SBIR Phase II: Development of a Distal Locking Hemodialysis Catheter System

SBIR 第二阶段：远端锁定血液透析导管系统的开发

• 批准号: 1430820
• 负责人: Adrian Ravenscroft
• 金额: $ 69.6万
• 依托单位: Phase One Medical, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-01-01 至 2017-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1430820&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Development; Distal

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is a new Distal Locking Hemodialysis Catheter System that will be the first to provide clinicians with a tool to manage the most significant complications (infection, thrombosis, and loss of lock solution) associated with chronic hemodialysis catheter use. More than 430,000 Americans currently receive hemodialysis treatments, and this prevalence is expected to grow 3-5% each year. A significant portion of the $29 billion spent annually treating ESRD patients in the U.S. is dedicated to managing complications with vascular access ? many of which are associated with catheters. It typically costs between $2,000 and $40,000 per patient to treat a blood-borne infection, which translates to more than $3 billion each year in the U.S. There is a need for this product to allow physicians to confidently use whatever lock therapy is clinically best on a per-patient basis. The catheter system will enable for the development and FDA approval of new, non-antibiotic antimicrobial agents, which have been unable to gain/maintain approval due to concerns of leakage. The device has the potential to be a market leader in the $3 billion U.S. market for vascular access devices and accessories. The proposed project shall improve and further evaluate a Distal Locking Hemodialysis Catheter System. Over 400,000 Americans undergo hemodialysis annually. Common complications are catheter-related bloodstream infection, thrombosis and thrombotic occlusions, each of which can be fatal. The primary solution to these complications is the use of heparin and antimicrobial lock solutions. However, existing catheters present the possibility of accidental infusion of these highly concentrated solutions into the circulation during the locking procedure or during the locked period between uses of the catheter. These leakages increase the risk of toxicity, and FDA-approved anticoagulants that leak into the systemic circulation can cause minor or major bleeding. The catheter system being developed in this project will significantly decrease complications tied to the loss of lock solutions, such as life-threatening infections, toxicity and bleeding events. The research shall include refinement of the catheter?s design (material selection and mechanical tests); ensuring that manufacture of catheters is consistent; and additional testing in vivo. The project is expected to demonstrate that the catheter system is compatible with lock solutions, shows adequate flow rate, has sufficient mechanical integrity, can be manufactured consistently, and is demonstrated to be biocompatible with an in vivo model.

该小型企业创新研究（SBIR）II期项目的更广泛影响/商业潜力是一种新型远端锁定血液透析导管系统，该系统将首次为临床医生提供管理与长期血液透析导管使用相关的最严重并发症（感染、血栓形成和锁定液丢失）的工具。目前有超过430，000美国人接受血液透析治疗，预计这种流行率每年增长3-5%。在美国，每年用于治疗ESRD患者的290亿美元中，有很大一部分用于治疗血管通路并发症？其中许多与导管有关。治疗血液传播感染的费用通常在2,000美元到40,000美元之间，在美国每年的费用超过30亿美元。该导管系统将能够开发和FDA批准新的非抗生素抗菌剂，这些抗菌剂由于担心泄漏而无法获得/维持批准。该设备有可能成为美国30亿美元血管通路设备和配件市场的市场领导者。申报项目应改进并进一步评价远端锁定血液透析导管系统。每年有超过40万美国人接受血液透析。常见的并发症是导管相关的血流感染、血栓形成和血栓性闭塞，其中每一种都可能是致命的。这些并发症的主要解决方案是使用肝素和抗菌封管液。然而，现有的导管存在在锁定过程期间或在导管使用之间的锁定期间将这些高浓度溶液意外输注到循环中的可能性。这些泄漏增加了毒性的风险，并且FDA批准的抗凝剂泄漏到体循环中可能导致轻微或严重出血。本项目开发的导管系统将显著减少与封管液丢失相关的并发症，如危及生命的感染、毒性和出血事件。研究应包括导管的改进？设计（材料选择和机械试验）;确保导管的制造一致;以及额外的体内试验。该项目预期将证明导管系统与封管液相容，显示出足够的流速，具有足够的机械完整性，可以一致地生产，并证明与体内模型具有生物相容性。