TUBULAR PEDIATRIC VENTRICULAR ASSIST DEVICE

专用搏动性心室支持装置（VAD）用于 循环支持正在成为一种可接受的治疗方式， 由于心切开术后泵故障而需要支持的成人患者 或AMI后心源性休克，并作为移植的桥梁。 虽然 在儿科患者中进行临时循环支持， 使用ECMO或离心泵，没有专门的脉动式VAD 为儿科应用而开发。 拟议的儿科VAD解决了这一需求，目标是 开发一种廉价的脉动装置。 该装置是管状的， 具有一体形成的流入阀、泵室和 流出阀 阀门和泵的驱动是同步的。 的 设计的每搏输出量低于10 cc，适用于新生儿和婴儿 重达10公斤。 该器械设计为具有最小表面 面积小，可最大限度地减少血液稀释、热量损失和 出血并发症 I期研究将侧重于体外和体内 器械的体内表征。 第二阶段的研究将侧重于 系统开发导致易于使用的设备， 灌注师或重症监护医师的持续关注。

The use of dedicated pulsatile ventricular support devices (VAD) for circulatory support is becoming an accepted treatment modality for adult patients requiring support due to post-cardiotomy pump failure or post-AMI cardiogenic shock, and as bridge to transplant. Although temporary circulatory support in pediatric patients is being performed with ECMO or centrifugal pumps, no dedicated pulsatile VAD have been developed for pediatric application. The proposed pediatric VAD addresses this need with the goal of developing an inexpensive pulsatile device. The device is tubular in construction with integrally formed inflow valve, pump chamber, and outflow valve. The valves and pumps are actuated pneumatically. The designed stroke volume is under 10cc suitable for neonates and infants weighing up to 10kg. The device is designed to have minimal surface area and is small in size to minimize hemodilution, heat loss and bleeding complications. Phase I study will focus on in vitro and in vivo characterization of the device. The Phase II study will focus on system development leading to an easy to use device with no need for continuous attention by a perfusionist or an intensivist.