Leaflet enhancement device

Abstract

The invention provides a valve leaflet reinforcing device which comprises a catheter, a first clamping arm, a second clamping arm, an opening and closing rod, a buckling piece, an implantation anchor, a release rod and a puncture driving piece, the buckling piece is arranged in the first clamping arm, the implantation anchor is arranged in the second clamping arm, a second containing groove used for containing the implantation anchor is formed in the far end of the second clamping arm, and an artificial valve leaflet is pre-connected to the implantation anchor; the release rod is arranged in the catheter in a penetrating manner and can move in the catheter, and the far end of the release rod is used for being inserted into the implantation anchor so as to fix the implantation anchor in the second accommodating groove of the second clamping arm; the puncture driving piece comprises a driving rod and a driving part arranged at the far end of the driving rod, the puncture driving piece can move in the catheter and the first clamping arm, a limiting groove used for limiting the buckling piece is formed in the driving part, and the driving part is used for moving the buckling piece towards the implantation anchor under the driving of the driving rod so as to fix the buckling piece on the implantation anchor. The invention is used for solving the technical problem of incomplete closure caused by insufficient involution height of mitral valve leaflets.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular, relates to a valve leaflet enhancement device. Background Art

[0002] This section merely provides background information related to the present disclosure and is not necessarily prior art.

[0003] Heart valves refer to valves between atria and ventricles or between ventricles and arteries, which are used to achieve unidirectional blood flow. When the valve is incompletely closed, blood will flow back. Blood backflow can cause a series of diseases, such as heart failure and heart failure, which pose a serious threat to human health. Surgery is one of the effective methods for treating valvular insufficiency, but it is not suitable for elderly patients and patients with many complications due to the large trauma caused by surgery to the human body. The current treatment plan is mainly through interventional surgery, which is the better choice for most heart diseases. The main interventional treatment methods include artificial chord implantation, mitral valve annuloplasty and mitral valve edge-to-edge repair. Among them, implanting artificial chords on the valve leaflets can effectively treat mitral valve insufficiency caused by chord rupture, valve leaflet prolapse, etc., but due to the incomplete closure caused by insufficient height of the anterior and posterior valve leaflets in some patients, it cannot be repaired by implanting artificial chords. Summary of the invention

[0004] The present invention provides a leaflet enhancement device, the purpose of which is to at least solve the technical problem of incomplete closure caused by insufficient coaptation height of mitral valve leaflets, and the purpose is achieved through the following technical solutions:

[0005] The leaflet enhancement device provided by the present invention comprises:

[0006] catheter;

[0007] A first clamping arm is fixedly disposed at the distal end of the catheter;

[0008] A second clamp arm, rotatably connected to the proximal end of the first clamp arm;

[0009] An opening and closing rod, fixedly connected to the proximal end of the second clamp arm and used for opening or closing the second clamp arm;

[0010] A buckle member is disposed in the first clamp arm, and a first receiving groove for receiving the buckle member is provided in the first clamp arm;

[0011] An implant anchor is arranged in the second clamp arm, a second receiving groove for receiving the implant anchor is provided at the distal end of the second clamp arm, and an artificial valve leaflet is pre-connected to the implant anchor;

[0012] a release rod, which is inserted into the catheter and can move in the catheter, and the distal end of the release rod is used to insert the implant anchor to fix the implant anchor in the second receiving groove of the second clamp arm;

[0013] The puncture drive member includes a drive rod and a drive part arranged at the distal end of the drive rod. The puncture drive member can move in the catheter and the first clamp arm. The drive part is provided with a limiting groove for limiting the fastening member. The drive part is used to move the fastening member toward the implant anchor under the drive of the drive rod and then fix the fastening member on the implant anchor.

[0014] The leaflet enhancement device of the present invention is provided with a catheter, a first clamp arm, a second clamp arm, an opening and closing rod, a buckle, an implant anchor, a release rod and a puncture drive component. The buckle and the implant anchor can fix the artificial leaflet on the native leaflet, thereby increasing the length of the leaflet, so as to solve the technical problem of incomplete closure caused by insufficient apposition height of the mitral valve leaflets and thus inability to eliminate reflux.

[0015] In addition, the leaflet enhancement device according to the embodiment of the present invention may also have the following additional technical features:

[0016] In some embodiments of the present invention, the fastening member includes a fastening plate and a puncture pin protruding from the fastening plate, and a limiting hole for the puncture pin to pass through is opened on the implant anchor, and the fastening member is inserted into the limiting hole through the puncture pin, thereby fixing the fastening member to the implant anchor.

[0017] In some embodiments of the present invention, the puncture nail includes a nail column and a nail cap, one end of the nail column is connected to the snap-fit ​​plate, the nail cap is arranged at the other end of the nail column, the limiting hole is an elastic deformation hole, the maximum diameter of the nail cap is larger than the aperture of the limiting hole, and the diameter of the nail column is less than or equal to the aperture of the limiting hole.

[0018] In some embodiments of the present invention, a first hinged portion is provided on the first clamp arm, a first through hole is opened on the first hinged portion, a second hinged portion is provided on the second clamp arm, a second through hole is opened on the second hinged portion, the first through hole and the second through hole are coaxially arranged, a rotating shaft is provided in the first through hole and the second through hole, the second clamp arm is rotatably connected to the first clamp arm via the rotating shaft and the second through hole, and the second clamp arm can rotate around the rotating shaft to open or close the second clamp arm.

[0019] In some embodiments of the present invention, the driving portion has a first inclined surface toward the second clamp arm, the distal end of the second clamp arm has a second inclined surface toward the driving portion, the first inclined surface is parallel to the second inclined surface, and the snap fit is located on the first inclined surface. When the puncture driving member moves from the distal end of the first clamp arm to the proximal end of the first clamp arm, the snap fit continuously moves toward the implant anchor in the first accommodating groove under the drive of the first inclined surface, thereby fixing the snap fit to the implant anchor.

[0020] In some embodiments of the present invention, the second accommodating groove is provided on the second inclined surface, the second clamping arm has an outer surface connected to the second inclined surface, a release hole is provided between the outer surface and the second inclined surface, and the release hole is connected to the second accommodating groove.

[0021] In some embodiments of the present invention, the implant anchor has a first surface facing the bottom of the second receiving groove, and a supporting wall is protruding from the first surface and oppositely arranged. A fixing hole is formed on the supporting wall for inserting the release rod, and the release rod fixes the implant anchor in the second receiving groove by inserting the fixing hole.

[0022] In some embodiments of the present invention, a reinforcing rib surrounding the limiting hole is protruded from the first surface, and the reinforcing rib is connected to the supporting wall end to end.

[0023] In some embodiments of the present invention, the first clamp arm has a retaining wall for abutting against the edge of the native leaflet, and the distance from the center of the fastening member to the retaining wall is d, 3mm≤d≤5mm.

[0024] In some embodiments of the present invention, artificial chordae are connected to the artificial valve leaflets, and the artificial chordae can be preset in the catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] By reading the detailed description of the preferred embodiment below, various other advantages and benefits will become clear to those of ordinary skill in the art. The accompanying drawings are only used for the purpose of illustrating the preferred embodiment and are not considered to be limitations of the present invention. Moreover, the same reference numerals are used to represent the same components throughout the accompanying drawings.

[0026] In the attached picture:

[0027] Figure 1 The schematic diagram of the structure of the valve leaflet enhancement device of the present application is shown;

[0028] Figure 2 A partial cross-sectional structure diagram of the leaflet enhancement device of the present application is shown;

[0029] Figure 3 A schematic diagram of the exploded structure of the leaflet enhancement device of the present application is shown;

[0030] Figure 4 A schematic diagram of the structure of the second clamping arm in the leaflet enhancement device of the present application is shown;

[0031] Figure 5 A schematic diagram of the structure of the second clamp arm in the leaflet enhancement device of the present application being opened is shown;

[0032] Figure 6 The schematic diagram of the structure of the implant anchor and the fastener in the leaflet enhancement device of the present application is shown;

[0033] Figure 7 The schematic diagram of the structure in which the fastener and the implant anchor in the present application are pre-installed with artificial valve leaflets and artificial tendon chordae;

[0034] Figure 8 A schematic diagram of the structure after the fastener is inserted into the implant anchor is shown;

[0035] Fig. 9 The schematic diagram of the structure of the valve leaflet enhancement device of the present application after clamping the native valve leaflet is shown;

[0036] Fig.10 A schematic diagram of the structure of fixing the artificial valve leaflet to the native valve leaflet by implanting anchors and fasteners is shown;

[0037] Fig.11 A schematic diagram of the heart structure after the artificial valve leaflet is fixed to the native valve leaflet by implanting anchors and fasteners is shown;

[0038] Fig.12 for Fig.11 Schematic diagram of the enlarged structure at point A in the middle.

[0039] The symbols in the accompanying drawings are as follows:

[0040] 1. leaflet reinforcement device; 10. first clamping arm; 11. first receiving groove; 12. first hinged part; 121. first through hole; 13. retaining wall; 20. second clamping arm; 21. second receiving groove; 22. second hinged part; 221. second through hole; 23. rotation axis; 24. second inclined surface; 25. outer surface; 26. release hole; 30. opening and closing rod; 40. buckle; 41. buckle plate; 42. through hole Spike; 421, nail column; 422, nail cap; 50, implant anchor; 51, limiting hole; 52, first surface; 53, support wall; 54, fixing hole; 55, reinforcing rib; 60, release rod; 70, puncture drive member; 71, drive rod; 72, drive unit; 721, limiting groove; 722, first inclined surface; 80, catheter; 90, handle; 2, artificial valve leaflet; 3, artificial chordae; 4, native valve leaflet. DETAILED DESCRIPTION

[0041] The exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided in order to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art.

[0042] It should be understood that the terms used herein are for the purpose of describing specific example embodiments only and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "a", "an", and "said" as used herein may also be meant to include plural forms. The terms "comprise", "include", "contain", and "have" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts, and / or combinations thereof.

[0043] Although the terms first, second, third, etc. can be used in the text to describe multiple elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates, terms such as "first", "second" and other numerical terms do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teaching of the example embodiments.

[0044] For ease of description, spatial relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figure, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, then the elements described as "below other elements or features" or "below other elements or features" will subsequently be oriented as "above other elements or features" or "above other elements or features". Therefore, the example term "below..." can include both upper and lower orientations. The device can be oriented otherwise (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.

[0045] It should be noted that "distal" and "proximal" are used as directional terms, which are commonly used terms in the field of medical devices, where "distal" refers to the end away from the operator during surgery, and "proximal" refers to the end close to the operator during surgery. Axial refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device; radial refers to the direction perpendicular to the above axial direction.

[0046] See also Figures 1 to 9 The leaflet enhancement device 1 of the present application includes a catheter 80, a first clamp arm 10, a second clamp arm 20, an opening and closing rod 30, a buckle 40, an implant anchor 50, a release rod 60 and a puncture drive 70, wherein the first clamp arm 10 is fixedly arranged at the distal end of the catheter 80, the second clamp arm 20 is rotatably connected to the proximal end of the first clamp arm 10, the opening and closing rod 30 is fixedly connected to the proximal end of the second clamp arm 20 and is used to open or close the second clamp arm 20, the buckle 40 is arranged in the first clamp arm 10, and a first receiving groove 11 for receiving the buckle 40 is provided in the first clamp arm 10; the implant anchor 50 is arranged in the second clamp arm 20, and a second receiving groove 11 for receiving the implant anchor 50 is provided at the distal end of the second clamp arm 20 The implant anchor 50 is pre-connected with an artificial valve leaflet 2; the release rod 60 is inserted into the catheter 80 and can move in the catheter 80, and the distal end of the release rod 60 is used to insert the implant anchor 50 and fix the implant anchor 50 in the second accommodating groove 21 of the second clamp arm 20; the puncture drive member 70 includes a drive rod 71 and a drive part 72 arranged at the distal end of the drive rod 71, the puncture drive member 70 can move in the catheter 80 and the first clamp arm 10, and the drive part 72 is provided with a limiting groove 721 for limiting the fastener 40, and the drive part 72 is used to move the fastener 40 toward the implant anchor 50 under the drive of the drive rod 71, and then fix the fastener 40 on the implant anchor 50.

[0047] Specifically, the first clamp arm 10 is fixedly arranged at the distal end of the catheter 80, which may refer to that the first clamp arm 10 is fixedly connected to the distal end of the catheter 80, or that the first clamp arm 10 is formed at the distal end of the catheter 80. The implant anchor 50 is pre-connected with an artificial valve leaflet 2, and the artificial valve leaflet 2 may be sutured to the implant anchor 50 by sutures, or the implant anchor 50 may be crimped onto the artificial valve leaflet 2, etc. There is no restriction on this connection method, as long as the artificial valve leaflet 2 is pre-connected to the implant anchor 50. In order to prevent the implant anchor 50 from falling out of the second accommodating groove 21, the distal end of the release rod 60 is inserted into the implant anchor 50, and the release rod 60 is arranged in the catheter 80 and the second clamp arm 20, so that the release rod 60 can fix the implant anchor 50 in the second accommodating groove 21. The valve leaflet enhancement device 1 may also include a handle 90, and the end of the handle 90 may control the movement of the release rod 60, and may control the release rod 60 to move toward the proximal end or the distal end. The handle 90 can also control the movement of the puncture drive member 70, and similarly, can also control the puncture drive member 70 to move toward the distal end or the proximal end. When the leaflet enhancement device 1 penetrates deep into the human body, in order to protect the tissue in the human body from being damaged, the second clamp arm 20 is in a closed state. When it reaches the target position in the human body, the second clamp arm 20 is opened, and then the native leaflet 4 is clamped and then the second clamp arm 20 is closed, so that the first clamp arm 10 and the second clamp arm 20 clamp the native leaflet 4, and then the puncture drive member 70 is driven to move, and then the drive part 72, driven by the drive rod 71, moves the snap member 40 toward the implantation anchor 50 and fixes the snap member 40 on the implantation anchor 50. There are native leaflets 4 and artificial leaflets 2 between the snap member 40 and the implantation anchor 50. Therefore, after the snap member 40 is fixed on the implantation anchor 50, the artificial leaflet 2 and the native leaflet 4 are fixedly connected, and then the length of the artificial leaflet 2 is increased on the native leaflet 4. By increasing the length of the native leaflet 4, the insufficient leaflet apposition height caused by insufficient length of the front and rear leaflets is avoided, thereby avoiding incomplete closure caused by insufficient apposition height.

[0048] In this application, artificial valve leaflets can be understood as artificial valves, and native valve leaflets can also be understood as native valves. The native valve leaflets can refer to the mitral valve, tricuspid valve, pulmonary valve, aortic valve, etc. The mitral valve mentioned in the background technology is just for distance. This application is not limited to solving the problem of mitral valve leaflets. As long as the valve leaflet apposition height is not enough, that is, the incomplete closure caused by too short length, the valve leaflet enhancement device of this application can be used to connect the artificial valve leaflets to the native valve leaflets, thereby increasing the length of the native valve leaflets. The accompanying drawings mainly use the mitral valve as an example for illustration.

[0049] In one embodiment of the leaflet enhancement device 1 of the present invention, please combine Figure 6 and Figure 7The buckle 40 includes a buckle plate 41 and a puncture pin 42 protruding from the buckle plate 41. The implant anchor 50 is provided with a limiting hole 51 for the puncture pin 42 to pass through. The buckle 40 is inserted into the limiting hole 51 through the puncture pin 42, so that the buckle 40 is fixed to the implant anchor 50. After the buckle 40 is fixed to the implant anchor 50, the native valve leaflet 4 and the artificial valve leaflet 2 are fixed between the buckle 40 and the implant anchor 50, and the artificial valve leaflet 2 is fixed to the native valve leaflet 4. By providing the buckle plate 41 and the puncture pin 42, it is more convenient to insert the buckle 40 into the implant anchor 50 through the puncture pin 42. At the same time, because the buckle plate 41 is provided, the contact area between the buckle 40 and the native valve leaflet 4 is increased, so that the buckle 40 and the native valve leaflet 4 are more stable, so that the buckle 40 and the implant anchor 50 can more stably fix the native valve leaflet 4 and the artificial valve leaflet 2 together.

[0050] In one or more embodiments of the present application, the puncture nail 42 includes a nail column 421 and a nail cap 422, one end of the nail column 421 is connected to the snap-fit ​​plate 41, and the nail cap 422 is arranged at the other end of the nail column 421, the limiting hole 51 is an elastic deformation hole, the maximum diameter of the nail cap 422 is greater than the aperture of the limiting hole 51, and the diameter of the nail column 421 is less than or equal to the aperture of the limiting hole 51. In order to facilitate the puncture nail 42 to be inserted into the implant anchor 50 more smoothly and fixed on the implant anchor 50, the puncture nail 42 includes a nail column 421 and a nail cap 422. The limiting hole 51 of the implant anchor 50 is an elastic deformation hole, so that when the nail cap 422 of the puncture nail 42 passes through the limiting hole 51, because the maximum diameter of the nail cap 422 is greater than the aperture of the limiting hole 51, the nail cap 422 will deform the limiting hole 51, so that the nail cap 422 passes through the limiting hole 51. After the nail cap 422 passes through the limiting hole 51, the limiting hole 51 will return to its original state, thereby ensuring that the nail cap 422 will not be dragged out of the limiting hole 51 again. The limiting hole 51 is set as an elastic deformation hole, and a certain crack can be opened around the limiting hole 51, so that the limiting hole 51 has a certain elastic deformation.

[0051] In one embodiment, see Figure 3 and Figure 4 The first clamp arm 10 is provided with a first hinged portion 12, and the first hinged portion 12 is provided with a first through hole 121. The second clamp arm 20 is provided with a second hinged portion 22, and the second hinged portion 22 is provided with a second through hole 221. The first through hole 121 and the second through hole 221 are coaxially arranged. A rotation axis 23 is arranged in the first through hole 121 and the second through hole 221. The second clamp arm 20 is rotatably connected to the first clamp arm 10 through the rotation axis 23 and the second through hole 221. The second clamp arm 20 can rotate around the rotation axis 23 to open or close the second clamp arm 20. Figure 3As shown, the first through hole 121 can be two and symmetrically arranged. Similarly, the second through hole 221 can be two and symmetrically arranged. The rotating shaft 23 can be set as one, that is, the rotating shaft 23 is inserted into both the two first through holes 121 and the two second through holes 221 at the same time; of course, the rotating shaft 23 can also be set as two, that is, one rotating shaft 23 is inserted into one of the first through holes 121 and one of the second through holes 221, and the other rotating shaft 23 is inserted into the other first through hole 121 and the other second through hole 221. There is no strict limitation to this method, as long as the second clamp arm 20 can be rotatably connected to the first clamp arm 10.

[0052] In one or more of these embodiments, see Figure 2 , Figure 8 and Fig. 9 The driving part 72 has a first inclined surface 722 facing the second clamp arm 20, and the distal end of the second clamp arm 20 has a second inclined surface 24 facing the driving part 72. The first inclined surface 722 is parallel to the second inclined surface 24. The buckle 40 is located on the first inclined surface 722. When the puncture driving part 70 moves from the distal end of the first clamp arm 10 to the proximal end of the first clamp arm 10, the buckle 40 is driven by the first inclined surface 722 to continuously move toward the implant anchor 50 in the first receiving groove 11, thereby fixing the buckle 40 to the implant anchor 50. By setting the first inclined surface 722 parallel to the second inclined surface 24, the implant anchor 50 and the buckle 40 are also at the same inclined angle, and the first clamp arm 10 also has an inclined surface with the same inclined angle. When the native leaflet 4 is clamped between the first clamp arm 10 and the second clamp arm 20, the native leaflet 4 is located on the inclined surface of the first clamp arm 10. The artificial valve leaflet 2 and the native valve leaflet 4 are parallel to each other, the fastener 40 and the implant anchor 50 are also parallel to each other, and the first inclined surface 722 where the fastener 40 is located is parallel to the second inclined surface 24, so that when the driving part 72 moves from the distal end to the proximal end, the first inclined surface 722 also moves from the distal end to the proximal end. The fastener 40 is limited in the first accommodating groove 11. Under the drive of the first inclined surface 722, the fastener 40 continuously moves toward the implant anchor 50 in the first accommodating groove 11, so that the fastener 40 is finally inserted into the implant anchor 50. Fig. 9 The initial state is when the driving portion 72 of the puncture driving member 70 is at the most distal position, and the buckle 40 and the implant anchor 50 are not fixed to each other. When the puncture driving member 70 is driven to move proximally, the driving portion 72 moves proximally, so that the driving portion 72 is at the most distal position. Figure 8 In the state shown, the fastener 40 is driven by the first inclined surface 722 to be inserted into the implant anchor 50 and then fixed in the implant anchor 50 .

[0053] In another embodiment, see Figures 2 to 4 ,as well as Figure 8 and Fig. 9 , the second receiving groove 21 is provided on the second inclined surface 24, the second clamp arm 20 has an outer surface 25 connected to the second inclined surface 24, a release hole 26 is provided between the outer surface 25 and the second inclined surface 24, and the release hole 26 is communicated with the second receiving groove 21. By providing the release hole 26, when the buckle 40 is fixed to the implant anchor 50, the artificial valve leaflet 2 and the native valve leaflet 4 are also fixedly connected, and then the release rod 60 is withdrawn from the implant anchor 50, so that the implant anchor 50 is no longer completely restricted in the second receiving groove 21. The existence of the release hole 26 prevents the implant anchor 50 from being sucked by the bottom surface of the second receiving groove 21, so that the implant anchor 50 can be better detached from the second receiving groove 21, avoiding the difficulty of releasing the implant anchor 50. Finally, the implant anchor 50 and the buckle 40 are both detached from the second clamp arm 20 and the first clamp arm 10, and the implant anchor 50 and the buckle 40 remain on the native valve leaflet 4 and the artificial valve leaflet 2, as shown in FIG. Figures 10 to 12 As shown, the leaflet reinforcement device 1 can then be withdrawn from the body.

[0054] In one or more embodiments of the present invention, please continue to refer to Figure 4 , Figure 6 and Figure 7 The implant anchor 50 has a first surface 52 facing the bottom of the second receiving groove 21, and a supporting wall 53 is convexly arranged on the first surface 52. The supporting wall 53 is provided with a fixing hole 54 for inserting the release rod 60. The release rod 60 fixes the implant anchor 50 in the second receiving groove 21 by inserting the fixing hole 54. The release rod 60 fixes the implant anchor 50 in the second receiving groove 21 in a manner that the release rod 60 is inserted into the fixing hole 54 on the implant anchor 50. The fixing hole 54 may be provided with two holes, and the fixing holes 54 may be provided on the supporting wall 53 opposite to the implant anchor 50, so that the release rod 60 fixes the implant anchor 50 more stably. Similarly, a hole for the release rod 60 to pass through is also provided on the wall of the second clamp arm 20 close to the second receiving groove 21. The release rod 60 first passes through the hole provided on the second clamp arm 20, and then passes through the two fixing holes 54 of the implant anchor 50, so that the implant anchor 50 is stably fixed in the second receiving groove 21, and the implant anchor 50 is prevented from falling off in advance.

[0055] In one or more embodiments of the present invention, a reinforcing rib 55 surrounding the limiting hole 51 is convexly provided on the first surface 52 of the implant anchor 50, and the reinforcing rib 55 is connected end to end with the supporting wall 53. The reinforcing rib 55 is added to increase the overall hardness of the implant anchor 50, thereby preventing the implant anchor 50 from bending or breaking. Furthermore, the reinforcing rib 55 is connected end to end with the supporting wall 53, thereby making the outer circumference of the implant anchor 50 smooth, thereby preventing the possibility of scratching tissues in the human body, and further increasing the strength.

[0056] In one or more embodiments of the present invention, the first clamp arm 10 has a retaining wall 13 for abutting against the edge of the primary leaflet 4, and the distance from the center of the fastening member 40 to the retaining wall 13 is d, 3mm≤d≤5mm. Figure 2 and Fig. 9 When clamping the native leaflet 4, the edge of the native leaflet 4 will be abutted against the retaining wall 13 of the first clamp arm 10. By setting a certain distance between the buckle 40 and the retaining wall 13, the position where the buckle 40 and the implant anchor 50 are fixed is at a certain distance from the edge of the native leaflet 4, which avoids the place where the artificial leaflet 2 and the native leaflet 4 are fixedly connected being too close to the edge of the native leaflet 4, thereby avoiding the situation where the buckle 40 and the implant anchor 50 are easily torn off from the edge of the native leaflet 4 and then fall off when they are too close to the edge of the native leaflet 4. Where d can be 3mm, 3.3mm, 3.5mm, 3.8mm, 4mm, 4.6mm, 5mm, etc., and any value within this range can be used.

[0057] In one or more embodiments of the present invention, artificial valve leaflets 2 are connected with artificial chordae 3, which can be preset in catheter 80. Artificial chordae 3 are preset on artificial valve leaflets 2. In order to enable artificial valve leaflets 2 to better open and close together with native valve leaflets 4, and also to solve the problem of valve leaflet prolapse or chordae rupture, artificial chordae 3 can be set on artificial valve leaflets 2. Artificial chordae 3 can achieve better opening and closing effects for artificial valve leaflets 2 during contraction and expansion. There is no limitation on the way of setting artificial chordae 3 on artificial valve leaflets 2, which can be as follows: Figure 7 The connection method shown may also be other connection methods, as long as the artificial chordae 3 can be connected to the artificial valve leaflets 2 in advance.

[0058] Taking the mitral valve leaflet as an example, the operation steps of the leaflet enhancement device 1 are briefly described below:

[0059] 1. The valve leaflet enhancement device 1 enters the heart through the apical path. When it reaches the vicinity of the target position, the second clamp arm 20 is opened, and the first clamp arm 10 and the second clamp arm 20 are used to capture the native valve leaflet 4. After the capture is in place, the second clamp arm 20 is closed;

[0060] 2. If Fig. 9 The state in which the first clamp arm 10 and the second clamp arm 20 are captured and the second clamp arm 20 is closed, at this time, the release rod 60 has fixed the implant anchor 50 in the second receiving groove 21, and then drives the puncture drive member 70 to move proximally, so that the puncture drive member 70 moves to the position as shown in FIG. Figure 8 state, at which time the fastener 40 is inserted into the implant anchor 50, so that the fastener 40 and the implant anchor 50 fix the native valve leaflet 4 and the artificial valve leaflet 2 together;

[0061] 3. After the fastening member 40 and the implant anchor 50 are fixed to each other, the release rod 60 is driven to move proximally, so that the release rod 60 is withdrawn from the fixing hole 54 of the implant anchor 50. Furthermore, due to the existence of the release hole 26 on the first clamp arm 10, the implant anchor 50 is smoothly disengaged from the second receiving groove 21. Then the second clamp arm 20 is opened. At this time, the implant anchor 50 is disengaged from the second receiving groove 21, and the fastening member 40 is disengaged from the first receiving groove 11, so that the implant anchor 50 and the fastening member 40 remain on the native valve leaflet 4 and the artificial valve leaflet 2. Then the second clamp arm 20 and the first clamp arm 10 are slowly withdrawn from the native valve leaflet 4 and the artificial valve leaflet 2.

[0062] 4. In the process of withdrawing the valve leaflet enhancement device 1 as a whole from the human body, in order to avoid scraping human tissue, the second clamping arm 20 can be closed after being away from the native valve leaflet 4 and the artificial valve leaflet 2, and then completely withdrawn from the human body, and the other end of the artificial chordae 3 can be fixed on the apex of the heart, as shown in FIG. Fig.11 As shown, the native leaflet 4 is strengthened in this way, the length of the native leaflet 4 is lengthened, and the apposition height of the front and rear leaflets is increased.

[0063] The above are only preferred specific embodiments of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed by the present invention should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. A leaflet enhancement device, characterized in that: The leaflet enhancing device comprises: catheter; A first clamping arm is fixedly disposed at the distal end of the catheter; A second clamp arm, rotatably connected to the proximal end of the first clamp arm; An opening and closing rod, fixedly connected to the proximal end of the second clamp arm and used for opening or closing the second clamp arm; A buckle member is disposed in the first clamp arm, and a first receiving groove for receiving the buckle member is provided in the first clamp arm; An implant anchor is arranged in the second clamp arm, a second receiving groove for receiving the implant anchor is provided at the distal end of the second clamp arm, and an artificial valve leaflet is pre-connected to the implant anchor; a release rod, which is inserted into the catheter and can move in the catheter, and the distal end of the release rod is used to insert the implant anchor to fix the implant anchor in the second receiving groove of the second clamp arm; The puncture drive member includes a drive rod and a drive part arranged at the distal end of the drive rod. The puncture drive member can move in the catheter and the first clamp arm. The drive part is provided with a limiting groove for limiting the fastening member. The drive part is used to move the fastening member toward the implant anchor under the drive of the drive rod and then fix the fastening member on the implant anchor.

2. The leaflet enhancement device according to claim 1, characterized in that: The fastening member includes a fastening plate and a puncture pin protruding from the fastening plate. A limiting hole for the puncture pin to pass through is opened on the implant anchor. The fastening member is inserted into the limiting hole through the puncture pin, thereby fixing the fastening member to the implant anchor.

3. The leaflet enhancement device according to claim 2, characterized in that: The puncture nail includes a nail column and a nail cap, one end of the nail column is connected to the buckle plate, the nail cap is arranged at the other end of the nail column, the limiting hole is an elastic deformation hole, the maximum diameter of the nail cap is larger than the aperture of the limiting hole, and the diameter of the nail column is less than or equal to the aperture of the limiting hole.

4. The leaflet enhancement device according to claim 1, characterized in that: The first clamp arm is provided with a first hinge portion, the first hinge portion is provided with a first through hole, the second clamp arm is provided with a second hinge portion, the second hinge portion is provided with a second through hole, the first through hole and the second through hole are coaxially arranged, a rotating shaft is arranged in the first through hole and the second through hole, the second clamp arm is rotatably connected to the first clamp arm via the rotating shaft and the second through hole, and the second clamp arm can rotate around the rotating shaft to open or close the second clamp arm.

5. The leaflet enhancement device according to claim 1, characterized in that: The driving portion has a first inclined surface facing the second clamp arm, the distal end of the second clamp arm has a second inclined surface facing the driving portion, the first inclined surface is parallel to the second inclined surface, and the buckle is located on the first inclined surface. When the puncture driving member moves from the distal end of the first clamp arm to the proximal end of the first clamp arm, the buckle continuously moves toward the implant anchor in the first accommodating groove under the drive of the first inclined surface, thereby fixing the buckle to the implant anchor.

6. The leaflet enhancement device according to claim 5, characterized in that: The second containing groove is provided on the second inclined surface, the second clamping arm has an outer surface connected to the second inclined surface, a release hole is provided between the outer surface and the second inclined surface, and the release hole is communicated with the second containing groove.

7. The leaflet enhancement device according to claim 2, characterized in that: The implant anchor has a first surface facing the bottom of the second receiving groove, and a supporting wall is protruding from the first surface and oppositely arranged. A fixing hole for the release rod to be inserted is opened on the supporting wall. The release rod fixes the implant anchor in the second receiving groove by inserting into the fixing hole.

8. The leaflet enhancement device according to claim 7, characterized in that: The first surface is also provided with reinforcing ribs surrounding the limiting holes, and the reinforcing ribs are connected to the supporting wall end to end.

9. The leaflet enhancement device according to claim 2, characterized in that: The first clamp arm has a retaining wall for abutting against the edge of the native leaflet, and the distance from the center of the buckle to the retaining wall is d, 3mm≤d≤5mm.

10. The leaflet enhancement device according to claim 1, characterized in that: The artificial valve leaflet is connected with artificial chordae tendineae, and the artificial chordae tendineae can be preset in the catheter.

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