Occlusion device with stranded wire support arms

• US 6,206,907 B1
• Filed: 05/07/1999
• Issued: 03/27/2001
• Est. Priority Date: 05/07/1999
• Status: Active Grant

• Current Assignee: Encore Medical Inc.
• Original Assignee: Cardia, Inc.
• Inventors: Marino, Joseph A., Corcoran, Michael P., Buonomo, Peter M.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/307,288
• Time in Patent Office: 690 Days
• Field of Search: 606/215, 606/213, 606/216, 606/232, 606/151, 606/78, 606/217, 606/157
• US Class Current: 606/215
• 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 2017/00243 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 2017/00867 shape memory effect for prostheses A61F2210/0014

Abstract

An occlusion device with stranded wire support arms for the closure of atrial or ventricular septal defects, for the closure of patent ductus arteriosus, patent foramen ovale, or other vascular defects. The occlusion device comprises a center section extending in an axial direction, with upper and lower stranded wire fixation devices emanating from the center section. The stranded wire fixation devices have been heat treated and formed with a shape memory. The stranded wire fixation devices are formed of multiple wire strands and have atraumatic tips. Attached to the fixation devices are sheets, which serve to occlude the opening.

Claims

1. An occlusion device for the closure of a physical anomaly, the occlusion device comprising:

a center section extending in an axial direction;

upper and lower elastic shape memory fixation devices emanating from the center section, wherein the fixation devices are formed of stranded wire comprising a plurality of wires laid together; and

first and second sheets attached to the upper and lower fixation devices, respectively.

2. The occlusion device of claim 1 wherein the first and second sheets are polyvinyl alcohol foam having a thickness of between about 0.2 mm and about 2.0 mm.

3. The occlusion device of claim 1 wherein the center section has an axial length of less than about 20 mm.

4. The occlusion device of claim 3 wherein the center section has an axial length of about 1 mm to about 10 mm.

5. The occlusion device of claim 1 wherein the fixation devices are preshaped and heat treated stranded wire formed of nickel-titanium wires.

6. The occlusion device of claim 1 wherein an atraumatic tip is located at an outer end of each fixation device.

7. The occlusion device of claim 1 wherein the stranded wire is formed of wires having a diameter of less than about 0.008 inch.

8. The occlusion device of claim 1 wherein the stranded wire is formed of wires having a diameter of less than about 0.005 inch.

9. The occlusion device of claim 1 wherein the stranded wire includes a center wire and a plurality of wires laid around the center wire.

10. The occlusion device of claim 9 wherein the center wire has a diameter which is different than diameters of the plurity of wires laid around the center wire.

11. The occlusion device of claim 9 wherein the center wire has a diameter of about 0.005 inch.

12. The occlusion device of claim 9 wherein the center wire has a diameter of about 0.001 inch.

13. The occlusion device of claim 9 wherein the stranded wire includes a center wire and six wires laid around the center wire.

14. The occlusion device of claim 13 wherein the center wire and the six wires each have a diameter of about 0.005 inch.

15. The occlusion device of claim 13 wherein the center wire and the six wires each have a diameter of about 0.001 inch.

16. The occlusion device of claim 9 wherein the stranded wire includes a center wire, a first layer of six wires laid around the center wire, and a second layer of twelve wires laid around the first layer.

17. The occlusion device of claim 9 wherein the stranded wire includes a center formed of multiple wire strands.

18. The occlusion device of claim 1 wherein the first and second fixation devices are formed by cables formed by multiple stranded wires.

19. The occlusion device of claim 1 wherein the first and second fixation devices are formed by cables formed by multiple stranded wires laid on a core.

20. The occlusion device of claim 19 wherein the core is formed by a multiwire strand.

21. The occlusion device of claim 19 wherein the cables have a diameter of less than about 0.025 inch.

22. The occlusion device of claim 1 wherein the fixation devices are a mesh of stranded wire.

23. The occlusion device of claim 1 wherein the center section is a mesh of stranded wire.

24. An occlusion device, the device comprising:

a support structure including a center section and first and second flexible arms extending outward from the center section, wherein each of the flexible arms is formed of stranded wire comprising a plurality of wires laid together; and

a first sheet attached to the first flexible arm.

25. The occlusion device in claim 24 and further comprising a second sheet attached to the second flexible arm.

26. The occlusion device in claim 25 wherein the sheets are polyvinyl alcohol foam having a thickness of between about 0.2 mm and about 2.0 mm.

27. The occlusion device in claim 24 wherein the center section has an axial length of less than about 20 mm.

28. The occlusion device in claim 24 wherein the first and second stranded wire flexible arms are pre-shaped and heat treated stranded wire formed of nickel-titanium wires.

29. The occlusion device of claim 24 wherein an atraumatic tip is located at an outer end of each stranded wire flexible arm.

30. The occlusion device of claim 24 wherein the stranded wire is formed of wires having a diameter of less than about 0.008 inches.

31. The occlusion device of claim 24 wherein the stranded wire includes a center wire and a plurality of wires laid around the center wire.

32. The occlusion device of claim 31 wherein the center wire has a diameter which is different than diameters of the plurality of wires laid around the center wire.

33. The occlusion device of claim 31 wherein the center wire has a diameter of less than about 0.005 inch.

34. The occlusion device of claim 33 wherein the cables have a diameter of less than about 0.025 inch.

35. The occlusion device of claim 24 wherein the stranded wire includes a center formed of multiple wire strands and a plurality of wires laid around the center.

36. The occlusion device of claim 24 wherein the first and second stranded wire arms are formed by cables formed by multiple stranded wires.

37. The occlusion device of claim 24 wherein the support structure comprises mesh of stranded wire.

38. An occlusion device, the device comprising:

a center strut;

a first plurality of elastic fixation devices formed of multiwire strands extending from a first end of the center strut, wherein each multiwire strand is formed of a plurality of wires laid together;

a first sheet attached to the first plurality of fixation devices; and

a second plurality of fixation devices formed of multiwire strands extending from a second end of the center strut, wherein each multiwire strand is formed of a plurality of wires laid together.

39. The occlusion device in claim 38 and further comprising a second sheet attached to the second plurality of fixation devices.

40. The occlusion device in claim 38 wherein the first and second sheets are polyvinyl alcohol foam having a thickness of between about 0.2 mm and about 2.0 mm.

41. The occlusion device in claim 38 wherein the center strut has an axial length of less than about 20 mm.

42. The occlusion device in claim 38 wherein the elastic fixation devices are pre-shaped and heat treated stranded wire formed of nickel-titanium wires.

43. The occlusion device in claim 38 wherein an atraumatic tip is located at the outer end of each fixation device.

44. The occlusion device of claim 38 wherein the multiwire strands are formed of wires having a diameter of less than about 0.008 inches.

45. The occlusion device of claim 38 wherein the multiwire strands include a center and a plurality of wires laid around the center.

46. The occlusion device of claim 45 wherein the center has a diameter which is different than diameters of the plurality of wires laid around the center.

47. The occlusion device of claim 45 wherein the center has a diameter of less than about 0.005 inch.

48. The occlusion device of claim 45 wherein the center is a strand formed of multiple wire strands.

49. The occlusion device of claim 38 wherein the first and second fixation devices are formed by cables formed by multiple stranded wires.

50. The occlusion devices of claim 38 wherein the center strut is a mesh of stranded wire.

51. The occlusion device of claim 38 wherein the fixation devices comprise a mesh of stranded wire.

52. An occlusion device comprising:

a center strut having distal and proximal ends;

a first set of elastic support arms extending from the distal end of the center strut;

a first sheet attached to the first set of elastic support arms;

a second set of elastic support arms extending from the proximal end of the center strut, wherein the first and second set of elastic support arms are formed of stranded wire comprising a plurality of wires laid together; and

a second sheet attached to the second set of elastic support arms.

53. The occlusion device in claim 52 wherein the first and second sheets are polyvinyl alcohol foam having a thickness of between about 0.2 mm and about 2.0 mm.

54. The occlusion device in claim 52 wherein the center strut has an axial length of less than about 20 mm.

55. The occlusion device in claim 52 wherein the elastic support arms are pre-shaped and heat treated stranded wire formed of nickel-titanium wires.

56. The occlusion device in claim 52 wherein an atraumatic tip is located at the outer end of each support arm.

57. The occlusion device of claim 52 wherein the stranded wire is formed of wires having a diameter of less than about 0.008 inches.

58. The occlusion device of claim 52 wherein the stranded wire includes a center and a plurality of wires laid around the center.

59. The occlusion device of claim 58 wherein the center has a diameter which is different than diameters of the plurality of wires laid around the center.

60. The occlusion device of claim 58 wherein the center has a diameter of less than about 0.005 inch.

61. The occlusion device of claim 58 wherein the center is a strand formed of multiple wire strands.

62. The occlusion device of claim 52 wherein the support arms are formed by cables formed by multiple stranded wires.

63. An occlusion device for the closure of a physical anomaly, the occlusion device comprising:

a center piece extending in an axial direction;

first and second collapsible support frames spaced from one another and emanating from the center piece, the support frames being formed of multiwire strands comprising a plurality of wires laid together; and

first and second sheets attached to the first and second collapsible support frames, respectively.

64. The occlusion device in claim 63 wherein the first and second sheets are polyvinyl alcohol foam having a thickness of between about 0.2 mm and about 2.0 mm.

65. The occlusion device in claim 63 wherein the center strut has an axial length of less than about 20 mm.

66. The occlusion device in claim 63 wherein the support frames are pre-shaped and heat treated stranded wire formed of nickel-titanium wires.

67. The occlusion device of claim 63 wherein the multiwire strand is formed of wires having a diameter of less than about 0.008 inches.

68. The occlusion device of claim 63 wherein the multiwire strand includes a center and a plurality of wires laid around the center.

69. The occlusion device of claim 68 wherein the center has a diameter which is different than diameters of the plurality of wires laid around the center.

70. The occlusion device of claim 68 wherein the center has a diameter of less than about 0.005 inch.

71. The occlusion device of claim 68 wherein the center is a strand formed of multiple wire strands.

72. The occlusion device of claim 63 wherein the first and support frames are formed by cables formed by multiple stranded wires.

73. The occlusion devices of claim 63 wherein the support frames are a mesh of stranded wire.

74. The occlusion device of claim 63 wherein the center piece is a mesh of stranded wire.

75. An occlusion device comprising:

a first collapsible support frame formed by multiwire strands comprising a plurality of wires laid together;

a second collapsible support frame formed by multiwire strands comprising a plurality of wires laid together, the second collapsible support frame being spaced from and connected to the first collapsible support frame;

a first sheet attached to the first collapsible support frame; and

a second sheet attached to the second collapsible support frame.

76. The occlusion device in claim 75 wherein the first and second sheets are polyvinyl alcohol foam having a thickness of between about 0.2 mm and about 2.0 mm.

77. The occlusion device in claim 75 wherein the first and second support frames are pre-shaped and heat treated stranded wire formed of nickel-titanium wires.

78. The occlusion device of claim 75 wherein the multiwire strands are formed of wires having a diameter of less than about 0.008 inches.

79. The occlusion device of claim 75 wherein the multiwire strands include a center and a plurality of wires laid around the center.

80. The occlusion device of claim 79 wherein the center has a diameter which is different than diameters of the plurality of wires laid around the center.

81. The occlusion device of claim 79 wherein the center has a diameter of less than about 0.005 inch.

82. The occlusion device of claim 79 wherein the center is a strand formed of multiple wire strands.

83. The occlusion device of claim 75 wherein the first and second support frames are formed by cables formed by multiple stranded wires.

84. The occlusion devices of claims 75 wherein the support frames are a mesh of stranded wire.