Tissue anchor, anchoring system and methods of using the same

• US 20070010857A1
• Filed: 07/05/2005
• Published: 01/11/2007
• Est. Priority Date: 07/05/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Mitralign, Inc. (Edwards Lifesciences Corporation)
• Inventors: Sugimoto, Hiroatsu, Call, Aaron, Leinsing, Karl
• Granted Patent: US 8,951,285 B2
• Time in Patent Office: Days
• US Class Current: 606/232
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0448 Additional elements on or within the anchor
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0459 Multiple holes in the anchor through which the suture extends and locking the suture when tension is applied
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0496 for tensioning sutures

Abstract

A tissue anchor includes an anchor member formed from a generally flexible material. An activation member, which may be a tensioning member, causes proximal and distal end portions of the anchor member to move toward each other into a shortened configuration suitable for anchoring against the tissue. The tissue anchor can optionally be deployed and activated using a catheter device.

Claims

1. A tissue anchor comprising:

a generally flexible anchor member capable of being inserted through tissue and moving between an elongate configuration and a shortened configuration suitable for anchoring against at least one side of the tissue, said anchor member having a proximal end portion, a distal end portion, and a compressible intermediate portion between said proximal end portion and said distal end portion, and

a tensioning member operatively connected to said anchor member such that said anchor member can slide relative to said tensioning member, said tensioning member capable of being pulled to cause said anchor member to move relative to said tensioning member from said elongate configuration to said shortened configuration wherein the compressible intermediate portion can compress and thereby adjust to the thickness of the tissue between the proximal and distal end portions.

2. The tissue anchor of claim 1, wherein said generally flexible anchor member is formed from a material selected from at least one of:

natural fibers, synthetic fibers, polymers, and metals.

3. The tissue anchor of claim 2, wherein said tensioning member further comprises a suture.

4. The tissue anchor of claim 1, wherein said tensioning member further comprises a suture.

5. The tissue anchor of claim 1, wherein said tensioning member includes a stop member engageable with said anchor member.

6. The tissue anchor of claim 5, wherein said stop member further comprises a knot in said tensioning member.

7. The tissue anchor of claim 1, wherein said tensioning member extends through said anchor member at multiple locations between the proximal end portion and the distal end portion.

8. The tissue anchor of claim 1, wherein said anchor member and said tensioning member are configured such that said anchor member forms at least one fold upon pulling said first end of said tensioning member.

9. The tissue anchor of claim 1, further comprising a lock member engageable with said tensioning member to retain said anchor member in the shortened configuration.

10. The tissue anchor of claim 1, further comprising at least one radiopaque marker on at least one of said anchor member and said tensioning member.

11. The tissue anchor of claim 10, further comprising a first radiopaque marker located proximate said proximal end portion when said anchor member is in the shortened configuration and a second radiopaque marker located proximate said distal end portion when said anchor member is in the shortened configuration.

12. The tissue anchor of claim 1, wherein said distal end portion includes a relatively rigid tip, said tip being of reduced width relative to an adjacent portion of said anchor member.

13. The tissue anchor of claim 12, wherein said tip acts as a compressive force applying member against the distal end portion of the anchor member when the anchor member is in the shortened configuration.

14. The tissue anchor of claim 1, wherein said anchor member varies in width along its length when in the elongate configuration.

15. The tissue anchor of claim 1, wherein said anchor member includes an edge portion that is more rigid than a central area of said anchor member.

56. The tissue anchor of claim 1, further comprising:

a force applying member configured to bear against the distal end portion of the anchor member when the anchor member is in the shortened configuration.

16. A tissue anchor comprising:

a flat, generally flexible anchor member capable of movement between an elongate configuration suitable for deployment and a shortened configuration suitable for anchoring against tissue, and

a tensioning member operatively connected to said anchor member such that said anchor member can slide relative to said tensioning member, said tensioning member capable of being pulled to cause said anchor member to move relative to said tensioning member from said elongate configuration to said shortened configuration.

57. The tissue anchor of claim 16, further comprising:

a force applying member configured to bear against the anchor member when the anchor member is in the shortened configuration.

17. A tissue anchor comprising:

a flat anchor member formed from a strip of fabric material and capable of movement between an elongate configuration suitable for deployment and a shortened configuration suitable for anchoring against tissue,

a tensioning member operatively connected to said anchor member such that said anchor member can slide relative to said tensioning member, said tensioning member capable of being pulled to cause said anchor member to move relative to said tensioning member from said elongate configuration to said shortened configuration, and

a lock member capable of securing the anchor member in the shortened configuration.

18. A tissue anchor comprising:

a flat, generally flexible anchor member capable of being inserted through tissue and moving between an elongate configuration suitable for deployment through a catheter and a shortened configuration suitable for anchoring against the tissue, and

a tensioning member operatively connected to said anchor member such that said anchor member can slide relative to said tensioning member, said tensioning member capable of being pulled to cause said anchor member to move relative to said tensioning member from said elongate configuration to said shortened configuration against the tissue.

58. The tissue anchor of claim 18, further comprising:

a force applying member configured to bear against the anchor member when the anchor member is in the shortened configuration.

19. A tissue anchor comprising:

a flat elongate strip formed from a generally flexible material and having proximal and distal end portions,

a tensioning member having first and second ends, said tensioning member operatively connected to said elongate strip such that pulling on said first end of said tensioning member causes said proximal and distal end portions of said elongate strip to move toward each other into a shortened configuration suitable for anchoring against the tissue.

59. The tissue anchor of claim 19, further comprising:

a force applying member configured to bear against the distal end portion of the anchor member when the anchor member is in the shortened configuration.

20. A tissue anchor comprising:

a generally flexible flat anchor strip capable of being inserted through tissue in an elongate configuration and movable to a shortened, folded configuration suitable for anchoring against at least one side of the tissue,

an activation member operatively connected to said anchor strip and operable to move the anchor strip from the elongate configuration to the shortened, folded configuration.

21. The tissue anchor of claim 20, wherein the shortened, folded configuration further comprises a zig-zag fold pattern.

60. The tissue anchor of claim 20, further comprising:

a force applying member configured to bear against the anchor strip when the anchor strip is in the shortened, folded configuration.

22. A tissue anchoring system, comprising:

a delivery catheter,

a generally flexible anchor member capable of being inserted through tissue and moving between an elongate configuration and a shortened configuration suitable for anchoring against at least one side of the tissue, said anchor member having a proximal end portion, a distal end portion, and a compressible intermediate portion between said proximal end portion and said distal end portion, and

a deploying device operatively associated with said delivery catheter and operable to extend the anchor member from said delivery catheter, and

a tensioning member operatively connected to said anchor member such that said anchor member can slide relative to said tensioning member, said tensioning member capable of being pulled to cause said anchor member to move relative to said tensioning member from said elongate configuration to said shortened configuration wherein the compressible intermediate portion can compress and thereby adjust to the thickness of the layer of tissue between the proximal and distal end portions.

23. The system of claim 22, wherein said deploying device further comprises a deploying catheter at least partially containing said anchor member and at least partially contained within said delivery catheter.

24. The system of claim 22, wherein said anchor member is formed from a material selected from at least one of:

natural fibers, synthetic fibers, polymers, and metals.

25. The system of claim 24, wherein said tensioning member further comprises a suture.

26. The system of claim 22, wherein said tensioning member further comprises a suture.

27. The system of claim 22, wherein said tensioning member includes a stop member engageable with said anchor member.

28. The system of claim 27, wherein said stop member further comprises a knot in said tensioning member.

29. The system of claim 22, wherein said tensioning member extends through said anchor member at multiple locations between the proximal end portion and the distal end portion.

30. The system of claim 22, wherein said anchor member and said tensioning member are configured such that said anchor member forms at least one fold upon pulling said first end of said tensioning member.

31. The system of claim 22, further comprising a lock member engageable with said tensioning member to retain said anchor member in the shortened configuration.

32. The system of claim 22, further comprising at least one radiopaque marker on at least one of said anchor member and said tensioning member.

33. The system of claim 32, further comprising a first radiopaque marker located proximate said proximal end portion when said anchor member is in the shortened configuration and a second radiopaque marker located proximate said distal end portion when said anchor member is in the shortened configuration.

34. The system of claim 22, wherein said distal end portion includes a relatively rigid tip, said tip being of reduced width relative to an adjacent portion of said anchor member.

35. The system of claim 34, wherein said tip acts as a compressive force applying member against the distal end portion of the anchor member when the anchor member is in the shortened configuration.

36. The system of claim 22, wherein said anchor member varies in width along its length when in the elongate configuration.

37. The system of claim 22, wherein said anchor member includes an edge portion that is more rigid than a central area of said anchor member.

61. The tissue anchoring system of claim 22, further comprising:

a force applying member configured to bear against the distal end portion of the anchor member when the anchor member is in the shortened configuration.

38. A method of anchoring tissue with a first generally flexible elongate anchor member having a proximal end portion, a distal end portion, and a compressible intermediate portion located between the proximal and distal end portions and movable between an elongated configuration and a shortened configuration, the method comprising:

inserting the first generally flexible elongate anchor member through the tissue, and

pulling a first end of a tensioning member coupled for sliding movement relative to the first anchor member to draw the proximal and distal end portions toward each other and to compress the intermediate portion into the shortened configuration with at least one of the proximal and distal end portions engaged against the tissue.

39. The method of claim 38, wherein the tissue comprises a single layer of tissue.

40. The method of claim 38, wherein the tissue comprises at least two discrete tissue portions and the method further comprises connecting the two tissue portions together between the proximal and distal end portions of the first anchor member.

41. The method of claim 38, further comprising:

engaging the first anchor member against only one side of the tissue.

42. The method of claim 38, further comprising:

engaging the first anchor against opposite sides of the tissue.

43. The method of claim 38, further comprising:

inserting a second generally flexible elongate anchor member through the tissue at a location spaced from the first anchor member,

engaging the second anchor member against the tissue,

drawing the first and second members toward each other to plicate the tissue between the first and second anchor members, and

locking the first and second anchor members in position relative to each other with the tissue plicated therebetween.

44. The method of claim 43, wherein the tissue comprises annulus tissue of the mitral valve and drawing the first and second anchor members toward each other plicates annulus tissue between the first and second anchor members.

45. The method of claim 38, wherein pulling the first end of the tensioning member forms at least one fold in the first anchor member.

46. The method of claim 38, wherein pulling the first end of the tensioning member forms multiple folds along the anchor member.

62. The method of claim 38, wherein a force applying member is coupled with the tensioning member, and the method further comprises:

engaging the force applying member against the distal end portion of the first anchor member in the shortened configuration to transfer force to the tissue.

47. A method of tissue anchoring comprising:

inserting a first generally flexible flat elongate strip having proximal and distal end portions through the tissue, and

pulling a first end of a tensioning member operatively connected to the first strip to draw the proximal and distal end portions of the first strip toward each other into a shortened configuration engaged against the tissue.

48. The method of claim 47, wherein the tissue comprises a single layer of tissue.

49. The method of claim 47, wherein the tissue comprises at least two discrete tissue portions and the method further comprises connecting the two tissue portions together between the first and second ends of the first strip.

50. The method of claim 47, further comprising:

engaging the first strip against only one side of the tissue.

51. The method of claim 47, further comprising:

engaging the first strip against opposite sides of the tissue.

52. The method of claim 47, further comprising:

inserting a second generally flexible flat elongate strip having first and second ends through the tissue at a location spaced from the first strip,

pulling a first end of a second tensioning member operatively connected to the second strip to draw the first and second ends of the second strip toward each other into a shortened configuration engaged against the tissue,

tensioning the first and second tensioning members to draw the first and second strips toward each other to plicate the tissue between the first and second strips, and

locking the first and second tensioning members to each other.

53. The method of claim 52, wherein the tissue comprises annulus tissue of the mitral valve and drawing the first and second strips toward each other plicates annulus tissue between the first and second strips.

54. The method of claim 47, further comprising:

inserting a second generally flexible flat elongate strip having first and second ends through the tissue at a location spaced from the first strip,

drawing the first and second ends of the second strip toward each other into a shortened configuration engaged against the tissue,

drawing the first and second strips toward each other to plicate the tissue between the first and second strips, and

locking the first and second strips in position relative to each other.

63. The method of claim 47, wherein a force applying member is coupled with the tensioning member, and the method further comprises:

engaging the force applying member against the distal end portion of the first strip in the shortened configuration to transfer force to the tissue.

55. A method of tissue anchoring comprising:

inserting a first generally flexible flat elongate strip through the tissue, and

pulling a first end of a tensioning member operatively connected to the first strip to configure at least a portion of the strip into a shortened configuration engaged against the tissue.

64. The method of claim 55, wherein a force applying member is coupled with the tensioning member, and the method further comprises:

engaging the force applying member against the first strip in the shortened configuration to transfer force to the tissue.

65. A method of securing tissue between respective first and second body lumens using a first generally flexible elongate anchor member having a proximal end portion, a distal end portion, and a compressible intermediate portion located between the proximal and distal end portions and movable between an elongated configuration and a shortened configuration, the method comprising:

inserting the first generally flexible elongate anchor member from the first body lumen to the second body lumen through the tissue, and

pulling a first end of a tensioning member coupled for sliding movement relative to the first anchor member to draw the proximal and distal end portions toward each other and to compress the intermediate portion into the shortened configuration with at least one of the proximal and distal end portions engaged against the tissue.

66. The method of claim 65, wherein the tissue comprises a single layer of tissue.

67. The method of claim 65, wherein the tissue comprises at least two discrete tissue portions and the method further comprises connecting the two tissue portions together between the proximal and distal end portions of the first anchor member.

68. The method of claim 65, further comprising:

engaging the first anchor member against only one side of the tissue.

69. The method of claim 65, further comprising:

engaging the first anchor against opposite sides of the tissue.

70. The method of claim 65, further comprising:

inserting a second generally flexible elongate anchor member through the tissue at a location spaced from the first anchor member,

engaging the second anchor member against the tissue,

drawing the first and second members toward each other to plicate the tissue between the first and second anchor members, and

locking the first and second anchor members in position relative to each other with the tissue plicated therebetween.

71. The method of claim 65, wherein the tissue comprises tissue connected with a vascular valve.

72. The method of claim 71, wherein the vascular valve further comprises a mitral valve.

73. The method of claim 65, wherein pulling the first end of the tensioning member forms at least one fold in the first anchor member.

74. The method of claim 65, wherein pulling the first end of the tensioning member forms multiple folds along the anchor member.

75. The method of claim 65, wherein a force applying member is coupled with the tensioning member and the method further comprises:

engaging the force applying member against the anchor member to transfer force to the tissue.

76. A method of tissue anchoring between respective first and second body lumens, the method comprising:

inserting a first generally flexible flat elongate strip having proximal and distal end portions through the tissue from the first body lumen to the second body lumen, and

pulling a first end of a tensioning member operatively connected to the first strip to draw the proximal and distal end portions of the first strip toward each other into a shortened configuration engaged against the tissue.

77. The method of claim 76, wherein the tissue comprises a single layer of tissue.

78. The method of claim 76, wherein the tissue comprises at least two discrete tissue portions and the method further comprises connecting the two tissue portions together between the first and second ends of the first strip.

79. The method of claim 76, further comprising:

engaging the first strip against only one side of the tissue.

80. The method of claim 76, further comprising:

engaging the first strip against opposite sides of the tissue.

81. The method of claim 76, further comprising:

inserting a second generally flexible flat elongate strip having first and second ends through the tissue at a location spaced from the first strip,

pulling a first end of a second tensioning member operatively connected to the second strip to draw the first and second ends of the second strip toward each other into a shortened configuration engaged against the tissue,

tensioning the first and second tensioning members to draw the first and second strips toward each other to plicate the tissue between the first and second strips, and

locking the first and second tensioning members to each other.

82. The method of claim 76, wherein the tissue comprises tissue connected with a vascular valve.

83. The method of claim 76, further comprising:

inserting a second generally flexible flat elongate strip having first and second ends through the tissue at a location spaced from the first strip,

drawing the first and second ends of the second strip toward each other into a shortened configuration engaged against the tissue,

drawing the first and second strips toward each other to plicate the tissue between the first and second strips, and

locking the first and second strips in position relative to each other.

84. The method of claim 76, wherein a force applying member is coupled with the tensioning member and the method further comprises:

engaging the force applying member against the anchor member to transfer force to the tissue.

85. A method of anchoring tissue between respective first and second body lumens, the method comprising:

inserting a first generally flexible flat elongate strip having proximal and distal end portions through the tissue from the first body lumen to the second body lumen, and

pulling a first end of a tensioning member operatively connected to the first strip to configure at least a portion of the strip into a shortened configuration engaged against the tissue.

86. The method of claim 85, wherein a force applying member is coupled with the tensioning member and the method further comprises:

engaging the force applying member against the anchor member to transfer force to the tissue.

87. A method of securing tissue using first and second generally flexible elongate anchor members, each of the first and second anchor members having a proximal end portion, a distal end portion, and a compressible intermediate portion located between the proximal and distal end portions and movable between an elongated configuration and a shortened configuration, the method comprising:

inserting the first generally flexible elongate anchor member through the tissue,

inserting the second generally flexible elongate anchor member through the tissue,

drawing the proximal and distal end portions of the respective first and second anchor members toward each other to compress the intermediate portions into their shortened configurations to engage the first and second anchor members against the tissue, and

coupling the first and second anchor members together.

88. The method of claim 87, further comprising:

moving the first and second anchor members towards each other using at least a first tensioning member.

89. The method of claim 88, wherein moving the first and second anchor members towards each other further comprises plicating the tissue between the first and second anchor members.

90. The method of claim 87, wherein the tissue comprises a single layer of tissue.

91. The method of claim 87, further comprising:

engaging the first and second anchor members against only one side of the tissue.

92. The method of claim 87, further comprising:

engaging the first and second anchor members against opposite sides of the tissue.

93. The method of claim 87, wherein the tissue comprises tissue connected with a vascular valve.

94. The method of claim 93, wherein the vascular valve further comprises a mitral valve.

95. The method of claim 87, further comprising:

forming at least one fold in each of the first and second anchor members.

96. The method of claim 87, further comprising:

forming multiple folds along each of the first and second anchor members.

97. The method of claim 87, wherein coupling the first and second anchor members together further comprises:

locking together first and second tensioning members coupled to the first and second anchor members.

98. The method of claim 87, wherein a force applying member is coupled with the tensioning member and the method further comprises:

engaging the force applying member against the anchor member to transfer force to the tissue.

99. A tissue anchoring system, comprising:

a first generally flexible anchor member capable of being inserted through tissue and moving between an elongate configuration and a shortened configuration suitable for anchoring against at least one side of the tissue, said anchor member having a proximal end portion, a distal end portion, and a compressible intermediate portion between said proximal end portion and said distal end portion,

a second generally flexible anchor member capable of being inserted through the tissue and moving between an elongate configuration and a shortened configuration suitable for anchoring against at least one side of the tissue, said second anchor member having a proximal end portion, a distal end portion, and a compressible intermediate portion between said proximal end portion and said distal end portion, and

a coupling structure operatively connecting said first and second anchor members.

100. The system of claim 99, wherein said coupling structure further comprises at least one tensioning member operatively connected to said first and second anchor members, said tensioning member capable of being pulled to cause at least one of said first and second anchor members to move relative to said tensioning member from said elongate configuration to said shortened configuration wherein the compressible intermediate portion can compress and thereby adjust to the thickness of the layer of tissue between the proximal and distal end portions.

101. The system of claim 100, wherein said tensioning member further comprises a suture.

102. The system of claim 100, further comprising a lock member engageable with said at least one tensioning member to retain said first and second anchor members in their respective shortened configurations.

103. The system of claim 99, further comprising:

a delivery catheter, and

a deploying device operatively associated with said delivery catheter and operable to extend at least one of the first and second anchor members from said delivery catheter.

104. The system of claim 103, wherein said deploying device further comprises a deploying catheter at least partially containing said anchor member and at least partially contained within said delivery catheter.

105. The system of claim 99, wherein said anchor member is formed from a material selected from at least one of:

natural fibers, synthetic fibers, polymers, and metals.

106. The system of claim 99, further comprising a stop member engageable with said anchor member.

107. The system of claim 99, wherein said first and second anchor members are configured such that said first and second anchor member each can form at least one fold in said compressible intermediate portion.

108. The system of claim 99, further comprising at least one radiopaque marker on at least one of said first anchor member, said second anchor member, or said coupling structure.

109. The system of claim 99, wherein said distal end portions of said first and second anchor members each includes a relatively rigid tip, said tips being of reduced widths relative to adjacent portions of said first and second anchor members.

110. The system of claim 109, wherein said tips act as compressive force applying members against the distal end portions of the respective first and second anchor members when the first and second anchor members are in their shortened configurations.

111. The tissue anchoring system of claim 99 further comprising:

a first force applying member configured to bear against the distal end portion of the first anchor member when the first anchor member is in the shortened configuration, and

a second force applying member configured to bear against the distal end portion of the second anchor member when the second anchor member is in the shortened configuration.