阅读说明：本技术 心脏瓣叶接合器 (Heart valve leaflet coaptation ware ) 是由 亚尼夫·马莫尔 安德里亚·吉多蒂 莫妮卡·托奇 大卫·萨尔巴塔尼 里卡多·罗曼 伊丹·托比 于 2020-01-14 设计创作，主要内容包括：本公开提供一种用于治疗一天然房室瓣的接合辅助装置(20、120A、120B、120C、320A、320B、420、720),包括一环形心室锚(30、130、330、430、730),所述环形心室锚包括一锚环线环(50、150、350、450、750),所述锚环线环界定所述环形心室锚的一边界的至少一部分,并且被配置为定位在一心室中,在一靶天然瓣叶的一心室心尖区域与一子环面之间延伸,以及保持锚定在抵靠周围解剖结构的位置,所述周围解剖结构包括所述子环面、一心室壁,以及所述心室心尖区域。一新瓣叶(32、132A、132B、132C、332A、332B、332A、332B、432、732)由所述环形心室锚支撑,并且被配置为与所述靶天然瓣叶相对的一或多个相对的天然瓣叶提供一接合的表面(34、434、734),以至少部分地替代所述靶天然瓣叶的功能。本公开亦描述其他的实施例。(The present disclosure provides a coaptation assistance 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) comprising an anchor loop (50, 150, 350, 450, 750) defining at least a portion of a boundary of the annular ventricular anchor and configured to be positioned in a ventricle, extend between a ventricular apex region and a subannular surface of a target native leaflet, and remain anchored in position against surrounding anatomy comprising the subannular surface, a ventricular wall, and the ventricular apex region. A new leaflet (32, 132A, 132B, 132C, 332A, 332B, 432, 732) is supported by the annular ventricular anchor and is configured such that one or more opposing native leaflets opposite the target native leaflet provide a coaptation surface (34, 434, 734) to at least partially replace the function of the target native leaflet. Other embodiments are also described.)

1. An coaptation assistance device for treating a natural atrioventricular valve of a subject, comprising: the coaptation assistance device includes:

an annular ventricular anchor comprising an anchor 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 apex region and a subannular surface of a target native leaflet of the native atrioventricular valve, and (b) remain anchored in position against surrounding anatomical structures, including the subannular surface, a ventricular wall, and the ventricular apex region; and

a neo-leaflet supported by the annular ventricular anchor and configured to at least partially replace a 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 positioned in the ventricle.

2. The coaptation assistance device of claim 1, wherein: the annular ventricular anchor is configured to maintain anchoring in place by a force applied to the surrounding anatomy by the anchor loop.

3. The coaptation assistance device of claim 2, wherein: the annular ventricular anchor is configured to apply a radially outwardly directed force to the surrounding anatomy through the anchor loop to maintain anchoring in place.

4. The coaptation assistance device of claim 1, wherein: the annular ventricular anchor is configured to remain anchored in place by friction between the anchor loop ring and the surrounding anatomy.

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

6. The coaptation assistance device of claim 1, wherein: the coaptation assistance device does not include any of a plurality of components configured to penetrate tissue.

7. The coaptation assistance device of claim 1, wherein: the anchor loop is shaped as a closed loop defining an entirety of the boundary of the annular ventricular anchor.

8. The coaptation assistance device of claim 1, wherein: the anchor loop ring comprises metal.

9. The coaptation assistance device of claim 1, wherein: the anchor loop is bent along at least 50% of a length of the anchor loop when the anchor loop is unconstrained, the length being sensed around the anchor loop.

10. The coaptation assistance device of claim 9, wherein: the anchor loop is bent along at least 75% of the length of the anchor loop when the anchor loop is unconstrained.

11. The coaptation assistance device of claim 1, wherein: the anchor loop is shaped to at least 75% of an elliptical shape when the anchor loop is unconstrained.

12. The coaptation assistance device of claim 1, wherein: the annular ventricular anchor further comprises at least one support wire connected to the anchor loop at two locations on the anchor loop.

13. The coaptation assistance device of claim 1, wherein: when the anchor loop is positioned in the ventricle, the anchor loop is configured to remain anchored in position against the sub-annulus, the ventricular wall, and one or more ventricular papillary muscles of the ventricular apex region.

14. The coaptation assistance device of claim 1, wherein: the anchor loop is shaped to define two or more lobes.

15. The coaptation assistance device of claim 14, wherein: the anchor loop is shaped to define exactly two lobes.

16. The coaptation assistance device of claim 1, wherein: the neo-leaflet is configured such that the coaptation surface is generally static throughout a cardiac cycle of the subject after implantation of the coaptation assistance device in a heart of the subject.

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

18. The coaptation assistance device of claim 1, wherein: the neo-leaflet extends directly from the annular ventricular anchor.

19. The coaptation assistance device of claim 1, whereinCharacterized in that: the bonding surface has a width of between 2cm²And 20cm²An area therebetween.

20. The coaptation assistance device of claim 1, wherein: when the anchor loop is unconstrained, the anchor loop includes a distal-most portion that bends away from a most-appropriate plane defined by lateral portions of the anchor loop.

21. The coaptation assistance device of claim 1, wherein: the anchor loop includes a distal-most portion configured to bend away from the ventricular wall when the anchor loop is positioned in the ventricle.

22. The coaptation assistance device of any one of claims 1 to 21, wherein: the coaptation assistance device further includes a native leaflet grasping forceps configured to grasp an atrial surface and a ventricular surface of the target native leaflet to support and orient the neo-leaflet relative to the native atrioventricular valve.

23. The coaptation assistance device of claim 22, wherein: the neo-leaflet is connected to the annular ventricular anchor via the native leaflet grabbing clamp.

24. The coaptation assistance device of claim 23, wherein: the coaptation assistance device includes a wire loop shaped to at least partially define the neo-leaflet and the native leaflet capturing forceps.

25. The coaptation assistance device of claim 22, wherein: the native leaflet grasping forceps are shaped to define a first portion and a second portion configured to grasp the atrial surface and the ventricular surface of the target native leaflet by sandwiching 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.

26. The coaptation assistance device of claim 25, wherein: the first and second portions are configured to fold toward each other such that the atrial surface and the ventricular surface of the target native leaflet is grasped by sandwiching the at least a portion of the atrial surface and the ventricular surface of the target native leaflet between the first and second portions of the native leaflet grasping forceps.

27. The coaptation assistance device of claim 26, wherein: the native leaflet grasping forceps are shaped to further define a third portion at a fold between the first portion and the second portion of the native leaflet grasping forceps, and wherein the third portion of the native leaflet grasping forceps is configured to extend around a free edge of the target native leaflet when the first portion and the second portion of the native leaflet grasping forceps are grasping the at least a portion of the atrial surface and the ventricular surface of the target native leaflet.

28. The coaptation assistance device of claim 25, wherein: the coaptation assistance device is configured such that:

the first portion of the native leaflet grabbing clamp is pivotally connected to the annular ventricular anchor,

the first portion of the native leaflet grasping forceps is pivotably connected to the second portion of the native leaflet grasping forceps, an

The second portion of the native leaflet grabbing clamp is pivotally connected to the neo-leaflet.

29. The coaptation assistance device of 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 loop is positioned in the ventricle.

30. The coaptation assistance device of claim 29, wherein: the native leaflet grasping forceps further include one or more looped supports configured to abut an atrial surface of the target native leaflet when the anchor loop is positioned in the ventricle such that the one or more sub-native leaflet supports and the one or more looped supports grasp and grasp the target native leaflet.

31. The coaptation assistance device of claim 22, wherein: the native leaflet grasping forceps include one or more looped supports configured to abut an atrial surface of the target native leaflet when the anchor loop is positioned in the ventricle.

32. The coaptation assistance device of any one of claims 1 to 21, wherein: the ventricular wall is a ventricular septal wall, and wherein the anchor loop is configured to remain anchored in position against the surrounding anatomical structure, the surrounding anatomical structure including the sub-annulus, the ventricular septal wall, and the ventricular apex region.

33. The coaptation assistance device of any one of claims 1 to 21, wherein: the native atrioventricular valve is a tricuspid valve, and wherein the neo-leaflet is configured to at least partially replace the function of the target native leaflet by providing an engaging surface for the one or more opposing native leaflets of the tricuspid valve when the anchor loop is positioned in the ventricle.

34. The coaptation assistance device of claim 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 loop is positioned in the ventricle and remains anchored in position against the surrounding anatomical structure, the surrounding anatomical structure including the sub-annulus, the ventricular septal wall, and the ventricular apex region, the new leaflet is configured to at least partially replace the function of the septal leaflet by providing an engaging surface for one or more of the opposing native posterior and native anterior leaflets of the tricuspid valve.

35. The coaptation assistance device of any one of claims 1 to 21, wherein: the native atrioventricular valve is a mitral valve, and wherein the neo-leaflet is configured to at least partially replace the function of the target native leaflet by providing an engaging surface for the opposite native leaflet of the mitral valve when the anchor loop is positioned in the ventricle.

36. The coaptation assistance device of claim 35, 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 anchor loop is positioned in the ventricle and against the surrounding anatomical structure, including the sub-annulus, the ventricular septal wall, and the ventricular apex region, the neo-leaflet is configured to at least partially replace the function of the native anterior leaflet by providing an engaging surface for an opposing native posterior leaflet of the mitral valve.

37. The coaptation assistance device of any one of claims 1 to 21, wherein: the coaptation assistance device is configured such that when the anchor loop is positioned in the ventricle, the coaptation surface of the neo-leaflet spans from an atrial side to a ventricular side of a native valve plane.

38. The coaptation assistance device of any one of claims 1 to 21, wherein: the annular ventricular anchor further includes an anchor ring cap connected to the anchor ring.

39. The coaptation assistance device of claim 38, wherein: the anchor eye cover comprises one or more sheets of material extending across a space at least partially surrounded by the anchor eye ring.

40. The coaptation assistance device of claim 38, wherein: the anchor eye covers include a plurality of braided wires.

41. The coaptation assistance device of claim 38, wherein: the anchor ring cap includes a coating on the anchor ring loop.

42. The coaptation assistance device of any one of claims 1 to 21, wherein: the coaptation assistance device includes a coaptation assistance device wire loop shaped to at least partially define the neo-leaflet and the anchor wire loop.

43. The coaptation assistance device of claim 42, wherein: the coaptation assistance device wire loop is shaped to further at least partially define a native leaflet grasping forceps configured to grasp an atrial surface and a ventricular surface of the target native leaflet to support and orient the neo-leaflet relative to the native atrioventricular valve.

44. The coaptation assistance device of claim 43, wherein: the coaptation assistance device wire loop is shaped to at least partially define the native leaflet capturing forceps along the coaptation assistance device wire loop between the neo-leaflet and the annular ventricular anchor.

45. The coaptation assistance device of any one of claims 1 to 21, wherein: the neo-leaflet includes a neo-leaflet wire loop defining at least a portion of a boundary of the neo-leaflet, and a neo-leaflet cover connected to the neo-leaflet wire loop and providing the coaptation surface.

46. The coaptation assistance device of claim 45, wherein: the coaptation assistance device is configured such that, when unconstrained, an angle is defined between (a) an anchor loop best fit plane defined by the anchor loop and (b) a neo-leaflet best fit plane defined by the neo-leaflet loop, the angle being between 60 degrees and 100 degrees.

47. The coaptation assistance device of claim 46, wherein: the angle is between 80 degrees and 90 degrees.

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

49. The coaptation assistance device of claim 48, wherein: the angle is between 35 degrees and 45 degrees.

50. The coaptation assistance device of any one of claims 1 to 21, wherein: the coaptation assistance device further includes a pouch configured to expand through blood flow during a cardiac cycle of a heart of the subject to urge the coaptation assistance device toward one or more of: a ventricular surface of the target native leaflet and a ring portion of the native atrioventricular valve, thereby stabilizing the coaptation assistance device relative to the native atrioventricular valve.

51. The coaptation assistance device of claim 50, wherein: the coaptation assistance device further includes a native leaflet grasping forceps configured to grasp an atrial surface and a ventricular surface of the target native leaflet to support the neo-leaflet and orient the neo-leaflet relative to the native atrioventricular valve, and wherein the capsular bag is defined by the native leaflet grasping forceps.

52. The coaptation assistance device of claim 51, wherein: the native leaflet grasping forceps are shaped to define the first portion and the second portion configured to grasp the atrial surface and the ventricular surface of the target native leaflet by sandwiching 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, and wherein the capsular bag is defined by a ventricular-facing surface of the second portion of the native leaflet grasping forceps.

53. The coaptation assistance device of any one of claims 1 to 21, wherein: the coaptation assistance device further includes a native leaflet spanning portion configured to be positioned through a perforation by the target native leaflet, and wherein the neo-leaflet is connected to the annular ventricular anchor via the native leaflet spanning portion.

54. The coaptation assistance device of claim 53, wherein: the coaptation assistance device includes a coaptation assistance 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 coaptation assistance devices as claimed in any one of claims 1 to 21, wherein: the system further includes a delivery tube, wherein the coaptation assistance device is removably disposed in a compressed configuration for minimally invasive or percutaneous delivery to a heart of the subject.

56. An coaptation assistance device for treating a natural atrioventricular valve of a subject, comprising: the coaptation assistance device includes:

an annular ventricular anchor comprising an anchor 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 to a ventricular apex region, and (b) remain anchored in position against surrounding anatomical structures, including the ventricular apex region; and

a neo-leaflet extending directly from and supported by the annular ventricular anchor and configured to at least partially replace a function of a target native leaflet of the native atrioventricular valve by providing an engagement surface for one or more opposing native leaflets opposite the target native leaflet when the anchor loop is positioned in the ventricle.

57. The coaptation assistance device of claim 56, wherein: the annular ventricular anchor is configured to maintain anchoring in place by a force applied to the surrounding anatomy by the anchor loop.

58. The coaptation assistance device of claim 57, wherein: the annular ventricular anchor is configured to apply a radially outwardly directed force to the surrounding anatomy through the anchor loop to maintain anchoring in place.

59. The coaptation assistance device of claim 56, wherein: the annular ventricular anchor is configured to remain anchored in place by friction between the anchor loop ring and the surrounding anatomy.

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

61. The coaptation assistance 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 coaptation assistance device of claim 56, wherein: the coaptation assistance device does not include any of a plurality of components configured to penetrate tissue.

63. The coaptation assistance device of claim 56, wherein: the anchor loop ring comprises metal.

64. The coaptation assistance device of claim 56, wherein: the anchor loop is bent along at least 50% of a length of the anchor loop when the anchor loop is unconstrained, the length being sensed around the anchor loop.

65. The coaptation assistance device of claim 64, wherein: the anchor loop is bent along at least 75% of the length of the anchor loop when the anchor loop is unconstrained.

66. The coaptation assistance device of claim 56, wherein: the anchor loop is shaped to at least 75% of an elliptical shape when the anchor loop is unconstrained.

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

68. The coaptation assistance device of claim 56, wherein: when the anchor loop is positioned in the ventricle, the anchor loop is configured to remain anchored in position against one or more ventricular papillary muscles of the ventricular apex region.

69. The coaptation assistance device of claim 56, wherein: the anchor loop is shaped to define two or more lobes.

70. The coaptation assistance device of claim 69, wherein: the anchor loop is shaped to define exactly two lobes.

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

72. The coaptation assistance device of claim 56, wherein: the bonding surface has a width of between 2cm²And 20cm²An area therebetween.

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

74. The coaptation assistance device of any one of claims 56-73, wherein: the coaptation assistance device further includes a native leaflet grasping forceps configured to grasp an atrial surface and a ventricular surface of the target native leaflet to support and orient the neo-leaflet relative to the native atrioventricular valve.

75. The coaptation assistance device of claim 74, wherein: the native leaflet grabbing clamp is connected to the annular ventricular anchor via the neo-leaflet.

76. The coaptation assistance 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 loop is positioned in the ventricle.

77. The coaptation assistance device of claim 76, wherein: the native leaflet grasping forceps further include one or more looped supports configured to abut an atrial surface of the target native leaflet when the anchor loop is positioned in the ventricle such that the one or more sub-native leaflet supports and the one or more looped supports grasp and grasp the target native leaflet.

78. The coaptation assistance device of claim 74, wherein: the coaptation assistance device is configured such that when the anchor loop is positioned in the ventricle and the native leaflet grabbing forceps grasp the surface atrium and the ventricular surface of the palladium native leaflet, the anchor loop does not extend to a sub-annulus of the target native leaflet.

79. The coaptation assistance device of any one of claims 56-73, wherein: the native atrioventricular valve is a tricuspid valve, and wherein the neo-leaflet is configured to at least partially replace the function of the target native leaflet by providing an engaging surface for the one or more opposing native leaflets of the tricuspid valve when the anchor loop is positioned in the ventricle.

80. The coaptation assistance device of claim 79, wherein: the target native leaflet is a natural spacer leaflet of the tricuspid valve, and wherein when the anchor loop is positioned in the ventricle and remains anchored in position against the surrounding anatomical structure, including the ventricular apex region, the new leaflet is configured to at least partially replace the function of the spacer leaflet by providing an engaging surface for one or more of the opposing native posterior and anterior leaflets of the tricuspid valve.

81. The coaptation assistance device of any one of claims 56-73, wherein: the native atrioventricular valve is a mitral valve, and wherein the neo-leaflet is configured to at least partially replace the function of the target native leaflet by providing an engaging surface for the opposite native leaflet of the mitral valve when the anchor loop is positioned in the ventricle.

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

83. The coaptation assistance device of any one of claims 56-73, wherein: the coaptation assistance device is configured such that when the anchor loop is positioned in the ventricle, the coaptation surface of the neo-leaflet spans from an atrial side to a ventricular side of a native valve plane.

84. The coaptation assistance device of any one of claims 56-73, wherein: the annular ventricular anchor further includes an anchor ring cap connected to the anchor ring.

85. The coaptation assistance device of claim 84, wherein: the anchor eye cover comprises one or more sheets of material extending across a space at least partially surrounded by the anchor eye ring.

86. The coaptation assistance device of claim 84, wherein: the anchor eye covers include a plurality of braided wires.

87. The coaptation assistance device of claim 84, wherein: the anchor ring cap includes a coating on the anchor ring loop.

88. The coaptation assistance device of any one of claims 56-73, wherein: the coaptation assistance device includes a neo-leaflet wire loop shaped to at least partially define the neo-leaflet and the annular ventricular anchor.

89. The coaptation assistance device of any one of claims 56-73, wherein: the neo-leaflet includes a neo-leaflet wire loop defining at least a portion of a boundary of the neo-leaflet, and a neo-leaflet cover connected to the neo-leaflet wire loop and providing the coaptation surface.

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

91. An coaptation assistance device for treating a natural atrioventricular valve of a subject, comprising: the coaptation assistance device includes:

an annular ventricular anchor that (i) comprises a woven flat sheet comprising a plurality of woven wires, and (ii) is configured to (a) be positioned in a ventricle extending between a ventricular apex region and a sub-annulus of a target native leaflet of the native atrioventricular valve, and (b) apply a force through the annular ventricular anchor to the surrounding anatomy, including the sub-annulus, the ventricular wall, and the ventricular apex region, to maintain anchoring in place; and

a neo-leaflet supported by the annular ventricular anchor and configured to at least partially replace a 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 positioned in the ventricle.

92. The coaptation assistance device of claim 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 anatomy.

93. The coaptation assistance 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 anatomy.

94. The coaptation assistance 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 coaptation assistance device of claim 91, wherein: the coaptation assistance device does not include any of a plurality of components configured to penetrate tissue.

96. The coaptation assistance device of claim 91, wherein: the plurality of braided wires comprise metal.

97. The coaptation assistance device of claim 91, wherein: the annular ventricular anchor is shaped to at least 75% of an ellipse when the annular ventricular anchor is unconstrained.

98. The coaptation assistance 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 sub-annulus, the ventricular wall, and one or more ventricular papillary muscles of the ventricular apex region.

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

100. The coaptation assistance device of claim 91, wherein: the bonding surface has a width of between 2cm²And 20cm²An area therebetween.

101. The coaptation assistance device of claim 91, wherein: the coaptation assistance device is configured such that, when unconstrained, an angle is defined between (a) an anchor loop best fit plane defined by the anchor loop and (b) a new leaflet best fit plane defined by the coaptation surface, the angle being less than 20 degrees; or the optimal fitting plane of the anchoring ring and the optimal fitting plane of the neo-leaflet are parallel to each other.

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

103. The coaptation assistance device of any one of claims 91-102, wherein: the coaptation assistance device further includes a native leaflet grasping forceps configured to grasp an atrial surface and a ventricular surface of the target native leaflet to support and orient the neo-leaflet relative to the native atrioventricular valve.

104. The coaptation assistance device of claim 103, wherein: the neo-leaflet is connected to the annular ventricular anchor via the native leaflet grabbing clamp.

105. The coaptation assistance device of claim 103, wherein: the native leaflet grasping forceps are shaped to define a first portion and a second portion configured to grasp the atrial surface and the ventricular surface of the target native leaflet by sandwiching 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.

106. The coaptation assistance device of claim 105, wherein: the first and second portions are configured to fold toward each other such that the atrial surface and the ventricular surface of the target native leaflet is grasped by sandwiching the at least a portion of the atrial surface and the ventricular surface of the target native leaflet between the first and second portions of the native leaflet grasping forceps.

107. The coaptation assistance device of any one of claims 91-102, 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 sub-annulus, the ventricular septal wall, and the ventricular apex region.

108. The coaptation assistance device of any one of claims 91-102, wherein: the native atrioventricular valve is a tricuspid valve, and wherein the neo-leaflet is configured to at least partially replace the function of the target native leaflet by providing an engaging surface for the one or more opposing native leaflets of the tricuspid valve when the annular ventricular anchor is positioned in the ventricle.

109. The coaptation assistance device of claim 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 in position against the surrounding anatomy, including the sub-annulus, the ventricular septal wall, and the ventricular apex region, the neo-leaflet is configured to at least partially replace the function of the septal leaflet by providing an engaging surface for one or more of the opposing native posterior and native anterior leaflets of the tricuspid valve.

110. The coaptation assistance device of any one of claims 91-102, wherein: the native atrioventricular valve is a mitral valve, and wherein the neo-leaflet is configured to at least partially replace the function of the target native leaflet by providing an engaging surface for the opposing native leaflet of the mitral valve when the annular ventricular anchor is positioned in the ventricle.

111. The coaptation assistance device of claim 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 against the surrounding anatomy, including the sub-annulus, the ventricular septal wall, and the ventricular apex region, the neo-leaflet is configured to at least partially replace the function of the native anterior leaflet by providing an engaging surface for an opposing native posterior leaflet of the mitral valve.

112. The coaptation assistance device of any one of claims 91-102, wherein: the coaptation assistance device is configured such that when the annular ventricular anchor is positioned in the ventricle, the coaptation surface of the neo-leaflet spans from an atrial side to a ventricular side of a native valve plane.

113. The coaptation assistance device of any one of claims 91-102, wherein: the annular ventricular anchor further comprises an anchor ring cover connected to the flat woven sheet and covering all or a portion of the flat woven sheet.

114. The coaptation assistance device of claim 113, wherein: the anchor eye cover comprises one or more sheet materials connected to the braided flat sheet.

115. A system of splice aids as claimed in any one of claims 91 to 102, wherein: the system further includes a delivery tube, wherein the coaptation assistance device is removably disposed in a compressed configuration for minimally invasive or percutaneous delivery to a heart of the subject.

Technical Field

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 regurgitation.

Background

Valvular Regurgitation (VR) is a condition in which the native valves of the heart fail to close properly, causing blood to flow back into the atria when the ventricles contract, thereby reducing their effectiveness. Today, severe reflux affects over 500 million patients in the united states and is estimated to affect 8% of the world's population.

Disclosure of Invention

Embodiments of the present invention provide a coaptation assistance device for treating a natural valve of a subject. Typically, native valves suffer from a valvular disorder, such as functional mitral regurgitation (mitral regurgitation) or tricuspid regurgitation (tricuspid regurgitation), which is often characterized by a lack of activity of the leaflets in the valve. The native valve is typically an atrioventricular valve, i.e. the tricuspid valve or the mitral valve.

Each coaptation assistance device includes an annular ventricular anchor (loop-shaped ventricular anchor) configured to be positioned in a ventricle, extend between a ventricular apex region (ventricular apex area) of a target native leaflet of the native atrioventricular valve, and maintain anchoring position against surrounding anatomical structures including a ventricular wall and the ventricular apex region. In some applications, each annular ventricular anchor includes an anchor-loop wire loop (anchor-loop) defining at least a portion of a boundary of the annular ventricular anchor and, optionally, an anchor-loop cover (anchor-loop cover) connected to the anchor-loop.

Each coaptation assistance device further includes a neo-leaflet (neo-leaflet) supported by the annular ventricular anchor and configured to at least partially replace a function of the target native leaflet by providing a coaptation surface to one or more opposing native leaflets opposite the target native leaflet when the annular ventricular anchor is positioned in the ventricle.

Thus, according to an inventive concept 1 of the present invention, there is provided an coaptation assistance device for treating a natural atrioventricular valve of a subject, the coaptation assistance device comprising:

an annular ventricular anchor comprising an anchor 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 apex region and a sub-annulus (subannular surface) of a target native leaflet of the native atrioventricular valve, and (b) remain anchored in position against surrounding anatomical structure (surrounding apex region), including the sub-annulus, a ventricular wall, and the ventricular apex region; and

a neo-leaflet supported by the annular ventricular anchor and configured to at least partially replace a 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 positioned in the ventricle.

Inventive concept 2. The coaptation assistance device of inventive concept 1, wherein the annular ventricular anchor is configured to maintain anchoring in place by a force applied to the surrounding anatomy by the anchor loop.

Inventive concept 3. The coaptation assistance device of inventive concept 2, wherein the annular ventricular anchor is configured to maintain anchoring in place by a radially outwardly directed force applied to the surrounding anatomy by the anchor loop.

Inventive concept 4. The coaptation assistance device of inventive concept 1, wherein the annular ventricular anchor is configured to remain anchored in place by friction between the anchor loop ring and the surrounding anatomy.

Inventive concept 5. The coaptation assistance device of inventive concept 1, wherein the annular ventricular anchor is configured to be atraumatic so as not to penetrate tissue of the surrounding anatomy.

Inventive concept 6. The coaptation assistance device of inventive concept 1, wherein the coaptation assistance device does not include a plurality of any components configured to penetrate tissue.

Inventive concept 7. The coaptation assistance device of inventive concept 1, wherein the anchor loop is shaped as a closed loop that defines an entirety of the boundary of the annular ventricular anchor.

Inventive concept 8. The coaptation assistance device of inventive concept 1, wherein the anchor loop comprises metal.

Inventive concept 9. The coaptation assistance device of inventive concept 1, wherein the anchor loop bends along at least 50% of a length of the anchor loop when the anchor loop is unconstrained, the length being detected around the anchor loop.

Inventive concept 10. The coaptation assistance device of inventive concept 9, wherein the anchor loop bends along at least 75% of the length of the anchor loop when the anchor loop is unconstrained.

Inventive concept 11. The coaptation assistance device of inventive concept 1, wherein the anchor loop is shaped to at least 75% of an ellipse when the anchor loop is unconstrained.

The inventive concept 12. The coaptation assistance device of inventive concept 1, wherein the annular ventricular anchor further comprises at least one support wire connected to the anchor loop at two locations on the anchor loop.

Inventive concept 13. The coaptation assistance device of inventive concept 1, wherein the anchor loop is configured to remain anchored in position against the sub-annulus, the ventricular wall, and one or more ventricular papillary muscles (ventricular papillary muscles) of the ventricular apex region when the anchor loop is positioned in the ventricle.

Inventive concept 14. The coaptation assistance device of inventive concept 1, wherein the anchor loop is shaped to define two or more lobes.

Inventive concept 15. The coaptation assistance device of inventive concept 14, wherein the anchor loop is shaped to define exactly two lobes.

The inventive concept 16. The coaptation assistance device of inventive concept 1, wherein the neo-leaflet is configured such that the coaptation surface is generally static throughout a cardiac cycle of the subject after implantation of the coaptation assistance device in a heart of the subject.

Inventive concept 17. The coaptation assistance device of inventive concept 1, wherein the neo-leaflet is configured such that the coaptation surface moves toward and away from the one or more opposing native leaflets during a cardiac cycle of the subject after implantation of the coaptation assistance device in a heart of the subject.

The inventive concept 18. The coaptation assistance device of inventive concept 1, wherein the neo-leaflet extends directly from an annular ventricular anchor.

Inventive concept 19. The coaptation assistance device of inventive concept 1, wherein the coaptation surface has a length of between 2cm²And 20cm²An area therebetween.

The inventive concept 20. The coaptation assistance device of inventive concept 1, wherein the anchor loop includes a distal-most portion that curves away from a most suitable plane defined by lateral portions of the anchor loop when the anchor loop is unconstrained.

Inventive concept 21. The coaptation assistance device of inventive concept 1, wherein the anchor loop includes a distal-most portion configured to bend away from the ventricular wall when the anchor loop is positioned in the ventricle.

The inventive concept 22. The coaptation assistance device of any one of inventive concepts 1-21, wherein the coaptation assistance device further comprises a native leaflet grasping forceps configured to grasp an atrial surface and a ventricular surface of the target native leaflet to support and orient the neo-leaflet with respect to the native atrioventricular valve.

Inventive concept 23. The coaptation assistance device of inventive concept 22, wherein the neo-leaflet is connected to the annular ventricular anchor via the native leaflet grabbing clamp.

Inventive concept 24. The coaptation assistance device of inventive concept 23, wherein the coaptation assistance device comprises a wire loop (wire loop) shaped to at least partially define the neo-leaflet and the native leaflet capturing forceps.

The inventive concept 25. The coaptation assistance device of inventive concept 22, wherein the native leaflet grabbing clamp is shaped to define a first portion and a second portion configured to grab the atrial surface and the ventricular surface of the target native leaflet by sandwiching 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 grabbing clamp.

The inventive concept 26. The coaptation assistance device of inventive concept 25, wherein the first portion and the second portion are configured to fold toward each other such that the atrial surface and the ventricular surface of the target native leaflet is grasped by sandwiching the 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.

The inventive concept 27. The coaptation assistance device of inventive concept 26, wherein the native leaflet grasping forceps are shaped to further define a third portion at a fold between the first portion and the second portion of the native leaflet grasping forceps, and wherein the third portion of the native leaflet grasping forceps is configured to extend around a free edge of the target native leaflet when the first portion and the second portion of the native leaflet grasping forceps are grasping the atrial surface and the at least a portion of the ventricular surface of the target native leaflet.

The inventive concept 28. The coaptation assistance device of inventive concept 25, wherein the coaptation assistance device is configured such that:

the first portion of the native leaflet grabbing clamp is pivotally connected to the annular ventricular anchor,

the first portion of the native leaflet grasping forceps is pivotably connected to the second portion of the native leaflet grasping forceps, an

The second portion of the native leaflet grabbing clamp is pivotally connected to the neo-leaflet.

The inventive concept 29. The coaptation assistance device of inventive concept 22, wherein the native leaflet grabbing clamp comprises 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 loop is positioned in the ventricle.

The inventive concept 30. The coaptation assistance device of inventive concept 29, wherein the native leaflet grasping forceps further comprise one or more supra-annular supports (supra-annular supports) configured to abut an atrial surface of the target native leaflet when the anchor loop is positioned in the ventricle such that the one or more sub-native leaflet supports and the one or more supra-annular supports grasp the target native leaflet.

The inventive concept 31. The coaptation assistance device of inventive concept 22, wherein the native leaflet grabbing clamp comprises one or more super-annular supports configured to abut an atrial surface of the target native leaflet when the anchor loop is positioned in the ventricle.

The inventive concept 32. The coaptation assistance device of any one of inventive concepts 1-21, wherein the ventricular wall is a ventricular septal wall, and wherein the anchor loop is configured to remain anchored in position against the surrounding anatomical structure comprising the sub-annulus, the ventricular septal wall, and the ventricular apex region.

The inventive concept 33. The coaptation assistance device of any one of inventive concepts 1-21, wherein the native atrioventricular valve is a tricuspid valve, and wherein when the anchor loop is positioned in the ventricle, the neo-leaflet is configured to at least partially replace the function of the target native leaflet by providing an coaptation surface for the one or more opposing native leaflets of the tricuspid valve.

The inventive concept 34. The coaptation assistance device of 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 loop is positioned in the ventricle and remains anchored in position against the surrounding anatomical structure, including the sub-annulus, the ventricular septal wall, and the ventricular apex region, the neo-leaflet is configured to at least partially replace the function of the septal leaflet by providing an engaging surface for one or more of the opposing native posterior and native anterior leaflets of the tricuspid valve.

The inventive concept 35. The coaptation assistance device of any one of inventive concepts 1-21, wherein the native atrioventricular valve is a mitral valve, and wherein when the anchor loop is positioned in the ventricle, the neo-leaflet is configured to at least partially replace the function of the target native leaflet by providing an coaptation surface for the opposing native leaflet of the mitral valve.

The inventive concept 36. The coaptation assistance device of inventive concept 35, 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 anchor loop is positioned in the ventricle and remains anchored in place against the surrounding anatomy, including the sub-annulus, the ventricular septal wall, and the ventricular apex region, the new leaflet is configured to at least partially replace the function of the native anterior leaflet by providing an coaptation surface for an opposing native posterior leaflet of the mitral valve.

Inventive concept 37. The coaptation assistance device of any one of inventive concepts 1 through 21, wherein the coaptation assistance device is configured such that when the anchor loop 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.

The inventive concept 38. The coaptation assistance device of any one of inventive concepts 1-21, wherein the annular ventricular anchor further comprises an anchor ring cap connected to the anchor ring.

Inventive concept 39. The coaptation assistance device of inventive concept 38, wherein the anchor loop cap comprises one or more sheets of material extending across a space at least partially surrounded by the anchor loop.

Inventive concept 40. The coaptation assistance device of inventive concept 38, wherein the anchor eye covers comprise a plurality of braided wires.

Inventive concept 41. The coaptation assistance device of inventive concept 38, wherein the anchor ring cap includes a coating on the anchor ring loop.

Inventive concept 42. The coaptation assistance device of any one of inventive concepts 1 through 21, wherein the coaptation assistance device comprises a coaptation-assistance-device wire loop (coaptation-assistance-wire loop) shaped to at least partially define the neo-leaflet and the anchor wire loop.

Inventive concept 43. The coaptation assistance device of inventive concept 42, wherein the coaptation assistance device wire loop is shaped to further at least partially define a native leaflet grasping forceps configured to grasp atrial and ventricular surfaces of the target native leaflet to support and orient the neo-leaflet relative to the native atrioventricular valve.

The inventive concept 44. The coaptation assistance device of inventive concept 43, wherein the coaptation assistance device wire loop is shaped to at least partially define the native leaflet grabbing grip along the coaptation assistance device wire loop between the neo-leaflet and the annular ventricular anchor.

Inventive concept 45. The coaptation assistance device of any one of inventive concepts 1-21, wherein the neo-leaflet includes a neo-leaflet wire loop (neo-leaflet wire loop) defining at least a portion of a boundary of the neo-leaflet, and a neo-leaflet cover (neo-leaflet cover) connected to the neo-leaflet wire loop and providing the coaptation surface.

Inventive concept 46. The coaptation assistance device according to inventive concept 45, wherein the coaptation assistance device is configured such that, when unconstrained, an angle is defined between (a) an anchor ring best fit plane defined by the anchor ring loop and (b) a neo-leaflet best fit plane defined by the neo-leaflet ring loop, the angle being between 60 degrees and 100 degrees.

Inventive concept 47. The coaptation assistance device of inventive concept 46, wherein the angle is between 80 degrees and 90 degrees.

Inventive concept 48. The coaptation assistance device according to inventive concept 45, wherein the coaptation assistance device is configured such that, when unconstrained, an angle is defined between (a) an anchor ring best fit plane defined by the anchor ring loop and (b) a neo-leaflet best fit plane defined by the neo-leaflet ring loop, the angle being between 15 degrees and 50 degrees.

Inventive concept 49. The coaptation assistance device of inventive concept 48, wherein the angle is between 35 degrees and 45 degrees.

Inventive concept 50. The coaptation assistance device according to any one of inventive concepts 1 to 21, wherein

Inventive concept 50. The coaptation assistance device of inventive concept 1, wherein the coaptation assistance device further comprises a pouch (pouch) configured to be inflated by blood flow during a cardiac cycle of a heart of the subject so as to urge the coaptation assistance device towards one or more of: a ventricular surface of the target native leaflet and a ring portion (annuus) of the native atrioventricular valve, thereby stabilizing the coaptation assistance device relative to the native atrioventricular valve.

The inventive concept 51. The coaptation assistance device of inventive concept 50, wherein the coaptation assistance device further comprises a native leaflet grabbing clamp configured to grab the atrial and ventricular surfaces of the target native leaflet to support and orient the neo-leaflet relative to the native atrioventricular valve, and wherein the capsular bag is defined by the native leaflet grabbing clamp.

Inventive concept 52. The coaptation assistance device of inventive concept 51, wherein the native leaflet grabbing clamp is shaped to define the first portion and the second portion configured to grab the atrial surface and the ventricular surface of the target native leaflet by sandwiching 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 grabbing clamp, and wherein the capsular bag is defined by a ventricular-facing surface of the second portion of the native leaflet grabbing clamp.

Inventive concept 53. The coaptation assistance device of any one of inventive concepts 1-21, wherein the coaptation assistance device further comprises a native leaflet spanning portion configured to be positioned through a perforation (punture) by the target native leaflet, and wherein the neo-leaflet is connected to the annular ventricular anchor via the native leaflet spanning portion.

Inventive concept 54. The coaptation assistance device of inventive concept 53, wherein the coaptation assistance device comprises a coaptation assistance device wire loop shaped to at least partially define the neo-leaflet, the annular ventricular anchor, and the native leaflet spanning portion.

Inventive concept 55. A system of coaptation assistance devices according to any one of inventive concepts 1-21, wherein the system further comprises a delivery tube, wherein the coaptation assistance devices are removably disposed in a compressed configuration for minimally invasive or percutaneous delivery to a heart of the subject.

There is further provided, in accordance with an inventive concept 56 of the present invention, a coaptation assistance device for treating a natural atrioventricular valve of a subject, wherein: the coaptation assistance device includes:

an annular ventricular anchor comprising an anchor 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 to a ventricular apex region, and (b) remain anchored in position against surrounding anatomical structures, including the ventricular apex region; and

a neo-leaflet extending directly from and supported by the annular ventricular anchor and configured to at least partially replace a function of a target native leaflet of the native atrioventricular valve by providing an engagement surface for one or more opposing native leaflets opposite the target native leaflet when the anchor loop is positioned in the ventricle.

Inventive concept 57. The coaptation assistance device of inventive concept 56, wherein the annular ventricular anchor is configured to maintain anchoring in place by a force applied to the surrounding anatomy by the anchor loop.

Inventive concept 58. The coaptation assistance device of inventive concept 57, wherein the annular ventricular anchor is configured to maintain anchoring in place by a radially outwardly directed force applied to the surrounding anatomy by the anchor loop.

Inventive concept 59. The coaptation assistance device of inventive concept 56, wherein the annular ventricular anchor is configured to remain anchored in place by friction between the anchor loop ring and the surrounding anatomy.

Inventive concept 60. The coaptation assistance device of inventive concept 56, wherein the coaptation assistance device is configured such that the anchor loop does not extend to a sub-annulus of the target native leaflet when the anchor loop is positioned in the ventricle.

Inventive concept 61. The coaptation assistance device of inventive concept 56, wherein the annular ventricular anchor is configured to be atraumatic so as not to penetrate tissue of the surrounding anatomy.

The inventive concept 62. The coaptation assistance device of inventive concept 56, wherein the coaptation assistance device does not include a plurality of any components configured to penetrate tissue.

Inventive concept 63. The coaptation assistance device of inventive concept 56, wherein the anchor loop comprises metal.

The inventive concept 64. The coaptation assistance device of inventive concept 56, wherein the anchor loop bends along at least 50% of a length of the anchor loop when the anchor loop is unconstrained, the length being detected around the anchor loop.

The inventive concept 65. The coaptation assistance device of inventive concept 64, wherein the anchor loop bends along at least 75% of the length of the anchor loop when the anchor loop is unconstrained.

Inventive concept 66. The coaptation assistance device of inventive concept 56, wherein the anchor loop is shaped to at least 75% of an ellipse when the anchor loop is unconstrained.

Inventive concept 67. The coaptation assistance device of inventive concept 56, wherein the annular ventricular anchor further comprises at least one support wire connected to the anchor loop at two locations on the anchor loop.

Inventive concept 68. The coaptation assistance device of inventive concept 56, wherein the anchor loop is configured to remain anchored in position against one or more ventricular papillary muscles of the ventricular apex region when the anchor loop is positioned in the ventricle.

The inventive concept 69. The coaptation assistance device of inventive concept 56, wherein the anchor loop is shaped to define two or more lobes.

Inventive concept 70. The coaptation assistance device of inventive concept 69, wherein the anchor loop is shaped to define exactly two lobes.

Inventive concept 71. The coaptation assistance device of inventive concept 56, wherein the neo-leaflet is configured such that the coaptation surface is generally static throughout a cardiac cycle of the subject after implantation of the coaptation assistance device in a heart of the subject.

Inventive concept 72. The coaptation assistance device of inventive concept 56, wherein the coaptation surface has a width of between 2cm²And 20cm²An area therebetween.

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

Inventive concept 74. The coaptation assistance device of any one of inventive concepts 56-73, wherein the coaptation assistance device further comprises a native leaflet grasping forceps configured to grasp an atrial surface and a ventricular surface of the target native leaflet to support and orient the neo-leaflet relative to the native atrioventricular valve.

Inventive concept 75. The coaptation assistance device of inventive concept 74, wherein the native leaflet grabbing clamp is connected to the annular ventricular anchor via the neo-leaflet.

Inventive concept 76. The coaptation assistance device of inventive concept 74, wherein the native leaflet grabbing clamp comprises 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 loop is positioned in the ventricle.

Inventive concept 77. The coaptation assistance device of inventive concept 76, wherein the native leaflet grabbing clamp further comprises one or more supra-annular supports configured to abut an atrial surface of the target native leaflet when the anchor loop is positioned in the ventricle such that the one or more sub-native leaflet supports and the one or more supra-annular supports grasp and grab the target native leaflet.

Inventive concept 78. The coaptation assistance device of inventive concept 74, wherein the coaptation assistance device is configured such that when the anchor loop is positioned in the ventricle and the native leaflet grabbing forceps grab the surface atrium and ventricle surface of the palladium native leaflet, the anchor loop does not extend to a sub-annulus of the target native leaflet.

Inventive concept 79. The coaptation assistance device of any one of inventive concepts 56-73, wherein the native atrioventricular valve is a tricuspid valve, and wherein when the anchor loop is positioned in the ventricle, the neo-leaflet is configured to at least partially replace the function of the target native leaflet by providing an coaptation surface for the one or more opposing native leaflets of the tricuspid valve.

Inventive concept 80. The coaptation assistance device of inventive concept 79, wherein the target native leaflet is a naturally spaced leaflet of the tricuspid valve, and wherein when the anchor loop is positioned in the ventricle and remains anchored in position against the surrounding anatomical structure, including the ventricular apex region, the neo-leaflet is configured to at least partially replace the function of the spaced leaflet by providing an engaging surface for one or more of the opposing native posterior and native anterior leaflets of the tricuspid valve.

Inventive concept 81. The coaptation assistance device of any one of inventive concepts 56-73, wherein the native atrioventricular valve is a mitral valve, and wherein when the anchor loop is positioned in the ventricle, the neo-leaflet is configured to at least partially replace the function of the target native leaflet by providing an coaptation surface for the opposing native leaflet of the mitral valve.

Inventive concept 82. The coaptation assistance device of inventive concept 81, wherein the target native leaflet is a native anterior leaflet of the mitral valve, and wherein when the anchor loop is positioned in the ventricle and remains anchored in position against the surrounding anatomy, including the ventricular apex region, the neo-leaflet is configured to at least partially replace the function of the native anterior leaflet by providing an engaging surface for an opposing native posterior leaflet of the mitral valve.

Inventive concept 83. The coaptation assistance device of any one of inventive concepts 56-73, wherein the coaptation assistance device is configured such that the coaptation surface of the new leaflet spans from an atrial side to a ventricular side of a native valve plane when the anchor loop is positioned in the ventricle.

Inventive concept 84. The coaptation assistance device of any one of inventive concepts 56-73, wherein the annular ventricular anchor further comprises an anchor ring cap connected to the anchor ring.

Inventive concept 85. The coaptation assistance device of inventive concept 84, wherein the anchor loop cap comprises one or more sheets of material that extend across a space at least partially surrounded by the anchor loop.

Inventive concept 86. The coaptation assistance device of inventive concept 84, wherein the anchor eye covers include a plurality of braided wires.

Inventive concept 87. The coaptation assistance device of inventive concept 1, wherein the anchor ring cap includes a coating on the anchor ring loop.

Inventive concept 88. The coaptation assistance device of any one of inventive concepts 56-73, wherein the coaptation assistance device comprises a neo-leaflet wire loop shaped to at least partially define the neo-leaflet and the annular ventricular anchor.

Inventive concept 89. The coaptation assistance device of any one of inventive concepts 56-73, wherein the neo-leaflet includes a neo-leaflet wire loop defining at least a portion of a boundary of the neo-leaflet, and a neo-leaflet cover connected to the neo-leaflet wire loop and providing the coaptation surface.

Inventive concept 90. A system of coaptation assistance devices according to any one of inventive concepts 56-73, wherein the system further comprises a delivery tube, wherein the coaptation assistance devices are removably disposed in a compressed configuration for minimally invasive or percutaneous delivery to a heart of the subject.

Yet further provided in accordance with an inventive concept 91 of the present invention is a coaptation assistance device for treating a natural atrioventricular valve of a subject, wherein the coaptation assistance device comprises:

an annular ventricular anchor that (i) comprises a woven flat sheet comprising a plurality of woven wires, and (ii) is configured to (a) be positioned in a ventricle extending between a ventricular apex region and a sub-annulus of a target native leaflet of the native atrioventricular valve, and (b) apply a force to the surrounding anatomy comprising the sub-annulus, the ventricular wall, and the ventricular apex region, by the annular ventricular anchor, to maintain anchoring in place; and

a neo-leaflet supported by the annular ventricular anchor and configured to at least partially replace a 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 positioned in the ventricle.

The inventive concept 92. The coaptation assistance device of inventive concept 91, wherein the annular ventricular anchor is configured to remain anchored in place by a radially outwardly directed force applied to the surrounding anatomy by the annular ventricular anchor.

The inventive concept 93. The coaptation assistance 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 anatomy.

The inventive concept 94. The coaptation assistance device of inventive concept 91, wherein the annular ventricular anchor is configured to be atraumatic so as not to penetrate tissue of the surrounding anatomy.

Inventive concept 95. The coaptation assistance device of inventive concept 91, wherein the coaptation assistance device does not include a plurality of any components configured to penetrate tissue.

The inventive concept 96. The coaptation assistance device of inventive concept 91, wherein the plurality of braided wires comprise metal.

Inventive concept 97. The coaptation assistance device of inventive concept 91, wherein the annular ventricular anchor is shaped to at least 75% of an ellipse when the annular ventricular anchor is unconstrained.

Inventive concept 98. The coaptation assistance 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 in position against the sub-annulus, the ventricular wall, and one or more ventricular papillary muscles of the ventricular apex region.

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

Inventive concept 100. The coaptation assistance device of inventive concept 91, wherein the coaptation surface has a width of between 2cm²And 20cm²An area therebetween.

The inventive concept 101. The coaptation assistance device of inventive concept 91, wherein the coaptation assistance device is configured such that, when unconstrained, an angle is defined between (a) an anchor ring best fit plane defined by the anchor ring loop and (b) a new leaflet best fit plane defined by the coaptation surface, the angle being less than 20 degrees; or the optimal fitting plane of the anchoring ring and the optimal fitting plane of the neo-leaflet are parallel to each other.

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

Inventive concept 103. The coaptation assistance device of any one of inventive concepts 91-102, wherein the coaptation assistance device further comprises a native leaflet grasping forceps configured to grasp an atrial surface and a ventricular surface of the target native leaflet to support and orient the neo-leaflet relative to the native atrioventricular valve.

The inventive concept 104. The coaptation assistance device of inventive concept 103, wherein the neo-leaflet is connected to the annular ventricular anchor via the native leaflet grabbing clamp.

The inventive concept 105. The coaptation assistance device of inventive concept 103, wherein the native leaflet grabbing clamp is shaped to define a first portion and a second portion configured to grab the atrial surface and the ventricular surface of the target native leaflet by sandwiching 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 grabbing clamp.

The inventive concept 106. The coaptation assistance device of inventive concept 105, wherein the first portion and the second portion are configured to fold toward each other such that the atrial surface and the ventricular surface of the target native leaflet is grasped by sandwiching the 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.

Inventive concept 107. The coaptation assistance device of any one of inventive concepts 91 through 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 comprising the sub-annulus, the ventricular septal wall, and the ventricular apex region.

The inventive concept 108. The coaptation assistance device of any one of inventive concepts 91-102, wherein the native atrioventricular valve is a tricuspid valve, and wherein the neo-leaflets are configured to at least partially replace the function of the target native leaflet by providing an coaptation surface for the one or more opposing native leaflets of the tricuspid valve when the annular ventricular anchor is positioned in the ventricle.

The inventive concept 109. The coaptation assistance device of 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 in position against the surrounding anatomy, including the sub-annulus, the ventricular septal wall, and the ventricular apex region, the neo-leaflet is configured to at least partially replace the function of the septal leaflet by providing an engaging surface for one or more of the opposing native posterior and native anterior leaflets of the tricuspid valve.

The inventive concept 110. The coaptation assistance device of any one of inventive concepts 91-102, wherein the native atrioventricular valve is a mitral valve, and wherein the neo-leaflet is configured to at least partially replace the function of the target native leaflet by providing an coaptation surface for the opposing native leaflet of the mitral valve when the annular ventricular anchor is positioned in the ventricle.

Inventive concept 111. The coaptation assistance device of 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 against the surrounding anatomy, including the sub-annulus, the ventricular septal wall, and the ventricular apex region, the neo-leaflet is configured to at least partially replace the function of the native anterior leaflet by providing an coaptation surface for an opposing native posterior leaflet of the mitral valve.

The inventive concept 112. The coaptation assistance device of any one of inventive concepts 91 through 102, wherein the coaptation assistance device is configured such that when the annular ventricular anchor 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.

The inventive concept 113. The coaptation assistance device of any one of inventive concepts 91 through 102, wherein the annular ventricular anchor further comprises an anchor ring cap connected to and covering all or a portion of the braided flat sheet.

Inventive concept 114. The coaptation assistance device of inventive concept 113, wherein the anchor eye covers comprise one or more sheet materials connected to the braided flat sheet.

The inventive concept 115. The coaptation assistance device of any one of inventive concepts 91-102, wherein the system further comprises a delivery tube, wherein the coaptation assistance device is removably disposed in a compressed configuration for minimally invasive or percutaneous delivery to a heart of the subject.

In accordance with an inventive concept 116 of the present invention, there is further provided a method of treating a natural atrioventricular valve of a subject, the method comprising the steps of:

positioning an annular ventricular anchor of a coaptation assistance device in a ventricle such that an anchor loop of the annular ventricular anchor extends between a ventricular apex region and a sub-loop surface of a target native leaflet of a native atrioventricular valve such that the anchor loop remains anchored in position against surrounding anatomical structures, including the sub-loop surface, a ventricular wall, and the ventricular apex region, wherein the anchor loop defines at least a portion of a boundary of the annular ventricular anchor; and

positioning a neo-leaflet of the coaptation assistance device such that the neo-leaflet at least partially replaces the function of the target native leaflet by providing an coaptation surface for one or more opposing native leaflets that are opposite the target native leaflet when the anchor loop is positioned in the ventricle.

Inventive concept 117. The method according to inventive concept 116, wherein anchoring the ring shaped ventricle comprises the steps of: positioning the annular ventricular anchor such that the anchor loop applies a force to the surrounding anatomy through the anchor loop to maintain anchoring in place.

The inventive concept 118. The method according to inventive concept 117, wherein anchoring the ring shaped ventricle comprises the steps of: positioning the annular ventricular anchor such that the anchor loop applies a radially outwardly directed force to the surrounding anatomy through the anchor loop to maintain anchoring in place.

Inventive concept 119. The method according to inventive concept 116, wherein anchoring the ring shaped ventricle comprises the steps of: positioning the annular ventricular anchor such that the anchor loop remains anchored in place by friction between the anchor loop and the surrounding anatomy.

The inventive concept 120. The method of inventive concept 116, wherein the ring-shaped ventricular anchor is configured to be atraumatic so as not to penetrate tissue of the surrounding anatomy, and wherein positioning the ring-shaped ventricular anchor does not include penetrating tissue of the surrounding anatomy using the ring-shaped ventricular anchor.

The inventive concept 121. The method of inventive concept 116, wherein the method does not include penetrating tissue using any of the plurality of components of the coaptation assistance device.

The inventive concept 122. The method according to inventive concept 116, wherein the method further comprises the steps of: positioning a native leaflet grasping forceps of the coaptation assistance device to grasp atrial and ventricular surfaces of the target native leaflet, to support the neo-leaflet, and to orient the neo-leaflet relative to the native atrioventricular valve.

The inventive concept 123. The method of inventive concept 122, wherein the neo-leaflet is connected to the annular ventricular anchor via the native leaflet grabbing clamp.

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

The inventive concept 125. The method according to inventive concept 122, wherein positioning the native leaflet grabbing clamp to grab the atrial and ventricular surfaces of the target native leaflet comprises the steps of: sandwiching 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 grabbing clamp.

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

The inventive concept 127. The method according to inventive concept 126, wherein folding the first and second portions of the native leaflet grabbing clamp towards each other comprises the steps of: a third portion is defined by the natural leaflet grasping forceps at a fold between the first portion and the second portion of the natural leaflet grasping forceps that extends around a free edge of the target natural leaflet.

The inventive concept 128. The method according to inventive concept 122, wherein positioning the native leaflet grabbing clamp to grab the ventricular surface of the target native leaflet includes the steps of: pressing the one or more sub-native leaflet support sections of the native leaflet grasping forceps against one or more portions of the ventricular surface of the target native leaflet when the anchor loop ring is positioned in the ventricle.

The inventive concept 129. The method of inventive concept 128, wherein positioning the native leaflet grabbing clamp to grab the atrial surface of the target native leaflet includes the steps of: pressing the one or more super-annular supports of the native leaflet grasping forceps against an atrial surface of the target native leaflet such that the one or more sub-native leaflet supports and the one or more super-annular supports grasp and grasp the target native leaflet when the anchor loop is positioned in the ventricle.

The inventive concept 130. The method according to inventive concept 122, wherein positioning the native leaflet grabbing clamp to grab the atrial surface of the target native leaflet includes the steps of: pressing the one or more toroidal supports of the native leaflet grabbing clamp against an atrial surface of the target native leaflet when the anchor loop ring is positioned in the ventricle.

Inventive concept 131. The method according to inventive concept 116, wherein anchoring the ring shaped ventricle comprises the steps of: positioning the annular ventricular anchor such that the anchor loop remains anchored in position against the sub-annulus, the ventricular wall, and one or more ventricular papillary muscles of the ventricular apex region.

Inventive concept 132. The method of inventive concept 116, wherein the anchor loop is shaped to define two or more lobes.

Inventive concept 133. The method of inventive concept 132, wherein the anchor loop is shaped to define exactly two lobes.

The inventive concept 134. The method of inventive concept 116, wherein the ventricular wall is a ventricular septal wall, and wherein anchoring the annular ventricle comprises the steps of: positioning the annular ventricular anchor such that the anchor loop remains anchored in position against the surrounding anatomical structure, the surrounding anatomical structure including the sub-annulus, the ventricular septum wall, and the ventricular apex region.

The 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 steps of: positioning the neo-leaflet such that the neo-leaflet at least partially replaces the function of the target native leaflet by providing an engaging surface for one or more opposing native leaflets of the tricuspid valve when the anchor loop is positioned in the ventricle.

Inventive concept 136. The method of inventive concept 135, wherein the target native leaflet is a natural septal leaflet of the tricuspid valve, wherein the ventricular wall is a ventricular septal wall, and wherein positioning the neo-leaflet comprises the steps of: positioning the neo-leaflet such that when the anchor loop is positioned in the ventricle and remains anchored in position against the surrounding anatomical structure, including the sub-annulus, the ventricular septal wall, and the ventricular apex region, the neo-leaflet at least partially replaces the function of the septal leaflet by providing a surface of coaptation for one or more of the opposing native posterior and anterior leaflets of the tricuspid valve.

Inventive concept 137. The method of inventive concept 116, wherein the native atrioventricular valve is a mitral valve, and wherein positioning the neo-leaflet comprises the steps of: positioning the neo-leaflet such that the neo-leaflet at least partially replaces the function of the target native leaflet by providing an coaptation surface against the opposing native leaflet of the mitral valve when the anchor loop is positioned in the ventricle.

The inventive concept 138. The method of 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 neo-leaflet comprises the steps of: positioning the neo-leaflet such that when the anchor loop is positioned in the ventricle and remains anchored in position against the surrounding anatomical structure, including the sub-annulus, the ventricular septal wall, and the ventricular apex region, the neo-leaflet at least partially replaces the function of the native anterior leaflet by providing an engaging surface for an opposing native posterior leaflet of the mitral valve.

Inventive concept 139. The method according to inventive concept 116, wherein positioning the neo-leaflet comprises the steps of: positioning the neo-leaflet such that the coaptation surface of the neo-leaflet spans from an atrial side to a ventricular side of a native valve plane when the anchor loop is positioned in the ventricle.

The inventive concept 140. The method according to inventive concept 116, wherein positioning the neo-leaflet comprises the steps of: positioning the neo-leaflet such that, after implantation of the coaptation assistance device in a heart of the subject, the coaptation surface is generally static throughout a cardiac cycle of the subject.

The inventive concept 141. The method according to inventive concept 116, wherein positioning the neo-leaflet comprises the steps of: positioning the neo-leaflet such that, upon implantation of the coaptation assistance device into 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.

The inventive concept 142. The method of inventive concept 116, wherein the anchor loop is shaped as a closed loop.

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

Inventive concept 144. The method according to inventive concept 116, wherein the ventricular ring anchor further comprises an anchor ring cap connected to the anchor ring.

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

Inventive concept 146. The method of inventive concept 144, wherein the anchor eye covers comprise a plurality of braided wires.

Inventive concept 147. The method of inventive concept 144, wherein the anchor ring cap comprises a coating on the anchor ring loop.

The inventive concept 148. The method according to inventive concept 116, wherein the ventricular ring anchor further comprises at least one support wire connected to the anchor loop at two locations on the anchor loop.

The inventive concept 149. The method according to inventive concept 116, wherein the method comprises a coaptation assistance device wire loop shaped to at least partially define the neo-leaflet and the annular ventricular anchor.

Inventive concept 150. The method of inventive concept 149, wherein the coaptation assistance device wire loop is shaped to further at least partially define a native leaflet grasping forceps configured to grasp an atrial surface and a ventricular surface of the target native leaflet to support and orient the neo-leaflet relative to the native atrioventricular valve.

Inventive concept 151. The method of inventive concept 150, wherein the coaptation assistance device wire loop is shaped to at least partially define the native leaflet grabbing clamp along the coaptation assistance device wire loop between the neo-leaflet and the annular ventricular anchor.

The inventive concept 152. The method of inventive concept 116, wherein the neo-leaflet includes a neo-leaflet wire loop defining at least a portion of a boundary of the neo-leaflet, and a neo-leaflet cover connected to the neo-leaflet wire loop and providing the coaptation surface.

Inventive concept 153. The method of inventive concept 116, wherein the coaptation assistance device further comprises a native leaflet spanning portion, and wherein the neo-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.

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

The inventive concept 155. The method according to inventive concept 116, wherein the method further comprises the steps of: prior to positioning the annular ventricular anchor and the neo-leaflet, minimally invasively or percutaneously delivering the coaptation assistance device to a heart of the subject while the coaptation assistance device is removably disposed in a delivery tube in a compressed configuration.

There is additionally provided in accordance with an inventive concept 156 of the present invention a method of treating a natural atrioventricular valve of a subject, said method comprising the steps of:

positioning a ring-shaped ventricular anchor of a coaptation assistance device in a ventricle such that an anchor loop of the ring-shaped ventricular anchor extends to a ventricular apex region such that the anchor loop remains anchored in position against surrounding anatomy, including the ventricular apex region, wherein the anchor loop defines at least a portion of a boundary of the ring-shaped ventricular anchor; and

positioning a neo-leaflet of the coaptation assistance device such that the neo-leaflet at least partially replaces the function of a target native leaflet of the native atrioventricular valve by providing an coaptation surface for one or more opposing native leaflets opposite the target native leaflet when the anchor loop is positioned in the ventricle.

The inventive concept 157. The method of inventive concept 156, wherein anchoring the annular ventricle comprises the steps of: positioning the annular ventricular anchor such that the anchor loop applies a force to the surrounding anatomy through the anchor loop to maintain anchoring in place.

The inventive concept 158. The method of inventive concept 157, wherein anchoring the annular ventricle comprises: positioning the annular ventricular anchor such that the anchor loop applies a radially outwardly directed force to the surrounding anatomy through the anchor loop to maintain anchoring in place.

Inventive concept 159. The method of inventive concept 156, wherein anchoring the annular ventricle comprises the steps of: positioning the annular ventricular anchor such that the anchor loop remains anchored in place by friction between the anchor loop and the surrounding anatomy.

Inventive concept 160. The method of inventive concept 156, wherein positioning the ring ventricular anchor in a ventricle comprises the steps of: anchoring the annular ventricular anchor in a ventricle such that the anchor loop does not extend to a sub-annulus of the target native leaflet.

The inventive concept 161. The method of inventive concept 156, wherein the ring ventricular anchor is configured to be atraumatic, and wherein positioning the ring ventricular anchor does not include penetrating tissue of the surrounding anatomy using the ring ventricular anchor.

Inventive concept 162. The method of inventive concept 156, wherein the method does not include penetrating tissue using any of the plurality of components of the coaptation assistance device.

The inventive concept 163. The method of inventive concept 156, wherein the method further comprises the steps of: positioning a native leaflet grasping forceps of the coaptation assistance device to grasp atrial and ventricular surfaces of the target native leaflet, to support the neo-leaflet, and to orient the neo-leaflet relative to the native atrioventricular valve.

The inventive concept 164. The method of inventive concept 163, wherein the native leaflet grabbing clamp is connected to the annular ventricular anchor via the neo-leaflet.

The inventive concept 165. The method according to inventive concept 163, wherein positioning the native leaflet grabbing clamp to grab the ventricular surface of the target native leaflet includes the steps of: pressing the one or more sub-native leaflet support sections of the native leaflet grasping forceps against one or more portions of the ventricular surface of the target native leaflet when the anchor loop ring is positioned in the ventricle.

The inventive concept 166. The method according to inventive concept 165, wherein positioning the native leaflet grabbing clamp to grab the atrial surface of the target native leaflet comprises the steps of: pressing the one or more super-annular supports of the native leaflet grasping forceps against an atrial surface of the target native leaflet such that the one or more sub-native leaflet supports and the one or more super-annular supports grasp and grasp the target native leaflet when the anchor loop is positioned in the ventricle.

Inventive concept 167. The method according to inventive concept 163, wherein positioning the native leaflet grabbing clamp to grab the atrial surface of the target native leaflet comprises the steps of: pressing the one or more toroidal supports of the native leaflet grabbing clamp against an atrial surface of the target native leaflet when the anchor loop ring is positioned in the ventricle.

Inventive concept 168. The method of inventive concept 156, wherein anchoring the annular ventricle comprises the steps of: positioning the annular ventricular anchor such that the anchor loop remains anchored in position against one or more ventricular papillary muscles of the ventricular apex region.

Inventive concept 169. The method of inventive concept 156, wherein the anchor loop is shaped to define two or more lobes.

Inventive concept 170. The method of inventive concept 169, wherein the anchor loop is shaped to define exactly two lobes.

Inventive concept 171. The method of inventive concept 156, wherein the native atrioventricular valve is a tricuspid valve, and wherein positioning the neo-leaflet comprises the steps of: positioning the neo-leaflet such that the neo-leaflet at least partially replaces the function of the target native leaflet by providing an engaging surface for one or more opposing native leaflets of the tricuspid valve when the anchor loop is positioned in the ventricle.

Inventive concept 172. The method of inventive concept 171, wherein the target native leaflet is a naturally spaced leaflet of the tricuspid valve, and wherein positioning the neo-leaflet comprises the steps of: positioning the neo-leaflet such that when the anchor loop is positioned in the ventricle and remains anchored in position against the surrounding anatomical structure, including the ventricular apex region, the neo-leaflet at least partially replaces the function of the septal leaflet by providing a surface of coaptation against one or more of the opposing native posterior and native anterior leaflets of the tricuspid valve.

Inventive concept 173. The method of inventive concept 156, wherein the native atrioventricular valve is a mitral valve, and wherein positioning the neo-leaflet comprises the steps of: positioning the neo-leaflet such that the neo-leaflet at least partially replaces the function of the target native leaflet by providing an coaptation surface against the opposing native leaflet of the mitral valve when the anchor loop is positioned in the ventricle.

Inventive concept 174. The method of inventive concept 173, wherein the target native leaflet is a native anterior leaflet of the mitral valve, and wherein positioning the neo-leaflet comprises the steps of: positioning the neo-leaflet such that when the anchor loop is positioned in the ventricle and remains anchored in position against the surrounding anatomical structure, including the ventricular apex region, the neo-leaflet at least partially replaces the function of the native anterior leaflet by providing an engaging surface for an opposing native posterior leaflet of the mitral valve.

The inventive concept 175. The method of inventive concept 156, wherein positioning the neo-leaflet comprises the steps of: positioning the neo-leaflet such that the coaptation surface of the neo-leaflet spans from an atrial side to a ventricular side of a native valve plane when the anchor loop is positioned in the ventricle.

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

Inventive concept 177. The method of inventive concept 156, wherein positioning the neo-leaflet comprises the steps of: positioning the neo-leaflet such that, upon implantation of the coaptation assistance device into 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.

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

Inventive concept 179. The method of inventive concept 156, wherein the ventricular ring anchor further comprises an anchor ring cap connected to the anchor ring.

The inventive concept 180. The method of inventive concept 179, wherein the anchor eye cover comprises one or more sheets of material extending across a space at least partially surrounded by the anchor eye.

The inventive concept 181. The method of inventive concept 179, wherein the anchor eye covers comprise a plurality of braided wires.

Inventive concept 182. The method of inventive concept 179, wherein the anchor ring cap comprises a coating on the anchor ring.

Inventive concept 183. The method of inventive concept 156, wherein the ventricular ring anchor further comprises at least one support wire connected to the anchor loop at two locations on the anchor loop.

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

Inventive concept 185. The method of inventive concept 156 wherein the neo-leaflet includes a neo-leaflet wire loop defining at least a portion of a boundary of the neo-leaflet, and a neo-leaflet cover connected to the neo-leaflet wire loop and providing the coaptation surface.

Inventive concept 186. The method of inventive concept 156, wherein the method further comprises the steps of: prior to positioning the annular ventricular anchor and the neo-leaflet, minimally invasively or percutaneously delivering the coaptation assistance device to a heart of the subject while the coaptation assistance device is removably disposed in a delivery tube in a compressed configuration.

Also provided according to an inventive concept 187 of the present invention is a method of treating a natural atrioventricular valve of a subject, the method comprising the steps of:

positioning an annular ventricular anchor of a coaptation assistance device in a ventricle such that the annular ventricular anchor extends between a ventricular apex region and a sub-annulus of a target native leaflet of the native atrioventricular valve and forces applied to the surrounding anatomy by the anchor loop to maintain anchoring in place, the surrounding anatomy comprising the sub-annulus, the ventricular wall, and the ventricular apex region, wherein the annular ventricular anchor comprises a woven flat sheet comprising a plurality of woven wires; and

positioning a neo-leaflet of the coaptation assistance device such that the neo-leaflet at least partially replaces the function of the target native leaflet by providing an coaptation surface for one or more opposing native leaflets that are opposite the target native leaflet when the anchor loop is positioned in the ventricle.

Inventive concept 188. The method of inventive concept 187, wherein positioning the annular ventricular anchor comprises the steps of: positioning the annular ventricular anchor such that the annular ventricular anchor applies a radially outwardly directed force to the surrounding anatomy through the annular ventricular anchor to maintain anchoring in place.

Inventive concept 189. The method of inventive concept 187, wherein positioning the annular ventricular anchor comprises the steps 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 anatomy.

The 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 anatomy with the annular ventricular anchor.

The inventive concept 191. The method of inventive concept 187 wherein the method does not include penetrating tissue using any of the plurality of components of the coaptation assistance device.

Inventive concept 192. The method of inventive concept 187, wherein the plurality of braided wires comprise metal.

Inventive concept 193. The method of inventive concept 187, wherein the annular ventricular anchor is shaped to at least 75% of an ellipse when the annular ventricular anchor is unconstrained.

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

The inventive concept 195. The method of inventive concept 187, wherein positioning the neo-leaflet comprises the steps of: positioning the neo-leaflet such that, upon implantation of the coaptation assistance device into 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.

The 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 assistance device to grasp atrial and ventricular surfaces of the target native leaflet, to support the neo-leaflet, and to orient the neo-leaflet relative to the native atrioventricular valve.

Inventive concept 197. The method of inventive concept 196, wherein the neo-leaflet is connected to the annular ventricular anchor via the native leaflet grabbing clamp.

The inventive concept 198. The method of inventive concept 196, wherein positioning the native leaflet grabbing clamp to grab the atrial and ventricular surfaces of the target native leaflet comprises the steps of: sandwiching 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 grabbing clamp.

The 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 steps of: folding the first and second portions toward each other to grasp the atrial surface and the ventricular surface of the target native leaflet.

The inventive concept 200. The method of inventive concept 187, wherein positioning the annular ventricular anchor comprises the steps of: positioning the annular ventricular anchor such that the annular ventricular anchor remains anchored in position against the sub-annulus, the ventricular wall, and one or more ventricular papillary muscles of the ventricular apex region.

The inventive concept 201. The method of inventive concept 187, wherein the ventricular wall is a ventricular septum wall, and wherein anchoring the annular ventricular wall comprises the steps of: positioning the annular ventricular anchor such that the annular ventricular anchor is anchored in position against the surrounding anatomy, the surrounding anatomy including the sub-annulus, the ventricular septum wall, and the ventricular apex region.

The 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 steps of: positioning the neo-leaflet such that the neo-leaflet at least partially replaces the function of the target native leaflet by providing an engaging surface for one or more opposing native leaflets of the tricuspid valve when the annular ventricular anchor is in the ventricle.

Inventive concept 203. The method according to inventive concept 202, wherein the target native leaflet is a natural septal leaflet of the tricuspid valve, wherein the ventricular wall is a ventricular septal wall, and wherein positioning the neo-leaflet comprises the steps of: positioning the neo-leaflet such that when the annular ventricular anchor is positioned in the ventricle and remains anchored in position against the surrounding anatomical structure, including the sub-annulus, the ventricular septal wall, and the ventricular apex region, the neo-leaflet at least partially replaces the function of the septal leaflet by providing a coaptation surface for one or more of the opposing native posterior and anterior leaflets of the tricuspid valve.

Inventive concept 204. The method of inventive concept 187 wherein the native atrioventricular valve is a mitral valve, and wherein positioning the neo-leaflet comprises the steps of: positioning the neo-leaflet such that the neo-leaflet at least partially replaces the function of the target native leaflet by providing a coaptation surface against the opposing native leaflet of the mitral valve when the annular ventricular anchor is positioned in the ventricle.

Inventive concept 205. The method of 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 neo-leaflet comprises the steps of: positioning the neo-leaflet such that when the annular ventricular anchor is positioned in the ventricle and remains anchored in position against the surrounding anatomical structure, including the sub-annulus, the ventricular septal wall, and the ventricular apex region, the neo-leaflet at least partially replaces the function of the native anterior leaflet by providing an engaging surface for an opposing native posterior leaflet of the mitral valve.

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

Inventive concept 207. The method of inventive concept 187 wherein the annular ventricular anchor further comprises an anchor ring cap connected to the woven flat plate segment and covering all or a portion of the woven flat plate segment.

The inventive concept 208. The method of inventive concept 207, wherein the anchor eye covers comprise one or more sheet materials connected to the woven flat sheet.

The inventive concept 209. The method according to inventive concept 187, wherein the method further comprises the step of: prior to positioning the annular ventricular anchor and the neo-leaflet, minimally invasively or percutaneously delivering the coaptation assistance device to a heart of the subject while the coaptation assistance device is removably disposed in a delivery tube in a compressed configuration.

The invention will be understood and appreciated more fully from the following detailed description of embodiments of the invention taken in conjunction with the accompanying drawings, in which:

drawings

Figures 1A to 1E are schematic views of a coaptation assistance device for treating a natural valve of a subject, according to an application of the present invention;

FIG. 2 is a schematic view of the coaptation assistance device of FIGS. 1A-1E and FIG. 2 implanted in a native valve according to an application of the present disclosure;

FIGS. 3A-3K are highly schematic views of a ring-shaped ventricular anchor according to related applications of the present invention;

FIGS. 4A-4B are schematic illustrations of another configuration of the coaptation assistance device of FIGS. 1A-1E and 2, in accordance with an application of the present invention;

FIGS. 5A-5B are schematic illustrations of yet another configuration of the coaptation assistance device of FIGS. 1A-1E and 2, in accordance with an application of the present invention;

FIGS. 6A-6C are schematic illustrations of yet another configuration of the coaptation assistance device of FIGS. 1A-1E and 2, in accordance with an application of the present invention;

FIG. 7 is a schematic view of another configuration of the coaptation assistance device of FIGS. 1A-1E and 2 in accordance with an application of the present invention;

fig. 8A to 8B are respectively schematic views of the additional coaptation assistance device according to the related application of the present invention;

FIGS. 9A-9H are schematic illustrations of the method of implanting the coaptation assistance device in a heart of a subject of FIGS. 1A-1E and 2 of FIG. 2, according to an application of the present invention;

FIGS. 10A-10C are schematic illustrations of a coaptation assistance device according to an application of the present invention;

FIGS. 10D-10F are schematic illustrations of another coaptation assistance device according to an application of the present invention;

FIG. 10G is a schematic view of the coaptation assistance device of FIGS. 10A-10C implanted in a native valve according to an application of the present disclosure;

FIGS. 11A-11D are schematic views of yet another coaptation assistance device, according to an application of the present invention;

FIGS. 12A-12E are schematic illustrations of yet another coaptation assistance device according to an application of the present invention;

FIGS. 13A-13E are schematic views of another coaptation assistance device according to an application of the present disclosure;

FIG. 14 is a schematic view of the coaptation assistance device of FIGS. 12A-12E implanted in a native valve according to an application of the present disclosure;

FIGS. 15A-15B are schematic illustrations of the coaptation assistance device of FIGS. 13A-13E implanted in a native valve, according to an application of the present invention;

FIGS. 16A-16F are schematic views of another coaptation assistance device according to an application of the present disclosure;

FIG. 17 is a schematic view of the coaptation assistance device of FIGS. 16A-16F implanted in a natural valve according to an application of the present disclosure;

FIGS. 18A-18F are schematic illustrations of another coaptation assistance device according to an application of the present invention;

FIG. 19 is a schematic view of the coaptation assistance device of FIGS. 18A-18F implanted in a native valve according to an application of the present disclosure;

FIGS. 20A-20B are schematic views of yet another coaptation assistance device, according to an application of the present invention;

FIG. 21 is a schematic view of another coaptation assistance device according to an application of the present disclosure;

FIG. 22 is a schematic view of the coaptation assistance device of FIG. 21 implanted in a natural valve according to one application of the present disclosure; and

FIG. 23 is a schematic view of a coaptation assistance device implanted in a native mitral valve, according to an application of the present invention.

Detailed Description

Fig. 1A-1E are schematic illustrations of a coaptation assistance device 20 for treating a natural valve 22 of a subject, according to an application of the present invention. Typically, the native valve suffers from a valvular disorder, such as functional mitral regurgitation (mitral regurgitation) or tricuspid regurgitation (tricuspid regurgitation), which is typically characterized by a lack of leaflet mobility in the valve. The native valve is typically an atrioventricular valve, i.e. the tricuspid valve or the mitral valve.

Referring additionally to FIG. 2, FIG. 2 is a schematic view of a coaptation assistance device 20 implanted in a native valve 22, according to one application of the present invention. In the particular implant shown in fig. 2, the native valve 22 is the tricuspid valve. Fig. 2 is a cross-sectional view of the heart with an anterior portion of the heart including the native anterior leaflet of the tricuspid valve removed, showing only the septal and posterior leaflets. (A natural "valve" is also known in the art as a natural "valve device")

The coaptation assistance device 20 includes an annular ventricular anchor 30, i.e., a ventricular anchor having an annular boundary, and a neo-leaflet 32 supported by the annular ventricular anchor 30. The annular 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".

Generally, 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 ring 50 comprises a metal or another semi-rigid material. The material of the anchor loop 50 is self-expanding or mechanically expandable. For example, the anchor loop 50 may comprise a shape-memory alloy (e.g., nickel-titanium alloy (Nitinol). For some applications, the anchor loop 50 is made by shaping a wire. For other applications, the anchor eye 50 is made by winding wire, with fixed or variable properties along the length of the eye; the variable characteristic may include one or more of an outer diameter, a pitch, and a stiffness. For other applications, the anchor loop 50 is made by laser cutting and shaping a tube or a flat sheet of metal, such as a shape memory alloy, e.g., nitinol.

The anchor loop 50 is configured to be positioned in a ventricle 23, extending between a ventricular apex region 24 (at the base of the ventricle 23) and a subannular surface 25 of a target native leaflet 26 of the native valve 22. As shown in fig. 2, the anchor loop 50 is configured to remain anchored in place against the surrounding anatomy (surrouding and anatomi), including the sub-annulus 25, a ventricular wall 27, and the ventricular apex region 24. In other words, the anchor loop 50 is configured to be secured under and behind the target native leaflet 26, in contact with the sub-annulus 25 to be located at the apex of the heart and stabilized by the ventricular wall 27. Generally, the anchor loop 50 is configured to pass behind a plurality of ventricular papillary muscles (46) of the ventricular apex region 24 or pass through a plurality of ventricular papillary muscles (46) of the ventricular apex region 24. Optionally, the surrounding anatomy to which the anchor loop 50 is anchored further comprises one or more of: an adjustment band, one or more chordae tendineae, and one or more papillary muscles on opposite sides of ventricle 23.

For some applications, the coaptation assistance device 20 does not include any of a number of components configured to penetrate (e.g., pierce) tissue. For other applications, coaptation assistance device 20 includes at least one component configured to penetrate tissue, such as described below with reference to fig. 21 and 22.

For example, as shown in fig. 2, when the anchor loop 50 is positioned in the ventricle 23, the neo-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 opposite the target native leaflet 26. The neo-leaflet 32 is generally configured to cover at least a portion of the target native leaflet 26.

For some applications, the engagement surface 34 has at least 2cm²(e.g., at least 10 cm)²) No more than 20cm²(e.g., no more than 15 cm)²) And/or between 2cm (e.g., 10 cm)²) And 20cm²(e.g., 15 cm)²) An area therebetween. Other bonding surfaces described below may also have these areas.

For some applications, neo-leaflet 32 includes a neo-leaflet wire loop 36 defining at least a portion of a boundary of the neo-leaflet, and a neo-leaflet cover 38 connected to the neo-leaflet wire loop 36. Generally, the neo-leaflet cover 38 provides the coaptation surface 34 described above. For some applications, neo-leaflet cover 38 comprises one or more biocompatible sheet materials, which may comprise a synthetic material or a biological tissue material, such as a fabric comprising a polymer or a biological material (e.g., polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), silicone, urethane, or pericardium). The neo-leaflet wire loop 36 can be shaped as a closed loop or an open loop that, if provided, opens proximally in the direction of the annular ventricular anchor 30 and the native leaflet grasping forceps 40. The neo-leaflet wire loop 36 comprises a metal or another semi-rigid material. The material of the neo-leaflet wire loop 36 is self-expanding or mechanically expandable. For example, the neo-leaflet wire loop 36 may comprise a shape memory alloy, such as nitinol. For some applications, the neo-leaflet wire loop 36 is made by shaping one or more wires. For other applications, the neo-leaflet wire loop 36 is made by winding wire, with fixed or variable properties along the length of the loop; including one or more of outer diameter, pitch, and stiffness. For some applications, the wire of the neo-leaflet wire loop 36 is circular in cross-section; alternatively, the wire has another cross-sectional shape, such as elliptical, rectangular, or substantially flat. For other applications, the neo-leaflet wire loop 36 is made by laser cutting and shaping a tube or sheet of metal in the shape of a plate, such as a shape memory alloy, e.g., nitinol.

For some applications, the neo-leaflet 32 has an inherent stiffness provided by the material of the neo-leaflet wire loop 36 and/or the neo-leaflet cover 38. Alternatively or additionally, the neo-leaflet 32 includes one or more stiffening elements (stiffening elements) inside the neo-leaflet cover 38 to prevent prolapse within the atrial chamber due to increased regurgitation pressure on the ventricular surface of the neo-leaflet during the cardiac cycle.

Generally, the anchor loop 50 is configured to remain anchored in place by forces applied to the surrounding anatomy by the anchor loop 50 (typically radially outwardly directed forces), and/or by frictional forces between the anchor loop 50 and the surrounding anatomy. For some applications, the anchor loop 50 comprises a self-expanding material, such as a shape memory alloy (e.g., nitinol) that 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 larger shape in its resting (relaxed) state than the surrounding anatomy, such that the surrounding anatomy limits expansion of the anchor loop 50 and the anchor loop 50 applies force to the surrounding anatomy (or vice versa). Furthermore, narrowing of the ventricular wall 27 in a sub-annulus-to-apical direction compresses the anchor-loop 50, generating a counter-radial force, and directing the anchor-loop 50 to stabilize itself at the sub-leaflet ventricular hinge level (i.e., at the level of the sub-annulus 25) (where optionally the annular ventricular anchor 30 (e.g., the anchor-loop 50) is also used to grasp the target native leaflet 26 in some configurations, optionally in conjunction with the native leaflet grasping forceps 40, described below with reference to fig. 1A-1E and 2).

Generally, the annular ventricular anchor 30 is configured to be atraumatic so as not to penetrate (e.g., pierce) tissue of the surrounding anatomy. To this end, the annular ventricular anchor 30 typically does not include any exposed sharp components that can penetrate tissue.

As noted above, for some applications, the native valve 22 is the tricuspid valve. For such applications, when the anchor loop 50 is positioned in the ventricle 23, the neo-leaflets 32 are 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 these applications, the target native leaflet 26 is a natural septal leaflet of the tricuspid valve, the ventricular wall 27 is a ventricular septal wall, and the neo-leaflet 32 is configured such that when the anchor loop 50 is positioned in the ventricle 23 and against the surrounding anatomical structures, including the sub-annulus 25, ventricular septal wall 27, and ventricular apex region 24, the neo-leaflet 32 replaces at least in part the function of the septal leaflet by providing a surface 34 of coaptation against the opposite native posterior and anterior leaflets of the tricuspid valve. Although in the cross-sectional view of the heart of fig. 2, the only opposing native leaflet 28 is shown as the posterior native leaflet, the opposing anterior native leaflet also coapts with the coaptation surface 34 when the opposing anterior native leaflet partially replaces the septal leaflet.

For other applications (described below, as shown in fig. 23), the native valve 22 is a mitral valve, and when the anchor loop 50 is positioned in the ventricle, the neo-leaflet 32 is configured to at least partially replace the function of the target native leaflet 26 (a native posterior or a native anterior leaflet) by providing an engagement surface 34 for the opposite 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 neo-leaflet 32 is configured such that when the anchor loop 50 is positioned in the ventricle 23 and against the surrounding anatomy, including the sub-annulus 25, ventricular septal wall 27, and ventricular apex region 24, the neo-leaflet 32 at least partially replaces the function of the native anterior leaflet by providing an engagement surface 34 for the opposing native posterior leaflet of the mitral valve.

For some applications, as shown in fig. 2, when the anchor loop 50 is positioned in the ventricle 23, the anchor loop 50 is configured to remain anchored in position against the sub-annulus 25, the ventricular septal wall 27, and the one or more ventricular papillary muscles 46 of the ventricular apex region 24.

For some applications, as shown in fig. 1A-1E, the anchor loop ring 50 is shaped as a closed ring that defines an entire boundary of the annular ventricular anchor 30. For other applications, the anchor loop 50 is shaped as an open loop that is shaped with a proximal opening facing the neo-leaflet 32 and the native leaflet grabbing forceps 40, if provided, as shown, for example, in fig. 5A, 10A-10F, 11A-11D, 12A-12E, 13A-13E, and 16A-16F. For these latter applications, a proximal side of the annular ventricular anchor 30 is defined by another component of the coaptation assistance device 20, as shown in fig. 10A-10C, 10D-10F, 11A-11D, and 16A-16F, such as the grasping forceps covers 144A, 144B, 144C, and 444 of the native leaflet grasping forceps 40, respectively, or the neo-leaflet covers 338A and 338B of the neo-leaflets 332A and 332B, respectively, as shown in fig. 12A-12E and 13A-13E.

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

an enclosed (surrounding) area of at least 2cm²Not more than 60cm²And/or between 2cm²And 60cm²In the above-mentioned manner,

a perimeter of at least 4 cm, not more than 15cm, and/or between 4 and 15cm,

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

A width of at least 1 cm, no more than 12 cm, and/or between 1 and 12 cm.

The anchor eye 50 may define a plane or a curved surface.

For some applications, when unconstrained (by application of any external force, including through the anatomy or delivery system), the anchor loop 50 is bent to at least 50% (e.g., at least 75%, such as at least 90%, e.g., 100%) along a length of the anchor loop 50, which length is detected around the anchor loop 50.

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

Referring now to fig. 3A-3K, fig. 3A-3K are highly schematic views of annular ventricular anchors 30A-30H, respectively, in accordance with 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 (proximal being the end near the neo-leaflet).

The annular ventricular anchor 30A of fig. 3A includes a plurality of connected anchor loop 50A, e.g., three anchor loop 50A, that respectively define a plurality of ring lobes 52, the plurality of ring lobes 52 configured to be positioned in the ventricular apex region 24.

The ventricular ring anchors 30B and 30C of fig. 3B and 3C, respectively, comprise anchor ring loops 50B and 50C, respectively. The anchor loop 50B has a uniform hourglass shape (hour glass shape), and the anchor loop 50B has a complete hourglass shape. The annular ventricular anchor 30C of fig. 3C includes an anchor loop 50C, the anchor loop 50C being shaped in a figure-8 shape.

The annular ventricular anchor 30D of fig. 3D includes an anchor loop 50D, the anchor loop 50D being twisted to define an hourglass shape.

The annular ventricular anchor 30E of fig. 3E includes an anchor loop 50E, the anchor loop 50E having a stadium shape (static shape). As used in this application, including in the various claims and various inventive concepts, a stadium shape is a two-dimensional geometry made up of a rectangle with semi-circles on a pair of opposing sides. The same shape is also known as an irregular rectangle, oblong or sausage (usage body).

The annular ventricular anchor 30F of FIG. 3F includes an anchor loop 50F, the anchor loop 50F having a plurality of undulating side edges.

The annular ventricular anchor 30G of fig. 3G includes an anchor loop 50G, the anchor loop 50G being shaped to define a plurality of lobes (e.g., three, as shown).

The annular ventricular anchor 30H of fig. 3H includes a plurality (e.g., at least 5, such as at least 10) of braided anchor loop loops 50H, the braided anchor loop loops 50H being shaped to define an annular space (which is formed by the braid itself such that its edges define a loop).

The annular ventricular anchor 30I of FIG. 3I is wider than it is tall.

The annular ventricular anchor 30J of fig. 3J includes one or more barbs 301J.

The annular ventricular anchor 30K of FIG. 3K includes a tightly coiled wire 301K.

For some applications, any of the annular ventricular anchors described herein, including with reference to fig. 1A-1E, 3A-3G, and I-K, may further include an anchor ring cap connected to the anchor ring. For some of these applications, the anchor loop cover comprises one or more biocompatible sheet materials 56 extending across and partially or completely occupying a space at least partially surrounded by the anchor loop. Typically, the one or more biocompatible sheet materials 56 are soft and atraumatic. For some applications, the one or more biocompatible sheet materials 56 are configured to promote endothelial healing (endothelization). The one or more biocompatible sheet materials 56 may comprise a synthetic material or a biological tissue material, such as a fabric comprising a polymer or biomaterial (e.g., polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), silicone, urethane, or pericardium). For other applications, the anchor ring cap includes a coating on the anchor ring, such as tissue, polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), or a foam. Alternatively or additionally, the anchor loop surface may be mechanically or chemically treated, such as by electropolishing or sandblasting, or provided with barbs (as shown in fig. 3J, such as barbs 301J) to create friction to help maintain the loop in place.

For other applications, the anchor ring cover comprises a plurality of braided wires, optionally additionally covered with one or more biocompatible thin sheet materials, as described above.

See again fig. 1A-1E and fig. 2. For some applications, the coaptation assistance device 20 further includes a native leaflet grasping forceps 40, the native leaflet grasping forceps 40 configured to grasp atrial and ventricular surfaces of the target native leaflet 26 to support and/or stabilize the neo-leaflet 32, and to orient the neo-leaflet 32 relative to the native valve 22. For example, the native leaflet grasping forceps 40 may help prevent the neo-leaflets 32 from tilting towards one of a plurality of native commissure planes (native comassure), and/or may help orient the neo-leaflets 32 at a desired angle to the native valve plane. Alternatively, coaptation assistance devices as described herein do not include a native leaflet grabbing clamp, e.g., as described below with reference to fig. 21-23.

For some applications, such as shown in fig. 1A-1E and 2, the neo-leaflet 32 is attached to the annular ventricular anchor 30 by a native leaflet grabbing clamp 40. For some of these applications, the coaptation assistance device 20 includes a wire loop(s) shaped to at least partially define the neo-leaflet 32 and the native leaflet grabbing forceps 40, as shown.

For some applications, the coaptation assistance device 20 includes a coaptation-assistance-device wire loop(s), such as shown, that is shaped to at least partially define the neo-leaflet 32, the native leaflet grabbing forceps 40, and the anchor wire loop 50. For some of these applications, for example as shown, the wire loop is shaped to at least partially define a natural leaflet grabbing jaw 40 along the wire loop between the neo-leaflet 32 and the anchor loop 50.

For some applications, the native leaflet grasping forceps 40 are shaped to define a first portion 42A and a second portion 42B, the first and second portions 42A and 42B configured to fold toward each other such that the atrial surface and the ventricular surface of the target native leaflet 26 are grasped by sandwiching the at least a portion of the atrial surface and the ventricular surface of the target native leaflet 26 between the first and second portions of the native leaflet grasping forceps 40, respectively.

For some applications, the engagement aid is configured such that:

the first portion 42A of the native leaflet grabbing clamp 40 is pivotally connected to the annular ventricular anchor 30,

the first portion 42A of the native leaflet grabbing clamp 40 is pivotably connected to the second portion 42B of the native leaflet grabbing clamp 40, and/or

The second portion 42B of the natural leaflet grabbing clamp 40 is pivotally connected to the neo-leaflet 32.

For some applications, the native leaflet grasping forceps 40 include one or more grasping forceps covers 44, the one or more grasping forceps covers 44 collectively including one or more biocompatible sheet materials (optionally, the same one or more sheets of material (e.g., an identical sheet of material) define the neo-leaflet cover 38 and the one or more grasping forceps covers 44; or, separate sheets of material define the neo-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 a ventricular surface and/or an atrial surface of the target native leaflet 26 to prevent blood flow between the target native leaflet and the coaptation assistance device. For some of these applications, the one or more grasping forceps covers 44 extend across, and partially or completely occupy, a space 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 portions of the wire loop described above. For some applications, the one or more grasping forceps covers 44 extend across and partially or completely occupy a space that is at least partially surrounded by portions of the frame 45, the portions of the frame 45 defining a first portion 42A of the native leaflet grasping forceps 40 (that is configured to grasp the atrial surface of the target native leaflet 26), and the one or more grasping forceps covers 44 do not at least partially cover a space that is at least partially surrounded by portions of the frame 45, the portions of the frame 45 defining a second portion 42B of the native leaflet grasping forceps 40 (that is configured to grasp the ventricular surface 26 of the target native leaflet).

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

For some of these applications, the native leaflet grasping forceps 40 are shaped to further define a third portion 42C at a fold between the first and second portions 42A, 42B of the native leaflet grasping forceps 40, and the third portion 42C is configured to extend around a free edge of the target native leaflet 26 when the first and second portions 42A, 42B grasp at least a portion of the atrial surface and the ventricular surface of the native leaflet 26.

For some applications, the neo-leaflet 32 is configured to completely surround the target native leaflet 26, including multiple sides of the target native leaflet, closing the target native leaflet from the ventricular native leaflet hinge (ventricular native leaflet hinge) to the atrial hinge (atrial hinge), near the valve annulus (valvular annuluses), and from commissure-to-commissure. For other applications, the neo-leaflet 32 is configured to partially surround the target native leaflet 26, covering and encompassing a portion of the target native leaflet, typically at least the free edge of the target native leaflet.

See fig. 1D. For some applications, the coaptation assistance device 20 is configured such that when unconstrained (by application of any external forces, including through the anatomy or delivery system), an angle α (alpha) is defined between (a) an anchor-loop best-fit plane (anchor-loop best-fit plane)62 defined by the anchor-loop 50 and (b) a new-leaflet best-fit plane (neo-leaf best-fit plane)64 defined by the neo-leaflet loop 36. Typically, the coaptation assistance device 20 is configured to automatically assume this angle; for example, the various components of the device may include a shape memory alloy, such as nitinol, configured to cause the device to assume this angle when in a resting, relaxed state, such as at 37 degrees celsius (body temperature). As used in this application, including in the claims and the inventive concepts, the "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 least square sum of the distances between the plane and the wire loop. Alternatively, the neo-leaflet best fit plane 64 defined by the neo-leaflet wire loop 36 is defined by the coaptation surface 34. (in coaptation assistance devices 220A and 220B, as described below and with reference to FIGS. 8A-8B, the anchor ring best fit plane 62 can be defined by a boundary of the annular ventricular anchors 230A and 230B, respectively, and the neo-leaflet best fit plane 64 can be defined by a boundary of the neo-leaflets 232A and 232B, respectively.)

For some applications, such as shown in fig. 1D, 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). As described below with reference to fig. 12D and 14, 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). As described below with reference to fig. 13C and 15A, a range of such angles may be suitable.

For some applications, all of the coaptation assistance devices can be configured to exhibit one of the ranges of angles described above.

See fig. 1E. For some applications, the coaptation assistance device 20 can be extended and planarized to an elongated planarized configuration shown in fig. 1E. After being planarized, the coaptation assistance device 20 can be crimped and then loaded into the delivery tube 304 for delivery as described below with reference to FIG. 9A. The coaptation assistance device 20 generally has a shape memory such that it automatically gradually returns to its original resting state as it is exposed and deployed from the delivery tube 304, as described below with reference to fig. 9A-9H.

Still referring to fig. 1A-1E and 2. For some applications, the neo-leaflet 32 is configured such that when the coaptation assistance device 20 is implanted in a heart of the subject, the coaptation surface 34 is generally static throughout a 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 neo-leaflets 32. For example, to achieve such a generally static state, the neo-leaflet wire loop 36 and/or the neo-leaflet cover 38 of the neo-leaflet 32 can be relatively rigid, and/or the neo-leaflet 32 can include one or more stiffening components within the neo-leaflet cover 38, as described above.

For other applications, the neo-leaflet 32 is configured such that, upon implantation of the coaptation assistance device 20 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 neo-leaflet 32 is configured such that the coaptation surface 34 is dynamic throughout a cardiac cycle. In these applications, coaptation is provided by the motion of the coaptation surface 34 provided by the neo-leaflet 32 and the one or more opposing native leaflets 28. For example, to allow the coaptation surface 34, the neo-leaflet wire loop 36, and/or the neo-leaflet cover 38 of the neo-leaflet 32 can be sufficiently flexible to allow it to move during a cardiac cycle. For example, as shown in fig. 1A-1E, the diameter of the wire of the neo-leaflet wire loop 36 (i.e., the wire gauge) may be less than a diameter of the wire of the anchor loop 50 of the annular ventricular anchor 30 and/or less than other wires of the coaptation assistance device 20, if provided, such as the wire of the native leaflet grabbing clamp 40. Alternatively, the neo-leaflet may not include a wire loop that defines at least a portion of the boundary, such as described below with reference to fig. 7. Further optionally, the neo-leaflet cover may have a surface area that is greater than an area defined and encompassed by the neo-leaflet loop to create a flexible parachute-like coaptation surface that expands and relaxes during the cardiac cycle, such as described below with reference to fig. 5A-5B and 6A-6C. The flexible parachute-like engagement surfaces are configured to inflate and relax the engaged ventricular surface along blood flow and pressure changes in the cardiac cycle such that during a systolic phase of the cardiac cycle, both blood flow and blood pressure rise and directly against the ventricular surface of the neo-leaflet. As a result, the neo-leaflets expand and dynamically increase the coaptated surface of the one or more opposing native leaflets 28. During diastole, blood flow and pressure against the ventricular surface of the neo-leaflet is reduced, causing the neo-leaflet to relax and deflate, leaving the neo-leaflet structure in a quiescent state during diastole so as not to block the orifice area blood passage from the atrial chamber to the ventricular chamber (orifice area). In other words, during diastole, the neo-leaflets contract and relax, allowing blood to flow from the atria to the ventricles.

Referring now to fig. 4A-4B, fig. 4A-4B are schematic illustrations of another configuration of the coaptation assistance device 20 according to an application of the present invention. In this configuration, the ventricular ring anchor 30 includes at least one support wire 70, which at least one support wire 70 is connected to the anchor loop 50 at two locations 72A and 72B on the anchor loop 50. For example, the two locations 72A and 72B may be on opposite sides of the anchor loop 50, as shown, and/or on multiple long sides of the anchor loop 50, also as shown.

Referring now to fig. 5A-5B, fig. 5A-5B are schematic illustrations of another configuration of the coaptation assistance device 20 according to an application of the present invention. In this configuration, the coaptation assistance device 20 includes a neo-leaflet 32B that is identical to the neo-leaflet 32 described above and can 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 attached to the neo-leaflet open wire loop 36B. If provided, the neo-leaflet open wire loop 36B opens on a distal side 37 in the direction of the annular ventricular anchor 30 and the native leaflet grabbing clamp 40. The neo-leaflet cover 38B has a surface area that is greater than an area defined by the neo-leaflet open wire loop 36B and surrounded on approximately three sides. As a result, when the neo-leaflet cover 38B is flexible in configuration, when the ventricular surface 39 of the neo-leaflet cover 38B is exposed to elevated blood pressure during a cardiac cycle, the neo-leaflet cover 38B struts away from the neo-leaflet open wire loop 36B, optionally more distally along the neo-leaflet cover 38B, providing a flexible parachute-like coaptation surface 34B that expands and relaxes during the cardiac cycle. The curvature of the coaptation surface 34B toward the distal side 37 and on the distal side 37 provides increased efficacy in coaptation with one or more opposing native leaflets 28. Optionally, the neo-leaflet cover 38B comprises an elastic material. In other configurations, the neo-leaflet cover 38B is not flexible, but rather rigid, such that the neo-leaflet cover 38B is configured to not expand and relax. In such configurations, the curvature of the neo-leaflet provides a greater coaptation surface for the one or more opposing native leaflets 28.

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

The neo-leaflet cover 38B can implement any of the features of the neo-leaflet cover 38 described above, mutatis mutandis.

Referring now to fig. 6A-6C, fig. 6A-6C are schematic illustrations of yet another configuration of the coaptation assistance device 20 according to an application of the present invention. In this configuration, the coaptation assistance device 20 includes a neo-leaflet 32C that is identical to the neo-leaflet 32 described above, except as described below, and can implement any of its features, mutatis mutandis. The neo-leaflet 32C includes a neo-leaflet loop 36C and a neo-leaflet cover 38C connected to the neo-leaflet loop 36C. For some applications, the neo-leaflet wire loop 36C opens 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 loop 36C is shaped as a neo-leaflet closed wire loop. The neo-leaflet cover 38C has a surface area that is greater than an area defined by the neo-leaflet open wire loop 36C and surrounded on approximately three sides. As a result, when a ventricular surface 39 of the neo-leaflet cover 38C is exposed to elevated blood pressure during a cardiac cycle, the neo-leaflet cover 38C struts away from the neo-leaflet open wire loop 36C, providing a flexible parachute-like coaptation surface 34C that expands (expands) and relaxes during the cardiac cycle. The neo-leaflet cover 38C is shown in a relaxed state in fig. 6A, and expanded (dilated) by blood flow in fig. 6B and 6C. The neo-leaflet cover 38C can implement any of the features of the neo-leaflet cover 38 described above, mutatis mutandis. Optionally, neo-leaflet cover 38C comprises an elastic material.

Referring now to fig. 7, fig. 7 is a schematic view of another configuration of the coaptation assistance device 20 in accordance with an application of the present invention. In this configuration, the coaptation assistance device 20 includes a neo-leaflet 32D, which is identical to the neo-leaflet 32 described above, except as described below, and can implement any of its features, mutatis mutandis. Similar to the neo-leaflet 32, the neo-leaflet 32D includes a neo-leaflet cover 38D, the neo-leaflet cover 38D defining the coaptation surface 34. Unlike the neo-leaflet 32, however, the neo-leaflet 32D does not include a wire loop that defines at least a portion of the boundary of the neo-leaflet and is connected to the neo-leaflet cover 38D. The absence of the wire loop provides greater flexibility to the coaptation surface 34 of the neo-leaflet 32, for example, as described above with reference to fig. 1A-1E and 2, allowing the coaptation surface to be dynamic throughout a cardiac cycle. The neo-leaflet 32D optionally includes one or more reinforcement members within the neo-leaflet cover 38D to prevent prolapse of the neo-leaflet within the atrial chamber due to the rise in ventricular surface regurgitation pressure of the neo-leaflet during the cardiac cycle.

Referring now to fig. 8A-8B, fig. 8A and 8B are schematic views of the supplemental coaptation assistance devices 220A and 220B, respectively, according to related applications of the present invention. Unlike the following description, the coaptation assistance devices 220A and 220B are substantially similar to the coaptation assistance device 20 described above with reference to fig. 1A-1E and 2, and like reference numerals refer to like components. The coaptation assistance devices 220A and 220B, including their respective neo-leaflets, annular ventricular anchors, and optional native leaflet grabbing clamps, can implement any of the features of the coaptation assistance device 20, mutatis mutandis, including the features described above and with reference to fig. 3A-3K, as well as the features described above and with reference to fig. 4A-4B.

The coaptation assistance devices 220A and 220B include annular ventricular anchors 230A and 230B, respectively, each annular ventricular anchor including a woven flat plate 215, the woven flat plate 215 including a plurality of woven wires, which typically include metal. The braided wires are configured to provide an annular boundary for an annular ventricular anchor 230A and 230B. The annular ventricular anchor 230B of the coaptation assistance device 220B further includes an anchor cover 253 that is attached to the braided flat sheet 215 and covers all or a portion (on one side, as shown, or on both sides) of the braided flat sheet 215. Anchor cap 253 may comprise a synthetic or biological material impregnated within the weave of woven flat sheet 215 or may comprise a separate synthetic or biological flat sheet material attached to woven flat sheet 215. Anchor cap 253 may implement any of the features of the various anchor ring caps described above with reference to fig. 1A-1E and 3A-3E, mutatis mutandis.

Generally, the annular ventricular anchors 230A and 230B are configured to remain anchored in place by forces applied to the surrounding anatomy by the annular ventricular anchors 230A and 230B (typically radially outwardly directed forces), and/or by frictional forces between the annular ventricular anchors 230A and 230B and the surrounding anatomy. For some applications, the annular ventricular anchors 230A and 230B comprise a self-expanding material, such as a shape memory alloy (e.g., nitinol) that causes the braid of the annular ventricular anchors 230A and 230B to expand radially outward to exert a force. For such applications, the annular ventricular anchors 230A and 230B are generally configured to have a shape in their resting (relaxed) state that is larger than the surrounding anatomy (at least in one direction, i.e., the height of a ring is larger than the height of the ventricle, or the width of the ring is larger than the width of the ventricular wall). As a result, the surrounding anatomy limits expansion of the annular ventricular anchors 230A and 230B, and the annular ventricular anchors 230A and 230B apply a force to the surrounding anatomy (and vice versa). In addition, narrowing of the ventricular wall 27 in a sub-ring-to-tip direction compresses the annular ventricular anchors 230A and 230B, creating a counter radial force and directing the annular ventricular anchors 230A and 230B to stabilize themselves at the sub-leaflet ventricular hinge level (i.e., at the level of the sub-ring plane 25) (where, optionally, the annular ventricular anchors 230A and 230B are also used to grasp the target native leaflet 26 in some configurations, optionally in conjunction with native leaflet grasping forceps 240A and 240B, respectively, described below).

Coaptation assistance devices 220A and 220B also include neo-leaflets 232A and 232B, respectively, the neo-leaflets 232A and 232B including a woven flat sheet 217 (shown and labeled in fig. 8A, but not shown in fig. 8B as it is covered by a neo-leaflet cover 238, as described below). The neo-leaflet 232B of the coaptation assistance device 220B further includes a neo-leaflet cover 238, the neo-leaflet cover 238 covering all or a portion of the woven flat sheet 217. Neo-leaflet cover 238 may comprise a synthetic or biologic material impregnated within the weave of woven flat sheet 217, or may comprise a separate synthetic or biologic flat sheet material attached to woven flat sheet 217. Neo-leaflet cover 238 can implement any of the features of neo-leaflet cover 238 described above with reference to fig. 1A-1E and 2, mutatis mutandis.

For some applications, the coaptation assistance devices 220A and 220B also include native leaflet grabbing jaws 240A and 240B, respectively, that include one or more woven flat sheets 219 (shown and labeled in fig. 8A, but not shown in fig. 8B, as they are covered by one or more grabbing jaw covers 244, described below). The native leaflet grabbing forceps 240B of the coaptation assistance device 220B further includes one or more grabbing forceps covers 244 that cover all or a portion of the woven flat sheet 219. The one or more grasping jaw covers 244 may implement any of the features of the grasping jaw cover 44 described above with reference to fig. 1A-1E and 2, mutatis mutandis.

For some applications, the coaptation assistance device 220B includes only a subset of the caps described above.

For some applications, the neo-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 assistance devices 220A and 220B, respectively, are implanted in a heart of the subject, such as described above with respect to coaptation assistance device 20. For some of these applications, the neo-leaflets 232A and 232B include a plurality of reinforcement elements thereon, and/or a braid extending from the free edges of the neo-leaflets 232A and 232B to the annular ventricular anchors 230A and 230B, respectively, after implantation, by a plurality of wires, a plurality of commissure lines, or a plurality of rods, respectively. These techniques help to avoid the neo-leaflets 232A and 232B moving into the atrium during a cardiac cycle.

For other applications, the neo-leaflets 232A and 232B are configured such that, upon implantation of the coaptation assistance devices 220A and 220B in a heart of the subject, such as described above with respect to coaptation assistance device 20, the coaptation surface 34 moves toward and away from the one or more opposing native leaflets 28 during a cardiac cycle of the subject.

Referring now to fig. 9A-9H, fig. 9A-9H are schematic illustrations of a method of implanting the coaptation assistance device 20 in a heart of a subject, according to an application of the present invention. Although the method is shown with respect to coaptation assistance device 20, it can also be used to implant other coaptation assistance devices described herein, mutatis mutandis. In addition, the native valve 22 is shown as a tricuspid valve 300, and the method can be modified to treat a mitral valve 302.

As shown in fig. 9A, the coaptation assistance device 20 is delivered percutaneously (intravascularly) to a heart of the subject, and the coaptation assistance device 20 is removably disposed in a compressed configuration in the delivery tube 304 of the delivery system. For some applications, the coaptation assistance device 20 is loaded into the delivery tube 304 in the compressed configuration by extending and planarizing the coaptation assistance device 20 into an elongated, flattened configuration as shown in fig. 1E, and then further radially compressing (e.g., crimping) the device. For example, the delivery tube 304 may be advanced into the right atrium 310 through the inferior or superior vena cava. For applications of the coaptation assistance device 20 to treat the mitral valve 302, the delivery tube 304 can be advanced transseptally into a left ventricle 314 using transseptal advancement techniques (transseptal advancement techniques) known in the art. Alternatively, the coaptation assistance device 20 is delivered in a minimally invasive procedure.

The delivery system generally includes a delivery tube 304 and optionally one or more additional tubes. One or more of the tubes are steerable (e.g., two are steerable, one for tracking and the other for positioning). Optionally, the coaptation assistance device 20 is partially disposed in the delivery tube 304 and partially disposed in another tube to allow for sequential deployment of the various components of the coaptation assistance device 20. For deployed delivery tubes 304 in which the coaptation assistance device 20 is fully disposed, the annular ventricular anchor 30 is typically disposed more distally within the tube (i.e., closer to the distal end of the tube) than the new leaflet 32 to allow the annular ventricular anchor 30 to deploy from the tube prior to deployment of the new leaflet 32. Alternatively, the arrangement is reversed to allow the neo-leaflet 32 to be deployed from the tube prior to deployment of the annular ventricular anchor 30.

As shown in fig. 9A-9C, the annular ventricular anchor 30 is deployed from the delivery tube 304 and positioned in the ventricle 23 (the right ventricle in the illustrated method) such that the anchor loop 50 extends between the ventricular apex region 24 and the sub-annulus 25 (shown in fig. 9B and subsequent figures) of the target native leaflet 26 of the native valve 22, 300 such that the anchor loop 50 remains anchored in position against the surrounding anatomy, including the sub-annulus 25, ventricular wall 27, and ventricular apex region 24. Typically, the annular ventricular anchor 30 is deployed by proximally withdrawing the delivery tube 304 and/or pushing the annular ventricular anchor out of the delivery tube 304.

For some applications, the annular ventricular anchor 30 is positioned such that the anchor loop 50 maintains the anchoring in place by the force applied by the anchor loop 50 to the surrounding anatomy. Alternatively or additionally, for some applications, the annular ventricular anchor 30 is positioned such that the anchor loop 50 remains anchored in place by friction between the anchor loop 50 and the surrounding anatomy.

For some applications, the annular ventricular anchor 30 is configured to be atraumatic, and positioning the annular ventricular anchor 30 does not include penetrating tissue of the surrounding anatomy using the annular ventricular anchor 30. For some applications, the deployment method does not include penetrating tissue using any of the multiple components of the coaptation assistance device 20. Alternatively, the tissue is penetrated, such as described below with reference to fig. 21-22, or has barbs (e.g., barbs 301J, as shown in fig. 3J) disposed along at least a portion of the anchor loop 50.

For some applications, as shown in fig. 9A-9H, 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 neo-leaflet 32 is positioned such that when the anchor loop 50 is positioned in the ventricle 23 and remains anchored in position against the surrounding anatomical structure, including the sub-annulus 25, ventricular septal wall 27, and ventricular apex region 24, the neo-leaflet 32 at least partially replaces the function of the septal leaflet by providing an coaptation surface 34 for one or more of the opposing native posterior and anterior leaflets of the tricuspid valve.

For other applications, the native valve 22 is the mitral valve 302, and the neo-leaflets 32 are positioned such that when the anchor loop 50 is positioned in the ventricle 23, the neo-leaflets 32 at least partially replace the function of the target native leaflets 26 by providing an engaging surface 34 for the opposite native leaflets 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 neo-leaflet 32 is positioned such that when the anchoring loop 50 is positioned in the ventricle 23 and remains anchored in position against the surrounding anatomy, including the inferior ring surface 25, the ventricular septal wall 27, and the ventricular apex region 24, the neo-leaflet 32 at least partially replaces the function of the native anterior leaflet by providing an engaging surface 34 for an opposing native posterior leaflet of the mitral valve 302.

As shown in fig. 9F-9H, the neo-leaflet 32 is deployed from the delivery tube 304 and positioned such that when the anchor loop 50 is positioned in the ventricle 23, the neo-leaflet 32 at least partially replaces the function of the target native leaflet 26 by providing an engagement surface 34 for one or more opposing native leaflets 28 opposite the target native leaflet 26. As described above, the neo-leaflet 32 is supported by the annular ventricular anchor 30. Typically, the annular ventricular anchor 30 is deployed by proximally withdrawing the delivery tube 304.

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

For some applications, as shown in fig. 9F-9H, when the anchor loop 50 is positioned in the ventricle 23, the neo-leaflet 32 is positioned such that the coaptation surface 34 of the neo-leaflet 32 crosses from an atrial side to a ventricular side of a native valve plane, such that the native leaflet 28 coapts with the neo-leaflet 32 during the cardiac cycle, the atrial surface of the native leaflet 28 contacting the atrial surface 345 of the neo-leaflet, thereby preventing blood flow from the ventricle to the atrium during systole.

For some applications, as shown in fig. 9C-9E, the deployment method further includes positioning the native leaflet grabbing forceps 40 to grab the atrial and ventricular surfaces of the target native leaflet 26 to support the neo-leaflet 32 and orient the neo-leaflet 32 relative to the native valve 22, 300. In the illustrated method, the native leaflet grabbing clamp 40 is positioned after positioning the annular ventricular anchor 30 and before positioning the neo-leaflet 32. Alternatively, the native leaflet grabbing forceps 40 are positioned at different points in the deployment method.

For some applications, as shown in fig. 9D-9H (labeled in fig. 9H) (and in fig. 2), positioning the native leaflet grabbing forceps 40 to grab the atrial and ventricular surfaces of the target native leaflet 26 includes the steps of: at least a portion of the atrial and ventricular surfaces of the target native leaflet 26 is sandwiched between the first and second portions 42A, 42B of the native leaflet capturing forceps 40. For some applications, as shown in fig. 9D-9H (labeled in fig. 9H) (and in fig. 2), sandwiching at least a portion of the atrial and ventricular surfaces of the target native leaflet 26 includes the steps of: the first and second portions 42A, 42B of the native leaflet grasping forceps 40 are folded toward each other to grasp the atrial and ventricular surfaces of the target native leaflet 26 by sandwiching at least a portion of the atrial and ventricular surfaces of the target native leaflet 26 between the first and second portions 42A, 42B of the native leaflet grasping forceps 40. For some of these applications, folding the first and second portions 42A, 42B of the native leaflet grabbing clamp 40 towards each other, as shown in fig. 9D-9H (labeled in fig. 9H) (and in fig. 2), comprises the steps of: a third portion 42C defined by the native leaflet grasping forceps 40 extends around the free edge of the target native leaflet 26 at a fold between the first portion 42A and the second portion 42B of the native leaflet grasping forceps 40.

For some applications, as shown in fig. 9A-9C, the annular ventricular anchor 30 is positioned such that the anchor loop 50 remains anchored in position against the sub-annulus 25, the ventricular septum wall 27, and one or more ventricular papillary muscles 46 of the ventricular apex region 24.

Reference is now made to fig. 10A-10C, which are schematic illustrations of an coaptation assistance device 120A in accordance with an application of the present invention. Referring also to fig. 10D-10F, fig. 10D-10F are schematic views of a coaptation assistance device 120B according to an application of the present invention. With additional reference to fig. 10G, fig. 10G is a schematic illustration of a coaptation assistance device 120A implanted in a native valve 22, according to an application of the present invention. Referring further to fig. 11A-11D, fig. 11A-11D are schematic views of a coaptation assistance device 120C according to an application of the present invention. Unlike the following description, the coaptation assistance devices 120A, 120B, and 120C are substantially similar to the coaptation assistance device 20 described above with reference to fig. 1A-1E and 2, and like reference numerals refer to like components. The coaptation assistance devices 120A, 120B, and 120C can implement any of the features of the coaptation assistance device 20, mutatis mutandis, including the features described above with reference to fig. 3A-3K and the features described above with reference to fig. 4A-4B.

The coaptation assistance devices 120A, 120B, and 120C include an annular ventricular anchor 130. Generally, the 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 ventricular anchor. The anchor loop 150 may implement any of the features of the anchor loop 50, as described above with reference to fig. 1A-1E, 2, and 3A-3K, mutatis mutandis.

The coaptation assistance devices 120A, 120B, and 120C further include neo-leaflets 132A, 132B, and 132C, respectively, supported by the annular ventricular anchor 130. An annular ventricular anchor 130 is disposed distal to the neo-leaflet.

The neo-leaflets 132A, 132B, and 132C are configured to at least partially replace the function of the target native leaflet 26 by providing the coaptation surface 34 for one or more opposing native leaflets 28 opposite the target native leaflet 26 when the anchor loop 150 is positioned in the ventricle 23. The neo-leaflets 132A, 132B, and 132C are generally configured to cover at least a portion of the target native leaflet 26.

For some applications, neo-leaflets 132A, 132B, and 132C include a neo-leaflet wire loop 136A, 136B, and 136C, respectively, that defines a portion of the respective periphery of the neo-leaflet, and neo-leaflet covers 138A, 138B, and 138C are connected to the neo-leaflet wire loops 136A, 136B, and 136C, respectively. Generally, the neo-leaflet cover provides the coaptation surface 34 described above. Neo-leaflet covers 138A, 138B, and 138C can implement any features of neo-leaflet cover 38, as described above with reference to fig. 1A-1E and 2, mutatis mutandis. In the illustrated configuration, the neo-leaflet wire loops 136A, 136B, and 136C are shaped as open loops that open proximally in the direction of the annular ventricular anchor 130 and the native leaflet grabbing forceps 140A, 140B, and 140C, respectively, as described below. (each loop is considered open even though it is defined by a line that also defines a portion of the native leaflet grabbing forceps because the portion of the line defining the loop is open.) or, as shown in fig. 1A-1E, the neo-leaflet wire loops 136A, 136B, and 136C are shaped as closed loops (the configuration of the coaptation assistance devices 120A, 120B, and 120C is not shown). The neo-leaflet wire loops 136A, 136B, and 136C can implement any of the features of the neo-leaflet wire loop 36, as described above with reference to fig. 1A-1E and 2, mutatis mutandis.

The coaptation assistance devices 120A, 120B, and 120C also include native leaflet grabbing forceps 140A, 140B, and 140C, respectively, configured to grab the atrial surface 345 and ventricular surface 343 of the target native leaflet 26 to support and orient the neo-leaflets 132A, 132B, and 132C relative to the native valve 22.

For some applications, the native leaflet grabbing clamps 140A, 140B, and 140C include one or more grabbing clamp covers 144A, 144B, and 144C, respectively. The one or more grasping caps collectively comprise one or more biocompatible sheet materials, respectively (optionally, the same one or more sheets of material (e.g., an identical sheet of material) define both the neo-leaflet caps 138A, 138B, and 138C and the one or more grasping jaw caps 144A, 144B, and 144C as described above, or separate sheets of material define the neo-leaflet caps 138A, 138B, and 138C and the one or more grasping jaw caps 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 assistance device. For some of these applications, the one or more grasping forceps covers 144A, 144B, and 144C extend across, and partially or completely occupy, a space at least partially enclosed by the frames 145A, 145B, and 14C of the native leaflet grasping forceps covers 144A, 144B, and 144C, respectively, which may include one or more wires, which may be part of a portion of the neo-leaflet wire loops 136A, 136B, and 136C described above. Typically, the one or more biocompatible sheet materials are soft and atraumatic. The one or more biocompatible sheet materials may comprise a synthetic or biological tissue material, such as a fabric comprising a polymer or biomaterial (e.g., polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), silicone, urethane, or pericardium).

For some applications, the neo-leaflets 132A, 132B, and 132C are connected to the annular ventricular anchor 130 by native leaflet grabbing clamps 140A, 140B, and 140C, respectively, as shown in fig. 10A-10F and 11A-11D.

For some of these applications, for example, as shown in fig. 10A-10F, the anchor loop 150 of the annular ventricular anchor 130 is connected to the grasping caps 144A, 144B, and 144C of the native leaflet grasping forceps 140A, 140B, and 140C, respectively, by passing through the openings defined by the grasping forceps caps 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 neo-leaflets 132A, 132B and 132C, respectively.

For other of these applications, for example as shown in fig. 11A-11D, the anchor loop ring 150 of the annular ventricular anchor 130 is attached to the frame 145C of the native leaflet grabbing clamp 140. The anchor 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 grabbing clamp 140C, and thus relative to the neo-leaflet 132C.

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, the first and second portions 142A and 142B configured to grasp an atrial surface and a ventricular surface, respectively, of the target native leaflet 26 by sandwiching at least a portion of an atrial surface 345 and a ventricular surface 343 of the target native leaflet 26 between the first and second portions of the native leaflet grasping forceps. Typically, in such configurations, the second portion 142B is defined by a proximal portion of the anchor loop 150, while the first portion 142A is defined by the frames 145A, 145B, and 145C of the native leaflet grabbing forceps 140A, 140B, and 140C, respectively, which are part of the neo-leaflet loops 136A, 136B, and 136C, respectively.

As described above, optionally, one or more grasping jaw covers 144A, 144B, and 144C extend across and partially or completely occupy a space at least partially surrounded by frames 145A, 145B, and 14C, respectively (as shown). Typically, during a portion of the cardiac cycle, the grasping forceps cover expands at this location by blood flow and against the ventricular surface of the target native leaflet 26 to prevent blood flow between the target native leaflet and the coaptation assistance device.

Optionally, the one or more grasping jaw 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 150 defining the second portion 142B (a configuration not shown).

For some applications, such as shown in fig. 10A-10C, the neo-leaflet wire loop 136A narrows at a boundary 149 between the neo-leaflet 132A and the first portion 142A of the native leaflet grabbing clamp 140A. This narrowing may reduce the interaction between the coaptation assistance device and the surrounding anatomy.

For other applications, for example, as shown in fig. 10D-10F and 11A-11D, the neo-leaflet wire loops 136B and 136C do not narrow at the boundary 149 between the neo-leaflets 132B and 132C, respectively, and at the first portion 142A of the native leaflet grabbing forceps 140B and 140C. This lack of narrowing may provide a larger contact surface between the grasping jaw covers 144B and 144C of the native leaflet grasping jaws 140B and 140C, respectively, and the ventricular surface 343 of the target native leaflet 26, and/or better expansion of the grasping jaw covers than the configurations shown in fig. 10A-10C.

See fig. 11A to 11D. For some applications, the coaptation assistance device 120C further includes a capsular bag (pouch)158 configured to be expanded by blood flow during a cardiac cycle so as to hold the coaptation assistance 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 assistance device 120C relative to the native valve 22. For some applications, the capsular bag 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 opposite a side of the first portion 142A that is configured to contact an atrial surface 345 of the target native leaflet 26). Optionally, other coaptation assistance devices described herein, such as the native leaflet grabbing forceps of other coaptation assistance devices, including the capsular bag 158, are mutatis mutandis.

Reference is now made to the figures. Reference is now made to fig. 12A-12E and 13A-13E, which are schematic illustrations of correspondingly adapted coaptation assistance devices 320A and 320B, respectively, in accordance with the present invention. Unlike the following description, the coaptation assistance devices 220A and 220B are substantially similar to the coaptation assistance device 20 described above with reference to fig. 1A-E and 2, and like reference numerals refer to like components. The coaptation assistance devices 320A and 320B, including their respective neo-leaflet and annular ventricular anchors, can implement (a) any of the features of the coaptation assistance device 20, including the features described above with reference to fig. 3A-3K, and the features described above with reference to fig. 4A-4B, and/or (B) any of the features of the other coaptation assistance devices described herein, mutatis mutandis.

Reference is also made to fig. 14 and 15A-15B, which are schematic illustrations of coaptation assistance devices 320A and 320B, respectively, implanted in a native valve 22, in accordance with respective applications of the present invention.

Each of the coaptation assistance devices 320A and 320B includes a ventricular ring anchor 330, which generally includes an anchor loop 350 that defines at least a portion of a boundary of the ventricular ring anchor. The ventricular anchor 330 and the anchor loop 350 may implement any of the features of the ventricular anchor and anchor loop described herein, mutatis mutandis. Coaptation assistance devices 320A and 320B also include neo-leaflets 332A and 332B, respectively, that can implement any of the features of the neo-leaflets described herein, mutatis mutandis. For some applications, the neo-leaflets 332A and 332B include a neo-leaflet wire loop 336A and 336B, respectively, that defines at least a portion of a boundary of the neo-leaflet, and the neo-leaflet covers 338A and 338B are connected to the neo-leaflet wire loops 336A and 336B, respectively. The neo-leaflet wire loops 336A and 336B can implement any of the features of the neo-leaflet wire loops described herein, mutatis mutandis, and the neo-leaflet covers 338A and 338B can implement any of the features of the neo-leaflet covers described herein, mutatis mutandis, respectively.

Each of the coaptation assistance devices 320A and 320B further includes a native leaflet grabbing clamp 340 including one or more sub-native-leaflet support portions 347 (e.g., two, as shown) 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.

For some applications, each of the neo-leaflets 332A and 332B extends directly from and is supported by the annular ventricular anchor 330. An annular ventricular anchor 330 is disposed distal to each of the neo-leaflets 332 and 332B.

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

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 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, which varies, 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. Generally, 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 anatomy, including the sub-annulus 25, the ventricular septal wall 27, and one or more ventricular papillary muscles 46 of the ventricular apex region 24, when the annular ventricular anchor 330 is positioned in the ventricle 23.

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

See fig. 12D, 13C, 14, and 15A. For some applications, the coaptation assistance devices 320A and 320B are configured such that when unconstrained (by application of any external force, including through the anatomy or delivery system), an angle α (alpha) is defined between (a) an anchor-loop best-fit plane (anchor-loop best-fit plane)362 defined by the anchor-loop 350 and (B) a neo-leaflet best-fit plane (neo-loop best-fit plane)364 defined by the neo-leaflet loop 336A and 336B. Typically, the coaptation assistance devices 320A and 320B are configured to automatically assume this angle; for example, the various components of the device may include a shape memory alloy, such as nitinol, configured to cause the device to assume this angle when in a resting, relaxed state, such as at 37 degrees celsius (body temperature). Alternatively, the neo-leaflet best fit plane 364 is defined by the coaptation surfaces of the neo-leaflets 332A and 332B, respectively.

For some applications, for example, as shown in fig. 12D and 14, 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). This angular range positions neo-leaflet 332A above (better than) one or more opposing native leaflets 28, and thus above the plane of coaptation of one or more opposing native leaflets 28 in systole, and tends towards the annulus level. As a result, one or more opposing native leaflets 28 coapt against the ventricular surface of the neo-leaflet 332A. Such a configuration is indicated in the case of prolapse or flail of one or more opposing native leaflets 28, particularly for mitral valve disease. The generally somewhat horizontal neo-leaflets 332A provide a coaptation surface for one or more opposing native leaflets 28 as they attempt to prolapse horizontally in the atrium or annulus.

For other applications, for example, as shown in fig. 13C and 15A, 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). This angular range positions the neo-leaflet 332B below one or more opposing native leaflets 28, thus below its coaptation plane during systole, and when in systole, tends to bring the apical ventricle of the neo-leaflet 332B below the free edge of the one or more opposing native leaflets 28. This configuration is useful for functional diseases, in tricuspid and mitral valve disease, leaflet binding and lack of leaflet coaptation. In this configuration, coaptation assistance device 320B is configured such that when annular ventricular anchor 330 is positioned in ventricle 23, an coaptation surface of neo-leaflet 332B spans from an atrial side to a ventricular side of a native valve plane.

In any of these angular configurations, the neo-leaflets 332A and 332B can be flexible or rigid, and can optionally move (open/close) with the heartbeat in order to be effective.

Referring now to fig. 16A-16F, fig. 16A-16F are schematic views of an coaptation assistance device 420 according to an application of the present disclosure. Unlike the following description, the coaptation assistance device 420 is substantially similar to the coaptation assistance device 20 described above with reference to fig. 1A-1E and 2. The coaptation assistance device 420, including its neo-leaflets and annular ventricular anchors, can implement (a) any of the features of the coaptation assistance device 20, including the features described above with reference to fig. 3A-3K, and the features described above with reference to fig. 4A-4B, mutatis mutandis, and/or (B) any of the features of the other coaptation assistance devices described herein, mutatis mutandis.

With additional reference to fig. 17, fig. 17 is a schematic view of a coaptation assistance device 620 implanted in a native valve 22, according to one application of the present disclosure. In the particular implant shown in fig. 17, the native valve 22 is the tricuspid valve. Fig. 19 is a cross-sectional view of the heart with the native anterior leaflet of the heart, including the tricuspid valve, removed, showing only the septal and posterior leaflets.

The coaptation assistance device 420 includes a ventricular anchor 430, which generally includes an anchor loop 450, the anchor loop 450 defining at least a portion of a boundary of the ventricular anchor. The ventricular ring anchor 430 and the anchor loop 450 may implement any of the features of the ventricular ring anchor and anchor loop described herein, mutatis mutandis.

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

The coaptation assistance device 420 further includes a neo-leaflet 432 that can implement any of the features of the neo-leaflets described herein, mutatis mutandis. The annular ventricular anchor 430 is disposed distal to the neo-leaflet 432. For some applications, the neo-leaflet 432 includes a neo-leaflet wire loop 436 defining at least a portion of a boundary of the neo-leaflet, and a leaflet cover 43, the leaflet cover 43 being connected to the neo-leaflet wire loop 436. (for clarity of illustration, in fig. 16B, the coaptation assistance device 420 is shown without the neo-leaflet cover 438 and without the grasping forceps cover 444, as described below.) the neo-leaflet wire loop 436 may implement any of the features of the neo-leaflet wire loop described herein, mutatis mutandis, and the neo-leaflet cover 438 may implement any of the features of the neo-leaflet cover described herein, mutatis mutandis, respectively.

For some applications, the neo-leaflet 432 is curved into a shield-like shape to better accommodate the annular region at the target native leaflet level. Such a shield shape may also provide an engagement surface 434, which engagement surface 434 is accessible to one or more opposing native leaflets 28.

The coaptation assistance device 420 further includes a native leaflet grabbing clamp 440 shaped to define a first portion 442A and a second portion 442B, the first portion 442A and the second portion 442B configured to grab the atrial surface 345 and the ventricular surface 343, respectively, of the target native leaflet 26 by pinching at least a portion of the atrial surface and the ventricular surface of the native leaflet 26 between the first portion and the second portion of the native leaflet grabbing clamp 440.

For some applications, the second portion 442B of the native leaflet grabbing clamp 440 includes one or more sub-native leaflet support portions 447 (e.g., two, as shown) configured to press against one or more portions of the target native ventricular surface 343 when the anchor loop 450 is positioned in the ventricle 23. For some applications, the sub-native leaflet support 447 extends from the wire of the anchor loop ring 450, which narrows in a proximal direction. Optionally, the proximal-most portion of sub-native leaflet support 447 is at approximately the same height as the proximal-most portion of neo-leaflet 432.

For some applications, the first portion 442A of the native leaflet grabbing clamp 440 includes a grabbing clamp cover 444 disposed between the neo-leaflet cover 438 and one or more sub-native leaflet support sections 447. Generally, 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 assistance device. For some of these applications, the grasping forceps cover 444 extends across, and partially or completely occupies, a space 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 a wire loop as described herein. (the shading of the grasping forceps cover 444 in FIGS. 16E and 16F is for clarity of illustration and does not imply that the grasping forceps cover 444 includes one piece of material separate from the neo-leaflet cover 438 or a different type of material from the neo-leaflet cover 438, although it could be.)

For some applications, neo-leaflet 432 is connected to annular ventricular anchor 430 via a sub-native leaflet support portion 447 and optionally one or more additional wire portions.

For some applications, the coaptation assistance device 420 includes a coaptation assistance device wire loop shaped to at least partially define (a) the neo-leaflet 432, (b) the anchor wire loop 450, (c) optionally, one or more sub-native leaflet supports 447, and (d) optionally, the frame 445 of the native leaflet capturing forceps 440.

For some applications, the coaptation assistance device 420 (e.g., the neo-leaflet cover 438) includes one or more (e.g., two) commissural capsular bags or parachutes (parachutes) 474 configured to expand and relax along blood flow and pressure changes, in a manner similar to the capsular bag 158 described above with reference to fig. 11A-11D, and/or the flexible parachute-like coaptation surfaces described above. The pockets 474 in fig. 11A-11D originate at the same level on the neo-leaflet wire loop 436 and the frame 445 so that each pocket 474 has a flat free edge. The pockets 474 in fig. E-F originate lower on the neo-leaflet wire loop 436 than on the frame 445 (closer to the neo-leaflet cusps), forming an uneven free edge on each pocket 474. This difference in juncture results in the surface of the capsular bag 474 in fig. 18E-18F being higher than the surface of the capsular bag 474 in fig. 18A-18D. As shown in fig. 18A-18D, the bladder, when inflated, is able to inflate more and cover a higher solid surface. A higher surface may result in better filling of the commissure regions, thereby reducing blood backflow in this region.

Reference is now made to the figures. Reference is made to fig. 18A-18F, which are schematic illustrations of a coaptation assistance device 520 for treating a native valve 22, according to one application of the present invention. The native valve is typically an atrioventricular valve, i.e. the tricuspid or mitral valve. For clarity, fig. 18B does not show the neo-leaflet cover 538 or the grasping forceps cover 544, even though the coaptation assistance device 520 generally includes such components, as described below.

Reference is additionally made to fig. 19, which is a schematic illustration of a coaptation assistance device 520 implanted in a native valve 22, in accordance with an application of the present invention. In the particular implant shown in fig. 19, the native valve 22 is the tricuspid valve. Fig. 19 is a cross-sectional view of the heart with the native anterior leaflet of the heart, including the tricuspid valve, removed, showing only the septal and posterior leaflets. The coaptation assistance device 520 is similar to the coaptation assistance device described above, except as described below, and any features thereof can be implemented, mutatis mutandis.

The coaptation assistance device 520 includes an annular ventricular anchor 530 and a neo-leaflet 532 that extends directly from and is supported by the annular ventricular anchor 530. An annular ventricular anchor 530 is disposed distal to the neo-leaflet 532. Generally, the ventricular ring anchor 530 includes an anchor loop 550 that defines at least a portion of a boundary of the ventricular ring anchor 530. The anchor loop ring 550 may implement any of the feature rings 50 of the anchor loop wire, as described above with reference to fig. 1A-1E and 2, mutatis mutandis.

The anchor loop 550 is configured to (a) be positioned in the ventricle 23, extending to the ventricular apex region 24, and (b) remain anchored in position against the surrounding anatomy, including the ventricular apex region 24 (and optionally one or more ventricular papillary muscles 46 of the ventricular apex region 24). In other words, the anchor loop 550 is configured to be located at the top. Optionally, the surrounding anatomy to which the anchor loop 550 is anchored further comprises one or more of: an adjustment band, one or more chordae tendineae, and one or more papillary muscles on opposite sides of ventricle 23.

In general, the coaptation assistance device 520 is configured such that when the anchor loop 550 is positioned in the ventricle 23, the anchor loop 550 does not extend to (and thus does not contact) a sub-annulus 25 of a target native leaflet 26. Generally, positioning the ring-shaped ventricular anchor 530 in the ventricle 33 includes the steps of: the annular ventricular anchor 530 is positioned in the ventricle 33 such that the anchor loop 550 does not extend to (and thus does not contact) the subannular surface 25 of a target native leaflet 26 of the native valve 22.

For some applications, the coaptation assistance device 520 does not include any of a number of components configured to penetrate (e.g., pierce) tissue. For other applications, the coaptation assistance device 520 includes at least one component configured to penetrate tissue, as described below with reference to fig. 20A-20B.

When the anchor loop 550 is positioned in the ventricle 23, the neo-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 opposite the target native leaflet 26.

For some applications, the neo-leaflet 532 includes a neo-leaflet wire loop 536, the neo-leaflet wire loop 536 defining at least a portion of a boundary of the neo-leaflet, and a neo-leaflet cover 538, the neo-leaflet cover 538 being connected to the neo-leaflet wire loop 536 and providing the coaptation surface 534. The neo-leaflet wire loop 536 and the neo-leaflet cover 538 can implement any of the features of the neo-leaflet wire loop 36 and the neo-leaflet cover 38, respectively, as described above with reference to fig. 1A-1E and 2, mutatis mutandis.

Generally, the anchor loop 550 is configured to remain anchored in place by forces applied to the surrounding anatomy by the anchor loop 550 (typically radially outwardly directed forces), and/or by frictional forces between the anchor loop 550 and the surrounding anatomy. For some applications, the anchor loop 550 includes a self-expanding material, such as a shape memory alloy (e.g., nitinol), which causes the anchor loop 550 to expand radially outward to apply the force. For such applications, the anchor loop 550 is generally configured to have a larger shape in its resting (relaxed) state than the surrounding anatomy, such that the surrounding anatomy limits expansion of the anchor loop 550 and the anchor loop 550 applies force to the surrounding anatomy (or vice versa).

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

For some applications, the coaptation assistance device 520 further includes a native leaflet grasping forceps 540 shaped to define a first portion 542A and a second portion 542B, the first portion 542A and the second portion 542B configured to grasp an atrial surface 345 and a ventricular surface 343, respectively, of the target native leaflet 26 to support the neo-leaflet 532 and orient the neo-leaflet 532 relative to the native valve 22 by sandwiching at least a portion of the atrial surface and the ventricular surface of the target native leaflet 26 between the first portion and the second portion of the native leaflet grasping forceps 540.

For some applications, as shown, the native leaflet grabbing clamp 540 is connected to the annular ventricular anchor 530 via a neo-leaflet 532.

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 loop 550 is positioned in the ventricle 23.

For some applications, the first portion 542A of the native leaflet grasping forceps 540 includes a grasping forceps cover 544 that is disposed between the neo-leaflet cover 538 and the one or more sub-native leaflet supports 547. Generally, 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 assistance device. For some of these applications, the grasping forceps cover 544 extends across, and partially or completely occupies, a space at least partially enclosed by the frame 545 of the native leaflet grasping forceps 540, which may include one or more wires, which may be portions of the wire loop described above. (the shading of the grasping jaw covers 544 in FIGS. 18C, 18E, and 18F is for clarity of illustration and does not imply that the grasping jaw covers 544 comprise a separate piece of material from the neo-leaflet covers 538 or a different type of material from the neo-leaflet covers 538, although it could be.)

For some applications, the native leaflet grasping forceps 540 further includes one or more native ring support sections 541 configured to further support the neo-leaflet 532 against the native ring section. Optionally, the native-annulus-support cover 551 (labeled in fig. 18F) further comprises a native-annulus-support lid (native-annulus-support) that partially or completely occupies a space that is at least partially surrounded by one or more native-annulus supports (native-annulus supports) 541 and that additionally provides a seal to prevent blood flow between the target native leaflets and the coaptation assistance device. For some applications, one or more natural ring support sections 541 extend from the neo-leaflet wire loop 536 in a direction opposite to the direction in which the engagement surface 534 points.

Generally, the coaptation assistance device 520 is configured such that when the anchor loop 550 is positioned in the ventricle 23 and the native leaflet grabbing forceps 540 grab the atrial surface 345 and the ventricular surface 343, respectively, of a target native leaflet 26, the anchor loop 550 does not extend to (and thus does not contact) a subannular surface 25 of a target native leaflet 26 of the native valve 22.

For some applications, when the anchor loop 550 is positioned in the ventricle 23, the anchor loop 550 is configured to remain anchored in place against one or more ventricular papillary muscles 46 of the ventricular apex region 24.

For some applications, the coaptation assistance device 520 includes a coaptation assistance device wire loop shaped to at least partially define the neo-leaflet wire loop 536 and the anchor wire loop 550.

Typically, the anchor loop 550 is larger than the neo-leaflet loop 536.

For some applications, the anchor loop 550 is more flexible (e.g., by including thinner wires) than the neo-leaflet loop 536.

For some applications, the anchor loop 550 is generally flat, and the neo-leaflet loop 536 is shaped to define a curved coaptation surface 534.

See fig. 18F. For some applications, the coaptation assistance device 520 is configured such that when unconstrained (by application of any external forces, including through the anatomy or delivery system), an angle β (beta) is defined between (a) an anchor ring best fit plane 562 defined by the anchor ring 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 neo-leaflet best fit plane 564 are parallel to each other. Generally, the coaptation assistance device 520 is configured to automatically assume this angle; for example, the components of the device may include a shape memory alloy, such as nitinol, configured to cause the device to assume this angle when in a resting, relaxed state, such as at 37 degrees celsius (body temperature). As used herein, including in the various claims and the various inventive concepts, the "best-fit plane" defined by engagement surface 534 is the plane that best matches the shape of the wire loop (even though the engagement surface is generally curved), i.e., the plane that results in the least sum of the squares of the distances between the plane and the engagement surface.

In one aspect of the present invention, a coaptation assistance device is provided that is a hybrid (hybrid) of the coaptation assistance device 520, as described above with reference to fig. 18A-18F, and one of the coaptation assistance devices 220A and 220B, as described above with reference to fig. 8A-8B. The annular ventricular anchor of the coaptation assistance device includes a braided flat sheet comprising a plurality of braided wires, as shown in coaptation assistance devices 220A and 220B, rather than an anchor loop 550. The coaptation assistance device can implement any of the features of coaptation assistance device 520, coaptation assistance device 220A, and/or coaptation assistance device 220B, mutatis mutandis.

Reference is now made to fig. 20A-20B, which are schematic illustrations of a coaptation assistance device 620 for treating a native valve 22, in accordance with an application of the present invention. The coaptation assistance device 620 is identical to the coaptation assistance device 520 described above with reference to fig. 18A-18F and 19, except as described below, and like reference numerals refer to like components. The features of the coaptation assistance device 620 can also implement any of the anchor loops described herein, mutatis mutandis.

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

Reference is now made to fig. 21, which is a schematic illustration of a coaptation assistance device 720 for treating a native valve 22, in accordance with an application of the present invention. The coaptation assistance device 720 can implement any of the features of the other coaptation assistance devices described herein, mutatis mutandis.

Reference is additionally made to fig. 22, which is a schematic illustration of a coaptation assistance device 720 implanted in a native valve 22, in accordance with an application of the present invention. In the particular implant shown in fig. 22, the native valve 22 is the tricuspid valve. Fig. 22 is a cross-sectional view of a heart with an anterior portion of the heart including the native anterior leaflet of the tricuspid valve removed, showing only the septal and posterior leaflets.

The coaptation assistance device 720 includes an annular ventricular anchor 730, a ventricular anchor of an annular boundary, and neo-leaflets 732 supported by the annular ventricular anchor 730. The annular ventricular anchor 730 is disposed distal to the neo-leaflet 732.

Generally, the ventricular ring anchor 730 includes an anchor loop 750, the anchor loop 750 defining at least a portion of a boundary of the ventricular ring anchor. The ventricular anchor 730 and the anchor loop 750 may implement any of the features of the ventricular anchor and anchor loop, respectively, described herein, mutatis mutandis. Generally, 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 generally does not include any exposed sharp components that can penetrate tissue.

The anchor loop 750 is configured to be positioned in the ventricle 23, extending between the ventricular apex region 24 (at the base of the ventricle 23) and the sub-annulus 25 of the target native leaflet 26 of the native valve 22. As shown in fig. 22, the anchor loop 750 is configured to remain anchored in position against the surrounding anatomy, including the sub-annulus 25, the ventricular wall 27, and the ventricular apex region 24. In other words, the anchor loop 750 is configured to be secured underneath and behind the target native leaflet 26, in contact with the sub-annulus 25, in position at the apex, and stabilized by the ventricular wall 27. Generally, the anchor loop 750 is configured to pass behind the ventricular papillary muscles 46 of the ventricular apex region 24 or through the ventricular papillary muscles 46 of the ventricular apex region 24. Optionally, the surrounding anatomy to which the anchor loop 750 is anchored further comprises one or more of: an adjustment band, one or more chordae tendineae, and one or more papillary muscles on opposite sides of ventricle 23.

As shown in fig. 22, when the anchor loop 750 is positioned in the ventricle 23, the neo-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 opposite the target native leaflet 26. The neo-leaflet 732 is generally configured to cover at least a portion of the target native leaflet 26, and can implement any of the features of the neo-leaflets described herein, mutatis mutandis.

The coaptation assistance device 720 further includes a native-leaflet intersection (native-leaflet-crossing) 790 configured to be positioned through a perforation of the target native leaflet 26 (even if the annular ventricular anchor 730 itself is configured to be atraumatic, i.e., as described above, without penetrating the surrounding ventricular anatomy). The neo-leaflet 732 is connected to the annular ventricular anchor 730 via a native leaflet intersection 790. For some applications, as shown, the coaptation assistance device 720 includes a coaptation assistance device wire loop 792 that is shaped to at least partially define the neo-leaflets 732, the annular ventricular anchor 730, and the native leaflet intersections 790.

For some applications, the bond assist device 720 may be extended and planarized to an elongated planarized configuration, similar to the planarized configuration of the bond assist device 20 shown in fig. 1E. After being planarized, the coaptation assistance device 720 can be crimped and then loaded into the delivery tube 304 for delivery as described above with reference to fig. 9A-9H, mutatis mutandis.

Unlike the delivery method described above with reference to fig. 9A-9H, during delivery of the annular ventricular anchor 730, the delivery system (e.g., a needle thereof) is used to form a perforation 974 through the target native leaflet 26, typically at and near the center of the native annulus. The annular ventricular anchor 730 passes from the atrium through the perforation 794 to the ventricular side of the native leaflet (while still disposed generally in the delivery tube 304) and deploys from the delivery tube and is allowed to expand in the ventricle. The neo-leaflet 732 is then deployed from the delivery tube into the ventricle, on the atrial side of the native leaflet, such that the neo-leaflet covers at least a portion of the atrial surface of the target native leaflet 26.

FIG. 23 is a schematic illustration of a coaptation assistance device implanted in a native mitral valve 22, in accordance with an application of the present invention.

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

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

U.S. patent application publication 2016/0302917

U.S. patent application publication 2019/0350705

It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not in the prior art.