Kovacs S G, Reynolds D G, McKeown P P, Augereau P G, Wasselle J A, Ondrovic L E, Aiba M
Department of Surgery, College of Medicine, University of Florida, Tampa.
ASAIO J. 1992 Jan-Mar;38(1):38-46. doi: 10.1097/00002480-199201000-00010.
Over the past 6 years, research has led to development of a small, lightweight, power-efficient, uniquely simple ventricular assist device driven by a magnetic actuator. Magnetic actuation permits total elimination of all mechanical motion converter components used for pusher plate displacement, resulting in a significant reduction in complexity and resultant increase in reliability. Extensive in vitro mock loop development has resulted in a left ventricular assist device (LVAD), the primary design parameters of which for the clinical prototype actuator and pump are 1) an actuator weight of 312 g, 2) actuator size of 32.5 cm3, 3) power requirements of 7.8 to 11.4 watts (60-100 beats per minute [BPM]), and 4) system efficiency of 24% to 34% and average dynamic stroke volume of 65 ml. Initial in vivo tests assessed this LVAD's performance in four sheep under three acute conditions of ventricular dysfunction. The results demonstrate that, at a pump-rate of 100 BPM, mean aortic pressure increased by 45-50 mmHg during 1) beta blockade, 2) coronary ligation, and 3) ventricular fibrillation. Pump flow ranged from 2.71 L/min to a maximum of 4.6 L/min. Acute test periods were arbitrarily set for 6 hours duration. Of the four sheep, two survived, one lived 5 hours, and the fourth lived 4.5 hours. Global fibrillation was the primary cause of failure. This initial in vivo data demonstrates the pump's ability to maintain satisfactory hemodynamic parameters of flow and pressure under three acute conditions of extreme left ventricular dysfunction in an animal model. These initial LVAD performances were encouraging. Further tests will use calves with a greatly expanded performance evaluation protocol.
在过去6年中,研究促使开发出一种由磁致动器驱动的小型、轻便、节能且极其简单的心室辅助装置。磁致动可完全消除用于推板位移的所有机械运动转换部件,从而显著降低复杂性并提高可靠性。广泛的体外模拟循环开发已产生一种左心室辅助装置(LVAD),其临床原型致动器和泵的主要设计参数为:1)致动器重312克,2)致动器体积32.5立方厘米,3)功率需求7.8至11.4瓦(每分钟60 - 100次心跳[BPM]),以及4)系统效率24%至34%,平均动态搏出量65毫升。最初的体内测试评估了该LVAD在三只患有急性心室功能障碍的绵羊中的性能。结果表明,在泵速为100 BPM时,在1)β受体阻滞剂、2)冠状动脉结扎和3)心室颤动期间,平均主动脉压升高了45 - 50 mmHg。泵流量范围为2.71升/分钟至最大4.6升/分钟。急性测试期任意设定为6小时。四只绵羊中,两只存活,一只存活5小时,第四只存活4.5小时。整体颤动是失败的主要原因。这些初步的体内数据表明该泵在动物模型的三种极端左心室功能障碍急性情况下能够维持令人满意的血流动力学参数,即流量和压力。这些LVAD的初步性能令人鼓舞。进一步的测试将使用小牛,并采用大幅扩展的性能评估方案。