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 being "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. 2-4, in conjunction with fig. 5-8, the present application provides a valve repair implant 30 for use in a heart valve repair device 100, wherein the heart valve repair device 100 can be used for performing edge-to-edge repair or chordae tendineae repair on a heart valve.
The heart valve repair device 100 includes an implant device 10 for implanting a valve repair implant 30 into a valve.
The implantation device 10 comprises a sheath 11, a proximal chuck 13, and a driving rod 15, wherein the proximal chuck 13 is fixedly connected to the distal end of the sheath 11, and the driving rod 15 is movably inserted into the sheath 11 and the proximal chuck 13 along the axial direction of the sheath 11. The driving rod 15 may be a solid structure or a hollow structure. The material of the driving rod 15 may be stainless steel, nickel-titanium alloy, high molecular polymer, etc., and the present application is not limited to the material of the driving rod 15.
The valve repair implant 30 includes a rigid spacer 31 and sutures 35 attached to the rigid spacer 31. The proximal face of the rigid spacer 31 includes a conforming plane 311 for conforming to the valve. The hard pad 31 further includes a peripheral wall 310 connected between the proximal face of the hard pad 31 and the distal face of the hard pad 31. The hard pad 31 is detachably connected to the driving rod 15. The hard pad 31, driven by the drive rod 15, can be moved toward or away from the proximal clamp 13 to engage the proximal clamp 13 to clamp the valve.
In the present embodiment, the bonding plane 311 is substantially circular, the cross-sectional shape of the hard pad 31 along the vertical axis is substantially circular, and the area range of the bonding plane 311 of the hard pad 31 is preferably 10mm2～50mm2, so as to ensure that there is enough contact area between the hard pad 31 and the leaflet, and not to affect the normal action of the leaflet. The Brinell hardness of the hard pad 31 is preferably 60HBS to 300HBS, the elastic modulus of the hard pad 31 is preferably 70GPa to 400GPa, the breaking strength of the hard pad 31 is preferably 400MPa to 1500MPa, and the thickness of the hard pad 31 is preferably 0.5mm to 2.8mm, so that the hard pad 31 has sufficient hardness, rigidity and deformation resistance. 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. It will be appreciated 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
The hard spacer 31 is provided with a pinhole 313 penetrating the bonding plane 311. The valve repair implant 30 also includes a puncture needle 33. The puncture needle 33 is axially movably inserted into the sheath 11 and the proximal chuck 13. The puncture needle 33 is used to penetrate or pass through the needle hole 313 to be connected with the hard pad 33.
The needle 33 includes a piercing section 331 at the distal end of the needle 33 and a shank section 333 fixedly attached to the proximal end of the piercing section 331. Distal to the penetration section 331 is a needle tip 3311, i.e., the portion of the needle 33 from the needle tip 3311 to the valve being penetrated. The piercing section 331 is adapted to pass through or into the needle hole 313 and connect with the rigid spacer 31 after piercing the valve. One end of the suture 35 may be fixedly attached to the proximal end of the needle shaft segment 333 by crimping, cementing, or the like. In a state where the puncture segment 331 of the puncture needle 33 is connected to the hard pad 31, the suture thread 35 is connected to the hard pad 31. Since the penetration section 331 penetrates from the attaching plane 311 of the hard spacer 31, the penetration section 331 is intersected with the attaching plane 311.
In the present embodiment, the bonding plane 311 is inclined with respect to the axis of the pinhole 313, and when the puncture needle 33 penetrates the pinhole 313 of the hard pad 33, the axis of the puncture needle 33 coincides with the axis of the pinhole 313. The angle between the attaching plane 311 and the axis of the needle hole 313 may be 45 ° to 85 °, preferably 65 °, so that the attaching plane 311 and the needle 33 form a hook structure when the needle 33 and the hard pad 31 are in a connected state, and the reason for this design is that the valve leaflet faces more towards the ventricle in a natural state, and the hook structure formed after the hard pad 31 and the needle 33 are connected more matches the natural state of the valve leaflet.
The distal end face of the hard pad 31 is provided with a boss 316, and a pinhole 313 extends from the fitting plane 311 of the hard pad 31 into the boss 316. Because the thickness of the area where the protruding portion 316 is located is greater than the thickness of the remaining area of the hard pad 31, the distal end of the puncture needle 33 can be hidden inside the protruding portion 316, and a sufficient connection length between the puncture needle 33 and the hard pad 31 is ensured.
In the state that the driving rod 15 is connected with the hard gasket 31, the driving rod 15 can drive the hard gasket 31 to be matched with the proximal chuck 13 to clamp the valve, wherein the driving rod 15 moves along the axial direction of the sheath 11 to the distal end, the hard gasket 31 can be far away from the proximal chuck 13, and the driving rod 15 moves along the axial direction of the sheath 11 to the proximal end, and the hard gasket 31 can be close to the proximal chuck 13 to be matched with the proximal chuck 13 to clamp the valve. The piercing section 331 of the piercing needle 33 is adapted to pierce the valve after the hard pad 31 and the proximal clamp 13 grip the valve, and is attached to the hard pad 31, and after the hard pad 31 is disengaged from the drive rod 15, the piercing needle 33 is implanted with the hard pad 31 along with the sutures 35.
More specifically, when the drive rod 15 drives the stiff spacer 31 and the proximal jaw 13 away from each other (as shown in fig. 5), the open area between the stiff spacer 31 and the proximal jaw 13 serves to capture leaflet tissue. After capturing the tissue of the valve leaflet, the hard pad 31 is relatively close to the proximal chuck 13 (as shown in fig. 6) under the drive of the driving rod 15 so as to clamp the valve leaflet, and the puncture needle 33 is penetrated from the proximal chuck 13 to the distal end, at this time, the hard pad 31 is still connected by the driving rod 15, which can be equivalent to the distal chuck to support the valve leaflet, so that conditions are provided for the puncture needle 33 to puncture the valve leaflet, and the distal end of the puncture needle 33 is matched and connected with the hard pad 31 after penetrating the valve leaflet.
The penetrating segment 331 further includes a connecting portion 3313 disposed proximal of the needle tip 3311, the connecting portion 3313 being adapted to penetrate the valve together with the penetrating segment 331 and to connect the rigid spacer 31. In this embodiment, the pinhole 313 is a threaded hole, the connection part 3313 is an external thread provided on the piercing section 331, and when the piercing section 331 penetrates the pinhole 313, the connection part 3313 is screwed with the pinhole 313.
The implant device 10 further includes a piercing push tube 16 movably disposed within the sheath 11, the suture 35 movably disposed within the lumen of the piercing push tube 16, and the distal end of the piercing push tube 16 removably coupled to the proximal end of the needle shaft segment 333. The puncture cannula 16 is used to drive the puncture needle 33 distally and out of the needle shaft section 333 after the puncture section 331 has pierced the valve and been connected to the rigid pad 31.
As shown in fig. 5-8, the implantation process of the valve repair implant 30 is illustrated with respect to tricuspid valve margin-to-margin repair between the right atrium and right ventricle.
First, referring to fig. 5, the heart valve repair device 100 is delivered to the right atrium via an interventional approach (e.g., femoral vein-inferior vena cava-right atrium, or directly via the right atrium) to access the valve She Chu, and then the drive rod 15 is maneuvered distally to move the stiff pad 31 away from the proximal collet 13 into the ventricular side and the leaflets into the open areas of the stiff pad 31 and proximal collet 13.
Next, referring to fig. 6, the driving rod 15 is retracted proximally, and drives the rigid pad 31 to approach the proximal chuck 13 to clamp the valve leaflet, pushing the puncture needle 33 distally, and the puncture needle 33 penetrates the valve leaflet.
Then, the puncture needle 33 is driven to rotate and screwed together with the hard pad 31 in a matched manner.
Next, the drive rod 15 is disconnected from the hard spacer 31, and then the drive rod 15 is retracted.
Next, the sheath 11, proximal collet 13, and components thereof are withdrawn, the rigid spacer 31, needle 33, and suture 35 are left on the leaflet, the rigid spacer 31 is on the ventricular side, and the suture 35 extends from the needle 33 all the way outside the body, see fig. 7, thus completing implantation of the valve repair implant 30 on one leaflet.
The above steps are repeated, and the valve repair implant 30 is also implanted on the other leaflets.
Finally, referring to FIG. 8, a locking element 200 (e.g., titanium pin) is used to hold all sutures 35 together and cut off the excess sutures 35, so that the edges of two adjacent leaflets can be brought together to complete the edge-to-edge repair of the heart valve.
As shown in fig. 9, the valve repair implant 30 may also be applied to chordae tendineae repair, substantially as described above, except that the insertion path is transapical, the stiff pad 31 is positioned on the atrial side after implantation, and the sutures 35 extend as artificial chordae tendineae within the ventricle and are secured to the papillary muscles or to the ventricular wall.
The above is merely an example of repairing a tricuspid valve, and it is understood that the valve repair implant 30 of the present application may also be applied to performing a limbic repair or chordae tendineae repair on the mitral valve, as long as an appropriate interventional path is selected, such as performing a mitral limbic repair via the femoral vein-inferior vena cava-right atrium-atrial septum-left atrium path, and performing a mitral chordae tendineae repair via the apex path.
According to the valve implant 30 disclosed by the application, the adopted hard gasket 31 cannot deform under the traction of the suture 35 like the traditional soft gasket, namely, the phenomena of middle collapse and two-end warping under the traction of the suture like the soft gasket are avoided, when blood impacts the valve leaflet, the hard gasket 31 can reliably support the valve leaflet, the proximal end face of the hard gasket 31 is adhered to the valve leaflet so as to always keep surface contact, and a larger contact area is continuously provided between the hard gasket 31 and the valve leaflet, so that the stress of the suture 35 to the valve leaflet is fully dispersed, the suture 35 is prevented from tearing the valve leaflet, and the safety and reliability of valve repair are improved.
In addition, the valve implant 30 is applied to the heart valve repair device 100, the hard pad 31 replaces the distal chuck in the prior art, the hard pad 31 can be matched with the proximal chuck 13 to clamp the valve leaflet, and can be used as a part of the valve implant by connecting the puncture needle 33 and the suture 35 after the puncture needle 33 punctures the valve, after the hard pad 31 and the driving rod 15 are released, the hard pad 31 does not need to be withdrawn from the body, the risk of hooking the valve leaflet tissue is avoided, other components such as the sheath tube 11, the proximal chuck 13 and the driving rod 15 can be smoothly withdrawn from the body, and the distal chuck and the embedded pad and suture in the distal chuck do not need to be additionally arranged like the prior art, so that the structure of the whole heart valve repair device is simplified.
In yet another aspect, the suture 35 is secured to the proximal end of the needle 33, and the needle 33 is directly coupled to the rigid spacer 31, which significantly shortens the length and volume of the distal end of the entire heart valve repair device 100, and the distal end of the heart valve repair device 100 can be more easily deflected and flexed within the heart without touching the chamber wall, particularly for valve repair in patients with atrial stenosis.
Second embodiment
Referring to fig. 10 to 12, the valve repair implant according to the second embodiment of the present application has substantially the same structure as the valve repair implant according to the first embodiment, except that the needle hole 313 is a light hole, the connection portion 3313 includes at least one elastic barb (only one is shown in fig. 10 to 12 by way of example), one end of the elastic barb is connected to the piercing section 331 in a natural state, the other end of the elastic barb extends toward the proximal end while facing away from the axis of the needle tip 3311, and the other end of the elastic barb abuts against the distal end surface of the hard pad 31 after passing through the needle hole 313 along with the piercing section 331. The natural state refers to a state in which the elastic barbs are 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 barb pierce through the needle hole 313 on the hard pad 31, and the elastic barb firstly follows the needle hole 313 to approach the puncture needle 33, so that the resistance when the puncture needle 33 penetrates through the hard pad 31 is reduced, and the smoothness of the puncture needle 33 penetrating through the hard pad 31 is improved. After passing through the pinhole 313, the elastic barb returns to the original natural state due to its own elasticity, and the elastic barb is blocked by the solid part at the periphery of the pinhole 313 on the hard pad 31 and cannot be retracted, so as to prevent the puncture needle 33 from moving relative to the hard pad 31, i.e. establish the connection relationship between the puncture needle 33 and the hard pad 31.
The proximal end of the needle bar 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 has a U-shape, and both free ends of the suture 35 may extend outside the human body. It will be readily appreciated that the valve repair implant 30 of the present embodiment is applied to chordae tendineae repair with a double strand suture as an artificial chordae tendineae.
The puncture needle 33 further comprises at least one elastic sheet 335 disposed on the needle bar section 333, wherein one end of the elastic sheet 335 is fixedly connected with the needle bar section 333, and the other end of the elastic sheet 335 extends outwards and simultaneously distally relative to the needle bar section 333, so as to limit the hard spacer 31 between the elastic barb of the connecting portion 3313 and the elastic sheet 335.
Third embodiment
Referring to fig. 13 and 14, the valve repair implant according to the third embodiment of the present application has a structure substantially the same as that of the valve repair implant according to the first embodiment, and is different in that the needle hole 313 is a blind hole, a retaining step 318 is disposed between a proximal end of the needle hole 313 and a distal end of the needle hole 313, the connecting portion 3313 includes at least one elastic back-off, one end of the elastic back-off is connected to the piercing section 331 in a natural state, the other end of the elastic back-off extends towards the proximal end while facing the outside of the piercing section 331, the elastic back-off is retained on the retaining step 318 when the piercing section 331 penetrates the needle hole 313, and a radial dimension of the retaining step 318 is larger than a radial dimension of the needle hole 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 pinhole 313, the elastic back-off buckle is blocked on the blocking step 318 due to the fact that the elastic back-off buckle needs to be restored to the original shape, and the elastic back-off buckle can be blocked by the blocking 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, which needle tip 3311 is received within the distal end of the needle opening 313. The needle aperture 313 may also provide cushioning and protection for the needle. 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 puncture needles 33 is two, and the proximal end of the needle shaft section 333 of each puncture needle 33 can correspondingly abut (only contact, not connect) the individual puncture push tubes 16, and the corresponding suture 35 is movably inserted into the respective puncture push tube 16.
Fourth embodiment
Referring to fig. 15, in the fourth embodiment of the present application, the surface of the hard pad 31 is further covered with a tissue climbing film 319, i.e. the proximal surface of the hard pad 31, the distal surface of the hard pad 31, and the peripheral wall connected between the proximal surface of the hard pad 31 and the hard pad 31 are covered with the tissue climbing film 319, so as to promote tissue climbing after the hard pad 31 is implanted into the heart, and make the hard pad 31 and the valve leaflet combine more quickly. The tissue climbing film 319 also protects against scratching of tissue by the edges of the hard pad. 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.
The hard spacer 31 is provided with a pinhole 313, and the pinhole 313 is a threaded hole. In this embodiment, the number of pinholes 313 is two corresponding to the number of two puncture needles (not shown) to form an implantation shape of two sutures to pull the hard pad, so that the acting force of the hard pad on the valve leaflet is more balanced.
Fifth embodiment
Referring to fig. 16 to 18, in the fifth embodiment of the present application, the pinhole 313 is a light hole, the connecting portion 3313 includes at least one elastic barb (only one is shown in fig. 17 by way of example), one end of the elastic barb is connected to the piercing section 331 in a natural state, the other end of the elastic barb extends toward the proximal end and away from the axis of the needle point 3311, and the other end of the elastic barb abuts against the distal end surface of the hard pad 31 after passing through the pinhole 313 along with the piercing section 331. The natural state refers to a state in which the elastic barbs are 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 barb pierce through the needle hole 313 on the hard pad 31, and the elastic barb firstly follows the needle hole 313 to approach the puncture needle 33, so that the resistance when the puncture needle 33 penetrates through the hard pad 31 is reduced, and the smoothness of the puncture needle 33 penetrating through the hard pad 31 is improved. After passing through the pinhole 313, the elastic barb returns to the original natural state due to its own elasticity, and the elastic barb is blocked by the solid part at the periphery of the pinhole 313 on the hard pad 31 and cannot be retracted, so as to prevent the puncture needle 33 from moving relative to the hard pad 31, i.e. establish the connection relationship between the puncture needle 33 and the hard pad 31.
The needle bar section 333 comprises a first supporting portion 3330, a second supporting portion 3332 and two needle body portions 3335, wherein the second supporting portion 3332 is fixed at the distal end of the first supporting portion 3330, the proximal ends of the two needle body portions 3335 are fixedly connected with the second supporting portion 3332, the proximal end of the first supporting portion 3330 is used for being connected with a suture 35, each needle body portion 3335 is provided with a puncture section 331, the distal end of the puncture section 331 is provided with a needle tip 3311, and therefore, after the puncture needle 33 punctures a valve leaflet from the proximal end to the distal end, two puncture points can be formed on the valve leaflet. The first support portion 3330 and the second support portion 3332 are connected to each other in a substantially T-shaped structure. The distance between the second support 3332 and the proximal ends of the resilient barbs is greater than the thickness of the rigid spacer 31. In this embodiment, the thickness of the hard spacer 31 is approximately 1mm, and the distance between the second support portion 3332 and the proximal end of the elastic barb is 2.4mm, so as to reserve a certain space for the leaflet, and prevent the barb from passing through the hard spacer 31. It will be appreciated that the thickness of the hard pad 31 is not limited, and the number of needle portions 3335 may be three or more.
The hard pad 31 further includes a peripheral wall 310 connected between the proximal surface of the hard pad 31 and the distal surface of the hard pad 31, and the peripheral wall 310 is recessed with a groove 320 penetrating the proximal surface of the hard pad 31 and the distal surface of the hard pad 31. In the present embodiment, the number of the grooves 319 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.