Developing a new aspiration catheter solution for the treatment of large and medium vessel occlusions

开发用于治疗大中型血管闭塞的新型抽吸导管解决方案

• 批准号: 10699636
• 负责人: Tim Becker
• 金额: $ 30.05万
• 依托单位: ANEUVAS TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10699636
• 关键词: Address; American; Arizona; Biomedical Engineering; Caring; Catheters; Circle of Willis; Clinical; Coagulation Process; Development; Devices; Diameter; Digestion; Disabled Persons; Distal; Eligibility Determination; Excision; Future; Goals; Human; Improve Access; In Vitro; Individual; Injury; Ischemia; Ischemic Stroke; Laboratories; Measures; Mechanics; Medical; Modeling; Monitor; Outcome; Patient-Focused Outcomes; Patients; Performance; Phase; Press Releases; Property; Quality of life; Radial; Recovery of Function; Resources; Retrieval; Safety; Small Business Technology Transfer Research; Stents; Stroke; System; Systems Development; Technology; Testing; Thrombectomy; Thrombus; Time; United States; Universities; Vascularization; Work; aspirate; biomaterial compatibility; brain tissue; clinically relevant; cost; design; disability; efficacy evaluation; efficacy testing; experience; improved; in vitro Model; in vivo Model; innovation; manufacture; meetings; migration; novel; pressure; prevent; prototype; research clinical testing; safety assessment; safety testing; standard of care; stroke patient; stroke therapy; success; technology/technique

Project Summary/Abstract Stroke is the leading cause of serious long-term disability and accounts for 4.6 million disabled people in the United States. Stroke-related costs total over $46 billion in the United States each year.1 Of the nearly 800,000 Americans who have a stroke per year, 87% experience ischemic stroke1, of which 49%-86% are attributed to either large vessel occlusions (LVO) or medium vessel occlusions (MeVOs).2,3 Mechanical thrombectomy, via a stent retriever or aspiration catheter, is now the standard of care for eligible patients who experience ischemic stroke.4–6 While mechanical thrombectomy has progressed dramatically over the past few years, existing aspiration catheter devices suffer from significant limitations. Major challenges to successful treatment of ischemic stroke include quickly navigating to the clot and fully capturing it in the first pass while avoiding thrombus breakage and further downstream ischemia. This project has two aims to address existing limitations of aspiration thrombectomy. The first aim develops, builds, and tests a prototype aspiration catheter with an adaptive radially expandable tip. This expandable tip is intended to improve clinical outcomes for all patients treated with mechanical thrombectomy due to its improved access and navigation capabilities and enhanced first pass effect (FPE). The second aim tests the efficacy of the novel aspiration catheter using an in vitro model. This project will lead to the development of a device intended to improve safety and efficacy by alleviating multiple pass attempts, clot fragmentation, and vessel injury. Through these goals, this project has the potential to improve the clinical outcome of patients who suffer from ischemic stroke by propelling the field of neuro-interventional treatments forward.

项目摘要/摘要 中风是导致严重长期残疾的主要原因，占全国残疾人总数的460万 美国。在美国，每年与中风相关的总成本超过460亿美元。 每年中风的美国人中，87%的人经历过缺血性中风，其中49%-86%被归因于 大血管闭塞(LVO)或中血管闭塞(MeVO)。2，3机械血栓切除术，通过 支架取回器或抽吸导管，现在是符合条件的患者的标准护理 缺血性中风。4-6尽管过去几年机械血栓摘除术取得了显著进展， 现有的抽吸导管装置存在明显的局限性。成功治疗的主要挑战 缺血性中风包括快速导航到血栓并在第一次通过时完全捕获它，同时避免 血栓破裂和进一步的下游缺血。该项目有两个目标，以解决现有的限制 抽吸血栓摘除术。第一个目标是开发、建造和测试带有 自适应径向可扩展尖端。这种可扩展的提示旨在改善所有患者的临床结果。 由于其改善的通道和导航能力以及增强的性能而采用机械血栓切除术治疗 首次通过效应(FPE)。第二个目的是用体外实验测试新型吸引管的疗效。 模特。该项目将导致开发一种旨在通过以下方式提高安全性和有效性的设备 减轻多次传球尝试、血栓碎裂和血管损伤。通过这些目标，这个项目已经 通过推进这一领域来改善缺血性卒中患者临床结局的潜力 神经介入治疗的未来。