Catheter associated urinary tract infection (CAUTI) remains a significant problem, being the most common nosocomial infection acquired in hospitals. The goal of this program is the fabrication and evaluation of a new medicated urinary catheter manufactured from a silicone rubber material which is loaded with the antimicrobial agent chlorhexidine gluconate (CHG). This material has previously been shown to be effective against organisms typically encountered with CAUTI. The CHG is contained in a polyethylene glycol matrix uniformly dispersed in the elastomer and designed to release the drug over a period of up to 4 weeks. The choice of CHG as the antimicrobial agent is based on its broad spectrum activity, low incidence of the development of bacterial resistance to its action, and its comparatively low toxicity. Catheters with 1%, 2%, 3%, and 4% CHG by weight will be fabricated by compression molding and also by a modified form of injection molding. The release of CHG from the catheters will be quantitated in vitro over a 4 week period using high performance liquid chromatography. Test specimens of each candidate formulation will then be evaluated for their potential as mucosal irritants in an adult rabbit animal model for a 7 day period of contact.
The aim of this medicated catheter system is to inhibit or prevent biofilm formation on either the luminal or tissue facing catheter surfaces, a situation which makes CAUTI very difficult to treat. Following biofilm formation, antibiotic concentrations ranging from 500-5,000 times that required to kill free floating organisms of the same species are needed.

Proposed Commercial Applications

A urinary catheter that effectively inhibits bacterial growth has the potential to significantly improve care for patients undergoing a wide variety of surgical procedures. The new urinary catheter has the potential to reduce hospital costs associated with the management of catheter associated infections.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43DK057918-01
Application #
6140878
Study Section
Special Emphasis Panel (ZRG1-SSS-Z (01))
Program Officer
Mullins, Christopher V
Project Start
2000-07-01
Project End
2001-06-30
Budget Start
2000-07-01
Budget End
2001-06-30
Support Year
1
Fiscal Year
2000
Total Cost
$100,045
Indirect Cost
Name
Whalen Biomedical, Inc
Department
Type
DUNS #
City
Somerville
State
MA
Country
United States
Zip Code
02420
Richards, Christopher L; Hoffman, Kimberly C; Bernhard, John M et al. (2003) Development and characterization of an infection inhibiting urinary catheter. ASAIO J 49:449-53