Granted Patent B2

US 8,455,008 · App. 13/488,519 · Granted Jun 4, 2013

Abstract

Claims (29)

1. A method for preparing a medical graft material, comprising:

providing an extracellular matrix (ECM) material containing native IgA and native FGF-2; and

treating the ECM material effectively to retain the native FGF-2 at a level of at least about 10 ng/g while decreasing the native IgA content to a level less than 20 μg/g, wherein said treating comprises contacting the ECM material with an aqueous detergent solution.

2. The method of claim 1 , wherein the method further comprises rinsing the ECM material after said contacting step so as to remove at least 90% of the detergent residues from the material.

3. The method of claim 1 , wherein said detergent solution has a detergent concentration of about 0.05% to about 1%.

4. The method of claim 3 , wherein the detergent is sodium dodecyl sulfate.

5. The method of claim 4 , wherein said detergent solution is a heated detergent solution.

6. The method of claim 3 , wherein said treating decreases the native IgA content to a level less than 15 μg/g.

7. The method of claim 3 , wherein said detergent solution is a heated detergent solution.

8. The method of claim 1 , wherein said detergent solution has a detergent concentration of about 0.05% to about 0.3%.

9. The method of claim 8 , wherein the detergent is sodium dodecyl sulfate.

10. The method of claim 1 , wherein the detergent is sodium dodecyl sulfate.

11. The method of claim 1 , also comprising:

prior to said contacting the ECM material with an aqueous detergent solution, removing lipids from the ECM material by contact with a polar organic solvent.

12. The method of claim 11 , also comprising:

after said contacting the ECM material with an aqueous detergent solution, removing deoxyribonucleic acid from the ECM material by contact with a basic aqueous medium in which deoxyribonucleic acid is soluble.

13. The method of claim 12 , also comprising:

after said removing deoxyribonucleic acid, disinfecting the ECM material by contact with an oxidizing disinfectant.

14. The method of claim 13 , wherein the polar organic solvent comprises isopropyl alcohol.

15. The method of claim 13 , wherein, after said disinfecting, the ECM material includes native FGF-2, native proteoglycans, and native glycosaminoglycans.

16. The method of claim 12 , wherein the polar organic solvent comprises isopropyl alcohol.

17. The method of claim 11 , wherein the polar organic solvent comprises isopropyl alcohol.

18. The method of claim 1 , wherein the ECM material comprises renal capsule membrane, dermal collagen, dura mater, pericardium, fascia lata, serosa, peritoneum or basement membrane.

19. A method for preparing a medical graft material, comprising:

treating an ECM material with a liquid detergent medium so as to reduce native IgA in the ECM material to a level less than about 10 μg/g while retaining native FGF-2 in the ECM material at a level of at least about 10 μg/g and while retaining native proteoglycans and glycosaminoglycans in the ECM material.

20. The method of claim 19 , also comprising:

treating the ECM material with a liquid medium in which lipids are soluble so as to remove lipids from the ECM material; and

treating the ECM material with a liquid medium in which deoxyribonucleic acid is soluble so as to remove deoxyribonucleic acid from the ECM.

21. The method of claim 19 , wherein said detergent medium has a detergent concentration of about 0.05% to about 0.3%.

Assignments (10)