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Development and evaluation of endurance test system for ventricular assist devices
Authors:Hirohito Sumikura  Akihiko Homma  Kentaro Ohnuma  Yoshiyuki Taenaka  Yoshiaki Takewa  Hiroshi Mukaibayashi  Kazuo Katano  Eisuke Tatsumi
Affiliation:1. Department of Artificial Organs, National Cerebral and Cardiovascular Center Research Institute, 5-7-1 Fujishirodai, Suita-Shi, Osaka, 565-8565, Japan
2. School of Science and Engineering, Tokyo Denki University, Saitama, Japan
3. IWAKI Co., Ltd., Saitama, Japan
Abstract:We developed a novel endurance test system that can arbitrarily set various circulatory conditions and has durability and stability for long-term continuous evaluation of ventricular assist devices (VADs), and we evaluated its fundamental performance and prolonged durability and stability. The circulation circuit of the present endurance test system consisted of a pulsatile pump with a small closed chamber (SCC), a closed chamber, a reservoir and an electromagnetic proportional valve. Two duckbill valves were mounted in the inlet and outlet of the pulsatile pump. The features of the circulation circuit are as follows: (1) the components of the circulation circuit consist of optimized industrial devices, giving durability; (2) the pulsatile pump can change the heart rate and stroke length (SL), as well as its compliance using the SCC. Therefore, the endurance test system can quantitatively reproduce various circulatory conditions. The range of reproducible circulatory conditions in the endurance test circuit was examined in terms of fundamental performance. Additionally, continuous operation for 6 months was performed in order to evaluate the durability and stability. The circulation circuit was able to set up a wide range of pressure and total flow conditions using the SCC and adjusting the pulsatile pump SL. The long-term continuous operation test demonstrated that stable, continuous operation for 6 months was possible without leakage or industrial device failure. The newly developed endurance test system demonstrated a wide range of reproducible circulatory conditions, durability and stability, and is a promising approach for evaluating the basic characteristics of VADs.
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