Methods and apparatus for inhibiting infection of subcutaneously implanted devices

• US 6,299,609 B1
• Filed: 06/15/1999
• 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): Seidel, Richard K.
• Assistant Examiner(s): Thissell, Jeremy
• Application Number:
  US09/333,827
• Time in Patent Office: 847 Days
• Field of Search: 604/500, 604/175, 604/502, 604/507, 604/506, 604/508, 604/93.01, 604/167.01, 604/167.02
• US Class Current: 604/502
• CPC Class Codes: A61M 2005/1403 Flushing or purging
• 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 2209/04 Tools for specific apparatus
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• 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 cleansed by the injection of a washing solution into a region in the device or in a tissue pocket surrounding the device. In a first embodiment, the washing solution is injected through an aperture in the device to flush internal regions of the device before infusing the tissue pocket and flushing outwardly through a tissue tract leading to the device. In other embodiments, the washing solution 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 washing solution. Kits will include devices, syringes, access devices, and instructions for cleansing according to the methods of the present invention.

Claims

1. A method for inhibiting infection of an implanted device, said method comprising percutaneously injecting or withdrawing a fluid through a single percutaneous access tract to the device;

and;

injecting a washing solution through the same percutaneous access tract to the device in an amount sufficient to flush a region within or surrounding the device such that the washing solution flows outwardly back through the access tract.

2. A method as in claim 1, wherein the washing solution is selected from the group consisting of saline, sterile water, and Ringer'"'"'s solution.

3. A method as in claim 1, wherein the washing solution is injected at a volume in the range from 0.5 ml to 1000 ml.

4. A method as in claim 1, wherein the washing solution is injected from a syringe through a needle which is percutaneously introduced to the device.

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 washing solution is injected against an external surface of the device.

8. A method as in claim 7, wherein the washing solution 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.

9. A method as in claim 1, wherein the washing solution is injected into an internal volume within the device and infuses outwardly from the volume to the region surrounding the device.

10. A method for inhibiting infection of an implanted port which has an aperture for receiving an access tube, said method comprising subcutaneously injecting a washing solution through a tissue tract into the aperture in an amount sufficient to at least partly fill said aperture and to overflow from said aperture to infuse a region surrounding the port within a pocket of tissue and to flow outwardly back through the access tract.

11. A method as in claim 10, wherein the washing solution is selected from the group consisting of saline, sterile water, and Ringer'"'"'s solution.

12. A method as in claim 10, wherein the washing solution is a liquid injected at a volume in the range from 0.5 ml to 1000 ml.

13. A method as in claim 10, wherein the washing solution is injected with a syringe through a needle which is passed through the aperture.

14. A method as in claim 10, wherein the aperture is sized to mate with a access tube having a preselected size and wherein the washing solution is injected with a needle having a size smaller than the preselected size so that the washing solution may infuse outwardly through the aperture past the needle.

15. A method as in claim 14, further comprising introducing or withdrawing a fluid through an access tube percutaneously positioned in the aperture.

16. A method as in claim 15, wherein the washing solution is injected before the fluid is withdrawn or introduced.

17. A method as in claim 15, wherein the washing solution is injected after the fluid is withdrawn or introduced.