A Total Infection Control Foley Catheter System

描述（由申请人提供）：导管相关性尿路感染，尿路感染，包括>40%的所有机构获得性感染，是一个巨大的和沉默的多药耐药微生物库，延迟患者康复，并增加医疗保健成本。（800-3000/集）。全世界每年使用超过8000万至1亿根Foley导管。约2/3的引起膀胱炎的微生物通过腔外途径进入膀胱（经由导管的外表面），并且约1/3的感染发生在来自收集袋的管腔内。在阶段II下，我们开发并进行了一项临床试验，（FoleyGuardTM），将其置于袋和商业抗微生物银水凝胶感染控制Foley导管之间，以研究其对管腔内感染的作用。结果显示腔内感染减少了约50%，但由于市售导管提供的腔外途径，总体PIMTI并未显著降低。认识到这一需求，我们已经开发了我们自己的涂层弗利导管的基础上，我们的专利配方，这是非常上级目前市场上的商业抗菌弗利导管。体外性能的高度增强与独特的银化学性质及其在生物液体中的持续递送有关，这是当前商业涂层所缺乏的;我们配方中的安全润滑剂、生物膜破坏剂和抗真菌剂提供了额外的防御。原型已通过基本生物相容性试验。涂层含有与挤出Foley Guard器械相同的抗菌成分。我们提出了一项继续开发组合产品的计划（TIC：与II期开发的袋附件连接的完全感染控制涂层Foley导管）。基于对银基产品的有利Meta分析和我们的比较数据，做出了乐观的预测。II期延续项目将与资质良好的OEM医疗器械制造合作伙伴试生产TIC系统，根据FDA指南文件收集用于FDA提交的数据，如洗脱曲线、生物膜抗性和生物相容性，进行临床试验，证明临床疗效，并使用将该产品快速推向市场的商业模式积极商业化该产品。

DESCRIPTION (provided by applicant): Catheter Associated Urinary Tract Infections, CAUTIs, comprising >40% of all institutionally acquired infections is a huge and silent reservoir of multi drug resistant organisms, delay patient recovery, and increase healthcare costs. (800-3000/episode). Over 80-100 million Foley catheters are used world wide per year. About 2/3rds of the microorganisms causing CAUTI gain access to the bladder extraluminally (via the external surface of the catheter), and about 1/3rd of the infections occur intraluminally from the collection bag.Under a phase II, we developed and conducted a pilot clinical trial on an antiseptic device (Foley GuardTM) that was placed between the bag and a commercial antimicrobial silver hydrogel infection control Foley catheter to study its effect on intraluminal infections. The results showed about a 50% reduction of the intraluminal infection, however the overall CAUTI was not significantly reduced due to the extraluminal route provided by the commercial catheter. Recognizing this need, we have developed our own coated Foley catheter based on our patented formulations, that is very superior the current commercial antimicrobial Foley catheters in the market today. The highly enhanced in vitro performance is related to the unique silver chemistry and its sustained delivery in biological fluids which is lacking in the current commercial coatings; safe lubricants, biofilm disruptors and antifungals in our formulation provide additional defenses. The prototypes have passed the basic biocompatibility tests. The coatings contain the same antimicrobial components as the extruded Foley Guard device. We present a plan for the continued development of a combined product (TIC :Total Infection Control - coated Foley catheter connected to the bag accessory developed in Phase II). An optimistic projection is made based on the favorable meta analysis for silver based products and our comparative data. The phase II continuation project will pilot manufacture the TIC system with well qualified OEM medical device manufacturing partners, collect data for FDA submission such as elution profiles, biofilm resistance and biocompatibility according to FDA guidance document, conduct clinical trials, demonstrate the clinical efficacy and aggressively commercialize this product using a business model that will bring this product quickly to the market.