Biologically implantable prosthesis and methods of using the same

• US 20040122516A1
• Filed: 12/20/2002
• Published: 06/24/2004
• Est. Priority Date: 12/20/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Drews, Michael J., Modesitt, D. Bruce, Holmgren, Neil, Fogarty, Thomas J.
• Granted Patent: US 8,551,162 B2
• Time in Patent Office: Days
• US Class Current: 623/2.37
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/0608 J-shaped
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2002/30545 for adjusting a diameter
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: Y10S 623/91 Heart

Abstract

A biologically implantable prosthesis is disclosed. The prosthesis can have a circumferentially expandable wall and elements that prevent the wall from collapsing once the wall is expanded. Methods of making and using the prosthesis are also disclosed.

Claims

1. A biologically implantable first prosthesis for a heart valve comprising:

a circumferentially expandable wall, wherein the wall has a longitudinal axis, and wherein the wall has a latitudinal cross-section perpendicular to the longitudinal axis, and wherein the wall has a longitudinal cross-section parallel to the longitudinal axis, and

an engagement element configured to self-engage a second prosthesis.

2. The first prosthesis of claim 1, further comprising a stop, wherein the stop prevents the wall from circumferentially decreasing.

3. The first prosthesis of claim 2, wherein the stop prevents the wall from circumferentially expanding.

4. The first prosthesis of claim 2, wherein the wall is resiliently expandable.

5. The first prosthesis of claim 2, wherein the wall is deformably expandable.

6. The first prosthesis of claim 2, wherein the wall is mechanically expandable.

7. The first prosthesis of claim 2, wherein the latitudinal cross-section comprises an open form.

8. The first prosthesis of claim 2, wherein the latitudinal cross-section comprises a spiral.

9. The first prosthesis of claim 2, wherein the wall comprises a first terminal end.

10. The first prosthesis of claim 9, wherein the wall comprises a second terminal end.

11. The first prosthesis of claim 9, wherein the latitudinal cross-section comprises a spiral.

12. The first prosthesis of claim 9, further comprising a first protrusion.

13. The first prosthesis of claim 12, wherein the first protrusion is attached to the wall.

14. The first prosthesis of claim 13, wherein the first protrusion extends from the wall with a vector having a radial component with respect to the longitudinal axis.

15. The first prosthesis of claim 14, wherein the first protrusion comprises a dimple.

16. The first prosthesis of claim 15, wherein the first protrusion comprises a tab.

17. The first prosthesis of claim 16, further comprising a receiving element.

18. The first prosthesis of claim 17, wherein the receiving element comprises an element in the wall.

19. The first prosthesis of claim 12, wherein the first protrusion extends from the wall with a vector having an angular component with respect to the longitudinal axis.

20. The first prosthesis of claim 19, wherein the first protrusion comprises a ball.

21. The first prosthesis of claim 20, further comprising a receiving element.

22. The first prosthesis of claim 21, wherein the receiving element comprises a collar.

23. The first prosthesis of claim 9, further comprising a receiving element.

24. The first prosthesis of claim 23, wherein the receiving element is configured to receive a protrusion extending from the wall with a vector with a radial component with respect to the longitudinal axis.

25. The first prosthesis of claim 24, wherein the receiving element is configured to receive a protrusion extending from the wall with a vector having an angular component with respect to the longitudinal axis.

26. The first prosthesis of claim 12, further comprising a second protrusion.

27. The first prosthesis of claim 26, wherein the first protrusion is located at a first length along the longitudinal axis and wherein the second protrusion is located at a second length along the longitudinal axis.

28. The first prosthesis of claim 26, wherein the first protrusion and the second protrusion are located at a first length along the longitudinal axis.

29. The first prosthesis of claim 26, wherein the first protrusion comprises a first tab, and the first prosthesis further comprises a first port in the wall for receiving the first tab.

30. The first prosthesis of claim 29, wherein the second protrusion comprises a second tab and a second port in the wall for receiving the second tab.

31. The first prosthesis of claim 29, wherein the second protrusion comprises a ball, and the first prosthesis further comprises a collar for receiving the ball.

32. The first prosthesis of claim 1, further comprising a fixturing device connector.

33. The first prosthesis of claim 32, wherein the fixturing device connector comprises a port in the wall.

34. The first prosthesis of claim 1, wherein the wall is corrugated.

35. The first prosthesis of claim 1, wherein the wall has a leading edge and a trailing edge, and further comprising a turned lip on the leading edge.

36. A heart valve assembly comprising:

the first prosthesis of claim 1, and

the second prosthesis received by the first prosthesis.

37. The assembly of claim 36, wherein the second prosthesis is a crown.

38. The assembly of claim 37, wherein the crown is engaged by the engagement element.

39. The assembly of claim 37, wherein the crown comprises a leaflet.

40. The assembly of claim 36, wherein the first prosthesis is a ring.

41. The assembly of claim 36, wherein the second prosthesis is fixedly connected to the first prosthesis.

42. The assembly of claim 36, wherein the second prosthesis is removably connected to the first prosthesis.

43. The assembly of claim 36, wherein the second prosthesis is snap-fitted to the first prosthesis.

44. A biologically implantable prosthetic assembly for a heart valve comprising:

the first prosthesis of claim 32, and

a fixturing device attached to the fixturing device connector, wherein the fixturing device fixes the first prosthesis to a biological mass.

45. The assembly of claim 44, wherein the fixturing device comprises a suture.

46. The assembly of claim 44, wherein the fixturing device comprises a clip.

47. The assembly of claim 44, wherein the fixturing device comprises a staple.

48. The assembly of claim 44, wherein the fixturing device comprises a pin.

49. The assembly of claim 44, wherein the fixturing device comprises a radially expandable wire.

82. A method of removing changing a heart valve comprising removing a second prosthesis from a first prosthesis, wherein the first prosthesis is the first prosthesis of claim 1.

83. The method of claim 82, further comprising replacing the second prosthesis with another prosthesis.

50. A biologically implantable first prosthesis for a heart valve comprising:

a wall comprising a first edge and a second edge, wherein the wall has a longitudinal axis at the center of the first prosthesis, and wherein at least a portion of the wall is angled away from or toward the longitudinal axis, and wherein the first edge comprises an engagement element for engaging a second prosthesis.

51. The first prosthesis of claim 50, wherein the engagement element is turned toward the second edge.

52. The first prosthesis of claim 50, wherein the first edge is the leading edge.

53. The first prosthesis of claim 50, wherein the engagement element is turned toward the longitudinal axis.

54. The first prosthesis of claim 50, wherein the engagement element is turned away from the longitudinal axis.

55. The first prosthesis of claim 50, wherein the engagement element comprises a first segment and a second segment, and wherein the first segment is turned away from the longitudinal axis and the second segment is turned toward the longitudinal axis.

56. The first prosthesis of claim 50, further comprising a fixturing device connector.

57. The first prosthesis of claim 56, wherein the fixturing device connector comprises a port in the wall.

58. The first prosthesis of claim 50, wherein the wall is corrugated.

59. The first prosthesis of claim 50, wherein the longitudinal cross-section comprises a convex curve with respect to the longitudinal axis.

60. The first prosthesis of claim 50, wherein the longitudinal cross-section is a convex curve with respect to the longitudinal axis.

61. The first prosthesis of claim 50, wherein the wall is circumferentially expandable.

62. A heart valve assembly comprising:

the first prosthesis of claim 50, and

the second prosthesis, wherein the second prosthesis is connected to the engagement element.

63. The assembly of claim 62, wherein the second prosthesis is a crown.

64. The assembly of claim 63, wherein the crown is engaged by the engagement element.

65. The assembly of claim 63, wherein the crown comprises a leaflet.

66. The assembly of claim 62, wherein the first prosthesis is a ring.

67. The assembly of claim 62, wherein the second prosthesis is fixedly connected to the first prosthesis.

68. The assembly of claim 62, wherein the second prosthesis is removably connected to the first prosthesis.

69. The assembly of claim 62, wherein the second prosthesis self-enagages to the first prosthesis.

70. A heart valve assembly comprising:

a first prosthesis;

a first magnet in the first prosthesis;

a second prosthesis; and

a second magnet in the second prosthesis, wherein an attraction between the first magnet and the second magnet engages the first prosthesis to the second prosthesis.

71. A method of implanting a heart valve in a valve annulus comprising:

attaching a first prosthesis to the valve annulus, the first prosthesis comprising a circumferentially expandable wall, wherein the wall has a longitudinal axis, and wherein the wall has a latitudinal cross-section perpendicular to the longitudinal axis, and

self-attaching a second prosthesis to the first prosthesis.

72. The method of claim 71, wherein the first prosthesis is a ring.

73. The method of claim 71, wherein the second prosthesis is a crown.

74. The method of claim 71, wherein the wall comprises a first terminal end.

75. The method of claim 74, wherein the wall comprises a second terminal end.

76. The method of claim 71, wherein the latitudinal cross-section comprises a spiral.

77. The method of claim 71, wherein attaching the first prosthesis comprises positioning the first prosthesis in the annulus and circumferentially expanding the first prosthesis.

78. The method of claim 71, wherein attaching the first prosthesis comprises fixing the first prosthesis to a biological mass with a fixturing device.

79. The method of claim 71, wherein attaching the first prosthesis comprises positioning the first prosthesis in the annulus.

80. The method of claim 71, wherein attaching the first prosthesis comprises snap-fitting the second prosthesis to the first prosthesis.

81. The method of claim 71, further comprising removing the second prosthesis.

84. A method of implanting a heart valve in a valve annulus comprising:

attaching a first prosthesis to the valve annulus, the first prosthesis comprising a wall, wherein the wall comprises a first edge and a second edge, and wherein the wall has a longitudinal axis, and wherein at least a portion of the wall is angled away from or toward the longitudinal axis, and wherein the first edge comprises an engagement element, and

attaching a second prosthesis to the first prosthesis.

85. The method of claim 84, wherein the engagement element is turned away from the longitudinal axis.

86. The method of claim 85, wherein the first prosthesis is a ring.

87. The method of claim 86, wherein the second prosthesis is a crown.

88. The method of claim 87, wherein the first edge is the leading edge and the second edge is the trailing edge.

89. The method of claim 88, wherein attaching the crown comprises snap-fitting the crown to the first prosthesis.

90. The method of claim 89, wherein the second edge comprises a retention element.

91. A method of increasing and maintaining the size of a biological valve annulus comprising:

placing a circumferentially expandable first prosthesis in the annulus,

circumferentially expanding the first prosthesis to an expanded size, and

circumferentially maintaining the first prosthesis at the expanded size.

92. The method of claim 91, wherein circumferentially expanding comprises increasing the radius of the annulus from about 0.1 mm to about 2.0 mm.

93. The method of claim 91, wherein the first prosthesis comprises an engagement element configured to receive a second prosthesis.

94. A method of fixing a heart valve assembly to a biological mass comprising:

positioning the assembly near the mass,

inserting a fixation device through the assembly and the mass, wherein the fixation device comprises a first end, a second end, and a middle, and wherein the first end is expandable, and wherein the first end and the second end are on opposite sides of the assembly and the mass, and

expanding the first end.