DEVICE FOR OCCLUDING VASCULAR DEFECTS

• US 20090062841A1
• Filed: 09/11/2008
• Published: 03/05/2009
• Est. Priority Date: 03/19/2004
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: AGA Medical Corporation (Abbott Laboratories Incorporated)
• Inventors: Russo, Patrick, AMPLATZ, KURT, Heidner, Matthew C., Ren, Brooke
• Granted Patent: US 9,039,724 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• 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 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 17/12163 having a string of elements connected to each other
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• 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 2017/00831 Material properties
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A multi-layer occluder for treating a target site within the body is provided. The occluder may include first and second layers. For example, the first layer may include braided strands of metallic material, and the second layer may include braided strands of polymeric material. At least one of the first or second layers may be configured to facilitate thrombosis.

Claims

1. A multi-layer occluder for treating a target site within the body, the occluder comprising:

a first layer comprising braided strands of metallic material; and

a second layer coupled to said first layer and comprising braided strands of polymeric material, wherein at least one of said first or second layers is configured to facilitate thrombosis.

2. The occluder of claim 1, wherein said strands of metallic material or polymeric material comprise at least one of a filament, a cord, a yarn, or a cable.

3. The occluder of claim 1, wherein said first layer is disposed radially within or around said second layer.

4. The occluder of claim 3, wherein said first and second layers are disposed generally concentrically relative to one another.

5. The occluder of claim 1, wherein said polymeric material includes a heat-settable polymer.

6. The occluder of claim 5, wherein said heat-settable polymer is a shape memory polymer.

7. The occluder of claim 1, wherein said polymeric material includes a non-heat set polymer.

8. The occluder of claim 1, wherein said first and second layers are configured to be cooperatively constrainable to a common reduced shape through the application of external force and to subsequently cooperatively assume a common expanded shape when the external force is removed.

9. The occluder of claim 8, wherein said first and second layers respectively comprise strands braided at a common pitch such that said first and second layers retain a substantially similar length-to-diameter ratio when axially elongated to the reduced shape.

10. The occluder of claim 1, wherein said polymeric material comprises at least one of polyester, polyolefin, polyamide, polysulphonate, polycarbonate, or polyurethane.

11. The occluder of claim 1, wherein said metallic material comprises a shape memory or super-elastic alloy.

12. The occluder of claim 1, wherein said second layer comprises strands of metallic material braided or twisted with said strands of polymeric material.

13. The occluder of claim 12, wherein said strands of metallic material of said second layer have diameters smaller than diameters of said strands of metallic material of said first layer.

14. The occluder of claim 12, further comprising an elastomeric coating that links cross-over points of said respective strands of said second layer, said elastomeric coating being constrainable to a reduced shape through the application of external force and being configured to subsequently assume an expanded shape when the external force is removed.

15. The occluder of claim 1, further comprising a fastener that couples said first and second layers, said fastener comprises at least one of an end clamp configured to secure free ends of the braided strands of said first and second layers, sutures, or an elastic adhesive.

16. The occluder of claim 1, further comprising a third layer comprising braided strands of metallic material, wherein said first layer is disposed radially within said second layer, and wherein said second layer is disposed radially within said third layer.

17. The occluder of claim 16, wherein said third layer is configured to be constrainable to a reduced shape through the application of external force and to subsequently assume, when the external force is removed, an expanded shape having at least a portion similar to the expanded shape of said first layer.

18. The occluder of claim 16, wherein said third layer has a metallic strand density that is different than that of said first layer.

19. The occluder of claim 16, wherein said strands of metallic material of said third layer have different diameters than those of said strands of metallic material of said first layer.

21. A method for fabricating a multi-layer occluder, said method comprising:

providing a first layer comprising braided strands of metallic material;

heat setting the first layer in an expanded shape;

providing a second layer comprising braided strands of polymeric material; and

coupling the second layer and the first layer.

22. The method of claim 21, wherein said providing a first layer includes providing a first tubular layer, said providing a second layer includes providing a second tubular layer, and said coupling the first and second layers includes disposing the second tubular layer generally radially within or around the first tubular layer.

23. The method of claim 21, further comprising heat setting the second layer in an expanded shape similar to the expanded shape of the first layer.

24. The method of claim 21, further comprising connecting the first layer and second layer at free ends of respective strands.

29. The method of claim 23, wherein heat setting the second layer in an expanded shape includes coating the second layer with a liquid elastomeric material and curing the elastomeric material while fixing the second layer in the expanded shape.

25. The method of claim 20, further comprising providing a third layer comprising braided strands of metallic material and positioning the second layer between the first and third layers.

26. The method of claim 25, further comprising braiding the first layer over a first mandrel and braiding the third layer over a second mandrel having a diameter that is different than that of the first mandrel.

27. The method of claim 25, wherein said providing a third layer includes providing a third layer comprising braided strands of metallic material having different diameters than those of the strands of the first layer.

28. The method of claim 25, further comprising heat setting the third layer in an expanded shape having at least a portion similar to the expanded shape of the first layer.

30. A method of delivering an occluder to a target site within the body, the method comprising:

providing an occluder comprising

a first layer comprising braided strands of metallic material; and

a second layer coupled to said first layer and comprising braided strands of polymeric material,

wherein the first and second layers have a preset expanded shape;

constraining the occluder to a reduced shape;

positioning the constrained occluder in a catheter;

delivering the occluder proximate to the target site; and

deploying the occluder from the catheter such that the occluder assumes the preset expanded shape.

31. The method of claim 30, wherein said constraining the occluder includes axially elongating the occluder.

32. The method of claim 30, wherein said providing an occluder includes providing an occluder further comprising a third layer coupled with the first and second layers and comprising braided strands of metallic material.

33. A multi-layer medical device for treating a target site within the body, the medical device comprising:

a first layer comprising braided strands of a first metallic material; and

a second layer coupled to said first layer and comprising braided respective strands of polymeric and a second metallic material.

34. The medical device of claim 33, wherein said strands of first and second metallic material and polymeric material comprise at least one of a filament, a cord, a yarn, or a cable.

35. The medical device of claim 33, wherein said first layer is disposed radially within or around said second layer.

36. The medical device of claim 35, wherein said first and second layers are disposed generally concentrically relative to one another.

37. The medical device of claim 33, wherein said polymeric material includes a heat-settable polymer.

38. The medical device of claim 37, wherein said heat-settable polymer is a shape memory polymer.

39. The medical device of claim 33, wherein said polymeric material comprises a non-heat set polymer.

40. The medical device of claim 33, wherein said first and second layers are configured to be cooperatively constrainable to a common reduced shape through the application of external force and to subsequently cooperatively assume a common expanded shape when the external force is removed.

41. The medical device of claim 40, wherein said first and second layers respectively comprise strands braided at a common pitch such that said first and second layers retain a substantially similar length-to-diameter ratio when axially elongated to the reduced shape.

42. The medical device of claim 33, wherein said polymeric material comprises at least one of polyester, polyolefin, polyamide, polysulphonate, polycarbonate, or polyurethane.

43. The medical device of claim 33, wherein said first metallic material comprises a shape memory alloy.

44. The occluder of claim 33, wherein said second layer comprises strands of said second metallic material braided or twisted with said strands of polymeric material.

45. The medical device of claim 33, wherein said strands of second metallic material have different diameters than those of said strands of first metallic material.

46. The medical device of claim 33, further comprising an elastomeric coating that links cross-over points of said respective strands of said second layer, said elastomeric coating being constrainable to a reduced shape through the application of external force and to subsequently assume an expanded shape when the external force is removed.

47. The medical device of claim 33, further comprising a fastener that couples said first and second layers, said fastener comprises at least one of an end clamp configured to secure free ends of the braided strands of said first and second layers, sutures, or an elastic adhesive.

48. The medical device of claim 33, wherein said second layer is disposed radially within said first layer, the medical device further comprising a third layer disposed radially within said second layer and configured to outwardly compress said second layer against said first layer.

49. The medical device of claim 48, wherein said third layer is configured to be constrainable to a reduced shape through the application of external force and to subsequently assume, when the external force is removed, an expanded shape having at least a portion similar to the expanded shape of said first layer.

50. The medical device of claim 48, wherein said third layer has a metallic strand density that is different than that of said first layer.

51. The medical device of claim 48, wherein said strands of metallic material of said third layer have different diameters than those of said strands of first metallic material of said first layer.

52. The medical device of claim 45, wherein at least one of said first and second layers comprises a material configured to facilitate thrombosis.

53. A medical device for treating a target site within the body, the medical device comprising:

a structure comprising braided strands of metallic material; and

at least one strand of polymeric material disposed spirally around and adjacent to said structure.

54. The medical device of claim 53, wherein said structure includes a braided tube having a longitudinal axis.

55. The medical device of claim 54, wherein said at least one polymeric strand spirals around the longitudinal axis.

56. The medical device of claim 53, wherein said at least one polymeric strand is continuously in contact with a radially exterior surface of said structure.

57. The medical device of claim 53, wherein said braided strands have a braid pitch, and wherein said at least one polymeric strand forms a spiral having substantially the same braid pitch as said braided strands.

58. The medical device of claim 53, wherein said braided strands have a braid pick that is substantially the same as that of said at least one polymeric strand.

59. The medical device of claim 53, wherein said strands of metallic material and polymeric material comprise at least one of a filament, a cord, a yarn, or a cable.

60. The medical device of claim 53, wherein said polymeric material includes a heat-settable polymer.

61. The medical device of claim 60, wherein said heat-settable polymer is a shape memory polymer.

62. The medical device of claim 53, wherein said polymeric material comprises a non-heat set polymer.

63. The medical device of claim 53, wherein said structure is configured to be constrainable to a reduced shape through the application of external force and to subsequently assume an expanded shape when the external force is removed.

64. The medical device of claim 53, wherein said polymeric material comprises at least one of polyester, polyolefin, polyamide, polysulphonate, polycarbonate, or polyurethane.

65. The medical device of claim 53, wherein said metallic material comprises a shape memory alloy.

66. The medical device of claim 53, wherein at least one of said structure and said at least one polymeric strand comprises a material configured to facilitate thrombosis.