Subcutaneous Electrotherapy Device for Arrhythmia Discomfort Mitigation

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Solution Overview

Problem

Subcutaneous implantable defibrillators cause discomfort to patients due to the need for higher-amplitude pulses to achieve therapeutic effects, which is less efficient and uncomfortable for conscious patients receiving brady pacing, anti-tachycardia pacing, and cardioversion therapies.

Innovation Solution

An electrotherapy device with a subcutaneous pulse generator and electrodes that apply far-field pacing pulses with reduced spectral power in higher frequencies, slower rise and fall times, and adjustable pulse widths to mitigate discomfort while ensuring cardiac capture, using a processor to determine arrhythmia and adjust pulse parameters based on patient response.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If higher-amplitude pulses are used to achieve therapeutic effects with subcutaneous electrodes, then cardiac cell capture is improved, but patient discomfort increases

Engineering Contradiction:
Improvecardiac cell captureVSAvoidpatient discomfort
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by modifying the pulse waveform characteristics - specifically using slower rise and fall times, and adjusting the spectral content to reduce high-frequency components. This allows achieving cardiac capture with lower peak amplitudes, thereby reducing patient discomfort while maintaining therapeutic effectiveness.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention employs dynamic pulse delivery by varying the pulse parameters (amplitude, width, rise time, fall time) based on real-time monitoring of cardiac response. The system dynamically adjusts these parameters to achieve reliable capture while minimizing discomfort, rather than using fixed high-amplitude pulses.

Inventive Principle:
Principle #15Dynamics

2Reliability

If higher-amplitude pulses are delivered through subcutaneous electrodes, then therapeutic effect is achieved, but energy efficiency deteriorates

Engineering Contradiction:
Improvetherapeutic effectVSAvoidenergy efficiency
Core Design Contradiction:
ReliabilityVSUse of energy by moving object

Solution Approach 1:

By changing the pulse parameters - specifically using optimized pulse widths, rise times, and fall times - the system achieves more efficient energy delivery. The modified waveform shape improves coupling efficiency to cardiac tissue, reducing the total energy required to achieve therapeutic effect compared to conventional high-amplitude square waves.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If higher-amplitude pulses are used for far-field pacing, then cardiac stimulation is achieved, but nerve and muscle stimulation increases causing discomfort

Engineering Contradiction:
Improvecardiac stimulationVSAvoidnerve and muscle stimulation
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent modifies the pulse waveform parameters - specifically using slower rise times and spectral shaping to reduce high-frequency content. This selective parameter modification allows preferential stimulation of cardiac tissue while minimizing activation of peripheral nerves and muscles, thereby reducing discomfort without compromising cardiac capture.

Inventive Principle:
Principle #35Parameter changes

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

The device effectively treats arrhythmias with reduced patient discomfort by delivering sufficient cardiac charge with lower peak amplitudes and longer pulse durations, balancing stimulation efficacy and energy efficiency while minimizing nerve and muscle stimulation.

Implementation Method 1

each delivering sufficient charge, through a set of electrodes positioned subcutaneously in far-field fashion relative to a heart of the patient, to initiate a cardiac cycle

Methodology Applied
Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentUS10143851B2Arrhythmia electrotherapy device and method with provisions for mitigating patient discomfort
Publication Date: 2018.12.04 GALVANI
  • US10143851B2 patent drawing
  • US10143851B2 patent drawing
  • US10143851B2 patent drawing

AI summary

Apparatus and method for treating an arrhythmia in a patient using an electrotherapy device such as a subcutaneous pacing device. The device applies a series of electrotherapy pulses in response to the presence of the arrhythmia. Various provisions are disclosed for mitigating pain or discomfort as a result of the electrotherapy pulses.