On the Accuracy of Hemolysis Models in Couette-Type Blood Shearing Devices.

Hemolysis is one of the most challenging issues faced by blood contacting devices. Empirical hemolysis models often relate hemolysis to shear stress and exposure time. These models were generally derived from the experimental results of Couette-type blood shearing devices, with assumption of uniform exposure time and shear stress. This assumption is not strictly valid since neither exposure time nor shear stress is uniform. Hence, this study evaluated the influence of the nonuniform exposure time and rotor eccentricity or run-out on the accuracy of power-law hemolysis models, using both theoretical and CFD analysis. This work first provided a systematic analysis of the flow regime in a typical Couette shearing device, and showed the axial flow component can be regarded as fully developed laminar plane Poiseuille flow. It was found that the influence of nonuniform exposure time is within 4% for several widely used power-law models, which were validated by steady CFD simulations. A theoretical relationship was then built between the rotor run-out and hemolysis. We noticed that the influence of rotor run-out on hemolysis is within 5% for a moderate rotor run-out ratio of 0.2. Next, transient CFD simulations were performed to investigate the influence of rotor run-out on hemolysis with run-out ratios of 0.1 and 0.2. The results showed negligible effects for a moderate run-out ratio of 0.1. However, a run-out ratio of 0.2 led to a significant increase of hemolysis, resulting from back flows induced by the run-out of the rotor. These findings will be of great importance for the improvement of the hemolysis estimation and blood compatibility design.