Infection and encrustation resistant stent materials

描述（由申请人提供）：本I期项目旨在证明由医用级聚合物和某些专有生物相容性抗菌制剂制成的仿生纳米复合材料制造支架配置的可行性。已发现塑料中的此类杀生物组合物在防止人尿中的生物膜形成和结壳以对抗多种病原体方面非常有效。第一阶段将研究由申报材料制成的胆道支架的“体外”性能，作为概念验证。与仅持续几天的抗生素浸渍材料不同，预期当前的配置有利于缓慢持续的作用，具有来自良好开发的多功能制剂（非抗生素）的自我更新能力，在几个月内提供优异的生物膜抗性、结壳和蛋白质吸附抗性。将评价具有三种不同制剂和适当对照品的原型的细菌粘附性及其在Oxbile培养基中连续清洗和挑战条件下提供连续杀菌表面的能力。这些实验的协议已经由ICET制定，并由ICET标准化。最佳支架材料将在消化科主任的监督下在加州大学戴维斯医学中心进行进一步的体外评价。体外研究将使用改良的罗宾斯装置和感染胆汁灌注。塑料组分和生物杀灭剂组分选自一组FDA批准的材料。医疗器械制造商将制造支架原型并最终将其推向市场。因此，一旦在体外证明了疗效，则过渡到II期规模扩大和临床试验预计将顺利进行。

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.