Durability improvement of polymer chamber of pulsatile extracorporeal life support system in terms of mechanical change |
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| Authors: | Hyuk Choi Seung Hoon Paik Kwang Ho Lee Byoung Goo Min Yong Soon Won |
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| Affiliation: | (1) Interdisciplinary Program in Biomedical Engineering Major, Seoul National University, Seoul, South Korea;(2) Department of Biomedical Engineering, College of Medicine, Seoul National University, Seoul, South Korea;(3) Institute of Medical and Biological Engineering, Medical Research Center, Seoul National University, Seoul, South Korea;(4) Korea Artificial Organ Center, Seoul, South Korea;(5) NewheartBio. Co., Ltd., Kyonggi-Do, South Korea;(6) Department of Thoracic and Cardiovascular Surgery College of Medicine, Sooncheonhyang University, 1174 Jung-dong, Wonmi-gu, Bucheon-Si, Gyeonggi-do, 420-767 Seoul, South Korea;(7) School of Mechanical and Aerospace Engineering, Seoul National University, Seoul, South Korea |
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| Abstract: | Twin Pulse Life Support, T-PLS™ has received the CE mark (2003) and Korea Food and Drug Administration (KFDA) approval (2004) for short-term application as an Extracorporeal Life Support system (ECLS). T-PLS’s original intention was to apply for not only short-term but also long-term application such as Extracorporeal ventricular assist device (VAD). Hence, a long-term durability test was conducted. The 1-year reliability of the systems tested in this study did not meet the STS/ASAIO standard of 80% reliability with 60% confidence for a 1-year mission life. However, without the disposable units, which are only designed to operate for 6 h, the 1-year reliability exceeded the STS/ASAIO standard of 80% reliability with 60% confidence. In this study, by using the existing analysis methods and analyzing the root cause of the failure used by a numerical analysis. As eliminating or mitigating of the root cause of the failure, we improved the durability of blood chamber and evaluated the performance of the modified system via the hemolysis test. |
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| Keywords: | Extracorporeal life support systems (ECLS) Reliability Durability Blood chamber Hemolysis testing |
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