Multi-layer braided structures for occluding vascular defects and for occluding fluid flow through portions of the vasculature of the body

• US 8,398,670 B2
• Filed: 06/23/2006
• Issued: 03/19/2013
• Est. Priority Date: 03/19/2004
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: AGA Medical Corporation (Abbott Laboratories)
• Inventors: Amplatz, Kurt, Gu, Xiaoping, Oslund, John C., Thill, Gary A.
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US11/473,971
• Publication Number:
  US 20060241690A1
• Time in Patent Office: 2,461 Days
• Field of Search: 606/200, 606/151, 606/159, 623/1.15, 623/1.18, 623/1.2, 623/1.11
• 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 17/12122 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 2017/00867 shape memory effect

Abstract

A collapsible medical device and associated methods of occluding an abnormal opening in, for example, a body organ, wherein the medical device is shaped from plural layers of a heat-treatable metal fabric. Each of the fabric layers is formed from a plurality of metal strands and the assembly is heat-treated within a mold in order to substantially set a desired shape of the device. By incorporating plural layers in the thus-formed medical device, the ability of the device to rapidly occlude an abnormal opening in a body organ is significantly improved.

Claims

1. A collapsible implantable medical device comprising an outer metal fabric surrounding an inner metal fabric, said outer and inner metal fabrics each having a plurality of braided metal strands with an expanded preset configuration, each of the outer and inner metal fabrics having a proximal end and a distal end, the outer metal fabric surrounding the inner metal fabric from the proximal end of the inner metal fabric to the distal end of the inner metal fabric, at least one of said proximal or distal ends of the outer or inner metal fabrics comprising at least one fastener adapted to secure the plurality of braided metal strands of the inner and/or outer metal fabrics together, said inner and outer fabrics configured to facilitate thrombus formation to thereby create an occlusion, wherein said occlusion blocks fluid flow passage through a portion of the vasculature of a body, said expanded preset configuration being deformable to a lesser cross-sectional dimension for delivery through a channel in a patient'"'"'s body, the outer and inner metal fabrics having a memory property such that the medical device tends to return to said expanded preset configuration when unconstrained.

2. The medical device of claim 1 wherein the pitch of the braided metal strands comprising the outer and inner metal fabrics are generally equal.

3. The medical device as in claim 1 wherein the braided metal strands comprising the outer metal fabric are of a larger diameter than the braided metal strands comprising the inner metal fabric.

4. The medical device as in claim 1 wherein the number of braided metal strands comprising the inner metal fabric is greater than the number of braided metal strands comprising the outer metal fabric.

5. The medical device as in claim 1 wherein the number of braided metal strands comprising the outer metal fabric comprises 72 and the number of braided metal strands comprising the inner metal fabric comprises 144.

6. The medical device as in claim 1 wherein the diameter of the braided metal strands comprising the outer metal fabric is in a range of 0.003 to 0.008 inches and the diameter of the braided metal strands comprising the inner metal fabric is in a range of from 0.001 to 0.002 inches.

7. The medical device as in claim 1 and further including a third metal fabric disposed within the confines of the inner metal fabrics, said third metal fabric comprising a plurality of braided metal strands with an expanded preset configuration corresponding to the expanded preset configuration of the outer and inner metal fabrics, the plurality of braided metal strands of the third metal fabric having proximal and distal ends that are secured to the respective proximal and distal ends of the plurality of braided strands comprising the outer and inner metal fabrics.

8. The medical device as in claim 7 wherein the pitch of the braided metal strands comprising the third metal fabric is equal to the pitch of the braided metal strands comprising the outer and inner metal fabrics.

9. The medical device as in claim 7 wherein the diameter of the braided metal strands comprising the third metal fabric is equal to the diameter of the braided metal strands comprising the inner metal fabric.

10. The medical device as in claim 9 wherein the diameter of the braided metal strands comprising the third metal fabric is in a range of from 0.001 and 0.002 inches.

11. The medical device as in claim 7 wherein the number of braided metal strands comprising the third metal fabric is equal to the number of braided metal strands comprising the inner metal fabric.

12. The medical device as in claim 7 wherein the number of braided metal strands comprising the third metal fabric is 144.

13. The medical device as in claim 1 further comprising:

a first pair of fasteners adapted to secure the braided metal strands at the proximal and distal ends of the outer metal fabric, respectively; and

a second pair of fasteners adapted to secure the braided metal strands at the proximal and distal ends of the inner metal fabric, respectively.

14. The medical device as in claim 1 further comprising a pair of fasteners adapted to secure the plurality of braided metal strands of the inner and outer fabrics together, each of the pair of fasteners secured individually to all of the strands of the outer and inner metal fabric at the proximal or distal ends thereof.

15. The medical device of claim 1 wherein the expanded preset configuration of the outer metal fabric is of a different geometrical shape than the expanded preset configuration of the inner metal fabric.

16. The medical device of claim 1 wherein the medical device is shaped to create an occlusion of an abnormal opening in a vascular organ.

17. The medical device of claim 1 wherein the medical device is shaped to create an occlusion of an atrial-venous malformation.

18. The medical device of claim 1 wherein the medical device is shaped to create an occlusion of an aneurysm.

19. The medical device of claim 1 wherein the medical device is shaped to create an occlusion of a blood vessel.

20. The medical device of claim 1 wherein the medical device has a proximal face, a distal face and at least two intermediate faces.

21. The medical device of claim 20 wherein the proximal, distal and intermediate faces are at least one of curved or flat in shape.

22. The medical device of claim 1 wherein the medical device has at least one intermediate clamp and at least four faces.

23. The medical device of claim 1 wherein at least one additional metal fabric is disposed between said outer metal fabric and said inner metal fabric.

24. The medical device of claim 1, wherein the sack comprises a plurality of layers of fabric, each layer comprising a plurality of braided metal strands.

25. The medical device of claim 24, wherein one of the plurality of layers of fabric at least partially surrounds the other of the plurality layers of fabric between the proximal and distal ends.

26. The medical device of claim 25, wherein one of the plurality of layers is braided as a cylindrical shape.

27. The medical device of claim 24, wherein the preset expanded configuration comprises at least one expanded volume section between the proximal and distal ends.

28. The medical device of claim 27, wherein the preset expanded configuration comprises a plurality of expanded volume sections, wherein each expanded volume section is separated by a reduced diameter portion having a diameter smaller than the diameter of each of the adjacent expanded volume portions.

29. The medical device of claim 28, wherein each expanded volume section is separated by an intermediate clamp.

30. The medical device of claim 28, wherein each of the expanded volume sections is one of cylindrical or bulbous in shape.

31. The medical device of claim 27, wherein the expanded volume section is one of cylindrical or bulbous in shape.

32. The medical device of claim 24, wherein the at least one fastener comprises a single fastener at the proximal end that secures the plurality of strands of both of the plurality of layers together.

33. The medical device of claim 24, wherein the at least one fastener comprises means for reversible connection to a delivery device.

34. An implantable occluder adapted to occlude a target site in a vessel, the occluder comprising:

a tubular member comprising at least two layers of braided fabric having a preset expanded configuration, each of the layers having proximal and distal ends and layered with respect to one another such that one of the layers extends from the proximal end of the other layer to the distal end of the other layer, each of the layers configured to be constrained to a reduced configuration for delivery to the target site and to at least partially return to the preset expanded configuration within the target site when unconstrained, wherein each of the layers comprises at least three expanded volume sections in the preset expanded configuration, each of the at least three expanded volume sections comprising a proximal and distal face, the at least three expanded volume sections arranged in a repeating pattern with a reduced diameter segment coupling each pair of expanded volume sections, and wherein at least one expanded volume section comprises a cross-sectional dimension at least as large as that of the target site.

35. The occluder of claim 34, wherein the at least three expanded volume sections comprise at least one of a cylindrical, a frustroconical, or an ovaloid in shape.

36. The occluder of claim 34, wherein each of the at least two layers of braided fabric comprises a plurality of braided metal strands.

37. The occluder of claim 36, wherein said plurality of braided metal strands comprises a shape memory alloy.

38. The occluder of claim 34, further comprising at least one end clamp wherein at least one of the proximal and distal ends is secured with the at least one end clamp.

39. The occluder of claim 38, wherein the at least one end clamp comprises a reversible connection configured to be coupled to a delivery device.

40. The occluder of claim 39, wherein the at least one end each clamp comprises a threaded coupler.

41. The occluder of claim 34, wherein the tubular member is configured to be disposed longitudinally within the target site such that at least one expanded volume section is configured to engage a lumen of the target site.

42. The occluder of claim 41, wherein each of the at least one expanded volume sections is configured to engage a lumen of the target site.

43. The occluder of claim 34, wherein a ratio of said tubular member length to a cross-sectional dimension of the at least one expanded volume section is in the range of 1.0-3.0.

44. The occluder of claim 34, wherein the target site is at least one of a vein or an artery.

45. The occluder of claim 34, wherein at least one of the reduced diameter segments is restrained by a clamp.

46. The occluder of claim 34, wherein at least one of the reduced diameter segments is preset by heat setting the tubular member.

47. The occluder of claim 34, comprising a third layer of fabric comprising a plurality of braided strands.

48. The occluder of claim 47, wherein the third layer of fabric comprises a plurality of braided metal strands comprising a shape memory alloy.

49. A medical device, for occlusion of a target vessel in a patient'"'"'s body, comprising:

a sack comprising a plurality of braided strands each of the plurality of braided strands having a proximal end and a distal end, the sack having a closed distal end and an opposing proximal end, the proximal end of the sack corresponding to the proximal and distal ends of each of the plurality of braided strands;

the sack comprising a preset expanded configuration shaped for occluding said target vessel, the expanded preset configuration being deformable to a lesser cross-sectional dimension for delivery through a channel in a patient'"'"'s body, the sack having a memory property such that the medical occlusion device tends to return to the expanded preset configuration when unconstrained; and

at least one fastener at the proximal end adapted to secure the ends of the plurality of braided strands together.