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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

基本信息

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
项目类别：
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

项目摘要

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.

项目总结