METHOD OF PLACEMENT OF A GRAFT OR GRAFT SYSTEM

• US 20090216315A1
• Filed: 02/20/2009
• Published: 08/27/2009
• Est. Priority Date: 02/22/2008
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Endologix
• Inventors: Schreck, Stefan G., Mayberry, Kevin, Benjamin, Joshua
• Granted Patent: US 8,221,494 B2
• Time in Patent Office: Days
• US Class Current: 623/1.350
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/30308 banana-shaped
• CPC Class Codes: A61F 2002/30327 differing in diameter
• CPC Class Codes: A61F 2002/30604 modular
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0063 Three-dimensional shapes
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

An endoluminal prosthesis system deployable in a region of a patient'"'"'s vasculature having one or more branch vessels, having a first main graft body having at least a first and second opening therein and a second main graft body having at least a first and a second opening therein. The first openings can be smaller than the second openings. The second main graft body can be expandable substantially within the first main graft body such that the second openings of each graft body do not substantially cover the first openings of the other graft body. The resulting graft system can have two openings therein, each being defined by the first openings in each of the first and second main graft bodies. One or more branch grafts can be attached to cover the openings in the main graft bodies, and the main graft bodies can have one or more cutouts therein.

Claims

1. An endoluminal prosthesis system comprising:

a first endoluminal prosthesis comprising a first main graft body having at least a first and a second opening therein; and

a second endoluminal prosthesis comprising a second main graft body having at least a first and a second opening therein;

wherein;

the first opening in the first main graft body is smaller than the second opening in the first main graft body;

the first opening in the second main graft body is smaller than the second opening in the second main graft body;

the second main graft body is configured to be expandable substantially within the first main graft body such that the second opening of the second main graft body does not cover any portion of the first opening in the first main graft body, and such that the second opening of the first main graft body does not cover any portion of the first opening in the second main graft body; and

when the second main graft body has been expanded within the first main graft body, the resulting endoluminal prosthesis system has two small openings therein that are each approximately equivalent in diameter to the first opening in each of the first and second main graft bodies.

2. The endoluminal prosthesis system of claim 1, wherein the main graft body of each of the first and second endoluminal prostheses defines a generally tubular shape.

3. The endoluminal prosthesis system of claim 1, wherein the first opening in at least one of the first and second main graft bodies is approximately diametrically opposed to the second opening in the same main graft body.

4. The endoluminal prosthesis system of claim 1, wherein the first opening in each of the first and second main graft bodies is significantly smaller than the second opening in each of the first and second main graft bodies.

5. The endoluminal prosthesis system of claim 1, wherein the second opening in each of the first and second main graft bodies defines a diameter that is at least approximately three times greater than the diameter of the first opening in each of the first and second main graft bodies.

6. The endoluminal prosthesis system of claim 1, wherein the second opening in each of the first and second main graft bodies defines a diameter that is at least approximately four times greater than the diameter of the first opening in each of the first and second main graft bodies.

7. The endoluminal prosthesis system of claim 1, wherein the two small openings in the resulting endoluminal prosthesis system are not mutually opposing.

8. The endoluminal prosthesis system of claim 1, wherein at least one of the first and second main graft bodies comprises one or more cutouts in an end portion thereof.

9. The endoluminal prosthesis system of claim 1, wherein the first opening in the first main graft body comprises a branch graft attached to the first main graft body so as to surround the first opening in the first main graft body.

10. The endoluminal prosthesis system of claim 9, wherein the branch graft attached to the first main graft body is expandable with a bare or covered metal stent.

11. The endoluminal prosthesis system of claim 9, wherein the first opening in the second main graft body comprises a branch graft attached to the second main graft body so as to surround the first opening in the second main graft body.

12. The endoluminal prosthesis system of claim 11, wherein at least one of the branch graft attached to the first main graft body and the branch graft attached to the second main graft body is expandable with a bare or covered metal stent.

13. The endoluminal prosthesis system of claim 1, further comprising a third endoluminal prosthesis positioned adjacent to or overlapping with at least a portion of one of the first endoluminal prosthesis and the second endoluminal prosthesis.

14. The endoluminal prosthesis system of claim 13, wherein the third prosthesis is a bifurcated endoluminal prosthesis.

15. The endoluminal prosthesis system of claim 13, wherein the third prosthesis is a bifurcated endoluminal prosthesis configured to be positioned adjacent to an abdominal aortic aneurysm.

16. The endoluminal prosthesis system of claim 13, wherein the third prosthesis comprises a third main graft body having at least a first and a second opening therein, wherein the third main graft body is configured such that at least a portion of the third main body is expandable within the second main graft body.

17. The endoluminal prosthesis system of claim 1, wherein at least one of the first endoluminal prosthesis and the second endoluminal prosthesis comprises a distensible polymeric material.

18. The endoluminal prosthesis system of claim 17, wherein the polymeric material is selected from the group consisting of PTFE, ePTFE, Dacron, Dacron®

, Teflon®

, and polyester.

19. The endoluminal prosthesis system of claim 1, wherein at least one of the first endoluminal prosthesis and the second endoluminal prosthesis has at least one radiopaque suture or marker attached thereto.

20. A method of deploying a branch graft system in a portion of a patient'"'"'s blood vessel having at least a first and a second branch blood vessel, comprising:

positioning a first main graft body having at least a first and a second opening therein in the patient'"'"'s blood vessel so that the first opening is substantially aligned with the first branch blood vessel and so that the second opening is sufficiently aligned with the second branch blood vessel so that the first main graft body does not substantially cover either the first or second branch blood vessel;

positioning at least a portion of a second main graft body having at least a first and a second opening therein within the inside of the first main graft body so that the first opening of the second main graft body is substantially aligned with the second branch blood vessel and so that the second opening of the second main graft body is sufficiently aligned with the first branch blood vessel so that the second main graft body does not substantially cover either the first or second branch blood vessel;

wherein;

the second opening in each of the first and second main graft bodies is substantially larger than the first opening in each of the first and second main graft bodies;

expanding the first and second main graft bodies against the patient'"'"'s blood vessel to create a multi-layer graft system having two openings through the wall thereof that are substantially aligned with the first and second blood vessels and have a diameter substantially equal to the first opening of each of the first and second main graft bodies; and

supporting the first and second main graft bodies against the patient'"'"'s blood vessel.

21. The method of deploying a branch graft system of claim 20, wherein the first main graft body is expanded against the patient'"'"'s blood vessel before a portion of the second main graft body is positioned within the first main graft body.

22. The method of deploying a branch graft system of claim 20, wherein supporting the first and second main graft bodies against the patient'"'"'s blood vessel comprises deploying a bare metal or covered stent against the inside surface of at least the second main graft body.

23. The method of deploying a branch graft system of claim 20, wherein a hollow guidewire is placed inside at least one of the first and second openings of the first main graft body before positioning the first main graft body in the patient'"'"'s blood vessel.

24. The method of deploying a branch graft system of claim 20, wherein a hollow guidewire is placed inside at least one of the first and second openings of the second main graft body before positioning the second main graft body in the patient'"'"'s blood vessel.

25. The method of deploying a branch graft system of claim 20, wherein a deployment catheter having three lumens therethrough is used for positioning the first main graft body in the patient'"'"'s blood vessel.

26. The method of deploying a branch graft system of claim 20, wherein the first main graft body further comprises a first branch graft attached to the first main graft body so as to surround the first opening in the first main graft body.

27. The method of deploying a branch graft system of claim 26, wherein the first branch graft is expanded within the first branch blood vessel before positioning at least a portion of the second main graft body within the inside of the first main graft body.

28. The method of deploying a branch graft system of claim 26, wherein the first branch graft is expanded within the first branch blood vessel with a self-expanding stent before positioning at least a portion of the second main graft body within the inside of the first main graft body.

29. The method of deploying a branch graft system of claim 26, wherein the second main graft body further comprises a second branch graft attached to the second main graft body so as to surround the first opening in the second main graft body.

30. The method of deploying a branch graft system of claim 29, wherein the second branch graft is expanded within the second branch blood vessel after positioning at least a portion of the second main graft body within the inside of the first main graft body.

31. The method of deploying a branch graft system of claim 29, wherein the second branch graft is expanded within the second branch blood vessel with a self-expanding stent after positioning at least a portion of the second main graft body within the inside of the first main graft body.

32. The method of deploying a branch graft system of claim 20, wherein at least one of the first main graft and second main graft are positioned in the patient'"'"'s blood vessel using one or more guidewires.

33. The method of deploying a branch graft system of claim 32, wherein a distal end portion of at least one of the one or more guidewires is configured to be secured to the first branch blood vessel or the second branch blood vessel.

34. The method of deploying a branch graft system of claim 33, wherein the distal end portion of at least one of the one or more guidewires comprises an inflatable balloon, a hooks, or a coil configured to secure at least the end portion of the guidewire within the first or the second branch blood vessel.

35. An endoluminal prosthesis comprising:

an expandable main graft portion having an axial opening therethrough and at least a first branch opening therein; and

an expandable branch graft portion having a proximal end portion, a distal end portion, and an axial opening therethrough;

wherein;

the branch graft portion is supported by the main graft portion;

the branch graft portion is supported by the main graft portion so that the proximal end portion of the branch graft portion is positioned around a periphery of the first branch opening in the main graft, and such that the axial opening through the branch graft portion is in communication with the first branch opening formed in the main graft portion; and

at least the distal end portion of the branch graft portion is unexpanded.

36. The endoluminal prosthesis of claim 35, wherein the distal end portion of the branch graft portion is expandable in a branch blood vessel to a diameter that is approximately equal to the diameter of the proximal end portion of the branch graft portion.

37. The endoluminal prosthesis of claim 35, wherein the distal end portion of the branch graft portion is expandable in a branch blood vessel using a stent.

38. The endoluminal prosthesis of claim 35, wherein the distal end portion of the branch graft portion is expandable in a branch blood vessel using a balloon expander.