Stent graft for reinforcement of vascular abnormalities and associated method

• US 8,163,004 B2
• Filed: 02/18/2008
• Issued: 04/24/2012
• Est. Priority Date: 02/18/2008
• 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, Laine, Robert
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Swaminathan, Seema
• Application Number:
  US12/032,938
• Publication Number:
  US 20090210047A1
• Time in Patent Office: 1,527 Days
• Field of Search: 623/1.13, 623/1.15, 623/1.18, 623/1.2, 623/1.53, 606/200
• US Class Current: 623/1.18
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2250/0037 differing in height or in length
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A stent graft for reinforcement of a vascular abnormalities and an associated method are provided. According to one embodiment, the stent graft includes a flexible tubular structure comprising a proximal end and a distal end and having an expanded heat set configuration. The tubular structure is configured to be constrained to a smaller diameter than the expanded heat set configuration, and the tubular structure is heat set such that at least a portion of the proximal and/or distal ends is configured to fold over on itself when unconstrained.

Claims

1. A stent graft for treating a vascular abnormality in a lumen, the stent comprising:

a flexible tubular structure comprising a proximal end and a distal end and having an expanded heat set configuration, wherein the tubular structure is configured to be constrained to a smaller diameter than the expanded heat set configuration, and wherein the tubular structure is heat set such that at least a portion of the proximal and/or distal ends is inverted against, and in direct contact with, itself when unconstrained.

2. The stent graft of claim 1, wherein the tubular structure comprises a plurality of layers of braided strands.

3. The stent graft of claim 2, wherein the plurality of layers comprise respective tubular structures coaxially disposed in an overlying relationship and that are joined together by a connecting member.

4. The stent graft of claim 1, wherein the tubular structure comprises braided strands of an elastic metallic alloy.

5. The stent graft of claim 1, wherein the tubular structure comprises an inner surface and an outer surface, and wherein the tubular structure is inverted against itself when unconstrained such that at least a portion of the inner surface of the tubular structure at the proximal and/or distal ends is facing outwardly to engage the lumen.

6. The stent graft of claim 5, wherein the tubular structure is folded back against itself when unconstrained such that a first portion of the outer surface lies adjacent to, and in direct contact with, a second portion of the outer surface.

7. The stent graft of claim 1, wherein the tubular structure is inverted within itself when unconstrained such that at least a portion of the outer surface of the tubular structure at the proximal end is facing inwardly.

8. The stent graft of claim 1, wherein the tubular structure is inverted against itself about a circumference of the tubular structure when unconstrained.

9. The stent graft of claim 1, wherein the tubular structure is configured to be constrained to a diameter of less than about 15 French for delivery within a catheter.

10. The stent graft of claim 1, wherein the tubular structure is configured to be constrained to a diameter of less than about 12 French for delivery within a catheter.

11. The stent graft of claim 1, wherein the tubular structure is configured to be constrained to a diameter of less than about 10 French for delivery within a catheter.

12. The stent graft of claim 1, wherein the tubular structure is configured to be constrained to a diameter of less than about 8 French for delivery within a catheter.

13. The stent graft of claim 1, wherein the tubular structure is configured to engage the lumen upstream and downstream of an aneurysm.

14. The stent graft of claim 1, wherein the tubular structure is inverted against itself without applying a compressive force thereto or employing a weakened fold line.

15. The stent graft of claim 1, wherein a ratio of a diameter of the expanded heat set configuration to the smaller second diameter is within the range of about 3:

1 to 7;

1.

16. The stent graft of claim 1, wherein the tubular structure is configured to be elongated from the expanded heat set configuration to a smaller diameter whereby the tubular structure is unfolded prior to deploying the tubular structure.

17. The stent graft of claim 1, wherein the proximal and/or distal end of the tubular structure is folded back against itself when unconstrained such that a first portion of the tubular structure at the proximal and/or distal end lies adjacent to, and in direct contact with, a second portion of the tubular structure along an entire length thereof.

18. A method for treating a vascular abnormality in a lumen, the method comprising:

constraining a stent graft to a smaller diameter than an expanded heat set configuration;

delivering the stent graft proximate to the vascular abnormality in the lumen; and

deploying the stent graft such that at least a portion of the proximal and/or distal ends self expands from the constrained smaller diameter and returns to its expanded heat set configuration, inverts over against, and in direct contact with, itself, and engages the lumen.

19. The method of claim 18, wherein deploying comprises deploying the stent graft such that the stent graft engages the lumen upstream and downstream of an aneurysm.

20. The method of claim 18, wherein deploying comprises urging the stent graft distally after the distal end initially expands outwardly to engage the lumen.

21. The method of claim 20, wherein deploying comprises further deploying the stent graft after the distal end is urged distally such that the distal end inverts against itself.

22. The method of claim 18, wherein deploying comprises deploying the stent graft such that at least a portion of an inner surface of the stent graft at the distal end inverts to face outwardly to engage the lumen.

23. The method of claim 18, wherein deploying comprises deploying the stent graft such that at least a portion of the stent inverts against itself about a circumference thereof.

24. The method of claim 18, wherein constraining comprises radially compressing the stent graft to a diameter of less than about 15 French.

25. The method of claim 18, wherein constraining comprises elongating the stent graft to a smaller diameter whereby the stent graft is unfolded prior to the deploying step.

26. The method of claim 18, wherein delivering comprises delivering the stent graft over a guide wire.

27. A stent graft for treating a vascular abnormality in a lumen, the stent graft comprising:

a tubular structure comprising an occlusive material and having a proximal end and a distal end, wherein the tubular structure has an expanded heat set configuration and is configured to be elongated to a smaller diameter than the expanded heat set configuration whereby the tubular structure is unfolded prior to being deployed, and wherein the tubular structure is heat set such that at least a portion of the tubular structure is folded over against, and in direct contact with, itself when deployed.

28. The stent graft of claim 27, wherein the tubular structure is heat set such that at least a portion of the proximal and/or distal ends is inverted against itself when deployed.

29. The stent graft of claim 28, wherein the tubular structure comprises an inner surface and an outer surface, and wherein the tubular structure is inverted against itself when deployed such that at least a portion of the inner surface of the tubular structure at the proximal and/or distal ends is facing outwardly to engage the lumen.

30. The stent graft of claim 27, wherein the occlusive material comprises braided strands.

31. A stent graft for treating a vascular abnormality in a lumen, the stent comprising:

a flexible tubular structure having an expanded heat set configuration including one or more folded portions, wherein the tubular structure is configured to be constrained to a smaller diameter than the expanded heat set configuration whereby the tubular structure is unfolded prior to being deployed, and wherein the tubular structure is heat set such that at least a portion of the tubular structure is folded over against, and in direct contact with, itself when unconstrained.