Durability improvement of polymer chamber of pulsatile extracorporeal life support system in terms of mechanical change

Hyuk Choi, Seung Hoon Paik, Kwang Ho Lee, Byoung Goo Min, Yong Soon Won

Research output: Contribution to journalArticle

4 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1127-1135
Number of pages9
JournalMedical and Biological Engineering and Computing
Volume45
Issue number11
DOIs
Publication statusPublished - 2007 Nov 1

Fingerprint

Life Support Systems
Extracorporeal Membrane Oxygenation
Polymers
Durability
Drug Approval
Heart-Assist Devices
United States Food and Drug Administration
Korea
Hemolysis
Numerical analysis
Blood

Keywords

  • Blood chamber
  • Durability
  • Extracorporeal life support systems (ECLS)
  • Hemolysis testing
  • Reliability

ASJC Scopus subject areas

  • Biomedical Engineering
  • Health Informatics
  • Health Information Management
  • Computer Science Applications
  • Computational Theory and Mathematics

Cite this

Durability improvement of polymer chamber of pulsatile extracorporeal life support system in terms of mechanical change. / Choi, Hyuk; Paik, Seung Hoon; Lee, Kwang Ho; Min, Byoung Goo; Won, Yong Soon.

In: Medical and Biological Engineering and Computing, Vol. 45, No. 11, 01.11.2007, p. 1127-1135.

Research output: Contribution to journalArticle

Choi, Hyuk ; Paik, Seung Hoon ; Lee, Kwang Ho ; Min, Byoung Goo ; Won, Yong Soon. / Durability improvement of polymer chamber of pulsatile extracorporeal life support system in terms of mechanical change. In: Medical and Biological Engineering and Computing. 2007 ; Vol. 45, No. 11. pp. 1127-1135.
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