Heart valve repair apparatus and methods

• US 20030083742A1
• Filed: 10/09/2002
• Published: 05/01/2003
• Est. Priority Date: 02/02/2000
• Status: Active Grant

• Current Assignee: Cardiac Lead Technologies, LLC
• Original Assignee: Paul A. Spence
• Inventors: Ortiz, Mark, Spence, Paul A.
• Granted Patent: US 6,797,002 B2
• Time in Patent Office: Days
• US Class Current: 623/2.16
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• 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 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type

Abstract

Valve repair apparatus and methods for ensuring proper coaptation and operation of the leaflets of a heart valve. Main aspects of the disclosure relate to devices including a support member configured for attachment to the heart valve annulus, a post extending from the support member away from the plane of the annulus and a connector coupled with the post and configured for attachment to at least one of the leaflets. The various embodiments may include a replacement heart valve connected with the support member for facilitating full replacement as opposed to near repair of an existing native heart valve. Various other devices include support structure and one or more posts connected to opposite sides of the support structure and extending from one side of the valve annulus to another to modify the shape of the annulus.

Claims

1. A device for supporting a heart valve in a patient, the heart valve including an annulus generally lying in a plane and a plurality of leaflets connected therewith and adapted to open and close to selectively allow and prevent blood flow, the device comprising:

a support member configured for attachment to the heart valve annulus, and

a post extending from said support member and configured to extend away from the plane of the annulus, and

a connector coupled with said post and configured for attachment to at least one of said leaflets.

2. The device of claim 1, wherein said connector further comprises at least one flexible tensile member coupled with said post for supporting said one leaflet during operation of the valve.

3. The device of claim 1, wherein said connector is configured to connect one end of said post directly adjacent an edge of at least one of said leaflets.

4. The device of claim 1, wherein said support member is adjustable such that at least a portion thereof may be moved with respect to another portion and retained in a selected configuration.

5. The device of claim 1, wherein said support member is ring-shaped and includes a straight section connected with a curved section.

6. The device of claim 5, wherein the straight section is more rigid than the curved section.

7. The device of claim 1, wherein said post is generally J-shaped with a long section and a shorter section, said long section connected to said support member and said shorter section coupled with said connector.

8. The device of claim 1, wherein said connector further comprises a wire connector extendable from said post.

9. The device of claim 1, wherein said flexible tensile member is adjustable in length with respect to said post to allow adjustment of a leaflet supporting length thereof between said post and said leaflet.

10. The device of claim 1, wherein said post has a blunt contact surface configured for insertion and retention within the heart chamber without damaging the heart during or after implantation.

11. The device of claim 10, wherein said blunt contact surface includes a generally annular portion connectable with at least one flexible tensile member serving as an artificial chord.

12. The device of claim 1, wherein said post is attached for adjustment in position relative to said support member.

13. The device of claim 1, wherein said post is separable from said support member.

14. The device of claim 1, wherein said post includes a length and said connector further comprises a flexible tensile member having a first portion that extends through the length of said post and a second, length adjustable portion that extends outward from said post.

15. The device of claim 1, wherein a portion of said support member is angled out of a plane containing another portion of said support member.

16. The device of claim 1, wherein said post is resilient to allow movement thereof with respect to said support member as the heart beats after implantation thereby reducing damage to an adjacent wall of the heart and/or reducing stress on the heart valve or the attachment point therewith.

17. The device of claim 1, further comprising:

at least one additional post connected with said support member, and

flexible tensile members coupled with each post for supporting at least one of said leaflets.

18. The device of claim 17, wherein said posts form part of a frame structure comprising a plurality of posts each having first and second ends and support members respectively connecting the first ends together and the second ends together.

19. The device of claim 1, wherein said post is configured to extend between the leaflets of said valve when affixed thereto.

20. The device of claim 1, wherein said post is configured to extend radially outside the annulus of said valve when affixed thereto.

21. The device of claim 1, wherein said post includes a first end connected with said support member and a second end in the shape of a loop.

22. The device of claim 21 further comprising a flexible tensile member connected with said loop and configured for further connection to at least one of said leaflets.

23. The device of claim 21 further comprising a replacement heart valve attached to said support member.

24. The device of claim 1, wherein said post includes a generally annular portion with a blunt contact surface configured for insertion and retention within the heart chamber and said flexible tensile member is adjustable in length with respect to said post to allow adjustment of a leaflet supporting length thereof between said generally annular portion and said leaflet.

25. The device of claim 24, wherein said flexible tensile member is comprised of a suture material.

26. The device of claim 1, wherein said flexible tensile member is comprised of a suture material.

27. The device of claim 1, wherein said support member is a ring which is asymmetric about each of two perpendicular axes.

28. A device for supporting a heart valve in a patient, the heart valve including an annulus generally lying in a plane and at least first and second leaflets adapted to open and close to selectively allow and prevent blood flow, the device comprising:

a support member configured for attachment to the heart valve annulus,

at least one post extending from said support member and configured to extend away from the plane of the annulus, and

a plurality of flexible tensile members coupled with said at least one post and configured to be connected with said first and second leaflets for supporting and aligning said leaflets for coaptation during operation of the valve.

29. The device of claim 28, wherein said support member is adjustable such that at least a portion thereof may be moved with respect to another portion and retained in a selected configuration.

30. The device of claim 28, wherein said support member includes a straight section connected with a curved section.

31. The device of claim 30, wherein the straight section is more rigid than the curved section.

32. The device of claim 28, wherein said post is generally J-shaped with a long section and a shorter section, said long section connected to said support member and said shorter section coupled with said plurality of flexible tensile members.

33. The device of claim 28, wherein said flexible tensile members are comprised a suture material.

34. The device of claim 28, wherein said flexible tensile members are adjustable in length with respect to said post to allow adjustment of leaflet supporting lengths thereof between said post and said leaflet.

35. The device of claim 28, wherein said post has a blunt contact surface configured for insertion and retention within the heart chamber without damaging the heart after implantation.

36. The device of claim 35, wherein said blunt contact surface includes a generally annular portion connected with said flexible tensile members.

37. The device of claim 36, wherein said flexible tensile members are adjustable in length.

38. The device of claim 28, wherein said post is attached for adjustment in position relative to said support member.

39. The device of claim 28, wherein said post is separable from said support member.

40. The device of claim 28, wherein said post includes a length and each of said flexible tensile members includes a first portion that extends through the length of said post and a second, length adjustable portion that extends outward from said post.

41. The device of claim 28, wherein said flexible tensile members extend along an outside surface of said post and are length adjustable.

42. The device of claim 28, wherein a portion of said support member is angled out of a plane containing another portion of said support member.

43. The device of claim 28, wherein said post is resilient to allow movement thereof with respect to said support member as the heart beats after implantation.

44. The device of claim 28, further comprising a plurality of said posts and another ring-shaped support member forming a frame structure comprising said plurality of posts each having first and second ends and said support members respectively connecting the first ends together and the second ends together.

45. The device of claim 28, wherein said post is configured to extend between the leaflets of said valve when affixed thereto.

46. The device of claim 28, wherein said post is configured to extend radially outside the annulus of said valve when affixed thereto.

47. The device of claim 28, wherein said post includes a first end connected with said support member and a second end in the shape of a loop, said flexible tensile members being connected with said loop and configured for further connection to at least one of said leaflets.

48. The device of claim 28 further comprising a replacement heart valve attached to said support member.

49. The device of claim 28, wherein said support member is ring-shaped.

50. A device for supporting a heart valve in a patient, the heart valve including an annulus generally contained in a plane and a plurality of leaflets adapted to open and close to selectively allow and prevent blood flow, said leaflets being supported by a plurality of artificial or natural chords, the device comprising:

a support member configured for attachment to the heart valve annulus,

at least one post extending from said support member and configured to extend away from the plane of the annulus, and

a first chord gripping member coupled with said post and configured to grip at least one of said chords and thereby fix the length of said one chord between said first chord gripping member and said leaflets thereby supporting and aligning said leaflets for coaptation during operation of the valve.

51. The device of claim 50, wherein said first chord gripping member further comprises a pair of movable jaws adapted to grip the first plurality of chords therebetween.

52. The device of claim 50 further comprising a second chord gripping member configured to grip a second plurality of said chords and thereby fix the length of said second plurality of said chords between said second chord gripping member and said leaflets to support and align said leaflets for coaptation during operation of the valve.

53. The device of claim 52, wherein said first and second chord gripping members each further comprises a pair of movable jaws adapted to grip the first and second pluralities of chords respectively therebetween.

54. The device of claim 50, wherein at least a portion of said first chord gripping member is formed of shape memory material allowing remote actuation thereof to grip the first plurality of chords.

55. The device of claim 50, further comprising an actuating structure coupled with said first chord gripping member and configured to move a portion of said first chord gripping member with respect to another portion of said first chord gripping member to grip the first plurality of chords.

56. The device of claim 50, wherein said support member is ring-shaped.

57. The device of claim 50, wherein said support member is shaped as a ring segment.

58. The device of claim 50 further comprising a replacement heart valve attached to said support member.

59. A device for supporting a heart valve in a patient, the heart valve including an annulus and a plurality of leaflets connected therewith and adapted to open and close to selectively allow and prevent blood flow, the device comprising:

a support structure configured for attachment to the heart valve annulus, and

a post connected to opposite sides of said support structure and configured to extend from one side of the annulus to another side of the annulus, whereby said support structure modifies the shape of said annulus.

60. The device of claim 59, wherein said post is length adjustable to allow variable modification of the shape of said annulus.

61. The device of claim 59 further comprising at least one additional post connected to opposite sides of said support structure and configured to extend from one side of the annulus to another side of the annulus.

62. The device of claim 59, wherein said support structure further comprises discrete support segments connected by said post.

63. The device of claim 59, wherein said post extends substantially in the same plane as the support structure.

64. The device of claim 59, wherein said post extends substantially out of a plane containing said support structure.

65. A device for adjusting the distance between a papillary muscle and an annulus of a heart valve, the device comprising:

a support member configured to be affixed to the annulus of said heart valve,

an elongate flexible member having first and second ends, said first end adapted to be fixed to the papillary muscle,

a connector configured to connect with said elongate flexible member and with said support member in a manner allowing adjustment in the length between said papillary muscle and said support member and fixation of said elongate flexible member at a desired length between the papillary muscle and the support member.

66. The device of claim 65, wherein said support member further comprises a ring member.

67. The device of claim 65, wherein said elongate flexible member further comprises a suture material.

68. The device of claim 65, wherein said connector further comprises a crimp member.

69. The device of claim 65 further comprising at least two of said elongate flexible members and two of said connectors associated with said support member.

70. A device for supporting a heart valve in a patient, the heart valve including an annulus and a plurality of leaflets connected therewith and adapted to open and close to selectively allow and prevent blood flow, the device comprising a support member adapted to be affixed to the annulus and having at least one selectively adjustable portion allowing one section of said support member to be moved with respect to another section and locked in place in order to maintain one or both of the annulus and the leaflets in a desired configuration.

71. The device of claim 70, wherein said support member is ring-shaped.

72. The device of claim 71, wherein the ring-shaped support member normally lies in a single plane and said selectively adjustable portion allows said one section to be angled out of the single plane.

73. The device of claim 71, wherein the ring-shaped support member lies in a single plane and said selectively adjustable portion allows one section to be bent with respect to another section while lying in the single plane.

74. A device for supporting a heart valve in a patient, the heart valve including an annulus and a plurality of leaflets connected therewith and adapted to open and close to selectively allow and prevent blood flow, the device comprising:

support structure configured for attachment on opposite sides of the heart valve annulus, and

a post connected to the support structure and configured to extend from one side of the annulus to another side of the annulus, whereby said support structure fixes the shape of said annulus.

75. The device of claim 74, wherein said post is adjustable in length to allow adjustment in the shape of said annulus.

76. The device of claim 74, further comprising a second post connected to the support structure and configured to extend from one side of the annulus to another side of the annulus.

77. The device of claim 74, wherein each of said posts is adjustable in length to allow adjustment in the shape of said annulus.

80. The device of claim 77, wherein said ring includes at least first and second portions lying in different planes.

78. A device for supporting a heart valve in a patient, said heart valve having an annulus and said device comprising a ring configured for fixation to the annulus and being asymmetric about two perpendicular planes.

79. The device of claim 78, wherein said ring lies in a first plane and first and second halves disposed on either side of a second, central plane lying perpendicular to said first plane, wherein said first half has a narrower width dimension than said second half.

81. A device for supporting a heart valve in a patient, said heart valve having an annulus and said device comprising a ring configured for fixation to the annulus and having at least first and second portions lying in different planes.

82. The device of claim 81, wherein one segment of said ring is angled out of the plane containing another segment of said ring.

83. A method of supporting a heart valve, the heart valve having an annulus generally lying in a plane and a plurality of leaflets connected therewith and adapted to open and close to selectively allow and prevent blood flow, the method comprising:

connecting a support structure to said annulus,

providing a post extending from said support structure, and

connecting the post to one of said valve leaflets to support the leaflet during opening and closing thereof.

84. The method of claim 83, wherein the step of connecting the post to one of the valve leaflets further comprises connecting a flexible tensile member between the post and the leaflet.

85. The method of claim 84, wherein the step of connecting the flexible tensile member between the post and the leaflet further comprises connecting a suture between the post and the leaflet.

86. The method of claim 84, wherein the step of connecting the flexible tensile member between the post and the leaflet further comprises connecting a native chord between the post and the leaflet.

87. The method of claim 83 further comprising:

connecting said post to another leaflet of said heart valve.

88. The method of claim 83 further comprising directly connecting said post to central portions of two adjacent leaflets to affix the central portions of said leaflets together.