Leaflet repair devices, systems, and methods

Abstract

The invention provides a valve leaflet repairing device, system and method. The valve leaflet repairing device comprises a fixing part; the first ends of the first clamping arm and the second clamping arm are respectively arranged on the fixing piece, and the second ends of the first clamping arm and the second clamping arm are oppositely arranged in an opening and closing manner; the implanted valve leaflet is partially arranged on the first clamping arm and extends to the side, away from the first clamping arm, of the fixing piece; the first clamp arm and the second clamp arm are configured to clamp the native valve leaflet such that the implanted valve leaflet becomes an extension of the native valve leaflet. According to the method, the original valve leaflet can be equivalently lengthened, the reflux problem is solved, the valve opening cannot be shrunk, and valve leaflet replacement can be easily carried out subsequently.

Description

Technical Field

[0001] The present application relates to the field of medical device technology. Specifically, the present application relates to a leaflet repair device, system and method. Background Art

[0002] Mitral regurgitation is the most common heart valve disease. Severe mitral regurgitation can lead to heart enlargement, heart failure, and ultimately death of the patient. It has a significant impact on human health and has a very poor prognosis.

[0003] The effective treatment method in the past was surgery to repair or replace the mitral valve. Transcatheter valve therapy uses a minimally invasive approach, using special instruments to reach the mitral valve from the peripheral blood vessels or the apex of the heart to intervene in the mitral valve, and has become the treatment direction for mitral regurgitation.

[0004] Although there are many R&D or experimental devices for transcatheter valve therapy, the most mature interventional treatment technology for mitral regurgitation is transcatheter mitral edge-to-edge repair (TEER). The principle is to use a metal mitral valve clip, which is sent to the mitral regurgitation area through a catheter to clamp the anterior and posterior native leaflets of the mitral valve, so as to reduce or eliminate the gap between the two native leaflets during the systole of the heart, thereby reducing or eliminating the regurgitation.

[0005] Although this method is widely used, it still has major flaws. First, the anterior and posterior leaflets of the mitral valve are clamped together, and the mitral valve in this area cannot open during diastole, causing the gap between the native leaflets of the mitral valve to change from a large hole to two small holes, resulting in a certain degree of narrowing of the valve orifice, and the area is reduced by about half, which causes the patient to have a certain degree of mitral stenosis. Moreover, this method is obviously inappropriate for cases with a small mitral valve orifice. Secondly, the gap between the native leaflets of the mitral valve forms a double hole, which makes subsequent transcatheter mitral valve replacement extremely difficult, and it is difficult to insert an interventional valve for replacement.

[0006] In the field of surgery, mitral valve repair has a significantly higher status than mitral valve replacement. Domestic and international guidelines currently recommend that repair treatment is the first choice for mitral valve surgery. Therefore, transcatheter mitral valve repair is theoretically superior to transcatheter mitral valve replacement.

[0007] However, due to the obvious defects of TEER mentioned above, other transcatheter mitral valve repair technologies that can repair the mitral valve without causing mitral stenosis are needed clinically. Summary of the invention

[0008] In view of the shortcomings of existing methods, the present application proposes a leaflet repair device, system and method to solve the technical problems existing in related technologies such as valve (such as mitral valve) repair leading to valve orifice narrowing and subsequent difficulty in valve replacement.

[0009] In a first aspect, an embodiment of the present application provides a valve leaflet repair device, comprising: Fixings; The first clamp arm and the second clamp arm, each of which has a first end disposed on the fixing member, and each of which has a second end disposed relatively to be openable and closable; An implant leaflet is partially disposed on the first clamp arm and extends to a side of the fixing member away from the first clamp arm; The first clamp arm and the second clamp arm are configured to clamp the native valve leaflet so that the implanted valve leaflet becomes an extension of the native valve leaflet.

[0010] Optionally, a first hollow portion is provided between the first end and the second end of the second clamping arm; The first clamp arm and the second clamp arm have a natural state of being close to each other for clamping; In a natural state, the second end of the first clamp arm passes through the first hollow portion, so that the first clamp arm and the second clamp arm are arranged crosswise.

[0011] Optionally, the second clamping arm includes a first main body section and a first bending section connected to each other; The first main body section is provided with a first hollow portion, and one end of the first main body section away from the first bending section serves as the second end of the second clamping arm; The first bending section is bent relative to the first main body section toward a side away from the first clamping arm; One end of the first bending section away from the first main body section serves as the first end of the second clamping arm and is fixed on the fixing member.

[0012] Optionally, the leaflet repair device includes at least one of the following: The material of the second clamp arm includes shape memory material; The second clamping arm has a second hollow portion, and at least part of the fixing member is located in the second hollow portion; The fixing piece is provided with a first mounting hole, the first end of the second clamping arm is provided with a first protrusion, and the first protrusion is fixedly installed in the first mounting hole.

[0013] Optionally, the fixing member includes a first mounting body, and the first mounting body is used to fix the delivery pipe; The first mounting body is provided with a through hole, and the through hole is used for the conveying rod to pass through.

[0014] Optionally, the leaflet repair device further comprises a rigid control member; The first end of the rigid control member is located on the side of the first end of the second clamp arm away from the fixing member, and is constructed to be detachably connected to the conveying rod. The second end of the rigid control member is fixedly connected to the second end of the second clamp arm to drive the second end of the second clamp arm to swing toward the side away from the first clamp arm under the delivery action of the conveying rod.

[0015] Optionally, the leaflet repair device further comprises a connecting piece; The first end of the rigid control member is fixedly connected to the connecting member, and the connecting member is configured to be detachably connected to the distal end of the delivery rod.

[0016] Optionally, the first end of the rigid control member is openably and closably arranged relative to the first end of the second clamp arm, and is configured to fit against the first end of the second clamp arm in a natural state after the delivery rod is withdrawn.

[0017] Optionally, the first clamping arm includes a second main body section and a second bending section connected to each other; The second bending section is bent relative to the second main body section toward a side close to the second clamping arm.

[0018] Optionally, the leaflet repair device includes at least one of the following: The material of the first clamp arm includes a shape memory material; The fixing piece is provided with a second mounting hole, the first end of the first clamping arm is provided with a second protrusion, and the second protrusion is fixedly installed in the second mounting hole.

[0019] Optionally, the leaflet repair device further includes stoppers arranged on both sides of the first clamp arm along the width direction; The limiting member comprises an outward extension section and a limiting section connected to each other; The outward extension section extends outwardly along the width direction relative to the first clamp arm; The limiting section extends toward a side close to the second clamping arm; The spacing between the limiting sections on both sides of the first clamping arm is greater than the width of the second clamping arm.

[0020] Optionally, the leaflet repair device further comprises a support frame; The support frame is installed on the first clamping arm and is located on a side of the first clamping arm away from the second clamping arm; The implanted valve leaflet is fixedly connected to the portion of the support frame close to the fixing piece.

[0021] In a second aspect, an embodiment of the present application provides a valve leaflet repair system, comprising: A valve leaflet repair device as described above; The delivery assembly comprises a delivery tube and a delivery rod, wherein the delivery tube is detachably connected to a fixing member of the valve leaflet repair device; the delivery rod passes through the delivery tube and the fixing member in sequence; The control structure includes a rigid control part of the leaflet repair device, which is connected to at least one of the first clamp arm and the second clamp arm of the leaflet repair device, and is used to control the opening and closing angles of the first clamp arm and the second clamp arm to clamp the native leaflet, so that the implanted leaflet of the leaflet repair device becomes an extension of the native leaflet.

[0022] In a third aspect, an embodiment of the present application provides a valve leaflet repair system, comprising: A valve leaflet repair device as described above; The delivery assembly comprises a delivery tube and a delivery rod, wherein the delivery tube is detachably connected to a fixing member of the valve leaflet repair device; the delivery rod passes through the delivery tube and the fixing member in sequence; The control structure includes a first flexible control member, which passes through the delivery rod and cooperates with the second end of the second clamp arm of the leaflet repair device to control the opening and closing angles of the first clamp arm and the second clamp arm to clamp the native leaflet, so that the implanted leaflet of the leaflet repair device becomes an extension of the native leaflet.

[0023] Optionally, the leaflet repair system further comprises: a sheath; The sheath is used to deliver the leaflet repair device, delivery assembly and control structure to the valve.

[0024] In a fourth aspect, an embodiment of the present application provides a leaflet repair method, comprising: The leaflet repair device is delivered to the valve through the sheath; releasing the valve leaflet repair device, so that the second clamping arm of the valve leaflet repair device swings toward a side close to the first clamping arm of the valve leaflet repair device; The control structure controls the second clamp arm to approach and hook the native leaflet of the valve from below; The opening and closing angles of the first clamp arm and the second clamp arm are controlled until the native valve leaflet is clamped, so that the implanted valve leaflet of the valve leaflet repair device becomes an extension of the native valve leaflet.

[0025] The beneficial technical effects brought about by the technical solution provided by the embodiment of the present application include: In the embodiment of the present application, the first end of the first clamp arm and the first end of the second clamp arm are respectively disposed on the fixing member, the implanted leaflet is partially disposed on the first clamp arm, and the fixing member is used to carry the first clamp arm, the second clamp arm and the implanted leaflet. The second end of the first clamp arm and the second end of the second clamp arm are relatively openably disposed, and the first clamp arm and the second clamp arm are used to clamp the native leaflet. The implanted leaflet extends to the side of the fixing member away from the first clamp arm, and the implanted leaflet can be clamped on the native leaflet by the first clamp arm and the second clamp arm, so that the implanted leaflet becomes an extension of the native leaflet, which is equivalent to extending the native leaflet, helping to reduce or even eliminate the gap between the native leaflets during contraction and improve the regurgitation problem.

[0026] Furthermore, in the embodiment of the present application, the implanted leaflet of a leaflet repair device is clamped on a native leaflet by the first clamp arm and the second clamp arm, which is equivalent to extending the native leaflet. Any two native leaflets still maintain their original independence and do not interfere with each other, and different native leaflets of the same valve can open normally during diastole.

[0027] Compared with the related art that clamps two leaflets together, resulting in a narrowing of the valve orifice, which is not suitable for patients with stenotic valve orifices, the leaflet repair device of the embodiment of the present application acts on a single native leaflet, and the implanted leaflet moves together with the clamped native leaflet, without the need to use two native leaflets together, and will not interfere with or hinder other native leaflets. Therefore, using implanted leaflets to extend the native leaflet will not cause the valve orifice to narrow, and can basically maintain the original size of the valve orifice. It is also applicable to patients with stenotic valve orifices and has a wide range of applications.

[0028] Moreover, in the embodiment of the present application, a leaflet repair device is clamped on a native leaflet, which does not affect the subsequent replacement of the native leaflet. Whether it is a native leaflet with an implanted leaflet clamped or a native leaflet without an implanted leaflet clamped, the leaflet can be replaced relatively easily later. Compared with the related technology, in the embodiment of the present application, the difficulty of leaflet replacement is reduced and better clinical results can be obtained.

[0029] In the embodiment of the present application, when the valve leaflet repair device is implanted, the first clamp arm and the second clamp arm are controlled to achieve unilateral clamping of the native valve leaflet, so that the implanted valve leaflet is clamped on the native valve leaflet. The past clinical practice can be used as a basis, so the feasibility of the operation is high and the learning period of the doctor is short.

[0030] Additional aspects and advantages of the present application will be partially given in the following description, which will become apparent from the following description, or will be understood through the practice of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The above and / or additional aspects and advantages of the present application will become apparent and easily understood from the following description of the embodiments in conjunction with the accompanying drawings, in which: Figure 1 A schematic structural diagram of a fixing member of a leaflet repair device provided in an embodiment of the present application from one perspective; Figure 2 A schematic structural diagram of a fixing member of a leaflet repair device provided in an embodiment of the present application from another perspective; Figure 3 A schematic structural diagram of a first clamping arm of a leaflet repair device provided in an embodiment of the present application from one perspective; Figure 4 A schematic structural diagram of a first clamping arm of a leaflet repair device provided in an embodiment of the present application from another perspective; Figure 5 A schematic diagram of a top view of a first clamping arm of a leaflet repair device provided in an embodiment of the present application; Figure 6 A schematic side structural diagram of a first clamping arm of a leaflet repair device provided in an embodiment of the present application; Figure 7 A schematic structural diagram of the connection between a first clamping arm and a fixing member of a leaflet repair device provided in an embodiment of the present application; Figure 8 A schematic structural diagram of a second clamping arm and a rigid control member of a leaflet repair device provided in an embodiment of the present application connected at one viewing angle; Fig. 9 A schematic structural diagram showing another perspective of the connection between the second clamping arm and the rigid control member of a leaflet repair device provided in an embodiment of the present application; Fig.10 A bottom-up structural schematic diagram of the connection between a second clamping arm and a rigid control member of a leaflet repair device provided in an embodiment of the present application; Fig.11 A schematic diagram of the side view of the structure of the connection between the second clamping arm and the rigid control member of a leaflet repair device provided in an embodiment of the present application; Fig.12 A schematic diagram of the structure of the connection between the second clamping arm, the rigid control member and the fixing member of a leaflet repair device provided in an embodiment of the present application; Fig.13 A schematic diagram of the structure of the connection between a first clamp arm, a second clamp arm, a rigid control member and a fixing member of a leaflet repair device provided in an embodiment of the present application; Fig.14 A schematic structural diagram of an implanted leaflet of a leaflet repair device provided in an embodiment of the present application from one perspective; Fig.15 A schematic structural diagram of an implanted leaflet of a leaflet repair device provided in an embodiment of the present application from another perspective; Fig.16 A schematic structural diagram of a support frame of a leaflet repair device provided in an embodiment of the present application from one perspective; Fig.17 A schematic structural diagram of a support frame of a leaflet repair device provided in an embodiment of the present application from another perspective; Fig.18 A schematic diagram of the structure of a valve leaflet repair device provided in an embodiment of the present application; Fig.19 A schematic structural diagram of a delivery tube of a valve leaflet repair system provided in an embodiment of the present application from one perspective; Fig. 20 A schematic structural diagram of a delivery tube of a leaflet repair device provided in an embodiment of the present application from another perspective; Fig.21 A schematic diagram of the structure of a delivery rod of a leaflet repair system provided in an embodiment of the present application; Fig. 22 A schematic diagram of the structure of the connection between a delivery assembly, a first clamp arm, a second clamp arm, a rigid control member and a fixing member of a leaflet repair system provided in an embodiment of the present application; Fig.23 A schematic diagram of a partially exploded structure of a delivery assembly, a first clamp arm, a second clamp arm, a rigid control member, and a fixing member of a valve leaflet repair system provided in an embodiment of the present application; Fig.24 for Fig.23 A partial enlarged view of an angle; Fig.25 for Fig.23 A partial enlarged view from another angle; Fig.26 A schematic diagram of the structure of a valve leaflet repair system provided in an embodiment of the present application; Fig. 27 A schematic diagram of the exploded structure of a valve leaflet repair system provided in an embodiment of the present application; Fig.28 A schematic diagram of the side structure of a valve leaflet repair system provided in an embodiment of the present application; Fig.29 A schematic diagram of a top view of a valve leaflet repair system provided in an embodiment of the present application; Fig.30 A schematic flow chart of a leaflet repair method provided in an embodiment of the present application.

[0032] Reference numerals: 100-valve leaflet repair device; 10-fixing parts; 11-first mounting hole; 12-first mounting body; 13-through hole; 14-second mounting hole; 15-second mounting body; 16-slot; 21- first clamping arm; 211-second main body section; 212-second bending section; 213-second protrusion; 214-anchoring piece; 215-control hole; 23-limiting structure; 231-limiting piece; 232-outward extension section; 233-limiting section; 22- second clamping arm; 221-first hollow portion; 222-first main body section; 223-first bending section; 224-first protrusion; 225-second hollow portion; 30-implantation of valve leaflets; 41- Rigid control member; 42- Connecting member; 50-support frame; 111 - delivery tube; 112 - delivery rod; 113 - buckle. DETAILED DESCRIPTION

[0033] The embodiments of the present application are described below in conjunction with the drawings in the present application. It should be understood that the implementation methods described below in conjunction with the drawings are exemplary descriptions for explaining the technical solutions of the embodiments of the present application and do not constitute a limitation on the technical solutions of the embodiments of the present application.

[0034] Those skilled in the art will appreciate that, unless expressly stated, the "said" and "the" used herein may also include plural forms. It should be further understood that the term "including" used in the specification of the present application refers to the presence of the features, integers, steps, operations and / or components, but does not exclude the implementation of other features, information, data, steps, operations, components and / or combinations thereof supported by the technical field. The term "and / or" used herein refers to at least one of the items defined by the term, for example, "A and / or B" may be implemented as "A", or as "B", or as "A and B".

[0035] In order to make the objectives, technical solutions and advantages of the present application clearer, the implementation methods of the present application will be further described in detail below with reference to the accompanying drawings.

[0036] It should be noted that, in the embodiments of the present application, "lower" refers to the side close to the ventricle when the device is implanted at the valve position (such as the mitral valve); "upper" refers to the side close to the atrium when the device is implanted at the valve position (such as the mitral valve); "proximal" refers to the end close to the operator during the operation; "distal" refers to the end away from the operator during the operation; "center" refers to the side close to the delivery component during the operation; "peripheral" refers to the side away from the delivery component during the operation.

[0037] It should be noted that, in the embodiments of the present application, the valve includes a membrane-like structure that can be opened and closed in the organs of humans or certain animals. Taking the valves of the human heart as an example, the human heart includes four valves, namely the aortic valve connecting the left ventricle and the aorta, the pulmonary valve connecting the right ventricle and the pulmonary artery, the mitral valve connecting the left atrium and the left ventricle, and the tricuspid valve connecting the right atrium and the right ventricle.

[0038] It should be noted that in the embodiment of the present application, the valve includes at least two leaflets, which are close to each other and fit together, so that the gap between the leaflets disappears, and the valve is closed. For example, the aortic valve and the pulmonary valve each include three semilunar valves (i.e., three leaflets each), the mitral valve includes two leaflets, the anterior cusp and the posterior cusp, and the tricuspid valve includes three leaflets, the anterior leaflet, the posterior leaflet, and the septal leaflet.

[0039] Based on the principle of surgical valve extension and repair, the present application designs and provides a leaflet repair device, system and method, aiming to extend the leaflets of a valve (such as a mitral valve) through minimally invasive transcatheter intervention, thereby repairing the valve and solving the regurgitation problem as well as the technical problems of valve orifice narrowing and subsequent difficulty in valve replacement after valve repair in related technologies.

[0040] The following is a detailed description of the technical solution of the present application and how the technical solution of the present application solves the above technical problems with specific embodiments. It should be noted that the following implementations can refer to, draw on or combine with each other, and the same terms, similar features and similar implementation steps in different implementations will not be described repeatedly.

[0041] The present application embodiment provides a leaflet repair device 100, the structure diagram of the leaflet repair device 100 is as follows Figures 1 to 18 As shown, it includes: a fixing member 10, a first clamp arm 21, a second clamp arm 22 and an implanted leaflet 30. The first ends (i.e., proximal ends) of the first clamp arm 21 and the second clamp arm 22 are respectively arranged on the fixing member 10, and the second ends (i.e., distal ends) of the first clamp arm 21 and the second clamp arm 22 are relatively arranged to be openable and closable; the implanted leaflet 30 is partially arranged on the first clamp arm 21 and extends to the side of the fixing member 10 away from the first clamp arm 21. The first clamp arm 21 and the second clamp arm 22 are configured to clamp the native leaflet, so that the implanted leaflet 30 becomes an extension of the native leaflet.

[0042] In the embodiment of the present application, the first end of the first clamp arm 21 and the first end of the second clamp arm 22 are respectively disposed on the fixing member 10, and the implanted leaflet 30 is partially disposed on the first clamp arm 21, and the fixing member 10 is used to carry the first clamp arm 21, the second clamp arm 22 and the implanted leaflet 30. The second end of the first clamp arm 21 and the second end of the second clamp arm 22 are relatively openably disposed, and the first clamp arm 21 and the second clamp arm 22 are used to clamp the native leaflet. The implanted leaflet 30 extends to the side of the fixing member 10 away from the first clamp arm 21, and the implanted leaflet 30 can be clamped on the native leaflet by the first clamp arm 21 and the second clamp arm 22, so that the implanted leaflet 30 becomes an extension of the native leaflet, which is equivalent to extending the native leaflet, which helps to reduce or even eliminate the gap between the native leaflets during contraction and improve the regurgitation problem.

[0043] Furthermore, in the embodiment of the present application, the implanted leaflet 30 of a leaflet repair device 100 is clamped on a native leaflet by the first clamp arm 21 and the second clamp arm 22, which is equivalent to extending the native leaflet. Any two native leaflets still maintain their original independence and do not interfere with each other, and different native leaflets of the same valve can open normally during diastole.

[0044] Compared with the related art that clamps two leaflets together, resulting in a narrowing of the valve orifice, which is not suitable for patients with stenotic valve orifices, the leaflet repair device 100 of the embodiment of the present application acts on a single native leaflet, and the implanted leaflet 30 moves together with the clamped native leaflet, and does not require the use of two native leaflets together, and will not interfere with or hinder other native leaflets. Therefore, using the implanted leaflet 30 to extend the native leaflet will not cause the valve orifice to narrow, and can basically maintain the original size of the valve orifice. It is also applicable to patients with stenotic valve orifices and has a wide range of applications.

[0045] Moreover, in the embodiment of the present application, a leaflet repair device 100 is clamped on a native leaflet, which does not affect the subsequent replacement of the native leaflet. Whether it is a native leaflet clamped with an implanted leaflet 30 or a native leaflet not clamped with an implanted leaflet 30, the leaflet can be replaced relatively easily later. Compared with the related technology, in the embodiment of the present application, the difficulty of leaflet replacement is reduced and better clinical results can be obtained.

[0046] In the embodiment of the present application, when the valve leaflet repair device 100 is implanted, the first clamping arm 21 and the second clamping arm 22 are controlled to achieve unilateral clamping of the native valve leaflet, so that the implanted valve leaflet 30 is clamped on the native valve leaflet. The past clinical practice can be used as a basis, the feasibility of the surgical operation is high, and the learning period of doctors is short.

[0047] Optionally, in the embodiment of the present application, the valve leaflet repair device 100 can be applied to the human body or other animal bodies. Further, the valve leaflet repair device 100 can be applied to valve structures such as the aortic valve, pulmonary valve, mitral valve and tricuspid valve of the human heart, or other diseases that require sheet-like extension of human tissue.

[0048] Optionally, in an embodiment of the present application, the leaflet repair device 100 may be implanted into the diseased native leaflet.

[0049] The key points of operation of the leaflet repair device 100 in the embodiment of the present application are similar to those of the traditional TEER mitral valve clip surgery and will not be repeated here.

[0050] Optionally, in the embodiment of the present application, a leaflet repair device 100 may be provided on one native leaflet of the same valve. Of course, according to actual needs, leaflet repair devices 100 may be provided one by one on two or more or even all native leaflets of the same valve. The implanted leaflets 30 of the corresponding leaflet repair device 100 form an extension of the native leaflet, so that one, two, more than two or even all native leaflets of the same valve are extended.

[0051] Optionally, in an embodiment of the present application, an extension portion is added to at least one native leaflet of the valve so that the valve can be closed during contraction, thereby solving the regurgitation problem.

[0052] Optionally, in an embodiment of the present application, the size of the extension portion added to at least one native leaflet of the valve is sufficient to block or cover the gap between the native leaflets of the valve during contraction, thereby closing the valve.

[0053] Optionally, in an embodiment of the present application, if an extension is added to one native leaflet of a valve, the size of the extension is greater than or equal to the size of the gap between the native leaflets of the valve during contraction; if extensions are added to two or more native leaflets of the valve respectively, the sum of the sizes of these extensions is greater than or equal to the size of the gap between the native leaflets of the valve during contraction.

[0054] In this way, when an extension portion is added to part of the native leaflets of the valve, and during the contraction period, the added extension portion and the native leaflets without the extension portion fit together, thereby eliminating the gap between the native leaflets of the valve; when an extension portion is added to all of the native leaflets of the valve, and during the contraction period, the added extension portions fit together, thereby eliminating the gap between the native leaflets of the valve; thereby closing the valve and solving the reflux problem.

[0055] Optionally, in the embodiment of the present application, the first clamp arm 21 and the second clamp arm 22 have deformation capability and shape memory of clamping in a natural state. That is, the first clamp arm 21 and the second clamp arm 22 can memorize the clamping shape, and the first clamp arm 21 and the second clamp arm 22 are deformed under external action, and when the external action disappears, the first clamp arm 21 and the second clamp arm 22 can naturally return to the clamping shape.

[0056] In this way, when it is necessary to clamp the native leaflet by the first clamp arm 21 and the second clamp arm 22, it is only necessary to adjust the angle and position of the first clamp arm 21 and the second clamp arm 22 relative to the native leaflet, and then the first clamp arm 21 and the second clamp arm 22 can be released. By utilizing the shape memory effect, the first clamp arm 21 and the second clamp arm 22 can switch to a natural clamped state, thereby clamping the native leaflet.

[0057] Optionally, in the embodiment of the present application, the material of the second clamp arm 22 includes a shape memory material. The material of the first clamp arm 21 includes a shape memory material.

[0058] Optionally, in an embodiment of the present application, the shape memory material includes but is not limited to nickel-titanium alloy.

[0059] Alternatively, if Figure 8 , Fig. 9 , Fig.11 and Fig.25As shown, in the embodiment of the present application, the fixing member 10 is provided with a first mounting hole 11, and the first end of the second clamping arm 22 is provided with a first protrusion 224, and the first protrusion 224 is fixedly installed in the first mounting hole 11. The second clamping arm 22 and the fixing member 10 are fixed by the first protrusion 224 and the first mounting hole 11.

[0060] Alternatively, if Figures 1 to 6 as well as Fig.24 As shown, in the embodiment of the present application, the fixing member 10 is provided with a second mounting hole 14, and the first end of the first clamping arm 21 is provided with a second protrusion 213, and the second protrusion 213 is fixedly installed in the second mounting hole 14. The first clamping arm 21 and the fixing member 10 are fixed by the second protrusion 213 and the second mounting hole 14.

[0061] In the embodiment of the present application, the first mounting hole 11 and the second mounting hole 14 provided on the fixing member 10 are used to fix the first end of the first clamp arm 21 and the first end of the second clamp arm 22 respectively. The first end of the first clamp arm 21 serves as the fixed end of the first clamp arm 21, and the first end of the second clamp arm 22 serves as the fixed end of the second clamp arm 22. In a natural state, the first clamp arm 21 and the second clamp arm 22 are fixed on the same side of the fixing member 10, and are parallel and close to form a pair of clamps.

[0062] Optionally, in the embodiment of the present application, the way in which the first protrusion 224 and the first mounting hole 11, and the second protrusion 213 and the second mounting hole 14 are fixedly connected or matched includes but is not limited to interlocking, snap-fitting, interference fit, welding (such as laser welding), etc.

[0063] Alternatively, if Figures 1 to 6 , Figure 8 , Fig. 9 , Fig.11 , Fig.24 and Fig.25 As shown, in the embodiment of the present application, there is one first protrusion 224 and one first mounting hole 11, respectively. There are two second protrusions 213 and two second mounting holes 14, respectively.

[0064] It should be noted that the number of the first protrusions 224 and the first mounting holes 11, the second protrusions 213, and the second mounting holes 14 can be increased, decreased, or adjusted according to actual needs. The number of the first mounting holes 11 is greater than or equal to the number of the first protrusions 224. The number of the second mounting holes 14 is greater than or equal to the number of the second protrusions 213.

[0065] Alternatively, if Figure 1 and Figure 2As shown, in the embodiment of the present application, the fixing member 10 includes a first mounting body 12 and a second mounting body 15. The second mounting body 15 is a block structure. The first mounting body 12 is fixedly connected to the second mounting body 15. The first mounting hole 11 and the second mounting hole 14 are respectively arranged on the second mounting body 15, and the first mounting hole 11 and the second mounting hole 14 are located on opposite sides of the second mounting body 15.

[0066] Alternatively, if Figure 1 and Figure 2 As shown, in the embodiment of the present application, the first mounting body 12 is located on the side of the second mounting body 15 . The first mounting hole 11 is located on the bottom surface (or below) of the second mounting body 15 . The second mounting hole 14 is located on the top surface (or above) of the second mounting body 15 .

[0067] Optionally, in the embodiment of the present application, the material of the second installation body 15 includes but is not limited to metal, that is, the second installation body 15 is a block-shaped metal body.

[0068] Alternatively, if Figures 8 to 10 As shown, in the embodiment of the present application, a first hollow portion 221 is provided between the first end and the second end of the second clamp arm 22; the first clamp arm 21 and the second clamp arm 22 have a natural state of being close to each other for clamping; in the natural state, the second end of the first clamp arm 21 passes through the first hollow portion 221, so that the first clamp arm 21 and the second clamp arm 22 are cross-arranged.

[0069] In the embodiment of the present application, the first ends of the first clamp arm 21 and the second clamp arm 22 are respectively fixed on the fixing member 10. In a natural state, the first clamp arm 21 and the second clamp arm 22 form a pair of clamps. The second end of the first clamp arm 21 is inserted into the first hollow portion 221 of the second clamp arm 22, so that the first clamp arm 21 and the second clamp arm 22 are in a crossed state to strengthen the clamping force between the first clamp arm 21 and the second clamp arm 22.

[0070] In the embodiment of the present application, the second end of the first clamp arm 21 serves as the free end of the first clamp arm 21 , and the second end of the second clamp arm 22 serves as the free end of the second clamp arm 22 .

[0071] Optionally, the free end of the second clamping arm 22 is a rounded blunt structure, which can reduce damage to the human body.

[0072] Alternatively, if Fig.13 As shown, in the embodiment of the present application, the overall length of the first clamp arm 21 is smaller than the overall length of the second clamp arm 22 .

[0073] Alternatively, if Figures 8 to 11As shown, in the embodiment of the present application, the second clamp arm 22 includes a first main body section 222 and a first bending section 223 connected to each other; the first main body section 222 is provided with a first hollow portion 221, and the end of the first main body section 222 away from the first bending section 223 serves as the second end of the second clamp arm 22; the first bending section 223 is bent relative to the first main body section 222 toward a side away from the first clamp arm 21; the end of the first bending section 223 away from the first main body section 222 serves as the first end of the second clamp arm 22, which is fixed on the fixing member 10.

[0074] In the embodiment of the present application, the first main section 222 and the first bending section 223 are connected and along the overall length direction (such as Fig.10 The first bending section 223 is bent relative to the first main section 222 toward the side away from the first clamping arm 21, which can improve the overall strength of the second clamping arm 22; the end of the first bending section 223 away from the first main section 222 serves as the first end of the second clamping arm 22, and is fixedly connected to the fixing member 10; the end of the first main section 222 away from the first bending section 223 serves as the second end of the second clamping arm 22. In comparison, the second end of the second clamping arm 22 is closer to the first clamping arm 21, and the first end of the second clamping arm 22 is farther from the first clamping arm 21.

[0075] Alternatively, if Figure 8 and Fig. 9 As shown, in the embodiment of the present application, the second clamping arm 22 has a second hollow portion 225 , and at least a portion of the fixing member 10 is located in the second hollow portion 225 .

[0076] Alternatively, if Figure 8 , Fig. 9 and Fig.12 As shown, in the embodiment of the present application, the first bending section 223 is provided with a second hollow portion 225, and at least a portion of the fixing member 10 is located in the second hollow portion 225. This arrangement can make the second clamping arm 22 and the fixing member 10 more compact.

[0077] Alternatively, if Figure 8 , Fig. 9 and Fig.12 As shown, in the embodiment of the present application, the second hollow portion 225 is connected to the first hollow portion 221. The first bending section 223 is bent relative to the first main section 222, which can improve the structural strength; most of the central area of ​​the second clamping arm 22 is hollowed out to form the first hollow portion 221 and the second hollow portion 225 connected, which can reduce the weight of the second clamping arm 22 and facilitate processing. This arrangement can ensure the structural strength of the second clamping arm 22 while reducing the weight of the second clamping arm 22 and improve stability.

[0078] Alternatively, if Figure 8 and Fig. 9As shown, in the embodiment of the present application, the first protrusion 224 is arranged in the second hollow portion 225. Further, the first protrusion 224 is arranged at the end of the first bending section 223 away from the first main section 222 and toward the second hollow portion 225. This arrangement can stably install the fixing member 10 in the second hollow portion 225.

[0079] Optionally, in the embodiment of the present application, the second clamping arm 22 is a long thin sheet formed by laser cutting and heat-setting of a nickel-titanium memory metal sheet.

[0080] Alternatively, if Figure 1 , Figure 2 , Figure 22 to Figure 24 As shown, in the embodiment of the present application, the first mounting body 12 is used to fix the delivery pipe 111; a through hole 13 is provided on the first mounting body 12, and the through hole 13 is used for the delivery rod 112 to pass through.

[0081] Optionally, as in 1, Figure 2 , Fig.23 and Fig.24 As shown, in the embodiment of the present application, the first mounting body 12 is a tubular structure, the inner cavity of the tubular structure serves as a through hole 13, and the axis of the through hole 13 coincides with the axis of the tubular structure.

[0082] Alternatively, if Figure 1 , Figure 2 , Fig.19 , Fig. 20 , Fig. 22 and Fig.24 As shown, in the embodiment of the present application, a slot 16 is provided on the side wall of the first mounting body 12 , and the slot 16 is used to engage with the buckle 113 on the delivery tube 111 , so that the first mounting body 12 fixes the delivery tube 111 , which is convenient for assembly and disassembly.

[0083] Alternatively, if Figure 1 , Figure 2 , Fig.19 and Fig. 20 As shown, in the embodiment of the present application, at least two slots 16 are provided, and at least two slots 16 are distributed along the circumference of the first mounting body 12 at intervals. At least two buckles 113 are provided, and at least two buckles 113 are distributed along the circumference of the delivery tube 111 at intervals.

[0084] Optionally, at least two slots 16 are evenly distributed. At least two buckles 113 are evenly distributed.

[0085] Optionally, the number of the buckles 113 is less than or equal to the number of the slots 16 .

[0086] Alternatively, if Figures 8 to 12 , Fig.23 as well as Fig.24As shown, in the embodiment of the present application, the leaflet repair device 100 also includes a rigid control member 41; the first end of the rigid control member 41 is located on the side of the first end of the second clamp arm 22 away from the fixing member 10, and is constructed to be detachably connected to the delivery rod 112; the second end of the rigid control member 41 is fixedly connected to the second end of the second clamp arm 22, so as to drive the second end of the second clamp arm 22 to swing toward the side away from the first clamp arm 21 under the delivery action of the delivery rod 112.

[0087] In the embodiment of the present application, one end of the delivery rod 112 passes through the through hole 13 of the first mounting body 12 and is detachably connected to the first end of the rigid control member 41; the second end of the rigid control member 41 is fixedly connected to the second end of the second clamping arm 22. When the delivery rod 112 is delivered along the axis of the through hole 13, the delivery rod 112 can drive the first end of the rigid control member 41 to move together, thereby driving the second end of the rigid control member 41 and the second end of the second clamping arm 22 to swing, thereby realizing the control of the opening and closing angle of the second clamping arm 22 relative to the first clamping arm 21.

[0088] Alternatively, if Figures 8 to 12 , Fig.23 as well as Fig.24 As shown, in the embodiment of the present application, the leaflet repair device 100 further includes a connector 42; the first end of the rigid control member 41 is fixedly connected to the connector 42, and the connector 42 is configured to be detachably connected to the distal end of the delivery rod 112. The rigid control member 41 is detachably connected to the delivery rod 112 through the connector 42.

[0089] Optionally, in the embodiment of the present application, the connecting piece 42 is a rounded blunt structure, and the rounded blunt design can reduce damage to human tissue.

[0090] Optionally, in the embodiment of the present application, the upper surface of the connector 42 has a threaded hole, which is connected to the threaded head of the end of the delivery rod 112 and can be separated from it. The connector 42 is threadedly connected to the delivery rod 112 for easy installation and removal. When the leaflet repair device 100 is installed in place and the delivery rod 112 needs to be removed, the delivery rod 112 is screwed off the connector 42 to facilitate the withdrawal of the delivery rod.

[0091] In the embodiment of the present application, the second end of the rigid control member 41 is connected to the free end of the second clamp arm 22, and the first end is connected to the connecting member 42, and the connecting member 42 is detachably connected to the conveying rod 112. By controlling the axial movement of the conveying rod 112, the connecting member 42 and the fixing member 10 can be moved closer to or farther away from each other. When the connecting member 42 and the fixing member 10 are moved away from each other, the second clamp arm 22 can be swung downward by operating the rigid control member 41, and the free end of the second clamp arm 22 moves downward toward the center (i.e., swings in a direction away from the first clamp arm 21 and closer to the axial direction of the conveying rod 112), so as to increase the angle between the second clamp arm 22 and the first clamp arm 21.

[0092] Optionally, in the embodiment of the present application, the first end of the rigid control member 41 is openably arranged relative to the first end of the second clamp arm 22, and is configured to fit the first end of the second clamp arm 22 in a natural state after the delivery rod 112 is withdrawn. In a natural state, the rigid control member 41 fits the second clamp arm 22, and such a configuration can reduce the space occupied by the second clamp arm 22 and the rigid control member 41. When the leaflet repair device 100 is installed in place and the delivery rod 112 is withdrawn, the rigid control member 41 can naturally return to a state of fitting the second clamp arm 22, occupying less space in the human body, and avoiding obstruction or influence on human tissue.

[0093] Optionally, in the embodiment of the present application, the rigid control member 41 and the second clamp arm 22 have deformation capability and shape memory of fitting in a natural state. That is, the rigid control member 41 and the second clamp arm 22 can memorize the fitting shape, and the rigid control member 41 and the second clamp arm 22 are deformed under the action of the conveying rod 112. When the action of the conveying rod 112 disappears, the rigid control member 41 can naturally return to the fitting shape relative to the second clamp arm 22.

[0094] In this way, when it is necessary to adjust the angle of the second clamping arm 22 relative to the first clamping arm 21, it is only necessary to control the axial movement of the conveying rod 112 to make the rigid control component 41 and the second clamping arm 22 swing relative to the first clamping arm 21, thereby adjusting the angle; when the position and angle adjustment of the second clamping arm 22 are completed, the conveying rod 112 and the connecting component 42 can be disassembled to separate the rigid control component 41 from the conveying rod 112, and by utilizing the shape memory effect, the rigid control component 41 switches to a natural state of being attached to the second clamping arm 22, and the rigid control component 41 and the second clamping arm 22 are attached together.

[0095] Optionally, in the embodiment of the present application, the material of the rigid control member 41 includes a shape memory material, which includes but is not limited to nickel-titanium alloy.

[0096] Optionally, in the embodiment of the present application, the connecting member 42 and the fixing member 10 need to be brought close together in the final stage of the operation, that is, when the delivery tube 111 and the first mounting body 12, the delivery rod 112 and the connecting member 42 are completely separated.

[0097] Optionally, in the embodiment of the present application, the rigid control member 41 and the second clamp arm 22 are an integrated V-shaped spring sheet, the angle between the two is very small, the closed end (i.e., the second end) is a free end, and the two open ends (i.e., the first ends) are respectively fixed to the connecting member 42 and the fixing member 10. The spring sheet is made of a shape memory metal, and in a natural state, the two open ends of the rigid control member 41 and the second clamp arm 22 are naturally fitted, so that the connecting member 42 and the fixing member 10 are naturally close, and the rigid control member 41 and the second clamp arm 22 are in an I shape; by operating the conveying rod 112, the free ends of the rigid control member 41 and the second clamp arm 22 can be separated, and the I shape becomes a V shape, so that the second clamp arm 22 can be swung downward.

[0098] In some other optional embodiments of the present application, a riveting structure is included between the connecting member 42 and the fixing member 10. By operating the conveying rod 112 and the conveying tube 111, the connecting member 42 and the fixing member 10 are brought close to each other and physically riveted. In this case, the control structure is an independent structure.

[0099] Optionally, the control structure is a first flexible control member, which includes but is not limited to a linear structure. The first flexible control member is connected to the free end of the second clamp arm 22, moves downward into the connecting member 42 and then enters the conveying assembly, separates the connecting member 42 and the fixing member 10, and then pulls the first flexible control member to achieve the second clamp arm 22 swinging downward toward the center.

[0100] It should be noted that when the control structure controlling the swing of the second clamp arm 22 is the first flexible control member, the first flexible control member needs to be removed from the human body after the first clamp arm 21 and the second clamp arm 22 are clamped on the native leaflet (that is, the leaflet repair device 100 is installed in place).

[0101] Alternatively, if Figures 3 to 6 As shown, in the embodiment of the present application, the first clamp arm 21 includes a second main body section 211 and a second bending section 212 connected to each other; the second bending section 212 is bent relative to the second main body section 211 toward a side close to the second clamp arm 22 .

[0102] In the embodiment of the present application, the second clamp arm 22 hooks the native leaflet from below, and the first clamp arm 21 anchors the native leaflet on the second clamp arm 22 to achieve clamping. The second bending section 212 of the first clamp arm 21 is bent relative to the second main section 211, so that the shape of the first clamp arm 21 can be more closely fitted or matched to the shape of the native leaflet, improving adaptability and anchoring effect, and improving structural strength.

[0103] Alternatively, if Figures 3 to 7As shown, in the embodiment of the present application, one end of the second main body section 211 away from the second bending section 212 serves as the first end of the first clamp arm 21 and is fixed on the fixing member 10; one end of the second bending section 212 away from the second main body section 211 serves as the second end of the first clamp arm 21, that is, the free end of the first clamp arm 21.

[0104] Optionally, in the embodiment of the present application, the free end of the first clamping arm 21 is a rounded blunt structure, which can reduce damage to the human body.

[0105] Optionally, in the embodiment of the present application, the control structure for controlling the swing of the first clamp arm 21 includes a second flexible control member, and the second flexible control member includes but is not limited to a control line. A control hole 215 is provided on the first clamp arm 21, and the control line passes through the control hole 215 and then runs into the conveying assembly. The control line can realize the upward center swing of the first clamp arm 21 (i.e., the swing away from the second clamp arm 22 and close to the conveying tube 111 and the conveying rod 112), and the first clamp arm 21 is pulled close to the conveying assembly so that the two overlap. When the control line is relaxed, the free end of the first clamp arm 21 is away from the conveying assembly, and the first clamp arm 21 and the conveying assembly form an angle.

[0106] It should be noted that the second flexible control member needs to be withdrawn from the human body after the first clamp arm 21 and the second clamp arm 22 are clamped on the native valve leaflet (ie the valve leaflet repair device 100 is installed in place).

[0107] Alternatively, if Figures 3 to 7 As shown, in the embodiment of the present application, an anchor 214 is provided on the first clamp arm 21, and the anchor 214 is used to anchor the native leaflet when the first clamp arm 21 and the second clamp arm 22 clamp the native leaflet.

[0108] Alternatively, if Figure 3 As shown, in the embodiment of the present application, there are multiple anchors 214 on both sides of the first clamp arm 21. The anchors 214 are sharp barbs extending downward (ie, toward the side close to the second clamp arm 22). The multiple anchors 214 are symmetrically and arranged in rows.

[0109] Optionally, in the embodiment of the present application, the first clamping arm 21 is a long thin sheet formed by laser cutting and heat setting of a nickel-titanium memory metal sheet.

[0110] Alternatively, if Figures 3 to 7 as well as Fig.13 As shown, in the embodiment of the present application, the leaflet repair device 100 also includes a limiting structure 23, and the limiting structure 23 is arranged on the first clamp arm 21. The limiting structure 23, the first clamp arm 21 and the second clamp arm 22 form a limiting space, which is used to prevent the first clamp arm 21 and the second clamp arm 22 from swinging relative to the native leaflet along the overall width direction after the first clamp arm 21 and the second clamp arm 22 clamp the native leaflet, so as to make the clamping more stable.

[0111] Alternatively, if Figures 3 to 7 as well as Fig.13 As shown, in the embodiment of the present application, the limiting structure 23 includes a first clamping arm 21 arranged along the width direction (such as Figure 5 The limiting member 231 includes an outward extension section 232 and a limiting section 233 connected to each other; the outward extension section 232 extends outwardly along the width direction relative to the first clamping arm 21; the limiting section 233 extends toward the side close to the second clamping arm 22; the spacing between the limiting sections 233 on both sides of the first clamping arm 21 is greater than the width of the second clamping arm 22.

[0112] In the embodiment of the present application, the spacing between the limiting sections 233 of the limiting members 231 located on both sides of the first clamp arm 21 along the width direction is greater than the width of the second clamp arm 22. In this way, when the first clamp arm 21 and the second clamp arm 22 clamp the native leaflets, the two limiting sections 233 are located on the outer side of the second clamp arm 22 along the width direction, that is, the second clamp arm 22 is limited between the two limiting sections 233. The two limiting sections 233 can limit the native leaflets clamped between the first clamp arm 21 and the second clamp arm 22, preventing the native leaflets from shifting or swinging along the width direction of the first clamp arm 21 and the second clamp arm 22, that is, making it difficult for the first clamp arm 21 and the second clamp arm 22 to swing relative to the native leaflets along the width direction, thereby improving the anchoring effect.

[0113] In the embodiment of the present application, the limiting section 233 is fixedly connected to the first clamp arm 21 through the extension section 232. The extension section 232 extends outwardly relative to the first clamp arm 21 along the width direction, so that the spacing between the limiting sections 233 located on both sides of the first clamp arm 21 along the width direction is greater than the width of the first clamp arm 21 and the width of the second clamp arm 22.

[0114] Optionally, in the embodiment of the present application, a plurality of limiting structures 23 may be provided according to actual needs. The plurality of limiting structures 23 are distributed at intervals along the entire length direction of the first clamping arm 21 .

[0115] Alternatively, if Figure 3 and Figure 5 As shown, in the embodiment of the present application, the limiting structure 23 is arranged on the second main body section 211, and two limiting members 231 are arranged on both sides of the second main body section 211 along the width direction. Of course, the limiting structure 23 can also be arranged on the second bending section 212 according to actual needs, or the limiting structure 23 can be arranged on the second main body section 211 and the second bending section 212 respectively.

[0116] Alternatively, if Figure 3 and Figure 5As shown, in the embodiment of the present application, the limiting structure 23 and the second main body section 211 are an integrally formed structure. Of course, the limiting structure 23 and the second main body section 211 can also be provided separately according to actual needs.

[0117] Alternatively, if Figures 3 to 5 As shown, in the embodiment of the present application, the limiting member 231 is a large barb, which is first expanded outward on the plane of the first clamp arm 21 to form an outward extension section 232, and then bent downward to form a limiting section 233, so as to increase the lateral anchoring range of the first clamp arm 21, so that the first clamp arm 21 and the second clamp arm 22 as a whole will not swing laterally after clamping the native valve leaflet.

[0118] Alternatively, if Fig.16 and Fig.17 As shown, in the embodiment of the present application, the valve leaflet repair device 100 further includes a support frame 50; the support frame 50 is mounted on the first clamp arm 21 and is located on the side of the first clamp arm 21 away from the second clamp arm 22; the implanted valve leaflet 30 is fixedly connected to the portion of the support frame 50 close to the fixing member 10. The implanted valve leaflet 30 is fixedly mounted on the first clamp arm 21 through the support frame 50.

[0119] Optionally, in the embodiment of the present application, a polymer or biological membrane can be sutured on the surface of the support frame 50 to promote rapid endothelialization after the device is implanted in the human body.

[0120] Optionally, in the embodiment of the present application, the material of the support frame 50 includes a shape memory material. The support frame 50 can memorize the shape in the natural state, and when the external effect disappears, the support frame 50 can return to the shape in the natural state.

[0121] Alternatively, if Fig.16 and Fig.17 As shown, in the embodiment of the present application, the support frame 50 is a mesh structure or a sheet structure.

[0122] Alternatively, if Fig.18 As shown, in the embodiment of the present application, the first end (i.e., the proximal end) of the support frame 50 is connected to the first end of the first clamp arm 21 and the fixing member 10, and the second end (i.e., the distal end) of the support frame 50 is connected to the second end of the first clamp arm 21, and the width of the first end of the support frame 50 is greater than the width of the second end.

[0123] Optionally, in the embodiment of the present application, the orthographic projection of the support frame 50 in the plane where the fixing member 10 is located is in the shape of a triangle, a trapezoid, a heart, or a fan.

[0124] Optionally, in the embodiment of the present application, the support frame 50 is a sheet-shaped (triangular, trapezoidal or quasi-trapezoidal, heart-shaped, fan-shaped, etc.) structure woven from nickel-titanium wires, which is narrow at the distal end and wide at the proximal end, and is attached to the atrial surface of the first clamp arm 21 and the fixing member 10. The distal end of the support frame 50 is narrower, forming a vertex, which is connected to the free end of the first clamp arm 21, and the proximal end of the support frame 50 is wider, forming a bottom edge, which is connected to the fixed end of the first clamp arm 21 and the fixing member 10.

[0125] Alternatively, if Fig.17 As shown, in the embodiment of the present application, the first end of the support frame 50 is bent along both sides of the width direction toward the second clamping arm 22, and the cross-sectional shape of the first end of the support frame 50 on the vertical section parallel to the width direction is arc-shaped.

[0126] In the embodiment of the present application, both sides of the support frame 50 may be recessed downward to form an arc, so that the proximal end of the support frame 50 may fit the native valve leaflet when implanted in the human body.

[0127] Optionally, in an embodiment of the present application, the implanted leaflet 30 is a sheet of biological tissue, which is connected and sutured to a side of the support frame 50 close to the fixing member 10 and is a functional component of the entire leaflet repair device 100 .

[0128] Optionally, in the embodiment of the present application, the implanted valve leaflet 30 may be made of prosthetic valve leaflet materials currently used in clinical practice, such as bovine pericardium, porcine pericardium, animal valve leaflets, or polymers.

[0129] In the embodiment of the present application, the leaflet repair device 100 specifically includes: a first clamp arm 21, a second clamp arm 22, a fixing member 10, a support frame 50, an implanted leaflet 30, a rigid control member 41 and a connecting member 42.

[0130] The first clamping arm 21 is a long sheet of metal sheet, which is cut by laser from a nickel-titanium metal sheet, and has a plurality of downward sharp spikes on both side edges of the long strip.

[0131] The second clamping arm 22 is also a nickel-titanium metal sheet, and most of the central area thereof is hollowed out.

[0132] The fixed ends of the first clamp arm 21 and the second clamp arm 22 are fixed on the fixing member 10, and the free ends are relatively clampable to form a pair of clamps, and the free end of the first clamp arm 21 is inserted into the central hollow area of ​​the second clamp arm 22, so that the first clamp arm 21 and the second clamp arm 22 are in a staggered state to strengthen the clamping force between the first clamp arm 21 and the second clamp arm 22.

[0133] The free ends of the first clamping arm 21 and the second clamping arm 22 are both provided with control structures to achieve the separation and approach of the free ends of the first clamping arm 21 and the second clamping arm 22 relative to the conveying assembly.

[0134] The second mounting body 15 of the fixing member 10 is a block of metal and is connected to the fixing ends of the first clamping arm 21 and the second clamping arm 22. The first mounting body 12 of the fixing member 10 has a through hole 13 through which the conveying rod 112 can pass.

[0135] The support frame 50 is a sheet-like structure made of nickel-titanium wires, which is narrow at the distal end and wide at the proximal end. It is attached to the atrial surface of the first clamp arm 21 and the fixing member 10 to expand the width and area of ​​the first clamp arm 21.

[0136] The implanted leaflet 30 is a sheet of biological tissue or polymer, which is connected and sutured to the proximal end of the support frame 50 and is a functional component of the entire leaflet repair device 100.

[0137] The connecting member 42 is a round blunt structure, connected to the end of the delivery rod 112 and can be separated therefrom, and one end of the rigid control member 41 is connected to the free end of the second clamp arm 22, and the other end is connected to the connecting member 42. By controlling the axial movement of the delivery rod 112, the connecting member 42 and the fixing member 10 can be brought close to and separated from each other.

[0138] The leaflet repair device 100 provided in the embodiment of the present application can lengthen the leaflets through minimally invasive intervention via a catheter, thereby repairing the valve and solving the regurgitation problem.

[0139] Based on the same inventive concept, the embodiment of the present application (first specific example) provides a valve leaflet repair system, the structural schematic diagram of the valve leaflet repair system is as follows: Figures 19 to 29 As shown, the leaflet repair system includes: the leaflet repair device 100 as described above, a delivery component and a control structure.

[0140] The delivery assembly includes a delivery tube 111 and a delivery rod 112 . The delivery tube 111 is detachably connected to the fixing member 10 of the leaflet repair device 100 ; the delivery rod 112 passes through the delivery tube 111 and the fixing member 10 in sequence.

[0141] The control structure includes a rigid control component 41 of the leaflet repair device 100, which is connected to at least one of the first clamp arm 21 and the second clamp arm 22 of the leaflet repair device 100, and is used to control the opening and closing angles of the first clamp arm 21 and the second clamp arm 22 to clamp the native leaflet, so that the implanted leaflet 30 of the leaflet repair device 100 becomes an extension of the native leaflet.

[0142] In the embodiment of the present application, the delivery tube 111 of the delivery assembly is detachably fixedly mounted on the fixing member 10 of the leaflet repair device 100, and the delivery rod 112 of the delivery assembly passes through the delivery tube 111 and the fixing member 10 (specifically, through the through hole 13 on the first mounting body 12 of the fixing member 10) in sequence. The delivery rod 112 moves axially, and the distal end of the delivery rod 112 is connected to the first end of the rigid control member 41, and the second end of the rigid control member 41 is connected to the second clamp arm 22 of the leaflet repair device 100. By moving the delivery rod 112 along the axis, the first end of the rigid control member 41 is controlled to approach or move away from the fixing member 10, driving the second end of the second clamp arm 22 to swing relative to the first clamp arm 21, thereby adjusting the opening and closing angle between the second clamp arm 22 and the first clamp arm 21, so that the second clamp arm 22 and the first clamp arm 21 clamp the native leaflet, so that the implanted leaflet 30 becomes an extension of the native leaflet.

[0143] It should be noted that in the embodiment of the present application, since the leaflet repair system provided in the embodiment of the present application includes the leaflet repair device 100 provided in the embodiment of the present application, the leaflet repair system provided in the embodiment of the present application also has the above-mentioned beneficial effects of the leaflet repair device 100 provided in the embodiment of the present application, which will not be repeated here.

[0144] Alternatively, if Figures 19 to 21 As shown, in the embodiment of the present application, the delivery rod 112 is a slender delivery rod, which is connected to the connecting member 42 by a threaded connection. The delivery tube 111 is a slender delivery tube. The end of the delivery tube 111 is connected to the first mounting body 12 of the fixing member 10. The delivery rod 112 runs in the delivery tube 111 and passes through the through hole 13 of the fixing member 10 to be detachably connected to the connecting member 42.

[0145] Optionally, in an embodiment of the present application, the control structure also includes a second flexible control member, which is used to control the first clamp arm 21 to swing relative to the second clamp arm 22, thereby adjusting the opening and closing angle between the first clamp arm 21 and the second clamp arm 22, so as to facilitate the second clamp arm 22 and the first clamp arm 21 to clamp the native leaflet.

[0146] Optionally, in an embodiment of the present application, the leaflet repair system further includes a sheath; the sheath is used to deliver the leaflet repair device 100, the delivery assembly and the control structure (including the rigid control member 41 and the second flexible control member) to the valve.

[0147] The embodiment of the present application provides a transcatheter leaflet lengthening and repair system, which achieves leaflet lengthening through a minimally invasive transcatheter interventional approach, thereby repairing the valve and solving the regurgitation problem.

[0148] In the embodiment of the present application, the overall structure of the leaflet repair device 100 is made of nickel-titanium alloy or membrane-like material, and the first clamp arm 21 and the second clamp arm 22 can be separated during transportation, so the overall structure can be compressed into a thinner pipe and transported in the pipe. When it reaches the surgical site, the delivery sheath is pushed out and the device can be restored to the designed large shape. Therefore, it can meet the requirements of minimally invasive intervention via catheter and reduce the trauma of surgery.

[0149] Optionally, in the embodiment of the present application, the valve leaflet repair system can be applied to the human body or other animal bodies. Further, the valve leaflet repair system can be applied to valve structures such as the aortic valve, pulmonary valve, mitral valve and tricuspid valve of the human heart, or other diseases that require sheet-like extension of human tissue.

[0150] Based on the same inventive concept, the embodiment of the present application (the second specific example) provides a valve leaflet repair system, the structural schematic diagram of the valve leaflet repair system is as follows: Figures 19 to 29 As shown (the rigid control member 41 is replaced by the first flexible control member), the leaflet repair system includes: the leaflet repair device 100 as described above, a delivery component and a control structure.

[0151] The delivery assembly includes a delivery tube 111 and a delivery rod 112 . The delivery tube 111 is detachably connected to the fixing member 10 of the leaflet repair device 100 ; the delivery rod 112 passes through the delivery tube 111 and the fixing member 10 in sequence.

[0152] The control structure includes a first flexible control member, which passes through the delivery rod 112 and cooperates with the second end of the second clamp arm 22 of the leaflet repair device 100 to control the opening and closing angles of the first clamp arm 21 and the second clamp arm 22 to clamp the native leaflet, so that the implanted leaflet 30 of the leaflet repair device 100 becomes an extension of the native leaflet.

[0153] Optionally, in an embodiment of the present application, the leaflet repair system further includes a sheath; the sheath is used to deliver the leaflet repair device 100, the delivery assembly and the control structure (including a first flexible control member and a second flexible control member) to the valve.

[0154] It should be noted that in the embodiment of the present application, since the leaflet repair system provided in the embodiment of the present application includes the leaflet repair device 100 provided in the embodiment of the present application, the leaflet repair system provided in the embodiment of the present application also has the above-mentioned beneficial effects of the leaflet repair device 100 provided in the embodiment of the present application, which will not be repeated here.

[0155] It should be noted that the difference between the second specific example of the present application and the first specific example is that in the first specific example, the control structure for controlling the swing of the second clamp arm 22 includes a rigid control member 41, and the rigid control member 41 naturally returns to a state of being attached to the second clamp arm 22 after the conveying assembly is withdrawn, and remains in the body with the second clamp arm 22. In the second specific example, the control structure for controlling the swing of the second clamp arm 22 includes a first flexible control member, and the first flexible control member is withdrawn from the body together with the conveying assembly.

[0156] The remaining structures and designs of the second specific example of the present application are the same as or similar to those of the first specific example and will not be described in detail.

[0157] Based on the same inventive concept, an embodiment of the present application provides a valve leaflet repair method, and the flow chart of the valve leaflet repair method is as follows: Fig.30 As shown, the valve leaflet repair method includes: S101. Deliver the leaflet repair device 100 to the valve through a sheath.

[0158] S102 , releasing the leaflet repair device 100 , so that the second clamping arm 22 of the leaflet repair device 100 swings toward a side close to the first clamping arm 21 of the leaflet repair device 100 .

[0159] S103, controlling the second clamping arm 22 to approach and hook the native leaflet of the valve from below through the control structure.

[0160] S104, controlling the opening and closing angles of the first clamping arm 21 and the second clamping arm 22 until the native leaflet is clamped, so that the implanted leaflet 30 of the leaflet repair device 100 becomes an extension of the native leaflet.

[0161] The leaflet repair method provided in the embodiment of the present application can use the leaflet repair system provided in the embodiment of the present application to perform leaflet repair.

[0162] In the embodiment of the present application, the leaflet repair device 100 is delivered to the valve to be repaired through a sheath; then, the leaflet repair device 100 is released, and the first clamp arm 21 and the second clamp arm 22 of the leaflet repair device 100 have a tendency to automatically recover to a natural state, so that the second clamp arm 22 swings toward the side close to the first clamp arm 21; then, the second clamp arm 22 is controlled by a control structure (such as a rigid control member 41 or a first flexible control member) to approach and hook the native leaflet of the valve from below; then, the opening and closing angles of the first clamp arm 21 and the second clamp arm 22 are controlled until the native leaflet is clamped, so that the implanted leaflet 30 of the leaflet repair device 100 becomes an extension of the native leaflet, thereby extending the native leaflet, which helps to reduce or even eliminate the gap between the native leaflets during contraction and improve the regurgitation problem.

[0163] It should be noted that in the embodiment of the present application, since the leaflet repair method provided in the embodiment of the present application can utilize the leaflet repair system provided in the embodiment of the present application to perform leaflet repair, the leaflet repair method provided in the embodiment of the present application also has the above-mentioned beneficial effects of the leaflet repair system provided in the embodiment of the present application, which will not be repeated here.

[0164] Optionally, in an embodiment of the present application, the sheath delivers the leaflet repair device 100 to the valve and then retracts, the entire leaflet repair device 100 is released, and the structure of the leaflet repair device 100 tends to recover to a natural state.

[0165] Optionally, in the above step S102 of the embodiment of the present application, releasing the leaflet repair device 100 so that the second clamping arm 22 of the leaflet repair device 100 swings toward a side close to the first clamping arm 21 of the leaflet repair device 100 includes: like Fig.28 As shown, the control structure (such as the rigid control member 41 or the first flexible control member) connected to the second clamp arm 22 in the leaflet repair system is loosened, so that the second clamp arm 22 switches to a natural state of clamping with the first clamp arm 21, and the second clamp arm 22 swings toward the side close to the first clamp arm 21, forming an angle between the second clamp arm 22 and the conveying component (such as the axial direction of the conveying rod 112).

[0166] Optionally, at this time, the control structure (such as the second flexible control member) connected to the first clamp arm 21 is tensioned so that the first clamp arm 21 is stationary relative to the fixing member 10, and there is a tendency for the first clamp arm 21 to rotate upward with the fixing member 10 as the rotation axis so that the second end (or the second bending section 212) of the first clamp arm 21 moves closer to the fixing member 10.

[0167] Optionally, in the above step S103 of the embodiment of the present application, controlling the second clamping arm 22 to approach and hook the native leaflet of the valve from below by the control structure includes: like Fig.28 As shown, through the delivery rod 112 of the delivery assembly and the control structure (such as the rigid control member 41 or the first flexible control member) connected to the second clamp arm 22, the position and angle of the second clamp arm 22 relative to the native leaflet are adjusted so that the second clamp arm 22 approaches and hooks the native leaflet from below to facilitate clamping of the native leaflet.

[0168] Optionally, in the above step S104 of the embodiment of the present application, the opening and closing angles of the first clamp arm 21 and the second clamp arm 22 are controlled until the native leaflet is clamped, so that the implanted leaflet 30 of the leaflet repair device 100 becomes an extension of the native leaflet, including: like Fig.28As shown, the control structure (such as the second flexible control member) connected to the first clamp arm 21 is released, so that the first clamp arm 21 switches to a natural state of clamping with the second clamp arm 22, and the second clamp arm 22 hooks the native leaflet from below, and the first clamp arm 21 swings toward the side close to the second clamp arm 22 until the first clamp arm 21 and the second clamp arm 22 clamp the native leaflet. The implanted leaflet 30 is clamped on the native leaflet by the first clamp arm 21 and the second clamp arm 22, serving as an extension of the native leaflet.

[0169] The following describes the operation process by taking the application of the leaflet repair system to the mitral valve or repairing the mitral valve by the leaflet repair method as an example: The first clamp arm 21 and the second clamp arm 22 of the leaflet repair device 100 are respectively straightened upward and downward to fit into the delivery assembly, and then compressed and loaded into the delivery sheath, which is delivered into the delivery sheath through the femoral vein through the atrial septum to above the mitral valve orifice, and the leaflet repair device 100 is delivered to the mitral valve orifice through the delivery sheath.

[0170] By loosening the rigid control part 41, the free end of the second clamp arm 22 is moved away from the conveying assembly and forms an angle therewith; by operating the conveying assembly, the second clamp arm 22 is moved close to the diseased native valve leaflet and hooks the native valve leaflet from below; the control line of the first clamp arm 21 is loosened, so that the end of the first clamp arm 21 moves closer to the second clamp arm 22, and the first clamp arm 21 and the second clamp arm 22 form a pair of clamps, and the first clamp arm 21 drives the support frame 50 to fit the native valve leaflet of the human body.

[0171] After the implantation position and effect of the leaflet repair device 100 are satisfactory, the control line is pulled out, and the delivery rod 112 and the connecting piece 42, and the delivery tube 111 and the fixing piece 10 are separated respectively, thereby releasing the entire leaflet repair device 100 and finally completing the operation.

[0172] If the effect is not satisfactory, the clamping between the first clamping arm 21 and the second clamping arm 22 can be released through the control structure and readjusted.

[0173] If the effect is still unsatisfactory, the first clamp arm 21 and the second clamp arm 22 can be straightened and brought close to the delivery assembly through the control structure, and then the entire leaflet repair device 100 can be pulled into the delivery sheath and recovered outside the body.

[0174] By applying the embodiments of the present application, at least the following beneficial effects can be achieved: In the embodiment of the present application, the first end of the first clamp arm and the first end of the second clamp arm are respectively disposed on the fixing member, the implanted leaflet is partially disposed on the first clamp arm, and the fixing member is used to carry the first clamp arm, the second clamp arm and the implanted leaflet. The second end of the first clamp arm and the second end of the second clamp arm are relatively openably disposed, and the first clamp arm and the second clamp arm are used to clamp the native leaflet. The implanted leaflet extends to the side of the fixing member away from the first clamp arm, and the implanted leaflet can be clamped on the native leaflet by the first clamp arm and the second clamp arm, so that the implanted leaflet becomes an extension of the native leaflet, which is equivalent to extending the native leaflet, helping to reduce or even eliminate the gap between the native leaflets during contraction and improve the regurgitation problem.

[0175] Furthermore, in the embodiment of the present application, the implanted leaflet of a leaflet repair device is clamped on a native leaflet by the first clamp arm and the second clamp arm, which is equivalent to extending the native leaflet. Any two native leaflets still maintain their original independence and do not interfere with each other, and different native leaflets of the same valve can open normally during diastole.

[0176] Compared with the related art that clamps two leaflets together, resulting in a narrowing of the valve orifice, which is not suitable for patients with stenotic valve orifices, the leaflet repair device of the embodiment of the present application acts on a single native leaflet, and the implanted leaflet moves together with the clamped native leaflet, without the need to use two native leaflets together, and will not interfere with or hinder other native leaflets. Therefore, using implanted leaflets to extend the native leaflet will not cause the valve orifice to narrow, and can basically maintain the original size of the valve orifice. It is also applicable to patients with stenotic valve orifices and has a wide range of applications.

[0177] Moreover, in the embodiment of the present application, a leaflet repair device is clamped on a native leaflet, which does not affect the subsequent replacement of the native leaflet. Whether it is a native leaflet with an implanted leaflet clamped or a native leaflet without an implanted leaflet clamped, the leaflet can be replaced relatively easily later. Compared with the related technology, in the embodiment of the present application, the difficulty of leaflet replacement is reduced and better clinical results can be obtained.

[0178] In the embodiment of the present application, when the valve leaflet repair device is implanted, the first clamp arm and the second clamp arm are controlled to achieve unilateral clamping of the native valve leaflet, so that the implanted valve leaflet is clamped on the native valve leaflet. The past clinical practice can be used as a basis, so the feasibility of the operation is high and the learning period of the doctor is short.

[0179] The terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, unless otherwise specified, "plurality" means two or more.

[0180] In the description of this application, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0181] In the description of this specification, specific features, structures, materials or characteristics may be combined in an appropriate manner in any one or more embodiments or examples.

[0182] The above is only a partial implementation method of the present application. It should be pointed out that for ordinary technicians in this technical field, without departing from the technical concept of the scheme of the present application, other similar implementation methods based on the technical ideas of the present application are also within the protection scope of the embodiments of the present application.

Claims

1. A valve leaflet repair device, characterized in that: include: Fixings; The first clamp arm and the second clamp arm, each of which has a first end disposed on the fixing member, and each of which has a second end disposed relatively to be openable and closable; An implant leaflet is partially disposed on the first clamp arm and extends to a side of the fixing member away from the first clamp arm; The first clamp arm and the second clamp arm are configured to clamp a native valve leaflet such that the implanted valve leaflet becomes an extension of the native valve leaflet.

2. The valve leaflet repair device according to claim 1, characterized in that: A first hollow portion is provided between the first end and the second end of the second clamping arm; The first clamp arm and the second clamp arm are in a natural state of being close to each other for clamping; In the natural state, the second end of the first clamp arm passes through the first hollow portion, so that the first clamp arm and the second clamp arm are arranged crosswise.

3. The valve leaflet repair device according to claim 1 or 2, characterized in that: The second clamping arm comprises a first main body section and a first bending section connected to each other; The first main body section is provided with the first hollow portion, and one end of the first main body section away from the first bending section serves as the second end of the second clamping arm; The first bending section is bent relative to the first main section toward a side away from the first clamping arm; One end of the first bending section away from the first main section serves as the first end of the second clamping arm and is fixed on the fixing member.

4. The valve leaflet repair device according to claim 1 or 2, characterized in that: Include at least one of the following: The material of the second clamp arm includes shape memory material; The second clamp arm has a second hollow portion, and at least part of the fixing member is located in the second hollow portion; The fixing member is provided with a first mounting hole, the first end of the second clamping arm is provided with a first protrusion, and the first protrusion is fixedly installed in the first mounting hole.

5. The valve leaflet repair device according to claim 1 or 2, characterized in that: The fixing member includes a first mounting body, and the first mounting body is used to fix the delivery pipe; The first mounting body is provided with a through hole, and the through hole is used for the conveying rod to pass through.

6. The valve leaflet repair device according to claim 5, characterized in that: Also included are rigid controls; The first end of the rigid control member is located on the side of the first end of the second clamp arm away from the fixing member, and is constructed to be detachably connected to the conveying rod. The second end of the rigid control member is fixedly connected to the second end of the second clamp arm to drive the second end of the second clamp arm to swing toward the side away from the first clamp arm under the delivery action of the conveying rod.

7. The valve leaflet repair device according to claim 6, characterized in that: Also includes connectors; The first end of the rigid control member is fixedly connected to the connecting member, and the connecting member is configured to be detachably connected to the distal end of the delivery rod.

8. The valve leaflet repair device according to claim 6, characterized in that: The first end of the rigid control member is openably disposed relative to the first end of the second clamp arm, and is configured to fit against the first end of the second clamp arm in a natural state after the delivery rod is withdrawn.

9. The valve leaflet repair device according to claim 1 or 2, characterized in that: The first clamping arm comprises a second main body section and a second bending section connected to each other; The second bending section is bent relative to the second main body section toward a side close to the second clamping arm.

10. The valve leaflet repair device according to claim 1 or 2, characterized in that: Include at least one of the following: The material of the first clamp arm includes shape memory material; The fixing member is provided with a second mounting hole, the first end of the first clamping arm is provided with a second protrusion, and the second protrusion is fixedly installed in the second mounting hole.

11. The valve leaflet repair device according to claim 1 or 2, characterized in that: It also includes limiting members arranged on both sides of the first clamping arm along the width direction; The limiting member comprises an outward extension section and a limiting section connected to each other; The outward extension section extends outwardly along the width direction relative to the first clamp arm; The limiting section extends toward a side close to the second clamping arm; The spacing between the limiting sections on both sides of the first clamping arm is greater than the width of the second clamping arm.

12. The valve leaflet repair device according to claim 1 or 2, characterized in that: Also includes a support frame; The support frame is installed on the first clamping arm and is located on a side of the first clamping arm away from the second clamping arm; The implanted leaflet is fixedly connected to a portion of the support frame close to the fixing member.

13. A valve leaflet repair system, characterized in that: include: The valve leaflet repair device according to any one of claims 1 to 12; A delivery assembly, comprising a delivery tube and a delivery rod, wherein the delivery tube is detachably connected to a fixing member of the leaflet repair device; and the delivery rod passes through the delivery tube and the fixing member in sequence; A control structure includes a rigid control part of the leaflet repair device, wherein the rigid control part is connected to at least one of the first clamp arm and the second clamp arm of the leaflet repair device, and is used to control the opening and closing angles of the first clamp arm and the second clamp arm to clamp the native leaflet, so that the implanted leaflet of the leaflet repair device becomes an extension of the native leaflet.

14. A valve leaflet repair system, characterized in that: include: The leaflet repair device according to any one of claims 1 to 5 or 9 to 12; A delivery assembly, comprising a delivery tube and a delivery rod, wherein the delivery tube is detachably connected to a fixing member of the leaflet repair device; and the delivery rod passes through the delivery tube and the fixing member in sequence; The control structure includes a first flexible control member, which passes through the delivery rod and cooperates with the second end of the second clamp arm of the leaflet repair device to control the opening and closing angles of the first clamp arm and the second clamp arm to clamp the native leaflet, so that the implanted leaflet of the leaflet repair device becomes an extension of the native leaflet.

15. The valve leaflet repair system according to claim 13 or 14, characterized in that: Also includes: Sheath; The sheath is used to deliver the leaflet repair device, the delivery assembly and the control structure to the valve.

16. A valve leaflet repair method, characterized in that: include: The leaflet repair device is delivered to the valve through the sheath; releasing the valve leaflet repair device, so that the second clamp arm of the valve leaflet repair device swings toward a side close to the first clamp arm of the valve leaflet repair device; Control the second clamp arm to approach and hook the native leaflet of the valve from below through a control structure; The opening and closing angles of the first clamp arm and the second clamp arm are controlled until the native leaflet is clamped, so that the implanted leaflet of the leaflet repair device becomes an extension of the native leaflet.

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