A Total Infection Control Foley Catheter System

描述(申请人提供)：导管相关性尿路感染，CAUTIs，占所有机构获得的感染的40%，是一个巨大的、沉默的多重耐药微生物的储存库，推迟患者的康复，并增加医疗成本。(800-3000集/集)。全球每年使用的Foley导尿管超过8000万至1亿。大约2/3的引起CAUTI的微生物通过铝外(通过导管的外表面)进入膀胱，大约1/3的感染发生在收集袋的铝内。在II期下，我们开发并进行了放置在袋和商用抗菌银水凝胶感染控制Foley导管之间的杀菌装置(Foley GuardTM)的试点临床试验，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途径，总体CAUTI并未显著减少。认识到这一需求，我们基于我们的专利配方开发了我们自己的涂层Foley导管，这比目前市场上现有的商业抗菌Foley导管要好得多。高度增强的体外性能与独特的银化学及其在生物液体中的持续输送有关，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。这些涂层含有与挤出的Foley Guard设备相同的抗微生物成分。我们提出了继续开发一种联合产品的计划(TIC：连接到第二阶段开发的袋子附件的TIC：完全感染控制涂层Foley导管)。基于对银基产品的有利荟萃分析和我们的比较数据，我们做出了乐观的预测。第二阶段延续项目将与合格的OEM医疗器械制造合作伙伴试生产TIC系统，根据FDA指导文件收集洗脱曲线、生物膜耐药性和生物兼容性等数据供FDA提交，进行临床试验，展示临床疗效，并以一种将该产品迅速推向市场的商业模式积极将该产品商业化。

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.