Methods and apparatus for disinfecting subcutaneously implanted devices

• US 6,436,084 B1
• Filed: 09/25/1998
• Issued: 08/20/2002
• Est. Priority Date: 01/07/1998
• Status: Expired due to Term

• Current Assignee: Vasca Inc.
• Original Assignee: Vasca Inc.
• Inventors: Finch, Charles David, Brugger, James M., Burbank, Jeffrey H., Wang, John H.
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): Thissell, Jeremy
• Application Number:
  US09/161,044
• Time in Patent Office: 1,425 Days
• Field of Search: 604/93, 604/500, 604/175, 604/167, 604/502, 604/506
• 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 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• 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 region in the device or in 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 and flushing outwardly through a tissue tract leading to the device. 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. Kits will include devices, syringes, access devices, and instructions for disinfection according to the methods of the present invention.

Claims

1. A method for detecting infection of an implanted device, said method comprising:

injecting a flowable material through a single tissue tract and into a region within or at least partially surrounding the device so that a portion of the injected material flows outwardly back through the single tissue tract;

observing the portion of material which flows outwardly through the single tissue tract to detect the presence of infection; and

withdrawing or injecting a fluid through the single tissue tract either before or after injecting the flowable material therethrough.

2. A method as in claim 1, wherein the observing step comprises observing signs including yellow appearance and cellular debris.

3. A method as in claim 1, further comprising injecting an antibiotic agent into the region within or surrounding the device to treat an infection when infection is observed.