Elastic stent graft

Patent metadata

Field	Value
Publication number	US-2019216592-A1
Application number	US-201916248490-A
Country	US
Kind code	A1
Filing date	Jan 15, 2019
Priority date	Nov 13, 2012
Publication date	Jul 18, 2019
Grant date	—

Abstract

A stent graft including (1) a stent having a wall having at least one opening, an outer surface, and an inner surface and (2) 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

1 .- 16 . (canceled)

17 . A method of manufacturing a stent graft comprising:
positioning a cover comprising a composite material under tension sufficient to overcome the retraction force of said composite material on at least one surface of a stent at an expanded diameter of said stent to form a stent graft; and bonding said cover to said stent, wherein said composite material comprises at least one expanded fluoropolymer membrane and an elastomer, and wherein said expanded fluoropolymer membrane comprises serpentine fibrils.

18 . The method of claim 17 , wherein each said serpentine fibril has a width of about 1.0 micron or less.

19 . The method of claim 18 , wherein each said serpentine fibril has a width of about 0.5 micron or less.

20 . The method of claim 17 , wherein said cover is wrinkle-free before loading and after deployment.

21 . The method of claim 17 , wherein said cover is positioned on at least one of an outer surface and an inner surface of said stent.

22 . The method of claim 17 , wherein said at least one expanded fluoropolymer membrane comprises a plurality of pores and said elastomer is present in substantially all of said pores.

23 . The method of claim 17 , further comprising applying an adhesive to said stent prior to positioning said cover on said at least one surface of said stent.

24 . The method of claim 17 , wherein the expanded fluoropolymer membrane comprises a microstructure of substantially only serpentine fibrils.

25 . The method of claim 17 , wherein the fluoropolymer membrane comprises polytetrafluoroethylene.

26 . The method of claim 17 , wherein the fluoropolymer membrane comprises a microstructure of substantially only fibrils.

27 . The method of claim 17 , wherein when said cover is wrinkle-free when expanded to about 80% of a nominal diameter.

28 . The method of claim 17 , wherein said cover has a diameter substantially larger than said nominal diameter.

29 . The method of claim 17 , wherein said bonding step occurs substantially at room temperature.

30 . The method of claim 17 , wherein said cover in a relaxed state has a diameter substantially smaller than said expanded diameter of said stent.

31 . The method of claim 17 , wherein the fluoropolymer membrane comprises a plurality of serpentine fibrils.

32 . A method of manufacturing a tubular member comprising:
positioning an expanded fluoropolymer membrane having therein an elastomer under tension sufficient to overcome the 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.

33 . A medical device comprising:
a cover comprising a composite material having at least one expanded fluoropolymer membrane and an elastomer, the expanded fluoropolymer membrane comprising a plurality of serpentine fibrils such that the composite material of the cover is configured to cause the cover to be wrinkle-free at a first diameter and wrinkle-free at a second diameter that is larger than the first diameter.

34 . The medical device of claim 33 , 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 cover.

35 . The medical device of claim 33 , wherein the elastomer is imbibed into the fluoropolymer membrane.

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

37 . The stent graft of claim 36 , wherein the stent graft exhibits substantially no infolding of the cover when a portion of the stent graft is compacted to a smaller profile than the expanded profile.

38 . The medical device of claim 36 , 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

• A61F2/07 Primary

  Stent-grafts · CPC title

• A61F2002/072

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

• A61L31/048

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