MINIATURE EXTERNAL DRIVE FOR JARVIK-7 BLOOD PUMP

使用位于外部的微型驱动系统的可行性 在第一阶段中证明了患者的身体为Jarvik-7血泵提供动力 努力 第二阶段工作的目标是继续 小型化的驱动系统，并提高和证明 驱动系统的能力通过体内动物试验。 然后在阶段 三、将微型化完成，临床前试验用人体 将对患者进行手术，并进一步完善该系统， 为商业化做准备。 在第二阶段，驱动系统将得到改进，以获得更好的尺寸，重量， 功耗、电池性能和控制。 6项体内试验 将使用小牛进行，其中Jarvik-7血泵将 植入动物体内并由改进的微型 外部液压驱动系统。 动物试验将在迈阿密谷医院生物科学部进行 中心 代顿大血管胸外科联合公司将 为动物实验提供外科专业知识。 外科医生和内科医生 这两个组织将协助规划、执行、分析和 报告体内试验。 第二阶段的工作将在 在Symbion Inc.的帮助下，和人造器官部门 犹他州大学的教授。

The feasibility of using a miniature drive system located exterior to the patient's body to power the Jarvik-7 blood pump was proven in the Phase I effort. The objective of this Phase II effort is to continue the miniaturization of the drive system, and to improve and demonstrate the drive system's capabilities through in-vivo animal testing. Then in Phase III, the miniaturization will be completed, pre-clinical trails with human patients will be performed, and the system will be further improved in preparation for its commercialization. In Phase II, the drive system will be improved for better size, weight, power consumption, battery performance, and control. Six in-vivo tests will be performed, using calves, wherein the Jarvik-7 blood pump will be implanted in the animal and will be powered by the improved miniature external hydraulic drive system. The animal tests will be performed at the Miami Valley Hospital Biosciences Center. The Dayton Cardiovascular-Thoracic Surgery Associates, Inc. will provide surgical expertise for the animal tests. Surgeons and physicians from both organizations will assist in the planning, conduct, analysis and reporting of the in-vivo tests. This Phase II effort will be performed with the assistance of Symbion Inc. and the Department of Artificial Organs of the University of Utah.