I-Corps: Addressing Pulmonary Embolism with QuickFlow PE

肺栓塞（PE）是一种栓塞，最常见的形式是血凝块，阻塞肺的主要动脉，导致呼吸衰竭和死亡的情况。在美国，肺栓塞的发病率估计为每年650，000例，死亡率估计为每年约100，000例死亡。肺栓塞是住院患者的第三大常见死因。 目前治疗肺栓塞的方法是静脉和口服抗凝剂。这些药物对大多数病例有效，但急性巨大和亚巨大患者除外（45%的患者）。 其他较少使用的治疗包括用于手动移除凝块的心内直视手术（栓子切除术）、溶栓药物和导管导向治疗。每一种方法都对患者的预后带来很大的风险，特别是心脏直视手术，而溶栓药物可能导致全身和大脑出血，导管导向治疗需要长时间的治疗和大导管。I-Corps团队发明了一种经皮机械血栓切除器械QuickFlow PE。经皮方法解决了当前治疗或外科手术的缺点。 申报项目包括三项主要活动：1）进行系统研究，以优化血栓切除器械的镍钛合金部分的设计，2）开发用于捕获血凝块的超弹性器械的概念验证，3）评估申报器械的商业化潜力。这些活动对镍钛合金医疗器械设计和制造领域做出了重大贡献。本研究将确定使用FDA批准的制造方法制造功能性超弹性装置的程序。该技术将促进患者专用医疗器械的制造。预计拟议的研究将对镍钛合金医疗器械的发展产生重大影响。在项目结束时，该团队将完成下一代原型的制造。

Pulmonary embolism (PE) is a condition where an embolus, most often in the form of a blood clot, blocks the main artery of the lung, causing respiratory failure and death. In the U.S., the incidence of pulmonary embolism is estimated to be 650,000 cases per year, and the mortality rate is estimated at approximately 100,000 deaths per year. Pulmonary embolism is the third most common cause of death for hospitalized patients. Current modalities for treating pulmonary embolism are intravenous and oral anticoagulation. These medications are effective for most cases with the exception of the acute massive and submassive patients (45% of patients). Other treatments that are used less frequently include open heart surgery for manual removal of clot (embolectomy), thrombolytic medications, and catheter-directed treatments. Each of these carries substantial risks for patient outcomes, particularly open heart surgery, while thrombolytic medications can cause bleeding throughout the body and in the brain, and catheter-directed treatments require long treatment periods, and large catheters. This I-Corps team has invented a percutaneous mechanical thrombectomy device QuickFlow PE. The percutaneous approach addresses the shortcoming of current therapies or surgical procedures. The proposed project includes three main activities: 1)performing methodical study toward optimizing the design of the Nitinol portion of the thrombectomy device, 2)developing a proof of concept super elastic device to capture blood clots, and 3)assessing the commercialization potential of the proposed device. These activities contribute significantly to the field of Nitinol medical device design and fabrication. This research would identify the procedure to fabricate functional super elastic devices using FDA approved fabrication methods. This technology will facilitate fabrication of patient-specific medical devices. It is anticipated that the proposed research will have a significant impact on the advancement of medical device made of Nitinol. At the end of the project the team will complete fabrication of the next generation prototype.