Tethered liquid perfluorocarbon coating for preventing urinary catheter colonization

用于防止导尿管定植的系留液体全氟化碳涂层

• 批准号: 10481166
• 负责人: Todd McFarland
• 金额: $ 29.94万
• 依托单位: FREEFLOW MEDICAL DEVICES, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2023-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10481166
• 关键词: Adherence; Adhesions; Antibiotic Therapy; Antibiotics; Antimicrobial Resistance; Area; Bacteremia; Bacteria; Bacterial Adhesion; Binding; Biological; Bladder; Blood; Catheters; Centers for Disease Control and Prevention (U.S.); Cessation of life; Chemicals; Complex; Cyclic GMP; Deposition; Devices; Drainage procedure; Effectiveness; Ensure; Environment; Escherichia coli; Fluorocarbons; Future; Gastrointestinal tract structure; Goals; Gram-Negative Bacteria; Gram-Positive Bacteria; Health care facility; Healthcare Systems; Hour; Human; Immobilization; Incubated; Indwelling Catheter; Infection; Institutes; Lead; Length; Liquid substance; Long-Term Care; Measures; Medical Device; Microbe; Microbial Biofilms; Nosocomial Infections; Patient Care; Patient-Focused Outcomes; Persons; Phase; Physiological; Preparation; Process; Property; Pseudomembranous Colitis; Resistance; Risk; Roentgen Rays; Scanning Electron Microscopy; Sepsis; Small Business Innovation Research Grant; Source; Specimen; Spectrum Analysis; Stream; Surface; Techniques; Technology; Testing; Thinness; Time; Treatment Cost; Urinary tract; Urinary tract infection; Urine; Venous; biomaterial compatibility; catheter associated UTI; chemical binding; clinically relevant; fungus; human pathogen; implantation; improved outcome; kidney infection; microbial; microbial colonization; microbiota; microorganism; mortality; multi-drug resistant pathogen; novel; pathogen; prevent; treatment strategy; urinary; vapor

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.

项目摘要 尿路感染（UTI）是全球最常见的感染之一，影响约1.5亿人 每年，尿导管（UCS）是UTI的主要原因。有> 100万个导管相关的 在美国，每年尿路感染（CAUTIS），治疗费用超过3.5亿美元/年。 未经治疗的小肠可导致肾脏和血液感染，败血症甚至死亡。而抗生素 治疗可以成功治疗小肠并降低败血症的风险，不适当的抗生素使用是常见的 并促进抗菌素的耐药性和艰难梭菌结肠炎的风险。那是更好的方法 需要 FreeFlow Medical Devices（FreeFlow）正在优化和商业化束缚液体全氟碳（TLP） 医疗设备上的涂料。这个SBIR项目的目的是验证TLP涂层UCS的假设 （TLP-UCS）将抵抗病原体的粘附和随后负责的生物膜形成 凯蒂。我们的长期目标是通过降低速率来改善需要UCS的患者的预后 由感染引起的并发症。我们的杂质涂层可阻止所有生物组件的粘合剂 （细菌，真菌，血液成分，尿液）通过固定薄薄的 高度惰性和生物相容性的全氟化液体层。我们优化的涂料技术结合了 在化学蒸气沉积技术的帮助下，各种表面上的荧光聚合物层薄。 我提出的这一阶段的目的是获得概念证明，即我们的TLP-UCS将抵抗 在物理尿流条件下，导致CAUTI≥30天的病原体的粘附。虽然 我们以前针对负责血液感染的病原体实现了这些目标 静脉导管（CVC），CVC和UC之间的继承差异及其身体暴露 意味着确保将这些特性保留在UCS中至关重要。该阶段I申请的目标 将通过调查以下特定目标来实现。目标1：测量TLP涂层的依从性 尿导管和评估抑制病原体定植的能力。目标2：确定TLP-的能力 涂层UC可以承受物理流动条件和病原体定殖。目标3：确定能力 TLP涂层的UC可以承受人类标本中的潜水员CATITI病原体定植。一旦证明 已经获得了概念，我们将进步为CGMP制造和FDA追踪的II阶段 生物相容性测试准备好批准前市场。