DEVICE AND METHOD FOR TREATING VASCULAR ABNORMALITIES

• US 20130073026A1
• Filed: 09/20/2011
• Published: 03/21/2013
• Est. Priority Date: 09/20/2011
• 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, Oslund, John, Heidner, Matthew C., Akers, Jessica
• Granted Patent: US 8,621,975 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0017 differing in yarn density
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: B21F 45/008 of medical instruments, e.g. stents, corneal rings medical science A61

Abstract

A vascular device is provided that includes a tubular structure and an occluding structure. The tubular structure has inner and outer layers, with the occluding structure located between the inner and outer layers. Each of the inner and outer layers may define a different pick count, and the tubular structure may include a leading edge at a transition between the pick counts. The leading edge may be disposed at the distal end of the vascular device when the device is deployed from a delivery device. Furthermore, the occluding structure may have first and second layers formed by the inversion or eversion of the occluding structure and the subsequent coupling of its free ends to form a continuous structure. Thus, any loose ends may be sealed to minimize unraveling and/or shifting of the occluding structure within the tubular structure. A method of making the vascular device is also provided.

Claims

1. A vascular device configured to move between a contracted state when constrained within a delivery device and an expanded state when deployed from the delivery device for delivery to a target site within the body lumen, wherein the vascular device includes a proximal end and a distal end, the vascular device comprising:

a tubular structure comprising an inner layer and an outer layer, wherein the inner layer defines a first pick count and the outer layer defines a second pick count,

wherein the inner layer of the tubular structure is continuously braided with the outer layer of the tubular structure,

wherein the first pick count, as braided, is different from the second pick count, as braided, and

wherein the first and second pick counts are selected such that the relationship between the reduction in diameter and the elongation of the inner layer is substantially the same as the relationship between the reduction in diameter and the elongation of the outer layer as the vascular device is moved between the expanded state and the contracted state.

2. The vascular device of claim 1, wherein the tubular structure comprises a leading edge at a transition between the first pick count and the second pick count, and wherein the leading edge is disposed proximate the distal end of the vascular device when the vascular device is in the expanded state.

3. The vascular device of claim 2, wherein the leading edge is disposed within an interior of the vascular device when the vascular device is in the contracted state and is configured to move to the distal end as the vascular device is deployed from the delivery device.

4. The vascular device of claim 1, wherein each of the inner and outer layers of the tubular structure comprises a free end proximate the proximal end of the vascular device.

5. The vascular device of claim 1, wherein the first pick count, as braided, is higher than the second pick count, as braided.

6. The vascular device of claim 1 further comprising an occluding structure disposed between the inner and outer layers of the tubular structure, wherein the occluding structure is tubular in shape and comprises a first layer and a second layer disposed between the inner and outer layers of the tubular structure.

7. The vascular device of claim 6, wherein the first and second layers of the occluding structure form a continuous structure via a coupling of free ends of the occluding structure.

8. The vascular device of claim 7, wherein the coupled free ends are disposed adjacent the inner layer of the tubular structure.

9. The vascular device of claim 6, wherein the occluding structure is attached to at least one of the inner layer or the outer layer of the tubular structure.

10. The vascular device of claim 6, wherein the occluding structure comprises a polymer material.

11. The vascular device of claim 6, wherein the occluding structure extends substantially from the distal end of the vascular device substantially to the proximal end of the vascular device.

12. The vascular device of claim 6, wherein the outer layer of the tubular structure includes a section of increased thickness configured to maintain the vascular device within a delivery device prior to deployment.

13. The vascular device of claim 1, wherein, in the expanded state, the inner layer of the tubular structure defines a length that is greater than a length defined by the outer layer of the tubular structure.

14. A method of making a vascular device for placement in a body lumen comprising:

braiding a tubular structure including a proximal portion and a distal portion, wherein the proximal portion defines a first pick count and the distal portion defines a second pick count, the first pick count being different than the second pick count; and

folding the tubular structure onto itself such that a surface of the proximal portion of the tubular structure is adjacent a surface of the distal portion of the tubular structure to form an inner layer and an outer layer,

wherein, after being folded, the relationship between the reduction in diameter and the elongation of the inner layer is substantially the same as the relationship between the reduction in diameter and the elongation of the outer layer as the vascular device is moved between an expanded state and a contracted state.

15. The method of claim 14, wherein the step of folding the tubular structure onto itself comprises defining a leading edge at a transition between the first pick count and the second pick count.

16. The method of claim 15 further comprising heat setting the tubular structure proximate the transition.

17. The method of claim 14, wherein the second pick count is lower than the first pick count, and wherein the step of folding the tubular structure onto itself comprises everting the tubular structure, such that the distal portion forms the outer layer.

18. The method of claim 14, wherein the second pick count is higher than the first pick count, and wherein the step of folding the tubular structure onto itself comprises inverting the tubular structure, such that the distal portion forms the inner layer.

19. The method of claim 14 further comprising placing an occluding structure between the inner and outer layers of the tubular structure.

20. The method of claim 19 further comprising attaching the occluding structure to at least one of the inner layer of the tubular structure or the outer layer of the tubular structure.

21. The method of claim 19 further comprising forming a section of increased thickness proximate a distal end of the outer layer of the tubular structure.

22. The method of claim 19 further comprising folding the occluding structure onto itself and coupling the ends thereof together to form first and second layers of the occluding structure.

23. The method of claim 22, wherein the coupled ends of the occluding structure define a seam, and wherein the seam is disposed proximate the distal end of the tubular structure.

24. A vascular device for placement in a body lumen, wherein the vascular device includes a proximal end and a distal end, the vascular device comprising:

a tubular structure comprising an inner layer and an outer layer, wherein the tubular structure comprises braided metal strands; and

an occluding structure comprising a first layer and a second layer disposed between the inner and outer layers of the tubular structures, wherein the occluding structure is independent of the tubular structure, and wherein the occluding structure comprises a polymer material.

25. The vascular device of claim 24, wherein the first and second layers of the occluding structure form a continuous structure via a coupling of free ends of the occluding structure.

26. The vascular device of claim 25, wherein the coupled ends of the occluding structure define a seam, and wherein the seam is disposed proximate the distal end of the tubular structure.

27. The vascular device of claim 24, wherein the vascular device is configured to move between a contracted state when constrained within a delivery device and an expanded state when deployed from the delivery device for delivery to a target site within the body lumen.

28. The vascular device of claim 27, wherein the inner layer of the tubular structure comprises a first pick count, as braided, and the outer layer of the tubular structure comprises a second pick count, as braided, and wherein the relationship between the reduction in diameter and the elongation of the inner layer is substantially the same as the relationship between the reduction in diameter and the elongation of the outer layer as the vascular device is moved between an expanded state and a contracted state.

29. The vascular device of claim 27, wherein the tubular structure comprises a leading edge at a transition between the first pick count and the second pick count, and wherein the leading edge is disposed proximate the distal end of the vascular device when the vascular device is in the expanded state.

30. The vascular device of claim 29, wherein the leading edge is disposed in an interior of the vascular device when the vascular device is in the contracted state and is configured to move toward the distal end as the vascular device is deployed from the delivery device.

31. A method of making a vascular device for placement in a body lumen comprising:

braiding a tubular structure including a proximal portion and a distal portion;

folding the tubular structure onto itself such that a surface of the proximal portion of the tubular structure is adjacent a surface of the distal portion of the tubular structure to form an inner layer and an outer layer;

folding an occluding structure onto itself, wherein the occluding structure is independent of the tubular structure; and

placing the occluding structure between the inner and outer layers of the tubular members.

32. The method of claim 31 further comprising coupling ends of the occluding structure together to form first and second layers of the occluding structure.

33. The method of claim 32, wherein the coupled ends of the occluding structure define a seam, and wherein the seam is disposed proximate the distal end of the tubular structure.

34. The method of claim 31 further comprising attaching the occluding structure to at least one of the inner layer or the outer layer of the tubular structure to hold the occluding structure in place.

35. The method of claim 31, wherein the proximal portion of the tubular structure defines a first pick count and the distal portion of the tubular structure defines a second pick count, wherein the first pick count, as braided, is different from the second pick count, as braided, and the relationship between the reduction in diameter and the elongation of the inner layer is substantially the same as the relationship between the reduction in diameter and the elongation of the outer layer as the vascular device is moved between an expanded state and a contracted state.

36. The method of claim 35, wherein the step of folding the tubular structure onto itself comprises defining a leading edge at a transition between the first pick count and the second pick count.