Closure devices, related delivery methods, and related methods of use

• US 20040267306A1
• Filed: 04/11/2003
• Published: 12/30/2004
• Est. Priority Date: 04/11/2003
• Status: Abandoned Application

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: Velocimed LLC (Abbott Laboratories)
• Inventors: Russo, Patrick P., Blaeser, David J., Wahr, Dennis W., Grudem, Jerome K. Jr., Olson, Scott A., Hanson, Scott M., Anderson, Edward J., Christianson, Mark R.
• Application Number:
  US10/411,152
• Publication Number:
  US 20040267306A1
• Time in Patent Office: Days
• US Class Current: 606/213
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A device for sealing a patent foramen ovale (PFO) in the heart is provided. The device includes a left atrial anchor adapted to be placed in a left atrium of the heart, a right atrial anchor adapted to be placed in a right atrium of the heart, and an elongate member adapted to extend through the passageway and connect the left and right atrial anchors. The right atrial anchor preferably includes a plurality of arms and a cover attached to the arms. The left atrial anchor preferably also includes a plurality of arms and preferably does not include a cover. Preferably, the elongate member has a first end fixedly connected to the left atrial anchor and a portion, proximal to the first end, passing through the right atrial anchor. Preferably, the elongate member is flexible.

Claims

1. A device for sealing a passageway in a human body, the device comprising:

a first anchor adapted to be placed proximate a first end of the passageway, the first anchor including a plurality of first loop structures, each first loop structure having a first end connected to the first anchor and a second free end;

a second anchor adapted to be placed proximate a second end of the passageway; and

an elongate member adapted to extend through the passageway and connect the first and second anchors, the elongate member having a first end fixedly connected to one of the first and second anchors.

2. The device of claim 1, wherein the passageway is a patent foramen ovale.

3. The device of claim 1, wherein the loop structures of the first anchor form first anchor arms.

4. The device of claim 3, wherein the first anchor arms extend from a central hub of the first anchor.

5. The device of claim 1, wherein the elongate member is flexible.

6. The device of claim 3, wherein the first anchor arms can assume a collapsed state and a deployed state.

7. The device of claim 1, wherein the second anchor includes a plurality of second loop structures.

8. The device of claim 7, wherein the loop structures of the second anchor form second anchor arms.

9. The device of claim 8, wherein the second anchor arms extend from a central hub of the second anchor.

10. The device of claim 9, wherein the second anchor includes a covering that spans the arms.

11. The device of claim 1, further comprising a lock.

12. The device of claim 11, wherein the lock includes a tube that is movable only in a distal direction along the elongate member.

13. The device of claim 1, further comprising means for preventing proximal movement of the second anchor with respect to the elongate member.

14. The device of claim 1, wherein each first loop structure includes a web portion.

15. The device of claim 14, wherein the web portion includes at least one radial strut and at least one cross strut.

16. The device of claim 1, wherein each first loop structure includes an outer loop portion and means for maintaining a connection between the first loop structure and the first anchor in case of fracture of the outer loop portion.

17. The device of claim 16, wherein the means for maintaining a connection includes a web portion.

18. The device of claim 17, wherein the web portion includes at least one radial strut and at least one cross strut.

19. The device of claim 17, wherein the web portion is thinner than the outer loop portion.

20. The device of claim 16, wherein the means for maintaining a connection includes a flexible line.

21. The device of claim 20, wherein the flexible line passes through a hole in the loop structure.

22. The device of claim 21, wherein the flexible line passes through the first end of the elongate member fixedly connected to the first anchor.

23. The device of claim 1, wherein the first anchor is pivotable relative to the elongate member.

24. The device of claim 1, wherein the second anchor is pivotable relative to the elongate member.

25. The device of claim 1, wherein the first end of the elongate member is fixedly connected to the first anchor.

26. The device of claim 7, wherein each second loop structure includes a web portion.

27. The device of claim 26, wherein the web portion includes at least one radial strut and at least one cross strut.

28. The device of claim 7, wherein each second loop structure includes a marker.

29. The device of claim 1, wherein each first loop structure includes a marker.

30. The device of claim 1, wherein at least a portion of each of the plurality of first loop structures is movable independently from the other first loop structures.

31. The device of claim 7, wherein each of the second loop structures has a first end connected to the second anchor and a second free end.

32. The device of claim 7, wherein at least a portion of each of the plurality of second loop structures is movable independently from the other second loop structures.

33. The device of claim 1, wherein each of the first loop structures is a planar loop.

34. The device of claim 7, wherein each of the second loop structures is a planar loop.

35. A device for sealing a passageway in a human body, the device comprising:

a first anchor adapted to be placed proximate a first end of the passageway, the first anchor including a plurality of first loop structures, each first loop structure having a first end connected to the first anchor and a second free end;

a second anchor adapted to be placed proximate a second end of the passageway; and

a flexible elongate member adapted to extend through the passageway and connect the first and second anchors, the elongate member capable of moving through the second anchor to vary a length of the elongate member between the first and second anchors.

36. A device for sealing a passageway in a human body, the device comprising:

a first anchor adapted to be placed proximate a first end of the passageway, the first anchor including a plurality of first loop structures, each first loop structure having a first end connected to the first anchor and a second free end;

a second anchor adapted to be placed proximate a second end of the passageway, the second anchor including a plurality of second loop structures; and

a flexible elongate member adapted to extend through the passageway and connect the first and second anchors, the elongate member capable of moving through the second anchor to vary a length of the elongate member between the first and second anchors.

37. A device for sealing a passageway in a human body, the device comprising:

a first anchor adapted to be placed proximate a first end of the passageway, the first anchor including a plurality of first loop structures, each first loop structure having a first end connected to the first anchor and a second free end;

a second anchor adapted to be placed proximate a second end of the passageway; and

a flexible elongate member adapted to extend through the passageway and connect the first and second anchors, wherein the first anchor pivots relative to the elongate member and the second anchor pivots relative to the elongate member.

38. A device for sealing a passageway in a human body, the device comprising:

a first anchor adapted to be placed proximate a first end of the passageway, the first anchor including a plurality of first loop structures, each first loop structure having a first end connected to the first anchor and a second free end;

a second anchor adapted to be placed proximate a second end of the passageway; and

a flexible elongate member adapted to extend through the passageway and connect the first and second anchors, wherein each of the first and second anchors is collapsible from a deployed state to a collapsed delivery state.

39. A device for sealing a passageway in a human body, the device comprising:

a first anchor adapted to be placed proximate a first end of the passageway, the first anchor including a plurality of first loop structures, each loop structure including an outer loop portion and a member connecting portions of outer loop portion;

a second anchor adapted to be placed proximate a second end of the passageway; and

an elongate member adapted to extend through the passageway and connect the first and second anchors, the elongate member having a first end fixedly connected to the first anchor.

40. The device of claim 39, wherein each loop structure is planar.

41. An assembly for sealing a passageway in a heart, the assembly comprising:

a guide catheter capable of extending to the passageway; and

a closure device capable of sealing the passageway, the closure device including a first anchor adapted to be placed proximate a first end of the passageway, the first anchor including a plurality of first loop structures, each first loop structure having a first end connected to the first anchor and a second free end, a second anchor adapted to be placed proximate a second end of the passageway, and a flexible elongate member adapted to extend through the passageway and connect the first and second anchors,

wherein the closure device is positionable within the guide catheter in a first collapsed state and extendable from the guide catheter in a second deployed state.

42. The assembly of claim 41, further comprising a delivery catheter capable of extending to the passageway, and wherein the delivery catheter is extendable through the guide catheter.

43. The assembly of claim 42, wherein the closure device further comprises a lock for preventing proximal movement of the second anchor.

44. The assembly of claim 43, wherein the lock is engagable by the delivery catheter to move the lock along the elongate member to a position adjacent the second anchor.

45. The assembly of claim 41, wherein the passageway is a patent foramen ovale.

46. The assembly of claim 41, wherein each of the plurality of first loop structures includes an outer loop portion and a web portion.

47. The assembly of claim 46, wherein the web portion includes at least one radial strut and at least one cross strut.

48. The assembly of claim 46, wherein the outer loop portion has a thickness greater than a thickness of the web portion.

49. The assembly of claim 41, wherein the second anchor includes a plurality of second loop portions.

50. The assembly of claim 49, wherein each of the plurality of second loop structures includes an outer loop portion and a web portion.

51. The assembly of claim 50, wherein the web portion includes at least one radial strut and at least one cross strut.

52. The assembly of claim 50, wherein the outer loop portion has a thickness greater than a thickness of the web portion.

53. The assembly of claim 41, wherein each of the plurality of first loop structures includes an outer loop portion and means for maintaining a connection between the outer loop portion and the first anchor during fracture of the outer loop portion.

54. The assembly of claim 53, wherein the means for maintaining a connection includes a web portion.

55. The assembly of claim 53, wherein the means for maintaining a connection includes a flexible line.

56. The assembly of claim 41, further comprising a loading tube.

57. The assembly of claim 56, wherein the closure device is positionable within the loading tube in its first collapsed state.

58. The assembly of claim 41, wherein each of the first loop structures is planar.

59. A method of sealing a passageway in a human body, comprising:

placing a first anchor proximate a first end of the passageway, the first anchor including a plurality of first loop structures;

placing a second anchor proximate a second end of the passageway; and

moving the second anchor relative to the first anchor along a flexible elongate member disposed between the first and second anchors within the passageway.

60. The method of claim 59, wherein placing the first anchor includes expanding the first anchor from a collapsed state to a deployed state.

61. The method of claim 59, wherein placing the second anchor includes expanding the second anchor from a collapsed state to a deployed state.

62. The method of claim 59, wherein the passageway is a patent foramen ovale.

63. The method of claim 59, wherein placing the first anchor includes contacting the septum primum of a heart with the first anchor.

64. The method of claim 59, wherein placing the second anchor includes contacting the septum secundum of a heart with the second anchor.

65. The method of claim 59, wherein moving the second anchor includes moving the second anchor towards the first anchor.

66. The method of claim 59, further comprising engaging the flexible elongate member with a lock to prevent proximal movement of the second anchor.

67. The method of claim 59, further comprising severing the flexible elongate member adjacent the second anchor.

68. The method of claim 59, wherein a first end of the flexible elongate member is connected to the first anchor, and wherein placing the first anchor includes pulling proximally on the flexible elongate member to bring the first anchor into contact with tissue defining the passage.

69. The method of claim 59, wherein the flexible elongate member passes through the second anchor, and wherein placing the second anchor includes pushing the second anchor in a distal direction to move the second anchor with respect to the flexible elongate member until the second anchor covers an end of the passage.

70. The method of claim 69, further comprising retrieving the second anchor for re-positioning.

71. The method of claim 70, wherein retrieving the second anchor includes:

advancing a snare catheter toward the second anchor,

engaging a portion of the second anchor with the snare; and

pulling the second anchor back toward a guide catheter.

72. A method of placing a closure device to seal a passageway in a human body, comprising:

advancing a catheter into a first end of the passageway and out a second end of the passageway;

advancing a first anchor of a closure device out of a distal end of the catheter;

withdrawing the catheter through the passageway;

positioning the first anchor adjacent the second end of the passageway;

advancing a second anchor of the closure device out of the distal end of the catheter;

positioning the second anchor of the closure device adjacent the first end of the passageway; and

advancing a lock to a position adjacent the second anchor.

73. The method of claim 72, further comprising:

positioning the closure device within the catheter.

74. The method of claim 73, wherein positioning the closure device includes advancing the first anchor, the second anchor, and the lock along a tether, wherein the first and second anchors and lock are pre-mounted on the tether.

75. The method of claim 72, wherein advancing the first anchor includes expanding the first anchor from a delivery configuration to a deployed configuration.

76. The method of claim 75, wherein advancing the first anchor further includes advancing a flexible elongate member having a first end connected to the first anchor.

77. The method of claim 76, wherein positioning the first anchor includes pivoting the first anchor with respect to the flexible elongate member.

78. The method of claim 72, wherein the first anchor is connected to a first end of a flexible elongate member, and wherein positioning the first anchor includes pivoting the first anchor about the flexible elongate member.

79. The method of claim 72, wherein advancing the second anchor includes expanding the second anchor from a delivery configuration to a deployed configuration.

80. The method of claim 79, wherein positioning the second anchor includes moving the second anchor along the flexible elongate member toward the first end of the passageway.

81. The method of claim 80, further comprising sealingly covering the first end of the passageway with the second anchor.

82. The method of claim 72, wherein advancing the lock includes moving the lock distally along the flexible elongate member toward the second anchor.

83. The method of claim 82, further comprising severing the flexible elongate member adjacent the lock after advancing the lock to a position adjacent the second anchor.

84. The method of claim 72, further comprising assessing the positioning of the first anchor prior to advancing the second anchor.

85. The method of claim 84, further comprising re-advancing the catheter through the passageway to retrieve the first anchor.

86. The method of claim 72, further comprising assessing the positioning of the second anchor.

87. The method of claim 86, further comprising advancing a device to retrieve the second anchor.

88. The method of claim 87, wherein advancing a device includes advancing a snare catheter.

89. The method of claim 88, further comprising engaging a portion of the second anchor with the snare catheter.

90. A closure device for sealing a passageway in a heart, the device comprising:

a left atrial anchor configured to close a first end of the passageway;

a right atrial anchor configured to close a second end of the passageway, at least one of the left atrial anchor and the right atrial anchor including a plurality of loop structures;

a flexible elongate member connecting the left and right atrial anchors, wherein the elongate member has a first end fixedly connected to the left atrial anchor and wherein the right atrial anchor is movable with respect to the elongate member; and

a lock configured to prevent proximal movement of the right atrial anchor relative to the flexible elongate member.

91. A system for sealing a passage in a heart, the system comprising:

a delivery catheter capable of extending to a position near the passage;

a closure device capable of sealing the passage, the device including a first anchor adapted to be placed proximate a first end of the passage, a second anchor adapted to be placed proximate a second end of the passage, and a flexible elongate member adapted to extend through the passage and connect the first and second anchors; and

a cutting tool capable of extending over the flexible elongate member to a position near the second anchor.

92. The system of claim 91, wherein the cutting tool includes a guide member for guiding the flexible elongate member.

93. The system of claim 92, wherein the guide member includes a distal opening through which the flexible elongate member enters the cutting tool and a lateral opening through which the flexible elongate member exits the cutting tool.

94. The system of claim 92, wherein the cutting tool further includes a cutting element disposed around the guide member.

95. The system of claim 94, wherein the cutting element is movable relative to the guide member to cut the flexible elongate member as it exits the guide member through a lateral opening of the guide member.

96. The system of claim 91, further comprising a guide catheter capable of extending to a position near the passage.

97. The system of claim 91, further comprising a loading tube.

98. The system of claim 97, wherein the closure device is positionable within the loading tube in a collapsed state.

99. The system of claim 91, wherein the second anchor includes a plurality of second loop structures.

100. A device for sealing a passageway in a human body, the device comprising:

a first anchor adapted to be placed proximate a first end of the passageway, the first anchor including a plurality of first loop structures, each loop structure having a first end connected to the first anchor and a second free end;

a second anchor adapted to be placed proximate a second end of the passageway, the second anchor including an element configured to engage a snare; and

a flexible elongate member connecting the first and second anchors.

101. The device of claim 100, wherein second anchor includes a central hub.

102. The device of claim 101, wherein the second anchor further includes a plurality of loop structures extending radially outward from the central hub.

103. The device of claim 101, wherein the snare engaging means includes a ring portion of the central hub.

104. A device for closing a passageway in a heart, the device comprising:

a left atrial anchor adapted to be placed in a left atrium of the heart and including a plurality of uncovered arms;

a right atrial anchor adapted to be placed in a right atrium of the heart and including a plurality of arms, a cover attached to the plurality of arms, and an element configured to engage a snare; and

a flexible elongate member adapted to extend through the passageway and connect the left and right atrial anchors, the elongate member having a first end fixedly connected to the left atrial anchor and a second end releasably connected to the right atrial anchor.

105. A device for closing a passageway in a heart, the device comprising:

a left atrial anchor adapted to be placed in a left atrium of the heart and including a plurality of uncovered arms;

a right atrial anchor adapted to be placed in a right atrium of the heart and including a plurality of arms and a cover attached to the plurality of arms;

a flexible elongate member adapted to extend through the passageway and connect the left and right atrial anchors, the elongate member having a first end fixedly connected to the left atrial anchor; and

a lock for preventing proximal movement of the right atrial anchor relative to the flexible elongate member.

106. A device for closing a passageway in a heart, the device comprising:

a left atrial anchor adapted to be placed in a left atrium of the heart and including a plurality of uncovered arms and at least one member connecting each arm to the left atrial anchor;

a right atrial anchor adapted to be placed in a right atrium of the heart and including a plurality of arms and a cover attached to the plurality of arms; and

a flexible elongate member adapted to extend through the passageway and connect the left and right atrial anchors, the elongate member having a first end fixedly connected to the left atrial anchor and a second end releasably connected to the right atrial anchor.

107. A method for retrieving a device for sealing a passageway in a heart, comprising:

advancing a snare catheter through a guide catheter toward the passageway covered by a second anchor of the device;

engaging a portion of the second anchor with the snare; and

drawing the second anchor into the guide catheter with the snare.

108. A cutting tool for severing a flexible elongate member, comprising:

a cutting tool body having a distal end and a proximal end, the cutting tool body capable of extending through a guide catheter;

a guide member for guiding the flexible elongate member, the guide member including a distal opening through which the flexible elongate member enters the cutting tool and a lateral opening through which the flexible elongate member exits the cutting tool; and

a cutting element surrounding the guide member, wherein the cutting element is movable relative to the guide member to cut the flexible elongate member as it exits the guide member through the lateral opening of the guide member.