Enhanced Suction Thrombectomy in Pulmonary Embolism Using Vortex Catheter Technology

项目总结 在美国，肺栓塞(PE)是导致心血管疾病死亡的第三大常见原因。 大约有500,000-600,000美国人被诊断出患有PE，每年导致多达180,000人死亡。 根据美国心脏协会(AHA)的说法，PE被分为三类：大块型，亚大块型， 或低风险。抗凝剂治疗是PE治疗的基石；然而，效果不佳，如 类似的30天死亡率，大出血风险增加~5倍， 与安慰剂相比，亚大面积和大面积PE患者的颅内出血风险，且仅 三分之一的不稳定PE患者(30%)即使在符合条件的情况下也接受了推荐的溶栓治疗。 抗凝剂的这些不理想的结果导致了其他治疗方法的使用，如导管引导 治疗(CDT)。CDT包括导管定向溶栓(CDL)和导管取栓术。确实有 CDL使用的一些限制，包括出血的风险，剂量仍在调查中，以及 关于这项技术的益处的证据仍然缺乏。尽管机械制造的令人信服的结果 血栓消融术(MT)具有里程碑意义的试验，在PE中很少进行MT。我们广泛的发现访谈中 多个KOL使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确立为亚大面积和大面积PE的金标准治疗，包括：1)安全 并顺利进入PAS(&lt；16F导管)；2)快速和持续地摄取再通的大血栓 和中等大小的肺树分支(相当于&gt；20F导管)；3)定向 血栓切除术；4)最少的失血；5)可忽略的致心律失常的溶血副产物的溢出。致信地址 针对这些问题，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)，它通过我们发现的一种突破性机制来增强负压导管的效率，从而产生 通过将高扭矩轴传递的高旋转能量转化为流体动力，形成强大的旋涡 漩涡。这种机制使小导管能够通过渐进旋转清除大而硬的凝块。 延长血栓并将其拉入导管(“一种小但作用大的装置”)，同时防止 血管内凝块消融，显著减少失血。我们之前已经完成了广泛的 在中风机器翻译的背景下，我们的设备的基础研究和迭代原型。在此阶段1 SBIR中， 我们将通过用户的关键工程、开发和临床前测试来扩展技术平台- 用于PE中血栓清除的特定V-Cath系统。为了确保V-Cath的适当性能 在样机开发沿线的关键点上，我们将进行以下目标：1)用户指定的设计 和V-Cath系统的开发；2)V-Cath系统的迭代测试和优化 幻影Pas和人类身体。如果我们实现了这些目标，E2将处于有利地位，向FDA迈进 提交，为干预界提供了一种专门的新工具，以解决PE护理方面的差距。

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.