Oral Muscle Training Device for Sleep Apnea via Electrical Stimulation

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Solution Overview

Problem

Current treatments for sleep disordered breathing (SDB) such as snoring and sleep apnea are either uncomfortable, require continuous use during sleep, or involve invasive surgery, and do not effectively address the underlying cause of the condition, leading to low compliance and maintenance issues.

Innovation Solution

A non-invasive oral muscle training device using electrical stimulation with a mouthpiece and external electrodes to increase muscle tone in the tongue and floor of the mouth, applying biphasic electric currents to stimulate muscles like the genioglossus and mylohyoid, which can be used during wakefulness to improve muscle tone and reduce SDB events during sleep.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If continuous positive airway pressure device is used to keep the breathing passage open, then the breathing passage remains open, but the device causes discomfort such as dry throat and requires continuous use during sleep

Engineering Contradiction:
Improvebreathing passage opennessVSAvoiduser comfort and compliance
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The device performs muscle training during wakefulness before sleep occurs, strengthening the airway muscles in advance so they can maintain airway openness during sleep without requiring continuous device intervention. The training effect carries over to provide protection during the sleep period.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If mandibular advancement device is worn to hold the jaw and tongue forward, then the space at the back of the throat increases, but the device must be used during sleep on an ongoing basis

Engineering Contradiction:
Improveairway space maintenanceVSAvoidcontinuous device use requirement
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The device strengthens the tongue and floor of mouth muscles during wakefulness through electrical stimulation, so that these muscles can actively maintain airway space during sleep without requiring a physical device to be worn continuously. The muscle strength gained during training provides ongoing protection.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If electrical nerve stimulators are implanted into the tongue and diaphragm, then SDB events are treated effectively, but intrusive surgery is required with maintenance and other complications

Engineering Contradiction:
ImproveSDB event treatment effectivenessVSAvoidsurgery and maintenance requirements
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The device replaces surgical implantation of electrical nerve stimulators with a non-invasive electrical stimulation approach using surface electrodes and a mouthpiece. This substitution eliminates surgery, battery replacement, and external security detection device issues while maintaining the ability to stimulate muscles to treat SDB.

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

4Reliability

If electrical stimulation is applied only during obstructive episodes during sleep, then the obstructive event is relieved, but the underlying cause of the condition is not addressed

Engineering Contradiction:
Improveobstructive event reliefVSAvoidunderlying cause treatment delay
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The device applies electrical stimulation during wakefulness to strengthen airway muscles before sleep occurs, proactively building muscle tone that prevents obstructive events rather than reacting to them. This preliminary training addresses the underlying cause by improving muscle strength that maintains airway patency throughout the sleep period.

Inventive Principle:
Principle #10Preliminary action

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 a sustainable reduction in SDB events by enhancing muscle tone in the airway, reducing collapsibility and improving sleep quality without the need for continuous device use during sleep, offering a more effective and comfortable solution than existing treatments.

Implementation Method 1

electrical circuitry operatively connected to the first and second electrode means, wherein the apparatus is configured to provide, in use, via the first and second electrode means electrical stimulation to one or more oral and/or floor of mouth muscles to increase resting muscle tone and/or muscle tone during sleep

Methodology Applied
Scientific EffectElectrical stimulation: Electrical Impedance Tomography

Data Source

PatentUS11745009B2Oral muscle training
Publication Date: 2023.09.05 SIGNIFIER MEDICAL TECHNOLOGIES LTD
  • US11745009B2 patent drawing
  • US11745009B2 patent drawing
  • US11745009B2 patent drawing

AI summary

Apparatus (100) for training oral muscle tone, the apparatus (100) includes a mouthpiece (103) having first electrode means (132a, 132b, 133a, 133b) associated with the mouthpiece (103) and second electrode means (152a, 152b) for location exterior of the mouth of the user, electrical circuitry operatively connected to the first (132a, 132b, 133a, 133b) and second (152a, 152b) electrode means, wherein the apparatus (100) is configured to provide, in use, via the first (132a, 132b, 133a, 133b) and/or second (152a, 152b) electrode means electrical stimulation to one or more oral muscles to increase resting muscle tone and/or muscle tone during sleep, the second electrode means (152a, 152b) including a first and second electrode (152a, 152b), the first and second electrodes (152a, 152b) of the second electrode means being located or locatable lateral of a midline of the face of the user.