Jiang, Zhihao

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2010 - 201825
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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, Rahul
    Designing 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
    Computer Aided Clinical Trials for Implantable Cardiac Devices
    (2016-08-19) Abbas, Houssam; Jiang, Zhihao; Jang, Kuk Jin; Beccani, Marco; Liang, Jackson; Dixit, Sanjay; Mangharam, Rahul
    In this effort we investigate the design and use of physiological and device models to conduct pre-clinical trials to provide early insight in the design and execution of the actual clinical trial. Computer models of physiological phenomena like cardiac electrical activity can be extremely complex. However, when the purpose of the model is to interact with a medical device, then it becomes sufficient to model the measurements that the device makes, e.g. the intra-cardiac electrograms (EGMs) that an Implantable Cardioverter Defibrillator (ICD) measures. We present a probabilistic generative model of EGMs, capable of generating exemplars of various arrhythmias. The model uses deformable shape templates, or motifs, to capture the variability in EGM shapes within one EGM channel, and a cycle length parameter to capture the variability in cycle length in one EGM channel. The relation between EGM channels, which is essential for determining whether the current arrhythmia is potentially fatal, is captured by a time-delayed Markov chain, whose states model the various combinations of (learned) motifs. The heart model is minimally parameterized and is learned from real patient data. Thus the statistics of key features reflect the statistics of a real cohort, but the model can also generate rare cases and new combinations from the inferred probabilities. On the device end, algorithms for signal sensing, detection and discrimination for major ICD manufacturers have been implemented both in simulation and on hardware platforms. The generated arrhythmia episodes are used as input to both the modeled ICD algorithms and real ICDs as part of a Computer Aided Clinical Trial (CACT). In a CACT, a computer model simulates the inputs to the device (such as a new, investigational ICD), and the device’s performance is evaluated. By incorporating these results into the appropriate statistical framework, the Computer Aided Clinical Trial results can serve as regulatory evidence when planning and executing an actual clinical trial. We demonstrate this by conducting a mock trial similar to the 2005-2010 RIGHT trial which compared the discrimination algorithms from two major ICD manufacturers. The results of the CACT clearly demonstrate that the failed outcome of the RIGHT trial could have been predicted and provides statistical support for deeper results that could have been captured prior to the trial.
  • Publication
    Technical Report: Abstraction-Tree For Closed-loop Model Checking of Medical Devices
    (2015-05-06) Jiang, Zhihao; Abbas, Houssam; Mosterman, Pieter J; Mangharam, Rahul
  • 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, Rahul
    Designing 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
    From Verification to Implementation: A Model Translation Tool and a Pacemaker Case Study
    (2012-01-01) Pajic, Miroslav; Jiang, Zhihao; Lee, Insup; Sokolsky, Oleg; Mangharam, Rahul
    Model-Driven Design (MDD) of cyber-physical systems advocates for design procedures that start with formal modeling of the real-time system, followed by the model’s verification at an early stage. The verified model must then be translated to a more detailed model for simulation-based testing and finally translated into executable code in a physical implementation. As later stages build on the same core model, it is essential that models used earlier in the pipeline are valid approximations of the more detailed models developed downstream. The focus of this effort is on the design and development of a model translation tool, UPP2SF, and how it integrates system modeling, verification, model-based WCET analysis, simulation, code generation and testing into an MDD based framework. UPP2SF facilitates automatic conversion of verified timed automata-based models (in UPPAAL) to models that may be simulated and tested (in Simulink/Stateflow). We describe the design rules to ensure the conversion is correct, efficient and applicable to a large class of models. We show how the tool enables MDD of an implantable cardiac pacemaker. We demonstrate that UPP2SF preserves behaviors of the pacemaker model from UPPAAL to Stateflow. The resultant Stateflow chart is automatically converted into C and tested on a hardware platform for a set of requirements.
  • Publication
    Real-time Heart Model for Implantable Cardiac Device Validation and Verification
    (2010-07-06) Jiang, Zhihao; Pajic, Miroslav; Connolly, Allison; Dixit, Sanjay; Mangharam, Rahul
    Designing bug-free medical device software is challenging, 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. This encompasses 41% of the devices recalled and continues to increase 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 construct a timed-automata model by extracting timing properties of the heart. The platform employs 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. This integrated functional and formal device design approach has potential to help expedite medical device certification for safe operation.
  • Publication
    Cyber-Physical Modeling of Implantable Cardiac Medical Devices
    (2011-12-29) Jiang, Zhihao; Pajic, Miroslav; Mangharam, Rahul
    The design of bug-free and safe medical device software is challenging, especially in complex implantable devices that control and actuate organs in unanticipated contexts. 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 and their effect continues 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. To this effect, a real-time Virtual Heart Model (VHM) has been developed to model the electrophysiological operation of the functioning and malfunctioning (i.e., during arrhythmia) heart. By extracting the timing properties of the heart and pacemaker device, we present a methodology to construct a timed-automata model for functional and formal testing and verification of the closed-loop system. The VHM's capability of generating clinically-relevant response has been validated for a variety of common arrhythmias. Based on a set of requirements, we describe a closed-loop testing environment that allows for interactive and physiologically relevant model-based test generation for basic pacemaker device operations such as maintaining the heart rate, atrial-ventricle synchrony and complex conditions such as pacemaker-mediated tachycardia. This system is a step toward a testing and verification approach for medical cyber-physical systems with the patient-in-the-loop.
  • Publication
    A Framework for Validation of Implantable Medical Devices
    (2010-04-01) Pajic, Miroslav; Jiang, Zhihao; Mangharam, Rahul; Connolly, Allison
    Designing bug-free medical device software is difficult, especially in complex implantable devices used for rhythm management of the cardiac or the neurological system. There is currently no formal methodology or open experimental platform to validate the correct operation of implantable medical device software. We describe our recent work on heart modeling for the validation and verification of artificial cardiac pacemakers. As we extend this platform to more complex devices such as cardioverter-defibrillators, there are several significant challenges in the modeling of biological systems and their patient-specific response to external stimulus. Our goal over the longer term is to explore the methodologies for experimental evaluation, modeling for validation and verification of implantable devices within the context of the underlying biological system. We present our early and promising results for simplified models and propose steps toward an integrated platform for validation of medical device systems.
  • Publication
    Using the Virtual Heart Model to Validate the Mode-Switch Pacemaker Operation
    (2010-08-31) Jiang, Zhihao; Mangharam, Rahul; Connolly, Allison
    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.
  • Publication
    Modeling Cardiac Pacemaker Malfunctions With the Virtual Heart Model
    (2011-06-20) Jiang, Zhihao; Mangharam, Rahul
    Implantable cardiac devices such as artificial pacemakers deliver therapies according to the timing information from the heart. Such devices work under the assumptions of perfect sensing, which are: (a) the pacemaker leads remain in place, and (b) the pacing therapy in one chamber (e.g. atrium) is insulated from the other chambers (e.g. ventricles). But there are common cases which violate these assumptions and the mechanisms for imperfect sensing cannot be captured by a simple signal generator. In this paper we use the Penn Virtual Heart Model (VHM) to investigate the spatial and temporal aspects of the electrical conduction system of the heart in a closed-loop with a pacemaker model. We utilize the spatial properties of the heart to model the sensing mechanism, and use clinical cases to show the validity of our sensing model. Such closed-loop evaluation of the pacemaker operation allows for functional testing of pacemaker software, the development of new algorithms for rhythm therapy and also serves as a tool for incoming cardiac electrophysiology fellows.