STTR Phase I: Endovascular Thrombectomy System for Ischemic Stroke

STTR 第一期：治疗缺血性中风的血管内血栓切除系统

• 批准号: 2136438
• 负责人: Jonathan McGrath
• 金额: $ 25.6万
• 依托单位: NEURX MEDICAL LIMITED LIABILITY COMPANY
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2136438&HistoricalAwards=false
• 关键词: STTR; Phase; Endovascular; Thrombectomy; System

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to improve survival and functional outcomes for stroke patients. Stroke remains a leading cause of death among Americans and is the largest source of long-term disability in the U.S. and around the world. Every 30 seconds, an American suffers a major stroke, most commonly caused by a clot obstructing a large cerebral artery supplying a critical area of the brain. This project’s clot-removal technology aims to enable rapid and efficient removal of clot from the cerebral vessels using minimally-invasive image-guided techniques, thereby improving the chances of full recovery and an independently functional outcome. The broader benefit for society is to reduce death or permanent disability from ischemic stroke with its resultant family, community, and economic burden. This Small Business Technology Transfer Phase I project will lead to the development of a medical device to enable efficient removal of blood clots from the brain arteries of a stroke victim. The platform technology is constructed from microscopic tubes of superelastic metal alloy integrated with a proprietary pattern of laser-cut apertures. The device can be delivered to the stroke clot through a microcatheter to create a shape-formed array of clot-capture elements within a patient’s artery. Tandem capture devices optimize the clot capture system and can be positioned on either edge of a clotted segment within a brain artery. Optimal shape, thickness and materials of the clot capture elements and the delivery system will be characterized, developed, and verified. The proposed work will utilize a previously validated model of stroke thrombectomy to characterize and quantify fundamental clot capture parameters (clot stabilization, retention, and retrieval) among multiple discrete capture node embodiments. Radial force, coefficient of drag during withdrawal inside a cerebral blood vessel and device trackability will be measured for each design using robust three-dimensional human anatomic models of cerebral vessels. The project will enable a design freeze of the optimal device design and validate its performance using a preclinical animal model.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

该小企业创新研究 (SBIR) 第一阶段项目的更广泛影响/商业潜力是改善中风患者的生存和功能结果。 中风仍然是美国人死亡的主要原因，也是美国和世界各地长期残疾的最大根源。 每 30 秒就有一名美国人遭受一次严重中风，最常见的原因是血凝块阻塞了为大脑关键区域供血的大脑动脉。 该项目的血栓清除技术旨在利用微创图像引导技术快速有效地清除脑血管中的血栓，从而提高完全康复和独立功能结果的机会。对社会更广泛的好处是减少缺血性中风造成的死亡或永久性残疾及其造成的家庭、社区和经济负担。 这个小企业技术转让第一阶段项目将开发一种医疗设备，能够有效去除中风患者脑动脉中的血凝块。 该平台技术由超弹性金属合金微型管构成，并集成了专有的激光切割孔径图案。 该装置可以通过微导管输送到中风血栓处，在患者动脉内形成血栓捕获元件的形状阵列。 串联捕获装置优化了凝块捕获系统，并且可以放置在脑动脉内凝块部分的任一边缘。凝块捕获元件和输送系统的最佳形状、厚度和材料将被表征、开发和验证。 所提出的工作将利用先前验证的中风血栓切除术模型来表征和量化多个离散捕获节点实施例中的基本凝块捕获参数（凝块稳定性、保留和恢复）。 将使用强大的脑血管三维人体解剖模型来测量每个设计的径向力、脑血管内撤回过程中的阻力系数和设备可追踪性。该项目将实现最佳设备设计的设计冻结，并使用临床前动物模型验证其性能。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力优点和更广泛的影响审查标准进行评估，被认为值得支持。