Endoluminal encapsulated stent and methods of manufacture and endoluminal delivery

• US 5,749,880 A
• Filed: 07/27/1995
• Issued: 05/12/1998
• Est. Priority Date: 03/10/1995
• Status: Expired due to Term

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: IMPRA Incorporated (Becton, Dickinson & Co)
• Inventors: Banas, Christopher E., Edwin, Tarun J.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US08/508,033
• Time in Patent Office: 1,020 Days
• Field of Search: 606/191-200, 606/151, 623/1, 623/11, 623/12
• US Class Current: 606/198
• 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 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining

Abstract

An radially expandable stent-graft and method of making the same, including at least one a stent member encapsulated between at least two longitudinally expanded polytetrafluoroethylene (ePTFE) coverings. The at least one stent member has openings through wall surfaces of the stent to permit radial expansion. The at least two longitudinally expanded ePTFE coverings are circumferentially applied over the at least one stent member in their unsintered state, and sintered during application of a circumferential pressure to bond the ePTFE around and through the wall surfaces of the stent. The sintered ePTFE forms a substantially continuous, monolithic and integral encapsulation of the at least one stent. Upon radial expansion of the stent-graft, the stent and the ePTFE node-fibril microstructure radially deform. Radial deformation of the ePTFE encapsulation results in nodal elongation in the axis of radial expansion. After radial expansion of the stent-graft, a substantial bonded area remains intact and maintains the encapsulation of the stent in vivo.

Claims

1. A radially expandable reinforced vascular graft comprising:

at least one tubular radially expandable support member having a plurality of openings passing through walls of the support member, and

an expanded polytetrafluoroethylene tubular member circumferentially surrounding and at least substantially enclosing the at least one tubular radially expandable support member and passing into and through the plurality of openings passing through the walls of the support member, the expanded polytetrafluoroethylene tubular member being radially expandable with the support member to an expanded diameter;

wherein the expanded polytetrafluoroethylene tubular member further comprises a node-fibril microstructure which undergoes nodal elongation during radial expansion to the expanded diameter.

2. The radially expandable reinforced vascular graft of claim 1 wherein the expanded polytetrafluoroethylene tubular member further comprises first and second expanded polytetrafluoroethylene graft members joined together thereby forming an integral structure passing through the openings of said support layer and substantially covering said support.

3. The radially expandable reinforced vascular graft of claim 1 wherein the plurality of openings in the support member are separated by a plurality of struts and the expanded polytetrafluoroethylene tubular member passes through said plurality of openings and between the plurality of struts.

4. The radially expandable reinforced vascular graft of claim 1 wherein the support member further comprises at least one of silver, titanium, Nitinol, stainless steel, gold alloy, tantalum and any suitable plastic material which is radially expandable and resists radial collapse.

5. The radially expandable reinforced vascular graft of claim 1 wherein the support member comprises a stent.

6. The radially expandable reinforced vascular graft of claim 5 wherein the expanded polytetrafluoroethylene tubular member is characterized by having internodal distances within the range of 0.10 to 100 microns.

7. The radially expandable reinforced vascular graft of claim 5 wherein the stent further comprises a balloon expandable stent.

8. The radially expandable reinforced vascular graft of claim 5, wherein the stent further comprises a self-expanding stent.

9. The radially expandable reinforced vascular graft of claim 5, wherein the stent further comprises a nitinol stent.

10. The radially expandable reinforced vascular graft of claim 1, wherein the expanded polytetrafluoroethylene tubular member further comprises first and second expanded polytetrafluoroethylene graft members, the first expanded polytetrafluoroethylene graft member positioned concentrically about an abluminal surface of the at least one radially expandable tubular support member and the second expanded polytetrafluoroethylene graft member positioned concentrically within and adjacent to a luminal surface of the at least one radially expandable tubular support member.

11. The radially expandable reinforced vascular graft of claim 10, wherein the first expanded polytetrafluoroethylene graft member and the second expanded polytetrafluoroethylene graft member have internodal distances which are different from one another.

12. The radially expandable reinforced vascular graft of claim 10, wherein wall thicknesses of said first expanded polytetrafluoroethylene graft member and said second expanded polytetrafluoroethylene graft member are different from one another.

13. The radially expandable reinforced vascular graft of claim 10, wherein the first and second expanded polytetrafluoroethylene tubular members are monolithically bonded to one another together through the openings passing through the at least one radially expandable tubular support member.

14. A radially expandable reinforced vascular graft comprising:

at least one radially expandable tubular support member having a plurality of openings passing through walls thereof; and

at least one longitudinally expanded polytetrafluoroethylene tubular member circumferentially surrounding the at least one radially expandable tubular support member on luminal and abluminal surfaces thereof such that the at least one radially expandable tubular support member is interdisposed and circumferentially enclosed over at least a substantial longitudinal extent thereof;

the at least one longitudinally expanded polytetrafluoroethylene tubular member passing through the plurality of openings in the walls of the tubular support member and radially expandable substantially concurrently with the tubular support member to an expanded diameter;

wherein the at least one longitudinally expanded polytetrafluoroethylene tubular member further comprises a node-fibril microstructure which undergoes nodal elongation during radial expansion to the expanded diameter.

15. The radially expandable reinforced vascular graft of claim 14, wherein the at least one radially expandable tubular support member further comprises a tubular stent having a plurality of openings separated by a plurality of struts.

16. The radially expandable vascular graft according to claim 14, wherein the at least one longitudinally expanded polytetrafluoroethylene tubular member further comprises a biased laminate of first and second longitudinally expanded polytetrafluoroethylene tubular members concentrically joined to one another.

17. The radially expandable reinforced vascular graft of claim 14 wherein the first and second longitudinally expanded polytetrafluoroethylene tubular members are monolithically joined to one another and surround first and second ends of said radially expandable tubular support member.

18. The radially expandable reinforced vascular graft of claim 14, wherein said first and second longitudinally expanded polytetrafluoroethylene tubular members further have internodal distances within the range of 0.10 to 100 microns.

19. The radially expandable reinforced vascular graft of claim 18, wherein the first and second longitudinally expanded polytetrafluoroethylene tubular members are selected to have at least one of differing internodal distances and wall thickness.

20. The radially expandable reinforced vascular graft of claim 14, wherein the at least one radially expandable tubular support member comprises at least two radially expandable tubular shaped support members positioned at predetermined distances from one another such that said radially expandable tubular shaped support members are positioned at opposing ends of each of the at least two longitudinally expanded polytetrafluoroethylene tubular members with an intermediate longitudinal region of the at least two radially expanded polytetrafluoroethylene tubular members being unsupported by a radially expandable tubular shaped support member.

21. The radially expandable vascular graft according to claim 14, wherein the at least one radially expandable tubular support member further comprises an endoluminal stent selected from the group consisting of balloon expandable stents, self expanding stents and nitinol stents.