Methods and apparatus for disinfecting subcutaneously implanted devices

• US 6,299,610 B1
• Filed: 01/07/1998
• Issued: 10/09/2001
• Est. Priority Date: 01/07/1998
• Status: Expired due to Fees

• Current Assignee: Vasca Inc.
• Original Assignee: Vasca Inc.
• Inventors: Brugger, James M., Burbank, Jeffrey H., Wang, John H., Finch, Charles D.
• Primary Examiner(s): LAM, ANN Y
• Assistant Examiner(s): LAM, ANN Y
• Application Number:
  US09/003,772
• Time in Patent Office: 1,371 Days
• Field of Search: 604/93, 604/264, 604/280, 604/175, 604/8, 604/190, 604/180, 604/252, 604/48, 604/500, 604/506, 604/514, 604/518, 604/265
• US Class Current: 604/506
• CPC Class Codes: A61M 2039/0226 having means for protecting the interior of the access site from damage due to the insertion of a needle
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 39/16 having provision for disinfection or sterilisation A61M39/143 takes precedence; methods or apparatus for disinfection or sterilisation A61L2/00

Abstract

Implantable ports and other devices are disinfected by the injection of an anti-microbial agent into a tissue pocket surrounding the device. In a first embodiment, the anti-microbial agent is injected through an aperture in the device to flush internal regions of the device before infusing the tissue pocket. In other embodiments, the anti-microbial agent is injected directly to a target site on the exterior of the device. Implantable devices may include special, usually hardened, target regions for receiving the sharpened end of a needle used to inject the anti-microbial agent.

Claims

1. A method for inhibiting infection of a device implanted in a tissue pocket, said method comprising percutaneously injecting a liquid anti-microbial agent to the device in an amount having a volume in the range from 1 to 50 ml sufficient to infuse and flush the tissue pocket, wherein the anti-microbial agent is injected against an external surface of the device.

2. A method as in claim 1, wherein the anti-microbial agent is selected from the group consisting of sodium hypochlorite, calcium hypochlorite, sodium oxychlorosone, alcohols, aldehydes, halides, providone iodine, and peroxides.

3. A method as in claim 1, wherein the agent is a liquid injected at a volume in the range from 2 ml to 25.

4. A method as in claim 1, wherein the agent is injected with a syringe through a needle.

5. A method as in claim 1, wherein the device is selected from the group consisting of ports, catheters, and pacemakers.

6. A method as in claim 5, wherein the device is a subcutaneously implanted port having a cannula connected to a blood vessel or other body lumen or cavity.

7. A method as in claim 1, wherein the anti-microbial agent is injected via a needle which is contacted against a target site on the external surface of the device, wherein the target site is harder than a distal tip of the needle.

8. A method as in claim 1, wherein the anti-microbial agent is injected into an internal volume within the device and infuses outwardly from the volume to the region surrounding the device.

20. A method as in claim 5, wherein the device is a subcutaneously implanted port having a cannula connected to a blood vessel or other body lumen or cavity.

9. A method for inhibiting infection of an implanted port which has an aperture for receiving an access tube through a tissue tract, said method comprising subcutaneously injecting a liquid anti-microbial agent into the aperture in an amount having a volume in the range from 1 ml to 50 ml sufficient to at least partly fill said aperture and to overflow from said aperture through a needle positioned in the same tissue tract as the access device, wherein the aperature is sized to mate with an access tube having a preselected size and wherein the anti-microbial fluid is injected with a needle having a size smaller than the preselected size so that the agent may infuse outwardly through the aperature past the needle.

10. A method as in claim 9, wherein the anti-microbial agent is selected from the group consisting of sodium hypochlorite, calcium hypochlorite, sodium oxychlorosone, alcohols, aldehydes, halides, providone iodine, and peroxides.

11. A method as in claim 9, wherein the agent is a liquid injected at a volume in the range from 2 ml to 25 ml.

12. A method as in claim 9, wherein the agent is injected with a syringe.

13. A method as in claim 9, further comprising introducing or withdrawing a fluid through an access tube percutaneously positioned in the aperture.

14. A method as in claim 13, wherein the anti-microbial agent is injected before the fluid is withdrawn or introduced.

15. A method as in claim 13, wherein the anti-microbial agent is injected after the fluid is withdrawn or introduced.

16. A method for inhibiting infection of a device implanted in a tissue pocket, said method comprising percutaneously injecting an anti-microbial agent to the device selected from the group consisting of ports, catheters, and pacemakers in an amount sufficient to infuse and flush the tissue pocket, wherein the anti-microbial agent is injected against an external surface of the device.

17. A method as in claim 16, wherein the anti-microbial agent is selected from the group consisting of sodium hypochlorite, calcium hypochlorite, sodium oxychlorosone, alcohols, aldehydes, halides, providone iodine, peroxides, and the like.

18. A method as in claim 16, wherein the agent is a liquid injected at a volume in the range from 1 ml to 50 ml.

19. A method as in claim 16, wherein the agent is injected with a syringe through a needle.

21. A method as in claim 16, wherein the anti-microbial agent is injected via a needle which is contacted against a target site on the external surface of the device, wherein the target site is harder than a distal tip of the needle.

22. A method as in claim 16, wherein the anti-microbial agent is injected into an internal volume within the device and infuses outwardly from the volume to the region surrounding the device.

23. A method for inhibiting infection of an implanted port which has an aperture for receiving an access tube through a tissue tract, said method comprising subcutaneously injecting an anti-microbial agent into the aperture in an amount sufficient to at least partly fill said aperture and to overflow from said aperture through a needle positioned in the same tissue tract as the access device wherein the anti-microbial fluid is injected with a needle having a size smaller than the preselected size so that the agent may infuse outwardly through the aperture past the needle.

24. A method as in claim 23, wherein the anti-microbial agent is selected from the group consisting of sodium hypochlorite, calcium hypochlorite, sodium oxychlorosone, alcohols, aldehydes, halides, providone iodine, peroxides, and the like.

25. A method as in claim 23, wherein the agent is a liquid injected at a volume in the range from 0.05 ml to 50 ml.

26. A method as in claim 23, wherein the agent is injected with a syringe.

27. A method as in claim 23, further comprising introducing or withdrawing a fluid through an access tube percutaneously positioned in the aperture.

28. A method as in claim 27, wherein the anti-microbial agent is injected before the fluid is withdrawn or introduced.

29. A method as in claim 27, wherein the anti-microbial agent is injected after the fluid is withdrawn or introduced.

30. A method for inhibiting infection of a device implanted in a tissue pocket, said method comprising percutaneously injecting an anti-microbial agent to the device in an amount sufficient to infuse and flush the tissue pocket, wherein the anti-microbial agent is injected against an external surface of the device.

31. A method as in claim 30, wherein the anti-microbial agent is selected from the group consisting of sodium hypochlorite, calcium hypochlorite, sodium oxychlorosone, alcohols, aldehydes, halides, providone iodine, peroxides, and the like.

32. A method as in claim 30, wherein the agent is a liquid injected at a volume in the range from 1 ml to 50 ml.

33. A method as in claim 30, wherein the agent is injected with a syringe through a needle.

34. A method as in claim 30, wherein the device is selected from the group consisting of ports, catheters, and pacemakers.

35. A method as in claim 34, wherein the device is a subcutaneously implanted port having a cannula connected to a blood vessel or other body lumen or cavity.

36. A method as in claim 30, wherein the anti-microbial agent is injected via a needle which is contacted against a target site on the external surface of the device, wherein the target site is harder than a distal tip of the needle.

37. A method as in claim 30, wherein the anti-microbial agent is injected into an internal volume within the device and infuses outwardly from the volume to the region surrounding the device.