Detailed Description
In order to make the objects, technical solutions and advantages of the present application more apparent, the present application will be further described in detail with reference to the accompanying drawings.
It is to be understood that the terms such as "comprises" and "comprising," which may be used in this application, indicate the presence of the disclosed functions, operations or elements, and are not limited to one or more additional functions, operations or elements. In this disclosure, terms such as "comprising" and/or "having" are to be construed as meaning a particular feature, number, operation, constituent element, component, or combination thereof, but are not to be construed as excluding the existence or addition of one or more other features, numbers, operations, constituent elements, components, or combinations thereof.
Furthermore, in the present application, the expression "and/or" includes any and all combinations of the words listed in association. For example, the expression "a and/or B" may include a, may include B, or may include both a and B.
In the present application, expressions including ordinal numbers such as "first" and "second" and the like may modify each element. However, such elements are not limited by the above expression. For example, the above description does not limit the order and/or importance of the elements. The above description is only intended to distinguish one element from another element. Similarly, a first element could be termed a second element, and, similarly, a second element could be termed a first element, without departing from the scope of the present disclosure.
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 or accessed to the other component, but that another component may also be present between the component and the other component. On the other hand, where components are referred to as "directly connected" or "directly accessed" to other components, it should be understood that there are no components between them.
In the technical field of interventional medical devices, the position close to the operator is generally defined as the proximal end, and the position far from the operator is defined as the distal end. The direction of the rotation center axis of the column, the tube, or the like is defined as the axial direction. The circumferential direction is the direction (perpendicular to the axis and also perpendicular to the radius of the cross section) around the axis of an object such as a cylinder, a pipe, etc. Radial is a straight direction along a diameter or radius.
Referring to fig. 1 and 2, a 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 limbal to limbal repair system 100 includes an implant device 10, a valve limbal to limbal repair implant 30, sutures 35, and a lockout device 50. The implant device 10 is used to implant a valve with a valve limbus repair implant 30. The locking device 50 is used for locking the valve edge-to-edge repair implant 30 to achieve edge-to-edge repair of the valve.
Implant device 10 includes sheath 11, proximal collet 13, and drive rod 15. The proximal collet 13 is fixedly attached to the distal end of the sheath 11.
The valve limbal to limbal repair implant 30 includes at least two rigid shims 31, at least two puncture needles 33, and a locking tab 34. The puncture needle 33 and the drive rod 15 are axially movably inserted into the sheath 11 and the proximal chuck 13. The drive rod 15 is detachably connected to the hard pad 31.
Referring to fig. 3 to 6, each puncture needle 33 includes a puncture section 331 and a locking section 333 fixedly connected to a proximal end of the puncture section 331, and a sharp needle tip 3311 is provided at a distal end of the puncture section 331. At least one elastic sheet 335 is arranged on the locking section 333, one end of the elastic sheet 335 is fixedly connected with the locking section 333, and the other end of the elastic sheet 335 extends outwards and simultaneously extends distally relative to the locking section 333. The proximal end of the locking section 333 is provided with a threading hole 3331, and the axial direction of the threading hole 3331 is mutually perpendicular to the axial direction of the locking section 333. The threading hole 3331 is used for threading the suture 35, the suture 35 is U-shaped, and two free ends of the suture 35 can extend out of the human body.
When the hard pad 31 is connected to the drive rod 15, the drive rod 15 moves along the axial direction of the sheath 11, so that the hard pad 31 can be driven relatively close to or far away from the proximal clamp 13, and thus the hard pad 31 can be matched with the proximal clamp 13 to clamp the valve. The puncture needles 33 puncture the valve after the hard gaskets 31 and the proximal chucks 13 clamp the valve, after all puncture needles 33 puncture the valve, each hard gasket 31 is at least connected with the puncture section 331 of one puncture needle 33 in a matched mode, the locking piece 34 is sleeved on the locking sections 333 of all puncture needles, the locking piece 34 is located between the hard gasket 31 and the other ends of the elastic sheets 335, and the locking piece 34 enables the locking sections 333 of all puncture needles 33 to be close to each other and lock all puncture needles 33 together. After the hard pad 31 is disengaged from the drive rod 15, the hard pad 31 is implanted with the needle 33.
The locking device 50 at least comprises a locking push tube 52, wherein the locking push tube 52 drives the locking piece 34 to be sleeved on the locking sections 333 of all the puncture needles 33 along the suture line 35, and the locking piece 34 is positioned between the hard gasket 31 and the other end of the elastic sheet 335.
The implant device 10 further includes a puncture push tube 16 movably mounted in the sheath 11, the puncture push tube 16 being configured to drive the puncture needle 33 distally, and the suture 35 extending from the interior of the puncture push tube 16 to the outside of the body. Wherein, when the puncture needle 33 is driven to move distally, the puncture push tube 16 can make the puncture needle 33 puncture the valve leaf and be matched and connected with the hard pad 31. During the drive of the puncture needle 33 by the puncture push tube 16, the puncture push tube 16 is axially aligned with but not connected to the puncture needle 33, and the puncture push tube 16 can push the puncture needle 33 when being advanced, and the puncture push tube 16 is separated from the puncture needle 33 when being retracted.
More specifically, the proximal face of the rigid spacer 31 includes a conforming plane 311 for conforming to the valve. The hard spacer 31 is provided with a pinhole 313 penetrating the bonding plane 311 and a connecting hole 315, and the pinhole 313 is used for being matched and connected with the puncture section 331 of the puncture needle 33. The connection hole 315 is for detachable connection with the driving lever 15. In this embodiment, the distal end of the driving rod 15 is provided with external threads, the wall of the connecting hole 315 is provided with internal threads, and the distal end of the driving rod 15 can be screwed with the connecting hole 315. The connection holes 315 are provided on both sides of the rigid spacer 31 opposite to the needle holes 313 to provide a sufficient leaflet clamping space and to ensure that the puncture needles 33 puncture the leaflets.
In the present embodiment, the bonding plane 311 is substantially circular, and the cross-sectional shape of the hard spacer 31 along the vertical axis is substantially circular, and the connection holes 315 and the pinholes 313 are disposed on both sides of the hard spacer 31, that is, the connection holes 315 and the pinholes 313 are respectively disposed on both sides of a plane passing through the center of the bonding plane 311 and parallel to the driving rod 15. It should be understood that the shape of the bonding plane 311 is not limited in the present application, and the cross-sectional shape of the hard pad 31 in the vertical axial direction is not limited in the present application, for example, the cross-sectional shape of the hard pad 31 in the vertical axial direction may be square, various irregular shapes, or the like.
In this embodiment, the attaching plane 311 is inclined relative to the driving rod 15, and the angle between the attaching plane 311 and the driving rod 15 may be 45 ° -85 °, preferably 65 °, so that the attaching plane 311 and the driving rod 15 form a hook structure, which is designed because the valve leaflet faces more towards the ventricle in the natural state, and the hook structure is more suitable for the natural state of the valve leaflet, so as to facilitate capturing the valve between the hard pad 31 and the proximal chuck 13. The axis of the needle hole 313 is preferably parallel to the drive rod 15.
In this embodiment, the area of the bonding plane 311 of the hard pad 31 may be 10mm2-50mm2, the brinell hardness of the hard pad 31 is preferably 60HBS-300HBS, the elastic modulus of the hard pad 31 is preferably 70GPa-400GPa, the breaking strength of the hard pad 31 is preferably 400Mpa-1500Mpa, the thickness of the hard pad 31 is preferably 0.5mm-2.8mm, and the hard pad 31 is made of at least one of stainless steel, cobalt-chromium alloy, pure titanium, nickel-titanium alloy, and polyether ether ketone, so that the hard pad 31 has high hardness, rigidity, and deformation resistance.
The rigid spacer 31 is further provided with a stop hole 317 (shown in fig. 3), and the implant device 10 further includes a stop bar 17. The stop rod 17 is movably inserted into the proximal chuck 13 along the axial direction of the proximal chuck 13. The distal end of the limit rod 17 is movably inserted into the limit hole 317 to prevent the hard spacer 31 from rotating along with the rotation of the driving rod 15.
The puncture needles 33 further comprise connection portions 3313 (as shown in fig. 4) disposed on the puncture sections 331, at least one needle hole 313 is disposed on each hard pad 31, and after the puncture sections 331 of each puncture needle 33 puncture the valve, the corresponding connection portions 3313 are cooperatively connected with the corresponding needle holes 313. In this embodiment, the pinhole 313 is a through hole, the connection part 3313 includes at least one elastic barb, in a natural state, one end of the elastic barb is connected to the piercing section 331, the other end of the elastic barb extends toward the proximal end and simultaneously toward the outside of the piercing section 331, and after the elastic barb passes through the pinhole 313 along with the piercing section 331, the other end of the elastic barb abuts against the distal end surface of the hard spacer 31. The natural state refers to a state in which the elastic barbs are not subjected to external force. Preferably, the angle between the connection 3313 and the piercing section 331 is set in the range of 30 ° -60 ° to reduce the resistance of the connection 3313 as it passes through the needle bore 313.
The puncture needle 33 punctures the valve leaflet from the proximal end to the distal end, the needle tip 3311 and the connecting portion 3313 pass through the needle hole 313 on the hard pad 31, and the connecting portion 3313 is firstly closed to the puncture needle 33 by conforming to the needle hole 313, so that the resistance when the puncture needle 33 passes through the hard pad 31 is reduced, and the smoothness of the puncture needle 33 passing through the hard pad 31 is improved. After passing through the pinhole 313, the connection part 3313 returns to its original shape due to its own elasticity, and is blocked by the solid portion around the pinhole 313 on the hard pad 31, so that the puncture needle 33 is prevented from moving proximally relative to the hard pad 31, i.e. the connection between the puncture needle 33 and the hard pad 31 is established.
In the present embodiment, the angle between the extending direction of the elastic sheet 335 in the natural state and the locking section 333 is in the range of 30 ° -60 ° (the angle a shown in fig. 4), i.e. the elastic sheet 335 is inclined relative to the locking section 333, so as to reduce the resistance of the locking sheet 34 passing through the elastic sheet 335 and improve the smoothness of the movement of the locking sheet 34 sleeved on the puncture needle 33 relative to the puncture needle 33. It will be appreciated that the present application is not limited to the number of spring plates 335.
The locking piece 34 is provided with a through hole 341 penetrating the proximal end face of the locking piece 34 and the distal end face 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 is drawn toward the puncture needle 33 after conforming to the through hole 341, and then the elastic piece 335 is rebounded to the original shape after passing through the through hole 341, and the elastic piece 335 is blocked by the solid part of the periphery of the through hole 341 of the locking piece 34 and cannot be retracted.
In this embodiment, the puncture needle 33 and the elastic sheet 335 and the connecting portion 3313 thereon may be cut from a nickel-titanium material, and when the puncture section 331 of the puncture needle 33 passes through the hard pad 31 or the locking piece 34 passes through the locking section 333 of the puncture needle 33, the puncture needle can pass through the hard pad 31 or the locking piece 34 relatively easily due to the high elasticity of the nickel-titanium material, however, after the elastic sheet 335 and the connecting portion 3313 are restored, the hard pad 31 cannot be separated distally under the action of the connecting portion 3313, and the locking piece 34 cannot be separated proximally under the action of the elastic sheet 335, so that the valve is fixed between the hard pad 31 and the locking piece 34 (see fig. 11).
In the present embodiment, the number of through holes 341 on the locking piece 34 corresponds to the number of the puncture needles 33, the locking section 333 of each puncture needle 33 passes through a through hole 341 correspondingly, and the other end of each elastic sheet 335 abuts against a solid portion of the locking piece 34 located at the periphery of 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 sheet 335 to the puncture needle 33 in the natural state. The thickness of the locking piece 34 may range from 0.3mm to 3mm, the area of the locking piece 34 may range from 5mm2-20mm2, and the material of the locking piece 34 may include at least one of stainless steel, cobalt chrome alloy, pure titanium, tantalum, nickel titanium alloy. It is understood that the thickness of the latch tab 34, the area of the latch tab 34, and the material of the latch tab 34 are not limited in the present application.
Referring to fig. 1, fig. 2, fig. 6 and fig. 7, the locking device 50 further includes a protection tube 54 movably sleeved outside the locking push tube 52. The protective tube 54 includes a tube body 542 and a protective sheet 544 disposed over a distal opening of the tube body 542. When the tube 542 and the lock push tube 52 are relatively stationary, the lock tab 34 is trapped between the protective tab 544 and the distal end of the lock push tube 52, preventing the lock tab 34 from falling out of the tube 542. When the lock push tube 52 is driven to move distally relative to the tube 542, the lock tab 34 is pushed by the lock push tube 52 out of the tube 542 and the protection tab 544 and is placed over the lock sections 333 of all the puncture needles 33. In this embodiment, the protecting piece 544 can be turned over relative to the tube 542, and when the lock push tube 52 moves axially distally relative to the protecting tube 54, the protecting piece 544 is pushed open to turn over to the outside of the tube 542, so that the lock tab 34 extends out of the protecting tube 54. A limit groove 523 is also formed on the inner wall of the distal opening of the latch push tube 52 for receiving the outer peripheral portion of the latch tab 34 to limit the latch tab 34 to the distal end of the latch push tube 52 during the distal pushing of the latch tab 34 by the latch push tube 52.
In this embodiment, the edge-to-edge repair system 100 is used for performing edge-to-edge repair on tricuspid valve, each leaflet corresponds to one hard pad 31 and one puncture needle 33, and the locking piece 34 is provided with through holes 341 corresponding to 33 puncture needles, so that the valve edge-to-edge repair implant 30 includes three hard pads 31 and three puncture needles 33, and the locking piece 34 is provided with three through holes 341. After the hard spacer 31 and the puncture needle 33 are implanted in each leaflet, the driving rod 15, the sheath 11 and the proximal chuck 13 are withdrawn from the body, the locking tab 34 is pushed into the predetermined position of the valve by the locking device 50, and the elastic sheet 335 is located distally of the locking tab 34 (as shown in fig. 7 and 8). Referring to fig. 9, the latch push tube 52 and the protecting tube 54 are pushed distally, so that each through hole 341 on the latch 34 passes through the corresponding elastic sheet 335 on the puncture needle 33, the latch 34 enters between the hard pad 31 and the elastic sheet 335, then the protecting tube 54 is kept still, the latch push tube 52 and the latch 34 are pushed distally, the protecting sheet 544 on the protecting tube 54 is pushed open and turned outwards, the latch 34 extends out of the protecting tube 54, finally the latch push tube 52 is retracted proximally, the latch 34 is separated from the latch push tube 52, and at this time, referring to fig. 10 and 11, the latch 34 is sleeved on all puncture needles 33, and the latch 34 is located between the hard pad 31 and the elastic sheet 335. The leaflets are omitted in fig. 6 to 11.
It will be appreciated that in some embodiments, the protective tube 54 may be omitted, for example, with magnetic members disposed between the latch tab 34 and the distal end of the latch push tube 52, with the latch tab 34 magnetically engaging the distal end of the latch push tube 52.
The use of this valve limbal-to-limbal repair system 100 is illustrated with the use of a limbal-to-limbal repair of the tricuspid valve performed via a femoral vein-inferior vena cava-right atrium-tricuspid valve path.
Referring to fig. 12a and 12b, the implant device 10 is delivered to the right atrium, the driving rod 15 pushes the rigid spacer 31 distally such that a leaflet is disposed between the rigid spacer 31 and the proximal chuck 13, and the driving rod 15 drives the rigid spacer 31 to retract to hold the leaflet.
Thereafter, the puncture needle 33 is driven to move distally by the puncture push tube 16, the puncture needle 33 punctures the valve leaflet and penetrates the needle hole 313 in the hard pad 31, and the puncture push tube 16 is withdrawn to be separated from the puncture needle 33.
After the puncture is completed, the driving rod 15 is unscrewed from the hard spacer 31, the implantation device 10 is withdrawn from the body, the first puncture needle 33 and the hard spacer 31 are implanted on the valve, and the suture 35 is also inserted into the proximal end of the puncture needle 33.
The above steps are repeated with the second needle 33 and hard pad 31 having the suture 35 threaded into the second flap She Zhiru, and the third needle 33 and hard pad 31 having the suture 35 threaded into the third flap She Zhiru, as shown in fig. 12 c.
With reference to fig. 6-11 and 12d and 12e, three sutures 35 corresponding to the three leaflets are respectively threaded through the three through holes 341 of the locking tab 34 and extend to the proximal end along the locking push tube 52, the locking tab 34 is conveyed to the tricuspid valve position by the locking push tube 52 and the protecting tube 54 along the sutures 35, the three sutures 35 are pulled and the locking push tube 52 and the protecting tube 54 are pushed to the distal end, so that the locking tab 34 is pushed to the distal end, the locking segments 333 of the three puncture needles 33 are gradually gathered until the elastic sheet 335 is elastically pressed down by the through holes 341 on the locking tab 34 and is reset, and the locking tab 34 is completely clamped on the locking segments 333 of the three puncture needles 33.
The protecting tube 54 is kept still, the locking push tube 52 and the locking piece 34 are pushed to the far end, the protecting piece 544 on the protecting tube 54 is pushed open to turn outwards, the locking piece 34 extends out of the protecting tube 54, the locking push tube 52 is withdrawn, and the locking piece 34 is separated from the locking push tube 52. The locking piece 34 is positioned between the valve leaflet and the elastic sheet 335, the valve leaflet is fixed between the locking piece 34 and the hard gasket 31, and finally, the locking device 50 is withdrawn, and three sutures 35 are respectively drawn, so that the edge-to-edge repair of the tricuspid valve is completed.
The three rigid gaskets 31, three puncture needles 33 and locking tabs 34 shown in fig. 11 and 12e constitute a valve edge-to-edge repair implant 30 that ultimately performs edge-to-edge repair.
It will be appreciated that tricuspid margin to margin repair may also be performed via the jugular vein-superior vena cava-right atrium-tricuspid valve path.
It will be appreciated that one leaflet may correspond to at least two piercing needles 33, and the number of through holes 341 of the locking tab 34 corresponds to the number of piercing needles 33, for example, one leaflet corresponds to two piercing needles 33, and the number of through holes 341 corresponds to six.
It will be appreciated that the valve limbic repair system 100 may also perform limbic repair on the mitral valve, for example, by performing a mitral limbic repair via the femoral vein-inferior vena cava-right atrium-atrial septum-left atrium-mitral valve path, or by performing a mitral limbic repair via the jugular vein-superior vena cava-right atrium-atrial septum-left atrium-mitral valve path. It will be appreciated that the valve limbal to limbal repair implant 30 for the mitral valve includes two rigid shims 31 and two piercing needles 33, with two through holes 341 provided in the locking tabs 34.
According to the valve edge butt-edge repair system 100 and the valve edge butt-edge repair implant 30 provided by the application, after the puncture section 331 of the puncture needle 33 punctures a valve, the puncture section 331 is matched and connected with the hard gasket 31, as long as the locking piece 34 is sleeved on the locking sections 333 of all puncture needles 33, the locking piece 34 is positioned between the hard gasket 31 and the other ends of the elastic pieces 335, and thus, the locking of all puncture needles 33 is completed, a suture is not needed to be implanted like the prior art, thereby omitting a thread cutting step, facilitating the locking operation, improving the locking efficiency, and also not needed to be forced to deform the locking nails to lock the suture through a complex pressing and holding structure like the prior art, simplifying the instrument structure, one end of the elastic pieces 335 is fixedly connected with the locking sections 333, the other ends of the elastic pieces 335 extend outwards and simultaneously towards the distal ends relative to the locking sections 333 of the puncture needles 33, the locking pieces 34 are very small when the locking pieces 34 pass through the elastic pieces 335 from near to far, the locking pieces 335 are conformably towards the locking sections 333, the locking pieces 34 are very small, the difficulty is greatly reduced, and the blocking force required by the locking pieces 34 is greatly reduced, and the driving force is reduced.
On the other hand, the distal chuck in the prior art is replaced by the hard gasket 31, the hard gasket 31 can be matched with the proximal chuck 13 to clamp the valve leaflet, and can be matched with the puncture needle 33 and the locking piece 34 to jointly form the valve edge-to-edge repair implant 30, after the hard gasket 31 and the driving rod 15 are released, the hard gasket 31 does not need to be withdrawn from the body, the risk of hooking the valve leaflet tissue is avoided, the distal chuck does not need to be additionally arranged, and the gasket and the suture are buried in the distal chuck as in the prior art, so that the instrument structure is simplified.
Second embodiment
Referring to fig. 13, the valve edge-to-edge repair system according to the second embodiment of the present application has a structure substantially the same as that of the valve edge-to-edge repair system according to the first embodiment, and is different in that the locking piece 34 is provided with through holes 341 penetrating through a proximal surface of the locking piece 34 and a distal surface of the locking piece 34, the number of the through holes 341 is one, all the locking sections 333 of the puncture needle 33 penetrate through the through holes 341, and the other end of each elastic sheet 335 abuts against a solid portion of the locking piece 34 located at the periphery of the through hole 341. The through hole 341 is a rectangular hole.
The puncture needle 33 further includes a first surface 332 and a second surface 334 disposed opposite to each other, and the connecting portion 3313 and the elastic member 335 are connected to the first surface 332 and extend away from the second surface 334. The second surfaces 334 of the respective lancets 33 can abut together and the connecting portions 3313 each extend toward the outside facing away from the first surface 332. The width direction of the through hole 341 corresponds to the holding spring 335.
It is understood that the shape of the through hole 341 is not limited in the present application, and the through hole 341 may be a circular hole or a hole with other shapes, and the minimum size of the through hole 341 should be larger than the diameter of the smallest circumcircle of the puncture needles 33 after being gathered together and smaller than the diameter of the smallest circumcircle of the distal end of each elastic sheet 335.
Third embodiment
Referring to fig. 14, the valve edge-to-edge repair system according to the third embodiment of the present application has a structure substantially the same as that of the valve edge-to-edge repair system according to the first embodiment, and is different in that the needle hole 313 is a threaded hole, the connecting portion 3313 is an external thread provided on the piercing section 331, and the connecting portion 3313 is screwed with the needle hole 313 when the piercing section 331 penetrates into the needle hole 313. A rotation stopping structure (such as a groove and a convex rib) may 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 push the puncture needle 33 along the axial direction and can drive the puncture needle 33 to rotate.
Fourth embodiment
Referring to fig. 15 and 16 (only the penetration section of the hard pad and the puncture needle is shown), the valve edge-to-edge repair system according to the fourth embodiment of the present application has substantially the same structure as the valve edge-to-edge repair system according to the first embodiment, except that the needle hole 313 is a blind hole, the hard pad 31 has a retaining 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 a natural state, one end of the elastic back-off is connected with the puncture section 331, the other end of the elastic back-off extends towards the proximal end and simultaneously towards the outside of the puncture section 331, the elastic back-off is clamped on the clamping step 318 when the puncture section 331 penetrates into the pinhole 313, and the radial dimension of the clamping step 318 is larger than that of the pinhole 313. The natural state refers to a state in which the elastic back-off is not subjected to external force.
After the puncture needle 33 punctures the valve leaflet from the proximal end to the distal end, the needle tip 3311 and the elastic back-off enter the needle hole 313 on the hard pad 31, and the elastic back-off firstly conforms to the needle hole 313 to be close to the puncture needle 33, so that the resistance when the puncture needle 33 enters the hard pad 31 is reduced, and the smoothness of the puncture needle 33 entering the hard pad 31 is improved. After entering the needle passing hole 313, the elastic back-off buckle is clamped on the clamping step 318 due to the elastic restoring shape of the elastic back-off buckle, and the elastic back-off buckle can be blocked by the clamping step 318 and can not be retracted, so that the puncture needle 33 is prevented from moving relative to the hard gasket 31, namely, the connection relationship between the puncture needle 33 and the hard gasket 31 is established.
In this embodiment, the hard spacer 31 is further provided with a clamping groove 3133 communicating with the needle hole 313, the clamping step 318 is located between the needle hole 313 and the clamping groove 3133, the elastic back-fastening of the puncture needle 33 needs to overcome a small (e.g. not more than 3N) force generated by the proximal end opening of the needle hole 313, so that the elastic back-fastening is retracted towards the puncture needle 33, and the elastic back-fastening automatically bounces out after entering the clamping groove 3133 through the proximal end opening of the needle hole 313, and is propped against the clamping step 318, and the puncture needle 33 is difficult to separate from the hard spacer 31 due to the extremely large withdrawal resistance of the puncture needle 33. At the distal end of the needle opening 313 is a conical structure that fits into the shape of the needle tip 3311, such that the needle tip 3311 is received within the distal end of the needle opening 313. It is understood that the shape of the elastic undercut and the shape of the locking groove 3133 are not limited in the present application, and the locking groove 3133 may be omitted and the locking step 318 may be directly protruded on the wall of the pinhole 313.
In this embodiment, the number of the puncture needles 33 to which one hard pad 31 is cooperatively connected is two, and the proximal end of the needle shaft section of each puncture needle 33 correspondingly abuts (contacts only, does not connect) the individual puncture push tube 16, and the corresponding suture 35 is movably inserted into the respective puncture push tube 16.
Fifth embodiment
Referring to fig. 17 and 18 (only the hard spacer and the driving rod are shown), the valve edge-to-edge repair system according to the fifth embodiment of the present application has a structure substantially the same as that of the valve edge-to-edge repair system 100 according to the first embodiment, except that the implantation device further comprises a pin 19, the driving rod 15 has an open slot 157 at a distal end thereof, the driving rod 15 has a shaft hole 158 extending axially through both sides of the open slot 157 and a proximal end of the driving rod 15, the hard spacer 31 is movably inserted into the open slot 157, a connecting hole (not shown) is disposed in the open slot 157 and is connected with the shaft hole 158, and the pin 19 is movably disposed in the connecting hole and the shaft hole 158 to detachably connect the hard spacer 31 with the driving rod 15. The drive rod 15 may disengage the rigid spacer 31 when the pin 19 is moved proximally until withdrawn from the attachment hole.
In this embodiment, the driving rod 15 includes a driving rod body 151 and a driving push tube 154, a distal end of the driving push tube 154 is connected to a proximal end of the driving rod body 151, an opening slot 157 is provided at a distal end of the driving rod body 151, a shaft hole 158 axially penetrates the driving rod body 151 and is communicated with an inner cavity of the driving push tube 154, and when the pin 19 is retracted proximally, the pin passes through the shaft hole 158 and then enters the inner cavity of the driving push tube 154.
Sixth embodiment
Referring to fig. 19, in the valve edge-to-edge repair system according to the sixth embodiment of the present application, the surface of the hard spacer 31 is further covered with a tissue climbing-promoting film 319 to promote tissue climbing after the hard spacer 31 is implanted into the heart, so that the hard spacer 31 is combined with the valve leaflet more quickly. The hard pad 31 may be made of a biocompatible non-metal material such as polyetheretherketone, or a biocompatible metal material such as stainless steel, cobalt-chromium alloy, pure titanium, nickel-titanium alloy, or the like, and the tissue climbing-promoting film 319 may be a polytetrafluoroethylene coating coated on the outer surface of the hard pad 31 or a polyester film coating the outer surface of the hard pad 31.
Seventh embodiment
Referring to fig. 20, the valve edge-to-edge repair system according to the seventh embodiment of the present application has substantially the same structure as the valve edge-to-edge repair system according to the first embodiment, and is different in that the hard spacer 31 further includes a peripheral wall 310 connected between a proximal surface of the hard spacer 31 and a distal surface of the hard spacer, and the peripheral wall 310 is concavely provided with a slot 320 penetrating the proximal surface of the hard spacer 31 and the distal surface of the hard spacer 31. In the present embodiment, the number of the grooves 320 is two, and the cross-sectional shape of the hard gasket 31 is a gourd shape, so that the mass of the hard gasket 31 can be reduced and the pressure of the hard gasket 31 itself on the valve can be reduced as compared with a circular cross-section.
The above is merely a preferred embodiment of the present application, and is not intended to limit the present application in any way. Although the present application has been described in terms of preferred embodiments, it is not limited thereto. Any person skilled in the art can make many possible variations and modifications to the technical solution of the present application or modifications to equivalent embodiments using the methods and technical contents disclosed above, without departing from the scope of the technical solution of the present application. Therefore, any simple modification, equivalent variation and modification of the above embodiments according to the technical substance of the present application still fall within the scope of the technical solution of the present application.