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Demo Abstract: A Platform for Implantable Medical Device Validation

机译：演示摘要：用于植入式医疗设备验证的平台

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摘要

Designing bug-free medical device software is difficult, especially in complex implantable devices that may be used in unanticipated contexts. In the 20-year period from 1985 to 2005, the US Food and Drug Administration's (FDA) Maude database records almost 30,000 deaths and almost 600,000 injuries from device failures [8]. There is currently no formal methodology or open experimental platform to validate and verify the correct operation of medical device software. To this effect, a real-time Virtual Heart Model (VHM) has been developed to model the electrophysiolog-ical operation of the functioning (i.e. during normal sinus rhythm) and malfunctioning (i.e. during arrhythmia) heart. We present a methodology to extract timing properties of the heart to construct a timed-automata model. The platform exposes functional and formal interfaces for validation and verification of implantable cardiac devices. We demonstrate the VHM is capable of generating clinically-relevant response to intrinsic (i.e. premature stimuli) and external (i.e. artificial pacemaker) signals for a variety of common arrhythmias. By connecting the VHM with a pacemaker model, we are able to pace and synchronize the heart during the onset of irregular heart rhythms. The VHM has been implemented on a hardware platform for closed-loop experimentation with existing and virtual medical devices. The VHM allows for exploratory electrophysiology studies for physicians to evaluate their diagnosis and determine the appropriate device therapy. This integrated functional and formal device design approach will potentially help expedite medical device certification for safer operation.
机译：设计无错误的医疗设备软件非常困难，尤其是在可能用于意外情况的复杂可植入设备中。在1985年至2005年的20年中，美国食品药品监督管理局（FDA）的Maude数据库记录了因设备故障而导致的近30,000人死亡和近600,000人受伤[8]。当前尚没有正式的方法论或开放的实验平台来验证和验证医疗设备软件的正确操作。为此，已经开发了实时虚拟心脏模型（VHM）以对功能性心脏（即正常窦性心律期间）和功能障碍（即心律失常期间）的电生理操作进行建模。我们提出了一种方法来提取心脏的定时特性以构建定时自动机模型。该平台展示了用于植入式心脏设备的验证和验证的功能和形式接口。我们证明了VHM能够针对各种常见的心律不齐产生内在的（即过早的刺激）和外部的（即人工起搏器）信号产生与临床相关的反应。通过将VHM与起搏器模型连接，我们可以在心律不规则发作期间对心脏进行起搏和同步。 VHM已在硬件平台上实现，用于使用现有和虚拟医疗设备进行闭环实验。 VHM允许医生进行探索性电生理研究，以评估他们的诊断并确定适当的设备疗法。这种集成的功能和正式设备设计方法将有可能帮助加快医疗设备认证，以实现更安全的操作。

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