A Total Infection Control Foley Catheter System

描述（由申请人提供）：导管相关性尿路感染（CAUTIs），占所有机构获得性感染的40%，是一个巨大而沉默的多药耐药菌库，延迟患者康复，增加医疗成本。(800 - 3000 /集)。全世界每年使用的福莱导尿管超过8000万至1亿个。引起CAUTI的微生物中约有2/3通过膀胱外腔（通过导管外表面）进入膀胱，约1/3的感染发生在膀胱内，来自收集袋。在II期研究中，我们开发并进行了一项临床试验，将一种消毒装置（Foley GuardTM）放置在袋子和商用抗菌银水凝胶感染控制Foley导管之间，以研究其对腔内感染的影响。结果显示，腔内感染减少了约50%，但由于商业导管提供的腔外路径，总体CAUTI并未显着减少。认识到这一需求，我们已经根据我们的专利配方开发了我们自己的涂层Foley导管，这是非常优越的目前市场上的商业抗菌Foley导管。高强度的体外性能与银的独特化学性质及其在生物流体中的持续传递有关，这是目前商业涂料所缺乏的；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。这些样品已经通过了基本的生物相容性测试。该涂层含有与挤压Foley Guard装置相同的抗菌成分。我们提出了一个继续开发联合产品的计划（TIC：完全感染控制涂层Foley导管连接到第二阶段开发的袋子配件）。基于对银基产品有利的meta分析和我们的比较数据，我们做出了一个乐观的预测。二期延续项目将与合格的OEM医疗器械制造合作伙伴一起试点生产TIC系统，根据FDA指导文件收集洗脱谱、生物膜耐药性和生物相容性等数据提交FDA，进行临床试验，证明临床疗效，并通过商业模式积极商业化该产品，将该产品快速推向市场。

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.