Non-invasive Vagus Nerve Stimulator with Feedback Positioning

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Self-administration of non-invasive vagus nerve stimulation for conditions like migraine headaches poses challenges due to the risk of incorrect nerve targeting, sub-optimal positioning, movement of the stimulator, and variable effectiveness, which can lead to inconsistent treatment outcomes and safety concerns.

Innovation Solution

A device with a dual-electrode stimulator housing applied to the neck, a docking station for charging and data transmission, and a computer program for managing stimulation parameters to ensure correct nerve targeting, minimize movement, and control energy delivery, allowing for wireless communication with a patient interface device for monitoring and recording treatment sessions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If non-invasive vagus nerve stimulation is used for self-treatment, then patient convenience and accessibility are improved, but treatment precision and safety deteriorate due to risk of incorrect nerve targeting

Engineering Contradiction:
Improvepatient convenienceVSAvoidnerve targeting precision
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The system incorporates feedback mechanisms where the patient interface device communicates with the stimulator to provide real-time information about electrode positioning and stimulation effectiveness. This allows the system to adjust and optimize nerve targeting based on patient responses, thereby maintaining treatment precision while enabling self-administration.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

A computer program acts as an intermediary between the patient and the stimulator device. This software intermediary guides the patient through proper electrode placement, monitors treatment parameters, and ensures correct nerve targeting without requiring direct medical professional intervention. The intermediary translates complex technical requirements into user-friendly instructions.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If the stimulator is made portable for self-administration, then ease of operation is improved, but device stability and positioning accuracy worsen due to movement

Engineering Contradiction:
Improveself-administration capabilityVSAvoidstimulator positioning stability
Core Design Contradiction:
Ease of operationVSStability of the object's composition

Solution Approach 1:

The system uses feedback from the patient interface device to monitor stimulator positioning and detect movement. When movement is detected, the system can provide real-time feedback to the patient for repositioning or automatically adjust stimulation parameters to compensate for positional changes, thereby maintaining treatment effectiveness despite the portable design.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system transitions from a static, fixed-position design to a dynamic, adaptable design. The stimulator and electrode positioning are made adjustable and reconfigurable, allowing the device to adapt to patient movement and anatomical variations while maintaining effective nerve stimulation. This dynamic approach enables portability without sacrificing positioning accuracy.

Inventive Principle:
Principle #15Dynamics

3Device complexity

If simple non-invasive electrodes are used, then ease of manufacture and device complexity are improved, but treatment effectiveness and energy delivery consistency worsen

Engineering Contradiction:
Improvedevice simplicityVSAvoidenergy delivery consistency
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The patient interface device provides feedback monitoring of energy delivery parameters and stimulation effectiveness. This feedback loop ensures that even with simple non-invasive electrodes, the system can detect and correct variations in energy delivery, maintaining treatment reliability and consistency. The feedback mechanism verifies that therapeutic energy levels are being delivered as prescribed.

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

The system ensures precise and safe self-treatment of migraines by preventing incorrect nerve stimulation, optimizing positioning, and maintaining consistent energy delivery, leading to rapid relief from headache pain and prolonged effectiveness.

Implementation Method 1

The energy impulses (and/or fields) that are used to treat those conditions comprise electrical and/or electromagnetic energy, delivered non-invasively to the patient, particularly to a vagus nerve of the patient.

Methodology Applied
Scientific EffectElectrical stimulation: Conduction (electrical)

Implementation Method 2

The energy impulses (and/or fields) that are used to treat those conditions comprise electrical and/or electromagnetic energy, delivered non-invasively to the patient

Methodology Applied
Scientific EffectElectromagnetic energy delivery: Electromagnetic Induction

Data Source

PatentEP2945690B1Medical self-treatment using non-invasive vagus nerve stimulation
Publication Date: 2021.05.12 ELECTROCORE INC
  • EP2945690B1 patent drawingFigure 1
  • EP2945690B1 patent drawingFigure 2A~2C
  • EP2945690B1 patent drawingFigure 3A~3

AI summary

Devices, systems and methods are disclosed that allow a patient to self-treat a medical condition, such as migraine headache, by electrical noninvasive stimulation of a vagus nerve. The system comprises a stimulator that is applied to the surface of the patient's neck, as well as a docking station that is used to charge a rechargeable battery within the stimulator. The docking station and stimulator housing transmit data to one another regarding the status of a stimulation session, as well as to a computer program in a patient interface device such as a mobile phone or computer. The interface device in turn communicates with medical record and billing databases contained within other computers, via the internet. The system is designed to address problems that arise particularly during self-treatment, when a medical professional is not present.