Method for conserving biological prostheses, conserved biological prostheses and conserving solutions

• US 7,014,655 B2
• Filed: 12/03/2001
• Issued: 03/21/2006
• Est. Priority Date: 12/06/2000
• Status: Expired due to Fees

• Current Assignee: Rainer Frey
• Original Assignee: Gerhard Wachauf, Rainer Frey
• Inventors: Barbarash, Leonid, Novikova, Svetlana, Jouravleva, Irina
• Primary Examiner(s): Wax, Robert A.
• Assistant Examiner(s): Kosson, Rosanne
• Application Number:
  US10/433,872
• Publication Number:
  US 20040136965A1
• Time in Patent Office: 1,569 Days
• Field of Search: 623/2.1, 623/2.13, 623/11.11, 514/56, 514/165, 514/723, 424/569, 424/570
• US Class Current: 623/2.13
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61L 2/18 Liquid substances or solutions comprising solids or dissolved gases

Abstract

The invention concerns a method of conserving biological prostheses, wherein the method includes the following steps: (a) treating biological prostheses with a solution which contains a mixture of epoxide compounds which are at least in part of different lengths; (b) treating the biological prosthesis treated in accordance with step (a) with an antithrombotic-bearing solution; and (c) possibly storing the prosthesis treated in accordance with step (b) in a sterilising solution. The invention further concerns a biological prosthesis produced in accordance with the method of the invention and a conserving agent.

Claims

1. A conserved biological prosthesis produced in accordance with a method comprising the following steps:

(a) treating a biological prosthesis with a solution which contains a mixture of epoxide compounds which are at least in part of different lengths, wherein said mixture of epoxide compounds includes at least one non-polymer epoxide compound with two epoxide groups;

(b) treating the biological prosthesis treated in accordance with step (a) with a solution containing an antithrombotic, wherein the antithrombotic is a mixture of heparin and acetylsalicylic acid; and

(c) optionally storing the prosthesis treated in accordance with step (b) in a sterilizing solution.

2. A conserved biological prosthesis as set forth in claim 1 wherein the biological prosthesis is selected from the group consisting of heart valves, artery segments, vein valves, valve-containing vein segments, and membranous tissues of a mammal.

3. The prosthesis as set forth is claim 2 wherein said prosthesis is a membranous tissue of a mammal.

4. The prosthesis as set forth in claim 3 wherein said membranous tissue is the pericardium of a mammal.

5. The prosthesis as set forth in claim 3 wherein said membranous tissue is the meninges of a mammal.

6. The prosthesis as set forth in claim 1 wherein the solution of step (a) contains a mixture of at least three different epoxide compounds.

7. The prosthesis as set forth in claim 1 wherein the mixture of epoxide compounds further includes at least one polymer epoxide compound with two or three epoxide groups and/or an epoxide compound with two or three epoxide groups, wherein arranged between at least two epoxide groups is a straight-chain or branched hydrocarbon chain with at least four carbon atoms.

8. The prosthesis as set forth in claim 1 wherein the mixture of epoxide compounds includes at least one epoxide compound with at least three epoxide groups.

9. The prosthesis as set forth in claim 1 wherein the epoxide group is a component of a glycidol residue.

10. The prosthesis as set forth in claim 1 wherein said at least one non-polymer epoxide compound is selected from the group which consists of alkylene glycol diglycidylethers, alkane diol diglycidylethers, polyalcohol diglycidylethers, and mixtures thereof.

11. The prosthesis as set forth in claim 10 wherein said at least one non-polymer epoxide compound is an alkylene glycol diglycidylether.

12. The prosthesis as set forth in claim 11 wherein said alkylene glycol diglycidylether is ethylene glycol diglycidylether.

13. The prosthesis as set forth in claim 10 wherein said at least one non-polymer epoxide compound is an alkane diol diglycidylether.

14. The prosthesis as set forth in claim 13 wherein said alkane diol diglycidylether is butane-1,4 diol diglycideylether.

15. The prosthesis as set forth in claim 10 wherein said at least one non-polymer epoxide compound is a polyalcohol diglycidylether.

16. The prosthesis as set forth in claim 15 wherein said polyalcohol diglycidylether is glycerine diglycidylether.

17. The prosthesis as set forth in claim 1 wherein the polymer epoxide compound is a polyalkylene glycol glycidylether.

18. The prosthesis as set forth in claim 17 wherein said polyakylene glycol glycidylether is selected from the group consisting of polyethylene glycol diglycidylether, polytetramethylene glycol glycidylether, polypropylene glycol diglycidylether, and mixtures thereof.

19. The prosthesis as set forth in claim 1 wherein the non-polymer epoxide compounds is/are alkane diol diglycidylether, and/or dicarboxylic acid diglycidylester.

20. The prosthesis as set forth in claim 19 wherein said non-polymer epoxide compound is hexane-1,6-diol-diglycidylether.

21. The prosthesis as set forth in claim 8 wherein the epoxide compounds with at least three epoxide groups are selected from the group which consists of polyalcohol polyglycidylethers, glycerine polyglycidylether, pentaerythrol polyglycidylether, polysaccharide polyglycidylether, and mixtures thereof.

22. The prosthesis as set forth in claim 21 wherein said epoxide compound with at least three epoxide groups is a polyalcolhol polyglycidylether.

23. The prosthesis as set forth in claim 22 wherein said polyalcohol polyglycidylether is sorbitol polyglycidylether.

24. The prosthesis as set forth in claim 1 wherein after the treatment in accordance with step (a) in step (b) the biological prosthesis is treated with a solution of heparin and acetylsalicylic acid without using additional reagents.

25. The prosthesis as set forth in claim 24 wherein after the treatment with heparin and acetylsalicylic acid in accordance with step (b) the biological prosthesis is rinsed in distilled water or an isotonic solution, in particular a 0.9% by weight NaCl solution, and then sterilized by treatment with a solution of an epoxide compound.

26. The prosthesis as set forth in claim 25 wherein the solution used for sterilization has a concentration of the epoxide compound of at least 2% by weight.