STTR Phase I: Endovascular Thrombectomy System for Ischemic Stroke

这个小型企业创新研究（SBIR）I期项目的更广泛的影响/商业潜力是改善中风患者的生存和功能结局。 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来源。 每隔30秒，就有一名美国人遭受严重中风，最常见的原因是血栓阻塞了供应大脑关键区域的大脑动脉。 该项目的血栓清除技术旨在使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局的机会。对社会的更广泛益处是减少缺血性卒中导致的死亡或永久性残疾及其导致的家庭、社区和经济负担。 这个小企业技术转让第一阶段项目将导致一种医疗设备的开发，以有效地清除中风患者脑动脉中的血块。 该平台技术是由超弹性金属合金的微型管与激光切割孔的专有模式集成。 该装置可以通过微导管递送到中风凝块，以在患者的动脉内产生凝块捕获元件的成形阵列。 串联捕获装置优化了凝块捕获系统，并且可以定位在脑动脉内的凝块段的任一边缘上。将对凝块捕获元件和输送系统的最佳形状、厚度和材料进行表征、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、保留和取回）。 将使用强大的三维人体脑血管解剖模型测量每种设计的径向力、脑血管内撤回期间的阻力系数和器械可跟踪性。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知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.