Slippery Omniphobic Coating for Hemodialysis Catheter to Improve Patency and Patient Outcomes

用于血液透析导管的光滑全疏涂层可提高通畅率和患者治疗效果

• 批准号: 9909518
• 负责人: Saibal Bandyopadhyay
• 金额: $ 22.46万
• 依托单位: FREEFLOW MEDICAL DEVICES, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-15 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9909518
• 关键词: Abscess; Adherence; Arteriovenous fistula; Bacterial Adhesion; Blood; Blood Vessels; Blood flow; Catheter-related bloodstream infection; Catheters; Cattle; Cessation of life; Complication; Cyclic GMP; Deposition; Devices; Dialysis procedure; Effectiveness; Endocarditis; Ensure; Environment; Fibrin; Fibrinolytic Agents; Fluorocarbons; Functional disorder; Goals; Gold; Hemodialysis; Hospitalization; Hospitals; Impairment; In Vitro; Incidence; Infection; Institutes; Lead; Length; Licensing; Limb structure; Liquid substance; Measures; Medical; Medical Device; Microbial Biofilms; Modeling; Morbidity - disease rate; Patient-Focused Outcomes; Patients; Peripheral; Peritoneal Dialysis; Phase; Physiological; Plasma Proteins; Postphlebitic Syndrome; Process; Property; Pulmonary Embolism; Roentgen Rays; Scanning Electron Microscopy; Secure; Serum; Small Business Innovation Research Grant; Spectrum Analysis; Surface; Technology; Testing; Thinness; Thrombosis; Thrombus; Treatment Cost; United States; Venous; Vertebral column; biomaterial compatibility; chemical binding; clinically relevant; cost; improved; pathogen; prevent; thrombogenesis

PROJECT SUMMARY Approximately 80% of patients beginning hemodialysis (HD) in the United States use a catheter at treatment initiation, and 18.6% of all HD patients were using a catheter in 2017. However, the use of tunneled catheters for HD vascular access is associated with a relatively high incidence of complications such as poor flow and catheter dysfunction, with a catheter dysfunction rate of 0.5–3.42 episodes/1000 catheter-days. The most common catheter-related problems are infections (catheter-related bloodstream infections; CRBSI) and catheter thrombosis. Catheter dysfunction due to intraluminal thrombosis and fibrin sheath formation impairs the delivery of adequate dialysis and often requires salvage by instillation of a thrombolytic agent into the catheter lumen and/or catheter exchange. It leads to significant morbidity of the limbs involved, including pulmonary embolism, and post-thrombotic syndrome. Infections can be caused by biofouling and biofilm formation; rates vary from 0.25 to 6.5 per 1,000 catheter days, which results in significant morbidity. CRBSI can result in serious complications such as spine abscess, endocarditis, and death. CRBSI frequently requires hospitalization and sometimes even ICU stays. However, no available solutions to prevent catheter dysfunction can successfully prevent both thrombosis and infection. FFMD has developed a coating technology to create a tethered liquid perfluorocarbon (TLP) surface that reduces the complication rate with catheter use during HD by ameliorating thrombosis, biofilm formation, and infections [3]. In a two-step process, a thin layer of perfluorocarbon is chemically bound and tethered to the surface of the HD catheter and is then is coated with a mobile thin layer of liquid perfluorocarbon to yield a super-repellent TLP coating. Slippery perfluorocarbon coatings are unique because they remain stable under the clinically relevant blood flow seen in catheters and dialysis machines, resist thrombosis, and prevent biofouling. The objective of this phase I proposal is to obtain proof of concept that our TLP coating could reduce thrombogenicity and prevent biofilm formation in HD catheters. Once proof of concept has been obtained, we will progress to a Phase II application for cGMP manufacturing and FDA-recommended biocompatibility testing ready for premarket approval. Our goal is to improve patient outcomes by enhancing the long-term patency of HD catheters by reducing thrombosis and complications associated with CRBSI.

项目摘要 在美国开始血液透析（HD）的患者中，约有80％在治疗时使用导管 启动，所有HD患者中有18.6％在2017年使用导管。但是，使用隧道导管 对于高清血管进入与并发症相对高的并发症（如流量差和 导管功能障碍，导管​​功能障碍率为0.5-3.42发作/1000个导管天线。最多 常见导管相关的问题是感染（导管相关的血液感染； CRBSI）和 传统血栓形成。导管功能障碍由于腔内血栓形成和纤维蛋白护套的形成损害 足够的透析，通常需要通过将溶栓剂滴注到 成型管腔和/或附件交换。它导致涉及的四肢的显着发病，包括 肺栓塞和栓性后综合征。感染可能是由生物污染和生物膜引起的 形成；速率从每1000个导管天数从0.25到6.5不等，这会导致明显的发病率。 crbsi 可能导致严重的并发症，例如脊柱脓肿，心内膜炎和死亡。 CRBSI经常需要 住院，有时甚至ICU停留。但是，没有可用的解决方案来防止导管功能障碍 可以成功防止血栓形成和感染。 FFMD开发了一种涂料技术，以创建一个束缚的液体液氟化碳（TLP）表面 通过改善血栓形成，生物膜形成，降低HD期间导管使用的并发症发生率， 和感染[3]。在两个步骤的过程中，全氟化合物的薄层是化学结合的 HD导管的表面，然后用移动的液体液体全氟化合物覆盖以产生 超级培养物TLP涂层。光滑的全氟化合物涂料是独一无二的，因为它们在下面保持稳定 在导管和透析机中看到的临床相关血流，抵抗血栓形成，并防止 生物污染。 我提出的这一阶段的目的是获得概念证明，表明我们的TLP涂层可以减少 血栓形成性并防止高清导管中的生物膜形成。一旦获得了概念证明，我们 将进展到II期CGMP制造和FDA强制性生物相容性测试的应用程序 准备上市批准。我们的目标是通过提高长期通畅来改善患者的预后 高清导管通过减少与CRBSI相关的血栓形成和并发症。