Biostatic Coatings to Prevent Biliary Stent Occlusions

描述（由申请人提供）：尽管内镜支架置入术是目前缓解胆管梗阻的最有效方法，但约4个月后，高达三分之一的塑料支架发生闭塞，导致黄疸，需要更换支架。I期的目标是研究和证明使用永久粘合、非粘附和自清洁涂层预防胆道支架闭塞的可行性，该涂层还可以破坏试图粘附在支架表面的导致闭塞的细菌。与很快耗尽的常规抗生素和药物浸渍支架不同，所提出的涂层将含有创新的长链聚合物复合物，其分子键合到支架表面并且不会浸出或耗尽。沥滤的一个主要问题是细菌可能对亚致死剂量的抗生素和杀生物剂产生耐药性。所提出的自清洁涂层不会降低功效，并且可能无限期地反复破坏与支架表面接触的细菌。 拟定商业应用：Hydromer以其商品名Biosearch生产塑料胆道支架，该支架将用于II期研究和评估，为临床试验和商业化提供平稳过渡的可能性。此外，胆道支架不是唯一受益于本研究的医疗器械。这种涂层技术将可转移到其他医疗应用中，例如用于减少尿道支架和尿道导管中的结壳，以及用于预防鼻胃管和空肠饲管中的感染和败血症。

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.