A Total Infection Control Foley Catheter System

全面感染控制 Foley 导管系统

• 批准号: 7624829
• 负责人: SHANTHA s SARANGAPANI
• 金额: $ 5.27万
• 依托单位: INNOVATIVE CHEMICAL/ENVIRONMENTAL TECH
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-05-01 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7624829
• 关键词: Acute; Adhesions; Advanced Development; Adverse reactions; Anti-Bacterial Agents; Antibiotics; Antifungal Agents; Antimicrobial Resistance; Appendix; Area; Australia; Back; Bacteria; Bacterial Vaccines; Base Composition; Binding; Biological; Bladder; Body Fluids; Boston; Businesses; Calcium; Canada; Catheters; Cell Wall; Cell membrane; Cells; Charge; Chelating Agents; Chemicals; Chemistry; Citrate; Citrates; Clinical; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials; Collaborations; Collection; Complex; Condition; Conduct Clinical Trials; Data; Data Analyses; Democracy; Development; Devices; Dissociation; Doctor of Philosophy; Drainage procedure; Drug Formulations; Due Process; Economics; Edetic Acid; Effectiveness; Electronic Mail; End Point; Engineering; Environment; Equilibrium; Europe; Fishes; Food, Drug and Cosmetic Act; Funding; Germ Cells; Goals; Growth; Head; Health Care Costs; Hospital Nursing; Hospitals; Human; Hydrogels; In Vitro; Industrial Microbiology; Industrial fungicide; Infection; Infection Control; Institution; International; Investigation; Ions; Israel; Japan; Joint Ventures; Kinetics; Latex; Leg; Legal patent; Letters; Life; Ligands; Liquid substance; Local Anti-Infective Agents; Long-Term Care; Lubricants; Marketing; Masks; Mechanics; Medical; Medical Device; Meta-Analysis; Metabolic; Metals; Methods; Microbial Biofilms; Microbiology; Modeling; Molds; Multi-Drug Resistance; Muscle; Names; National Institute of Diabetes and Digestive and Kidney Diseases; Nature; Nosocomial Infections; Notification; Nursing Homes; Operative Surgical Procedures; Organic Chemistry; Organism; Other Agency or Organization; Parabens; Patients; Penetration; Performance; Permeability; Personal Satisfaction; Phase; Plant Resins; Plastics; Polyethylene Glycols; Polymers; Polyurethanes; Prevention; Primula; Process; Production; Property; Proteins; Purpose; Qualifying; Quality Control; R44 grant; Rate; Readiness; Recording of previous events; Recovery; Research; Resistance; Role; Route; Safety; Salts; Sampling; Screening procedure; Secure; Services; Shipping; Ships; Silicones; Silver; Silver Nitrate; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Solid; Solubility; Solutions; Standards of Weights and Measures; Sterilization for infection control; Stretching; Structure; Surface; System; Technology; Testing; Time; Today; Touch sensation; United States Food and Drug Administration; United States National Institutes of Health; Urinary tract infection; Urine; Validation; Yeasts; antimicrobial; aqueous; base; biomaterial compatibility; catheter associated UTI; cell killing; clinical efficacy; clinically relevant; commercialization; comparative; cytotoxicity; day; density; design; drug resistant bacteria; implantation; improved; in vitro Assay; innovation; interest; irritation; killings; mecarzole; metal complex; microorganism; novel; organic acid; prevent; programs; prototype; research clinical testing; scale up; silver chloride; success; toxic metal; urinary

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.

导管相关性尿路感染，包括>40%的所有机构获得性 感染是一个巨大的和沉默的水库多药耐药生物体，延迟病人康复， 增加医疗费用。（800 -3000美元/集）。全世界使用的Foley导管超过8000万至1亿件 每一年。约2/3的引起膀胱炎的微生物通过腔外途径（经 导管的外表面），大约三分之一的感染发生在导管的腔内 在t1阶段，我们开发并进行了一项关于抗菌装置的试验性临床试验。 （Foley GuardTM），其置于袋和商业抗微生物银水凝胶之间 感染控制Foley导管，以研究其对管腔内感染的作用。结果显示， 管腔内感染减少50%，但由于以下原因，总体TBI并未显著降低： 市售导管提供的腔外路径。认识到这一需要，我们制定了 基于我们的专利配方，我们自己的涂层Foley导管，这是非常上级目前的商业 抗菌Foley导管在市场上的今天。高度增强的体外性能与 独特的银化学及其在生物流体中的持续递送， 商用涂料;我们配方中的安全润滑剂、生物膜破坏剂和抗真菌剂， 的防御合作.原型已通过基本生物相容性试验。该涂料含有相同的 抗菌成分作为挤出Foley Guard器械。我们提出了一个计划， 开发了一种组合产品（TIC：连接至导管的完全感染控制涂层Foley导管）， 第二阶段开发的袋附件）。乐观的预测是基于有利的Meta 银基产品的分析和我们的比较数据。第二阶段继续项目将试行 与合格的OEM医疗器械制造合作伙伴一起制造TIC系统，收集数据 用于FDA提交，如FDA规定的洗脱曲线、生物膜抗性和生物相容性 指导性文件，开展临床试验，证明临床疗效，并积极商业化 该产品使用的商业模式将使该产品迅速推向市场。