Development of an Infant VAD System for Long Term Uni- and Bi-ventricular Support

描述（由申请人提供）：用于长期单心室和双心室支持的婴儿VAD系统的开发项目摘要该项目的目标是开发一种心室辅助系统（VAS），用于支持患有严重心力衰竭的婴儿。VAS包括一个婴儿大小的心室辅助装置（VAD），可用于支持左心室或右心室，或两个心室（双心室支持），以及一个便携式BiVAD驱动器，可为左右心室辅助装置供电。尽管VADs已经成功地用于成人心力衰竭患者超过30年，但其在儿科的应用进展缓慢。气动驱动的脉动式VAD非常适合儿科应用，特别是婴儿。它可用于右、左或双心室支持。Penn State和Minnetronix在成人尺寸的Pierce-Donachy (Thoratec(R)) VAD的设计基础上开发了一种脉动气动气囊型儿科心室辅助系统。婴儿VAD的动态中风容量为14毫升，能够支持循环长达一年。这项工作将开发扩展到便携式气动驱动器和控制系统，这将完成婴儿VAS的开发，为临床前测试做准备。该驱动器将采用创新功能，自动优化泵的运行，在所有预负荷条件下实现最大流量，并最大限度地降低血栓形成的风险，包括在脱机期间。特别强调将放在儿童心脏中心不熟悉VAD系统的可用性。

DESCRIPTION (provided by applicant): Development of an Infant VAD System for Long Term Uni- and Bi-ventricular Support Project Summary This objective of the project is to develop a Ventricular Assist System (VAS) for supporting infants with severe heart failure. The VAS consists of an Infant-sized Ventricular Assist Device (VAD) which can be used to support the left ventricle or right ventricle, or both ventricles (biventricular support), and a portable BiVAD driver which can power left and right VADs. Although VADs have been successfully used for adult heart-failure patients for over 30 years, their introduction to pediatrics has been slow to evolve. The pneumatically-actuated, pulsatile VAD is well-suited to the pediatric application, especially in infants. It may be utilized for right, left, or bi-ventricular support. Penn State and Minnetronix have developed a pulsatile pneumatic sac-type pediatric Ventricular Assist System based on the design of the adult-sized Pierce-Donachy (Thoratec(R)) VAD. The Infant VAD has a dynamic stroke volume of 14 ml, and is capable of supporting the circulation for periods up to one year. This work extends that development to a portable pneumatic driver and control system which will complete the development of the infant VAS in preparation for pre-clinical testing. The driver will incorporate innovative features to automatically optimize the pump operation to achieve maximum flow rate under all preload conditions, and minimize thrombembolic risk, including during weaning. Special emphasis will be placed on usability in pediatric heart centers unfamiliar with VAD systems.