Enhanced Suction Thrombectomy in Pulmonary Embolism Using Vortex Catheter Technology

使用涡流导管技术增强肺栓塞抽吸血栓切除术

• 批准号: 10324705
• 负责人: Michael Rosenthal
• 金额: $ 29.82万
• 依托单位: ENDOVASCULAR ENGINEERING, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-20 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10324705
• 关键词: Achievement; Address; American; American Heart Association; Anatomy; Anticoagulants; Arteries; Aspirate substance; Benchmarking; Blood; Bypass; Cadaver; Caliber; Cardiovascular system; Caring; Categories; Catheters; Cessation of life; Clinical; Coagulation Process; Data; Development; Devices; Diagnosis; Dose; Elements; Embolectomy; Embolism; Engineering; Ensure; Equilibrium; Excision; Extravasation; Failure; Feedback; Foundations; Funding; Generations; Geometry; Glass; Goals; Gold; Heart; Hemoglobin concentration result; Hemolysis; Hemorrhage; Human; Inferior; Ingestion; Interview; Intracranial Hemorrhages; Lung; Mechanics; Michigan; Modeling; Morbidity - disease rate; Names; Outcome; Patients; Performance; Phase; Physiological; Placebos; Preclinical Testing; Procedures; Process; Pulmonary Embolism; Pulmonary artery structure; Pump; Recurrence; Research; Risk; Rotation; Shapes; Small Business Innovation Research Grant; Societies; Specific qualifier value; Speed; Stroke; Suction; System; Technology; Testing; Thrombectomy; Thrombolytic Therapy; Time; Torque; Travel; Trees; Tube; Tumor Debulking; United States; Universities; Venous; Ventricular; analog; base; community intervention; design; experience; experimental study; good laboratory practice; high risk; improved; mortality; pressure; prevent; programs; prototype; reconstitution; standard care; success; thrombolysis; tool; usability

PROJECT SUMMARY Pulmonary embolism (PE) is the third most common cause of cardiovascular death in the United States. Approximately 500,000-600,000 Americans are diagnosed with PE, which causes up to 180,000 death per year. According to the American Heart Association (AHA), PE is classified into three categories: massive, submassive, or low risk. Treatment with anticoagulants is the cornerstone for treatment of PE; however, suboptimal results such as a similar 30-days mortality, and an ~five-fold increase in the risk of major bleeding, and a 10-fold increase in the risk of intracranial hemorrhage, compared with placebo, in patients with submassive and massive PE, and only one-third of unstable PE patients (30%) received recommended thrombolytic therapy even when they are eligible. These suboptimal results with anticoagulants have led to the use of other treatments such as catheter-directed therapies (CDT). CDT includes catheter-directed thrombolysis (CDL) and catheter-based embolectomy. There are some limitations to the use of CDL, including the risk of hemorrhage, doses are still being investigated, and the evidence for the benefits of this technology is still lacking. Despite the compelling results of mechanical thrombectomy (MT) landmark trials, MT in PE is rarely performed. Our extensive discovery interviews among multiple KOLs have led us to identify the requirements of the new device to improve clinical outcomes and usability acceptance and establish MT as gold-standard treatment for submassive and massive PE, which include: 1) safe and smooth navigation into the PAs(<16F catheter); 2) rapid and continuous ingestion of emboli recanalizing large and medium-size branches of the pulmonary tree (efficacy equivalent to >20F catheter); 3) directional thrombectomy; 4) minimal blood loss; 5) negligible spillage of arrhythmogenic hemolysis byproducts. To address these issues, we propose to develop an entirely new class of MT devices, named Vortex Catheter Technology (V- CaTh), that augments suction catheters efficacy by a breakthrough mechanism we identified that generates a powerful whirlpool by converting the high rotational energy transmitted by a high-torque shaft into a hydrodynamic vortex. This mechanism enables the small catheter to remove large and stiff clots by progressive rotational elongation and pulling of the clot into the catheter (“a device that is small but acts big”) while preventing intravascular clot maceration and significantly reducing blood loss. We have previously completed extensive foundational research and iterative prototyping of our device in the context of MT for stroke. In this Phase 1 SBIR, we will expand the technological platform with pivotal engineering, development, and preclinical testing of a user- specified V-CaTh system for thrombectomy in PE. In order to ensure the adequate performance of the V-CaTh prototypes at key points along the development, we will carry out the following objectives: 1) user-specified design and development of the V-CaTh system and; 2) Iterative testing and optimization of the V-CaTh system in phantom PAs and human cadavers. If we achieve these Aims, E2 will be well-situated to move toward FDA submission, providing the interventional community with a specialized new tool to address the gap in PE care.

项目概要 肺栓塞（PE）是美国心血管死亡的第三大常见原因。 大约 500,000-600,000 名美国人被诊断患有 PE，每年导致多达 180,000 人死亡。 根据美国心脏协会 (AHA)，PE 分为三类：大面积、次大面积、 抗凝剂治疗是治疗 PE 的基石，但效果不佳； 30 天死亡率相似，大出血风险增加约五倍，出血风险增加 10 倍 与安慰剂相比，亚大块和大块 PE 患者有颅内出血的风险，并且仅 三分之一的不稳定肺栓塞患者 (30%) 即使符合条件也接受了推荐的溶栓治疗。 抗凝剂的这些次优结果导致了其他治疗方法的使用，例如导管引导 治疗（CDT）包括导管定向溶栓（CDL）和基于导管的取栓术。 使用 CDL 的一些限制，包括出血风险、剂量仍在研究中，并且 尽管机械结果令人信服，但仍缺乏证明该技术优势的证据。 血栓切除术 (MT) 具有里程碑意义的试验，我们很少对 PE 中的 MT 进行广泛的发现访谈。 多位 KOL 引导我们确定了新设备的要求，以改善临床结果和可用性 接受并将 MT 确立为次大面积和大面积 PE 的黄金标准治疗方法，其中包括：1) 安全 并顺利导航至 PA（<16F 导管）；2）快速、持续摄入大栓塞再通； 和中等大小的肺树分支（功效相当于>20F导管）；3）定向； 血栓切除术；4) 失血量极少；5) 致心律失常性溶血副产物的溢出可忽略不计。 针对这些问题，我们建议开发一类全新的 MT 设备，名为 Vortex Catheter Technology（V- CaTh），通过我们发现的突破性机制增强抽吸导管的功效，该机制产生 通过将高扭矩轴传输的高旋转能转化为流体动力，产生强大的漩涡 这种机制使小导管能够通过渐进旋转去除大而僵硬的凝块。 伸长并将凝块拉入导管（“一种小但作用大的装置”），同时防止 我们之前已经完成了广泛的血管内凝块浸渍并减少失血。 在中风 MT 的背景下，我们的设备进行了基础研究和迭代原型设计。在第一阶段 SBIR 中， 我们将通过关键工程、开发和用户临床前测试来扩展技术平台 为PE血栓切除术指定V-CaTh系统，以确保V-CaTh的充分性能。 在原型开发的关键点上，我们将进行以下目标： 1）用户指定设计 2）V-CaTh系统的迭代测试和优化 如果我们实现这些目标，E2 将有能力向 FDA 迈进。 提交，为介入界提供了专门的新工具来解决PE护理方面的差距。