Tethered liquid perfluorocarbon coating for preventing urinary catheter colonization

项目总结 尿路感染是世界范围内最常见的感染之一，影响约1.5亿人 尿管(UC)是尿路感染的主要原因。有&gt；100万个导管相关 美国每年都有尿路感染(CAUTIs)，治疗费用超过3.5亿美元/年。 如果不进行治疗，CAUTIs可能会导致肾脏和血液感染、败血症，甚至死亡。而抗生素 治疗可以成功治疗CAUTIs并降低脓毒症的风险，不适当的抗生素使用是常见的 并增加抗菌素耐药性和艰难梭菌结肠炎的风险。因此，更好的方法是 需要 自由流医疗设备公司(Freeflow)正在优化捆绑液体全氟碳(TLP)并将其商业化 医疗器械上的涂层。该SBIR项目的目标是验证TLP涂层UCs (TLP-UC)将抵抗病原体的黏附和随后的生物膜形成，这是导致 卡蒂。我们的长期目标是通过降低UCS的发生率来改善需要UC的患者的预后 感染引起的并发症。我们的全能涂层阻止了所有生物成分的粘连 (细菌、真菌、血液成分、尿液)通过固定化的薄片到医疗器械表面 一层高度惰性和生物相容的全氟化液。我们优化的涂层技术结合了 借助化学气相沉积技术，在各种表面上形成薄的氟聚合物层。 此第一阶段提案的目标是获得概念证明，即我们的TLP-UC将抵制 生理性尿流条件下引起≥的病原菌黏附30天。虽然 我们以前实现了这些目标，以对抗导致中枢神经系统血液感染的病原体 静脉导管(CVC)、CVC与UC的内在差异及其生理性暴露 意味着确保这些属性被保留在UC中是至关重要的。此第一阶段应用程序的目标是 将通过调查以下具体目标来实现。目标1：测量TLP涂层对 并评估其抑制病原体定植的能力。目标2：确定TLP的能力 包被UC以抵御生理流动条件和病原体定植。目标3：确定 TLP包被UC，以抵御来自人类标本的不同CAUTI病原体的定植。一旦证明了 概念已经得到，我们将进入cGMP生产和FDA推荐的第二阶段 生物兼容性测试准备上市前批准。

PROJECT SUMMARY Urinary tract infections (UTIs) are one of the most common infections worldwide, effecting ~150 million people annually, and urinary catheters (UCs) are a major cause of UTIs. There are >1 million Catheter-Associated Urinary Tract Infections (CAUTIs) each year in the US, with treatment costs exceeding $350 million/year. Untreated CAUTIs can lead to kidney and bloodstream infections, sepsis, or even death. While antibiotic treatment can successfully treat CAUTIs and reduce the risk of sepsis, inappropriate antibiotic use is common and promotes antimicrobial resistance and risk of Clostridium difficile colitis. Thus, better approaches are needed FreeFlow Medical Devices (FreeFlow) is optimizing and commercializing tethered liquid perfluorocarbon (TLP) coatings on medical devices. The goal of this SBIR project is to validate the hypothesis that TLP-coated UCs (TLP-UCs) will resist the adhesion of pathogens and subsequent biofilm formation that are responsible for CAUTI. Our long-term goal is to improve outcomes for patients requiring UCs by reducing the rate of complications caused by infection. Our omniphobic coating stops the adhesion of all biological components (bacteria, fungi, blood components, urine) to the surface of medical devices through the immobilization of a thin layer of highly inert and biocompatible perfluorinated liquid. Our optimized coating technology incorporates a thin fluoropolymer layer on various surfaces with the help of chemical vapor deposition technique. The objective of this phase I proposal is to obtain the proof of concept that our TLP-UCs will resist the adhesion of pathogens responsible for CAUTI for ≥30 days under physiological urine flow conditions. Although we previously achieved these goals against the pathogens responsible for bloodstream infections with central venous catheters (CVC), the inherent differences between CVC and UC and their physiological exposure mean that it is critical to ensure that these properties are retained in UCs. The goals of this phase I application will be achieved by investigating the following Specific Aims. Aim 1: Measure adherence of the TLP coating to urinary catheters and assess the ability to inhibit pathogen colonization. Aim 2: Determine the ability of TLP- coated UC to withstand physiological flow conditions and pathogen colonization. Aim 3: Determine the ability of TLP-coated UC to withstand colonization by diverse CAUTI pathogens from human specimens. Once proof of concept has been obtained, we will progress to Phase II for cGMP manufacturing and FDA-recommended biocompatibility testing ready for premarket approval.