Heart valve leaflet adapter

Abstract

The present disclosure provides a coaptation assist device (20, 120A, 120B, 120C, 320A, 320B, 420, 720) for treating a native atrioventricular valve, comprising an annular ventricular anchor (30, 130, 330, 430, 730), the annular ventricular anchor comprising an anchor wire ring (50, 150, 350, 450, 750), the anchor wire ring defining at least a portion of a boundary of the annular ventricular anchor and being configured to be positioned in a ventricle, extending between a ventricular apical region and a subannulus of a target native valve leaflet, and to remain anchored in position against surrounding anatomical structures, the surrounding anatomical structures comprising the subannulus, a ventricular wall, and the ventricular apical region. A new leaflet (32, 132A, 132B, 132C, 332A, 332B, 332A, 332B, 432, 732) is supported by the annular ventricular anchor and is configured to provide an engaging surface (34, 434, 734) with one or more opposing native leaflets opposing the target native leaflet to at least partially replace the function of the target native leaflet. Other embodiments are also described in the present disclosure.

Description

[0001] Cross-reference to related applications

[0002] This patent application claims priority to U.S. Provisional Application No. 62 / 792,092, filed on January 14, 2019, which has been assigned to the assignee of the present application and is incorporated herein by reference. Technical Field

[0003] The present invention relates generally to medical devices and methods. More particularly, the present invention relates to prosthetic devices and methods for improving the function of heart valves and other circulatory leaflet valve regurgitation. Background Art

[0004] Valvular regurgitation (VR) is a condition in which the heart's natural valves fail to close properly, causing blood to flow back into the atria when the ventricles contract, reducing their efficiency. Today, severe regurgitation affects more than 5 million patients in the United States and is estimated to affect 8% of the world's population. Summary of the invention

[0005] Embodiments of the present invention provide a coaptation assist device for treating a native valve of a subject. Typically, the native valve suffers from a valvular disease, such as functional mitral regurgitation or tricuspid regurgitation, which is typically characterized by a lack of mobility of the leaflets in the valve. The native valve is typically an atrioventricular valve, i.e., the tricuspid valve or the mitral valve.

[0006] Each coaptation assist device includes a loop-shaped ventricular anchor configured to be positioned in a ventricle, extending between a ventricular apical area of ​​a target native leaflet of a native atrioventricular valve, and maintained in position anchored against surrounding anatomical structures, including a ventricular wall and the ventricular apical area. In some applications, each loop-shaped ventricular anchor includes an anchor-loop wire loop defining at least a portion of a boundary of the loop-shaped ventricular anchor, and optionally, an anchor-loop cover connected to the anchor-loop wire loop.

[0007] Each coaptation assist device further includes a neo-leaflet supported by the annular ventricular anchor and configured to at least partially replace the function of the target native leaflet by providing a coaptation surface for one or more opposing native leaflets opposite the target native leaflet when the annular ventricular anchor is located in the ventricle.

[0008] Therefore, according to an inventive concept 1 of the present invention, there is provided a coaptation assist device for treating a native atrioventricular valve of a subject, the coaptation assist device comprising:

[0009] an annular ventricular anchor comprising an anchor wire loop that (i) defines at least a portion of a boundary of the annular ventricular anchor and (ii) is configured to (a) be positioned in a ventricle, extending between a ventricular apical region and a subannular surface of a target native leaflet of the native atrioventricular valve, and (b) remain anchored in position against surrounding anatomy, including the subannular surface, a ventricular wall, and the ventricular apical region; and

[0010] A new leaflet is supported by the annular ventricular anchor and is configured to at least partially replace the function of the target native leaflet by providing an engaging surface for one or more opposing native leaflets opposite the target native leaflet when the anchor loop is located in the ventricle.

[0011] Inventive Concept 2. The coaptation assist device according to Inventive Concept 1, wherein the annular ventricular anchor is configured to maintain the anchor in place by applying force to the surrounding anatomical structure via the anchor wire loop.

[0012] Inventive Concept 3. The coaptation assist device according to Inventive Concept 2, wherein the annular ventricular anchor is configured to apply a radially outwardly directed force to the surrounding anatomical structure via the anchor wire loop to maintain the anchor in place.

[0013] Inventive Concept 4. The coaptation assist device according to Inventive Concept 1, wherein the annular ventricular anchor is configured to remain anchored in place by friction between the anchor wire loop and the surrounding anatomical structure.

[0014] Inventive Concept 5. The coaptation assist device according to Inventive Concept 1, wherein the annular ventricular anchor is configured to be atraumatic so as not to penetrate tissue of the surrounding anatomical structure.

[0015] Inventive Concept 6. The anastomosis assist device according to Inventive Concept 1, wherein the anastomosis assist device does not include any components configured to penetrate tissue.

[0016] Inventive Concept 7. The coaptation assist device according to Inventive Concept 1, wherein the anchor wire loop is formed into a closed loop that defines a complete boundary of the annular ventricular anchor.

[0017] Inventive Concept 8. The engagement assist device according to Inventive Concept 1, wherein the anchor wire loop comprises metal.

[0018] Inventive Concept 9. The engagement assist device of Inventive Concept 1, wherein when the anchor loop is unconstrained, the anchor loop is bent along at least 50% of a length of the anchor loop, the length being detected around the anchor loop.

[0019] Inventive Concept 10. The engagement assist device of Inventive Concept 9, wherein the anchor loop wire loop is bent along at least 75% of the length of the anchor loop wire loop when the anchor loop wire loop is unconstrained.

[0020] Inventive Concept 11. The engagement assist device of Inventive Concept 1, wherein the anchor loop wire loop is shaped into at least 75% of an oval when the anchor loop wire loop is unconstrained.

[0021] Inventive Concept 12. The coaptation assist device according to Inventive Concept 1, wherein the annular ventricular anchor further comprises at least one support wire connected to the anchor wire loop at two locations on the anchor wire loop.

[0022] Inventive Concept 13. The coaptation assist device according to Inventive Concept 1, wherein when the anchor loop is positioned in the ventricle, the anchor loop is configured to remain anchored against the subannulus, the ventricular wall, and one or more ventricular papillary muscles of the ventricular apical region.

[0023] Inventive Concept 14. The coaptation assist device according to Inventive Concept 1, wherein the anchor wire loop is shaped to define two or more lobes.

[0024] Inventive Concept 15. The coaptation assist device according to Inventive Concept 14, wherein the anchor wire loop is shaped to exactly define two lobes.

[0025] Inventive Concept 16. The coaptation assist device of Inventive Concept 1, wherein the neo-leaflet is configured such that, after implantation of the coaptation assist device in a heart of the subject, the coaptation surface is generally static throughout a cardiac cycle of the subject.

[0026] Inventive Concept 17. The coaptation assist device according to Inventive Concept 1, wherein the neo-valve leaflet is configured such that, after implantation of the coaptation assist device in a heart of the subject, the coaptation surface moves toward and away from the one or more opposing native leaflets during a cardiac cycle of the subject.

[0027] Inventive Concept 18. The coaptation assist device of Inventive Concept 1, wherein the neo-leaflet extends directly from the annular ventricular anchor.

[0028] Inventive concept 19. The joining auxiliary device according to Inventive concept 1, wherein the joining surface has a width between 2 cm 2 With 20cm 2 An area between.

[0029] Inventive Concept 20. The coaptation assist device of Inventive Concept 1, wherein when the anchor loop is unconstrained, the anchor loop includes a distal-most portion that curves away from a best fit plane defined by a plurality of lateral portions of the anchor loop.

[0030] Inventive Concept 21. The coaptation assist device of Inventive Concept 1, wherein the anchor wire loop includes a distal-most portion configured to bend away from the ventricular wall when the anchor wire loop is positioned in the ventricle.

[0031] Inventive concept 22. The coaptation assist device according to any one of Inventive concepts 1 to 21, wherein the coaptation assist device further comprises a native leaflet grasping forceps, the native leaflet grasping forceps being configured to grasp the atrial surface and the ventricular surface of the target native leaflet to support the new leaflet and orient the new leaflet relative to the native atrioventricular valve.

[0032] Inventive Concept 23. The coaptation assist device according to Inventive Concept 22, wherein the neo-valve leaflet is connected to the annular ventricular anchor via the native leaflet grasping forceps.

[0033] Inventive Concept 24. The coaptation assist device of Inventive Concept 23, wherein the coaptation assist device comprises a wire loop shaped to at least partially define the neo-leaflet and the native-leaflet grasping forceps.

[0034] Inventive concept 25. A coaptation assist device according to inventive concept 22, wherein the native leaflet grasping forceps is shaped to define a first portion and a second portion, and the first portion and the second portion are configured to grasp the atrial surface and the ventricular surface of the target native leaflet by clamping at least a portion of the atrial surface and the ventricular surface of the target native leaflet between the first portion and the second portion of the native leaflet grasping forceps.

[0035] Inventive concept 26. According to the coaptation assist device of inventive concept 25, the first portion and the second portion are configured to be folded toward each other so that the atrial surface and the ventricular surface of the target native leaflet are grasped by clamping at least a portion of the atrial surface and the ventricular surface of the target native leaflet between the first portion and the second portion of the native leaflet grasping forceps.

[0036] Inventive concept 27. A coaptation assist device according to inventive concept 26, wherein the natural leaflet grasping forceps is formed to further define a third portion at a fold between the first portion and the second portion of the natural leaflet grasping forceps, and wherein when the first portion and the second portion of the natural leaflet grasping forceps clamp the at least a portion of the atrial surface and the ventricular surface of the target natural leaflet, the third portion of the natural leaflet grasping forceps is configured to extend around the free edge of the target natural leaflet.

[0037] Inventive concept 28. According to the engagement assisting device of inventive concept 25, the engagement assisting device is configured such that:

[0038] The first portion of the native leaflet grasping forceps is pivotally connected to the annular ventricular anchor,

[0039] The first portion of the native leaflet grasping forceps is pivotally connected to the second portion of the native leaflet grasping forceps, and

[0040] The second portion of the native leaflet grasping forceps is pivotally connected to the neo leaflet.

[0041] Inventive Concept 29. A coaptation assist device according to Inventive Concept 22, wherein the native leaflet grasping forceps includes one or more sub-native-leaflet supports, and when the anchor wire ring is positioned in the ventricle, the one or more sub-native leaflet supports are configured to abut one or more portions of the ventricular surface of the target native leaflet.

[0042] Inventive concept 30. A coaptation assist device according to inventive concept 29, wherein the native leaflet grasping forceps further comprises one or more supra-annular supports, and when the anchor wire loop is positioned in the ventricle, the one or more supra-annular supports are configured to abut against an atrial surface of the target native leaflet, so that the one or more sub-native leaflet supports and the one or more supra-annular supports clamp and grasp the target native leaflet.

[0043] Inventive Concept 31. The coaptation assist device according to Inventive Concept 22, wherein the native leaflet grasping forceps comprises one or more supra-annular supports configured to abut against an atrial surface of the target native leaflet when the anchor wire loop is positioned in the ventricle.

[0044] Inventive Concept 32. The coaptation assist device according to any one of Inventive Concepts 1 to 21, wherein the ventricular wall is a ventricular septal wall, and wherein the anchor wire loop is configured to remain anchored in position against the surrounding anatomical structure, the surrounding anatomical structure comprising the subannulus, the ventricular septal wall, and the ventricular apical region.

[0045] Inventive concept 33. A coaptation assist device according to any one of Inventive concepts 1 to 21, wherein the native atrioventricular valve is a tricuspid valve, and wherein when the anchor wire ring is positioned in the ventricle, the new leaflet is configured to at least partially replace the function of the target native leaflet by providing a coaptation surface for the one or more opposing native leaflets of the tricuspid valve.

[0046] Inventive concept 34. A coaptation assist device according to inventive concept 33, wherein the target native leaflet is a native septal leaflet of the tricuspid valve, wherein the ventricular wall is a ventricular septal wall, and wherein when the anchor wire ring is positioned in the ventricle and remains anchored against the surrounding anatomical structures, the surrounding anatomical structures including the subannulus, the ventricular septal wall, and the ventricular apical region, the new leaflet is configured to at least partially replace the function of the septal leaflet by providing a coaptation surface for one or more of the opposing native posterior leaflets and native anterior leaflets of the tricuspid valve.

[0047] Inventive concept 35. A coaptation assist device according to any one of Inventive concepts 1 to 21, wherein the native atrioventricular valve is a mitral valve, and wherein when the anchor wire ring is positioned in the ventricle, the new leaflet is configured to at least partially replace the function of the target native leaflet by providing a coaptation surface for the opposing native leaflet of the mitral valve.

[0048] Inventive concept 36. A coaptation assist device according to inventive concept 35, wherein the target native leaflet is a native anterior leaflet of the mitral valve, wherein the ventricular wall is a ventricular septum, and wherein when the anchor wire ring is positioned in the ventricle and held against a position anchored to the surrounding anatomical structure, the surrounding anatomical structure including the subannulus, the ventricular septum, and the ventricular apical region, the new leaflet is configured to at least partially replace the function of the native anterior leaflet by providing a coaptation surface for an opposing native posterior leaflet of the mitral valve.

[0049] Inventive Concept 37. The coaptation assist device according to any one of Inventive Concepts 1 to 21, wherein the coaptation assist device is configured such that when the anchor wire ring is positioned in the ventricle, the coaptation surface of the new leaflet spans from an atrial side to a ventricular side of a native valve plane.

[0050] Inventive Concept 38. The coaptation assist device according to any one of Inventive Concepts 1 to 21, wherein the annular ventricular anchor further comprises an anchor ring cover connected to the anchor ring wire ring.

[0051] Inventive Concept 39. The engagement assist device of Inventive Concept 38, wherein the anchor loop cover comprises one or more sheets of sheet material extending across a space at least partially surrounded by the anchor loop wire loop.

[0052] Inventive Concept 40. The engagement assist device according to Inventive Concept 38, wherein the anchor ring cover comprises a plurality of braided wires.

[0053] Inventive Concept 41. The engagement assist device of Inventive Concept 38, wherein the anchor ring cover comprises a coating on the anchor ring wire loop.

[0054] Inventive Concept 42. The coaptation-assist-device according to any one of Inventive Concepts 1 to 21, wherein the coaptation-assist-device comprises a coaptation-assist-device wire loop shaped to at least partially define the neo-leaflet and the anchor ring wire loop.

[0055] Inventive concept 43. A coaptation assist device according to inventive concept 42, wherein the coaptation assist device wire loop is shaped to further at least partially define a native leaflet grasping forceps, the native leaflet grasping forceps being configured to grasp the atrial surface and the ventricular surface of the target native leaflet to support the new leaflet and orient the new leaflet relative to the native atrioventricular valve.

[0056] Inventive Concept 44. The coaptation assist device of Inventive Concept 43, wherein the coaptation assist device wire loop is shaped to at least partially define the native leaflet grasping forceps along the coaptation assist device wire loop between the neo leaflet and the annular ventricular anchor.

[0057] Inventive concept 45. A coaptation assist device according to any one of Inventive concepts 1 to 21, wherein the neo-leaflet comprises a neo-leaflet wire loop that defines at least a portion of a boundary of the neo-leaflet, and a neo-leaflet cover that is connected to the neo-leaflet wire loop and provides the coaptation surface.

[0058] Inventive concept 46. The coaptation assist device according to inventive concept 45, wherein the coaptation assist device is configured so that when unconstrained, an angle is defined between (a) an anchor ring best fit plane defined by the anchor ring wire ring and (b) a new leaflet best fit plane defined by the new leaflet wire ring, the angle being between 60 degrees and 100 degrees.

[0059] Inventive Concept 47. The engagement assist device according to Inventive Concept 46, wherein the angle is between 80 degrees and 90 degrees.

[0060] Inventive concept 48. The coaptation assist device according to inventive concept 45, wherein the coaptation assist device is configured so that when unconstrained, an angle is defined between (a) an anchor ring best fit plane defined by the anchor ring wire ring and (b) a new leaflet best fit plane defined by the new leaflet wire ring, the angle being between 15 degrees and 50 degrees.

[0061] Inventive Concept 49. The engagement assist device according to Inventive Concept 48, wherein the angle is between 35 degrees and 45 degrees.

[0062] Inventive concept 50. The joining assisting device according to any one of Inventive concepts 1 to 21, wherein

[0063] Inventive concept 50. A coaptation assist device according to inventive concept 1, wherein the coaptation assist device further comprises a pouch, the pouch being configured to be expanded by blood flow during a cardiac cycle of a heart of the subject so as to push the coaptation assist device toward one or more of: a ventricular surface of the target native leaflet and an annulus of the native atrioventricular valve, thereby stabilizing the coaptation assist device relative to the native atrioventricular valve.

[0064] Inventive concept 51. A coaptation assist device according to inventive concept 50, wherein the coaptation assist device further comprises a native leaflet grasping forceps, the native leaflet grasping forceps being configured to grasp the atrial surface and the ventricular surface of the target native leaflet to support the new leaflet and to orient the new leaflet relative to the native atrioventricular valve, and wherein the pocket is defined by the native leaflet grasping forceps.

[0065] Inventive concept 52. A coaptation assist device according to inventive concept 51, wherein the natural leaflet grasping forceps is formed to define the first portion and the second portion, the first portion and the second portion being configured to grasp the atrial surface and the ventricular surface of the target natural leaflet by clamping at least a portion of the atrial surface and the ventricular surface of the target natural leaflet between the first portion and the second portion of the natural leaflet grasping forceps, and wherein the pocket is defined by a surface of the second portion of the natural leaflet grasping forceps that faces the ventricle.

[0066] Inventive Concept 53. A coaptation assist device according to any one of Inventive Concepts 1 to 21, wherein the coaptation assist device further comprises a native leaflet spanning portion, the native leaflet spanning portion being configured to be positioned to pass through a puncture through the target native leaflet, and wherein the new leaflet is connected to the annular ventricular anchor via the native leaflet spanning portion.

[0067] Inventive Concept 54. The coaptation assist device of Inventive Concept 53, wherein the coaptation assist device comprises a coaptation assist device wire loop shaped to at least partially define the neo-leaflet, the annular ventricular anchor, and the native leaflet spanning portion.

[0068] Inventive Concept 55. A system of an anastomosis assist device according to any one of Inventive Concepts 1 to 21, wherein the system further comprises a delivery tube, wherein the anastomosis assist device is removably configured in a compressed configuration for minimally invasive or percutaneous delivery to a heart of the subject.

[0069] According to an inventive concept 56 of the present invention, there is further provided a coaptation assist device for treating a natural atrioventricular valve of a subject, characterized in that the coaptation assist device comprises:

[0070] an annular ventricular anchor comprising an anchor wire loop that (i) defines at least a portion of a boundary of the annular ventricular anchor and (ii) is configured to (a) be positioned in a ventricle, extend to a ventricular apical region, and (b) remain anchored in position against surrounding anatomical structures, including the ventricular apical region; and

[0071] A neo-leaflet extends directly from and is supported by the annular ventricular anchor and is configured to at least partially replace the function of a target native leaflet of the native atrioventricular valve by providing an engaging surface for one or more opposing native leaflets that are opposite the target native leaflet when the anchor wire loop is located in the ventricle.

[0072] Inventive Concept 57. The coaptation assist device of Inventive Concept 56, wherein the annular ventricular anchor is configured to maintain the anchor in place by applying force to the surrounding anatomical structure via the anchor wire loop.

[0073] Inventive Concept 58. The coaptation assist device of Inventive Concept 57, wherein the annular ventricular anchor is configured to apply a radially outwardly directed force to the surrounding anatomical structure via the anchor wire loop to maintain the anchor in place.

[0074] Inventive Concept 59. The coaptation assist device of Inventive Concept 56, wherein the annular ventricular anchor is configured to remain anchored in place by friction between the anchor wire loop and the surrounding anatomical structure.

[0075] Inventive Concept 60. The coaptation assist device of Inventive Concept 56, wherein the coaptation assist device is configured such that when the anchor wire loop is positioned in the ventricle, the anchor wire loop does not extend to a sub-annulus of the target native leaflet.

[0076] Inventive Concept 61. The coaptation assist device of Inventive Concept 56, wherein the annular ventricular anchor is configured to be atraumatic so as not to penetrate tissue of the surrounding anatomical structure.

[0077] Inventive Concept 62. The anastomosis assist device according to Inventive Concept 56, wherein the anastomosis assist device does not include any components configured to penetrate tissue.

[0078] Inventive Concept 63. The engagement assist device according to Inventive Concept 56, wherein the anchor loop wire loop comprises metal.

[0079] Inventive Concept 64. The engagement assist device of Inventive Concept 56, wherein when the anchor loop wire loop is unconstrained, the anchor loop wire loop is bent along at least 50% of a length of the anchor loop wire loop, the length being detected around the anchor loop wire loop.

[0080] Inventive Concept 65. The engagement assist device of Inventive Concept 64, wherein the anchor loop wire loop is curved along at least 75% of the length of the anchor loop wire loop when the anchor loop wire loop is unconstrained.

[0081] Inventive Concept 66. The engagement assist device of Inventive Concept 56, wherein the anchor loop wire loop is shaped to be at least 75% of an oval when the anchor loop wire loop is unconstrained.

[0082] Inventive Concept 67. The coaptation assist device of Inventive Concept 56, wherein the annular ventricular anchor further comprises at least one support wire connected to the anchor wire loop at two locations on the anchor wire loop.

[0083] Inventive Concept 68. The coaptation assist device of Inventive Concept 56, wherein when the anchor loop wire loop is positioned in the ventricle, the anchor loop wire loop is configured to remain anchored in position against one or more ventricular papillary muscles at an apical region of the ventricle.

[0084] Inventive Concept 69. The coaptation assist device of Inventive Concept 56, wherein the anchor wire loop is shaped to define two or more lobes.

[0085] Inventive Concept 70. The coaptation assist device according to Inventive Concept 69, wherein the anchor wire loop is shaped to define exactly two lobes.

[0086] Inventive Concept 71. The coaptation assist device of Inventive Concept 56, wherein the neo-leaflet is configured such that, after implantation of the coaptation assist device in a heart of the subject, the coaptation surface is generally static throughout a cardiac cycle of the subject.

[0087] Inventive concept 72. The joining assisting device according to inventive concept 56, wherein the joining surface has a width between 2 cm 2 With 20cm 2 An area between.

[0088] Inventive concept 73. The coaptation assist device according to inventive concept 56, wherein the neo-leaflet is configured such that, after implantation of the coaptation assist device in a heart of the subject, the coaptation surface moves toward and away from the one or more opposing native leaflets during a cardiac cycle of the subject.

[0089] Inventive concept 74. A coaptation assist device according to any one of inventive concepts 56 to 73, wherein the coaptation assist device further comprises a native leaflet grasping forceps, the native leaflet grasping forceps being configured to grasp the atrial surface and the ventricular surface of the target native leaflet to support the new leaflet and orient the new leaflet relative to the native atrioventricular valve.

[0090] Inventive Concept 75. The coaptation assist device according to Inventive Concept 74, wherein the native leaflet grasping forceps is connected to the annular ventricular anchor via the neo leaflet.

[0091] Inventive concept 76. A coaptation assist device according to inventive concept 74, wherein the native leaflet grasping forceps includes one or more sub-native leaflet supports, and when the anchor wire ring is positioned in the ventricle, the one or more sub-native leaflet supports are configured to abut one or more portions of the ventricular surface of the target native leaflet.

[0092] Inventive concept 77. A coaptation assist device according to inventive concept 76, wherein the native leaflet grasping forceps further comprises one or more supra-annular support portions, and when the anchor wire loop is positioned in the ventricle, the one or more supra-annular support portions are configured to abut against an atrial surface of the target native leaflet, so that the one or more sub-native leaflet support portions and the one or more supra-annular support portions clamp and grasp the target native leaflet.

[0093] Inventive concept 78. A coaptation assist device according to inventive concept 74, wherein the coaptation assist device is configured so that when the anchor wire loop is positioned in the ventricle and the native leaflet grasping forceps grasp the surface atrial and ventricular surfaces of the target native leaflet, the anchor wire loop does not extend to a sub-annulus of the target native leaflet.

[0094] Inventive concept 79. A coaptation assist device according to any one of inventive concepts 56 to 73, wherein the native atrioventricular valve is a tricuspid valve, and wherein when the anchor wire ring is positioned in the ventricle, the new leaflet is configured to at least partially replace the function of the target native leaflet by providing a coaptation surface for the one or more opposing native leaflets of the tricuspid valve.

[0095] Inventive concept 80. A coaptation assist device according to inventive concept 79, wherein the target native leaflet is a native septal leaflet of the tricuspid valve, and wherein when the anchor wire ring is positioned in the ventricle and remains anchored against the surrounding anatomical structure, the surrounding anatomical structure including the ventricular apical region, the new leaflet is configured to at least partially replace the function of the septal leaflet by providing a coaptation surface for one or more of the opposing native posterior leaflets and native anterior leaflets of the tricuspid valve.

[0096] Inventive concept 81. A coaptation assist device according to any one of inventive concepts 56 to 73, wherein the native atrioventricular valve is a mitral valve, and wherein when the anchor wire ring is positioned in the ventricle, the new leaflet is configured to at least partially replace the function of the target native leaflet by providing a coaptation surface for the opposing native leaflet of the mitral valve.

[0097] Inventive concept 82. A coaptation assist device according to inventive concept 81, wherein the target native leaflet is a native anterior leaflet of the mitral valve, and wherein when the anchor wire ring is positioned in the ventricle and remains anchored against the surrounding anatomical structure, the surrounding anatomical structure including the ventricular apical region, the new leaflet is configured to at least partially replace the function of the native anterior leaflet by providing a coaptation surface for an opposing native posterior leaflet of the mitral valve.

[0098] Inventive Concept 83. The coaptation assist device according to any one of Inventive Concepts 56 to 73, wherein the coaptation assist device is configured such that when the anchor wire ring is positioned in the ventricle, the coaptation surface of the new leaflet spans from an atrial side to a ventricular side of a native valve plane.

[0099] Inventive Concept 84. The coaptation assist device according to any one of Inventive Concepts 56 to 73, wherein the annular ventricular anchor further comprises an anchor ring cover connected to the anchor ring wire ring.

[0100] Inventive concept 85. The engagement assist device of inventive concept 84, wherein the anchor loop cover comprises one or more sheets of sheet material extending across a space at least partially surrounded by the anchor loop wire loop.

[0101] Inventive Concept 86. The engagement assist device of Inventive Concept 84, wherein the anchor ring cover comprises a plurality of braided wires.

[0102] Inventive Concept 87. The engagement assist device of Inventive Concept 1, wherein the anchor ring cover comprises a coating on the anchor ring wire loop.

[0103] Inventive Concept 88. The coaptation assist device of any one of Inventive Concepts 56 to 73, wherein the coaptation assist device comprises a neo-leaflet wire ring shaped to at least partially define the neo-leaflet and the annular ventricular anchor.

[0104] Inventive concept 89. A coaptation assisting device according to any one of inventive concepts 56 to 73, wherein the new leaflet comprises a new leaflet wire ring, the new leaflet wire ring defining at least a portion of a boundary of the new leaflet, and a new leaflet cover, the new leaflet cover being connected to the new leaflet wire ring and providing the coaptation surface.

[0105] Inventive Concept 90. A system of an anastomosis assist device according to any one of Inventive Concepts 56 to 73, wherein the system further comprises a delivery tube, wherein the anastomosis assist device is removably configured in a compressed configuration for minimally invasive or percutaneous delivery to a heart of the subject.

[0106] According to an inventive concept 91 of the present invention, there is further provided a coaptation assist device for treating a native atrioventricular valve of a subject, wherein the coaptation assist device comprises:

[0107] An annular ventricular anchor (i) comprising a braided sheet including a plurality of braided strands and (ii) configured to (a) be positioned in a ventricle extending between a ventricular apex region and a subannulus of a target native leaflet of the native atrioventricular valve, and (b) maintain the anchor in place by applying forces to the surrounding anatomical structures, including the subannulus, the ventricular wall, and the ventricular apex region, through the annular ventricular anchor; and

[0108] A new leaflet is supported by the annular ventricular anchor and is configured to at least partially replace the function of the target native leaflet by providing an engaging surface for one or more opposing native leaflets opposite the target native leaflet when the annular ventricular anchor is located in the ventricle.

[0109] Inventive Concept 92. The coaptation assist device of Inventive Concept 91, wherein the annular ventricular anchor is configured to remain anchored in place by a radially outwardly directed force applied by the annular ventricular anchor to the surrounding anatomical structure.

[0110] Inventive Concept 93. The coaptation assist device of Inventive Concept 91, wherein the annular ventricular anchor is configured to remain anchored in place by friction between the annular ventricular anchor and the surrounding anatomical structure.

[0111] Inventive Concept 94. The coaptation assist device of Inventive Concept 91, wherein the annular ventricular anchor is configured to be atraumatic so as not to penetrate tissue of the surrounding anatomical structure.

[0112] Inventive Concept 95. The anastomosis assist device according to Inventive Concept 91, wherein the anastomosis assist device does not include any components configured to penetrate tissue.

[0113] Inventive Concept 96. The joint assist device according to Inventive Concept 91, wherein the plurality of braided wires comprises metal.

[0114] Inventive Concept 97. The coaptation assist device of Inventive Concept 91, wherein the annular ventricular anchor is shaped as at least 75% of an ellipse when the annular ventricular anchor is unconstrained.

[0115] Inventive Concept 98. The coaptation assist device of Inventive Concept 91, wherein when the annular ventricular anchor is positioned in the ventricle, the annular ventricular anchor is configured to remain anchored against the subannulus, the ventricular wall, and one or more ventricular papillary muscles of the ventricular apical region.

[0116] Inventive Concept 99. The coaptation assist device of inventive concept 91, wherein the neo-leaflet is configured such that, after implantation of the coaptation assist device in a heart of the subject, the coaptation surface is generally static throughout a cardiac cycle of the subject.

[0117] Inventive concept 100. The joining assisting device according to inventive concept 91, wherein the joining surface has a width between 2 cm 2 With 20cm 2 An area between.

[0118] Inventive concept 101. The coaptation assist device according to inventive concept 91, wherein the coaptation assist device is configured such that when unconstrained, an angle is defined between (a) an anchor ring best fit plane defined by the anchor ring wire loop and (b) a new leaflet best fit plane defined by the coaptation surface, the angle being less than 20 degrees; or the anchor ring best fit plane and the new leaflet best fit plane are parallel to each other.

[0119] Inventive concept 102. The coaptation assist device of inventive concept 91, wherein the neo-leaflet is configured such that, after implantation of the coaptation assist device in a heart of the subject, the coaptation surface moves toward and away from the one or more opposing native leaflets during a cardiac cycle of the subject.

[0120] Inventive concept 103. The coaptation assist device according to any one of inventive concepts 91 to 102, wherein the coaptation assist device further comprises a native leaflet grasping forceps, the native leaflet grasping forceps being configured to grasp the atrial surface and the ventricular surface of the target native leaflet to support the new leaflet and orient the new leaflet relative to the native atrioventricular valve.

[0121] Inventive concept 104. The coaptation assist device according to inventive concept 103, wherein the neo-valve leaflet is connected to the annular ventricular anchor via the native leaflet grasping forceps.

[0122] Inventive concept 105. A coaptation assist device according to inventive concept 103, wherein the native leaflet grasping forceps is shaped to define a first portion and a second portion, the first portion and the second portion being configured to grasp the atrial surface and the ventricular surface of the target native leaflet by clamping at least a portion of the atrial surface and the ventricular surface of the target native leaflet between the first portion and the second portion of the native leaflet grasping forceps.

[0123] Inventive concept 106. According to the coaptation assist device of inventive concept 105, the first portion and the second portion are configured to be folded toward each other so that the atrial surface and the ventricular surface of the target native leaflet are grasped by clamping at least a portion of the atrial surface and the ventricular surface of the target native leaflet between the first portion and the second portion of the native leaflet grasping forceps.

[0124] Inventive concept 107. The coaptation assist device according to any one of inventive concepts 91 to 102, wherein the ventricular wall is a ventricular septal wall, and wherein the annular ventricular anchor is configured to remain anchored in position against the surrounding anatomical structure, the surrounding anatomical structure including the subannulus, the ventricular septal wall, and the ventricular apical region.

[0125] Inventive concept 108. A coaptation assist device according to any one of inventive concepts 91 to 102, wherein the native atrioventricular valve is a tricuspid valve, and wherein when the annular ventricular anchor is positioned in the ventricle, the new leaflet is configured to at least partially replace the function of the target native leaflet by providing a coaptation surface for the one or more opposing native leaflets of the tricuspid valve.

[0126] Inventive concept 109. A coaptation assist device according to inventive concept 108, wherein the target native leaflet is a native septal leaflet of the tricuspid valve, wherein the ventricular wall is a ventricular septal wall, and wherein when the annular ventricular anchor is positioned in the ventricle and remains anchored against the surrounding anatomical structures, the surrounding anatomical structures including the subannulus, the ventricular septal wall, and the ventricular apical region, the new leaflet is configured to at least partially replace the function of the septal leaflet by providing a coaptation surface for one or more of the opposing native posterior leaflets and native anterior leaflets of the tricuspid valve.

[0127] Inventive concept 110. A coaptation assist device according to any one of inventive concepts 91 to 102, wherein the native atrioventricular valve is a mitral valve, and wherein when the annular ventricular anchor is positioned in the ventricle, the new leaflet is configured to at least partially replace the function of the target native leaflet by providing a coaptation surface for the opposing native leaflet of the mitral valve.

[0128] Inventive concept 111. A coaptation assist device according to inventive concept 110, wherein the target native leaflet is a native anterior leaflet of the mitral valve, wherein the ventricular wall is a ventricular septal wall, and wherein when the annular ventricular anchor is positioned in the ventricle and abuts against the surrounding anatomical structures, the surrounding anatomical structures including the subannulus, the ventricular septal wall, and the ventricular apical region, the new leaflet is configured to at least partially replace the function of the native anterior leaflet by providing a coaptation surface for an opposing native posterior leaflet of the mitral valve.

[0129] Inventive Concept 112. The coaptation assist device of any one of Inventive Concepts 91 to 102, wherein the coaptation assist device is configured such that when the annular ventricular anchor is positioned in the ventricle, the coaptation surface of the neo-valve leaflet spans from an atrial side to a ventricular side of a native valve plane.

[0130] Inventive concept 113. The coaptation assist device according to any one of inventive concepts 91 to 102, wherein the annular ventricular anchor further comprises an anchor ring cover, the anchor ring cover being connected to the braided flat sheet and covering all or a portion of the braided flat sheet.

[0131] Inventive concept 114. The engagement assist device of inventive concept 113, wherein the anchor ring cover comprises one or more sheet materials connected to the woven flat sheet.

[0132] Inventive Concept 115. The coaptation assist device of any one of Inventive Concepts 91 to 102, wherein the system further comprises a delivery tube, wherein the coaptation assist device is removably configured in a compressed configuration for minimally invasive or percutaneous delivery to a heart of the subject.

[0133] According to an inventive concept 116 of the present invention, there is also provided a method of treating a native atrioventricular valve of a subject, the method comprising the steps of:

[0134] positioning an annular ventricular anchor of a coaptation assist device in a ventricle such that an anchor wire loop of the annular ventricular anchor extends between a ventricular apical region and a subannulus of a target native leaflet of a native atrioventricular valve such that the anchor wire loop remains anchored in position against surrounding anatomical structures, including the subannulus, a ventricular wall, and the ventricular apical region, wherein the anchor wire loop defines at least a portion of a boundary of the annular ventricular anchor; and

[0135] A neo leaflet of the coaptation assist device is positioned so that when the anchor wire loop is located in the ventricle, the neo leaflet at least partially replaces the function of the target native leaflet by providing a surface for coaptation with one or more opposing native leaflets that oppose the target native leaflet.

[0136] Inventive concept 117. The method of inventive concept 116, wherein positioning the annular ventricular anchor comprises the step of positioning the annular ventricular anchor such that the anchor wire loop applies a force to the surrounding anatomical structure via the anchor wire loop to maintain the anchor in place.

[0137] Inventive concept 118. The method of inventive concept 117, wherein positioning the annular ventricular anchor comprises the step of positioning the annular ventricular anchor such that the anchor wire loop applies a radially outwardly directed force to the surrounding anatomical structure via the anchor wire loop to maintain the anchor in place.

[0138] Inventive concept 119. The method of inventive concept 116, wherein positioning the annular ventricular anchor comprises the step of positioning the annular ventricular anchor such that the anchor wire loop is maintained anchored in place by friction between the anchor wire loop and the surrounding anatomical structure.

[0139] Inventive concept 120. The method of inventive concept 116, wherein the annular ventricular anchor is configured to be atraumatic so as not to penetrate tissue of the surrounding anatomical structure, and wherein positioning the annular ventricular anchor does not include penetrating tissue of the surrounding anatomical structure with the annular ventricular anchor.

[0140] Inventive concept 121. The method of inventive concept 116, wherein the method does not comprise penetrating tissue using any of the plurality of components of the anastomosis assist device.

[0141] Inventive concept 122. The method according to inventive concept 116, wherein the method further comprises the step of positioning a native leaflet grasping forceps of the coaptation assist device to grasp the atrial and ventricular surfaces of the target native leaflet to support the new leaflet and orient the new leaflet relative to the native atrioventricular valve.

[0142] Inventive concept 123. The method according to inventive concept 122, wherein the neo-valve leaflet is connected to the annular ventricular anchor via the native leaflet grasping forceps.

[0143] Inventive concept 124. The method of inventive concept 123, wherein the method comprises a wire loop shaped to at least partially define the neo-leaflet and the native leaflet grasping forceps.

[0144] Inventive concept 125. The method according to inventive concept 122, wherein positioning the native leaflet grasping forceps to grasp the atrial surface and the ventricular surface of the target native leaflet comprises the step of clamping at least a portion of the atrial surface and the ventricular surface of the target native leaflet between the first portion and the second portion of the native leaflet grasping forceps.

[0145] Inventive concept 126. The method according to inventive concept 125, wherein sandwiching at least a portion of the atrial surface and the ventricular surface of the target native leaflet comprises the step of folding the first portion and the second portion of the native leaflet grasping forceps toward each other to grasp the atrial surface and the ventricular surface of the target native leaflet.

[0146] Inventive concept 127. The method according to inventive concept 126, wherein folding the first portion and the second portion of the native leaflet grasping forceps toward each other comprises the step of defining a third portion through the native leaflet grasping forceps at a fold between the first portion and the second portion of the native leaflet grasping forceps, extending around the free edge of the target native leaflet.

[0147] Inventive concept 128. The method according to inventive concept 122, wherein positioning the native leaflet grasping forceps to grasp the ventricular surface of the target native leaflet comprises the step of: when the anchor wire loop is positioned in the ventricle, pressing the one or more sub-native leaflet supporting portions of the native leaflet grasping forceps against one or more portions of the ventricular surface of the target native leaflet.

[0148] Inventive concept 129. A method according to inventive concept 128, wherein positioning the native leaflet grasping forceps to grasp the atrial surface of the target native leaflet comprises the step of pressing the one or more supra-annular support portions of the native leaflet grasping forceps against an atrial surface of the target native leaflet, so that when the anchor wire ring is positioned in the ventricle, the one or more sub-native leaflet support portions and the one or more supra-annular support portions clamp and grasp the target native leaflet.

[0149] Inventive concept 130. The method of inventive concept 122, wherein positioning the native leaflet grasping forceps to grasp the atrial surface of the target native leaflet comprises the step of: when the anchor wire loop is positioned in the ventricle, pressing the one or more supra-annular support portions of the native leaflet grasping forceps against an atrial surface of the target native leaflet.

[0150] Inventive concept 131. The method according to inventive concept 116, wherein positioning the annular ventricular anchor comprises the step of positioning the annular ventricular anchor so that the anchor wire loop remains anchored against the subannulus, the ventricular wall, and one or more ventricular papillary muscles in the ventricular apical region.

[0151] Inventive concept 132. The method of inventive concept 116, wherein the anchor wire ring is shaped to define two or more lobes.

[0152] Inventive concept 133. The method of inventive concept 132, wherein the anchor wire ring is shaped to define exactly two lobes.

[0153] Inventive concept 134. The method according to inventive concept 116, wherein the ventricular wall is a ventricular septal wall, and wherein positioning the annular ventricular anchor comprises the step of positioning the annular ventricular anchor so that the anchor wire loop remains anchored in a position against the surrounding anatomical structures, the surrounding anatomical structures including the subannulus, the ventricular septal wall, and the ventricular apical region.

[0154] Inventive concept 135. The method according to inventive concept 116, wherein the native atrioventricular valve is a tricuspid valve, and wherein positioning the neo leaflet comprises the step of positioning the neo leaflet so that when the anchor wire ring is located in the ventricle, the neo leaflet at least partially replaces the function of the target native leaflet by providing a surface for engagement with one or more opposing native leaflets of the tricuspid valve.

[0155] Inventive concept 136. A method according to inventive concept 135, wherein the target native leaflet is a native septal leaflet of the tricuspid valve, wherein the ventricular wall is a ventricular septal wall, and wherein positioning the new leaflet comprises the steps of positioning the new leaflet so that when the anchor wire ring is positioned in the ventricle and remains anchored against the surrounding anatomical structures, including the subannulus, the ventricular septal wall, and the ventricular apical region, the new leaflet at least partially replaces the function of the septal leaflet by providing a surface for engagement with one or more of the opposing native posterior leaflets and native anterior leaflets of the tricuspid valve.

[0156] Inventive concept 137. The method according to inventive concept 116, wherein the native atrioventricular valve is a mitral valve, and wherein positioning the new leaflet comprises the step of positioning the new leaflet so that when the anchor wire ring is positioned in the ventricle, the new leaflet at least partially replaces the function of the target native leaflet by providing a surface for engagement with the opposing native leaflet of the mitral valve.

[0157] Inventive concept 138. A method according to inventive concept 137, wherein the target native leaflet is a native anterior leaflet of the mitral valve, wherein the ventricular wall is a ventricular septal wall, and wherein positioning the new leaflet includes the step of positioning the new leaflet so that when the anchor wire ring is positioned in the ventricle and remains anchored against the surrounding anatomical structures, including the subannulus, the ventricular septal wall, and the ventricular apical region, the new leaflet at least partially replaces the function of the native anterior leaflet by providing a surface for engagement with an opposing native posterior leaflet of the mitral valve.

[0158] Inventive concept 139. The method of inventive concept 116, wherein positioning the neo-leaflet comprises the step of positioning the neo-leaflet such that when the anchor wire ring is positioned in the ventricle, the engagement surface of the neo-leaflet spans from an atrial side to a ventricular side of a native valve plane.

[0159] Inventive concept 140. The method of inventive concept 116, wherein positioning the neo-leaflet comprises the step of positioning the neo-leaflet such that the coaptation surface is generally static throughout a cardiac cycle of the subject after implantation of the coaptation assist device in a heart of the subject.

[0160] Inventive concept 141. The method according to inventive concept 116, wherein positioning the new leaflet comprises the step of positioning the new leaflet such that after implanting the coaptation assist device in a heart of the subject, the coaptation surface moves toward and away from the one or more opposing native leaflets during a cardiac cycle of the subject.

[0161] Inventive concept 142. The method according to inventive concept 116, wherein the anchor line loop is formed into a closed loop.

[0162] Inventive concept 143. The method of inventive concept 116, wherein the anchor line loop comprises metal.

[0163] Inventive concept 144. The method of inventive concept 116, wherein the annular ventricular anchor further comprises an anchor ring cover connected to the anchor ring wire ring.

[0164] Inventive concept 145. The method of inventive concept 144, wherein the anchor loop cover comprises one or more sheets of sheet material extending across a space at least partially surrounded by the anchor loop wire loop.

[0165] Inventive concept 146. The method of inventive concept 144, wherein the anchor ring cover comprises a plurality of braided wires.

[0166] Inventive concept 147. The method of inventive concept 144, wherein the anchor ring cover comprises a coating on the anchor ring wire loop.

[0167] Inventive concept 148. The method of inventive concept 116, wherein the annular ventricular anchor further comprises at least one support wire connected to the anchor wire loop at two locations on the anchor wire loop.

[0168] Inventive concept 149. The method of inventive concept 116, wherein the method comprises a coaptation assist device wire loop shaped to at least partially define the neo-leaflet and the annular ventricular anchor.

[0169] Inventive concept 150. The method according to inventive concept 149, wherein the coaptation assist device wire loop is shaped to further at least partially define a native leaflet grasping forceps, the native leaflet grasping forceps being configured to grasp the atrial surface and the ventricular surface of the target native leaflet to support the new leaflet and orient the new leaflet relative to the native atrioventricular valve.

[0170] Inventive concept 151. The method of inventive concept 150, wherein the coaptation assist device wire loop is shaped to at least partially define the native leaflet grasping forceps along the coaptation assist device wire loop between the neo leaflet and the annular ventricular anchor.

[0171] Inventive concept 152. The method according to inventive concept 116, wherein the new leaflet comprises a new leaflet wire ring, the new leaflet wire ring defining at least a portion of a boundary of the new leaflet, and a new leaflet cover, the new leaflet cover connected to the new leaflet wire ring and providing the coaptation surface.

[0172] Inventive concept 153. The method according to inventive concept 116, wherein the coaptation assist device further comprises a native leaflet spanning portion, and wherein the new leaflet is connected to the annular ventricular anchor via the native leaflet spanning portion, and wherein the method further comprises the steps of: forming a perforation through the target native leaflet, and positioning the native leaflet spanning portion through the perforation.

[0173] Inventive concept 154. The method of inventive concept 153, wherein the coaptation assist device comprises a coaptation assist device wire loop shaped to at least partially define the neo-leaflet, the annular ventricular anchor, and the native leaflet spanning portion.

[0174] Inventive concept 155. The method according to inventive concept 116, wherein the method further comprises the step of minimally invasively or percutaneously delivering the coaptation assist device to a heart of the subject before positioning the annular ventricular anchor and the new valve leaflet, while the coaptation assist device is removably disposed in a delivery tube in a compressed configuration.

[0175] An inventive concept 156 according to the present invention also additionally provides a method of treating a native atrioventricular valve of a subject, the method comprising the steps of:

[0176] positioning an annular ventricular anchor of a coaptation assist device in a ventricle such that an anchor wire loop of the annular ventricular anchor extends to a ventricular apical region such that the anchor wire loop remains anchored in position against surrounding anatomical structures, including the ventricular apical region, wherein the anchor wire loop defines at least a portion of a boundary of the annular ventricular anchor; and

[0177] A neo leaflet of the coaptation assist device is positioned so that when the anchor wire ring is located in the ventricle, the neo leaflet at least partially replaces the function of a target native leaflet of the native atrioventricular valve by providing a coaptation surface for one or more opposing native leaflets opposite the target native leaflet.

[0178] Inventive concept 157. The method of inventive concept 156, wherein positioning the annular ventricular anchor comprises the step of positioning the annular ventricular anchor such that the anchor wire loop applies a force to the surrounding anatomical structure via the anchor wire loop to maintain the anchor in place.

[0179] Inventive concept 158. The method of inventive concept 157, wherein positioning the annular ventricular anchor comprises the step of positioning the annular ventricular anchor such that the anchor wire loop applies a radially outwardly directed force to the surrounding anatomical structure via the anchor wire loop to maintain the anchor in place.

[0180] Inventive concept 159. The method of inventive concept 156, wherein positioning the annular ventricular anchor comprises the step of positioning the annular ventricular anchor such that the anchor wire loop is held anchored in place by friction between the anchor wire loop and the surrounding anatomical structure.

[0181] Inventive concept 160. The method of inventive concept 156, wherein positioning the annular ventricular anchor in a ventricle comprises the step of positioning the annular ventricular anchor in a ventricle such that the anchor wire loop does not extend into a sub-annulus of the target native leaflet.

[0182] Inventive concept 161. The method of inventive concept 156, wherein the annular ventricular anchor is configured to be atraumatic, and wherein positioning the annular ventricular anchor does not include penetrating tissue of the surrounding anatomical structure with the annular ventricular anchor.

[0183] Inventive concept 162. The method of inventive concept 156, wherein the method does not comprise penetrating tissue using any of the plurality of components of the anastomosis assist device.

[0184] Inventive concept 163. The method according to inventive concept 156, wherein the method further comprises the step of positioning a native leaflet grasping forceps of the coaptation assist device to grasp the atrial and ventricular surfaces of the target native leaflet to support the new leaflet and orient the new leaflet relative to the native atrioventricular valve.

[0185] Inventive concept 164. The method according to inventive concept 163, wherein the native leaflet grasping forceps is connected to the annular ventricular anchor via the neo leaflet.

[0186] Inventive concept 165. The method according to inventive concept 163, wherein positioning the native leaflet grasping forceps to grasp the ventricular surface of the target native leaflet comprises the step of: when the anchor wire loop is positioned in the ventricle, pressing the one or more sub-native leaflet supporting portions of the native leaflet grasping forceps against one or more portions of the ventricular surface of the target native leaflet.

[0187] Inventive concept 166. A method according to inventive concept 165, wherein positioning the native leaflet grasping forceps to grasp the atrial surface of the target native leaflet comprises the step of pressing the one or more supra-annular support portions of the native leaflet grasping forceps against an atrial surface of the target native leaflet, so that when the anchor wire ring is positioned in the ventricle, the one or more sub-native leaflet support portions and the one or more supra-annular support portions clamp and grasp the target native leaflet.

[0188] Inventive concept 167. The method according to inventive concept 163, wherein positioning the native leaflet grasping forceps to grasp the atrial surface of the target native leaflet comprises the step of: when the anchor wire loop is positioned in the ventricle, pressing the one or more supra-annular support portions of the native leaflet grasping forceps against an atrial surface of the target native leaflet.

[0189] Inventive concept 168. The method of inventive concept 156, wherein positioning the annular ventricular anchor comprises the step of positioning the annular ventricular anchor such that the anchor wire loop remains anchored against one or more ventricular papillary muscles at the ventricular apex region.

[0190] Inventive concept 169. The method of inventive concept 156, wherein the anchor wire ring is shaped to define two or more lobes.

[0191] Inventive concept 170. The method of inventive concept 169, wherein the anchor wire ring is shaped to define exactly two lobes.

[0192] Inventive concept 171. The method according to inventive concept 156, wherein the native atrioventricular valve is a tricuspid valve, and wherein positioning the neo leaflet comprises the step of positioning the neo leaflet so that when the anchor wire ring is located in the ventricle, the neo leaflet at least partially replaces the function of the target native leaflet by providing a surface for engagement with one or more opposing native leaflets of the tricuspid valve.

[0193] Inventive concept 172. A method according to inventive concept 171, wherein the target native leaflet is a native septal leaflet of the tricuspid valve, and wherein positioning the new leaflet comprises the steps of positioning the new leaflet so that when the anchor wire ring is positioned in the ventricle and remains anchored against the surrounding anatomical structure, including the ventricular apical region, the new leaflet at least partially replaces the function of the septal leaflet by providing a surface for engagement with one or more of the opposing native posterior leaflets and native anterior leaflets of the tricuspid valve.

[0194] Inventive concept 173. The method according to inventive concept 156, wherein the native atrioventricular valve is a mitral valve, and wherein positioning the new leaflet comprises the step of positioning the new leaflet so that when the anchor wire ring is positioned in the ventricle, the new leaflet at least partially replaces the function of the target native leaflet by providing a surface for engagement with the opposing native leaflet of the mitral valve.

[0195] Inventive concept 174. A method according to inventive concept 173, wherein the target native leaflet is a native anterior leaflet of the mitral valve, and wherein positioning the new leaflet includes the step of positioning the new leaflet so that when the anchor wire ring is positioned in the ventricle and remains anchored against the surrounding anatomical structure, including the ventricular apical region, the new leaflet at least partially replaces the function of the native anterior leaflet by providing a surface for engagement with an opposing native posterior leaflet of the mitral valve.

[0196] Inventive concept 175. The method of inventive concept 156, wherein positioning the neo-leaflet comprises the step of positioning the neo-leaflet such that when the anchor wire ring is positioned in the ventricle, the engagement surface of the neo-leaflet spans from an atrial side to a ventricular side of a native valve plane.

[0197] Inventive concept 176. The method of inventive concept 156, wherein positioning the neo-leaflet comprises the step of positioning the neo-leaflet such that the coaptation surface is generally static throughout a cardiac cycle of the subject after implantation of the coaptation assist device in a heart of the subject.

[0198] Inventive concept 177. The method according to inventive concept 156, wherein positioning the new leaflet comprises the step of positioning the new leaflet such that after implanting the coaptation assist device in a heart of the subject, the coaptation surface moves toward and away from the one or more opposing native leaflets during a cardiac cycle of the subject.

[0199] Inventive concept 178. The method of inventive concept 156, wherein the anchor line loop comprises metal.

[0200] Inventive concept 179. The method of inventive concept 156, wherein the annular ventricular anchor further comprises an anchor ring cover connected to the anchor ring wire ring.

[0201] Inventive concept 180. The method of inventive concept 179, wherein the anchor loop cover comprises one or more sheets of sheet material extending across a space at least partially surrounded by the anchor loop wire loop.

[0202] Inventive concept 181. The method of inventive concept 179, wherein the anchor ring cover comprises a plurality of braided wires.

[0203] Inventive concept 182. The method of inventive concept 179, wherein the anchor ring cover comprises a coating on the anchor ring wire loop.

[0204] Inventive Concept 183. The method of Inventive Concept 156, wherein the annular ventricular anchor further comprises at least one support wire connected to the anchor wire loop at two locations on the anchor wire loop.

[0205] Inventive concept 184. The method of inventive concept 156, wherein the method comprises a coaptation assist device wire loop shaped to at least partially define the neo-leaflet and the annular ventricular anchor.

[0206] Inventive concept 185. The method according to inventive concept 156, wherein the new leaflet comprises a new leaflet wire ring, the new leaflet wire ring defining at least a portion of a boundary of the new leaflet, and a new leaflet cover, the new leaflet cover connected to the new leaflet wire ring and providing the coaptation surface.

[0207] Inventive concept 186. The method according to inventive concept 156, wherein the method further comprises the step of minimally invasively or percutaneously delivering the coaptation assist device to a heart of the subject before positioning the annular ventricular anchor and the new valve leaflet, while the coaptation assist device is removably disposed in a delivery tube in a compressed configuration.

[0208] According to an inventive concept 187 of the present invention there is also provided a method of treating a native atrioventricular valve of a subject, the method comprising the steps of:

[0209] Positioning an annular ventricular anchor of a coaptation assist device in a ventricle such that the annular ventricular anchor extends between a ventricular apical region and a subannulus of a target native leaflet of the native atrioventricular valve and applying force to the surrounding anatomical structures through the anchor wire loop to maintain the anchor in place, the surrounding anatomical structures including the subannulus, the ventricular wall, and the ventricular apical region, wherein the annular ventricular anchor comprises a braided sheet comprising a plurality of braided wires; and

[0210] A neo leaflet of the coaptation assist device is positioned so that when the anchor wire loop is located in the ventricle, the neo leaflet at least partially replaces the function of the target native leaflet by providing a surface for coaptation with one or more opposing native leaflets that oppose the target native leaflet.

[0211] Inventive concept 188. The method of inventive concept 187, wherein positioning the annular ventricular anchor comprises the step of positioning the annular ventricular anchor such that the annular ventricular anchor applies a radially outwardly directed force to the surrounding anatomical structure through the annular ventricular anchor to maintain the anchor in place.

[0212] Inventive concept 189. The method of inventive concept 187, wherein positioning the annular ventricular anchor comprises the step of positioning the annular ventricular anchor such that the annular ventricular anchor remains anchored in place by friction between the annular ventricular anchor and the surrounding anatomical structure.

[0213] Inventive Concept 190. The method of inventive concept 187, wherein the annular ventricular anchor is configured to be atraumatic, and wherein positioning the annular ventricular anchor does not include penetrating tissue of the surrounding anatomical structure with the annular ventricular anchor.

[0214] Inventive concept 191. The method of inventive concept 187, wherein the method does not comprise penetrating tissue using any of the plurality of components of the anastomosis assist device.

[0215] Inventive concept 192. The method of inventive concept 187, wherein the plurality of braided wires comprises metal.

[0216] Inventive Concept 193. The method of Inventive Concept 187, wherein the annular ventricular anchor is shaped as at least 75% of an ellipse when the annular ventricular anchor is unconstrained.

[0217] Inventive concept 194. The method of inventive concept 187, wherein positioning the neo-leaflet comprises the step of positioning the neo-leaflet such that the coaptation surface is generally static throughout a cardiac cycle of the subject after implantation of the coaptation assist device in a heart of the subject.

[0218] Inventive concept 195. The method according to inventive concept 187, wherein positioning the neo-leaflet comprises the step of positioning the neo-leaflet such that after implanting the coaptation assist device in a heart of the subject, the coaptation surface moves toward and away from the one or more opposing native leaflets during a cardiac cycle of the subject.

[0219] Inventive concept 196. The method according to inventive concept 187, wherein the method further comprises the step of positioning a native leaflet grasping forceps of the coaptation assist device to grasp the atrial and ventricular surfaces of the target native leaflet to support the new leaflet and orient the new leaflet relative to the native atrioventricular valve.

[0220] Inventive concept 197. The method according to inventive concept 196, wherein the neo-valve leaflet is connected to the annular ventricular anchor via the native leaflet grasping forceps.

[0221] Inventive concept 198. The method according to inventive concept 196, wherein positioning the native leaflet grasping forceps to grasp the atrial surface and the ventricular surface of the target native leaflet comprises the step of clamping at least a portion of the atrial surface and the ventricular surface of the target native leaflet between a first portion and a second portion of the native leaflet grasping forceps.

[0222] Inventive concept 199. The method according to inventive concept 198, wherein sandwiching at least a portion of the atrial surface and the ventricular surface of the target native leaflet comprises the step of folding the first portion and the second portion toward each other to grasp the atrial surface and the ventricular surface of the target native leaflet.

[0223] Inventive concept 200. The method according to inventive concept 187, wherein positioning the annular ventricular anchor comprises the step of positioning the annular ventricular anchor so that the annular ventricular anchor remains anchored against the subannulus, the ventricular wall, and one or more ventricular papillary muscles in the ventricular apical region.

[0224] Inventive concept 201. The method according to inventive concept 187, wherein the ventricular wall is a ventricular septal wall, and wherein positioning the annular ventricular anchor comprises the steps of: positioning the annular ventricular anchor so that the annular ventricular anchor is anchored at a position against the surrounding anatomical structure, the surrounding anatomical structure including the sub-annulus, the ventricular septal wall, and the ventricular apical region.

[0225] Inventive concept 202. The method of inventive concept 187, wherein the native atrioventricular valve is a tricuspid valve, and wherein positioning the neo leaflet comprises the step of positioning the neo leaflet such that when the annular ventricular anchor is located in the ventricle, the neo leaflet at least partially replaces the function of the target native leaflet by providing a surface for engagement with one or more opposing native leaflets of the tricuspid valve.

[0226] Inventive concept 203. A method according to inventive concept 202, wherein the target native leaflet is a native septal leaflet of the tricuspid valve, wherein the ventricular wall is a ventricular septal wall, and wherein positioning the new leaflet comprises the steps of positioning the new leaflet so that when the annular ventricular anchor is positioned in the ventricle and remains anchored against the surrounding anatomical structures, including the subannulus, the ventricular septal wall, and the ventricular apical region, the new leaflet at least partially replaces the function of the septal leaflet by providing a surface for engagement with one or more of the opposing native posterior leaflets and native anterior leaflets of the tricuspid valve.

[0227] Inventive concept 204. The method according to inventive concept 187, wherein the native atrioventricular valve is a mitral valve, and wherein positioning the neo leaflet comprises the step of positioning the neo leaflet so that when the annular ventricular anchor is positioned in the ventricle, the neo leaflet at least partially replaces the function of the target native leaflet by providing a surface for engagement with the opposing native leaflet of the mitral valve.

[0228] Inventive concept 205. A method according to inventive concept 204, wherein the target native leaflet is a native anterior leaflet of the mitral valve, wherein the ventricular wall is a ventricular septal wall, and wherein positioning the new leaflet comprises the steps of positioning the new leaflet so that when the annular ventricular anchor is positioned in the ventricle and remains anchored against the surrounding anatomical structures, including the subannulus, the ventricular septal wall, and the ventricular apical region, the new leaflet at least partially replaces the function of the native anterior leaflet by providing a surface for engagement with an opposing native posterior leaflet of the mitral valve.

[0229] Inventive concept 206. The method of inventive concept 187, wherein positioning the neo-leaflet comprises the step of positioning the neo-leaflet such that when the annular ventricular anchor is positioned in the ventricle, the engagement surface of the neo-leaflet spans from an atrial side to a ventricular side of a native valve plane.

[0230] Inventive concept 207. The method according to inventive concept 187, wherein the annular ventricular anchor further comprises an anchor ring cover, wherein the anchor ring cover is connected to the woven flat sheet and covers the whole or a part of the woven flat sheet.

[0231] Inventive concept 208. The method of inventive concept 207, wherein the anchor ring cover comprises one or more sheet materials connected to the woven flat sheet.

[0232] Inventive concept 209. The method according to inventive concept 187, wherein the method further comprises the step of minimally invasively or percutaneously delivering the coaptation assist device to a heart of the subject before positioning the annular ventricular anchor and the new valve leaflet, wherein the coaptation assist device is removably disposed in a delivery tube in a compressed configuration.

[0233] The present invention will be more fully understood and appreciated from the following detailed description of embodiments of the present invention in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS

[0234] Figures 1A to 1E is a schematic diagram of a coaptation assist device for treating a native valve of a subject according to an application of the present invention;

[0235] Figure 2 is implanted in a natural valve according to an application of the present invention Figures 1A to 1E and Figure 2 A schematic diagram of the joining auxiliary device;

[0236] FIG. 3A to FIG. 3K They are respectively highly schematic diagrams of annular ventricular anchors according to relevant applications of the present invention;

[0237] FIG. 4A to FIG. 4B According to an application of the present invention Figures 1A to 1E and Figure 2 A schematic diagram of another configuration of the engagement assist device;

[0238] FIG. 5A to FIG. 5B According to an application of the present invention Figures 1A to 1E and Figure 2 A schematic diagram of yet another configuration of the engagement assist device;

[0239] FIG. 6A to FIG. 6C According to an application of the present invention Figures 1A to 1E and Figure 2 A schematic diagram of yet another configuration of the engagement assist device;

[0240] Figure 7 According to an application of the present invention Figures 1A to 1E and Figure 2 A schematic diagram of another configuration of the engagement assist device;

[0241] FIG. 8A to FIG. 8B They are schematic diagrams of the additional joining auxiliary device according to the relevant application of the present invention;

[0242] 9A to 9H According to an application of the present invention Figures 1A to 1E and Figure 2 2 is a schematic diagram of a method for implanting the coaptation assist device in a heart of a subject;

[0243] FIG. 10A to FIG. 10C is a schematic diagram of a joining assisting device according to an application of the present invention;

[0244] FIG. 10D to FIG. 10F is a schematic diagram of another joining auxiliary device according to an application of the present invention;

[0245] Figure 10G is implanted in a natural valve according to an application of the present invention FIG. 10A to FIG. 10C A schematic diagram of the joining auxiliary device;

[0246] FIG. 11A to FIG. 11D is a schematic diagram of yet another joining auxiliary device according to an application of the present invention;

[0247] FIG. 12A to FIG. 12E is a schematic diagram of another joining auxiliary device according to an application of the present invention;

[0248] FIG. 13A to FIG. 13E is a schematic diagram of another joining auxiliary device according to an application of the present invention;

[0249] Fig.14is implanted in a natural valve according to an application of the present invention FIG. 12A to FIG. 12E A schematic diagram of the joining auxiliary device;

[0250] FIG. 15A to FIG. 15B is implanted in a natural valve according to an application of the present invention FIG. 13A to FIG. 13E A schematic diagram of the joining auxiliary device;

[0251] FIG. 16A to FIG. 16F is a schematic diagram of another joining auxiliary device according to an application of the present invention;

[0252] Fig.17 is implanted in a natural valve according to an application of the present invention FIG. 16A to FIG. 16F A schematic diagram of the joining auxiliary device;

[0253] 18A to 18F is a schematic diagram of another joining auxiliary device according to an application of the present invention;

[0254] Fig.19 is implanted in a natural valve according to an application of the present invention FIG. 18A to FIG. 18F A schematic diagram of the joining auxiliary device;

[0255] FIG. 20A to FIG. 20B is a schematic diagram of yet another joining auxiliary device according to an application of the present invention;

[0256] Fig.21 is a schematic diagram of another joining auxiliary device according to an application of the present invention;

[0257] Fig. 22 is implanted in a natural valve according to an application of the present invention Fig.21 A schematic diagram of the joining assist device; and

[0258] Fig.23 is a schematic diagram of a coaptation assist device implanted in a native mitral valve according to an application of the present invention. DETAILED DESCRIPTION

[0259] Figures 1A to 1E Schematic diagram of a coaptation assist device 20 for treating a native valve 22 of a subject according to an application of the present invention. Typically, the native valve suffers from a valvular disease, such as functional mitral regurgitation or tricuspid regurgitation, which is typically characterized by a lack of mobility of the leaflets in the valve. The native valve is typically an atrioventricular valve, i.e., the tricuspid valve or the mitral valve.

[0260] See also Figure 2 , Figure 2FIG. 2 is a schematic diagram of a coaptation assist device 20 implanted in a native valve 22 according to an application of the present invention. Figure 2 In the particular implant shown, the native valve 22 is the tricuspid valve. Figure 2 is a cross-sectional view of the heart in which an anterior portion of the heart including the native anterior leaflet of the tricuspid valve is removed, thereby showing only the septal and posterior leaflets. (A native "valve" is also referred to in the art as a native "valvular device.")

[0261] The coaptation assist device 20 includes a loop-shaped ventricular anchor 30, i.e., a ventricular anchor having a loop boundary, and a neo-leaflet 32 ​​supported by the loop-shaped ventricular anchor 30. The loop-shaped ventricular anchor 30 is disposed distal to the neo-leaflet 32. As used in this application, including in the various claims and inventive concepts, the term “neo-leaflet” refers to a “prosthetic leaflet”.

[0262] Typically, the annular ventricular anchor 30 includes an anchor-loop wire loop 50 that defines at least a portion of a boundary of the annular ventricular anchor. The anchor-loop wire loop 50 includes metal or another semi-rigid material. The material of the anchor-loop wire loop 50 is self-expanding or mechanically expandable. For example, the anchor-loop wire loop 50 may include a shape-memory alloy, such as Nitinol. For some applications, the anchor-loop wire loop 50 is made by shaping a wire. For other applications, the anchor-loop wire loop 50 is made by winding a wire and has fixed or variable properties along the length of the loop; the variable properties may include one or more of an outer diameter, a pitch, and a stiffness. For other applications, the anchor-loop wire loop 50 is made by laser cutting and shaping a metal sheet in the shape of a tube or a flat plate, such as a shape-memory alloy, such as Nitinol.

[0263] The anchor wire loop 50 is configured to be positioned in a ventricle 23, extending between a ventricular apical region 24 (at the bottom of the ventricle 23) and a subannular surface 25 of a target native leaflet 26 of the native valve 22. Figure 2As shown, the anchoring wire ring 50 is configured to abut against surrounding anatomy to remain anchored in place, the surrounding anatomy including the subannulus 25, a ventricular wall 27, and the ventricular apical region 24. In other words, the anchoring wire ring 50 is configured to be fixed below and behind the target native valve leaflet 26, in contact with the subannulus 25 to be located at the apex, and stabilized by the ventricular wall 27. Typically, the anchoring wire ring 50 is configured to pass behind or through a plurality of ventricular papillary muscles 46 at the ventricular apical region 24. Optionally, the surrounding anatomy to which the anchoring wire ring 50 is anchored further includes one or more of the following: an adjustment band, one or more chordae tendineae, and one or more papillary muscles on the opposite side of the ventricle 23.

[0264] For some applications, the engagement assist device 20 does not include any components configured to penetrate (eg, pierce) tissue. For other applications, the engagement assist device 20 includes at least one component configured to penetrate tissue, such as described below. Fig.21 and Fig. 22 as described.

[0265] For example Figure 2 As shown, when the anchor wire loop 50 is positioned in the ventricle 23, the new leaflet 32 ​​is configured to at least partially replace the function of the target native leaflet 26 by providing an engaging surface 34 for one or more opposing native leaflets 28 opposing the target native leaflet 26. The new leaflet 32 ​​is generally configured to cover at least a portion of the target native leaflet 26.

[0266] For some applications, the engagement surface 34 has a width of at least 2 cm. 2 (For example, at least 10 cm 2 ), not more than 20cm 2 (For example, no more than 15cm 2 ), and / or between 2 cm (e.g., 10 cm 2 ) and 20cm 2 (For example, 15cm 2 ) between the two surfaces. Other bonding surfaces described below may also have such areas.

[0267] For some applications, the neo-leaflet 32 ​​includes a neo-leaflet wire loop 36 that defines at least a portion of a boundary of the neo-leaflet, and a neo-leaflet cover 38 that is connected to the neo-leaflet wire loop 36. Typically, the neo-leaflet cover 38 provides the above-mentioned engagement surface 34. For some applications, the neo-leaflet cover 38 includes one or more biocompatible sheet materials, which may include a synthetic material or a biological tissue material, for example, a fabric including a polymer or a biological material (e.g., polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), silicone, urethane, or pericardium). The new leaflet wire ring 36 can be formed as a closed ring or an open ring, if provided, with a proximal opening in the direction of the annular ventricular anchor 30 and the native leaflet grasping forceps 40. The new leaflet wire ring 36 includes metal or another semi-rigid material. The material of the new leaflet wire ring 36 is self-expanding or mechanically expandable. For example, the new leaflet wire ring 36 may include a shape memory alloy, such as nickel titanium alloy. For some applications, the new leaflet wire ring 36 is made by shaping one or more wires. For other applications, the new leaflet wire ring 36 is made by winding a wire and has fixed or variable characteristics along the length of the ring; including one or more of an outer diameter, a pitch and a stiffness. For some applications, the cross-section of the wire of the new leaflet wire ring 36 is circular; alternatively, the wire has another cross-sectional shape, such as an elliptical, a rectangular or substantially flat. For other applications, the new leaflet wire ring 36 is made by laser cutting and forming a metal sheet in the shape of a tube or a flat plate, such as a shape memory alloy, such as Nitinol.

[0268] For some applications, the new leaflets 32 have an inherent stiffness provided by the material of the new leaflet wire ring 36 and / or the new leaflet cover 38. Alternatively or additionally, the new leaflets 32 include one or more stiffening elements inside the new leaflet cover 38 to prevent the new leaflets from prolapsing within the atrial cavity due to increased backflow pressure on the ventricular surface of the new leaflets during the cardiac cycle.

[0269] Typically, the anchor loop 50 is configured to remain anchored in place by a force (typically a radially outwardly directed force) applied by the anchor loop 50 to the surrounding anatomical structure, and / or by friction between the anchor loop 50 and the surrounding anatomical structure. For some applications, the anchor loop 50 includes a self-expanding material, such as a shape memory alloy (e.g., Nitinol), which causes the anchor loop 50 to expand radially outward to apply the force. For such applications, the anchor loop 50 is typically configured to have a shape larger than the surrounding anatomical structure in its resting (relaxed) state, such that the surrounding anatomical structure limits expansion of the anchor loop 50 and the anchor loop 50 applies force to the surrounding anatomical structure (and vice versa). In addition, the narrowing of the ventricular wall 27 in a sub-annular to apical direction compresses the anchor wire ring 50, generates a counter-radial force, and guides the anchor wire ring 50 to stabilize itself at the sub-leaflet ventricular hinge level (i.e., at the level of the sub-annular surface 25) (wherein, optionally, the annular ventricular anchor 30 (e.g., the anchor wire ring 50) is also used to grasp the target native leaflet 26 in some configurations, optionally in combination with the native leaflet grasping forceps 40, see below). Figures 1A to 1E and Figure 2 for description).

[0270] Typically, the annular ventricular anchor 30 is configured to be atraumatic so as not to penetrate (eg, puncture) tissue of the surrounding anatomical structure. To this end, the annular ventricular anchor 30 typically does not include any exposed sharp components that can penetrate tissue.

[0271] As described above, for some applications, the native valve 22 is the tricuspid valve. For such applications, when the anchor wire ring 50 is positioned in the ventricle 23, the new leaflet 32 ​​is configured to at least partially replace the function of the target native leaflet 26 by providing an engagement surface 34 for one or more opposing native leaflets 28 of the tricuspid valve. For some of such applications, the target native leaflet 26 is a native septal leaflet of the tricuspid valve, the ventricular wall 27 is a ventricular septal wall, and the new leaflet 32 ​​is configured to at least partially replace the function of the septal leaflet by providing an engagement surface 34 for the opposing native posterior leaflet and the native anterior leaflet of the tricuspid valve when the anchor wire ring 50 is positioned in the ventricle 23 and abuts against the surrounding anatomical structures, including the subannulus 25, the ventricular septal wall 27, and the ventricular apical region 24. Although in Figure 2In the cross-sectional view of the heart, the only opposing native leaflet 28 shown is the posterior native leaflet, which also engages with the engagement surface 34 when the opposing anterior native leaflet partially replaces the septal leaflet.

[0272] For other applications (as described below, such as Fig.23 ), the native valve 22 is a mitral valve, and when the anchor wire ring 50 is positioned in the ventricle, the new leaflet 32 ​​is configured to at least partially replace the function of the target native leaflet 26 (a posterior mitral leaflet or a native anterior leaflet) by providing an engagement surface 34 for the opposing native leaflet of the mitral valve. For some of these applications, the target native leaflet 26 is the native anterior leaflet of the mitral valve, the ventricular wall 27 is a ventricular septal wall, and the new leaflet 32 ​​is configured to at least partially replace the function of the native anterior leaflet by providing an engagement surface 34 for the opposing native posterior leaflet of the mitral valve when the anchor wire ring 50 is positioned in the ventricle 23 and abuts against the surrounding anatomical structures, including the subannulus 25, the ventricular septal wall 27, and the ventricular apical region 24.

[0273] For some applications, such as Figure 2 As shown, when the anchor wire loop 50 is positioned in the ventricle 23 , the anchor wire loop 50 is configured to remain anchored in position against the subannulus 25 , the ventricular septal wall 27 , and one or more ventricular papillary muscles 46 of the ventricular apical region 24 .

[0274] For some applications, such as Figures 1A to 1E As shown, the anchor wire ring 50 is formed as a closed ring that defines an entire boundary of the annular ventricular anchor 30. For other applications, the anchor wire ring 50 is formed as an open ring that is formed with a proximal opening facing the new leaflet 32 ​​and the native leaflet grasping forceps 40, if provided, for example Figure 5A , FIG. 10A to FIG. 10F , FIG. 11A to FIG. 11D , FIG. 12A to FIG. 12E , FIG. 13A to FIG. 13E and FIG. 16A to FIG. 16F For the latter applications, a proximal side of the annular ventricular anchor 30 is defined by another component of the coaptation assist device 20, such as FIG. 10A to FIG. 10C , FIG. 10D to FIG. 10F , FIG. 11A to FIG. 11D and FIG. 16A to FIG. 16F As shown, for example, the grasping forceps covers 144A, 144B, 144C and 444 of the natural leaflet grasping forceps 40, or as shown in FIG. 12A to FIG. 12E and FIG. 13A to FIG. 13E Shown are new leaflet covers 338A and 338B for new leaflets 332A and 332B, respectively.

[0275] For some applications, anchor line loop 50 has one or more of the following dimensions:

[0276] A closed (enclosed) area of ​​at least 2 cm 2 , not more than 60cm 2 , and / or between 2cm 2 With 60cm 2 between,

[0277] · a circumference of at least 4 cm and not more than 15 cm and / or between 4 and 15 cm,

[0278] a length of at least 2 cm and not more than 12 cm, and / or between 2 and 12 cm, and / or

[0279] A width of at least 1 cm and not more than 12 cm, and / or between 1 and 12 cm.

[0280] The anchor line loop 50 may define a flat surface or a curved surface.

[0281] For some applications, when unconstrained (by application of any external force, including by the anatomical structure or the delivery system), anchor loop wire loop 50 is bent to detect at least 50% (e.g., at least 75%, such as at least 90%, for example, 100%) along a length of anchor loop wire loop 50 around which the length is detected.

[0282] Alternatively or additionally, for some applications, when unconstrained (by application of any external force, including by the anatomy or delivery system), anchor wire loop 50 is shaped as at least 75% of an ellipse, such as at least 90%, such as 100% of an ellipse.

[0283] See now FIG. 3A to FIG. 3K , FIG. 3A to FIG. 3K 30A to 30H are schematic diagrams of annular ventricular anchors according to the related applications of the present invention. In these figures, the proximal end of the annular ventricular anchor is shown above the distal end of the sheet (the proximal end is the end close to the new valve leaflet).

[0284] Figure 3A The annular ventricular anchor 30A includes a plurality of connected anchor wire loops 50A, for example three anchor wire loops 50A, which respectively define a plurality of annular leaflets 52 configured to be positioned in the ventricular apical region 24 .

[0285] Figure 3B and Figure 3CThe respective annular ventricular anchors 30B and 30C include anchor wire loops 50B and 50C, respectively. The anchor wire loop 50B has a symmetrical hourglass shape, and the anchor wire loop 50B has a complete hourglass shape. Figure 3C The annular ventricular anchor 30C includes an anchor wire loop 50C formed into a figure 8 shape.

[0286] Figure 3D The annular ventricular anchor 30D includes an anchor wire loop 50D that is twisted to define an hourglass shape.

[0287] Figure 3E The annular ventricular anchor 30E includes an anchor wire loop 50E having a stadium shape. As used in this application, including in various claims and various inventive concepts, a stadium shape is a two-dimensional geometric shape formed by a rectangle having semicircles on a pair of opposing sides. The same shape is also known as an irregular rectangle, an oblong, or a sausage body.

[0288] Figure 3F The annular ventricular anchor 30F includes an anchor wire ring 50F having a plurality of wavy side edges.

[0289] Figure 3G The annular ventricular anchor 30G includes an anchor wire ring 50G shaped to define a plurality of leaflets (eg, three, as shown).

[0290] Figure 3H The annular ventricular anchor 30H includes a plurality (eg, at least 5, such as at least 10) of braided anchor loops 50H shaped to define an annular space (which is formed by the braid itself such that its edges define a ring).

[0291] Fig. 3I The width of the annular ventricular anchor 30I is greater than its height.

[0292] Figure 3J The annular ventricular anchor 30J includes one or more barbs 301J.

[0293] Figure 3K The annular ventricular anchor 30K comprises a tightly coiled wire 301K.

[0294] For some applications, any of the annular ventricular anchors described herein, including those described in Figures 1A to 1E , Figures 3A to 3G, and FIGS. I to K , may further include an anchor ring cover connected to the anchor ring line loop. For some of these applications, the anchor ring cover includes one or more biocompatible sheet materials 56, which extend across a space and partially or completely occupy a space that is at least partially surrounded by the anchor ring line loop. Typically, the one or more biocompatible sheet materials 56 are soft and non-traumatic. For some applications, the one or more biocompatible sheet materials 56 are configured to promote endothelial healing. The one or more biocompatible sheet materials 56 may include a synthetic material or a biological tissue material, such as a fabric including a polymer or a biomaterial (e.g., polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), silicone, urethane, or pericardium). For other applications, the anchor ring cover comprises a coating on the anchor ring wire loop, such as tissue, polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE) or a foam. Alternatively or additionally, the anchor ring wire loop surface may be mechanically or chemically treated, such as by electropolishing or sandblasting, or provided with a plurality of barbs (such as Figure 3J As shown, for example, barbs 301J) may be provided to create friction to help maintain the ring in place.

[0295] For other applications, the anchor ring cover includes a plurality of braided wires, as described above, which are optionally additionally covered with one or more biocompatible sheet materials.

[0296] See again Figures 1A to 1E and Figure 2 . For some applications, the coaptation assist device 20 further includes a native leaflet grasping forceps 40, which are configured to grasp the atrial and ventricular surfaces of the target native leaflet 26 to support and / or stabilize the new leaflet 32, and to orient the new leaflet 32 ​​relative to the native valve 22. For example, the native leaflet grasping forceps 40 can help prevent the new leaflet 32 ​​from tilting toward one of a plurality of native commissures, and / or can help orient the new leaflet 32 ​​to a desired angle with respect to the native valve plane. Alternatively, the coaptation assist device as described herein does not include a native leaflet grasping forceps, for example, as described below Figure 21 to Figure 23 described.

[0297] For some applications, such as Figures 1A to 1E and Figure 2 As shown, the new leaflets 32 are connected to the annular ventricular anchor 30 via native leaflet grasping forceps 40. For some of these applications, the coaptation assist device 20 includes a wire loop, which is shaped to at least partially define the new leaflets 32 and the native leaflet grasping forceps 40 as shown.

[0298] For some applications, the coaptation-assist-device 20 includes a coaptation-assist-device wire loop, such as shown, which is shaped to at least partially define the new leaflets 32, the native leaflet grasping forceps 40, and the anchoring ring wire loop 50. For some of these applications, such as shown, the wire loop is shaped to at least partially define the wire loop of the native leaflet grasping forceps 40 along the new leaflets 32 and the anchoring ring wire loop 50.

[0299] For some applications, the natural leaflet grasping forceps 40 is formed to define a first portion 42A and a second portion 42B, and the first portion 42A and the second portion 42B are configured to fold toward each other so that the atrial surface and the ventricular surface of the target natural leaflet 26 are grasped respectively by clamping at least a portion of the atrial surface and the ventricular surface of the target natural leaflet 26 between the first portion and the second portion of the natural leaflet grasping forceps 40.

[0300] For some applications, the engagement assist device is configured such that:

[0301] The first portion 42A of the native leaflet grasping forceps 40 is pivotally connected to the annular ventricular anchor 30,

[0302] The first portion 42A of the native leaflet grasping forceps 40 is pivotally connected to the second portion 42B of the native leaflet grasping forceps 40, and / or

[0303] The second portion 42B of the native leaflet grasping forceps 40 is pivotally connected to the new leaflet 32 ​​.

[0304] For some applications, the native leaflet grasping forceps 40 includes one or more grasping forceps covers 44, which together include one or more biocompatible thin sheets of material (optionally, the same one or more sheets of material (for example, an identical sheet of material) define the new leaflet cover 38 and the one or more grasping forceps covers 44; or, separate sheets of material define the new leaflet cover 38 and the one or more grasping forceps covers 44). Typically, at least one of the one or more grasping forceps covers 44 pushes against the ventricular surface and / or atrial surface of the target native leaflet 26 to prevent blood flow between the target native leaflet and the coaptation assist device. For some of these applications, the one or more grasping forceps covers 44 extend across a space and partially or completely occupy a space that is at least partially surrounded by a frame 45 of the native leaflet grasping forceps 40, which may include one or more wires, which may be part of the wire ring described above. For some applications, the one or more grasping forceps covers 44 extend across a space and partially or completely occupy a space, wherein the space is at least partially surrounded by a portion of a frame 45, the portion of which defines a first portion 42A of the natural leaflet grasping forceps 40 (which is configured to grasp the atrial surface of the target natural leaflet 26), and the one or more grasping forceps covers 44 do not at least partially cover a space, wherein the space is at least partially surrounded by a portion of a frame 45, the portion of which defines a second portion 42B of the natural leaflet grasping forceps 40 (which is configured to grasp the ventricular surface 26 of the target natural leaflet).

[0305] Typically, the one or more biocompatible sheet materials are soft and atraumatic. The one or more biocompatible sheet materials may include a synthetic material or a biological tissue material, such as a fabric including a polymer or a biomaterial (e.g., polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), silicone, urethane, or pericardium).

[0306] For some of these applications, the natural leaflet grasping forceps 40 is formed to further define a third portion 42C at a fold between the first portion 42A and the second portion 42B of the natural leaflet grasping forceps 40, and when the first portion 42A and the second portion 42B clamp at least a portion of the atrial surface and the ventricular surface of the natural leaflet 26, the third portion 42C is configured to extend around the free edge of the target natural leaflet 26.

[0307] For some applications, the new leaflet 32 ​​is configured to completely surround the target native leaflet 26, including multiple sides of the target native leaflet, from the ventricular native leaflet hinge to the atrial hinge, near the valvular annulus, and enclose the target native leaflet from commissure to commissure. For other applications, the new leaflet 32 ​​is configured to partially surround the target native leaflet 26, covering and enclosing a portion of the target native leaflet, typically at least the free edge of the target native leaflet.

[0308] See also Figure 1D For some applications, the coaptation assist device 20 is configured such that when unconstrained (by the application of any external force, including by the anatomical structure or the delivery system), an angle alpha is defined between (a) an anchor-loop best-fit plane 62 defined by the anchor-loop wire loop 50 and (b) a neo-leaflet best-fit plane 64 defined by the neo-leaflet wire loop 36. Typically, the coaptation assist device 20 is configured to automatically assume this angle; for example, multiple components of the device may include a shape memory alloy, such as a nickel-titanium alloy, which is configured to cause the device to assume this angle when in a static, relaxed state, such as at 37 degrees Celsius (body temperature). As used in this application, including in multiple claims and multiple inventive concepts, a "best-fit plane" defined by a wire loop is the plane that best matches the shape of the wire loop, i.e., the plane that results in the minimum sum of squares of distances between the plane and the wire loop. Alternatively, the new leaflet optimal fit plane 64 defined by the new leaflet wire ring 36 is defined by the coaptation surface 34. (In coaptation assist devices 220A and 220B, as described below and see FIG. 8A to FIG. 8B , the anchor ring optimal fit plane 62 can be defined by a boundary of the annular ventricular anchors 230A and 230B, respectively, and the new leaflet optimal fit plane 64 can be defined by a boundary of the new leaflet 232A and 232B, respectively.

[0309] For some applications, such as Figure 1D As shown, the angle α (alpha) is at least 60 degrees (e.g., at least 80 degrees), no more than 100 degrees (e.g., no more than 90 degrees), and / or between 60 degrees (e.g., 80 degrees) and 100 degrees (e.g., 90 degrees). Fig.12D and Fig.14As described above, a range of such angles may be suitable. For other applications, the angle α (alpha) is at least 15 degrees (e.g., at least 35 degrees), no more than 50 degrees (e.g., no more than 45 degrees), and / or between 15 degrees (e.g., 35 degrees) and 50 degrees (e.g., 45 degrees). Fig. 13C and Fig.15A As described, a range of this angle may be suitable.

[0310] For some applications, all engagement assist devices may be configured to present one of the above-mentioned ranges of angles.

[0311] See also Figure 1E For some applications, the bonding aid 20 may be extended and planarized to become Figure 1E After being planarized, the splice assist device 20 can be rolled and then loaded into a delivery tube 304 for use as described below. Fig.9A The delivery of the described delivery. The engagement assist device 20 generally has a shape memory so that when it is exposed and deployed from the delivery tube 304, it automatically and gradually restores its initial resting state, as described below. 9A to 9H described.

[0312] Still see Figures 1A to 1E and Figure 2 . For some applications, the new leaflet 32 ​​is configured such that when the coaptation assist device 20 is implanted in a heart of the subject, the coaptation surface 34 is generally static during an entire cardiac cycle of the subject. In such applications, coaptation is provided by movement of the one or more opposing native leaflets 28 against the substantially static coaptation surface 34 provided by the new leaflet 32. For example, to achieve such generally static properties, the new leaflet wire ring 36 and / or the new leaflet cover 38 of the new leaflet 32 ​​may be relatively rigid, and / or, as described above, the new leaflet 32 ​​may include one or more reinforcement components within the new leaflet cover 38.

[0313] For other applications, the new leaflet 32 ​​is configured such that after the coaptation assist device 20 is implanted in a heart of the subject, the coaptation surface 34 moves toward and away from the one or more opposing native leaflets 28 during a cardiac cycle of the subject. In other words, the new leaflet 32 ​​is configured such that the coaptation surface 34 is dynamic throughout a cardiac cycle. In such applications, coaptation is provided by movement of the coaptation surface 34 provided by the new leaflet 32 ​​and the one or more opposing native leaflets 28. For example, to allow for the coaptation surface 34, the new leaflet wire ring 36 and / or the new leaflet cover 38 of the new leaflet 32 ​​may be sufficiently flexible to allow it to move during a cardiac cycle. For example, as Figures 1A to 1EAs shown, a diameter (i.e., wire gauge) of the wire of the new leaflet wire ring 36 may be smaller than a diameter of the wire of the anchor ring wire ring 50 of the annular ventricular anchor 30 and / or smaller than other wires of the coaptation assist device 20, if provided, such as the wire of the native leaflet grasping forceps 40. Alternatively, for example, see below Figure 7 As described, the new leaflet may not include a wire loop that defines at least a portion of the border. Alternatively, the new leaflet cover may have a surface area that is greater than an area defined and enclosed by the new leaflet wire loop to create a flexible parachute-like coaptation surface that expands and relaxes during the cardiac cycle, such as described below. FIG. 5A to FIG. 5B and FIG. 6A to FIG. 6C Described. The flexible parachute-shaped engagement surface is configured to inflate and relax the engaged ventricular surface along blood flow and pressure changes during the cardiac cycle, so that during the systolic phase of the cardiac cycle, both blood flow and blood pressure increase and are directly against the ventricular surface of the new leaflet. As a result, the new leaflet expands and dynamically increases the engaged surface of the one or more opposing native leaflets 28. During the diastolic phase, the blood flow and blood pressure acting against the ventricular surface of the new leaflet decrease, causing the new leaflet to relax and deflate, so that the new leaflet structure is in a static state during the diastolic phase to avoid blocking the orifice area blood passage from the atrial cavity to the ventricular cavity. In other words, during the diastolic phase, the new leaflet contracts and relaxes, allowing blood to flow from the atrium to the ventricle.

[0314] See now FIG. 4A to FIG. 4B , FIG. 4A to FIG. 4B is a schematic diagram of another configuration of an anastomosis assist device 20 according to an application of the present invention. In this configuration, the annular ventricular anchor 30 includes at least one support wire 70 connected to the anchor wire loop 50 at two locations 72A and 72B on the anchor wire loop 50. For example, as shown, the two locations 72A and 72B can be on opposite sides of the anchor wire loop 50, and / or, as also shown, on multiple long sides of the anchor wire loop 50.

[0315] See now FIG. 5A to FIG. 5B , FIG. 5A to FIG. 5Bis a schematic diagram of another configuration of a coaptation assist device 20 according to an application of the present invention. In this configuration, the coaptation assist device 20 includes a neo-leaflet 32B which is identical to the neo-leaflet 32 ​​described above and may implement any of its features, mutatis mutandis, except as described below. The neo-leaflet 32B includes a neo-leaflet open wire loop 36B and a neo-leaflet cover 38B connected to the neo-leaflet open wire loop 36B. The neo-leaflet open wire loop 36B is open on a distal side 37 in the direction of the annular ventricular anchor 30 and the native leaflet grasping forceps 40, if provided. The neo-leaflet cover 38B has a surface area which is greater than an area defined by the neo-leaflet open wire loop 36B and surrounded on approximately three sides. As a result, the new leaflet cover 38B is flexible in configuration, and when the ventricular surface 39 of the new leaflet cover 38B is exposed to elevated blood pressure during a cardiac cycle, the new leaflet cover 38B spreads away from the new leaflet opening line ring 36B, optionally to a greater extent further along the new leaflet cover 38B, providing a flexible parachute-like engagement surface 34B that expands and relaxes during the cardiac cycle. The curvature of the engagement surface 34B toward and on the distal side 37 provides increased efficacy in engagement with one or more opposing natural leaflets 28. Optionally, the new leaflet cover 38B includes an elastic material. In other configurations, the new leaflet cover 38B is not flexible, but rather rigid, such that the new leaflet cover 38B is configured not to expand and relax. In such configurations, the curvature of the new leaflet provides a larger surface for engagement with the one or more opposing natural leaflets 28.

[0316] Alternatively, the neo-leaflet wire loop 36B is formed as a neo-leaflet closed wire loop, in which case the neo-leaflet cover 38B is typically not connected to the distal side of the neo-leaflet closed wire loop.

[0317] The new leaflet cover 38B may implement any of the features of the new leaflet cover 38 described above, mutatis mutandis.

[0318] See now FIG. 6A to FIG. 6C , FIG. 6A to FIG. 6Cis a schematic diagram of yet another configuration of a coaptation assist device 20 according to an application of the present invention. In this configuration, the coaptation assist device 20 includes a neo-leaflet 32C, which is the same as the neo-leaflet 32 ​​described above, and may implement any of its features, mutatis mutandis, except as described below. The neo-leaflet 32C includes a neo-leaflet wire ring 36C and a neo-leaflet cover 38C connected to the neo-leaflet wire ring 36C. For some applications, the neo-leaflet wire ring 36C is open on the distal side 37 in the direction of the annular ventricular anchor 30 and the native leaflet grasping forceps 40, if provided, as shown, while for other applications, the neo-leaflet wire ring 36C is formed as a neo-leaflet closure wire ring. The neo-leaflet cover 38C has a surface area that is larger than an area defined by the neo-leaflet opening wire ring 36C and surrounded on approximately three sides. As a result, when a ventricular surface 39 of the new leaflet cover 38C is exposed to elevated blood pressure during a cardiac cycle, the new leaflet cover 38C spreads away from the new leaflet opening wire ring 36C, providing a flexible parachute-like engagement surface 34C that expands (inflates) and relaxes during the cardiac cycle. Fig. 6A The relaxed state is shown in Figure 6B and Figure 6C The new leaflet cover 38C can implement any of the features of the new leaflet cover 38 described above, mutatis mutandis. Optionally, the new leaflet cover 38C includes an elastic material.

[0319] See now Figure 7 , Figure 7 is a schematic diagram of another configuration of a coaptation assist device 20 according to an application of the present invention. In this configuration, the coaptation assist device 20 includes a neoleaflet 32D, which is the same as the neoleaflet 32 ​​described above, and may implement any of its features, mutatis mutandis, except as described below. Similar to the neoleaflet 32, the neoleaflet 32D includes a neoleaflet cover 38D that defines a coaptation surface 34. However, unlike the neoleaflet 32, the neoleaflet 32D does not include a wire loop that defines at least a portion of the boundary of the neoleaflet and is connected to the neoleaflet cover 38D. The absence of a wire loop provides greater flexibility to the coaptation surface 34 of the neoleaflet 32, for example, as described above with reference to FIG. Figures 1A to 1E and Figure 2 The above allows the engagement surface to be dynamic throughout a cardiac cycle. Optionally, the new leaflet 32D includes one or more reinforcement components within the new leaflet cover 38D to prevent the new leaflet from prolapsing within the atrial cavity due to increased regurgitant pressure on the ventricular surface of the new leaflet during the cardiac cycle.

[0320] See now FIG. 8A to FIG. 8B , Fig. 8A and Figure 8B2 and 2 are schematic diagrams of the additional joint assisting devices 220A and 220B according to the related applications of the present invention. Figures 1A to 1E and Figure 2 The coaptation assist device 20 is described herein and like reference numerals refer to like parts. Coaptation assist devices 220A and 220B, including their respective neo-leaflets, annular ventricular anchors, and optional native leaflet grasping forceps, may implement any of the features of coaptation assist device 20, mutatis mutandis, including those described above and with reference to the accompanying drawings. FIG. 3A to FIG. 3K The features described above and see FIG. 4A to FIG. 4B .

[0321] The coaptation assist devices 220A and 220B include annular ventricular anchors 230A and 230B, respectively, each of which includes a braided sheet 215, the braided sheet 215 including a plurality of braided wires, the plurality of braided wires typically comprising metal. The plurality of braided wires are configured to provide an annular boundary for annular ventricular anchors 230A and 230B. The annular ventricular anchor 230B of the coaptation assist device 220B further includes an anchor cover 253, the anchor cover is connected to the braided sheet 215, and covers all or a portion of the braided sheet 215 (on one side, as shown, or on both sides). The anchor cover 253 may include a synthetic material or a biological material impregnated into the braid of the braided sheet 215, or may include a separate synthetic sheet material or a biological sheet material connected to the braided sheet 215. The anchor cover 253 may be implemented as shown in FIG. Figures 1A to 1E and FIG. 3A to FIG. 3E Any features of the anchor ring covers described above may apply mutatis mutandis.

[0322] Typically, the annular ventricular anchors 230A and 230B are configured to remain anchored in place by forces applied to the surrounding anatomical structures by the annular ventricular anchors 230A and 230B (typically radially outwardly directed forces), and / or by friction between the annular ventricular anchors 230A and 230B and the surrounding anatomical structures. For some applications, the annular ventricular anchors 230A and 230B include a self-expanding material, such as a shape memory alloy (e.g., a nickel-titanium alloy), which causes the braid of the annular ventricular anchors 230A and 230B to expand radially outwardly to apply the force. For such applications, the annular ventricular anchors 230A and 230B are typically configured to have a shape in their resting (relaxed) state that is larger than the surrounding anatomical structures (at least in one direction, i.e., a ring height that is larger than the height of the ventricle, or a ring width that is larger than the width of the ventricle wall). As a result, the surrounding anatomical structures limit the expansion of the annular ventricular anchors 230A and 230B, and the annular ventricular anchors 230A and 230B apply a force to the surrounding anatomical structures (and vice versa). In addition, the narrowing of the ventricular wall 27 in a subannular to apical direction compresses the annular ventricular anchors 230A and 230B, generates a reverse radial force, and guides the annular ventricular anchors 230A and 230B to stabilize themselves at the sub-leaflet ventricular hinge level (i.e., at the level of the subannular surface 25) (wherein, optionally, the annular ventricular anchors 230A and 230B are also used to grasp the target native leaflet 26 in some configurations, optionally in combination with the native leaflet grasping forceps 240A and 240B, respectively, described below).

[0323] The coaptation assist devices 220A and 220B also include new leaflets 232A and 232B, respectively, each of which includes a woven flat sheet 217 (in Fig. 8A Displayed and marked in Figure 8B 20B because it is covered by a neo-leaflet cover 238, as described below). The neo-leaflet 232B of the coaptation assist device 220B further includes a neo-leaflet cover 238 that covers all or a portion of the woven flat sheet 217. The neo-leaflet cover 238 may include a synthetic material or biological material impregnated into the braid of the woven flat sheet 217, or may include a separate synthetic flat sheet material or biological flat sheet material attached to the woven flat sheet 217. The neo-leaflet cover 238 may be implemented as shown in FIG. Figures 1A to 1E and Figure 2 Any features of the new leaflet cover 238 described above may be used mutatis mutandis.

[0324] For some applications, the coaptation assist devices 220A and 220B also include native leaflet grasping forceps 240A and 240B, respectively, which include one or more braided flat sheets 219 (in Fig. 8A Displayed and marked in Figure 8BThe natural leaflet grasping forceps 240B of the coaptation assist device 220B further include one or more grasping forceps covers 244 that cover all or a portion of the braided flat sheet 219. The one or more grasping forceps covers 244 can achieve the purpose of referring to Figures 1A to 1E and Figure 2 Any features of the gripper cover 44′ described above may be used mutatis mutandis.

[0325] For some applications, engagement assist device 220B includes only a subset of the covers described above.

[0326] For some applications, the new leaflets 232A and 232B are configured such that the coaptation surface 34 is generally static throughout a cardiac cycle of the subject after the coaptation assist device 220A and 220B, respectively, is implanted in a heart of the subject, such as described above with respect to the coaptation assist device 20. For some of these applications, the new leaflets 232A and 232B include a plurality of reinforcement elements thereon and / or extend from the free edges of the new leaflets 232A and 232B, respectively, to the braid of the annular ventricular anchors 230A and 230B, respectively, via a plurality of wires, a plurality of coaptation wires, or a plurality of rods after implantation. Such techniques help prevent the new leaflets 232A and 232B from moving into the atrium during a cardiac cycle.

[0327] For other applications, the new leaflets 232A and 232B are respectively configured such that after the coaptation assist devices 220A and 220B are implanted in a heart of the subject, such as described above with respect to the coaptation assist device 20, the coaptation surface 34 moves toward and away from the one or more relative native leaflets 28 during a cardiac cycle of the subject.

[0328] See now 9A to 9H , 9A to 9H is a schematic diagram of a method for implanting the coaptation assist device 20 in a heart of a subject according to an application of the present invention. Although the method is shown for the coaptation assist device 20, it can also be used to implant other coaptation assist devices described herein, with the necessary changes in details. In addition, the native valve 22 shown is a tricuspid valve 300, and the method can also be modified to treat the mitral valve 302.

[0329] like Fig.9A As shown, the coaptation assist device 20 is delivered percutaneously (intravascularly) to a heart of the subject, and the coaptation assist device 20 is removably disposed in a delivery tube 304 of a delivery system in a compressed configuration. For some applications, the coaptation assist device 20 is extended and flattened into a shape such as Figure 1EThe delivery tube 304 is loaded into the delivery tube 304 in the compressed configuration and then further radially compresses (e.g., curls) the device. For example, the delivery tube 304 can be advanced into the right atrium 310 through the inferior vena cava or the superior vena cava. For applications where the coaptation assist device 20 is used to treat the mitral valve 302, the delivery tube 304 can be advanced transseptally into a left ventricle 314 using a transseptal advancement technique known in the art. Alternatively, the coaptation assist device 20 is delivered in a minimally invasive procedure.

[0330] The delivery system typically includes a delivery tube 304 and optionally one or more additional tubes. One or more tubes are steerable (e.g., two are steerable, one for trajectory and the other for positioning). Optionally, the coaptation assist device 20 is partially disposed in the delivery tube 304 and partially disposed in another tube to allow sequential deployment of multiple components of the coaptation assist device 20. For a delivery tube 304 configured with the coaptation assist device 20 fully disposed therein, typically the annular ventricular anchor 30 is disposed within the tube more distally than the new leaflet 32 ​​(i.e., closer to the distal end of the tube) to allow the annular ventricular anchor 30 to be deployed from the tube before the new leaflet 32 ​​is configured. Alternatively, the configuration is reversed to allow the new leaflet 32 ​​to be deployed from the tube before the annular ventricular anchor 30 is deployed.

[0331] like 9A to 9C As shown, the annular ventricular anchor 30 is deployed from the delivery tube 304 and positioned in the ventricle 23 (the right ventricle in the method shown) so that the anchor wire ring 50 is located between the ventricular apex region 24 and the sub-annulus 25 ( Fig. 9B 2 and later figures) so that the anchor wire loop 50 remains anchored in place against surrounding anatomical structures, including the subannulus 25, the ventricular wall 27, and the ventricular apex region 24. Typically, the annular ventricular anchor 30 is deployed by withdrawing the delivery tube 304 proximally and / or pushing the annular ventricular anchor out of the delivery tube 304.

[0332] For some applications, the annular ventricular anchor 30 is positioned so that the anchor loop wire loop 50 is maintained in place by the force applied to the surrounding anatomical structure by the anchor loop wire loop 50. Alternatively or additionally, for some applications, the annular ventricular anchor 30 is positioned so that the anchor loop wire loop 50 is maintained in place by friction between the anchor loop wire loop 50 and the surrounding anatomical structure.

[0333] For some applications, annular ventricular anchor 30 is configured to be atraumatic, and positioning annular ventricular anchor 30 does not include penetrating tissue of surrounding anatomical structures with annular ventricular anchor 30. For some applications, the method of deployment does not include penetrating tissue with any of the multiple components of coaptation assist device 20. Alternatively, tissue is penetrated, such as described below. Figure 21 to Figure 22 As described above, or having a barb disposed along at least a portion of the anchor loop 50 (e.g., barb 301J, such as Figure 3J shown).

[0334] For some applications, such as 9A to 9H As shown, the target native leaflet 26 is the native septal leaflet of the tricuspid valve 300, and the ventricular wall 27 is the ventricular septal wall. The new leaflet 32 ​​is positioned so that when the anchor wire ring 50 is positioned in the ventricle 23 and remains anchored against the surrounding anatomical structures, including the subannulus 25, the ventricular septal wall 27, and the ventricular apical region 24, the new leaflet 32 ​​at least partially replaces the function of the septal leaflet by providing a surface 34 for engagement with one or more opposing native posterior leaflets and the native anterior leaflet of the tricuspid valve.

[0335] For other applications, the native valve 22 is a mitral valve 302, and the new leaflet 32 ​​is positioned so that when the anchoring wire ring 50 is positioned in the ventricle 23, the new leaflet 32 ​​at least partially replaces the function of the target native leaflet 26 by providing a coaptation surface 34 for the opposing native leaflet of the mitral valve. For some of these applications, the target native leaflet 26 is the native anterior leaflet of the mitral valve 302, the ventricular wall 27 is a ventricular septal wall, and the new leaflet 32 ​​is positioned so that when the anchoring wire ring 50 is positioned in the ventricle 23 and remains anchored in position against the surrounding anatomical structures, including the annular inferior surface 25, the ventricular septal wall 27, and the ventricular apical region 24, the new leaflet 32 ​​at least partially replaces the function of the native anterior leaflet by providing a coaptation surface 34 for an opposing native posterior leaflet of the mitral valve 302.

[0336] like FIG. 9F to FIG. 9H As shown, the new leaflets 32 are deployed from the delivery tube 304 and positioned so that when the anchor wire loop 50 is positioned in the ventricle 23, the new leaflets 32 at least partially replace the function of the target native leaflets 26 by providing an engagement surface 34 for one or more opposing native leaflets 28 that are opposed to the target native leaflets 26. As described above, the new leaflets 32 are supported by the annular ventricular anchor 30. Typically, the annular ventricular anchor 30 is deployed by withdrawing the delivery tube 304 proximally.

[0337] Although the annular ventricular anchor 30 is shown and described as being deployed before the neoleaflets 32, in some configurations, the order of deployment is reversed (configuration not shown).

[0338] For some applications, such as Figures 9F to 9H As shown, when the anchor wire ring 50 is positioned in the ventricle 23, the new leaflet 32 ​​is positioned so that the engagement surface 34 of the new leaflet 32 ​​crosses from an atrial side to a ventricular side of a native valve plane, so that the native leaflet 28 engages with the new leaflet 32 ​​during the cardiac cycle, and the atrial surface of the natural leaflet 28 contacts the atrial surface 345 of the new leaflet, thereby preventing blood from flowing from the ventricle to the atrium during the heart's contraction phase.

[0339] For some applications, such as FIG. 9C to FIG. 9E As shown, the deployment method further includes positioning native leaflet grasping forceps 40 to grasp the atrial and ventricular surfaces of the target native leaflets 26 to support the new leaflets 32 and orient the new leaflets 32 relative to the native valve 22, 300. In the method shown, the native leaflet grasping forceps 40 are positioned after positioning the annular ventricular anchor 30 and before positioning the new leaflets 32. Alternatively, the native leaflet grasping forceps 40 are positioned at a different point in the deployment method.

[0340] For some applications, such as FIG. 9D to FIG. 9H (exist Figure 9H Marked in (and in Figure 2 As shown in FIG. 2 , positioning the native leaflet grasping forceps 40 to grasp the atrial surface and the ventricular surface of the target native leaflet 26 includes the steps of: clamping at least a portion of the atrial surface and the ventricular surface of the target native leaflet 26 between the first portion 42A and the second portion 42B of the native leaflet grasping forceps 40. For some applications, such as FIG. 9D to FIG. 9H (exist Figure 9H Marked in (and in Figure 2 As shown in FIG. 2 , sandwiching at least a portion of the atrial surface and the ventricular surface of the target native leaflet 26 comprises the steps of: sandwiching at least a portion of the atrial surface and the ventricular surface of the target native leaflet 26 between the first portion 42A and the second portion 42B of the native leaflet grasping forceps 40, and folding the first portion 42A and the second portion 42B of the native leaflet grasping forceps 40 toward each other to grasp the atrial surface and the ventricular surface of the target native leaflet 26. For some of these applications, such as FIG. 9D to FIG. 9H (exist Figure 9H Marked in (and in Figure 2 As shown in the figure, folding the first part 42A and the second part 42B of the natural leaflet grasping forceps 40 toward each other includes the steps of: extending a third part 42C defined by the natural leaflet grasping forceps 40 around the free edge of the target natural leaflet 26 at a fold between the first part 42A and the second part 42B of the natural leaflet grasping forceps 40.

[0341] For some applications, such as 9A to 9CAs shown, the annular ventricular anchor 30 is positioned such that the anchor wire loop 50 remains anchored against the subannulus 25 , the ventricular septal wall 27 , and one or more ventricular papillary muscles 46 of the ventricular apical region 24 .

[0342] See now FIG. 10A to FIG. 10C , which is a schematic diagram of a joint assisting device 120A according to an application of the present invention. FIG. 10D to FIG. 10F , FIG. 10D to FIG. 10F is a schematic diagram of a joint assisting device 120B according to an application of the present invention. Figure 10G , Figure 10G is a schematic diagram of a coaptation assist device 120A implanted in a native valve 22 according to an application of the present invention. FIG. 11A to FIG. 11D , FIG. 11A to FIG. 11D 1 is a schematic diagram of a joint assisting device 120C according to an application of the present invention. Figures 1A to 1E and Figure 2 The described joint assist device 20 is similar to the described joint assist device 20, and like reference numerals refer to like parts. The joint assist devices 120A, 120B, and 120C may implement any of the features of the joint assist device 20, mutatis mutandis, including those described above with reference to the above. FIG. 3A to FIG. 3K The features described and those mentioned above are FIG. 4A to FIG. 4B Features described.

[0343] The coaptation assist devices 120A, 120B, and 120C include an annular ventricular anchor 130. Typically, the annular ventricular anchor 130 includes an anchor loop 150, and a distal portion of the anchor loop 150 defines at least a portion of a boundary of the annular ventricular anchor. The anchor loop 150 may implement any of the features of the anchor loop 50, as described above with reference to FIG. Figures 1A to 1E , Figure 2 and FIG. 3A to FIG. 3K , making necessary changes in the details.

[0344] The coaptation assist devices 120A, 120B, and 120C further include neo-valve leaflets 132A, 132B, and 132C, respectively, supported by an annular ventricular anchor 130. The annular ventricular anchor 130 is disposed distally of the neo-valve leaflets.

[0345] The new leaflets 132A, 132B, and 132C are configured to at least partially replace the function of the target native leaflets 26 by providing an engagement surface 34 for one or more opposing native leaflets 28 opposing the target native leaflets 26 when the anchor wire loop 150 is positioned in the ventricle 23. The new leaflets 132A, 132B, and 132C are generally configured to cover at least a portion of the target native leaflets 26.

[0346] For some applications, new leaflets 132A, 132B, and 132C include new leaflet wire rings 136A, 136B, and 136C, respectively, which define portions of the respective peripheries of the new leaflets, and new leaflet covers 138A, 138B, and 138C are connected to the new leaflet wire rings 136A, 136B, and 136C, respectively. Typically, the new leaflet covers provide the above-mentioned engagement surface 34. New leaflet covers 138A, 138B, and 138C can implement any of the features of the new leaflet cover 38, as described above. Figures 1A to 1E and Figure 2 As described above, mutatis mutandis. In the illustrated configuration, the neo-leaflet wire rings 136A, 136B, and 136C are formed as open rings that are open proximally in the direction of the annular ventricular anchor 130 and the native leaflet grasping forceps 140A, 140B, and 140C, respectively, as described below. (Each ring is considered open even if it is bounded by a line that also defines a portion of the native leaflet grasping forceps, because the portion of the line that defines the ring is open.) Alternatively, as Figures 1A to 1E As shown in FIG. 1 , the new leaflet wire rings 136A, 136B, and 136C are formed into closed rings (the configuration of the coaptation assist devices 120A, 120B, and 120C is not shown). The new leaflet wire rings 136A, 136B, and 136C can implement any of the features of the new leaflet wire ring 36, as described above with reference to FIG. Figures 1A to 1E and Figure 2 as described above, mutatis mutandis to the details.

[0347] The coaptation assist devices 120A, 120B and 120C also include native leaflet grasping forceps 140A, 140B and 140C, respectively, which are configured to grasp the atrial surface 345 and ventricular surface 343 of the target native leaflets 26 to support the new leaflets 132A, 132B and 132C and orient the new leaflets relative to the native valve 22.

[0348] For some applications, native leaflet grasping forceps 140A, 140B, and 140C include one or more grasping forceps covers 144A, 144B, and 144C, respectively. The one or more grasping forceps covers respectively collectively include one or more biocompatible thin sheets of material (optionally, the same one or more sheets of material (e.g., exactly the same one sheet of material) define both the new leaflet covers 138A, 138B, and 138C as described above and the one or more grasping forceps covers 144A, 144B, and 144C; or, separate sheets of material define the new leaflet covers 138A, 138B, and 138C and the one or more grasping forceps covers 144A, 144B, and 144C). Typically, at least one of the one or more grasping forceps covers pushes against the atrial surface 345 of the target native leaflet 26 to prevent blood flow between the target native leaflet and the coaptation assist device. For some of these applications, one or more capture forceps covers 144A, 144B, and 144C extend across a space and partially or completely occupy a space that is at least partially surrounded by frames 145A, 145B, and 14C of the native leaflet capture forceps covers 144A, 144B, and 144C, respectively, which may include one or more wires that may be part of a portion of the new leaflet wire rings 136A, 136B, and 136C described above. Typically, the one or more biocompatible sheet materials are soft and non-traumatic. The one or more biocompatible sheet materials may include a synthetic material or a biological tissue material, such as a fabric including a polymer or a biological material (e.g., polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), silicone, urethane, or pericardium).

[0349] For some applications, such as FIG. 10A to FIG. 10F and FIG. 11A to FIG. 11D As shown, the new leaflets 132A, 132B and 132C are connected to the annular ventricular anchor 130 via native leaflet grasping forceps 140A, 140B and 140C, respectively.

[0350] For some of these applications, for example FIG. 10A to FIG. 10F As shown, the anchor wire loop 150 of the annular ventricular anchor 130 is connected to the grabbing forceps covers 144A, 144B and 144C of the native leaflet grabbing forceps 140A, 140B and 140C, respectively, by passing through the openings defined by the grabbing forceps covers 144A, 144B and 144C. This configuration allows the annular ventricular anchor 130 to pivot and slide relative to the native leaflet grabbing forceps 140A, 140B and 140C, and thus relative to the new leaflets 132A, 132B and 132C, respectively.

[0351] For other applications in these applications, such as FIG. 11A to FIG. 11D , the anchor wire loop 150 of the annular ventricular anchor 130 is connected to the frame 145C of the native leaflet grasping forceps 140. The anchor wire loop is fixed (e.g., welded) to the frame 145C, or may not be fixed to the frame 145C to allow the annular ventricular anchor 130 to pivot and slide relative to the native leaflet grasping forceps 140C, and therefore relative to the new leaflet 132C.

[0352] For some applications, each of the native leaflet grasping forceps 140A, 140B, and 140C is shaped to define a first portion 142A and a second portion 142B configured to grasp the atrial surface and the ventricular surface of the target native leaflet 26 by sandwiching at least a portion of the atrial surface 345 and the ventricular surface 343 of the target native leaflet 26 between the first portion and the second portion of the native leaflet grasping forceps. Typically, in such configurations, the second portion 142B is defined by the proximal portion of the anchor loop wire ring 150, while the first portion 142A is defined by the frames 145A, 145B, and 145C of the native leaflet grasping forceps 140A, 140B, and 140C, respectively, which are a portion of the new leaflet wire rings 136A, 136B, and 136C, respectively.

[0353] As described above, optionally, one or more grabber covers 144A, 144B, and 144C extend across and partially or completely occupy a space that is at least partially surrounded by frames 145A, 145B, and 144C, respectively (as shown). Typically, during a portion of the cardiac cycle, the grabber covers expand due to blood flow at these locations and abut against the ventricular surface of the target native leaflet 26 to prevent blood flow between the target native leaflet and the coaptation assist device.

[0354] Optionally, the one or more grabber forceps covers 144A and 144B extend across and partially or completely occupy a space at least partially surrounded by a proximal portion of the anchor loop wire loop 150 defining the second portion 142B (configuration not shown).

[0355] For some applications, such as FIG. 10A to FIG. 10C As shown, the new leaflet wire ring 136A is narrowed at a boundary 149 between the new leaflet 132A and the first portion 142A of the native leaflet grasping forceps 140A. This narrowing can reduce the interaction between the coaptation assist device and the surrounding anatomical structure.

[0356] For other applications, e.g. FIG. 10D to FIG. 10F and FIG. 11A to FIG. 11DAs shown, the new leaflet wire rings 136B and 136C do not narrow at the boundary 149 between the new leaflets 132B and 132C, respectively, and at the first portion 142A of the native leaflet grasping forceps 140B and 140C. This lack of narrowing can provide a larger contact surface between the grasping forceps caps 144B and 144C of the native leaflet grasping forceps 140B and 140C and the ventricular surface 343 of the target native leaflet 26, and / or a larger contact surface between the grasping forceps caps 144B and 144C of the native leaflet grasping forceps 140B and 140C, respectively, and / or a larger contact surface between the target native leaflet 26 and the ventricular surface 343 of the target native leaflet 26. FIG. 10A to FIG. 10C The configuration shown in , better gripping of the pliers cover expansion.

[0357] See also FIG. 11A to FIG. 11D . For some applications, the coaptation assist device 120C further includes a pouch 158 configured to be expanded by blood flow during a cardiac cycle so as to press the coaptation assist device 120C against the ventricular surface of the target native leaflet 26 and / or the annulus of the native valve 22, thereby stabilizing the coaptation assist device 120C relative to the native valve 22. For some applications, the pouch 158 is defined by a native leaflet grasping forceps 140C, such as by a ventricular-facing surface of a first portion 142A of the native leaflet grasping forceps 140C (this ventricular-facing surface is on a side of the first portion 142A, the side of the first portion 142A being opposite to a side of the first portion 142A configured to contact the atrial surface 345 of the target native leaflet 26). Optionally, other coaptation assist devices described herein, such as native leaflet grasping forceps of other coaptation assist devices, include the pouch 158, mutatis mutandis.

[0358] Now refer to Fig. Now refer to FIG. 12A to FIG. 12E and FIG. 13A to FIG. 13E , which are schematic diagrams of joint assisting devices 320A and 320B according to the corresponding applications of the present invention. Different from the following description, the joint assisting devices 220A and 220B are substantially similar to the above-mentioned reference Figure 1A To E and Figure 2 The coaptation assist device 20 is described above, and like reference numerals refer to like parts. Coaptation assist devices 320A and 320B, including their respective neo-valve leaflets and annular ventricular anchors, can implement any of the features of (a) coaptation assist device 20, mutatis mutandis, including those described above with reference to FIG. 3A to FIG. 3K The features described, and the above reference FIG. 4A to FIG. 4B The described features and / or (b) any features of other engagement assist devices described herein, mutatis mutandis.

[0359] See also Fig.14 and FIG. 15A to FIG. 15B , which are schematic diagrams of coaptation assist devices 320A and 320B implanted in the native valve 22 according to corresponding applications of the present invention.

[0360] Each of the coaptation assist devices 320A and 320B includes an annular ventricular anchor 330, which generally includes an anchor loop wire ring 350 that defines at least a portion of a boundary of the annular ventricular anchor. The annular ventricular anchor 330 and the anchor loop wire ring 350 can implement any of the features of the annular ventricular anchors and anchor loop wire rings described herein, mutatis mutandis. The coaptation assist devices 320A and 320B also include neoleaflets 332A and 332B, respectively, which can implement any of the features of the neoleaflets described herein, mutatis mutandis. For some applications, the neoleaflets 332A and 332B include neoleaflet wire rings 336A and 336B, respectively, that define at least a portion of a boundary of the neoleaflets, and the neoleaflet covers 338A and 338B are connected to the neoleaflet wire rings 336A and 336B, respectively. The new leaflet wire rings 336A and 336B can implement any feature of the new leaflet wire rings described herein, making necessary changes in details, and the new leaflet covers 338A and 338B can implement any feature of the new leaflet covers described herein, making necessary changes in details, respectively.

[0361] Each of the coaptation assist devices 320A and 320B further includes a native leaflet grasping forceps 340, which includes one or more sub-native-leaflet supports 347 (e.g., two, as shown) that are configured to press against one or more portions of a ventricular surface 343 of the target native leaflet 26 when the annular ventricular anchor 330 is positioned in the ventricle 23.

[0362] For some applications, each of the neo-valve leaflets 332A and 332B extends directly from and is supported by the annular ventricular anchor 330. The annular ventricular anchor 330 is disposed distally of each of the neo-valve leaflets 332 and 332B.

[0363] For some applications, the native leaflet grasping forceps 340 further include one or more supra-annular supports 341 (e.g., two, as shown) configured to press against an atrial surface 345 of the target native leaflet 26 so that when the annular ventricular anchor 330 is positioned in the ventricle 23, one or more sub-native leaflet supports 347 and one or more supra-annular supports 341 clamp and grasp the target native leaflet 26.

[0364] For some applications, the annular ventricular anchor 330 is shaped to define two or more leaflets 352, such as exactly two leaflets 352 (as shown), such as to allow space for one of the plurality of papillary muscles 46 between the two leaflets when the annular ventricular anchor 330 is positioned in the ventricle 23. Alternatively, depending on the particular anatomy of the subject, variations thereof, one or more leaflets may allow space for other anatomical components, such as one or more chordae tendineae, or no anatomical component may utilize the space provided. Typically, the one or more leaflets 352 extend to a distal end 354 of the annular ventricular anchor 330. For some applications, the ventricular wall 27 is a ventricular septal wall, and the annular ventricular anchor 330 is configured to remain anchored in position against surrounding anatomical structures, including the subannulus 25, the ventricular septal wall 27, and one or more ventricular papillary muscles 46 at the ventricular apical region 24, when the annular ventricular anchor 330 is positioned in the ventricle 23.

[0365] For some applications, coaptation assist devices 320A and 320B include respective wire loops shaped to at least partially define both (a) neo-leaflets 332A and 332B, and (b) annular ventricular anchor 330 .

[0366] See also Fig.12D , Fig. 13C , Fig.14 and Fig.15A For some applications, coaptation assist devices 320A and 320B are configured such that when unconstrained (by application of any external force, including by the anatomical structure or delivery system), an angle alpha is defined between (a) an anchor-loop best-fit plane 362 defined by anchor-loop wire loop 350 and (b) a neo-leaflet best-fit plane 364 defined by neo-leaflet wire loops 336A and 336B. Typically, coaptation assist devices 320A and 320B are configured to automatically assume this angle; for example, multiple components of the device may include a shape memory alloy, such as nickel-titanium alloy, which is configured to cause the device to assume this angle when in a static, relaxed state, such as at 37 degrees Celsius (body temperature). Alternatively, neo-leaflet best-fit plane 364 is defined by the coaptation surfaces of neo-leaflets 332A and 332B, respectively.

[0367] For some applications, such as Fig.12D and Fig.14As shown, angle α (alpha) is at least 60 degrees (e.g., at least 80 degrees), no more than 100 degrees (e.g., no more than 90 degrees), and / or between 60 degrees (e.g., 80 degrees) and 100 degrees (e.g., 90 degrees). This range of angles positions the new leaflet 332A above (superior to) one or more opposing native leaflets 28, and therefore above the plane of coaptation of one or more opposing native leaflets 28 during systole, and toward the annulus level. As a result, one or more opposing native leaflets 28 coapt against the ventricular surface of the new leaflet 332A. This configuration is indicated in situations where one or more opposing native leaflets 28 prolapse or flail, particularly for mitral valve disease. When one or more opposing native leaflets 28 attempt to prolapse at the atrial or annulus level, the generally somewhat horizontal new leaflet 332A provides a coaptation surface for it.

[0368] For other applications, e.g. Fig. 13C and Fig.15A As shown, angle α (alpha) is at least 15 degrees (e.g., at least 35 degrees), no more than 50 degrees (e.g., no more than 45 degrees), and / or between 15 degrees (e.g., 35 degrees) and 50 degrees (e.g., 45 degrees). This range of angles positions the new leaflet 332B below one or more opposing native leaflets 28, and thus below its coaptation plane during systole, and tends to bring the tip ventricular of the new leaflet 332B below the free edge of one or more opposing native leaflets 28 when in systole. This configuration is suitable for functional diseases, such as leaflet binding and lack of leaflet coaptation in tricuspid and mitral valve diseases. In this configuration, the coaptation assist device 320B is configured so that when the annular ventricular anchor 330 is positioned in the ventricle 23, an coapted surface of the new leaflet 332B spans from an atrial side to a ventricular side of a native valve plane.

[0369] In either of these angular configurations, the new leaflets 332A and 332B can be flexible or rigid, and can optionally move (open / close) with the heartbeat in order to be effective.

[0370] See now FIG. 16A to FIG. 16F , FIG. 16A to FIG. 16F 4 is a schematic diagram of a joint assisting device 420 according to an application of the present invention. Figures 1A to 1E and Figure 2 The described coaptation assist device 20. The coaptation assist device 420, including its new valve leaflet and annular ventricular anchor, can implement any of the features of (a) the coaptation assist device 20, mutatis mutandis, including those described above with reference to FIG. 3A to FIG. 3K The features described, and the above reference FIG. 4A to FIG. 4BThe features described herein, and / or (b) any features of other engagement assist devices described herein, mutatis mutandis.

[0371] See also Fig.17 , Fig.17 FIG. 6 is a schematic diagram of a coaptation assist device 620 implanted in a native valve 22 according to an application of the present invention. Fig.17 In the particular implant shown, the native valve 22 is a tricuspid valve. Fig.19 is a cross-sectional view of the heart with the anterior portion of the heart including the native anterior leaflet of the tricuspid valve removed so that only the septal and posterior leaflets are shown.

[0372] The coaptation assist device 420 includes an annular ventricular anchor 430 that generally includes an anchor loop wire ring 450 that defines at least a portion of a boundary of the annular ventricular anchor. The annular ventricular anchor 430 and the anchor loop wire ring 450 may implement any of the features of the annular ventricular anchors and anchor loop wire rings described herein, mutatis mutandis.

[0373] For some applications, anchor loop 450 is shaped as a generally circular portion defining a distal end, such as at least 50% (e.g., at least 75%) of a length of anchor loop 450 detected around anchor loop 450. For other applications, anchor loop 450 has another shape, such as any shape of the annular ventricular anchors (and anchor loops generally) described herein.

[0374] Coaptation assist device 420 further includes a neo-leaflet 432, which may implement any of the features of the neo-leaflets described herein, mutatis mutandis. Annular ventricular anchor 430 is disposed distal to neo-leaflet 432. For some applications, neo-leaflet 432 includes a neo-leaflet wire ring 436 that defines at least a portion of a boundary of the neo-leaflet, and a leaflet cover 43 that is connected to neo-leaflet wire ring 436. (For clarity of description, the annular ventricular anchor 430 is disposed distal to neo-leaflet 432.) Fig. 16B ), the coaptation assist device 420 is shown without the neo-leaflet cover 438 and without the grasping forceps cover 444, as described below. ) The neo-leaflet wire ring 436 can implement any feature of the neo-leaflet wire ring described herein, mutatis mutandis, and the neo-leaflet cover 438 can implement any feature of the neo-leaflet cover described herein, mutatis mutandis, respectively.

[0375] For some applications, the new leaflet 432 is bent into a shield shape to better fit the annular area at the level of the target native leaflet. This shield shape can also provide an engagement surface 434 that can easily contact one or more opposing native leaflets 28.

[0376] The coaptation assist device 420 further includes a natural leaflet grasping forceps 440, which is formed to define a first part 442A and a second part 442B, and the first part 442A and the second part 442B are configured to grasp the atrial surface 345 and the ventricular surface 343 of the target natural leaflet 26 by clamping at least a portion of the atrial surface and the ventricular surface of the natural leaflet 26 between the first part and the second part of the natural leaflet grasping forceps 440.

[0377] For some applications, the second portion 442B of the native leaflet grasping forceps 440 includes one or more sub-native leaflet supports 447 (e.g., two, as shown) that are configured to press against one or more portions of the target native ventricular surface 343 when the anchoring ring wire loop 450 is positioned in the ventricle 23. For some applications, the sub-native leaflet supports 447 extend from the line of the anchoring ring wire loop 450, which narrows in a proximal direction. Optionally, the most proximal portion of the sub-native leaflet supports 447 is at approximately the same height as the most proximal portion of the new leaflet 432.

[0378] For some applications, the first portion 442A of the native leaflet grasping forceps 440 includes a grasping forceps cover 444 disposed between the new leaflet cover 438 and one or more sub-native leaflet supports 447. Typically, the grasping forceps cover 444 pushes against the atrial surface 345 of the target native leaflet 26 to prevent blood flow between the target native leaflet and the coaptation assist device. For some of these applications, the grasping forceps cover 444 extends across a space and partially or completely occupies a space that is at least partially surrounded by a frame 445 of the native leaflet grasping forceps 440, which may include one or more wires, which may be part of the wire loop described herein. (In Fig.16E and 16F The shading of the grabber cover 444 in FIG. 4 is for clarity of illustration and does not imply that the grabber cover 444 comprises a separate piece of material from the new leaflet cover 438 or a different type of material than the new leaflet cover 438, although it may be so. )

[0379] For some applications, neo-leaflets 432 are connected to annular ventricular anchor 430 via sub-native leaflet supports 447 and optionally one or more additional wire portions.

[0380] For some applications, the coaptation assist device 420 includes a coaptation assist device wire loop that is shaped to at least partially define (a) a new leaflet 432, (b) an anchor ring wire loop 450, (c) optionally, one or more sub-native leaflet supports 447, and (d) optionally, a frame 445 of a native leaflet grasping forceps 440.

[0381] For some applications, coaptation assist device 420 (e.g., neoleaflet cover 438) includes one or more (e.g., two) commissural pouches or parachutes 474 configured to expand and relax along with blood flow and pressure changes to provide a coaptation assist device similar to that described above. FIG. 11A to FIG. 11D In a similar manner to the bladder 158 described above, and / or the flexible parachute-like engagement surface described above. FIG. 11A to FIG. 11D The pockets 474 in Figures 4 and 5 originate at the same level on the new leaflet ring 436 and frame 445, so that each pocket 474 has a flat free edge. The pockets 474 in Figures E to F originate lower on the new leaflet ring 436 than on the frame 445 (closer to the tip of the new leaflet), resulting in an uneven free edge on each pocket 474. This difference in the junction point results in FIG. 18E to FIG. 18F The surface of the bag 474 in 18A to 18D The surface of the capsule 474 in the is higher. 18A to 18D As shown, the bladder can inflate more and cover a higher three-dimensional surface when inflated. A higher surface can lead to better filling of the commissure area, thereby reducing blood backflow in this area.

[0382] Now refer to Figure. FIG. 18A to FIG. 18F , which is a schematic diagram of a coaptation assist device 520 for treating a native valve 22 according to an application of the present invention. The native valve is typically an atrioventricular valve, i.e., a tricuspid valve or a mitral valve. For clarity, Fig.18B Not shown are the new leaflet cover 538 or the capture forceps cover 544, described below, even though the coaptation assist device 520 typically includes such components.

[0383] See also Fig.19 , which is a schematic diagram of a coaptation assist device 520 implanted in a native valve 22 according to an application of the present invention. Fig.19 In the particular implant shown, the native valve 22 is a tricuspid valve. Fig.19 is a cross-sectional view of a heart with the anterior portion of the heart including the native anterior leaflet of the tricuspid valve removed to show only the septum and posterior leaflets. Except as described below, coaptation assist device 520 is similar to the coaptation assist device described above and any of its features may be implemented mutatis mutandis.

[0384] The coaptation assist device 520 includes an annular ventricular anchor 530 and a neovalvular leaflet 532 extending directly from and supported by the annular ventricular anchor 530. The annular ventricular anchor 530 is disposed distally of the neovalvular leaflet 532. Typically, the annular ventricular anchor 530 includes an anchor wire ring 550 that defines at least a portion of a boundary of the annular ventricular anchor 530. The anchor wire ring 550 may implement any of the features of the anchor wire ring 50, as described above with reference to FIG. Figures 1A to 1E and Figure 2, making necessary changes in the details.

[0385] The anchor loop wire loop 550 is configured to (a) be positioned in the ventricle 23, extending to the ventricular apical region 24, and (b) remain anchored in position against surrounding anatomical structures, including the ventricular apical region 24 (optionally including one or more ventricular papillary muscles 46 of the ventricular apical region 24). In other words, the anchor loop wire loop 550 is configured to be located at the top. Optionally, the surrounding anatomical structures to which the anchor loop wire loop 550 is anchored further include one or more of the following: an adjustment band, one or more chordae tendineae, and one or more papillary muscles on the opposite side of the ventricle 23.

[0386] Typically, the coaptation assist device 520 is configured such that when the anchor loop wire loop 550 is positioned in the ventricle 23, the anchor loop wire loop 550 does not extend to (and therefore does not contact) a sub-annulus 25 of a target native leaflet 26. Typically, positioning the annular ventricular anchor 530 in the ventricle 33 includes the steps of positioning the annular ventricular anchor 530 in the ventricle 33 such that the anchor loop wire loop 550 does not extend to (and therefore does not contact) a sub-annulus 25 of a target native leaflet 26 of the native valve 22.

[0387] For some applications, the joint assist device 520 does not include any components configured to penetrate (eg, pierce) tissue. For other applications, the joint assist device 520 includes at least one component configured to penetrate tissue, as described below. FIG. 20A to FIG. 20B described.

[0388] When the anchor wire ring 550 is positioned in the ventricle 23 , the new leaflet 532 is configured to at least partially replace the function of the target native leaflet 26 of the native valve 22 by providing an engaging surface 534 for one or more opposing native leaflets 28 that are opposite the target native leaflet 26 .

[0389] For some applications, the new leaflet 532 includes a new leaflet wire ring 536 that defines at least a portion of a boundary of the new leaflet, and a new leaflet cover 538 that is connected to the new leaflet wire ring 536 and provides the engagement surface 534. The new leaflet wire ring 536 and the new leaflet cover 538 can respectively implement any of the features of the new leaflet wire ring 36 and the new leaflet cover 38, as described above. Figures 1A to 1E and Figure 2 , making necessary changes in the details.

[0390] Typically, the anchor loop wire loop 550 is configured to remain anchored in place by a force applied by the anchor loop wire loop 550 to the surrounding anatomical structure (typically a force directed radially outward), and / or by friction between the anchor loop wire loop 550 and the surrounding anatomical structure. For some applications, the anchor loop wire loop 550 includes a self-expanding material, such as a shape memory alloy (e.g., Nitinol), which causes the anchor loop wire loop 550 to expand radially outward to apply the force. For such applications, the anchor loop wire loop 550 is typically configured to have a shape that is larger than the surrounding anatomical structure in its resting (relaxed) state, such that the surrounding anatomical structure limits expansion of the anchor loop wire loop 550, and the anchor loop wire loop 550 applies force to the surrounding anatomical structure (and vice versa).

[0391] Typically, the annular ventricular anchor 530 is configured to be atraumatic so as not to penetrate tissue of the surrounding anatomy.

[0392] For some applications, the coaptation assist device 520 further includes a natural leaflet grasping forceps 540, which is formed to define a first portion 542A and a second portion 542B, and the first portion 542A and the second portion 542B are configured to grasp the atrial surface 345 and the ventricular surface 343 of the target natural leaflet 26 by clamping at least a portion of the atrial surface and the ventricular surface of the target natural leaflet 26 between the first portion and the second portion of the natural leaflet grasping forceps 540, respectively, to support the new leaflet 532 and orient the new leaflet 532 relative to the natural valve 22.

[0393] For some applications, as shown, native leaflet grasping forceps 540 are connected to annular ventricular anchor 530 via neo leaflets 532 .

[0394] For some applications, the second portion 542B of the native leaflet grasping forceps 540 includes one or more sub-native leaflet supports 547 that are configured to press against one or more portions of the ventricular surface of the target native leaflet 26 when the anchor wire ring 550 is positioned in the ventricle 23.

[0395] For some applications, the first portion 542A of the native leaflet grasping forceps 540 includes a grasping forceps cover 544 disposed between the new leaflet cover 538 and one or more sub-native leaflet supports 547. Typically, the grasping forceps cover 544 pushes against the atrial surface 345 of the target native leaflet 26 to prevent blood flow between the target native leaflet and the coaptation assist device. For some of these applications, the grasping forceps cover 544 extends across a space and partially or completely occupies a space that is at least partially surrounded by a frame 545 of the native leaflet grasping forceps 540, which may include one or more wires that may be portions of the wire loops described above. ( Fig.18C , 18EThe shading of the grabber cover 544 in 18F and 18F is for clarity of illustration and does not imply that the grabber cover 544 comprises a separate piece of material from the new leaflet cover 538 or a different type of material than the new leaflet cover 538, although it may be so.)

[0396] For some applications, the native leaflet grasping forceps 540 further include one or more native annulus supports 541, which are configured to further support the new leaflet 532 against the native annulus. Optionally, the native leaflet grasping forceps 540 further include a native-annulus-support cover 551 (native-annulus-support cover) (in Fig.18F ), which partially or completely occupies a space that is at least partially surrounded by one or more native-annulus supports 541 and additionally provides a seal to prevent blood flow between the target native leaflets and the coaptation assist device. For some applications, one or more native-annulus supports 541 extend from the new leaflet wire ring 536 in a direction opposite to the direction in which the coaptation surface 534 points.

[0397] Typically, the engagement assist device 520 is configured such that when the anchor wire ring 550 is positioned in the ventricle 23 and the native leaflet grasping forceps 540 grasp the atrial surface 345 and the ventricular surface 343 of the target native leaflet 26, respectively, the anchor wire ring 550 does not extend to (and therefore does not contact) the sub-annular surface 25 of a target native leaflet 26 of the native valve 22.

[0398] For some applications, when anchor wire loop 550 is positioned in ventricle 23 , anchor wire loop 550 is configured to abut against one or more ventricular papillary muscles 46 at ventricular apical region 24 , maintaining the anchor in place.

[0399] For some applications, coaptation assist device 520 includes a coaptation assist device wire loop shaped to at least partially define neo-leaflet wire loop 536 and anchor ring wire loop 550 .

[0400] Typically, the anchor wire loop 550 is larger than the new leaflet wire loop 536 .

[0401] For some applications, anchor wire ring 550 is more flexible than new leaflet wire ring 536 (eg, by including thinner wires).

[0402] For some applications, anchor wire ring 550 is generally flat and new leaflet wire ring 536 is shaped to define a curved engagement surface 534 .

[0403] See also Fig.18F. For some applications, the coaptation assist device 520 is configured such that when unconstrained (by the application of any external force, including by the anatomical structure or the delivery system), an angle β (beta) is defined between (a) an anchor ring best fit plane 562 defined by the anchor ring wire loop 550 and (b) a new leaflet best fit plane 564 defined by the coaptation surface 534 of 532. Typically, the angle β (beta) is less than 20 degrees. Alternatively, the anchor ring best fit plane 562 and the new leaflet best fit plane 564 are parallel to each other. Typically, the coaptation assist device 520 is configured to automatically assume this angle; for example, a component of the device may include a shape memory alloy, such as a nickel-titanium alloy, which is configured to cause the device to assume this angle when in a static, relaxed state, such as at 37 degrees Celsius (body temperature). As used in this application, including in multiple claims and multiple inventive concepts, the "best-fit plane" defined by the joining surface 534 is the plane that best matches the shape of the wire loop (even if the joining surface is generally curved), that is, the plane that results in the smallest sum of the squares of the distances between the plane and the joining surface.

[0404] In one application of the present invention, a joint assist device is provided, which is a hybrid of the joint assist device 520, as described above. FIG. 18A to FIG. 18F , and one of the joint assist devices 220A and 220B, as described above see FIG. 8A to FIG. 8B The annular ventricular anchor of the coaptation assist device includes a braided sheet comprising a plurality of braided wires, as shown in coaptation assist devices 220A and 220B, rather than anchor wire loop 550. The coaptation assist device may implement any of the features of coaptation assist device 520, coaptation assist device 220A, and / or coaptation assist device 220B, mutatis mutandis.

[0405] See now FIG. 20A to FIG. 20B , which is a schematic diagram of a coaptation assist device 620 for treating a native valve 22 according to an application of the present invention. Except as described below, the coaptation assist device 620 is similar to the above-mentioned FIG. 18A to FIG. 18F and Fig.19 The described engagement assist device 520 is identical and like reference numerals refer to like parts. The features of the engagement assist device 620 may also be implemented with any anchor loop line loop described herein, mutatis mutandis.

[0406] An anchor wire loop 650 of an annular ventricular anchor 630 of the coaptation assist device 620 includes a distal-most portion 680 that curves away from a best fit plane 682 defined by sides 684A and 684B of the anchor wire loop 650 when the anchor wire loop 650 is unconstrained (by application of any external force, including by the anatomical structure or the delivery system) such that the distal-most portion 680 curves away from the ventricular wall 27 when the anchor wire loop 650 is positioned in the ventricle 23. Optionally, a distal-most end 686 of the distal-most portion 680 is partially proximally directed in a direction toward the neo-leaflet 532. Such curvature of the distal-most portion 680 may help the anchor wire loop 650 accommodate different ventricular lengths.

[0407] See now Fig.21 , which is a schematic diagram of a coaptation assist device 720 for treating a native valve 22 according to an application of the present invention. Coaptation assist device 720 may implement any of the features of other coaptation assist devices described herein, mutatis mutandis.

[0408] See also Fig. 22 , which is a schematic diagram of a coaptation assist device 720 implanted in a native valve 22 according to an application of the present invention. Fig. 22 In the particular implant shown, the native valve 22 is a tricuspid valve. Fig. 22 is a cross-sectional view of a heart in which an anterior portion of the heart including the native anterior leaflet of the tricuspid valve is removed so that only the septal and posterior leaflets are shown.

[0409] The coaptation assist device 720 includes an annular ventricular anchor 730, that is, a ventricular anchor with an annular boundary, and a new valve leaflet 732 supported by the annular ventricular anchor 730. The annular ventricular anchor 730 is disposed at the distal side of the new valve leaflet 732.

[0410] Typically, the annular ventricular anchor 730 includes an anchor loop wire ring 750 that defines at least a portion of a boundary of the annular ventricular anchor. The annular ventricular anchor 730 and the anchor loop wire ring 750 can implement any of the features of the annular ventricular anchor and the anchor loop wire ring described herein, respectively, with changes in detail. Typically, the annular ventricular anchor 730 is configured to be atraumatic so as not to penetrate (e.g., puncture) the set of surrounding anatomical structures. To this end, the annular ventricular anchor 730 typically does not include a plurality of any exposed sharp components that can penetrate tissue.

[0411] The anchor wire loop 750 is configured to be positioned in the ventricle 23, extending between the ventricular apical region 24 (at the bottom of the ventricle 23) and the subannular surface 25 of the target native leaflet 26 of the native valve 22. Fig. 22As shown, the anchor wire ring 750 is configured to remain anchored in position against surrounding anatomical structures, including the subannulus 25, the ventricular wall 27, and the ventricular apical region 24. In other words, the anchor wire ring 750 is configured to be fixed below and behind the target native leaflet 26, in contact with the subannulus 25, in place at the apex, and stabilized by the ventricular wall 27. Typically, the anchor wire ring 750 is configured to pass behind or through the ventricular papillary muscle 46 of the ventricular apical region 24. Optionally, the surrounding anatomical structure to which the anchor wire ring 750 is anchored further includes one or more of the following: an adjustment band, one or more chordae tendineae, and one or more papillary muscles on the opposite side of the ventricle 23.

[0412] like Fig. 22 As shown, when the anchor wire loop 750 is positioned in the ventricle 23, the new leaflet 732 is configured to at least partially replace the function of the target native leaflet 26 by providing an engaging surface 734 for one or more opposing native leaflets 28 opposing the target native leaflet 26. The new leaflet 732 is generally configured to cover at least a portion of the target native leaflet 26, and any of the features of the new leaflet described herein can be implemented, with the necessary changes in detail.

[0413] Coaptation assist device 720 further includes a native-leaflet-crossing portion 790 that is configured to be positioned through a puncture of the target native leaflet 26 (even though the annular ventricular anchor 730 itself is configured to be atraumatic, i.e., not to penetrate the surrounding ventricular anatomy, as described above). The neo-leaflet 732 is connected to the annular ventricular anchor 730 via the native-leaflet-crossing portion 790. For some applications, as shown, coaptation assist device 720 includes a coaptation assist device wire loop 792 that is shaped to at least partially define the neo-leaflet 732, the annular ventricular anchor 730, and the native-leaflet-crossing portion 790.

[0414] For some applications, the bonding assist device 720 can be extended and planarized into an elongated planarized configuration similar to Figure 1E . After being planarized, the joint assist device 720 can be rolled and then loaded into the delivery tube 304 for use as described above with reference to 9A to 9H The transportation described above is as such, mutatis mutandis.

[0415] See above 9A to 9HUnlike the delivery method described, during delivery of the annular ventricular anchor 730, a delivery system (e.g., a needle thereof) is used to form a perforation 974 through the target native leaflet 26, typically at or near the center of the native annulus. The annular ventricular anchor 730 is passed from the atrium through the perforation 794 to the ventricular side of the native leaflet (typically while still disposed in the delivery tube 304), and is deployed from the delivery tube and allowed to expand in the ventricle. Subsequently, the new leaflet 732 is deployed from the delivery tube into the ventricle, on the atrial side of the native leaflet, such that the new leaflet covers at least a portion of the atrial surface of the target native leaflet 26.

[0416] Fig.23 is a schematic diagram of a coaptation assist device implanted in a native mitral valve 22 according to an application of the present invention.

[0417] Although the coaptation assist device described herein has been described as being configured to treat a native atrioventricular valve, it may alternatively be configured to treat other native valves, such as an aortic valve or a pulmonary valve. For some such applications, the annular ventricular anchor is placed inverted, the anchor wire ring is placed in the outflow artery, i.e., in the aortic root and the pulmonary artery, respectively, and the grasping forceps grasp one of the multiple tips of the native valve.

[0418] The scope of the present invention includes the embodiments described in the following applications, which have been assigned to the assignee of the present application and are incorporated herein by reference. In one embodiment, the techniques and devices described in one or more of the following applications are combined with the techniques and devices described herein:

[0419] US Patent Application Publication 2016 / 0302917

[0420] U.S. Patent Application Publication 2019 / 0350705

[0421] Those skilled in the art will appreciate that the present invention is not limited to what is specifically shown and described above. Rather, the scope of the present invention includes combinations and sub-combinations of the various features described above, as well as changes and modifications thereof that are not prior art, which will occur to those skilled in the art after reading the foregoing description.

Claims

1. A coaptation assist device for treating a native atrioventricular valve of a subject, characterized in that: The engagement assist device comprises: an annular ventricular anchor comprising an anchor wire loop that (i) defines at least a portion of a boundary of the annular ventricular anchor and (ii) is configured to (a) be positioned in a ventricle, extending between a ventricular apical region and a subannulus of a target native leaflet of the native atrioventricular valve, and (b) remain anchored in position against surrounding anatomical structures, including the subannulus, a ventricular wall, and the ventricular apical region; and A new leaflet is supported by the annular ventricular anchor and is configured to at least partially replace the function of the target native leaflet by providing an engaging surface for one or more opposing native leaflets opposite the target native leaflet when the anchor loop is located in the ventricle.

2. The joining assisting device according to claim 1, characterized in that: The annular ventricular anchor is configured to apply force to the surrounding anatomical structure via the anchor wire loop to maintain the anchor in place.

3. The joining assisting device according to claim 2, characterized in that: The annular ventricular anchor is configured to apply a radially outwardly directed force to the surrounding anatomical structure via the anchor wire loop to maintain the anchor in place.

4. The joining assisting device according to claim 1, characterized in that: The annular ventricular anchor is configured to remain anchored in place by friction between the anchor wire loop and the surrounding anatomical structure.

5. The joining assisting device according to claim 1, wherein: The annular ventricular anchor is configured to be atraumatic so as not to penetrate tissue of the surrounding anatomy.

6. The joining assisting device according to claim 1, wherein: The coaptation assist device does not include any components configured to penetrate tissue.

7. The joining assisting device according to claim 1, wherein: The anchor wire loop is shaped as a closed loop that defines a complete boundary of the annular ventricular anchor.

8. The joining assisting device according to claim 1, wherein: The anchor loop wire loop comprises metal.

9. The joining assisting device according to claim 1, wherein: When the anchor loop is unconstrained, the anchor loop is bent along at least 50% of a length of the anchor loop, the length being detected around the anchor loop.

10. The joining assisting device according to claim 9, characterized in that: When the anchor loop line loop is unconstrained, the anchor loop line loop is bent along at least 75% of the length of the anchor loop line loop.

11. The joining assisting device according to claim 1, wherein: When the anchor loop is unconstrained, the anchor loop is shaped to be at least 75% of an oval.

12. The joining assisting device according to claim 1, wherein: The annular ventricular anchor further includes at least one support wire connected to the anchor wire loop at two locations on the anchor wire loop.

13. The joining assisting device according to claim 1, characterized in that: When the anchor loop wire ring is positioned in the ventricle, the anchor loop wire ring is configured to remain anchored in position against the subannulus, the ventricular wall, and one or more ventricular papillary muscles of the ventricular apical region.

14. The joining assisting device according to claim 1, wherein: The anchor wire ring is shaped to define two or more lobes.

15. The joining assisting device according to claim 14, characterized in that: The anchor wire ring is shaped to define exactly two lobes.

16. The joining assisting device according to claim 1, wherein: The neo-leaflet is configured such that, following implantation of the coaptation assist device in a heart of the subject, the coaptation surface is generally static throughout a cardiac cycle of the subject.

17. The joining assisting device according to claim 1, wherein: The neo leaflet is configured such that, following implantation of the coaptation assist device in a heart of the subject, the coaptation surface moves toward and away from the one or more opposing native leaflets during a cardiac cycle of the subject.

18. The joining assisting device according to claim 1, wherein: The neo-valve leaflets extend directly from the annular ventricular anchor.

19. The joining assisting device according to claim 1, wherein: The bonding surface has a width between 2 cm 2 With 20cm 2 An area between.

20. The joining assisting device according to claim 1, wherein: The anchor loop includes a distal-most portion that curves away from a best fit plane defined by the plurality of lateral portions of the anchor loop when the anchor loop is unconstrained.

21. The joining assisting device according to claim 1, characterized in that: The anchor wire loop includes a distal-most portion configured to bend away from the ventricle wall when the anchor wire loop is positioned in the ventricle.

22. The joining assisting device according to any one of claims 1 to 21, characterized in that: The coaptation assist device further includes a native leaflet grasping forceps configured to grasp the atrial and ventricular surfaces of the target native leaflet to support and orient the neo leaflet relative to the native atrioventricular valve.

23. The joining assisting device according to claim 22, characterized in that: The new leaflet is connected to the annular ventricular anchor via the native leaflet grasping forceps.

24. The joining assisting device according to claim 23, characterized in that: The coaptation assist device includes a wire loop shaped to at least partially define the neo-leaflet and the native-leaflet grasping forceps.

25. The joining assist device according to claim 22, characterized in that: The natural leaflet grasping forceps is formed to define a first portion and a second portion, and the first portion and the second portion are configured to grasp the atrial surface and the ventricular surface of the target natural leaflet by clamping at least a portion of the atrial surface and the ventricular surface of the target natural leaflet between the first portion and the second portion of the natural leaflet grasping forceps.

26. The joining assisting device according to claim 25, characterized in that: The first portion and the second portion are configured to be folded toward each other so that the atrial surface and the ventricular surface of the target natural leaflet are grasped by clamping at least a portion of the atrial surface and the ventricular surface of the target natural leaflet between the first portion and the second portion of the natural leaflet grasping forceps.

27. The joining assisting device according to claim 26, characterized in that: The natural leaflet grasping forceps is formed to further define a third portion at a fold between the first portion and the second portion of the natural leaflet grasping forceps, and wherein when the first portion and the second portion of the natural leaflet grasping forceps clamp the atrial surface and at least a portion of the ventricular surface of the target natural leaflet, the third portion of the natural leaflet grasping forceps is configured to extend around the free edge of the target natural leaflet.

28. The joining assist device according to claim 25, characterized in that: The engagement assist device is configured such that: The first portion of the native leaflet grasping forceps is pivotally connected to the annular ventricular anchor, The first portion of the native leaflet grasping forceps is pivotally connected to the second portion of the native leaflet grasping forceps, and The second portion of the native leaflet grasping forceps is pivotally connected to the neo leaflet.

29. The joining assist device according to claim 22, wherein: The native leaflet grasping forceps include one or more sub-native leaflet supports configured to abut one or more portions of the ventricular surface of the target native leaflet when the anchor wire loop is positioned in the ventricle.

30. The joining assist device according to claim 29, characterized in that: The natural leaflet grasping forceps further include one or more supra-annular support portions, which are configured to abut against an atrial surface of the target natural leaflet when the anchor wire ring is positioned in the ventricle, so that the one or more sub-natural leaflet support portions and the one or more supra-annular support portions clamp and grasp the target natural leaflet.

31. The joining assist device according to claim 22, characterized in that: The native leaflet capture forceps include one or more supra-annular supports configured to abut an atrial surface of the target native leaflet when the anchor wire loop is positioned in the ventricle.

32. The joining assisting device according to any one of claims 1 to 21, characterized in that: The ventricular wall is a septal wall, and wherein the anchor wire loop is configured to remain anchored in place against the surrounding anatomical structures, including the subannulus, the septal wall, and the ventricular apical region.

33. The joining assist device according to any one of claims 1 to 21, characterized in that: The native atrioventricular valve is a tricuspid valve, and wherein when the anchor wire ring is positioned in the ventricle, the new leaflet is configured to at least partially replace the function of the target native leaflet by providing an engagement surface for one or more opposing native leaflets of the tricuspid valve.

34. The joining assist device according to claim 33, characterized in that: The target native leaflet is a native septal leaflet of the tricuspid valve, wherein the ventricular wall is a ventricular septum, and wherein when the anchor wire ring is positioned in the ventricle and remains anchored against the surrounding anatomical structures, including the subannulus, the ventricular septum, and the ventricular apical region, the new leaflet is configured to at least partially replace the function of the septal leaflet by providing a surface for engagement with one or more of the opposing native posterior leaflets and native anterior leaflets of the tricuspid valve.

35. The joining assisting device according to any one of claims 1 to 21, characterized in that: The native atrioventricular valve is a mitral valve, and wherein when the anchor wire ring is positioned in the ventricle, the new leaflet is configured to at least partially replace the function of the target native leaflet by providing a coaptation surface for the opposing native leaflet of the mitral valve.

36. The joining assist device according to claim 35, characterized in that: The target native leaflet is a native anterior leaflet of the mitral valve, wherein the ventricular wall is a ventricular septum, and wherein when the anchor wire ring is positioned in the ventricle and abuts the surrounding anatomical structures, including the subannulus, the ventricular septum, and the ventricular apical region, the new leaflet is configured to at least partially replace the function of the native anterior leaflet by providing a coaptation surface for an opposing native posterior leaflet of the mitral valve.

37. A joining assist device according to any one of claims 1 to 21, characterized in that: The coaptation assist device is configured such that when the anchor wire ring is positioned in the ventricle, the coaptation surfaces of the neo-valve leaflets span from an atrial side to a ventricular side of a native valve plane.

38. A joining assist device according to any one of claims 1 to 21, characterized in that: The annular ventricular anchor further includes an anchor ring cover connected to the anchor ring wire ring.

39. The joining assist device according to claim 38, characterized in that: The anchor ring cover includes one or more sheets of sheet material extending across a space at least partially surrounded by the anchor ring wire loop.

40. The joining assist device according to claim 38, wherein: The anchor ring cover includes a plurality of braided wires.

41. The joining assist device according to claim 38, characterized in that: The anchor ring cover includes a coating on the anchor ring wire loop.

42. The joining assist device according to any one of claims 1 to 21, characterized in that: The coaptation assist device includes a coaptation assist device wire loop shaped to at least partially define the neo-leaflet and the anchor ring wire loop.

43. The joining assist device according to claim 42, characterized in that: The coaptation assist device wire loop is shaped to further at least partially define a native leaflet grasping forceps configured to grasp the atrial and ventricular surfaces of the target native leaflet to support the new leaflet and orient the new leaflet relative to the native atrioventricular valve.

44. The joining assist device according to claim 43, characterized in that: The coaptation assist device wire loop is shaped to at least partially define the native leaflet grasping forceps along the coaptation assist device wire loop between the neo leaflet and the annular ventricular anchor.

45. A joining assist device according to any one of claims 1 to 21, characterized in that: The new leaflet includes a new leaflet wire ring, which defines at least a portion of a boundary of the new leaflet, and a new leaflet cover, which is connected to the new leaflet wire ring and provides the bonding surface.

46. ​​The joining assist device according to claim 45, characterized in that: The coaptation assist device is configured such that, when unconstrained, an angle is defined between (a) an anchor ring best fit plane defined by the anchor ring wire ring and (b) a new leaflet best fit plane defined by the new leaflet wire ring, the angle being between 60 degrees and 100 degrees.

47. The joining assist device according to claim 46, characterized in that: The angle is between 80 and 90 degrees.

48. The joining assist device of claim 45, wherein: The coaptation assist device is configured such that, when unconstrained, an angle is defined between (a) an anchor ring best fit plane defined by the anchor ring wire ring and (b) a new leaflet best fit plane defined by the new leaflet wire ring, the angle being between 15 degrees and 50 degrees.

49. The joining assist device according to claim 48, characterized in that: The angle is between 35 and 45 degrees.

50. The joining assist device according to any one of claims 1 to 21, characterized in that: The coaptation assist device further includes a bag configured to be expanded by blood flow during a cardiac cycle of a heart of the subject so as to push the coaptation assist device toward one or more of: a ventricular surface of the target native valve leaflet and an annulus of the native atrioventricular valve, thereby stabilizing the coaptation assist device relative to the native atrioventricular valve.

51. The joining assist device according to claim 50, characterized in that: The coaptation assist device further includes a native leaflet grasping forceps configured to grasp the atrial and ventricular surfaces of the target native leaflet to support the new leaflet and orient the new leaflet relative to the native atrioventricular valve, and wherein the pocket is defined by the native leaflet grasping forceps.

52. The joining assist device according to claim 51, characterized in that: The natural leaflet grasping forceps is formed to define a first portion and a second portion, the first portion and the second portion being configured to grasp the atrial surface and the ventricular surface of the target natural leaflet by clamping at least a portion of the atrial surface and the ventricular surface of the target natural leaflet between the first portion and the second portion of the natural leaflet grasping forceps, and wherein the pocket is defined by a ventricular-facing surface of the second portion of the natural leaflet grasping forceps.

53. A joining assist device according to any one of claims 1 to 21, characterized in that: The coaptation assist device further comprises a native leaflet spanning portion configured to be positioned through a perforation through the target native leaflet, and wherein the neo leaflet is coupled to the annular ventricular anchor via the native leaflet spanning portion.

54. The joining assist device according to claim 53, characterized in that: The coaptation assist device includes a coaptation assist device wire loop shaped to at least partially define the neo-leaflet, the annular ventricular anchor, and the native leaflet spanning portion.

55. A system of joint assist devices as claimed in any one of claims 1 to 21, characterized in that: The system further includes a delivery tube, wherein the coaptation assist device is removably disposed in a compressed configuration for minimally invasive or percutaneous delivery to a heart of the subject.

56. A coaptation assist device for treating a native atrioventricular valve in a subject, characterized in that: The engagement assist device comprises: an annular ventricular anchor comprising an anchor wire loop that (i) defines at least a portion of a boundary of the annular ventricular anchor and (ii) is configured to (a) be positioned in a ventricle, extend to a ventricular apical region, and (b) remain anchored in position against surrounding anatomical structures, including the ventricular apical region; and A new leaflet extends directly from and is supported by the annular ventricular anchor and is configured to at least partially replace the function of the target native leaflet of the native atrioventricular valve by providing an engaging surface for one or more opposing native leaflets opposing the target native leaflet when the anchor loop is located in the ventricle.

57. The joining assist device of claim 56, wherein: The annular ventricular anchor is configured to apply force to the surrounding anatomical structure via the anchor wire loop to maintain the anchor in place.

58. The joining assist device of claim 57, wherein: The annular ventricular anchor is configured to apply a radially outwardly directed force to the surrounding anatomical structure via the anchor wire loop to maintain the anchor in place.

59. The joining assist device of claim 56, wherein: The annular ventricular anchor is configured to remain anchored in place by friction between the anchor wire loop and the surrounding anatomical structure.

60. The joining assist device of claim 56, wherein: The coaptation assist device is configured such that when the anchor wire loop is positioned in the ventricle, the anchor wire loop does not extend to a sub-annulus of the target native leaflet.

61. The joining assist device of claim 56, wherein: The annular ventricular anchor is configured to be atraumatic so as not to penetrate tissue of the surrounding anatomy.

62. The joining assist device of claim 56, wherein: The coaptation assist device does not include any components configured to penetrate tissue.

63. The joining assist device of claim 56, wherein: The anchor loop wire loop comprises metal.

64. The joining assist device of claim 56, wherein: When the anchor loop is unconstrained, the anchor loop is bent along at least 50% of a length of the anchor loop, the length being detected around the anchor loop.

65. The joining assist device of claim 64, wherein: When the anchor loop line loop is unconstrained, the anchor loop line loop is bent along at least 75% of the length of the anchor loop line loop.

66. The joining assist device of claim 56, wherein: When the anchor loop is unconstrained, the anchor loop is shaped to be at least 75% of an oval.

67. The joining assist device of claim 56, wherein: The annular ventricular anchor further includes at least one support wire connected to the anchor wire loop at two locations on the anchor wire loop.

68. The joining assist device of claim 56, wherein: When the anchor wire loop is positioned in the ventricle, the anchor wire loop is configured to remain anchored in position against one or more ventricular papillary muscles at the apical region of the ventricle.

69. The joining assist device of claim 56, wherein: The anchor wire ring is shaped to define two or more lobes.

70. The joining assist device of claim 69, wherein: The anchor wire ring is shaped to define exactly two lobes.

71. The joining assist device of claim 56, wherein: The neo-leaflet is configured such that, following implantation of the coaptation assist device in a heart of the subject, the coaptation surface is generally static throughout a cardiac cycle of the subject.

72. The joining assist device of claim 56, wherein: The bonding surface has a width between 2 cm 2 With 20cm 2 An area between.

73. The joining assist device of claim 56, wherein: The neo leaflet is configured such that, following implantation of the coaptation assist device in a heart of the subject, the coaptation surface moves toward and away from the one or more opposing native leaflets during a cardiac cycle of the subject.

74. A joining assist device as claimed in any one of claims 56 to 73, characterized in that: The coaptation assist device further includes a native leaflet grasping forceps configured to grasp the atrial and ventricular surfaces of the target native leaflet to support and orient the neo leaflet relative to the native atrioventricular valve.

75. The joining assist device of claim 74, wherein: The native leaflet grasping forceps are connected to the annular ventricular anchor via the neo leaflet.

76. The joining assist device of claim 74, wherein: The native leaflet grasping forceps include one or more sub-native leaflet supports configured to abut one or more portions of the ventricular surface of the target native leaflet when the anchor wire loop is positioned in the ventricle.

77. The joining assist device of claim 76, wherein: The natural leaflet grasping forceps further include one or more supra-annular support portions, which are configured to abut against an atrial surface of the target natural leaflet when the anchor wire ring is positioned in the ventricle, so that the one or more sub-natural leaflet support portions and the one or more supra-annular support portions clamp and grasp the target natural leaflet.

78. The joining assist device of claim 74, wherein: The coaptation assist device is configured such that when the anchor wire loop is positioned in the ventricle and the native leaflet grasping forceps grasp the surface atrial and ventricular surfaces of the target native leaflet, the anchor wire loop does not extend to a sub-annulus of the target native leaflet.

79. A joining assist device as claimed in any one of claims 56 to 73, characterized in that: The native atrioventricular valve is a tricuspid valve, and wherein when the anchor wire ring is positioned in the ventricle, the new leaflet is configured to at least partially replace the function of the target native leaflet by providing an engagement surface for one or more opposing native leaflets of the tricuspid valve.

80. The joining assist device of claim 79, wherein: The target native leaflet is a native septal leaflet of the tricuspid valve, and wherein when the anchor wire ring is positioned in the ventricle and remains anchored against the surrounding anatomical structure, including the ventricular apical region, the new leaflet is configured to at least partially replace the function of the septal leaflet by providing a surface for engagement with one or more of the opposing native posterior leaflets and native anterior leaflets of the tricuspid valve.

81. A joining assist device as claimed in any one of claims 56 to 73, characterized in that: The native atrioventricular valve is a mitral valve, and wherein when the anchor wire ring is positioned in the ventricle, the new leaflet is configured to at least partially replace the function of the target native leaflet by providing a coaptation surface for the opposing native leaflet of the mitral valve.

82. The joining assist device of claim 81, wherein: The target native leaflet is a native anterior leaflet of the mitral valve, and wherein when the anchor wire ring is positioned in the ventricle and remains anchored against the surrounding anatomical structure, including the ventricular apical region, the new leaflet is configured to at least partially replace the function of the native anterior leaflet by providing a coaptation surface for an opposing native posterior leaflet of the mitral valve.

83. A joining assist device as claimed in any one of claims 56 to 73, characterized in that: The coaptation assist device is configured such that when the anchor wire ring is positioned in the ventricle, the coaptation surfaces of the neo-valve leaflets span from an atrial side to a ventricular side of a native valve plane.

84. A joining assist device as claimed in any one of claims 56 to 73, characterized in that: The annular ventricular anchor further includes an anchor ring cover connected to the anchor ring wire ring.

85. The joining assist device of claim 84, wherein: The anchor ring cover includes one or more sheets of sheet material extending across a space at least partially surrounded by the anchor ring wire loop.

86. The joining assist device of claim 84, wherein: The anchor ring cover includes a plurality of braided wires.

87. The joining assist device of claim 84, wherein: The anchor ring cover includes a coating on the anchor ring wire loop.

88. A joining assist device as claimed in any one of claims 56 to 73, characterized in that: The coaptation assist device includes a neo-leaflet wire ring shaped to at least partially define the neo-leaflets and the annular ventricular anchor.

89. A joining assist device according to any one of claims 56 to 73, characterized in that: The new leaflet includes a new leaflet wire ring, which defines at least a portion of a boundary of the new leaflet, and a new leaflet cover, which is connected to the new leaflet wire ring and provides the bonding surface.

90. A system of joint assist devices as claimed in any one of claims 56 to 73, characterized in that: The system further includes a delivery tube, wherein the coaptation assist device is removably disposed in a compressed configuration for minimally invasive or percutaneous delivery to a heart of the subject.

91. A coaptation assist device for treating a native atrioventricular valve in a subject, characterized in that: The engagement assist device comprises: An annular ventricular anchor (i) comprising a braided plate sheet, the braided plate comprising a plurality of braided wires, and (ii) configured to (a) be positioned in a ventricle, extending between a ventricular apex region and a subannulus of a target native leaflet of the native atrioventricular valve, and (b) maintain the anchor in place by forces applied by the annular ventricular anchor to surrounding anatomical structures, the surrounding anatomical structures including the subannulus, the ventricular wall, and the ventricular apex region; and A new leaflet is supported by the annular ventricular anchor and is configured to at least partially replace the function of the target native leaflet by providing an engaging surface for one or more opposing native leaflets opposite the target native leaflet when the annular ventricular anchor is located in the ventricle.

92. The joining assist device of claim 91, wherein: The annular ventricular anchor is configured to remain anchored in place via radially outwardly directed forces applied by the annular ventricular anchor to the surrounding anatomical structure.

93. The joining assist device of claim 91, wherein: The annular ventricular anchor is configured to remain anchored in place by friction between the annular ventricular anchor and the surrounding anatomical structure.

94. The joining assist device of claim 91, wherein: The annular ventricular anchor is configured to be atraumatic so as not to penetrate tissue of the surrounding anatomy.

95. The joining assist device of claim 91, wherein: The coaptation assist device does not include any components configured to penetrate tissue.

96. The joining assist device of claim 91, wherein: The plurality of braided wires include metal.

97. The joining assist device of claim 91, wherein: When the annular ventricular anchor is unconstrained, the annular ventricular anchor is shaped as at least 75% of an ellipse.

98. The joining assist device of claim 91, wherein: When the annular ventricular anchor is positioned in the ventricle, the annular ventricular anchor is configured to remain anchored in position against the subannulus, the ventricular wall, and one or more ventricular papillary muscles of the ventricular apical region.

99. The joining assist device of claim 91, wherein: The neo-leaflet is configured such that, following implantation of the coaptation assist device in a heart of the subject, the coaptation surface is generally static throughout a cardiac cycle of the subject.

100. The joining assist device of claim 91, wherein: The bonding surface has a width between 2 cm 2 With 20cm 2 An area between.

101. The joining assist device of claim 91, wherein: The neo leaflet is configured such that, following implantation of the coaptation assist device in a heart of the subject, the coaptation surface moves toward and away from the one or more opposing native leaflets during a cardiac cycle of the subject.

102. The joining assist device according to any one of claims 91 to 101, characterized in that: The coaptation assist device further includes a native leaflet grasping forceps configured to grasp the atrial and ventricular surfaces of the target native leaflet to support and orient the neo leaflet relative to the native atrioventricular valve.

103. The joining assist device of claim 102, wherein: The new leaflet is connected to the annular ventricular anchor via the native leaflet grasping forceps.

104. The joining assist device of claim 102, wherein: The natural leaflet grasping forceps is formed to define a first portion and a second portion, and the first portion and the second portion are configured to grasp the atrial surface and the ventricular surface of the target natural leaflet by clamping at least a portion of the atrial surface and the ventricular surface of the target natural leaflet between the first portion and the second portion of the natural leaflet grasping forceps.

105. The joining assist device of claim 104, wherein: The first portion and the second portion are configured to be folded toward each other so that the atrial surface and the ventricular surface of the target natural leaflet are grasped by clamping at least a portion of the atrial surface and the ventricular surface of the target natural leaflet between the first portion and the second portion of the natural leaflet grasping forceps.

106. The joining assist device according to any one of claims 91 to 101, characterized in that: The ventricular wall is a septal wall, and wherein the annular ventricular anchor is configured to remain anchored in position against the surrounding anatomical structures, including the subannulus, the septal wall, and the ventricular apical region.

107. The joining assist device according to any one of claims 91 to 101, characterized in that: The native atrioventricular valve is a tricuspid valve, and wherein when the annular ventricular anchor is positioned in the ventricle, the new leaflet is configured to at least partially replace the function of the target native leaflet by providing an engagement surface for one or more opposing native leaflets of the tricuspid valve.

108. The joining assist device of claim 107, wherein: The target native leaflet is a native septal leaflet of the tricuspid valve, wherein the ventricular wall is a ventricular septum, and wherein when the annular ventricular anchor is positioned in the ventricle and remains anchored against the surrounding anatomical structures, including the subannulus, the ventricular septum, and the ventricular apical region, the new leaflet is configured to at least partially replace the function of the septal leaflet by providing a surface for engagement with one or more of the opposing native posterior leaflets and native anterior leaflets of the tricuspid valve.

109. The joining assist device according to any one of claims 91 to 101, characterized in that: The native atrioventricular valve is a mitral valve, and wherein when the annular ventricular anchor is positioned in the ventricle, the new leaflet is configured to at least partially replace the function of the target native leaflet by providing a coaptation surface for the opposing native leaflet of the mitral valve.

110. The joining assist device of claim 109, wherein: The target native leaflet is a native anterior leaflet of the mitral valve, wherein the ventricular wall is a ventricular septum, and wherein when the annular ventricular anchor is positioned in the ventricle and abuts the surrounding anatomical structures, including the subannulus, the ventricular septum, and the ventricular apical region, the new leaflet is configured to at least partially replace the function of the native anterior leaflet by providing a coaptation surface for an opposing native posterior leaflet of the mitral valve.

111. The joining assist device according to any one of claims 91 to 101, characterized in that: The coaptation assist device is configured such that when the annular ventricular anchor is positioned in the ventricle, the coaptation surfaces of the neo-valve leaflets span from an atrial side to a ventricular side of a native valve plane.

112. The joining assist device according to any one of claims 91 to 101, characterized in that: The annular ventricular anchor further comprises an anchor ring cover, which is connected to the woven flat sheet and covers the whole or a part of the woven flat sheet.

113. The joining assist device of claim 112, wherein: The anchor ring cover includes one or more sheet materials connected to the woven flat sheet.

114. A system of joint assist devices as claimed in any one of claims 91 to 101, characterized in that: The system further includes a delivery tube, wherein the coaptation assist device is removably disposed in a compressed configuration for minimally invasive or percutaneous delivery to a heart of the subject.

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