ICorps Administrative Supplement for A Remotely-Operated Robotic Endovascular Platform to Improve Thrombectomy Access

ICorps 针对远程操作机器人血管内平台的行政补充，以改善血栓切除术的可及性

• 批准号: 10045638
• 负责人: Francis Milton Creighton
• 金额: $ 5.5万
• 依托单位: UNANDUP, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-24 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10045638
• 关键词: Acute; Address; Administrative Supplement; Alloys; American; American Heart Association; Anterior; Beds; Blood Circulation; Blood Vessels; Blood coagulation; Caring; Cause of Death; Certification; Cessation of life; Clinical Research; Cobalt; Collaborations; Complex; Custom; Data; Data Set; Devices; Economic Burden; Equipment; Face; Fluoroscopy; Geography; Goals; Health Services Accessibility; Hospitals; Hour; Image; In Vitro; Intensive Care; Intervention; Ischemic Stroke; Joints; Magnetism; Medical Device; Modeling; Modernization; Neurologic; Neurology; Patients; Performance; Phase; Platinum; Procedures; Robotics; Roentgen Rays; Services; Site; Small Business Innovation Research Grant; Stroke; System; Technology; Thrombectomy; Time; Training; Underserved Population; United States; acute care; artery occlusion; base; certificate program; cost; cost effective; disability; health care disparity; improved; innovation; meetings; neurovascular; novel; operation; programs; prototype; standard of care; stroke therapy; stroke victims; thrombolysis; tool

Acute ischemic stroke (AIS) results from a blood clot in the neurovasculature. Currently, AIS remains the 5th leading cause of death in the United States (US) and is the leading cause of neurological disability. AIS will impact more than 700,000 Americans in 2018 and, despite the recent advances in stroke care, there still exists a 65% chance of death or severe disability. By 2030, it is expected that the US’s AIS economic burden will exceed $180B. Standard of care AIS therapies include the use of thrombolysis within 4.5 hours of stroke onset and thrombectomy for large vessel occlusions as early as possible. However, despite thrombectomy’s proven value, poor geographic access to early thrombectomy still results in a large disparity in care. In the US, thrombectomies are largely performed at Comprehensive Stroke Centers (CSCs), for which there are less than 170. CSC certification is associated with extensive requirements, including access to high- level expertise, 24/7 access to care, dedicated neuro intensive care beds, on-site thrombectomy, CT/MR/CTA/MRA imaging, and participation in clinical research. Because considerable costs are associated with setting up and maintaining a CSC, these centers are concentrated near highly-populated urban centers, which can provide larger patient volumes. However, the consequence is that more than half of Americans face transfer times longer than 1hr, and for many, transfer delays can exceed 2hrs. To help address this considerable gap in providing equal thrombectomy access to all Americans, the Joint Commission (in collaboration with the AHA/ASA) announced the Thrombectomy-Capable Stroke Center (TSC) certification program on January 1, 2018, with the goal of creating a geographically-dispersed thrombectomy- capable hospital network. However, building this TSC network will be a challenge given that 1) the associated costs in staffing a 24/7 TSC program will be high, 2) there are less than 3500 US neuroradiologists to draw from, and 3) the highest-level of expertise will likely remain concentrated within in high-volume CSCs. UN&UP has invented a novel and remotely-enabled robotic technology that bolsters the Joint Commission’s TSC initiative. The technology’s innovation relates to the use of an angiosuite-compatible magnet-based workstation to navigate neurovascular tools composed of a unique magnetic alloy, which can be shaped into small, remotely-navigable guidewires and microcatheters. The result is a magnet-based robotic platform than is 40X smaller than previously possible and, for the first time, offers robotic solutions to the neurointerventionalist. UN&UP’s team consists of leading magnetics, robotics, telemedical, and stroke experts. The project’s aims include 1) building the prototype magnet workstation, 2) building novel magnetic guidewires and microcatheters, and 3) assessing device performance in vascular phantoms based upon CTA/MRA neurovascular datasets. Given strong FDA 510k predicates, the technology is expected to be regulated per the 510k framework. An FDA pre-submission meeting will be conducted in advance of a Phase II proposal.

急性缺血性中风（AIS）是由神经血管系统中的血栓引起的，目前，AIS 仍然是第五位。 是美国 (US) 的首要死因，也是 AIS 的首要原因。 2018 年影响了超过 70 万美国人，尽管最近在中风治疗方面取得了进展，但仍然存在 到 2030 年，预计美国 AIS 的经济负担将达到 65%。 超过 $180B 护理标准 AIS 疗法包括在中风发作 4.5 小时内使用溶栓治疗。 以及尽早进行血栓切除术治疗大血管闭塞然而，尽管血栓切除术已被证明。 尽管早期血栓切除术的价值有限，但地理位置较差仍然导致护理方面存在巨大差异。 在美国，血栓切除术主要在综合中风中心 (CSC) 进行，其中 不到 170 个。CSC 认证涉及广泛的要求，包括获得高 专业水平、24/7 全天候护理、专用神经重症监护病床、现场血栓切除术、 CT/MR/CTA/MRA 成像以及参与临床研究因为涉及相当大的成本。 通过建立和维护 CSC，这些中心集中在人口密集的城市中心附近， 这可以提供更大的患者量，但结果是超过一半的美国人面临。 转乘时间超过 1 小时，对于许多人来说，转乘延迟可能超过 2 小时。 为了帮助解决在向所有美国人提供平等的血栓切除术机会方面存在的巨大差距，联合 委员会（与 AHA/ASA 合作）宣布成立具备血栓切除术的中风中心 (TSC) 2018年1月1日推出认证计划，目标是创建地域分散的血栓切除术—— 然而，考虑到 1) 相关的医院网络，建立这个 TSC 网络将是一个挑战。 24/7 TSC 计划的人员配备成本会很高，2) 可供抽调的美国神经放射科医生不到 3500 名 3) 最高水平的专业知识可能仍然集中在高容量的 CSC 中。 UN&UP 发明了一种新颖的远程机器人技术，可支持联合 该技术的创新与 angiosuite 兼容的使用有关。 基于磁铁的工作站，用于导航由独特磁性合金组成的神经血管工具，可以 形成小型、可远程导航的导丝和微导管，最终形成了基于磁铁的机器人。 该平台比以前小 40 倍，并且首次为 UN&UP 的团队由领先的磁学、机器人学、远程医疗和中风专家组成。 该项目的目标包括 1) 构建原型磁体工作站，2) 构建新型磁性导丝 和微导管，3) 基于 CTA/MRA 评估血管模型中的装置性能 鉴于 FDA 510k 的强大谓词，该技术预计将受到监管 510k 框架将在第二阶段提案之前召开 FDA 提交前会议。