Device for occluding vascular defects

• US 9,039,724 B2
• Filed: 09/11/2008
• Issued: 05/26/2015
• 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: Amplatz, Kurt, Heidner, Matthew C., Russo, Patrick, Ren, Brooke, Adams, Daniel O.
• Primary Examiner(s): NGUYEN, TUAN VAN
• Application Number:
  US12/208,787
• Publication Number:
  US 20090062841A1
• Time in Patent Office: 2,448 Days
• Field of Search: 606/151, 606/191, 606/194, 606/198, 606/200, 606/213, 623/1.12
• US Class Current: 606/191
• 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,

wherein said first and second layers are tubular in shape and are disposed in an overlying relationship with respect to one another along a common central axis extending therethrough, at least one of said first or second layers comprising at least one plane of occlusion oriented generally transverse to the central axis, and wherein said first and second layers are configured to be radially constrained to a reduced configuration in relation to the central axis through the application of external force and to subsequently assume an expanded configuration when the external force is removed,

wherein the expanded configuration comprises a pair of disks oriented generally transverse to the central axis and a cylindrical portion extending therebetween, the pair of disks having a larger cross-sectional diameter than the cylindrical portion, and

wherein the expanded configuration comprises a waist extending between one of the disks and the cylindrical portion for facilitating articulation therebetween, the waist having a smaller cross-sectional diameter than the cylindrical portion.

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 elongated to a common radially 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 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 elongated to a radially 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.

20. The occluder of claim 1, wherein said first and second layers are configured to be elongated from an expanded configuration to a radially reduced configuration so as to reduce a respective outer diameter of each of the layers.

21. The occluder of claim 1, wherein said first and second layers are configured to be axially elongated from an expanded configuration to a radially reduced configuration such that a length of said first and second layers in the reduced configuration is greater than a length of said first and second layers in the expanded configuration.

22. The occluder of claim 1, wherein said first and second layers are disposed coaxially along the central axis.

23. The occluder of claim 1, wherein at least one of said first or second layers comprises a plurality of planes of occlusion oriented generally transverse to the central axis.

24. The occluder of claim 1, wherein each of said first and seconds layers comprises a tubular member having proximal and distal ends corresponding to the ends of the plurality of braided strands, and wherein the proximal ends of each tubular member are coupled together and the distal ends of each tubular member are coupled together so as to prevent the first and second layers from unraveling.

25. The occluder of claim 1, wherein each of the first and second layers comprises a plurality of planes of occlusion oriented generally transverse to the central axis.

26. The occluder of claim 1, wherein said first and second layers are configured to be elongated from a first length in the expanded configuration to a second length in the radially reduced configuration by a ratio of at least about 1 to 3.

27. 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,

wherein each of said first and seconds layers comprises a tubular member having proximal and distal ends corresponding to the ends of the plurality of braided strands,

wherein the proximal ends of each tubular member are coupled together and the distal ends of each tubular member are coupled together so as to prevent the first and second layers from unraveling,

wherein said first and second layers are disposed in an overlying relationship with respect to one another along a common central axis extending therethrough, at least one of said first or second layers comprising at least one plane of occlusion oriented generally transverse to the central axis, and

wherein said first and second layers are configured to be radially constrained to a reduced configuration in relation to the central axis through the application of external force and to subsequently assume an expanded configuration when the external force is removed.

28. The occluder of claim 27, wherein said strands of metallic material or polymeric material comprise at least one of a filament, a cord, a yarn, or a cable.

29. The occluder of claim 27, wherein said first layer is disposed radially within or around said second layer.

30. The occluder of claim 29, wherein said first and second layers are disposed generally concentrically relative to one another.

31. The occluder of claim 27, wherein said polymeric material includes a heat-settable polymer.

32. The occluder of claim 31, wherein said heat-settable polymer is a shape memory polymer.

33. The occluder of claim 27, wherein said polymeric material comprises a non-heat set polymer.

34. The occluder of claim 27, wherein said first and second layers are configured to be cooperatively elongated to a common radially reduced shape through the application of external force and to subsequently cooperatively assume a common expanded shape when the external force is removed.

35. The occluder of claim 34, 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.

36. The occluder of claim 27, wherein said polymeric material comprises at least one of polyester, polyolefin, polyamide, polysulphonate, polycarbonate, or polyurethane.

37. The occluder of claim 27, wherein said metallic material comprises a shape memory or super-elastic alloy.

38. The occluder of claim 27, wherein said second layer comprises strands of metallic material braided or twisted with said strands of polymeric material.

39. The occluder of claim 38, 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.

40. The occluder of claim 38, 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.

41. The occluder of claim 27, 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.

42. The occluder of claim 41, wherein said third layer is configured to be elongated to a radially 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.

43. The occluder of claim 41, wherein said third layer has a metallic strand density that is different than that of said first layer.

44. The occluder of claim 41, 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.

45. The occluder of claim 27, wherein at least one of said first and second layers comprises a material configured to facilitate thrombosis.