Micro-patterned surfaces for reducing the risk of catheter-associated UTI

微图案表面可降低导管相关尿路感染的风险

• 批准号: 8057427
• 负责人: Shravanthi Reddy
• 金额: $ 63.19万
• 依托单位: SHARKLET TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2013-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8057427
• 关键词: Accounting; Achievement; Address; Animal Model; Animals; Antibiotic susceptibility; Antibiotics; Antimicrobial Resistance; Area; Bacteria; Bacteriuria; Bladder; Caring; Catheterization; Catheters; Centers for Disease Control and Prevention (U.S.); Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Cost Savings; Data; Development; Devices; Distal; Ensure; Enterococcus faecalis; Escherichia coli; Evaluation; Goals; Growth; Health Personnel; Hospital Costs; Hospitals; Human; Immigration; In Vitro; Incentives; Incidence; Indwelling Catheter; Infection; Laser Scanning Confocal Microscopy; Length of Stay; Link; Manufacturer Name; Marketing; Measures; Medical; Methods; Microbial Biofilms; Modeling; Morbidity - disease rate; Nosocomial Infections; Outcome; Patient Care; Patients; Pattern; Performance; Phase; Pilot Projects; Polymers; Preparation; Pseudomonas aeruginosa; Public Health; Recovery; Relative (related person); Research; Resistance; Risk; Shark; Silicones; Skin; Small Business Innovation Research Grant; Staging; Staphylococcus aureus; Surface; Symptoms; Technology; Testing; Treatment Cost; Tube; United States Centers for Medicare and Medicaid Services; Urinalysis; Urinary tract; Urine; Uropathogen; Uropathogenic E. coli; Work; antimicrobial; antimicrobial drug; bacterial resistance; base; biomaterial compatibility; catheter associated UTI; clinically relevant; commercialization; cost; design; efficacy testing; follow-up; improved; in vitro testing; in vivo; industry partner; manufacturing process; meetings; migration; neglect; new technology; novel; performance tests; prevent; prospective; prototype; research and development; seal; soy; success; tool; urinary

DESCRIPTION (provided by applicant): Catheter-associated urinary tract infections (CAUTI) are the most common hospital- acquired infections, accounting for over one million cases and hospital costs of more than $500 million each year in the U.S. alone. Recent reimbursement changes from the Centers of Medicare and Medicaid Services will place this cost burden directly onto hospitals, creating an immediate incentive to address this neglected aspect of care. The current paradigm for preventing bacterial UTIs has been to introduce antimicrobial agents to reduce the occurrence of bacteriuria. However, antimicrobial agents produce resistance patterns that make indwelling catheter infections more difficult to treat. No antimicrobial catheter now on the market has been endorsed by either CDC/APIC due to a lack of clinically relevant supporting data. Sharklet Technologies therefore proposes to further develop a novel Foley catheter design that inhibits bacterial colonization and that does not rely on traditional antibiotic coatings or treatments. Our Phase I SBIR work proved the feasibility of using the novel Sharklet" micro-pattern polymer surface to inhibit bacterial biofilm growth-setting the stage for a larger Phase II project designed to fully prototype and demonstrate the potential for the Sharklet technology. The overall goal of this multi-phase SBIR project is to commercialize a silicone Foley catheter with the Sharklet micro-pattern that will reduce CAUTI. During Phase I the Sharklet R&D team demonstrated this new concept by reducing colonization of uropathogenic Escherichia coli with in vitro via testing of three Sharklet micro-patterns relative to a smooth surface and by successfully fabricating silicone tube prototypes with the Sharklet pattern on the extraluminal and intraluminal surfaces. Based on that success, Phase II work will focus on the following three Aims: First, to extend in vitro efficacy testing to three additional, relevant uropathogens and to test inhibition of bacterial migration in an in vitro bladder model. Second, Sharklet-patterned Foley catheters will be manufactured via our OEM partner, Medical Components Inc. The manufactured catheters will undergo standard testing to ensure they meet FDA criteria for biocompatibility and functional performance, as well as repeated in vitro bladder model testing to obtain device claims for the FDA 510(k) submission that will be made at the end of Phase II. Third, Phase II will conclude with a pilot clinical study to evaluate the ability of the Sharklet-patterned Foley catheter to inhibit bacterial migration on the catheter surface. This study will be an integral precursor to a statistically powered clinical trial for confirming the Sharklet Foley catheter's ability to reduce CAUTI. Phase II success will set the stage for providing a much-needed tool for clinicians/hospitals to improve patient care and reap significant cost savings with the reduced burden of infection enabled by the Sharklet Foley catheter. The Phase II data is critical for engaging the "Phase III" investors/industry partners needed to complete the required development/approval work and to ultimately commercialize this new technology. PUBLIC HEALTH RELEVANCE: Catheter-associated urinary tract infections (CAUTI) are the most common hospital- acquired infections, resulting in significant patient setbacks, discomfort, and medical costs of over half a billion dollars annually in the U.S. alone. With its successful Phase I SBIR work, Sharklet Technologies proved the feasibility of its new Sharklet" micro-pattern concept (based on shark skin) for Foley catheter manufacture that inhibits bacterial colonization without the use of antimicrobial coatings or treatments. The Sharklet team now proposes a Phase II project to fully prototype and demonstrate efficacy of the Sharklet Foley catheter in preparation for the FDA clearance required to ultimately commercialize a new product that will substantially reduce the occurrence of CAUTI.

描述（由申请人提供）：与导管相关的尿路感染（CAUTI）是最常见的医院感染，仅在美国，就占每年一百万个病例超过5亿美元的病例。 Medicare和Medicaid Services中心的最新报销变化将把这一成本负担直接承担到医院，从而立即激励解决这一被忽视的护理方面。当前用于预防细菌UTI的范例是引入抗菌剂以减少细菌的发生。但是，抗菌剂产生的抗性模式使留置导管感染更难以治疗。由于缺乏临床相关的支持数据，CDC/APIC现在没有CDC/APIC认可市场上的抗菌导管。因此，鲨鱼技术提议进一步开发一种新型的Foley导管设计，该设计抑制细菌定植，并且不依赖传统的抗生素涂层或处理。 Our Phase I SBIR work proved the feasibility of using the novel Sharklet" micro-pattern polymer surface to inhibit bacterial biofilm growth-setting the stage for a larger Phase II project designed to fully prototype and demonstrate the potential for the Sharklet technology. The overall goal of this multi-phase SBIR project is to commercialize a silicone Foley catheter with the Sharklet micro-pattern that will reduce CAUTI. During Phase I the鲨鱼的研发团队通过测试三个鲨鱼的微观图案相对于平稳的表面，并成功地基于sharklet fortro fortro，sharklet r＆d团队通过测试三个鲨鱼的微观图案，并成功地基于shark，从而延伸了三个阶段的范围，从而延伸了三个阶段，从而延伸了三个阶段，鲨鱼的研发团队通过在体外进行了测试，从而证明了这一新概念。在体外膀胱模型中测试三个附加相关的尿道病并测试细菌迁移的抑制作用。其次，将通过我们的OEM合作伙伴Medical Components Inc.制造鲨鱼模式的Foley导管。制造的导管将进行标准测试，以确保它们符合FDA的生物相容性和功能性能的标准，并重复在体外Bladder模型测试中重复获得FDA 510（k）的设备索赔，该（k）将逐步提出II。第三，第二阶段将以试验临床研究的结论，以评估鲨鱼图案的Foley导管抑制导管表面细菌迁移的能力。这项研究将是一项统计上动力的临床试验不可或缺的先驱，该试验证实了鲨鱼Foley导管减少CAUTI的能力。第二阶段的成功将为临床医生/医院提供急需的工具，以改善患者护理，并节省大量成本，并减轻鲨鱼Foley导管造成的感染负担。第二阶段数据对于参与完成所需开发/批准工作所需的“ III期”投资者/行业合作伙伴至关重要，并最终使这项新技术商业化。 公共卫生相关性：与导管相关的尿路感染（CAUTI）是最常见的医院感染，仅在美国，就会导致患者挫折，不适和医疗费用大量超过50亿美元。借助其成功的第一阶段SBIR的工作，鲨鱼技术证明了其新鲨鱼“微图案概念（基于鲨鱼皮肤）用于Foley导管制造的可行性，该概念可以抑制细菌殖民化的殖民化，而无需使用抗菌涂层或处理，而无需使用抗菌涂层或处理。最终将新产品商业化所需的清除率，该产品将大大减少Cauti的发生。