Dry Electrode Nerve Stimulation Device for Vagus Nerve

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Solution Overview

Problem

Current nerve stimulation devices for the vagus nerve are uncomfortable, often deliver painful shocks, require skin preparation, and can cause muscle contraction due to their design and the need for wet or sticky electrodes.

Innovation Solution

A non-invasive nerve stimulation device using dry electrolyte electrodes that are comfortable, do not require skin preparation, and minimize muscle contraction by targeting specific nerve junctions with a design that avoids painful shocks and the use of saline or gel solutions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If metal electrodes are used to stimulate the vagus nerve through the ear, then nerve stimulation is achieved, but painful shocks are delivered to the ear

Engineering Contradiction:
Improvenerve stimulation effectivenessVSAvoidpainful shock
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces an electrolyte solution as an intermediary medium between the metal electrode and the skin. This mediator distributes the electrical current more evenly across the electrode-skin interface, preventing concentrated current density that causes painful shocks while maintaining effective nerve stimulation through the ear canal to the vagus nerve.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the electrical parameters by using alternating current (AC) waveforms instead of direct current, and controls the amplitude and frequency parameters to remain within comfortable thresholds. This parameter optimization allows effective vagus nerve stimulation while preventing painful sensations in the ear.

Inventive Principle:
Principle #35Parameter changes

2Stability of the object's composition

If sticky gel electrodes are used to remain in place on the neck, then electrode stability is improved, but skin preparation and irritation are required

Engineering Contradiction:
Improveelectrode position stabilityVSAvoidskin preparation requirement
Core Design Contradiction:
Stability of the object's compositionVSEase of operation

Solution Approach 1:

The patent uses an electrolyte solution as a dual-function intermediary: it provides the necessary ionic conductivity for electrical stimulation while also serving as a positioning medium that allows the electrode to be held in place without requiring sticky gels or skin preparation. The solution fills the space between electrode and skin, maintaining stable contact.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes from using adhesive materials to using a fluid electrolyte medium for electrode positioning. This parameter change eliminates the need for skin preparation (shaving, alcohol cleansing) while maintaining electrode stability through the physical properties of the electrolyte solution.

Inventive Principle:
Principle #35Parameter changes

3Stability of the object's composition

If large electrode surface area is used to provide sufficient sticking area, then electrode stability is improved, but contact with non-target areas increases causing muscle contraction

Engineering Contradiction:
Improveelectrode position stabilityVSAvoidmuscle contraction
Core Design Contradiction:
Stability of the object's compositionVSObject-generated harmful factors

Solution Approach 1:

The patent applies local quality by concentrating the electrical current delivery to a specific small target area (the vagus nerve in the neck) rather than using large diffuse electrodes. The electrode design focuses the stimulatory effect locally at the nerve junction while the electrolyte solution maintains stable contact, preventing the need for large electrodes that would contact non-target muscle areas.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The electrolyte solution acts as a mediator that enables stable electrode positioning with smaller surface area. By filling the interface between electrode and skin, it maintains reliable electrical contact without requiring large electrode areas, thus preventing stimulation of surrounding muscle tissue.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Reliability

If wet gel electrodes are used for non-invasive stimulation, then nerve stimulation is achieved, but skin preparation and gel soaking are required

Engineering Contradiction:
Improvenerve stimulation effectivenessVSAvoidelectrode preparation requirement
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent uses an electrolyte solution as an intermediary that combines the benefits of wet gel electrodes (effective electrical conduction) with ease of use. The solution is applied directly to the skin and electrode, eliminating the need for pre-soaking electrodes in gel or preparing the skin, while maintaining reliable vagus nerve stimulation.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes from using pre-formed wet gel electrodes requiring soaking and skin preparation to using a liquid electrolyte solution that is simply applied to the electrode and skin interface. This parameter change maintains effective electrical conduction for nerve stimulation while dramatically simplifying the preparation process.

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 provides effective and comfortable non-invasive nerve stimulation of the great auricular nerve and the auricular branch of the vagus nerve, reducing the occurrence of muscle contraction and eliminating the need for skin preparation or painful shocks.

Implementation Method 1

at least first and second dry electrolyte electrodes coupled to the electrode support structure and electrically coupled to the output terminal of the electrical waveform generator

Methodology Applied
Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentUS11801380B2Non-invasive nerve stimulation devices, electrode assemblies, and methods of use thereof
Publication Date: 2023.10.31 HOOLEST PERFORMANCE TECHNOLOGIES INC
  • US11801380B2 patent drawing
  • US11801380B2 patent drawing
  • US11801380B2 patent drawing

AI summary

Nerve stimulation devices and methods for performing non-invasive nerve stimulation are provided that are particularly well suited for performing non-invasive stimulation of one or both of the great auricular nerve and auricular branch of the vagus nerve through a target nerve junction in the neck of the subject. The nerve stimulation devices use dry electrolyte electrodes that (1) are comfortable to use, (2) suitable for long-term use, (3) avoid delivering painful shocks to the subject, (4) do not require soaking of the electrodes in saline solutions or covering them in sticky or wet gels, (5) do not require skin preparation, and (6) avoid causing muscle contraction in areas outside of the target nerve junction containing the great auricular nerve and the auricular branch of the vagus nerve during use.