Graft material, stent graft and method

• US 8,211,168 B2
• Filed: 02/20/2007
• Issued: 07/03/2012
• Est. Priority Date: 02/21/2006
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Biotech Incorporated (Cook Group Incorporated), Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Purdy, James D., Grewe, David D., Dierking, Kurt, Ninan, Lal, Sun, Jichao
• Primary Examiner(s): Prebilic, Paul
• Assistant Examiner(s): IWAMAYE, ANDREW MICHAEL
• Application Number:
  US11/708,412
• Publication Number:
  US 20070237973A1
• Time in Patent Office: 1,960 Days
• Field of Search: 623 138- 139, 623 142- 148, 623/1.13, 623 14- 141, 623 2372- 2376
• US Class Current: 623/1.44
• 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 polymeric sheet having a tissue side, the tissue side having at least one one-end-closed hole;

a bioremodelable extracellular matrix material (ECM) disposed on at least a portion of the tissue side of the polymeric sheet and extending into the at least one one-end-closed hole of the polymeric sheet, and

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

wherein the polymeric sheet and the at least one polymer layer both comprise a polyetherurethane urea and a surface modifying agent,

wherein the ECM is processed from a source tissue to retain one or more growth factors native to the source tissue and to provide biotropic properties, and

wherein the polymeric sheet, the at least one polymer layer, and the ECM are distinct and separate layers.

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 surface modifying agent is siloxane.

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

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

6. The graft material of claim 5, wherein the small intestine submucosa is comminuted.

7. The graft material of claim 5, wherein the small intestine submucosa is in a gel form.

8. 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.

9. The graft material of claim 1, further comprising a porous polymeric sheet disposed on at least a portion of the polymeric sheet.

10. An endoluminal prosthesis, comprising:

a tubular graft material comprising

a polymeric sheet having a tissue side and at least one one-end-closed hole only on the tissue side of the polymeric sheet,

a bioremodelable extracellular matrix material (ECM) disposed on at least a portion of the tissue side of the polymeric sheet and extending into the at least one one-end-closed hole of the polymeric sheet,

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

a stent disposed about the graft material;

wherein the polymeric sheet and the at least one polymer layer both comprise a polyetherurethane urea and a surface modifying agent;

wherein the ECM is processed from a source tissue to retain one or more growth factors native to the source tissue and to provide biotropic properties, and

wherein the polymeric sheet, the at least one polymer layer, and the ECM are distinct and separate layers.

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

12. The prosthesis of claim 10, wherein the ECM is small intestine submucosa.

13. The prosthesis of claim 10, wherein the surface modifying agent is siloxane.

14. The prosthesis of claim 10, wherein the polymer layer is disposed on the entire ECM.

15. The endoluminal prosthesis of claim 10, further comprising a porous polymeric sheet disposed on at least a portion of the polymeric sheet.

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

providing a polymeric sheet having a tissue side, the tissue side having at least one one-end-closed hole, the polymeric sheet comprising a polyetherurethane urea and a surface modifying agent;

providing a bioremodelable extracellular matrix material (ECM);

disposing ECM on at least a portion of the tissue side of the polymeric sheet so that the ECM extends into the at least one one-end-closed hole of the polymeric sheet,

and

disposing at least one layer of a polymer material comprising a polyetherurethane urea and a surface modifying agent on at least a portion of the ECM;

wherein the ECM remains disposed on the polymeric sheet until after implantation;

wherein the ECM is processed from a source tissue to retain one or more growth factors native to the source tissue and to provide biotropic properties;

wherein the at least one one-end-closed hole is disposed only on the tissue side of the graft; and

wherein the polymeric sheet, the at least one polymer layer, and the ECM are distinct and separate layers.

17. The method of claim 16, further comprising disposing a porous polymeric sheet on at least a portion of the at least one layer of the polymer material.

18. The method of claim 17, further comprising disposing another layer of ECM on at least a portion of the porous polymeric sheet.

19. The method of claim 16, further comprising disposing a porous polymeric sheet on at least a portion of the polymeric sheet.