“Therapeutic Oral Device” in Patent Application Approval Process (USPTO 20230190514): Patent Application

2023 JUL 10 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- A patent application by the inventor Hao, Phinarak (Jacksonville, FL, US), filed on February 10, 2023, was made available online on June 22, 2023, according to news reporting originating from Washington, D.C., by NewsRx correspondents.

This patent application has not been assigned to a company or institution.

The following quote was obtained by the news editors from the background information supplied by the inventors: “Sleep apnea is a sleeping disorder in which the sleeper’s breathing is stopped repeatedly throughout the night. The disorder may cause snoring, restless sleep, difficulty falling asleep or insomnia, excessive sleepiness throughout the day, and more. A number of factors may cause or exacerbate sleep apnea, such as being obese; having a large neck circumference or narrow air passageways; being male; aging; using sedatives, alcohol, or narcotics; and smoking.

“There are three types of sleep apnea: obstructive, central, and complex. Obstructive sleep apnea is the most common type and occurs when the throat muscles relax, narrowing the passageway for air to enter or leave. This causes a lack of oxygen flow that alerts the brain and wakes up the sleeper, so that breathing may continue as normal. Although the wake often goes unnoticed by the sleeper because it is so brief, this adds to the restlessness and sleepiness symptoms of the sleeper. Central sleep apnea occurs when the brain fails to transmit signals to the breathing muscles. So rather than a physical obstruction preventing someone from breathing, the sleeper simply makes no effort to breathe and may awaken with shortness of breath. Complex sleep apnea is a combination of obstructive and central.

“In addition to the many symptoms of sleep apnea, there may also be long term complications that arise as a result of the disorder. Extreme fatigue may occur, and may not only consist of drowsiness, but may also affect an individual’s ability to concentrate, which may affect work performance, increase the risk of workplace or motor vehicle accidents, or cause drastic mood changes. Due to the sudden drops in oxygen levels, the heart may have to work harder than normal, which may increase the chance of high blood pressure, stroke, heart attacks, and more. Furthermore, those with sleep apnea have an increased risk of developing type 2 diabetes. Additionally, sleep apnea may cause complications with standard medications or medical procedures, including surgeries.

“Many treatments, devices, and even surgeries have been developed over the years to remedy sleep apnea, though each solution comes with its unique pros and cons. One of the most commonly used treatment devices is the continuous positive airway pressure (CPAP) machine. The CPAP machine requires the sleeper to wear a mask over the nose and mouth, which delivers air at a greater pressure than the surrounding air. This higher air pressure helps the airways stay open, preventing sleep apnea. CPAP machines, however, may be uncomfortable for the wearer, cause claustrophobia or anxiety, and increase the likelihood of dry mouth, nose bleeds, and nasal congestion. Additionally, CPAP machines cost anywhere from $500-$3000, require a prescription, and may not be covered by health insurance.

“Other treatments may include wearing an oral appliance, such as a mouthguard or orthodontic retainer, which places pressure on the tongue; nerve stimulation, which sends precise stimuli to nerves in the airway, and nutrition or exercise therapies. Surgery may also work in some instances. This treatment type is most effective for children who get large adenoids or tonsils removed. For adults, it may be difficult to pinpoint what exactly is causing the sleep apnea. Some adult surgical procedures may consist of removing tissue through uvulopalatopharyngoplasty, shrinking tissue with radiofrequency ablation, repositioning the jaw, or implanting rods. Although these procedures may be successful for some, the CPAP machine is still the recommended method of treatment by most physicians.

“Being that the mouth and throat are among the main instruments that the body uses to interact with the environment, they can be the site of many health concerns or treatment regimens beyond those associated with sleep apnea. For example, the temperature, air flow, and muscle or jaw movement within the mouth or throat can be indicative of various conditions, particularly when an individual is asleep or under anesthesia. Such conditions often go undiagnosed or misdiagnosed as they are difficult to observe or detect.”

In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventor’s summary information for this patent application: “What is needed is a convenient and comfortable way to treat sleep apnea and assess or alleviate other health concerns that is accessible, budget-friendly, and does not cause other health issues. A removable oral appliance with one or more simple electrical components may increase design simplicity. An oral appliance that mimics the basic form of a mouth guard may possess a familiarity through association that enables a user to quickly discern its functionality. The compact nature of an oral appliance that resembles a mouth guard may allow for transportability and compact storage. The removable aspect of the oral appliance may avoid issues of prolonged wear such as tissue necrosis and inflammation.

“The present disclosure provides generally for a therapeutic oral device for sleep apnea and other health conditions. According to the present disclosure, the therapeutic oral device may comprise a hard palate portion, a mouth guard portion, and a tongue retainer portion. In some embodiments, the hard palate portion may comprise one or more materials. In some implementations, the hard palate portion may also comprise a composite of materials, including but not limited to one or more embedded materials.

“In some aspects, the mouth guard portion may comprise one or more components that provide stability and maintain the position of the therapeutic oral device within the mouth of a user. In some embodiments, the tongue retainer portion may comprise at least one airway and a predetermined length. In some implementations, a method of using the therapeutic oral appliance may comprise the utilization of one or more incremental oral devices to overcome a user’s gag reflex. In aspects wherein the therapeutic oral device may be formed from a mold, the mouth guard portion and the hard palate portion may be customized to fit to the dimensions of the mouth of an intended user.

“The present disclosure relates to a therapeutic oral appliance that may include a mouth guard portion, wherein the mouth guard portion may be configured to at least partially interface with one or more teeth of a user; a hard palate portion configured to at least partially interface with a hard palate of a mouth of the user, wherein the hard palate portion may extend upwardly from the mouth guard portion; a tongue retainer portion, wherein the tongue retainer portion may extend from the hard palate portion into at least a portion of a throat of the user, wherein the tongue retainer portion may comprise an upper surface, a lower surface, and a longitudinal length; and at least one airway, wherein the at least one airway may comprise one or more recesses within at least one of the upper surface of the tongue retainer portion and the lower surface of the tongue retainer portion, wherein the at least one airway may extend along at least a portion of the longitudinal length of the tongue retainer portion.

“In some embodiments, the mouth guard portion may comprise at least one safety mechanism. In some implementations, the tongue retainer portion may be fixed to a distal end of the hard palate portion. In some aspects, the longitudinal length of the tongue retainer portion may be adjustable. In some embodiments, the mouth guard portion may comprise at least one external attachment configured to interface with at least one supplemental device. In some implementations, the at least one external attachment may comprise at least one aperture.

“In some aspects, the at least one supplemental device may comprise a tube. In some embodiments, the mouth guard portion may comprise a universal fit that may be used by a generic user. In some implementations, the therapeutic oral appliance may be configured to interface with at least one wearable device. In some aspects, the at least one wearable device may comprise a smart watch. In some embodiments, the mouth guard portion may be configured to interface with one or more dental fixtures. In some implementations, the one or more dental fixtures may comprise braces.

“In some aspects, the therapeutic oral appliance may further comprise one or more sensors or electrodes. In some embodiments, the one or more sensors or electrodes may comprise at least one of: one or more electromyography electrodes, one or more acceleromyography sensors, one or more piezoelectric myography sensors, one or more temperature sensors, one or more peripheral artery tonometry sensors, one or more photoplethysmography sensors, one or more pulse oximetry sensors, one or more moisture sensors, one or more potential hydrogen (pH) sensors, one or more audio sensors, one or more force sensors or force transducers, one or more light-emitting sensors, one or more light absorption sensors, one or more muscle movement sensors, one or more accelerometers, one or more heart rate monitors, or one or more capnography sensors.

“In some implementations, the therapeutic oral appliance of the present disclosure may be configured to interface with at least one external device. In some aspects, the at least one external device may comprise at one of: a smartphone, a desktop computing device, a laptop computing device, a tablet computing device, and a medical apparatus. In some embodiments, the mouth guard portion may comprise at least one wire. In some implementations, the mouth guard portion may comprise an at least partially customized fit for a specific user. In some aspects, the mouth guard portion may be adjustable. In some embodiments, the hard palate portion may extend upwardly from the mouth guard portion to a point of central convergence.”

The claims supplied by the inventors are:

“1. A therapeutic oral appliance comprising: a mouth guard portion, wherein the mouth guard portion is configured to at least partially interface with one or more teeth of a user; a hard palate portion configured to at least partially interface with a hard palate of a mouth of the user, wherein the hard palate portion extends upward from the mouth guard portion; and at least one of: at least one sensor and at least one electrode.

“2. The therapeutic oral appliance of claim 1, wherein the therapeutic oral appliance further comprises a tongue retainer portion, wherein the tongue retainer portion extends from the hard palate portion into at least a portion of a throat of the user, wherein the tongue retainer portion comprises an upper surface, a lower surface, two opposing sidewalls, and a longitudinal length.

“3. The therapeutic oral appliance of claim 2, wherein the tongue retainer portion is fixed to a distal end of the hard palate portion.

“4. The therapeutic oral appliance of claim 2, further comprising: at least one airway, wherein the at least one airway comprises one or more indentations recesses within each of the two sidewalls of the tongue retainer portion, wherein the at least one airway extends along at least a portion of the longitudinal length of the tongue retainer portion, wherein the at least one airway comprises an air flow pathway that follows a natural anatomical airway passage of the user.

“5. The therapeutic oral appliance of claim 1, wherein the mouth guard portion comprises a universal fit that may be used by a generic user.

“6. The therapeutic oral appliance of claim 1, wherein the therapeutic oral appliance further comprises at least one electrical wire connected to the at least one of: the at least one sensor and the at least one electrode.

“7. The therapeutic oral appliance of claim 6, wherein the at least one electrical wire is at least partially embedded within at least one portion of the therapeutic oral appliance.

“8. The therapeutic oral appliance of claim 6, wherein the at least one electrical wire is configured upon one or more external surfaces of the therapeutic oral appliance.

“9. The therapeutic oral appliance of claim 2, wherein the tongue retainer portion extends directly from the hard palate portion into the at least a portion of the throat of the user.

“10. The therapeutic oral appliance of claim 2, wherein a cross section of the tongue retainer portion substantially comprises an I-beam structure.

“11. The therapeutic oral appliance of claim 1, wherein the therapeutic oral appliance at least partially comprises at least one silicone material.

“12. The therapeutic oral appliance of claim 1, wherein the therapeutic oral appliance at least partially comprises at least one material that comprises a low shore hardness.

“13. The therapeutic oral appliance of claim 1, wherein the therapeutic oral appliance comprises at least one material that becomes pliable when exposed to heat.

“14. The therapeutic oral appliance of claim 4, wherein the at least one airway originates and extends from a top portion of the mouth guard portion.

“15. The therapeutic oral appliance of claim 1, wherein the therapeutic oral appliance at least partially comprises at least one optically transparent material.

“16. The therapeutic oral appliance of claim 1, wherein the at least one of: the at least one sensor and the at least one electrode comprises at least one of: at least one electromyography electrode, at least one acceleromyography sensor, at least one piezoelectric myography sensors, at least one temperature sensor, at least one peripheral artery tonometry sensor, at least one one photoplethysmography sensor, at least one pulse oximetry sensor, at least one moisture sensor, at least one pH sensor, at least one audio sensor, at least one force sensor, at least one light-emitting sensor, at least one light absorption sensor, at least one muscle movement sensor, at least one accelerometer, at least one heart rate monitor, and at least one capnography sensor.

“17. The therapeutic oral appliance of claim 1, wherein the therapeutic oral appliance further comprises at least one transmitting device.

“18. The therapeutic oral appliance of claim 17, wherein the at least one transmitting device is configured to transmit data obtained from the at least one of: the at least one sensor and the at least one electrode.

“19. The therapeutic oral appliance of claim 18, wherein data obtained from the at least one of: the at least one sensor and the at least one electrode is transmitted to at least one database for storage.

“20. The therapeutic oral appliance of claim 1, wherein the therapeutic oral appliance further comprises at least one power source.”

URL and more information on this patent application, see: Hao, Phinarak. Therapeutic Oral Device. U.S. Patent Application Number 20230190514, filed February 10, 2023 and posted June 22, 2023. Patent URL (for desktop use only): https://ppubs.uspto.gov/pubwebapp/external.html?q=(20230190514)&db=US-PGPUB&type=ids

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