Progress on the Design and Development of the Continuous‐Flow Total Artificial Heart

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Abstract
Cleveland Clinic's continuous-flow total artificial heart has one motor and one rotating assembly supported by a hydrodynamic bearing. The right hydraulic output is self regulated by passive axial movement of the rotating assembly to balance itself with the left output. The purpose of this article is to present progress in four areas of development: the automatic speed control system, self-regulation to balance right/left inlet pressures and flows, hemolysis testing using calf blood, and coupled electromagnetics (EMAG) and computational fluid dynamics (CFD) analysis. The relationships between functions of motor power and speed, systemic flow, and systemic vascular resistance (SVR) were used for the sensorless speed control algorithm and demonstrated close correlations. Based on those empirical relationships, systemic flow and SVR were calculated in the system module and showed good correlation with measured pump flow and SVR. The automatic system adjusted the pump's speed to obtain the target flow in response to the calculated SVR. Atrial pressure difference (left minus right atrial pressure) was maintained within ±10 mm Hg for a wide range of SVR/pulmonary vascular resistance ratios, demonstrating a wide margin of self-regulation under fixed-speed mode and 25% sinusoidally modulated speed mode. Hemolysis test results indicated acceptable values (normalized index of hemolysis <0.01 mg/dL). The coupled EMAG/CFD model was validated for use in further device development.