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带有磁悬浮转子的Heartmate III离心式左心室辅助系统的设计特点、发展状况及实验结果。

Design features, developmental status, and experimental results with the Heartmate III centrifugal left ventricular assist system with a magnetically levitated rotor.

作者信息

Farrar David J, Bourque Kevin, Dague Charles P, Cotter Christopher J, Poirier Victor L

机构信息

Thoratec Corporation, Pleasanton, California 94588, USA.

出版信息

ASAIO J. 2007 May-Jun;53(3):310-5. doi: 10.1097/MAT.0b013e3180536694.

Abstract

A long-term left ventricular assist system for permanent use in advanced heart failure is being developed on the basis of a compact centrifugal pump with a magnetically levitated rotor and single-fault-tolerant electronics. Key features include its "bearingless" (magnetic levitation) design, textured surfaces similar to the HeartMate XVE left ventricular assist device (LVAD) to reduce anticoagulation requirements and thromboembolism, a sensorless flow estimator, and an induced pulse mode for achieving an increased level of pulsatility with continuous flow assistance. In vitro design verification testing is underway. Preclinical testing has been performed in calves demonstrating good in vivo performance at an average flow rate of 6 L/min (maximum: >11 L/min) and normal end-organ function and host response. Induced pulse mode demonstrated the ability to produce a physiological pulse pressure in vivo. Thirteen LVADs have achieved between 16 to 40 months of long-term in vitro reliability testing and will be continued until failure. Both percutaneous and fully implanted systems are in development, with a modular connection for upgrading without replacing the LVAD.

摘要

一种用于晚期心力衰竭长期永久使用的左心室辅助系统正在基于一种带有磁悬浮转子和单故障容错电子设备的紧凑型离心泵进行开发。关键特性包括其“无轴承”(磁悬浮)设计、与HeartMate XVE左心室辅助装置(LVAD)类似的纹理表面以减少抗凝需求和血栓栓塞、无传感器流量估计器以及用于在连续血流辅助下实现更高脉动水平的诱导脉冲模式。体外设计验证测试正在进行中。在小牛身上进行了临床前测试,结果表明在平均流速为6升/分钟(最大值:>11升/分钟)时具有良好的体内性能,且终末器官功能和宿主反应正常。诱导脉冲模式证明了在体内产生生理脉压的能力。13个LVAD已完成16至40个月的长期体外可靠性测试,并将持续到出现故障。经皮和完全植入系统都在开发中,具有模块化连接以便在不更换LVAD的情况下进行升级。

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