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

描述(由申请人提供)：开发一种婴儿VAD系统，用于长期的单、双室支持项目摘要该项目的目标是开发一种用于支持患有严重心力衰竭的婴儿的VAS系统。VAS由一个婴儿大小的脑室辅助装置(VAD)和一个便携式BiVAD驱动器组成，VAD可用于支持左、右室，或两个室(双室支持)，便携式BiVAD驱动器可为左右VAD供电。虽然VADs已经成功地用于成人心力衰竭患者超过30年，但它们对儿科的介绍进展缓慢。气动脉动VAD非常适合儿科应用，尤其适用于婴儿。它可用于右、左或双心室的支持。宾夕法尼亚州立大学和Minnetronix公司开发了一种脉动气囊式儿科心脏辅助系统，该系统基于成人大小的皮尔斯-多纳奇(Thoratec(R))VAD的设计。婴儿VAD的动态每搏量为14毫升，能够支持循环长达一年。这项工作将这一开发扩展到便携式气动驱动器和控制系统，该系统将完成婴儿VAS的开发，为临床前测试做准备。该驱动器将结合创新功能，自动优化泵操作，以在所有预负荷条件下实现最大流量，并将血栓栓子风险降至最低，包括在断奶期间。将特别强调不熟悉VAD系统的儿科心脏中心的可用性。 公共卫生相关性：儿科心脏辅助装置(VAD)将为患有心力衰竭或先天性心脏病的婴儿提供目前无法提供的安全、长期的支持。由于它将能够在更长的时间内安全地替换心脏两个泵室的功能，该系统将提供一种有价值的新护理选择。

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. PUBLIC HEALTH RELEVANCE: The pediatric Ventricular Assist Device (VAD) will provide a currently-unavailable option for safe, long term support for infants with failing hearts or congenital heart defects. Because it will be able to safely replace the function of both pumping chambers of the heart for extended periods of time, this system will provide a valuable new care option.