Heart valve repair fixture

Abstract

The present invention belongs to the technical field of medical devices, and specifically relates to a heart valve repair fixture. A heart valve repair fixture includes a capture device; the capture device includes: at least two capture members, with capture member barbs provided on the inner side to capture the leaflets; a fitting member, having at least two fitting surfaces, the fitting surfaces being arranged opposite to the capture members, the proximal ends of the fitting surfaces being located at and fixedly connected to the connection position of the proximal end of the capture member, and the fitting surfaces being rotatable relative to the connection position to adjust the opening and closing of the capture device. In the present invention, multiple capture members share one fitting member, which reduces the number of components and also increases the angle between the capture member and the fitting member during use, making it more convenient to capture the leaflets. The fitting member is fixedly connected to the proximal end of the capture member, without axial relative movement, thereby avoiding misalignment of the joint surfaces of the two and axial relative friction.

Description

Technical Field

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

[0002] Heart valve insufficiency, particularly mitral and tricuspid atrioventricular regurgitation or regurgitation, is gaining increasing attention due to its high prevalence. According to statistics, approximately 7.5 million patients in my country will require interventional treatment for mitral regurgitation in 2020. However, due to the current immaturity of the market and the high cost of surgery, only 40,000 surgical procedures are performed annually, resulting in an extremely low cure rate.

[0003] Edge-to-edge repair has been the most researched approach. Currently, a mitral valve repair fixture is used to perform transvalvular mitral valve repair, passing from the femoral vein through the right atrium, puncturing the atrial septum, and then into the left atrium. This involves numerous components, a complex manufacturing process, and the surgical procedure requires the participation of experienced medical staff from multiple departments, resulting in high costs.

[0004] The transapical edge-to-edge repair has a shorter stroke and avoids the drawbacks of traditional open-chest surgery requiring cardiac arrest and extracorporeal circulation. Furthermore, the product is low-cost and easier to market. Chinese patent CN109875726A discloses a flexible valve repair clamp, in which the first clamping arm and the second clamping arm of the repair clamp are plugged into a clamp that captures the leaflet and then tightens within a sleeve to secure the clamp. The technology involved in this patent has the problem that the first clamping arm and the second clamping arm are separate, and thus the two clamping arms are prone to rotation when mated or become stuck within the plug-in channel, making transportation difficult. Therefore, there is a need to design a transapical integrated heart valve repair clamp. Summary of the Invention

[0005] The present invention aims to provide a heart valve repair clamp for edge-to-edge repair of the heart valve, and solves the technical problem that a repair clamp for the heart valve is difficult to transport.

[0006] A heart valve repair fixture includes a capture device for capturing a heart valve;

[0007] The capture device comprises:

[0008] at least two capturing elements, with capturing element barbs provided on the inner sides thereof for capturing the leaflets;

[0009] A fitting member has at least two fitting surfaces, the number of the fitting surfaces is the same as the number of the capturing members, the fitting surfaces are arranged opposite to the capturing members, the proximal ends of the fitting surfaces are fixedly connected to the connecting position located at the proximal end of the capturing member, and the fitting surfaces can be rotated relative to the connecting position to adjust the opening and closing of the capturing device.

[0010] As a preferred solution, the capture device further includes:

[0011] At least two capture control members, the number of which is the same as the number of the capture members, one end of which is detachably connected to the capture member and the other end of which is connected to an external conveyor, are provided. The rotation of the capture member is controlled by the capture control member to capture the leaflet or clamp the leaflet with the fitting surface to prevent the leaflet from escaping.

[0012] As a preferred solution, the capture member includes:

[0013] The two layers of clips are an outer layer clip and an inner layer clip, the outer layer clip and the inner layer clip are fixedly connected, and the inner side surface of the inner layer clip is integrally connected with the capture component barb.

[0014] As a preferred solution, the barbs of the capture member may be a shuttle-like structure with narrow ends and a wide middle.

[0015] As a preferred solution, the barb of the capture member may also be wide at the top and narrow at the bottom (pointed), with a pointed end at the bottom and a connecting hole provided at the pointed end;

[0016] The fitting surface is provided with a connector that is plugged into the pin through hole, and the fitting surface and the capturing member are fitted and clamped together by locking the connector with the connecting hole.

[0017] As a preferred embodiment, the barb of the capture member is inclined toward the proximal end of the capture member, and the angle between the length direction of the barb of the capture member and the length direction of the capture member is an acute angle, preferably 20°-70°, and can be 30°, 45° or 60°, etc.

[0018] As a preferred solution, the capture member barbs include:

[0019] A plurality of first barbs are arranged in a matrix or staggered manner on the inner side of the capture member.

[0020] As a preferred solution, the length of the first barb gradually shortens from the distal end to the proximal end.

[0021] As a preferred solution, the capture member barbs further include:

[0022] A second barb is located at the distal end of the capture member, and a locking member is provided on the second barb and the fitting surface.

[0023] As a preferred solution, the end of the second barb has a barb;

[0024] The laminating surface has:

[0025] A barb through hole is formed with the barb to cooperate with the locking piece to realize the locking connection between the fitting surface and the capturing piece.

[0026] As a preferred solution, an elastic sheet is provided in the barb through hole, and a clamping piece engaged with the barb is provided at the distal end of the elastic sheet.

[0027] As a preferred solution, the distal ends of at least two of the fitting surfaces are connected to form an integral structure.

[0028] As a preferred solution, the distal ends of at least two of the fitting surfaces are connected in a smooth transition connection, forming an arcuate surface that is convex or concave toward the distal end at the distal end of the fitting.

[0029] As a preferred solution, the distal distance between at least two of the fitting surfaces is greater than the distance between other parts to prevent distal reflux.

[0030] As a preferred solution, the fitting member may be a columnar structure or a rectangular parallelepiped structure, and is located in the middle of the plurality of capturing members.

[0031] As a preferred solution, the barbs of the capture member are snap-connected with the corresponding fitting surface and inserted into the interior of the fitting;

[0032] The plurality of barbs of the capture member located on the same horizontal plane are arranged at staggered angles, so that the barbs of the capture member located on the same horizontal plane can be staggered with each other after being inserted into the fitting to avoid mutual squeezing.

[0033] As a preferred solution, the heart valve repair fixture further includes:

[0034] A connecting base has a distal end connected to the proximal end of the capturing member and the proximal end of the fitting member, and a proximal end detachably connected to an external conveyor, which conveys the capturing device to a target position.

[0035] As a preferred solution, a blind hole, a through hole, a screw hole or a snap-fit piece is provided at the proximal end of the connecting base, and the connecting base is threadedly connected or snap-fitted to the external conveyor.

[0036] As a preferred solution, the heart valve repair fixture further includes:

[0037] At least two auxiliary clamping pieces with restoring elasticity, the number of which is the same as the number of the capturing pieces, are located outside the corresponding capturing pieces, and the proximal ends are connected to the connecting base.

[0038] The auxiliary clamping piece is a hollow inverted U-shaped structure, the open end of the auxiliary clamping piece is connected to the connecting base, the distal transverse section of the auxiliary clamping piece abuts against the distal outer side of the capturing piece, and the two vertical sections of the auxiliary clamping piece abut against the outer side of the capturing piece along the axial direction of the capturing piece to apply an inward clamping force to the capturing piece through the auxiliary clamping piece.

[0039] The positive and progressive effects of the present invention are as follows: the present invention utilizes a heart valve repair fixture suitable for transapical mitral and / or tricuspid valve repair. Multiple capture components share a single fitting component, which not only reduces the number of components but also increases the angle between the capture component and the fitting component during use, making it easier to capture the valve leaflets. The fitting component is fixedly connected to the proximal end of the capture component without axial relative movement, thus avoiding misalignment of the joint surface and axial relative friction between the two. The opening and closing of the capture component is controlled by a pull wire at the handle end of the external conveyor, making it easier to control the opening and closing degree of the capture component. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 A structural schematic diagram of the present invention;

[0041] Figure 2 for Figure 1 Side view of

[0042] Figure 3 for Figure 1 Schematic diagram of part of the structure;

[0043] Figure 4 for Figure 3 A partial enlarged view of point A in the middle;

[0044] Figure 5 for Figure 3 Bottom view of

[0045] Figure 6 A state diagram of the capture member of the present invention when it is opened;

[0046] Figure 7 A schematic structural diagram of a capture element of the present invention;

[0047] Figure 8 for Figure 7 A partial enlarged view of point B in the middle;

[0048] Figure 9 is another structural schematic diagram of the capture member of the present invention;

[0049] Figure 10 for Figure 9 A partial enlarged view of point C in the middle;

[0050] Figure 11 A schematic diagram of a connection between the capture member and the fitting surface of the present invention;

[0051] Figure 12 for Figure 11 A partial enlarged view of point D in the middle;

[0052] Figure 13 Another structural diagram of the present invention;

[0053] Figure 14 for Figure 13 A partial enlarged view of point E in the middle;

[0054] Figure 15 Another structural diagram of the present invention;

[0055] Figure 16 A schematic structural diagram of a bonding member of the present invention;

[0056] Figure 17 is another structural schematic diagram of the bonding member of the present invention;

[0057] Figure 18 for Figure 17 A main view of

[0058] Figure 19 for Figure 17 A cross-sectional view of

[0059] Figure 20 for Figure 17 Another cross-sectional view of . DETAILED DESCRIPTION

[0060] In order to make the technical means, creative features, objectives and effects achieved by the present invention easier to understand, the present invention is further described below with reference to specific illustrations.

[0061] Reference Figures 1 to 20 A heart valve repair fixture includes a capture device 100, at least two capture control components, a connecting base 200 and at least two auxiliary clamping components 300.

[0062] Reference Figures 1 to 6 The capture device 100 is used to capture a heart valve. The capture device 100 includes at least two capture parts 110 and a fitting part 120.

[0063] The number of the capture members 110 can be determined according to the number of leaflets of the heart valve to be captured, such as two capture members 110 or three capture members 110. The inner side of the capture member 110 is provided with a capture member barb 111. Figure 7 and Figure 8The barbs 111 of the capture member can be a shuttle-like structure with narrow ends and wide in the middle. After the capture member 110 grabs the leaflet, it can be pushed to the narrower part of the top of the barbs 111 of the capture member, reducing the tearing stress of the barbs 111 on the leaflet. The wider part of the barbs 111 of the capture member can prevent the leaflet from slipping out after the leaflet is fixed. Figure 9 and Figure 10 , the capture member barb 111 can also be wide at the top and narrow at the bottom (pointed), and the bottom of the capture member barb 111 is a pointed tip, and a connecting hole 112 is provided at the tip, and the connecting hole 112 is preferably a pin through hole. The capture member barb 111 of the above structure, after capturing the leaflet, is locked with the connecting member 125 on the fitting member 120 through the connecting hole 112 at the bottom to prevent the leaflet from escaping. The capture member barb 111 is tilted toward the proximal end of the capture member 110, and the angle between the length direction of the capture member barb 111 and the length direction of the capture member 110 is an acute angle, preferably 20°-70°, and can be 30°, 45° or 60°, etc. The capture member barb 111 can be divided into a plurality of first barbs 111a located at the proximal end and the middle part, and a second barb 111b located at the distal end. With reference to Figure 7 and Figure 9 , a plurality of first barbs 111a are arranged in a matrix or staggered on the inner side of the capture member 110. Figure 2 The length of the plurality of first barbs 111a gradually shortens from the distal end to the proximal end. The second barb 111b is located at the distal end of the capture member 110. Figure 4 The end of the second barb 111b has a barb 113. Figure 15 The end of the second barb 111b may not be provided with the barb 113.

[0064] The capture piece 110 includes two layers of clips, namely an outer layer clip and an inner layer clip. The outer layer clip and the inner layer clip are fixedly connected together. The outer layer clip is not provided with a capture piece barb 111. The inner side surface of the inner layer clip is integrally connected with a capture piece barb 111 to ensure that the capture piece 110 has appropriate strength and elasticity.

[0065] Reference Figures 1 to 6 The fitting member 120 has at least two fitting surfaces 121. The number of fitting surfaces 121 is the same as the number of capturing members 110. One fitting surface 121 is disposed opposite to a corresponding capturing member 110. The proximal end of the fitting surface 121 is fixedly connected to a connecting portion located at the proximal end of the corresponding capturing member 110. The fitting surface 121 can rotate relative to the connecting portion to adjust the opening and closing of the capturing device. Figure 4 The fitting surface 121 has a hook through hole 122, and the hook through hole 122 and the hook 113 form a locking member to achieve the locking connection between the fitting surface 121 and the capture member 110. Figure 13 and Figure 14, an elastic sheet 123 is provided in the barb through hole 122, and a clamping member 124 is provided at the distal end of the elastic sheet 123 to engage with the barb 113. When the capture member 110 does not capture the leaflet, after the capture member 110 is pulled by an external force, the capture member 110 and the elastic sheet 123 are separated, and the clamping member 124 and the barb 113 are separated. When the capture member 110 is reset, under the action of the recovery force of the capture member 110 itself, the clamping member 124 is engaged with the barb 113, and the leaflet is stably clamped between the capture member 110 and the fitting surface 121. Figure 15 When the end of the second barb 111b is not provided with a barb 113, the barb through hole 122 on the fitting surface 121 is a fitting surface through hole, and the end of the second barb 111b can be plugged into the fitting surface through hole to achieve plug-in connection.

[0066] Reference Figure 11 and Figure 12 When the barbs 111 on the capturing member 110 are wide at the top and narrow at the bottom, a connector 125 is provided on the contact surface 121 to engage with the connection hole 112. The connector 125 is preferably a pin. The locking of the connector 125 with the connection hole 112 allows the contact surface 121 and the capturing member 110 to contact and clamp the leaflets.

[0067] Reference Figures 1 to 6 , Figures 13 to 19 The distal ends of the multiple bonding surfaces 121 are connected to form an integral structure. When connected, a smooth transition is preferably used to form a curved surface that is convex or concave toward the distal end at the distal ends of the multiple bonding pieces 120. The distal ends of at least two bonding surfaces 121 are farther apart than the distances of other parts, that is, the distal ends of at least two bonding surfaces 121 are farther apart than the distances of the middle and proximal ends, so as to prevent distal reflux. Figure 2 As shown in FIG, the two fitting surfaces 121 are arranged opposite to each other, and the distance between the opposite surfaces gradually increases from the proximal end to the distal end.

[0068] Reference Figures 16 to 20 The fitting member 120 may be a columnar structure or a rectangular parallelepiped structure and is located in the middle of the plurality of capturing members 110. This allows the plurality of capturing members 110 to share one fitting member 120. Figure 19 As shown in , a card interface can be opened on each fitting surface 121, and the capture member barb 111 can be snapped into the corresponding card interface and inserted into the fitting member 120 to achieve the purpose of snap connection between the capture member 110 and the corresponding fitting surface 121. Figure 20 As shown, the multiple capture barbs 111 located on the same horizontal plane are arranged at staggered angles so that the multiple capture barbs 111 located on the same horizontal plane can be staggered with each other after being inserted into the fitting 120 to avoid mutual squeezing.

[0069] The number of capture control members is the same as the number of capture members 110. One end of the capture control member is detachably connected to the capture member 110, and the other end of the capture control member is connected to an external conveyor. The capture control member controls the rotation of the capture member 110 to capture the leaflet or to fit the leaflet with the fitting surface 121 to prevent the leaflet from escaping. The capture control member is preferably a pull wire. Figure 6 The left capture member 110 can be opened to clamp the leaflet by pulling the wire. Specifically, a pull wire through hole 114 can be dug on the capture member 110, and one end of the pull wire is passed through the pull wire through hole 114 to achieve a detachable connection with the capture member 110.

[0070] Reference Figures 1 to 6 、 Figure 13 、 Figures 15 to 19 The distal end of the connecting base 200 is connected to the proximal end of the capturing member 110 and the proximal end of the attaching member 120, respectively. The proximal end of the connecting base 200 is detachably connected to an external conveyor, which transports the capturing device 100 to a target location. The proximal end of the connecting base 200 is provided with a blind hole, through hole, screw hole, or snap-fitting member, and the connecting base 200 is threadedly or snap-fitted to the external conveyor.

[0071] The auxiliary clamping member 300 is an auxiliary clamping member 300 with restoring elasticity. The number of the auxiliary clamping members 300 is the same as the number of the capture members 110. The auxiliary clamping members 300 are located outside the corresponding capture members 110 and are connected to the connection base 200 at their proximal ends. Figure 1 and Figure 2 The auxiliary clamping member 300 is a hollow inverted U-shaped structure. The open end of the auxiliary clamping member 300 is connected to the connecting base 200. The distal horizontal section of the auxiliary clamping member 300 abuts against the distal outer side of the capturing member 110. The two vertical sections of the auxiliary clamping member 300 abut against the outer side of the capturing member 110 along the axial direction of the capturing member 110, so as to apply an inward clamping force to the capturing member 110 through the auxiliary clamping member 300.

[0072] When the present invention is used, the external conveyor is detachably connected to the proximal end of the connection base 200, and the capture control member is also connected to the external conveyor. The capture device 100 is delivered to the target position via the external conveyor. The capture control member is pulled by the external conveyor to open the capture member 110. The capture device 100 is further pushed, and the leaflets fall between the capture member 110 and the corresponding fitting surface 121. The capture control member is released, and the capture member 110 returns to its original position and engages with the fitting surface 121, clamping the leaflets between the two. The capture member barbs 111 on the capture member 110 further clamp the leaflets to prevent them from escaping. The external conveyor is separated from the connection base 200, and the connection between the capture control member and the capture member is released. The external conveyor and the capture control member are then pulled back. The heart valve repair clamp of the present invention remains at the target position, achieving stable clamping of the heart valve.

[0073] The basic principles, main features, and advantages of the present invention are shown and described above. Those skilled in the art should understand that the present invention is not limited to the foregoing embodiments. The foregoing embodiments and descriptions are merely illustrative of the principles of the present invention. Various changes and modifications may be made to the present invention without departing from the spirit and scope of the present invention. Such changes and modifications are intended to fall within the scope of the present invention. The scope of protection claimed in the present invention is defined by the appended claims and their equivalents.

Claims

1. A heart valve repair fixture comprising a capture device for capturing a heart valve; It is characterized by: The capturing device comprises: at least two capturing elements, with capturing element barbs provided on the inner sides thereof for capturing the leaflets; at least two capture control members, the number of which is the same as the number of the capture members, one end of which is detachably connected to the capture member and the other end of which is connected to an external conveyor, and the rotation of the capture member is controlled by the capture control member; At least two auxiliary clamping members with restoring elasticity, the number of which is the same as the number of the capturing members, and located outside the corresponding capturing members; a fitting member having at least two fitting surfaces, the number of the fitting surfaces being the same as the number of the capturing members, the fitting surfaces being disposed opposite the capturing members, the proximal ends of the fitting surfaces being fixedly connected to a connection portion located at the proximal end of the capturing member, and the fitting surfaces being rotatable relative to the connection portion to adjust the opening and closing of the capturing device; The heart valve repair fixture further comprises: A connecting base has a distal end connected to the proximal end of the capturing member, the proximal end of the fitting member, and the proximal end of the auxiliary clamping member, and a proximal end detachably connected to an external conveyor, which conveys the capturing device to the target position.

2. The heart valve repair fixture according to claim 1, wherein: The capture member comprises: The two layers of clips are an outer layer clip and an inner layer clip, the outer layer clip and the inner layer clip are fixedly connected, and the inner side surface of the inner layer clip is integrally connected with the capture component barb.

3. The heart valve repair fixture according to claim 1, wherein: The barbs of the capture member are of a shuttle-like structure that is narrow at both ends and wide in the middle; or, The barb of the capture member is wide at the top and narrow at the bottom, with a pointed end at the bottom and a connecting hole at the pointed end; The fitting surface is provided with a connector that is plugged into the connecting hole. The fitting surface and the capturing member can fit and clamp the leaflets by locking the connector with the connecting hole.

4. The heart valve repair fixture according to claim 1, wherein: The barbs of the capture member are arranged obliquely toward the proximal end of the capture member, and an angle between the length direction of the barbs of the capture member and the length direction of the capture member is an acute angle.

5. The heart valve repair fixture according to claim 1, wherein: The capture member barbs include: A second barb is located at the distal end of the capture member, and a locking member is provided on the second barb and the fitting surface.

6. The heart valve repair fixture according to claim 5, characterized in that: The end of the second barb has a barb; The laminating surface has: A barb through hole is formed with the barb to cooperate with the locking piece to realize the locking connection between the fitting surface and the capturing piece.

7. The heart valve repair fixture according to claim 3, wherein: The barbs of the capture member include: a plurality of first barbs arranged in a matrix or staggered manner on the inner side surface of the capture member, and the length of the first barbs gradually shortens from the distal end to the proximal end.

8. The heart valve repair fixture according to claim 6, wherein: An elastic sheet is arranged in the barb through hole, and a clamping piece engaged with the barb is arranged at the distal end of the elastic sheet.

9. The heart valve repair fixture according to claim 1, wherein: The distal ends of at least two of the fitting surfaces are connected to form an integral structure.

10. The heart valve repair fixture according to claim 9, wherein: The distal ends of at least two of the fitting surfaces are connected in a smooth transition connection, forming an arcuate surface that is convex or concave toward the distal end at the distal end of the fitting.

11. The heart valve repair fixture according to claim 10, wherein: The distance between the distal ends of at least two of the fitting surfaces is greater than the distance between other parts to prevent distal end reflux.

12. The heart valve repair fixture according to claim 1, wherein: The fitting member is a columnar structure or a rectangular parallelepiped structure and is located in the middle of the plurality of capturing members; The barbs of the capture piece are snap-connected with the corresponding fitting surface and inserted into the interior of the fitting piece.

13. The heart valve repair fixture according to claim 12, wherein: The plurality of barbs of the capture member located on the same horizontal plane are arranged at staggered angles, so that the barbs of the capture member located on the same horizontal plane can be staggered with each other after being inserted into the fitting to avoid mutual squeezing.

14. The heart valve repair fixture according to claim 1, wherein: The auxiliary clamping piece is a hollow inverted U-shaped structure, the open end of the auxiliary clamping piece is connected to the connecting base, the distal transverse section of the auxiliary clamping piece abuts against the distal outer side of the capturing piece, and the two vertical sections of the auxiliary clamping piece abut against the outer side of the capturing piece along the axial direction of the capturing piece to apply an inward clamping force to the capturing piece through the auxiliary clamping piece.

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