Method of sterilization in diffusion restricted environments

• US 5,961,921 A
• Filed: 04/04/1997
• Issued: 10/05/1999
• Est. Priority Date: 04/04/1996
• Status: Expired due to Fees

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Johnson & Johnson Medical Incorporated (Johnson & Johnson)
• Inventors: Lin, Szu-Min, Jacobs, Paul Taylor, Addy, Tralance O., Jacobs, Jon Morrell
• Primary Examiner(s): MCKANE, ELIZABETH L
• Application Number:
  US08/833,375
• Time in Patent Office: 914 Days
• Field of Search: 422/28, 422/33, 422/300, 422/297, 422/292
• US Class Current: 422/33
• CPC Class Codes: A61L 2/14 Plasma, i.e. ionised gases
• CPC Class Codes: A61L 2/16 using chemical substances
• CPC Class Codes: A61L 2/186 Peroxide solutions
• CPC Class Codes: A61L 2/208 Hydrogen peroxide
• CPC Class Codes: A61L 2202/122 Chambers for sterilisation
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: Y10S 220/913 Ventilated container
• CPC Class Codes: Y10S 422/906 Plasma or ion generation means

Abstract

Methods for peroxide vapor sterilization of medical devices and similar instruments having long narrow lumens or diffusion restricted areas includes the step of contacting the article to be sterilized or a diffusion-restricted environment containing said article with a source of peroxide prior to exposure to a vacuum or a vacuum followed by plasma. The methods are such that, upon vaporization of the source of peroxide caused by the vacuum, the peroxide remains in contact with the article for a time sufficient to achieve sterilization.

Claims

1. A method for sterilizing an article within a container in a vacuum chamber, said method comprising:

(a) placing said article in said container, wherein said container is in fluid communication with the chamber through an exit tube having a length to internal diameter ratio greater than or equal to 1.1;

(b) contacting the interior of the container with a source of peroxide which releases hydrogen peroxide vapor, said placing and contacting steps being performed in either order;

(c) reducing the pressure of the chamber and container below the vapor pressure of hydrogen peroxide;

(d) generating hydrogen peroxide vapor in the container;

(e) diffusing said hydrogen peroxide vapor from the container through the exit tube into said vacuum chamber; and

(f) exposing said article to said hydrogen peroxide vapor for a time period sufficient to effect sterilization of said article.

2. The method of claim 1, wherein the exposing step is repeated one or more times.

3. The method of claim 1, wherein the entire method is repeated one or more times.

4. The method of claim 1, wherein said contacting step comprises delivery via one or more methods selected from the group consisting of injection, static soak, liquid flow-through, aerosol spray, condensation or physical placement.

5. The method of claim 1, further comprising the step of exposing said container to a plasma during the step of exposing the article to the hydrogen peroxide vapor.

6. The method of claim 5, wherein said method is performed within a sealed chamber and said plasma is generated within said chamber.

7. The method of claim 1, wherein said exposing step is performed for 60 minutes or less.

8. The method of claim 1, further comprising the step of heating said container during said exposing step.

9. The method of claim 1, further comprising heating said source of peroxide prior to said contacting step.

10. The method of claim 1, wherein said exposing step further comprises exposing said container to negative pressure between 0 and 100 Torr.

11. The method of claim 1, wherein said source of peroxide comprises a liquid, a solid or condensed vapor.

12. The method of claim 11, wherein said liquid comprises hydrogen peroxide or peracetic acid.

13. The method of claim 11, wherein said solid comprises a urea peroxide complex or sodium pyrophosphate peroxide complex or like complex.

14. The method of claim 11, wherein said condensed vapor comprises hydrogen peroxide or peracetic acid vapor.

15. The method of claim 1, wherein said exit tube has a filter therein.

16. The method of claim 15, wherein said filter prevents entry of bacteria into said container.

17. The method of claim 1, wherein said exit tube is at least 1.0 cm in length.

18. The method of claim 1, wherein said exit tube has an internal diameter of 9 mm or less.

19. The method of claim 1, wherein said exit tube is additionally connected to a valve outside said container, said valve being in communication with the vacuum chamber.

20. A method for sterilizing a lumened article having an exterior surface and an interior surface within a container in a vacuum chamber, wherein said container is in fluid communication with the chamber through a communication port on the container, said method comprising:

(a) placing said article in said container, said article having a lumen with a length to internal diameter ratio greater than or equal to 90;

(b) connecting the lumen of said article to the communication port through a connector;

(c) contacting the interior of the container with a source of peroxide which releases hydrogen peroxide vapor, said placing, connecting, and contacting steps being performed in any order;

(d) reducing the pressure of the chamber and container below the vapor pressure of hydrogen peroxide;

(e) generating said hydrogen peroxide vapor in the container;

(f) diffusing said hydrogen peroxide vapor from the container through the lumen, the connector, the communication port and into said vacuum chamber; and

(g) exposing said article to said hydrogen peroxide vapor to effect sterilization of the interior surface and the exterior surface of said article.

21. The method of claim 20, wherein said connector comprises tubing or an adaptor which can be attached to the lumen of said article or an enclosure which contains a portion of said article.

22. The method of claim 20, wherein the container is diffusion restricted.

23. The method of claim 22, wherein the diffusion restriction in said container results from said communication port.

24. The method of claim 20, wherein said communication port comprises an exit tube.

25. The method of claim 24, wherein said exit tube is at least 1.0 cm in length.

26. The method of claim 24, wherein said exit tube has an internal diameter of 9 mm or less.

27. The method of claim 20, wherein said communication port comprises an air and vapor permeable window.

28. The method of claim 27, wherein said window is impermeable to microorganisms.

29. The method of claim 20, wherein said container additionally contains one or more articles not having a lumen.

30. The method of claim 20, wherein said container additionally contains an article having a lumen with a length to internal diameter ratio less than 90.

31. The method of claim 20, further comprising the step of exposing said container to a plasma during the step of exposing the container to negative pressure.

32. The method of claim 31, wherein said method is performed within a sealed chamber and said plasma is generated in said chamber.

33. The method of claim 20, wherein said container is a rigid container.

34. The method of claim 20, wherein said container is a flexible pouch.