A Total Infection Control Foley Catheter System

全面感染控制 Foley 导管系统

基本信息

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
项目类别：
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

项目摘要

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.

导管相关的尿路感染，cautis，占所有机构收购的40％感染是多种耐药生物，延迟患者康复的巨大而沉默的水库，增加医疗保健费用。（$ 800-3000/插曲）。超过80-1亿的Foley导管已在全球范围内使用每年。大约2/3的微生物，导致小肠进入膀胱外（通过导管的外表面），大约1/3感染从肿瘤内发生收集袋。在TL期间，我们在杀菌装置上开发并进行了试验临床试验（Foley Guardtm）放置在袋子和商业抗菌银水凝胶之间感染控制Foley导管以研究其对腔内感染的影响。结果表明腔内感染减少了50％，但是由于商用导管提供的腔外路线。认识到这种需求，我们已经发展了根据我们的专利配方，自己的涂层Foley导管，这是当前广告的优越性当今市场上的抗菌Foley导管。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，目前缺乏商业涂料；我们配方中的安全润滑剂，生物膜破坏者和抗真菌剂提供了额外的防御。原型通过了基本的生物相容性测试。涂料包含相同的抗菌成分作为挤出的Foley防护装置。我们提出了一个持续的计划合并产品的开发（TIC：全感染控制 - 连接到在第二阶段开发的袋子配件）。根据有利的元来进行乐观的投影基于银产品和我们的比较数据的分析。第二阶段延续项目将驾驶使用合格的OEM医疗设备制造合作伙伴制造TIC系统，收集数据对于FDA提交，例如根据FDA的洗脱剖面，生物膜抵抗和生物相容性指导文件，进行临床试验，证明临床功效并积极地商业化该产品使用业务模型将该产品迅速推向市场。