Unique Antimicrobial Catheter to Prevent Urinary Tract Infections

独特的抗菌导管可预防尿路感染

• 批准号: 9255008
• 负责人: Joel L Williams
• 金额: $ 52.6万
• 依托单位: BRIGHTON DEVELOPMENT, LLC
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-18 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9255008
• 关键词: Anti-Bacterial Agents; Antibiotics; Catheters; Cessation of life; Clinical Trials; Contracts; Development; Devices; Elastomers; FDA approved; Filler; Formaldehyde; Goals; Guidelines; Health Care Costs; Health Priorities; Healthcare; Human; Infection; Infection prevention; Injection of therapeutic agent; Legal patent; Length of Stay; Licensing; Liquid substance; Local Anti-Infective Agents; Manufactured Materials; Manufacturer Name; Marketing; Medical; Medical Device; Membrane; Methenamine; Molds; Mucous body substance; Oxides; Patients; Phase; Polymers; Process; Property; Services; Silicon Dioxide; Silicone Elastomers; Source; Sterilization; Surface; Technology; Testing; Time; United States National Institutes of Health; Urinary tract; Urinary tract infection; Uropathogen; Validation; Work; antimicrobial; antimicrobial drug; base; biomaterial compatibility; carbene; catheter associated UTI; commercialization; controlled release; cost; delrin; depolymerization; design; innovation; irritation; manufacturing process; meetings; monomer; novel strategies; pathogen; performance tests; prevent; prototype; research and development; urinary

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.

II阶段努力的目标是推销独特的抗菌导管 为了减少最普遍的医疗保健相关感染的实例， 与导管相关的尿路感染（CAUTI）。这项研究和 开发工作将是开发具有固有持久固有的泌尿导管 防腐特性保护患者并防止感染。我们已经开始 与FDA的讨论，并有明确的要求 完成监管批准过程。提出的设备是新的 抗菌导管的方法。它将使用常见的Foley导管设计 和材料，并在弹性体中添加了添加剂以渲染 导管抗菌素。添加剂代替了二氧化硅加固填充物 弹性体，旨在给出持久的抗菌时间 导管表面的代理。导管可以廉价地生产 使用标准的医疗管道制造工艺和材料，但会 具有抗菌活性的增值特性。耐用有效的 可以预防或减少cauti的抗菌导管将节省数百万 每年的医疗保健费用和成千上万的生命。