Connolly, Allison
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Publication Real-time Heart Model for Implantable Cardiac Device Validation and Verification(2010-01-20) Jiang, Zhihao; Pajic, Miroslav; Connolly, Allison T; Dixit, Sanjay; Mangharam, RahulDesigning bug-free medical device software is dif- ficult, especially in complex implantable devices that may be used in unanticipated contexts. Safety recalls of pacemakers and implantable cardioverter defibrillators due to firmware problems between 1990 and 2000 affected over 200,000 devices, comprising 41% of the devices recalled and are increasing in frequency. 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 electrophysiological 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 also 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.Publication Real-time Heart Model for Implantable Cardiac Device Validation and Verification(2010-03-26) Jiang, Zhihao; Pajic, Miroslav; Connolly, Allison T; Dixit, Sanjay; Mangharam, RahulDesigning bug-free medical device software is difficult, especially in complex implantable devices that may be used in unanticipated contexts. Safety recalls of pacemakers and implantable cardioverter defibrillators due to firmware problems between 1990 and 2000 affected over 200,000 devices, comprising 41% of the devices recalled and are increasing in frequency. 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 electrophysiological 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 also 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.Publication Using the Virtual Heart Model to Validate the Mode-Switch Pacemaker Operation(2010-08-31) Jiang, Zhihao; Connolly, Allison; Mangharam, RahulArtificial 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.