Expandable covered stent with wide range of wrinkle-free deployed diameters

• US 8,425,584 B2
• Filed: 04/21/2006
• Issued: 04/23/2013
• Est. Priority Date: 04/21/2006
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Cully, Edward H., Vonesh, Michael J.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US11/408,474
• Publication Number:
  US 20070250153A1
• Time in Patent Office: 2,559 Days
• Field of Search: 623/1.1, 623/1.12, 623/1.13, 623/1.15, 623/1.18, 623/1.19, 623/1.2, 623/1.44, 623/1.46
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: Y10T 29/49908 Joining by deforming
• CPC Class Codes: Y10T 29/49911 by expanding inner annulus
• CPC Class Codes: Y10T 29/49913 by constricting outer annulus

Abstract

An improved stent-graft device is provided that delivers a smooth flow surface over a range of operative expanded diameters by applying a unique cover material to the stent through a technique that allows the cover to become wrinkle-free prior to reaching fully deployed diameter. The unique cover material then allows the device to continue to expand to a fully deployed diameter while maintaining a smooth and coherent flow surface throughout this additional expansion. Employed with a self-expanding device, when the device is unconstrained from a compacted diameter it will self-expand up to a fully deployed diameter with the graft being substantially wrinkle-free over diameters ranging from about 30-50% to 100% of the fully deployed diameter.

Claims

1. A diametrically self-expanding stent-graft comprising:

a self-expanding stent having an inside and an outside and provided with a graft covering attached to at least a portion of the stent, the graft covering applied to only one of the inside or outside of the stent, the graft comprising an ePTFE film possessing a density in a range of about 0.2 to about 0.6 g/cc, a matrix tensile strength in a range of about 70 to about 550 MPa in a longitudinal direction and in a range of about 15 to about 50 MPa in a transverse direction, and a Young'"'"'s modulus in a range of about 100 to about 500 MPa in the longitudinal direction and in a range of about 0.5 to about 20 MPa in the transverse direction, wherein the longitudinal direction of the ePTFE film is substantially aligned with a longitudinal axis of the self-expanding stent, wherein the ePTFE film is exceedingly distensible in the transverse direction;

wherein said stent-graft has a compacted diameter for insertion into a body conduit; and

wherein the stent-graft when unconstrained from the compacted diameter up to a fully self expanded deployed diameter of the stent, said graft being substantially wrinkle-free over diameters ranging from 50% to 100% of fully deployed diameter.

2. The stent-graft of claim 1 wherein the graft has a thickness of less than about 0.25 mm.

3. The stent-graft of claim 1 wherein the ePTFE includes a microstructure of fibrils, the fibrils being generally oriented parallel to the longitudinal axis of the stent.

4. The stent-graft of claim 1 wherein the ePTFE is sintered.

5. The stent-graft of claim 1 wherein an adhesive material is coated on the ePTFE.

6. The stent-graft of claim 1 wherein the graft comprises a porous material.

7. The stent-graft of claim 1 wherein the graft comprises a non-porous material.

8. The stent-graft of claim 1 wherein the graft comprises a permeable material.

9. The stent-graft of claim 1 wherein the graft comprises an impermeable material.

10. The stent-graft of claim 1 wherein the graft is substantially wrinkle-free over a diameters ranging from about 30% to 100%.

11. The stent-graft of claim 1 wherein the graft has an inner-surface and the inner-surface comprises only fluoropolymer.

14. The stent-graft of claim 1 wherein the ePTFE film possesses a density in a range of about 0.3 to about 0.5 g/cc.

15. The stent-graft of claim 1 wherein the ePTFE film possesses a matrix tensile strength in the range of about 150 to about 400 MPa in the longitudinal direction and in the range of about 20 to about 40 MPa in the transverse direction.

16. The stent-graft of claim 1 wherein the ePTFE film possesses a Young'"'"'s modulus in the range of about 200 to about 400 MPa in the longitudinal direction and in the range of about 1 to about 10 MPa in the transverse direction.

17. The stent-graft of claim 1 wherein the ePTFE film possesses a Young'"'"'s modulus of about 300 MPa in the longitudinal direction and about 2 MPa in the transverse direction.

18. The stent-graft of claim 1 wherein the ePTFE film possesses a thickness of about 0.02 mm, a density of about 0.4 g/cc, a longitudinal matrix strength of about 260 MPa, and a transverse matrix tensile strength of about 30 MPa.

12. A diametrically expandable stent-graft comprising:

a self-expanding stent provided with a graft covering over at least a portion of the outer surface of the stent, the graft comprising an ePTFE film possessing a density in a range of about 0.2 to about 0.6 a/cc, a matrix tensile strength in a range of about 70 to about 550 MPa in a longitudinal direction and in a range of about 15 to about 50 MPa in a transverse direction and a Young'"'"'s modulus in a range of about 100 to about 500 MPa in the longitudinal direction and in a range of about 0.5 to about 20 MPa in the transverse direction, wherein the longitudinal direction of the ePTFE film is substantially aligned with a longitudinal axis of the self-expanding stent, wherein the ePTFE film is exceedingly distensible in the transverse direction,

wherein said stent has a compacted diameter for insertion into a body conduit and self-expands following release from the compacted diameter to a fully deployed diameter of the stent, wherein said graft covering is substantially wrinkle-free over diameters ranging from 50% to 100% of the fully deployed diameter.

19. The stent-graft of claim 12 wherein the ePTFE film possesses a density in a range of about 0.3 to about 0.5 g/cc.

20. The stent-graft of claim 12 wherein the ePTFE film possesses a matrix tensile strength in the range of about 150 to about 400 MPa in the longitudinal direction and in the range of about 20 to about 40 MPa in the transverse direction.

21. The stent-graft of claim 12 wherein the ePTFE film possesses a Young'"'"'s modulus in the range of about 200 to about 400 MPa in the longitudinal direction and in the range of about 1 to about 10 MPa in the transverse direction.

22. The stent-graft of claim 12 wherein the ePTFE film possesses a Young'"'"'s modulus of about 300 MPa in the longitudinal direction and about 2 MPa in the transverse direction.

23. The stent-graft of claim 12 wherein the ePTFE film possesses a thickness of about 0.02 mm, a density of about 0.4 g/cc, a longitudinal matrix strength of about 260 MPa, and a transverse matrix tensile strength of about 30 MPa.

13. A diametrically self-expanding stent-graft comprising:

a self-expanding stent having an inside and an outside and provided with at least one graft covering attached to at least a portion of the stent, the graft comprising an ePTFE film possessing a density in a range of about 0.2 to about 0.6 q/cc, a matrix tensile strength in a range of about 70 to about 550 MPa in a longitudinal direction and in a range of about 15 to about 50 MPa in a transverse direction, and a Young'"'"'s modulus in a range of about 100 to about 500 MPa in the longitudinal direction and in a range of about 0.5 to about 20 MPa in the transverse direction, wherein the longitudinal direction of the ePTFE film is substantially aligned with a longitudinal axis of the self-expanding stent, wherein the ePTFE film is exceedingly distensible in the transverse direction,

wherein said stent-graft has a compacted diameter for insertion into a body conduit; and

wherein when the stent-graft fully self expands from the compacted diameter up to a fully deployed diameter of the stent, said graft covering is adapted to be substantially wrinkle-free over diameters ranging from 50% to 100% of the fully deployed diameter.

24. The stent-graft of claim 13 wherein the ePTFE film possesses a density in a range of about 0.3 to about 0.5 g/cc.

25. The stent-graft of claim 13 wherein the ePTFE film possesses a matrix tensile strength in the range of about 150 to about 400 MPa in the longitudinal direction and in the range of about 20 to about 40 MPa in the transverse direction.

26. The stent-graft of claim 13 wherein the ePTFE film possesses a Young'"'"'s modulus in the range of about 200 to about 400 MPa in the longitudinal direction and in the range of about 1 to about 10 MPa in the transverse direction.

27. The stent-graft of claim 13 wherein the ePTFE film possesses a Young'"'"'s modulus of about 300 MPa in the longitudinal direction and about 2 MPa in the transverse direction.

28. The stent-graft of claim 13 wherein the ePTFE film possesses a thickness of about 0.02 mm, a density of about 0.4 g/cc, a longitudinal matrix strength of about 260 MPa, and a transverse matrix tensile strength of about 30 MPa.