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.

项目摘要 肺栓塞（PE）是美国心血管死亡的第三大常见原因。 大约50万至60万美国人被诊断患有PE，每年导致多达18万人死亡。 根据美国心脏协会（AHA），PE分为三类：大规模，亚大规模， 或低风险。抗凝剂治疗是PE治疗的基础;然而， 30天死亡率相似，大出血风险增加约5倍， 与安慰剂相比，在次大面积和大面积PE患者中， 三分之一的不稳定PE患者（30%）接受了推荐的溶栓治疗，即使他们符合条件。 抗凝剂的这些次优结果导致了其他治疗方法的使用，例如导管导向的 治疗（CDT）CDT包括导管导向溶栓（CDL）和基于导管的栓子切除术。有 CDL使用的一些局限性，包括出血的风险，剂量仍在研究中， 这项技术的好处仍然缺乏证据。尽管机械的结果令人信服， 血栓切除术（MT）标志性试验中，很少在PE中进行MT。我们对这些人进行了广泛的访谈， 多个KOL使我们确定了新器械的要求，以改善临床结局和可用性 接受MT并将其确立为亚大块和大块PE的金标准治疗，包括：1）安全 并顺利导航到PA（<16 F导管）; 2）快速和连续摄入栓子， 和肺树的中等大小分支（功效相当于> 20 F导管）; 3）定向 血栓切除术; 4）最小失血量; 5）可忽略的致血栓性溶血副产物溢出。解决 这些问题，我们建议开发一种全新的MT设备，命名为涡流导管技术（V- CaTh），通过我们发现的一种突破性机制增强了吸引导管的功效， 通过将高扭矩轴传递的高旋转能量转换为流体动力学， 漩涡这种机制使小导管能够通过渐进旋转来移除大而硬的凝块。 将凝块拉长并拉入导管（“小但作用大的装置”），同时防止 血管内凝块浸渍和显著减少失血。我们之前已经完成了大量的 我们的设备在MT治疗中风的背景下的基础研究和迭代原型设计。在第1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， 指定用于PE血栓切除术的V-CaTh系统。为了确保V-CaTh的充分性能， 在沿着开发的关键点上，我们将进行以下目标：1）用户指定的设计 和开发的V-CaTh系统; 2）迭代测试和优化的V-CaTh系统， 幻影PA和人类尸体。如果我们实现这些目标，E2将处于有利地位，向FDA迈进 提交，为介入社区提供专门的新工具，以解决体育保健中的差距。