Disposable MagLev centrifugal blood pump utilizing a cone-shaped impeller.

To enhance the durability and reduce the blood trauma of a conventional blood pump with a cone-shaped impeller, a magnetically levitated (MagLev) technology has been applied to the BioPump BPX-80 (Medtronic Biomedicus, Inc., Minneapolis, MN, USA), whose impeller is supported by a mechanical bearing. The MagLev BioPump (MagLev BP), which we have developed, has a cone-shaped impeller, the same as that used in the BPX-80. The suspension and driving system, which is comprised of two degrees of freedom, radial-controlled magnetic bearing, and a simply structured magnetic coupling, eliminates any physical contact between the impeller and the housing. To reduce both oscillation of the impeller and current in the coils, the magnetic bearing system utilizes repetitive and zero-power compensators. In this article, we present the design of the MagLev mechanism, measure the levitational accuracy of the impeller and pressure-flow curves (head-quantity [HQ] characteristics), and describe in vitro experiments designed to measure hemolysis. For the flow-induced hemolysis of the initial design to be reduced, the blood damage index was estimated by using computational fluid dynamics (CFD) analysis. Stable rotation of the impeller in a prototype MagLev BP from 0 to 2750 rpm was obtained, yielding a flow rate of 5 L/min against a head pressure in excess of 250 mm Hg. Because the impeller of the prototype MagLev BP is levitated without contact, the normalized index of hemolysis was 10% less than the equivalent value with the BPX-80. The results of the CFD analysis showed that the shape of the outlet and the width of the fluid clearances have a large effect on blood damage. The prototype MagLev BP satisfied the required HQ characteristics (5 L/min, 250 mm Hg) for extracorporeal circulation support with stable levitation of the impeller and showed an acceptable level of hemolysis. The simulation results of the CFD analysis indicated the possibility of further reducing the blood damage of the prototype MagLev BP.