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We have been developing an implantable left ventricular assist system (T-ILVAS) featuring a magnetically suspended centrifugal pump (MSCP) since 1995. In vitro and in vivo studies using a prototype MSCP composed of a polycarbonate housing and impeller (196 ml) have demonstrated long-term durability and excellent blood compatibility for up to 864 days, and excellent stability of the magnetic bearing of the MSCP. These preliminary results strongly suggested that the magnetic bearing of the MSCP is reliable and is a most feasible mechanism for a long-term circulatory assist device. We have recently devised a clinical version pump made of titanium (180 ml) with a new position sensor mechanism and a wearable controller with batteries. Cadaver fit study confirmed that the Type IV pump could be implanted in a small patient with a body surface area as small as 1.3. The in vitro performance tests of the Type IV pump demonstrated excellent hydrodynamic performances with an acceptable hemolysis rate. New position sensors for the titanium housing showed more uniform sensor outputs of a magnetic bearing than in the prototype polycarbonate pump. The Type IV pump then was evaluated in vivo in 6 sheep at the Oxford Heart Centre. Four sheep were electively sacrificed at 3 months and were allowed to survive for more than 6 months for long-term evaluation. In this particular series of experiments, no anticoagulant/antiplatelet regimen was utilized except for a bolus dose of heparin during surgery. There was a left ventricular mural thrombi around the inflow cannula in 1 sheep. Otherwise, there was no mechanical failure nor sign of thromboembolism throughout the study.

We have been developing a new type of centrifugal pump for long-term use. The magnetically suspended centrifugal pump (MSCP) contains no shaft and seal so that long life expectancy is predicted. Paracorporeal left ventricular (LV) assist circulation between the left atrium and the descending aorta was instituted using sheep. The flow rates ranged from 2.5-5.5 L/min. The sheep that lived the longest (46 days) died of an embolism as a result of the thrombus in the pump. No thrombus formation was observed in other pumps. Plasma free hemoglobin levels ranged from 9 to 18 mg/dl, which led to the conclusion that the hemolysis level remained within an acceptable range. Two driving modes were compared. The slope of the pressure-flow relationship plot under a constant motor current mode was steeper than that under a constant rotational speed mode, and thus, the flow fluctuation decreased. In conclusion, the MSCP is durable for more than a month at the current stage of development and is a promising device for long-term ventricular assist.

Indirect measurement of the flow rate of a centrifugal blood pump using the driving motor current was studied. The pump flow rate can be expressed as a function of the motor current under a given motor speed in the absence of energy loss resulting from uncertain mechanical contact friction. The magnetically suspended centrifugal blood pump (MSCP), developed by the collaboration of Kyoto University and NTN Inc., was suitable for the application of this measuring method because the impeller is suspended magnetically inside the pump housing without any mechanical contact. The effect of fluid viscosity on the pump performance was investigated in detail, and it was possible to estimate the pump flow rate and the pressure difference through the pump (from inlet port to outlet port) accurately by monitoring the motor current and speed when the kinematic viscosity of working fluids was known. The kinematic viscosity of working fluids can also be measured with the MSCP. The motor current and motor speed were monitored in a chronic animal experiment, and the estimated flow rate and pressure difference showed good correlation with directly measured data.

This study proposes a method of predicting hemolysis induced by turbulent shear stress (Reynolds stress) in a simplified orifice pipe flow. In developing centrifugal blood pumps, there has been a serious problem with hemolysis at the impeller or casing edge; because of flow separation and turbulence in these regions. In the present study, hemolysis caused by turbulent shear stress must occur at high shear stress levels in regions near the edge of an orifice pipe flow. We have computed turbulent shear flow using the low-Reynolds number k-epsilon model. We found that the computed turbulent shear stress near the edge was several hundreds times that of the laminar shear stress (molecular shear stress). The peak turbulent shear stress is much greater than that obtained in conventional hemolysis testing using a viscometer apparatus. Thus, these high turbulent shear stresses should not be ignored in estimating hemolysis in this blood flow. Using an integrated power by shear force, it is optimal to determine the threshold of the turbulent shear stress by comparing computed stress levels with those of hemolysis experiments or pipe orifice blood flow.

To overcome problems derived from the shaft within the conventional centrifugal pump, we have been developing a new centrifugal pump, namely a magnetically suspended centrifugal pump (MSCP), which has no shaft and operates as a noncontacting and bearingless pump. The impeller is suspended magnetically between the magnetic bearing and the driving motor. Hemolysis tests were performed in comparison with the Biopump (BP80, BioMedicus). The index of hemolysis (IH) was significantly lower in the MSCP than in the Biopump. In addition, a smaller gap in the MSCP induced lower hemolysis. In preliminary studies using mongrel dogs, the layer of thrombus adherent to the impeller was observed in a few hours, which impaired the pumping efficiency. However, by using an impeller coated with silicone, no aggregations of platelets or fibrin on the impeller were observed in 24 h of continuous pumping. In conclusion, the MSCP had a gentler influence on blood cells than the Biopump, and the impeller coated with silicone may contribute to the long-term pumping of the MSCP.

We have been developing a centrifugal blood pump with a magnetically suspended impeller. To improve pump efficiency, we investigated the pump performances of many kinds of impeller vanes and diffusers, as well as the flow in the gap between the impeller discs and the pump housing. We found the vanes and the diffusers with high pump efficiency; however, high efficiency does not mean low hemolysis. It seems important to prevent generation of small-sized eddies with high shear stress. Hemolysis tests are carried out to find the optimal vane profile and gap clearance. The index of hemolysis and temperature change of our pump is better than those of the Biopump. Short-term in vivo studies show that the layer of white thrombi adheres to the machined rough surface of polycarbonate, which composes the narrow gap (0.2 mm) between the impeller and the pump wall, but a smooth surface coated with silicon prevents adhesion of that layer.

A centrifugal blood pump with a magnetically suspended impeller has been developed. It has a single inlet and outlet, and it generates centrifugal forces by the rotating impeller. The fluid-dynamical design for inflow and outflow through the impeller leads to elimination of the axial force and unbalanced radial force acting on the impeller. Consequently, three-component control systems, instead of five-component ones, are enough to position the impeller. The magnetically suspended impeller rotates by the magnetic coupling with the permanent magnets embedded in the outer rotator of the motor. This pump has enough performance to function as a blood pump. Further research on the null-power magnetic suspension and the generation of an efficient rotating magnetic field is in progress.