Schaldach M
Zentralinstitut für Biomedizinische Technik der Universität Erlangen-Nürnberg, FRG.
Med Prog Technol. 1987;13(2):85-102.
Examples of electrical heart stimulation techniques are presented to illustrate for the physician and biomedical engineer the technical feasibility of realizing many therapeutic concepts by means of microelectronics. Because of the life-supporting applications, extremely high system reliabilty must be guaranteed. The usual methods of enhancing safety by providing redundancy cannot be used, and the service life requirements can be met only by appropriate adaptation of the current consumption due to the limited battery capacity. Based on the practical experience gained in the manufacture of more than 100,000 implantable devices, it can be reported that by rigid application of, and adherence to, quality assurance measures reliability values can be achieved of lambda = 10(-7)h-1 at a confidence level of 90% for the hybrid components and of lambda = 10(-9)h-1 for integrated circuits and passive components. The requirement for technical reliability of the implantable device for patient safety requires a thorough understanding of all technical and medical details of the therapeutic device. The success of future developments (e.g. the automatically-controlled systems which are meant to substitute for the multiprogrammable pacemakers) will not only require utilization of currently available technologies but also will depend to a great extent on active participation of the physicians in the development process itself.
本文介绍了心脏电刺激技术的实例，旨在向医生和生物医学工程师说明通过微电子技术实现多种治疗理念的技术可行性。由于这些技术应用于维持生命，因此必须确保极高的系统可靠性。常规的通过提供冗余来提高安全性的方法无法使用，而且由于电池容量有限，只有通过适当调整电流消耗才能满足使用寿命要求。根据在制造超过10万件可植入设备过程中获得的实践经验，可以报告的是，通过严格应用和遵守质量保证措施，对于混合组件，在90%的置信水平下可实现的可靠性值为λ = 10^(-7)h^(-1)，对于集成电路和无源组件，可实现的可靠性值为λ = 10^(-9)h^(-1)。为了患者安全，可植入设备对技术可靠性的要求需要全面了解治疗设备的所有技术和医学细节。未来发展的成功（例如旨在替代多程控起搏器的自动控制系统）不仅需要利用当前可用的技术，而且在很大程度上还将取决于医生积极参与开发过程本身。
