Project Description: 

Boston Scientific manufactures vascular sheaths to accommodate varying sizes of interventional cardiology devices used in procedures such as Left Atrial Appendage Closure (LAAC), Extracorporeal Membrane Oxygenation (ECMO), and Transcatheter Aortic Valve Replacement (TAVR). As devices increase in size and procedures become more complicated, the required vascular sheaths may become longer, more prominent in diameter, and must be left in the body for extended periods. As vascular sheath size and duration in the vessel increases, so does the patient’s risk of developing limb ischemia, when the amount of blood flow beyond the sheath is insufficient to bring enough oxygen and nutrients to the surrounding tissue. Although lower limb ischemia has a low incidence rate, it has become a more considerable concern for our project due to the necessity for larger vascular sheaths to be left in vessels for extended periods. Before bringing new clinical solutions to the market, Boston Scientific requires an accurate and patient-specific testing method for their product line of vascular sheaths that would quantify any patient risks directly and during the design phase. The purpose of this project is to design and develop a clinically relevant test method that could be patient-specific to evaluate the operative risk for Boston Scientific’s various product lines of vascular sheaths. To guide our development of a test method solution, we have defined numerous critical and essential design inputs based on user needs collected from interviews with Boston Scientific research and development scientists and engineers, and interventional cardiology surgeons.