Fenestrated prosthesis

• US 8,945,202 B2
• Filed: 04/28/2010
• Issued: 02/03/2015
• Est. Priority Date: 04/28/2009
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation, Endologix
• Original Assignee: Cleveland Clinic Foundation, Endologix
• Inventors: Mayberry, Kevin, Clair, Daniel, Welk, Craig, Schreck, Stefan G.
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US12/769,581
• Publication Number:
  US 20110054594A1
• Time in Patent Office: 1,742 Days
• Field of Search: 606/108, 606151-156, 606191-200, 623 111- 154, 623 21- 242, 623 1111- 1512
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: Y10T 29/49863 with prestressing of part

Abstract

Some embodiments of the present disclosure are directed to endoluminal prostheses having one or more reinforced fenestrations therein. The one or more reinforced fenestrations can have improved sealing capabilities with respect to branch grafts deployed within the fenestrations, improved tear resistance and expandability, and improved pull-out resistance for branch grafts. In some embodiments, the endoluminal prosthesis can have a main graft body defining a flow lumen therethrough, a first opening passing through a wall of the main graft body, and a first support member supported by the main graft body and overlapping an edge of the first opening, the first support member being configured to at least increase the tear resistance of the main graft body adjacent to the first opening. The support member can be stitched or otherwise attached to the main graft adjacent to the fenestration.

Claims

1. An endoluminal prosthesis comprising:

a main graft body defining a flow lumen therethrough, an inside surface, and an outside surface;

a first opening passing through a wall of the main graft body; and

a first support member having an inside surface, an outside surface, and a lumen therethrough defined by the inside surface, the first support member also having a first end, a second end, and a middle portion extending between the first and second ends;

wherein;

the first support member is positioned within the first opening so as to overlap an edge of the first opening;

the first end of the first support member is fixed to the inside surface of the main graft body adjacent to and around the first opening;

the second end of the first support member is fixed to the outside surface of the main graft body adjacent to and around the first opening;

the first support member comprises a tubular graft having an inner diameter that is larger than an unstretched diameter of the first opening; and

when the first and second ends of first support member have been fixed to the inside and outside surfaces of the main graft body, a length along the outside surface of the first support member between a midpoint between said first and second ends of the first support member and the first end of the first support member where the first end is fixed to the main graft body is greater than a length along the main graft body between an edge of the first opening and where the first end of the first support member is fixed to the main graft body, such that the first support member is generally spaced apart from the main graft body between the first opening in the main graft body and the first end of the first support member where the first end is fixed to the main graft body.

2. The endoluminal prosthesis of claim 1, wherein the first support member comprises a tubular graft having an inner diameter that is significantly larger than an unstretched diameter of the first opening.

3. The endoluminal prosthesis of claim 1, wherein the tubular graft has an inner diameter that is at least twice as large as a diameter of the first opening in an unstretched state of the first opening.

4. The endoluminal prosthesis of claim 1, wherein the tubular graft has an inner diameter that is at least four times as large as a diameter of the first opening in an unstretched state of the first opening.

5. The endoluminal prosthesis of claim 1, further comprising a radiopaque marker supported by the endoluminal prosthesis adjacent to the first opening.

6. The endoluminal prosthesis of claim 1, further comprising a second opening passing through the wall of the main graft body and a second support member supported by the main graft body and overlapping an edge of the second opening.

7. The endoluminal prosthesis of claim 6, wherein the first and second openings are separated by an angle of approximately 150 degrees.

8. The endoluminal prosthesis of claim 1, wherein the main graft body comprises a first portion and a second portion, the second portion having a cross-sectional size that is significantly larger than a cross-sectional size of the first portion and also significantly larger than a cross-sectional size of a target vessel of the endoluminal prosthesis, and wherein the first opening is positioned in the second portion.

9. The endoluminal prosthesis of claim 8, wherein the cross-sectional size of the second portion is from approximately 20% to approximately 40% larger than the cross-sectional size of a target vessel of the endoluminal prosthesis.

10. The endoluminal prosthesis of claim 1, further comprising a bare or covered stent advanceable through the first opening and first support member.

11. The endoluminal prosthesis of claim 1, wherein the main graft body is bifurcated.

12. The endoluminal prosthesis system of claim 1, wherein the main graft body is formed from a bi-directionally expanded, layered PTFE material.

13. A method of forming an endoluminal prosthesis having at least one reinforced fenestration in a main portion thereof, comprising:

forming a graft body having a tubular main body portion, the main body portion having an inside surface and an outside surface, and defining a lumen therethrough;

forming a first opening through a wall of the main body portion, the first opening having a first state in which the first opening is substantially unstretched and a second state in which the first opening is stretched so that a size of the first opening increases;

advancing a tubular member having a first end and a second end partially through the first opening so that the first end is positioned within the lumen of the main body portion, the second end is positioned outside of the main body portion, and so that the tubular member completely overlaps an edge of the first opening;

positioning the first end of the tubular member against the inside surface of the main body portion adjacent to and around the first opening;

fastening the first end of the tubular member to the inside surface of the main body portion adjacent to and around the first opening;

positioning the second end of the tubular member against the outside surface of the main body portion adjacent to and around the first opening; and

fastening the second end of the tubular member to the outside surface of the main body portion adjacent to and around the first opening;

wherein;

the tubular member is seamless along an entire length of the tubular member between the first end where the tubular member is fastened to the inside surface of the main body portion and the second end where the tubular member is fastened to the outside surface of the main body portion; and

a length of the tubular member between the first end and the second end is greater than a sum of a distance from the first opening of the main body portion to the first end of the tubular member where said first end is fastened to the main body portion, a distance from the first opening of the main body portion to the second end of the tubular member where said second end is fastened to the main body portion, and the thickness of the main body portion, to thereby provide a seal length against which an outside surface of a branch graft deployable within the inside of said tubular member and through the first opening of the main body portion may seal.

14. The method of forming an endoluminal prosthesis of claim 13, wherein the tubular member has an inner diameter that is significantly larger than the size of the first opening in the first state.

15. The method of forming an endoluminal prosthesis of claim 13, wherein the tubular member has an inner diameter that is at least twice as large as a diameter of the first opening in the first state.

16. The method of forming an endoluminal prosthesis of claim 13, wherein the tubular member has an inner diameter that is at least four times as large as a diameter of the first opening in the first state.

17. The method of forming an endoluminal prosthesis of claim 13, further comprising positioning a radiopaque marker adjacent to the first opening.

18. The method of forming an endoluminal prosthesis of claim 13, further comprising forming a second opening through the wall of the main body portion, the second opening having a first state in which the second opening is substantially unstretched and a second state in which the second opening is stretched so that a size of the second opening increases.

19. The method of forming an endoluminal prosthesis of claim 18, further comprising advancing a second tubular member partially through the second opening and fastening a first end and a second end of the second tubular member to the wall of the main body portion adjacent to the second opening so that the tubular member completely overlaps an edge of the second opening.

20. The method of forming an endoluminal prosthesis of claim 19, wherein the second tubular member has a diameter that is significantly larger than the size of the second opening in the first state.

21. The method of forming an endoluminal prosthesis of claim 18, wherein the first and second openings are separated by an angle of approximately 150 degrees.

22. The method of forming an endoluminal prosthesis of claim 13, wherein at least a portion of the graft body defines a diameter that is from approximately 20% to approximately 40% larger than the cross-sectional size of a target vessel of the endoluminal prosthesis.

23. The method of forming an endoluminal prosthesis of claim 13, wherein the graft body is formed from a bi-directionally expanded, layered PTFE material.

24. The method of forming an endoluminal prosthesis of claim 13, further comprising fastening a first stent to a first end of the graft body and a second stent to a second end of the graft body such that the first opening formed in the wall of the main body portion is positioned between the first and second stents.

25. The method of forming an endoluminal prosthesis of claim 24, further comprising positioning at least one connecting member in communication with the first and second stents so that the connecting member is positioned between the first and second stents.

26. An endoluminal prosthesis comprising:

a main graft body defining a flow lumen therethrough, an inside surface, and an outside surface;

a first opening in a wall of the main graft body, from said inside to said outside surface;

a single-piece tubular member having a first end, a second end, and a middle portion extending between the first and second ends passing through said first opening;

wherein;

the first end of the tubular member is fixed to the inside surface of the main graft body around and spaced radially away from the first opening; and

the second end of the tubular member is fixed to the outside surface of the main graft body around and spaced radially away from the first opening;

the tubular member is seamless along a length of the tubular member between the first end of the tubular member where the tubular member is fixed to the inside surface of the main graft body and the second end of the tubular member where the tubular member is fixed to the outside surface of the main graft body; and

the tubular member is fixed to the main graft body so as to create a space between the tubular member and the main graft body along a length of the tubular member adjacent to an inside surface of the tubular member.

27. The endoluminal prosthesis of claim 26, wherein the tubular member is fixed to the main graft body so as to create a space between the tubular member and the main graft body along a length of the tubular member adjacent to an outside surface of the tubular member.

28. The endoluminal prosthesis of claim 26, wherein the tubular graft has an inner diameter that is at least twice as large as a diameter of the first opening in an unstretched state of the first opening.

29. The endoluminal prosthesis of claim 26, further comprising a second opening passing through the wall of the main graft body and a second support member supported by the main graft body and overlapping an edge of the second opening.

30. The endoluminal prosthesis of claim 26, wherein the main graft body comprises a first portion and a second portion, the second portion having a cross-sectional size that is significantly larger than a cross-sectional size of the first portion and also significantly larger than a cross-sectional size of a target vessel of the endoluminal prosthesis, and wherein the first opening is positioned in the second portion.

31. The endoluminal prosthesis of claim 26, further comprising a bare or covered stent advanceable through the first opening and first support member.