Unique Antimicrobial Catheter to Prevent Urinary Tract Infections

这一第二阶段工作目标是将一种独特的抗菌导管推向市场 为了减少最普遍的医疗保健相关感染的情况， 导管相关性尿路感染(CAUTI)。这项研究和 开发工作将是开发一种固有的长效导尿管 杀菌性能，以保护患者和防止感染。我们已经开始了 与FDA的讨论，并有明确的要求路径 完成监管审批流程。建议的设备是一种新的 使用抗菌导尿管的方法。它将使用普通的Foley导管设计 和材料，在弹性体中添加添加剂以使 导管抗菌剂。该添加剂替代了白炭黑补强填充剂 弹性体，可提供持久的抗菌剂释放 将药剂添加到导管表面。这种导管的制造成本很低 使用标准的医疗管材制造工艺和材料，但将 具有抗菌活性的增值特性。一种耐用而有效的 可以预防或减少CAUTI的抗菌导管将节省数百万 每年的医疗费用和数千人的生命。

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.