Valve edge-to-edge repair implant and valve edge-to-edge repair system

Abstract

The present application provides a valve edge-to-edge repair implant, which includes at least two rigid gaskets, at least two puncture needles, and a locking piece. Each puncture needle includes a puncture section and a locking section fixedly connected to the proximal end of the puncture section. At least one elastic piece is provided on the locking section. One end of the elastic piece is fixedly connected to the locking section, and the other end of the elastic piece extends outward and distally relative to the locking section. After all the puncture needles puncture the valve, each rigid gasket is at least cooperatively connected with the puncture section of one puncture needle. The locking piece is sleeved on the locking sections of all the puncture needles. The locking piece is located between the rigid gasket and the other end of the elastic piece. The structure of the valve edge-to-edge repair implant is simple, can greatly reduce the locking driving force, and improve the locking efficiency. The present application also provides a valve edge-to-edge repair system, which includes the valve edge-to-edge repair implant.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and particularly relates to a valve edge-to-edge repair implant and a valve edge-to-edge repair system. Background Art

[0002] Heart valves such as the mitral valve and tricuspid valve are one-way valves between the atrium and the ventricle. A normal and healthy valve can control the blood flow from the atrium to the ventricle, while preventing the blood from flowing from the ventricle to the atrium. When the atrium contracts, the valve opens, and the blood flows from the atrium to the ventricular side; when the ventricle contracts, the valve should close to prevent the blood flow from rushing to the atrial side. When the leaflets, chordae tendineae, annulus or other related structures of the valve are diseased, such as poor coaptation between the leaflets, then, when the ventricle contracts, the valve cannot close completely, resulting in blood reflux from the ventricle to the atrium, thereby causing a series of pathophysiological changes.

[0003] Edge-to-edge repair is an effective way to treat valve diseases clinically. For edge-to-edge repair, sutures can be implanted on adjacent leaflets respectively. By pulling the sutures, the edges of the adjacent leaflets that cannot be normally coapted are made to coapt with each other, and the side of the suture away from the valve is locked to reduce the total area of the valve orifice and reduce or eliminate the reflux.

[0004] In an existing edge-to-edge repair method, first, a suture and a gasket are implanted on the leaflet through a valve suture device, and the free end of the suture extends out of the body. Then, a locking nail is threaded through the suture by a locking device, and the locking nail is sent along the suture to the vicinity of the leaflet. Then, the locking device is controlled to press and hold the locking nail so that the locking nail deforms and compresses the suture. Finally, the redundant suture extending out of the body from the locking nail is cut off. Thus, the suture, gasket and locking nail are left in the heart as a valve edge-to-edge repair implant. However, driving the locking nail to deform requires a relatively complex pressing and holding structure and a large driving force, and a wire cutting step is also required, so the operation is rather cumbersome, reducing the locking efficiency. Summary of the Invention

[0005] The technical problem to be solved by the present application is to provide a valve edge-to-edge repair implant and a valve edge-to-edge repair system, which can simplify the instrument structure, greatly reduce the locking driving force, make the operation more convenient, and improve the locking efficiency.

[0006] To achieve the above object, the embodiments of the present application adopt the following technical solutions:

[0007] In a first aspect, the present application provides a valve edge-to-edge repair implant, comprising at least two rigid gaskets, at least two puncture needles and a locking piece; each of the puncture needles includes a puncture section and a locking section fixedly connected to the proximal end of the puncture section, at least one elastic piece is provided on the locking section, one end of the elastic piece is fixedly connected to the locking section, and the other end of the elastic piece extends outward and distally relative to the locking section. After all the puncture needles puncture the valve, each of the rigid gaskets is cooperatively connected to at least one puncture section of the puncture needles, the locking piece is sleeved on the locking sections of all the puncture needles, and the locking piece is located between the rigid gasket and the other end of the elastic piece.

[0008] In a second aspect, the present application provides a valve edge-to-edge repair system, comprising an implantation device, a locking device, the above-mentioned valve edge-to-edge repair implant and a suture. The implantation device includes a sheath, a proximal chuck and a driving rod. The proximal chuck is fixedly connected to the distal end of the sheath; the puncture needle and the driving rod are both movably inserted into the sheath and the proximal chuck along the axial direction of the sheath; the driving rod is detachably connected to the rigid gasket; the suture movably passes through the proximal end of the locking section of the puncture needle; the locking device includes a locking push tube, and the locking push tube drives the locking piece to be sleeved on the locking sections of all the puncture needles along the suture, and makes the locking piece located between the rigid gasket and the other end of the elastic piece.

[0009] In the valve edge-to-edge repair implant and the valve edge-to-edge repair system provided by the present application, after the puncture section of the puncture needle punctures the valve and is cooperatively connected to the rigid gasket, as long as the locking piece is sleeved on the locking sections of all the puncture needles, so that the locking piece is located between the rigid gasket and the other end of the elastic piece, the locking of all the puncture needles is completed. There is no need to implant a suture as in the prior art, thus omitting the suture cutting step, making the locking operation more convenient, improving the locking efficiency, and there is no need to force the locking nail to deform to lock the suture by setting a complex pressing structure as in the prior art, simplifying the instrument structure; one end of the elastic piece is fixedly connected to the locking section, and the other end of the elastic piece extends outward and distally relative to the locking section of the puncture needle. When the locking piece passes through the elastic piece from near to far, the elastic piece compliantly moves closer to the locking section, and the resistance to the locking piece is very small. In this way, the locking driving force required to push the locking piece is greatly reduced, and the difficulty of the locking operation is reduced. Description of the Drawings

[0010] Figure 1 is a three-dimensional schematic diagram of the valve edge-to-edge repair system provided by the first embodiment of the present application;

[0011] Figure 2 is Figure 1Exploded perspective view of the locking device in the valve edge-to-edge repair system shown;

[0012] Figure 3 is Figure 1 Schematic diagram of the hard gasket, drive rod, limit rod, puncture needle and puncture push tube in [[ ]] assembled together;

[0013] Figure 4 is Figure 1 Cross-sectional view of the hard gasket, drive rod, puncture needle and suture in [[ ]] assembled together;

[0014] Figure 5 is Figure 1 Stereo diagram of the hard gasket, puncture needle and suture in [[ ]] assembled together;

[0015] Figure 6 Stereo diagram of the locking device pushing the locking piece when the valve edge-to-edge repair system performs edge-to-edge repair surgery on the tricuspid valve;

[0016] Figure 7 is Figure 6 Cross-sectional view of the locking device pushing the locking piece as shown in [[ ]];

[0017] Figure 8 Stereo diagram of three hard gaskets and three puncture needles implanted into the valve when the valve edge-to-edge repair system performs edge-to-edge repair surgery on the tricuspid valve;

[0018] Figure 9 Cross-sectional view of the locking piece passing through the elastic piece when the valve edge-to-edge repair system performs edge-to-edge repair surgery on the tricuspid valve;

[0019] Figure 10 Schematic diagram of the locking device locking the puncture needle with suture after being withdrawn from the body when the valve edge-to-edge repair system performs edge-to-edge repair surgery on the tricuspid valve;

[0020] Figure 11 Stereo diagram of the valve edge-to-edge repair implant after the suture is withdrawn when the valve edge-to-edge repair system performs edge-to-edge repair surgery on the tricuspid valve;

[0021] Figures 12a - 12e Schematic diagram of the process of the valve edge-to-edge repair system performing edge-to-edge repair surgery on the tricuspid valve;

[0022] Figure 13 Partial structural schematic diagram of the valve edge-to-edge repair system provided by the second embodiment of the present application;

[0023] Figure 14 Partial structural schematic diagram of the valve edge-to-edge repair system provided by the third embodiment of the present application;

[0024] Figure 15 Schematic three-dimensional view of the puncture needle of the valve edge-to-edge repair system provided in the fourth embodiment of the present application when connected to the rigid gasket;

[0025] Figure 16 is Figure 15 Cross-sectional view of a partial structure of the valve edge-to-edge repair system shown;

[0026] Figure 17 Schematic three-dimensional view of the drive rod of the valve edge-to-edge repair system provided in the fifth embodiment of the present application when connected to the rigid gasket;

[0027] Figure 18 is Figure 17 Side view of the drive rod when connected to the rigid gasket shown;

[0028] Figure 19 Schematic three-dimensional view of the rigid gasket provided in the sixth embodiment of the present application;

[0029] Figure 20 Schematic three-dimensional view of the rigid gasket provided in the seventh embodiment of the present application. Specific embodiments

[0030] In order to make the objectives, technical solutions and advantages of the present application clearer, the present application will be further described in detail below with reference to the accompanying drawings.

[0031] It should be understood that expressions such as "including" and "may include" that can be used in the present application indicate the existence of the disclosed functions, operations or constituent elements, and do not limit one or more additional functions, operations and constituent elements. In the present disclosure, terms such as "including" and / or "having" can be interpreted as indicating a specific characteristic, number, operation, constituent element, component or a combination thereof, but cannot be interpreted as excluding the existence or possibility of addition of one or more other characteristics, numbers, operations, constituent elements, components or a combination thereof.

[0032] In addition, in the present application, the expression "and / or" includes any and all combinations of the associated listed words. For example, the expression "A and / or B" can include A, can include B, or can include both A and B.

[0033] In the present application, expressions including ordinals such as "first" and "second" can modify each element. However, such elements are not limited by the above expressions. For example, the above expressions do not limit the order and / or importance of the elements. The above expressions are only used to distinguish one element from other elements. Similarly, without departing from the scope of the present disclosure, the first element can be called the second element, and similarly, the second element can also be called the first element.

[0034] When a component is referred to as "connected" or "accessed" to another component, it should be understood that: the component is not only directly connected or accessed to the other component, but there may also be another component between the component and the other component. On the other hand, when a component is referred to as "directly connected" or "directly accessed" to another component, it should be understood that there is no component between them.

[0035] In the field of interventional medical device technology, the orientation close to the operator is generally defined as the proximal end, and the orientation far from the operator is defined as the distal end. The direction of the rotation center axis of an object such as a cylinder or a tube is defined as the axial direction. The circumferential direction is the direction around the axis of an object such as a cylinder or a tube (perpendicular to the axis and perpendicular to the cross-sectional radius at the same time). The radial direction is the straight-line direction along the diameter or radius.

[0036] Please refer to Figure 1 and Figure 2 , the first embodiment of the present application provides a valve edge-to-edge repair system 100 for performing edge-to-edge repair on a heart valve. The valve edge-to-edge repair system 100 includes an implantation device 10, a valve edge-to-edge repair implant 30, a suture 35, and a locking device 50. The implantation device 10 is used to implant the valve edge-to-edge repair implant 30 into the valve. The locking device 50 is used to lock the valve edge-to-edge repair implant 30 to achieve edge-to-edge repair of the valve.

[0037] The implantation device 10 includes a sheath 11, a proximal chuck 13, and a drive rod 15. The proximal chuck 13 is fixedly connected to the distal end of the sheath 11.

[0038] The valve edge-to-edge repair implant 30 includes at least two rigid gaskets 31, at least two puncture needles 33, and a locking piece 34. The puncture needles 33 and the drive rod 15 are both axially movably inserted into the sheath 11 and the proximal chuck 13. The drive rod 15 is detachably connected to the rigid gasket 31.

[0039] Please refer to Figures 3 to 6 , each puncture needle 33 includes a puncture section 331 and a locking section 333 fixedly connected to the proximal end of the puncture section 331. The distal end of the puncture section 331 is a sharp needle tip 3311. At least one elastic piece 335 is provided on the locking section 333. One end of the elastic piece 335 is fixedly connected to the locking section 333, and the other end of the elastic piece 335 extends outward and distally relative to the locking section 333. A threading hole 3331 is provided at the proximal end of the locking section 333. The axial direction of the threading hole 3331 is perpendicular to the axial direction of the locking section 333. The threading hole 3331 is used to thread the suture 35. The suture 35 is in a U shape, and the two free ends of the suture 35 can extend outside the human body.

[0040] When the rigid gasket 31 is connected to the drive rod 15, the drive rod 15 moves along the axial direction of the sheath tube 11, and can drive the rigid gasket 31 to relatively approach or move away from the proximal chuck 13, so that the rigid gasket 31 can cooperate with the proximal chuck 13 to clamp the valve. The puncture needle 33 punctures the valve after the rigid gasket 31 and the proximal chuck 13 clamp the valve. After all the puncture needles 33 puncture the valve, each rigid gasket 31 is at least cooperatively connected to the puncture section 331 of one puncture needle 33. The locking piece 34 is sleeved on the locking sections 333 of all the puncture needles. The locking piece 34 is located between the rigid gasket 31 and the other end of the elastic piece 335. The locking piece 34 makes the locking sections 333 of all the puncture needles 33 approach each other and locks all the puncture needles 33 together. After the rigid gasket 31 is separated from the drive rod 15, the rigid gasket 31 is implanted into the valve together with the puncture needle 33.

[0041] The locking device 50 at least includes a locking push tube 52. The locking push tube 52 drives the locking piece 34 along the suture 35 to be sleeved on the locking sections 333 of all the puncture needles 33, and makes the locking piece 34 located between the rigid gasket 31 and the other end of the elastic piece 335.

[0042] The implantation device 10 further includes a puncture push tube 16 movably inserted into the sheath tube 11. The puncture push tube 16 is used to drive the puncture needle 33 to move distally, and the suture 35 extends out of the human body from the inner cavity of the puncture push tube 16. Wherein, when the puncture push tube 16 drives the puncture needle 33 to move distally, the puncture needle 33 can pierce the valve leaf and be cooperatively connected to the rigid gasket 31. During the process of the puncture push tube 16 driving the puncture needle 33, although the puncture push tube 16 and the puncture needle 33 are axially aligned but not connected, the puncture push tube 16 can push the puncture needle 33 when advancing, and the puncture push tube 16 is separated from the puncture needle 33 when retreating.

[0043] More specifically, the proximal end surface of the rigid gasket 31 includes a fitting plane 311 for fitting the valve. The rigid gasket 31 is provided with a needle hole 313 and a connection hole 315 penetrating through the fitting plane 311. The needle hole 313 is used for cooperatively connecting with the puncture section 331 of the puncture needle 33. The connection hole 315 is used for detachably connecting with the drive rod 15. In this embodiment, the distal end of the drive rod 15 is provided with an external thread, and the inner wall of the connection hole 315 is provided with an internal thread. The distal end of the drive rod 15 and the connection hole 315 can be screwed. The connection hole 315 and the needle hole 313 are oppositely arranged on both sides of the rigid gasket 31 to provide sufficient valve leaf clamping space and ensure that the puncture needle 33 punctures the valve leaf.

[0044] In this embodiment, the fitting plane 311 is generally circular, the cross-sectional shape of the hard gasket 31 along the vertical axis is generally circular, and the connection hole 315 and the needle hole 313 are oppositely arranged on both sides of the hard gasket 31, which means that the connection hole 315 and the needle hole 313 are respectively located on both sides of the plane passing through the center of the fitting plane 311 and parallel to the driving rod 15. It can be understood that the shape of the fitting plane 311 is not limited in this application, and the cross-sectional shape of the hard gasket 31 along the vertical axis is not limited in this application. For example, the cross-sectional shape of the hard gasket 31 along the vertical axis can also be square or various irregular shapes, etc.

[0045] In this embodiment, the fitting plane 311 is inclined relative to the driving rod 15, and the angle range of the included angle between the fitting plane 311 and the driving rod 15 can be 45° - 85°, preferably 65°, so that the fitting plane 311 and the driving rod 15 form a hook-like structure. The reason for this design is that the leaflets tend to face the ventricle more in the natural state, and the hook-like structure better fits the natural state of the leaflets, facilitating the capture of the valve between the hard gasket 31 and the proximal chuck 13. The axis of the needle hole 313 is preferably parallel to the driving rod 15.

[0046] In this embodiment, the area range of the fitting plane 311 of the hard gasket 31 can be 10 mm 2 - 50 mm 2 ; the Brinell hardness range of the hard gasket 31 is preferably 60 HBS - 300 HBS; the elastic modulus range of the hard gasket 31 is preferably 70 GPa - 400 GPa; the fracture strength range of the hard gasket 31 is preferably 400 Mpa - 1500 Mpa; the thickness range of the hard gasket 31 is preferably 0.5 mm - 2.8 mm; the material of the hard gasket 31 includes at least one of stainless steel, cobalt-chromium alloy, pure titanium, nickel-titanium alloy, and polyetheretherketone, so that the hard gasket 31 has high hardness, stiffness, and anti-deformation performance.

[0047] The hard gasket 31 is also provided with a limiting hole 317 (as Figure 3 shown), and the implanting device 10 further includes a limiting rod 17. The limiting rod 17 is movably inserted into the proximal chuck 13 along the axial direction of the proximal chuck 13. The distal end of the limiting rod 17 can be movably inserted into the limiting hole 317 to prevent the hard gasket 31 from rotating along with the rotation of the driving rod 15.

[0048] The puncture needle 33 further includes a connecting portion 3313 provided on the puncture section 331 (as Figure 4As shown, at least one needle hole 313 is provided on each rigid gasket 31; after the puncturing section 331 of each puncturing needle 33 punctures the valve, the corresponding connecting portion 3313 is cooperatively connected with the corresponding needle hole 313. In this embodiment, the needle hole 313 is a through hole, and the connecting portion 3313 includes at least one elastic barb; in the natural state, one end of the elastic barb is connected to the puncturing section 331, and the other end of the elastic barb extends towards the proximal end and towards the outside of the puncturing section 331; after the elastic barb passes through the needle hole 313 along with the puncturing section 331, the other end of the elastic barb abuts against the distal end surface of the rigid gasket 31. The natural state refers to the state where the elastic barb is not subjected to an external force. Preferably, the angle range of the angle between the connecting portion 3313 and the puncturing section 331 is set to 30°-60°, so as to reduce the resistance when the connecting portion 3313 passes through the needle hole 313.

[0049] The puncturing needle 33 punctures the valve leaf from the proximal end to the distal end, and the needle tip 3311 and the connecting portion 3313 pass through the needle hole 313 on the rigid gasket 31. The connecting portion 3313 first conforms to the needle hole 313 and approaches the puncturing needle 33, so as to reduce the resistance when the puncturing needle 33 passes through the rigid gasket 31 and improve the smoothness of the puncturing needle 33 passing through the rigid gasket 31. After the connecting portion 3313 passes through the needle hole 313, due to its own elastic recovery to the initial shape, it is blocked by the solid portion outside the needle hole 313 on the rigid gasket 31 and cannot retreat, preventing the puncturing needle 33 from moving towards the proximal end relative to the rigid gasket 31, that is, establishing a connection relationship between the puncturing needle 33 and the rigid gasket 31.

[0050] In this embodiment, the angle range of the angle between the extending direction of the elastic piece 335 in the natural state and the locking section 333 is 30°-60° (such as Figure 4 the included angle a shown), that is, the elastic piece 335 is inclined relative to the locking section 333, so as to reduce the resistance of the locking piece 34 passing through the elastic piece 335 and improve the smoothness of the locking piece 34 sleeved on the puncturing needle 33 and moving relative to the puncturing needle 33. It can be understood that the number of the elastic pieces 335 in the present application is not limited.

[0051] The locking piece 34 is provided with a through hole 341 that penetrates the proximal end surface and the distal end surface of the locking piece 34. When the through hole 341 of the locking piece 34 passes through the locking section 333 and the elastic piece 335 from the proximal end to the distal end, the elastic piece 335 first conforms to the through hole 341 and approaches the puncturing needle 33. After the elastic piece 335 passes through the through hole 341, it rebounds to the original shape, and the elastic piece 335 will be blocked by the solid portion outside the through hole 341 of the locking piece 34 and cannot retreat.

[0052] In this embodiment, the puncture needle 33, the elastic piece 335 thereon, and the connecting portion 3313 can be made of nitinol material by cutting. When the puncturing section 331 of the puncture needle 33 passes through the hard gasket 31 or the locking piece 34 passes through the locking section 333 of the puncture needle 33, due to the high elasticity of the nitinol material, it can pass relatively easily. However, after the elastic piece 335 and the connecting portion 3313 are reset, the hard gasket 31 cannot move distally away under the action of the connecting portion 3313, and the locking piece 34 cannot move proximally away under the action of the elastic piece 335. Thus, the valve is fixed between the hard gasket 31 and the locking piece 34 (see Figure 11 ).

[0053] In this embodiment, the number of through holes 341 on the locking piece 34 corresponds to the number of puncture needles 33, and the locking section 333 of each puncture needle 33 correspondingly passes through a through hole 341; the other ends of the elastic pieces 335 respectively abut against the solid part of the locking piece 34 located outside the corresponding through hole 341. The diameter of the through hole 341 should be smaller than the distance from the distal end of the elastic piece 335 to the puncture needle 33 in the natural state. The thickness range of the locking piece 34 can be 0.3 mm - 3 mm, and the area range of the locking piece 34 can be 5 mm 2 -20 mm 2 , and the material of the locking piece 34 includes at least one of stainless steel, cobalt-chromium alloy, pure titanium, tantalum, and nitinol alloy. It can be understood that this application does not limit the thickness of the locking piece 34, the area range of the locking piece 34, and the material of the locking piece 34.

[0054] Please refer to Figure 1 Figure 2 , Figure 6 and Figure 7 , the locking device 50 further includes a protection tube 54 movably sleeved outside the locking push tube 52. The protection tube 54 includes a tube body 542 and a protection piece 544 provided at the distal opening of the tube body 542. When the tube body 542 and the locking push tube 52 are relatively stationary, the locking piece 34 is limited between the protection piece 544 and the distal end of the locking push tube 52 to prevent the locking piece 34 from falling off from the inside of the tube body 542. When the locking push tube 52 is driven to move distally relative to the tube body 542, the locking piece 34 is pushed by the locking push tube 52 to disengage from the tube body 542 and the protection piece 544, and is sleeved on the locking sections 333 of all the puncture needles 33. In this embodiment, the protection piece 544 can be flipped relative to the tube body 542. When the locking push tube 52 moves axially distally relative to the protection tube 54, the protection piece 544 is pushed open and flipped outside the tube body 542, so that the locking piece 34 extends out of the protection tube 54. A limiting groove 523 is further formed on the inner wall of the distal opening of the locking push tube 52 for receiving the outer peripheral part of the locking piece 34 to limit the locking piece 34 at the distal end of the locking push tube 52 during the process of the locking push tube 52 pushing the locking piece 34 distally.

[0055] In this embodiment, the edge-to-edge repair system 100 is used to perform edge-to-edge repair on the tricuspid valve. Each leaflet corresponds to a rigid gasket 31 and a puncture needle 33. The locking sheet 34 is provided with through holes 341 corresponding to the number of puncture needles 33. Thus, the valve edge-to-edge repair implant 30 includes three rigid gaskets 31 and three puncture needles 33, and three through holes 341 are provided on the locking sheet 34. As Figure 8 shown, after the rigid gasket 31 and the puncture needle 33 are implanted on each leaflet, the drive rod 15, the sheath 11, and the proximal chuck 13 are all withdrawn from the body; the locking sheet 34 is pushed by the locking device 50 into the predetermined position of the valve, and the elastic piece 335 is located on the distal side of the locking sheet 34 (as Figure 7 , Figure 8 shown). Please refer to Figure 9 . Push the locking push tube 52 and the protection tube 54 distally, so that each through hole 341 on the locking sheet 34 passes through the elastic piece 335 on the corresponding puncture needle 33, and the locking sheet 34 enters between the rigid gasket 31 and the elastic piece 335; then, keep the protection tube 54 stationary, continue to push the locking push tube 52 and the locking sheet 34 distally, the protection piece 544 on the protection tube 54 is pushed open and turned outwards, and the locking sheet 34 extends out of the protection tube 54; finally, withdraw the locking push tube 52 proximally, and the locking sheet 34 disengages from the locking push tube 52. At this time, please refer to Figure 10 and Figure 11 . The locking sheet 34 is sleeved on all the puncture needles 33, and the locking sheet 34 is located between the rigid gasket 31 and the elastic piece 335. It should be noted that Figures 6 - 11 the leaflets are all omitted.

[0056] It can be understood that in some embodiments, the protection tube 54 can be omitted. For example, magnetic members are provided between the distal ends of the locking sheet 34 and the locking push tube 52, and the locking sheet 34 and the distal ends of the locking push tube 52 are magnetically attracted to each other.

[0057] Taking the path of trans-femoral vein - inferior vena cava - right atrium - tricuspid valve to perform edge-to-edge repair on the tricuspid valve as an example to illustrate the use process of the valve edge-to-edge repair system 100.

[0058] Please refer to Figure 12a and Figure 12b . Deliver the implant device 10 to the right atrium. The drive rod 15 pushes the rigid gasket 31 distally, so that a leaflet is placed between the rigid gasket 31 and the proximal chuck 13, and the drive rod 15 drives the rigid gasket 31 to retract and clamp the leaflet.

[0059] After that, the puncture needle 33 is driven by the puncture push tube 16 to move distally. The puncture needle 33 pierces the leaflet and penetrates into the needle hole 313 on the rigid gasket 31; the puncture push tube 16 retracts and separates from the puncture needle 33.

[0060] After the puncture is completed, the driving rod 15 is disengaged from the hard gasket 31, and the implantation device 10 is withdrawn from the body, completing the implantation of the first puncture needle 33 and the hard gasket 31 on the valve. The proximal end of the puncture needle 33 is also penetrated by a suture 35.

[0061] Repeat the above steps to implant the second puncture needle 33 and the hard gasket 31 with a suture 35 penetrated into the second leaflet, and implant the third puncture needle 33 and the hard gasket 31 with a suture 35 penetrated into the third leaflet, as Figure 12c shown.

[0062] Combined Figures 6 - 11 and Figure 12d with Figure 12e , the three sutures 35 corresponding to the three leaflets respectively penetrate through the three through holes 341 of the locking piece 34 and extend to the proximal end along the locking push tube 52; the locking push tube 52 and the protection tube 54 are transported along the suture 35 to reach the tricuspid valve position with the locking piece 34; the three sutures 35 are tightened and the locking push tube 52 and the protection tube 54 are pushed distally, so that the locking piece 34 is pushed distally, and the locking segments 333 of the three puncture needles 33 will gradually gather until the elastic piece 335 is elastically depressed and reset by the through hole 341 on the locking piece 34, and the locking piece 34 is completely stuck on the locking segments 333 of the three puncture needles 33.

[0063] Keep the protection tube 54 stationary, continue to push the locking push tube 52 and the locking piece 34 distally, the protection piece 544 on the protection tube 54 is pushed open and turned outwards, and the locking piece 34 extends out of the protection tube 54; withdraw the locking push tube 52, and the locking piece 34 will be disengaged from the locking push tube 52. The locking piece 34 is located between the leaflet and the elastic piece 335, and the leaflet is fixed between the locking piece 34 and the hard gasket 31; finally, the locking device 50 is withdrawn, and the three sutures 35 are respectively pulled out, and the edge-to-edge repair of the tricuspid valve is completed.

[0064] Figure 11 and Figure 12e shown, the three hard gaskets 31, the three puncture needles 33 and the locking piece 34 constitute the valve edge-to-edge repair implant 30 for finally implementing edge-to-edge repair.

[0065] It can be understood that the edge-to-edge repair of the tricuspid valve can also be performed through the path of jugular vein - superior vena cava - right atrium - tricuspid valve.

[0066] It can be understood that at least two puncture needles 33 can also correspond to one leaflet, and the number of through holes 341 of the locking piece 34 corresponds to the number of puncture needles 33. For example, if two puncture needles 33 correspond to one leaflet, the number of through holes 341 corresponds to six.

[0067] It can be understood that the edge-to-edge valve repair system 100 can also perform edge-to-edge repair on the mitral valve. For example, edge-to-edge repair of the mitral valve can be performed through the path of femoral vein - inferior vena cava - right atrium - atrial septum - left atrium - mitral valve, or through the path of jugular vein - superior vena cava - right atrium - atrial septum - left atrium - mitral valve. It should be understood that the edge-to-edge valve repair implant 30 for the mitral valve includes two rigid gaskets 31 and two puncture needles 33, and two through holes 341 are provided on the locking piece 34.

[0068] For the edge-to-edge valve repair system 100 and its edge-to-edge valve repair implant 30 provided by the present application, the puncture section 331 of the puncture needle 33 is connected with the rigid gasket 31 after puncturing the valve. As long as the locking piece 34 is sleeved on the locking section 333 of all the puncture needles 33, so that the locking piece 34 is located between the rigid gasket 31 and the other end of the elastic piece 335, the locking of all the puncture needles 33 is completed. There is no need to implant sutures like the prior art, thus omitting the suture cutting step, making the locking operation more convenient, improving the locking efficiency, and there is no need to force the locking nail to deform to lock the suture by setting a complex pressing structure like the prior art, simplifying the instrument structure; one end of the elastic piece 335 is fixedly connected with the locking section 333, and the other end of the elastic piece 335 extends outward and distally relative to the locking section 333 of the puncture needle 33. When the locking piece 34 passes through the elastic piece 335 from near to far, the elastic piece 335 compliantly approaches the locking section 333, and the obstruction to the locking piece 34 is very small. In this way, the locking driving force required to push the locking piece 34 is greatly reduced, and the difficulty of the locking operation is reduced.

[0069] On the other hand, the rigid gasket 31 replaces the distal chuck in the prior art. The rigid gasket 31 can not only cooperate with the proximal chuck 13 to clamp the valve leaf, but also cooperate with the puncture needle 33 and the locking piece 34 to jointly form the edge-to-edge valve repair implant 30. After the rigid gasket 31 is disengaged from the driving rod 15, the rigid gasket 31 does not need to be withdrawn from the body, avoiding the risk of hooking the valve leaf tissue, and there is no need to additionally set a distal chuck and bury a gasket and a suture in the distal chuck like the prior art, simplifying the instrument structure.

[0070] Second Embodiment

[0071] Please refer to Figure 13 , the edge-to-edge valve repair system provided by the second embodiment of the present application has a structure substantially the same as that of the edge-to-edge valve repair system provided by the first embodiment. The difference is that a through hole 341 penetrating the proximal end face and the distal end face of the locking piece 34 is provided on the locking piece 34, the number of the through holes 341 is one, and the locking sections 333 of all the puncture needles 33 pass through the through hole 341; the other ends of the elastic pieces 335 abut against the solid part of the locking piece 34 located outside the through hole 341. The through hole 341 is a rectangular hole.

[0072] The puncture needle 33 further includes a first surface 332 and a second surface 334 that are arranged opposite to each other, and the connecting portion 3313 and the elastic sheet 335 are both connected to the first surface 332 and extend in a direction away from the second surface 334. The second surfaces 334 of each puncture needle 33 can be close together, and the connecting portion 3313 is extended toward the outside away from the first surface 332. The width direction of the through hole 341 corresponds to the elastic sheet 335.

[0073] It can be understood that the present application does not limit the shape of the through hole 341. The through hole 341 can also be a circular hole or a hole of other shapes. The minimum size of the through hole 341 should be larger than the diameter of the smallest circumscribed circle of each puncture needle 33 when it is put together, and smaller than the diameter of the smallest circumscribed circle of the distal end of each spring piece 335.

[0074] Third embodiment

[0075] See also Figure 14 The valve edge-to-edge repair system provided in the third embodiment of the present application has a substantially similar structure to the valve edge-to-edge repair system provided in the first embodiment, except that the needle hole 313 is a threaded hole, and the connecting portion 3313 is an external thread provided on the puncture section 331. When the puncture section 331 penetrates the needle hole 313, the connecting portion 3313 is threadedly connected with the needle hole 313. A rotation-stopping structure (such as the combination of a groove and a convex rib) can be added between the puncture push tube (not shown) and the proximal end of the puncture needle 33, so that the puncture push tube can both push the puncture needle 33 axially and drive the puncture needle 33 to rotate.

[0076] Fourth embodiment

[0077] See also Figure 15 and Figure 16 (Only the hard gasket and the puncture section of the puncture needle are shown). The structure of the valve edge-to-edge repair system provided in the fourth embodiment of the present application is roughly the same as that of the valve edge-to-edge repair system provided in the first embodiment, except that the needle hole 313 is a blind hole, the hard gasket 31 is provided with a holding step 318 between the proximal end of the needle hole 313 and the distal end of the needle hole 313, and the connecting portion 3313 includes at least one elastic undercut. In the natural state, one end of the elastic undercut is connected to the puncture section 331, and the other end of the elastic undercut extends toward the proximal end and toward the outside of the puncture section 331; the elastic undercut is held on the holding step 318 when the puncture section 331 penetrates the needle hole 313; the radial dimension of the holding step 318 is greater than the radial dimension of the needle hole 313. The natural state refers to the state in which the elastic undercut is not subjected to external force.

[0078] After the puncture needle 33 punctures the valve leaflet from the proximal end to the distal end, the needle tip 3311 and the elastic buckle enter the needle hole 313 on the hard gasket 31, and the elastic buckle first moves toward the puncture needle 33 in accordance with the needle hole 313, thereby reducing the resistance of the puncture needle 33 when entering the hard gasket 31 and improving the smoothness of the puncture needle 33 entering the hard gasket 31. After entering the needle hole 313, the elastic buckle returns to its original shape due to its own elasticity and is clamped on the clamping step 318. The elastic buckle will be blocked by the clamping step 318 and cannot be withdrawn, preventing the puncture needle 33 from moving relative to the hard gasket 31, that is, establishing a connection relationship between the puncture needle 33 and the hard gasket 31.

[0079] In this embodiment, the hard gasket 31 is further provided with a slot 3133 connected to the needle hole 313, and the holding step 318 is located between the needle hole 313 and the slot 3133. The elastic buckle of the puncture needle 33 needs to overcome a relatively small force (for example, no more than 3N) generated by the proximal opening of the needle hole 313 to enter the slot 3133, so that the elastic buckle retracts toward the puncture needle 33. After the elastic buckle enters the slot 3133 through the proximal opening of the needle hole 313, it automatically pops open and abuts against the holding step 318. Since the resistance to the withdrawal of the puncture needle 33 is very large, the puncture needle 33 is difficult to detach from the hard gasket 31. At the distal end of the needle hole 313 is a conical structure that matches the shape of the needle tip 3311, so that the needle tip 3311 is accommodated at the distal end of the needle hole 313. It can be understood that the present application does not limit the shape of the elastic undercut and the shape of the slot 3133 , and the slot 3133 can be omitted and the retaining step 318 can be directly protruded on the hole wall of the pinhole 313 .

[0080] In this embodiment, the number of puncture needles 33 connected to a hard gasket 31 is two, and the proximal end of the needle shaft section of each puncture needle 33 corresponds to abutting (only contacting, not connected) a separate puncture push tube 16, and the corresponding suture 35 is movably inserted into the respective puncture push tube 16.

[0081] Fifth embodiment

[0082] See also Figure 17 and Figure 18(Only the rigid gasket and the drive rod are shown). The edge-to-edge valve repair system provided by the fifth embodiment of the present application is substantially the same in structure as the edge-to-edge valve repair system 100 provided by the first embodiment. The difference is that the implant device further includes a pin shaft 19; an opening groove 157 is provided at the distal end of the drive rod 15, and a shaft hole 158 is axially provided through both sides of the opening groove 157 and the proximal end of the drive rod 15; the rigid gasket 31 is movably inserted into the opening groove 157, and a connection hole (not shown in the figure) is located in the opening groove 157 and communicates with the shaft hole 158; the pin shaft 19 is movably inserted through the connection hole and the shaft hole 158 to detachably connect the rigid gasket 31 to the drive rod 15. When the pin shaft 19 moves proximally until it withdraws from the connection hole, the drive rod 15 can be separated from the rigid gasket 31.

[0083] In this embodiment, the drive rod 15 includes a drive rod body 151 and a drive push tube 154. The distal end of the drive push tube 154 is connected to the proximal end of the drive rod body 151. The opening groove 157 is provided at the distal end of the drive rod body 151. The shaft hole 158 axially penetrates the drive rod body 151 and communicates with the inner cavity of the drive push tube 154. When the pin shaft 19 withdraws proximally, it first passes through the shaft hole 158 and then enters the inner cavity of the drive push tube 154.

[0084] Sixth Embodiment

[0085] Please refer to Figure 19 , in the edge-to-edge valve repair system provided by the sixth embodiment of the present application, the surface of the rigid gasket 31 is further covered with a tissue-promoting climbing film layer 319 to promote tissue climbing after the rigid gasket 31 is implanted into the heart, so that the rigid gasket 31 can be combined with the valve leaflets faster. The material of the rigid gasket 31 can be a biocompatible non-metallic material such as polyether ether ketone, or a biocompatible metallic material such as stainless steel, cobalt-chromium alloy, pure titanium, nickel-titanium alloy, etc. The tissue-promoting climbing film layer 319 can be a polytetrafluoroethylene coating coated on the outer surface of the rigid gasket 31 or a polyester material film covering the outer surface of the rigid gasket 31.

[0086] Seventh Embodiment

[0087] Please refer to Figure 20 , the edge-to-edge valve repair system provided by the seventh embodiment of the present application is substantially the same in structure as the edge-to-edge valve repair system provided by the first embodiment. The difference is that the rigid gasket 31 further includes a peripheral wall 310 connected between the proximal end face and the distal end face of the rigid gasket 31, and a slot 320 is recessed in the peripheral wall 310 and penetrates through the proximal end face and the distal end face of the rigid gasket 31. In this embodiment, the number of the slots 320 is two, and the cross-sectional shape of the rigid gasket 31 is in a gourd shape. Compared with a circular cross-section, the mass of the rigid gasket 31 can be reduced, and the pressure of the rigid gasket 31 itself on the valve can be reduced.

[0088] The above are only the preferred embodiments of the present application and do not impose any formal restrictions on the present application. Although the present application has been disclosed above in the preferred embodiments, it is not intended to limit the present application. Any person skilled in the art can make many possible changes and modifications to the technical solution of the present application, or modify it into an equivalent embodiment with equivalent changes, without departing from the scope of the technical solution of the present application. Therefore, any simple modification, equivalent change and modification made to the above embodiments based on the technical essence of the present application without departing from the content of the technical solution of the present application still fall within the scope of protection of the technical solution of the present application.

Claims

1. A valve edge-to-edge repair implant, characterized in that, it includes at least two rigid gaskets, at least two puncture needles and a locking piece; each of the puncture needles includes a puncture section and a locking section fixedly connected to the proximal end of the puncture section, and at least one elastic piece is provided on the locking section, one end of the elastic piece is fixedly connected to the locking section, and the other end of the elastic piece extends outward and distally relative to the locking section; after all the puncture needles puncture the valve, each rigid gasket is at least cooperatively connected to the puncture section of one of the puncture needles, the locking piece is sleeved on the locking sections of all the puncture needles, and the locking piece is located between the rigid gasket and the other end of the elastic piece.

2. The valve edge-to-edge repair implant according to claim 1, characterized in that, the angle range between the extending direction of the elastic piece in the natural state and the locking section is 30° - 60°.

3. The valve edge-to-edge repair implant according to claim 1, characterized in that, the locking piece is provided with through holes penetrating its proximal end face and its distal end face, and the number of the through holes corresponds to the number of the puncture needles, and the locking section of one puncture needle correspondingly passes through one through hole; the other ends of the respective elastic pieces respectively abut against the solid part of the locking piece located outside the corresponding through hole.

4. The valve edge-to-edge repair implant according to claim 1, characterized in that, the locking piece is provided with a through hole penetrating its proximal end face and its distal end face, the number of the through holes is one, and the locking sections of all the puncture needles pass through the through hole; the other ends of the respective elastic pieces all abut against the solid part of the locking piece located outside the through hole.

5. The valve edge-to-edge repair implant according to claim 1, characterized in that, the puncture needle further includes a connecting portion provided on the puncture section, and at least one needle hole is provided on each rigid gasket; after the puncture section of each puncture needle punctures the valve, the corresponding connecting portion is cooperatively connected to the corresponding needle hole.

6. The valve edge-to-edge repair implant according to claim 1, characterized in that, a threading hole is provided at the proximal end of the locking section, the axial direction of the threading hole is perpendicular to the axial direction of the locking section, and the threading hole is used for threading a suture.

7. The valve edge-to-edge repair implant according to claim 1, characterized in that, The thickness of the locking piece ranges from 0.3 mm to 3 mm, and the area of the locking piece ranges from 5 mm 2 - 20 mm 2 .

8. The valve edge-to-edge repair implant according to claim 1, characterized in that, the material of the locking piece includes at least one of stainless steel, cobalt-chromium alloy, pure titanium, tantalum, and nickel-titanium alloy.

9. The valve edge-to-edge repair implant according to claim 1, characterized in that, the material of the rigid gasket includes at least one of stainless steel, cobalt-chromium alloy, pure titanium, nickel-titanium alloy, and polyetheretherketone.

10. A valve edge-to-edge repair system, characterized in that, it includes an implantation device, a suture, a locking device, and a valve edge-to-edge repair implant according to any one of claims 1 - 9; the implantation device includes a sheath tube, a proximal chuck, and a drive rod; The proximal chuck is fixedly connected to the distal end of the sheath tube; the puncture needle and the drive rod are both axially movably inserted through the sheath tube and the proximal chuck; the drive rod is detachably connected to the rigid gasket; The suture movably passes through the proximal end of the knotting section of the puncture needle; The knotting device includes a knotting push tube, and the knotting push tube drives the knotting piece to be sleeved on the knotting sections of all the puncture needles along the suture, and the knotting piece is located between the rigid gasket and the other end of the elastic piece.

11. The valve edge-to-edge repair system according to claim 10, characterized in that, The knotting device further includes a protection tube movably sleeved outside the knotting push tube; The protection tube includes a tube body and a protection piece arranged on the distal opening of the tube body; When the tube body and the knotting push tube are relatively stationary, the knotting piece is defined between the protection piece and the distal end of the knotting push tube; When the knotting push tube is driven to move distally relative to the tube body, the knotting piece is pushed by the knotting push tube to disengage from the tube body and the protection piece.

12. The valve edge-to-edge repair system according to claim 10, characterized in that, The rigid gasket is screwed to the distal end of the drive rod, and the drive rod and the puncture needle are oppositely arranged on both sides of the rigid gasket.

13. The valve edge-to-edge repair system according to claim 12, characterized in that, The implantation device further includes a limiting rod, and the rigid gasket is further provided with a limiting hole. The limiting rod is axially movably inserted through the proximal chuck and the sheath tube, and the distal end of the limiting rod is movably inserted into the limiting hole.

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