Occlusion device with non-thrombogenic properties

• US 6,379,368 B1
• Filed: 05/13/1999
• Issued: 04/30/2002
• Est. Priority Date: 05/13/1999
• Status: Active Grant

• Current Assignee: Encore Medical Inc.
• Original Assignee: Cardia, Inc.
• Inventors: Corcoran, Michael P., Marino, Joseph A., Buonomo, Peter M.
• Primary Examiner(s): Robert, Eduardo C.
• Application Number:
  US09/311,508
• Time in Patent Office: 1,083 Days
• Field of Search: 606/153, 606/151-155, 606/213, 606/215, 613/22
• US Class Current: 606/153
• 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 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• 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 2017/1205 Introduction devices
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 33/0029 using an intermediate layer of polymer
• CPC Class Codes: A61L 33/007 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 33/064 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L33/062 takes precedence
• CPC Class Codes: C08L 29/04 Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids

Abstract

An occlusion device 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 heparin treated sheets, which serve to occlude the opening and significantly reduce the occurrence of thrombosis at the device.

Claims

1. An occlusion device, the device comprising:

a center section extending in an axial direction;

upper and lower elastic shape memory fixation devices emanating from the center section; and

first and second foam sheets attached to the upper and lower fixation devices, respectively, wherein the foam sheets are formed of a foam mixture comprising polyvinyl alcohol and heparin chemically bonded to the polyvinyl alcohol.

2. The occlusion device of claim 1 wherein the heparin is bonded to the polyvinyl alcohol during formation of the polyvinyl alcohol foam.

3. The occlusion device of claim 1 wherein the first and second sheets have a thickness of between about 0.2 millimeter and about 2.0 millimeters.

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

5. The occlusion device of claim 4 wherein the center section has an axial length of between about 1 millimeter and about 10 millimeters.

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

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

8. The occlusion device of claim 1 wherein the fixation devices are formed of multiple stranded wires.

9. The occlusion device of claim 1 wherein the fixation devices are formed of cable.

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

11. The occlusion device of claim 1 wherein the center section is a mesh of wires.

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

a support structure including a center section and first and second flexible arms extending outward from the center section; and

a first foam sheet attached to the first flexible arm, wherein the first foam sheet is formed of a foam mixture comprising polyvinyl alcohol and heparin chemically bonded to the polyvinyl alcohol.

13. The occlusion device in claim 12 and further comprising a second foam sheet attached to the second flexible arm, wherein the second foam sheet is formed of a foam comprising polyvinyl alcohol and heparin chemically bonded to the polyvinyl alcohol.

14. The occlusion device in claim 13 wherein the polyvinyl alcohol foam sheets have a thickness of between about 0.2 millimeter and about 2.0 millimeters.

15. The occlusion device of claim 13 wherein the sheets are treated with heparin by dipping each sheet in a solution comprising heparin.

16. The occlusion device of claim 13 wherein the sheets are treated with heparin by plasma etching a surface of the sheets and dipping the sheets in a solution comprising heparin.

17. The occlusion device of claim 13 wherein the heparin is bonded to the polyvinyl alcohol during formation of the polyvinyl alcohol foam sheets.

18. The occlusion device in claim 12 wherein the center section has an axial length of less than about 20 millimeters.

19. The occlusion device in claim 12 wherein the first and second flexible arms are pre-shaped and heat treated stranded wire formed of nickel-titanium wires.

20. The occlusion device of claim 12 wherein an atraumatic tip is located at an outer end of each stranded wire flexible arm.

21. The occlusion device of claim 12 wherein the first and second flexible arms are formed by cables formed by multiple stranded wire.

22. The occlusion device of claim 12 wherein the first and second flexible arms are formed of multiple stranded wires.

23. The occlusion device of claim 12 wherein the first and second flexible arms are a mesh of stranded wire.

24. The occlusion device of claim 12 wherein the center section is a mesh of stranded wire.

25. An occlusion device, the device comprising:

a center strut;

a first plurality of fixation devices extending from a first end of the center strut;

a first sheet attached to the first plurality of fixation devices, wherein the first sheet is formed of a foam mixture comprising polyvinyl alcohol and heparin chemically bonded to the polyvinyl alcohol; and

a second plurality of fixation devices extending from a second end of the center strut.

26. The occlusion device of claim 25 and further comprising a second sheet attached to the second plurality of fixation devices, wherein the second sheet is formed of a foam comprising polyvinyl alcohol and heparin chemically bonded to the polyvinyl alcohol.

27. The occlusion device of claim 26 wherein the sheets are treated with heparin by dipping the sheets in a solution of comprising heparin.

28. The occlusion device of claim 26 wherein the sheets are treated with heparin by plasma etching the surface of the sheets and dipping the sheets in a solution comprising heparin.

29. The occlusion device of claim 26 wherein the heparin is chemically bonded to the polyvinyl alcohol during formation of the polyvinyl alcohol foam.

30. The occlusion device in claim 25 wherein the center strut has an axial length of less than about 20 millimeters.

31. The occlusion device in claim 25 wherein the fixation devices are pre-shaped and heat treated stranded wire formed of nickel-titanium wires.

32. The occlusion device in claim 25 wherein an atraumatic tip is located at the outer end of each fixation device.

33. The occlusion device of claim 25 wherein the fixation devices are formed by cables formed of multiple wire strands.

34. The occlusion device of claim 25 wherein the fixation devices are formed of multiple wire strands.

35. The occlusion device of claim 25 wherein the fixation devices are a mesh of stranded wires.

36. The occlusion device of claim 35 wherein the center strut is a mesh of stranded wire.

37. The occlusion device of claim 25 wherein the center strut is a mesh of stranded wires.

38. An occlusion device, the device comprising:

a center strut having distal and proximal ends;

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

a first sheet attached to the first set of arms, wherein the first sheet is formed from a foam mixture comprising polyvinyl alcohol and heparin chemically bonded to the polyvinyl alcohol;

a second set of stranded wire support arms extending from the proximal end of the center strut; and

a second sheet attached to the second set of support arms, wherein the second sheet is formed from a foam mixture comprising polyvinyl alcohol and heparin chemically bonded to the polyvinyl alcohol.

39. The occlusion device in claim 38 wherein the first and second sheets have a thickness of between about 0.2 millimeter and about 2.0 millimeters.

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

41. The occlusion device in claim 38 wherein the support arms are pre-shaped and heat treated stranded wire formed of nickel-titanium wires.

42. The occlusion device in claim 38 wherein an atraumatic tip is located at the outer end of each support arm.

43. The occlusion device of claim 38 wherein the first and second sheets are treated with heparin by dipping the sheets in a solution comprising heparin.

44. The occlusion device of claim 38 wherein the first and second sheets are treated with heparin by plasma etching a surface of the sheets and dipping the sheets in a solution comprising heparin.

45. The occlusion device of claim 38 wherein the support arms are formed of cables.

46. The occlusion device of claim 38 wherein the support arms are a mesh of stranded wire.

47. The occlusion device of claim 38 wherein the heparin chemically bonds to the polyvinyl alcohol foam.

48. 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 by multiwire strands; and

first and second foam sheets attached to the first and second collapsible support frames, respectively, wherein the sheets are formed from a foam mixture comprising polyvinyl alcohol and heparin chemically bonded to the polyvinyl alcohol.

49. The occlusion device of claim 48 wherein the first and second sheets have a thickness of between about 0.2 millimeter and about 2.0 millimeters.

50. The occlusion device of claim 48 wherein the first and second sheets are treated with heparin by dipping the sheets in a solution comprising heparin.

51. The occlusion device of claim 48 wherein the first and second sheets are treated with heparin by plasma etching a surface of the sheets and dipping the sheets in a solution comprising heparin.

52. The occlusion device of claim 48 wherein the heparin chemically bonds to the polyvinyl alcohol.

53. The occlusion device of claim 48 wherein the center strut has an axial length of less than about 20 millimeters.

54. The occlusion device of claim 48 wherein the multiple wire strands are pre-shaped and heat treated nickel-titanium wires.

55. The occlusion device of claim 48 wherein the support frames are formed of cables formed by multiple stranded wires.

56. The occlusion device of claim 48 wherein the support frames are a mesh of stranded wire.

57. The occlusion device of claim 48 wherein the center strut is a mesh of stranded wire.

58. An occlusion device, the device comprising:

a first collapsible support frame;

a second collapsible support frame, 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, wherein the first sheet is formed from a foam mixture comprising polyvinyl alcohol and heparin chemically bonded to the polyvinyl alcohol; and

a second polyvinyl alcohol sheet attached to the second collapsible support frame, wherein the second sheet is formed from a foam comprising polyvinyl alcohol and heparin chemically bonded to the polyvinyl alcohol.

59. The occlusion device in claim 58 wherein the first and second sheets are polyvinyl alcohol foam having a thickness of between about 0.2 millimeter and about 2.0 millimeters.

60. The occlusion device of claim 58 wherein the first and second sheets are treated with heparin by dipping the sheets in a solution comprising heparin.

61. The occlusion device of claim 58 wherein the first and second sheets are treated with heparin by plasma etching a surface of the sheets and dipping the sheets in a solution comprising heparin.

62. The occlusion device of claim 58 wherein the heparin is chemically bonded to the polyvinyl alcohol during manufacturing of the sheets.

63. The occlusion device in claim 58 wherein the first and second support frames are pre-shaped and heat treated stranded wire formed of nickel-titanium wires.

64. The occlusion device of claim 58 wherein the center section has an axial length of less than about 20 millimeters.

65. The occlusion device of claim 58 wherein the support frames are formed by cables formed by multiple stranded wires.

66. The occlusion device of claim 58 wherein the support frames are a mesh of stranded wire.

67. The occlusion device of claim 58 wherein the center section is a mesh of stranded wire.

68. An occlusion device, the device comprising:

a support structure; and

a polyvinyl alcohol foam occlusion member attached to the support structure wherein the occlusion member is formed from a foam mixture comprising polyvinyl alcohol and heparin chemically bonded to the polyvinyl alcohol.

69. The occlusion device of claim 68 wherein the foam member is treated with heparin by dipping the foam member in a solution comprising heparin.

70. The occlusion device of claim 68 wherein the heparin is bonded to the foam when the member is manufactured.