Artificial organs within the blood stream are generally associated with flow-induced blood damage, particularly hemolysis of red blood cells. These damaging effects are known to be dependent on shear forces and exposure times. The determination of a correlation between these flow-dependent properties and actual hemolysis is the subject of this study. For this purpose, a Couette device has been developed. A fluid seal based on fluorocarbon is used to separate blood from secondary external damage effects. The shear rate within the gap is controlled by the rotational speed of the inner cylinder, and the exposure time by the amount of blood that is axially pumped through the device per given time. Blood damage is quantified by the index of hemolysis (IH), which is calculated from photometric plasma hemoglobin measurements. Experiments are conducted at exposure times from texp=25 - 1250 ms and shear rates ranging from tau=30 up to 450 Pa ensuring Taylor-vortex free flow characteristics. Blood damage is remarkably low over a broad range of shear rates and exposure times. However, a significant increase in blood damage can be observed for shear stresses of tau>or= 425 Pa and exposure times of texp>or= 620 ms. Maximum hemolysis within the investigated range is IH=3.5%. The results indicate generally lower blood damage than reported in earlier studies with comparable devices, and the measurements clearly indicate a rather abrupt (i.e., critical levels of shear stresses and exposure times) than gradual increase in hemolysis, at least for the investigated range of shear rates and exposure times.

A computational assessment or even quantification of shear induced hemolysis in the predesign phase of artificial organs (e.g., cardiac assist devices) would largely decrease efforts and costs of design and development. In this article, a general approach of hemolysis analysis by means of computational fluid dynamics (CFD) is discussed. A validated computational model of a microaxial blood pump is used for detailed analysis of shear stress distribution. Several methods are presented that allow for a qualitative assessment of shear stress distribution and related exposure times using a Lagrangian approach and mass distribution in combination with shear stress analysis. The results show that CFD offers a convenient tool for the general assessment of shear-induced hemolysis. The determination of critical regions and an estimation of the amount of blood subject to potential damage in relation to the total mass flow are shown to be feasible. However, awareness of limitations and potential flaws in CFD based hemolysis assessments is crucial.

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Devices for modern heart support are minimized to reduce priming blood volume and contact area with foreign surfaces. Their flow fields are partly governed by very high velocity gradients. In order to investigate blood damage, porcine and human blood was passed through a narrow Couette type shear gap applying defined high shear rates within the typical range for devices such as blood pumps or artificial heart valves (gamma = 1800/s to 110,000/s for 400 ms). Traumatization profiles of both blood species were recorded in terms of hemolysis and platelet count. Sublethal damage in terms of platelet (PF4) and complement activation (C5a) was additionally measured for human blood. Results for porcine and human blood were very similar. Hemolysis was not started until critical shear rates of about 80,000/s. Impact on platelets was severe with drops in cell count of up to 65% (at gamma = 55,000/s to 110,000/s) likely to set stronger limits to the design layout of devices than hemolysis. Concentrations of PF4 and C5a clearly increased with shear rate exhibiting stronger gradients where hemolysis started. Due to the similar results of porcine and human blood for hemolysis and platelet drop, porcine blood seems to be suitable for device testing. Selection of blood species would thus depend on handling, availability and analysis demands.

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