Hemodynamic Stability Discrimination via Pressure Impedance Phase

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Solution Overview

Problem

Current implantable medical devices (IMDs) face challenges in accurately distinguishing between hemodynamically stable and unstable cardiac rhythms, leading to unnecessary high-power therapies during ventricular tachycardia (VT) and ventricular fibrillation (VF), which can be painful and inefficient.

Innovation Solution

The integration of a microprocessor with both pressure and impedance sensors to determine hemodynamic stability by analyzing the phase relationship between ventricular pressure and impedance data, allowing for the selective delivery of therapies based on the stability of the cardiac rhythm.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If high-power therapy is delivered immediately upon detecting ventricular tachycardia or fibrillation, then the arrhythmia is treated effectively, but the patient experiences pain and discomfort and the therapy may be unnecessary if the arrhythmia terminates spontaneously

Engineering Contradiction:
Improvearrhythmia treatment effectivenessVSAvoidpatient pain and discomfort
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device performs preliminary assessment of hemodynamic stability using impedance cardiography parameters (stroke volume, ejection fraction, cardiac output) immediately upon arrhythmia detection, before delivering therapy. This preliminary evaluation determines whether the arrhythmia is hemodynamically stable or unstable, allowing the device to delay therapy delivery until the arrhythmia terminates spontaneously if it is stable, thereby avoiding unnecessary painful shocks while maintaining treatment effectiveness when needed.

Inventive Principle:
Principle #10Preliminary action

2Loss of time

If therapy is delivered quickly after detection, then the time to therapy is minimized, but the device cannot determine whether the arrhythmia is hemodynamically stable or unstable

Engineering Contradiction:
Improvetime to therapyVSAvoidhemodynamic stability assessment
Core Design Contradiction:
Loss of timeVSMeasurement precision

Solution Approach 1:

The device performs preliminary assessment of hemodynamic stability using impedance cardiography parameters (stroke volume, ejection fraction, cardiac output) immediately upon arrhythmia detection, before delivering therapy. This preliminary evaluation determines whether the arrhythmia is hemodynamically stable or unstable, allowing the device to delay therapy delivery until the arrhythmia terminates spontaneously if it is stable, thereby avoiding unnecessary painful shocks while maintaining treatment effectiveness when needed.

Inventive Principle:
Principle #10Preliminary action

3Device complexity

If the device monitors only heart rate, then the device complexity is low, but the device cannot accurately distinguish between hemodynamically stable and unstable rhythms

Engineering Contradiction:
Improvemonitoring system complexityVSAvoidrhythm classification accuracy
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The device merges heart rate monitoring with impedance cardiography monitoring to create a comprehensive assessment system. The impedance sensor measures electrical impedance changes in the thorax during the cardiac cycle, allowing calculation of stroke volume, ejection fraction, and cardiac output. This combined approach enables accurate distinction between hemodynamically stable and unstable rhythms, improving rhythm classification accuracy while adding only moderate complexity through the integration of an impedance sensor and signal processing algorithms.

Inventive Principle:
Principle #5Merging (Combining)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This approach enhances the sensitivity and specificity of VT/VF detection, reducing the frequency of unnecessary shocks by differentiating between stable and unstable rhythms, enabling less aggressive therapies when possible and avoiding unnecessary high-power interventions.

Implementation Method 1

a pressure sensor coupled with the microprocessor and configured to provide ventricular pressure data to the microprocessor

Methodology Applied
Scientific EffectPressure sensing:

Implementation Method 2

an impedance sensor coupled with the microprocessor and configured to provide ventricular impedance data to the microprocessor

Methodology Applied
Scientific EffectElectrical impedance sensing: Electrical Resistance

Data Source

PatentUS8478400B2Pressure and impedance based discrimination of hemodynamic stability
Publication Date: 2013.07.02 MEDTRONIC INC
  • US8478400B2 patent drawing
  • US8478400B2 patent drawing
  • US8478400B2 patent drawing

AI summary

An implantable cardioverter defibrillator evaluates the hemodynamic stability of an arrhythmia to determine whether or not to defibrillate. The device obtains cardiac pressure and cardiac impedance data and evaluates a phase relationship between these parameters. Hemodynamically stable rhythms will result in an out of phase relationship.