Pacemaker Optimization via Non-Invasive Pre-Ejection Time Monitoring

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Solution Overview

Problem

Current methods for optimizing biventricular pacemaker settings, such as echocardiographic-guided CRT optimization, are time-consuming, expensive, and prone to errors due to their invasive nature and reliance on echocardiograms, which are laborious and inconvenient for patients.

Innovation Solution

A non-invasive system that simultaneously measures electrocardiogram (ECG) and peripheral blood pressure waveforms to calculate the pre-ejection time (PET) and ejection duration (ED) for the left ventricle, allowing for real-time optimization of pacemaker settings using a tonometer strapped to the patient's wrist, with software analysis to display and adjust settings efficiently.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If echocardiographic-guided CRT optimization is used, then cardiac function improvement is achieved, but procedural time and cost increase significantly

Engineering Contradiction:
Improvecardiac function improvementVSAvoidprocedural time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent replaces the mechanical echocardiographic imaging system with a non-invasive hemodynamic monitoring system that uses pressure sensors and ECG electrodes to measure cardiovascular parameters. This substitution eliminates the need for complex ultrasound imaging while providing sufficient data for pacemaker optimization, thereby reducing procedural time and cost while maintaining reliability of cardiac function improvement.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent uses indirect measurement by copying hemodynamic information from easily accessible peripheral sites (finger, wrist, or ankle pressure) and ECG signals from the skin surface to infer central cardiovascular parameters. This copying approach avoids the need for direct echocardiographic imaging of the heart while providing sufficient data for pacemaker optimization.

Inventive Principle:
Principle #26Copying

2Reliability

If echocardiographic-guided CRT optimization is used, then cardiac function improvement is achieved, but procedural complexity and cost increase

Engineering Contradiction:
Improvecardiac function improvementVSAvoidprocedural complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent replaces the complex echocardiographic imaging system with simple non-invasive pressure sensors and standard ECG electrodes. This substitution dramatically reduces device complexity while maintaining the ability to measure cardiovascular parameters necessary for pacemaker optimization, thereby reducing both procedural complexity and cost.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent employs automated analysis of hemodynamic parameters and ECG signals to determine optimal pacemaker settings. The system self-calibrates and processes data without requiring expert echocardiographic interpretation, reducing procedural complexity and making the optimization process accessible to routine clinical practice.

Inventive Principle:
Principle #25Self-service

3Reliability

If echocardiographic-guided CRT optimization is used, then cardiac function improvement is achieved, but patient convenience deteriorates

Engineering Contradiction:
Improvecardiac function improvementVSAvoidpatient convenience
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent replaces the invasive echocardiographic procedure with simple non-invasive pressure measurements and ECG recordings. Patients only need to have pressure sensors placed on their finger, wrist, or ankle and ECG electrodes on their skin, which is much more comfortable and convenient than undergoing echocardiographic imaging, while still achieving reliable cardiac function improvement.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

4Productivity

If default factory settings are used, then implantation time is reduced, but individual patient optimization is lost

Engineering Contradiction:
Improveimplantation speedVSAvoidindividual patient optimization
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent enables continuous real-time measurement of hemodynamic parameters and ECG signals during pacemaker implantation, allowing optimization to be performed immediately without interrupting the implantation process. This continuous monitoring approach maintains implantation speed while ensuring individual patient optimization through data-driven parameter adjustment.

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The patent implements real-time feedback by continuously monitoring hemodynamic parameters and ECG signals during pacemaker implantation. The system provides immediate feedback on the effect of different pacing parameters, allowing the physician to optimize settings for each patient individually while maintaining efficient implantation timing.

Inventive Principle:
Principle #23Feedback

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

Enables quick and efficient optimization of pacemaker settings, reducing procedural time and costs while improving cardiac function by providing accurate, non-invasive monitoring of PET and ED, thereby facilitating better heart muscle contraction coordination.

Implementation Method 1

the electrical activity of a patient's heart is measured using a conventional electrocardiogram (ECG) technique

Methodology Applied
Scientific EffectElectrocardiogram (ECG):

Implementation Method 2

the patient's peripheral pressure waveform is measured... a tonometer mounted in a fixed position on the patient's wrist... is used to measure the pressure waveform of the patient's radial artery

Methodology Applied
Scientific EffectBlood pressure waveform measurement:

Implementation Method 3

the electrocardiogram is analyzed to determine a time correlating to the ventricular impulse and this time is defined as an impulse time (T0)... the time (T2) corresponding to the realization of systolic onset in the detected peripheral pressure waveform is also determined

Methodology Applied
Scientific EffectTime interval analysis:

Data Source

PatentUS8112150B2Optimization of pacemaker settings
Publication Date: 2012.02.07 ATCOR MEDICAL
  • US8112150B2 patent drawing
  • US8112150B2 patent drawing
  • US8112150B2 patent drawing

AI summary

The system provides information to facilitate efficient optimization of programmer settings for cardiac pacemakers. It uses simultaneous measurement of a patient's electrocardiogram and peripheral blood pressure waveform in order to calculate, in real-time, a value correlated to the patient's pre-ejection time (PET) and, optionally, ejection duration (ED) for the patient's left ventricle. The peripheral blood pressure waveform is preferably monitored with a wrist mounted tonometer. Data including the electrocardiogram and peripheral blood pressure trace, as well as the surrogate pre-ejection time interval (SPET) for each heart beat and trending is displayed on a computer monitor, thereby allowing a physician or nurse to quickly optimize PET for the patient and adjusting programmer settings for an implanted pacemaker.