A Total Infection Control Foley Catheter System

导管相关性尿路感染占机构获得性尿路感染的40% 感染是多药耐药微生物的一个巨大而沉默的储存库，推迟患者的康复，以及 增加医疗成本。(每集800-3000美元)。全世界使用的Foley导尿管超过8000万到1亿 每年。引起CAUTI的微生物中约有2/3通过铝外途径进入膀胱 导管的外表面)，大约1/3的感染发生在铝内 在tl阶段下，我们开发并进行了一项关于杀菌设备的试点临床试验 (Foley GuardTM)，放在袋子和商业抗菌银水凝胶之间 感染控制Foley导管，研究其对腔内感染的影响。结果显示，大约有一个 腔内感染减少50%，但总体CAUTI并未显著减少，原因是 由商业导管提供的腔外途径。认识到这一需求，我们开发了我们的 自己的涂层Foley导管基于我们的专利配方，这是非常优越的当前商业 今天市场上有抗菌的福利导尿管。体外性能的高度增强与 独特的银化学及其在目前所缺乏的生物液中的持续释放 商用涂料；我们配方中的安全润滑剂、生物膜干扰剂和抗真菌药物提供了额外的 防御。样机已经通过了基本的生物兼容性测试。涂层中含有相同的 抗菌成分，如挤出的Foley Guard设备。我们提出了一个继续发展的计划 一种联合产品的开发(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)。基于有利的Meta做出了乐观的预测 银基产品的分析和我们的比较数据。第二阶段续建项目将进行试点 与合格的OEM医疗器械制造合作伙伴制造TIC系统，收集数据 根据FDA的要求提交FDA的文件，如洗脱图谱、生物膜耐药性和生物相容性 指导文件，进行临床试验，展示临床疗效并积极商业化 这种产品采用了一种商业模式，将这种产品迅速推向市场。

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 tl, 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.