Impact of extracorporeal blood pump gap sizes on the performance and hemocompatibility under off-design operation.

Hemocompatibility remains the dominant challenge in rotary blood pumps, and more information on the relationship between individual pump design features, hemodynamics, and blood trauma in various operation conditions is necessary. The study evaluated the variation of gap sizes in extracorporeal blood pumps concerning their influence on blood compatibility, particularly during off-design conditions. We developed a parametric generic blood pump framework for in-silico and in-vitro design feature analysis. Thirty-six designs with varying axial and radial gap sizes between 0.5 mm and 3 mm were generated. CFD was applied to calculate and compare device hemodynamics and evaluate the performance and hemocompatibility during off-design and target operation conditions. The following quantities were analyzed: pressure difference, hemolysis potential, residence times, hydraulic efficiency, and recirculation ratio. The in-vitro prototype showed excellent agreement with in-silico predictions regarding hydraulic performance (R2 = 0.996 with a RMSE = 2.07). Our results show a modest impact of gap size variations ±10% on key metrics. Domain-resolved analyses revealed a significant contribution of the gap regions to the device's overall hemolytic performance, with an increasing contribution for off-design flow rates. Overall elevated hemolysis levels were identified if at least one gap size was held minimal. We introduced and showed the feasibility of a parametric rotary blood pump framework to systematically investigate design feature impact. Results suggest, larger and uniformly sized gaps being overall beneficial regarding hemocompatibility.