TUBLULAR PEDIATRIC VENTRICULAR ASSIST DEVICE

专用搏动性心室支持装置（VAD）用于 循环支持正在成为成人患者接受的治疗方式 由于心切开术后泵故障或术后 AMI心源性休克，并作为移植的桥梁。 虽然是暂时的 儿科患者的循环支持是通过ECMO进行的 或离心泵，没有专门的脉动VAD已经开发用于 儿科应用。 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 流入阀和泵同时启动。 流出阀被动操作。 设计的每搏输出量为 l0 cc适用于新生儿和体重不超过10公斤的婴儿。 设备 被设计成具有最小的表面积并且尺寸小， 尽量减少血液稀释、热量损失和出血并发症。 I期体外研究证明了良好的填充特性 而体内研究证实了血液动力学功能 以及该装置的血液相容性。第二阶段计划 将专注于完成一个便携式控制台与闭环 控制对灌装压力敏感。 体外可靠性试验 并将进行体内研究，以符合7天预期 使用. 将进行额外的体内表征研究， 单心室和双心室支持。 建议的商业应用： 申报器械用于约20，000例儿科心脏手术 每年在美国进行的案例。 首次申请将 在涉及心脏切开术后支持的情况下， 先天性心脏缺陷的矫正或 继发于心肌炎的心肺功能损害和/或 心肌病

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 inflow valve and pump are actuated pneumatically. The outflow valve is passively operated. The designed stroke volume is l0cc suitable for neonates and infants weighing up to l0kg. The device is designed to have minimal surface area and is small in size to minimize hemodilution, heat loss and bleeding complications. Phase I in vitro studies demonstrated the good filling characteristics of the pump, while the in vivo studies verified the hemodynamic function and the hematologic compatibility of the device. The Phase II program will focus on the completion of a portable console with a close-loop control sensitive to filling pressures. In vitro reliability testing and in vivo studies will be conducted to qualify for a 7-day intended use. Additional in vivo characterization studies will be conducted for uni- and bi-ventricular support. PROPOSED COMMERCIAL APPLICATION: The potential application of the proposed device is in the approximately 20,000 pediatric cardiac surgery cases performed in the United States annually. Initial application will be in cases involving post-cardiotomy support subsequent to the correction of congenital heart defect or in patients with cardiopulmonary compromise secondary to myocarditis and/or cardiomyopathy.