Pajic, Miroslav

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Author: Jiang, Zhihao ×

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Now showing 1 - 10 of 11
  • 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
    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
    Modeling and Verification of a Dual Chamber Implantable Pacemaker
    (2012-04-16) Jiang, Zhihao; Pajic, Miroslav; Moarref, Salar; Alur, Rajeev; Mangharam, Rahul
    The design and implementation of software for medical devices is challenging due to their rapidly increasing functionality and the tight coupling of computation, control, and communication. The safety-critical nature and the lack of existing industry standards for verification, make this an ideal domain for exploring applications of formal modeling and analysis. In this paper, we use a dual chamber implantable pacemaker as a case study for modeling and verification of control algorithms for medical devices in UPPAAL. We present detailed models of different components of the pacemaker based on the algorithm descriptions from Boston Scientific. We formalize basic safety requirements based on specifications from Boston Scientific as well as additional physiological knowledge. The most critical potential safety violation for a pacemaker is that it may lead the closed-loop system into an undesirable pattern (for example, Tachycardia). Modern pacemakers are implemented with termination algorithms to prevent such conditions. We show how to identify these conditions and check correctness of corresponding termination algorithms by augmenting the basic models with monitors for detecting undesirable patterns. Along with emerging tools for code generation from UPPAAL models, this effort enables model driven design and certification of software for medical devices.
  • Publication
    Demo Abstract: A Platform for Implantable Medical Device Validation
    (2010-10-01) Pajic, Miroslav; Jiang, Zhihao; Mangharam, Rahul; Connolly, Allison; Dixit, Sanjay
  • 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
    Model-Based Closed-Loop Testing of Implantable Pacemakers
    (2011-03-01) Jiang, Zhihao; Pajic, Miroslav; Mangharam, Rahul
    The increasing complexity of software in implantable medical devices such as cardiac pacemakers and defibrillators accounts for over 40% of device recalls. Testing remains the principal means of verification in the medical device certification regime. Traditional software test generation techniques, where the tests are generated independently of the operational environment, are not effective as the device must be tested within the context of the patient's condition and the current state of the heart. It is necessary for the testing system to observe the system state and conditionally generate the next input to advance the purpose of the test. To this effect, a set of general and patient condition-specific temporal requirements is specified for the closed-loop heart and pacemaker system. Based on these requirements, we describe a closed-loop testing environment between a timed automata-based heart model and a pacemaker. This allows for interactive and physiologically relevant model-based test generation for basic pacemaker device operations such as maintaining the heart rate and atrial-ventricle synchrony. We also demonstrate the flexibility and efficacy of the testing environment for more complex common timing anomalies such as reentry circuits, pacemaker mode switch operation and pacemaker-mediated tachycardia. This system is a step toward a testing approach for medical cyber-physical systems with the patient-in-the-loop.
  • Publication
    Safety-Critical Medical Device Development Using the UPP2SF Model
    (2014-01-01) Pajic, Miroslav; Jiang, Zhihao; Lee, Insup; Sokolsky, Oleg; Mangharam, Rahul
    Software-based control of life-critical embedded systems has become increasingly complex, and to a large extent has come to determine the safety of the human being. For example, implantable cardiac pacemakers have over 80,000 lines of code which are responsible for maintaining the heart within safe operating limits. As firmware-related recalls accounted for over 41% of the 600,000 devices recalled in the last decade, there is a need for rigorous model-driven design tools to generate verified code from verified software models. To this effect we have developed the UPP2SF model-translation tool, which facilitates automatic conversion of verified models (in UPPAAL) to models that may be simulated and tested (in Simulink/Stateflow). We describe the translation rules that ensure correct model conversion, applicable to a large class of models. We demonstrate how UPP2SF is used in the model-driven design of a pacemaker whose model is (a) designed and verified in UPPAAL (using timed automata), (b) automatically translated to Stateflow for simulation-based testing, and then (c) automatically generated into modular code for hardware-level integration testing of timing-related errors. In addition, we show how UPP2SF may be used for worst-case execution time estimation early in the design stage. Using UPP2SF, we demonstrate the value of integrated end-to-end modeling, verification, code-generation and testing process for complex software-controlled embedded systems.
  • 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
    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.