WO2024168249A1 - Therapeutic oral appliance or device - Google Patents
Therapeutic oral appliance or device Download PDFInfo
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- WO2024168249A1 WO2024168249A1 PCT/US2024/015169 US2024015169W WO2024168249A1 WO 2024168249 A1 WO2024168249 A1 WO 2024168249A1 US 2024015169 W US2024015169 W US 2024015169W WO 2024168249 A1 WO2024168249 A1 WO 2024168249A1
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- Prior art keywords
- oral appliance
- therapeutic oral
- sensor
- therapeutic
- user
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/56—Devices for preventing snoring
- A61F5/566—Intra-oral devices
Definitions
- THERAPEUTIC ORAL APPLIANCE OR DEVICE FIELD [0001] This disclosure relates to therapeutic oral appliances for sleep apnea and other health conditions.
- BACKGROUND [0002] 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.
- 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.
- CPAP continuous positive airway pressure
- 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 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.
- 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.
- 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.
- SUMMARY OF THE DISCLOSURE 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.
- the present disclosure provides generally for a therapeutic oral appliance or device for sleep apnea and other health conditions.
- the therapeutic oral appliance or device may comprise a hard palate portion, a mouth guard portion, and a tongue retainer portion.
- the hard palate portion may comprise one or more materials.
- the hard palate portion may also comprise a composite of materials, including but not limited to one or more embedded materials.
- the mouth guard portion may comprise one or more components that provide stability and maintain the position of the therapeutic oral appliance or device within the mouth of a user.
- the tongue retainer portion may comprise at least one airway and a predetermined length.
- a method of using the therapeutic oral appliance may comprise the utilization of one or more incremental oral appliances or devices to overcome a user’s gag reflex.
- the therapeutic oral appliance or 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.
- a therapeutic oral appliance 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.
- the mouth guard portion may comprise at least one safety mechanism.
- the tongue retainer portion may be fixed to a distal end of the hard palate portion.
- the longitudinal length of the tongue retainer portion may be adjustable.
- the mouth guard portion may comprise at least one external attachment configured to interface with at least one supplemental device.
- the at least one external attachment may comprise at least one aperture.
- the at least one supplemental device may comprise a tube.
- the mouth guard portion may comprise a universal fit that may be used by a generic user.
- the therapeutic oral appliance may be configured to interface with at least one wearable device.
- the at least one wearable device may comprise a smart watch.
- the mouth guard portion may be configured to interface with one or more dental fixtures.
- the one or more dental fixtures may comprise braces.
- the therapeutic oral appliance may further comprise one or more sensors or electrodes.
- the one or more sensors or electrodes may comprise at least one of: one or more electromyography electrodes, one or more acceleromyography sensors (e.g.
- one or more piezoelectric myography sensors for measuring muscle activity
- one or more temperature sensors for measuring muscle activity
- one or more peripheral artery tonometry sensors for measuring muscle activity
- one or more photoplethysmography sensors for measuring muscle activity
- one or more pulse oximetry sensors for measuring muscle activity
- one or more moisture sensors for measuring muscle activity
- one or more potential hydrogen (pH) sensors e.g. for measuring acid reflux
- one or more audio sensors e.g.
- one or more force sensors or force transducers for detection of snoring, airway obstruction, or airflow
- one or more force sensors or force transducers one or more pressure sensors (such as thin film pressure sensors), one or more piezoelectric sensors, one or more bite sensors, one or more gas concentration sensors, one or more gas pressure sensors, one or more electroencephalography electrodes, one or more actigraphy sensors, one or more magnetoencephalography sensors (such as optically pumped magnetometers), 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.
- one or more electrical wires may be in contact with one or more sensors or electrodes.
- the therapeutic oral appliance or device may further include a clock or timer (e.g. for starting or stopping measurements at specific times, for maintaining a measurement for a specific timeframe, or for adding time stamps to the measurement or sensor data). Sensors, monitors and electrodes may be located in or on different portions, areas or regions of the therapeutic oral appliance according to their purpose.
- the therapeutic oral appliance of the present disclosure may be configured to interface with at least one external device.
- the at least one external device may comprise at least one of: a smartphone, a desktop computing device, a laptop computing device, a tablet computing device, and a medical apparatus.
- the mouth guard portion may comprise at least one wire.
- the mouth guard portion may comprise an at least partially customized fit for a specific user.
- the mouth guard portion may be adjustable.
- the hard palate portion may extend upwardly from the mouth guard portion to a point of central convergence.
- FIG.2B illustrates a cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance.
- FIG.3A illustrates an exemplary therapeutic oral appliance comprising a tongue retainer portion.
- FIG. 3B illustrates an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance.
- FIG.4A illustrates an exemplary therapeutic oral appliance comprising a tongue retainer portion.
- FIG. 4B illustrates an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance.
- FIG.5A illustrates an exemplary therapeutic oral appliance comprising a tongue retainer portion.
- FIG. 5B illustrates an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance.
- FIG.6A illustrates an exemplary therapeutic oral appliance comprising a tongue retainer portion.
- FIG. 6B illustrates an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance.
- FIG.7A illustrates an exemplary therapeutic oral appliance comprising a tongue retainer portion.
- FIG. 7B illustrates an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance.
- FIG.8A illustrates a front view of an exemplary therapeutic oral appliance.
- FIG.8B illustrates a rear view of an exemplary therapeutic oral appliance.
- FIG.9 illustrates a mouth wearing an exemplary therapeutic oral appliance.
- FIG.10 illustrates an exemplary therapeutic oral appliance with a safety mechanism.
- FIG. 11A illustrates a side view of an exemplary therapeutic oral appliance with a mouth guard portion attachment.
- FIG. 11B illustrates a perspective view of a therapeutic oral appliance with a mouth guard portion attachment.
- FIG. 11A illustrates a side view of an exemplary therapeutic oral appliance with a mouth guard portion attachment.
- FIG. 12A illustrates a side view of an exemplary therapeutic oral appliance interfacing with an external device.
- FIG. 12B illustrates a side view of an exemplary therapeutic oral appliance interfacing with an external device.
- FIG. 12C illustrates a perspective view of an exemplary therapeutic oral appliance interfacing with an external device.
- FIG. 13A illustrates a side view of an exemplary therapeutic oral appliance with a mouth guard portion attachment.
- FIG. 13B illustrates a perspective view of an exemplary therapeutic oral appliance with a mouth guard portion attachment.
- FIG. 14A illustrates a side view of an exemplary therapeutic oral appliance with a mouth guard portion attachment.
- FIG. 14B illustrates a perspective view of an exemplary therapeutic oral appliance with a mouth guard portion attachment.
- FIG. 15A illustrates a side view of an exemplary therapeutic oral appliance with an adjustable tongue retainer portion.
- FIG.15B illustrates a top-down view of an exemplary therapeutic oral appliance with an adjustable tongue retainer portion.
- FIG. 16A illustrates a side view of an exemplary therapeutic oral appliance with an adjustable tongue retainer portion.
- FIG.16B illustrates a top-down view of an exemplary therapeutic oral appliance with an adjustable tongue retainer portion.
- FIG.17 illustrates an exemplary therapeutic oral appliance.
- FIG.18 illustrates an exemplary therapeutic oral appliance.
- FIG.19 illustrates an exemplary adjustable therapeutic oral appliance.
- FIG.20 illustrates an exemplary therapeutic oral appliance attachable to dental fixtures.
- FIG.21 illustrates an exemplary therapeutic oral appliance with wireless data transmission capabilities.
- FIG.22 illustrates a process of forming an exemplary therapeutic oral appliance.
- FIG.23 illustrates a process of forming an exemplary therapeutic oral appliance.
- FIG.24 illustrates an exemplary therapeutic oral appliance with wireless data transmission capabilities.
- FIG.25A illustrates an exemplary therapeutic oral appliance comprising a tongue retainer portion.
- FIG.25B illustrates a sectional view of an oral cavity comprising an exemplary therapeutic oral appliance.
- FIG.26 illustrates a perspective view of an exemplary therapeutic oral appliance.
- FIG.27A illustrates an exemplary therapeutic oral appliance.
- FIG.27B illustrates a perspective view of an exemplary therapeutic oral appliance.
- FIG.27C illustrates a sectional view of an oral cavity comprising an exemplary therapeutic oral appliance.
- FIG.28A illustrates an exemplary therapeutic oral appliance.
- FIG.28B illustrates a perspective view of an exemplary therapeutic oral appliance.
- FIG.29 illustrates a perspective view of an exemplary therapeutic oral appliance.
- DETAILED DESCRIPTION [0017]
- Therapeutic oral appliance refers to a device that may be removably inserted into the mouth of a user, wherein the therapeutic oral appliance may be configured to assess one or more health aspects of the user or alleviate one or more medical conditions experienced by the user.
- a therapeutic oral appliance may at least partially alleviate sleep apnea or teeth grinding of a user or a therapeutic oral appliance may detect a body temperature or blood oxygen level of a user.
- Tongue retainer portion refers to a portion of a therapeutic oral appliance that limits backward movement of the tongue when the therapeutic oral appliance is worn.
- a tongue retainer portion may comprise one or more airways that may prevent occlusion of the throat, allowing for unobstructed breathing.
- Hard palate portion refers to a portion of a therapeutic oral appliance that is configured to at least partially interface with the hard palate within the mouth of a user.
- Mouth guard portion refers to a portion of a therapeutic oral appliance that fits to or over at least a portion of one or more teeth of a user.
- a mouth guard portion may be customized to fit a user’s teeth, such as, for example and not limitation, by using a dental mold.
- a mouth guard portion may comprise an at least partially customized fit for a specific user.
- a mouth guard portion may comprise a substantially universal fit that may be used by any generic user without requiring a custom fitting.
- OSA as used herein refers to obstructive sleep apnea.
- the therapeutic oral appliance 100 may comprise a tongue retainer portion 110.
- the tongue retainer portion 110 may comprise one or more predetermined lengths. This may allow the user to gradually become accustomed to the presence of the tongue retainer portion 110 within at least a portion of the throat. Gradual introduction may allow for the suppression of the gag reflex, which may occur as the length of the tongue retainer portion 110 enters the throat.
- the tongue retainer portion 110 may comprise an upper surface, a lower surface, and a longitudinal length.
- the therapeutic oral appliance 100 may be utilized to relieve airway obstruction from one or more sources.
- the therapeutic oral appliance 100 may directly relieve obstruction caused by obstruction at the back or base of the tongue, uvula, and soft palate.
- the therapeutic oral appliance 100 may partially relieve obstruction that is caused by issues below the epiglottis such as hypopharyngeal issues, vocal cord folds and arytenoids, anterior-posterior soft palate collapse, lateral soft palate collapse, complete concentric collapse, epiglottic and tonsillar collapse.
- the therapeutic oral appliance 100 may address a plurality of issues of obstruction simultaneously through prescribed therapeutic use.
- the therapeutic oral appliance 100 may contribute to partial relief of obstruction by improving overall muscle tone of the oropharynx. This improvement may result as muscles resist and gain tone by resisting the therapeutic oral appliance 100.
- an airway 115 may provide airflow from the mouth to the soft palate. This may improve breathing and decrease airway obstruction.
- the material of the therapeutic oral appliance 100 may comprise materials that are sufficiently durable and chemical resistant to sanitize the therapeutic oral appliance 100 on a daily basis by chemical (e.g., mouth wash or alcohols) means or physical means (e.g., steam sterilization), as non-limiting examples.
- the removable aspect of the therapeutic oral appliance 100 may allow the user to clean and sanitize the therapeutic oral appliance 100 frequently. This may facilitate accessible cleaning that may reduce the possibility of tissue necrosis and infection, as a non- limiting list.
- the therapeutic oral appliance 100 may comprise a hard palate portion 130.
- the mating connected by symmetric surfaces between the hard palate and the hard palate portion 130 may improve the stability of the therapeutic oral appliance 100 within the oral cavity.
- the therapeutic oral appliance 100 may comprise a mouth guard portion 120.
- the hard palate portion 130 may extend upward from the mouth guard portion 120 to a central point of convergence.
- the mouth guard portion 120 may comprise a composite of materials. This may prevent fracture and fragment wear that could cause worn parts of the therapeutic oral appliance 100 to be swallowed.
- the substrate material may be embedded within the primary material.
- a hard plastic plate may be embedded in the medium of ethylene-vinyl acetate (EVA), or an elastomeric polymer, as the softer plastic cures within the teeth mold.
- EVA ethylene-vinyl acetate
- the embedded substrate may be fragmentary.
- an EVA material may have plates of harder plastic embedded in the regions over the rear molars to reduce wear from teeth grinding.
- the therapeutic oral appliance 100 may comprise a coated aspect.
- the therapeutic oral appliance 100 may be coated in a hardened plastic film that reduces torsional fatigue within the structure of the therapeutic oral appliance 100.
- the mouth guard portion 120 may be configured to at least partially interface with one or more teeth of a user.
- the therapeutic oral appliance 100 may comprise a hard palate portion 130.
- the hard palate portion 130 may interface with the hard palate within the mouth.
- the mouth guard portion 120 and the hard palate portion 130 may reduce point pressure by spreading the retaining force for the therapeutic oral appliance 100 across a larger surface area.
- the mouth guard portion 120 may provide protection to the soft sensitive tissue of the oral pharynx.
- a mouth guard portion 120 may protect the parts of the hard palate, soft palate, and oral pharynx from pressure points, as a non-limiting list. The pressure may originate from the oral airway.
- the mouth guard portion 120 may prevent pain and possible tissue necrosis by preventing these pressure points.
- the mouth guard portion 120 may extend to cover the hard and soft palate to protect sensitive tissues. This protection may assist in pushing the oral airway away from the oropharynx. In some embodiments, moving the oral airway away from the oropharynx may decrease the gag reflex.
- the level of customization of the therapeutic oral appliance 100 may vary. As an illustrative example, a user may receive a dental impression in a dentist’s office that provides a high- fidelity model of the unique aspects of the user’s mouth. This impression may be formed via physical or digital dental impression. This impression may become the casting for the therapeutic oral appliance 100. This high level of customization may allow the fit of the therapeutic oral appliance 100 to match the form of the hard palate and teeth with precision.
- the oral appliance or device can be customized to fit each user's unique dentition, maxillary or dental arch, palatal arch or vault, and palatal mucosa and rugae, thus making the least intrusive oral airway size and path for maximal comfort.
- a user may purchase a therapeutic oral appliance 100 remotely.
- the therapeutic oral appliance 100 may be delivered as a generic casting of a therapeutic oral appliance 100.
- the generic mold may fit most mouths in a loose composition.
- the generic casting may then become pliable after boiling it in water.
- the therapeutic oral appliance 100 may interface with the oral cavity.
- the quality of the interface may contribute to safety, comfort, and effectiveness as a therapeutic device, as a non-limiting list.
- the removable aspect of the therapeutic oral appliance 100 may also provide opportunity for frequent sanitation. This may prevent infection, inflammation, and tissue necrosis, as non-limiting examples.
- the mouth guard portion 120 may interface with the teeth. This interface may maintain the position of the therapeutic oral appliance 100 in the mouth and prevent ingestion of the therapeutic oral appliance 100.
- the therapeutic oral appliance 100 may comprise a hard palate portion 130.
- the mouth guard portion 120 and the hard palate portion 130 may reduce the probability of subconscious rejection of the therapeutic oral appliance 100 by spitting it out.
- the custom fit of the therapeutic oral appliance 100 may reduce this probability by increasing comfort.
- the interface between the therapeutic oral appliance 100 and the oral cavity may assist in alignment of the tongue retainer portion 110 within the throat. Unsecured movement of the tongue retainer portion 110 may result in triggering the gag reflex or choking.
- the tongue retainer portion 110 may be fixed to and extend from a distal end of the hard palate portion 130 into at least a portion of the throat sufficient to reduce movement of the tongue.
- the tongue retainer portion 110 may be trimmable for preferential comfort and fit within the throat, as non-limiting examples. In some aspects, the tongue retainer portion 110 may prevent the tongue from falling back and touching the soft palate, which may otherwise create airway obstruction. In some embodiments, the tongue retainer portion 110 may comprise an airway 115 that ensures airflow when the tongue retainer portion 110 occupies the throat. [0032] In some aspects, the tongue retainer portion 110 may comprise an airway 115. In some implementations, the airway 115 may comprise one or more recesses or slots within the upper and/or lower surface of the tongue retainer portion 110 that extend along at least a portion of the longitudinal length of the tongue retainer portion 110, thereby forming one or more channels or grooves.
- airway 115 channels may provide an airway to allow air flow.
- the airway 115 may follow the natural anatomical airway passage of the user. This may decrease the chance of inadvertent airway obstruction by the therapeutic oral appliance 100.
- the conformity to the natural anatomy of the oral cavity may result from the custom fit of the therapeutic oral appliance 100.
- Fig.2A an exemplary therapeutic oral appliance 200 is illustrated.
- Fig. 2B a cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance 200 is illustrated.
- the therapeutic oral appliance 200 may comprise a hard palate portion 230.
- the therapeutic oral appliance 200 may comprise a mouth guard portion 220.
- the hard palate portion 230 may extend upward from the mouth guard portion 220 to a central point of convergence. [0034] In some embodiments, the hard palate portion 230 may interface with the hard palate 260. In some aspects, the surface of the hard palate portion 230 may mirror the geometry of the hard palate 260 to provide a custom fit. In some embodiments, the hard palate portion 230 may comprise identical geometry to the hard palate 260 by being cured in a mold formed from an impression of the user’s oral cavity. In some implementations, this mold may be a standard mold used in creating denture impressions. [0035] In some implementations, the distal end of the therapeutic oral appliance 200 may align with the beginning of the soft palate 270 within the oral cavity.
- the mouth guard portion 220 may interface with the teeth 250.
- the interaction between the guard portion 220 and the teeth 250 may operate as a mated interface that is formed by curing the resin for the therapeutic oral appliance 200 within a casting made from an impression of the user’s teeth 250.
- a patient may wear a therapeutic oral appliance 200 without the tongue retainer portion to begin the incremental process to suppress the gag reflex. Wearing a therapeutic oral appliance 200 may be uncomfortable at first, particularly for those who are unaccustomed to wearing oral appliances. A patient may get used to the therapeutic oral appliance 200 by wearing it for a few hours and then overnight, as a way to build up to the gag reflex suppression process with the tongue retainer portion.
- the mouth guard portion 220 may comprise a generic cast that, upon inducing heat to increase malleability, may be formed to the shape of the intended teeth 250. This may provide greater comfort when wearing the therapeutic oral appliance 200. A formed therapeutic oral appliance 200 may prevent unconscious rejection from the mouth. For example, a user may unconsciously spit out the therapeutic oral appliance while sleeping unless the therapeutic oral appliance 200 is homogeneous with the structure of the oral cavity.
- the mouth guard portion 220 may comprise a cavity designed to enclose a plurality of teeth 250 simultaneously. The thickness of the outside edge of the mouth guard portion 220 may be of minimal thickness to ensure an unobstructive fit within the oral cavity.
- a minimal thickness may increase the comfort of the therapeutic oral appliance 200 and the effectiveness of therapeutic utilization by avoiding subconscious rejection, as non-limiting examples.
- Fig.3A an exemplary therapeutic oral appliance 300 comprising a tongue retainer portion 310 is illustrated.
- Fig. 3B an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance 300 is illustrated.
- the therapeutic oral appliance 300 may comprise a hard palate portion 330.
- the therapeutic oral appliance 300 may comprise a mouth guard portion 320.
- the hard palate portion 330 may interface with the hard palate 360.
- the tongue retainer portion 310 may align with the soft palate 370.
- the tongue retainer portion 310 may comprise an upper surface, a lower surface, and a longitudinal length.
- the therapeutic oral appliance 300 may enter the throat 380 via the tongue retainer portion 310.
- the therapeutic oral appliance 300 may comprise a tongue retainer portion 310 of a plurality of predetermined lengths. This may allow the user to gradually become accustomed to the presence of the tongue retainer portion 310 within the throat 380. This may train the gag reflex to refrain from engaging the tongue retainer portion 310 sufficient to allow the user to insert the therapeutic oral appliance 300 daily.
- the tongue retainer portion 310 may be fixed to a distal end of the hard palate portion 330.
- the therapeutic oral appliance 300 may interface with the tongue 340.
- the tongue retainer portion 310 may direct the tongue 340 through the physical presence of the tongue retainer portion 310.
- the tongue retainer portion 310 may restrain the tongue 340 sufficient to facilitate unobstructed breathing.
- a person in a coma may need a clear airway to receive sufficient oxygen. In an unconscious state, the tongue 340 may otherwise reduce or impair the user’s airway.
- the mouth guard portion 320 may be configured to at least partially interface with one or more teeth 350. This may prevent the therapeutic oral appliance 300 from dislodgement and potential ingestion.
- the therapeutic oral appliance 400 may comprise a hard palate portion 430.
- the therapeutic oral appliance 400 may comprise a mouth guard portion 420.
- the hard palate portion 430 may extend upward from the mouth guard portion 420 to a central point of convergence.
- the hard palate portion 430 may interface with the hard palate 460.
- the tongue retainer portion 410 may align with the soft palate 470.
- the tongue retainer portion 410 may comprise an upper surface, a lower surface, and a longitudinal length.
- the therapeutic oral appliance 400 may enter the throat 480.
- the tongue retainer portion 410 may enter the throat incrementally to avoid triggering a gag reflex.
- the tongue retainer portion 410 may be fixed to a distal end of the hard palate portion 430.
- a gag reflex is a contraction of the throat that occurs when an object makes contact with the back of the tongue 440 or throat 480. This gag reflex may be overcome through incremental introduction of the tongue retainer portion 410 into the throat 480.
- this may be introduced by wearing a therapeutic oral appliance 400 with an incremental increase in tongue retainer portion length 410 for a predetermined time.
- the length of the tongue retainer portion 410 may be sufficiently short to prevent the grasping of the tongue retainer portion 410 by the throat 480 via throat contraction caused by the gag reflex.
- the length of the tongue retainer portion 410 may be sufficiently short to prevent irregular swallowing due to the throat exerting a downward force on the therapeutic oral appliance 400 by grasping the end of the tongue retainer portion 410 during throat contraction.
- the therapeutic oral appliance 400 may interface with the tongue 440.
- the tongue retainer portion 410 may restrain the tongue 440 sufficiently to facilitate unobstructed breathing.
- the mouth guard portion 420 may be configured to at least partially interface with one or more teeth 450. In some aspects, the mouth guard portion 420 may secure the therapeutic oral appliance 400 within the oral cavity. This may prevent ingestion of the therapeutic oral appliance 400.
- Fig.5A an exemplary therapeutic oral appliance 500 comprising a tongue retainer portion 510 is illustrated.
- Fig. 5B an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance 500 is illustrated.
- the therapeutic oral appliance 500 may comprise a hard palate portion 530. In some embodiments, the hard palate portion 530 may interface with the hard palate 560.
- the interface between the hard palate 560 and the hard palate portion 530 may provide stability that reduces movement of the tongue retainer portion 510 within the throat 580.
- the therapeutic oral appliance 500 may comprise a mouth guard portion 520.
- the hard palate portion 530 may extend upward from the mouth guard portion 520 to a central point of convergence.
- the mouth guard portion 520 may be configured to at least partially interface with one or more teeth 550.
- the mouth guard portion 520 may provide a generic fit to the teeth 550 with limited malleable properties. This generic tooth form may provide sufficient stability to prevent ingestion of the therapeutic oral appliance 500.
- the tongue retainer portion 510 may align with the soft palate 570.
- the tongue retainer portion 510 may comprise an upper surface, a lower surface, and a longitudinal length.
- the therapeutic oral appliance 500 may enter the throat 580.
- the user may modify the length of the tongue retainer portion 510.
- the tongue retainer portion 510 may be shortened by severing the tongue retainer portion 510 with scissors to the desired length. This may allow a user to customize the length of the tongue retainer portion 510. Shortening the tongue retainer portion 510 may be necessary if the tongue retainer portion 510 extends into the throat 580 sufficient to trigger the gag reflex.
- the therapeutic oral appliance 500 may interface with the tongue 540.
- the therapeutic oral appliance 600 may comprise a hard palate portion 630.
- the therapeutic oral appliance 600 may comprise a mouth guard portion 620.
- the hard palate portion 630 may extend upward from the mouth guard portion 620 to a central point of convergence.
- the mouth guard portion 620 may be configured to at least partially interface with one or more teeth 650.
- the hard palate portion 630 may interface with the hard palate 660.
- the tongue retainer portion 610 may align with the soft palate 670.
- the tongue retainer portion 610 may comprise an upper surface, a lower surface, and a longitudinal length.
- the tongue retainer portion 610 may be fixed to a distal end of the hard palate portion 630 and encroach into the throat 680.
- the tongue retainer portion 610 may increase in length incrementally.
- a user may, upon ordering the therapeutic oral appliance, receive a plurality of therapeutic oral appliances comprising therapeutic oral appliances with incremental tongue retainer portions, such as described in Figures 2A-6A.
- the user may use a therapeutic oral appliance with incrementally longer tongue retainer portions until snoring is effectively prevented.
- a user may wear each size for a few days to a few weeks each, depending on the comfort level of each therapeutic oral appliance.
- the user may use the therapeutic oral appliance daily while sleeping to acclimate the throat to the tongue retainer portion and overcome the gag reflex.
- the user may discover that an intermediary length of the tongue retainer portion is of sufficient length for therapeutic purposes, where the user may not benefit from an incrementally longer tongue retainer portion.
- the user may incrementally increase the length of the tongue retainer portion 610 until the length is sufficient to relieve obstruction but remain sufficiently comfortable for use while sleeping.
- the user may discover a need to trim the length of the tongue retainer portion 610 of the therapeutic oral appliance to achieve a desired length that is between the incremental tongue retainer portions.
- the length of the tongue retainer portion 610 may remain shorter than the distance to the epiglottis to ensure swallowing remains possible.
- Fig.7A an exemplary therapeutic oral appliance 700 comprising a tongue retainer portion 710 is illustrated, wherein the therapeutic oral appliance 700 is fitted for a child.
- Fig.7B an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance 700 is illustrated.
- the therapeutic oral appliance 700 may comprise a hard palate portion 730.
- the therapeutic oral appliance 700 may comprise a mouth guard portion 720.
- the hard palate portion 730 may extend upward from the mouth guard portion 720 to a central point of convergence.
- the hard palate portion 730 may interface with the hard palate 760.
- the tongue retainer portion 710 may align with the soft palate 770.
- the tongue retainer portion 710 may comprise an upper surface, a lower surface, and a longitudinal length.
- the therapeutic oral appliance 700 may enter the throat 780.
- the therapeutic oral appliance 700 may interface with the tongue 740.
- the mouth guard portion 720 may be configured to at least partially interface with one or more teeth 750.
- tongue retainer portions 710 For smaller mouths, such as with children, incremental increases in tongue retainer portions 710 may be smaller to allow for a more refined fit. Smaller size increases may allow for easier transition with increased likelihood that the gag reflex suppression may occur without issue. Smaller mouths may require shorter tongue retainer portions 710. In some aspects, the incremental sizes of tongue retainer portions 710 may depend on predefined factors, such as strength of gag reflex, mouth size, user preference, practitioner recommendations, or level of customization. For example, where the therapeutic oral appliance is prescribed by a practitioner, the increments may be more customized than an over-the-counter version of a therapeutic oral appliance. [0058] Referring now to Figs. 8A–8B, a front view of an exemplary therapeutic oral appliance 800 is illustrated.
- the tongue retainer portion 810 of the therapeutic oral appliance 800 may comprise one or more uniform recesses or slots that span the longitudinal length of the tongue retainer portion 810 to create an airway 815.
- the airway 815 may comprise uniform indentations along the sidewall of the tongue retainer portion 810.
- the airway 815 may comprise air flow pathways that are parallel to the direction of the throat.
- the tongue retainer portion 810 may comprise one or more airway 815 tubes that continue for the longitudinal length of the tongue retainer portion 810. This may be useful if the throat is inflamed or otherwise restricted so as to render embedded channels within the walls of the tongue retainer portion 810 ineffective.
- the airway 815 may comprise an integrated tube that runs through the center of the tongue retainer portion 810. This may reduce the required insertion diameter and prevent obstruction by utilizing existing material that extends the length of the therapeutic oral appliance 800.
- a mouth wearing an exemplary therapeutic oral appliance 900 is illustrated.
- the mouth guard portion 920 may be configured to at least partially interface with one or more teeth 950 in a form fit.
- the therapeutic oral appliance 900 may fit similarly to a sport mouth guard, teeth whitening tray, incremental braces systems, or teeth grinding protectors, as non-limiting examples.
- a therapeutic oral appliance 900 may fit over dentures.
- a therapeutic oral appliance 900 may fit over gums for user’s who may remove their dentures at night.
- the therapeutic oral appliance 1000 may comprise at least one safety mechanism 1005.
- the safety mechanism 1005 may extend the entirety of the length of the therapeutic oral appliance 1000. In some aspects, this may prevent the ingestion of a portion of the therapeutic oral appliance 1000 that may break off from the therapeutic oral appliance 1000. This may be possible after prolonged use creates fatigue within the therapeutic oral appliance 1000 that creates structural instability within the therapeutic oral appliance 1000.
- the mouth guard portion 1120 may comprise at least one external attachment.
- the external attachment may maintain a partially opened state for the mouth.
- the external attachment may be configured to interface with at least one supplemental device.
- the external attachment may comprise at least one aperture or opening that allows for the insertion of a variety of supplemental devices in the form of tubes into the oral cavity.
- an anesthesiologist may insert tubes to regulate sedation during surgery. This opening in the external attachment, with support from the hard palate portion 1130, may provide stability that allows the tube to remain in a fixed state.
- a source of humidified air or oxygen may be diffused near the oral cavity to provide humidification. This may assist in preventing dryness in the mouth and oropharynx. The reduced dryness may provide increased user comfort.
- a feeding tube may interface with the external attachment to provide nutrition to a user in a coma. Supplemental tubes may also sustain health for users with a variety of health challenges.
- a tube opening may provide access to the oral cavity while a user undergoes an epileptic seizure.
- the tongue retainer portion 1110 may assist in stabilizing the tongue and maintaining an unobstructed airway.
- the tube opening may assist in dampening muscular contractions within the jaw that may otherwise harm the user during the epileptic seizure.
- the tube opening may also maintain an orifice for the duration of the episode in case vomiting occurs.
- Physical disabilities may also necessitate the utilization of supplemental tubes for sustenance.
- a user with cerebral palsy may struggle with aspiration due to muscle weakness. This may necessitate a breathing tube. Due to other muscular atrophy and fatigue, a feeding tube may also be employed to ensure adequate nutrition.
- a therapeutic oral appliance 1100 may allow for prolonged use with reduced risk of damage to a user’s mouth, throat, respiratory system, and overall health.
- Figs.12A–12B an exemplary therapeutic oral appliance 1200 with a mouth guard portion 1220 attachment is illustrated.
- the mouth guard portion 1220 may comprise at least one external attachment.
- the mouth guard portion 1220 may interface with at least one supplemental device 1290. In some embodiments, the mouth guard portion 1220 may interface with at least one supplemental device 1290 via the external attachment. In some aspects, the external attachment may maintain a partially opened state for the mouth. In some embodiments, the external attachment may comprise an aperture or opening that allows for the insertion of a variety of supplemental devices 1290 in the form of tubes into the oral cavity. [0067] As an example, an anesthesiologist may insert a tube to regulate sedation during surgery. This opening in the external attachment, with support from the hard palate portion 1230, may provide stability that allows the tube to remain in a fixed state. The opening in the external attachment may comprise a similar diameter to commonly interfaced sedation tubes.
- a source of humidified air or oxygen may be diffused near the oral cavity to provide humidification. This may assist in preventing dryness in the mouth and oropharynx. The reduced dryness may provide increased user comfort.
- Physical disabilities may also necessitate the utilization of supplemental tubes for sustenance. For example, a user with cerebral palsy may struggle with aspiration due to muscle weakness. This may necessitate a breathing tube. Due to other muscular atrophy and fatigue, a feeding tube may also be employed to ensure adequate nutrition.
- a therapeutic oral appliance 1200 may allow for prolonged use with reduced risk of damage to a user’s mouth, throat, respiratory system, and overall health.
- a side view of exemplary therapeutic oral appliance 1300 with a mouth guard portion attachment is illustrated.
- the therapeutic oral appliance 1300 may comprise a mouth guard portion 1320.
- the mouth guard portion 1320 may comprise an attachment to prevent the grinding of the teeth.
- the therapeutic oral appliance 1300 may comprise a hard palate portion 1330 that may assist with reducing translational movement caused by teeth grinding.
- the hard palate portion 1330 may extend upward from the mouth guard portion 1320 to a central point of convergence.
- the therapeutic oral appliance 1400 may comprise a mouth guard portion 1420.
- the mouth guard portion 1420 may comprise an attachment to prevent the grinding of the teeth.
- the therapeutic oral appliance 1400 may comprise a hard palate portion 1430 that may assist with reducing translational movement caused by teeth grinding.
- the hard palate portion 1430 may extend upward from the mouth guard portion 1420 to a central point of convergence.
- the therapeutic oral appliance 1400 may interface with the lower jaw via attachment to a lower therapeutic oral appliance 1400.
- a therapeutic oral appliance may cover the lower teeth.
- the therapeutic oral appliance may connect to the therapeutic oral appliance 1400 secured to the upper palate. This may increase comfort and security, as non-limiting attributes.
- the tongue retainer portion 1510 may comprise an upper surface, a lower surface, and a longitudinal length. In some aspects, the tongue retainer portion 1510 may extend into the throat at a variety of lengths that are determined by a plurality of predetermined longitudinal lengths that are adjusted in a region of the therapeutic oral appliance 1500. In some embodiments, the tongue retainer portion 1510 may be fixed to a distal end of the hard palate portion 1530. In some implementations, the tongue retainer portion 1510 may be removed from the therapeutic oral appliance 1500.
- the adjustable aspect of the tongue retainer portion 1510 may interface with an extrusion connected to the mouth guard portion 1520.
- the adjustment of the tongue retainer portion 1510 may comprise a mechanism that exerts force on a fixture attached to the therapeutic oral appliance 1500.
- the hard palate portion 1530 may provide stability as the therapeutic oral appliance 1500 is adjusted within the oral cavity.
- the tongue retainer portion 1510 may comprise an airway 1515 that extends in conjunction with the extension of the tongue retainer portion 1510.
- the airway 1515 may originate on the top of the mouth guard portion 1520.
- the airway 1515 and tongue retainer portion 1520 may be molded to follow the contour of the hard palate and soft palate.
- one or more channels for airway patency are included along the sides of airway 1515. In some embodiments, these channels may begin between the teeth or gums, as non-limiting options, in the case of edentulism, to provide airway patency so the airway 1515 is not occluded by the teeth or lips.
- the airway 1515 and the tongue retainer portion 1520 may comprise a reinforced bridge portion that runs along the midline, near the midline, or parallel to midline of the hard palate and soft palate, as non-limiting alternatives.
- this reinforced portion may be attached to a flattened section that runs parallel to the hard palate portion 1530. This may provide increased surface area to push and stabilize the tongue and soft palate tissue away from each other to provide an airway 1515.
- the gap created by the reinforced bridge between the palate and the flattened plane may facilitate air flow.
- the parallel planes separated by the reinforced bridge may form the airway 1515.
- the cross section of this structural design may be similar to an I-beam.
- the I-beam consists of two horizontal planes, known as flanges, connected by one vertical component, or the web. The shape of the flanges and the web create an “I” cross-section.
- the flanges correlate to the planes touching the palate on one end and the tongue on the other end.
- the web correlates to the reinforced bridge that is the vertical component that connects the two horizontal planes.
- the space between the flanges created by the web is the channel where the air flow passes.
- the cross-sectional area for the airway 1515 may be sufficient to prevent increased respiratory effort or increased negative pressure on the lungs.
- the tongue retainer portion 1610 may extend into the throat at a variety of lengths that are determined by a plurality of predetermined longitudinal lengths that are adjusted in a region of the therapeutic oral appliance 1600. In some implementations, the tongue retainer portion 1610 may be removed from the therapeutic oral appliance 1600. [0078] In some embodiments, the mouthguard portion 1620 may remain fixed while the airway 1615 may be moved and secured at different depths within the throat. In some implementations, the airway 1615 channel may be slid back and forth until the desired depth into the throat is reached. In some aspects, the airway 1615 may be secured into this position by a clamp or another non-limiting securing device.
- a client may purchase a single therapeutic oral appliance and, at first, may use the therapeutic oral appliance with an airway that is completely retracted. The client may gradually increase the extension of the airway into the throat until the airway has extended the originally intended distance into the throat.
- the airway 1615 may originate on the top of the mouth guard portion 1620.
- the airway 1615 and tongue retainer portion 1620 may be molded to follow the contour of the hard palate and soft palate.
- one or more channels for airway patency are included along the sides of airway 1615.
- these channels may begin between the teeth or gums, as non-limiting options, in the case of edentulism, to provide airway patency so the airway 1615 is not occluded by the teeth or lips.
- the mouth guard portion 1720 may comprise a plurality of components.
- the mouth guard portion 1720 may comprise a brace with selective teeth caps.
- at least one flexible wire may prevent slipping by applying a minimal retaining force upon the front teeth.
- a symmetrical plurality of tooth caps may be attached to the flexible wire and secure the therapeutic oral appliance 1700 by enclosing a plurality of teeth on both sides of the mouth.
- the tooth caps may comprise a generic cast that, upon inducing heat to increase malleability, may be formed to the shape of the intended teeth.
- the tooth cap may comprise a cavity designed to enclose a plurality of teeth simultaneously. The thickness of the outside edge of the tooth cap may be of minimal thickness to ensure a fit between the teeth enclosed within the tooth cap and those excluded.
- a mold may provide a mated fit between the hard palate portion 1730 and the hard palate within the oral cavity.
- an exemplary therapeutic oral appliance 1800 is illustrated.
- the mouth guard portion 1820 may comprise a plurality of components.
- the mouth guard portion 1820 may comprise a brace with selective teeth caps.
- the teeth caps may enclose a plurality of teeth singularly.
- the mouth guard portion 1820 may allow a user to bite down on the therapeutic oral appliance 1800 without requiring a fitting over teeth. This may allow for a more universal fit, such as for over-the-counter solutions.
- the teeth caps may enclose three teeth separately on both sides of the mouth to ensure the required stability and security for the therapeutic oral appliance 1800.
- a mold may provide a mated fit between the hard palate portion 1830 and the hard palate within the oral cavity.
- the hard palate portion 1830 may comprise a variety of materials to accommodate a plurality of preferences.
- the therapeutic oral appliance 1800 may comprise silicone for ideal softness, durability, and hygiene.
- the therapeutic oral appliance may comprise a soft silicone material with low shore hardness. This may provide an airway 1815 channel for breathing that allows for flexibility. The flexibility may allow the patient to swallow and maintain some tongue movement. This allowance may increase comfort for the patient.
- the mouth guard portion 1820 may cover one or more teeth or gums as a means to protect teeth from pressure points from the oral airway. The mouth guard portion 1820 may stabilize the oral airway while the user is unconscious to reduce the chance of inadvertent rejection by spitting out the therapeutic oral appliance 1800.
- a user’s hard palate may be prone to inflammation when interfacing with typical medical grade plastics and polymers.
- the user may experience greater comfort and utility by utilizing a therapeutic oral appliance 1800 that comprises a hard palate portion 1830 composed of a metal or silicone mesh.
- a flexible or meshed hard palate portion 1830 may allow for a snug fit without requiring a custom mold.
- FIG.19 an exemplary adjustable therapeutic oral appliance 1900 is illustrated.
- the mouth guard portion 1920 may comprise a plurality of components.
- the dimensions of the therapeutic oral appliance 1900 may be adjustable.
- the tongue retainer portion 1910 may attach to a frame of the therapeutic oral appliance 1900.
- the hard palate portion 1930 may interface with a minimized region of the hard palate.
- a mouth may be changing and growing quickly, such as with children. Their mouth size and shape may change between incremental tongue retainer portions 1910, which may make it impractical to use one mouth mold to create the incremental therapeutic oral appliances 1900.
- a mouth guard portion 1920 may fit over a few teeth, such as front teeth and back molars, that are unlikely to shift or change drastically during the acclimation period for the therapeutic oral appliance 1900. This may be combined with an extendable hard palate portion 1930 that may allow for growth.
- an exemplary therapeutic oral appliance 2000 configured to interface with one or more dental fixtures, such as by being attachable thereto, is illustrated.
- the dental fixtures may be attached to the teeth 2050.
- the therapeutic oral appliance 2000 may connect to the metal fastening rods located on braces 2055 that are secured to the teeth 2050.
- a teenager may overcome sleep apnea while wearing braces by attaching the therapeutic oral appliance 2000 to hooks on braces attached to the canine teeth.
- the mouth guard portion 2020 may extend rearward into the mouth.
- the hard palate portion 2030 may interface with a minimized region of the hard palate.
- the therapeutic oral appliance may contain a plurality of electronic components that may be configured to interface with at least one external device 2190.
- the therapeutic oral appliance 2100 may be configured to interface with and relay information to at least one wearable device 2195 (such as, for example and not limitation, a smart watch).
- the tongue retainer portion 2110 may comprise one or more sensors.
- the airway 2115 may contain a plurality of electronic components.
- the therapeutic oral appliance 2100 may comprise electrodes that may provide transcutaneous electrical stimulation to oropharyngeal and tongue muscles. This may increase muscle tone, allowing for an opening of the patient airway channel.
- a child prone to seizures may use a therapeutic oral appliance 2100 with an embedded accelerometer that notifies the parents of sharp increases in rapid movement that may be indicative of a seizure. This may be helpful at night when the family is asleep and the parents may otherwise remain unaware of the child’s seizure.
- the therapeutic oral appliance 2100 may limit likelihood that a seizure may cause the tongue to obstruct the child’s airway, which may cause permanent or temporary brain damage.
- a user may purchase a therapeutic oral appliance 2100 to overcome sleep apnea that pairs with an external device 2190 in the form of the user’s phone (such as, for example and not limitation, a smartphone) or computing device, such as a desktop computer, a laptop computer, or tablet as non-limiting examples.
- Embedded accelerometers and heart rate monitors may record information as the user sleeps to display quality of sleep information. The user may be able to see how restless they slept as well as their rest heart rate and oxygen levels. This may assist in overcoming sleep apnea by emitting vibrational frequencies during sleep to reposition the user to a better sleeping position when oxygen levels are too low.
- a user may be recovering from an illness that has a high rate of respiratory issues.
- the therapeutic oral appliance 2100 may track oxygenation levels (for example, by using a pulse oximeter) and heart rate to monitor and manage symptoms. Where levels drop below predefined threshold parameters, a practitioner or hospital may be notified. If a user is unresponsive to the practitioner, an ambulance may be sent.
- an anesthesiologist may insert a therapeutic oral appliance 2100 during a surgery that comprises one or more health monitors. The anesthesiologist may monitor heart rate, oxygen levels, and breathing rate during the surgery.
- This information may display via Bluetooth ® connection with one or more external devices 2190 in the form of one or more medical apparatuses stationed within the operation room.
- the medical equipment may be configured to convey notifications and alarms for predetermined thresholds.
- the medical equipment may notify the anesthesiologist of recommended times to routinely evaluate specific health criterion based on current health levels of the patient.
- the therapeutic oral appliance 2100 may comprise a capnograph or gas analyzer.
- a capnograph may measure predefined gases, such as inhaled oxygen and expired carbon dioxide.
- a gas analyzer may indicate how much oxygen therapy may be required to achieve a desired blood oxygen saturation.
- the gas monitors may provide indicative information regarding a patient’s ventilation.
- therapeutic oral appliance may be formed from an impression.
- the impression may comprise an impression of teeth and an impression of the hard palate, as non-limiting options.
- physical impressions may be made of the upper hard palate, dentition, and as much of the soft palate as can be tolerated.
- the impressions of the patient’s mouth may be rendered digitally.
- an impression may be scanned by a high-fidelity 3-D scanner to render a virtual representation of the impression within a modeling software.
- a digital rendering of an airway may be created along the longitudinal length of the digital impression of the therapeutic oral appliance.
- a physical construction of the digital rendering and airway may be formed.
- the digital rendering may be printed by a 3-D printer.
- this physical construction may provide a tangible medium to further the formation of the therapeutic oral appliance, such as by providing a shape for a mold.
- a mold may be formed using the physical rendition of the impression and the airway.
- the mold may be used to create a therapeutic oral appliance by using the mold for casting.
- a 3-D printed prototype may be place in casting clay to form an impression that is subsequently filled with a soft silicone material.
- a synthetic polymer may be poured into the mold and, upon solidifying, may produce a therapeutic oral appliance in the form of the impression and the airway.
- a method 2300 of forming an exemplary therapeutic oral appliance is illustrated.
- physical impressions of a patient’s mouth may be formed.
- the impressions may comprise an impression of the teeth and an impression of the hard palate, as non-limiting options.
- the impressions of the patient’s mouth may be scanned in three dimensions.
- an impression may be scanned by a high-fidelity 3-D scanner to render a virtual representation of the impression within a modeling software.
- a digital rendering of an airway may be created along the longitudinal length of the digital impression.
- a physical construction of the digital impression and airway may be constructed.
- the digital rendering of the impression and the airway may be printed by a 3-D printer.
- a mold may be formed using the physical rendition of the impression and the airway.
- the mold may be used to create a therapeutic oral appliance by using the mold for casting.
- a synthetic polymer may be poured into the mold and, upon solidifying, may produce a therapeutic oral appliance in the form of the impression and the airway.
- the therapeutic oral appliance 2400 may comprise one or more electronic components, wherein at least one of the electronic components may be configured to interface with at least one external device 2490.
- the therapeutic oral appliance 2400 may be configured to interface with at least one wearable technology device 2495 (such as, for example and not limitation, a smart watch).
- the one or more electronic components of the therapeutic oral appliance 2400 may enable the therapeutic oral appliance 2400 to transmit data to and/or receive data from the external device 2490 and/or the wearable technology device 2495.
- At least one internal or external portion of at least one of: a tongue retainer portion 2410, a mouth guard portion 2416, a hard palate portion 2417, or any other appropriate portion of the therapeutic oral appliance 2400 may comprise one or more electronic components in the form of one or more sensors and/or one or more electrodes.
- one or more electrical wires may be placed upon at least a portion of at least one external surface of the therapeutic oral appliance 2400 and/or at least partially embedded within at least one internal portion of the therapeutic oral appliance 2400.
- one or more electrical wires may be embedded inside the therapeutic oral appliance 2400 to block contact between the electrical wire(s) and the inside of a user’s mouth to minimize the user’s likelihood of experiencing irritation or encountering injury, as well as increase the useful longevity of the therapeutic oral appliance 2400.
- one or more electrical wires may be used to couple two or more electronic components together, such as, for example and not limitation, to couple one or more sensors or electrodes to each other and/or to one or more batteries or other power sources.
- the therapeutic oral appliance 2400 may comprise one or more transmitting devices and/or one or more receiving devices for transmitting or receiving data, respectively.
- each transmitting device may comprise at least one of: a radio-frequency (RF) transmitter or a Bluetooth ® transmitter
- each receiving device may comprise at least one of: an RF receiver and a Bluetooth ® receiver.
- one or more electrical wires may couple each transmitting device and/or each receiving device to one or more sensors and/or one or more electrodes, as well as to at least one power source, such as, for example and not limitation, a battery.
- the transmitting device(s) of the therapeutic oral appliance 2400 may transmit data obtained from one or more sensors and/or one or more electrodes to at least one of: the external device 2490, the wearable technology device 2495, or at least one external or remote database or similar memory resource for at least temporary storage therein.
- one or more sensors or electrodes within or upon the therapeutic oral appliance 2400 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 pH sensors, one or more audio sensors, one or more force sensors, one or more pressure sensors, one or more bite sensors, one or more gas concentration sensors, one or more gas pressure sensors, one or more electroencephalography electrode, one or more actigraphy sensor, one or more magnetoencephalography sensor, 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, and/or one or more capnography sensors.
- the therapeutic oral appliance or device may further include a clock or timer.
- a clock or timer when one or more sensors in the therapeutic oral appliance detects that the therapeutic oral appliance is no longer in a proper position, an alert can be sent to a nearby monitoring device or app (such as a cell phone or display unit) so that the device or app can sound an alarm to alert the patient to reposition the therapeutic oral appliance properly. In this way, the patient will know when the oral appliance has inadvertently been displaced or dislodged from the correct position.
- one or more sensors and/or electrodes may be configured upon or within the therapeutic oral appliance 2400 at a location that may be most advantageous to its purpose.
- one or more temperature sensors such as a thermometer
- a thermometer may be configured proximate to a deeper region within a user’s oral cavity, such as at or near the distal end of the tongue retainer portion 2410, thus allowing the temperature sensor(s) to obtain measurements closer to a core region of the user’s body, thereby improving the accuracy of the measurements.
- the functionality of one or more sensors of the therapeutic oral appliance 2400 may be at least partially dependent on emitting light and/or measuring light absorption, such as may be the case with one or more pulse oximetry sensors; therefore, it may be advantageous to configure such sensor(s) proximate to one or more thin membranes of the upper hard and/or soft palate, and so such sensor(s) may be arranged upon or within at least one portion of the therapeutic oral appliance 2400 adjacent thereto, such as, for example and not limitation, upon or within a superior surface of the tongue retainer portion 2410 and/or the hard palate portion 2417.
- the therapeutic oral appliance 2400 may comprise one or more at least partially opaque materials or structures to block ambient light from interfering with the performance or functionality of any sensor(s) and/or electrode(s) that may be at least partially dependent on emitting or absorbing light.
- the therapeutic oral appliance 2400 may comprise one or more sensors configured to measure the movement of one or more muscles within a user’s mouth, throat, or oral cavity.
- such sensor(s) may be located upon or within one or more portions of the tongue retainer portion 2410 to measure interactions between the therapeutic oral appliance 2400 and the user’s tongue or soft palate.
- one or more sensors may be configured to measure a user’s bite force, wherein the sensor(s) may be located at or near one or more external or internal portions of the mouth guard portion 2416 of the therapeutic oral appliance 2400 to detect and measure an amount of force applied to the mouth guard portion 2416 when at least a portion of the mouth guard portion 2416 experiences physical contact from at least a portion of the user’s upper teeth and at least a portion of the user’s lower teeth in a substantially simultaneous manner.
- sensor(s) for measuring a user’s bite force may comprise one or more of: at least one strain gauge transducer, at least one piezoresistive transducer, at least one pressure transducer, at least one piezoelectric transducer, at least one pressure sensitive film, or at least one optical sensor, as well as any other appropriate sensing device(s).
- one or more sensors configured to detect or measure airway channel occlusion for a user may be located at or near one or more internal or external portions of the mouth guard portion 2416 of the therapeutic oral appliance 2400.
- the therapeutic oral appliance 2400 may comprise one or more materials that may facilitate the functionality or performance of one or more sensors or electrodes configured therewith.
- the therapeutic oral appliance 2400 may at least partially comprise at least one optically transparent material to prevent interference of the functionality of at least one pulse oximetry sensor.
- the therapeutic oral appliance 2400 may comprise one or more electrodes that may be configured to facilitate transcutaneous electrical nerve or electrical muscle stimulation.
- one or more electrodes may be located within or upon one or more portions of an inferior or superior surface of the therapeutic oral appliance 2400 to help strengthen and tone one or more muscles within a user’s mouth, throat, or oral cavity, such as, for example and not limitation, the user’s upper airway dilator muscles and/or the user’s tongue muscles.
- each of the one or more electrodes may at least partially comprise and/or may be at least partially embedded within one or more electrically conductive materials.
- the one or more electrodes may at least partially comprise and/or may be at least partially embedded within one or more of: carbon- infused medical grade silicone rubber, one or more carbon nanotube silicone composites, polydimethylsiloxane (PDMS), or one or more PDMS composites including those that may be combined with nickel, carbon nanotubes, and/or silver, as non-limiting examples.
- at least one airway 2415 of the therapeutic oral appliance 2400 may comprise one or more electronic components.
- the airway 2415 may comprise one or more electrodes that may be configured to facilitate transcutaneous electrical stimulation to one or more oropharyngeal and/or tongue muscles of a user. In some implementations, this stimulation may facilitate an increase in muscle tone, thereby promoting opening of the user’s airway channel.
- the therapeutic oral appliance 2400 may comprise one or more electrodes 2480 configured to facilitate neuromuscular electrical stimulation.
- such neuromuscular electrical stimulation may be implemented in conjunction with one or more sensors 2401 in the form of capnography sensors, respiratory sensors, thoracic sensors, and/or other breathing sensors.
- the one or more neuromuscular electrical stimulation electrodes 2480 may be configured to send at least one electrical pulse that may cause the user’s tongue and/or upper airway dilator muscles to contract at least partially to facilitate opening of the user’s airway passage.
- the therapeutic oral appliance 2400 may be used to alleviate one or more health concerns for a user, such as sleep apnea.
- neuromuscular electrical stimulation provided by one or more electrodes 2480 of the therapeutic oral appliance 2400 may facilitate an increase in muscle tone within the user’s mouth, oral cavity, or throat, thereby reducing sleep apnea symptoms.
- this increase in muscle tone may allow the size of the center portion (or web) of the airway channel 2415 and/or a cross section of the tongue retainer portion 2410 to be incrementally and gradually decreased overtime, such as, for example and not limitation, by being compressed or compacted in an adjustable manner, by being replaced by a succession of one or more modular components, or by using a plurality of therapeutic oral appliances 2400 of different sizes.
- one or more electrodes 2480 for facilitating neuromuscular electrical stimulation may be configured within or upon one or more portions of the therapeutic oral appliance 2400 at a location that may be advantageous to its purpose or functionality, which may be to assist a user in overcoming sleep apnea, as a non-limiting example.
- one or more neuromuscular electrical stimulation electrodes 2480 may be located on any portion(s) of the therapeutic oral appliance 2400 that may at least partially contact a user’s tongue, such as, for example and not limitation, the tongue retainer portion 2410.
- At least one neuromuscular electrical stimulation electrode 2480 may be placed upon or near the user’s chin to facilitate stimulation of the genioglossus muscle.
- the simulation of the genioglossus muscle may cause the tongue to tighten and at least partially protrude from the user’s mouth, thereby increasing the opening of the user’s airway channel.
- this direct stimulation of the genioglossus muscle may produce an effect similar to that facilitated by hypoglossal nerve stimulators without the need for any surgical implants.
- the one or more neuromuscular electrical stimulation sensors may be configured within or upon the therapeutic oral appliance 2400 at a location that may be advantageous to its purpose or functionality, which may be to overcome sleep apnea.
- the one or more neuromuscular electrical stimulation sensors may be located on any portion of the therapeutic oral appliance that comes into contact with the tongue.
- the one or more neuromuscular electrical stimulation sensors may be located near the chin to allow stimulation of the genioglossus muscle.
- the simulation of the genioglossus muscle may cause the muscle to tighten and protrude, opening the airway.
- a child prone to seizures may use a therapeutic oral appliance 2400 with an embedded accelerometer connected to a Bluetooth ® transmitter that may send one or more notifications to at least one external device 2490 in the form of a smartphone that may inform the child’s parents of sharp increases in rapid movement that may be indicative of a seizure. This information may be helpful at night when the family is asleep, and the parents may otherwise remain unaware of the child’s seizure.
- the therapeutic oral appliance 2400 may limit the likelihood that a seizure may cause the tongue to obstruct the child’s airway, which may cause permanent or temporary brain damage.
- a user may purchase a therapeutic oral appliance 2400 to overcome sleep apnea, wherein the therapeutic oral appliance 2400 may pair with at least one external device 2490 in the form of the user’s phone (such as, for example and not limitation, a smartphone) or computing device, such as a desktop computer, a laptop computer, or tablet, as non-limiting examples, via a Bluetooth ® or similar connection.
- One or more accelerometers and heart rate monitors embedded within one or more portions of the therapeutic oral appliance 2400 may detect and record data as the user sleeps to determine and present quality of sleep information to the user. Using this information, the user may be able to see how restlessly they slept as well as the user’s rest heart rate and oxygen levels throughout the night.
- the therapeutic oral appliance 2400 may comprise one or more electrodes or similar mechanisms configured to emit one or more vibrational frequencies that may prompt the user to reposition to a better sleeping position when oxygen levels may drop below a minimum threshold.
- a user may be recovering from an illness that may include substantial respiratory issues.
- the therapeutic oral appliance 2400 may be configured to monitor the user’s oxygenation levels (for example, by using at least one pulse oximeter) as well as the user’s heart rate (such as by using a heart rate monitor) to monitor and manage the user’s symptoms.
- a medical practitioner or hospital may be notified via at least one transmitting device upon or within a portion of the therapeutic oral appliance 2400.
- a medical professional may attempt to communicate with the user via at least one audio emitting device within or upon the therapeutic oral appliance 2400, wherein the audio emitting device may be electronically coupled, such as, for example and not limitation, via at least one electrical wire, to at least one power source and at least one receiving device configured to receive incoming communication data from the medical professional.
- an ambulance or other emergency vehicle may be sent to the user’s location as may be determined by at least one geolocation device within or upon the therapeutic oral appliance 2400.
- an anesthesiologist may insert a therapeutic oral appliance 2400 within a user’s oral cavity during a surgery, wherein the therapeutic oral appliance 2400 may comprise one or more sensors in the form of one or more health monitors.
- the anesthesiologist may use the therapeutic oral appliance 2400 to monitor the user’s heart rate, oxygen levels, breathing rate, and/or other health aspects during the surgery.
- the user’s health information may be displayed upon one or more external devices 2490 via a Bluetooth ® connection, wherein the external device(s) 2490 may comprise one or more medical apparatuses stationed within the operation room.
- the medical equipment may be configured to convey one or more notifications or alarms when one or more of the user’s health aspects reach one or more predetermined thresholds.
- the medical equipment may notify the anesthesiologist of recommended times to routinely evaluate specific health criterion of the user based on one or more current health levels of the user.
- the therapeutic oral appliance 2400 may comprise at least one sensor in the form of a capnography sensor or gas analyzer.
- a capnography sensor within or upon the therapeutic oral appliance 2400 may measure one or more predefined gases, such as oxygen inhaled and/or carbon dioxide exhaled by a user.
- a gas analyzer within or upon the therapeutic oral appliance 2400 may indicate how much oxygen therapy may be required to achieve a desired blood oxygen saturation for a user.
- these or similar gas monitors may provide indicative information regarding a user’s ventilation.
- one or more transmitting devices upon or within the therapeutic oral appliance 2400 may communicate data to one or more external devices 2490 and/or wearable technology devices 2495 to cause the external device(s) 2490 and/or wearable technology device(s) 2495 to emit one or more audible and/or visual indicators that may notify at least one healthcare professional if a user may be experiencing airway obstruction or hypercarbic symptoms due to OSA or poor ventilation.
- Figs. 25A and 25B an exemplary therapeutic oral appliance 2500 comprising a tongue retainer portion 2510, 2570, and an oral cavity comprising a therapeutic oral appliance 2500, according to some embodiments of the present disclosure, are illustrated.
- the therapeutic oral appliance 2500 may comprise a tongue retainer portion 2510, 2570; a mouth guard portion 2520, 2550; and/or a hard palate portion 2530, 2560 that may comprise one or more electronic components in the form of one or more sensors and/or one or more electrodes.
- one or more electrical wires may be configured upon or embedded within one or more external or internal portions of the therapeutic oral appliance 2500. [00127] As a non-limiting example, one or more electrical wires may be embedded within the therapeutic oral appliance 2500 so that the electrical wire(s) are blocked from physically contacting one or more interior portions of a user’s mouth, thereby minimizing the likelihood of the user experiencing discomfort or injury and minimizing damage to the therapeutic oral appliance 2500.
- one or more electrical wires may be used to electronically couple one or more sensors or electrodes to each other, to at least one power source (such as, for example and not limitation, a battery), to at least one transmitting device (such as, for example and not limitation, an RF transmitter or Bluetooth ® transmitter, and/or to at least one receiving device (such as, for example and not limitation, an RF receiver or a Bluetooth ® receiver).
- the therapeutic oral appliance 2500 may be configured to transmit data obtained from one or more sensors and/or one or more electrodes to at least one external device, at least one wearable technology device, and/or at least one database.
- the therapeutic oral appliance 2500 may comprise one or more sensors or electrodes that 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 pH sensors, one or more audio sensors, one or more force sensors, one or more pressure sensors, one or more bite sensors, one or more gas concentration sensors, one or more gas pressure sensors, one or more electroencephalography electrodes, one or more actigraphy sensors, one or more magnetoencephalography sensors, 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, and/or one or more capnography sensors.
- the therapeutic oral appliance or device may further include a clock or timer.
- one or more sensors may be configured within or upon the therapeutic oral appliance 2500 at a location that may be advantageous to its purpose or functionality.
- one or more temperature sensors (such as, for example and not limitation, one or more thermometers) may be configured proximate to a deeper region within a user’s oral cavity, such as by being located within, upon, or near a distal end of the tongue retainer portion 2510, 2570, thereby allowing the temperature sensor(s) to obtain measurements closer to the user’s core body region, thus increasing the accuracy of the measurements.
- the therapeutic oral appliance 2600 may comprise one or more electrical wires that may be attached to one or more electrodes 2680.
- the one or more electrical wires may be connected to at least one power source, such as, by way of example and not limitation, at least one battery.
- such electrodes 2680 may be configured to facilitate diagnostic techniques including electroencephalography magnetoencephalography and electromyography.
- the therapeutic oral appliance 2600 may comprise one or more transmitting devices, such as, for example and not limitation, one or more RF transmitters or Bluetooth ® transmitters, wherein the transmitting device(s) may be connected to the one or more electrical wires to facilitate electronic coupling to the at least one power source and the one or more electrodes 2680.
- the therapeutic oral appliance 2600 may transmit data obtained from the one or more electrodes 2680 to at least one external device, at least one wearable technology device, and/or at least one database or similar memory resource via the one or more transmitting devices.
- each of the one or more electrodes 2680 may comprise an electromyography electrode or any similar mechanism.
- the therapeutic oral appliance 2600 may comprise a tongue retainer portion 2610, a mouth guard portion 2620, and/or a hard palate portion 2630 that may comprise one or more electrodes 2680.
- the therapeutic oral appliance 2680 may comprise one or more electrodes 2680 configured to facilitate transcutaneous electrical nerve or electrical muscle stimulation.
- one or more electrodes 2680 may be configured within or upon one or more portions of an inferior and/or superior surface of the therapeutic oral appliance 2600 to facilitate the strengthening and toning of one or more of a user’s upper airway dilator muscles, tongue muscles, and/or other muscles.
- each of the one or more electrodes 2680 may at least partially comprise and/or may be at least partially embedded within one or more electrically conductive materials.
- each of the one or more electrodes 2680 may at least partially comprise and/or may be at least partially embedded within a material that comprises at least one of: carbon- infused medical grade silicone rubber, one or more carbon nanotube silicone composites, PDMS, or one or more PDMS composites, including those in combination with nickel, carbon nanotubes, and/or silver.
- At least one airway 2615 of the therapeutic oral appliance 2600 may comprise one or more electrodes 2680 that may be configured to provide transcutaneous electrical stimulation to one or more oropharyngeal and/or tongue muscles of a user. In some aspects, this stimulation may cause an increase in muscle tone that may facilitate the opening of the user’s oral airway channel.
- the electrical stimulation produced by one or more electrodes 2680 may be strong enough to be sensed by a user so as to prompt or stimulate the user to perform an action.
- a person prone to snoring may use a therapeutic oral appliance 2600 with one or more embedded electrodes 2680 that generate a subtle electrical impulse in the form of a slight shock or vibration that wakes the user when snoring may be detected, such as via at least one sensor in the form of a microphone or other audio capturing device.
- the therapeutic oral appliance 2700 may comprise a tongue retainer portion 2770, a mouth guard portion 2750, and/or a hard palate portion 2760 that may comprise one or more sensors 2701.
- one or more electrical wires 2725 may be configured upon or embedded within one or more external or internal portions of the therapeutic oral appliance 2700. In some implementations, one or more electrical wires 2725 may be embedded within at least one internal portion of the therapeutic oral appliance 2700 to block the electrical wire(s) 2725 from physically contacting one or more interior portions of a user’s mouth, thereby reducing the likelihood of inflicting discomfort or injury upon the user and prolonging the useful duration of the therapeutic oral appliance 2700.
- the one or more electrical wires 2725 may be attached to one or more sensors 2701 to electronically couple the sensor(s) 2701 to each other, to at least one power source 2735 (such as, for example and not limitation, at least one battery), at least one transmitting device 2745 (such as, for example and not limitation, an RF transmitter or a Bluetooth ® transmitter), and/or at least one receiving device (such as, for example and not limitation, an RF receiver or a Bluetooth ® receiver).
- at least one power source 2735 such as, for example and not limitation, at least one battery
- at least one transmitting device 2745 such as, for example and not limitation, an RF transmitter or a Bluetooth ® transmitter
- at least one receiving device such as, for example and not limitation, an RF receiver or a Bluetooth ® receiver.
- each of the one or more sensors 2701 may comprise at least one of: 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 pH sensors, one or more audio sensors, one or more force sensors, one or more pressure sensors, one or more bite sensors, one or more gas concentration sensors, one or more gas pressure sensors, one or more electroencephalography electrodes, one or more actigraphy sensors, one or more magnetoencephalography sensors, 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, and/or one or more capnography sensors.
- the therapeutic oral appliance or device may further include a clock or timer.
- one or more sensors 2701 may be configured upon or within one or more portions of the therapeutic oral appliance 2700 at one or more locations that may facilitate the utility or functionality of the sensor(s) 2701.
- one or more temperature sensors may be configured proximate to a deeper region within a user’s oral cavity, such as at or near a distal end of the tongue retainer portion 2770 thereby allowing the temperature sensor(s) to obtain measurements closer to a core body region, thus increasing the accuracy of the measurements.
- the therapeutic oral appliance 2700 may comprise one or more sensors 2701 that may comprise functionality that is at least partially dependent on emitting light and/or measuring light absorption, such as, for example and not limitation, one or more pulse oximetry sensors.
- sensors 2701 may comprise functionality that is at least partially dependent on emitting light and/or measuring light absorption, such as, for example and not limitation, one or more pulse oximetry sensors.
- such sensor(s) may be configured proximate to one or more thin membranes of a user’s upper hard and/or soft palate by being located within or upon one or more portions of a superior surface of the therapeutic oral appliance 2700, such as the tongue retainer portion 2770 and/or the hard palate portion 2760.
- the therapeutic oral appliance 2700 may comprise one or more sensors 2701 configured to measure one or more muscle movements within a user’s mouth, throat, or oral cavity, wherein the sensor(s) 2701 may be positioned upon or within one or more portions of the tongue retainer portion 2770 to detect or measure any interactions between the therapeutic oral appliance 2700 and one or more portions of the user’s tongue and/or soft palate.
- one or more sensors 2701 may be configured to measure a user’s bite force, wherein the sensor(s) 2701 may be located at or near one or more external or internal portions of the mouth guard portion 2750 of the therapeutic oral appliance 2700 to detect and measure an amount of force applied to the mouth guard portion 2750 when at least a portion of the mouth guard portion experiences physical contact from at least a portion of the user’s upper teeth and at least a portion of the user’s lower teeth in a substantially simultaneous manner.
- one or more sensors 2701 may be configured to detect or measure airway channel occlusion for a user, wherein such sensor(s) 2701 may be located at or near one or more internal or external portions of the mouth guard portion 2750 of the therapeutic oral appliance 2700. Pressure or force sensors may be used to monitor teeth grinding or bruxism.
- the therapeutic oral appliance 2700 may comprise one or more materials that may facilitate the performance and functionality of the sensor(s) 2701.
- the therapeutic oral appliance 2700 may at least partially comprise at least one optically transparent material so as not to interfere with the functioning of one or more sensors 2701 that may be at least partially dependent on producing, detecting, or measuring emitted and/or absorbed light, such as, by way of example and not limitation, one or more pulse oximetry sensors.
- Figs.28A and 28B an exemplary therapeutic oral appliance 2800, in accordance with some embodiments of the present disclosure, is illustrated.
- the therapeutic oral appliance 2800 may comprise one or more sensors 2801 and/or one or more electrodes 2880 configured within or upon one or more internal or external portions of a tongue retainer portion 2810, a mouth guard portion 2820, and/or a hard palate portion 2830 thereof.
- one or more electrical wires 2825 may be configured upon or embedded within one or more internal or external portions of the therapeutic oral appliance 2800.
- one or more electrical wires 2825 may be embedded within one or more internal portions of the therapeutic oral appliance 2800 to block the electrical wire(s) 2825 from physically contacting one or more interior portions of a user’s mouth.
- the electrical wires and electrodes may be configured so as to facilitate diagnostic techniques including electroencephalography, magnetoencephalography and electromyography.
- the electrical wire(s) 2825 may be attached to one or more sensors 2801, one or more electrodes 2880, at least one transmitting device 2845 (such as, for example and not limitation, an RF transmitter or Bluetooth ® transmitter), at least one power source 2835 (such as, for example and not limitation, a battery), and/or at least one receiving device (such as, for example and not limitation, an RF receiver or a Bluetooth ® receiver).
- the at least one transmitting device 2845 may comprise dual functionality in that it may also serve as a receiving device.
- the therapeutic oral appliance 2800 may transmit data obtained from one or more sensors 2801 and/or one or more electrodes 2880 to at least one external device, at least one wearable technology device, and/or at least one database or similar memory resource via the at least one transmitting device 2845.
- the performance or functionality of the one or more sensors 2801 and/or the one or more electrodes 2880 may be directed or altered by the at least one external device or the at least one wearable technology device via the at least one receiving device.
- the therapeutic oral appliance 2800 may comprise one or more sensors 2801 and/or one or more electrodes 2880 that 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 pH sensors, one or more audio sensors, one or more force sensors, one or more pressure sensors, one or more bite sensors, one or more gas concentration sensors, one or more gas pressure sensors, one or more electroencephalography electrodes, one or more actigraphy sensors, one or more magnetoencephalography sensors, one or more light-emitting sensors, one or more light absorption sensors, one or more muscle movement sensors, one or more heart rate monitors, and/or one or more capnography sensors.
- one or more electromyography electrodes may comprise at least one of: one or more electromyography electrodes, one or more acceleromy
- the therapeutic oral appliance or device may further include a clock or timer.
- the therapeutic oral appliance 2800 may comprise one or more sensors 2801 and/or electrodes 2880 that may be configured upon or within one or more external or internal portions of the therapeutic oral appliance 2800 so as to optimize the performance or functionality of the sensor(s) 2801 and/or electrode(s) 2880.
- one or more temperature sensors may be configured proximate to a deeper region within the oral cavity of a user, such as, for example and not limitation, by being positioned at or near the distal end of the tongue retainer portion 2810, thereby enabling the temperature sensor(s) to obtain measurements closer to the user’s core body region, thus increasing the accuracy of the measurements.
- the therapeutic oral appliance 2800 may comprise one or more sensors 2801 that comprise functionality that is at least partially dependent on emitting light and/or measuring light absorption, such as, for example and not limitation, one or more pulse oximetry sensors.
- such sensor(s) 2801 may be located proximate to one or more thin membranes of one or more portions of a user’s upper hard and/or soft palate by being positioned at or near one or more portions of a superior surface of the tongue retainer portion 2810 and/or the hard palate portion 2830 of the therapeutic oral appliance 2800.
- the therapeutic oral appliance 2800 may comprise one or more sensors 2801 configured to measure one or more muscle movements within a user’s mouth, throat, or oral cavity, wherein the sensor(s) 2801 may be configured upon or within one or more external or internal portions of the tongue retainer portion 2810 to detect and/or measure, by way of example and not limitation, one or more interactions between the therapeutic oral appliance 2800 and a user’s tongue and/or soft palate.
- the therapeutic oral appliance 2800 may comprise one or more sensors 2801 configured to measure a user’s bite force by being located at, upon, within, or proximate to one or more portions of the mouth guard portion 2820, or any other appropriate portion of the therapeutic oral appliance 2800.
- the therapeutic oral appliance 2800 may comprise one or more sensors 2801 configured to detect and/or measure at least partial airway channel occlusion for a user by being configured, by way of example and not limitation, within, upon, or proximate to one or more internal or external portions of the mouth guard portion 2820 of the therapeutic oral appliance 2800.
- the therapeutic oral appliance 2800 may comprise at least one material that may facilitate the functionality and/or performance of the sensor(s) 2801 and/or electrode(s) 2880.
- the therapeutic oral appliance 2800 may at least partially comprise at least one optically transparent material to minimize potential interference of the functioning of at least one pulse oximetry sensor.
- the therapeutic oral appliance 2800 may comprise one or more electrodes 2880 configured to facilitate transcutaneous electrical nerve and/or electrical muscle stimulation.
- one or more electrodes 2880 may be configured within, upon, or proximate to one or more portions of an interior and/or superior surface of the therapeutic oral appliance 2800 to help strengthen and tone one or more upper airway dilator muscles and/or tongue muscles of a user.
- one or more electrodes 2880 may at least partially comprise and/or be at least partially configured within one or more electrically conductive materials.
- one or more electrodes 2880 may at least partially comprise and/or may be at least partially configured within at least one material that comprises one or more of: carbon-infused medical grade silicone rubber, one or more carbon nanotube silicone composites, PDMS, or one or more PDMS composites, including those used in combination with nickel, carbon nanotubes, and/or silver.
- one or more portions of the tongue retainer portion 2810, such as, for example and not limitation, at least one airway 2815 may comprise one or more electronic components.
- the therapeutic oral appliance 2800 may comprise one or more electrodes 2880 that may be configured to provide transcutaneous electrical stimulation to one or more oropharyngeal and/or tongue muscles of a user.
- such stimulation may facilitate an increase in muscle tone, thereby promoting opening of a user’s oral airway channel.
- the therapeutic oral appliance 2800 may comprise one or more electrodes 2880 configured to facilitate neuromuscular electrical stimulation.
- neuromuscular electrical stimulation may be implemented in conjunction with one or more sensors 2801 in the form of capnography sensors, respiratory sensors, thoracic sensors, and/or other breathing sensors.
- the one or more neuromuscular electrical stimulation electrodes 2880 may be configured to send at least one electrical pulse that may cause the user’s tongue and/or upper airway dilator muscles to at least partially contract to facilitate opening of the user’s airway passage.
- the therapeutic oral appliance 2800 may be used to alleviate one or more health concerns for a user, such as sleep apnea.
- neuromuscular electrical stimulation provided by one or more electrodes 2880 of the therapeutic oral appliance 2800 may facilitate an increase in muscle tone within the user’s mouth, oral cavity, or throat, thereby reducing sleep apnea symptoms.
- this increase in muscle tone may allow the size of the center portion (or web) of the airway channel 2815 and/or a cross section of the tongue retainer portion 2810 to be incrementally and gradually decreased overtime, such as, for example and not limitation, by being compressed or compacted in an adjustable manner, by being replaced by a succession of one or more modular components, or by using a plurality of therapeutic oral appliances 2800 of different sizes.
- one or more electrodes 2880 for facilitating neuromuscular electrical stimulation may be configured within or upon one or more portions of the therapeutic oral appliance 2800 at a location that may be advantageous to its purpose or functionality, which may be to assist a user in overcoming sleep apnea, as a non-limiting example.
- one or more neuromuscular electrical stimulation electrodes 2880 may be located on any portion(s) of the therapeutic oral appliance 2800 that may at least partially contact a user’s tongue, such as, for example and not limitation, the tongue retainer portion 2810.
- At least one neuromuscular electrical stimulation electrode 2880 may be placed upon or near the user’s chin to facilitate stimulation of the genioglossus muscle.
- the simulation of the genioglossus muscle may cause the tongue to tighten and at least partially protrude from the user’s mouth, thereby increasing the opening of the user’s airway channel.
- this direct stimulation of the genioglossus muscle may produce an effect similar to that facilitated by hypoglossal nerve stimulators without the need for any surgical implants.
- Fig. 29 a perspective view of an exemplary therapeutic oral appliance 2900, according to some embodiments of the present disclosure, is illustrated.
- the therapeutic oral appliance 2900 may comprise at least one amount of substantially hollow tubing 2910.
- the hollow tubing 2910 may be used to measure airflow being inhaled or exhaled by a user.
- the hollow tubing 2910 may be used to at least partially encapsulate one or more electrical wires 2920.
- the electrical wire(s) 2920 may be removably or securely attached to one or more sensors 2901 and/or one or more electrodes 2980.
- the hollow tubing 2910 may be attached to or integrated with one or more gas flow meters and/or one or more gas analyzers, such as, for example and not limitation, one or more air flow meters, one or more capnography devices, and/or one or more oxygen analyzers 2930 in order to measure one or more aspects of the gases 2940 flowing into or out of a user’s body.
- the hollow tubing 2910 may be used to deliver one or more gasses 2940, including but not limited to, supplemental oxygen, nitric oxide, and/or humidification to a user.
- the hollow tubing 2910 may be used to deliver one or more medicated gases 2940 to a user, such as, for example and not limitation, one or more aerosolized or nebulized medications within one or more gases 2940 in the form of air or oxygen.
- the therapeutic oral appliance may include an integrated computer processor.
- the therapeutic oral appliance may further include a non-volatile memory for the storage of data gathered by the at least one sensor or electrode.
- the data gathered and stored in the non-volatile memory may be periodically transmitted or transferred to an external database, either by wired connection or wireless connection.
- the integrated processor and/or non-volatile memory may in some implementations be programmable in order to instruct the at least one sensor or electrode to carry out sequences of therapeutic activities and/or monitor patient responses, for example to perform periodic or patterned neuromuscular electrical stimulation and/or measure the response through the at least one sensor.
- the integrated computer processor may cooperate with the clock or timer so that the integrated computer processor can keep track of time. Further embodiments may include a physical computer interface, such as a USB or serial connection, or a wireless connection for loading a program to the integrated processor and/or non-volatile memory and downloading data to an external computer or database. The data may be analysed in real-time or off-line.
- the integrated computer processor may be connected to a power source, such as a battery, preferably a rechargeable battery.
- one or more electroencephalography electrodes and/or one or more magnetoencephalography sensors are placed on or throughout the therapeutic oral appliance in such a way that they are placed in contact with the palatal and oropharyngeal mucosa.
- the location of the magnetoencephalography sensors on or throughout the therapeutic oral appliance enables real-time, non- invasive measurement of brain electrical activity (e.g. of the hippocampus or other parts of the brain), without requiring surgical implantation of electrodes within the brain.
- the magnetoencephalography sensors may be strategically located on or throughout the therapeutic oral appliance to optimise the brain electrical activity measurement.
- Locating the magnetoencephalography sensors inside the mouth produces enhanced sensitivity to hippocampal generators within the mouth, which is believed to improve the magnetoencephalography sensors’ selectivity, both spectrally and spatially, to the human hippocampus.
- Some embodiments of the therapeutic oral appliance include more than one electromyography electrode configured to perform electromyography (such as surface electromyography) so as to measure muscle response or electrical activity, for example in response to neuromuscular electrical stimulation.
- the electromyography measurements can be performed by a pair of electromyography electrodes or by a more complex array of electromyography electrodes.
- the therapeutic oral appliance can be used to aid myofunctional therapy exercises (such as moving the tongue along the surfaces of the teeth, hard palate, soft palate and floor of the mouth, swallowing, chewing, nasal inhalation and oral exhalation) intended to improve the function of the muscles of the tongue or soft palate in order to maintain an open airway, thereby helping to treat sleep apnea.
- myofunctional therapy exercises such as moving the tongue along the surfaces of the teeth, hard palate, soft palate and floor of the mouth, swallowing, chewing, nasal inhalation and oral exhalation
- Muscles of the soft palate and tongue including musculus uvulae, levator veli palatine, tensor veli palatini, palatopharyngeus, palatoglossus, genioglossus, hyoglossus, styloglossus, superior longitudinal, inferior longitudinal, transverse, and vertical muscles of the tongue can be toned and strengthened with the oral appliance.
- the tongue can be used to squeeze the therapeutic oral appliance between the tongue and the hard and soft palates, thereby strengthening and toning the tongue.
- the muscles of the soft palate can squeeze the therapeutic oral appliance against the tongue, thereby strengthening and toning the soft palate muscles.
- some embodiments include pressure or force sensors which are located or embedded throughout the therapeutic oral appliance in order to measure the forces or pressures exerted by the muscles of the tongue or soft palate on different areas of the therapeutic oral appliance.
- the effectiveness and progress of the myofunctional therapy exercises can be measured by the pressure or force sensors.
- the measurement collected by the pressure or force sensors enables the provision of feedback to help patients understand target areas to apply pressure in order to ensure optimal myofunctional therapy efficacy.
- the multitude of pressure or force sensors will give patients a better idea of whether they are doing the exercises correctly. Display readouts will allow patients to track their progress in strengthening these oral muscles.
- electrodes may be placed on the tongue retainer portion and be configured to perform neuromuscular electrical stimulation (NMES), particularly on the tongue and upper airway dilator muscles.
- NMES neuromuscular electrical stimulation
- NMES involves applying an electrical current through the electrodes placed over target muscle areas in order to induce muscular contraction, particular muscle areas that are difficult to activate voluntarily.
- respiratory capability can be improved and/or the muscles can be trained to be responsive to various conditions (such as snoring and OSA) in order to improve airway space and patency.
- Muscles of the soft palate and tongue including musculus uvulae, levator veli palatine, tensor veli palatini, palatopharyngeus, palatoglossus, genioglossus, hyoglossus, styloglossus, superior longitudinal, inferior longitudinal, transverse and vertical muscles of the tongue can be stimulated, toned, and strengthened with the therapeutic oral appliance's electrical stimulation.
- Some embodiments of the therapeutic oral appliance may include one or more actigraphy sensors for collecting data generated by user movement or activity. Actigraphy may include data from an accelerometer or acceleromyograph and a clock or timer.
- the clock or timer is programmable to start and stop the actigraph measurement at specific times, and to maintain the actigraph measurement for a specific time frame. It may further include measurements of temperature, ambient light, sound or audio levels, movement or tremors, skin resistance and electroencephalography data.
- the electronics for performing actigraphy may further include a low-pass filter configured to filter out external vibrations. As an example, a range of frequencies which could be allowed by the low-pass filter is in the range of 2-3 Hz.
- a waterproof casing may be included to house the components provided for actigraphy. [00161] Sensors, monitors and electrodes may be advantageously configured in or on different portions, areas or regions of the therapeutic oral appliance according to their purpose.
- heart rate monitors pulse oximetry sensors or other sensors which require light to be emitted or absorbed through bodily tissues are located on the superior surface of the therapeutic oral appliance so as to contact or interface with the thinner tissues of the mouth and throat.
- a pulse oximetry sensor or heart rate monitor may be placed on the superior surface of the therapeutic oral appliance (e.g. on the superior surface of the hard palate portion) so as to emit and absorb light though the hard palatal tissues.
- Gas concentration sensors, gas pressure sensors and capnography sensors are preferentially located near the front or anterior of the appliance so as not to become blocked by saliva and other fluids. Pressure sensors are preferably placed based on the desired pressure measurements.
- pressure sensors should be placed along the airway channel dependent on which muscle movement is to be measured. Acceleromyography and electromyography sensors are likewise preferentially located (e.g. along the airway channel) proximal to the muscles for which monitoring is sought.
- the pressure sensors may be placed on the superior or inferior surface of the therapeutic oral appliance.
- pressure, force, or bite sensors for measuring bruxism, grinding and biting are preferentially located in the mouthguard portion of the device.
- Electrodes for NMES are preferentially located along the airway channel according to which muscle(s) is (are) to be stimulated.
- stimulation electrodes targeting the tongue should be placed on the inferior surface of the therapeutic oral appliance and in contact with the tongue of the patient.
- electrodes can be located on the superior surface of the therapeutic oral appliance in communication with the soft palate in order to stimulate the upper airway dilator muscles.
- Temperature sensors are preferentially located such that they provide an accurate reading of core body temperature. For example, they may be placed in the back of the airway channel, posteriorly on the therapeutic oral appliance or at a distal end of the tongue retainer portion. pH and moisture sensors are preferably located on the therapeutic oral appliance (e.g. posteriorly on the therapeutic oral appliance) so as to be near the esophageal opening in order to provide the most accurate measurements, though other locations may be situationally advantageous.
- Audio sensors, actigraphy sensors, accelerometers, and sensors intended to provide data regarding e.g., overall movement or sound may be placed in any location on the appliance which does not impede their function.
- Electroencephalography and magnetoencephalography sensors and electrodes are preferentially located on the superior surface of the appliance and disposed (i.e. facing) towards the brain of the patient.
- CONCLUSION [00165] A number of embodiments of the present disclosure have been described. While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any disclosures or of what may be claimed, but rather as descriptions of features specific to particular embodiments of the present disclosure.
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Abstract
There is provided a therapeutic oral appliance (2700) 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 (2701) and at least one electrode.
Description
THERAPEUTIC ORAL APPLIANCE OR DEVICE FIELD [0001] This disclosure relates to therapeutic oral appliances for sleep apnea and other health conditions. BACKGROUND [0002] 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. [0003] 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. [0004] 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. [0005] 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. [0006] 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. [0007] 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. SUMMARY OF THE DISCLOSURE [0008] 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. [0009] The present disclosure provides generally for a therapeutic oral appliance or device for sleep apnea and other health conditions. According to the present disclosure, the therapeutic oral appliance or 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. [0010] In some aspects, the mouth guard portion may comprise one or more components that provide stability and maintain the position of the therapeutic oral appliance or 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 appliances or devices to overcome a user’s gag reflex. In aspects wherein the therapeutic oral appliance or 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. [0011] 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. [0012] 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. [0013] 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. [0014] 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 (e.g. for measuring muscle activity), 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 (e.g. for measuring acid reflux), one or more audio sensors (e.g. for detection of snoring, airway obstruction, or airflow), one or more force sensors or force transducers, one or more pressure sensors (such as thin film pressure sensors), one or more piezoelectric sensors, one or more bite sensors, one or more gas concentration sensors, one or more gas pressure sensors, one or more electroencephalography electrodes, one or more actigraphy sensors, one or more magnetoencephalography sensors (such as optically pumped magnetometers), 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 certain embodiments, one or more electrical wires may be in contact with one or more sensors or electrodes. In some embodiments, the therapeutic oral appliance or device may further include a clock or timer (e.g. for starting or stopping measurements at specific times, for maintaining a measurement for a specific timeframe, or for adding time stamps to the measurement or sensor data). Sensors, monitors and electrodes may be located in or on different portions, areas or regions of the therapeutic oral appliance according to their purpose. [0015] 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 least 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. BRIEF DESCRIPTION OF THE DRAWINGS [0016] The accompanying drawings that are incorporated in and constitute a part of this specification illustrate several embodiments of the disclosure and, together with the description, serve to explain the principles of the disclosure: FIG.1A illustrates a top-down view of an exemplary therapeutic oral appliance. FIG.1B illustrates a side view of an exemplary therapeutic oral appliance. FIG.1C illustrates a perspective view of an exemplary therapeutic oral appliance. FIG.2A illustrates an exemplary therapeutic oral appliance. FIG.2B illustrates a cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance. FIG.3A illustrates an exemplary therapeutic oral appliance comprising a tongue retainer portion. FIG. 3B illustrates an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance. FIG.4A illustrates an exemplary therapeutic oral appliance comprising a tongue retainer portion. FIG. 4B illustrates an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance. FIG.5A illustrates an exemplary therapeutic oral appliance comprising a tongue retainer portion. FIG. 5B illustrates an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance. FIG.6A illustrates an exemplary therapeutic oral appliance comprising a tongue retainer portion. FIG. 6B illustrates an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance. FIG.7A illustrates an exemplary therapeutic oral appliance comprising a tongue retainer portion. FIG. 7B illustrates an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance. FIG.8A illustrates a front view of an exemplary therapeutic oral appliance. FIG.8B illustrates a rear view of an exemplary therapeutic oral appliance. FIG.9 illustrates a mouth wearing an exemplary therapeutic oral appliance. FIG.10 illustrates an exemplary therapeutic oral appliance with a safety mechanism. FIG. 11A illustrates a side view of an exemplary therapeutic oral appliance with a mouth guard portion attachment. FIG. 11B illustrates a perspective view of a therapeutic oral appliance with a mouth guard portion attachment.
FIG. 12A illustrates a side view of an exemplary therapeutic oral appliance interfacing with an external device. FIG. 12B illustrates a side view of an exemplary therapeutic oral appliance interfacing with an external device. FIG. 12C illustrates a perspective view of an exemplary therapeutic oral appliance interfacing with an external device. FIG. 13A illustrates a side view of an exemplary therapeutic oral appliance with a mouth guard portion attachment. FIG. 13B illustrates a perspective view of an exemplary therapeutic oral appliance with a mouth guard portion attachment. FIG. 14A illustrates a side view of an exemplary therapeutic oral appliance with a mouth guard portion attachment. FIG. 14B illustrates a perspective view of an exemplary therapeutic oral appliance with a mouth guard portion attachment. FIG. 15A illustrates a side view of an exemplary therapeutic oral appliance with an adjustable tongue retainer portion. FIG.15B illustrates a top-down view of an exemplary therapeutic oral appliance with an adjustable tongue retainer portion. FIG. 16A illustrates a side view of an exemplary therapeutic oral appliance with an adjustable tongue retainer portion. FIG.16B illustrates a top-down view of an exemplary therapeutic oral appliance with an adjustable tongue retainer portion. FIG.17 illustrates an exemplary therapeutic oral appliance. FIG.18 illustrates an exemplary therapeutic oral appliance. FIG.19 illustrates an exemplary adjustable therapeutic oral appliance. FIG.20 illustrates an exemplary therapeutic oral appliance attachable to dental fixtures. FIG.21 illustrates an exemplary therapeutic oral appliance with wireless data transmission capabilities. FIG.22 illustrates a process of forming an exemplary therapeutic oral appliance. FIG.23 illustrates a process of forming an exemplary therapeutic oral appliance. FIG.24 illustrates an exemplary therapeutic oral appliance with wireless data transmission capabilities. FIG.25A illustrates an exemplary therapeutic oral appliance comprising a tongue retainer portion. FIG.25B illustrates a sectional view of an oral cavity comprising an exemplary therapeutic oral appliance. FIG.26 illustrates a perspective view of an exemplary therapeutic oral appliance. FIG.27A illustrates an exemplary therapeutic oral appliance. FIG.27B illustrates a perspective view of an exemplary therapeutic oral appliance. FIG.27C illustrates a sectional view of an oral cavity comprising an exemplary therapeutic oral appliance. FIG.28A illustrates an exemplary therapeutic oral appliance.
FIG.28B illustrates a perspective view of an exemplary therapeutic oral appliance. FIG.29 illustrates a perspective view of an exemplary therapeutic oral appliance. DETAILED DESCRIPTION [0017] In the following sections, detailed descriptions of examples and methods of the disclosure will be given. The descriptions of both preferred and alternative examples, though thorough, are exemplary only, and it is understood to those skilled in the art that variations, modifications, and alterations may be apparent. It is therefore to be understood that the examples do not limit the broadness of the aspects of the underlying disclosure as defined by the claims. Therapeutic oral appliance: as used herein refers to a device that may be removably inserted into the mouth of a user, wherein the therapeutic oral appliance may be configured to assess one or more health aspects of the user or alleviate one or more medical conditions experienced by the user. By way of example and not limitation, a therapeutic oral appliance may at least partially alleviate sleep apnea or teeth grinding of a user or a therapeutic oral appliance may detect a body temperature or blood oxygen level of a user. Tongue retainer portion: as used herein refers to a portion of a therapeutic oral appliance that limits backward movement of the tongue when the therapeutic oral appliance is worn. In some embodiments, a tongue retainer portion may comprise one or more airways that may prevent occlusion of the throat, allowing for unobstructed breathing. Hard palate portion: as used herein refers to a portion of a therapeutic oral appliance that is configured to at least partially interface with the hard palate within the mouth of a user. Mouth guard portion: as used herein refers to a portion of a therapeutic oral appliance that fits to or over at least a portion of one or more teeth of a user. In some aspects, a mouth guard portion may be customized to fit a user’s teeth, such as, for example and not limitation, by using a dental mold. In some implementations, a mouth guard portion may comprise an at least partially customized fit for a specific user. In some embodiments, a mouth guard portion may comprise a substantially universal fit that may be used by any generic user without requiring a custom fitting. OSA: as used herein refers to obstructive sleep apnea. [0018] Referring now to Figs. 1A–1C, an exemplary therapeutic oral appliance 100 is illustrated. In some embodiments, the therapeutic oral appliance 100 may comprise a tongue retainer portion 110. In some implementations, the tongue retainer portion 110 may comprise one or more predetermined lengths. This may allow the user to gradually become accustomed to the presence of the tongue retainer portion 110 within at least a portion of the throat. Gradual introduction may allow for the suppression of the gag reflex, which may occur as the length of the tongue retainer portion 110 enters the throat. In some aspects, the tongue retainer portion 110 may comprise an upper surface, a lower surface, and a longitudinal length. [0019] In some embodiments, the therapeutic oral appliance 100 may be utilized to relieve airway obstruction from one or more sources. As an illustrative example, the therapeutic oral appliance 100 may directly relieve obstruction caused by obstruction at the back or base of the tongue, uvula, and soft palate. The therapeutic oral appliance 100 may partially relieve obstruction that is caused by issues below the
epiglottis such as hypopharyngeal issues, vocal cord folds and arytenoids, anterior-posterior soft palate collapse, lateral soft palate collapse, complete concentric collapse, epiglottic and tonsillar collapse. The therapeutic oral appliance 100 may address a plurality of issues of obstruction simultaneously through prescribed therapeutic use. [0020] In some implementations, the therapeutic oral appliance 100 may contribute to partial relief of obstruction by improving overall muscle tone of the oropharynx. This improvement may result as muscles resist and gain tone by resisting the therapeutic oral appliance 100. In some aspects, an airway 115 may provide airflow from the mouth to the soft palate. This may improve breathing and decrease airway obstruction. [0021] In some embodiments, the material of the therapeutic oral appliance 100 may comprise materials that are sufficiently durable and chemical resistant to sanitize the therapeutic oral appliance 100 on a daily basis by chemical (e.g., mouth wash or alcohols) means or physical means (e.g., steam sterilization), as non-limiting examples. In some implementations, the removable aspect of the therapeutic oral appliance 100 may allow the user to clean and sanitize the therapeutic oral appliance 100 frequently. This may facilitate accessible cleaning that may reduce the possibility of tissue necrosis and infection, as a non- limiting list. [0022] In some implementations, the therapeutic oral appliance 100 may comprise a hard palate portion 130. In some embodiments, the mating connected by symmetric surfaces between the hard palate and the hard palate portion 130 may improve the stability of the therapeutic oral appliance 100 within the oral cavity. In some aspects, the therapeutic oral appliance 100 may comprise a mouth guard portion 120. In some additional aspects, the hard palate portion 130 may extend upward from the mouth guard portion 120 to a central point of convergence. [0023] In some embodiments, the mouth guard portion 120 may comprise a composite of materials. This may prevent fracture and fragment wear that could cause worn parts of the therapeutic oral appliance 100 to be swallowed. In some implementations, the substrate material may be embedded within the primary material. [0024] As an example, a hard plastic plate may be embedded in the medium of ethylene-vinyl acetate (EVA), or an elastomeric polymer, as the softer plastic cures within the teeth mold. In some aspects, the embedded substrate may be fragmentary. As another example, an EVA material may have plates of harder plastic embedded in the regions over the rear molars to reduce wear from teeth grinding. In some embodiments, the therapeutic oral appliance 100 may comprise a coated aspect. As an example, the therapeutic oral appliance 100 may be coated in a hardened plastic film that reduces torsional fatigue within the structure of the therapeutic oral appliance 100. [0025] The mouth guard portion 120 may be configured to at least partially interface with one or more teeth of a user. This interface may maintain the position of the therapeutic oral appliance 100 in the mouth and prevent ingestion of the therapeutic oral appliance 100. In some aspects, the therapeutic oral appliance 100 may comprise a hard palate portion 130. The hard palate portion 130 may interface with the hard palate
within the mouth. In some implementations, the mouth guard portion 120 and the hard palate portion 130 may reduce point pressure by spreading the retaining force for the therapeutic oral appliance 100 across a larger surface area. [0026] The mouth guard portion 120 may provide protection to the soft sensitive tissue of the oral pharynx. A mouth guard portion 120 may protect the parts of the hard palate, soft palate, and oral pharynx from pressure points, as a non-limiting list. The pressure may originate from the oral airway. The mouth guard portion 120 may prevent pain and possible tissue necrosis by preventing these pressure points. In some aspects, the mouth guard portion 120 may extend to cover the hard and soft palate to protect sensitive tissues. This protection may assist in pushing the oral airway away from the oropharynx. In some embodiments, moving the oral airway away from the oropharynx may decrease the gag reflex. [0027] In some implementations, the level of customization of the therapeutic oral appliance 100 may vary. As an illustrative example, a user may receive a dental impression in a dentist’s office that provides a high- fidelity model of the unique aspects of the user’s mouth. This impression may be formed via physical or digital dental impression. This impression may become the casting for the therapeutic oral appliance 100. This high level of customization may allow the fit of the therapeutic oral appliance 100 to match the form of the hard palate and teeth with precision. It may also improve the overall comfort and performance of the oral appliance or device. The oral appliance or device can be customized to fit each user's unique dentition, maxillary or dental arch, palatal arch or vault, and palatal mucosa and rugae, thus making the least intrusive oral airway size and path for maximal comfort. [0028] As another illustrative example, a user may purchase a therapeutic oral appliance 100 remotely. The therapeutic oral appliance 100 may be delivered as a generic casting of a therapeutic oral appliance 100. The generic mold may fit most mouths in a loose composition. The generic casting may then become pliable after boiling it in water. This pliability may allow the user to press the therapeutic oral appliance 100 firmly into their mouth to allow the therapeutic oral appliance 100 to harden in the shape of the user’s mouth. This formed fit may provide sufficient stability, without requiring a dentist visit. [0029] In some embodiments, the therapeutic oral appliance 100 may interface with the oral cavity. The quality of the interface may contribute to safety, comfort, and effectiveness as a therapeutic device, as a non-limiting list. In some implementations, the removable aspect of the therapeutic oral appliance 100 may also provide opportunity for frequent sanitation. This may prevent infection, inflammation, and tissue necrosis, as non-limiting examples. [0030] In some embodiments, the mouth guard portion 120 may interface with the teeth. This interface may maintain the position of the therapeutic oral appliance 100 in the mouth and prevent ingestion of the therapeutic oral appliance 100. In some aspects, the therapeutic oral appliance 100 may comprise a hard palate portion 130. The mouth guard portion 120 and the hard palate portion 130 may reduce the probability of subconscious rejection of the therapeutic oral appliance 100 by spitting it out. The custom fit of the therapeutic oral appliance 100 may reduce this probability by increasing comfort. In some aspects, the interface between the therapeutic oral appliance 100 and the oral cavity may assist in alignment of the
tongue retainer portion 110 within the throat. Unsecured movement of the tongue retainer portion 110 may result in triggering the gag reflex or choking. [0031] In some embodiments, the tongue retainer portion 110 may be fixed to and extend from a distal end of the hard palate portion 130 into at least a portion of the throat sufficient to reduce movement of the tongue. In some implementations, the tongue retainer portion 110 may be trimmable for preferential comfort and fit within the throat, as non-limiting examples. In some aspects, the tongue retainer portion 110 may prevent the tongue from falling back and touching the soft palate, which may otherwise create airway obstruction. In some embodiments, the tongue retainer portion 110 may comprise an airway 115 that ensures airflow when the tongue retainer portion 110 occupies the throat. [0032] In some aspects, the tongue retainer portion 110 may comprise an airway 115. In some implementations, the airway 115 may comprise one or more recesses or slots within the upper and/or lower surface of the tongue retainer portion 110 that extend along at least a portion of the longitudinal length of the tongue retainer portion 110, thereby forming one or more channels or grooves. In some embodiments, airway 115 channels may provide an airway to allow air flow. In some implementations, the airway 115 may follow the natural anatomical airway passage of the user. This may decrease the chance of inadvertent airway obstruction by the therapeutic oral appliance 100. The conformity to the natural anatomy of the oral cavity may result from the custom fit of the therapeutic oral appliance 100. [0033] Referring now to Fig.2A, an exemplary therapeutic oral appliance 200 is illustrated. Referring now to Fig. 2B, a cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance 200 is illustrated. In some embodiments, the therapeutic oral appliance 200 may comprise a hard palate portion 230. In some implementations, the therapeutic oral appliance 200 may comprise a mouth guard portion 220. In some aspects, the hard palate portion 230 may extend upward from the mouth guard portion 220 to a central point of convergence. [0034] In some embodiments, the hard palate portion 230 may interface with the hard palate 260. In some aspects, the surface of the hard palate portion 230 may mirror the geometry of the hard palate 260 to provide a custom fit. In some embodiments, the hard palate portion 230 may comprise identical geometry to the hard palate 260 by being cured in a mold formed from an impression of the user’s oral cavity. In some implementations, this mold may be a standard mold used in creating denture impressions. [0035] In some implementations, the distal end of the therapeutic oral appliance 200 may align with the beginning of the soft palate 270 within the oral cavity. This may prevent damage from continual applied force on the soft palate 270. In some implementations, the mouth guard portion 220 may interface with the teeth 250. In some aspects, the interaction between the guard portion 220 and the teeth 250 may operate as a mated interface that is formed by curing the resin for the therapeutic oral appliance 200 within a casting made from an impression of the user’s teeth 250. [0036] A patient may wear a therapeutic oral appliance 200 without the tongue retainer portion to begin the incremental process to suppress the gag reflex. Wearing a therapeutic oral appliance 200 may be uncomfortable at first, particularly for those who are unaccustomed to wearing oral appliances. A patient
may get used to the therapeutic oral appliance 200 by wearing it for a few hours and then overnight, as a way to build up to the gag reflex suppression process with the tongue retainer portion. [0037] In some embodiments, the mouth guard portion 220 may comprise a generic cast that, upon inducing heat to increase malleability, may be formed to the shape of the intended teeth 250. This may provide greater comfort when wearing the therapeutic oral appliance 200. A formed therapeutic oral appliance 200 may prevent unconscious rejection from the mouth. For example, a user may unconsciously spit out the therapeutic oral appliance while sleeping unless the therapeutic oral appliance 200 is homogeneous with the structure of the oral cavity. [0038] In some aspects, the mouth guard portion 220 may comprise a cavity designed to enclose a plurality of teeth 250 simultaneously. The thickness of the outside edge of the mouth guard portion 220 may be of minimal thickness to ensure an unobstructive fit within the oral cavity. In some embodiments, a minimal thickness may increase the comfort of the therapeutic oral appliance 200 and the effectiveness of therapeutic utilization by avoiding subconscious rejection, as non-limiting examples. [0039] Referring now to Fig.3A, an exemplary therapeutic oral appliance 300 comprising a tongue retainer portion 310 is illustrated. Referring now to Fig. 3B, an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance 300 is illustrated. In some embodiments, the therapeutic oral appliance 300 may comprise a hard palate portion 330. In some implementations, the therapeutic oral appliance 300 may comprise a mouth guard portion 320. In some embodiments, the hard palate portion 330 may interface with the hard palate 360. [0040] In some implementations, the tongue retainer portion 310 may align with the soft palate 370. In some embodiments, the tongue retainer portion 310 may comprise an upper surface, a lower surface, and a longitudinal length. In some aspects, the therapeutic oral appliance 300 may enter the throat 380 via the tongue retainer portion 310. In some implementations, the therapeutic oral appliance 300 may comprise a tongue retainer portion 310 of a plurality of predetermined lengths. This may allow the user to gradually become accustomed to the presence of the tongue retainer portion 310 within the throat 380. This may train the gag reflex to refrain from engaging the tongue retainer portion 310 sufficient to allow the user to insert the therapeutic oral appliance 300 daily. In some embodiments, the tongue retainer portion 310 may be fixed to a distal end of the hard palate portion 330. [0041] In some embodiments, the therapeutic oral appliance 300 may interface with the tongue 340. In some aspects, the tongue retainer portion 310 may direct the tongue 340 through the physical presence of the tongue retainer portion 310. In some embodiments, the tongue retainer portion 310 may restrain the tongue 340 sufficient to facilitate unobstructed breathing. [0042] For example, a person in a coma may need a clear airway to receive sufficient oxygen. In an unconscious state, the tongue 340 may otherwise reduce or impair the user’s airway. In some implementations, the mouth guard portion 320 may be configured to at least partially interface with one or more teeth 350. This may prevent the therapeutic oral appliance 300 from dislodgement and potential ingestion.
[0043] Referring now to Fig.4A, an exemplary therapeutic oral appliance 400 comprising a tongue retainer portion 410 is illustrated. Referring now to Fig. 4B, an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance 400 is illustrated. In some embodiments, the therapeutic oral appliance 400 may comprise a hard palate portion 430. In some implementations, the therapeutic oral appliance 400 may comprise a mouth guard portion 420. In some aspects, the hard palate portion 430 may extend upward from the mouth guard portion 420 to a central point of convergence. [0044] In some embodiments, the hard palate portion 430 may interface with the hard palate 460. In some implementations, the tongue retainer portion 410 may align with the soft palate 470. In some embodiments, the tongue retainer portion 410 may comprise an upper surface, a lower surface, and a longitudinal length. In some aspects, the therapeutic oral appliance 400 may enter the throat 480. In some implementations, the tongue retainer portion 410 may enter the throat incrementally to avoid triggering a gag reflex. In some embodiments, the tongue retainer portion 410 may be fixed to a distal end of the hard palate portion 430. [0045] A gag reflex is a contraction of the throat that occurs when an object makes contact with the back of the tongue 440 or throat 480. This gag reflex may be overcome through incremental introduction of the tongue retainer portion 410 into the throat 480. In some aspects, this may be introduced by wearing a therapeutic oral appliance 400 with an incremental increase in tongue retainer portion length 410 for a predetermined time. [0046] The length of the tongue retainer portion 410 may be sufficiently short to prevent the grasping of the tongue retainer portion 410 by the throat 480 via throat contraction caused by the gag reflex. The length of the tongue retainer portion 410 may be sufficiently short to prevent irregular swallowing due to the throat exerting a downward force on the therapeutic oral appliance 400 by grasping the end of the tongue retainer portion 410 during throat contraction. [0047] In some embodiments, the therapeutic oral appliance 400 may interface with the tongue 440. In some embodiments, the tongue retainer portion 410 may restrain the tongue 440 sufficiently to facilitate unobstructed breathing. In some implementations, the mouth guard portion 420 may be configured to at least partially interface with one or more teeth 450. In some aspects, the mouth guard portion 420 may secure the therapeutic oral appliance 400 within the oral cavity. This may prevent ingestion of the therapeutic oral appliance 400. [0048] Referring now to Fig.5A, an exemplary therapeutic oral appliance 500 comprising a tongue retainer portion 510 is illustrated. Referring now to Fig. 5B, an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance 500 is illustrated. In some embodiments, the therapeutic oral appliance 500 may comprise a hard palate portion 530. In some embodiments, the hard palate portion 530 may interface with the hard palate 560. The interface between the hard palate 560 and the hard palate portion 530 may provide stability that reduces movement of the tongue retainer portion 510 within the throat 580. [0049] In some implementations, the therapeutic oral appliance 500 may comprise a mouth guard portion 520. In some implementations, the hard palate portion 530 may extend upward from the mouth guard portion 520 to a central point of convergence. In some implementations, the mouth guard portion 520 may
be configured to at least partially interface with one or more teeth 550. In some aspects, the mouth guard portion 520 may provide a generic fit to the teeth 550 with limited malleable properties. This generic tooth form may provide sufficient stability to prevent ingestion of the therapeutic oral appliance 500. [0050] In some implementations, the tongue retainer portion 510 may align with the soft palate 570. In some embodiments, the tongue retainer portion 510 may comprise an upper surface, a lower surface, and a longitudinal length. In some aspects, the therapeutic oral appliance 500 may enter the throat 580. In some implementations, the user may modify the length of the tongue retainer portion 510. In some aspects, the tongue retainer portion 510 may be shortened by severing the tongue retainer portion 510 with scissors to the desired length. This may allow a user to customize the length of the tongue retainer portion 510. Shortening the tongue retainer portion 510 may be necessary if the tongue retainer portion 510 extends into the throat 580 sufficient to trigger the gag reflex. In some embodiments, the therapeutic oral appliance 500 may interface with the tongue 540. [0051] Referring now to Fig.6A, an exemplary therapeutic oral appliance 600 comprising a tongue retainer portion 610 is illustrated. Referring now to Fig. 6B, an exemplary cross- sectional view of an oral cavity with an exemplary therapeutic oral appliance 600 is illustrated. In some embodiments, the therapeutic oral appliance 600 may comprise a hard palate portion 630. In some implementations, the therapeutic oral appliance 600 may comprise a mouth guard portion 620. In some aspects, the hard palate portion 630 may extend upward from the mouth guard portion 620 to a central point of convergence. In some implementations, the mouth guard portion 620 may be configured to at least partially interface with one or more teeth 650. [0052] In some embodiments, the hard palate portion 630 may interface with the hard palate 660. In some implementations, the tongue retainer portion 610 may align with the soft palate 670. In some embodiments, the tongue retainer portion 610 may comprise an upper surface, a lower surface, and a longitudinal length. In some aspects, the tongue retainer portion 610 may be fixed to a distal end of the hard palate portion 630 and encroach into the throat 680. In some implementations, the tongue retainer portion 610 may increase in length incrementally. [0053] As an illustrative example, a user may, upon ordering the therapeutic oral appliance, receive a plurality of therapeutic oral appliances comprising therapeutic oral appliances with incremental tongue retainer portions, such as described in Figures 2A-6A. In preparation for using the therapeutic capabilities of the therapeutic oral appliance, the user may use a therapeutic oral appliance with incrementally longer tongue retainer portions until snoring is effectively prevented. A user may wear each size for a few days to a few weeks each, depending on the comfort level of each therapeutic oral appliance. The user may use the therapeutic oral appliance daily while sleeping to acclimate the throat to the tongue retainer portion and overcome the gag reflex. [0054] Dependent upon individual anatomy, the user may discover that an intermediary length of the tongue retainer portion is of sufficient length for therapeutic purposes, where the user may not benefit from an incrementally longer tongue retainer portion. In some embodiments, the user may incrementally increase
the length of the tongue retainer portion 610 until the length is sufficient to relieve obstruction but remain sufficiently comfortable for use while sleeping. In some aspects, the user may discover a need to trim the length of the tongue retainer portion 610 of the therapeutic oral appliance to achieve a desired length that is between the incremental tongue retainer portions. In some implementations, the length of the tongue retainer portion 610 may remain shorter than the distance to the epiglottis to ensure swallowing remains possible. [0055] Referring now to Fig.7A, an exemplary therapeutic oral appliance 700 comprising a tongue retainer portion 710 is illustrated, wherein the therapeutic oral appliance 700 is fitted for a child. Referring now to Fig.7B, an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance 700 is illustrated. In some embodiments, the therapeutic oral appliance 700 may comprise a hard palate portion 730. In some implementations, the therapeutic oral appliance 700 may comprise a mouth guard portion 720. In some aspects, the hard palate portion 730 may extend upward from the mouth guard portion 720 to a central point of convergence. [0056] In some embodiments, the hard palate portion 730 may interface with the hard palate 760. In some implementations, the tongue retainer portion 710 may align with the soft palate 770. In some embodiments, the tongue retainer portion 710 may comprise an upper surface, a lower surface, and a longitudinal length. In some aspects, the therapeutic oral appliance 700 may enter the throat 780. In some embodiments, the therapeutic oral appliance 700 may interface with the tongue 740. In some implementations, the mouth guard portion 720 may be configured to at least partially interface with one or more teeth 750. [0057] For smaller mouths, such as with children, incremental increases in tongue retainer portions 710 may be smaller to allow for a more refined fit. Smaller size increases may allow for easier transition with increased likelihood that the gag reflex suppression may occur without issue. Smaller mouths may require shorter tongue retainer portions 710. In some aspects, the incremental sizes of tongue retainer portions 710 may depend on predefined factors, such as strength of gag reflex, mouth size, user preference, practitioner recommendations, or level of customization. For example, where the therapeutic oral appliance is prescribed by a practitioner, the increments may be more customized than an over-the-counter version of a therapeutic oral appliance. [0058] Referring now to Figs. 8A–8B, a front view of an exemplary therapeutic oral appliance 800 is illustrated. In some embodiments, the tongue retainer portion 810 of the therapeutic oral appliance 800 may comprise one or more uniform recesses or slots that span the longitudinal length of the tongue retainer portion 810 to create an airway 815. In some implementations, the airway 815 may comprise uniform indentations along the sidewall of the tongue retainer portion 810. In some aspects, the airway 815 may comprise air flow pathways that are parallel to the direction of the throat. [0059] For example, the tongue retainer portion 810 may comprise one or more airway 815 tubes that continue for the longitudinal length of the tongue retainer portion 810. This may be useful if the throat is inflamed or otherwise restricted so as to render embedded channels within the walls of the tongue retainer portion 810 ineffective. In some embodiments, the airway 815 may comprise an integrated tube that runs
through the center of the tongue retainer portion 810. This may reduce the required insertion diameter and prevent obstruction by utilizing existing material that extends the length of the therapeutic oral appliance 800. [0060] Referring now to Fig.9, a mouth wearing an exemplary therapeutic oral appliance 900 is illustrated. In some embodiments, the mouth guard portion 920 may be configured to at least partially interface with one or more teeth 950 in a form fit. The therapeutic oral appliance 900 may fit similarly to a sport mouth guard, teeth whitening tray, incremental braces systems, or teeth grinding protectors, as non-limiting examples. In some aspects, a therapeutic oral appliance 900 may fit over dentures. In some embodiments, a therapeutic oral appliance 900 may fit over gums for user’s who may remove their dentures at night. [0061] Referring now to Fig.10, an exemplary therapeutic oral appliance 1000 with a safety mechanism is illustrated. In some embodiments, the therapeutic oral appliance 1000 may comprise at least one safety mechanism 1005. In some implementations, the safety mechanism 1005 may extend the entirety of the length of the therapeutic oral appliance 1000. In some aspects, this may prevent the ingestion of a portion of the therapeutic oral appliance 1000 that may break off from the therapeutic oral appliance 1000. This may be possible after prolonged use creates fatigue within the therapeutic oral appliance 1000 that creates structural instability within the therapeutic oral appliance 1000. [0062] Referring now to Figs.11A–11B, an exemplary therapeutic oral appliance 1100 with a mouth guard portion 1120 attachment is illustrated. In some embodiments, the mouth guard portion 1120 may comprise at least one external attachment. In some aspects, the external attachment may maintain a partially opened state for the mouth. In some implementations, the external attachment may be configured to interface with at least one supplemental device. The external attachment may comprise at least one aperture or opening that allows for the insertion of a variety of supplemental devices in the form of tubes into the oral cavity. [0063] As an example, an anesthesiologist may insert tubes to regulate sedation during surgery. This opening in the external attachment, with support from the hard palate portion 1130, may provide stability that allows the tube to remain in a fixed state. A source of humidified air or oxygen may be diffused near the oral cavity to provide humidification. This may assist in preventing dryness in the mouth and oropharynx. The reduced dryness may provide increased user comfort. As another example, a feeding tube may interface with the external attachment to provide nutrition to a user in a coma. Supplemental tubes may also sustain health for users with a variety of health challenges. [0064] As an illustrative example, a tube opening may provide access to the oral cavity while a user undergoes an epileptic seizure. The tongue retainer portion 1110 may assist in stabilizing the tongue and maintaining an unobstructed airway. The tube opening may assist in dampening muscular contractions within the jaw that may otherwise harm the user during the epileptic seizure. The tube opening may also maintain an orifice for the duration of the episode in case vomiting occurs. [0065] Physical disabilities may also necessitate the utilization of supplemental tubes for sustenance. For example, a user with cerebral palsy may struggle with aspiration due to muscle weakness. This may necessitate a breathing tube. Due to other muscular atrophy and fatigue, a feeding tube may also be
employed to ensure adequate nutrition. A therapeutic oral appliance 1100 may allow for prolonged use with reduced risk of damage to a user’s mouth, throat, respiratory system, and overall health. [0066] Referring now to Figs.12A–12B, an exemplary therapeutic oral appliance 1200 with a mouth guard portion 1220 attachment is illustrated. In some embodiments, the mouth guard portion 1220 may comprise at least one external attachment. In some implementations, the mouth guard portion 1220 may interface with at least one supplemental device 1290. In some embodiments, the mouth guard portion 1220 may interface with at least one supplemental device 1290 via the external attachment. In some aspects, the external attachment may maintain a partially opened state for the mouth. In some embodiments, the external attachment may comprise an aperture or opening that allows for the insertion of a variety of supplemental devices 1290 in the form of tubes into the oral cavity. [0067] As an example, an anesthesiologist may insert a tube to regulate sedation during surgery. This opening in the external attachment, with support from the hard palate portion 1230, may provide stability that allows the tube to remain in a fixed state. The opening in the external attachment may comprise a similar diameter to commonly interfaced sedation tubes. A source of humidified air or oxygen may be diffused near the oral cavity to provide humidification. This may assist in preventing dryness in the mouth and oropharynx. The reduced dryness may provide increased user comfort. [0068] Physical disabilities may also necessitate the utilization of supplemental tubes for sustenance. For example, a user with cerebral palsy may struggle with aspiration due to muscle weakness. This may necessitate a breathing tube. Due to other muscular atrophy and fatigue, a feeding tube may also be employed to ensure adequate nutrition. A therapeutic oral appliance 1200 may allow for prolonged use with reduced risk of damage to a user’s mouth, throat, respiratory system, and overall health. [0069] Referring now to Figs. 13A–13B, a side view of exemplary therapeutic oral appliance 1300 with a mouth guard portion attachment is illustrated. In some embodiments, the therapeutic oral appliance 1300 may comprise a mouth guard portion 1320. In some implementations, the mouth guard portion 1320 may comprise an attachment to prevent the grinding of the teeth. In some aspects, the therapeutic oral appliance 1300 may comprise a hard palate portion 1330 that may assist with reducing translational movement caused by teeth grinding. In some implementations, the hard palate portion 1330 may extend upward from the mouth guard portion 1320 to a central point of convergence. [0070] Referring now to Figs. 14A–14B, a side view of exemplary therapeutic oral appliance 1400 with a mouth guard portion attachment is illustrated. In some embodiments, the therapeutic oral appliance 1400 may comprise a mouth guard portion 1420. In some implementations, the mouth guard portion 1420 may comprise an attachment to prevent the grinding of the teeth. In some aspects, the therapeutic oral appliance 1400 may comprise a hard palate portion 1430 that may assist with reducing translational movement caused by teeth grinding. In some embodiments, the hard palate portion 1430 may extend upward from the mouth guard portion 1420 to a central point of convergence. [0071] In some aspects, the therapeutic oral appliance 1400 may interface with the lower jaw via attachment to a lower therapeutic oral appliance 1400. In some embodiments, a therapeutic oral appliance may cover
the lower teeth. In some implementations, the therapeutic oral appliance may connect to the therapeutic oral appliance 1400 secured to the upper palate. This may increase comfort and security, as non-limiting attributes. A lower therapeutic oral appliance may decrease the probability of the user spitting out the therapeutic oral appliance 1400. [0072] Referring now to Figs.15A–15B, an exemplary therapeutic oral appliance 1500 with an adjustable tongue retainer portion 1510 is illustrated. In some embodiments, the tongue retainer portion 1510 may comprise an upper surface, a lower surface, and a longitudinal length. In some aspects, the tongue retainer portion 1510 may extend into the throat at a variety of lengths that are determined by a plurality of predetermined longitudinal lengths that are adjusted in a region of the therapeutic oral appliance 1500. In some embodiments, the tongue retainer portion 1510 may be fixed to a distal end of the hard palate portion 1530. In some implementations, the tongue retainer portion 1510 may be removed from the therapeutic oral appliance 1500. This may be a helpful state for users who are beginning the acclimation process of the tongue retainer portion 1510 within the throat. [0073] In some embodiments, the adjustable aspect of the tongue retainer portion 1510 may interface with an extrusion connected to the mouth guard portion 1520. In some aspects, the adjustment of the tongue retainer portion 1510 may comprise a mechanism that exerts force on a fixture attached to the therapeutic oral appliance 1500. In some implementations, the hard palate portion 1530 may provide stability as the therapeutic oral appliance 1500 is adjusted within the oral cavity. In some aspects, the tongue retainer portion 1510 may comprise an airway 1515 that extends in conjunction with the extension of the tongue retainer portion 1510. [0074] In some embodiments, the airway 1515 may originate on the top of the mouth guard portion 1520. In some implementations, the airway 1515 and tongue retainer portion 1520 may be molded to follow the contour of the hard palate and soft palate. In some aspects, one or more channels for airway patency are included along the sides of airway 1515. In some embodiments, these channels may begin between the teeth or gums, as non-limiting options, in the case of edentulism, to provide airway patency so the airway 1515 is not occluded by the teeth or lips. [0075] In some embodiments, the airway 1515 and the tongue retainer portion 1520 may comprise a reinforced bridge portion that runs along the midline, near the midline, or parallel to midline of the hard palate and soft palate, as non-limiting alternatives. In some implementations, this reinforced portion may be attached to a flattened section that runs parallel to the hard palate portion 1530. This may provide increased surface area to push and stabilize the tongue and soft palate tissue away from each other to provide an airway 1515. In some aspects, the gap created by the reinforced bridge between the palate and the flattened plane may facilitate air flow. In some embodiments, the parallel planes separated by the reinforced bridge may form the airway 1515. [0076] As an illustrative example, the cross section of this structural design may be similar to an I-beam. The I-beam consists of two horizontal planes, known as flanges, connected by one vertical component, or the web. The shape of the flanges and the web create an “I” cross-section. The flanges correlate to the planes
touching the palate on one end and the tongue on the other end. The web correlates to the reinforced bridge that is the vertical component that connects the two horizontal planes. The space between the flanges created by the web is the channel where the air flow passes. The cross-sectional area for the airway 1515 may be sufficient to prevent increased respiratory effort or increased negative pressure on the lungs. [0077] Referring now to Figs.16A–16B, an exemplary therapeutic oral appliance 1600 with an adjustable tongue retainer portion 1610 is illustrated. In some embodiments, the tongue retainer portion 1610 may comprise an upper surface, a lower surface, and a longitudinal length. In some aspects, the tongue retainer portion 1610 may extend into the throat at a variety of lengths that are determined by a plurality of predetermined longitudinal lengths that are adjusted in a region of the therapeutic oral appliance 1600. In some implementations, the tongue retainer portion 1610 may be removed from the therapeutic oral appliance 1600. [0078] In some embodiments, the mouthguard portion 1620 may remain fixed while the airway 1615 may be moved and secured at different depths within the throat. In some implementations, the airway 1615 channel may be slid back and forth until the desired depth into the throat is reached. In some aspects, the airway 1615 may be secured into this position by a clamp or another non-limiting securing device. [0079] For example, a client may purchase a single therapeutic oral appliance and, at first, may use the therapeutic oral appliance with an airway that is completely retracted. The client may gradually increase the extension of the airway into the throat until the airway has extended the originally intended distance into the throat. [0080] In some embodiments, the airway 1615 may originate on the top of the mouth guard portion 1620. In some implementations, the airway 1615 and tongue retainer portion 1620 may be molded to follow the contour of the hard palate and soft palate. In some aspects, one or more channels for airway patency are included along the sides of airway 1615. In some embodiments, these channels may begin between the teeth or gums, as non-limiting options, in the case of edentulism, to provide airway patency so the airway 1615 is not occluded by the teeth or lips. [0081] Referring now to Fig. 17, an exemplary therapeutic oral appliance 1700 is illustrated. In some embodiments, the mouth guard portion 1720 may comprise a plurality of components. In some aspects, the mouth guard portion 1720 may comprise a brace with selective teeth caps. For example, at least one flexible wire may prevent slipping by applying a minimal retaining force upon the front teeth. A symmetrical plurality of tooth caps may be attached to the flexible wire and secure the therapeutic oral appliance 1700 by enclosing a plurality of teeth on both sides of the mouth. [0082] In some embodiments, the tooth caps may comprise a generic cast that, upon inducing heat to increase malleability, may be formed to the shape of the intended teeth. In some aspects, the tooth cap may comprise a cavity designed to enclose a plurality of teeth simultaneously. The thickness of the outside edge of the tooth cap may be of minimal thickness to ensure a fit between the teeth enclosed within the tooth cap and those excluded. In some implementations, a mold may provide a mated fit between the hard palate portion 1730 and the hard palate within the oral cavity.
[0083] Referring now to Fig. 18, an exemplary therapeutic oral appliance 1800 is illustrated. In some embodiments, the mouth guard portion 1820 may comprise a plurality of components. In some aspects, the mouth guard portion 1820 may comprise a brace with selective teeth caps. In some embodiments, the teeth caps may enclose a plurality of teeth singularly. In some implementations, the mouth guard portion 1820 may allow a user to bite down on the therapeutic oral appliance 1800 without requiring a fitting over teeth. This may allow for a more universal fit, such as for over-the-counter solutions. [0084] For example, the teeth caps may enclose three teeth separately on both sides of the mouth to ensure the required stability and security for the therapeutic oral appliance 1800. In some implementations, a mold may provide a mated fit between the hard palate portion 1830 and the hard palate within the oral cavity. In some aspects, the hard palate portion 1830 may comprise a variety of materials to accommodate a plurality of preferences. As an example, the therapeutic oral appliance 1800 may comprise silicone for ideal softness, durability, and hygiene. [0085] In some embodiments, the therapeutic oral appliance may comprise a soft silicone material with low shore hardness. This may provide an airway 1815 channel for breathing that allows for flexibility. The flexibility may allow the patient to swallow and maintain some tongue movement. This allowance may increase comfort for the patient. In some implementations, the mouth guard portion 1820 may cover one or more teeth or gums as a means to protect teeth from pressure points from the oral airway. The mouth guard portion 1820 may stabilize the oral airway while the user is unconscious to reduce the chance of inadvertent rejection by spitting out the therapeutic oral appliance 1800. [0086] For example, a user’s hard palate may be prone to inflammation when interfacing with typical medical grade plastics and polymers. The user may experience greater comfort and utility by utilizing a therapeutic oral appliance 1800 that comprises a hard palate portion 1830 composed of a metal or silicone mesh. A flexible or meshed hard palate portion 1830 may allow for a snug fit without requiring a custom mold. [0087] Referring now to FIG.19, an exemplary adjustable therapeutic oral appliance 1900 is illustrated. In some embodiments, the mouth guard portion 1920 may comprise a plurality of components. In some implementations, the dimensions of the therapeutic oral appliance 1900 may be adjustable. In some aspects, the tongue retainer portion 1910 may attach to a frame of the therapeutic oral appliance 1900. In some embodiments, the hard palate portion 1930 may interface with a minimized region of the hard palate. [0088] In some implementations, a mouth may be changing and growing quickly, such as with children. Their mouth size and shape may change between incremental tongue retainer portions 1910, which may make it impractical to use one mouth mold to create the incremental therapeutic oral appliances 1900. In some aspects, a mouth guard portion 1920 may fit over a few teeth, such as front teeth and back molars, that are unlikely to shift or change drastically during the acclimation period for the therapeutic oral appliance 1900. This may be combined with an extendable hard palate portion 1930 that may allow for growth.
[0089] Referring now to Fig.20, an exemplary therapeutic oral appliance 2000 configured to interface with one or more dental fixtures, such as by being attachable thereto, is illustrated. In some aspects, the dental fixtures may be attached to the teeth 2050. For example, the therapeutic oral appliance 2000 may connect to the metal fastening rods located on braces 2055 that are secured to the teeth 2050. For example, a teenager may overcome sleep apnea while wearing braces by attaching the therapeutic oral appliance 2000 to hooks on braces attached to the canine teeth. In some embodiments, the mouth guard portion 2020 may extend rearward into the mouth. In some implementations, the hard palate portion 2030 may interface with a minimized region of the hard palate. [0090] Referring now to Fig. 21, an exemplary therapeutic oral appliance 2100 with wireless data transmission capabilities is illustrated. In some embodiments, the therapeutic oral appliance may contain a plurality of electronic components that may be configured to interface with at least one external device 2190. In some implementations, the therapeutic oral appliance 2100 may be configured to interface with and relay information to at least one wearable device 2195 (such as, for example and not limitation, a smart watch). In some aspects, the tongue retainer portion 2110 may comprise one or more sensors. [0091] In some embodiments, the airway 2115 may contain a plurality of electronic components. For example, the therapeutic oral appliance 2100 may comprise electrodes that may provide transcutaneous electrical stimulation to oropharyngeal and tongue muscles. This may increase muscle tone, allowing for an opening of the patient airway channel. [0092] For example, a child prone to seizures may use a therapeutic oral appliance 2100 with an embedded accelerometer that notifies the parents of sharp increases in rapid movement that may be indicative of a seizure. This may be helpful at night when the family is asleep and the parents may otherwise remain unaware of the child’s seizure. The therapeutic oral appliance 2100 may limit likelihood that a seizure may cause the tongue to obstruct the child’s airway, which may cause permanent or temporary brain damage. [0093] As another example, a user may purchase a therapeutic oral appliance 2100 to overcome sleep apnea that pairs with an external device 2190 in the form of the user’s phone (such as, for example and not limitation, a smartphone) or computing device, such as a desktop computer, a laptop computer, or tablet as non-limiting examples. Embedded accelerometers and heart rate monitors may record information as the user sleeps to display quality of sleep information. The user may be able to see how restless they slept as well as their rest heart rate and oxygen levels. This may assist in overcoming sleep apnea by emitting vibrational frequencies during sleep to reposition the user to a better sleeping position when oxygen levels are too low. [0094] As another example, a user may be recovering from an illness that has a high rate of respiratory issues. The therapeutic oral appliance 2100 may track oxygenation levels (for example, by using a pulse oximeter) and heart rate to monitor and manage symptoms. Where levels drop below predefined threshold parameters, a practitioner or hospital may be notified. If a user is unresponsive to the practitioner, an ambulance may be sent.
[0095] As an illustrative example, an anesthesiologist may insert a therapeutic oral appliance 2100 during a surgery that comprises one or more health monitors. The anesthesiologist may monitor heart rate, oxygen levels, and breathing rate during the surgery. This information may display via Bluetooth® connection with one or more external devices 2190 in the form of one or more medical apparatuses stationed within the operation room. The medical equipment may be configured to convey notifications and alarms for predetermined thresholds. The medical equipment may notify the anesthesiologist of recommended times to routinely evaluate specific health criterion based on current health levels of the patient. [0096] As another illustrative example, the therapeutic oral appliance 2100 may comprise a capnograph or gas analyzer. A capnograph may measure predefined gases, such as inhaled oxygen and expired carbon dioxide. A gas analyzer may indicate how much oxygen therapy may be required to achieve a desired blood oxygen saturation. The gas monitors may provide indicative information regarding a patient’s ventilation. Audible and visual indicators may notify the healthcare professional if there is obstruction or hypercarbic symptoms due to OSA or poor ventilation. [0097] Referring now to Figs.22A-22B, a process 2200 of forming an exemplary therapeutic oral appliance is illustrated. In some embodiments, therapeutic oral appliance may be formed from an impression. In some implementations, the impression may comprise an impression of teeth and an impression of the hard palate, as non-limiting options. For example, physical impressions may be made of the upper hard palate, dentition, and as much of the soft palate as can be tolerated. [0098] In some aspects, the impressions of the patient’s mouth may be rendered digitally. As an example, an impression may be scanned by a high-fidelity 3-D scanner to render a virtual representation of the impression within a modeling software. In some embodiments, a digital rendering of an airway may be created along the longitudinal length of the digital impression of the therapeutic oral appliance. In some implementations, a physical construction of the digital rendering and airway may be formed. For example, the digital rendering may be printed by a 3-D printer. In some embodiments, this physical construction may provide a tangible medium to further the formation of the therapeutic oral appliance, such as by providing a shape for a mold. [0099] In some aspects, a mold may be formed using the physical rendition of the impression and the airway. In some embodiments, the mold may be used to create a therapeutic oral appliance by using the mold for casting. For example, a 3-D printed prototype may be place in casting clay to form an impression that is subsequently filled with a soft silicone material. As another example, a synthetic polymer may be poured into the mold and, upon solidifying, may produce a therapeutic oral appliance in the form of the impression and the airway. [00100] Referring now to Fig. 23, a method 2300 of forming an exemplary therapeutic oral appliance is illustrated. At 2305, physical impressions of a patient’s mouth may be formed. In some embodiments, the impressions may comprise an impression of the teeth and an impression of the hard palate, as non-limiting options. At 2310, the impressions of the patient’s mouth may be scanned in three dimensions. As an
example, an impression may be scanned by a high-fidelity 3-D scanner to render a virtual representation of the impression within a modeling software. [00101] At 2315, a digital rendering of an airway may be created along the longitudinal length of the digital impression. At 2320, a physical construction of the digital impression and airway may be constructed. For example, the digital rendering of the impression and the airway may be printed by a 3-D printer. [00102] At 2325, a mold may be formed using the physical rendition of the impression and the airway. At 2330, the mold may be used to create a therapeutic oral appliance by using the mold for casting. For example, a synthetic polymer may be poured into the mold and, upon solidifying, may produce a therapeutic oral appliance in the form of the impression and the airway. [00103] Referring now to Fig. 24, an exemplary therapeutic oral appliance 2400 with wireless data transmission capabilities, according to some embodiments of the present disclosure, is illustrated. In some embodiments, the therapeutic oral appliance 2400 may comprise one or more electronic components, wherein at least one of the electronic components may be configured to interface with at least one external device 2490. In some implementations, the therapeutic oral appliance 2400 may be configured to interface with at least one wearable technology device 2495 (such as, for example and not limitation, a smart watch). In some aspects, the one or more electronic components of the therapeutic oral appliance 2400 may enable the therapeutic oral appliance 2400 to transmit data to and/or receive data from the external device 2490 and/or the wearable technology device 2495. [00104] In some aspects, at least one internal or external portion of at least one of: a tongue retainer portion 2410, a mouth guard portion 2416, a hard palate portion 2417, or any other appropriate portion of the therapeutic oral appliance 2400 may comprise one or more electronic components in the form of one or more sensors and/or one or more electrodes. In some embodiments, one or more electrical wires may be placed upon at least a portion of at least one external surface of the therapeutic oral appliance 2400 and/or at least partially embedded within at least one internal portion of the therapeutic oral appliance 2400. As a non-limiting example, one or more electrical wires may be embedded inside the therapeutic oral appliance 2400 to block contact between the electrical wire(s) and the inside of a user’s mouth to minimize the user’s likelihood of experiencing irritation or encountering injury, as well as increase the useful longevity of the therapeutic oral appliance 2400. [00105] In some embodiments, one or more electrical wires may be used to couple two or more electronic components together, such as, for example and not limitation, to couple one or more sensors or electrodes to each other and/or to one or more batteries or other power sources. In some implementations, the therapeutic oral appliance 2400 may comprise one or more transmitting devices and/or one or more receiving devices for transmitting or receiving data, respectively. By way of example and not limitation, each transmitting device may comprise at least one of: a radio-frequency (RF) transmitter or a Bluetooth® transmitter, and each receiving device may comprise at least one of: an RF receiver and a Bluetooth® receiver. In some aspects, one or more electrical wires may couple each transmitting device and/or each receiving device to one or more sensors and/or one or more electrodes, as well as to at least one power
source, such as, for example and not limitation, a battery. In some embodiments, the transmitting device(s) of the therapeutic oral appliance 2400 may transmit data obtained from one or more sensors and/or one or more electrodes to at least one of: the external device 2490, the wearable technology device 2495, or at least one external or remote database or similar memory resource for at least temporary storage therein. [00106] In some embodiments, one or more sensors or electrodes within or upon the therapeutic oral appliance 2400 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 pH sensors, one or more audio sensors, one or more force sensors, one or more pressure sensors, one or more bite sensors, one or more gas concentration sensors, one or more gas pressure sensors, one or more electroencephalography electrode, one or more actigraphy sensor, one or more magnetoencephalography sensor, 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, and/or one or more capnography sensors. In some embodiments, the therapeutic oral appliance or device may further include a clock or timer. In a preferred embodiment, when one or more sensors in the therapeutic oral appliance detects that the therapeutic oral appliance is no longer in a proper position, an alert can be sent to a nearby monitoring device or app (such as a cell phone or display unit) so that the device or app can sound an alarm to alert the patient to reposition the therapeutic oral appliance properly. In this way, the patient will know when the oral appliance has inadvertently been displaced or dislodged from the correct position. [00107] In some embodiments, one or more sensors and/or electrodes may be configured upon or within the therapeutic oral appliance 2400 at a location that may be most advantageous to its purpose. As a non- limiting example, one or more temperature sensors, such as a thermometer, may be configured proximate to a deeper region within a user’s oral cavity, such as at or near the distal end of the tongue retainer portion 2410, thus allowing the temperature sensor(s) to obtain measurements closer to a core region of the user’s body, thereby improving the accuracy of the measurements. [00108] In some non-limiting exemplary embodiments, the functionality of one or more sensors of the therapeutic oral appliance 2400 may be at least partially dependent on emitting light and/or measuring light absorption, such as may be the case with one or more pulse oximetry sensors; therefore, it may be advantageous to configure such sensor(s) proximate to one or more thin membranes of the upper hard and/or soft palate, and so such sensor(s) may be arranged upon or within at least one portion of the therapeutic oral appliance 2400 adjacent thereto, such as, for example and not limitation, upon or within a superior surface of the tongue retainer portion 2410 and/or the hard palate portion 2417. Additionally, in some implementations, the therapeutic oral appliance 2400 may comprise one or more at least partially opaque materials or structures to block ambient light from interfering with the performance or functionality of any sensor(s) and/or electrode(s) that may be at least partially dependent on emitting or absorbing light.
[00109] In some aspects, the therapeutic oral appliance 2400 may comprise one or more sensors configured to measure the movement of one or more muscles within a user’s mouth, throat, or oral cavity. By way of example and not limitation, such sensor(s) may be located upon or within one or more portions of the tongue retainer portion 2410 to measure interactions between the therapeutic oral appliance 2400 and the user’s tongue or soft palate. [00110] In some implementations, one or more sensors may be configured to measure a user’s bite force, wherein the sensor(s) may be located at or near one or more external or internal portions of the mouth guard portion 2416 of the therapeutic oral appliance 2400 to detect and measure an amount of force applied to the mouth guard portion 2416 when at least a portion of the mouth guard portion 2416 experiences physical contact from at least a portion of the user’s upper teeth and at least a portion of the user’s lower teeth in a substantially simultaneous manner. [00111] By way of example and not limitation, sensor(s) for measuring a user’s bite force may comprise one or more of: at least one strain gauge transducer, at least one piezoresistive transducer, at least one pressure transducer, at least one piezoelectric transducer, at least one pressure sensitive film, or at least one optical sensor, as well as any other appropriate sensing device(s). In some aspects, one or more sensors configured to detect or measure airway channel occlusion for a user may be located at or near one or more internal or external portions of the mouth guard portion 2416 of the therapeutic oral appliance 2400. [00112] In some aspects, the therapeutic oral appliance 2400 may comprise one or more materials that may facilitate the functionality or performance of one or more sensors or electrodes configured therewith. As a non-limiting example, the therapeutic oral appliance 2400 may at least partially comprise at least one optically transparent material to prevent interference of the functionality of at least one pulse oximetry sensor. [00113] In some embodiments, the therapeutic oral appliance 2400 may comprise one or more electrodes that may be configured to facilitate transcutaneous electrical nerve or electrical muscle stimulation. As a non-limiting example, one or more electrodes may be located within or upon one or more portions of an inferior or superior surface of the therapeutic oral appliance 2400 to help strengthen and tone one or more muscles within a user’s mouth, throat, or oral cavity, such as, for example and not limitation, the user’s upper airway dilator muscles and/or the user’s tongue muscles. In some aspects, each of the one or more electrodes may at least partially comprise and/or may be at least partially embedded within one or more electrically conductive materials. In some non-limiting exemplary embodiments, the one or more electrodes may at least partially comprise and/or may be at least partially embedded within one or more of: carbon- infused medical grade silicone rubber, one or more carbon nanotube silicone composites, polydimethylsiloxane (PDMS), or one or more PDMS composites including those that may be combined with nickel, carbon nanotubes, and/or silver, as non-limiting examples. [00114] In some aspects, at least one airway 2415 of the therapeutic oral appliance 2400 may comprise one or more electronic components. By way of example and not limitation, the airway 2415 may comprise one or more electrodes that may be configured to facilitate transcutaneous electrical stimulation to one or more
oropharyngeal and/or tongue muscles of a user. In some implementations, this stimulation may facilitate an increase in muscle tone, thereby promoting opening of the user’s airway channel. [00115] In some aspects, the therapeutic oral appliance 2400 may comprise one or more electrodes 2480 configured to facilitate neuromuscular electrical stimulation. By way of example and not limitation, such neuromuscular electrical stimulation may be implemented in conjunction with one or more sensors 2401 in the form of capnography sensors, respiratory sensors, thoracic sensors, and/or other breathing sensors. In some embodiments, when one or more of these sensors 2401 may detect that a user is not breathing or that the user’s breathing is at least partially obstructed, the one or more neuromuscular electrical stimulation electrodes 2480 may be configured to send at least one electrical pulse that may cause the user’s tongue and/or upper airway dilator muscles to contract at least partially to facilitate opening of the user’s airway passage. [00116] In some implementations, the therapeutic oral appliance 2400 may be used to alleviate one or more health concerns for a user, such as sleep apnea. In some aspects, neuromuscular electrical stimulation provided by one or more electrodes 2480 of the therapeutic oral appliance 2400 may facilitate an increase in muscle tone within the user’s mouth, oral cavity, or throat, thereby reducing sleep apnea symptoms. In some non-limiting exemplary embodiments, this increase in muscle tone may allow the size of the center portion (or web) of the airway channel 2415 and/or a cross section of the tongue retainer portion 2410 to be incrementally and gradually decreased overtime, such as, for example and not limitation, by being compressed or compacted in an adjustable manner, by being replaced by a succession of one or more modular components, or by using a plurality of therapeutic oral appliances 2400 of different sizes. By way of example and not limitation, the gradual reduction of the size of the center portion of the airway channel 2415 or the tongue retainer portion 2410 may result in increased user comfort. [00117] In some embodiments, one or more electrodes 2480 for facilitating neuromuscular electrical stimulation may be configured within or upon one or more portions of the therapeutic oral appliance 2400 at a location that may be advantageous to its purpose or functionality, which may be to assist a user in overcoming sleep apnea, as a non-limiting example. In some aspects, one or more neuromuscular electrical stimulation electrodes 2480 may be located on any portion(s) of the therapeutic oral appliance 2400 that may at least partially contact a user’s tongue, such as, for example and not limitation, the tongue retainer portion 2410. By way of example and not limitation, at least one neuromuscular electrical stimulation electrode 2480 may be placed upon or near the user’s chin to facilitate stimulation of the genioglossus muscle. As a non-limiting example, the simulation of the genioglossus muscle may cause the tongue to tighten and at least partially protrude from the user’s mouth, thereby increasing the opening of the user’s airway channel. In some aspects, this direct stimulation of the genioglossus muscle may produce an effect similar to that facilitated by hypoglossal nerve stimulators without the need for any surgical implants. [00118] In some embodiments, the one or more neuromuscular electrical stimulation sensors may be configured within or upon the therapeutic oral appliance 2400 at a location that may be advantageous to its purpose or functionality, which may be to overcome sleep apnea. As a non- limiting example, the one or
more neuromuscular electrical stimulation sensors may be located on any portion of the therapeutic oral appliance that comes into contact with the tongue. As a non- limiting example, the one or more neuromuscular electrical stimulation sensors may be located near the chin to allow stimulation of the genioglossus muscle. As a non-limiting example, the simulation of the genioglossus muscle may cause the muscle to tighten and protrude, opening the airway. As an illustrative example, a child prone to seizures may use a therapeutic oral appliance 2400 with an embedded accelerometer connected to a Bluetooth® transmitter that may send one or more notifications to at least one external device 2490 in the form of a smartphone that may inform the child’s parents of sharp increases in rapid movement that may be indicative of a seizure. This information may be helpful at night when the family is asleep, and the parents may otherwise remain unaware of the child’s seizure. In this manner, the therapeutic oral appliance 2400 may limit the likelihood that a seizure may cause the tongue to obstruct the child’s airway, which may cause permanent or temporary brain damage. [00119] As another example, a user may purchase a therapeutic oral appliance 2400 to overcome sleep apnea, wherein the therapeutic oral appliance 2400 may pair with at least one external device 2490 in the form of the user’s phone (such as, for example and not limitation, a smartphone) or computing device, such as a desktop computer, a laptop computer, or tablet, as non-limiting examples, via a Bluetooth® or similar connection. One or more accelerometers and heart rate monitors embedded within one or more portions of the therapeutic oral appliance 2400 may detect and record data as the user sleeps to determine and present quality of sleep information to the user. Using this information, the user may be able to see how restlessly they slept as well as the user’s rest heart rate and oxygen levels throughout the night. To assist the user in overcoming sleep apnea, the therapeutic oral appliance 2400 may comprise one or more electrodes or similar mechanisms configured to emit one or more vibrational frequencies that may prompt the user to reposition to a better sleeping position when oxygen levels may drop below a minimum threshold. [00120] As another example, a user may be recovering from an illness that may include substantial respiratory issues. In such aspects, the therapeutic oral appliance 2400 may be configured to monitor the user’s oxygenation levels (for example, by using at least one pulse oximeter) as well as the user’s heart rate (such as by using a heart rate monitor) to monitor and manage the user’s symptoms. In some implementations, when the user’s oxygen levels, heart rate, or other health aspects drop below one or more predefined threshold parameters, a medical practitioner or hospital may be notified via at least one transmitting device upon or within a portion of the therapeutic oral appliance 2400. [00121] In some embodiments, a medical professional may attempt to communicate with the user via at least one audio emitting device within or upon the therapeutic oral appliance 2400, wherein the audio emitting device may be electronically coupled, such as, for example and not limitation, via at least one electrical wire, to at least one power source and at least one receiving device configured to receive incoming communication data from the medical professional. In some aspects, if the user does not respond to the medical professional, such as, for example and not limitation, via a microphone or similar mechanism within or upon the therapeutic oral appliance 2400 and electronically coupled to the transmitting device
and the power source(s), an ambulance or other emergency vehicle may be sent to the user’s location as may be determined by at least one geolocation device within or upon the therapeutic oral appliance 2400. [00122] As another illustrative example, an anesthesiologist may insert a therapeutic oral appliance 2400 within a user’s oral cavity during a surgery, wherein the therapeutic oral appliance 2400 may comprise one or more sensors in the form of one or more health monitors. This may enable the anesthesiologist to use the therapeutic oral appliance 2400 to monitor the user’s heart rate, oxygen levels, breathing rate, and/or other health aspects during the surgery. In some aspects, the user’s health information may be displayed upon one or more external devices 2490 via a Bluetooth® connection, wherein the external device(s) 2490 may comprise one or more medical apparatuses stationed within the operation room. [00123] In some implementations, the medical equipment may be configured to convey one or more notifications or alarms when one or more of the user’s health aspects reach one or more predetermined thresholds. In some embodiments, the medical equipment may notify the anesthesiologist of recommended times to routinely evaluate specific health criterion of the user based on one or more current health levels of the user. [00124] As a further illustrative example, the therapeutic oral appliance 2400 may comprise at least one sensor in the form of a capnography sensor or gas analyzer. In some aspects, a capnography sensor within or upon the therapeutic oral appliance 2400 may measure one or more predefined gases, such as oxygen inhaled and/or carbon dioxide exhaled by a user. In some implementations, a gas analyzer within or upon the therapeutic oral appliance 2400 may indicate how much oxygen therapy may be required to achieve a desired blood oxygen saturation for a user. In some aspects, these or similar gas monitors may provide indicative information regarding a user’s ventilation. [00125] In some non-limiting exemplary embodiments, one or more transmitting devices upon or within the therapeutic oral appliance 2400 may communicate data to one or more external devices 2490 and/or wearable technology devices 2495 to cause the external device(s) 2490 and/or wearable technology device(s) 2495 to emit one or more audible and/or visual indicators that may notify at least one healthcare professional if a user may be experiencing airway obstruction or hypercarbic symptoms due to OSA or poor ventilation. [00126] Referring now to Figs. 25A and 25B, an exemplary therapeutic oral appliance 2500 comprising a tongue retainer portion 2510, 2570, and an oral cavity comprising a therapeutic oral appliance 2500, according to some embodiments of the present disclosure, are illustrated. In some aspects, the therapeutic oral appliance 2500 may comprise a tongue retainer portion 2510, 2570; a mouth guard portion 2520, 2550; and/or a hard palate portion 2530, 2560 that may comprise one or more electronic components in the form of one or more sensors and/or one or more electrodes. In some embodiments, one or more electrical wires may be configured upon or embedded within one or more external or internal portions of the therapeutic oral appliance 2500. [00127] As a non-limiting example, one or more electrical wires may be embedded within the therapeutic oral appliance 2500 so that the electrical wire(s) are blocked from physically contacting one or more interior
portions of a user’s mouth, thereby minimizing the likelihood of the user experiencing discomfort or injury and minimizing damage to the therapeutic oral appliance 2500. In some embodiments, one or more electrical wires may be used to electronically couple one or more sensors or electrodes to each other, to at least one power source (such as, for example and not limitation, a battery), to at least one transmitting device (such as, for example and not limitation, an RF transmitter or Bluetooth® transmitter, and/or to at least one receiving device (such as, for example and not limitation, an RF receiver or a Bluetooth® receiver). In some non-limiting exemplary embodiments, the therapeutic oral appliance 2500 may be configured to transmit data obtained from one or more sensors and/or one or more electrodes to at least one external device, at least one wearable technology device, and/or at least one database. [00128] In some aspects, the therapeutic oral appliance 2500 may comprise one or more sensors or electrodes that 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 pH sensors, one or more audio sensors, one or more force sensors, one or more pressure sensors, one or more bite sensors, one or more gas concentration sensors, one or more gas pressure sensors, one or more electroencephalography electrodes, one or more actigraphy sensors, one or more magnetoencephalography sensors, 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, and/or one or more capnography sensors. In some embodiments, the therapeutic oral appliance or device may further include a clock or timer. [00129] In some embodiments, one or more sensors may be configured within or upon the therapeutic oral appliance 2500 at a location that may be advantageous to its purpose or functionality. As a non-limiting example, one or more temperature sensors (such as, for example and not limitation, one or more thermometers) may be configured proximate to a deeper region within a user’s oral cavity, such as by being located within, upon, or near a distal end of the tongue retainer portion 2510, 2570, thereby allowing the temperature sensor(s) to obtain measurements closer to the user’s core body region, thus increasing the accuracy of the measurements. [00130] Referring now to Fig. 26, a perspective view of an exemplary therapeutic oral appliance 2600, according to some embodiments of the present disclosure, is illustrated. In some embodiments, the therapeutic oral appliance 2600 may comprise one or more electrical wires that may be attached to one or more electrodes 2680. In some implementations, the one or more electrical wires may be connected to at least one power source, such as, by way of example and not limitation, at least one battery. In some implementations, such electrodes 2680 may be configured to facilitate diagnostic techniques including electroencephalography magnetoencephalography and electromyography. In some aspects, the therapeutic oral appliance 2600 may comprise one or more transmitting devices, such as, for example and not limitation, one or more RF transmitters or Bluetooth® transmitters, wherein the transmitting device(s) may be connected to the one or more electrical wires to facilitate electronic coupling to the at least one power
source and the one or more electrodes 2680. In some embodiments, the therapeutic oral appliance 2600 may transmit data obtained from the one or more electrodes 2680 to at least one external device, at least one wearable technology device, and/or at least one database or similar memory resource via the one or more transmitting devices. By way of example and not limitation, each of the one or more electrodes 2680 may comprise an electromyography electrode or any similar mechanism. [00131] In some aspects, the therapeutic oral appliance 2600 may comprise a tongue retainer portion 2610, a mouth guard portion 2620, and/or a hard palate portion 2630 that may comprise one or more electrodes 2680. In some embodiments, the therapeutic oral appliance 2680 may comprise one or more electrodes 2680 configured to facilitate transcutaneous electrical nerve or electrical muscle stimulation. As a non- limiting example, one or more electrodes 2680 may be configured within or upon one or more portions of an inferior and/or superior surface of the therapeutic oral appliance 2600 to facilitate the strengthening and toning of one or more of a user’s upper airway dilator muscles, tongue muscles, and/or other muscles. [00132] In some aspects, each of the one or more electrodes 2680 may at least partially comprise and/or may be at least partially embedded within one or more electrically conductive materials. In some aspects, by way of example and not limitation, each of the one or more electrodes 2680 may at least partially comprise and/or may be at least partially embedded within a material that comprises at least one of: carbon- infused medical grade silicone rubber, one or more carbon nanotube silicone composites, PDMS, or one or more PDMS composites, including those in combination with nickel, carbon nanotubes, and/or silver. [00133] In some embodiments, at least one airway 2615 of the therapeutic oral appliance 2600 may comprise one or more electrodes 2680 that may be configured to provide transcutaneous electrical stimulation to one or more oropharyngeal and/or tongue muscles of a user. In some aspects, this stimulation may cause an increase in muscle tone that may facilitate the opening of the user’s oral airway channel. In some non-limiting exemplary embodiments, the electrical stimulation produced by one or more electrodes 2680 may be strong enough to be sensed by a user so as to prompt or stimulate the user to perform an action. As an illustrative example, a person prone to snoring may use a therapeutic oral appliance 2600 with one or more embedded electrodes 2680 that generate a subtle electrical impulse in the form of a slight shock or vibration that wakes the user when snoring may be detected, such as via at least one sensor in the form of a microphone or other audio capturing device. [00134] Referring now to Figs. 27A, 27B, and 27C, an exemplary therapeutic oral appliance 2700, according to some embodiments of the present disclosure, is illustrated. In some aspects, the therapeutic oral appliance 2700 may comprise a tongue retainer portion 2770, a mouth guard portion 2750, and/or a hard palate portion 2760 that may comprise one or more sensors 2701. In some aspects, one or more electrical wires 2725 may be configured upon or embedded within one or more external or internal portions of the therapeutic oral appliance 2700. In some implementations, one or more electrical wires 2725 may be embedded within at least one internal portion of the therapeutic oral appliance 2700 to block the electrical wire(s) 2725 from physically contacting one or more interior portions of a user’s mouth, thereby reducing the likelihood of inflicting discomfort or injury upon the user and prolonging the useful duration of the
therapeutic oral appliance 2700. In some embodiments, the one or more electrical wires 2725 may be attached to one or more sensors 2701 to electronically couple the sensor(s) 2701 to each other, to at least one power source 2735 (such as, for example and not limitation, at least one battery), at least one transmitting device 2745 (such as, for example and not limitation, an RF transmitter or a Bluetooth® transmitter), and/or at least one receiving device (such as, for example and not limitation, an RF receiver or a Bluetooth® receiver). [00135] In some non-limiting exemplary embodiments, each of the one or more sensors 2701 may comprise at least one of: 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 pH sensors, one or more audio sensors, one or more force sensors, one or more pressure sensors, one or more bite sensors, one or more gas concentration sensors, one or more gas pressure sensors, one or more electroencephalography electrodes, one or more actigraphy sensors, one or more magnetoencephalography sensors, 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, and/or one or more capnography sensors. In some embodiments, the therapeutic oral appliance or device may further include a clock or timer. [00136] In some embodiments, one or more sensors 2701 may be configured upon or within one or more portions of the therapeutic oral appliance 2700 at one or more locations that may facilitate the utility or functionality of the sensor(s) 2701. As a non-limiting example, one or more temperature sensors may be configured proximate to a deeper region within a user’s oral cavity, such as at or near a distal end of the tongue retainer portion 2770 thereby allowing the temperature sensor(s) to obtain measurements closer to a core body region, thus increasing the accuracy of the measurements. [00137] In some aspects, the therapeutic oral appliance 2700 may comprise one or more sensors 2701 that may comprise functionality that is at least partially dependent on emitting light and/or measuring light absorption, such as, for example and not limitation, one or more pulse oximetry sensors. By way of example and not limitation, such sensor(s) may be configured proximate to one or more thin membranes of a user’s upper hard and/or soft palate by being located within or upon one or more portions of a superior surface of the therapeutic oral appliance 2700, such as the tongue retainer portion 2770 and/or the hard palate portion 2760. [00138] In some aspects, the therapeutic oral appliance 2700 may comprise one or more sensors 2701 configured to measure one or more muscle movements within a user’s mouth, throat, or oral cavity, wherein the sensor(s) 2701 may be positioned upon or within one or more portions of the tongue retainer portion 2770 to detect or measure any interactions between the therapeutic oral appliance 2700 and one or more portions of the user’s tongue and/or soft palate. [00139] In some implementations, one or more sensors 2701 may be configured to measure a user’s bite force, wherein the sensor(s) 2701 may be located at or near one or more external or internal portions of the
mouth guard portion 2750 of the therapeutic oral appliance 2700 to detect and measure an amount of force applied to the mouth guard portion 2750 when at least a portion of the mouth guard portion experiences physical contact from at least a portion of the user’s upper teeth and at least a portion of the user’s lower teeth in a substantially simultaneous manner. In some aspects, one or more sensors 2701 may be configured to detect or measure airway channel occlusion for a user, wherein such sensor(s) 2701 may be located at or near one or more internal or external portions of the mouth guard portion 2750 of the therapeutic oral appliance 2700. Pressure or force sensors may be used to monitor teeth grinding or bruxism. [00140] In some aspects, the therapeutic oral appliance 2700 may comprise one or more materials that may facilitate the performance and functionality of the sensor(s) 2701. As a non-limiting example, the therapeutic oral appliance 2700 may at least partially comprise at least one optically transparent material so as not to interfere with the functioning of one or more sensors 2701 that may be at least partially dependent on producing, detecting, or measuring emitted and/or absorbed light, such as, by way of example and not limitation, one or more pulse oximetry sensors. [00141] Referring now to Figs.28A and 28B, an exemplary therapeutic oral appliance 2800, in accordance with some embodiments of the present disclosure, is illustrated. In some aspects, the therapeutic oral appliance 2800 may comprise one or more sensors 2801 and/or one or more electrodes 2880 configured within or upon one or more internal or external portions of a tongue retainer portion 2810, a mouth guard portion 2820, and/or a hard palate portion 2830 thereof. In some embodiments, one or more electrical wires 2825 may be configured upon or embedded within one or more internal or external portions of the therapeutic oral appliance 2800. As a non-limiting example, one or more electrical wires 2825 may be embedded within one or more internal portions of the therapeutic oral appliance 2800 to block the electrical wire(s) 2825 from physically contacting one or more interior portions of a user’s mouth. In some embodiments the electrical wires and electrodes may be configured so as to facilitate diagnostic techniques including electroencephalography, magnetoencephalography and electromyography. [00142] In some embodiments, the electrical wire(s) 2825 may be attached to one or more sensors 2801, one or more electrodes 2880, at least one transmitting device 2845 (such as, for example and not limitation, an RF transmitter or Bluetooth® transmitter), at least one power source 2835 (such as, for example and not limitation, a battery), and/or at least one receiving device (such as, for example and not limitation, an RF receiver or a Bluetooth® receiver). In some implementations, the at least one transmitting device 2845 may comprise dual functionality in that it may also serve as a receiving device. [00143] In some embodiments, the therapeutic oral appliance 2800 may transmit data obtained from one or more sensors 2801 and/or one or more electrodes 2880 to at least one external device, at least one wearable technology device, and/or at least one database or similar memory resource via the at least one transmitting device 2845. In some implementations, the performance or functionality of the one or more sensors 2801 and/or the one or more electrodes 2880 may be directed or altered by the at least one external device or the at least one wearable technology device via the at least one receiving device.
[00144] In some embodiments, by way of example and not limitation, the therapeutic oral appliance 2800 may comprise one or more sensors 2801 and/or one or more electrodes 2880 that 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 pH sensors, one or more audio sensors, one or more force sensors, one or more pressure sensors, one or more bite sensors, one or more gas concentration sensors, one or more gas pressure sensors, one or more electroencephalography electrodes, one or more actigraphy sensors, one or more magnetoencephalography sensors, one or more light-emitting sensors, one or more light absorption sensors, one or more muscle movement sensors, one or more heart rate monitors, and/or one or more capnography sensors. In some embodiments, the therapeutic oral appliance or device may further include a clock or timer. [00145] In some embodiments, the therapeutic oral appliance 2800 may comprise one or more sensors 2801 and/or electrodes 2880 that may be configured upon or within one or more external or internal portions of the therapeutic oral appliance 2800 so as to optimize the performance or functionality of the sensor(s) 2801 and/or electrode(s) 2880. As a non-limiting example, one or more temperature sensors may be configured proximate to a deeper region within the oral cavity of a user, such as, for example and not limitation, by being positioned at or near the distal end of the tongue retainer portion 2810, thereby enabling the temperature sensor(s) to obtain measurements closer to the user’s core body region, thus increasing the accuracy of the measurements. [00146] By way of further example and not limitation, the therapeutic oral appliance 2800 may comprise one or more sensors 2801 that comprise functionality that is at least partially dependent on emitting light and/or measuring light absorption, such as, for example and not limitation, one or more pulse oximetry sensors. In some implementations, such sensor(s) 2801 may be located proximate to one or more thin membranes of one or more portions of a user’s upper hard and/or soft palate by being positioned at or near one or more portions of a superior surface of the tongue retainer portion 2810 and/or the hard palate portion 2830 of the therapeutic oral appliance 2800. [00147] In some aspects, the therapeutic oral appliance 2800 may comprise one or more sensors 2801 configured to measure one or more muscle movements within a user’s mouth, throat, or oral cavity, wherein the sensor(s) 2801 may be configured upon or within one or more external or internal portions of the tongue retainer portion 2810 to detect and/or measure, by way of example and not limitation, one or more interactions between the therapeutic oral appliance 2800 and a user’s tongue and/or soft palate. In some aspects, the therapeutic oral appliance 2800 may comprise one or more sensors 2801 configured to measure a user’s bite force by being located at, upon, within, or proximate to one or more portions of the mouth guard portion 2820, or any other appropriate portion of the therapeutic oral appliance 2800. In some aspects, the therapeutic oral appliance 2800 may comprise one or more sensors 2801 configured to detect and/or measure at least partial airway channel occlusion for a user by being configured, by way of example and
not limitation, within, upon, or proximate to one or more internal or external portions of the mouth guard portion 2820 of the therapeutic oral appliance 2800. [00148] In some aspects, the therapeutic oral appliance 2800 may comprise at least one material that may facilitate the functionality and/or performance of the sensor(s) 2801 and/or electrode(s) 2880. As a non- limiting example, the therapeutic oral appliance 2800 may at least partially comprise at least one optically transparent material to minimize potential interference of the functioning of at least one pulse oximetry sensor. [00149] In some embodiments, the therapeutic oral appliance 2800 may comprise one or more electrodes 2880 configured to facilitate transcutaneous electrical nerve and/or electrical muscle stimulation. As a non- limiting example, one or more electrodes 2880 may be configured within, upon, or proximate to one or more portions of an interior and/or superior surface of the therapeutic oral appliance 2800 to help strengthen and tone one or more upper airway dilator muscles and/or tongue muscles of a user. In some aspects, one or more electrodes 2880 may at least partially comprise and/or be at least partially configured within one or more electrically conductive materials. In some aspects, by way of example and not limitation, one or more electrodes 2880 may at least partially comprise and/or may be at least partially configured within at least one material that comprises one or more of: carbon-infused medical grade silicone rubber, one or more carbon nanotube silicone composites, PDMS, or one or more PDMS composites, including those used in combination with nickel, carbon nanotubes, and/or silver. [00150] In some embodiments, one or more portions of the tongue retainer portion 2810, such as, for example and not limitation, at least one airway 2815 may comprise one or more electronic components. For example, the therapeutic oral appliance 2800 may comprise one or more electrodes 2880 that may be configured to provide transcutaneous electrical stimulation to one or more oropharyngeal and/or tongue muscles of a user. In some aspects, such stimulation may facilitate an increase in muscle tone, thereby promoting opening of a user’s oral airway channel. [00151] In some aspects, the therapeutic oral appliance 2800 may comprise one or more electrodes 2880 configured to facilitate neuromuscular electrical stimulation. By way of example and not limitation, such neuromuscular electrical stimulation may be implemented in conjunction with one or more sensors 2801 in the form of capnography sensors, respiratory sensors, thoracic sensors, and/or other breathing sensors. In some embodiments, when one or more of these sensors 2801 may detect that a user is not breathing or that the user’s breathing is at least partially obstructed, the one or more neuromuscular electrical stimulation electrodes 2880 may be configured to send at least one electrical pulse that may cause the user’s tongue and/or upper airway dilator muscles to at least partially contract to facilitate opening of the user’s airway passage. [00152] In some implementations, the therapeutic oral appliance 2800 may be used to alleviate one or more health concerns for a user, such as sleep apnea. In some aspects, neuromuscular electrical stimulation provided by one or more electrodes 2880 of the therapeutic oral appliance 2800 may facilitate an increase in muscle tone within the user’s mouth, oral cavity, or throat, thereby reducing sleep apnea symptoms. In
some non-limiting exemplary embodiments, this increase in muscle tone may allow the size of the center portion (or web) of the airway channel 2815 and/or a cross section of the tongue retainer portion 2810 to be incrementally and gradually decreased overtime, such as, for example and not limitation, by being compressed or compacted in an adjustable manner, by being replaced by a succession of one or more modular components, or by using a plurality of therapeutic oral appliances 2800 of different sizes. By way of example and not limitation, the gradual reduction of the size of the center portion of the airway channel 2815 or the tongue retainer portion 2810 may result in increased user comfort. [00153] In some embodiments, one or more electrodes 2880 for facilitating neuromuscular electrical stimulation may be configured within or upon one or more portions of the therapeutic oral appliance 2800 at a location that may be advantageous to its purpose or functionality, which may be to assist a user in overcoming sleep apnea, as a non-limiting example. In some aspects, one or more neuromuscular electrical stimulation electrodes 2880 may be located on any portion(s) of the therapeutic oral appliance 2800 that may at least partially contact a user’s tongue, such as, for example and not limitation, the tongue retainer portion 2810. By way of example and not limitation, at least one neuromuscular electrical stimulation electrode 2880 may be placed upon or near the user’s chin to facilitate stimulation of the genioglossus muscle. As a non-limiting example, the simulation of the genioglossus muscle may cause the tongue to tighten and at least partially protrude from the user’s mouth, thereby increasing the opening of the user’s airway channel. In some aspects, this direct stimulation of the genioglossus muscle may produce an effect similar to that facilitated by hypoglossal nerve stimulators without the need for any surgical implants. [00154] Referring now to Fig. 29, a perspective view of an exemplary therapeutic oral appliance 2900, according to some embodiments of the present disclosure, is illustrated. In some aspects, the therapeutic oral appliance 2900 may comprise at least one amount of substantially hollow tubing 2910. In some non- limiting exemplary embodiments, the hollow tubing 2910 may be used to measure airflow being inhaled or exhaled by a user. In some aspects, the hollow tubing 2910 may be used to at least partially encapsulate one or more electrical wires 2920. In some aspects, the electrical wire(s) 2920 may be removably or securely attached to one or more sensors 2901 and/or one or more electrodes 2980. [00155] In some aspects, the hollow tubing 2910 may be attached to or integrated with one or more gas flow meters and/or one or more gas analyzers, such as, for example and not limitation, one or more air flow meters, one or more capnography devices, and/or one or more oxygen analyzers 2930 in order to measure one or more aspects of the gases 2940 flowing into or out of a user’s body. In some implementations, the hollow tubing 2910 may be used to deliver one or more gasses 2940, including but not limited to, supplemental oxygen, nitric oxide, and/or humidification to a user. In some embodiments, the hollow tubing 2910 may be used to deliver one or more medicated gases 2940 to a user, such as, for example and not limitation, one or more aerosolized or nebulized medications within one or more gases 2940 in the form of air or oxygen. [00156] Some embodiments of the therapeutic oral appliance may include an integrated computer processor. In some aspects the therapeutic oral appliance may further include a non-volatile memory for
the storage of data gathered by the at least one sensor or electrode. In some embodiments the data gathered and stored in the non-volatile memory may be periodically transmitted or transferred to an external database, either by wired connection or wireless connection. The integrated processor and/or non-volatile memory may in some implementations be programmable in order to instruct the at least one sensor or electrode to carry out sequences of therapeutic activities and/or monitor patient responses, for example to perform periodic or patterned neuromuscular electrical stimulation and/or measure the response through the at least one sensor. The integrated computer processor may cooperate with the clock or timer so that the integrated computer processor can keep track of time. Further embodiments may include a physical computer interface, such as a USB or serial connection, or a wireless connection for loading a program to the integrated processor and/or non-volatile memory and downloading data to an external computer or database. The data may be analysed in real-time or off-line. The integrated computer processor may be connected to a power source, such as a battery, preferably a rechargeable battery. [00157] In some embodiments of the invention, one or more electroencephalography electrodes and/or one or more magnetoencephalography sensors are placed on or throughout the therapeutic oral appliance in such a way that they are placed in contact with the palatal and oropharyngeal mucosa. The location of the magnetoencephalography sensors on or throughout the therapeutic oral appliance enables real-time, non- invasive measurement of brain electrical activity (e.g. of the hippocampus or other parts of the brain), without requiring surgical implantation of electrodes within the brain. Furthermore, the magnetoencephalography sensors may be strategically located on or throughout the therapeutic oral appliance to optimise the brain electrical activity measurement. Locating the magnetoencephalography sensors inside the mouth produces enhanced sensitivity to hippocampal generators within the mouth, which is believed to improve the magnetoencephalography sensors’ selectivity, both spectrally and spatially, to the human hippocampus. Some embodiments of the therapeutic oral appliance include more than one electromyography electrode configured to perform electromyography (such as surface electromyography) so as to measure muscle response or electrical activity, for example in response to neuromuscular electrical stimulation. The electromyography measurements can be performed by a pair of electromyography electrodes or by a more complex array of electromyography electrodes. [00158] In some aspects, the therapeutic oral appliance can be used to aid myofunctional therapy exercises (such as moving the tongue along the surfaces of the teeth, hard palate, soft palate and floor of the mouth, swallowing, chewing, nasal inhalation and oral exhalation) intended to improve the function of the muscles of the tongue or soft palate in order to maintain an open airway, thereby helping to treat sleep apnea. Muscles of the soft palate and tongue including musculus uvulae, levator veli palatine, tensor veli palatini, palatopharyngeus, palatoglossus, genioglossus, hyoglossus, styloglossus, superior longitudinal, inferior longitudinal, transverse, and vertical muscles of the tongue can be toned and strengthened with the oral appliance. The tongue can be used to squeeze the therapeutic oral appliance between the tongue and the hard and soft palates, thereby strengthening and toning the tongue. Conversely, the muscles of the soft palate can squeeze the therapeutic oral appliance against the tongue, thereby strengthening and toning the
soft palate muscles. In this respect, some embodiments include pressure or force sensors which are located or embedded throughout the therapeutic oral appliance in order to measure the forces or pressures exerted by the muscles of the tongue or soft palate on different areas of the therapeutic oral appliance. The effectiveness and progress of the myofunctional therapy exercises can be measured by the pressure or force sensors. In particular, the measurement collected by the pressure or force sensors enables the provision of feedback to help patients understand target areas to apply pressure in order to ensure optimal myofunctional therapy efficacy. The multitude of pressure or force sensors will give patients a better idea of whether they are doing the exercises correctly. Display readouts will allow patients to track their progress in strengthening these oral muscles. [00159] In further embodiments, electrodes may be placed on the tongue retainer portion and be configured to perform neuromuscular electrical stimulation (NMES), particularly on the tongue and upper airway dilator muscles. NMES involves applying an electrical current through the electrodes placed over target muscle areas in order to induce muscular contraction, particular muscle areas that are difficult to activate voluntarily. By training the tongue and upper airway dilator muscles, respiratory capability can be improved and/or the muscles can be trained to be responsive to various conditions (such as snoring and OSA) in order to improve airway space and patency. Muscles of the soft palate and tongue including musculus uvulae, levator veli palatine, tensor veli palatini, palatopharyngeus, palatoglossus, genioglossus, hyoglossus, styloglossus, superior longitudinal, inferior longitudinal, transverse and vertical muscles of the tongue can be stimulated, toned, and strengthened with the therapeutic oral appliance's electrical stimulation. [00160] Some embodiments of the therapeutic oral appliance may include one or more actigraphy sensors for collecting data generated by user movement or activity. Actigraphy may include data from an accelerometer or acceleromyograph and a clock or timer. The clock or timer is programmable to start and stop the actigraph measurement at specific times, and to maintain the actigraph measurement for a specific time frame. It may further include measurements of temperature, ambient light, sound or audio levels, movement or tremors, skin resistance and electroencephalography data. The electronics for performing actigraphy may further include a low-pass filter configured to filter out external vibrations. As an example, a range of frequencies which could be allowed by the low-pass filter is in the range of 2-3 Hz. In some aspects, a waterproof casing may be included to house the components provided for actigraphy. [00161] Sensors, monitors and electrodes may be advantageously configured in or on different portions, areas or regions of the therapeutic oral appliance according to their purpose. Preferably, heart rate monitors, pulse oximetry sensors or other sensors which require light to be emitted or absorbed through bodily tissues are located on the superior surface of the therapeutic oral appliance so as to contact or interface with the thinner tissues of the mouth and throat. For example, a pulse oximetry sensor or heart rate monitor may be placed on the superior surface of the therapeutic oral appliance (e.g. on the superior surface of the hard palate portion) so as to emit and absorb light though the hard palatal tissues. Gas concentration sensors, gas pressure sensors and capnography sensors are preferentially located near the front or anterior of the
appliance so as not to become blocked by saliva and other fluids. Pressure sensors are preferably placed based on the desired pressure measurements. As an example, for the measurement of pressures exerted by the tongue or palate or upper airway dilator muscles, pressure sensors should be placed along the airway channel dependent on which muscle movement is to be measured. Acceleromyography and electromyography sensors are likewise preferentially located (e.g. along the airway channel) proximal to the muscles for which monitoring is sought. The pressure sensors may be placed on the superior or inferior surface of the therapeutic oral appliance. As a further non-limiting example, pressure, force, or bite sensors for measuring bruxism, grinding and biting are preferentially located in the mouthguard portion of the device. [00162] Electrodes for NMES are preferentially located along the airway channel according to which muscle(s) is (are) to be stimulated. For example, stimulation electrodes targeting the tongue should be placed on the inferior surface of the therapeutic oral appliance and in contact with the tongue of the patient. As a further example, electrodes can be located on the superior surface of the therapeutic oral appliance in communication with the soft palate in order to stimulate the upper airway dilator muscles. [00163] Temperature sensors are preferentially located such that they provide an accurate reading of core body temperature. For example, they may be placed in the back of the airway channel, posteriorly on the therapeutic oral appliance or at a distal end of the tongue retainer portion. pH and moisture sensors are preferably located on the therapeutic oral appliance (e.g. posteriorly on the therapeutic oral appliance) so as to be near the esophageal opening in order to provide the most accurate measurements, though other locations may be situationally advantageous. Audio sensors, actigraphy sensors, accelerometers, and sensors intended to provide data regarding e.g., overall movement or sound may be placed in any location on the appliance which does not impede their function. [00164] Electroencephalography and magnetoencephalography sensors and electrodes are preferentially located on the superior surface of the appliance and disposed (i.e. facing) towards the brain of the patient. CONCLUSION [00165] A number of embodiments of the present disclosure have been described. While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any disclosures or of what may be claimed, but rather as descriptions of features specific to particular embodiments of the present disclosure. [00166] Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination or in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in combination in multiple embodiments separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or variation of a sub-combination.
[00167] Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous. [00168] Moreover, the separation of various system components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the described program components and systems can generally be integrated together in a single software product or packaged into multiple software products. [00169] Thus, particular embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results. In addition, the processes depicted in the accompanying Figures do not necessarily require the particular order show, or sequential order, to achieve desirable results. In certain implementations, multitasking and parallel processing may be advantageous. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the claimed disclosure.
Claims
CLAIMS 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 at least one power source.
3. The therapeutic oral appliance of any one of the preceding claims wherein the at least one sensor is or includes at least one light-emitting sensor.
4. The therapeutic oral appliance of any one of the preceding claims wherein the at least one sensor is or includes at least one light absorption sensor.
5. The therapeutic oral appliance of any one of the preceding claims wherein the at least one sensor is or includes at least one pulse oximetry sensor.
6. The therapeutic oral appliance of any one of the preceding claims wherein the at least one sensor is or includes at least one heart rate monitor.
7. The therapeutic oral appliance of any one of Claims 3 to 6 wherein the at least one light-emitting sensor, the at least one light absorption sensor, the at least one pulse oximetry sensor or the least one heart rate monitor is located on a superior surface of the therapeutic oral appliance for contacting with a hard palate of a mouth of a user.
8. The therapeutic oral appliance of any one of the preceding claims wherein the at least one sensor is or includes at least one capnography sensor, at least one gas concentration sensor or at least one gas pressure sensor.
9. The therapeutic oral appliance of Claim 8 wherein the at least one capnography sensor, the at least one gas concentration sensor or the at least one gas pressure sensor is located at or near a front or anterior of the appliance.
10. The therapeutic oral appliance of any one of the preceding claims wherein the at least one sensor is or includes at least one photoplethysmography sensor.
11. The therapeutic oral appliance of any one of the preceding claims wherein the at least one sensor is or includes at least one peripheral artery tonometry sensor.
12. The therapeutic oral appliance of any one of the preceding claims wherein the at least one sensor is or includes at least one pressure or force sensor.
13. The therapeutic oral appliance of any one of the preceding claims wherein the at least one sensor is or includes at least one bite sensor.
14. The therapeutic oral appliance of Claim 12 or Claim 13 wherein the at least one force, pressure or bite sensor is located in or on the mouthguard portion of the appliance.
15. The therapeutic oral appliance of any one of the preceding claims wherein the at least one sensor is or includes at least one piezoelectric sensor, preferably at least one piezoelectric myography sensor.
16. The therapeutic oral appliance of any one of the preceding claims wherein the at least one sensor is or includes at least one actigraphy sensor.
17. The therapeutic oral appliance of any one of the preceding claims wherein the at least one sensor is or includes at least one temperature sensor.
18. The therapeutic oral appliance of any one of the preceding claims wherein the at least one sensor is or includes at least one moisture sensor.
19. The therapeutic oral appliance of any one of the preceding claims wherein the at least one sensor is or includes at least one audio sensor.
20. The therapeutic oral appliance of any one of the preceding claims wherein the at least one sensor is or includes at least one pH sensor.
21. The therapeutic oral appliance of any of Claims 17 to 20 wherein the at least one sensor is preferably located posteriorly on the therapeutic oral appliance.
22. The therapeutic oral appliance of any one of the preceding claims wherein the at least one sensor is or includes at least one muscle movement sensor.
23. The therapeutic oral appliance of any one of the preceding claims wherein the at least one electrode is configured to perform neuromuscular electrical stimulation.
24. The therapeutic oral appliance of Claim 23 wherein the at least one neuromuscular electrical stimulation electrode is located on an inferior surface of the therapeutic oral appliance for contact with a tongue of a user, or on a superior surface of the therapeutic oral appliance for contact with a soft palate of a user.
25. The therapeutic oral appliance of any one of the preceding claims wherein the at least one electrode is or includes at least one electromyography electrode.
26. The therapeutic oral appliance of any one of the preceding claims wherein the at least one electrode is or includes at least one electroencephalography electrode.
27. The therapeutic oral appliance of any one of the preceding claims wherein at least one electrode is or includes at least one magnetoencephalography sensor.
28. The therapeutic oral appliance of Claim 26 or Claim 27 wherein the at least one electrode is placed on a superior surface of the therapeutic oral appliance.
29. The therapeutic oral appliance of Claim 28 wherein the at least one electrode is arranged to, in use, face a brain of the patient.
30. The therapeutic oral appliance of any one of the preceding claims wherein the at least one sensor is or includes at least one acceleromyography sensor.
31. The therapeutic oral appliance of any one of the preceding claims, wherein the therapeutic oral appliance further comprises at least one transmitting device.
32. The therapeutic oral appliance of Claim 31, 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.
33. The therapeutic oral appliance of Claim 32, 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.
34. The therapeutic oral appliance of any of the preceding claims wherein the therapeutic oral appliance further comprises an integrated processor.
35. The therapeutic oral appliance of any one of the preceding claims wherein the therapeutic oral appliance further comprises a non-volatile memory configured to store data from the at least one sensor or at least one electrode.
36. The therapeutic oral appliance of any one of the preceding claims wherein the therapeutic oral appliance at least partially comprises at least one optically transparent material.
37. The therapeutic oral appliance of any one of the preceding claims, wherein the therapeutic oral appliance comprises at least one material which becomes pliable when exposed to heat.
38. The therapeutic oral appliance of any one of the preceding claims, 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.
39. The therapeutic oral appliance of Claim 38, wherein the at least one electrical wire is at least partially embedded within at least one portion of the therapeutic oral appliance.
40. The therapeutic oral appliance of Claim 38 or Claim 39, wherein the at least one electrical wire is configured upon one or more external surfaces of the therapeutic oral appliance.
41. The therapeutic oral appliance of any one of the preceding claims further including a timer.
42. The therapeutic oral appliance of any one of the preceding claims, 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.
43. The therapeutic oral appliance of Claim 42, further comprising at least one airway, wherein the at least one airway comprises one or more indentations or 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.
44. The therapeutic oral appliance of Claim 42 or Claim 43, wherein the tongue retainer portion is fixed to a distal end of the hard palate portion.
45. The therapeutic oral appliance of Claim 43 wherein the at least one sensor or electrode includes at least one neuromuscular electrical stimulation electrode, and the at least one neuromuscular electrical stimulation electrode is located on or along the airway channel.
46. The therapeutic oral appliance of Claim 43 wherein the at least one sensor or electrode includes at least one pressure sensor, at least one electromyography electrode or at least one acceleromyography sensor, and the at least one sensor or electrode is located on or along the airway channel.
47. The therapeutic oral appliance of Claim 43 wherein the at least one sensor or electrode includes at least one of: at least one temperature sensor, at least one moisture sensor, at least one audio sensor, and at least one pH sensor, and the at least one sensor or electrode is located at or towards a back or posterior of the airway channel.
48. The therapeutic oral appliance of any one of the preceding claims, wherein the mouth guard portion comprises a universal fit that may be used by a generic user.
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US18/108,405 | 2023-02-10 | ||
US18/108,405 US20230190514A1 (en) | 2021-01-19 | 2023-02-10 | Therapeutic Oral Device |
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US20200060611A1 (en) * | 2016-04-07 | 2020-02-27 | Achaemenid, Llc | Intra-oral electroencephalography device and method |
WO2022104354A1 (en) * | 2020-11-14 | 2022-05-19 | Ghuge Raghavendra Vitthalrao | Maxillary and mandibular devices, controller station |
US20220226145A1 (en) * | 2021-01-19 | 2022-07-21 | 3 Little Ladies Inc. | Therapeutic Oral Device for Sleep Apnea |
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US20200060611A1 (en) * | 2016-04-07 | 2020-02-27 | Achaemenid, Llc | Intra-oral electroencephalography device and method |
WO2022104354A1 (en) * | 2020-11-14 | 2022-05-19 | Ghuge Raghavendra Vitthalrao | Maxillary and mandibular devices, controller station |
US20220226145A1 (en) * | 2021-01-19 | 2022-07-21 | 3 Little Ladies Inc. | Therapeutic Oral Device for Sleep Apnea |
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