematic perspective view of the resilient closure of fig. 4 in a natural state.

Fig. 12 is a front view of the resilient closure of fig. 11.

Fig. 13-16 are schematic views of a procedure for using an atrioventricular valve clamping device as provided herein.

Fig. 17 is a perspective view of a capture clip of an atrioventricular valve clamping device according to a second embodiment of the present application.

Fig. 18 is a perspective view of a partial structure of an atrioventricular valve clamping device according to a second embodiment of the present application.

Fig. 19 is a perspective view of a capturing leaf spring of an atrioventricular valve clamping device according to a third embodiment of the present application.

Fig. 20 is a schematic perspective view of a resilient closure member of an atrioventricular valve clamping device according to a fourth embodiment of the present application.

Fig. 21 is a front view of the resilient closure of fig. 20.

Figure 22 is a front view of an atrioventricular valve clamping device provided in accordance with a fifth embodiment of the present application, connected to the distal end of a delivery device.

Description of the main element symbols:

atrioventricular valve clamping device 1

Support 10

First connection portion 11

Second connecting part 13

Guide groove 15

Adjusting part 20

A first direction X

Second direction Y

First dimension W

Second dimension L

Clamping member 30

Accommodating space 31

Connecting frame 32

First anchoring structure 33

Holding frame 34

Connecting pin 35

Drive assembly 40

Opening member 42

Drive rod 422

Connecting rod 424

Resilient closure member 44

Substrate 442

Resilient arm 444

Connecting ring 4445

Catch assembly 50

Catching spring plate 52

Threading structure 521

Second anchoring structure 523

Securing tab 524

Through hole 525

Control line 54

Conveying device 2

Outer tube 201

Mandrel 202

Valve leaflet 3

First distance L1

Second distance L2

Third distance L3

Negative included angle A

Negative included angle B

The following specific examples will further illustrate the application in conjunction with the above figures.

DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION

The technical solutions in the embodiments of the present application will be described clearly and completely with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments in the present application without any inventive step are within the scope of protection of the present application.

In addition, the following description of the various embodiments refers to the accompanying drawings, which are included to illustrate specific embodiments that can be used to practice the present application. Directional phrases used in this application, such as "upper," "lower," "front," "rear," "left," "right," "inner," "outer," "side," and the like, refer only to the direction of the appended figures and, therefore, are used in order to better and more clearly illustrate and understand the present application and are not intended to indicate or imply that the device or element so referred to must have a particular orientation, be constructed and operated in the particular orientation, and, therefore, should not be taken to be limiting of the present application.

It should be noted that, in order to describe the structure of the atrioventricular valve clamping device and the atrioventricular valve clamping system more clearly, the terms "proximal" and "distal" are used herein as the common terms in the field of interventional medicine. Specifically, "distal" refers to the end of the surgical procedure that is distal from the operator, and "proximal" refers to the end of the surgical procedure that is proximal to the operator; the direction of a rotating central shaft of an object such as a column body, a pipe body and the like is defined as an axial direction; the circumferential direction is the direction around the axis of an object such as a column, a tube, or the like (perpendicular to the axis and perpendicular to the radius of the section); radial is the direction along a diameter or radius. It is noted that the term "end" as used in the expressions "proximal end", "distal end", "one end", "another end", "first end", "second end", "initial end", "terminal end", "both ends", "free end", "upper end", "lower end", and the like, is not limited to a tip, an end point or an end surface, but also includes a portion extending from a tip, an end point or an end surface for an axial distance and/or a radial distance on the tip, an end point or an element to which the end surface belongs. Unless defined otherwise, all 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 terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

Referring to fig. 3 and 4 together, a first embodiment of the present application provides an atrioventricular valve clamping system, which includes an atrioventricular valve clamping device 1 and a delivery device 2 detachably connected to the atrioventricular valve clamping device 1, wherein the delivery device 2 is used for delivering the atrioventricular valve clamping device 1 to an atrioventricular valve (not limited to a mitral valve and a tricuspid valve) and controlling the atrioventricular valve clamping device 1 to clamp leaflets, so as to repair the atrioventricular valve edge to edge.

Specifically, as shown in fig. 3 and 4, the atrioventricular valve clamping device 1 comprises a support member 10, an adjusting member 20, at least two clamping members 30, a driving assembly 40, and at least one catching assembly 50. The adjusting member 20 is sleeved on the supporting member 10 and has elastic self-expansion performance. At least two clamping members 30 are provided on the outer side of the adjusting member 20 (i.e., the side away from the supporting member 10 in the radial direction), and one end of each clamping member 30 is rotatably connected to one end of the supporting member 10. The driving assembly 40 includes an opening member 42 and a resilient closing member 44 connected to each of the clamping members 30, the opening member 42 is used for driving at least two of the clamping members 30 to open relative to the adjusting member 20 against the action of the resilient closing member 44, and the resilient closing member 44 is used for enabling at least two of the clamping members 30 to automatically close relative to the adjusting member 20 and to keep the at least two clamping members 30 closed relative to the adjusting member 20 in a natural state. Each catching assembly 50 comprises a catching spring 52 and a control wire 54 correspondingly connected with the catching spring 52, wherein one catching spring 52 is correspondingly arranged between one clamping piece 30 and the adjusting piece 20, and the control wire 54 is used for controlling the corresponding catching spring 52 to move away from or close to the corresponding clamping piece 10. It should be noted that, in the embodiments of the present application, for any element of the atrioventricular valve clamping device 1, the natural state refers to the state of the element when the element is not affected by external force or force of other elements.

Wherein the number of the clamping members 30 may be equal to the number of the catching

assemblies

50, or 1 more than the number of the catching assemblies 50. Preferably, in the first embodiment, the number of the clamping members 30 is equal to the number of the capturing assemblies 50, so that each leaflet to be repaired by clamping is captured by one capturing spring 52 and one clamping member 30, and the capturing spring 52 is controlled to move away from or close to the corresponding clamping member 30 through the corresponding control line 54, so that the individual capturing or releasing of each leaflet can be realized, or the leaflet is captured on one side.

In other embodiments, when the number of the clamping members 30 is 1 more than the number of the capturing assemblies 50, one of the valve leaflets to be repaired by clamping can be captured by the cooperation of the clamping members 30 and the adjusting members 20, and the other valve leaflets to be repaired by clamping can be captured by a capturing spring 54 and a corresponding clamping member 30.

The number of leaflets to be repaired by clamping is generally two, and the leaflets may be anterior leaflet and posterior leaflet of mitral valve, anterior leaflet and septal leaflet, or posterior leaflet and septal leaflet of tricuspid valve. In this first embodiment, the number of the gripping members 30 and the number of the capturing members 50 are both 2, so as to clamp and repair any two adjacent leaflets.

As shown in fig. 3 and 4, the delivery device 2 comprises a tube assembly including an outer tube 201 and a mandrel 202, which are coaxially sleeved together from outside to inside, a distal end of the outer tube 201 is detachably connected with the support 10 for pushing the atrioventricular valve clamping device 1, and the mandrel 202 is detachably connected with the opening member 42 for controlling the opening member 42 to drive the clamping member 30 to open relative to the adjusting member 20. The tube assembly is also adapted to pass the control wire 54 so that the control wire 54 extends outside the patient. Specifically, in the first embodiment, the outer tube 201 has a first threading channel (not shown) extending axially and penetrating through both ends thereof, and the control wire 54 is movably inserted into the first threading channel and extends to the outside of the patient body, so as to prevent different control wires 54 from being entangled.

When the atrioventricular valve clamping system of the first embodiment is used, the distal end of the atrioventricular valve clamping device 1 and the delivery device 2 can be delivered into the heart of the patient in a catheter manner, the atrioventricular valve clamping device 1 is pushed to the vicinity of the atrioventricular valve by the delivery device 2, the opening member 42 is controlled by the mandrel 202 to drive each clamping member 30 to open relative to the adjusting member 20, and each capturing elastic sheet 52 is pulled to be attached to the outer surface of the adjusting member 20 through the corresponding control line 54, and at this time, a leaflet accommodating space is formed between each capturing elastic sheet 52 and the corresponding clamping member 30; when one of the leaflets of the atrioventricular valve enters the leaflet containing space corresponding to one capturing elastic piece 52 and the area entering the leaflet containing space is large enough, releasing the control line 54 corresponding to the capturing elastic piece 52 to enable the capturing elastic piece 52 to rebound and approach to the corresponding clamping piece 30, so that one leaflet is separately captured and clamped between one capturing elastic piece 52 and the corresponding clamping piece 30; repeating the operation of the previous step, and clamping the other opposite valve leaf by using the other capturing elastic sheet 52 and the corresponding clamping piece 30; therefore, the two valve leaflets of the atrioventricular valve are respectively clamped by a capturing elastic sheet 52 and a corresponding clamping piece 30; thereafter, the control of the mandrel 202 on the opening member 42 is removed, each clamping member 30 is rapidly and automatically closed relative to the adjusting member 20 under the closing force of the elastic closing member 44, and each clamping member 30 is kept closed relative to the adjusting member 20 under the closing force of the elastic closing member 44, so that the two leaflets of the atrioventricular valve are clamped together and pulled towards each other; finally, the conveying device 2 is disconnected from the atrioventricular valve clamping device 1, the conveying device 2 is withdrawn from the body of the patient, the atrioventricular valve clamping device 1 is kept in the heart as an implant, so that the involution positions of the two valve leaflets are kept together, the edge-to-edge clamping repair of the atrioventricular valve is realized, and the purpose of treating regurgitation is achieved.

It is understood that in other embodiments, when the number of the clamping members 30 is 1 more than the number of the capturing assemblies 50, after one of the leaves of the atrioventricular valve is captured and clamped by the capturing elastic sheet 52 and the corresponding clamping member 30, the other leaf is captured and clamped by the closing of the clamping member 30 without the capturing elastic sheet 52 relative to the adjusting member 20, and the edge-to-edge clamping repair of the atrioventricular valve can be realized to treat regurgitation.

When any valve leaflet of the atrioventricular valve is clamped by the capturing elastic sheet 52 and the corresponding clamping piece 30, if the captured and clamped area of the valve leaflet is small, the capturing elastic sheet 52 can be controlled to be far away from the corresponding clamping piece 30 through the control line 54 to release the valve leaflet, and the control line 54 is released again by adjusting the position of the valve leaflet relative to the atrioventricular valve clamping device 1 and when the area of the valve leaflet entering between the capturing elastic sheet 52 and the corresponding clamping piece 30 is large, so that the capturing elastic sheet 52 approaches the corresponding clamping piece 30 again to capture and clamp the valve leaflet, the captured and clamped area of the valve leaflet is large enough, and the finally clamped stability and reliability of the valve leaflet are ensured. It can be understood that when the number of the clamping elements 30 is 1 more than the number of the capturing assemblies 50, after one of the leaflets of the atrioventricular valve is captured and clamped by the capturing elastic pieces 52 and the corresponding clamping elements 30, the other leaflet can be controlled by the mandrel 202 to move relative to the atrioventricular valve clamping device 1 so as to enter the other leaflet between the other clamping element 30 which is not provided with the capturing elastic pieces 52 and the adjusting element 20, and when the entering area of the other leaflet is large enough, the control of the opening element 42 is removed, and each clamping element 30 is controlled by the elastic closing element 44 to rapidly and automatically close relative to the adjusting element 20, so that the other leaflet is captured and clamped by a large area, the clamping stability and reliability of the other leaflet are ensured, and the clamping of the two leaflets is simultaneously performed. It should be noted that the position of the valve leaflet relative to the atrioventricular valve clamping device 1 can be adjusted by the pulsation of the valve leaflet itself, or by changing the position of the atrioventricular valve clamping device 1 by the delivery device 2, which is not described in detail herein.

In the application, the atrioventricular valve clamping device 1 is additionally provided with the capturing elastic sheet 52 between at least one clamping piece 30 for clamping the valve leaflets and the adjusting piece 20, the capturing elastic sheet 52 is correspondingly connected with the control line 54, the capturing elastic sheet 52 is controlled by the control line 54 to be matched with the corresponding clamping piece 30, so that the valve leaflets can be captured on one side, two valve leaflets do not need to be captured and clamped simultaneously in one moment like the prior art, the operation difficulty of capturing the valve leaflets by the atrioventricular valve clamping device 1 is obviously reduced, and the valve leaflets are easy to capture; moreover, compared with the valve clamping device in the prior art, by operating the control line 54 and the corresponding capturing elastic sheet 52, it is easy to implement single-side capturing of a valve leaflet when the area of the valve leaflet entering between the capturing elastic sheet 52 and the corresponding clamping piece 30 is large enough, so that the capturing and clamping area of the valve leaflet is increased, and the stability and reliability of the final clamping of the valve leaflet are improved.

The atrioventricular valve clamping device 1 can be applied to mitral valve clamping and can also be applied to tricuspid valve clamping, and only the intervention paths through the catheter are different, for example, the intervention path of the mitral valve clamping can be femoral vein-inferior vena cava-right atrium-interatrial septum-left atrium-left ventricle, and the intervention path of the tricuspid valve clamping can be femoral vein-inferior vena cava-right atrium-right ventricle. As introduced in the background, the tricuspid valve is less visible under an image than the mitral valve, and it is more difficult to determine the correct, brief moment that two leaflets can be captured simultaneously, i.e., the leaflets capture difficulty is greater, and the leaflets of the tricuspid valve are thinner, which has higher requirements on the stability and reliability of the clamping of the leaflets, and the atrioventricular valve clamping device 1 greatly reduces the leaflet capture difficulty and increases the stability and reliability of the final clamping of the leaflets by enabling unilateral capture of the leaflets before the elastic closure member 44 automatically closes each clamping member 30 quickly, thereby being particularly suitable for tricuspid valve clamping to treat tricuspid regurgitation.

To ensure safety after implantation, the components of the atrioventricular valve clamping device 1 should be made of a metal material with good biocompatibility, such as but not limited to stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel-titanium alloy, or a polymer material, such as but not limited to polyester, silicone, etc. Preferably, the supporting member 10 and the holding member 30 are made of stainless steel with high hardness, and the capturing elastic sheet 52 is made of nitinol with high elasticity.

Referring to fig. 5 and 6, the supporting member 10 is a hollow rod or tube, and includes a first end and a second end opposite to each other in the axial direction. In the first embodiment, the supporting member 10 is a hollow tube, and has a first end provided with a first connecting portion 11 for detachably connecting to the distal end of the outer tube 201, and a second end provided with a second connecting portion 13 for rotatably connecting to the clamping member 30.

Specifically, referring to fig. 3 and 5, in the present embodiment, the first connecting portion 11 is an external thread disposed on an outer wall of the first end of the supporting member 10, an internal thread (not shown) is correspondingly disposed on an inner wall of the distal end of the outer tube 201, and the supporting member 10 is in threaded connection with the outer tube 201; the second connecting portion 13 is a through hole formed at the second end of the supporting member 10, the through hole extends along the radial direction of the supporting member 10, and two ends of the through hole respectively penetrate through the outer wall of the supporting member 10, a first circular hole is formed at one end of each clamping member 30, the first circular hole of each clamping member 30 is correspondingly communicated with the through hole of the supporting member 10, and a rotating shaft or a pin is inserted into the through hole, so that the clamping member 30 is rotatably connected to the second end of the supporting member 10.

In other embodiments, the first connecting portion 11 may be an internal thread provided at the first end of the supporting member 10, an external thread is correspondingly provided on the outer wall of the distal end of the outer tube 201, and the supporting member 10 is also screwed with the outer tube 201; alternatively, the first connecting portion 11 and the distal end of the outer tube 201 may be detachably connected by other methods, such as a snap connection, which is not described herein.

In other embodiments, the second connecting portion 13 may be a pin protruding from the outer wall of the second end of the supporting member 10, the pin extending along the radial direction of the supporting member 10, and each of the clamping members 30 is rotatably connected to the second end of the supporting member 10 by engaging the pin of the supporting member 10 through a first circular hole thereof.

It will be appreciated that in this embodiment, the support member 10 is detachably connected to the distal end of the outer tube 201 of the delivery device 2 by the first connecting portion 11 at the first end, that is, when the atrioventricular valve clamping device 1 of the first embodiment is used, the end of the atrioventricular valve clamping device 1 close to the first end of the support member 10 is a proximal end, and correspondingly, the end of the atrioventricular valve clamping device 1 close to the second end of the support member 10 is a distal end.

Further, as shown in fig. 5 and 6, in the first embodiment, the supporting member 10 has a receiving cavity extending along the axial direction and penetrating at least the first end thereof, and the receiving cavity is used for penetrating the driving rod 422 of the opening member 42. The distal end of the core shaft 202 extends into the accommodating cavity from the first end of the support 10, and is detachably connected to the driving rod 422 through any one of a threaded connection or a snap-fit connection (preferably, the threaded connection is adopted in this embodiment), and the core shaft 202 moves in the axial direction to drive the driving rod 422 to move in the accommodating cavity of the support 10 in the axial direction. The supporting member 10 is further provided with a guide groove 15 extending along the axial direction and radially penetrating through the outer walls of the two sides, and the guide groove 15 is communicated with the accommodating cavity of the supporting member 10.

Preferably, in the present embodiment, the receiving cavities of the support member 10 penetrate through the two opposite ends of the support member 10, so as to reduce the weight of the support member 10, and thus the overall weight of the atrioventricular valve clamping device 1. Of course, in other embodiments, the receiving cavity of the support member 10 may extend through only the first end of the support member 10.

Referring to fig. 3 and 4 again, the adjusting member 20 may be a net structure with elastic self-expansion property, preferably made of a wire material with shape memory function (including but not limited to nitinol wire) by weaving and heat setting, or made of a tube material with shape memory function (including but not limited to nitinol tube) by cutting and heat setting, or other structures with elastic self-expansion property (including but not limited to compact structure of silica gel or porous structure of sponge). The overall shape of the adjusting element 20 in the self-expansion state includes, but is not limited to, an inverted cone, an oblate sphere, an ellipsoid and the like. Specifically, as shown in fig. 3 and 4, in the first embodiment, the adjusting member 20 is a net structure formed by weaving nitinol wires and performing a heat setting process, and the overall shape of the adjusting member 20 is an inverted cone. In this embodiment, along the direction from the first end to the second end of the supporting member 10, the radial dimension of the adjusting member 20 in the shape of an inverted cone is gradually reduced, which helps the two clamping members 30 to approach the supporting member 10 to a greater extent, so that the clamping angle between the two clamping members 30 is smaller, which is beneficial to reducing the distance between the two clamped valve leaflets.

Further, the adjusting member 20 is sleeved outside the supporting member 10, and at least one end of the adjusting member is fixedly connected to the supporting member 10. As shown in fig. 3 and 4, in the first embodiment, one end of the adjusting member 20 close to the second end of the supporting member 10 can be fixedly connected to the second end of the supporting member 10 by welding, crimping, or the like, and one end of the adjusting member 20 close to the first end of the supporting member 10 is only close to the outside of the first end of the supporting member 10 but is not fixed. In other embodiments, the end of the adjusting member 20 near the first end of the supporting member 10 can be gathered and fixedly connected to the first end of the supporting member 10, and the end of the adjusting member 20 near the second end of the supporting member 10 only encloses the outside of the second end of the supporting member 10 but is not fixed. It can be understood that one end of the adjusting element 20 is fixedly connected to the support element 10, and the other end is not fixed, so that the non-fixed end of the adjusting element 20 can slide relative to the support element 10 when the adjusting element 20 is squeezed, which not only increases the attaching area of the capturing elastic sheet 52 and the adjusting element 10, but also provides more sufficient radial supporting force for the capturing elastic sheet 52 and the valve leaflet, so as to improve the clamping force for the valve leaflet, and further improve the adaptability of the adjusting element 20 to different valve leaflet distances. It will be appreciated that in other embodiments, both ends of the adjustment member 20 may be brought together and fixedly attached to opposite ends of the support member 10, respectively.

Preferably, referring to fig. 7, in this embodiment, in a same plane perpendicular to the axial direction of the supporting member 10, the cross-sectional shape of the adjusting member 20 is an oblate or elliptical shape, a first dimension W of the adjusting member 20 along a first direction X (i.e., a minor axis direction of the oblate or elliptical shape) is smaller than a second dimension L of the adjusting member 20 along a second direction Y (i.e., a major axis direction of the oblate or elliptical shape), the second direction Y (i.e., a major axis direction of the oblate or elliptical shape) is parallel to a width direction of the clamping member 30 (i.e., a width direction is a direction of a perpendicular line between a pair of connecting pieces of the clamping frame 34 on the clamping member 30), and the first direction is perpendicular to the second direction. By setting the second dimension L of the adjusting element 20 in the second direction Y to be larger than the first dimension W in the first direction X, after the atrioventricular valve clamping device 1 clamps the two leaflets and is deformed by being pressed by the two clamping elements 30, the first dimension W of the adjusting element 20 in the first direction X is reduced, but the second dimension L in the second direction Y is increased, and the adjusting element 20 is pressed to be flat in the second direction Y, which is the extending direction of the gap between the two leaflets, in other words, the second dimension L of the adjusting element 20 is pressed to extend in the direction of the gap between the leaflets. Compared with the mitral valve, the gap area between the adjacent valve leaflets of the tricuspid valve is longer, and the gap area between the two valve leaflets filled and blocked by the flat adjusting piece 20 after being extended is correspondingly increased, so that the adjusting piece is particularly suitable for blocking the gap between the adjacent valve leaflets of the tricuspid valve, the treatment effect on the tricuspid regurgitation is improved, and the number of atrioventricular valve clamping devices required to be implanted is reduced.

In the first embodiment, when the atrioventricular valve clamping device 1 clamps two valve leaflets, the adjusting piece 20 is elastically clamped between the pair of capturing elastic sheets 52, and the adjusting piece 20 is extruded and deformed by the capturing elastic sheets 52 to fill and close an open gap between the clamped two valve leaflets, so that blood regurgitated from the center of the atrioventricular valve clamping device 1 can be effectively blocked, and the treatment effect on regurgitation can be improved or enhanced; furthermore, the elastic adjusting piece 20 has a buffer function on the pulsating valve leaflets, so that the pulling degree of the atrioventricular valve clamping device 1 on the two valve leaflets can be adjusted when the atrioventricular valve clamping device 1 is closed, and the valve leaflets are prevented from being excessively pulled; in addition, the elastic adjusting part 20 can buffer the direct scouring of blood flow to the inside of the atrioventricular valve clamping device 1, so that the atrioventricular valve clamping device 1 is prevented from falling off due to continuous scouring of blood, and thrombus formed by the deposition of blood at dead angles in the atrioventricular valve clamping device 1 can also be prevented. Optionally, the outer surface of the regulating member 20 is covered with a biocompatible mesh film, and the covered regulating member 20 can increase biocompatibility and form an artificial barrier on the atrial side of the valve leaflet to block thrombus in blood; wherein, the reticular film can be made of polymer materials such as polypropylene, polytetrafluoroethylene, polyurethane and the like.

Referring to fig. 3 and 4, in the first embodiment, the number of the clamping members 30 and the catching elastic pieces 52 is two, and the clamping members and the catching elastic pieces are symmetrically arranged about the axis of the supporting member 10. The two clamping members 30 can be driven by the opening member 42 to be opened relative to the adjusting member 20 to form a V shape, each catching elastic sheet 52 can be jointed with the surface of the adjusting member 20 under the pulling of the corresponding control line 54, so that a valve leaflet containing space is formed between each catching elastic sheet 52 and the corresponding clamping member 30, and when the valve leaflet enters the valve leaflet containing space, the valve leaflet can be clamped by the corresponding clamping member 30 through releasing the catching elastic sheet 52.

Specifically, as shown in fig. 3 and 8, in the present embodiment, each of the clamping members 30 includes a connecting frame 32 rotatably connected to the second end of the supporting member 10, and a clamping frame 34 connected to an end of the connecting frame 32 away from the supporting member 10. The first through hole is formed at the end of the connecting frame 32 of each clamping member 30 away from the clamping frame 34, and the second through hole is formed at the end of the connecting frame 32 of each clamping member 30 close to the clamping frame 34.

Wherein, the connecting frame 32 of each clamping member 30 is composed of a pair of connecting sheets arranged in parallel and spaced, and the direction of the perpendicular line between the pair of connecting sheets is parallel to the axial direction of the through hole (i.e. the second connecting portion 13) of the supporting member 10. When the two connecting frames 32 of the two clamping members 30 are located at the same side, and the ends of the two connecting frames 32 are far away from the clamping frame 34 and are stacked on each other, and are located on the outer wall of the side corresponding to the second end of the supporting member 10, the respective first through holes of the two clamping members 30 are correspondingly communicated with the through holes of the supporting member 10, and a rotating shaft or a pin is inserted, so that one end of each clamping member 30 is rotatably connected with the second end of the supporting member 10. The second through hole of each clamp member 30 is used to rotatably couple the opening member 42 of the driving assembly 40.

The holding frame 34 of each holding member 30 is recessed toward one side of the support member 10 to form a receiving space, and the receiving space 31 is used for receiving the clamped leaflet so as to increase the contact area between the holding member 30 and the leaflet and further increase the holding force on the leaflet.

Further, as shown in fig. 8, each of the clamping members 30 is further provided with a first anchoring structure 33 on the side facing the adjusting member 20 to enhance the friction force when the clamping member 30 contacts the valve leaflet and help to provide a stable clamping force. The first anchoring structure 33 may be a protrusion or a groove disposed on the inner surface of the accommodating space 31 of the clamping frame 34, or a pad adhered to the inner surface of the accommodating space 31 and made of a biocompatible material with a high friction coefficient, or may be at least one barb protruding on the clamping frame 34. In the first embodiment, the first anchoring structure 33 of each clamping member 30 is a plurality of barbs protruding from the clamping frame 34, and the plurality of barbs are respectively arranged on two opposite sides of the clamping frame 34, thereby forming a double row of barbs. Preferably, in this embodiment, the outer surface of the adjusting element 20 is provided with a receiving groove corresponding to the first anchoring structure 33 of the clamping element 30, when each clamping element 30 is closed relative to the adjusting element 20, the first anchoring structure 33 on each clamping element 30 is inserted into the corresponding receiving groove of the adjusting element 30, so that each clamping element 30 can be closer to the adjusting element 20, the clamping angle between the two clamping elements 30 is smaller, and the reduction of the distance between the two clamped valve leaflets is also facilitated.

Wherein, a connecting pin 35 for connecting the elastic closing element 44 of the driving assembly 40 is further disposed in the receiving space 31 of each clamping member 30, and the connecting pin 35 is protruded on the inner surface of the clamping frame 34.

Optionally, an active drug may also be applied to the inner surface of the receiving space 31 of each clip 30 to promote endothelial cell attachment and growth of the valve leaflets on the inner surface of the clip 30.

As shown in fig. 4 and 9, each catching spring 52 is substantially plate-shaped, and one end of each catching spring 52 is fixedly connected to the supporting member 10 or the corresponding clamping member 30. In the first embodiment, the two catching domes 52 are integrally formed. As shown in fig. 9, in the present embodiment, the connecting portion between the two capturing elastic pieces 52 is separately provided with a through hole 525 for the support member 10 to pass through, and the two capturing elastic pieces 52 integrally formed are fixedly connected with the support member 10 by the connecting portion therebetween, and the fixing connection manner includes but is not limited to welding, crimping, bonding, and the like. The outer contour of the portion of the support member 10 contacting the through hole 525 matches the shape of the through hole 525, and the shape of the through hole 525 includes, but is not limited to, a circle or a polygon, preferably a polygon, thereby playing a role of limiting, and preventing the capturing elastic sheet 52 from rotating relative to the support member 10.

Further, as shown in fig. 9, in the present embodiment, at least one threading structure 521 is disposed at an end of each capturing elastic piece 52 away from the support 10, and the threading structure 521 is used for detachably connecting a corresponding control wire 54, so that the capturing elastic piece 52 is controlled by the control wire 54. Specifically, by tightening the control wire 54, the end of the catching elastic piece 52 away from the support member 10 is made to abut against the surface of the adjusting member 20; after releasing the control wire 54 to control the end of the catch spring 52 remote from the support 10, the catch spring 52 is released, so that the catch spring 52 springs back, tending to resume its natural state, and presses the leaflet against the corresponding gripping member 30 to catch, grip the leaflet.

The threading structure 521 may be a threading hole formed in the capturing elastic piece 52 or a threading ring protruding from the capturing elastic piece 52. In this embodiment, the threading structure 521 of each capturing elastic piece 52 is a threading hole, and the threading holes may be provided in multiple numbers, and the multiple threading holes are preferably symmetrically arranged about the axis of the capturing elastic piece 52, so that when the control wire 54 passes through the multiple threading holes and is connected to the corresponding capturing elastic piece 52, the force acting on the capturing elastic piece 52 through the control wire 54 is symmetric about the axis of the capturing elastic piece 52, and thus the capturing elastic piece 52 is not twisted. It should be noted that the control wire 54 includes, but is not limited to, a wire made of nitinol or the like.

Preferably, as shown in fig. 9, in this embodiment, a second anchoring structure 523 is further provided on a side of each capturing spring 52 facing the corresponding clamping member 30 to increase the friction force when the capturing spring 52 contacts with the valve leaflet, so as to provide a stable clamping force. Similar to the first anchoring structure 33 of the clamping member 30, the second anchoring structure 523 may also be a protrusion, a groove, or a pad made of a biocompatible material with a higher friction coefficient attached to one side of the capturing elastic sheet 52 facing the corresponding clamping member 30, or at least one barb protruding from one side of the capturing elastic sheet 52 facing the corresponding clamping member 30. In this embodiment, the second anchoring structure 33 of each catching elastic sheet 52 is a plurality of barbs protruding from the catching elastic sheet 52, each barb may have an axial length of 0.3mm to 1.2mm, preferably 0.5mm to 0.9mm, and the distance between two adjacent barbs is 0.8mm to 1.4mm, preferably 1.0mm to 1.2mm. By limiting the axial length of each barb and the distance between two adjacent barbs within a reasonable size range, the method is beneficial to ensuring that the catching elastic sheet 52 has stable clamping force on the valve leaflets, and meanwhile, the valve leaflets, especially the valve leaflets of a thin tricuspid valve, cannot be seriously damaged due to the overlong or over-dense barbs.

It should be noted that, in the present application, when the capturing elastic sheet 52 is close to the corresponding clamping member 30 to clamp the leaflet, at least one end of the capturing elastic sheet 52 away from the supporting member 10 is pressed against the corresponding clamping member 30, or a gap is left between one end of the capturing elastic sheet 52 away from the supporting member 10 and the corresponding clamping member 30, but the gap is smaller than the thickness of the leaflet after being clamped and deformed. Thus, when the catching spring 52 and the corresponding clamping member 30 clamp the leaflet, a sufficient clamping force is applied to the leaflet between the end of the catching spring 52 remote from the support 10 and the corresponding clamping member 30.

Preferably, in this embodiment, a first included angle between the capturing elastic sheet 52 and the axial direction of the support member 10 in the natural state is greater than a second included angle between the clamping members 30 and the axial direction of the support member 10 when the clamping members 30 are opened to the capturing position, and more preferably, the first included angle is greater than the second included angle by 5 ° to 15 °, so as to ensure that at least one end of the capturing elastic sheet 52 away from the support member 30 can press against the corresponding clamping member 30 or be recessed into the corresponding clamping member 30 to form a gap smaller than the thickness of the clamped and deformed leaflet with the corresponding clamping member 30 in the state that the capturing elastic sheet 52 is released and is close to the corresponding clamping member 30, thereby reliably clamping the leaflet between the capturing elastic sheet 52 and the corresponding clamping member 30 and ensuring that the leaflet does not separate. It should be noted that the opening angle between the two holding members 30 may be 0 to 180 degrees, or even more than 180 degrees; the opening angle between the two gripping members 30 in the catching position, i.e. the position in which the gripping members 30 are opened most suitably for catching a leaflet, is preferably 120 deg. -140 deg., more preferably 130 deg., i.e. the second angle between the catching position and the axial direction of the support 10 is preferably 60 deg. -70 deg., more preferably 65 deg..

Referring to fig. 4 and 6 again, the opening member 42 includes a driving rod 422 and at least two connecting rods 424 with one end rotatably connected to the driving rod 422, the driving rod 422 movably penetrates through the accommodating cavity of the supporting member 10, and the other end of each connecting rod 424 is rotatably connected to the corresponding clamping member 30.

In the first embodiment, the driving rod 422 is provided with a rotating shaft (or pin) along the radial direction thereof, and opposite ends of the rotating shaft respectively penetrate out of the guide grooves 15; the connecting frame 32 of each clamping member 30 is rotatably connected to the rotating shaft of the driving rod 422 through a pair of connecting rods 424. Specifically, one ends of two connecting rods 424 located on the same side of the support 10 are stacked on each other and hinged to one end of the rotating shaft, and the other ends of the two connecting rods 424 are respectively hinged to the second through holes of the connecting frames 32 of the corresponding clamping members 30 through one rotating shaft (or pin), so that the clamping members 30 are connected to the driving rods 422 through the corresponding connecting rods 424. When the driving rod 422 is driven by the mandrel 202 to move axially in the receiving cavity of the supporting member 10, the driving rod 422 drives the clamping member 30 to open relative to the supporting member 10 through the connecting rod 424.

When the driving rod 422 moves in the axial direction, opposite ends of the rotation shaft for connecting the driving rod 422 and the connection rod 424 slide along the guide grooves 15. It should be noted that, when the adjusting element 20 is sleeved outside the supporting element 10 and covers the guide slot 15 of the supporting element 10, a portion of the adjusting element 20 corresponding to the guide slot 15 is opened, so that the opposite ends of the rotating shaft will not be interfered to slide along the guide slot 15, and the driving rod 422 will not be prevented from driving the clamping element 30 to open relative to the supporting element 10.

It will be appreciated that in order to ensure that the clamping member 30 can close relative to the support member 10 to clamp the leaflets after clamping the leaflets, the guide slots 15 of the support member 10 should provide sufficient axial sliding space for the driving rod 422 to drive the shaft to slide in the guide slots 15. Specifically, as shown in fig. 10, in the embodiment of the present application, the hole center distance of the hinge holes at the two opposite ends of each connecting rod 424 is defined as a first distance L1, the hole center distance from the first through hole to the second through hole of the connecting frame 32 of each clamping member 30 is defined as a second distance L2, the distance from the hole center of the through hole (i.e., the second connecting portion 13) at the second end of the supporting member 10 to one end of the guide slot 15 far from the through hole is defined as a third distance L3, and the first distance L1, the second distance L2 and the third distance L3 should satisfy the following relation: l3 is more than or equal to L1+ L2. By limiting the length relationship of the first distance L1, the second distance L2 and the third distance L3, it can be ensured that each clamping member 30 can be closed to the outer wall of the support member 10 relative to the support member 10, thereby ensuring that the clamping members 30 can be closely sleeved on the adjusting member 20 outside the support member 10, and the clamped valve leaflets can be tightly clamped.

Referring to fig. 11 and 12, the elastic closure element 44 includes a base 442 and at least two elastic arms 444 extending from the base 442, and each elastic arm 444 is connected to a corresponding clip 30. Specifically, as shown in fig. 11 and 12, in the first embodiment, the elastic closure member 44 is a torsion spring, the torsion spring includes a spring body and at least two spring arms extending from the spring body, the spring body is a base 442 of the elastic closure member 44, the spring arms are elastic arms 444 of the elastic closure member 44, and the torsion spring may be made of a metal material such as stainless steel, nickel titanium, and the like. In this embodiment, the number of the elastic arms 444 is equal to the number of the clamping members 30, and the elastic arms 444 are symmetrically arranged about the central axis of the supporting member 10, wherein one end of each elastic arm 444 away from the base 442 is curled to form a connecting ring 4445, and the connecting ring 4445 is adapted to be sleeved on the connecting pin 35 of the corresponding clamping member 30, so that each elastic arm 444 is correspondingly connected to one clamping member 30.

The parts of the two spring arms of the existing V-shaped torsion spring extending from the spring body are far away from each other, if the existing V-shaped torsion spring is used as the elastic closing part, the clamping force of the two clamping pieces 30 to the valve leaflet is not strong, the valve leaflet is not closed firmly, and when the valve leaflet is clamped by the clamping device and continuously beats along with the heart, the clamping device may be separated from the valve leaflet. In order to improve the clamping stability of the two clamping members 30, in the elastic closing member 44 of the embodiment of the present application, in a natural state, the portions of the two elastic arms 444 extending from the base 442 are set to be parallel to each other, converge to each other, or intersect each other, so that a negative included angle of 0 degree or more than 0 degree can be formed between the two elastic arms 444 (the negative included angle means that the position of the included angle formed by the extension lines of the two elastic arms 444 or the extension lines of the two elastic arms 444 intersecting each other is located on the side of the base 442 close to the clamping members 30, rather than the position of the included angle formed by the extension lines of the two spring arms intersecting each other is located on the side of the base away from the clamping members as in the conventional V-shaped torsion spring), so that the two elastic arms 444 can make the two clamping members 30 close tightly, provide a larger and more reliable closing force for the two corresponding clamping members 30, ensure the stability of the two clamping members 30 after clamping leaflets are clamped, and especially, the situation that a thinner tricuspid valve requires a larger clamping force to stably clamp the valve.

Preferably, as shown in fig. 12, in the present embodiment, the portions of the two opposite elastic arms 444 extending from the base 442 intersect with each other, and each elastic arm 444 forms a negative intersection angle a with the central axis of the elastic closure element 44. It will be appreciated that the angle of intersection a should not be too large to avoid the need to overcome a large resistance to opening of clamp 39 relative to support 10 by actuating rod 422 by means of mandrel 202, and that in this embodiment, the angle of negative intersection a is preferably in the range 5 to 60 degrees.

In the process of assembling the elastic closing part 44, the elastic arm 444 extending in a right-inclined manner in a natural state is corresponding to the clamping piece 30 to be connected with the left side, the elastic arm 444 extending in a left-inclined manner in a natural state is corresponding to the clamping piece 30 to be connected with the right side, and the closing force of the elastic closing part 44 acting on each clamping piece 30 is about 8N-12N, so that the two clamping pieces 30 clamp the valve leaf, and the stability of clamping the valve leaf by the two clamping pieces 30 is ensured.

Referring to fig. 13 to 16, the following description will be made by taking the repair process of the anterior and posterior leaflets of the tricuspid valve as an example, and the operation method of the atrioventricular valve clamping system according to the first embodiment of the present application mainly includes the following steps:

the distal end of the conveying device 2 and the atrioventricular valve clamping device 1 are delivered to the right atrium through the inferior vena cava by adopting a transfemoral mode;

enabling the atrioventricular valve clamping device 1 to approach the anterior valve leaflet and the posterior valve leaflet of the tricuspid valve, firstly controlling the driving rod 422 to move towards the far end along the axial direction through the mandrel 202, enabling the two clamping pieces 30 to be opened relative to the adjusting piece 20, adjusting the opening direction of the clamping pieces 30, keeping the control of the mandrel 202 on the driving rod 422, then pushing the atrioventricular valve clamping device 1 to the right ventricle through the conveying device 2, placing the atrioventricular valve clamping device 1 under the anterior valve leaflet and the posterior valve leaflet of the tricuspid valve, and continuously enabling the two clamping pieces 30 to be opened to the catching position; operating the corresponding control wire 54 to pull each catching spring 52 to be attached to the surface of the adjusting member 20, wherein a leaflet accommodating space is formed between each catching spring 52 and a corresponding clamping member 30;

as shown in fig. 13, the entire atrioventricular valve clamping device 1 is slightly withdrawn proximally by the delivery device 2 so that at least one of the anterior leaflet and the posterior leaflet of the tricuspid valve enters a leaflet receiving space;

as shown in fig. 14, when it is observed that the area of a leaflet entering the receiving space is large enough, the control wire 54 on the side is released, so that the correspondingly connected capturing spring 52 rebounds and approaches towards the corresponding clamping piece 30, thereby capturing and clamping the leaflet on the corresponding side between one capturing spring 52 and the corresponding clamping piece 30;

as shown in fig. 15, after the leaflet on one side is successfully clamped, when it is observed that the area of the other leaflet entering the receiving space on the opposite side is large enough, the control line 54 on the other side is released, so that the capturing shrapnel 52 correspondingly connected with the control line rebounds and approaches towards the corresponding clamping piece 30, and the leaflet on the other side is captured and clamped between the capturing shrapnel 52 and the corresponding clamping piece 30;

as shown in fig. 16, after the leaflets on both sides are successfully clamped, the control of the spindle 202 on the driving rod 422 is removed, so that the two clamping members 30 are automatically and rapidly folded relative to the adjusting member 20 under the closing force of the elastic closing member 44, and the adjusting member 20 is subjected to the squeezing action of the two capturing elastic sheets 52 to generate adaptive deformation, so as to fill and close the space between the two capturing elastic sheets 52, at this time, the anterior leaflet and the posterior leaflet of the tricuspid valve are clamped together;

one end of the control wire 54 is loosened, the control wire 54 is withdrawn from the patient through the first threading channel of the outer tube 201, then the threaded connection of the mandrel 202 and the driving rod 422 and the threaded connection of the outer tube 201 and the support member 10 are released, and the delivery device 2 is withdrawn from the patient, thereby completing the edge-to-edge clamping repair of the anterior leaflet and the posterior leaflet of the tricuspid valve.

It should be noted that, if the area of the leaflet being clamped is not large enough, the control line 54 can control the corresponding capturing spring 52 to move away from the corresponding clamping element 30 for capturing and clamping the leaflet again, and the steps are repeated until the area of the leaflet being clamped is large enough to ensure the stability and reliability of the leaflet being clamped.

Referring to fig. 17 and 18 together, the atrioventricular valve clamping device of the second embodiment of the present application has a structure similar to that of the atrioventricular valve clamping device 1 of the first embodiment, except that: in the second embodiment, the two capturing elastic pieces 52b are independent pieces, and each capturing elastic piece 52b is fixedly connected to the corresponding clamping piece 30. In the second embodiment, each capturing elastic piece 52b can be designed into a non-integrated single-leaf capturing elastic piece, and the manufacturing process is simpler.

Specifically, as shown in fig. 17 and 18, each capturing elastic piece 52b includes a main body segment provided with a second anchoring structure 523 and a connecting segment 524 connected to one end of the main body segment, the main body segment and the connecting segment 524 are in a V-shaped structure, and the connecting segment 524 is located on one side of the main body segment provided with the second anchoring structure 523. As shown in fig. 18, the connecting section 524 of each catching spring piece 52b is attached to the inner surface of the receiving space of the corresponding holder 30 and fixed by any one of welding, bonding, crimping, or caulking. Preferably, in a natural state, the free end of the main body segment of the capturing elastic piece 52b is located below the free end of the connecting segment 524 (not shown), and an included angle between the main body segment and the connecting segment 524 is 0-30 °, so as to ensure that the capturing elastic piece 52b can be recessed or pressed against the corresponding clamping piece 30, and provide a clamping force through the clamping piece 30 and the main body segment of the capturing elastic piece 52b, so as to ensure that the valve leaflet is captured and cannot be separated after being clamped.

Referring to fig. 19, the atrioventricular valve clamping device according to the third embodiment of the present application has a structure similar to that of the atrioventricular valve clamping device according to the second embodiment, except that: in the third embodiment, the connecting section 524 of each capturing elastic piece 52c is located at a side of the main body section of the capturing elastic piece 52c facing away from the second anchoring structure 523, and the connecting section 524 of each capturing elastic piece 52c is provided with a through hole 525 for the support member 10 to pass through, so that each capturing elastic piece 52c can be fixedly connected to the support member 10 by any method such as welding. In the third embodiment, each catching elastic piece 52c is also designed as a non-integrated single-leaf type catching elastic piece, so that the manufacturing process is simpler.

Referring to fig. 20 and 21, a structure of an atrioventricular valve clamping device according to a fourth embodiment of the present application is similar to that of the atrioventricular valve clamping device 1 according to the first embodiment, except that: in the fourth embodiment, the elastic closing element 44b is an elastic sheet, the overall shape of the elastic sheet is similar to a dovetail shape, the elastic sheet includes a combining portion and two connecting sheets extending from the combining portion, the combining portion is a base 442 of the elastic closing element 44b, the connecting sheets are elastic arms 444 of the elastic closing element 44b, and one end of each connecting sheet, which is far away from the combining portion, is curled to form a connecting ring 4445. In the natural state, the portions of the two resilient arms 444 extending away from the base 442 are parallel to each other, converge on each other, or cross each other, preferably cross each other. The elastic closure member 44b of the spring structure is made of a metal material selected from stainless steel, nickel titanium, and the like.

In the fourth embodiment, the axial direction of each of the two mutually intersecting elastic arms 444 forms a negative included angle B with the central axis of the elastic closing part 44B, and preferably, the negative included angle B in the fourth embodiment is in a range of 5 degrees to 60 degrees, so as to provide more reliable clamping force for the two clamping members 30 and ensure more stability after the leaflet is clamped.

Referring to fig. 22, a fifth embodiment of the present application provides an atrioventricular valve clamping device 1b having a structure similar to that of the atrioventricular valve clamping device 1 of the first embodiment, except that: in the fifth embodiment, the second end of the supporting member 10 is provided with a first connecting portion (not shown) for detachably connecting the outer tube 201, and the mandrel 202 extends from the second end of the supporting member 10 into the receiving cavity of the supporting member 10 and is detachably connected to the driving rod.

In the fifth embodiment, the support member 10 is detachably connected to the distal end of the outer tube 201 by a first connection part of the second end, that is, when the atrioventricular valve clamping device 1b of the fifth embodiment is used, the atrioventricular valve clamping device 1b is proximal to the second end of the support member 10, and correspondingly, the atrioventricular valve clamping device 1b is distal to the first end of the support member 10. Thus, the atrioventricular valve clamping device 1b provided by the fifth embodiment can be delivered to the vicinity of the atrioventricular valve such as mitral valve and tricuspid valve in a transapical manner by the delivery device 2 for the edge-to-edge clamping repair of the atrioventricular valve.

It should be noted that the above description is made by taking the atrioventricular valve clamping device 1 as an example for the edge-to-edge clamping repair of two leaflets. It is understood that, in other embodiments, the atrioventricular valve clamping device provided in any of the embodiments of the present application can also be used for the edge-to-edge clamping repair of three flap valves, and only three corresponding clamping members 30 and three corresponding capturing assemblies 50 need to be provided, which have substantially the same principle and structure as the atrioventricular valve clamping device provided in the embodiments of the present application, and therefore, the detailed description thereof will be omitted.

The foregoing is illustrative of embodiments of the present application and it will be appreciated by those skilled in the art that various modifications and adaptations can be made without departing from the principles of the embodiments of the present application and are intended to be within the scope of the present application.

Claims

1. An atrioventricular valve clamping device, comprising a support member, an adjustment member, at least two clamping members, a drive assembly and at least one capture assembly:

the adjusting piece is sleeved on the supporting piece; the at least two clamping pieces are arranged on the outer side of the adjusting piece, and one end of each clamping piece is rotatably connected to one end of the supporting piece; the driving assembly comprises an opening piece and an elastic closing piece; the opening piece is connected with each clamping piece and used for driving the at least two clamping pieces to open relative to the adjusting piece; the elastic closing part is connected with each clamping piece and is used for enabling the at least two clamping pieces to be automatically closed and to be kept closed relative to the adjusting piece in a natural state; each capture assembly comprises a capture elastic sheet and a control line correspondingly connected with the capture elastic sheet, the capture elastic sheet is correspondingly arranged between the clamping piece and the adjusting piece, and the control line is used for controlling the corresponding capture elastic sheet to be far away from or close to the corresponding clamping piece.

2. The atrioventricular valve clamping device of claim 1, wherein the number of said gripping members is equal to the number of said catching assemblies, or the number of said gripping members is 1 more than the number of said catching assemblies.

3. The atrioventricular valve clamping device of claim 2, wherein the number of said clamping members and the number of said catching assemblies are both 2, and said catching springs are integrally formed or separate members.

4. The atrioventricular valve clamping device of claim 1, wherein one end of the capturing elastic piece is fixedly connected to the supporting member or fixedly connected to the corresponding clamping member, and when the capturing elastic piece is closed with the corresponding clamping member, at least the other end of the capturing elastic piece is pressed against the corresponding clamping member.

5. The atrioventricular valve clamping device according to claim 4, wherein a first angle between said catching spring and an axial direction of said support member in a natural state is larger than a second angle between said clamping member and the axial direction of said support member when said clamping member is opened to the catching position.

6. The atrioventricular valve clamping device of claim 5, wherein said first included angle is between 5 ° and 15 ° greater than said second included angle.

7. The atrioventricular valve clamping device as claimed in claim 4, wherein each of said clamping members has a receiving space at a side thereof facing said supporting member, and at least a portion of said catching elastic piece is received in said receiving space of said clamping member when said catching elastic piece is drawn close to said corresponding clamping member.

8. The atrioventricular valve clamping device of claim 1, wherein a side of said capturing spring facing said clamping member is provided with an anchoring structure.

9. The atrioventricular valve clamping device according to claim 8, wherein said anchoring structure is at least one barb provided on said capturing spring, each of said barbs having an axial length of 0.3mm to 1.2mm;

when the number of barbs is multiple, the distance between two adjacent barbs is 0.8mm-1.4mm.

10. The atrioventricular valve clamping device as claimed in claim 1, wherein said adjustment member has elastic self-expanding properties; the adjusting piece is of a net structure, a silica gel body or a sponge body.

11. The atrioventricular valve clamping device of claim 10, wherein said adjusting member has a cross-sectional shape of an oblate or elliptical shape in a natural state in a same plane perpendicular to an axial direction of said support member, and a major axis direction of said oblate or elliptical shape is parallel to a width direction of said clamping member.

12. The atrioventricular valve clamping device of claim 1, wherein at least one end of said adjusting member is fixedly connected to said support member.

13. The atrioventricular valve clamping device of claim 1, wherein at least one threading structure is provided on said capturing elastic piece, and said threading structure is used for connecting with a corresponding control wire.

14. The atrioventricular valve clamping device according to any one of claims 1 to 13, wherein said resilient closure member comprises a base and at least two resilient arms extending from said base, each of said resilient arms being associated with a respective one of said clamping members;

under the natural state, the parts of the two elastic arms which are oppositely arranged and extend out of the base body are mutually parallel, mutually gathered or mutually crossed.

15. The atrioventricular valve clamping device of claim 14, wherein said resilient closure member is a torsion spring comprising a spring body and at least two spring arms extending from said spring body, said spring body being said base, said spring arms being said resilient arms.

16. The atrioventricular valve clamping device of claim 14, wherein said resilient closure member is a leaf spring comprising a bonding portion and at least two connecting tabs extending from said bonding portion, said bonding portion being said base and said connecting tabs being said resilient arms.

17. An atrioventricular valve clamping system, comprising a delivery device and an atrioventricular valve clamping device according to any one of claims 1-16, said delivery device being detachably connectable to said atrioventricular valve clamping device, said delivery device being adapted to deliver said atrioventricular valve clamping device and to control said actuation assembly.