INFECTION AND ENCRUSTATION RESISTANT STENT MATERIALS

DESCRIPTION (provided by applicant): This phase I project proposes to demonstrate the feasibility of fabricating stent configurations from a biomimetic nanocomposite material made of medical grade polymers and certain proprietary biocompatible antimicrobial formulations. Such biocidal compositions in plastics have been found to be very effective in preventing biofilm formation and encrustation in human urine against a variety of pathogens. The phase I will study the "in vitro" performance of biliary stents made from the proposed material as a proof of concept. Unlike the antibiotic impregnated materials which last only for a few days, the current configuration is anticipated to facilitate the slow sustained action with self renewing ability from a well developed multifunctional formulation (non-antibiotic) offering excellent biofilm resistance, encrustation and protein adsorption resistance over several months. The prototypes with three different formulations and the appropriate controls will be evaluated for bacterial adherence and their ability to provide a continuous bactericidal surface under continuous wash and challenge conditions in Oxbile medium. The protocols for such experiments have been developed by ICET and standardized by ICET. The best-optimized stent material would be further evaluated in vitro at UC Davis Medical Center under the supervision of the chief of gastroenterology. The in vitro study would make use of a modified Robbins device and perfusion with infected bile. The plastic components and the biocidal components have been chosen from a group of FDA approved materials. A medical device manufacturer would make the stent prototypes and eventually market them. Therefore once the efficacy is proven in vitro the transition to the phase II scale up and clinical trials is expected to proceed smoothly.