Valve repair implants

Abstract

The present application provides a valve repair implant, comprising a hard gasket and a suture connecting the hard gasket, wherein the proximal surface of the hard gasket comprises a fitting plane for fitting the valve. The hard gasket used in the valve repair implant will not deform under the traction of the suture like the existing soft gasket, that is, it will not collapse in the middle and warp at both ends under the traction of the suture like the soft gasket. When blood impacts the leaflet, the hard gasket reliably supports the leaflet, and the proximal surface of the hard gasket fits the leaflet to always maintain surface contact. There is a continuous large contact area between the hard gasket and the leaflet, so that the stress of the suture on the leaflet is fully dispersed, which can prevent the suture from tearing the leaflet, thereby improving the safety and reliability of valve repair.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a valve repair implant. Background Art

[0002] Heart valves such as the mitral valve and tricuspid valve are one-way valves between the atria and ventricles. Normal and healthy valves can control the flow of blood from the atria to the ventricles, while preventing blood from flowing from the ventricles to the atria. When the atria contract, the valves open and blood flows from the atria to the ventricles; when the ventricles contract, the valves should close to prevent blood from rushing to the atrial side. When the valve leaflets or chordae tendineae, valve ring and other related structures are diseased, such as partial rupture of the chordae tendineae, poor coaptation between the leaflets, then when the ventricles contract, the valve cannot close completely, causing blood to flow back from the ventricles to the atria, thereby causing a series of pathological and physiological changes.

[0003] Clinically, repair techniques for valvular lesions include chordae tendineae repair and edge-to-edge repair. In chordae tendineae repair, sutures are implanted into the heart as artificial chordae, with one end secured to the valve leaflets and the other to the ventricular wall or papillary muscle. In edge-to-edge repair, sutures are implanted into adjacent leaflets. The sutures are pulled to align the edges of the adjacent leaflets that are not properly aligned, and the sutures are locked on the side away from the valve to reduce the total area of ​​the valve orifice and reduce or eliminate the amount of regurgitation.

[0004] Whether it is chordae tendineae repair or edge-to-edge repair, a gasket is usually placed on the implanted suture. The gasket is located between the valve leaflet and the end of the suture pulling the valve leaflet. The gasket with a larger area can disperse the force of the suture on the valve leaflet and prevent the suture from tearing the valve leaflet. The existing gaskets used for heart valve repair are usually made of polytetrafluoroethylene, polyester cloth and other materials. In actual application, it is found that Figure 1 As shown, since the existing gasket 1000 is usually soft, the gasket 1000 is prone to collapse in the middle and curl up at both ends under the traction of the suture 2000, that is, the actual contact area between the gasket 1000 and the leaflet 3000 does not increase significantly, and there is still a greater risk of tearing the leaflet tissue. Summary of the Invention

[0005] The technical problem to be solved by the present application is to provide a valve repair implant that can reduce the risk of tearing valve leaflet tissue.

[0006] In order to achieve the above-mentioned objectives, the present application provides a valve repair implant, comprising a hard gasket and sutures connecting the hard gasket, wherein the proximal surface of the hard gasket comprises a fitting plane for fitting the valve.

[0007] The valve repair implant provided by the present application uses a hard gasket that will not deform under the pull of the suture like the existing soft gasket, that is, it will not collapse in the middle and curl up at both ends under the pull of the suture like the soft gasket. When blood impacts the leaflet, the hard gasket reliably supports the leaflet, and the proximal surface of the hard gasket fits the leaflet to always maintain surface contact. There is a continuous large contact area between the hard gasket and the leaflet, so that the stress of the suture on the leaflet is fully dispersed, which can prevent the suture from tearing the leaflet, thereby improving the safety and reliability of valve repair. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 A schematic diagram of a soft gasket in an existing valve repair implant collapsing in the middle and warping at both ends under the pull of sutures;

[0009] Figure 2 This is a schematic three-dimensional assembly diagram of the valve repair implant according to the first embodiment of the present application;

[0010] Figure 3 for Figure 2 A perspective schematic diagram of the valve repair implant shown in another perspective;

[0011] Figure 4 for Figure 2 A cross-sectional view of a valve repair implant is shown;

[0012] Figure 5-Figure 8 Schematic diagram of a process of performing edge-to-edge valve repair using a heart valve repair implant by a heart valve repair device according to an embodiment of the present application;

[0013] Figure 9 A schematic diagram of the valve repair implant of the present application performing chordae tendineae repair on a heart valve;

[0014] Figure 10 A schematic three-dimensional assembly diagram of a valve repair implant provided in the second embodiment of the present application;

[0015] Figure 11 for Figure 10 A cross-sectional view of a valve repair implant is shown;

[0016] Figure 12 for Figure 10 A perspective exploded schematic diagram of a valve repair implant is shown;

[0017] Figure 13 A schematic three-dimensional assembly diagram of a partial structure of a valve repair implant provided in a third embodiment of the present application;

[0018] Figure 14 for Figure 13 A cross-sectional view of a portion of the valve repair implant is shown;

[0019] Figure 15 A schematic perspective view of a hard gasket of a valve repair implant provided in a fourth embodiment of the present application;

[0020] Figure 16 A schematic three-dimensional assembly diagram of a valve repair implant provided in a fifth embodiment of the present application;

[0021] Figure 17 for Figure 16 A schematic three-dimensional assembly diagram of the valve repair implant shown in another perspective;

[0022] Figure 18 for Figure 16 A schematic perspective view of a hard gasket of a valve repair implant is shown. DETAILED DESCRIPTION

[0023] In order to make the purpose, technical solutions and advantages of this application clearer, this application will be further described in detail below with reference to the accompanying drawings.

[0024] It should be understood that expressions such as "including" and "may include" used in this 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 this disclosure, terms such as "including" and / or "having" may be interpreted as indicating specific characteristics, numbers, operations, constituent elements, components, or combinations thereof, but may not be interpreted as excluding the existence or possibility of adding one or more other characteristics, numbers, operations, constituent elements, components, or combinations thereof.

[0025] In addition, in this application, the expression "and / or" includes any and all combinations of the associated listed words. For example, the expression "A and / or B" may include A, may include B, or may include both A and B.

[0026] In this application, expressions including ordinal numbers such as "first" and "second" may modify various elements. 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 this disclosure, a first element may be referred to as a second element, and similarly, a second element may be referred to as a first element.

[0027] When a component is referred to as being "connected" or "accessed" to another component, it should be understood that the component is not only directly connected to or accessed to the other component, but also that another component may exist between the component and the other component. On the other hand, when a component is referred to as being "directly connected to" or "directly accessed" to another component, it should be understood that no component exists between them.

[0028] In the field of interventional medical device technology, the direction closest to the operator is generally defined as proximal, and the direction away from the operator is defined as distal. The direction of the rotational axis of an object such as a cylinder or tube is defined as the axial direction. The circumferential direction is the direction around the axis of the object (perpendicular to the axis and also perpendicular to the cross-sectional radius). The radial direction is the direction along the diameter or radius.

[0029] See also Figures 2 to 4 , combined with Figures 5 to 8 The present application provides a valve repair implant 30, which is used in a heart valve repair device 100. The heart valve repair device 100 can be used to perform edge-to-edge repair or chordae tendineae repair on a heart valve.

[0030] The heart valve repair device 100 includes an implantation device 10 for implanting a valve repair implant 30 into a valve.

[0031] The implant device 10 includes a sheath 11, a proximal clamp 13, and a drive rod 15. The proximal clamp 13 is fixedly connected to the distal end of the sheath 11, and the drive rod 15 is movably installed in the sheath 11 and the proximal clamp 13 along the axial direction of the sheath 11. The drive rod 15 can be a solid structure or a hollow structure. The material of the drive rod 15 can be stainless steel, nickel-titanium alloy, or a polymer, etc. This application does not limit the material of the drive rod 15.

[0032] The valve repair implant 30 includes a rigid gasket 31 and a suture 35 connecting the rigid gasket 31. The proximal surface of the rigid gasket 31 includes a flat surface 311 for conforming to the valve. The rigid gasket 31 also includes a peripheral wall 310 connected between the proximal surface and the distal surface of the rigid gasket 31. The rigid gasket 31 is detachably connected to the drive rod 15. Driven by the drive rod 15, the rigid gasket 31 can move closer to or further from the proximal clamp 13 to cooperate with the proximal clamp 13 in clamping the valve.

[0033] In this embodiment, the bonding plane 311 is substantially circular, and the cross-sectional shape of the hard gasket 31 along the vertical axis is substantially circular; the area range of the bonding plane 311 of the hard gasket 31 is preferably 10mm 2 ~50mm 2, to ensure that there is sufficient contact area between the hard gasket 31 and the leaflet without affecting the normal movement of the leaflet. The Brinell hardness range of the hard gasket 31 is preferably 60HBS~300HBS; the elastic modulus range of the hard gasket 31 is preferably 70GPa~400GPa; the fracture strength range of the hard gasket 31 is preferably 400Mpa~1500Mpa; the thickness range of the hard gasket 31 is preferably 0.5mm~2.8mm, so that the hard gasket 31 has sufficient hardness, rigidity and deformation resistance. The material of the hard gasket 31 includes at least one of stainless steel, cobalt-chromium alloy, pure titanium, nickel-titanium alloy, and polyetheretherketone. It can be understood that the present application does not limit the shape of the bonding plane 311, and the present application does not limit the cross-sectional shape of the hard gasket 31 along the vertical axis. For example, the cross-sectional shape of the hard gasket 31 along the vertical axis can also be square or various irregular shapes.

[0034] The hard gasket 31 is provided with a needle hole 313 extending through the contact surface 311. The valve repair implant 30 further includes a puncture needle 33. The puncture needle 33 is axially movable within the sheath 11 and the proximal clamp 13. The puncture needle 33 is used to penetrate or pass through the needle hole 313 to connect with the hard gasket 33.

[0035] The puncture needle 33 includes a puncture section 331 at the distal end of the puncture needle 33 and a shank section 333 fixedly connected to the proximal end of the puncture section 331. The distal end of the puncture section 331 is the needle tip 3311, which is the portion of the puncture needle 33 from the needle tip 3311 to the valve to be punctured. After puncturing the valve, the puncture section 331 is used to pass through or penetrate the needle hole 313 and connect to the rigid gasket 31. One end of the suture 35 can be fixedly connected to the proximal end of the shank section 333 by means of crimping, gluing, or the like. When the puncture section 331 of the puncture needle 33 is connected to the rigid gasket 31, the suture 35 is connected to the rigid gasket 31. Because the puncture section 331 penetrates the contact surface 311 of the rigid gasket 31, the puncture section 331 and the contact surface 311 intersect.

[0036] In this embodiment, the fitting plane 311 is inclined relative to the axis of the needle hole 313. When the puncture needle 33 penetrates the needle hole 313 of the hard gasket 33, the axis of the puncture needle 33 coincides with the axis of the needle hole 313. The angle between the fitting plane 311 and the axis of the needle hole 313 can range from 45° to 85°, preferably 65°. When the puncture needle 33 and the hard gasket 31 are connected, the fitting plane 311 and the puncture needle 33 form a hook-shaped structure. The reason for this design is that the leaflets naturally face more toward the ventricle, and the hook-shaped structure formed after the hard gasket 31 and the puncture needle 33 are connected better fits the natural state of the leaflets.

[0037] The distal end of the hard gasket 31 is provided with a raised portion 316, and the needle hole 313 extends from the contact surface 311 of the hard gasket 31 into the raised portion 316. Because the thickness of the area where the raised portion 316 is located is greater than the thickness of the rest of the hard gasket 31, the distal end of the puncture needle 33 can be concealed within the raised portion 316, ensuring a sufficient connection length between the puncture needle 33 and the hard gasket 31.

[0038] When the drive rod 15 is connected to the hard gasket 31, the drive rod 15 can drive the hard gasket 31 to cooperate with the proximal clamp 13 to clamp the valve. Specifically, the drive rod 15 can move distally along the axial direction of the sheath 11 to move the hard gasket 31 away from the proximal clamp 13; the drive rod 15 can move proximally along the axial direction of the sheath 11 to move the hard gasket 31 closer to the proximal clamp 13, thereby cooperating with the proximal clamp 13 to clamp the valve. The puncture section 331 of the puncture needle 33 is used to puncture the valve after the hard gasket 31 and the proximal clamp 13 clamp the valve. It is connected to the hard gasket 31. After the hard gasket 31 is separated from the drive rod 15, the puncture needle 33 is implanted into the valve along with the hard gasket 31 and the suture 35.

[0039] More specifically, when the driving rod 15 drives the hard gasket 31 and the proximal clamp 13 to move away from each other (e.g. Figure 5 As shown in FIG, the opening area between the hard gasket 31 and the proximal clamp 13 is used to capture the leaflet tissue. After capturing the leaflet tissue, the hard gasket 31 is driven by the driving rod 15 to move closer to the proximal clamp 13 (as shown in FIG. Figure 6 As shown in the figure, the puncture needle 33 is used to clamp the leaflet, and the puncture needle 33 is inserted from the proximal clamp 13 to the distal end. At this time, the hard gasket 31 is still connected by the driving rod 15, which can be equivalent to the distal clamp to support the leaflet, providing conditions for the puncture needle 33 to puncture the leaflet. After the distal end of the puncture needle 33 pierces the leaflet, it is connected with the hard gasket 31.

[0040] The puncture section 331 also includes a connecting portion 3313 disposed proximal to the needle tip 3311. The connecting portion 3313 is used to puncture the valve together with the puncture section 331 and connect to the hard gasket 31. In this embodiment, 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 is inserted into the needle hole 313, the connecting portion 3313 is threadedly connected to the needle hole 313.

[0041] The implant device 10 also includes a puncture push tube 16 that is movably mounted within the sheath 11. The suture 35 is movably disposed within the lumen of the puncture push tube 16. The distal end of the puncture push tube 16 is detachably connected to the proximal end of the needle shaft segment 333. The puncture push tube 16 is used to drive the puncture needle 33 toward the distal end and is released from the needle shaft segment 333 after the puncture segment 331 punctures the valve and connects to the hard gasket 31.

[0042] like Figures 5 to 8As shown, the implantation process of the valve repair implant 30 is described by taking the edge-to-edge repair of the tricuspid valve between the right atrium and the right ventricle as an example.

[0043] First, see Figure 5 The heart valve repair device 100 is delivered to the right atrium near the valve leaflet through an interventional route (such as the femoral vein-inferior vena cava-right atrium, or directly through the right atrium), and then the drive rod 15 is manipulated to move distally, and the hard gasket 31 moves away from the proximal clamp 13 into the ventricular side, and the valve leaflet enters the opening area between the hard gasket 31 and the proximal clamp 13.

[0044] Next, see Figure 6 The driving rod 15 retreats toward the proximal end, driving the hard gasket 31 to approach the proximal clamp 13 to clamp the leaflet, and pushes the puncture needle 33 toward the distal end, and the puncture needle 33 penetrates the leaflet.

[0045] Then, the puncture needle 33 is driven to rotate and screwed together with the hard gasket 31 .

[0046] Next, the drive rod 15 is disconnected from the hard washer 31 , and then the drive rod 15 is retracted.

[0047] Then, the sheath 11, the proximal clamp 13 and the components inside the two are withdrawn, and the hard gasket 31, the puncture needle 33 and the suture 35 are left on the valve leaflet. The hard gasket 31 is located on the ventricular side, and the suture 35 extends from the puncture needle 33 to the outside of the body. Figure 7 , thus completing the implantation of the valve repair implant 30 on one leaflet.

[0048] Repeat the above steps to implant valve repair implants 30 on other leaflets.

[0049] Finally, see Figure 8 , use a locking piece 200 (such as a titanium nail) to fix all the sutures 35 together and cut off the excess sutures 35, so that the partial edges of the two adjacent leaflets can be brought together to complete the edge-to-edge repair of the heart valve.

[0050] like Figure 9 As shown, the valve repair implant 30 can also be used in chordal repair procedures, which are basically the same as the above steps, except that the intervention route is transapical. After implantation, the hard gasket 31 is located on the atrial side, and the suture 35 extends into the ventricle as an artificial chordal tendon and is fixed to the papillary muscle or the ventricular wall.

[0051] The above is only an example of repairing the tricuspid valve. It can be understood that the valve repair implant 30 of the present application can also be used to perform edge-to-edge repair or chordae tendineae repair on the mitral valve, as long as an appropriate interventional pathway is selected, such as edge-to-edge repair of the mitral valve via the femoral vein-inferior vena cava-right atrium-atrial septum-left atrium pathway, and chordae tendineae repair of the mitral valve via the apical pathway.

[0052] The valve implant 30 of the present application uses a hard gasket 31 that will not deform under the traction of the suture 35 like the existing soft gasket, that is, it will not collapse in the middle and curl up at both ends under the traction of the suture like the soft gasket. When blood impacts the leaflet, the hard gasket 31 can reliably support the leaflet, and the proximal surface of the hard gasket 31 fits the leaflet to always maintain surface contact. There is a continuous large contact area between the hard gasket 31 and the leaflet, so that the stress of the suture 35 on the leaflet is fully dispersed, preventing the suture 35 from tearing the leaflet, thereby improving the safety and reliability of valve repair.

[0053] In addition, the valve implant 30 is used in the heart valve repair device 100, and the hard gasket 31 replaces the distal clamp in the prior art. The hard gasket 31 can cooperate with the proximal clamp 13 to clamp the valve leaflet, and can also be connected to the puncture needle 33 and the suture 35 after the puncture needle 33 punctures the valve and serve as a part of the valve implant. After the hard gasket 31 is released from the drive rod 15, the hard gasket 31 does not need to be withdrawn from the body, avoiding the risk of hooking the valve leaflet tissue. Other components such as the sheath 11, the proximal clamp 13 and the drive rod 15 can be smoothly withdrawn from the body, and there is no need to set up an additional distal clamp and bury gaskets and sutures in the distal clamp as in the prior art, which simplifies the structure of the entire heart valve repair device.

[0054] On the other hand, the suture 35 is fixed to the proximal end of the puncture needle 33, and the puncture needle 33 is directly connected to the hard gasket 31, which can significantly shorten the length and volume of the distal end of the entire heart valve repair device 100. The distal end of the heart valve repair device 100 can be turned and bent more easily in the heart without hitting the atrioventricular wall, which is particularly suitable for valve repair in patients with atrial stenosis.

[0055] Second embodiment

[0056] See also Figures 10 to 12 The valve repair implant provided in the second embodiment of the present application has a substantially similar structure to the valve repair implant provided in the first embodiment, except that the pinhole 313 is a light hole and the connecting portion 3313 includes at least one elastic barb ( Figures 10 to 12Only one is shown as an example; in its natural state, one end of the elastic barb is connected to the puncture section 331, and the other end of the elastic barb extends toward the proximal end and away from the axis of the needle tip 3311. After the elastic barb passes through the needle hole 313 along with the puncture section 331, the other end of the elastic barb abuts the distal end surface of the hard gasket 31. The natural state refers to the state in which the elastic barb is not subjected to external force.

[0057] After the puncture needle 33 punctures the leaflet from the proximal end to the distal end, the needle tip 3311 and the elastic barb pass through the needle hole 313 on the hard gasket 31. The elastic barb first moves toward the puncture needle 33 along the needle hole 313, thereby reducing the resistance of the puncture needle 33 when passing through the hard gasket 31 and improving the smoothness of the puncture needle 33 passing through the hard gasket 31. After passing through the needle hole 313, the elastic barb returns to its original natural state due to its own elasticity. The elastic barb is blocked by the solid portion outside the needle hole 313 on the hard gasket 31 and cannot retreat, preventing the puncture needle 33 from moving relative to the hard gasket 31, thus establishing a connection between the puncture needle 33 and the hard gasket 31.

[0058] A threading hole 3331 is provided at the proximal end of the needle shaft segment 333. The axis of the threading hole 3331 is perpendicular to the axis of the locking segment 333. The threading hole 3331 is used to pass a suture 35. The suture 35 is U-shaped, and the two free ends of the suture 35 can extend outside the human body. It will be readily understood that when the valve repair implant 30 of this embodiment is used for chordae tendineae repair, a double strand of suture serves as an artificial chordae tendineae.

[0059] The puncture needle 33 also includes at least one spring piece 335 provided on the needle rod segment 333, one end of the spring piece 335 is fixedly connected to the needle rod segment 333, and the other end of the spring piece 335 extends outward and distally relative to the needle rod segment 333 to limit the hard gasket 31 between the elastic barb of the connecting part 3313 and the spring piece 335.

[0060] Third embodiment

[0061] See also Figure 13 and Figure 14 The valve repair implant provided in the third embodiment of the present application has a substantially similar structure to the valve repair implant provided in the first embodiment, except that the needle hole 313 is a blind hole, and a retaining step 318 is provided between the proximal end and the distal end of the needle hole 313. The connecting portion 3313 includes at least one elastic undercut. In its 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 outward of the puncture section 331. The elastic undercut retains on the retaining step 318 when the puncture section 331 penetrates the needle hole 313. The radial dimension of the retaining 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.

[0062] After the puncture needle 33 punctures the valve leaflet from the proximal end to the distal end, the needle tip 3311 and the elastic undercut enter the needle hole 313 on the hard gasket 31. The elastic undercut first moves toward the puncture needle 33 along 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 undercut needs to return to its original shape due to its own elasticity and is locked on the locking step 318. The elastic undercut is blocked by the locking step 318 and cannot retreat, preventing the puncture needle 33 from moving relative to the hard gasket 31, thus establishing a connection between the puncture needle 33 and the hard gasket 31.

[0063] In this embodiment, the hard gasket 31 is further provided with a slot 3133 communicating with the needle hole 313, with a retaining step 318 located between the needle hole 313 and the slot 3133. The elastic undercut of the puncture needle 33 must overcome a relatively small force (e.g., no more than 3N) generated by the proximal opening of the needle hole 313 to enter the slot 3133, causing the elastic undercut to retract toward the puncture needle 33. After passing through the proximal opening of the needle hole 313 and entering the slot 3133, the elastic undercut automatically springs open, resting against the retaining step 318. Due to the significant resistance to the puncture needle 33's retraction, it is difficult for the puncture needle 33 to escape 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, which is received at the distal end of the needle hole 313. The needle hole 313 also provides cushioning and protection for the puncture needle. It is understandable that the present application does not limit the shape of the elastic undercut and the shape of the locking groove 3133 . The locking groove 3133 can be omitted and the locking step 318 can be directly protruded on the hole wall of the needle hole 313 .

[0064] In this embodiment, there are two puncture needles 33, and the proximal end of the needle shaft section 333 of each puncture needle 33 can correspondingly abut (only contact, not connect) a separate puncture push tube 16, and the corresponding suture 35 is movably arranged in the respective puncture push tube 16.

[0065] Fourth embodiment

[0066] See also Figure 15In the fourth embodiment of the present application, the surface of the hard gasket 31 is also covered with a tissue-climbing-promoting membrane layer 319, that is, the proximal surface of the hard gasket 31, the distal surface of the hard gasket 31, and the peripheral wall connected to the proximal surface of the hard gasket 31 and the hard gasket 31 are all covered with a tissue-climbing-promoting membrane layer 319, so as to promote tissue climbing after the hard gasket 31 is implanted in the heart, so that the hard gasket 31 and the leaflet can be combined more quickly. The tissue-climbing-promoting membrane layer 319 also plays a protective role, preventing the edges of the hard gasket from scratching the tissue. The material of the hard gasket 31 can be a biocompatible non-metallic material such as polyetheretherketone, or a biocompatible metal material such as stainless steel, cobalt-chromium alloy, pure titanium, nickel-titanium alloy, etc. The tissue-climbing-promoting membrane layer 319 can be a polytetrafluoroethylene coating coated on the outer surface of the hard gasket 31 or a polyester material film covering the outer surface of the hard gasket 31.

[0067] The rigid gasket 31 is provided with a threaded pinhole 313. In this embodiment, there are two pinholes 313, each of which can be connected with two puncture needles (not shown) to form an implant configuration in which two sutures are pulled to pull the rigid gasket, thereby achieving a more balanced force on the valve leaflets.

[0068] Fifth embodiment

[0069] See also Figures 16 to 18 In the fifth embodiment of the present application, the pinhole 313 is a light hole, and the connecting portion 3313 includes at least one elastic barb ( Figure 17 Only one is shown as an example); in the natural state, one end of the elastic barb is connected to the puncture section 331, and the other end of the elastic barb extends toward the proximal end and at the same time toward the direction of the axis away from the needle tip 3311; after the elastic barb passes through the needle hole 313 along with the puncture section 331, the other end of the elastic barb abuts against the distal surface of the hard gasket 31. The natural state refers to the state in which the elastic barb is not subjected to external force. After the puncture needle 33 punctures the leaflet from the proximal end to the distal end, the needle tip 3311 and the elastic barb pass through the needle hole 313 on the hard gasket 31, and the elastic barb first follows the needle hole 313 to move closer to the puncture needle 33. In this way, the resistance of the puncture needle 33 when passing through the hard gasket 31 is reduced, and the smoothness of the puncture needle 33 passing through the hard gasket 31 is improved. After the elastic barb passes through the needle hole 313, it returns to its original natural state due to its own elasticity. The elastic barb will be blocked by the solid part outside the needle hole 313 on the hard gasket 31 and cannot retreat, 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.

[0070] The needle shaft section 333 includes a first support portion 3330, a second support portion 3332, and two needle bodies 3335. The second support portion 3332 is fixed to the distal end of the first support portion 3330. The proximal ends of the two needle bodies 3335 are fixedly connected to the second support portion 3332. The proximal end of the first support portion 3330 is used to connect to the suture 35. Each needle body 3335 is provided with a puncture section 331. The distal end of the puncture section 331 is provided with a needle tip 3311. In this way, after the puncture needle 33 punctures the leaflet from the proximal end to the distal end, two puncture points can be formed on the leaflet. The first support portion 3330 and the second support portion 3332 are connected to form a roughly T-shaped structure. The distance between the second support portion 3332 and the proximal end of the elastic barb is greater than the thickness of the hard gasket 31. In this embodiment, the thickness of the hard gasket 31 is approximately 1 mm, and the distance between the second support portion 3332 and the proximal end of the elastic barb is 2.4 mm, leaving space for the leaflets and preventing the barb from penetrating the hard gasket 31. It is understood that the thickness of the hard gasket 31 is not limited; the number of needle portions 3335 can also be three or more.

[0071] In addition, the hard gasket 31 includes a peripheral wall 310 connected between the proximal and distal ends of the hard gasket 31. The peripheral wall 310 is recessed with a slot 320 extending through the proximal and distal ends of the hard gasket 31. In this embodiment, there are two slots 319, and the cross-section of the hard gasket 31 is gourd-shaped. Compared to a circular cross-section, this reduces the mass of the hard gasket 31 and reduces the pressure exerted by the hard gasket 31 on the valve.

[0072] The above is only a preferred embodiment of the present application and does not constitute any formal limitation to the present application. Although the present application has been disclosed as above in terms of a preferred embodiment, it is not intended to limit the present application. Any technician familiar with the art can, without departing from the scope of the technical solution of the present application, use the methods and technical contents disclosed above to make many possible changes and modifications to the technical solution of the present application, or modify it into an equivalent embodiment of an equivalent change. Therefore, any simple modification, equivalent change and modification made to the above embodiment based on the technical essence of the present application without departing from the content of the technical solution of the present application still falls within the scope of protection of the technical solution of the present application.

Claims

1. A valve repair implant, characterized in that: It includes a hard gasket and a suture connecting the hard gasket. The proximal surface of the hard gasket includes a fitting plane, which is used to fit the valve. The hard gasket is provided with a needle hole passing through the fitting plane. The valve repair implant also includes a puncture needle. The suture is connected to the proximal end of the puncture needle. The puncture needle is used to directly connect with the needle hole after puncturing the valve.

2. The valve repair implant according to claim 1, wherein: The puncture needle includes a puncture section located at its distal end and a needle shaft section fixedly connected to the proximal end of the puncture section. The distal end of the puncture section is a needle tip. The puncture section is used to pass through or enter the needle hole after puncturing the valve and connect to the hard gasket. The suture is connected to the proximal end of the needle shaft section.

3. The valve repair implant according to claim 2, wherein: The puncture needle further includes a connecting portion disposed on the proximal side of the needle tip, and the connecting portion is used to puncture the valve together with the puncture section and connect to the hard gasket.

4. The valve repair implant according to claim 3, wherein: The needle hole is a through hole, and the connecting part is at least one elastic barb; in a natural state, one end of the elastic barb is connected to the puncture section, and the other end of the elastic barb extends toward the proximal end and in a direction away from the axis of the needle tip; after the elastic barb passes through the needle hole of the hard gasket along with the puncture section, the other end of the elastic barb abuts against the distal surface of the hard gasket.

5. The valve repair implant according to claim 3, wherein: The needle hole is a blind hole, and a holding step is provided between the proximal end and the distal end of the needle hole, and the connecting part is at least one elastic undercut; in a natural state, one end of the elastic undercut is connected to the puncture section, and the other end of the elastic undercut extends toward the proximal end and in a direction away from the axis of the needle tip; the elastic undercut is held on the holding step when the puncture section penetrates the needle hole; the radial dimension of the holding step is larger than the radial dimension of the needle hole.

6. The valve repair implant according to claim 3, wherein: The needle hole is a threaded hole, and the connecting portion is an external thread provided on the puncture section. When the puncture section penetrates the needle hole, the connecting portion is threadedly connected to the needle hole.

7. The valve repair implant according to claim 1, wherein: The fitting plane is arranged to be inclined relative to the axis of the pinhole, and the angle between the fitting plane and the axis of the pinhole is in the range of 45° to 85°.

8. The valve repair implant according to claim 1, wherein: The area range of the fitting plane of the hard gasket is 10mm 2 ~50mm 2 .

9. The valve repair implant according to claim 1, wherein: The Brinell hardness of the hard gasket ranges from 60HBS to 300HBS.

10. The valve repair implant according to claim 9, wherein: The elastic modulus of the hard gasket is in the range of 70 GPa to 400 GPa, and the fracture strength of the hard gasket is in the range of 400 MPa to 1500 MPa.

11. The valve repair implant according to claim 1, wherein: The thickness of the hard gasket ranges from 0.5 mm to 2.8 mm.

12. The valve repair implant according to claim 1, wherein: The surface of the hard gasket is covered with a tissue climbing promoting film layer.

13. The valve repair implant according to claim 9, wherein: The material of the hard gasket includes at least one of stainless steel, cobalt-chromium alloy, pure titanium, nickel-titanium alloy, and polyetheretherketone.

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