Toward urinary catheterization with long-term resistance to bacterial colonization

实现长期抵抗细菌定植的导尿术

• 批准号: 10603793
• 负责人: Olga Zolotarskaya
• 金额: $ 51.46万
• 依托单位: WYNNVISION, LLC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-08 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10603793
• 关键词: Accidents; Address; Amines; Anatomy; Animals; Antibiotic Resistance; Antibiotics; Bacteria; Bacterial Attachment Site; Belief; Biocide; Boston; Catheterization; Catheters; Characteristics; Charge; Chemicals; Classification; Clinical; Coupled; Critical Care; Data; Device Safety; Devices; Disabled Persons; Drug Combinations; Ear; Economics; Effectiveness; Elderly; Escherichia coli; Evaluation; Female; Gram-Negative Bacteria; Growth; Health; Health care facility; Heavy Metals; Hospital Costs; Hospitalization; Hospitals; Human; Hydrogels; Immersion; In Vitro; Indwelling Catheter; Infection; Knowledge; Legal patent; Licensing; Manufacturer; Marketing; Medical; Medical Device; Microbial Biofilms; Microscopy; Modification; Morbidity - disease rate; Multi-Drug Resistance; North America; Nose; Nursing Homes; Oryctolagus cuniculus; Paralysed; Pathway interactions; Patients; Performance; Pharmaceutical Preparations; Pharyngeal structure; Phase; Pilot Projects; Population; Positioning Attribute; Predisposition; Prevalence; Price; Procedures; Process; Progress Reports; Protocols documentation; Publishing; Radiologic Health; Rattus; Research; Research Activity; Resistance; Risk; Safety; Silicones; Silver; Surface; Technology; Testing; Toxicity Tests; Urinary Catheterization; Urinary tract infection; Urine; Weight; Woman; Work; antimicrobial; bacterial resistance; biomaterial compatibility; catheter associated UTI; cell growth; commercialization; cost; design; experimental study; fighting; flasks; high risk; hospice environment; hospital care; hydrophilicity; in vivo; innovation; insight; interest; manufacture; meetings; men; new technology; novel; novel strategies; pathogen; research and development; response; systemic toxicity; urinary

PD/PI Kennard Brunson Project Summary Toward urinary catheterization with long-term resistance to bacterial colonization Problem: Catheter Associated Urinary Tract Infections (CAUTI) are one of the most common infections in hospitals and health care facilities. A study of urinary catheterisation involving over 9 million hospitalized patients found 12.9% were catheterised overall, but 72.9% were catheterized in critical care. A long list of those who are susceptible to CAUTIs include those who are disabled and the elderly and infirm with longer catheter indwelling times. Because of anatomy, women are more susceptible to CAUTIs (~75%) compared to men (~25%). Increased antibiotic resistance, and the increased prevalence of multidrug-resistant Gram-negative bacteria are serious threats in view of the decreased pipeline of antibiotics. Solution: To fight CAUTIs, WynnVision LLC is developing a new approach by introducing a robust surface component for silicone Foley catheters that reduces bacterial colonization and biofilm formation. With discovery of “WynnGard- 1” silicone in 2010, WynnVision redirected research activities during Phase II. Patented WynnGard-1 technology is novel compared to prior technologies that leach heavy metals or antimicrobials. With no depletion of a leached agent, WynnGard-1 has the potential for long term antimicrobial effectiveness. Challenge: A response from FDA to a WynnVision Pre-Request For Designation in December 2021 posed questions that require experimental studies concerning safety and efficacy. This Phase IIB proposal addresses FDA concerns that are embodied in Specific Aims. Aim 1. Demonstrate negligible or undetectable leaching from WynnGard-1 silicone with in vitro studies exceeding the maximum timeframe of patient use; Aim 2. Demonstrate reduction of bacterial colonization in media comparable to human urine; Aim 3. Animal studies to evaluate antimicrobial efficacy and biocompatibility; Aim 4. Establish a pathway to partnership for licensing and manufacturing. WynnVision is confident in providing information to FDA that will merit the designation “device” for WynnGard-1 silicone by FDA Office of Combination Products and requirements for approval of a 510(k) application to the Center for Devices and Radiological Health (CDRH). The proposed Phase IIB research and FDA actions will de-risk the technology and make WynnGard-1 silicone attractive for commercialization. Impact: Low cost WynnGard-1 silicone will make this CAUTI-fighting technology widely available for all.

PD/PI肯纳德布伦森 项目摘要 长期抵抗细菌定植的导尿术 问题：导管相关性尿路感染（CANTI）是最常见的 医院和卫生保健设施中的感染。9例以上患者导尿的临床研究 100万住院患者中，12.9%的患者接受了导管插入，但72.9%的患者接受了导管插入 在重症监护室易受艾滋病感染的人包括残疾人， 老年人和体弱者留置导管时间较长。由于解剖学的原因， 与男性（约25%）相比，女性（约75%）更易患上子宫内膜异位症。抗生素耐药性增加， 和多重耐药革兰氏阴性菌的流行率增加是严重的威胁， 减少抗生素的管道。解决方案：为了对抗疟疾，WynnVision LLC 通过为硅胶Foley引入坚固的表面组件开发新方法 减少细菌定植和生物膜形成的导管。随着“WynnGard”的发现- 2010年，WynnVision在第二阶段重新调整了研究活动。专利 WynnGard-1技术与现有技术相比是新颖的， 抗菌剂由于没有耗尽沥滤剂，WynnGard-1具有长期使用的潜力。 抗菌效果。挑战：FDA对WynnVision预申请的回应 2021年12月的指定提出了需要进行实验研究的问题， 安全性和有效性。本IIB期提案解决了FDA关注的问题， 具体目标。目标1.证明WynnGard-1硅胶的沥滤可忽略不计或不可检测 体外研究超过患者使用的最大时间范围;目标2。证明 与人尿相当的培养基中细菌定植的减少;目的3.动物研究以 评价抗菌效果和生物相容性;目的4.建立伙伴关系， 许可和制造。WynnVision有信心向FDA提供信息， FDA组合产品办公室将WynnGard-1硅胶命名为“器械” 以及向器械和辐射中心提交510（k）申请的批准要求 健康（CDRH）。拟议的IIB期研究和FDA行动将降低该技术的风险 并使WynnGard-1有机硅具有商业化的吸引力。影响：低成本WynnGard-1 硅树脂将使这种对抗疟疾的技术为所有人广泛使用。