PRESSURE SENSOR CONTROL OF VENTRICULAR ASSIST DEVICES

心室辅助装置的压力传感器控制

• 批准号: 2645516
• 负责人: Justin S Clark
• 金额: $ 9.97万
• 依托单位: MEDICAL PHYSICS, INC.
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-15 至 2000-03-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2645516
• 关键词: auxiliary heart prosthesis; biomaterial compatibility; biomedical equipment development; blood flow measurement; blood pressure; cardiac output; circulatory assist; clinical biomedical equipment; implant; monitoring device; sheep

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.

充血性心力衰竭（CHF）导致超过50万例 美国每年的住院人数和这些患者的预后 一直很惨淡心脏移植被认为是唯一 终末期CHF的积极治疗和心室辅助装置 (VAD)在移植之前，它只被视为一种过渡方法。 然而，最近的研究表明，如果有足够的长期 心室工作负荷减少，约三分之一的患者 可以充分改善以允许脱离机械支持。 针对这些令人鼓舞的发现，微型VAD和总VAD 人工心脏（TAH）的发展已经或正在被设计为 长期替代心脏移植一例这样的 开发的是DeBakey VAD。这个装置是微型的，完全 植入式VAD设计用于满足正常心输出量要求， 低能耗率。然而，开发合适的VAD 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。 了解入口和出口压力对于控制 这样的VAD。然而，尽管国家的本质特征-- 最先进的压力传感器芯片满足VAD控制器的要求，这些 在血液环境中长期使用还不能满足要求。 要克服的障碍是：1）设备与 恶劣的环境，和2）提供一定水平的生物相容性， 确保患者保护和可靠的设备操作。目标 第一阶段研究的目的是确定发展的可行性， 传感器表面处理的准备，使用现代等离子体辅助- 化学气相沉积（PA-CVD）技术，这将提供 所需的生物相容性和器械绝缘水平。 拟议的商业应用： 全人工心脏和心室的年需求量估计 辅助设备的范围从17，000名患者到240，000名患者不等 每年仅在美国就有患者。在1991年，只有2,075个 可以通过心脏给患者提供长期的解决方案， 移植对全人工心脏的需求如此之高， 心室辅助设备在美国，市场巨大 机会预计连续流装置将具有 由于其简单性， 更高的可靠性和更低的成本。