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

• US 7,717,937 B2
• Filed: 08/08/2005
• Issued: 05/18/2010
• Est. Priority Date: 06/01/2001
• Status: Expired due to Fees

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Ressemann, Thomas V., Blaeser, David J., Keith, Peter T., Wahr, Dennis W.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US11/198,325
• Publication Number:
  US 20060036282A1
• Time in Patent Office: 1,744 Days
• Field of Search: 606/151, 606/153, 606/157, 606/139, 606213-217, 606/232
• 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 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2017/00597 Implements comprising a membrane
• 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 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00351 Heart

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 also includes a plurality of arms and preferably does not include a cover. Preferably, the elongate member has a first end of fixedly connected to the left atrial anchor and a portion, proximal to the first end, releasably connected to the right atrial anchor. Preferably, the elongate member is flexible.

Claims

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

a first anchor adapted to be placed proximate a first end of the passageway, the first anchor including a plurality of arms radiating from a first central hub;

a second anchor adapted to be placed proximate a second end of the passageway, the second anchor including a plurality of arms radiating from a second central hub;

an elongate member adapted to extend through the passageway and connect the first and second anchors, the elongate member being configured to permanently connect the first and second anchors implanted in the body; and

an actuatable securing element positioned on and movable relative to the elongate member to permanently secure the location of the second anchor on the elongate member, wherein the securing element is actuatable when the second anchor is in any desired position along the elongate member, such that movement of the second anchor in at least one direction along the elongate member from the desired position is prevented when the securing element is actuated.

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

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

4. The device of claim 1, wherein the plurality of arms of the first anchor can assume a collapsed state and a deployed state.

5. The device of claim 1, wherein the plurality of arms of the second anchor can assume a collapsed state and a deployed state.

6. The device of claim 1, wherein the first anchor pivots relative to the elongate member.

7. The device of claim 1, wherein the second anchor pivots relative to the elongate member.

8. The device of claim 1, wherein the elongate member is capable of moving through the second anchor to vary a length of the elongate member between the first and second anchors.

9. The device of claim 1, wherein the second anchor is movable with respect to the elongate member.

10. The device of claim 1, wherein the elongate member includes an operative portion configured to receive the securing element to secure the position of the second anchor relative to the elongate member, and wherein the securing element may be positioned at any point along a length of the operative portion of the elongate member.

11. The device of claim 1, wherein the elongate member is configured to move through the second anchor to vary a tension of the elongate member.

12. The device of claim 1, wherein the securing element is movable in only one direction along the elongate member.

13. The device of claim 1, wherein the second anchor includes a cover spanning between its plurality of arms.

14. The device of claim 13, wherein the first anchor does not include structure spanning between its plurality of arms.

15. The device of claim 1, wherein the elongate member has sufficient flexibility to conform to a shape of the passageway.

16. The device of claim 1, wherein the plurality of arms of the first anchor are made of a first material and the elongate member is made of a second material different from the first material.

17. The device of claim 16, wherein the plurality of arms of the second anchor are made from the first material.

18. The device of claim 1, wherein the elongate member is a braided structure.

19. The device of claim 1, wherein the elongate member is a multifilar structure.

58. The device of claim 1, wherein the securing element prevents movement of the second anchor in any direction along the elongate member from the desired position when the securing element is actuated.

59. The device of claim 1, wherein the securing element is releasable to allow movement of the second anchor in any direction along the elongate member.

60. The device of claim 59, wherein the securing element is adapted to be actuated and released by the inflation and deflation of a balloon.

61. The device of claim 1, wherein the securing element includes a contacting element configured to securely engage the elongate member, and the securing element, when actuated, securely engages the elongate member with the contacting element.

62. The device of claim 61, wherein the contacting element includes at least one piercing pin, and the securing element, when actuated, pierces the elongate member with the piercing pin.

63. The device of claim 61, wherein the contacting element includes at least one grip, and the securing element, when actuated, grips the elongate member with the at least one grip.

64. The device of claim 61, wherein the contacting element is biased towards a position securely engaging the elongate member, and the securing element, when actuated, releases the contacting element so that the contacting element moves into the position securely engaging the elongate member.

65. The device of claim 61, wherein the contacting element is configured to directly engage a portion of the second anchor after moving along the elongate member.

66. The device of claim 65, wherein the contacting element is configured to securely engage the elongate member in response to direct engagement between the contacting element and the portion of the second anchor.

67. The device of claim 65, wherein the contacting element includes at least one grip, and the contacting element is configured to securely engage the elongate member by biting into the elongate member with the at least one grip.

20. A device for sealing a passageway in a human heart, the device comprising:

a first anchor adapted to be placed proximate a first end of the passageway, the first anchor including a plurality of arms radiating from a first central hub;

a second anchor adapted to be placed proximate a second end of the passageway, the second anchor including a plurality of arms radiating from a second central hub;

an elongate member adapted to extend through the passageway and connect the first and second anchors, the elongate member including a portion having a substantially uniform diameter; and

an actuatable securing element movable on the elongate member to permanently secure the location of the second anchor on the portion of the elongate member having a substantially uniform diameter, wherein the securing element is actuatable when the second anchor is in any desired position along the portion of the elongate member having a substantially uniform diameter, such that movement of the second anchor in at least one direction along the elongate member from the desired position is prevented when the securing element is actuated.

21. The device of claim 20, wherein the passageway is a patent foramen ovale.

22. The device of claim 20, wherein the elongate member is flexible.

23. The device of claim 20, wherein the plurality of arms of the first anchor can assume a collapsed state and a deployed state.

24. The device of claim 20, wherein the plurality of arms of the second anchor can assume a collapsed state and a deployed state.

25. The device of claim 20, wherein the elongate member is capable of moving through the second anchor to vary a length of the elongate member between the first and second anchors.

26. The device of claim 20, wherein the securing element may be positioned at any point along the portion of the elongate member having a substantially uniform diameter.

27. The device of claim 20, wherein the elongate member is configured to move through the second anchor to vary a tension of the elongate member.

28. The device of claim 20, wherein the securing element is movable in only one direction along the elongate member.

29. The device of claim 20, wherein the second anchor includes a cover spanning between its plurality of arms.

30. The device of claim 29, wherein the first anchor does not include structure spanning between its plurality of arms.

31. The device of claim 20, wherein the elongate member has sufficient flexibility to conform to a shape of the passageway.

32. The device of claim 20, wherein the plurality of arms of the first anchor are made of a first material and the elongate member is made of a second material different from the first material.

33. The device of claim 32, wherein the plurality of arms of the second anchor are made from the first material.

34. The device of claim 20, wherein the elongate member is a braided structure.

35. The device of claim 20, wherein the elongate member is a multifilar structure.

68. The device of claim 20, wherein the securing element prevents movement of the second anchor in any direction along the elongate member from the desired position when the securing element is actuated.

69. The device of claim 20, wherein the securing element is releasable to allow movement of the second anchor in any direction along the elongate member.

70. The device of claim 69, wherein the securing element is adapted to be actuated and released by the inflation and deflation of a balloon.

71. The device of claim 20, wherein the securing element includes a contacting element configured to securely engage the elongate member, and the securing element, when actuated, securely engages the elongate member with the contacting element.

72. The device of claim 71, wherein the contacting element includes at least one piercing pin, and the securing element, when actuated, pierces the elongate member with the piercing pin.

73. The device of claim 71, wherein the contacting element includes at least one grip, and the securing element, when actuated, grips the elongate member with the at least one grip.

74. The device of claim 71, wherein the contacting element is biased towards a position securely engaging the elongate member, and the securing element, when actuated, releases the contacting element so that the contacting element moves into the position securely engaging the elongate member.

75. The device of claim 71, wherein the contacting element is configured to directly engage a portion of the second anchor after moving along the elongate member.

76. The device of claim 75, wherein the contacting element is configured to securely engage the elongate member in response to direct engagement between the contacting element and the portion of the second anchor.

77. The device of claim 75, wherein the contacting element includes at least one grip, and the contacting element is configured to securely engage the elongate member by biting into the elongate member with the at least one grip.

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

a first anchor adapted to be placed proximate a first end of the passageway, the first anchor including a plurality of arms radiating from a first central hub;

a second anchor adapted to be placed proximate a second end of the passageway, the second anchor including a plurality of arms radiating from a second central hub; and

an elongate member connected to the first central hub of the first anchor, the elongate member being free to move longitudinally through the second central hub of the second anchor, wherein the device is movable between a collapsed configuration and a deployed configuration, the device being configured to fit within a delivery sheath in the collapsed configuration such that, when in the collapsed configuration, the first central hub of the first anchor abuts the second central hub of the second anchor.

78. The device of claim 36, wherein the device further includes an actuatable securing element, the securing element being actuatable when the second anchor is in any desired position along the elongate member, such that movement of the second anchor in at least one direction along the elongate member from the desired position is prevented when the securing element is actuated.

79. The device of claim 78, wherein the securing element prevents movement of the second anchor in any direction along the elongate member from the desired position when the securing element is actuated.

80. The device of claim 78, wherein the securing element is releasable to allow movement of the second anchor in any direction along the elongate member.

81. The device of claim 80, wherein the securing element is adapted to be actuated and released by the inflation and deflation of a balloon.

82. The device of claim 78, wherein the securing element includes a contacting element configured to securely engage the elongate member, and the securing element, when actuated, securely engages the elongate member with the contacting element.

83. The device of claim 82, wherein the contacting element includes at least one piercing pin, and the securing element, when actuated, pierces the elongate member with the piercing pin.

84. The device of claim 82, wherein the contacting element includes at least one grip, and the securing element, when actuated, grips the elongate member with the at least one grip.

85. The device of claim 82, wherein the contacting element is biased towards a position securely engaging the elongate member, and the securing element, when actuated, releases the contacting element so that the contacting element moves into the position securely engaging the elongate member.

86. The device of claim 82, wherein the contacting element is configured to directly engage a portion of the second anchor after moving along the elongate member.

87. The device of claim 86, wherein the contacting element is configured to securely engage the elongate member in response to direct engagement between the contacting element and the portion of the second anchor.

88. The device of claim 86, wherein the contacting element includes at least one grip, and the contacting element is configured to securely engage the elongate member by biting into the elongate member with the at least one grip.

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

a first anchor configured to be placed proximate a first end of the passageway;

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

an elongate member configured to extend through the passageway and connect the first and second anchors; and

an actuatable securing element positionable on and movable relative to the elongate member to secure the location of the second anchor on the elongate member, wherein the securing element is actuatable when the second anchor is in any desired position along the elongate member, such that movement of the second anchor in at least one direction along the elongate member from the desired position is prevented when the securing element is actuated.

38. The device of claim 37, wherein the passageway is a patent foramen ovale.

39. The device of claim 37, wherein the elongate member is flexible.

40. The device of claim 37, wherein the first anchor includes a plurality of arms radiating from a first central hub.

41. The device of claim 40, wherein the plurality of arms of the first anchor can assume a collapsed state and a deployed state.

42. The device of claim 37, wherein the second anchor includes a plurality of arms radiating from a second central hub.

43. The device of claim 42, wherein plurality of arms of the second anchor can assume a collapsed state and a deployed state.

44. The device of claim 37, wherein the first anchor pivots relative to the elongate member.

45. The device of claim 37, wherein the second anchor pivots relative to the elongate member.

46. The device of claim 37, wherein the elongate member is capable of moving through the second anchor to vary a length of the elongate member between the first and second anchors.

47. The device of claim 37, wherein the second anchor is movable with respect to the elongate member.

48. The device of claim 37, wherein the elongate member is configured to move through the second anchor to vary a tension of the elongate member.

49. The device of claim 37, wherein the securing element is movable in only one direction along the elongate member.

50. The device of claim 37, wherein the second anchor includes a cover spanning between its plurality of arms.

51. The device of claim 50, wherein the first anchor does not include structure spanning between its plurality of arms.

52. The device of claim 37, wherein the elongate member has sufficient flexibility to conform to a shape of the passageway.

53. The device of claim 37, wherein the plurality of arms of the first anchor are made of a first material and the elongate member is made of a second material different from the first material.

54. The device of claim 53, wherein the plurality of arms of the second anchor are made from the first material.

55. The device of claim 37, wherein the elongate member is a braided structure.

56. The device of claim 37, wherein the elongate member is a multifilar structure.

57. The device of claim 37, wherein at least a portion of the elongate member is configured to remain implanted in the body with the device.

89. The device of claim 37, wherein the securing element prevents movement of the second anchor in any direction along the elongate member from the desired position when the securing element is actuated.

90. The device of claim 37, wherein the securing element is releasable to allow movement of the second anchor in any direction along the elongate member.

91. The device of claim 90, wherein the securing element is adapted to be actuated and released by the inflation and deflation of a balloon.

92. The device of claim 37, wherein the securing element includes a contacting element configured to securely engage the elongate member, and the securing element, when actuated, securely engages the elongate member with the contacting element.

93. The device of claim 92, wherein the contacting element includes at least one piercing pin, and the securing element, when actuated, pierces the elongate member with the piercing pin.

94. The device of claim 92, wherein the contacting element includes at least one grip, and the securing element, when actuated, grips the elongate member with the at least one grip.

95. The device of claim 92, wherein the contacting element is biased towards a position securely engaging the elongate member, and the securing element, when actuated, releases the contacting element so that the contacting element moves into the position securely engaging the elongate member.

96. The device of claim 92, wherein the contacting element is configured to directly engage a portion of the second anchor after moving along the elongate member.

97. The device of claim 96, wherein the contacting element is configured to securely engage the elongate member in response to direct engagement between the contacting element and the portion of the second anchor.

98. The device of claim 96, wherein the contacting element includes at least one grip, and the contacting element is configured to securely engage the elongate member by biting into the elongate member with the at least one grip.