Devices and methods for heart valve treatment

• US 20030130731A1
• Filed: 01/09/2002
• Published: 07/10/2003
• Est. Priority Date: 01/09/2002
• Status: Active Grant

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Myocor, Inc. (Edwards Lifesciences Corporation)
• Inventors: Vidlund, Robert M., Mortier, Todd J., Schweich, Cyril J. Jr., Schroeder, Richard, Kalgreen, Jason E., Kusz, David
• Granted Patent: US 6,764,510 B2
• Time in Patent Office: Days
• US Class Current: 623/2.37
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints

Abstract

Devices and methods for treating heart valves include members that assist the valve in closing during at least a portion of the cardiac cycle. Such devices include members configured to alter the shape of a valve annulus, reposition at least one papillary muscle, and/or plug an orifice of the valve so as to provide a coaptation surface for the valve leaflets.

Claims

1. A method for treating a heart valve, comprising:

providing a device having an arcuate portion and at least one elongate portion configured to extend from the arcuate portion;

encircling at least a portion of an annulus of a heart valve with the arcuate portion;

adjusting a size of at least one of the arcuate portion and the elongate portion so as to alter a shape of the portion of the annulus; and

securing the at least one elongate portion to an exterior surface of the heart.

2. The method of claim 1, wherein providing the arcuate portion and the at least one elongate portion includes providing an elongate member and forming a loop in the elongate member such that the elongate portion extends from the loop.

3. The method of claim 2, further comprising adjusting the size of the loop so as to alter the shape of at least the portion of the annulus.

4. The method of claim 3, further comprising an adjusting mechanism configured to slide along the elongate portion, wherein adjusting the size of the loop includes sliding the adjusting mechanism along the elongate portion.

5. The method of claim 3, further comprising extending the elongate portion from the arcuate portion through the heart wall.

6. The method of claim 5, wherein securing the elongate portion includes engaging an anchor assembly with the elongate portion adjacent the exterior surface of the heart wall.

7. The method of claim 6, wherein engaging the anchor assembly includes slidably engaging the anchor assembly with the elongate portion, and wherein the adjusting includes sliding the anchor assembly along the elongate portion to adjust the respective dimensions of the elongate portion and the loop.

8. The method of claim 7, further comprising compressing the exterior surface of the heart wall via the anchor assembly.

9. The method of claim 1, wherein providing the device includes providing a plurality of elongate portions extending from the arcuate portion.

10. The method of claim 2, wherein providing the device includes providing a tubular member disposed on at least a portion of the arcuate portion.

11. The method of claim 10, wherein the heart valve is a mitral valve and encircling at least the portion of the annulus includes positioning the tubular member adjacent a posterior aspect of the annulus.

12. The method of claim 11, wherein the tubular member is made of a substantially rigid material.

13. A method of treating a heart valve, comprising:

providing a device having an arcuate portion and at least one elongate member configured to extend from the arcuate portion;

placing the arcuate portion proximate an annulus of a heart valve;

extending the at least one elongate member from the arcuate portion; and

securing the at least one elongate member to an exterior surface of the heart,

wherein the at least one elongate member extends from the arcuate portion to the heart wall in substantially the same plane as the arcuate portion.

14. The method of claim 13, further comprising connecting the at least one elongate member to the arcuate portion.

15. The method of claim 13, wherein the at least one elongate member includes a tension member.

16. The method of claim 15, further comprising extending the at least one elongate member from the arcuate portion through a heart wall surrounding a heart chamber associated with the valve.

17. The method of claim 16, further comprising adjusting a length of the elongate member between the arcuate portion and the heart wall so as to alter the shape of at least the portion of the annulus.

18. The method of claim 16, wherein securing the at least one elongate member comprises engaging an anchor assembly with the at least one elongate member exterior to the heart.

19. The method of claim 18, further comprising sliding the anchor assembly along a length of the at least one elongate member and adjusting the length of the elongate member between the arcuate portion and the heart wall.

20. The method of claim 13, further comprising a plurality of elongate members extending from the arcuate portion at differing angular positions along the arcuate portion.

21. The method of claim 20, wherein securing the at least one elongate member includes securing each of the plurality of elongate members to an exterior surface of the heart wall at differing angular positions along the heart wall.

22. The method of claim 21, wherein adjusting the size includes adjusting a length of each of the elongate members between the arcuate portion and the heart wall.

23. A device for treating a heart valve, the device comprising:

an arcuate portion configured to at least partly encircle an annulus of the heart valve; and

at least one elongate portion extending from the arcuate portion and configured to be secured to an exterior surface of a heart wall surrounding a heart chamber associated with the valve,

wherein at least one of the arcuate portion and the elongate portion is configured to be adjusted in size so as to alter a shape of at least a portion of the annulus.

24. The device of claim 23, wherein the arcuate portion and the at least one elongate portion are made as a single piece.

25. The device of claim 24, wherein the arcuate portion and the elongate portion are formed by an elongate member having a portion formed into a loop.

26. The device of claim 25, wherein the loop is configured to be adjusted in size.

27. The device of claim 26, further comprising an adjusting mechanism configured to slide along the elongate portion to adjust the respective sizes of the loop and the elongate portion.

28. The device of claim 25, wherein the elongate portion is configured to extend through the heart wall.

29. The device of claim 28, further comprising an anchor assembly configured to engage with the elongate portion at the exterior surface of the heart wall.

30. The device of claim 29, wherein the anchor assembly is slidably engageable with the elongate portion.

31. The device of claim 29, wherein the anchor assembly is configured to compress the external surface of the heart wall.

32. The device of claim 23, further comprising a plurality of elongate portions extending from the arcuate portion.

33. The device of claim 23, further comprising a tubular member disposed on at least a portion of the arcuate portion.

34. The device of claim 33, wherein the heart valve is a mitral valve and the tubular member is configured to be positioned adjacent a posterior aspect of the valve annulus.

35. The device of claim 34, wherein the tubular member is made of a substantially rigid material.

36. A device for treating a heart valve, the device comprising:

an arcuate portion configured to be positioned proximate an annulus of the heart valve; and

at least one elongate member extending from the arcuate portion and configured to be secured to an exterior surface of the heart wall,

wherein the at least one elongate member extends from the arcuate portion to the heart wall in substantially the same plane as the arcuate portion.

37. The device of claim 36, wherein the at least one elongate member is configured to connect to the arcuate portion.

38. The device of claim 36, wherein the at least one elongate member includes a tension member.

39. The device of claim 36, wherein the at least one elongate member is configured to extend from the arcuate portion through the heart wall surrounding the chamber associated with the valve.

40. The device of claim 36, wherein a length of the elongate member between the arcuate portion and the heart wall is configured to be adjusted.

41. The device of claim 36, further comprising an anchor assembly configured to engage the at least one elongate member exterior to the heart to secure the device in place with respect to the heart.

42. The device of claim 41, wherein the anchor assembly is slidable along a length of the at least one elongate member.

43. The device of claim 36, further comprising a plurality of elongate members extending from the arcuate portion at differing angular positions along the arcuate portion.

44. The device of claim 43, wherein each of the elongate members is configured to be secured to an exterior surface of the heart wall at differing angular positions along the heart wall.

45. The device of claim 43, wherein each of the elongate members is configured to have an adjustable length between the arcuate portion and the heart wall.

46. The device of claim 36, wherein the arcuate portion is substantially ring-shaped.

47. A device for treating a heart valve, the device comprising:

at least one substantially elongate member configured to be implanted in a lumen of a coronary vessel so as to encircle at least a portion of an annulus of the heart valve and alter a shape of at least the portion of the annulus; and

a shape change element associated with the elongate member and configured to impart a local shape change to a portion of the valve annulus at a location corresponding to the shape change element.

48. The device of claim 47, wherein the heart valve is a mitral valve and at least a portion of the elongate member is configured to be positioned adjacent a posterior aspect of the valve.

49. The device of claim 47, further comprising at least one anchoring member configured to secure the elongate member in place within the lumen of the coronary vessel.

50. The device of claim 49, further comprising a plurality of anchoring members disposed along a length of the elongate member and configured to engage with a wall of the coronary vessel to secure the elongate member in place.

51. The device of claim 49, further comprising an anchoring member provided at each end of the elongate member.

52. The device of claim 51, wherein the anchoring members provided at each end of the elongate member are configured to engage a heart wall surrounding a heart chamber associated with the valve.

53. The device of claim 47, wherein the elongate member is configured to be friction fit within the lumen of the coronary sinus.

54. The device of claim 47, wherein the elongate member is heat-shrinkable.

55. The device of claim 47, wherein the shape change element includes a retractable wire disposed along a length of the elongate member.

56. The device of claim 55, wherein the wire is configured to form a bulge extending outward from the elongate member.

57. The device of claim 47, wherein the shape change element includes an annular shape change element disposed on the elongate member.

58. The device of claim 56, wherein the shape change element is slidably disposed on the elongate member.

59. A device for treating a heart valve, the device comprising:

at least one substantially elongate member comprising a plurality of rotatable elements, the elongate member being configured to be implanted in a lumen of a coronary vessel so as to encircle at least a portion of an annulus of the heart valve and alter a shape of at least the portion of the valve annulus,

wherein a shape of at least a portion of the elongate member is configured to be adjustable so as to impart a local shape change to a portion of the valve annulus at a location corresponding to at least the adjustable portion.

60. The device of claim 59, wherein the rotatable elements are configured to rotate about a longitudinal axis of the elongate member.

61. The device of claim 59, wherein the rotatable elements are independently rotatable.

62. The device of claim 59, wherein the rotatable elements are configured such that rotation of the rotatable elements alters the shape of at least the portion of the elongate member.

63. A method for treating a heart valve, comprising:

providing at least one substantially elongate member;

extending at least a portion of the elongate member within a heart wall surrounding a chamber of the heart associated with the heart valve so as to encircle at least a portion of the heart chamber;

securing the elongate member in place with respect to the heart; and

compressing at least a portion of a heart wall surrounding at least the portion of the heart chamber so as to move leaflets of the valve toward each other so as to assist the valve in closing during at least a portion of the cardiac cycle.

64. The method of claim 63, wherein the compressing includes compressing a portion of the heart wall proximate an annulus of the valve.

65. The method of claim 63, wherein the compressing includes compressing a portion of the heart wall proximate at least one papillary muscle associated with the valve.

66. The method of claim 63, further comprising engaging a pad with the at least one elongate member and compressing a portion of the heart wall proximate a location of the pad.

67. The method of claim 63, wherein moving the leaflets of the valve includes changing a shape of at least a portion of the valve annulus.

68. The method of claim 63, wherein moving the leaflets of the valve includes repositioning at least one papillary muscle to which at least one leaflet connects.

69. The method of claim 63, wherein the elongate member is made of a biocompatible material.

70. The method of claim 63, wherein providing the at least one elongate member includes providing at least one curved elongate member.

71. A method for treating a heart valve, comprising:

providing at least one substantially elongate member;

extending at least a portion of the elongate member within a lumen of a coronary sinus so as to encircle at least a portion of a heart chamber;

securing the elongate member in place with respect to the heart via at least one securement mechanism; and

compressing at least a portion of a heart wall surrounding at least the portion of the heart chamber so as to move leaflets of the valve toward each other so as to assist the valve in closing during at least a portion of the cardiac cycle.

72. The method of claim 71, further comprising delivering the elongate member endovascularly to the coronary sinus lumen.

73. The method of claim 71, wherein extending at least the portion of the elongate member includes extending at least the portion of the elongate member within the coronary sinus lumen adjacent a posterior aspect of a mitral valve.

74. The method of claim 71, wherein the valve is a mitral valve.

75. A device for treating a heart valve, the device comprising:

an elongate member having first and second oppositely disposed ends, the elongate member being relatively rigid;

a first anchoring member configured to be attached to the first end of the elongate member;

a second anchoring member configured to be attached to the second end of the elongate member,

wherein the first anchoring member is configured to engage a first exterior surface of a wall of the heart and the second anchoring member is configured to engage a second exterior surface of the wall of the heart to maintain a position of the elongate member transverse a heart chamber associated with the valve and substantially along a line of coaptation of the valve, and

wherein a length of the elongate member is such that the elongate member is capable of maintaining a substantially normal distance between trigones of the valve.

76. The device of claim 75, wherein the length of the elongate member is adjustable.

77. The device of claim 75, wherein the elongate member is a telescoping member.

78. The device of claim 75, wherein the elongate member is a bar.

79. The device of claim 75, wherein the elongate member is made of a material chosen from biocompatible metals and biocompatible polymers.

80. The device of claim 75, wherein the elongate member includes a first elongate member and the device further comprises a second elongate member having a first end portion configured to be connected to the first elongate member and a second opposite free end portion.

81. The device of claim 80, wherein the second elongate member is configured to extend substantially perpendicular to the first elongate member and is configured to be secured to a third exterior surface of the heart wall surrounding the chamber associate with the valve.

82. The device of claim 81, further comprising a third anchoring member configured to be attached to the free end portion of the second elongate member.

83. The device of claim 81, wherein the third anchoring member is configured to secure the second elongate member to the third exterior surface of the heart wall to thereby alter a shape of an annulus of the valve.

84. The device of claim 80, wherein the second elongate member is a tension member.

85. The device of claim 80, wherein the second elongate member is relatively flexible.

86. A method for treating a heart valve, the method comprising:

providing a relatively rigid elongate member having first and second oppositely disposed ends;

securing the first end of the elongate member to a first exterior heart wall surface; and

securing the second end of the elongate member to a second exterior heart wall surface, the second exterior surface being located substantially opposite to the first exterior surface such that the elongate member extends substantially transverse a heart chamber associated with the valve and substantially along a line of coaptation of the valve; and

maintaining a substantially normal distance between the trigones of the valve via the elongate member.

87. The method of claim 86, further comprising adjusting a length of the elongate member.

88. The method of claim 87, wherein adjusting the length of the elongate member includes telescoping the elongate member.

89. The method of claim 87, wherein the elongate member is a bar.

90. The method of claim 86, wherein the elongate member is made of a material chosen from biocompatible metals and biocompatible polymers.

91. The method of claim 86, wherein the elongate member is a first elongate member and the method further comprises providing a second elongate member and connecting a first end of the second elongate member to the first elongate member.

92. The method of claim 91, further comprising extending the second elongate member substantially perpendicular to the first elongate member and securing a second end of the second elongate member to a third exterior heart wall surface.

93. The method of claim 92, wherein securing the second end of the second elongate member to the third exterior heart wall surface includes altering a shape of an annulus of the valve.

94. The method of claim 91, wherein the second elongate member is a tension member.

95. The method of claim 91, wherein the second elongate member is relatively flexible.

96. The method of claim 86, further comprising providing a first anchoring member and a second anchoring member, and securing the first end of the elongate member to the first exterior surface via the first anchoring member and securing the second end of the elongate member to the second exterior surface via the second anchoring member

97. A device for treating leakage of a heart valve, the device comprising:

an expandable plug member having an external surface, at least a portion of the plug member being configured to be positioned proximate leaflets of the heart valve; and

a securement mechanism attached to the plug member and configured to secure the plug member with respect to the heart,

wherein during at least a portion of the cardiac cycle, the leaflets abut the external surface of the plug member to restrict bloodflow through the valve.

98. The device of claim 97, wherein the plug member is inflatable.

99. The device of claim 97, wherein the plug member is foldable.

100. The device of claim 97, wherein the securement mechanism includes at least one elongate member configured to suspend the plug member between the valve leaflets.

101. The device of claim 100 wherein the securement mechanism further comprises at least one anchoring member configured to secure the elongate member to a heart wall surrounding a chamber containing the valve.

102. The device of claim 101, wherein the elongate member is in the form of a tether.

103. The device of claim 97, wherein at least a portion of the plug member is configured to be positioned between the valve leaflets.

104. The device of claim 97, wherein at least a portion of the plug member is configured to be positioned below free ends of the valve leaflets.

105. The device of claim 97, wherein at least a portion of the plug member is configured to be positioned approximately at a level of an annulus of the valve.

106. The device of claim 97, wherein the plug member is configured to expand and collapse in response to pressure changes in the heart.

107. The device of claim 106, wherein the plug member is configured to collapse during systole.

108. The device of claim 106, wherein the plug member is configured to expand during diastole.

109. The device of claim 97, wherein the plug member defines at least one passage configured to permit bloodflow therethrough.

110. A device for treating leakage of a heart valve, the device comprising:

a plug member having a piston-like configuration and an external surface being configured to abut free ends of leaflets of the valve to restrict bloodflow through the valve during at least the portion of the cardiac cycle; and

a securement mechanism attached to the plug member and configured to secure the plug member with respect to the heart.

111. A method of preventing leakage in a heart valve comprising:

providing an expandable plug member having an external surface;

delivering the plug member to a heart chamber containing a valve; and

positioning the plug member proximate leaflets of the valve such that the leaflets contact the external surface of the plug member during at least a portion of the cardiac cycle so as to restrict bloodflow through the valve.

112. The method of claim 111, further comprising inflating the plug member during at least a portion of the cardiac cycle.

113. The method of claim 111, further comprising expanding the plug member during at least a portion of the cardiac cycle.

114. The method of claim 111, further comprising unfolding the plug member upon delivery of the plug member to the heart chamber.

115. The method of claim 111, wherein positioning the plug member includes suspending the plug member via at least one elongate member.

116. The method of claim 115, further comprising securing the elongate member to a heart wall surrounding the heart chamber.

117. The method of claim 116, wherein securing the elongate member includes securing the elongate member via an anchoring member configured to engage the heart wall.

118. The method of claim 115, wherein the elongate member is in the form of a tether.

119. The method of claim 111, wherein positioning the plug member includes positioning at least a portion of the plug member between the valve leaflets.

120. The method of claim 111, wherein positioning the plug member includes positioning at least a portion of the plug member below free ends of the valve leaflets.

121. The method of claim 111, further comprising, in response to pressure changes in the heart, respectively expanding and collapsing the plug member.

122. The method of claim 121, further comprising collapsing the plug member during systole.

123. The method of claim 121, further comprising expanding the plug member during diastole.

124. The method of claim 111, further comprising flowing blood through at least one passage defined in the plug member during at least another portion of the cardiac cycle.