Graft material, stent graft and method

• US 20070237973A1
• Filed: 02/20/2007
• Published: 10/11/2007
• Est. Priority Date: 02/21/2006
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Sun, Jichao, Grewe, David, Ninan, Lal, Purdy, James, Dierking, Kurt
• Granted Patent: US 8,211,168 B2
• Time in Patent Office: Days
• US Class Current: 428/497
• CPC Class Codes: A61L 27/34 Macromolecular materials
• 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 27/48 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 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/128 containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: B32B 1/08 Tubular products
• CPC Class Codes: B32B 2262/0276 Polyester fibres
• CPC Class Codes: B32B 2266/06 Open cell foam
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses or catheter
• CPC Class Codes: B32B 27/065 of foam
• CPC Class Codes: B32B 27/12 next to a fibrous or filamentary layer
• CPC Class Codes: B32B 27/18 characterised by the use of special additives
• CPC Class Codes: B32B 27/205 the fillers creating voids or cavities, e.g. by stretching
• CPC Class Codes: B32B 27/28 comprising synthetic resins not wholly covered by any one of the sub-groups B32B27/30 - B32B27/42
• CPC Class Codes: B32B 27/283 comprising polysiloxanes
• CPC Class Codes: B32B 27/40 comprising polyurethanes
• CPC Class Codes: B32B 5/02 : characterised by structural features of a fibrous or filamentary layer layer formed of metallic wires B32B15/02; layer formed of natural mineral fibres B32B19/02; layer formed of wood fibres B32B21/02
• CPC Class Codes: B32B 5/18 : characterised by features of a layer of foamed material
• CPC Class Codes: C08F 255/00 : Macromolecular compounds obtained by polymerising monomers on to polymers of hydrocarbons as defined in group C08F10/00
• CPC Class Codes: C08F 283/006 : on to polymers provided for in C08G18/00 C08F283/004 takes precedence
• CPC Class Codes: C08F 283/12 : on to polysiloxanes
• CPC Class Codes: C08F 289/00 : Macromolecular compounds obtained by polymerising monomers on to macromolecular compounds not provided for in groups C08F251/00 - C08F287/00
• CPC Class Codes: C08F 291/00 : Macromolecular compounds obtained by polymerising monomers on to macromolecular compounds according to more than one of the groups C08F251/00 - C08F289/00
• CPC Class Codes: C08G 18/3228 : acyclic
• CPC Class Codes: C08G 18/4854 : Polyethers containing oxyalkylene groups having four carbon atoms in the alkylene group
• CPC Class Codes: C08G 18/61 : Polysiloxanes
• CPC Class Codes: C08G 2101/00 : Manufacture of cellular products
• CPC Class Codes: Y10T 428/31844 : Of natural gum, rosin, natural oil or lac

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 porous polymeric sheet, extracellular matrix material (ECM) disposed on at least a portion of the porous polymeric sheet and at least one polymer layer disposed on at least a portion of the ECM. The ECM may be in a gel form. The polymeric sheet and the polymer layer may be made from foam material and may comprise a polyurethane urea and a surface modifying agent such as siloxane.

Claims

1. A graft material, comprising:

a porous polymeric sheet;

extracellular matrix material (ECM) disposed on at least a portion of the polymeric sheet; and

at least one polymer layer disposed on at least a portion of the ECM.

2. The graft material of claim 1, wherein the polymer layer is disposed on the entire ECM.

3. The graft material of claim 1, wherein the polymeric sheet has holes and the ECM extends into the holes.

4. The graft material of claim 1, wherein the polymer layer comprises a polyetherurethane urea and a surface modifying agent.

5. The graft material of claim 4, wherein the surface modifying agent is siloxane.

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

7. The graft material of claim 6, wherein the surface modifying agent is siloxane.

8. The graft material of claim 1, wherein the polymeric sheet is in the form of a foam.

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

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

11. The graft material of claim 9, wherein the small intestine submucosa is in a gel form.

12. The graft material of claim 1, wherein the polymeric sheet has disposed thereon one or more pairs of a further ECM layer and a further polymer layer.

13. An endoluminal prosthesis, comprising:

a tubular graft material comprising a porous polymeric sheet, extracellular matrix material (ECM) disposed on at least a portion of the porous polymeric sheet, and at least one polymer layer disposed on at least a portion of the ECM; and

a stent disposed about the graft material.

14. The prosthesis of claim 13, wherein the stent is a self-expanding stent or a balloon expandable stent.

15. The prosthesis of claim 13, wherein the ECM is small intestine submucosa.

16. The prosthesis of claim 13, wherein the polymer layer comprises a polyetherurethane urea and a surface modifying agent.

17. The prosthesis of claim 16, wherein the surface modifying agent is siloxane.

18. The prosthesis of claim 13, wherein the polymer layer is disposed on the entire ECM.

19. The prosthesis of claim 13, wherein the polymeric sheet has holes and the ECM layer extends into the holes.

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

providing a porous polymeric sheet;

providing ECM;

disposing ECM on at least a portion of the porous polymeric sheet; and

disposing at least one polymer layer on at least a portion of the ECM;

wherein the ECM remains disposed on the porous polymeric sheet until after implantation.