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Pacemaker Verification

Abstract


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 verifi cation, make this an ideal domain for exploring applications of formal modeling and analysis. The algorithms of the device are represented as abstract model and their safety and efficacy can be mathematically proved using model checking techniques. In this project, we use a dual chamber implantable pacemaker as a case study for modeling and verifi cation of control algorithms for medical devices in UPPAAL.

On-going Research


On-going Research

  • Quantitative Verification

Safety requirements are 0 or 1 criteria which are not enough to address the complexity of the interaction of the human heart and the pacemaker over the variety of patient conditions. For a more comprehensive evaluation of pacemaker performance, we need to introduce quantitative criteria for both efficacy of therapy and energy consumption of the device.

Personnel


  • Zhihao Jiang
  • Miroslav Pajic
  • Salar Moarref
  • Prof. Rajeev Alur
  • Prof. Rahul Mangharam

Resources


  • Case Studies
  • Media & Presentations
  • Model Downloads

Publications


2012

Jiang, Zhihao; Pajic, Miroslav; Moarref, Salar; Alur, Rajeev; Mangharam, Rahul

Closed-loop Verification of Medical Devices with Model Abstraction and Refinement (Submitted) (Article)

International Journal on Software Tools for Technology Transfer, 2012.

(BibTeX)

@article{STTT12,
name = {Closed-loop Verification of Medical Devices with Model Abstraction and Refinement (Submitted)},
author = {Zhihao Jiang and Miroslav Pajic and Salar Moarref and Rajeev Alur and Rahul Mangharam},
year = {2012},
date = {2012-09-30},
journal = {International Journal on Software Tools for Technology Transfer},
}

Close

Jiang, Zhihao; Pajic, Miroslav; Moarref, Salar; Alur, Rajeev; Mangharam, Rahul

Modeling and Verification of a Dual Chamber Implantable Pacemaker (Article)

18th International Conference on Tools and Algorithms for the Construction and Analysis of Systems (TACAS), 7214, Page(s): 188-203, 2012.

(Abstract | Links | BibTeX)

@article{123,
name = {Modeling and Verification of a Dual Chamber Implantable Pacemaker},
author = {Zhihao Jiang and Miroslav Pajic and Salar Moarref and Rajeev Alur and Rahul Mangharam},
url = {http://repository.upenn.edu/mlab_papers/43},
year = {2012},
date = {2012-01-06},
journal = {18th International Conference on Tools and Algorithms for the Construction and Analysis of Systems (TACAS)},
volume = {7214},
pages = {188-203},
abstract = {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 study, we use a dual chamber implantable pacemaker as a case study for modeling and verification of control algorithms for medical devices in UPPAAL. We begin with detailed models of the pacemaker, based on the specifications and algorithm descriptions from Boston Scientific. We then define the state space of the closed-loop system based on its heart rate and developed a heart model which can non-deterministically cover the whole state space. For verification, we first specify unsafe regions within the state space and verify the closed-loop system against corresponding safety requirements. As stronger assertions are attempted, the closed-loop unsafe state may result from healthy open-loop heart conditions. Such unsafe transitions are investigated with two clinical cases of Pacemaker Mediated Tachycardia and their corresponding correction algorithms in the pacemaker. Along with emerging tools for code generation from UPPAAL models, this effort enables model-driven design and certification of software for medical devices.},
}

Close

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 study, we use a dual chamber implantable pacemaker as a case study for modeling and verification of control algorithms for medical devices in UPPAAL. We begin with detailed models of the pacemaker, based on the specifications and algorithm descriptions from Boston Scientific. We then define the state space of the closed-loop system based on its heart rate and developed a heart model which can non-deterministically cover the whole state space. For verification, we first specify unsafe regions within the state space and verify the closed-loop system against corresponding safety requirements. As stronger assertions are attempted, the closed-loop unsafe state may result from healthy open-loop heart conditions. Such unsafe transitions are investigated with two clinical cases of Pacemaker Mediated Tachycardia and their corresponding correction algorithms in the pacemaker. Along with emerging tools for code generation from UPPAAL models, this effort enables model-driven design and certification of software for medical devices.

Close

  • http://repository.upenn.edu/mlab_papers/43

Close

Awards

  • Heart On a Chip won 1st prize (Award of Excellence) of High-tech Medical Service in the World Embedded Software Contest(WESC)
    December 7, 2012
  • mLab wins the 1st prize in the SEAS Senior Design Competition! Congrats to the PVS team!
    August 20, 2012
  • TACAS PM verification paper nominated for Best Paper Award
    May 10, 2012
  • RTAS UPP2SF paper won IEEE Best Student Paper Award!
    April 24, 2012
  • VHM in Distinguished Lecture Series @UIUC (March 2011)
    February 13, 2012

Navigation

  • Medical Device V & V
    • Pacemaker Verification
    • Penn Virtual Heart Model
    • Multi-level model translation
    • Heart On a Chip (HOC)
  • Case Studies
  • Media & Presentations
  • Downloads

Recent News

  • Heart On a Chip won 1st prize (Award of Excellence) of High-tech Medical Service in the World Embedded Software Contest(WESC)
    December 7, 2012
  • The VHM team and the Protodrive team are going to participate in WESC’2012 in Seoul Korea
    November 9, 2012
  • mLab wins the 1st prize in the SEAS Senior Design Competition! Congrats to the PVS team!
    August 20, 2012
  • TACAS PM verification paper nominated for Best Paper Award
    May 10, 2012
  • RTAS UPP2SF paper won IEEE Best Student Paper Award!
    April 24, 2012
  • VHM Simulink model v1.0 released
    February 14, 2012
  • Pacemaker Verification UPPAAL model release
    February 13, 2012
  • Pacemaker Verification paper published in TACAS, 2012
    February 13, 2012
  • VHM in Distinguished Lecture Series @UIUC (March 2011)
    February 13, 2012
  • Model-based Closed-loop Testing paper published in IEEE ICCPS’11 (April 2011)
    February 13, 2012
  • VHM Matlab model release
    February 13, 2012
  • VHM published in Proceeding of IEEE Special Issue on Cyber-Physical Systems, 2012
    February 8, 2012
  • Pacemaker Malfunction paper published in IEEE EMBC’11, Auguest 2011
    February 8, 2012
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News

  • Protodrive won 3rd prize (Award of Merit) of Free Theme in The World Embedded Software Contest(WESC)

    ...

  • Heart On a Chip won 1st prize (Award of Excellence) of High-tech Medical Service in the World Embedded Software Contest(WESC)

    ...

  • The VHM team and the Protodrive team are going to participate in WESC’2012 in Seoul Korea

    ...

Awards

  • Protodrive won 3rd prize (Award of Merit) of Free Theme in The World Embedded Software Contest(WESC)
    December 7, 2012
  • Heart On a Chip won 1st prize (Award of Excellence) of High-tech Medical Service in the World Embedded Software Contest(WESC)
    December 7, 2012
  • mLab wins the 1st prize in the SEAS Senior Design Competition! Congrats to the PVS team!
    August 20, 2012
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