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.

Thromboembolic complications remain as one of the main problems for blood contacting artificial organs such as heart valves, bloodpumps and others. In vitro evaluation of thrombogenesis in prototypes has not previously been part of the standard evaluation of these devices. In comparison to hemolysis testing, evaluation of the thrombogenic potential is more difficult to perform because of the complexity of the blood coagulation system. We present an in vitro testing procedure that allows the accelerated examination of the thrombogenic potential of different types of blood pumps. Additionally, first results are presented that indicate the reliability of the accelerated clotting test for mechanical heart valves. Results for the centrifugal pump BioMedicus and two microaxial pumps have shown typical thrombus formation at locations such as bearings. The results indicate that the accelerated clotting test is an excellent addition to the much more expensive animal testing of artificial organs or assist devices. In vitro testing permits studies of thrombus formation to be performed at an early stage and at low costs and also facilitates a more precise investigation of device areas known to be potential hot spots for thrombus formation.

Damage of red blood cells (hemolysis) in miniaturized pump systems for heart support is induced by contact with artificial surfaces and high mechanical shear forces. In vitro experiments with porcine blood under well defined material and flow conditions with a new Couette model showed hemolysis not starting until shear stresses of 400 Pa and exposure times of 400 ms. Hemolysis in general was much lower than predicted in earlier investigations. Heparinized blood revealed a more sensitive behaviour as compared to citrated blood (CPDA‐1).

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