Biostatic Coatings to Prevent Biliary Stent Occlusions

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DESCRIPTION (provided by applicant): Although endoscopic stent insertion is currently the most effective method for palliating biliary duct obstruction, up to one third of all plastic stents become occluded after about 4 months, resulting in jaundice and requiring stent replacement. The goal of Phase I is to research and demonstrate the feasibility of preventing biliary stent occlusions with a permanently bonded, non-adhering and self cleansing coating that can also destroy occlusion causing bacteria that attempt to adhere to the stent surface. Unlike conventional antibiotic and drug impregnated stents that become depleted very quickly, the proposed coating would contain an innovative long chained polymeric complex that is molecularly bonded to the stent surface and would not leach out nor become depleted. A major problem with leaching is the possibility of bacteria developing a resistance to the sublethal doses of antibiotics and biocides. The proposed self-cleansing coating would not diminish in efficacy, and repeatedly destroy bacteria that come in contact with the stent surface, potentially indefinitely. PROPOSED COMMERCIAL APPLICATION: Hydromer manufactures plastic biliary stents under its Biosearch trade name, that would be used for Phase II research and evaluations, providing a smooth transition to clinical trials and commercialization possibilities. Additionally, biliary stents would not be the only medical device to benefit from this research. This coating technology would be transferable to other medical applications, such as for reducing encrustation in urethral stents and urethral catheters, and for preventing infections and sepsis in nasogastric and jejunal feeding tubes.