Preclinical evaluation of a hollow fiber silicone membrane oxygenator for extracorporeal membrane oxygenator application

A silicone membrane hollow fiber oxygenator applicable for use as an extrac orporeal membrane oxygenator (ECMO) has been developed in our laboratory. T his silicone hollow fiber displays astonishing mechanical stability, is bar ely compressible or stretchable, and assembles easily while maintaining goo d gas permeability. The priming volume is 140 cc with a surface area of 0.8 m(2). This study evaluated the gas transfer performances and biocompatibil ity of the oxygenator under ECMO and CPB conditions. In vitro studies that were performed at a blood flow rate of 2 L/min, and revealed O-2 and CO2 ga s transfer rates of 82.35 +/- 0.56 ml/m(2)/L/min and 38.72 +/- 2.88 ml/m(2) /L/min, respectively. The commercially available Kolobow (Avecor 1500) oxyg enator was used as the control, and had O-2 and CO2 gas transfer rates of 5 3.8 +/- 0.5 ml/m(2)/L/min and 24.7 +/- 2.0 ml/m(2)/L/min. To evaluate blood trauma, Normalized Index of Hemolysis (NIH) was measured according to Amer ican Society of Testing and Materials (ASTM) standards. The NIH findings we re 0.0112 g/100L at a blood flow of 1 L/min, and 0.0152 g/100L at 5 L/min. Three ex vivo experiments, using a blood flow rate of 1 L/min, were perform ed with venoarterial bypass, and O-2 transfer rate and CO2 transfer rate of the oxygenators were well maintained. This indicates that this preclinical silicone membrane hollow fiber oxygenator has superior efficiency, less bl ood trauma, and is smaller when compared with the only clinically available Kolobow oxygenator.