Non-Invasive Vagus Nerve Stimulation Device

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Solution Overview

Problem

Current non-invasive electrical stimulation methods struggle to selectively stimulate the vagus nerve in the neck without causing pain or inadvertently stimulating other nerves, such as the phrenic nerve, which can lead to undesirable side effects like respiratory issues and discomfort.

Innovation Solution

A non-invasive device using a combination of electrical and magnetic stimulators with specific waveform parameters and electrode configurations that shape an elongated electric field parallel to the vagus nerve, minimizing stimulation of surrounding tissues and nerves that cause pain, and employing a conducting medium that conforms to the body's surface for targeted nerve stimulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If non-invasive electrical stimulation is applied to the neck region, then the vagus nerve can be stimulated to treat headaches and sinus symptoms, but other nerves such as the phrenic nerve may be inadvertently stimulated causing respiratory issues and discomfort

Engineering Contradiction:
Improveselectivity of nerve stimulationVSAvoidpain and side effects from stimulating wrong nerves
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies local quality by using a conducting medium with specific electrical properties that concentrates the electric field in a localized region around the vagus nerve. The medium's conductivity distribution is tailored to enhance field concentration at the target nerve while minimizing spread to adjacent structures, thereby achieving selective stimulation without affecting the phrenic nerve or causing pain.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent introduces a new dimension by using a three-dimensional conducting medium that conforms to the body surface and wraps around the target region. This volumetric approach creates an elongated electric field pattern that follows the anatomical course of the vagus nerve, providing spatial selectivity that two-dimensional electrode configurations cannot achieve.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Reliability

If traditional electrical stimulation methods are used, then nerve stimulation can be achieved, but the stimulation is not selective and causes pain and discomfort

Engineering Contradiction:
Improveselectivity of nerve stimulationVSAvoidpatient comfort during stimulation
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent employs parameter changes by modifying the electrical conductivity distribution through the use of a specialized conducting medium. The medium's conductivity is optimized to shape the electric field in a specific pattern that concentrates energy at the target nerve while reducing intensity in surrounding areas, thereby achieving pain-free selective stimulation.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The conducting medium serves as an intermediary between the electrode and the body surface. It acts as a field-shaping element that transforms the electric field generated by the electrode into a controlled elongated pattern, mediating the interaction to achieve selective nerve stimulation without direct contact between the electrode and the skin.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Productivity

If electrical stimulation parameters are increased to achieve therapeutic effect, then headache relief can be obtained, but surrounding tissues and nerves are more likely to be stimulated causing pain

Engineering Contradiction:
Improvetherapeutic effectivenessVSAvoidpain from stimulating surrounding tissues
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent applies local quality by using a conducting medium with specific electrical properties that concentrates the electric field in a localized region around the vagus nerve. The medium's conductivity distribution is tailored to enhance field concentration at the target nerve while minimizing spread to adjacent structures, thereby achieving selective stimulation without affecting the phrenic nerve or causing pain.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent introduces a new dimension by using a three-dimensional conducting medium that conforms to the body surface and wraps around the target region. This volumetric approach creates an elongated electric field pattern that follows the anatomical course of the vagus nerve, providing spatial selectivity that two-dimensional electrode configurations cannot achieve.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

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 achieves selective and pain-free stimulation of the vagus nerve, providing rapid relief from headaches and sinus symptoms, with effects lasting several hours without the side effects associated with traditional medications, and can be used to treat co-morbid disorders like anxiety.

Implementation Method 1

a non-invasive magnetic stimulator device is used to modulate electrical activity of the vagus nerve or other nerves or tissue

Methodology Applied
Scientific EffectElectromagnetic induction: Electromagnetic Induction

Implementation Method 2

A non-invasive device using a combination of electrical and magnetic stimulators with specific waveform parameters and electrode configurations that shape an elongated electric field parallel to the vagus nerve

Methodology Applied
Scientific EffectElectric field: Electric Field

Data Source

PatentUS8676324B2Electrical and magnetic stimulators used to treat migraine/sinus headache, rhinitis, sinusitis, rhinosinusitis, and comorbid disorders
Publication Date: 2014.03.18 ELECTROCORE INC
  • US8676324B2 patent drawing
  • US8676324B2 patent drawing
  • US8676324B2 patent drawing

AI summary

Transcutaneous electrical nerve stimulation devices and magnetic stimulation devices are disclosed, along with methods of treating medical disorders using energy that is delivered noninvasively by such devices. The disorders comprise migraine and other primary headaches such as cluster headaches, including nasal or paranasal sinus symptoms that resemble an immune-mediated response (“sinus” headaches). The devices and methods may also be used to treat rhinitis, sinusitis, or rhinosinusitis, irrespective of whether those disorders are co-morbid with a headache. They may also be used to treat other disorders that may be co-morbid with migraine or cluster headaches, such as anxiety disorders. In preferred embodiments of the disclosed methods, one or both of the patient's vagus nerves are stimulated non-invasively. In other embodiments, parts of the sympathetic nervous system and/or the adrenal glands are stimulated.