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

描述(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，仅在美国每年就占100多万例，医院费用超过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施加到医院身上，从而立即激励医院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剂以减少菌尿的发生。然而，抗菌剂会产生耐药模式，使留置导管感染更难治疗。由于缺乏临床相关的支持数据，目前市场上没有一种抗菌导管被CDC/APIC认可。因此，Sharklet科技公司建议进一步开发一种新的Foley导管设计，该设计可以抑制细菌定植，并且不依赖于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的Sharklet“微图案聚合物表面来抑制细菌生物膜生长的可行性，为一个更大的第二阶段项目奠定了基础，该项目旨在全面制作Sharklet技术的原型并展示其潜力。这个多阶段SBIR项目的总体目标是将一种带有Sharklet微图案的硅胶Foley导管商业化，从而减少CAUTI。在第一阶段，Sharklet研发团队展示了这一新概念，通过测试相对于光滑表面的三个Sharklet微图案，以及通过在腔外和腔内表面成功制造出带有Sharklet图案的硅胶管原型，减少了体外培养的致尿性大肠杆菌的定植。在这一成功的基础上，第二阶段的工作将集中在以下三个目标上：第一，将体外疗效测试扩展到另外三种相关的泌尿病原体，并在体外膀胱模型中测试对细菌迁移的抑制。其次，Sharklet图案的Foley导管将由我们的OEM合作伙伴医疗组件公司制造。制造的导管将经过标准测试，以确保它们符合FDA的生物兼容性和功能性能标准，以及重复的体外膀胱模型测试，以获得将在第二阶段结束时提交FDA 510(K)的装置声明。第三，第二阶段将以一项试点临床研究结束，以评估Sharklet图案的Foley导管抑制导管表面细菌迁移的能力。这项研究将成为确定Sharklet Foley导管减少CAUTI的能力的统计动力临床试验的完整先导。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导管减少感染负担，实现显著的成本节约。第二阶段的数据对于吸引完成所需的开发/批准工作并最终将这项新技术商业化所需的“第三阶段”投资者/行业合作伙伴至关重要。 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，仅在美国每年就会导致严重的患者挫折、不适和超过5亿美元的医疗费用。Sharklet Technologies通过其成功的第一阶段SBIR工作，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，这种概念可以在不使用抗菌涂层或治疗的情况下抑制细菌定植。Sharklet团队现在提出了一个第二阶段项目，以全面制作Sharklet Foley导管的原型并展示其有效性，为FDA的批准做准备，最终将一种新产品商业化，从而大大减少CAUTI的发生。

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.