ORAL MUSCLE TRAINING
A trans mucosal neuromuscular electrical stimulation device including a mouthpiece, electrodes associated with the mouthpiece. The device and/or mouthpiece incorporates electrical circuitry operatively connecting to the electrodes to a power source and is configured to provide, in use, electrical stimulation to one or more palate and/or tongue muscles via the electrodes through the oral mucosa. The treatment regime, including the location of stimulation and the parameters used, is designed to increase resting muscle tone and/or muscle tone during sleep.
1 . A system for reducing or preventing snoring or sleep-disordered breathing in a subject, the system comprising:
a mouthpiece configured to be positioned within an oral cavity of the subject while the subject is awake;
a plurality of electrodes disposed on the mouthpiece and configured to contact one or more oral surfaces selected from the group consisting of a dorsal tongue surface, a sublingual tongue surface, and a palate surface;
electrical circuitry operatively connected to the electrodes and configured to deliver a biphasic electric impulse current through an oral mucosa to stimulate one or more oral muscles;
a control unit configured to adjust one or more stimulation parameters selected from the group consisting of frequency, pulse duration, current amplitude, and treatment duration;
wherein the system is configured to increase resting muscle tone and/or muscle tone during sleep in the one or more oral muscles.
2 . The system of claim 1 , wherein the mouthpiece comprises a pair of arms joined at one end and diverging to form a horseshoe shape, each arm comprising one or more flanges shaped to accommodate a dorsal or sublingual tongue surface.
3 . The system of claim 1 , wherein the electrodes are disposed on opposing surfaces of the mouthpiece to simultaneously stimulate both dorsal and sublingual tongue surfaces.
4 . The system of claim 1 , wherein the electrical circuitry is configured to deliver a first biphasic current to palate muscles and a second biphasic current to tongue muscles, each current having independently adjustable parameters.
5 . The system of claim 1 , wherein the control unit comprises a programmable interface configured to store and execute a treatment regime comprising multiple stimulation sessions over a period of weeks.
6 . The system of claim 1 , wherein the mouthpiece includes shielding material to electrically isolate electrode sets targeting different muscle groups.
7 . The system of claim 1 , further comprising a power source housed within the mouthpiece or a connected handle, and a charging station configured to recharge the power source.
8 . The system of claim 1 , further comprising a wireless communication module configured to transmit and receive data between the control unit and a mobile application on a user device.
9 . The system of claim 8 , wherein the mobile application is configured to:
initiate or terminate stimulation sessions;
adjust stimulation parameters including frequency, pulse duration, current amplitude, and treatment duration;
store and display treatment history and progress data; and
provide user alerts or reminders for scheduled sessions.
10 . The system of claim 8 , wherein the wireless communication module comprises Bluetooth Low Energy (BLE), Wi-Fi, or NFC.
11 . The system of claim 8 , wherein the mobile application includes a user interface for selecting between a muscle tone building mode and a maintenance mode.
12 . The system of claim 8 , wherein the mobile application is configured to receive feedback from sensors embedded in the mouthpiece or control unit to monitor treatment compliance or muscle response.
13 . A method for reducing or preventing snoring or sleep-disordered breathing in a subject, the method comprising:
positioning a mouthpiece within an oral cavity of the subject while the subject is awake, the mouthpiece comprising one or more electrodes;
applying a biphasic electric impulse current via the electrodes to one or more oral muscles selected from the group consisting of tongue muscles and palate muscles, through an oral mucosa;
wherein the biphasic electric impulse current is configured to increase resting muscle tone and/or muscle tone during sleep in the one or more oral muscles.
14 . The method of claim 13 , wherein the biphasic electric impulse current has a frequency between 20 Hz and 1320 Hz.
15 . The method of claim 13 , wherein the biphasic electric impulse current is applied for a duration between 130 and 20 minutes per session, twice daily, over a period of at least six weeks.
16 . The method of claim 13 , wherein the mouthpiece comprises a first set of electrodes configured to contact a dorsal surface of a tongue and a second set of electrodes configured to contact a sublingual surface of the tongue.
17 . The method of claim 13 , wherein the biphasic electric impulse current is applied to stimulate one or more muscles selected from the group consisting of genioglossus, palatopharyngeus, and levator veli palatini muscles.
18 . The method of claim 13 , further comprising adjusting one or more stimulation parameters selected from the group consisting of frequency, pulse duration, current amplitude, and treatment duration, based on a predetermined treatment regime.
19 . The method of claim 13 , wherein the biphasic electric impulse current is applied in a first phase to build muscle tone and in a second phase to maintain muscle tone.
20 . The method of claim 13 , wherein the biphasic electric impulse current is applied simultaneously to both dorsal and sublingual surfaces of a tongue.