PRESSURE SENSOR CONTROL OF VENTRICULAR ASSIST DEVICES

充血性心力衰竭(CHF)导致超过50万人 美国每年的住院人数和这类患者的预后 一直都很惨淡。心脏移植一直被视为唯一的 终末期充血性心力衰竭的积极治疗及心脏辅助装置 在移植之前，VaD仅被视为一种桥接方法。 然而，最近的研究表明，如果有足够的长期 减少脑室工作负荷，这些患者中约有三分之一 可以得到足够的改善，以允许断奶时不依赖机械支持。 为了回应这样令人鼓舞的发现，微型VAD和道达尔 人工心脏(TAH)的开发已经或正在被设计为 心脏移植的长期替代方案。这是一个这样的例子 开发是DeBakey VAD。这个装置是一个微型的，完全 植入型VAD旨在满足正常心输出量要求 能源消耗率低。然而，适合VAD的开发 控制器已经成为一个严重的问题。缺乏适当的VAD 控制器是目前临床应用的主要障碍。 对于这样的设备。 进口和出口压力的知识对于控制 这样的VAD。不幸的是，虽然国家的内在特征- 最先进的压力传感器芯片符合VAD控制器要求，这些 在血液环境中还没有达到长期的要求。 要克服的障碍是1)设备要有足够的绝缘 恶劣环境，以及2)提供一定程度的生物兼容性， 既确保患者保护，又确保设备可靠运行。目标是 这项第一阶段研究的目的是确定发展的可行性和 传感器表面处理的制备，使用现代等离子体辅助- 化学气相沉积(PA-CVD)技术，它将提供 所需的生物兼容性和设备绝缘水平。 建议的商业应用： 估计每年人工心脏和心脏的总需求量 辅助设备的范围从最低的17,000人到最高的240,000人 每年仅在美国就有患者。1991年，只有2075个这样的 患者可以通过心脏提供长期的解决方案 移植。对完全人工心脏的需求如此之高 心脏辅助装置在美国，有很大的市场 机会。预计连续流设备将具有 比脉动设备更大的市场份额，因为它们简单， 可靠性更高，成本更低。

Congestive heart failure (CHF) is responsible for over one half million hospitalizations per year in the U.S. and the prognosis for such patients has been bleak. Cardiac transplantation has been seen as the only positive therapy for end stage CHF, and the ventricular assist device (VAD) has been viewed only as a bridging method until transplantation. However, recent studies have demonstrated that with adequate long-term reduction of the ventricular work load, about one third of these patients can be improved sufficiently to permit weaning from mechanical support. Responding to such encouraging findings, miniature VAD and total artificial heart (TAH) developments have been or are being designed as long term alternatives to heart transplants. An example of such a development is the DeBakey VAD. The device is a miniature, totally implantable VAD designed to meet normal cardiac output requirements at a low energy consumption rate. However, the development of a suitable VAD controller has become a serious problem. Lack of an adequate VAD controller is now the major obstacle in the way of clinical application for such devices. Knowledge of inlet and outlet pressures is critical for the control of such VADs. Unfortunately, while the intrinsic characteristics of state- of-the art pressure sensor chips meet VAD controller requirements, these requirements have not yet been met long term in a blood environment. Obstacles to overcome are 1) adequate insulation of the device from hostile environments, and 2) providing a level of biocompatibility which assures both patient protection and reliable device operation. The goal of this Phase I study is to establish feasibility for the development and preparation of sensor surface treatments, using modern plasma assisted- chemical vapor deposition (PA-CVD) technology, which will provide the needed levels of biocompatibility and device insulation. PROPOSED COMMERCIAL APPLICATIONS: Estimates of the annual need for total artificial hearts and ventricular assist devices range from a low of 17,000 patients to a high of 240,000 patients annually in the U.S. alone. In 1991, only 2,075 of these patients could be provided with a long-term solution through cardiac transplantation. With such a high need for total artificial hearts and ventricular assist devices in the U.S., there is significant market opportunity. It is anticipated that continuous flow devices will have a larger market share than pulsatile devices because of their simplicity, higher reliability, and lower cost.