Leaflet involution enhancing device

Abstract

The invention provides a valve leaflet involution enhancing device which comprises a multi-cavity tube, a far-end clamping head, a near-end clamping head, a sliding rod and a bearing arm, the near-end clamping head is connected to the far end of the multi-cavity tube, the far-end clamping head can be driven by the sliding rod to move relative to the near-end clamping head, the bearing arm is connected to the multi-cavity tube, the far end of the bearing arm is connected with an artificial valve leaflet, and the near-end clamping head can be driven by the sliding rod to move relative to the near-end clamping head. A puncture channel for the puncture tube to pass through is arranged in the bearing arm, the puncture tube is arranged in the multi-cavity tube and / or the bearing arm, the puncture tube can puncture the artificial valve leaflet and the native valve leaflet after penetrating out of the puncture channel, an anchoring part is arranged in the puncture tube, and the anchoring part can fixedly connect the artificial valve leaflet and the native valve leaflet. According to the valve leaflet involution enhancing device, the multi-cavity tube, the far-end clamping head, the near-end clamping head and the bearing arm are arranged, the artificial valve leaflet can be fixed to the original valve leaflet through the anchoring piece in the bearing arm, then the length of the valve leaflet is increased, and the technical problem of incomplete involution caused by the fact that the mitral valve leaflet is too short can be solved.

Description

Technical Field

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

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

[0003] Mitral regurgitation is one of the most common heart valve diseases today. The main causes are rheumatic heart disease, myxoid degeneration of the mitral valve, ischemic heart disease, myocardial lesions, etc., which lead to lesions in the valve ring, valve leaflets, chordae tendineae and papillary muscles in the mitral valve structure, resulting in the inability of the mitral valve leaflets to close completely. Surgery is one of the effective methods for treating mitral regurgitation, but due to the large trauma caused by surgery to the human body, it is not suitable for elderly patients and patients with many complications. Most of them are now treated with minimally invasive 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 chordae on the valve leaflets can effectively treat mitral regurgitation caused by chord rupture, valve leaflet prolapse, etc. However, some patients have incomplete closure caused by too short mitral valve leaflets, or incomplete closure of valve leaflets caused by enlarged mitral valve ring, which cannot eliminate regurgitation. Summary of the invention

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

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

[0006] Multi-lumen tube;

[0007] A proximal clamp connected to the distal end of the multi-lumen tube;

[0008] A slide rod is movably connected to the multi-lumen tube, and a through hole is provided on the proximal clamp for the slide rod to pass through;

[0009] A distal clamp connected to the distal end of the slide rod, the distal clamp can move relative to the proximal clamp under the drive of the slide rod, and the distal joint and the proximal clamp are used to clamp the native valve leaflet;

[0010] A support arm is connected to the multi-lumen tube, an artificial valve leaflet is connected to the distal end of the support arm, a puncture channel is provided in the support arm for a puncture tube to pass through, the puncture tube is provided in the multi-lumen tube and / or the support arm, and the puncture tube can pass through the puncture channel and then puncture the artificial valve leaflet and the native valve leaflet, an anchor is provided in the puncture tube, and the anchor can fix the artificial valve leaflet and the native valve leaflet in connection.

[0011] The leaflet coaptation enhancement device of the present invention is provided with a multi-lumen tube, a distal clamp, a proximal clamp and a support arm. The anchoring member in the support arm can fix the artificial leaflet on the native leaflet, thereby increasing the length of the leaflet, thereby solving the technical problem of incomplete closure caused by too short mitral valve leaflets and the inability to eliminate reflux.

[0012] In addition, the leaflet coaptation enhancement device according to the embodiment of the present invention may also have the following additional technical features:

[0013] In some embodiments of the present invention, a receiving opening for placing the support arm is formed between the multi-lumen tube and the proximal clamp, and the support arm has an expanded and closed state. When the support arm is in the closed state, the support arm is embedded in the receiving opening.

[0014] In some embodiments of the present invention, a sliding member is connected to the proximal end of the supporting arm, and the sliding member can move in the multi-lumen tube to drive the supporting arm to move.

[0015] In some embodiments of the present invention, a driving rod is fixedly connected to the proximal end of the sliding member, and the leaflet coaptation enhancement device further includes a handle, which can be used to control the movement of the driving rod.

[0016] In some embodiments of the present invention, a screw is provided in the multi-lumen tube, and a spiral disk is sleeved on the screw and cooperates with the screw thread. The leaflet apposition enhancement device also includes a connecting rod, one end of which is movably connected to the proximal end of the support arm, and the other end of the connecting rod is movably connected to the spiral disk. The connecting rod can expand or close the support arm under the drive of the spiral disk.

[0017] In some embodiments of the present invention, a limiting portion is convexly provided at the proximal end of the screw rod, and a limiting groove matching the limiting portion is formed on the sliding member, and the limiting portion can rotate circumferentially in the limiting groove.

[0018] In some embodiments of the present invention, the anchoring member includes an anchoring wire and a clamping member fixedly connected to the proximal end of the anchoring wire, the clamping member includes a limiting arm, a push rod is provided in the puncture tube, the push rod is provided at the proximal end of the clamping member, and the push rod is used to support the clamping member when the puncture tube is withdrawn toward the proximal end, thereby fixing the anchoring member to the native valve leaflet and the artificial valve leaflet.

[0019] In some embodiments of the present invention, a sliding groove through which the limiting arm can pass is provided on the puncture tube and the supporting arm.

[0020] In some embodiments of the present invention, three supporting arms are provided, and the three supporting arms are evenly arranged in the accommodating opening.

[0021] In some embodiments of the present invention, artificial chordae tendineae are preset on the artificial valve leaflet. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] 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.

[0023] In the attached picture:

[0024] Figure 1 The structural schematic diagram of the valve leaflet coaptation enhancement device of the present invention is shown;

[0025] Figure 2 A partial structural schematic diagram of the valve leaflet coaptation enhancement device of the present invention is shown;

[0026] Figure 3 A cross-sectional schematic diagram illustrating a local structure of the valve leaflet coaptation enhancement device of the present invention;

[0027] Figure 4 The schematic diagram of the structure of the valve leaflet coaptation enhancement device of the present invention clamping the native valve leaflet is shown;

[0028] Figure 5a A schematic diagram of the structure of the support arm in the valve leaflet coaptation enhancement device of the present invention when one of the angles is unfolded is shown;

[0029] Figure 5b A schematic diagram of the structure of another angle at which the support arm in the valve leaflet apposition enhancement device of the present invention is unfolded is shown;

[0030] Figure 6 A schematic diagram of the structure between the support arm and the anchoring member and the push rod in the puncture tube in the valve leaflet apposition enhancement device of the present invention is shown;

[0031] Figure 7A schematic diagram of the structure in which the puncture tube in the valve leaflet apposition enhancement device of the present invention is located in the supporting arm is shown;

[0032] Figure 8 A schematic diagram of the structure of the puncture tube puncturing the artificial valve leaflet and the native valve leaflet in the valve leaflet coaptation enhancement device of the present invention is shown;

[0033] Fig. 9 A schematic diagram of the structure of the anchoring member in the valve leaflet apposition enhancement device of the present invention when anchored to the native valve leaflet and the artificial valve leaflet is shown;

[0034] Fig.10 A schematic diagram of the structure after the anchoring member is anchored to the native valve leaflet and the artificial valve leaflet is shown;

[0035] Fig.11 A partial structural schematic diagram of the valve leaflet coaptation enhancement device is shown;

[0036] Fig.12 The schematic diagram of the structure of the valve leaflet coaptation enhancement device entering the heart through the apex is shown;

[0037] Fig.13 The schematic diagram of the structure of the valve leaflet coaptation enhancement device clamping the native valve leaflet is shown;

[0038] Fig.14 A schematic diagram of the structure of the support arm of the valve leaflet coaptation enhancement device is shown;

[0039] Fig.15 A schematic diagram of the structure of the valve leaflet coaptation enhancement device being withdrawn from the heart is shown;

[0040] Fig.16 for Fig.15 Schematic diagram of the enlarged structure at point A in the middle.

[0041] The symbols in the accompanying drawings are as follows:

[0042] 1. Leaflet apposition enhancement device; 10. Support arm; 11. Puncture channel; 12. Puncture tube; 121. Slide groove; 13. Anchoring member; 131. Anchoring wire; 132. Clamp; 1321. Limiting arm; 14. Push rod; 15. Fixing hole; 16. First connecting hole; 17. Third connecting hole; 20. Distal clamp; 21. Slide rod; 30. Proximal clamp; 40. Multi-lumen tube; 41. Receiving port; 42. Screw; 421. Limiting part; 43. Spiral disk; 44. Connecting rod; 441. Second connecting hole; 442. Fifth connecting hole; 50. Sliding member; 51. Limiting groove; 52. Fourth connecting hole; 60. Driving rod; 70. Handle; 2. Native leaflet; 3. Artificial leaflet; 4. Artificial tendon. DETAILED DESCRIPTION

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] See also Figures 1 to 9 The leaflet coaptation enhancement device 1 of the present invention comprises a multi-lumen tube 40, a distal clamp 20, a proximal clamp 30, a slide bar 21 and a support arm 10, wherein the proximal clamp 30 is connected to the distal end of the multi-lumen tube 40, the slide bar 21 is movably connected to the multi-lumen tube 40, a through hole for the slide bar 21 to pass through is provided on the proximal clamp 30, the distal clamp 20 is connected to the distal end of the slide bar 21, and the distal clamp 20 can move relative to the proximal clamp 30 under the drive of the slide bar 21, and the distal clamp 20 and the proximal clamp 30 are movable. It is used to clamp the native valve leaflet 2; the support arm 10 is connected to the multi-lumen tube 40, and the distal end of the support arm 10 is connected to the artificial valve leaflet 3. The support arm 10 is provided with a puncture channel 11 for the puncture tube 12 to pass through. The puncture tube 12 is arranged in the multi-lumen tube 40 and / or the support arm 10, and the puncture tube 12 can pass through the puncture channel 11 and then puncture the artificial valve leaflet 3 and the native valve leaflet 2. Anchors 13 are provided in the puncture tube 12, and the anchors 13 can fix the artificial valve leaflet 3 and the native valve leaflet 2.

[0049] Specifically, the distal clamp 20 is located at the distal end of the proximal clamp 30, and in order to avoid damaging the tissue when entering the body, the distal surface of the distal clamp 20 is preferably set to a smooth round surface. The distal clamp 20 can move toward the proximal clamp 30, that is, the proximal clamp 30 head does not move, and the handle 70 is used to control the movement of the slide bar 21 so that the distal clamp 20 moves toward the proximal end or the distal end, and the native leaflet 2 is clamped successfully. The distal end of the support arm 10 is connected to the artificial leaflet 3, and the artificial leaflet 3 can be pre-fixed on the support arm 10 by opening a fixing hole 15 at the distal end of the support arm 10, and then sutures can be passed through the fixing hole 15 and the artificial leaflet 3. The puncture tube 12 can be only arranged in the multi-lumen tube 40, that is, when it is necessary to puncture the artificial valve leaflet 3 and the native valve leaflet 2, the handle 70 can be used to drive the puncture tube 12 to first enter the support arm 10 and then extend it out of the support arm 10; the puncture tube 12 can also be only arranged in the support arm 10, and when puncture is required, the handle 70 can be used to further drive the puncture tube 12 to extend out of the support arm 10; the puncture tube 12 can also be arranged in the multi-lumen tube 40 and the support arm 10, that is, part of the puncture tube 12 is located in the support arm 10, and part of it is located in the multi-lumen tube 40. Such an arrangement allows the puncture tube 12 to always be located in the multi-lumen tube 40 and the support arm 10, thereby avoiding the situation where the puncture tube 12 cannot enter the support arm 10 due to inaccurate docking when passing through the multi-lumen tube 40 to enter the support arm 10. The accompanying drawings mainly only show the situation where the puncture tube 12 is arranged in the support arm 10 and the multi-lumen tube 40. The support arm 10 can stably support and support the artificial valve leaflets 3 and the native valve leaflets 2 when the puncture tube 12 punctures the artificial valve leaflets 3 and the native valve leaflets 2. After the puncture tube 12 punctures the artificial valve leaflets 3 and the native valve leaflets 2, the anchor 13 in the puncture tube 12 can be pushed out by the push rod 14 in the puncture tube 12, thereby fixing the artificial valve leaflets 3 and the native valve leaflets 2, thereby increasing the length of the artificial valve leaflets 3 on the native valve leaflets 2, thereby solving the technical problem of incomplete closure caused by too short mitral valve leaflets. Of course, by fixing the artificial valve leaflets on the native valve leaflets, the incomplete closure of the mitral valve leaflets caused by the expansion of the valve ring due to ventricular dilation can also be solved, thereby solving the regurgitation caused by incomplete closure of the mitral valve leaflets during ventricular contraction.

[0050] The artificial valve leaflets 3 in this application can be understood as artificial valves, and the native valve leaflets 2 can also be understood as native valves. The native valve leaflets 2 can refer to the mitral valve, tricuspid valve, pulmonary valve, aortic valve, etc. As long as the valve cannot be closed due to its short length, the valve leaflet apposition enhancement device of this application can be used to connect the artificial valve leaflets to increase the length of the native valve leaflets. The accompanying drawings mainly use the mitral valve as an example for illustration.

[0051] In addition, please combine Fig.11The support arm 10 has an open and closed state. In order to prevent damage to tissues in the human body during the delivery of the leaflet apposition enhancement device 1 into the body, the support arm 10 can be in a closed state (such as Figure 1 As shown). An accommodating opening 41 for accommodating the support arm 10 is formed between the multi-lumen tube 40 and the proximal clamp 30. When the support arm 10 is in a closed state, the support arm 10 is embedded in the accommodating opening 41. In this way, during the process of delivering the leaflet apposition enhancement device 1, the support arm 10 can be embedded in the accommodating opening 41 without protruding from the proximal clamp 30, which has a better protective effect on the tissue in the body.

[0052] In one embodiment of the valve leaflet coaptation enhancement device 1 of the present invention, please refer to Figures 2 to 4 ,as well as Figures 6 to 11The multi-lumen tube 40 is provided with a screw rod 42, and a spiral disk 43 is sleeved on the screw rod 42 and is threadedly matched with the screw rod 42. The leaflet coaptation enhancement device 1 also includes a connecting rod 44, one end of which is movably connected to the proximal end of the support arm 10, and the other end of which is movably connected to the spiral disk 43. The connecting rod 44 can expand or close the support arm 10 under the drive of the spiral disk 43. The outer periphery of the screw rod 42 has an external thread, and the spiral disk 43 is provided with a through hole for the screw rod 42 to pass through. The hole wall of the through hole of the spiral disk 43 is provided with an internal thread. The spiral disk 43 is threadedly matched with the external thread on the outer periphery of the screw rod 42 through the internal thread, so when the screw rod 42 rotates, that is, rotates on its own, the spiral disk 43 will move on the screw rod 42. One end of the connecting rod 44 is movably connected to the proximal end of the supporting arm 10, and the first connecting hole 16 is provided at the proximal end of the supporting arm 10, and the second connecting hole 441 is provided at one end of the connecting rod 44. The first connecting hole 16 and the second connecting hole 441 can be pin holes, and the first connecting hole 16 and the second connecting hole 441 are coaxially arranged during installation, and a pin or a latch is provided in the first connecting hole 16 and the second connecting hole 441, thereby realizing the hinged connection between the connecting rod 44 and the supporting arm 10, that is, the rotation connection. A fifth connecting hole 442 is provided at the other end of the connecting rod 44, and a pin hole matching the fifth connecting hole 442 is provided on the spiral disk 43. A pin or a latch can be provided in the fifth connecting hole 442 and the pin hole on the spiral disk 43, and the other end of the connecting rod 44 is movably connected to the spiral disk 43 through the fifth connecting hole 442 and the pin hole on the spiral disk 43. When the screw 42 rotates, the spiral disk 43 moves on the screw 42. When the spiral disk 43 moves, it drives the connecting rod 44 movably connected to the spiral disk 43 to move, and then the connecting rod 44 drives the support arm 10 to expand or close. Moreover, the degree to which the supporting arm 10 is expanded by the connecting rod 44 can be controlled by controlling the moving distance of the spiral disk 43 on the screw 42. That is, the supporting arm 10 can achieve different expansion angles, and thus can support different artificial valve leaflets 3. Because different patients are different, the corresponding native valve leaflets 2 have different sizes and thicknesses. In order to adapt to different patients, different artificial valve leaflets 3 need to be connected to different native valve leaflets 2. In order to enable the valve leaflet apposition enhancement device 1 to be able to connect artificial valve leaflets on different native valve leaflets, the support arm 10 can be expanded to different angles to adapt to different native valve leaflets, thereby improving the versatility of the valve leaflet apposition enhancement device 1. Among them, Figure 5a and Figure 5b It is just to better illustrate the positional relationship between the support arm 10 and the artificial valve leaflet at different deployment angles, such as Figure 5a As shown, the angle at which the support arm 10 is unfolded is relatively small. Figure 5b As shown, the support arm 10 is unfolded at a relatively large angle, so that it can meet the needs of different sizes of artificial valve leaflets 3 and be adjusted to a more appropriate supporting position and puncture position.

[0053] In one or more embodiments of this application, please refer to Figures 2 to 4 , Figure 8 and Fig. 9 , the proximal end of the support arm 10 is connected to a sliding member 50, and the sliding member 50 can move in the multi-lumen tube 40 and thus drive the support arm 10 to move. A third connecting hole 17 is provided on the support arm 10, and a fourth connecting hole 52 is provided on the sliding member 50. By providing pins or latches in the third connecting hole 17 and the fourth connecting hole 52, the connection between the sliding member 50 and the support arm 10 can be achieved. By moving the sliding member 50 distally and thus causing the support arm 10 to move distally as well, after the distal chuck 20 and the proximal chuck 30 clamp the native leaflet 2, the support arm 10 can be moved in the direction of the native leaflet 2 by the sliding member 50, so that the plane of the distal end of the support arm 10 and the supporting surface of the proximal chuck 30 are on the same plane, as shown in FIG. Figure 4 As shown, the native valve leaflet 2 and the artificial valve leaflet 3 are fitted together, and the supporting arm 10 has a good supporting effect on the artificial valve leaflet 3 and the native valve leaflet 2, so that the subsequent puncture tube 12 punctures the artificial valve leaflet 3 and the native valve leaflet 2 more smoothly.

[0054] In one embodiment, please continue to refer to Figure 3 and Figure 4 , Figure 8 and Fig. 9 In order to better drive the sliding member 50 to move, the proximal end of the sliding member 50 is fixedly connected with a driving rod 60, and the leaflet coaptation enhancement device 1 also includes a handle 70, which can be used to control the movement of the driving rod 60. A blind hole for accommodating the driving rod 60 can be provided in the sliding member 50, and the driving rod 60 can be fixedly connected to the sliding member 50 by interference fit with the blind hole. The driving rod 60 can also be fixedly connected by other methods, such as welding, bonding, crimping, etc. There is no restriction on the connection method, and it only needs to be fixedly connected to the sliding member 50. The handle 70 is connected to the driving rod 60, and the handle 70 only needs to control the driving rod 60 to control the movement of the sliding member 50.

[0055] In one or more embodiments, a limiting portion 421 is convexly disposed at the proximal end of the screw rod 42, and a limiting groove 51 matching the limiting portion 421 is provided on the sliding member 50, and the limiting portion 421 can rotate circumferentially in the limiting groove 51. In this way, when the sliding member 50 moves in a direction close to the distal clamp 20 or away from the distal clamp 20, due to the setting of the limiting groove 51 and the limiting portion 421, the screw rod 42 is also driven to move simultaneously with the sliding member 50, and the screw rod 42 can move back and forth between the distal end and the proximal end, and has a certain range of movement. Because the screw 42 is connected to the spiral disk 43, the spiral disk 43 is connected to the connecting rod 42, the connecting rod 42 is connected to the support arm 10, and the sliding member 50 is connected to the support arm 10, the movement of the sliding member 50 drives the support arm 10, the screw 42, the spiral disk 43, and the connecting rod 44 to move as a whole, which can better adjust the positional relationship between the support arm 10 and the proximal clamp 30, so that the support arm 10 can better support the native leaflet 2, which is conducive to adjusting the distance between the support arm 10 and the native leaflet 2. At the same time, the limiting portion 421 can rotate circumferentially in the limiting groove 51. For example, the limiting portion 421 can be set as a convex ring, and the limiting groove 51 is a ring groove, so that the self-rotation of the screw 42 will not be affected. That is, when the support arm 10 does not need to adjust the position between the distal end and the proximal end, but only needs to expand or close the support arm 10 at different angles, the self-rotation of the screw 42 can still drive the movement of the spiral disk 43, and then drive the movement of the connecting rod 44 to make the support arm 10 expand or close. Such a setting can realize the expansion or closing of the support arm 10, and at the same time, it can realize the movement of the support arm 10 to the distal end or the proximal end. In this embodiment, the limiting portion 421 is convexly provided on the screw 42, and the limiting groove 51 matching the limiting portion 421 is provided on the sliding member 50. In other examples, it can also be set that the limiting portion 421 is convexly provided on the sliding member 50, and the limiting groove 51 matching the limiting portion 421 is provided on the screw 42.

[0056] In another embodiment, see Figures 4 to 10 The anchoring member 13 includes an anchoring wire 131 and a clamping member 132 fixedly connected to the proximal end of the anchoring wire 131. The clamping member 132 and the anchoring wire 131 can be fixedly connected by welding, crimping, bonding, etc. The clamping member 132 includes a limiting arm 1321. A push rod 14 is provided in the puncture tube 12. The push rod 14 is provided at the proximal end of the clamping member 132. The push rod 14 is used to support the clamping member 132 when the puncture tube 12 is withdrawn to the proximal end, so that the anchoring member 13 is fixed to the native valve leaflet 2 and the artificial valve leaflet 3. The anchoring wire 131 is a memory alloy wire, such as nickel titanium wire, etc. Figure 6 As shown, the anchor wire 131 is in the shape of a coil in a free state, and when it is located in the puncture tube 12, it is an extended straight wire (such as Figure 3 and Figure 4The specific operation process is that after the distal clamp 20 and the proximal clamp 30 clamp the native valve leaflet 2, the support arm 10 is in place and supports the artificial valve leaflet 3 and the native valve leaflet 2 (such as Figure 4 As shown), after the puncture tube 12 punctures the artificial valve leaflet 3 and the native valve leaflet 2 (as shown Figure 8 As shown), the push rod 14 then presses against the clamp 132, and the puncture tube 12 is withdrawn toward the proximal end (as shown in FIG. Fig. 9 As shown), that is, the anchoring member 13 will not be withdrawn with the puncture tube 12 at this time, but will remain in position under the action of the push rod 14. After the puncture tube 12 is withdrawn, because the anchoring wire 131 is a memory alloy wire, the anchoring wire 131 will become a disc in a free state after being released, and will be anchored above the native leaflet 2, as shown in FIG. Fig.10 As shown, the upper and lower parts here are just pointers to the upper and lower positional relationship shown in the figure, and the limiting arm 1321 is located below the artificial valve leaflet 3. If the puncture tube 12 is withdrawn further, the anchor 13 will remain on the native valve leaflet 2 and the artificial valve leaflet 3, and the native valve leaflet 2 and the artificial valve leaflet 3 will be anchored and connected. Finally, the anchor wire 131 of the anchor 13 is located on the side of the native valve leaflet 2, and the limiting arm 1321 is located on the side of the artificial valve leaflet 3, so that the native valve leaflet 2 and the artificial valve leaflet 3 are fixedly connected.

[0057] In one or more embodiments of the present invention, see Figure 2 , Figure 6 and Figure 7 The puncture tube 12 and the supporting arm 10 are provided with a slide groove 121 for the limiting arm 1321 to pass through, so that when the limiting arm 1321 and the puncture tube 12 move together, they can move smoothly relative to the supporting arm 10. At the same time, when the puncture tube 12 is withdrawn toward the proximal end, the limiting arm 1321 can also move relative to the puncture tube 12 inside the puncture tube 12.

[0058] In one or more embodiments of the present invention, please continue to refer to Figures 2 to 11, three support arms 10 are provided, and the three support arms 10 are evenly arranged at the accommodating port 41. Because the native valve leaflets 2 and the artificial valve leaflets 3 have a certain area, in order to better support the native valve leaflets 2 and the artificial valve leaflets 3, three support arms 10 are provided by increasing the supporting area, and each support arm 10 is provided with a puncture tube 12, an anchor 13, etc., and at the same time, the connecting rod 14 is also provided with the same number corresponding to the support arm 10, and each support arm 10 is also connected to the sliding member 50, so that each support arm 10 has the same movement. Moreover, by providing three support arms 10, three anchor points with adjustable spacing can be provided, which can be used for fixing artificial valve leaflets 3 of different lengths to adapt to various widths of implanted valve leaflets required by different patients, and the three anchor points are distributed in the center and both sides of the artificial valve leaflets 3, increasing the force-bearing area of ​​the artificial valve leaflets 3 and the native valve leaflets 2, and reducing the risk of damage to the native valve leaflets 2. Here, the number of the supporting arms 10 is set to three for example only, and there is no limitation on the number of the supporting arms 10 , and the number of the supporting arms 10 can be set to two, four, five, etc., and can be set according to the needs.

[0059] In one or more embodiments of the present invention, Fig.16 As shown, artificial chordae 4 are preset on the artificial leaflet 3. In order to make the artificial leaflet 3 better open and close with the native leaflet 2 at the same time, and also to solve the problem of leaflet prolapse or chordae rupture, artificial chordae 4 can be set on the artificial leaflet 3. Artificial chordae 4 can achieve better opening and closing effect for the artificial leaflet 3 during the contraction and expansion periods. There is no limitation on the way of setting artificial chordae 4 on the artificial leaflet 3, which can be as follows Fig.16 The connection method shown may also be other connection methods, as long as the artificial chordae 4 can be connected to the artificial valve leaflets 3 in advance.

[0060] The following uses the mitral valve leaflets as an example. Figures 12 to 16 , the operation steps of the valve leaflet coaptation enhancement device 1 are briefly described:

[0061] 1. The valve leaflet coaptation enhancement device 1 enters the heart through the apical path, and the distal clamp 20 and the proximal clamp 30 are opened to capture the native valve leaflet;

[0062] 2. Adjust the position and the unfolding angle of the supporting arm 10 to a suitable position so that the artificial valve leaflet 3 and the native valve leaflet 2 fit together;

[0063] 3. The puncture tube 12 is used for puncture. After the puncture is completed, the push rod 14 is pressed against the anchor 13, and the puncture tube 12 is withdrawn. The anchor 13 is fixed to the artificial valve leaflet 3 and the native valve leaflet 2. The artificial valve leaflet 3 and the native valve leaflet 2 are tightly fixed. The artificial valve leaflet fixed on the support arm 10 by sutures can be withdrawn from the support arm 10 by sutures. Here, one end of the suture can be set in the handle, and the suture is withdrawn from the support arm 10 by operating the handle end, so that the artificial valve leaflet 3 is freely separated from the support arm 10, and then the distal clamp 20 and the proximal clamp 30 release the native valve leaflet 2, and the artificial chordae 4 pre-fixed on the artificial valve leaflet 3 is withdrawn from the body along with the valve leaflet apposition enhancement device 1, thereby completing the enhancement of the native valve leaflet 2.

[0064] 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 valve leaflet coaptation enhancement device, characterized in that: The valve leaflet coaptation enhancement device comprises: Multi-lumen tube; A proximal clamp connected to the distal end of the multi-lumen tube; A slide rod is movably connected to the multi-lumen tube, and a through hole is provided on the proximal clamp for the slide rod to pass through; A distal clamp connected to the distal end of the slide rod, the distal clamp can move relative to the proximal clamp under the drive of the slide rod, and the distal joint and the proximal clamp are used to clamp the native valve leaflet; A support arm is connected to the multi-lumen tube, an artificial valve leaflet is connected to the distal end of the support arm, a puncture channel is provided in the support arm for a puncture tube to pass through, the puncture tube is provided in the multi-lumen tube and / or the support arm, and the puncture tube can pass through the puncture channel and then puncture the artificial valve leaflet and the native valve leaflet, an anchor is provided in the puncture tube, and the anchor can fix the artificial valve leaflet and the native valve leaflet in connection.

2. The leaflet coaptation enhancement device according to claim 1, characterized in that: An accommodating opening for accommodating the supporting arm is formed between the multi-lumen tube and the proximal clamp. The supporting arm has an expanded state and a closed state. When the supporting arm is in the closed state, the supporting arm is embedded in the accommodating opening.

3. The leaflet coaptation enhancement device according to claim 1, characterized in that: The proximal end of the support arm is connected with a sliding member, and the sliding member can move in the multi-lumen tube and thus drive the support arm to move.

4. The leaflet coaptation enhancement device according to claim 3, characterized in that: The proximal end of the sliding member is fixedly connected to a driving rod, and the leaflet coaptation enhancement device also includes a handle, which can be used to control the movement of the driving rod.

5. The leaflet coaptation enhancement device according to claim 3, characterized in that: A screw is provided in the multi-lumen tube, and a spiral disk is sleeved on the screw and cooperates with the screw thread. The leaflet apposition enhancement device also includes a connecting rod, one end of which is movably connected to the proximal end of the support arm, and the other end of the connecting rod is movably connected to the spiral disk. The connecting rod can expand or close the support arm under the drive of the spiral disk.

6. The leaflet coaptation enhancement device according to claim 5, characterized in that: A limiting portion is convexly arranged at the proximal end of the screw rod, and a limiting groove matching the limiting portion is arranged on the sliding member, and the limiting portion can rotate circumferentially in the limiting groove.

7. The leaflet coaptation enhancement device according to claim 1, characterized in that: The anchoring member includes an anchoring wire and a clamping member fixedly connected to the proximal end of the anchoring wire, the clamping member includes a limiting arm, a push rod is provided in the puncture tube, the push rod is provided at the proximal end of the clamping member, and the push rod is used to support the clamping member when the puncture tube is withdrawn toward the proximal end, thereby fixing the anchoring member to the native valve leaflet and the artificial valve leaflet.

8. The leaflet coaptation enhancement device according to claim 7, characterized in that: The puncture tube and the supporting arm are provided with a sliding groove through which the limiting arm can pass.

9. The leaflet coaptation enhancement device according to claim 2, characterized in that: The number of the supporting arms is three, and the three supporting arms are evenly arranged at the accommodating opening.

10. The leaflet coaptation enhancement device according to claim 1, characterized in that: Artificial chordae tendineae are preset on the artificial valve leaflet.

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