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 中风是严重长期残疾的主要原因，占460万残疾人 美国。美国每年与中风相关的成本总计超过460亿美元。在近80万 每年中风的美国人有87％的缺血性中风1，其中49％-86％归因于 大容器闭塞（LVO）或中型容器闭塞（MEVOS）。 现在是经验经验的合格患者的支架检索器或吸气导管 缺血性中风。4–6尽管机械血栓切除术在过去几年中取得了巨大进展，但 现有的吸气导管设备受到重大局限性。成功治疗的主要挑战 缺血性中风包括快速导航到凝块，并在避免的同时完全捕获它 血栓破裂和进一步的下游缺血。该项目有两个目的是解决现有的限制 抽吸血栓切除术。第一个目标开发，构建和测试了一个原型吸气导管， 自适应径向扩展的尖端。这种可扩展的技巧旨在改善所有患者的临床结果 通过机械血栓切除术治疗，由于其提高了访问和导航功能并增强了 第一通过效应（FPE）。第二个目标测试了使用体外的新型抽吸导管的有效性 模型。该项目将导致旨在通过 减轻多次通行证，凝块碎片和船舶伤害。通过这些目标，这个项目有 通过推动现场来改善患有缺血性中风的患者的临床结果的潜力 神经间歇性治疗的前进。