Forehead Electrode Trigeminal Stimulation for Non-Invasive Neurotherapy

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Solution Overview

Problem

Current neurostimulation techniques for treating neurological disorders, such as seizure disorders and neuropsychiatric conditions, are invasive and carry surgical risks, and existing non-invasive methods like trigeminal nerve stimulation (TNS) lack customization for specific disorders.

Innovation Solution

A cutaneous electrode assembly is applied to the forehead to stimulate the ophthalmic nerves, allowing for non-invasive and safe transcutaneous stimulation of the trigeminal nerve using a pair of electrode contacts that can be easily positioned by a lay person, with a portable pulse generator and regulation device to control current levels, ensuring minimal exposure to the brain.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If invasive neurostimulation techniques (VNS, DBS, RNS) are used, then therapeutic efficacy is improved, but surgical risks and invasiveness increase

Engineering Contradiction:
Improvetherapeutic efficacyVSAvoidsurgical risks
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent uses the trigeminal nerve as an intermediary pathway to deliver neurostimulation effects to the brain without direct brain access. Electrical stimulation of the trigeminal nerve (particularly the ophthalmic division) transmits signals through the trigeminal ganglion to affect brain regions involved in seizure control and mood regulation, achieving therapeutic effects of invasive methods while avoiding their surgical risks

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical/surgical implantation system with a non-invasive transcutaneous electrical stimulation system. Instead of surgically implanting electrodes directly into the brain or on cranial nerves, the system uses surface electrodes applied to the forehead to deliver electrical pulses through the skin and fascia to stimulate the trigeminal nerve, eliminating surgical intervention while maintaining therapeutic capability

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Object-affected harmful factors

If generic TNS is used, then non-invasive treatment is achieved, but customization for specific disorders is lost

Engineering Contradiction:
ImproveinvasivenessVSAvoiddisorder-specific customization
Core Design Contradiction:
Object-affected harmful factorsVSAdaptability or versatility

Solution Approach 1:

The patent implements dynamic, customizable stimulation parameters that can be adjusted based on the specific disorder being treated. The system allows modification of pulse frequency, pulse width, amplitude, and stimulation patterns to match the physiological requirements of different conditions such as epilepsy, depression, or anxiety, transforming static generic TNS into a dynamic, adaptive therapy

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent utilizes parameter changes in the electrical stimulation to achieve disorder-specific treatment. By varying key parameters including pulse frequency (e.g., 1-200 Hz), pulse duration (e.g., 50-500 microseconds), and voltage/amplitude levels, the system tailors the neurostimulation effect to match the specific pathophysiology of different disorders while maintaining non-invasive application

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If precise electrode positioning is required, then stimulation accuracy is improved, but ease of application decreases

Engineering Contradiction:
Improvestimulation accuracyVSAvoidapplication simplicity
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent positions electrodes at anatomically equipotential locations on the forehead that naturally align with the underlying trigeminal nerve pathways. By placing electrodes over the supraorbital and supratrochlear nerve regions (approximately 2-3 cm above the medial aspect of each eyebrow), the system achieves consistent nerve stimulation without requiring complex positioning procedures or specialized training, as these locations are easily identifiable landmarks

Inventive Principle:
Principle #12Equipotentiality

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 approach provides effective neurostimulation without the risks of invasive procedures, allowing for tailored treatment of various disorders by adjusting parameters like pulse frequency, duration, and number, effectively managing conditions like epilepsy and depression.

Implementation Method 1

a pulse generator is configured to deliver electrical pulses through a pair of electrode contacts

Methodology Applied
Scientific EffectElectrical stimulation: Electric Field

Data Source

PatentUS10537729B2Trigeminal neurostimulation based upon pulse counting and chronobiology
Publication Date: 2020.01.21 NEUROSIGMA INC
  • US10537729B2 patent drawing
  • US10537729B2 patent drawing
  • US10537729B2 patent drawing

AI summary

Trigeminal nerves are stimulated based upon pulse counting and chronobiology. A cutaneous electrode assembly is applied to the forehead to stimulate the ophthalmic nerves. A method may include determining a number of pulses to be administered to a patient based upon the disorder being treated, and pulsing current through an electrode assembly to stimulate the patient's supraorbital and supratrochlear nerves with the determined number of pulses. Another method may include determining a pulse repetition frequency for pulses to be administered to a patient based upon the disorder being treated, and pulsing current through an electrode assembly to stimulate the patient's supraorbital and supratrochlear nerves at the pulse repetition frequency.