Elastic stent graft

Patent metadata

Field	Value
Publication number	US-11357611-B2
Application number	US-201916248490-A
Country	US
Kind code	B2
Filing date	Jan 15, 2019
Priority date	Nov 13, 2012
Publication date	Jun 14, 2022
Grant date	Jun 14, 2022

Abstract

A stent graft including a stent having a wall having at least one opening, an outer surface, and an inner surface and a covering of a composite material having a least one expanded fluoropolymer membrane and an elastomer is provided. The cover can be used to cover the outer and/or the inner surface of the stent. The expanded fluoropolymer membrane contains serpentine fibrils. In exemplary embodiments, the fluoropolymer is polytetrafluoroethylene. The composite material may be axially and/or circumferentially wrapped around the stent. The composite material is fold-free throughout its operating diameter range and exhibits a sharp increase in stiffness at a predetermined diameter. The stent graft can be designed to have a stop point in either a radial or axial direction. The stent graft can advantageously be implanted undersized with respect to a nominal diameter without having material infolding.

First claim

What is claimed is:

1. A method of manufacturing an implantable tubular member comprising:
positioning a tubular member comprising a composite material under tension sufficient to overcome a retraction force of said composite material on at least one surface of a stent at an expanded diameter of said stent; and
bonding said tubular member to said stent,
wherein said composite material comprises at least one expanded fluoropolymer membrane and an elastomer, and
wherein said at least one expanded fluoropolymer membrane comprises serpentine fibrils, wherein each serpentine fibril curves or turns generally one direction and then generally in another direction.

2. The method of claim 1 , wherein each serpentine fibril of said serpentine fibrils has a width of about 1.0 micron or less.

3. The method of claim 2 , wherein each said serpentine fibril has a width of about 0.5 micron or less.

4. The method of claim 1 , wherein said tubular member is wrinkle-free before a loading and after a deployment of said tubular member.

5. The method of claim 1 , wherein said at least one surface of the stent is at least one of an outer surface and an inner surface of said stent.

6. The method of claim 1 , wherein said at least one expanded fluoropolymer membrane comprises a plurality of pores and said elastomer is present in substantially all of said pores.

7. The method of claim 1 , further comprising applying an adhesive to said stent prior to positioning said tubular member on said at least one surface of said stent.

8. The method of claim 1 , wherein the expanded fluoropolymer membrane comprises a microstructure of substantially only said serpentine fibrils.

9. The method of claim 1 , wherein the fluoropolymer membrane comprises polytetrafluoroethylene.

10. The method of claim 1 , wherein the fluoropolymer membrane comprises a microstructure of substantially only a plurality of fibrils, including said serpentine fibrils.

11. The method of claim 1 , wherein said tubular member is wrinkle-free when expanded to about 80% of a nominal diameter.

12. The method of claim 1 , wherein said tubular member has a diameter substantially larger than a nominal diameter.

13. The method of claim 1 , wherein said bonding step occurs substantially at room temperature.

14. The method of claim 1 , wherein said tubular member in a relaxed state has a diameter substantially smaller than said expanded diameter of said stent.

15. A method of manufacturing an implantable tubular member comprising:
positioning an expanded fluoropolymer membrane having therein an elastomer under tension sufficient to overcome a retraction force of said fluoropolymer membrane onto a mandrel;
bonding said fluoropolymer membrane to itself to form a tubular member; and
removing said tubular membrane from said mandrel,
wherein said expanded fluoropolymer membrane comprises serpentine fibrils, wherein each serpentine fibril curves or turns generally one direction and then generally in another direction.

16. An implantable tubular member comprising:
a composite material having at least one expanded fluoropolymer membrane and an elastomer, the at least one expanded fluoropolymer membrane comprising a plurality of serpentine fibrils such that the composite material of the implantable tubular member is configured to cause the implantable tubular member to be wrinkle-free at an unexpanded diameter and wrinkle-free at a second diameter that is larger than the unexpanded diameter.

17. The implantable tubular member of claim 16 , further comprising a stent having a wall having at least one opening, an outer surface, and an inner surface, the stent being coupled to the implantable tubular member.

18. The implantable tubular member of claim 16 , wherein the elastomer is imbibed into the at least one fluoropolymer membrane.

19. An implantable tubular member having an inner lumen and an outer surface, the implantable tubular member comprising:
a tubular member formed of a composite material including an elastomer and an expanded fluoropolymer with a microstructure comprising nodes interconnected by S-shaped fibrils; and
a stent coupled to the tubular member and having a wall having one or more openings, the stent being coupled to the tubular member such that the stent is configured to transition the implantable tubular member from a delivery profile to an expanded profile that is larger than the delivery profile and such that the tubular member exhibits substantially no material infolding into the inner lumen of the implantable tubular member when the implantable tubular member is compacted from the expanded profile to the delivery profile,

wherein each fibril curves or turns generally one direction and then generally in another direction.

20. The implantable tubular member of claim 19 , wherein the implantable tubular member exhibits substantially no infolding of the tubular member when a portion of the implantable tubular member is compacted to a smaller profile than the expanded profile.

21. The implantable tubular member of claim 19 , wherein the elastomer is imbibed into the fluoropolymer membrane.

Assignees

• Gore & Ass

Inventors

• Cully Edward H
• Duncan Jeffrey B
• Kariniemi Ryan D
• Kariniemi Thomas E
• Kustusch Jeffrey J
• Nelson Jared S

Classifications

• A61F2002/072

  Encapsulated stents, e.g. wire or whole stent embedded in lining · CPC title

• A61F2/07 Primary

  Stent-grafts · CPC title

• A61L31/048

  obtained by reactions only involving carbon-to-carbon unsaturated bonds (A61L31/041 takes precedence) · CPC title

• C08L27/18

  Homopolymers or copolymers or tetrafluoroethene · CPC title