Using the Virtual Heart Model to Validate the Mode-Switch Pacemaker Operation

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Real-Time and Embedded Systems Lab (mLAB)
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implantable medical devices
cardiac pacemakers
heart model
formal methods
timed automata
Biomedical Engineering and Bioengineering
Electrical and Computer Engineering
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Artificial pacemakers are one of the most widely-used implantable devices today, with millions implanted worldwide. The main purpose of an artificial pacemaker is to treat bradycardia, or slow heart beats, by pacing the atrium and ventricles at a faster rate. While the basic functionality of the device is fairly simple, there are many documented cases of death and injury due to device malfunctions. The frequency of malfunctions due to firmware problems will only increase as the pacemaker operations become more complex in an attempt to expand the use of the device. One reason these malfunctions arise is that there is currently no methodology for formal validation and verification of medical device software, as there are in the safety-critical domains of avionics and industrial control automation. We have developed a timed-automata based Virtual Heart Model (VHM) to act as platform for medical device software validation and verification. Through a case study involving multiple arrhythmias, this investigation shows how the VHM can be used with closed-loop operation of a pacemaker to validate the necessity and functionality of the complex mode-switch pacemaker operation. We demonstrate the correct pacemaker operation, to switch from one rhythm management mode to another, in patients with supraventricular tachycardias.

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2010-08-31
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Real-Time and Embedded Systems Lab (mLAB)
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2023-05-17T06:39:03.000
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Jiang, Z., Connolly, A., & Mangharam, R. (2010). Using the virtual heart model to validate the mode-switch pacemaker operation. 32nd Intl. Conf. IEEE Engineering in Medicine and Biology Society, 6690-3. doi: 10.1109/IEMBS.2010.5626262 © 2010 IEEE. Personal use of this material is permitted. Permission from IEEE must be obtained for all other uses, in any current or future media, including reprinting/republishing this material for advertising or promotional purposes, creating new collective works, for resale or redistribution to servers or lists, or reuse of any copyrighted component of this work in other works.
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