CAREER: Medical Cyber-Physical Systems

该项目从设备和器官的经验证的闭环模型(S)开发经验证的医疗设备软件和系统的建模、综合和开发的基础。这项努力既包括心脏起搏器等植入式医疗设备，也包括具有多个联网医疗系统的药物输注泵等生理控制系统。在这两种情况下，设备都与身体物理连接，并对回路中患者的生理和安全施加直接控制。其目标是确保该设备在提供有效治疗的同时，永远不会将患者推入不安全的状态。的贡献体现在三个方面：闭环患者设备建模；针对优化的患者特定设备的定量验证；生命关键系统的平台。开发了集成建模方法，以产生用于医疗设备的临床相关测试的功能生理信号，并且还产生用于正式验证的设备-患者交互的正式时序。从医疗设备软件的安全性和正确性验证问题入手，利用基于生理数据的概率患者模型，开发定量验证技术，以保证治疗对患者的S疗效和设备的操作效率。为了促进CPS社区、食品和药物管理局(FDA)、医生和制造商的参与，开发了设备/患者模型的开源库、用于验证和模型转换的软件工具以及用于使用真实医疗设备进行测试的硬件平台。这里开发的医疗器械软件和患者的闭环设计和验证技术，对人类健康、医疗质量和医疗成本具有直接的潜在好处。设计无缺陷和安全的医疗设备软件是具有挑战性的，特别是在控制和驱动器官反应的复杂可植入设备中，这些设备的反应尚不完全清楚。安全召回起搏器和植入型心脏复律？1990至2000年间，除颤器影响了60多万台设备。其中，200,000人(41%)是由于固件问题(即软件问题)，而固件问题的频率不断增加。目前还没有正式的方法学或开放的实验平台来测试和验证医疗器械软件在患者闭环范围内的正确操作。如果成功，该项目不仅有可能提高此类设备的安全性，而且还有可能加快开发和认证过程。后者可以降低成本，缩短新设备的上市时间。该项目还包括广泛的教育和推广部分，包括医疗网络物理系统的课程开发，本科生和研究生参与研究，以及与医院、医疗器械制造商和FDA合作。该项目的交叉性质将涉及临床医生、电气工程师、计算机科学家和医疗安全监管机构的社区聚集在一起。

This project develops the foundations of modeling, synthesis and development of verified medical device software and systems, from verified closed-loop models of the device and organ(s). The effort spans both implantable medical devices such as cardiac pacemakers and physiological control systems such as drug infusion pumps that have multiple networked medical systems. In both cases, the devices are physically connected to the body and exert direct control over the physiology and safety of the patient-in-the-loop. The goal is to ensure the device will never drive the patient into an unsafe state, while providing effective therapy. The contributions of are in three areas: closed-loop patient-device modeling; quantitative verification for optimized patient-specific devices; platforms for life-critical systems. Integrated modeling methodologies are developed to produce both the functional physiological signals, for clinically relevant testing with a medical device, and also generate the formal timing of device-patient interaction for formal verification. Starting with the problem of verifying the safety and correctness of medical device software, probabilistic patient models based on physiological data are then used to develop quantitative verification techniques to maintain the therapy?s efficacy on the patient and operational efficiency of the device. To facilitate participation of the CPS community, the Food and Drug Administration (FDA), physicians and manufacturers, open source libraries of device/patient models, software tools for verification and model translation and hardware platforms for testing with real medical devices are developed. The closed-loop design and verification techniques for medical device software and patients, developed here, have direct potential benefits on human health, and the quality and cost of medical care. Design of bug-free and safe medical device software is challenging, especially in complex implantable devices that control and actuate organs who's response is not fully understood. Safety recalls of pacemakers and implantable ?cardioverter? defibrillators between 1990 and 2000 affected over 600,000 devices. Of these, 200,000 or 41%, were due to firmware issues (i.e. software) that continue to increase in frequency. There is currently no formal methodology or open experimental platform to test and verify the correct operation of medical device software within the closed-loop context of the patient. If successful, this project has potential to not only increase the safety of such devices, but also to accelerate the development and certification process. The latter could reduce costs, and shorten the time to market for new devices. The project also has an extensive education and outreach component, including curriculum development in medical cyber-physical systems, involvement of undergraduate and graduate students in research, and cooperation with hospitals, makers of medical devices, and the FDA. The cross-cutting nature of the project brings together communities involving clinical physicians, electrical engineers, computer scientists and regulators of health care safety.