I-Corps: Addressing Pulmonary Embolism with QuickFlow PE

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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.