Heart valve repair devices

Abstract

The present application provides a heart valve repair device comprising a sheath, a proximal chuck, a drive rod, and a valve repair implant. The valve repair implant comprises a puncture needle, a suture, and a hard gasket. The proximal chuck is fixed to the distal end of the sheath; the drive rod and the puncture needle are both movably installed in the sheath and the proximal chuck along the axial direction of the sheath; the suture is connected to the proximal end of the puncture needle. The hard gasket is detachably connected to the distal end of the drive rod; the hard gasket is used to clamp the valve in conjunction with the proximal chuck when the drive rod and the hard gasket are connected. The puncture needle is used to puncture the valve when the hard gasket and the proximal chuck clamp the valve, and is connected to the hard gasket. After the hard gasket is detached from the drive rod, the puncture needle is implanted into the valve along with the hard gasket and suture. The heart valve repair device can prevent the instrument from hooking the valve leaflet tissue during withdrawal, thereby improving the safety of valve repair surgery.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a heart valve repair device. 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] A heart valve repair device is currently available that clamps the valve leaflets through the cooperation of a distal clamp and a proximal clamp, wherein a suture, a gasket, and a sleeve are embedded in the distal clamp. When the proximal and distal clamps are relatively closed and the valve leaflets are clamped, a puncture needle is pushed distally, causing the puncture needle to puncture the valve leaflets and connect to the sleeve. The puncture needle is then withdrawn proximally to pull out the suture connected to the sleeve and the soft gasket inserted into the suture, thereby suturing the soft gasket and suture to the valve. Afterwards, the distal clamp is driven away from the proximal clamp, releasing the clamping of the valve leaflets. Then, with the distal and proximal clamps relatively open, the entire device is withdrawn. However, when the device is withdrawn, the distal clamp may hook onto the valve leaflet tissue located between the distal and proximal clamps, hindering the withdrawal of the device. In more serious cases, it may pull or even damage the valve leaflet tissue. Summary of the Invention

[0005] The technical problem to be solved by the present application is to provide a heart valve repair device that can prevent the instrument from hooking the valve leaflet tissue during withdrawal, thereby improving the safety of valve repair surgery.

[0006] In order to achieve the above-mentioned objectives, the present application provides a heart valve repair device, comprising a sheath, a proximal clamp, a drive rod and a valve repair implant; the valve repair implant comprises a puncture needle, a suture and a hard gasket; the proximal clamp is fixed to the distal end of the sheath; the drive rod and the puncture needle are both movably installed in the sheath and the proximal clamp along the axial direction of the sheath; the suture is connected to the proximal end of the puncture needle; the hard gasket is detachably connected to the distal end of the drive rod; the hard gasket is used to be driven by the drive rod to cooperate with the proximal clamp to clamp the valve when the drive rod and the hard gasket are connected; the puncture needle is used to puncture the valve when the hard gasket and the proximal clamp clamp the valve, and is connected to the hard gasket, and after the hard gasket is detached from the drive rod, the puncture needle is implanted into the valve together with the hard gasket and the suture.

[0007] The heart valve repair device provided by the present application replaces the distal clamp in the prior art with a hard gasket. The hard gasket can cooperate with the proximal clamp to clamp the valve leaflet, and can also be connected to the puncture needle and suture after the puncture needle punctures the valve to serve as a valve implant. After the hard gasket is released from the drive rod, the hard gasket does not need to be withdrawn from the body, avoiding the risk of hooking the valve leaflet tissue. Other components such as the sheath, proximal clamp and drive rod can be smoothly withdrawn from the body, and there is no need to additionally set up a distal clamp and bury gaskets and sutures in the distal clamp, thereby simplifying the structure of the entire heart valve repair device. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 A three-dimensional schematic diagram of a heart valve repair device provided in the first embodiment of the present application;

[0009] Figure 2 for Figure 1 A three-dimensional schematic diagram of the heart valve repair device when the hard gasket and the proximal clamp are close together;

[0010] Figure 3 for Figure 1 A three-dimensional schematic diagram of the heart valve repair device shown when the hard gasket and the proximal clamp are away from each other;

[0011] Figure 4 for Figure 3 A cross-sectional view of a heart valve repair device is shown;

[0012] Figure 5 for Figure 3 A three-dimensional schematic diagram of a partial structure of the heart valve repair device shown in another perspective;

[0013] Figure 6 for Figure 5 A three-dimensional schematic diagram of a partial structure of a heart valve repair device with the sheath removed;

[0014] Figure 7 This is a schematic exploded perspective view of the hard gasket, driving rod, and limiting member in the heart valve repair device of the present application;

[0015] Figure 8 for Figure 7 Schematic diagram of a medium-hard gasket;

[0016] Figure 9 for Figure 7 Cross-sectional view of the medium-hard gasket and the puncture needle when not connected;

[0017] Figure 10 for Figure 6 A three-dimensional schematic diagram of the puncture needle, puncture push tube and suture assembled together;

[0018] Figure 11 for Figure 10 A cross-sectional view of the puncture needle, puncture push tube and suture assembled together;

[0019] Figure 12a-12d A schematic diagram of the process of performing edge-to-edge heart valve repair using the heart valve repair device of the present application;

[0020] Figure 13 A schematic diagram of a heart valve repair device according to the present application performing chordal repair on a heart valve;

[0021] Figure 14 This is a perspective schematic diagram of a heart valve repair device provided in the second embodiment of the present application, wherein the puncture needle does not extend out of the proximal clamp;

[0022] Figure 15 for Figure 14 A three-dimensional schematic diagram of a puncture needle passing through a needle hole in a heart valve repair device is shown;

[0023] Figure 16 A three-dimensional schematic diagram of a puncture needle entering a needle hole in a heart valve repair device provided in a third embodiment of the present application;

[0024] Figure 17 for Figure 16 Cross-sectional view of a medium-hard spacer, puncture needle, and suture;

[0025] Figure 18 This is a three-dimensional schematic diagram of the connection between the driving rod and the hard gasket of the heart valve repair device provided by the fourth embodiment of the present application;

[0026] Figure 19 for Figure 18 A side view of the drive rod shown connected to the hard washer;

[0027] Figure 20A perspective schematic diagram of a hard gasket provided in a fifth embodiment of the present application;

[0028] Figure 21 This is a three-dimensional schematic diagram of the hard gasket provided in the sixth embodiment of the present application. DETAILED DESCRIPTION

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] When a component is referred to as being "connected" or "accessed" to another component, it should be understood that the component may not only be 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.

[0034] 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.

[0035] See also Figure 1The first embodiment of the present application provides a heart valve repair device 100 that can be used to perform edge-to-edge repair or chordae tendineae repair on a heart valve. The heart valve repair device 100 includes an implantation device 10 and a valve repair implant 30. The implantation device 10 is used to implant the valve repair implant 30 into the valve.

[0036] Please see further Figures 2 to 4 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.

[0037] The valve repair implant 30 includes a hard gasket 31, a puncture needle 33 and a suture 35. The puncture needle 33 is axially movably installed in the sheath 11 and the proximal clamp 13. The suture 35 is connected to the proximal end of the puncture needle 33. The hard gasket 31 is detachably connected to the distal end of the drive rod 15. 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, wherein the drive rod 15 moves axially toward the distal end along the sheath 11, which can move the hard gasket 31 away from the proximal clamp 13; the drive rod 15 moves axially toward the proximal end along the sheath 11, which can move the hard gasket 31 close to the proximal clamp 13 and thus cooperate with the proximal clamp 13 to clamp the valve. The puncture needle 33 is used to puncture the valve after the hard gasket 31 and the proximal clamp 13 clamp the valve, and 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 together with the hard gasket 31 and the suture 35.

[0038] 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 3 and Figure 4 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 2 The puncture needle 33 is inserted distally from the proximal clamp 13 (as shown). At this point, the hard gasket 31 is still connected by the drive rod 15, which acts as a distal clamp to support the valve leaflets, providing conditions for the puncture needle 33 to puncture the valve leaflets. After the distal end of the puncture needle 33 pierces the valve leaflets, it mates with the hard gasket 31. The drive rod 15 can be a circular rod or tube. Furthermore, the puncture needle 33 includes a puncture section 331 at the distal end of the puncture needle 33 and a needle shaft section 333 fixedly connected to the proximal end of the puncture section 331.

[0039] 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.

[0040] The heart valve repair device 100 further includes an operating handle 50 (eg, Figure 1 (as shown), the distal end of the operating handle 50 is fixedly connected to the proximal end of the sheath 11. The end of the suture 35, distal from the needle shaft segment 333, passes through the lumen of the puncture push tube 16 and extends to the outside of the operating handle 50. The operating handle 50 is provided with corresponding control members to respectively control the movement of the puncture push tube 16 and the drive rod 15, so that the drive rod 15 drives the hard gasket 31 to move axially or disengage from the hard gasket 31, and the puncture push tube 16 drives the puncture needle 33 to puncture the valve or connect the puncture needle 33 with the hard gasket 31.

[0041] See also Figure 5 、 Figure 6 and Figure 7 The proximal surface of the hard gasket 31 includes a fitting plane 311 for fitting the valve. The hard gasket 31 is provided with a needle hole 313 and a connecting hole 315 that pass through the fitting plane 311. The needle hole 313 is used to cooperate with the distal end of the puncture section 331. In this embodiment, there are two needle holes 313 and two puncture needles 33 to form an implantation form in which two sutures 35 pull the hard gasket 31, so that the force of the hard gasket 31 on the leaflets is more balanced. The connecting hole 315 is used to be detachably connected to the distal end of the drive rod 15. In this embodiment, the distal end of the drive rod 15 is provided with an external thread, and the hole wall of the connecting hole 315 is provided with an internal thread, and the distal end of the drive rod 15 is screwed to the connecting hole 315. Preferably, the connecting hole 315 and the needle hole 313 are arranged on both sides of the hard gasket 31 relative to each other to provide sufficient leaflet clamping space and ensure that the puncture needle 33 punctures the leaflets.

[0042] In this embodiment, the mating plane 311 is generally circular, and the cross-sectional shape of the hard gasket 31 along the vertical axis is generally circular. The connection hole 315 and the pinhole 313 are disposed on opposite sides of the hard gasket 31, meaning that the connection hole 315 and the pinhole 313 are located on opposite sides of a plane passing through the center of the mating plane 311 and parallel to the drive rod 15. It should be understood that this application does not limit the shape of the mating plane 311, nor does it 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 may also be square or various irregular shapes.

[0043] In this embodiment, the contact plane 311 is inclined relative to the driving rod 15, and the angle between the contact plane 311 and the driving rod 15 (eg Figure 3 The angle a) shown can range from 45° to 85°, preferably 65°, so that the contact plane 311 and the drive rod 15 form a hook-like structure. This design is due to the fact that the leaflets naturally face more toward the ventricle, and the hook-like structure better conforms to the natural position of the leaflets, facilitating the capture of the valve between the hard gasket 31 and the proximal clamp 13. The axis of the needle hole 313 is preferably parallel to the drive rod 15.

[0044] Please refer to Figure 8 and Figure 9 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 that the threaded connection length between the puncture needle 33 and the hard gasket 31 is sufficient.

[0045] In this embodiment, the area range of the bonding plane 311 of the hard gasket 31 is preferably 10mm 2 -50mm 2 ; 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; 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 sufficient hardness, rigidity and anti-deformation performance.

[0046] Please refer again Figures 5 to 7 The hard gasket 31 is further provided with a limiting hole 317. The implant device 10 further includes a limiting member 17. The limiting member 17 is movably mounted in the proximal chuck 13 along the axial direction of the proximal chuck 13. The limiting member 17 is movably inserted into the limiting hole 317 and is used to prevent the hard gasket 31 from rotating along with the drive rod 15 when the drive rod 15 and the hard gasket 31 are unthreaded. The limiting member 17 includes a guide rod 171 and a sliding block 173. The guide rod 171 is movably mounted in the proximal chuck 13 along the axial direction. The sliding block 173 is fixedly connected to the proximal end of the guide rod 171 and movably received in the proximal chuck 13.

[0047] More specifically, the drive rod 15 includes a drive rod body 151 and a first stopper 153 protruding from the outer wall of the drive rod body 151. The drive rod body 151 movably passes through the sliding block 173; during the process of threading the distal end of the drive rod body 151 to the hard gasket 31, the first stopper 153 abuts against the proximal end surface of the sliding block 173, allowing the distal end of the guide rod 171 to be inserted into the limiting hole 317. In this embodiment, the sliding block 173 is provided with two grooves 1731. The drive rod body 151 movably passes through one groove 1731, and the proximal end of the guide rod 171 is fixed to the other groove 1731 of the sliding block 173 by welding or other means.

[0048] The drive rod 15 also includes a second stopper (not shown) protruding from the drive rod body 151. The sliding block 173 is located between the first stopper 153 and the second stopper. The second stopper has a similar structure to the first stopper 153. The axial distance between the first stopper 153 and the second stopper along the drive rod body 151 is greater than the axial length of the threaded connection between the distal end of the drive rod body 151 and the connecting hole 315.

[0049] During the threaded connection between the drive rod 15 and the hard gasket 31, the first stop 153 abuts the sliding block 173. When the drive rod 15 moves distally, it can drive the sliding block 173 and the guide rod 171 to move distally, so that the distal end of the guide rod 171 is inserted into the limiting hole 317. After separating from the hard gasket 31, the drive rod body 151 first moves relative to the limiting member 17. When the proximal end surface of the second stop comes into abutment with the sliding block 173, the drive rod 15 drives the limiting member 17 to withdraw proximally, thereby separating the drive rod 15 and the guide rod 171 from the hard gasket 31.

[0050] Please see further Figure 10 and Figure 11 As previously described, the puncture needle 33 comprises a puncture section 331 and a shaft 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. The puncture section 331 is the portion of the puncture needle 333 extending from the needle tip 3311 to the valve to be punctured. After puncturing the valve, the puncture section 331 is designed to penetrate the needle hole 313 and connect to the hard gasket 31. One end of the suture 35 can be fixedly connected to the proximal end of the shaft section 333 by crimping, gluing, or other methods.

[0051] 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.

[0052] A rotation-stop structure 160 is provided between the proximal end of the needle shaft segment 333 and the distal end of the puncture push tube 16 to prevent the puncture needle 33 from rotating relative to the puncture push tube 16. The rotation-stop structure 160 includes a block 3334 located at the proximal end of the needle shaft segment 333 and a slot 161 located at the distal end of the puncture push tube 16. The block 3334 engages within the slot 161. The distal end of the puncture push tube 16 abuts the proximal end of the needle shaft segment 333, and the puncture needle 33 and puncture push tube 16 are housed together within the same lumen of the sheath 11. When the puncture push tube 16 is axially pushed toward the distal end, it drives the puncture needle 33 to move axially, thereby puncturing the valve. Because a rotation stop 160 is provided between the proximal end of the needle shaft section 333 and the distal end of the puncture push tube 16, rotating the puncture push tube 16 drives the puncture needle 33 to rotate, threading the connection portion 3313 into the needle hole 313 of the hard gasket 31. In this embodiment, the end of the suture 35 distal from the puncture needle 33 can remain inserted into the lumen of the puncture push tube 16 without affecting the alignment of the puncture needle 33 and the puncture push tube 16. When the puncture push tube 16 is withdrawn, the suture 35 can remain connected to the proximal end of the puncture needle 33. The suture 35 can be made of polytetrafluoroethylene thread, polyester fiber thread, or the like.

[0053] It can be understood that the present application does not limit the detachable connection method between the puncture push tube 16 and the needle rod segment 333. In other embodiments, a card slot can be provided at the proximal end of the needle rod segment 333, and a card block can be provided at the distal end of the puncture push tube 16.

[0054] It is understood that the present application does not limit the detachable connection between the puncture needle 33 and the hard gasket 31. In other embodiments, the puncture needle 33 can pass through the hard gasket 31 without being separated from the hard gasket 31, and the anti-rotation structure 160 between the puncture push tube 16 and the puncture needle 33 can be omitted. When the puncture push tube 16 drives the puncture needle 33 to move distally, the puncture needle 33 can puncture the leaflet and penetrate the needle hole 313 on the hard gasket 31. During the process of the puncture push tube 16 driving the puncture needle 33, 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 it advances, and it can separate from the puncture needle 33 when it retreats.

[0055] It is understandable that in other embodiments, the sliding block 173 may not be provided, the driving rod 15 and the guide rod 171 are independent of each other, and a driving rod control member is provided on the operating handle 50 to control the driving rod and a guide rod control member is provided to control the guide rod.

[0056] like Figures 12a to 12d As shown, the use process of the heart valve repair device 100 of the present application is explained by taking the repair of the tricuspid valve between the right atrium and the right ventricle as an example.

[0057] First, see Figure 12aThe 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.

[0058] Next, see Figure 12b The driving rod 15 is withdrawn toward the proximal end, driving the hard gasket 31 to approach the proximal clamp 13 to clamp the leaflet, and then the puncture push tube 16 is manipulated to push the puncture needle 33 toward the distal end, and the puncture needle 33 penetrates the leaflet.

[0059] Then, the puncture push tube 16 is rotated so that the puncture needle 33 and the hard gasket 31 are screwed together.

[0060] Next, the driving rod 15 is rotated to release the screw connection between the driving rod 15 and the hard washer 31 , and then the driving rod 15 is retracted, and the guide rod 171 is also separated from the hard washer 31 .

[0061] 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 12c , thus completing the implantation of the valve repair implant 30 on one leaflet.

[0062] Repeat the above steps to implant hard gaskets 31, puncture needles 33 and sutures 35 on other leaflets.

[0063] Finally, see Figure 12d , 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.

[0064] like Figure 13 As shown, the heart valve repair device 100 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 serves as an artificial chordal tendon extending in the ventricle and fixed to the papillary muscle or the ventricular wall.

[0065] The above is only an example of repairing the tricuspid valve. It can be understood that the heart valve repair device 100 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.

[0066] In the heart valve repair device 100 of the present application, 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 to serve as a 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 additionally set up a distal clamp and bury gaskets and sutures in the distal clamp as in the prior art, thereby simplifying the structure of the entire heart valve repair device.

[0067] In addition, the hard gasket 31 will not be deformed under the pull 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 pull of the suture like the soft gasket. When blood impacts the leaflet, the proximal surface of the hard gasket 31 fits the leaflet and always maintains surface contact, so that there is a continuous large contact area between the hard gasket 31 and the leaflet. The hard gasket 31 can better support 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 the operation.

[0068] 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.

[0069] Second embodiment

[0070] See also Figure 14 and Figure 15 The heart valve repair device provided in the second embodiment of the present application has a substantially similar structure to the heart valve repair device 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 ( Figure 14 and Figure 15 Only one is shown in the figure for 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.

[0071] 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.

[0072] In this embodiment, the needle rod section 333 includes a first support portion 3331, a second support portion 3332 and two needle body portions 3335. The second support portion 3332 is fixed to the distal end of the first support portion 3331, and the proximal ends of the two needle body portions 3335 are fixedly connected to the second support portion 3332. The proximal end of the first support portion 3331 is detachably connected to the distal end of the puncture push tube 16. A needle tip 3311 is provided at the distal end of each needle body portion 3335. 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.

[0073] The first support portion 3331 and the second support portion 3332 are connected to form a roughly T-shaped structure. The proximal chuck 13 is provided with a first receiving groove 133 and a second receiving groove 135 connected to the first receiving groove 133. The first receiving groove 133 is used to accommodate the needle body 3335 and the second supporting portion 3332, and the second receiving groove 135 is used to accommodate the elastic barb. Before the puncture needle 33 punctures the valve, the second supporting portion 3332 is received in the first receiving groove 133. The first supporting portion 3331 is received in the inner cavity of the puncture push tube 16 and fixedly connected to a suture 35. The suture 35 extends from the proximal end of the operating handle (not shown). The first receiving groove 133 is a flat groove extending along the axial direction of the proximal chuck 13. A step (not shown) is provided between the first receiving groove 133 and the passageway of the puncture push tube 16 to prevent the puncture needle 33 from withdrawing.

[0074] It can be understood that the number of the needle body parts 3335 can also be three or more, and the proximal end of the needle body part 3335 is fixedly connected to the second support part 3332.

[0075] Third embodiment

[0076] See also Figure 16 and Figure 17The heart valve repair device provided in the third embodiment of the present application has a substantially similar structure to that 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 is retained 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.

[0077] 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.

[0078] In this embodiment, the hard gasket 31 is further provided with a slot 3133 communicating with the needle hole 313, and a retaining step 318 is located between the needle hole 313 and the slot 3133. The elastic undercut of the puncture needle 33 needs to 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, so that the elastic undercut retracts toward the puncture needle 33. After the elastic undercut passes through the proximal opening of the needle hole 313 and enters the slot 3133, it automatically springs open and abuts against the retaining step 318. However, due to the significant resistance to the withdrawal of the puncture needle 33, it is difficult for the puncture needle 33 to separate 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. 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 retaining step 318 can be directly protruded on the hole wall of the needle hole 313 .

[0079] 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.

[0080] Fourth embodiment

[0081] See also Figure 18 and Figure 19The heart valve repair device provided in the fourth embodiment of the present application has a structure that is substantially the same as that provided in the first embodiment, except that the implant device further includes a pin 19; an opening slot 157 is provided at the distal end of the drive rod 15, and an axial hole 158 is provided along the axial direction of the drive rod 15, which passes through both sides of the opening slot 157 and the proximal end of the drive rod 15; the hard gasket 31 is movably inserted into the opening slot 157, and a connecting hole (not shown) is located in the opening slot 157 and is connected to the axial hole 158; the pin 19 is movably inserted into the connecting hole and the axial hole 158 to detachably connect the hard gasket 31 to the drive rod 15. When the pin 19 moves proximally and is withdrawn from the connecting hole, the drive rod 15 can be detached from the hard gasket 31. Since the connection between the drive rod 15 and the hard gasket 31 can be released directly by pulling out the pin 19 without rotating the drive rod 15, the operation is simplified.

[0082] In this embodiment, the driving rod 15 includes a driving rod body 151 and a driving push tube 154. The distal end of the driving push tube 154 is connected to the proximal end of the driving rod body 151. The opening groove 157 is provided at the distal end of the driving rod body 151. The axial hole 158 penetrates the driving rod body 151 axially and is connected to the inner cavity of the driving push tube 154. When the pin shaft 19 retracts toward the proximal end, it first passes through the axial hole 158 and then enters the inner cavity of the driving push tube 154.

[0083] Fifth embodiment

[0084] See also Figure 20 In the fifth embodiment of the present application, the surface of the hard gasket 31 is further covered with a tissue creeping-promoting membrane layer 319. This promotes tissue creeping after the hard gasket 31 is implanted in the heart, allowing the hard gasket 31 to more quickly integrate with the valve leaflet. The hard gasket 31 can be made of a biocompatible non-metallic material such as polyetheretherketone, or a biocompatible metallic material such as stainless steel, cobalt-chromium alloy, pure titanium, or nickel-titanium alloy. The tissue creeping-promoting membrane layer 319 can be a polytetrafluoroethylene coating applied to the outer surface of the hard gasket 31, or a polyester film covering the outer surface of the hard gasket 31.

[0085] Sixth embodiment

[0086] See also Figure 21 In the sixth embodiment of the present application, the hard gasket 31 further includes a peripheral wall 310 connected between the proximal end surface and the distal end surface of the hard gasket 31. The peripheral wall 310 is recessed with a slot 320 that passes through the proximal end surface and the distal end surface of the hard gasket 31. In this embodiment, there are two slots 320, and the cross-section of the hard gasket 31 is gourd-shaped. Compared to a circular cross-section, this can reduce the mass of the hard gasket 31 and reduce the pressure exerted by the hard gasket 31 on the valve.

[0087] 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 heart valve repair device, characterized in that: It comprises a sheath, a proximal chuck, a driving rod, a puncture push tube and a valve repair implant; the valve repair implant comprises a puncture needle, a suture and a hard gasket; the proximal chuck is fixed to the distal end of the sheath; the driving rod and the puncture needle are both movably installed in the sheath and the proximal chuck along the axial direction of the sheath; the puncture needle comprises a puncture section located at the distal end of the puncture needle and a needle rod section fixedly connected to the proximal end of the puncture section, the distal end of the puncture section being a needle tip; the suture is connected to the proximal end of the needle rod section, and the suture is used to be passed through the inner cavity of the puncture push tube; the distal end of the puncture push tube is detachably connected to the proximal end of the needle rod section, and the puncture push tube is used to drive the puncture needle to move toward the distal end; The hard gasket is used to be driven by the driving rod to cooperate with the proximal clamp to clamp the valve when the driving rod is connected to the hard gasket; The hard gasket is provided with a connecting hole and a needle hole penetrating the proximal end surface of the hard gasket; the connecting hole is detachably connected to the driving rod; the needle hole is used to penetrate the puncture needle; The puncture needle is used to puncture the valve when the hard gasket and the proximal clamp clamp the valve. After puncturing the valve, the puncture section passes through or enters the needle hole and is connected to the hard gasket. After the connecting hole of the hard gasket is detached from the driving rod, the puncture needle is implanted into the valve along with the hard gasket and the suture.

2. The heart valve repair device according to claim 1, wherein: A rotation-stop structure is provided between the proximal end of the needle rod segment and the distal end of the puncture push tube.

3. The heart valve repair device according to claim 1, 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 heart valve repair device according to claim 1, wherein: The connecting hole is threadedly connected to the distal end of the driving rod.

5. The heart valve repair device according to claim 1, wherein: The connecting hole and the pinhole are arranged opposite to each other on two sides of the hard gasket.

6. The heart valve repair device according to claim 1, wherein: The heart valve repair device also includes a limiter, and a limiter hole is provided on the hard gasket. The limiter is movably installed in the proximal clamp along the axial direction of the proximal clamp, and the limiter is movably inserted into the limiter hole to limit the hard gasket from rotating along with the drive rod when the drive rod is separated from the hard gasket.

7. The heart valve repair device according to claim 1, wherein: It also includes a pin shaft; an open groove is provided at the distal end of the driving rod, and the driving rod is axially provided with an axial hole that passes through both sides of the open groove and the proximal end of the driving rod; the hard gasket is movably inserted into the open groove, and the connecting hole is located in the open groove and passes through the axial hole; the pin shaft is movably passed through the connecting hole and the axial hole to detachably connect the hard gasket to the driving rod; when the pin shaft moves toward the proximal end and is withdrawn from the connecting hole, the driving rod can be separated from the hard gasket.

8. The heart valve repair device according to claim 1, wherein: The proximal end surface of the hard gasket is tilted relative to the driving rod, and the angle between the proximal end surface of the hard gasket and the driving rod is in the range of 45°-85°.

9. The heart valve repair device according to claim 1, wherein: The thickness of the hard gasket is in the range of 0.5mm-2.8mm, and the area of the proximal end surface of the hard gasket is in the range of 10mm. 2 -50 mm 2 .

10. The heart valve repair device according to claim 1, wherein: The Brinell hardness of the hard gasket is in the range of 60HBS-300HBS, the elastic modulus of the hard gasket is in the range of 70GPa-400GPa, and the fracture strength of the hard gasket is in the range of 400Mpa-1500Mpa.

11. The heart valve repair device according to claim 1, wherein: The surface of the hard gasket is covered with a tissue-climbing-promoting membrane layer.

12. The heart valve repair device according to claim 1, 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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