Graft prosthesis materials

• US 6,206,931 B1
• Filed: 08/22/1997
• Issued: 03/27/2001
• Est. Priority Date: 08/23/1996
• Status: Expired due to Term

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated), Elutia Med LLC
• Original Assignee: Cook Biotech Incorporated (Cook Group Incorporated), Cook Incorporated (Cook Group Incorporated), MED Institute, Inc. (Cook Group Incorporated)
• Inventors: Cook, William A., Hiles, Michael C., Patel, Umesh H., Kozma, Thomas G.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/916,490
• Time in Patent Office: 1,313 Days
• Field of Search: 623/11, 623/16, 623/11.11, 623/23.71, 623/23.61, 623/23.75, 623/924, 623/925, 523/105, 523/113
• US Class Current: 623/23.75
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61L 2/0088 Liquid substances
• CPC Class Codes: A61L 27/24 Collagen
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3662 Ligaments, tendons
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/3695 characterised by the function or physical properties of the final product, where no specific conditions are defined to achieve this A61L27/3687, A61L27/3691 take precedence
• CPC Class Codes: A61L 27/3839 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3843 Connective tissue
• CPC Class Codes: A61L 27/386 Ligaments, tendons
• CPC Class Codes: A61L 29/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: Y10S 623/925 Natural

Abstract

A graft prostheses (11), materials and method for implanting, transplanting, replacing, or repairing a part of a patient. The graft prosthesis includes a purified, collagen-based matrix structure removed from a submucosa tissue source. The submucosa tissue source is purified by disinfection and removal steps to deactivate and remove contaminants, thereby making the purified structure biocompatible and suitable for grafting on and/or in a patient.

Claims

1. A graft prosthesis, comprising:

a purified, collagen-based matrix structure removed from a submucosa tissue source, said purified structure having a contaminant level making said purified structure biocompatible, said purified structure further having an endotoxin level of less than 12 endotoxin units per gram.

2. The graft prosthesis of claim 1, wherein said endotoxin level is less than 10 endotoxin units per gram.

3. The graft prosthesis of claim 2, wherein said endotoxin level is less than 5 endotoxin units per gram.

4. The graft prosthesis of claim 3, wherein said endotoxin level is less than 1 endotoxin unit per gram.

5. The graft prosthesis of claim 1, wherein said purified structure has a bioburden level of less than 2 colony forming units per gram.

6. The graft prosthesis of claim 5, wherein said bioburden level is less than 1 colony forming unit per gram.

7. The graft prosthesis of claim 6, wherein said bioburden level is less than 0.5 colony forming units per gram.

8. The graft prosthesis of claim 1, wherein said purified structure has a nucleic acid content level of less than 10 micrograms per milligram.

9. The graft prosthesis of claim 8, wherein said nucleic acid content is less than 2 micrograms per milligram.

10. The graft prosthesis of claim 1, wherein said purified structure has a virus level of less than 500 plaque forming units per gram.

11. The graft prosthesis of claim 10, wherein said virus level is less than 100 plaque forming units per gram.

12. The graft prosthesis of claim 11, wherein said virus level is less than 1 plaque forming unit per gram.

13. The graft prosthesis of claim 1, wherein said purified structure has a processing agent level of less than 100,000 parts per million per kilogram.

14. The graft prosthesis of claim 13, wherein said processing agent level is less than 1,000 parts per million per kilogram.

15. The graft prosthesis of claim 14, wherein said processing agent level is less than 100 parts per million per kilogram.

16. The graft prosthesis of claim 1, wherein said purified structure has a fungus level of less than 2 colony forming units per gram.

17. The graft prosthesis of claim 16, wherein said fungus level is less than 1 colony forming units per gram.

18. The graft prosthesis of claim 17, wherein said fungus level is less than 0.5 colony forming units per gram.

19. The graft prosthesis of claim 1, wherein said purified structure comprise s a delaminated submucosa tissue source.

20. The graft prosthesis of claim 1, wherein said purified structure comprises a disinfected and delaminated submucosa tissue source.

21. The graft prosthesis of claim 1, wherein said purified structure comprises a disinfected and then delaminated submucosa tissue source.

26. The graft prosthesis of claim 1, wherein said purified structure is tubular.

27. The graft prosthesis of claim 1, wherein said purified structure is further processed into a fluidized form.

28. The graft prosthesis of claim 1, wherein said purified structure is further processed into a powder form.

29. The graft prosthesis of claim 1, wherein said purified structure is adapted for tendon or ligament repair.

30. The graft prosthesis of claim 1, comprising multiple layers, wherein each of said layers is formed of said collagen-based matrix.

31. The graft prosthesis of claim 1, wherein said purified structure is comprised of tela submucosa in strip form, said graft prosthesis comprising a plurality of said tela submucosa strips fused to one another.

32. The graft prosthesis of claim 1, also comprising a cultured epidermal graft on said collagen-based matrix.

33. The graft prosthesis of claim 32, wherein said cultured epidermal graft comprises keratinocytes or fibroblasts.

22. A graft prosthesis comprising:

a purified, collagen-based matrix structure removed from a submucosa tissue source, said purified structure having an endotoxin level of less than 12 endotoxin units per gram.

23. A graft prosthesis, comprising:

a purified, collagen-based matrix structure removed from a submucosa tissue source, said purified structure having a nucleic acid content level of less than 2 micrograms per milligram and an endotoxin level of less than 12 endotoxin units per gram.

24. A graft prosthesis comprising:

a purified, collagen-based matrix structure removed from a submucosa tissue source, said purified structure having a virus level of less than 500 plaque forming units per gram and an endotoxin level of less than 12 endotoxin units per gram.

25. A graft prosthesis comprising:

a purified, collagen-based matrix structure removed from a submucosa tissue source, said purified structure having a processing agent level of less than 100,000 parts per million per kilogram and an endotoxin level of less than 12 endotoxin units per gram.

34. A graft prosthesis, comprising:

a purified collagen-containing matrix obtained from a mammalian tissue source, said matrix comprising tela submucosa and residual contaminants from said mammalian tissue source, said matrix obtainable by a process which comprises disinfecting said mammalian tissue and then removing said matrix from the disinfected mammalian tissue, said matrix having an endotoxin level of less than 12 endotoxin units Per gram.

35. The graft prosthesis of claim 34, wherein said matrix has a contaminant level making said matrix biocompatible in humans.

36. The graft prosthesis of claim 34, wherein said disinfecting comprises contacting said mammalian tissue with an oxidizing agent.

37. The graft prosthesis of claim 35, wherein said mammalian tissue source is a porcine tissue source.

38. The graft prosthesis of claim 37, wherein said porcine tissue source is porcine small intestine.