Leaflet repair devices, systems, and methods

Abstract

The application provides a leaflet repair device, system and method. The leaflet repair device comprises a fixing member, a first clamping arm and a second clamping arm, the first ends of the first clamping arm and the second clamping arm are respectively arranged on the fixing member, and the second ends of the first clamping arm and the second clamping arm are oppositely and openably arranged; an implanted leaflet is arranged on the first clamping arm and extends to the side of the fixing member away from the first clamping arm; the first clamping arm and the second clamping arm are configured to clamp a native leaflet, so that the implanted leaflet becomes an extension of the native leaflet. The application can achieve equivalent extension of the native leaflet, improve the regurgitation problem, will not cause the orifice to be reduced, and can be more easily replaced with a leaflet in the future.

Description

TECHNICAL FIELD

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

[0002] Mitral regurgitation is the most common heart valve disease, severe mitral regurgitation can lead to heart enlargement, heart failure, and eventually lead to patient death, which has a major impact on human health and a poor prognosis.

[0003] The previous effective treatment method is surgery, which repairs or replaces the mitral valve. Transcatheter valve therapy uses a minimally invasive approach, using specially designed instruments to reach the mitral valve from the peripheral blood vessels or apex of the heart to intervene and treat the mitral valve, which has become the direction of treatment for mitral regurgitation.

[0004] Although there are many research and development or experimental instruments for transcatheter valve therapy, the current mature mitral regurgitation interventional therapy technology is transcatheter edge-to-edge repair (TEER). The principle is to use a metal-made mitral valve clip, which is delivered to the mitral regurgitation area by catheter, and clamps the anterior and posterior native leaflets of the mitral valve, so as to reduce or eliminate the gap between the two native leaflets during systole, thus reducing or eliminating regurgitation.

[0005] Although this method is widely used, it still has some defects. First, the anterior and posterior leaflets of the mitral valve are clamped together, and the mitral valve in this area cannot open during diastole, resulting in the gap between the native leaflets of the mitral valve changing from one large hole to two small holes, causing the orifice to narrow to some extent, and the area to decrease by about half, which causes the patient to develop some degree of mitral stenosis. Moreover, for cases with a small mitral orifice, this method is obviously unsuitable. Secondly, the gap between the native leaflets of the mitral valve forms a double hole, making it extremely difficult to perform transcatheter mitral valve replacement, and it is difficult to insert an interventional valve for replacement.

[0006] In the field of surgical procedures, mitral valve repair is significantly superior to mitral valve replacement, and current guidelines at home and abroad recommend that for mitral valve surgery, repair treatment is the first choice, so transcatheter mitral valve repair is theoretically superior to transcatheter mitral valve replacement.

[0007] However, due to the obvious defects of TEER, other transcatheter mitral valve repair techniques that can repair the mitral valve without causing mitral stenosis are needed in clinical practice. SUMMARY

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

[0009] In a first aspect, an embodiment of the present application provides a leaflet repair device, comprising:

[0010] fixings;

[0011] The first clamping arm and the second clamping arm, each having a first end disposed on the fixing member, and each having a second end disposed relatively to be openable and closable;

[0012] 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;

[0013] The first clamping arm and the second clamping arm are configured to clamp the native valve leaflet such that the implanted valve leaflet becomes an extension of the native valve leaflet.

[0014] Optionally, a first hollow portion is provided between the first end and the second end of the second clamping arm;

[0015] The first clamping arm and the second clamping arm have a natural state of being close to each other for clamping;

[0016] In a natural state, the second end of the first clamping arm passes through the first hollow portion, so that the first clamping arm and the second clamping arm are arranged crosswise.

[0017] Optionally, the second clamping arm includes a first main body section and a first bending section connected to each other;

[0018] 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;

[0019] The first bending section is bent relative to the first main section toward a side away from the first clamping arm;

[0020] 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.

[0021] Optionally, the leaflet repair device includes at least one of the following:

[0022] The material of the second clamping arm includes shape memory material;

[0023] The second clamping arm has a second hollow portion, and at least part of the fixing member is located in the second hollow portion;

[0024] A first mounting hole is provided on the fixing member, a first protrusion is provided on the first end of the second clamping arm, and the first protrusion is fixedly installed in the first mounting hole.

[0025] Optionally, the fixing member includes a first mounting body, and the first mounting body is used to fix the delivery pipe;

[0026] A through hole is provided on the first mounting body, and the through hole is used for the conveying rod to pass through.

[0027] Optionally, the leaflet repair device further comprises a rigid control member;

[0028] The first end of the rigid control member is located on the side of the first end of the second clamping 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 clamping arm to drive the second end of the second clamping arm to swing toward the side away from the first clamping arm under the delivery action of the conveying rod.

[0029] Optionally, the leaflet repair device further comprises a connector;

[0030] 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.

[0031] Optionally, the first end of the rigid control member is openably and closably arranged relative to the first end of the second clamping arm, and is configured to fit against the first end of the second clamping arm in a natural state after the delivery rod is withdrawn.

[0032] Optionally, the first clamping arm includes a second main body section and a second bending section connected to each other;

[0033] The second bending section is bent relative to the second main body section toward a side close to the second clamping arm.

[0034] Optionally, the leaflet repair device includes at least one of the following:

[0035] The material of the first clamping arm includes a shape memory material;

[0036] A second mounting hole is provided on the fixing member, a second protrusion is provided on the first end of the first clamping arm, and the second protrusion is fixedly installed in the second mounting hole.

[0037] Optionally, the leaflet repair device further includes limiting members provided on both sides of the first clamping arm along the width direction;

[0038] The limiting member includes an outward extension section and a limiting section connected thereto;

[0039] The outward extension section extends outward along the width direction relative to the first clamping arm;

[0040] The limiting section extends toward a side close to the second clamping arm;

[0041] The spacing between the limiting sections on both sides of the first clamping arm is greater than the width of the second clamping arm.

[0042] Optionally, the leaflet repair device further comprises a support frame;

[0043] 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;

[0044] The implanted leaflet is fixedly connected to the portion of the support frame close to the fixing piece.

[0045] In a second aspect, an embodiment of the present application provides a valve leaflet repair system, comprising:

[0046] A valve leaflet repair device as described above;

[0047] The delivery assembly includes a delivery tube and a delivery rod, wherein the delivery tube is detachably connected to the fixing member of the valve leaflet repair device; the delivery rod passes through the delivery tube and the fixing member in sequence;

[0048] The control structure includes a rigid control part of the leaflet repair device, which is connected to at least one of the first clamping arm and the second clamping arm of the leaflet repair device, and is used to control the opening and closing angles of the first clamping arm and the second clamping arm to clamp the native leaflet, so that the implanted leaflet of the leaflet repair device becomes an extension of the native leaflet.

[0049] In a third aspect, an embodiment of the present application provides a valve leaflet repair system, comprising:

[0050] A valve leaflet repair device as described above;

[0051] The delivery assembly includes a delivery tube and a delivery rod, wherein the delivery tube is detachably connected to the fixing member of the valve leaflet repair device; the delivery rod passes through the delivery tube and the fixing member in sequence;

[0052] The control structure includes a first flexible control member, which passes through the delivery rod and cooperates with the second end of the second clamping arm of the leaflet repair device to control the opening and closing angles of the first clamping arm and the second clamping arm to clamp the native leaflet, so that the implanted leaflet of the leaflet repair device becomes an extension of the native leaflet.

[0053] Optionally, the leaflet repair system further comprises: a sheath;

[0054] The sheath is used to deliver the leaflet repair device, delivery assembly, and control structure to the valve.

[0055] In a fourth aspect, an embodiment of the present application provides a leaflet repair method, comprising:

[0056] The leaflet repair device is delivered to the valve through the sheath;

[0057] releasing the leaflet repair device, causing the second clamping arm of the leaflet repair device to swing toward a side close to the first clamping arm of the leaflet repair device;

[0058] The control structure controls the second clamping arm to approach and hook the native leaflet of the valve from below;

[0059] The opening and closing angles of the first clamping arm and the second clamping 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.

[0060] The beneficial technical effects brought about by the technical solutions provided in the embodiments of the present application include:

[0061] In an embodiment of the present application, the first end of the first clamp arm and the first end of the second clamp arm are respectively arranged on the fixing member, the implanted leaflet is partially arranged on the first clamp arm, and the fixing member is used to support 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 openable, 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 improving the regurgitation problem.

[0062] Furthermore, in this embodiment of the present application, the implanted leaflet of a valve leaflet repair device is clamped to a native leaflet by the first and second clamping arms, effectively extending the native leaflet. Any two native leaflets remain independent of each other, without interfering with each other, and different native leaflets of the same valve can open normally during diastole.

[0063] Compared to the related art method of clamping two leaflets together, which results in a narrowing of the valve orifice and is unsuitable for patients with stenosis, the leaflet repair device of the embodiment of the present application acts on a single native leaflet. The implanted leaflet moves along with the clamped native leaflet, eliminating the need for two native leaflets to be used together and without interfering with or obstructing the other native leaflets. Therefore, using the implanted leaflet to extend the native leaflet does not result in a narrowing of the valve orifice, and can basically maintain the original valve orifice size. It is also suitable for patients with stenosis and has a wide range of applications.

[0064] 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.

[0065] In this embodiment of the present application, when implanting the valve leaflet repair device, the first and second clamping arms are controlled to achieve unilateral clamping of the native valve leaflet, thereby clamping the implanted valve leaflet against the native leaflet. This can be based on previous clinical practice, making the surgical operation highly feasible and shortening the learning cycle for doctors.

[0066] Additional aspects and advantages of the present application will be given in part in the following description, which will become apparent from the following description, or will be learned through practice of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0067] 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:

[0068] 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;

[0069] 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;

[0070] 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;

[0071] 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;

[0072] Figure 5 A schematic top view of the first clamping arm of a leaflet repair device provided in an embodiment of the present application;

[0073] Figure 6 A schematic side view of the first clamping arm of a leaflet repair device provided in an embodiment of the present application;

[0074] 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;

[0075] Figure 8 A schematic structural diagram showing a perspective view 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;

[0076] Figure 9 A schematic structural diagram showing 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 from another perspective;

[0077] Figure 10 A bottom-view structural diagram 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;

[0078] Figure 11 A schematic 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;

[0079] Figure 12 A schematic structural diagram of the connection between a second clamping arm, a rigid control member, and a fixing member of a leaflet repair device provided in an embodiment of the present application;

[0080] Figure 13 A schematic structural diagram of the connection between a first clamping arm, a second clamping arm, a rigid control member, and a fixing member of a leaflet repair device provided in an embodiment of the present application;

[0081] Figure 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;

[0082] Figure 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;

[0083] Figure 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;

[0084] Figure 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;

[0085] Figure 18 A schematic structural diagram of a valve leaflet repair device provided in an embodiment of the present application;

[0086] Figure 19 A schematic structural diagram of a delivery tube of a leaflet repair system provided in an embodiment of the present application from one perspective;

[0087] Figure 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;

[0088] Figure 21 A schematic structural diagram of a delivery rod of a leaflet repair system provided in an embodiment of the present application;

[0089] Figure 22 A schematic diagram of the structure of the connection between a delivery assembly, a first clamping arm, a second clamping arm, a rigid control member, and a fixing member of a leaflet repair system provided in an embodiment of the present application;

[0090] Figure 23 A schematic diagram of a partially exploded structure of a delivery assembly, a first clamping arm, a second clamping arm, a rigid control member, and a fixing member of a leaflet repair system provided in an embodiment of the present application;

[0091] Figure 24 for Figure 23 A partial enlarged view of an angle;

[0092] Figure 25 for Figure 23 A partial enlarged view from another angle;

[0093] Figure 26 A schematic structural diagram of a valve leaflet repair system provided in an embodiment of the present application;

[0094] Figure 27 A schematic diagram of the exploded structure of a leaflet repair system provided in an embodiment of the present application;

[0095] Figure 28 A schematic side view of a valve leaflet repair system provided in an embodiment of the present application;

[0096] Figure 29 A schematic diagram of a top view of a valve leaflet repair system provided in an embodiment of the present application;

[0097] Figure 30 A flow chart of a leaflet repair method provided in an embodiment of the present application.

[0098] Reference numerals:

[0099] 100-Leaflet Repair Device;

[0100] 10-fixing parts;

[0101] 11-first mounting hole; 12-first mounting body; 13-through hole; 14-second mounting hole; 15-second mounting body; 16-slot;

[0102] 21- first clamping arm;

[0103] 211 - second main body section; 212 - second bending section; 213 - second protrusion; 214 - anchoring member; 215 - control hole; 23 - limiting structure; 231 - limiting member; 232 - extension section; 233 - limiting section;

[0104] 22- second clamping arm;

[0105] 221 - first hollow portion; 222 - first main section; 223 - first bending section; 224 - first protrusion; 225 - second hollow portion;

[0106] 30-implantation of valve leaflets;

[0107] 41- Rigid control member; 42- Connecting member;

[0108] 50-support frame;

[0109] 111 - delivery tube; 112 - delivery rod; 113 - buckle. DETAILED DESCRIPTION

[0110] The following describes the embodiments of the present application in conjunction with the accompanying drawings. It should be understood that the embodiments described below in conjunction with the accompanying 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.

[0111] Those skilled in the art will understand that, unless otherwise stated, the terms "said" and "the" used herein may also include plural forms. It should be further understood that the term "including" used in the specification of this 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" can be implemented as "A", or as "B", or as "A and B".

[0112] In order to make the objectives, technical solutions and advantages of this application clearer, the implementation methods of this application will be further described in detail below with reference to the accompanying drawings.

[0113] It should be noted that, in the embodiment of the present application, "lower" refers to the side close to the ventricle when the device is implanted in the valve (such as the mitral valve); "upper" refers to the side close to the atrium when the device is implanted in the valve (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.

[0114] It should be noted that in the embodiments of the present application, valves include membranous structures that can open and close inside organs of humans or certain animals. Taking the valves of the human heart as an example, the human heart includes four valves: 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.

[0115] It should be noted that in the embodiments of the present application, the valve includes at least two leaflets, which are close to each other and fit together, eliminating the gap between the leaflets and achieving valve closure. For example, the aortic valve and pulmonary valve each include three semilunar valves (i.e., each includes three leaflets), 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.

[0116] Based on the principle of surgical valve extension and repair, this 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, solving the regurgitation problem and the technical problems in related technologies such as valve orifice narrowing and subsequent difficulty in valve replacement after valve repair.

[0117] 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-mentioned technical problems with specific embodiments. It should be noted that the following embodiments can refer to, draw on, or combine with each other, and the same terms, similar features, and similar implementation steps in different embodiments will not be repeated.

[0118] The embodiment of the present application provides a leaflet repair device 100, the structure diagram of the leaflet repair device 100 is as follows Figures 1 to 18 As shown, the device comprises: a fixing member 10, a first clamping arm 21, a second clamping arm 22, and an implanted leaflet 30. The first end (i.e., proximal end) of each of the first clamping arm 21 and the second clamping arm 22 is respectively disposed on the fixing member 10, and the second end (i.e., distal end) of each of the first clamping arm 21 and the second clamping arm 22 is relatively openable and closable. The implanted leaflet 30 is partially disposed on the first clamping arm 21 and extends to the side of the fixing member 10 away from the first clamping arm 21. The first clamping arm 21 and the second clamping arm 22 are configured to clamp the native leaflet, so that the implanted leaflet 30 becomes an extension of the native leaflet.

[0119] 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 arranged on the fixing member 10, and the implanted leaflet 30 is partially arranged on the first clamp arm 21. 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 openable, 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. 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, helping to reduce or even eliminate the gap between the native leaflets during contraction and improve the regurgitation problem.

[0120] Furthermore, in this embodiment of the present application, the implanted leaflet 30 of a leaflet repair device 100 is clamped to a native leaflet by the first clamping arm 21 and the second clamping arm 22, effectively extending the native leaflet. Any two native leaflets remain independent of each other, without interfering with each other, and the different native leaflets of the same valve can open normally during diastole.

[0121] Compared to the related art method of clamping two leaflets together, which results in a narrowing of the valve orifice and is unsuitable for patients with stenosis, the leaflet repair device 100 of the present embodiment acts on a single native leaflet. The implanted leaflet 30 moves along with the clamped native leaflet, eliminating the need for both leaflets and preventing interference or obstruction with the other leaflets. Therefore, using the implanted leaflet 30 to extend the native leaflet does not result in a narrowing of the valve orifice, but can essentially maintain the original size of the valve orifice. This makes it equally applicable to patients with stenosis and has a wide range of applications.

[0122] 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 native leaflet replacement. Whether it is a native leaflet with an implanted leaflet 30 clamped or a native leaflet without an implanted leaflet 30 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.

[0123] In this embodiment of the present application, when implanting the leaflet repair device 100, the first clamping arm 21 and the second clamping arm 22 are controlled to achieve unilateral clamping of the native leaflet, thereby clamping the implanted leaflet 30 on the native leaflet. This is based on previous clinical practice, making the surgical operation more feasible and shortening the learning cycle for doctors.

[0124] Optionally, in the embodiments of the present application, the valve leaflet repair device 100 can be applied to the human body or other animals. Furthermore, the valve leaflet repair device 100 can be applied to valve structures such as the aortic valve, pulmonary valve, mitral valve, and tricuspid valve in the human heart, or to other diseases requiring sheet-like extension of human tissue.

[0125] Optionally, in an embodiment of the present application, the leaflet repair device 100 can be implanted into the diseased native leaflet.

[0126] 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.

[0127] Optionally, in the embodiment of the present application, a leaflet repair device 100 can be installed on one native leaflet of the same valve. Of course, according to actual needs, leaflet repair devices 100 can also be installed on two or more, or even all, native leaflets of the same valve in a one-to-one correspondence. The implanted leaflets 30 of the corresponding leaflet repair devices 100 form an extension of the native leaflet, thereby extending one, two, or more, or even all of the native leaflets of the same valve.

[0128] 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.

[0129] 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.

[0130] Optionally, in an embodiment of the present application, if an extension is added to one native leaflet of the 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.

[0131] In this way, when an extension is added to part of the native leaflets of the valve, and during the contraction period, the added extension and the native leaflets without the extension fit together, which can eliminate the gaps between the native leaflets of the valve; when an extension is added to all of the native leaflets of the valve, and during the contraction period, the added extensions fit together, which can eliminate the gaps between the native leaflets of the valve; thereby closing the valve and solving the reflux problem.

[0132] Optionally, in the embodiment of the present application, the first clamping arm 21 and the second clamping arm 22 have deformability and shape memory when clamped in a natural state. That is, the first clamping arm 21 and the second clamping arm 22 can memorize the clamped shape. When the first clamping arm 21 and the second clamping arm 22 are deformed by an external force, the first clamping arm 21 and the second clamping arm 22 can naturally return to the clamped shape when the external force disappears.

[0133] In this way, when it is necessary to clamp the native leaflet using 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. Using the shape memory effect, the first clamp arm 21 and the second clamp arm 22 switch to the natural clamping state, thereby clamping the native leaflet.

[0134] Optionally, in the embodiment of the present application, the second clamping arm 22 is made of a shape memory material. The first clamping arm 21 is made of a shape memory material.

[0135] Optionally, in an embodiment of the present application, the shape memory material includes but is not limited to nickel-titanium alloy.

[0136] Alternatively, as Figure 8 、 Figure 9 、 Figure 11 and Figure 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, which is fixedly mounted in the first mounting hole 11. The second clamping arm 22 and the fixing member 10 are fixed together by the first protrusion 224 and the first mounting hole 11.

[0137] Alternatively, as Figures 1 to 6 as well as Figure 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, which is fixedly mounted in the second mounting hole 14. The first clamping arm 21 and the fixing member 10 are fixed together by the second protrusion 213 and the second mounting hole 14.

[0138] 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 clamping arm 21 and the first end of the second clamping arm 22, respectively. The first end of the first clamping arm 21 serves as the fixed end of the first clamping arm 21, and the first end of the second clamping arm 22 serves as the fixed end of the second clamping arm 22. In a natural state, the first clamping arm 21 and the second clamping arm 22 are fixed to the same side of the fixing member 10 and are parallel and close together to form a pair of clamps.

[0139] Optionally, in the embodiment of the present application, the manner 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, snapping, interference fit, welding (such as laser welding), etc.

[0140] Alternatively, as Figures 1 to 6 、 Figure 8 、 Figure 9 、 Figure 11 、 Figure 24 and Figure 25 As shown, in the embodiment of the present application, there is one first protrusion 224 and one first mounting hole 11, and two second protrusions 213 and two second mounting holes 14, respectively.

[0141] It should be noted that the number of first protrusions 224, first mounting holes 11, second protrusions 213, and second mounting holes 14 can be increased, decreased, or adjusted based on actual needs. The number of first mounting holes 11 is greater than or equal to the number of first protrusions 224. The number of second mounting holes 14 is greater than or equal to the number of second protrusions 213.

[0142] Alternatively, as 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-shaped 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 provided 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.

[0143] Alternatively, as 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.

[0144] 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.

[0145] Alternatively, as 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 clamping arm 22; the first clamping arm 21 and the second clamping arm 22 have a natural state of being close to each other for clamping; in the natural state, the second end of the first clamping arm 21 passes through the first hollow portion 221, so that the first clamping arm 21 and the second clamping arm 22 are cross-arranged.

[0146] In the embodiment of the present application, the first ends of the first clamping arm 21 and the second clamping arm 22 are respectively fixed on the fixing member 10. In the natural state, the first clamping arm 21 and the second clamping arm 22 form a pair of clamps, and the second end of the first clamping arm 21 is inserted into the first hollow portion 221 of the second clamping arm 22, so that the first clamping arm 21 and the second clamping arm 22 are in a cross state to strengthen the clamping force between the first clamping arm 21 and the second clamping arm 22.

[0147] In the embodiment of the present application, the second end of the first clamping arm 21 serves as the free end of the first clamping arm 21 , and the second end of the second clamping arm 22 serves as the free end of the second clamping arm 22 .

[0148] Optionally, the free end of the second clamping arm 22 is a rounded blunt structure, which can reduce damage to the human body.

[0149] Alternatively, as Figure 13 As shown, in the embodiment of the present application, the overall length of the first clamping arm 21 is smaller than the overall length of the second clamping arm 22 .

[0150] Alternatively, as Figures 8 to 11As shown, in the embodiment of the present application, the second clamping 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 clamping arm 22; the first bending section 223 is bent relative to the first main body section 222 toward a side away from the first clamping 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 clamping arm 22, which is fixed on the fixing member 10.

[0151] In the embodiment of the present application, the first main section 222 and the first bending section 223 are connected and along the entire length direction (eg Figure 10 The first bent section 223 bends relative to the first main section 222 toward the side away from the first clamping arm 21, thereby increasing the overall strength of the second clamping arm 22. The end of the first bent 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 bent 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, while the first end of the second clamping arm 22 is farther away from the first clamping arm 21.

[0152] Alternatively, as Figure 8 and Figure 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 .

[0153] Alternatively, as Figure 8 、 Figure 9 and Figure 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.

[0154] Alternatively, as Figure 8 、 Figure 9 and Figure 12 As shown, in this embodiment of the present application, the second hollow portion 225 is connected to the first hollow portion 221. The first bent section 223 is bent relative to the first main section 222 to improve structural strength. A large portion of the center of the second clamping arm 22 is hollowed out to form the connected first hollow portion 221 and second hollow portion 225. This reduces the weight of the second clamping arm 22 and facilitates machining. This arrangement reduces the weight of the second clamping arm 22 while maintaining its structural strength and improving stability.

[0155] Alternatively, as Figure 8 and Figure 9As shown, in the embodiment of the present application, the first protrusion 224 is disposed within the second hollow portion 225. Furthermore, the first protrusion 224 is disposed at the end of the first bent section 223 away from the first main section 222 and toward the second hollow portion 225. This arrangement allows the fixing member 10 to be stably installed within the second hollow portion 225.

[0156] 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.

[0157] Alternatively, as Figure 1 、 Figure 2 、 Figures 22 to 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.

[0158] Alternatively, as in 1, Figure 2 、 Figure 23 and Figure 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.

[0159] Alternatively, as Figure 1 、 Figure 2 、 Figure 19 、 Figure 20 、 Figure 22 and Figure 24 As shown, in the embodiment of the present application, a card slot 16 is provided on the side wall of the first installation body 12, and the card slot 16 is used to engage with the buckle 113 on the delivery tube 111, so that the first installation body 12 fixes the delivery tube 111, which is convenient for assembly and disassembly.

[0160] Alternatively, as Figure 1 、 Figure 2 、 Figure 19 and Figure 20 As shown, in the embodiment of the present application, there are at least two slots 16 , which are spaced apart along the circumference of the first mounting body 12 . There are at least two buckles 113 , which are spaced apart along the circumference of the delivery tube 111 .

[0161] Optionally, at least two slots 16 and at least two buckles 113 are evenly distributed.

[0162] Optionally, the number of the buckles 113 is less than or equal to the number of the slots 16 .

[0163] Alternatively, as Figures 8 to 12 、 Figure 23 as well as Figure 24As shown, in an 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.

[0164] 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 move the first end of the rigid control member 41 together, thereby causing the second end of the rigid control member 41 and the second end of the second clamping arm 22 to swing, thereby controlling the opening and closing angle of the second clamping arm 22 relative to the first clamping arm 21.

[0165] Alternatively, as Figures 8 to 12 、 Figure 23 as well as Figure 24 As shown, in this embodiment of the present application, the leaflet repair device 100 further includes a connector 42; a 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 via the connector 42.

[0166] 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.

[0167] Optionally, in this embodiment of the present application, the connector 42 has a threaded hole on its upper surface that connects to and detaches from the threaded end of the delivery rod 112. The connector 42 is threadedly connected to the delivery rod 112, facilitating assembly and disassembly. Once the leaflet repair device 100 is installed, if the delivery rod 112 needs to be removed, the delivery rod 112 is unscrewed from the connector 42 to facilitate removal.

[0168] 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 clamping arm 22, and the first end is connected to the connecting member 42. 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 fixed member 10 can be moved toward and away from each other. When the connecting member 42 and the fixed member 10 move away from each other, the rigid control member 41 can be operated to swing the second clamping arm 22 downward, and the free end of the second clamping arm 22 can be moved downward toward the center (i.e., swinging away from the first clamping arm 21 and toward the axial direction of the conveying rod 112), thereby increasing the angle between the second clamping arm 22 and the first clamping arm 21.

[0169] Optionally, in the embodiment of the present application, the first end of the rigid control member 41 is configured to be openable and closable relative to the first end of the second clamping arm 22, and is configured to fit against the first end of the second clamping arm 22 in a natural state after the delivery rod 112 is withdrawn. In the natural state, the rigid control member 41 fits against the second clamping arm 22. This configuration can reduce the space occupied by the second clamping 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 against the second clamping arm 22, occupying less space in the human body and avoiding obstruction or impact on human tissue.

[0170] Optionally, in the embodiment of the present application, the rigid control member 41 and the second clamping arm 22 have deformability and shape memory, allowing them to fit together in their natural state. That is, the rigid control member 41 and the second clamping arm 22 can memorize their fitted shape. While the rigid control member 41 and the second clamping arm 22 deform under the action of the conveying rod 112, the rigid control member 41 can naturally return to its fitted shape relative to the second clamping arm 22 when the action of the conveying rod 112 is removed.

[0171] 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.

[0172] 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.

[0173] 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.

[0174] Optionally, in the embodiment of the present application, the rigid control member 41 and the second clamping arm 22 are integral V-shaped spring clips, with a minimal angle between them. 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 clip is made of a shape-memory metal. In a natural state, the two open ends of the rigid control member 41 and the second clamping arm 22 naturally fit together, causing the connecting member 42 and the fixing member 10 to naturally come together, and the rigid control member 41 and the second clamping arm 22 form an I-shape. By operating the conveying rod 112, the free ends of the rigid control member 41 and the second clamping arm 22 can be separated, and the I-shape becomes a V-shape, thereby achieving the downward swing of the second clamping arm 22.

[0175] In other optional embodiments of the present application, a riveting structure is contained 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. At this time, the control structure is an independent structure.

[0176] 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 clamping 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 downward swing of the second clamping arm 22 toward the center.

[0177] It should be noted that when the control structure for controlling the swing of the second clamp arm 22 is the first flexible control member, the first 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 leaflet (that is, the leaflet repair device 100 is installed in place).

[0178] Alternatively, as Figures 3 to 6 As shown, in the embodiment of the present application, the first clamping 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 clamping arm 22 .

[0179] In this embodiment of the present application, the second clamping arm 22 hooks onto the native leaflets from below, and the first clamping arm 21 anchors the native leaflets to the second clamping arm 22, achieving clamping. The second bent section 212 of the first clamping arm 21 is bent relative to the second main section 211, allowing the shape of the first clamping arm 21 to more closely match or match the shape of the native leaflets, improving adaptability and anchoring effectiveness, and enhancing structural strength.

[0180] Alternatively, as Figures 3 to 7As shown, in the embodiment of the present application, the end of the second main body section 211 away from the second bending section 212 serves as the first end of the first clamping arm 21, which is fixed on the fixing member 10; the end of the second bending section 212 away from the second main body section 211 serves as the second end of the first clamping arm 21, that is, the free end of the first clamping arm 21.

[0181] 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.

[0182] Optionally, in the embodiment of the present application, the control structure for controlling the swing of the first clamping arm 21 includes a second flexible control member, which includes but is not limited to a control wire. A control hole 215 is provided in the first clamping arm 21. The control wire passes through the control hole 215 and then travels into the conveying assembly. The control wire enables the first clamping arm 21 to swing upward toward the center (i.e., away from the second clamping arm 22 and toward the conveying tube 111 and conveying rod 112), thereby pulling the first clamping arm 21 closer to the conveying assembly so that the two overlap. When the control wire is released, the free end of the first clamping arm 21 moves away from the conveying assembly, and the first clamping arm 21 and the conveying assembly form an angle.

[0183] It should be noted that the second flexible control member needs to be removed from the human body after the first clamping arm 21 and the second clamping arm 22 are clamped on the native leaflet (ie the leaflet repair device 100 is installed in place).

[0184] Alternatively, as 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.

[0185] Alternatively, as Figure 3 As shown, in the embodiment of the present application, a plurality of anchors 214 are provided on both sides of the first clamping arm 21. The anchors 214 are sharp barbs extending downward (i.e., toward the side close to the second clamping arm 22). The plurality of anchors 214 are symmetrically arranged in rows.

[0186] 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 a nickel-titanium memory metal sheet.

[0187] Alternatively, as Figures 3 to 7 as well as Figure 13 As shown, in the embodiment of the present application, the leaflet repair device 100 also includes a limiting structure 23, which is arranged on the first clamping arm 21. The limiting structure 23, the first clamping arm 21 and the second clamping arm 22 form a limiting space, which is used to prevent the first clamping arm 21 and the second clamping arm 22 from swinging relative to the native leaflet along the overall width direction after the first clamping arm 21 and the second clamping arm 22 clamp the native leaflet, so as to make the clamping more stable.

[0188] Alternatively, as Figures 3 to 7 as well as Figure 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 members 231 are provided on both sides of the first clamping arm 21 (in the left and right directions as shown); 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.

[0189] In an 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 leaflet, the two limiting sections 233 are located on the outside 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 leaflet clamped between the first clamp arm 21 and the second clamp arm 22, preventing the native leaflet 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 leaflet along the width direction, thereby improving the anchoring effect.

[0190] In the embodiment of the present application, the limiting section 233 is fixedly connected to the first clamping arm 21 via the outward extension section 232. The outward extension section 232 extends outward relative to the first clamping arm 21 along the width direction, so that the spacing between the limiting sections 233 located on both sides of the first clamping arm 21 along the width direction is greater than the width of the first clamping arm 21 and the width of the second clamping arm 22.

[0191] 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 .

[0192] Alternatively, as Figure 3 and Figure 5 As shown, in the embodiment of the present application, the limiting structure 23 is provided on the second main section 211, and two limiting members 231 are provided on both sides of the second main section 211 along the width direction. Of course, the limiting structure 23 can also be provided on the second bending section 212, or the limiting structures 23 can be provided on both the second main section 211 and the second bending section 212, depending on actual needs.

[0193] Alternatively, as 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.

[0194] Alternatively, as Figures 3 to 5 As shown, in the embodiment of the present application, the stopper 231 is a large barb. It first expands outward from the plane of the first clamping arm 21 to form an outward extension section 232, and then bends downward to form a stopper section 233, thereby increasing the lateral anchoring range of the first clamping arm 21. This ensures that the first clamping arm 21 and the second clamping arm 22 will not swing laterally after clamping the native valve leaflet.

[0195] Alternatively, as Figure 16 and Figure 17 As shown, in the embodiment of the present application, the leaflet repair device 100 further includes a support frame 50; the support frame 50 is mounted on the first clamping arm 21 and is located on a side of the first clamping arm 21 away from the second clamping arm 22; the implanted leaflet 30 is fixedly connected to the portion of the support frame 50 near the fixing member 10. The implanted leaflet 30 is fixedly mounted on the first clamping arm 21 via the support frame 50.

[0196] Optionally, in the embodiment of the present application, the surface of the support frame 50 can be sutured with polymers or biological membranes to promote rapid endothelialization after the device is implanted in the human body.

[0197] 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 force disappears, the support frame 50 can return to the shape in the natural state.

[0198] Alternatively, as Figure 16 and Figure 17 As shown, in the embodiment of the present application, the support frame 50 is a mesh structure or a sheet structure.

[0199] Alternatively, as Figure 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 clamping 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 clamping arm 21, and the width of the first end of the support frame 50 is greater than the width of the second end.

[0200] 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 triangular, trapezoidal, heart-shaped or fan-shaped.

[0201] Optionally, in the embodiment of the present application, the support frame 50 is a sheet-shaped structure (e.g., triangular, trapezoidal, or quasi-trapezoidal, heart-shaped, or fan-shaped) braided from nickel-titanium wire, with a narrow distal end and a wide proximal end. The support frame 50 is attached to the atrial surface of the first clamping 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 clamping arm 21. The proximal end of the support frame 50 is wider, forming a base, which is connected to the fixed end of the first clamping arm 21 and the fixing member 10.

[0202] Alternatively, as Figure 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 side close to 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.

[0203] In the embodiment of the present application, both sides of the support frame 50 can be recessed downward to form an arc shape, so that the proximal end of the support frame 50 can fit the native valve leaflet when implanted in the human body.

[0204] Optionally, in an embodiment of the present application, the implanted leaflet 30 is a sheet of biological tissue, which is connected and sutured to the side of the support frame 50 close to the fixing member 10 and is a functional component of the entire leaflet repair device 100.

[0205] Optionally, in the embodiment of the present application, the implanted leaflet 30 may be made of prosthetic leaflet materials currently used in clinical practice, such as bovine pericardium, porcine pericardium, animal leaflets, or polymers.

[0206] In the embodiment of the present application, the leaflet repair device 100 specifically includes: a first clamping arm 21, a second clamping arm 22, a fixing member 10, a support frame 50, an implanted leaflet 30, a rigid control member 41 and a connecting member 42.

[0207] The first clamping arm 21 is a long sheet of metal sheet, which is cut from a nickel-titanium metal sheet by laser. The two side edges of the long strip are respectively provided with a plurality of downward sharp spikes.

[0208] The second clamping arm 22 is also made of a nickel-titanium metal sheet, and most of its central area is hollowed out.

[0209] The fixed ends of the first clamping arm 21 and the second clamping arm 22 are fixed on the fixing member 10, and the free ends are arranged relatively to be clamped to form a pair of clamps, and the free end of the first clamping arm 21 is inserted into the central hollow area of ​​the second clamping arm 22, so that the first clamping arm 21 and the second clamping arm 22 are in a staggered state to strengthen the clamping force between the first clamping arm 21 and the second clamping arm 22.

[0210] 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.

[0211] The second mounting body 15 of the fixing member 10 is a block of metal and is connected to the fixed 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.

[0212] The support frame 50 is a sheet-like structure made of nickel-titanium wire, which is narrow at the distal end and wide at the proximal end. It is attached to the atrial surface of the first clamping arm 21 and the fixing member 10 to expand the width and area of ​​the first clamping arm 21.

[0213] 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.

[0214] The connecting member 42 is a rounded, blunt structure that is connected to the end of the delivery rod 112 and can be separated therefrom. One end of the rigid control member 41 is connected to the free end of the second clamping 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 moved closer to and separated from each other.

[0215] The leaflet repair device 100 provided in the embodiment of the present application can extend the leaflet through minimally invasive catheter intervention, thereby repairing the valve and solving the regurgitation problem.

[0216] Based on the same inventive concept, the embodiment of the present application (first specific example) provides a valve leaflet repair system, the structural diagram of which is shown in FIG. 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.

[0217] 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.

[0218] The control structure includes a rigid control part 41 of the leaflet repair device 100, which is connected to at least one of the first clamping arm 21 and the second clamping arm 22 of the leaflet repair device 100, and is used to control the opening and closing angles of the first clamping arm 21 and the second clamping 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.

[0219] 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 clamping 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 clamping arm 22 to swing relative to the first clamping arm 21, thereby adjusting the opening and closing angle between the second clamping arm 22 and the first clamping arm 21, so that the second clamping arm 22 and the first clamping arm 21 can clamp the native leaflet, thereby making the implanted leaflet 30 an extension of the native leaflet.

[0220] 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.

[0221] Alternatively, as 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, and 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 and is detachably connected to the connecting member 42.

[0222] 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 clamping arm 21 to swing relative to the second clamping arm 22, thereby adjusting the opening and closing angle between the first clamping arm 21 and the second clamping arm 22, so as to facilitate the second clamping arm 22 and the first clamping arm 21 to clamp the native leaflet.

[0223] 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.

[0224] The embodiments of the present application provide a transcatheter leaflet extension and repair system, which uses a minimally invasive transcatheter interventional approach to extend the leaflets, thereby repairing the valve and solving the regurgitation problem.

[0225] 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 tube and transported in the tube. When it reaches the surgical site, the delivery sheath is pushed out and the device can be restored to the designed large block shape. Therefore, it can meet the requirements of minimally invasive intervention through a catheter and reduce the trauma of the operation.

[0226] Optionally, in embodiments of the present application, the valve leaflet repair system can be applied to humans or other animals. Furthermore, the valve leaflet repair system can be applied to valve structures such as the aortic valve, pulmonary valve, mitral valve, and tricuspid valve in the human heart, or to other diseases requiring sheet-like extension of human tissue.

[0227] Based on the same inventive concept, the embodiment of the present application (the second specific example) provides a valve leaflet repair system, the structural diagram of which is shown in FIG. Figures 19 to 29 As shown (the rigid control member 41 is replaced by a first flexible control member), the leaflet repair system includes: the leaflet repair device 100 as described above, a delivery component and a control structure.

[0228] 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.

[0229] 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 clamping arm 22 of the leaflet repair device 100 to control the opening and closing angles of the first clamping arm 21 and the second clamping 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.

[0230] 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 first flexible control member and the second flexible control member) to the valve.

[0231] 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.

[0232] It should be noted that the differences between the second embodiment of the present application and the first embodiment include: in the first embodiment, the control structure for controlling the swing of the second clamp arm 22 includes a rigid control member 41. After the delivery assembly is withdrawn, the rigid control member 41 naturally returns to a state of contact with the second clamp arm 22 and remains in the body with the second clamp arm 22. In the second embodiment, the control structure for controlling the swing of the second clamp arm 22 includes a first flexible control member, which is withdrawn from the body along with the delivery assembly.

[0233] The remaining structures and design methods 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.

[0234] Based on the same inventive concept, the present application provides a leaflet repair method, the flow chart of which is as follows: Figure 30 As shown, the leaflet repair method includes:

[0235] S101 . Deliver the leaflet repair device 100 to the valve through the sheath.

[0236] 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 .

[0237] S103 , controlling the second clamping arm 22 to approach and hook the native leaflet of the valve from below through the control structure.

[0238] 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.

[0239] 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.

[0240] In an 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 clamping arm 21 and the second clamping arm 22 of the leaflet repair device 100 have a tendency to automatically recover to a natural state, so that the second clamping arm 22 swings toward the side close to the first clamping arm 21; then, the second clamping 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 clamping arm 21 and the second clamping 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.

[0241] 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 use 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.

[0242] 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.

[0243] Optionally, in 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:

[0244] like Figure 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).

[0245] Optionally, at this time, the control structure (such as the second flexible control member) connected to the first clamping arm 21 is tensioned so that the first clamping arm 21 is stationary relative to the fixing member 10, and there is a tendency for the second end of the first clamping arm 21 (or the second bending section 212) to move closer to the fixing member 10 while rotating upward with the fixing member 10 as the rotation axis.

[0246] 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 leaflets of the valve from below by the control structure includes:

[0247] like Figure 28 As shown, the position and angle of the second clamping arm 22 relative to the native leaflet are adjusted through the conveying rod 112 of the conveying assembly and the control structure (such as the rigid control member 41 or the first flexible control member) connected to the second clamping arm 22, so that the second clamping arm 22 approaches and hooks the native leaflet from below to facilitate clamping of the native leaflet.

[0248] Optionally, in step S104 of the embodiment of the present application, controlling the opening and closing angles of the first clamping arm 21 and the second clamping arm 22 until the native leaflets are clamped, so that the implanted leaflets 30 of the leaflet repair device 100 become extensions of the native leaflets, includes:

[0249] like Figure 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 being clamped with the second clamp arm 22, and the second clamp arm 22 hooks the native leaflet from below. 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.

[0250] The following describes the operation process using the leaflet repair system applied to the mitral valve or the leaflet repair method to repair the mitral valve as an example:

[0251] The first clamping arm 21 and the second clamping arm 22 of the leaflet repair device 100 are straightened upward and downward respectively to fit into the delivery assembly, and then compressed and loaded into the delivery sheath. The delivery sheath is delivered through the femoral vein through the atrial septum to the top of the mitral valve orifice, and the leaflet repair device 100 is delivered to the mitral valve orifice through the delivery sheath.

[0252] 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 with it; by operating the conveying assembly, the second clamp arm 22 is moved close to the diseased native leaflet and hooks the native leaflet from below; the control line of the first clamp arm 21 is loosened, so that the end of the first clamp arm 21 is moved 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 leaflet of the human body.

[0253] 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 part 42, and the delivery tube 111 and the fixing part 10 are disengaged respectively, thereby releasing the entire leaflet repair device 100 and finally completing the operation.

[0254] If the effect is not satisfactory, the clamping between the first clamping arm 21 and the second clamping arm 22 can be loosened through the control structure and readjusted.

[0255] 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.

[0256] By applying the embodiments of the present application, at least the following beneficial effects can be achieved:

[0257] In an embodiment of the present application, the first end of the first clamp arm and the first end of the second clamp arm are respectively arranged on the fixing member, the implanted leaflet is partially arranged on the first clamp arm, and the fixing member is used to support 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 openable, 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 improving the regurgitation problem.

[0258] Furthermore, in this embodiment of the present application, the implanted leaflet of a valve leaflet repair device is clamped to a native leaflet by the first and second clamping arms, effectively extending the native leaflet. Any two native leaflets remain independent of each other, without interfering with each other, and different native leaflets of the same valve can open normally during diastole.

[0259] Compared to the related art method of clamping two leaflets together, which results in a narrowing of the valve orifice and is unsuitable for patients with stenosis, the leaflet repair device of the embodiment of the present application acts on a single native leaflet. The implanted leaflet moves along with the clamped native leaflet, eliminating the need for two native leaflets to be used together and without interfering with or obstructing the other native leaflets. Therefore, using the implanted leaflet to extend the native leaflet does not result in a narrowing of the valve orifice, and can basically maintain the original valve orifice size. It is also suitable for patients with stenosis and has a wide range of applications.

[0260] 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.

[0261] In this embodiment of the present application, when implanting the valve leaflet repair device, the first and second clamping arms are controlled to achieve unilateral clamping of the native valve leaflet, thereby clamping the implanted valve leaflet against the native leaflet. This can be based on previous clinical practice, making the surgical operation highly feasible and shortening the learning cycle for doctors.

[0262] The terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature specified as "first" or "second" may explicitly or implicitly include one or more of such features. Throughout this application, unless otherwise specified, "plurality" means two or more.

[0263] In the description of the application, it should be noted that, unless otherwise expressly specified and limited, the terms "mounting", "connection", "connecting" should be understood broadly, for example, can be fixed connection, can also be detachable connection, or integrally connected; can be directly connected, or indirectly connected through an intermediate medium, can be the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in this application can be understood according to the specific circumstances.

[0264] In the description of the present application, the specific features, structures, materials or characteristics can be combined in any one or more embodiments or examples in a suitable manner.

[0265] The above is only part of the embodiments of the present application, it should be pointed out that, for those skilled in the art, without departing from the technical concept of the application, other similar implementation means based on the technical idea of the present application, also belongs to the protection scope of the present application.

Claims

1. A valve leaflet repair device, characterized in that: include: fixings; The first clamping arm and the second clamping arm, each first end of which is respectively arranged on the fixing member, and each second end of which is relatively arranged to be openable and closable; An implant leaflet, partially disposed on the first clamp arm and extending to a side of the fixing member away from the first clamp arm; The first clamping arm and the second clamping arm are configured to clamp the native valve leaflet so that the implanted valve leaflet becomes an extension of the native valve leaflet; 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; 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 clamping 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 clamping arm to drive the second end of the second clamping arm to swing toward the side away from the first clamping arm under the delivery action of the conveying rod.

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 clamping arm and the second clamping arm are in a natural state of being close to each other for clamping; In the natural state, the second end of the first clamping arm passes through the first hollow portion, so that the first clamping arm and the second clamping arm are arranged crosswise.

3. The valve leaflet repair device according to claim 2, characterized in that: 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 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 to 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 clamping 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 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, 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.

6. The valve leaflet repair device according to claim 1, characterized in that: The first end of the rigid control member is openably and closably arranged relative to the first end of the second clamping arm, and is configured to fit against the first end of the second clamping arm in a natural state after the delivery rod is withdrawn.

7. The valve leaflet repair device according to claim 1 or 2, characterized in that: 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.

8. 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 clamping arm includes shape memory material; A second mounting hole is provided on the fixing member, a second protrusion is provided on the first end of the first clamping arm, and the second protrusion is fixedly installed in the second mounting hole.

9. 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 includes 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 clamping 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.

10. 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.

11. A valve leaflet repair system, characterized in that: include: The leaflet repair device according to any one of claims 1 to 10; A delivery assembly, comprising a delivery tube and a delivery rod, wherein the delivery tube is detachably connected to the fixing member of the leaflet repair device; the delivery rod passes through the delivery tube and the fixing member in sequence; The control structure includes a rigid control member of the leaflet repair device, which 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.

12. A valve leaflet repair system, characterized in that: include: The leaflet repair device according to any one of claims 1 to 10; A delivery assembly, comprising a delivery tube and a delivery rod, wherein the delivery tube is detachably connected to the fixing member of the 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 clamping arm of the leaflet repair device to control the opening and closing angles of the first clamping arm and the second clamping arm to clamp the native leaflet, so that the implanted leaflet of the leaflet repair device becomes an extension of the native leaflet.

13. The valve leaflet repair system according to claim 11 or 12, characterized in that: Also includes: sheath; The sheath is used to deliver the leaflet repair device, delivery assembly and control structure to the valve.

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