PROTECTIVE TREATMENT FOR POLYMERIC SOLIDS

长期目标：测试和商业化， 将抗微生物剂浸渍到 硅橡胶 从目前的研究模型的成功结果， （脊髓液分流和中心静脉导管）将在稍后 适用于许多商业设备，这些设备将硅橡胶带入慢性 与活体组织接触。 预计主要人道主义援助将在2010年12月31日至2011年12月31日期间 由于这一点，感染的发生率降低， 创新 第二阶段-具体目标： 1.结束体外临床前试验（保护证明 抗定植，灌注导管中抗菌剂的定量） 和体内（小鼠脑内植入物，狗静脉内导管 植入物、血清和尿中抗微生物水平的定量 中心静脉导管和丹佛脑积水分流管 2.完成浸渍中心静脉导管的临床试验 从而满足FDA对上市前批准的要求， 产品 在第三阶段，将使用抗菌剂浸渍的中心静脉导管 上市销售，并将启动临床试验， 抗菌浸渍Denver脑积水分流管。

Long Term Objectives: To test and make commercially available, an already defined laboratory process for impregnating antimicrobial agents into silicone rubber. Successful results from the current study models, (cerebro-spinal fluid shunts and central venous catheters) will later be applied to many commercial devices which bring silicone rubber into chronic contact with living body tissue. It is expected that major humanitarian benefits will result because of lowered incidence of infection due to this innovation. Phase II -Specific Aims: 1. To conclude pre-clinical testing in vitro, (demonstration of protection against colonization, quantitation of antimicrobials in perfused catheters) and in vivo (mouse intra-cerebral implant, dog intravenous catheter implant, quantitation of antimicorbial levels in serum and urine) jointly in a central venous catheter and in the Denver Hydrocephalus Shunt. 2. To complete a clinical trial with impregnated central venous catheters and thereby meet the FDA requirements for pre-market approval of the product. In Phase III an antimicrobial-impregnated central venous catheter will be made commercially available and a clinical trial will be initiated with antimicrobial impregnated Denver Hydrocephalus Shunts.