Restoring an ISO:5840-compliant Pulse Duplicator Device for Hydrodynamic Performance Characterization of Artificial Cardiac Valves
Date of Graduation
Bachelor of Science in Biomedical Engineering
During the summer of 2021, I was employed as an intern at Dynatek Labs, an implantable prosthetics testing company located in southern Missouri. My primary project was to modernize an abandoned pulse duplicator device and protocol to allow the company to re-enter a market area which they left nearly 15 years prior: heart valve testing. The company halted this initiative due to changes in international testing standards in previous years. The International Standards Organization Cardiac Valves Working Group released the latest version of standards concerning artificial heart valve testing (ISO 5840) in January of 2021. Accordingly, my project required that I become abundantly familiar with requirements for the apparatus, procedure, and testing conditions for in vitro evaluations of artificial heart valves. With this knowledge, I made appropriate alterations to the existing device, software, and operation protocols to bring them into accordance with updated regulatory demands. Additionally, I coordinated the purchase of a new particle image velocimetry system which would be used to further characterize implants’ thrombogenic and haemolytic potential. I generated new documentation for the device including a comprehensive manual, user guide and test protocol. Hundreds of tests were performed to fully calibrate, produce the documentation, and implement the new system and device software. By the conclusion of my appointment at Dynatek Labs, the pulse duplicator was fully functional, data acquisition was conducted in full accordance with the most recent standards, and the auxiliary PIV system was successfully integrated into the overall device setup.
cardiac valve, heart valve, pulse duplicator, particle image velocimetry, testing, industry
Eagar, D. (2022). Restoring an ISO:5840-compliant Pulse Duplicator Device for Hydrodynamic Performance Characterization of Artificial Cardiac Valves. Biomedical Engineering Undergraduate Honors Theses Retrieved from https://scholarworks.uark.edu/bmeguht/132
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