TUBLULAR PEDIATRIC VENTRICULAR ASSIST DEVICE

使用专用的搏动性心室支持装置(VAD)治疗 循环系统支持正在成为成年人接受的治疗方式 因心脏切开术后泵故障或术后需要支持的患者 AMI心源性休克，并作为移植的桥梁。虽然是暂时的 在儿科患者中使用ECMO进行循环支持 或离心泵，还没有开发出专门的脉冲式VAD 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。该设备是管状的 具有整体成型的进水阀、泵室和 流出阀。进水阀和泵是气动驱动的。 流出阀是被动操作的。设计冲程为 10cc，适用于体重在10公斤以下的新生儿和婴儿。该设备 被设计成具有最小的表面积，并且尺寸小到 最大限度地减少血液稀释、热量损失和出血并发症。 I期体外试验证实了良好的充填特性 在活体研究中验证了血流动力学功能 以及设备的血液学兼容性。第二阶段计划 将专注于完成具有闭合回路的便携式控制台 对灌装压力敏感的控制。体外可靠性试验 并将进行体内研究，以获得7天的预期 使用。将进行更多的体内特征研究，以 单心和双心支持。 建议的商业应用： 建议的设备在大约20,000名儿童心脏手术中 每年在美国执行的案件。最初的申请将 在心脏切开术后需要支持的情况下 先天性心脏病或先天性心脏病患者的矫治 继发性心肌炎和/或心肺损害 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.