Advanced endovascular graft

• US 7,766,954 B2
• Filed: 01/17/2006
• Issued: 08/03/2010
• Est. Priority Date: 12/20/2001
• Status: Expired due to Fees

• Current Assignee: Endologix
• Original Assignee: Trivascular Incorporated
• Inventors: Chobotov, Michael V., Whirley, Robert G.
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US11/333,595
• Publication Number:
  US 20060178732A1
• Time in Patent Office: 1,659 Days
• Field of Search: 623/1.13, 623/1.25, 623/23.67, 623/8
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/844 folded prior to deployment
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• 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 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91583 by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 : soldered or brazed or welded
• CPC Class Codes: A61F 2250/0003 : having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0036 : differing in thickness
• CPC Class Codes: A61M 2025/0177 : having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes

Abstract

This invention is a system for the treatment of body passageways; in particular, vessels with vascular disease. The system includes an endovascular graft with a low-profile delivery configuration and a deployed configuration in which it conforms to the morphology of the vessel or body passageway to be treated as well as various connector members and stents. The graft is made from an inflatable graft body section and may be bifurcated. One or more inflatable cuffs may be disposed at either end of the graft body section. At least one inflatable channel is disposed between and in fluid communication with the inflatable cuffs.

Claims

1. An endovascular graft comprising:

a graft body section having an inflatable cuff and wherein the inflatable cuff contains a three-component inflation medium, wherein the inflation medium comprises the combination of polyethylene glycol diacrylate with pentaerthyritol tetra 3(mercaptopropionate) or a thiolated polyethyleneamine, and a buffer.

2. The endovascular graft of claim 1 wherein the buffer comprises glycylglycine.

3. The endovascular graft of claim 1 wherein the buffer comprises triethanolamine in phosphate-buffered saline.

4. The endovascular graft of claim 1 wherein the polyethylene glycol diacrylate is present in a proportion ranging from about 50 to about 55 weight percent.

5. The endovascular graft of claim 1 wherein the polyethylene glycol diacrylate has a molecular weight ranging from about 350 to about 850.

6. The endovascular graft of claim 1 wherein the pentaerthyritol tetra 3(mercaptopropionate) is present in a proportion ranging from about 22 to about 27 weight percent.

7. The endovascular graft of claim 2 wherein the glycylglycine is present in a proportion ranging from about 22 to about 27 weight percent.

8. The endovascular graft of claim 1 wherein a post-cure elastic modulus of the inflation medium is between about 175 and about 250 pounds per square inch.

9. The endovascular graft of claim 8 wherein the inflation medium exhibits a cure time between about two minutes and about ten minutes.

10. The endovascular graft of claim 1 wherein the inflation medium additionally comprises saline or other inert biocompatible material.

11. The endovascular graft of claim 10 wherein the inflation medium comprises between about 20 and about 50 percent by volume saline.

12. The endovascular graft of claim 1 wherein the graft body section comprises an inflatable channel in fluid communication with the inflatable cuff.

13. The endovascular graft of claim 12 wherein the inflatable cuff is disposed at a proximal portion of the graft body section and further comprising a second inflatable cuff disposed at a distal portion of the graft body section and wherein the second inflatable cuff is in fluid communication with the inflatable channel and inflatable cuff.

14. An endovascular graft comprising:

a graft body section having an inflatable cuff and wherein the inflatable cuff contains an inflation medium that comprises two components, a buffer, and a radiopaque material comprising an iodinated aqueous solution.

15. The endovascular graft of claim 14 wherein the buffer comprises a glycylglycine.

16. The endovascular graft of claim 14 wherein the inflation material becomes less radiopaque over time.

17. The endovascular graft of claim 14 further comprising an insoluble contrast agent.

18. The endovascular graft of claim 17 wherein the insoluble contrast agent comprises barium sulfate.

19. An endovascular graft comprising:

a graft body section having an inflatable cuff and wherein the inflatable cuff contains a three-component inflation medium that cures via a Michael addition process, wherein the inflation medium comprises a polymer having conjugated unsaturated groups, a nucleophile and a buffer.

20. The graft of claim 19 wherein the unsaturated groups are selected from the group consisting of acrylate, acrylamide, quinine, vinylpyridinium and combinations thereof.

21. The graft of claim 19 wherein the polymer is selected from the group consisting of poly(ethylene glycol), poly(ethylene oxide), poly(vinyl alcohol), poly(ethylene-co-vinyl alcohol), poly(acrylic acid), poly(ethylene-co-acrylic acid), poly(ethyloxazoline), poly(vinyl pyrrolidone), poly(ethylene-co-vinyl pyrrolidone), poly(maleic acid), poly(ethylene-co-maleic acid), poly(acrylamide), poly(ethylene oxide)-co-poly(propylene oxide) block copolymers, and combinations or copolymers thereof.

22. The graft of claim 19 wherein the nucleophile is selected from the group consisting of thiols, amines and combinations thereof.

23. The graft of claim 19 wherein the polymer is a polyethylene glycol diacrylate and the nucleophile is a thiol.

24. The graft of claim 23 wherein the nucleophile is trimethylolpropane tris(3-mercaptopropionate), pentaerythritol tetrakis (3-mercaptopropionate) or combinations thereof.