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 患者的身体为Jarvik-7血泵提供动力在第一阶段得到证实 努力。这项第二阶段工作的目标是继续 驱动系统的小型化，并改进和展示 通过体内动物试验来驱动系统的能力。然后是同相 III、微型化将完成，临床前人类试验 将对患者进行检查，并将在#年进一步改进系统 为其商业化做准备。 在第二阶段，驱动系统将得到改进，以实现更大的尺寸、更轻的重量、 功耗、电池性能和控制。六项体内试验 将使用小牛进行，其中Jarvik-7血泵将是 植入动物体内，并将由改进后的微型模型提供动力 外置液压驱动系统。 动物实验将在迈阿密山谷医院生物科学中心进行 中心。代顿心血管-胸部外科协会公司将 为动物试验提供外科专业知识。外科医生和内科医生 将协助规划、实施、分析和 对体内试验的报告。这项第二阶段的工作将进行 在Symbion Inc.和人造器官部门的协助下 犹他州大学的。

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.