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

• US 20070250153A1
• Filed: 04/21/2006
• Published: 10/25/2007
• 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: Vonesh, Michael, Cully, Edward
• Granted Patent: US 8,425,584 B2
• Time in Patent Office: Days
• US Class Current: 623/1.130
• 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;

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 deployed diameter, 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 graft comprises ePTFE.

4. The stent-graft of claim 3 wherein the ePTFE comprises a film.

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

6. The stent-graft of claim 3 wherein the ePTFE is sintered.

7. The stent-graft of claim 3 wherein an adhesive material is coated on the ePTFE.

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

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

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

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

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

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

14. A process for producing the stent-graft of claim 1 wherein the graft is attached to the stent without the use of a mandrel.

15. A process for producing the stent-graft of claim 1 wherein the graft is attached to the stent without the use of heat.

16. 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,

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, wherein said graft covering is substantially wrinkle-free over diameters ranging from 50% to 100% of the fully deployed diameter.

17. 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,

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

and

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

18. A method of producing a stent-graft device that comprises

providing a stent;

applying adhesive to the stent;

chilling the stent;

reducing the stent in diameter while chilled;

providing a tubular cover;

inserting the tubular cover into a tubular constraining device;

chilling the cover and constraining device;

inserting the chilled stent inside the cover to create an assembly;

adhering the stent and cover together to create the stent-graft.

19. The method of claim 18 that further comprises adhering the stent and cover together at a temperature warmer than the temperature at which the stent was chilled.

20. The method of claim 18 that further comprises compacting the resulting stent-graft and placing into a delivery system.