Infection-resistant Polyurethane Materials

Period of Performance: 09/04/2000 - 08/31/2001

$250K

Phase 2 STTR

Recipient Firm

Cardiotech International, Inc.
Woburn, MA 01801
Principal Investigator

Abstract

Infection of polymeric biomaterials is a major problem. In phase I, the antibiotic ciprofloxacin (Cipro) was applied to an ionic polyurethane (cPU) using textile dyeing technology, and the application parameters were optimized. No exogenous binding agents were involved. This "dyed"-cPU demonstrated slow release of Cipro with sustained antimicrobial activity. The goal of this phase II application is to evaluate this Cipro-dyed CPU in vivo. We hypothesize that dyeing the cPU with Cipro will result in sustained infection resistance in vivo. cPU polymer will be coated onto pre-formed indwelling catheters. Cipro will be dyed onto cPU-coated catheters using parameters from phase I. Chemical and physical characteristics of the cPU- coated catheter will be assessed pre and post-dyeing. Cipro-dyed catheters will then be evaluated for Cipro release and sustained antimicrobial activity. Catheters will be subjected to an in vitro flow model in order to determine antibiotic release pharmacokinetics. Optimized Cipro-dyed catheters will then be evaluated using an in vivo subcutaneous implant model. A successful indwelling polyurethane catheter with long-term infection resistance would generate a U.S. market greater than $300 million annually. This technology could be applied to other biomedical materials (vascular grafts, wound dressings) and commercial products (shower curtains, clothing). PROPOSED COMMERCIAL APPLICATIONS: Development of a successful indwelling polyurethane catheter with long- term infection resistance could conservatively result in a U.S. market greater than $300 million annually. Additionally, this technology could be applied to a wide range of other biomedical applications such as implantable devices (i.e. vascular grafts, artificial heart) and wound dressings as well as application for commercial products such as shower curtains, clothing or foam cushions were bacteria/fungi presence is not desired.