Graft material, stent graft and method

• US 20050220848A1
• Filed: 03/30/2005
• Published: 10/06/2005
• Est. Priority Date: 03/31/2004
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Bates, Brian L.
• Granted Patent: US 7,244,444 B2
• Time in Patent Office: Days
• US Class Current: 424/443
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61L 27/3629 Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 27/3633 Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/3679 Hollow organs, e.g. bladder, esophagus, urether, uterus, intestine
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 31/128 containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges

Abstract

This invention is directed to graft materials for implanting, transplanting, replacing, or repairing a part of a patient and to methods of making the graft materials. The present invention is also directed to stent grafts and endoluminal prostheses formed of the graft materials. More specifically, the present invention is a graft material which includes polymeric sheet comprising holes. The graft material also comprises an ECM disposed in the holes of the polymeric sheet. The polymeric sheet of the graft material could be a textile or a porous polymer.

Claims

1. A graft material, comprising:

a polymeric sheet comprising interstices; and

an ECM disposed in the holes of the polymeric sheet.

2. The graft material of claim 1, wherein the polymeric sheet is a textile selected from the group consisting of woven, non-woven, and knitted textiles.

3. The graft material of claim 2, wherein the textile comprises fibers and the holes are between the fibers.

4. The graft material of claim 3, wherein the fibers comprise a synthetic polymer.

5. The graft material of claim 4, wherein the synthetic polymer is polyethylene terephthalate.

6. The graft material of claim 1, wherein the polymeric sheet comprises a polymer selected from the group consisting of polyesters, fluorinated polymers, polysiloxanes, polyurethanes, polyolefins, polyacrylonitrile, nylons, polyaramids and polysulfones.

7. The graft material of claim 1, wherein the polymeric sheet further comprises a polyetherurethane urea and a surface modifying agent comprising a siloxane.

8. The graft material of claims 1, wherein the ECM is a small intestine submucosa.

9. The graft material of claim 8, wherein the small intestine submucosa is a comminuted small intestine submucosa.

10. An endoluminal prosthesis, comprising:

a tubular graft material comprising a polymeric sheet comprising holes, and an ECM disposed in the holes of the polymeric sheet; and

a stent disposed about the graft material.

11. The endoluminal prosthesis of claim 10, wherein the ECM is a small intestine submucosa.

12. The endoluminal prosthesis of claim 11, wherein the small intestine submucosa is a comminuted small intestine submucosa.

13. The endoluminal prosthesis of claim 10, wherein the prosthesis is a bifurcated prosthesis.

14. The endoluminal prosthesis of claim 10, wherein the tubular graft material comprises a single proximal opening and first and second distal openings.

15. The endoluminal prosthesis of claim 14, further comprising a stent connected to and extending from the proximal opening.

16. The endoluminal prosthesis of claim 10, wherein the stent is a self-expanding stent or a balloon expandable stent.

17. The endoluminal prosthesis of claim 10, further comprising a plurality of stents.

18. A method of making a graft material for implantation, comprising:

providing a polymeric sheet comprising holes;

providing an ECM;

introducing the ECM into the holes of the polymeric sheet wherein the ECM remains in the holes until after implantation.

19. The method of claim 18, wherein the step of providing the ECM comprises providing a small intestine submucosa.

20. The method of claim 19, wherein the step of providing a small intestine submucosa comprises providing a comminuted small intestine submucosa.