Evaluation method and platform of vibrational disturbance test for ventricular assist devices.

Abstract

For ventricular assist devices utilizing levitation bearing technology, collision and wear of the rotor would occur if the bearing cannot resist disturbances from patient activities and vibration/shock impacts. The reliability of ventricular assist devices can be seriously affected, potentially impairing blood compatibility (e.g. thrombus generation) and threatening patient safety. In this article, we proposed a vibrational disturbance test protocol for ventricular assist devices. Two kinds of vibrational disturbances-translational and rotational-were defined and the disturbance levels determined as 6G and 10 rad/s per possible patient activity impact. A test platform was built according to the disturbance level requirements. The test platform successfully generated the required disturbance. The vibration test evaluation criteria for ventricular assist device assistance (characterized by the pressure head, flow rate, and driving current waveform) were well verified. Compared with translational vibration, rotational vibration had a greater impact on the rotor. Accurate control of high-speed rotor is difficult because of the gyroscopic effect. As conventional random vibration tests cannot cover all risk situations, it is recommended that translational and rotational disturbance tests are carried out for levitation ventricular assist devices. We recommend that researchers and manufacturers pay attention to the vibrational impact of rotor-levitated ventricular assist devices.