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Development of a left heart simulator for prosthetic valve evaluation
Thesis   Open access

Development of a left heart simulator for prosthetic valve evaluation

Gabrielle Toner
Master of Science (M.S.), Drexel University
Apr 2017
DOI:
https://doi.org/10.17918/etd-7335
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Toner_Gabrielle_201728.54 MBDownloadView

Abstract

Prosthetic heart valves Cardiovascular system--Diseases--Treatment Biomedical Engineering
Cardiovascular disease is the number one cause of death globally, and many valve diseases contribute to this statistic. Heart valve prostheses have rapidly evolved for both mitral and aortic valves, embodied in both mechanical and bioprosthetic designs. Prosthetic valves undergo extensive in vitro testing to qualify the device's performance prior to clinical implantation, according to ISO 5840:1. ISO 5840:1 describes the testing requirements for pulse duplication, and currently, device manufacturers utilize academic or commercial pulse duplicators to evaluate their devices. However, both avenues have limitations in quality control or flexibility that bring about the need for a custom pulse duplicator. The objective of this research project was to develop a cardiac pulse duplicator to test mechanical, aortic prosthetic valves in a 3rd party pre-clinical laboratory and validate the benchtop system using ISO criteria. The design incorporated the use of a driving mechanism composed of MTS MiniBionix 858 and a bellow adapted from the TA Electroforce Stent Graft Tester and rigid custom housing to mimic the left ventricle, left atrium, and aorta, reporting pressure as the primary deliverable for analysis. The design was constructed and experimentally validated using criteria from ISO 5840:1, including aortic pressure ranges, peak diastolic differential pressure, systolic and diastolic ratios, motor capacity and tester repeatability. The design conformed with most criteria; however, further work will be needed to implement an additional dashpot component to decrease systolic oscillations.

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