an electrophysiological heart model for formal and ...€¦ · • fda has no formal method for...
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An Electrophysiological Heart Model for Formal and Functional Model for Formal and Functional
Device Verification
Allison ConnollyBME 2010 Johns Hopkins UniversityBME 2010, Johns Hopkins University
Advisor: Rahul Mangharam, ESE, UPenn
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Introduction
• FDA has no formal method for verifying medical device software
• Develop heart model as a testing tool• Plug-and-play with devices, patients, and software• Allows for testing and detection of malfunctions• My role: start a new project
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Motivation
Problem: Over 200,000 cardiac medical devices recalled from 1990-2000 due to software. From 1985-2005, nearly 30,000 deaths and 600,000 injuries from device failuresinjuries from device failures.
Goal: F ilit t th d i f b f di l d i ftFacilitate the design of bug-free medical device software.
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Overview
Virtual Patient Medical DevicesPatient
•Context•Patient historyHeart Model •Pacemaker
•ICD•Recordings•Synthesized •Patient history
•Stored data•Generic EP•Patient specific
ICD•Monitors•Future Devices
ysignals•Combination
•Patient specific•Formal
•Virtual Devices
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Background: Data Collection
•Electrocardiogram (ECG)(ECG)•ElectrogramCARTO M i•CARTO Mapping
•MRI images
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Background: ECG
•Electrocardiogram (ECG)(ECG)•Measures electrical activity of heart fromactivity of heart from surface of chest•Up to 12 leadsUp to eads•Diagnose arrhythmias and heart diseases
P QRS T
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Background: ECG
Normal Sinus Rhythm Atrial Fibrillation
Ventricular FibrillationVentricular Tachycardia
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Vectorcardiogram
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Closed Loop System
Normal Sinus
Rhythm
pace paceshock on T
a eBradychardia Ventricular
Tachycardia
wave
do
shock
nothing for s1seconds
Ventricular Fibrillation Death
do nothing for s2
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2seconds
Open Loop Example
Ventricular Tachycardia
do nothing for s1seconds
DeathVentricular Fibrillation do
nothing for s2
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2seconds
ICD Closed Loop Example
Normal Sinus
Rhythm
paceshock on T
a eVentricular
Tachycardia
wave
do thinothing
for s1seconds
shock
Ventricular Fibrillation
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ICD Closed Loop Example
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Heart Response to PacemakerNormal P
wavePaced P
wave
pace
Paced QRS Normal QRS
pace ventricle
ventricle
complex complex
T waveVentricular Fibrillation
pace atriapace ventricle
Tp interval pace atriapace ventricle
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Pacemaker Closed Loop
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Medical Device Testing
•Model embedded in hardware
–Direct connection to devices
V lid t d if•Validate and verify software
–Reduce recallsReduce recalls•Develop new software
–Better discrimination algorithms
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Conclusions
+ Created model that responds to device actuationactuation+ Model covers broad spectrum of arrhythmias
-Current model is too simple, only ECG-Need to model intracardiac signals for implantable devices-Need in depth model for proper device verification
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Acknowledgements
•Prof. Rahul Mangharam•Zhihou JiangZhihou Jiang•mLab members•Dr. Ed Gerstenfeld QUESTIONS?•Gorman Lab•Jan Van der Spiegel
QU S O S
•SUNFEST staff•NSF
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