Methods of sterilizing articles

• US 6,379,615 B1
• Filed: 02/24/2000
• Issued: 04/30/2002
• Est. Priority Date: 02/24/2000
• Status: Expired due to Term

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Ogle, Matthew Frank
• Primary Examiner(s): JASTRZAB, KRISANNE MARIE
• Application Number:
  US09/512,123
• Time in Patent Office: 796 Days
• Field of Search: 422/28, 422/34, 422/1, 549/512, 564/503, 564/297, 564/320, 424/405, 514/1
• US Class Current: 422/28
• CPC Class Codes: A61L 2/0088 Liquid substances
• CPC Class Codes: A61L 2/18 Liquid substances or solutions comprising solids or dissolved gases

Abstract

Approaches are described for sterilizing medical and biological articles using sterilizing compositions. The sterilizing compositions include epoxy amine compounds and, optionally, alcohol. The epoxy amine compounds act as antimicrobial agents in the sterilizing compositions. In particular, medical articles can be sterilized and/or stored in the compositions described.

Claims

1. A method of treating an article, the method comprising contacting the article with a sterilizing composition comprising an epoxy amine compound and an alcohol.

2. The method of claim 1, wherein the contact inactivates microbes associated with the article.

3. The method of claim 1, wherein the contact reduces the viable microbes associated with the article by about 1×

10<sup>−

6</sup>.

4. The method of claim 1, wherein the contact inhibits microbial proliferation.

5. The method of claim 1, wherein the epoxy amine compound is a polyepoxy amine.

6. The method of claim 1, wherein the epoxy amine compound is triglycidyl amine.

7. The method of claim 1, wherein the articles are medical articles.

8. The method of claim 1, wherein the articles comprise tissue.

9. The method of claim 1, wherein the articles are biological articles.

10. The method of claim 1, wherein the composition comprises the epoxy amine compound at a concentration between about 0.5 percent by weight to about 10 percent by weight.

11. The method of claim 1, wherein the composition comprises the epoxy amine compound at a concentration between about 3 percent by weight to about 8 percent by weight.

12. The method of claim 1, wherein the article is contacted with the composition between about 1 hour and about 48 hours.

13. The method of claim 1, wherein the article is contacted with the composition for greater than about 48 hours.

14. The method of claim 1, wherein the article is contacted with the composition at a temperature between about 10°

C. and about 40°

C.

15. The method of claim 1, wherein the composition is an aqueous solution.

16. The method of claim 1, wherein the composition is vaporized.

17. The method of claim 1, wherein the contact comprises immersing the article in the sterilizing composition.

18. The method of claim 1, wherein the contact comprises exposing the article to vapors of the sterilizing composition.

19. The method of claim 1, wherein the alcohol is selected from the group consisting of methanol, ethanol, n-propanol, isopropanol, benzyl alcohol, cresol and carbinol.

20. The method of claim 1, wherein the composition has a concentration of the alcohol between about 10 percent by weight and about 40 percent by weight.

21. The method of claim 1, wherein the composition comprises additional antimicrobial agents.

22. A method of treating an article comprising cross-linked tissue, the method comprising contacting the article with a sterilizing composition comprising an epoxy amine compound, the cross-linked tissue having been further processed prior to contact with sterilizing composition.

23. The method of claim 22, wherein the contact reduces the viable microbes associated with the article by about 1×

10<sup>−

6</sup>.

24. The method of claim 22, wherein the cross-linked tissue has been further processed by treatment with an anti-calcification agent prior to contact with the sterilizing composition.

25. The method of claim 22, wherein the epoxy amine compound is triglycidyl amine.

26. The method of claim 22, wherein the articles are selected from the group consisting of heart valves, prosthesis and vascular grafts.

27. The method of claim 22, wherein the article further comprises synthetic materials.

28. The method of claim 22, wherein the tissue has been cross-linked with gluteraldehyde.

29. The method of claim 22, wherein the tissue has been cross-linked with epoxy amine compounds.

30. A method of treating a non-proteinaceous article, the method comprising contacting the article with a sterilizing composition comprising an epoxy amine compound.

31. The method of claim 30 wherein the epoxy amine compound is a polyepoxy amine compound.

32. The method of claim 30, wherein the articles are selected from the group consisting of surgical implements, dental implements, mechanical heart valves, bioreactors, containers, pipetmen, and tubing.

33. A sterilizing composition comprising an epoxy amine compound and an alcohol.