FENESTRATED PROSTHESIS

• US 20110054594A1
• Filed: 04/28/2010
• Published: 03/03/2011
• Est. Priority Date: 04/28/2009
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation, Endologix
• Original Assignee: Endologix
• Inventors: Schreck, Stefan G., Clair, Daniel, Welk, Craig, Mayberry, Kevin
• Granted Patent: US 8,945,202 B2
• Time in Patent Office: Days
• US Class Current: 623/1.34
• 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;

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 increase the tear resistance of the main graft body adjacent to the first opening.

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

the tubular graft overlaps the edge of the first opening; and

the tubular graft has a first and a second end portion, the first and second end portions being stitched to the main graft body adjacent to the first opening.

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

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

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.

7. The endoluminal prosthesis of claim 6, further comprising a second support member supported by the main graft body and overlapping an edge of the second opening, the second support member being configured to increase the tear resistance of the main graft body adjacent to the second opening.

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

9. 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 the target vessel, and wherein the opening is positioned in the second portion.

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

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

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

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

14. 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;

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 partially through the first opening; and

fastening a first end portion and a second end portion of the tubular member to the wall of the main body portion adjacent to the first opening so that the tubular member completely overlaps an edge of the first opening.

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

16. The method of forming an endoluminal prosthesis of claim 14, wherein the tubular graft has a diameter that is at least twice as large as a diameter of the first opening in the first state.

17. The method of forming an endoluminal prosthesis of claim 14, wherein the tubular graft has a diameter that is at least four times as large as a diameter of the first opening in the first state.

18. The method of forming an endoluminal prosthesis of claim 14, further comprising positioning a radiopaque marker adjacent to the first opening.

19. The method of forming an endoluminal prosthesis of claim 14, 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.

20. The method of forming an endoluminal prosthesis of claim 19, further comprising advancing a second tubular member partially through the second opening and fastening a first end portion and a second end portion 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.

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

22. The method of forming an endoluminal prosthesis of claim 19, wherein the first and second openings are separated by an angle of approximately 150 degrees.

23. The method of forming an endoluminal prosthesis of claim 14, 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 the target vessel

24. The method of forming an endoluminal prosthesis of claim 14, wherein the graft body is formed from a bi-directionally expanded, layered PTFE material.

25. The method of forming an endoluminal prosthesis of claim 14, further comprising fastening a first stent to a first end portion of the graft body and a second stent to a second end portion 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.

26. The method of forming an endoluminal prosthesis of claim 25, 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.