Biostatic Coatings to Prevent Biliary Stent Occlusions

防止胆道支架闭塞的生物静电涂层

• 批准号: 6833713
• 负责人: RAINER GRUENING
• 金额: $ 9.79万
• 依托单位: HYDROMER, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-30 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6833713
• 关键词: adhesions; antibacterial agents; bile obstruction; biofilm; biomaterial development /preparation; biomaterial evaluation; biomaterial interface interaction; biotechnology; chemical chain length; chemical stability; chemical structure function; covalent bond; disease /disorder prevention /control; fluid flow; gastrointestinal surgery; intermolecular interaction; medical implant science; molecular film; nonblood rheology; physical property; polymers; polyurethanes; postoperative complications; prosthesis; quaternary ammonium compound; surface coating

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.

描述（由申请人提供）：尽管内窥镜支架插入目前是姑息胆管阻塞的最有效方法，但大约4个月后，多达三分之一的塑料支架的最多三分之一被阻塞，导致黄疸并需要支架替换。第一阶段的目的是研究并证明具有永久粘合，不粘附和自我清洁涂层的胆管支架闭塞的可行性，该涂层也可能破坏闭塞，从而导致试图粘附在支架表面的细菌。与常规的抗生素和药物浸渍的支架很快耗尽不同，所提出的涂层将包含一种创新的长期链式聚合物复合物，该复合物将分子键合到支架表面，不会渗出，也不会耗尽。浸出的一个主要问题是细菌可能产生对抗生素和杀菌剂的抗药性。提出的自我清洁涂层不会降低功效，并且反复破坏与支架表面接触的细菌，可能无限期地。 拟议的商业应用：Hydromer以其BioSearch商业名称制造塑料胆道支架，该塑料型式支架将用于II期研究和评估，从而使临床试验和商业化可能性顺利过渡。此外，胆道支架将不是从这项研究中受益的唯一医疗设备。该涂料技术可以转移到其他医疗应用中，例如减少尿道支架和尿道导管中的包裹，以及预防鼻胃和空肠喂养管中的感染和败血症。