A Total Infection Control Foley Catheter System

全面感染控制 Foley 导管系统

• 批准号: 7292781
• 负责人: SHANTHA s SARANGAPANI
• 金额: $ 62.31万
• 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/7292781
• 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

DESCRIPTION (provided by applicant): 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 II, 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.

描述（由申请人提供）：导管相关尿路感染 (CAUTI) 占所有机构获得性感染的 40% 以上，是一个巨大且无声的多重耐药微生物库，会延迟患者康复并增加医疗费用。 （800-3000/集）。全球每年使用超过 80-1 亿根 Foley 导管。大约 2/3 的引起 CAUTI 的微生物通过管腔外（通过导管的外表面）进入膀胱，大约 1/3 的感染发生在收集袋的管腔内。在第二阶段，我们开发了一种抗菌装置 (Foley GuardTM) 并进行了一项试点临床试验，该装置放置在收集袋和商业抗菌银水凝胶感染控制之间 Foley导管研究其对管腔内感染的影响。结果显示管腔内感染减少了约 50%，但由于商用导管提供了管腔外途径，总体 CAUTI 并未显着减少。认识到这一需求，我们根据我们的专利配方开发了自己的涂层弗利导管，这比当今市场上目前的商业抗菌弗利导管更加优越。体外性能的高度增强与独特的银化学性质及其在生物液体中的持续递送有关，而这是当前商业涂层所缺乏的；我们配方中的安全润滑剂、生物膜破坏剂和抗真菌剂提供了额外的防御。原型已经通过了基本的生物相容性测试。该涂层含有与挤压 Foley Guard 装置相同的抗菌成分。我们提出了继续开发组合产品的计划（TIC：全面感染控制 - 涂层 Foley 导管连接到第二阶段开发的袋子配件）。基于对银基产品有利的荟萃分析和我们的比较数据做出了乐观的预测。第二阶段延续项目将与合格的 OEM 医疗器械制造合作伙伴一起试制 TIC 系统，根据 FDA 指导文件收集洗脱曲线、生物膜抗性和生物相容性等数据以供 FDA 提交，进行临床试验，证明临床疗效，并使用一种商业模式积极将该产品商业化，从而将该产品快速推向市场。