Durability improvement of polymer chamber of pulsatile extracorporeal life support system in terms of mechanical change.
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.
Choi
Hyuk
H
Interdisciplinary Program in Biomedical Engineering Major, Seoul National University, Seoul, South Korea.
Paik
Seung Hoon
SH
Lee
Kwang Ho
KH
Min
Byoung Goo
BG
Won
Yong Soon
YS
D004867:Equipment Design; D004868:Equipment Failure; D019544:Equipment Failure Analysis / Q000379:methods; D015199:Extracorporeal Membrane Oxygenation / Q000295:instrumentation* / Q000592:standards; D006461:Hemolysis; D006801:Humans; D008422:Materials Testing / Q000379:methods; D011108:Polymers; D011673:Pulsatile Flow
D011108:Polymers