Unique Antimicrobial Catheter to Prevent Urinary Tract Infections

第二阶段的目标是将一种独特的抗菌导管推向市场 为了减少最普遍的健康护理相关感染的情况， 导管相关性尿路感染（CANTI）。这项研究和 开发工作将是开发一种具有固有的持久 抗菌性能，以保护患者并防止感染。我们已经开始 与FDA的讨论，并有一个明确的要求路径， 完成监管审批流程。该装置是一种新的 抗菌导管的方法。它将使用常见的Foley导管设计 和材料，并向弹性体中添加添加剂， 导管抗菌剂。该添加剂替代了该组合物中的二氧化硅增强填料， 弹性体，旨在提供持久的时间释放抗菌 药剂到达导管表面。该导管可以廉价地制造， 与标准的医疗管制造工艺和材料，但将 具有抗微生物活性的增值特性。一种持久有效的 一种可以预防或减少尿路感染的抗菌导管将节省数百万美元， 美元的医疗费用和每年数千人的生命。

The goal of this Phase II effort is bring to market a unique antimicrobial catheter to reduce the instances of the most prevalent healthcare associated infection, Catheter-Associated Urinary Tract Infection (CAUTI). This research and development effort will be to develop a urinary catheter with inherent long lasting antiseptic properties to protect the patient and prevent infection. We have begun the discussions with the FDA and have a clear path of the requirements to complete the regulatory approval process. The proposed device is a new approach to antimicrobial catheters. It will use common Foley catheter designs and materials, with the addition of an additive to the elastomer to render the catheter antimicrobial. The additive replaces the silica reinforcing filler in the elastomer and is designed to give a long lasting time release of antibacterial agent to the catheter surface. The catheter can be manufactured inexpensively with standard medical tubing manufacturing processes and materials, but will have the value-added property of antimicrobial activity. A durable and effective antimicrobial catheter that can prevent or reduce CAUTI will save millions of dollars in healthcare cost and thousands of lives annually.