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）：导管相关性尿路感染 (CAUTI) 是最常见的医院获得性感染，仅在美国每年就有超过 100 万例病例，住院费用超过 5 亿美元。医疗保险和医疗补助服务中心最近的报销变化将把这一成本负担直接转嫁给医院，从而立即激励人们解决这一被忽视的护理方面。目前预防细菌性尿路感染的范例是引入抗菌药物来减少菌尿的发生。然而，抗菌药物会产生耐药性，使留置导管感染更加难以治疗。由于缺乏临床相关支持数据，目前市场上的抗菌导管尚未获得 CDC/APIC 的认可。因此，Sharklet Technologies 建议进一步开发一种新型 Foley 导管设计，该设计可抑制细菌定植，且不依赖传统的抗生素涂层或治疗。我们的第一阶段 SBIR 工作证明了使用新型 Sharklet”微图案聚合物表面抑制细菌生物膜生长的可行性，为更大的第二阶段项目奠定了基础，该项目旨在完全原型化并展示 Sharklet 技术的潜力。总体目标这个多阶段 SBIR 项目的目的是将具有 Sharklet 微图案的硅胶 Foley 导管商业化，该导管将减少 CAUTI 在第一阶段期间，Sharklet 研发团队通过减少尿路致病菌的定植证明了这一新概念。通过测试相对于光滑表面的三种 Sharklet 微图案，并在腔外和腔内表面上成功制造具有 Sharklet 图案的硅胶管原型，在体外对大肠杆菌进行研究。基于这一成功，第二阶段工作将重点关注以下三个方面。目的：首先，将体外功效测试扩展到另外三种相关的尿路病原体，并在体外膀胱模型中测试细菌迁移的抑制作用。其次，Sharklet 图案的 Foley 导管将通过我们的 OEM 合作伙伴 Medical Components Inc 制造。制造的导管将接受标准测试，以确保它们符合 FDA 的生物相容性和功能性能标准，并进行重复的体外膀胱模型测试以获得设备FDA 510(k) 提交的索赔将在第二阶段结束时提出。第三，第二阶段将以一项试点临床研究结束，以评估 Sharklet 型 Foley 导管抑制导管表面细菌迁移的能力。这项研究将成为一项具有统计学意义的临床试验的前奏，旨在确认 Sharklet 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奠定基础，以改善患者护理，并通过 Sharklet Foley 导管减轻感染负担，显着节省成本。第二阶段数据对于吸引“第三阶段”投资者/行业合作伙伴完成所需的开发/审批工作并最终将这项新技术商业化至关重要。 公共卫生相关性：导管相关性尿路感染 (CAUTI) 是最常见的医院获得性感染，仅在美国每年就会给患者带来严重的困扰、不适和超过 5 亿美元的医疗费用。凭借第一阶段 SBIR 工作的成功，Sharklet Technologies 证明了其新的 Sharklet“微图案概念（基于鲨鱼皮）用于 Foley 导管制造的可行性，该概念无需使用抗菌涂层或处理即可抑制细菌定植。Sharklet 团队现在提出这是一个 II 期项目，旨在全面原型化并证明 Sharklet Foley 导管的功效，为最终将新产品商业化所需的 FDA 许可做准备，从而大大减少 CAUTI 的发生。