Leadless Pacemaker Pressure Capture Verification

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Solution Overview

Problem

Existing pacemakers face challenges in reliably verifying pacing capture without wasting energy, as they often rely on electrical signals, which can be unreliable due to electrode polarization and limited hardware constraints in leadless cardiac pacemakers.

Innovation Solution

Incorporating a pressure sensor to monitor intracardiac pressure signals for evoked capture verification, using features like peak pressure, minimum pressure, pressure slope, and area under the curve to determine capture, and optionally communicating with external devices for confirmation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If electrical signals are used for pacing capture verification, then the verification can be performed using existing hardware, but the verification reliability is reduced due to electrode polarization and limited hardware constraints

Engineering Contradiction:

Improvepacing capture verification reliabilityVSAvoidhardware constraints

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent replaces the electrical sensing system with a pressure sensing system for capture verification. The pressure sensor detects mechanical pressure changes in the heart chamber that occur when the paced contraction is effective, thereby substituting mechanical detection for electrical detection and avoiding electrode polarization issues.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If output energy of pacemaker is set too high to ensure reliable capture, then capture reliability is improved, but battery life is reduced due to increased energy consumption

Engineering Contradiction:

Improvepacing capture reliabilityVSAvoidbattery energy consumption

Core Design Contradiction:

ReliabilityVSUse of energy by moving object

Solution Approach 1:

The patent implements feedback by using pressure sensor data to verify whether each paced beat achieved capture. This feedback mechanism allows the device to confirm effective capture at the actual output energy level being used, enabling optimization of pacing amplitude to the minimum effective level rather than using excessive energy margins.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The patent changes the verification parameter from electrical signal characteristics to pressure waveform characteristics. By monitoring pressure changes, area under the curve, and other pressure-based parameters, the system can accurately verify capture without relying on high energy output, allowing optimization of energy consumption.

Inventive Principle:

Principle #35Parameter changes

3Loss of energy

If periodic or occasional confirmation of output energy is performed, then battery waste is reduced, but the frequency of capture verification may be insufficient to ensure reliable capture

Engineering Contradiction:

Improvebattery wasteVSAvoidcapture verification frequency

Core Design Contradiction:

Loss of energyVSReliability

Solution Approach 1:

The patent enables continuous capture verification by integrating the pressure sensor into the normal pacing operation. The pressure sensor continuously monitors pressure waveforms following each paced beat, providing ongoing verification of capture without requiring periodic separate testing, thus maintaining both energy efficiency and verification frequency.

Inventive Principle:

Principle #20Continuity of useful action

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 method provides a reliable and energy-efficient means to verify pacing capture, reducing battery waste and improving the accuracy of pacing therapy delivery in leadless cardiac pacemakers.

Implementation Method 1

a pressure sensor for sensing intracardiac pressure

Methodology Applied

Scientific EffectPressure sensing:

Data Source

PatentUS10426962B2Leadless pacemaker using pressure measurements for pacing capture verification

Publication Date: 2019.10.01 CARDIAC PACEMAKERS INC

AI summary

Methods, devices, and systems for performing pacing capture verification in implantable medical devices such as a leadless cardiac pacemakers using a pressure signal. An example medical device includes a pressure sensor and is configured to monitor for an evoked capture response using the pressure sensor following pace delivery. Various factors of the pressure waveform may be used including the use of threshold, templating, and slope, as well as comparing cross-domain sensed events including using a fiducial point from the pressure signal for comparison to an acoustic, electrical, or motion event, or the use of data obtained from a second device which may be implanted, wearable, or external to the patient.