An Electrophysiological Heart Model for Formal and ...€¦ · • FDA has no formal method for...

transcript

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

SUNFEST Final Presentation

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

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.

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

Background: Data Collection

•Electrocardiogram (ECG)(ECG)•ElectrogramCARTO M i•CARTO Mapping

•MRI images

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

Background: ECG

Normal Sinus Rhythm Atrial Fibrillation

Ventricular FibrillationVentricular Tachycardia

Vectorcardiogram

Closed Loop System

Normal Sinus

Rhythm

pace paceshock on T

a eBradychardia Ventricular

Tachycardia

nothing for s1seconds

Ventricular Fibrillation Death

do nothing for s2

2seconds

Open Loop Example

Ventricular Tachycardia

do nothing for s1seconds

DeathVentricular Fibrillation do

nothing for s2

2seconds

ICD Closed Loop Example

Normal Sinus

Rhythm

paceshock on T

a eVentricular

Tachycardia

do thinothing

for s1seconds

Ventricular Fibrillation

ICD Closed Loop Example

Heart Response to PacemakerNormal P

wavePaced P

Paced QRS Normal QRS

pace ventricle

ventricle

complex complex

T waveVentricular Fibrillation

pace atriapace ventricle

Tp interval pace atriapace ventricle

Pacemaker Closed Loop

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

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

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

An Electrophysiological Heart Model for Formal and ...€¦ · • FDA has no formal method for...

Documents