Device for vapor sterilization of articles having lumens

• US 5,580,530 A
• Filed: 05/08/1995
• Issued: 12/03/1996
• Est. Priority Date: 07/30/1987
• Status: Expired due to Term

• Current Assignee: Johnson & Johnson Medical Incorporated (Johnson & Johnson)
• Original Assignee: Johnson & Johnson Medical Incorporated (Johnson & Johnson)
• Inventors: Howlett, Charles, Soto, Toby, Kowatsch, Reinhard
• Primary Examiner(s): SNAY, JEFFREY R
• Application Number:
  US08/436,999
• Time in Patent Office: 575 Days
• Field of Search: 422/102, 422/292, 422/294, 422/302, 422/303, 422/103, 422/305, 220/278, 604/411, 604/415
• US Class Current: 422/559
• CPC Class Codes: A61B 1/121 provided with means for cleaning post-use
• CPC Class Codes: A61L 2/14 Plasma, i.e. ionised gases
• CPC Class Codes: A61L 2/20 Gaseous substances, e.g. vapours
• CPC Class Codes: A61L 2/208 Hydrogen peroxide
• CPC Class Codes: A61L 2/22 Phase substances, e.g. smokes, aerosols or sprayed or atomised substances
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 2202/122 Chambers for sterilisation
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps

Abstract

A method and device for enhancing the vapor sterilization of the lumen of medical instruments and like articles under reduced pressure. A vessel containing a small amount of a vaporizable liquid antimicrobial solution is attached to the lumen. The antimicrobial vaporizes and flows directly into the lumen of the article as the pressure is reduced for the sterilization cycle. Preferred embodiments illustrate a sealed chamber containing the antimicrobial and an opener for opening the chamber with the device already attached to the article. Preferably, the opener comprises a hollow spike. A ring between the opener and chamber must be removed prior to opening the chamber and removal of the ring destroys the ring so that it can not be replaced.

Claims

1. A device for delivering an antimicrobial vapor to a lumen of an article during solution vapor sterilization, the device comprising:

a first member comprising a vessel having an inner sealed chamber containing an antimicrobial solution and a wall forming at least a portion of the chamber;

a connector in communication with the wall for connecting the vessel to the article lumen;

a second member connected to the first member in moveable relation thereto, the second member comprising an opening member whereby movement of the second member in a predetermined direction relative to the first member moves the opening member toward wall to open the wall and place the chamber into fluid communication with the article lumen;

wherein the chamber containing the antimicrobial solution may be opened and placed into communication with the article lumen with the connector connected to the article lumen whereby a user is thereby isolated from the antimicrobial solution during a process of opening the chamber.

2. A device according to claim 1 and further comprising a first abutting surface on the first member, a second abutting surface on the second member and a removable guard between the first and second abutting surfaces wherein the removable guard prevents the first and second members from moving together sufficiently to breach the wall.

3. A device according to claim 2 wherein the guard further comprises a contrasting appearance to the first and second members whereby the presence or absence of the guard can easily be visually determined.

4. A device according to claim 2 wherein the guard comprises a ring encircling the device between the first and second members.

5. A device according to claim 4 wherein the ring is inelastic whereby to remove the ring from between the first and second abutting surfaces it must be deformed beyond its elastic limit.

6. A device according to claim 1 wherein the opening member comprises a penetrating member for penetrating the wall.

7. A device according to claim 6 wherein the penetrating member comprises a spike having a first end which faces the wall and comprises a sharpened tip.

8. A device according to claim 7 wherein the spike further comprises a second end and a central lumen extending coaxially therethrough, the spike lumen having a first end at the first end of the spike and a second end, the second end of the spike lumen being in fluid communication with the connector whereby the vessel is placed into fluid communication with the article lumen through the spike lumen when the spike penetrates the wall.

9. A device according to claim 8 and further comprising a passage for the antimicrobial solution from the chamber to the connector exterior of spike lumen.

10. A device according to claim 9 wherein the second member is tubular and has an inner wall, the first and second members are disposed in telescoping relation to one another and the spike is supported within the second member by at least one post extending from the second member inner wall wherein the spike is spaced therefrom to form the passage exterior of the spike lumen.

11. A device according to claim 1 wherein the first and second members are interconnected in telescoping relationship with each other.

12. A device according to claim 11 and further comprising a first detent extending from one of the first and second members and a first surface extending from the other of the first and second members, the first detent engaging the first surface to limit the degree to which the first and second members can telescope apart, wherein the other of the first and second members is free from obstructions such that the first and second members can move from a position with the first detent and first surface engaged to a position wherein the opening member contacts the wall without interference with each other.

13. A device according to claim 11 wherein one of the first and second members comprises a projection and the other of the first and second members is tubular and telescopically receive the projection therein.

14. A device according to claim 11 wherein the second member is tubular and wherein a projection on the first member extends axially from adjacent the wall and is telescopically received within the second member.

15. A device according to claim 14 wherein the connector is disposed at the proximal end of the second member whereby the vessel can be placed into fluid communication with the article lumen through the tubular second member and through the connector.

16. A device according to claim 14 and further comprising a mist filter in the second member between the first member and the connector to prevent liquid antimicrobial solution or contaminants from entering the article lumen.

17. A device according to claim 14 wherein the opening member comprises a spike received within the second member in a position to breach the wall when the first and second members are telescoped together.

18. A device according to claim 17 wherein the spike further comprises a first end facing the wall, a second end and a central lumen extending coaxially therethrough, the spike lumen having a first end at the first end of the spike and a second end, the second end of the spike lumen being in fluid communication with the connector whereby the vessel is placed into fluid communication with the article lumen through the spike lumen when the spike penetrates the wall.

19. A device according to claim 18 and further comprising a first abutting surface on the first member, a second abutting surface on the second member and a removable guard between the first and second abutting surfaces wherein the removable guard prevents the first and second members from moving together sufficiently to breach the wall.

20. A device according to claim 14 and further comprising a threaded interconnection between the first and second members wherein rotation of the first and second members relative to each other moves them together to breach the wall.

21. A device according to claim 20 wherein the device further comprises a sharp leading cutting edge on the spike which is positioned so that when the first and second members are rotated together, the cutting edge cuts through the wall.

22. A device according to claim 20 and further comprising a tactile detent on one of the first and second members positioned to engage a tactile detent engaging surface on the other of the first and second members as the first and second members are rotated together whereby the interaction of the tactile detent and the tactile detent engaging surface produces a tactile feedback to a user that the first and second members are fully rotated together.

23. A device according to claim 20 wherein the projection comprises a thread, the second member comprises a thread engaging protuberance and wherein the tactile detent is disposed within the thread and wherein the tactile detent engaging surface comprises the thread engaging protuberance.