Prosthetic heart valve

• US 9,232,996 B2
• Filed: 02/24/2012
• Issued: 01/12/2016
• Est. Priority Date: 02/25/2011
• Status: Active Grant

• Current Assignee: University of Connecticut (State of Connecticut)
• Original Assignee: University of Connecticut (State of Connecticut)
• Inventors: Sun, Wei, Sirois, Eric, Pham, Thuy Minh, Li, Kewei
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): Shipmon, Tiffany
• Application Number:
  US14/001,162
• Publication Number:
  US 20140155995A1
• Time in Patent Office: 1,418 Days
• Field of Search: 623/2.18, 623/2.11
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped

Abstract

A prosthetic heart valve having a stent, a plurality of leaflets positioned within the stent, and a suspension assembly coupled to the leaflets and the stent. The suspension assembly includes a central support structure that is spaced from the plurality of leaflets in the direction of blood flow. A plurality of elongate suspension members are secured to the central support structure, and at least one elongate suspension member is secured to each leaflet of the valve, thereby providing mechanical reinforcement for the leaflets.

Claims

1. A prosthetic heart valve for implantation into a selected channel within the heart of a subject, wherein blood flows through the selected channel in a flow direction, the prosthetic heart valve comprising:

a stent having an inner surface, the inner surface of the stent defining an interior region of the stent, wherein the stent is radially collapsible and expandable to an expanded configuration;

a lining skirt positioned within the interior space of the stent, wherein the lining skirt is radially collapsible and expandable with the stent;

a plurality of leaflets positioned within the interior region of the stent, each leaflet of the plurality of leaflets defining a free edge, an attachment edge, and a pair of spaced commissure regions, the attachment edge of each leaflet being attached to the stent such that each commissure region of each respective leaflet is positioned proximate a commissure region of an adjacent leaflet;

a suspension assembly comprising;

a central support structure coupled to the stent such that the central support structure is spaced from the plurality of leaflets in the flow direction; and

a plurality of elongate suspension members secured thereto the central support structure, at least one suspension member of the plurality of suspension members being secured thereto each respective leaflet,

wherein, following implantation of the prosthetic heart valve within the selected channel, the suspension assembly is configured to mechanically reinforce the plurality of leaflets, wherein the attachment edge of each leaflet is attached to the stent through the lining skirt, and wherein the central support structure of the suspension assembly is coupled to the stent through the lining skirt.

2. The prosthetic heart valve of claim 1, wherein the plurality of leaflets and the suspension assembly are radially collapsible and expandable with the stent.

3. The prosthetic heart valve of claim 1, wherein the stent comprises a shape-memory material that is configured to expand the stent into the expanded configuration, wherein, in the expanded configuration, the inner surface of the stent defines a desired cross-sectional profile.

4. The prosthetic heart valve of claim 1, wherein at least one leaflet of the plurality of leaflets has a substantially different size than another leaflet of the plurality of leaflets.

5. The prosthetic heart valve of claim 1, wherein at least a portion of the central support structure is uniformly spaced from the inner surface of the stent and at least a portion of the central support structure is directly secured to the stent.

6. The prosthetic heart valve of claim 1, wherein at least a portion of the central support structure is coupled to the stent by at least one connecting member and at least a portion of the central support structure is directly secured to the stent.

7. The prosthetic heart valve of claim 1, wherein the central support structure comprises a plurality of offset support members spaced circumferentially about the inner surface of the valve such that each support member of the plurality of support members spans between two points on the inner surface of the valve and overlaps with at least one other support member at an intersection point.

8. The prosthetic heart valve of claim 7, wherein each suspension member of the plurality of suspension members is secured to the central support structure at an intersection point.

9. The prosthetic heart valve of claim 1, wherein the support assembly comprises at least one substructure that extends from the central support member to a point on the stent that is spaced from the central support structure in a direction opposite the flow direction.

10. The prosthetic heart valve of claim 1, wherein at least one suspension member of the plurality of suspension members is secured to each commissure region of at least one leaflet of the plurality of leaflets.

11. The prosthetic heart valve of claim 1, wherein at least one suspension member of the plurality of suspension members is secured to the free edge of at least one leaflet of the plurality of leaflets.

12. The prosthetic heart valve of claim 1, wherein each leaflet of the plurality of leaflets defines a belly region positioned therebetween the free edge, the attachment edge, and the commissure regions of the leaflet, and wherein at least one suspension member of the plurality of suspension members is secured to the belly region of at least one leaflet.

13. The prosthetic heart valve of claim 1, wherein, following implantation of the prosthetic heart valve within the selected channel of the heart of the subject, at least one suspension member of the plurality of elongate suspension members is configured to be angularly oriented relative to the free edge of the leaflet of the plurality of leaflets to which it is attached.

14. The prosthetic heart valve of claim 1, wherein, following implantation of the prosthetic heart valve within the selected channel of the heart of the subject, at least one suspension member of the plurality of elongate suspension members is configured to be substantially perpendicularly oriented relative to the free edge of the leaflet of the plurality of leaflets to which it is attached.

15. The prosthetic heart valve of claim 1, wherein the free edge of at least one leaflet of the plurality of leaflets comprises an extended edge portion that, following implantation of the prosthetic heart valve within the selected chamber of the heart of the subject, is configured to project from the leaflet in the flow direction, and wherein at least one suspension member of the plurality of suspension members is secured to the extended edge portion of the at least one leaflet of the plurality of leaflets.

16. The prosthetic heart valve of claim 1, wherein the plurality of suspension members are secured to the central support structure at a plurality of attachment points, and wherein the plurality of attachment points are substantially positioned within a common plane when the prosthetic heart valve is in an unloaded state.

17. A prosthetic heart valve for implantation into a selected channel within the heart of a subject, wherein blood flows through the selected channel in a flow direction, the prosthetic heart valve comprising:

a stent having an inner surface, the inner surface of the stent defining an interior region of the stent;

a plurality of leaflets positioned within the interior region of the stent, each leaflet of the plurality of leaflets defining a free edge, an attachment edge, and a pair of spaced commissure regions, the attachment edge of each leaflet being attached to the stent such that each commissure region of each respective leaflet is positioned proximate a commissure region of an adjacent leaflet; and

a suspension assembly comprising;

a central support structure coupled to the stent such that the central support structure is spaced from the plurality of leaflets in the flow direction; and

a plurality of elongate suspension members secured thereto the central support structure, at least one suspension member of the plurality of suspension members being secured thereto each respective leaflet,

wherein, following implantation of the prosthetic heart valve within the selected channel, the suspension assembly is configured to mechanically reinforce the plurality of leaflets, and wherein at least a portion of the central support structure is uniformly spaced from the inner surface of the stent and at least a portion of the central support structure is directly secured to the stent.

18. The prosthetic heart valve of claim 17, wherein the stent is radially collapsible and expandable to an expanded configuration.

19. The prosthetic heart valve of claim 18, wherein the plurality of leaflets and the suspension assembly are radially collapsible and expandable with the stent.

20. The prosthetic heart valve of claim 18, wherein the stent comprises a shape-memory material that is configured to expand the stent into the expanded configuration, wherein, in the expanded configuration, the inner surface of the stent defines a desired cross-sectional profile.

21. The prosthetic heart valve of claim 18, further comprising a lining skirt positioned within the interior space of the stent, wherein the attachment edge of each leaflet is attached to the stent through the lining skirt, wherein the central support structure of the suspension assembly is coupled to the stent through the lining skirt, and wherein the lining skirt is radially collapsible and expandable with the stent.

22. The prosthetic heart valve of claim 17, wherein at least one leaflet of the plurality of leaflets has a substantially different size than another leaflet of the plurality of leaflets.

23. The prosthetic heart valve of claim 17, wherein at least a portion of the central support structure is coupled to the stent by at least one connecting member and at least a portion of the central support structure is directly secured to the stent.

24. The prosthetic heart valve of claim 17, wherein the central support structure comprises a plurality of offset support members spaced circumferentially about the inner surface of the valve such that each support member of the plurality of support members spans between two points on the inner surface of the valve and overlaps with at least one other support member at an intersection point.

25. The prosthetic heart valve of claim 24, wherein each suspension member of the plurality of suspension members is secured to the central support structure at an intersection point.

26. The prosthetic heart valve of claim 17, wherein the support assembly comprises at least one sub-structure that extends from the central support member to a point on the stent that is spaced from the central support structure in a direction opposite the flow direction.

27. The prosthetic heart valve of claim 17, wherein at least one suspension member of the plurality of suspension members is secured to each commissure region of at least one leaflet of the plurality of leaflets.

28. The prosthetic heart valve of claim 17, wherein at least one suspension member of the plurality of suspension members is secured to the free edge of at least one leaflet of the plurality of leaflets.

29. The prosthetic heart valve of claim 17, wherein each leaflet of the plurality of leaflets defines a belly region positioned therebetween the free edge, the attachment edge, and the commissure regions of the leaflet, and wherein at least one suspension member of the plurality of suspension members is secured to the belly region of at least one leaflet.

30. The prosthetic heart valve of claim 17, wherein, following implantation of the prosthetic heart valve within the selected channel of the heart of the subject, at least one suspension member of the plurality of elongate suspension members is configured to be gularly oriented relative to the free edge of the leaflet of the plurality of leaflets to which it is attached.

31. The prosthetic heart valve of claim 17, wherein, following implantation of the prosthetic heart valve within the selected channel of the heart of the subject, at least one suspension member of the plurality of elongate suspension members is configured to be substantially perpendicularly oriented relative to the free edge of the leaflet of the plurality of leaflets to which it is attached.

32. The prosthetic heart valve of claim 17, wherein the free edge of at least one leaflet of the plurality of leaflets comprises an extended edge portion that, following implantation of the prosthetic heart valve within the selected chamber of the heart of the subject, is configured to project from the leaflet in the flow direction, and wherein at least one suspension member of the plurality of suspension members is secured to the extended edge portion of the at least one leaflet of the plurality of leaflets.

33. The prosthetic heart valve of claim 17, wherein the plurality of suspension members are secured to the central support structure at a plurality of attachment points, and wherein the plurality of attachment points are substantially positioned within a common plane when the prosthetic heart valve is in an unloaded state.

34. A prosthetic heart valve for implantation into a selected channel within the heart of a subject, wherein blood flows through the selected channel in a flow direction, the prosthetic heart valve comprising:

a stent having an inner surface, the inner surface of the stent defining an interior region of the stent;

a plurality of leaflets positioned within the interior region of the stent, each leaflet of the plurality of leaflets defining a free edge, an attachment edge, and a pair of spaced commissure regions, the attachment edge of each leaflet being attached to the stent such that each commissure region of each respective leaflet is positioned proximate a commissure region of an adjacent leaflet; and

a suspension assembly comprising;

a central support structure coupled to the stent such that the central support structure is spaced from the plurality of leaflets in the flow direction; and

a plurality of elongate suspension members secured thereto the central support structure, at least one suspension member of the plurality of suspension members being secured thereto each respective leaflet,

wherein, following implantation of the prosthetic heart valve within the selected channel, the suspension assembly is configured to mechanically reinforrce the plurality of leaflets, and wherein at least a portion of the central support structure is coupled to the stent by at least one connecting member and at least a portion of the central support structure is directly secured to the stent.

35. The prosthetic heart valve of claim 34, wherein the stent is radially collapsible and expandable to an expanded configuration.

36. The prosthetic heart valve of claim 35, wherein the plurality of leaflets and the suspension assembly are radially collapsible and expandable with the stent.

37. The prosthetic heart valve of claim 35, wherein the stent comprises a shape-memory material that is configured to expand the stent into the expanded configuration, wherein, in the expanded configuration, the inner surface of the stent defines a desired cross-sectional profile.

38. The prosthetic heart valve of claim 35, further comprising a lining skirt positioned within the interior space of the stent, wherein the attachment edge of each leaflet is attached to the stent through the lining skirt, wherein the central support structure of the suspension assembly is coupled to the stent through the lining skirt, and wherein, the lining skirt is radially collapsible and expandable with the stent.

39. The prosthetic heart valve of claim 34, wherein at least one leaflet of the plurality of leaflets has a substantially different size than another leaflet of the plurality of leaflets.

40. The prosthetic heart valve of claim 34, wherein at least a portion of the central support structure is uniformly spaced from the inner surface of the stent and at least a portion of the central support structure is directly secured to the stent.

41. The prosthetic heart valve of claim 34, wherein the central support structure comprises a plurality of offset support members spaced circumferentially about the inner surface of the valve such that each support member of the plurality of support members spans between two points on the inner surface of the valve and overlaps with at least one other support member at an intersection point.

42. The prosthetic heart valve of claim 41, wherein each suspension member of the plurality of suspension members is secured to the central support structure at an intersection point.

43. The prosthetic heart valve of claim 34, wherein the support assembly comprises at least one sub-structure that extends from the central support member to a point on the stent that is spaced from the central support structure in a direction opposite the flow direction.

44. The prosthetic heart valve of claim 34, wherein at least one suspension member of the plurality of suspension members is secured to each conunissure region of at least one leaflet of the plurality of leaflets.

45. The prosthetic heart valve of claim 34, wherein at least one suspension member of the plurality of suspension members is secured to the free edge of at least one leaflet of the plurality of leaflets.

46. The prosthetic heart valve of claim 34, wherein each leaflet of the plurality of leaflets defines a belly region positioned therebetween the free edge, the attachment edge, and the commissure regions of the leaflet, and wherein at least one suspension member of the plurality of suspension members is secured to the belly region of at least one leaflet.

47. The prosthetic heart valve of claim 34, wherein, following implantation of the prosthetic heart valve within the selected channel of the heart of the subject, at least one suspension member of the plurality of elongate suspension members is configured to be angularly oriented relative to the free edge of the leaflet of the plurality of leaflets to which it is attached.

48. The prosthetic heart valve of claim 34, wherein, following implantation of the prosthetic heart valve within the selected channel of the heart of the subject, at least one suspension member of the plurality of elongate suspension members is configured to be substantially perpendicularly oriented relative to the free edge of the leaflet of the plurality of leaflets to which it is attached.

49. The prosthetic heart valve of claim 34, wherein the free edge of at least one leaflet of the plurality of leaflets comprises an extended edge portion that, following implantation of the prosthetic heart valve within the selected chamber of the heart of the subject, is configured to project from the leaflet in the flow direction, and wherein at least one suspension member of the plurality of suspension members is secured to the extended edge portion of the at least one leaflet of the plurality of leaflets.

50. The prosthetic heart valve of claim 34, wherein the plurality of suspension members are secured to the central support structure at a plurality of attachment points, and wherein the plurality of attachment points are substantially positioned within, a common plane when the prosthetic heart valve is in an unloaded state.

51. A prosthetic heart valve for implantation into a selected channel within the heart of a subject, wherein blood flows through the selected channel in a flow direction, the prosthetic heart valve comprising:

a stent having an inner surface, the inner surface of the stent defining an interior region of the stent;

a plurality of leaflets positioned within the interior region of the stent, each leaflet of the plurality of leaflets defining a free edge, an attachment edge, and a pair of spaced commissure regions, the attachment edge of each leaflet being attached to the stent such that each commissure region of each respective leaflet is positioned proximate a commissure region of an adjacent leaflet; and

a suspension assembly comprising;

a central support structure coupled to the stent such that the central support structure is spaced from the plurality of leaflets in the flow direction; and

a plurality of elongate suspension members secured thereto the central support structure, at least one suspension member of the plurality of suspension members being secured thereto each respective leaflet,

wherein, following implantation of the prosthetic heart valve within the selected channel, the suspension assembly is configured to mechanically reinforce the plurality of leaflets, and wherein at least one suspension member of the plurality of suspension members is secured to each commissure region of at least one leaflet of the plurality of leaflets.

52. The prosthetic heart valve of claim 51, wherein the stent is radially collapsible and expandable to an expanded configuration.

53. The prosthetic heart valve of claim 52, wherein the plurality of leaflets and the suspension assembly are radially collapsible and expandable with the stent.

54. The prosthetic heart valve of claim 52, wherein the stent comprises a shape-memory material that is configured to expand the stent into the expanded configuration, wherein, in the expanded configuration, the inner surface of the stent defines a desired cross-sectional profile.

55. The prosthetic heart valve of claim 52, further comprising a lining skirt positioned within the interior space of the stent, wherein the attachment edge of each leaflet is attached to the stent through the lining skirt, wherein the central support structure of the suspension assembly is coupled to the stent through the lining skirt, and wherein the lining skirt is radially collapsible and expandable with the stent.

56. The prosthetic heart valve of claim 51, wherein at least one leaflet of the plurality of leaflets has a substantially different size than another leaflet of the plurality of leaflets.

57. The prosthetic heart valve of claim 51, wherein at least a portion of the central support structure is uniformly spaced from the inner surface of the stent and at least a portion of the central support structure is directly secured to the stent.

58. The prosthetic heart valve of claim 51, wherein at least a portion of the central support structure is coupled to the stent by at least one connecting member and at least a portion of the central support structure is directly secured to the stent.

59. The prosthetic heart valve of claim 51, wherein the central support structure comprises a plurality of offset support members spaced circumferentially about the inner surface of the valve such that each support member of the plurality of support members spans between two points on the inner surface of the valve and overlaps with at least one other support member at an intersection point.

60. The prosthetic heart valve of claim 59, wherein each suspension member of the plurality of suspension members is secured to the central support structure at an intersection point.

61. The prosthetic heart valve of claim 51, wherein the support assembly comprises at least one sub-structure that extends from the central support member to a point on the stent that is spaced from the central support structure in a direction opposite the flow direction.

62. The prosthetic heart valve of claim 51, wherein at least one suspension member of the plurality of suspension members is secured to the free edge of at least one leaflet of the plurality of leaflets.

63. The prosthetic heart valve of claim 51, wherein each leaflet of the plurality of leaflets defines a belly region positioned therebetween the free edge, the attachment edge, and the commissure regions of the leaflet, and wherein at least one suspension member of the plurality of suspension members is secured to the belly region of at least one leaflet.

64. The prosthetic heart valve of claim 51, wherein, following implantation of the prosthetic heart valve within the selected channel of the heart of the subject, at least one suspension member of the plurality of elongate suspension members is configured to be angularly oriented relative to the free edge of the leaflet of the plurality of leaflets to which it is attached.

65. The prosthetic heart valve of claim 51, wherein, following implantation of the prosthetic heart valve within the selected channel of the heart of the subject, at least one suspension member of the plurality of elongate suspension members is configured to be substantially perpendicularly oriented relative to the free edge of the leaflet of the plurality of leaflets to which it is attached.

66. The prosthetic heart valve of claim 51, wherein the free edge of at least one leaflet of the plurality of leaflets comprises an extended edge portion that, following implantation of the prosthetic heart valve within the selected chamber of the heart of the subject, is configured to project from the leaflet in the flow direction, and wherein at least one suspension member of the plurality of suspension members is secured to the extended edge portion of the at least one leaflet of the plurality of leaflets.

67. The prosthetic heart valve of claim 51, wherein the plurality of suspension members are secured to the central support structure at a plurality of attachment points, and wherein the plurality of attachment points are substantially positioned within a common plane when the prosthetic heart valve is in an unloaded state.

68. A prosthetic heart valve for implantation into a selected channel within the heart of a subject, wherein blood flows through the selected channel in a flow direction, the prosthetic heart valve comprising:

a stent having an inner surface, the inner surface of the stent defining an interior region of the stent;

a plurality of leaflets positioned within the interior region of the stent, each leaflet of the plurality of leaflets defining a free edge, an attachment edge, and a pair of spaced commissure regions, the attachment edge of each leaflet being attached to the stent such that each commissure region of each respective leaflet is positioned proximate a commissure region of an adjacent leaflet; and

a suspension assembly comprising;

a central support structure coupled to the stent such that the central support structure is spaced from the plurality of leaflets in the flow direction; and

a plurality of elongate suspension members secured thereto the central support structure, at least one suspension member of the plurality of suspension members being secured thereto each respective leaflet,

wherein, following implantation of the prosthetic heart valve within the selected channel, the suspension assembly is configured to mechanically reinforce the plurality of leaflets, and

wherein at least one suspension member of the plurality of suspension members is secured to the free edge of at least one leaflet of the plurality of leaflets.

69. The prosthetic heart valve of claim 68, wherein the stent is radially collapsible and expandable to an expanded configuration.

70. The prosthetic heart valve of claim 69, wherein the plurality of leaflets and the suspension assembly are radially collapsible and expandable with the stent.

71. The prosthetic heart valve of claim 69, wherein the stent comprises a shape-memory material that is configured to expand the stent into the expanded configuration, wherein, in the expanded configuration, the inner surface of the stent defines a desired cross-sectional profile.

72. The prosthetic heart valve of claim 69, further comprising a lining skirt positioned within the interior space of the stent, wherein the attachment edge of each leaflet is attached to the stent through the lining skirt, wherein the central support structure of the suspension assembly is coupled to the stent through the lining skirt, and wherein the lining skirt is radially collapsible and expandable with the stent.

73. The prosthetic heart valve of claim 68, wherein at least one leaflet of the plurality of leaflets has a substantially different size than another leaflet of the plurality of leaflets.

74. The prosthetic heart valve of claim 68, wherein at least a portion of the central support structure is uniformly spaced from the inner surface of the stent and at least a portion of the central support structure is directly secured to the stent.

75. The prosthetic heart valve of claim 68, wherein at least a portion of the central support structure is coupled to the stent by at least one connecting member and at least a portion of the central support structure is directly secured to the stent.

76. The prosthetic heart valve of claim 68, wherein the central support structure comprises a plurality of offset support members spaced circumferentially about the inner surface of the valve such that each support member of the plurality of support members spans between two points on the inner surface of the valve and overlaps with at least one other support member at an intersection point.

77. The prosthetic heart valve of claim 76, wherein each suspension member of the plurality of suspension members is secured to the central support structure at an intersection point.

78. The prosthetic heart valve of claim 68, wherein the support assembly comprises at least one sub-structure that extends from the central support member to a point on the stent that is spaced from the central support structure in a direction opposite the flow direction.

79. The prosthetic heart valve of claim 68, wherein at least one suspension member of the plurality of suspension members is secured to each commissure region of at least one leaflet of the plurality of leaflets.

80. The prosthetic heart valve of claim 68, wherein each leaflet of the plurality of leaflets defines a belly region positioned therebetween the free edge, the attachment edge, and the commissure regions of the leaflet, and wherein at least one suspension member of the plurality of suspension members is secured to the belly region of at least one leaflet.

81. The prosthetic heart valve of claim 68, wherein, following implantation of the prosthetic heart valve within the selected channel of the heart of the subject, at least one suspension member of the plurality of elongate suspension members is configured to be angularly oriented relative to the free edge of the leaflet of the plurality of leaflets to which it is attached.

82. The prosthetic heart valve of claim 68, wherein, following implantation of the prosthetic heart valve within the selected channel of the heart of the subject, at least one suspension member of the plurality of elongate suspension members is configured to be substantially perpendicularly oriented relative to the free edge of the leaflet of the plurality of leaflets to which it is attached.

83. The prosthetic heart valve of claim 68, wherein the free edge of at least one leaflet of the plurality of leaflets comprises an extended edge portion that, following implantation of the prosthetic heart valve within the selected chamber of the heart of the subject, is configured to project from the leaflet in the flow direction, and wherein at least one suspension member of the plurality of suspension members is secured to the extended edge portion of the at least one leaflet of the plurality of leaflets.

84. The prosthetic heart valve of claim 68, wherein the plurality of suspension members are secured to the central support structure at a plurality of attachment points, and wherein the plurality of attachment points are substantially positioned within a common plane when the prosthetic heart valve is in an unloaded state.

85. A prosthetic heart valve for implantation into a selected channel within the heart of a subject, wherein blood flows through the selected channel in a flow direction, the prosthetic heart valve comprising:

a stent having an inner surface, the inner surface of the stent defining an interior region of the stent;

a plurality of leaflets positioned within the interior region of the stent, each leaflet of the plurality of leaflets defining a free edge, an attachment edge, and a pair of spaced commissure regions, the attachment edge of each leaflet being attached to the stent such that each commissure region of each respective leaflet is positioned proximate a commissure region of an adjacent leaflet, wherein the free edge of at least one leaflet of the plurality of leaflets comprises an extended edge portion that, following implantation of the prosthetic heart valve within the selected chamber of the heart of the subject, is configured to project from the leaflet in the flow direction; and

a suspension assembly comprising;

a central support structure coupled to the stent such that the central support structure is spaced from the plurality of leaflets in the flow direction; and

a plurality of elongate suspension members secured thereto the central support structure, at least one suspension member of the plurality of suspension members being secured thereto each respective leaflet,

wherein, following implantation of the prosthetic heart valve within the selected channel, the suspension assembly is configured to mechanically reinforce the plurality of leaflets, and

wherein at least one suspension member of the plurality of suspension members is secured to the extended edge portion of the at least one leaflet of the plurality of leaflets.

86. The prosthetic heart valve of claim 85, wherein the stent is radially collapsible and expandable to an expanded configuration.

87. The prosthetic heart valve of claim 86, wherein the plurality of leaflets and the suspension assembly are radially collapsible and expandable with the stent.

88. The prosthetic heart valve of claim 86, wherein the stent comprises a shape-memory material that is configured to expand the stent into the expanded configuration, wherein, in the expanded configuration, the inner surface of the stent defines a desired cross-sectional profile.

89. The prosthetic heart valve of claim 86, further comprising a lining skirt positioned within the interior space of the stent, wherein the attachment edge of each leaflet is attached to the stent through the lining skirt, wherein the central support structure of the suspension assembly is coupled to the stent through the lining skirt, and wherein the lining skirt is radially collapsible and expandable with the stent.

90. The prosthetic heart valve of claim 85, wherein at least one leaflet of the plurality of leaflets has a substantially different size than another leaflet of the plurality of leaflets.

91. The prosthetic heart valve of claim 85, wherein at least a portion of the central support structure is uniformly spaced from the inner surface of the stent and at least a portion of the central support structure is directly secured to the stent.

92. The prosthetic heart valve of claim 85, wherein at least a portion of the central support structure is coupled to the stent by at least one connecting member and at least a portion of the central support structure is directly secured to the stent.

93. The prosthetic heart valve of claim 85, wherein the central support structure comprises a plurality of offset support members spaced circumferentially about the inner surface of the valve such that each support member of the plurality of support members spans between two points on the inner surface of the valve and overlaps with at least one other support member at an intersection point.

94. The prosthetic heart valve of claim 93, wherein each suspension member of the plurality of suspension members is secured to the central support structure at an intersection point.

95. The prosthetic heart valve of claim 85, wherein the support assembly comprises at least one sub-structure that extends from the central support member to a point on the stent that is spaced from the central support structure in a direction opposite the flow direction.

96. The prosthetic heart valve of claim 85, wherein at least one suspension member of the plurality of suspension members is secured to each commissure region of at least one leaflet of the plurality of leaflets.

97. The prosthetic heart valve of claim 85, wherein at least one suspension member of the plurality of suspension members is secured to the free edge of at least one leaflet of the plurality of leaflets.

98. The prosthetic heart valve of claim 85, wherein each leaflet of the plurality of leaflets defines a belly region positioned therebetween the free edge, the attachment edge, and the commissure regions of the leaflet, and wherein at least one suspension member of the plurality of suspension members is secured to the belly region of at least one leaflet.

99. The prosthetic heart valve of claim 85, wherein, following implantation of the prosthetic heart valve within the selected channel of the heart of the subject, at least one suspension member of the plurality of elongate suspension members is configured to be angularly oriented relative to the free edge of the leaflet of the plurality of leaflets to which it is attached.

100. The prosthetic heart valve of claim 85, wherein, following implantation of the prosthetic heart valve within the selected channel of the heart of the subject, at least one suspension member of the plurality of elongate suspension members is configured to be substantially perpendicularly oriented relative to the free edge of the leaflet of the plurality of leaflets to which it is attached.

101. The prosthetic heart valve of claim 85, wherein the plurality of suspension members are secured to the central support structure at a plurality of attachment points, and wherein the plurality of attachment points are substantially positioned within a common plane when the prosthetic heart valve is in an unloaded state.