Non-Invasive Neuromodulation Mouthpiece for Neurorehabilitation

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Solution Overview

Problem

Current treatments for traumatic brain injury, stroke, multiple sclerosis, Alzheimer's, and Parkinson's diseases often rely on invasive neurostimulation methods, which are not sufficient when combined with traditional neurorehabilitation therapies, leading to a need for non-invasive neuromodulation techniques that can effectively address long-term neurological impairments.

Innovation Solution

A mouthpiece designed for non-invasive neuromodulation that includes an elongated housing with a non-planar exterior and internal structural members responding to biting forces, featuring a printed circuit board with electrodes for subcutaneous local electrical stimulation, and a spacer to minimize tooth contact, providing effective neuromodulation while withstanding significant forces without deformation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If invasive neurostimulation methods are used, then treatment effectiveness is improved, but patient comfort and safety deteriorate

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidpatient discomfort and safety risks
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces invasive mechanical/electrical stimulation methods with non-invasive electrical stimulation delivered through a mouthpiece. The electrodes contact the tongue and transmit electrical signals to the brainstem without penetrating skin or tissue, substituting invasive mechanical intervention with a non-invasive electrical field approach that maintains treatment effectiveness while eliminating surgical risks and patient discomfort.

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

Solution Approach 2:

The mouthpiece acts as an intermediary device between the external stimulator and the patient's nervous system. It houses electrodes that contact the tongue and transmit electrical signals indirectly to the brainstem through neural pathways, serving as a mediator that achieves therapeutic effects without direct invasive contact with neural tissue.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If non-invasive neuromodulation is implemented, then patient comfort is improved, but treatment efficacy deteriorates

Engineering Contradiction:
Improvepatient comfortVSAvoidtreatment efficacy
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The mouthpiece employs localized electrical stimulation through electrodes positioned to contact specific regions of the tongue. This local quality approach concentrates the electrical field in targeted areas to stimulate specific neural pathways (trigeminal, facial, glossopharyngeal nerves) effectively, ensuring treatment efficacy is maintained despite the non-invasive method.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The system utilizes controlled electrical stimulation parameters including pulse width (20-500 microseconds), frequency (1-100 Hz), and voltage (0-50 volts) to optimize neural activation. By precisely adjusting these electrical parameters, the device achieves effective neuromodulation of brainstem nuclei while maintaining patient comfort through non-invasive delivery.

Inventive Principle:
Principle #35Parameter changes

3Ease of manufacture

If the mouthpiece structure is simplified, then ease of manufacture is improved, but structural strength deteriorates

Engineering Contradiction:
Improvedevice fabrication simplicityVSAvoidbite force resistance
Core Design Contradiction:
Ease of manufactureVSStrength

Solution Approach 1:

The mouthpiece is constructed from composite materials including acrylic resin or polyetherimide for the housing, which provide both structural strength to withstand bite forces and ease of manufacturing through injection molding. The combination of rigid housing material with integrated elastomeric components creates a structurally sound device that can be efficiently produced.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The mouthpiece is divided into distinct functional segments: a rigid housing structure for strength, an elastomeric component for comfort and sealing, and integrated electrodes for stimulation. This segmentation allows each component to be optimized independently for its specific function while simplifying the overall manufacturing process through modular assembly or one-shot molding.

Inventive Principle:
Principle #1Segmentation

4Object-affected harmful factors

If the housing is made thinner, then patient comfort is improved, but structural strength deteriorates

Engineering Contradiction:
Improvepatient comfortVSAvoidbite force withstanding capability
Core Design Contradiction:
Object-affected harmful factorsVSStrength

Solution Approach 1:

The mouthpiece employs an elastomeric component or flexible housing that can be made relatively thin to enhance patient comfort and tongue contact. This flexible material maintains structural integrity under bite forces through its elastic properties, allowing the housing to deform slightly and return to shape, thereby providing both comfort and strength in a thin-walled construction.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The housing incorporates curved and contoured surfaces that follow the natural anatomy of the oral cavity. These curved geometries distribute bite forces more evenly across the structure, preventing stress concentration points that would require thicker walls. The ergonomic shaping enhances patient comfort while maintaining structural strength through optimized load distribution.

Inventive Principle:
Principle #14Spheroidality (Curvature)

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 mouthpiece effectively combines non-invasive neuromodulation with traditional neurorehabilitation therapies, improving recovery outcomes for patients with TBI, stroke, MS, AD, and PD by delivering targeted electrical stimulation, enhancing treatment efficacy and patient comfort.

Implementation Method 1

a printed circuit board mounted to a bottom portion of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue

Methodology Applied
Scientific EffectElectrical stimulation: Electric Field

Implementation Method 2

internal structural members disposed within the housing, the internal structural members elastically responding to biting forces generated by the patient

Methodology Applied
Scientific EffectElastic response: Elasticity

Data Source

PatentUS9415210B2Methods of manufacturing devices for the neurorehabilitation of a patient
Publication Date: 2016.08.16 BIONESS MEDICAL INC
  • US9415210B2 patent drawing
  • US9415210B2 patent drawing
  • US9415210B2 patent drawing

AI summary

A mouthpiece for providing non-invasive neuromodulation to a patient, the mouthpiece including an elongated housing having an anterior region and a posterior region, the elongated housing having a non-planar exterior top surface and internal structural members disposed within the housing, the internal structural members elastically responding to biting forces generated by the patient, a spacer attached to the top surface of the housing for limiting contact between a patient's upper teeth and the exterior top surface of the elongated housing, and a printed circuit board mounted to a bottom portion of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue.