Therapeutic oral appliance or device

Abstract

There is provided a therapeutic oral appliance (2700) comprising: a mouthguard portion, where the mouthguard portion is configured to at least partially engage with one or more teeth of a user; a hard palate portion configured to at least partially engage the hard palate of the user's mouth, where the hard palate portion extends upwardly from the mouthguard portion; and at least one of at least one sensor (2701) and at least one electrode.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to therapeutic oral appliances for sleep apnea and other health conditions. BACKGROUND

[0002] Sleep apnea is a sleep disorder in which a sleeper's breathing stops repeatedly throughout the night. The disorder can cause snoring, sleep unrest, difficulty falling or staying asleep, excessive sleepiness throughout the day, and more. Many factors can cause or exacerbate sleep apnea, such as obesity; a large neck or narrow air passageways; being male; aging; use of 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 throat muscles relax, narrowing the passageway for air to come in and out. This causes a lack of oxygen flow, which alerts the brain and wakes the sleeper so that breathing can continue normally. This adds to the sleeper's unrest and symptoms of sleepiness, although it is often not noticed by the sleeper because the time of waking is so short. Central sleep apnea occurs when the brain fails to transmit signals to the breathing muscles. So, rather than a physical blockage preventing someone from breathing, the sleeper simply does not try to breathe, and can wake up gasping for air. Complex sleep apnea is a combination of obstructive and central sleep apnea.

[0004] In addition to the many symptoms of sleep apnea, there can also be long-term complications that arise from the disorder. Extreme fatigue can occur, and this fatigue is not just composed of drowsiness, but can also affect a person's ability to concentrate, which can impact work performance, increase the risk of workplace or motor vehicle accidents, or cause severe mood changes. The heart can have to work harder than normal due to sudden drops in oxygen levels, which can increase the chances of developing high blood pressure, stroke, heart disease, and more. Additionally, those with sleep apnea have an increased risk of developing type 2 diabetes. Furthermore, sleep apnea can cause complications with standard medications or medical procedures, including surgery.

[0005] Over the years, many treatments, devices, and even surgeries have been developed to treat sleep apnea, though each solution has its unique advantages and disadvantages. One of the most commonly used treatment devices is a continuous positive airway pressure (CPAP) machine. CPAP machines require 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 keep the airway open, thus preventing sleep apnea. However, CPAP machines can make the wearer feel uncomfortable, induce claustrophobia or anxiety, and increase the likelihood of dry mouth, nosebleeds, and congestion. Additionally, CPAP machines cost anywhere from $500 to $3,000, require a prescription, and can not be covered by health insurance.

[0006] Other treatments can include wearing an oral appliance, such as a mouth guard or orthodontic retainer, which exerts pressure on the tongue; nerve stimulation, which sends precise stimulation to nerves in the airway, and nutrition or exercise therapy. Surgery can also work in some cases. This type of treatment is most effective for children who have their large adenoids or tonsils removed. For adults, it can be difficult to pinpoint exactly what is causing sleep apnea. Some adult surgical procedures can consist of removing tissue through uvulopalatopharyngoplasty, shrinking tissue with radiofrequency ablation, repositioning the jawbone, or implanting a rod. Although these procedures can be successful for some people, CPAP machines are still the treatment method recommended by most doctors.

[0007] Because the mouth and throat are the primary organs the body uses to interact with the environment, they can also be the site of many health concerns or treatment solutions other than those associated with sleep apnea. For example, the temperature, gas flow, and muscle or jaw movement within the mouth or throat can be indicative of various conditions, particularly when the individual is asleep or under anesthesia. Because such conditions are difficult to observe or detect, they are often missed or misdiagnosed. SUMMARY

[0008] What is needed is a convenient and comfortable method to treat sleep apnea, and to assess or alleviate other health concerns, that is accessible, affordable, and does not cause other health problems. A removable oral appliance with one or more simple electronic components can add design simplicity. An oral appliance that mimics the basic form of a mouth guard can create a sense of familiarity through association that enables the user to quickly discern its functionality. The compact nature of an oral appliance similar to a mouth guard can allow for portability and compressed storage. The removable aspect of the oral appliance can avoid problems associated with long-term wear, such as tissue necrosis and inflammation.

[0009] The present disclosure generally provides a therapeutic oral appliance or device for sleep apnea and other health conditions. In accordance with the present disclosure, the therapeutic oral appliance or device can include a hard palate portion, a mouthguard portion, and a tongue retainer portion. In some embodiments, the hard palate portion can include one or more materials. In some implementations, the hard palate portion can also include a composite of materials, including but not limited to one or more embedded materials.

[0010] In some aspects, the mouthguard portion can include one or more components that provide stability and maintain the position of the therapeutic oral appliance or device within the mouth of the user. In some embodiments, the tongue retainer portion can include at least one airway and a predetermined length. In some implementations, a method of using a therapeutic oral appliance can include utilizing one or more progressive oral appliances or devices to overcome the pharyngeal reflex of the user. In aspects where the therapeutic oral appliance or device can be formed from a mold, the mouthguard portion and the hard palate portion can be customized to fit the size of the mouth of the intended user.

[0011] The present disclosure relates to a therapeutic oral appliance that can include a mouthguard portion, where the mouthguard portion can 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 a user, where the hard palate portion can extend upwardly from the mouthguard portion, a tongue retainer portion, where the tongue retainer portion can extend from the hard palate portion into at least a portion of a larynx of the user, where the tongue retainer portion can include an upper surface, a lower surface, and a longitudinal length, and at least one airway, where the at least one airway can include one or more grooves within at least one of the upper surface of the tongue retainer portion and the lower surface of the tongue retainer portion, where the at least one airway can extend along at least a portion of the longitudinal length of the tongue retainer portion.

[0012] In some embodiments, the mouthguard portion can include at least one safety mechanism. In some implementations, the tongue retainer portion can be secured to a distal end of the hard palate portion. In some aspects, the longitudinal length of the tongue retainer portion can be adjustable. In some embodiments, the mouthguard portion can include at least one external attachment configured to interface with at least one auxiliary device. In some implementations, the at least one external attachment can include at least one aperture.

[0013] In some aspects, the at least one auxiliary device can include a tube. In some embodiments, the mouthguard portion can include a universal fit that can be used by a general user. In some implementations, the therapeutic oral appliance can be configured to interface with at least one wearable device. In some aspects, the at least one wearable device can include a smart watch. In some embodiments, the mouthguard portion can be configured to interface with one or more dental fixtures. In some implementations, the one or more dental fixtures can include a dental brace.

[0014] In some aspects, the therapeutic oral appliance can further include one or more sensors or electrodes. In some embodiments, the one or more sensors or electrodes can include at least one of one or more electromyography electrodes, one or more acceleromyography sensors (e.g., to measure muscle activity), one or more piezoelectric myography sensors, one or more temperature sensors, one or more peripheral arterial tonometry sensors, one or more photoplethysmography sensors, one or more pulse oximetry sensors, one or more humidity sensors, one or more potential hydrogen (pH) sensors (e.g., to measure acid reflux), one or more audio sensors (e.g., to detect snoring, airway obstruction, or airflow), one or more force sensors or force transducers, one or more pressure sensors (such as a thin film pressure sensor), 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 absorbing sensors, one or more muscle movement sensors, one or more accelerometers, one or more heart rate monitors, or one or more capnography sensors. In some embodiments, one or more wires can be in contact with the one or more sensors or electrodes. In some embodiments, the therapeutic oral appliance or device can further include a clock or timer (e.g., to start or stop measurements at a particular time, to maintain measurements for a particular time frame, or to add a time stamp to measurement or sensor data). The sensors, monitors, and electrodes can be positioned in or on different portions, regions, or zones of the therapeutic oral appliance according to their purpose.

[0015] In some embodiments, the therapeutic oral appliance of the present disclosure can be configured to interface with at least one external device. In some aspects, the at least one external device can comprise at least one of the following: a smartphone, a desktop computing device, a laptop computing device, a tablet computing device, and a medical device. In some embodiments, the mouthguard portion can comprise at least one wire. In some embodiments, the mouthguard portion can comprise an at least partially customized fit for a particular user. In some aspects, the mouthguard portion can be adjustable. In some embodiments, the hard palate portion can extend upwardly from the mouthguard portion to a central convergence point. BRIEF DESCRIPTION OF DRAWINGS

[0016] The accompanying drawings, which are incorporated in and form a part of the specification, illustrate several embodiments of the present disclosure and together with the description, serve to explain the principles of the present disclosure: FIG. 1A A top view of an example therapeutic oral appliance is shown.

[0017] FIG. 1B A side view of an example therapeutic oral appliance is shown.

[0018] FIG. 1C A perspective view of an example therapeutic oral appliance is shown.

[0019] FIG. 2A An example therapeutic oral appliance is shown.

[0020] FIG. 2B A cross-sectional view of an oral cavity with an example therapeutic oral appliance is shown.

[0021] FIG. 3A An example therapeutic oral appliance including a tongue retainer portion is shown.

[0022] FIG. 3B An example cross-sectional view of an oral cavity with an example therapeutic oral appliance is shown.

[0023] FIG. 4A An example therapeutic oral appliance including a tongue retainer portion is shown.

[0024] FIG. 4B An example cross-sectional view of an oral cavity with an example therapeutic oral appliance is shown.

[0025] FIG. 5A An example therapeutic oral appliance including a tongue retainer portion is shown.

[0026] FIG. 5B An example cross-sectional view of an oral cavity with an example therapeutic oral appliance is shown.

[0027] FIG. 6A An exemplary therapeutic oral appliance including a tongue retainer portion is shown.

[0028] FIG. 6B An exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance is shown.

[0029] FIG. 7A An exemplary therapeutic oral appliance including a tongue retainer portion is shown.

[0030] FIG. 7B An exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance is shown.

[0031] FIG. 8A A front view of an exemplary therapeutic oral appliance is shown.

[0032] FIG. 8B A back view of an exemplary therapeutic oral appliance is shown.

[0033] FIG. 9 An oral cavity with an exemplary therapeutic oral appliance is shown.

[0034] FIG. 10 An exemplary therapeutic oral appliance with a safety mechanism is shown.

[0035] FIG. 11A A side view of an exemplary therapeutic oral appliance with a mouth guard portion accessory is shown.

[0036] FIG. 11B A perspective view of a therapeutic oral appliance with a mouth guard portion accessory is shown.

[0037] FIG. 12A A side view of an exemplary therapeutic oral appliance engaged with an external device is shown.

[0038] FIG. 12B A side view of an exemplary therapeutic oral appliance engaged with an external device is shown.

[0039] FIG. 12C A perspective view of an exemplary therapeutic oral appliance engaged with an external device is shown.

[0040] FIG. 13A A side view of an exemplary therapeutic oral appliance with a mouth guard portion accessory is shown.

[0041] FIG. 13B A perspective view of an exemplary therapeutic oral appliance with a mouth guard portion accessory is shown.

[0042] FIG. 14A A side view of an exemplary therapeutic oral appliance with a mouth guard portion accessory is shown.

[0043] FIG. 14B A perspective view of an exemplary therapeutic oral appliance with a mouthguard portion attachment is shown.

[0044] FIG. 15A A side view of an exemplary therapeutic oral appliance with an adjustable tongue retainer portion is shown.

[0045] FIG. 15B A top view of an exemplary therapeutic oral appliance with an adjustable tongue retainer portion is shown.

[0046] FIG. 16A A side view of an exemplary therapeutic oral appliance with an adjustable tongue retainer portion is shown.

[0047] FIG. 16B A top view of an exemplary therapeutic oral appliance with an adjustable tongue retainer portion is shown.

[0048] FIG. 17 An exemplary therapeutic oral appliance is shown.

[0049] FIG. 18 An exemplary therapeutic oral appliance is shown.

[0050] FIG. 19 An exemplary adjustable therapeutic oral appliance is shown.

[0051] FIG. 20 An exemplary therapeutic oral appliance attachable to a dental fixture is shown.

[0052] FIG. 21 An exemplary therapeutic oral appliance with wireless data transfer capability is shown.

[0053] FIG. 22A And 22B show a process of forming an exemplary therapeutic oral appliance.

[0054] Fig. 23 shows a process of forming an exemplary therapeutic oral appliance.

[0055] FIG. 24 An exemplary therapeutic oral appliance with wireless data transfer capability is shown.

[0056] FIG. 25A An exemplary therapeutic oral appliance including a tongue retainer portion is shown.

[0057] FIG. 25B A cross-sectional view of an oral cavity including an exemplary therapeutic oral appliance is shown.

[0058] FIG. 26 A perspective view of an exemplary therapeutic oral appliance is shown.

[0059] FIG. 27A An exemplary therapeutic oral appliance is shown.

[0060] FIG. 27B A perspective view of an exemplary therapeutic oral appliance is shown.

[0061] FIG. 27C A cross-sectional view of an oral cavity including an exemplary therapeutic oral appliance is shown.

[0062] FIG. 28A An exemplary therapeutic oral appliance is shown.

[0063] FIG. 28B A perspective view of an exemplary therapeutic oral appliance is shown.

[0064] FIG. 29 A perspective view of an exemplary therapeutic oral appliance is shown. DETAILED DESCRIPTION

[0065] In the following sections, a detailed description of examples and methods of the present disclosure will be given. The description of both preferred and alternative examples, although detailed, is merely exemplary, and those skilled in the art will understand that variations, modifications, and alterations can be apparent. It is understood that these examples are not limiting of the breadth of aspects of the disclosure below as defined by the claims.

[0066] Therapeutic oral appliance: as used herein refers to a device that can be removably inserted into a user's mouth, where the therapeutic oral appliance can 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, the therapeutic oral appliance can at least partially alleviate sleep apnea or bruxism of the user, or the therapeutic oral appliance can detect the body temperature or blood oxygen level of the user.

[0067] Tongue retainer portion: as used herein refers to a portion of the therapeutic oral appliance that restricts the backward movement of the tongue when the therapeutic oral appliance is worn. In some embodiments, the tongue retainer portion can include one or more airways that can prevent laryngeal occlusion, thereby allowing unobstructed breathing.

[0068] Hard palate portion: as used herein refers to a portion of the therapeutic oral appliance that is configured to at least partially interface with the hard palate within the user's mouth.

[0069] Mouthguard portion: As used herein refers to a portion of a therapeutic oral appliance that fits to or on at least a portion of one or more teeth of a user. In some aspects, the mouthguard portion can be customized to fit the teeth of a user, such as, for example and without limitation, by using a dental impression. In some embodiments, the mouthguard portion can include at least partially customized fit for a particular user. In some embodiments, the mouthguard portion can include a substantially universal fit that can be used by any general user without the need for customizing the fitting.

[0070] OSA: As used herein refers to obstructive sleep apnea.

[0071] Referring now to FIGS. 1A-1C An exemplary therapeutic oral appliance 100 is shown. In some embodiments, the therapeutic oral appliance 100 can include a tongue retainer portion 110. In some embodiments, the tongue retainer portion 110 can include one or more predetermined lengths. This can allow a user to gradually become accustomed to the presence of the tongue retainer portion 110 within at least a portion of the larynx. Gradual introduction can allow for suppression of the gag reflex, which can occur as the length of the tongue retainer portion 110 enters the larynx. In some aspects, the tongue retainer portion 110 can include an upper surface, a lower surface, and a longitudinal length.

[0072] In some embodiments, the therapeutic oral appliance 100 can be utilized to alleviate airway obstruction from one or more sources. As an illustrative example, the therapeutic oral appliance 100 can directly alleviate obstruction caused by obstruction at the back or base of the tongue, the uvula, and the soft palate. The therapeutic oral appliance 100 can partially alleviate obstruction caused by problems below the epiglottis, such as hypopharyngeal problems, vocal cord folds and arytenoid cartilage, anterior and posterior soft palate collapse, lateral soft palate collapse, complete concentric collapse, epiglottis and tonsil collapse. The therapeutic oral appliance 100 can simultaneously address multiple obstruction problems through a prescribed therapeutic use.

[0073] In some embodiments, the therapeutic oral appliance 100 can contribute to partial alleviation of obstruction by improving overall muscle tone of the oropharynx. This improvement can be due to the muscles resisting and gaining tone by resisting the therapeutic oral appliance 100. In some aspects, the airway 115 can provide airflow from the mouth to the soft palate. This can improve breathing and reduce airway obstruction.

[0074] In some embodiments, the material of the therapeutic oral appliance 100 can include a material that is sufficiently durable and resistant to chemicals so as to be sterilized daily by chemical (e.g., mouthwash or alcohol) means or physical means (e.g., steam sterilization) as non-limiting examples. In some implementations, the removable aspect of the therapeutic oral appliance 100 can allow the user to clean and sterilize the therapeutic oral appliance 100 frequently. This can facilitate accessible cleaning, which can reduce the probability of tissue necrosis and infection as a non-limiting list.

[0075] In some implementations, the therapeutic oral appliance 100 can include a hard palate portion 130. In some embodiments, the fit connected by the symmetrical surface between the hard palate and the hard palate portion 130 can improve the stability of the therapeutic oral appliance 100 within the oral cavity. In some aspects, the therapeutic oral appliance 100 can include a mouthguard portion 120. In some additional aspects, the hard palate portion 130 can extend upward from the mouthguard portion 120 to a central convergence point.

[0076] In some embodiments, the mouthguard portion 120 can include a composite of materials. This can prevent chipping and fragment wear that can cause worn portions of the therapeutic oral appliance 100 to be swallowed. In some implementations, a base material can be embedded within a primary material.

[0077] As an example, a hard plastic plate can be embedded in a medium of ethylene-vinyl acetate (EVA) or an elastomeric polymer, as the softer plastic would solidify within the dental mold. In some aspects, the embedded base can be chipped. As another example, an EVA material can have a harder plastic plate embedded in the area over the back molars to reduce wear from the molars. In some embodiments, the therapeutic oral appliance 100 can include a coating aspect. As an example, the therapeutic oral appliance 100 can be coated with a hardening plastic film that reduces torsional fatigue within the structure of the therapeutic oral appliance 100.

[0078] The mouthguard portion 120 can be configured to at least partially engage with one or more teeth of the user. This engagement can 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 can include a hard palate portion 130. The hard palate portion 130 can engage with the hard palate within the mouth. In some implementations, the mouthguard portion 120 and the hard palate portion 130 can reduce point pressure by spreading the retention force for the therapeutic oral appliance 100 across a larger surface area.

[0079] The mouth guard portion 120 can provide protection to the soft sensitive tissues of the oropharynx. As a non-limiting list, the mouth guard portion 120 can protect the hard palate, soft palate, and portions of the oropharynx from pressure points. The pressure can originate from the oral airway. The mouth guard portion 120 can prevent pain and possible tissue necrosis by preventing these pressure points. In some aspects, the mouth guard portion 120 can extend to cover the hard palate and soft palate to protect sensitive tissue. This protection can assist in pushing the oral airway away from the oropharynx. In some embodiments, moving the oral airway away from the oropharynx can reduce the gag reflex.

[0080] In some implementations, the level of customization of the therapeutic oral appliance 100 can vary. As an illustrative example, a user can get a dental impression at a dentist office that provides a high fidelity model of the unique aspects of the user’s mouth. This impression can be formed via a physical or digital dental impression. This impression can become a cast for the therapeutic oral appliance 100. This high level of customization can allow the therapeutic oral appliance 100 to be fitted to exactly match the shape of the hard palate and teeth. It can 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, resulting in the least invasive oral airway size and path for maximum comfort.

[0081] As another illustrative example, a user can purchase a therapeutic oral appliance 100 remotely. The therapeutic oral appliance 100 can be delivered as a general cast of the therapeutic oral appliance 100. The general mold can fit most mouths in a loose composition. The general cast can then become pliable after it is boiled in water. This pliability allows the user to press the therapeutic oral appliance 100 firmly into the mouth to allow the therapeutic oral appliance 100 to harden into the shape of the user’s mouth. The fit thus formed can provide enough stability without the need to see a dentist.

[0082] In some embodiments, the therapeutic oral appliance 100 can interface with the oral cavity. As a non-limiting list, the quality of the interface can contribute to the safety, comfort, and effectiveness as a therapeutic device. In some implementations, the removable aspects of the therapeutic oral appliance 100 can also provide an opportunity for frequent cleaning. This can prevent infection, inflammation, and tissue necrosis as non-limiting examples.

[0083] In some embodiments, the mouth guard portion 120 can engage with the teeth. Such engagement can 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 can include a hard palate portion 130. The mouth guard portion 120 and the hard palate portion 130 can reduce the probability of the therapeutic oral appliance 100 being subconsciously rejected by being spat out. Custom fitting of the therapeutic oral appliance 100 can reduce such probability by increasing comfort. In some aspects, engagement between the therapeutic oral appliance 100 and the oral cavity can assist the tongue retainer portion 110 to align within the larynx. Unsecured movement of the tongue retainer portion 110 can cause triggering of the gag reflex or suffocation.

[0084] In some embodiments, the tongue retainer portion 110 can be secured to and extend from a distal end of the hard palate portion 130 into at least a portion of the larynx sufficient to reduce tongue movement. In some embodiments, the tongue retainer portion 110 can be trimmable, by way of non-limiting example, to achieve preferred comfort and fit within the larynx. In some aspects, the tongue retainer portion 110 can prevent the tongue from falling back and contacting the soft palate, which can otherwise cause airway obstruction. In some embodiments, the tongue retainer portion 110 can include an airway 115 that ensures air flow when the tongue retainer portion 110 occupies the larynx.

[0085] In some aspects, the tongue retainer portion 110 can include an airway 115. In some embodiments, the airway 115 can include one or more grooves or slots within an upper surface and / or a lower surface of the tongue retainer portion 110 that extend along at least a portion of a longitudinal length of the tongue retainer portion 110, thereby forming one or more channels or grooves. In some embodiments, the airway 115 channels can provide an airway to allow air flow. In some embodiments, the airway 115 can follow the natural anatomic airway pathway of the user. This can reduce the probability of accidental airway obstruction caused by the therapeutic oral appliance 100. Conformity to the natural anatomy of the oral cavity can result from custom fitting of the therapeutic oral appliance 100.

[0086] Referring now to FIG. 2A , an example therapeutic oral appliance 200 is shown. Referring now to FIG. 2B , a cross-sectional view of an oral cavity with the example therapeutic oral appliance 200 is shown. In some embodiments, the therapeutic oral appliance 200 can include a hard palate portion 230. In some embodiments, the therapeutic oral appliance 200 can include a mouth guard portion 220. In some aspects, the hard palate portion 230 can extend upwardly from the mouth guard portion 220 to a central convergence point.

[0087] In some embodiments, the hard palate portion 230 can interface with the hard palate 260. In some aspects, the surface of the hard palate portion 230 can mirror the geometry of the hard palate 260 to provide a custom fit. In some embodiments, the hard palate portion 230 can include the same geometry as the hard palate 260 by being cured in a mold formed by an impression of the user's mouth. In some implementations, such a mold can be a standard mold used in creating a denture impression.

[0088] In some embodiments, the distal end of the therapeutic oral appliance 200 can align with the beginning of the soft palate 270 within the oral cavity. This can prevent injury from the constant application of force on the soft palate 270. In some embodiments, the mouth guard portion 220 can interface with the teeth 250. In some aspects, the interaction between the mouth guard portion 220 and the teeth 250 can operate as a mating engagement formed by curing resin for the therapeutic oral appliance 200 within a casting made from an impression of the user's teeth 250.

[0089] A patient can wear the therapeutic oral appliance 200 without the tongue retainer portion to begin the progressive process to suppress the gag reflex. Wearing the therapeutic oral appliance 200 can be initially uncomfortable, especially for those not accustomed to wearing oral appliances. The patient can acclimate to it by wearing the therapeutic oral appliance 200 for a few hours and then overnight as a way to establish the gag reflex suppression process with the tongue retainer portion.

[0090] In some embodiments, the mouth guard portion 220 can include a general casting that can form to the shape of the intended teeth 250 when subjected to heat to increase malleability. This can provide greater comfort when wearing the therapeutic oral appliance 200. The formed therapeutic oral appliance 200 can prevent involuntary rejection of the mouth. For example, unless the therapeutic oral appliance 200 is similar to the structure of the oral cavity, the user can involuntarily spit out the therapeutic oral appliance while sleeping.

[0091] In some aspects, the mouth guard portion 220 can include a cavity designed to wrap around multiple teeth 250 at the same time. The thickness of the outer lateral edges of the mouth guard portion 220 can be a minimum thickness to ensure unobstructed fit within the oral cavity. In some embodiments, the minimum thickness can increase the comfort and effectiveness of therapeutic utilization of the therapeutic oral appliance 200 by avoiding subconscious rejection, by way of non-limiting example.

[0092] Referring now to FIG. 3A , an example therapeutic oral appliance 300 including a tongue retainer portion 310 is shown. Referring now to FIG. 3B, an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance 300 is shown. In some embodiments, the therapeutic oral appliance 300 can include a hard palate portion 330. In some implementations, the therapeutic oral appliance 300 can include a mouthguard portion 320. In some embodiments, the hard palate portion 330 can engage with a hard palate 360.

[0093] In some implementations, the tongue retainer portion 310 can align with a soft palate 370. In some embodiments, the tongue retainer portion 310 can include an upper surface, a lower surface, and a longitudinal length. In some aspects, the therapeutic oral appliance 300 can access a larynx 380 via the tongue retainer portion 310. In some implementations, the therapeutic oral appliance 300 can include a plurality of predetermined lengths of tongue retainer portions 310. This can allow a user to gradually become accustomed to the presence of the tongue retainer portion 310 within the larynx 380. This can train the gag reflex to limit engaging the tongue retainer portion 310 sufficiently to allow the user to insert the therapeutic oral appliance 300 daily. In some embodiments, the tongue retainer portion 310 can be fixed to a distal end of the hard palate portion 330.

[0094] In some embodiments, the therapeutic oral appliance 300 can engage with a tongue 340. In some aspects, the tongue retainer portion 310 can direct the tongue 340 by the physical presence of the tongue retainer portion 310. In some embodiments, the tongue retainer portion 310 can sufficiently restrict the tongue 340 to facilitate unobstructed breathing.

[0095] For example, a person in a coma can require an unobstructed airway to receive sufficient oxygen. In an unconscious state, the tongue 340 can lower or compromise the user’s airway. In some implementations, the mouthguard portion 320 can be configured to at least partially engage with one or more teeth 350. This can prevent the therapeutic oral appliance 300 from being displaced and potentially ingested.

[0096] Referring now to FIG. 4A , an exemplary therapeutic oral appliance 400 including a tongue retainer portion 410 is shown. Referring now to FIG. 4B , an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance 400 is shown. In some embodiments, the therapeutic oral appliance 400 can include a hard palate portion 430. In some implementations, the therapeutic oral appliance 400 can include a mouthguard portion 420. In some aspects, the hard palate portion 430 can extend upward from the mouthguard portion 420 to a central convergence point.

[0097] In some embodiments, the hard palate portion 430 can engage with the hard palate 460. In some implementations, the tongue retainer portion 410 can align with the soft palate 470. In some embodiments, the tongue retainer portion 410 can include an upper surface, a lower surface, and a longitudinal length. In some aspects, the therapeutic oral appliance 400 can access the larynx 480. In some implementations, the tongue retainer portion 410 can progressively access the larynx to avoid triggering a gag reflex. In some embodiments, the tongue retainer portion 410 can be secured to a distal end of the hard palate portion 430.

[0098] A gag reflex is a laryngeal constriction that occurs when an object contacts the tongue 440 or the back of the larynx 480. This gag reflex can be overcome by progressively introducing the tongue retainer portion 410 into the larynx 480. In some aspects, this can be induced by wearing the therapeutic oral appliance 400 with a progressive increase in the length of the tongue retainer portion 410 for a predetermined time.

[0099] The length of the tongue retainer portion 410 can be short enough to prevent the tongue retainer portion 410 from being grabbed by a laryngeal constriction caused by the larynx 480 via a gag reflex. The length of the tongue retainer portion 410 can be short enough to prevent irregular swallowing due to the larynx exerting a downward force on the therapeutic oral appliance 400 by grabbing the end of the tongue retainer portion 410 during a laryngeal constriction.

[0100] In some embodiments, the therapeutic oral appliance 400 can engage with the tongue 440. In some embodiments, the tongue retainer portion 410 can sufficiently restrict the tongue 440 to facilitate unobstructed breathing. In some implementations, the mouth guard portion 420 can be configured to at least partially engage with one or more teeth 450. In some aspects, the mouth guard portion 420 can secure the therapeutic oral appliance 400 within the oral cavity. This can prevent ingestion of the therapeutic oral appliance 400.

[0101] Referring now to FIG. 5A , an example therapeutic oral appliance 500 including a tongue retainer portion 510 is shown. Referring now to FIG. 5B , an example cross-sectional view of an oral cavity with an example therapeutic oral appliance 500 is shown. In some embodiments, the therapeutic oral appliance 500 can include a hard palate portion 530. In some embodiments, the hard palate portion 530 can engage with the hard palate 560. The engagement between the hard palate 560 and the hard palate portion 530 can provide stability, which reduces the movement of the tongue retainer portion 510 within the larynx 580.

[0102] In some embodiments, the therapeutic oral appliance 500 can include a mouthguard portion 520. In some embodiments, the hard palate portion 530 can extend upward from the mouthguard portion 520 to a central convergence point. In some embodiments, the mouthguard portion 520 can be configured to at least partially engage with one or more teeth 550. In some aspects, the mouthguard portion 520 can provide a general fit with the teeth 550 having limited plasticity properties. This general tooth shape can provide enough stability to prevent ingestion of the therapeutic oral appliance 500.

[0103] In some embodiments, the tongue retainer portion 510 can align with the soft palate 570. In some embodiments, the tongue retainer portion 510 can include an upper surface, a lower surface, and a longitudinal length. In some aspects, the therapeutic oral appliance 500 can enter the larynx 580. In some embodiments, the user can modify the length of the tongue retainer portion 510. In some aspects, the tongue retainer portion 510 can be shortened by cutting the tongue retainer portion 510 to a desired length with scissors. This can allow the user to customize the length of the tongue retainer portion 510. Shortening the tongue retainer portion 510 can be necessary if the tongue retainer portion 510 extends into the larynx 580 enough to trigger a gag reflex. In some embodiments, the therapeutic oral appliance 500 can engage with the tongue 540.

[0104] Referring now to FIG. 6A , an example therapeutic oral appliance 600 including a tongue retainer portion 610 is shown. Referring now to FIG. 6B , an example cross-sectional view of an oral cavity with an example therapeutic oral appliance 600 is shown. In some embodiments, the therapeutic oral appliance 600 can include a hard palate portion 630. In some embodiments, the therapeutic oral appliance 600 can include a mouthguard portion 620. In some aspects, the hard palate portion 630 can extend upward from the mouthguard portion 620 to a central convergence point. In some embodiments, the mouthguard portion 620 can be configured to at least partially engage with one or more teeth 650.

[0105] In some embodiments, the hard palate portion 630 can engage with the hard palate 660. In some embodiments, the tongue retainer portion 610 can align with the soft palate 670. In some embodiments, the tongue retainer portion 610 can include an upper surface, a lower surface, and a longitudinal length. In some aspects, the tongue retainer portion 610 can be fixed to a distal end of the hard palate portion 630 and intrude into the larynx 680. In some embodiments, the tongue retainer portion 610 can progressively increase in length.

[0106] As an illustrative example, a user can receive a plurality of therapeutic oral appliances upon ordering therapeutic oral appliances, including a therapeutic oral appliance with a progressively lengthening tongue retainer portion, such as FIGS. 2A-6A In preparation for using the therapeutic capabilities of the therapeutic oral appliance, the user can use the therapeutic oral appliance with the progressively lengthening tongue retainer portion until snoring is effectively prevented. The user can wear each size for a few days to a few weeks at a time, depending on the level of comfort of each therapeutic oral appliance. The user can use the therapeutic oral appliance while sleeping each night to acclimate the larynx to the tongue retainer portion and overcome the gag reflex.

[0107] Depending on the individual anatomy, the user can find that an intermediate length of the tongue retainer portion is a sufficient length to achieve therapeutic purposes, where the user can not benefit from a progressively lengthening tongue retainer portion. In some embodiments, the user can progressively increase the length of the tongue retainer portion 610 until the length is sufficient to alleviate obstruction, but remains sufficiently comfortable for use while sleeping. In some aspects, the user can find that it is necessary to trim the length of the tongue retainer portion 610 of the therapeutic oral appliance to achieve a desired length between the progressively lengthening tongue retainer portions. In some embodiments, the length of the tongue retainer portion 610 can remain shorter than the distance to the epiglottis to ensure that swallowing can still occur.

[0108] Referring now to FIG. 7A , an example therapeutic oral appliance 700 is shown that includes a tongue retainer portion 710, where the therapeutic oral appliance 700 is adapted for use by a child. Referring now to FIG. 7B , an example cross-sectional view of an oral cavity with an example therapeutic oral appliance 700 is shown. In some embodiments, the therapeutic oral appliance 700 can include a hard palate portion 730. In some embodiments, the therapeutic oral appliance 700 can include a mouth guard portion 720. In some aspects, the hard palate portion 730 can extend upward from the mouth guard portion 720 to a central convergence point.

[0109] In some embodiments, the hard palate portion 730 can interface with a hard palate 760. In some embodiments, the tongue retainer portion 710 can align with a soft palate 770. In some embodiments, the tongue retainer portion 710 can include an upper surface, a lower surface, and a longitudinal length. In some aspects, the therapeutic oral appliance 700 can enter a larynx 780. In some embodiments, the therapeutic oral appliance 700 can interface with a tongue 740. In some embodiments, the mouth guard portion 720 can be configured to at least partially interface with one or more teeth 750.

[0110] For smaller mouths, such as for children, the incremental increase of the tongue retainer portion 710 can be smaller to allow for more precise fitting. Smaller size increases can allow for easier transitioning, with an increased likelihood of an unproblematic inhibition of the gag reflex. Smaller mouths can require shorter tongue retainer portions 710. In some aspects, the incremental size of the tongue retainer portion 710 can depend on predefined factors, such as gag reflex strength, mouth size, user preference, practitioner recommendation, or level of customization. For example, where the therapeutic oral appliance is prescribed by a practitioner, the increments can be more customized than a non-prescription version of the therapeutic oral appliance.

[0111] Referring now to FIGS. 8A-8B , a front view of an example therapeutic oral appliance 800 is shown. In some embodiments, the tongue retainer portion 810 of the therapeutic oral appliance 800 can include one or more uniform grooves or slots that span the longitudinal length of the tongue retainer portion 810 to create airways 815. In some implementations, the airways 815 can include uniform indentations along the sidewalls of the tongue retainer portion 810. In some aspects, the airways 815 can include air flow paths that are parallel to the direction of the throat.

[0112] For example, the tongue retainer portion 810 can include one or more airway 815 tubes that run the longitudinal length of the tongue retainer portion 810. This can be useful in order to nullify the embedded passageways within the walls of the tongue retainer portion 810 if the throat is inflamed or otherwise restricted. In some embodiments, the airways 815 can include integrated tubes that extend through the center of the tongue retainer portion 810. This can reduce the required insertion diameter and prevent obstruction by utilizing existing material that extends the length of the therapeutic oral appliance 800.

[0113] Referring now to FIG. 9 , a mouth wearing an example therapeutic oral appliance 900 is shown. In some embodiments, the mouthguard portion 920 can be configured to at least partially engage one or more teeth 950 in a form-fitting manner. The therapeutic oral appliance 900 can similarly fit into a sports mouthguard, a teeth whitening tray, a progressive orthodontic system, or a mouth guard for grinding teeth, as non-limiting examples. In some aspects, the therapeutic oral appliance 900 can fit over a denture. In some embodiments, the therapeutic oral appliance 900 can fit over the gums of a user that can remove the denture at night.

[0114] Referring now to FIG. 10, an example therapeutic oral appliance 1000 with a safety mechanism is shown. In some embodiments, the therapeutic oral appliance 1000 can include at least one safety mechanism 1005. In some implementations, the safety mechanism 1005 can extend the entire length of the therapeutic oral appliance 1000. In some aspects, this can prevent ingestion of a portion of the therapeutic oral appliance 1000 that can become dislodged from the therapeutic oral appliance 1000. This is possible after long term use creates fatigue within the therapeutic oral appliance 1000 that creates structural instability within the therapeutic oral appliance 1000.

[0115] Referring now to FIGS. 11A-11B , an example therapeutic oral appliance 1100 with mouth guard portion 1120 accessories is shown. In some embodiments, the mouth guard portion 1120 can include at least one external accessory. In some aspects, the external accessory can maintain a partially open state of the mouth. In some implementations, the external accessory can be configured to interface with at least one auxiliary device. The external accessory can include at least one hole or opening that allows for insertion of a variety of auxiliary devices in the form of a tube into the oral cavity.

[0116] As an example, an anesthesiologist can insert a tube to regulate sedation during surgery. This opening in the external accessory can provide stability under the support of the hard palate portion 1130, which allows the tube to remain in a fixed state. A source of humidified air or oxygen can be diffused near the oral cavity to provide humidification. This can assist in preventing dryness in the mouth and oropharynx. Reducing dryness can provide increased user comfort. As another example, a feeding tube can interface with the external accessory to provide nutrition to a user in a coma. Auxiliary tubes can also maintain health for users with a variety of health concerns.

[0117] As an illustrative example, when a user experiences a seizure, the tube opening can provide access to the oral cavity. The tongue retainer portion 1110 can assist in stabilizing the tongue and keeping the airway unobstructed. The tube opening can assist in suppressing muscle contractions within the jawbone that can otherwise harm the user during a seizure. The tube opening can also keep the orifice open for the duration of the seizure in case of vomiting.

[0118] Physical disabilities can also require the use of auxiliary tubes to maintain life. For example, a user with cerebral palsy can have difficulty inhaling due to muscle weakness. This can require a breathing tube. Due to other muscle atrophy and fatigue, a feeding tube can also be employed to ensure adequate nutrition. The therapeutic oral appliance 1100 can allow for long term use with reduced risk of injury to the user's mouth, throat, respiratory system, and overall health.

[0119] Referring now to FIGS. 12A-12B, an exemplary therapeutic oral appliance 1200 is shown with mouthguard portion 1220 accessories. In some embodiments, mouthguard portion 1220 can include at least one external accessory. In some implementations, mouthguard portion 1220 can interface with at least one auxiliary device 1290. In some embodiments, mouthguard portion 1220 can interface with at least one auxiliary device 1290 via an external accessory. In some aspects, the external accessory can maintain a partially open state of the mouth. In some embodiments, the external accessory can include a hole or opening that allows for insertion of a variety of auxiliary devices 1290 in the form of a tube into the oral cavity.

[0120] As an example, an anesthesiologist can insert a tube to regulate sedation during surgery. This opening in the external accessory can provide stability under the support of hard palate portion 1230, which allows the tube to remain in a fixed state. The opening in the external accessory can include a similar diameter as a common interfacing sedation tube. A source of humidified air or oxygen can be diffused near the oral cavity to provide humidification. This can assist in preventing dryness in the mouth and oropharynx. Reducing dryness can provide increased user comfort.

[0121] Physical disabilities can also require the use of auxiliary tubes to sustain life. For example, a user with cerebral palsy can have difficulty inhaling due to muscle weakness. This can require a breathing tube. Due to other muscle atrophy and fatigue, a feeding tube can also be employed to ensure adequate nutrition. Therapeutic oral appliance 1200 can allow for long-term use with reduced risk of injury to the user's mouth, throat, respiratory system, and overall health.

[0122] Referring now to FIGS. 13A-13B , a side view of an exemplary therapeutic oral appliance 1300 is shown with mouthguard portion accessories. In some embodiments, therapeutic oral appliance 1300 can include a mouthguard portion 1320. In some implementations, mouthguard portion 1320 can include accessories to prevent teeth grinding. In some aspects, therapeutic oral appliance 1300 can include a hard palate portion 1330 that can assist in reducing translational movement caused by teeth grinding. In some implementations, hard palate portion 1330 can extend upward from mouthguard portion 1320 to a central convergence point.

[0123] Referring now to FIGS. 14A-14BThis image shows a side view of an exemplary therapeutic oral appliance 1400 with a mouthguard attachment. In some embodiments, the therapeutic oral appliance 1400 may include a mouthguard portion 1420. In some embodiments, the mouthguard portion 1420 may include an attachment to prevent molar molarization. In some aspects, the therapeutic oral appliance 1400 may include a hard palate portion 1430 that may assist in reducing translational movements caused by molar molarization. In some embodiments, the hard palate portion 1430 may extend upward from the mouthguard portion 1420 to a central convergence point.

[0124] In some aspects, the therapeutic oral appliance 1400 can engage with the mandible via an attachment connected to the lower therapeutic oral appliance 1400. In some embodiments, the therapeutic oral appliance can cover the lower teeth. In some embodiments, the therapeutic oral appliance can be connected to a therapeutic oral appliance 1400 secured to the hard palate. As a non-limiting attribute, this can increase comfort and safety. The lower therapeutic oral appliance can reduce the probability of the user spitting out the therapeutic oral appliance 1400.

[0125] Now for reference FIGS. 15A-15B An exemplary therapeutic oral appliance 1500 with an adjustable tongue retainer portion 1510 is shown. In some embodiments, the tongue retainer portion 1510 may include an upper surface, a lower surface, and a longitudinal length. In some aspects, the tongue retainer portion 1510 may extend into the larynx at multiple lengths, determined by a plurality of predetermined longitudinal lengths adjustable in the region of the therapeutic oral appliance 1500. In some embodiments, the tongue retainer portion 1510 may be secured to the distal end of the hard palate portion 1530. In some embodiments, the tongue retainer portion 1510 may be removed from the therapeutic oral appliance 1500. This may be useful for a user beginning the adaptation process of the tongue retainer portion 1510 within the larynx.

[0126] In some embodiments, the adjustable aspect of the tongue retainer portion 1510 may engage with an extruder connected to the mouthguard portion 1520. In some aspects, adjustment of the tongue retainer portion 1510 may include a mechanism that applies force to a fixation device attached to the therapeutic oral appliance 1500. In some embodiments, the hard palate portion 1530 may provide stability when the therapeutic oral appliance 1500 is adjusted within the oral cavity. In some aspects, the tongue retainer portion 1510 may include an airway 1515 that extends in conjunction with an extension of the tongue retainer portion 1510.

[0127] In some embodiments, airway 1515 can originate at the top of mouthguard portion 1520. In some implementations, airway 1515 and tongue retainer portion 1520 can be molded to follow the contours of the hard and soft palate. In some aspects, the sides along airway 1515 include one or more channels for airway patency. In some embodiments, these channels can originate between the teeth or gums, as a non-limiting alternative, in the absence of teeth, to provide airway patency such that airway 1515 is not obstructed by teeth or lips.

[0128] In some embodiments, airway 1515 and tongue retainer portion 1520 can include a reinforcing bridge portion, as a non-limiting alternative, that extends along, near, or parallel to the midline of the hard and soft palate. In some implementations, the reinforcing portion can be attached to a flattened section that extends parallel to hard palate portion 1530. This can provide increased surface area to push and stabilize the tongue and soft palate tissue away from each other, thereby providing airway 1515. In some aspects, the gap created between the palate and the flattened plane by the reinforcing bridge can facilitate air flow. In some embodiments, the parallel planes separated by the reinforcing bridge can form airway 1515.

[0129] As an illustrative example, the cross-section of this structural design can resemble an I-beam. An I-beam is composed of two horizontal planes, called flanges, connected by a vertical component, or web. The shape of the flanges and web creates an "I" shaped cross-section. The flanges are related to the planes that contact the palate on one end and the tongue on the other end. The web is related to the reinforcing bridge that is the vertical component connecting the two horizontal planes. The space between the flanges created by the web is the channel through which air flows. The cross-sectional area of airway 1515 can be sufficient to prevent increased respiratory effort or increased negative pressure on the lungs.

[0130] Referring now to FIGS. 16A-16B , an example therapeutic oral appliance 1600 with an adjustable tongue retainer portion 1610 is shown. In some embodiments, tongue retainer portion 1610 can include an upper surface, a lower surface, and a longitudinal length. In some aspects, tongue retainer portion 1610 can extend into the throat in a variety of lengths, determined by a plurality of predetermined longitudinal lengths that are adjusted in the region of therapeutic oral appliance 1600. In some implementations, tongue retainer portion 1610 can be removed from therapeutic oral appliance 1600.

[0131] In some embodiments, the mouthpiece portion 1620 can remain stationary while the airway 1615 can be moved and secured at different depths within the larynx. In some implementations, the airway 1615 passage can slide forward and backward until a desired depth of entry into the larynx is reached. In some aspects, the airway 1615 can be secured to this position by a clamp or another non-limiting securing device.

[0132] For example, a customer can purchase a single therapeutic oral appliance and initially use the therapeutic oral appliance with the airway fully retracted. The customer can gradually increase the extension of the airway into the larynx until the airway has extended the initially intended distance into the larynx.

[0133] In some embodiments, the airway 1615 can originate at the top of the mouthpiece portion 1620. In some implementations, the airway 1615 and the tongue retainer portion 1620 can be molded to follow the contours of the hard and soft palate. In some aspects, the sides of the airway 1615 include one or more passages for airway patency. In some embodiments, these passages can begin between the teeth or gums, as a non-limiting option, in the absence of teeth, to provide airway patency so that the airway 1615 is not obstructed by teeth or lips.

[0134] Referring now to FIG. 17 , an example therapeutic oral appliance 1700 is shown. In some embodiments, the mouthpiece portion 1720 can include multiple components. In some aspects, the mouthpiece portion 1720 can include a dental band with selective dental guards. For example, at least one flexible wire can prevent slippage by exerting a minimal holding force on the front teeth. Multiple dental guards that are symmetrical can be attached to the flexible wire and secure the therapeutic oral appliance 1700 by wrapping around multiple teeth on both sides of the mouth.

[0135] In some embodiments, the dental guards can include a general casting that can be formed into the shape of the intended teeth when heat is induced to increase ductility. In some aspects, the dental guards can include cavities designed to wrap around multiple teeth simultaneously. The thickness of the outer edge of the dental guards can be a minimal thickness to ensure a fit between the teeth wrapped within the dental guard and the teeth excluded. In some implementations, the mold can provide a fit between the hard palate portion 1730 and the hard palate within the oral cavity.

[0136] Referring now to FIG. 18therapeutic oral appliance 1800. In some embodiments, the mouthguard portion 1820 can include multiple components. In some aspects, the mouthguard portion 1820 can include a mouthpiece with selective dental covers. In some embodiments, the dental covers can individually wrap multiple teeth. In some implementations, the mouthguard portion 1820 can allow the user to bite down on the therapeutic oral appliance 1800 without having to fit it over the teeth. This can allow for more universal fitting, such as for over-the-counter solutions.

[0137] For example, the dental covers can individually wrap three teeth on both sides of the mouth to ensure the stability and safety required by the therapeutic oral appliance 1800. In some implementations, the mold can provide a fitted adaptation between the hard palate portion 1830 and the hard palate within the oral cavity. In some aspects, the hard palate portion 1830 can include multiple materials to accommodate multiple preferences. As an example, the therapeutic oral appliance 1800 can include silicone to achieve the ideal softness, durability, and hygiene.

[0138] In some embodiments, the therapeutic oral appliance can include a soft silicone material with a low Shore hardness. This can provide an airway 1815 passage for breathing that allows flexibility. The flexibility can allow the patient to swallow and maintain certain tongue movements. This allowance can increase the comfort of the patient. In some implementations, the mouthguard portion 1820 can cover one or more teeth or gums as a means of protecting the teeth from pressure points of the oral airway. The mouthguard portion 1820 can stabilize the oral airway when the user is unconscious to reduce the chances of accidental expulsion from expelling the therapeutic oral appliance 1800.

[0139] For example, the hard palate of the user can be prone to irritation when interfacing with typical medical grade plastics and polymers. By utilizing the therapeutic oral appliance 1800, which includes a hard palate portion 1830 composed of metal or silicone mesh, the user can experience greater comfort and utility. The flexible or mesh hard palate portion 1830 can allow for a tight fit without the need for custom molds.

[0140] Referring now to FIG. 19 , an example adjustable therapeutic oral appliance 1900 is shown. In some embodiments, the mouthguard portion 1920 can include multiple components. In some implementations, the size of the therapeutic oral appliance 1900 can be adjustable. In some aspects, the tongue retainer portion 1910 can be attached to the frame of the therapeutic oral appliance 1900. In some embodiments, the hard palate portion 1930 can interface with a minimized area of the hard palate.

[0141] In some embodiments, the mouth can change and grow quickly, such as for children. Their mouth size and shape can change between progressive tongue retainer portions 1910, which can make it impractical to use one mouth mold to create a progressive therapeutic oral appliance 1900. In some aspects, a mouth guard portion 1920 can fit over several teeth, such as the incisors and molars, which are less likely to shift or change substantially during the adaptation period of the therapeutic oral appliance 1900. This can be combined with a stretchable hard palate portion 1930 that can allow for growth.

[0142] Referring now to FIG. 20 , an example therapeutic oral appliance 2000 is shown that is configured to interface with one or more dental fixtures, such as by being attachable thereto. In some aspects, the dental fixtures can be attached to teeth 2050. For example, the therapeutic oral appliance 2000 can connect to metal fastening rods positioned on braces 2055 that are secured to teeth 2050. For example, a teenager can overcome sleep apnea by attaching the therapeutic oral appliance 2000 to hooks on braces attached to canines while wearing the braces. In some embodiments, a mouth guard portion 2020 can extend back into the mouth. In some embodiments, a hard palate portion 2030 can interface with a minimized area of the hard palate.

[0143] Referring now to FIG. 21 , an example therapeutic oral appliance 2100 is shown with wireless data transfer capabilities. In some embodiments, the therapeutic oral appliance can contain a plurality of electronic components that can be configured to interface with at least one external device 2190. In some embodiments, the therapeutic oral appliance 2100 can be configured to interface with and relay information to at least one wearable device 2195, such as, for example, but not limited to, a smart watch. In some aspects, a tongue retainer portion 2110 can include one or more sensors.

[0144] In some embodiments, the airway 2115 can contain a plurality of electronic components. For example, the therapeutic oral appliance 2100 can include electrodes that can provide transcutaneous electrical stimulation to the oropharynx and tongue muscles. This can increase muscle tone, allowing for the opening of a patient's airway passage.

[0145] For example, a child prone to seizures can use a therapeutic oral appliance 2100 with an embedded accelerometer that will notify a parent of a sharp increase in rapid motion that can indicate a seizure. This can be helpful at night when the family is asleep and the parent can otherwise remain unaware of a child's seizure. The therapeutic oral appliance 2100 can limit the possibility that a seizure can cause a child's tongue to block their airway, which can result in permanent or temporary brain damage.

[0146] As another example, a user can purchase a therapeutic oral appliance 2100 to overcome sleep apnea, which is paired with an external device 2190, in the form of, as non-limiting examples, a user's phone, such as, for example, but not limited to, a smart phone, or a computing device, such as a desktop computer, laptop computer, or tablet. The embedded accelerometer and heart rate monitor can record information while the user is sleeping to display sleep quality information. The user can see how restless their sleep was as well as resting heart rate and oxygen levels. This can assist in overcoming sleep apnea by emitting a vibration frequency during sleep to reposition the user to a better sleep position when oxygen levels are too low.

[0147] As another example, a user can be recovering from a disease with high frequency of respiratory problems. The therapeutic oral appliance 2100 can track oxygenation levels (e.g., by using a pulse oximeter) and heart rate to monitor and manage symptoms. In the event that this level drops below a predefined threshold parameter, a practitioner or hospital can be notified. If the user is unresponsive to the practitioner, an ambulance can be dispatched.

[0148] As an illustrative example, an anesthesiologist can insert a therapeutic oral appliance 2100 including one or more health monitors during surgery. The anesthesiologist can monitor heart rate, oxygen levels, and respiratory rate during surgery. This information can be displayed via a Bluetooth® connection with one or more external devices 2190 in the form of one or more medical devices stationed within the operating room. The medical devices can be configured to transmit notifications and alerts for predetermined thresholds. The medical devices can notify the anesthesiologist of recommended times to periodically assess certain health criteria based on the patient's current health levels.

[0149] As another illustrative example, the therapeutic oral appliance 2100 can include a capnograph or gas analyzer. The capnograph can measure predefined gases, such as inhaled oxygen and exhaled carbon dioxide. The gas analyzer can indicate how much oxygen therapy can be needed to reach a desired blood oxygen saturation. The gas monitor can provide indicative information about the patient's ventilation. Audible and visual indicators can notify a healthcare professional if there are signs of obstruction or hypercapnia due to OSA or poor ventilation.

[0150] Referring now to FIG. 22A To FIG. 22B, a process 2200 of forming an example therapeutic oral appliance is shown. In some embodiments, the therapeutic oral appliance can be formed from an impression. In some embodiments, the impression can include, as non-limiting options, a dental impression and a hard palate impression. For example, the physical impression can be made up of the upper hard palate, the dentition, and as much of the soft palate as can be tolerated.

[0151] In some aspects, an impression of a patient's mouth can be rendered digitally. As an example, the impression can be scanned by a high-fidelity 3D scanner to render a virtual representation of the impression within modeling software. In some embodiments, a digital rendering of the airway can be created along a longitudinal length of the digital impression of the therapeutic oral appliance. In some implementations, a digital rendering and a physical construct of the airway can be formed. For example, the digital rendering can be printed by a 3D printer. In some embodiments, such a physical construct can provide a tangible medium to further form the therapeutic oral appliance, such as by providing a shape of a mold.

[0152] In some aspects, a mold can be formed using the physical reproduction of the impression and the airway. In some embodiments, the mold can be used to create the therapeutic oral appliance by using the mold for casting. For example, a 3D printed prototype can be placed in casting clay to form an impression, which is subsequently filled with a soft silicone material. As another example, a synthetic polymer can be poured into the mold, and upon solidification, a therapeutic oral appliance in the form of the impression and the airway can be produced.

[0153] Referring now to FIG. 23, a method 2300 of forming an exemplary therapeutic oral appliance is illustrated. At 2305, a physical impression of a patient's mouth can be formed. In some embodiments, as a non-limiting option, the impression can include a dental impression and a hard palate impression. At 2310, the impression of the patient's mouth can be scanned in three dimensions. As an example, the impression can be scanned by a high-fidelity 3D scanner to render a virtual representation of the impression within modeling software.

[0154] At 2315, a digital rendering of the airway can be created along a longitudinal length of the digital impression. At 2320, a physical construct of the digital impression and the airway can be constructed. For example, the digital rendering of the impression and the airway can be printed by a 3D printer.

[0155] At 2325, a mold can be formed using the physical reproduction of the impression and the airway. At 2330, the mold can be used to create the therapeutic oral appliance by using the mold for casting. For example, a synthetic polymer can be poured into the mold, and upon solidification, a therapeutic oral appliance in the form of the impression and the airway can be produced.

[0156] Referring now to FIG. 24FIG. 24 illustrates an exemplary therapeutic oral appliance 2400 having wireless data transmission capabilities, in accordance with some embodiments of the present disclosure. In some embodiments, the therapeutic oral appliance 2400 can include one or more electronic components, at least one of which can be configured to interface with at least one external device 2490. In some implementations, the therapeutic oral appliance 2400 can be configured to interface with at least one wearable technology device 2495, such as, for example, but not limited to, a smart watch. In some aspects, one or more electronic components of the therapeutic oral appliance 2400 can 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.

[0157] In some aspects, at least one internal or external portion of at least one of the tongue retainer portion 2410, the mouthguard portion 2416, the hard palate portion 2417, or any other suitable portion of the therapeutic oral appliance 2400 can include 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 wires can be placed on 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, the one or more wires can be embedded within the inside of the therapeutic oral appliance 2400 to prevent contact between the wires and the inside of the user’s mouth, thereby minimizing the likelihood that the user experiences irritation or encounters injury, as well as increasing the useful life of the therapeutic oral appliance 2400.

[0158] In some embodiments, one or more electrical wires can be used to couple two or more electronic components together, such as, for example and without limitation, 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 can include one or more transmission devices and / or one or more receiving devices for transmitting or receiving data, respectively. By way of example and without limitation, each transmission device can include at least one of a radio frequency (RF) transmitter or a Bluetooth® transmitter, and each receiving device can include at least one of an RF receiver and a Bluetooth® receiver. In some aspects, one or more electrical wires can couple each transmission 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 without limitation, a battery. In some embodiments, the transmission devices of the therapeutic oral appliance 2400 can transmit data obtained from one or more sensors and / or one or more electrodes to at least one of an external device 2490, a wearable technology device 2495, or at least one external or remote database or similar memory resource for at least temporary storage therein.

[0159] In some embodiments, one or more sensors or electrodes within or on the therapeutic oral appliance 2400 can include 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 arterial tonometry sensors, one or more photoplethysmography sensors, one or more pulse oximetry sensors, one or more humidity 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 emission 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 can further include a clock or timer. In preferred embodiments, when one or more sensors in the therapeutic oral appliance detect that the therapeutic oral appliance is no longer in the correct position, a reminder can be sent to a nearby monitoring device or application, such as a cell phone or display unit, so that the device or application can sound an alarm to remind the patient to reposition the therapeutic oral appliance correctly. In this way, the patient will know when the oral appliance has been inadvertently shifted or moved out of the correct position.

[0160] In some embodiments, one or more sensors and / or electrodes can be configured on or within the therapeutic oral appliance 2400 at locations that can be most advantageous for their purposes. By way of non-limiting example, one or more temperature sensors, such as a thermometer, can be configured proximal to a deeper region within the user’s oral cavity, such as at or near the distal end of the tongue retainer portion 2410, thereby allowing the temperature sensor to obtain measurements closer to the user’s body core region, thereby improving the accuracy of the measurements.

[0161] In some non-limiting example embodiments, the functionality of one or more sensors of the therapeutic oral appliance 2400 can depend at least in part on emitting light and / or measuring light absorption, such as can be the case with one or more pulse oximetry sensors; thus, it can be advantageous to configure such sensors proximal to one or more membranes of the hard and / or soft palate, and thus such sensors can be disposed on or within at least one portion of the therapeutic oral appliance 2400 adjacent thereto, such as, for example and without limitation, on or within the upper surface of the tongue retainer portion 2410 and / or the hard palate portion 2417. Additionally, in some embodiments, the therapeutic oral appliance 2400 can include one or more at least partially opaque materials or structures to block ambient light from interfering with the performance or functionality of any sensors and / or electrodes that can depend at least in part on emitting or absorbing light.

[0162] In some aspects, the therapeutic oral appliance 2400 can include one or more sensors configured to measure the movement of one or more muscles of the user’s mouth, throat, or oral cavity. By way of example and not limitation, such sensors can be positioned on or within one or more portions of the tongue retainer portion 2410 to measure the interaction between the therapeutic oral appliance 2400 and the user’s tongue or soft palate.

[0163] In some embodiments, one or more sensors can be configured to measure the bite force of the user, where the sensors can be positioned at or near one or more external or internal portions of the mouthguard portion 2416 of the therapeutic oral appliance 2400 to detect and measure the amount of force applied to the mouthguard portion 2416 when at least a portion of the mouthguard portion 2416 experiences physical contact with 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.

[0164] By way of example and not limitation, the sensors for measuring the bite force of the user can include one or more of the following: at least one strain gauge transducer, at least one piezoresistive transducer, at least one pressure transducer, at least one piezoelectric transducer, at least one piezo- resistive film, or at least one optical sensor, as well as any other suitable sensing means. In some aspects, the one or more sensors configured to detect or measure occlusion of the user’s airway passage can be positioned at or near one or more internal or external portions of the mouthpiece portion 2416 of the therapeutic oral appliance 2400.

[0165] In some aspects, the therapeutic oral appliance 2400 can include one or more materials that can facilitate functionality or performance with the one or more sensors or electrodes configured therewith. By way of example and not limitation, the therapeutic oral appliance 2400 can include, at least in part, at least one optically transparent material to prevent interference with the functionality of the at least one pulse oximetry sensor.

[0166] In some embodiments, the therapeutic oral appliance 2400 can include one or more electrodes that can be configured to facilitate transcutaneous electrical nerve stimulation or muscle electrical stimulation. By way of example and not limitation, the one or more electrodes can be positioned within or on one or more portions of the lower or upper surface of the therapeutic oral appliance 2400 to help strengthen and tone one or more muscles of the 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 can include, at least in part, and / or can be embedded, at least in part, within one or more electrically conductive materials. In some non-limiting example embodiments, the one or more electrodes can include, at least in part, and / or can be embedded, at least in part, within one or more of the following: carbon-infused medical grade silicone rubber, one or more carbon nanotube silicone composite materials, polydimethylsiloxane (PDMS), or one or more PDMS composite materials (including, by way of example and not limitation, materials that can be combined with nickel, carbon nanotubes, and / or silver).

[0167] In some aspects, at least one airway 2415 of the therapeutic oral appliance 2400 can include one or more electronic components. By way of example and not limitation, the airway 2415 can include one or more electrodes that can be configured to facilitate transcutaneous electrical stimulation of one or more oropharyngeal muscles and / or tongue muscles of the user. In some implementations, such stimulation can facilitate an increase in muscle tone, thereby facilitating opening of the user’s airway passage.

[0168] In some aspects, the therapeutic oral appliance 2400 can include one or more electrodes 2480 configured to facilitate neuromuscular electrical stimulation. By way of example and not limitation, such neuromuscular electrical stimulation can be implemented in conjunction with one or more sensors 2401 in the form of capnography sensors, respiration sensors, thoracic sensors, and / or other respiration sensors. In some embodiments, when one or more of these sensors 2401 detect that the user is not breathing or that the user’s breathing is at least partially obstructed, the one or more neuromuscular electrical stimulation electrodes 2480 can be configured to send at least one electrical pulse that can cause the user’s tongue muscles and / or upper airway dilator muscles to at least partially contract to facilitate opening of the user’s airway passage.

[0169] In some embodiments, the therapeutic oral appliance 2400 can be used to alleviate one or more health concerns of the user, such as sleep apnea. In some aspects, the neuromuscular electrical stimulation provided by the one or more electrodes 2480 of the therapeutic oral appliance 2400 can facilitate an increase in muscle tone within the user’s mouth, oral cavity, or throat, thereby reducing sleep apnea symptoms. In some non-limiting example embodiments, this increase in muscle tone can allow the size of the central portion (or web) of the airway passage 2415 and / or the cross-section of the tongue retainer portion 2410 to be progressively and gradually reduced over time, such as, for example and without limitation, by compressing or compacting in an adjustable manner, by replacing with a succession of one or more modular components, or by using multiple therapeutic oral appliances 2400 of different sizes. By way of example and not limitation, the gradual reduction in size of the airway passage 2415 or the central portion of the tongue retainer portion 2410 can result in increased user comfort.

[0170] In some embodiments, one or more electrodes 2480 for facilitating neuromuscular electrical stimulation can be configured within or on one or more portions of the therapeutic oral appliance 2400 in a location that can be advantageous to its purpose or functionality, which can be, as one non-limiting example, assisting a user in overcoming sleep apnea. In some aspects, one or more neuromuscular electrical stimulation electrodes 2480 can be positioned on any portion of the therapeutic oral appliance 2400 that can at least partially contact the tongue of a user, such as, for example and without limitation, the tongue retainer portion 2410. By way of example and not limitation, at least one neuromuscular electrical stimulation electrode 2480 can be placed on or near the chin of a user to facilitate stimulation of the genioglossus muscle. Stimulation of the genioglossus muscle can cause the tongue to tighten and at least partially protrude from the mouth of a user, thereby increasing the opening of the airway passage to the user, as a non-limiting example. In some aspects, this direct stimulation of the genioglossus muscle can produce similar effects to those facilitated by a hypoglossal nerve stimulator without the need for any surgically implanted devices.

[0171] In some embodiments, one or more neuromuscular electrical stimulation sensors can be configured within or on the therapeutic oral appliance 2400 in a location that can be advantageous to its purpose or functionality, which can be overcoming sleep apnea. As a non-limiting example, one or more neuromuscular electrical stimulation sensors can be positioned on any portion of the therapeutic oral appliance that contacts the tongue. As a non-limiting example, one or more neuromuscular electrical stimulation sensors can be positioned near the chin to allow for stimulation of the genioglossus muscle. Stimulation of the genioglossus muscle can cause the muscle to tighten and protrude, thereby opening the airway, as a non-limiting example. As an illustrative example, a child prone to seizures can use a therapeutic oral appliance 2400 with an embedded accelerometer connected to a Bluetooth® transmitter that can send one or more notifications to at least one external device 2490 in the form of a smartphone that can inform the child’s parents of a sharp increase in rapid motion that can be indicative of a seizure. This information can be helpful during the night when the family is asleep and otherwise the parents can remain unaware of the child’s seizure. In this way, the therapeutic oral appliance 2400 can limit the possibility that a seizure can cause the tongue to block the child’s airway, which can result in permanent or temporary brain damage.

[0172] As another example, a user can purchase a therapeutic oral appliance 2400 to overcome sleep apnea, where the therapeutic oral appliance 2400 can be paired with at least one external device 2490, by way of Bluetooth® or similar connection, in the form of, by way of non-limiting example, a user's phone, such as, for example and without limitation, a smartphone, or a computing device, such as a desktop computer, laptop computer, or tablet. One or more accelerometers and heart rate monitors embedded within one or more portions of the therapeutic oral appliance 2400 can detect and record data while the user is sleeping to determine and present sleep quality information to the user. Using this information, the user can see how restless their sleep was and the user's resting heart rate and oxygen levels throughout the night. To assist the user in overcoming sleep apnea, the therapeutic oral appliance 2400 can include one or more electrodes or similar mechanisms configured to emit one or more vibration frequencies that can prompt the user to reposition to a better sleep position when oxygen levels can drop below a minimum threshold.

[0173] As another example, a user can be recovering from an illness that can include severe respiratory problems. In such aspects, the therapeutic oral appliance 2400 can be configured to monitor the user's oxygenation levels (e.g., by using at least one pulse oximeter) and the user's heart rate (such as by using a heart rate monitor) to monitor and manage the user's symptoms. In some embodiments, 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 can be notified via at least one transmission device on or within a portion of the therapeutic oral appliance 2400.

[0174] In some embodiments, a medical professional can attempt to communicate with the user via at least one audio transmission device within or on the therapeutic oral appliance 2400, where the audio transmission device can be electronically coupled to at least one power source and at least one receiving device, such as, for example and without limitation, via at least one wire, that is 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 without limitation, via a microphone or similar device within or on the therapeutic oral appliance 2400 and electronically coupled to the transmission device and power source, an ambulance or other emergency vehicle can be dispatched to the user's location, which can be determined by at least one geolocation device within or on the therapeutic oral appliance 2400.

[0175] As another illustrative example, an anesthesiologist may insert a therapeutic oral appliance 2400 into the patient's mouth during surgery. The therapeutic oral appliance 2400 may include one or more sensors in the form of one or more health monitors. This allows the anesthesiologist to use the therapeutic oral appliance 2400 to monitor the patient's heart rate, oxygen level, respiratory rate, and / or other health aspects during surgery. In some aspects, the patient's health information may be displayed on one or more external devices 2490 via Bluetooth® connection, wherein the external devices 2490 may include one or more medical devices placed in the operating room.

[0176] In some implementations, the medical device can be configured to send one or more notifications or alarms when one or more aspects of a user's health reach one or more predetermined thresholds. In some embodiments, the medical device can notify an anesthesiologist of recommended times for periodic assessments of specific health criteria for the user, based on one or more of the user's current health levels.

[0177] As a further illustrative example, the therapeutic oral appliance 2400 may include at least one sensor, which may be in the form of a carbon dioxide tracing sensor or a gas analyzer. In some aspects, the carbon dioxide tracing sensor within or on the therapeutic oral appliance 2400 may measure one or more predefined gases, such as oxygen inhaled and / or carbon dioxide exhaled by the user. In some embodiments, the gas analyzer within or on the therapeutic oral appliance 2400 may indicate how much oxygen therapy may be required to achieve the user's desired blood oxygen saturation. In some aspects, these or similar gas monitors may provide indicative information about the user's ventilation volume.

[0178] In some non-limiting exemplary embodiments, one or more transmission devices on or within the therapeutic oral appliance 2400 may transmit data to one or more external devices 2490 and / or wearable technology devices 2495, causing the external devices 2490 and / or wearable technology devices 2495 to emit one or more audible and / or visual indicators that may notify at least one healthcare professional if the user may be experiencing airway obstruction or hypercapnia symptoms due to OSA or poor ventilation.

[0179] Now for reference FIG. 25A and FIG. 25B, illustrating an exemplary therapeutic oral appliance 2500 including tongue retainer portions 2510, 2570 and an oral cavity including the therapeutic oral appliance 2500, in accordance with some embodiments of the present disclosure. In some aspects, the therapeutic oral appliance 2500 can include: tongue retainer portions 2510, 2570; mouthguard portions 2520, 2550; and / or hard palate portions 2530, 2560, which can include 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 wires can be configured on or embedded within one or more external or internal portions of the therapeutic oral appliance 2500.

[0180] As non-limiting examples, one or more wires can be embedded within the therapeutic oral appliance 2500 such that the wires are prevented from making physical contact with one or more internal portions of the 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 wires can be used to electronically couple one or more sensors or electrodes to one another, to at least one power source (such as, for example and without limitation, a battery), to at least one transmission device (such as, for example and without limitation, an RF transmitter or a Bluetooth® transmitter), and / or to at least one receiving device (such as, for example and without limitation, an RF receiver or a Bluetooth® receiver). In some non-limiting exemplary embodiments, the therapeutic oral appliance 2500 can 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.

[0181] In some aspects, the therapeutic oral appliance 2500 can include one or more sensors or electrodes, which can include at least one of the following: one or more electromyography electrodes, one or more acceleromyography sensors, one or more piezomyography sensors, one or more temperature sensors, one or more peripheral arterial tonometry sensors, one or more photoplethysmography sensors, one or more pulse oximetry sensors, one or more humidity 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 emission 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 can further include a clock or timer.

[0182] In some embodiments, one or more sensors can be configured within or on the therapeutic oral appliance 2500 at locations that can be advantageous to their purpose or functionality. As a non-limiting example, one or more temperature sensors, such as, for example, but not limited to, one or more thermometers, can be configured proximal to a deeper region within the user’s oral cavity, such as by being positioned within, on, or near the distal end of the tongue retainer portion 2510, 2570, thereby allowing the temperature sensor to obtain measurements closer to the user’s core body region, thereby increasing the accuracy of the measurements.

[0183] Reference is now made to FIG. 26FIG. 26B, for example, illustrates a perspective view of an exemplary therapeutic oral appliance 2600, in accordance with some embodiments of the present disclosure. In some embodiments, the therapeutic oral appliance 2600 can include one or more wires that can be attached to one or more electrodes 2680. In some embodiments, the one or more wires can be connected to at least one power source, such as, by way of example and not limitation, at least one battery. In some embodiments, such electrodes 2680 can be configured to facilitate diagnostic techniques including electroencephalography, magnetoencephalography, and electromyography. In some aspects, the therapeutic oral appliance 2600 can include one or more transmission devices, such as, for example and without limitation, one or more RF transmitters or Bluetooth® transmitters, where the transmission devices can be connected to the one or more wires to facilitate electronic coupling with the at least one power source and the one or more electrodes 2680. In some embodiments, the therapeutic oral appliance 2600 can 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 transmission devices. By way of example and not limitation, each of the one or more electrodes 2680 can include an electromyography electrode or any similar mechanism.

[0184] In some aspects, the therapeutic oral appliance 2600 can include a tongue retainer portion 2610, a mouthguard portion 2620, and / or a hard palate portion 2630, which can include one or more electrodes 2680. In some embodiments, the therapeutic oral appliance 2680 can include one or more electrodes 2680 configured to facilitate transcutaneous electrical nerve stimulation or muscle electrical stimulation. By way of non-limiting example, the one or more electrodes 2680 can be configured within or on one or more portions of a lower surface and / or an upper surface of the therapeutic oral appliance 2600 to facilitate augmentation and strengthening of one or more of a user’s upper airway dilator muscles, tongue muscles, and / or other muscles.

[0185] In some aspects, each of the one or more electrodes 2680 can at least partially include and / or can 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 can at least partially include and / or can be at least partially embedded within a material including at least one of: carbon infused medical grade silicone rubber, one or more carbon nanotube silicone composite materials, PDMS, or one or more PDMS composite materials including materials combined with nickel, carbon nanotubes, and / or silver.

[0186] In some embodiments, at least one airway 2615 of the therapeutic oral appliance 2600 can include one or more electrodes 2680 that can be configured to provide transcutaneous electrical stimulation to one or more oropharyngeal muscles and / or tongue muscles of a user. In some aspects, such stimulation can cause an increase in muscle tone, which can facilitate the opening of the user's oral airway passage. In some non-limiting example embodiments, the electrical stimulation generated by the one or more electrodes 2680 can be strong enough to be perceived by the user, prompting or stimulating the user to perform an action. As an illustrative example, a person prone to snoring can use a therapeutic oral appliance 2600 with one or more embedded electrodes 2680 that generate a subtle electrical pulse in the form of a mild shock or vibration to wake the user when snoring can be detected, such as via at least one sensor in the form of a microphone or other audio capture device.

[0187] Reference is now made to FIG. 27A , FIG. 27B and FIG. 27C , which illustrate an example therapeutic oral appliance 2700 according to some embodiments of the present disclosure. In some aspects, the therapeutic oral appliance 2700 can include a tongue retainer portion 2770, a mouthguard portion 2750, and / or a hard palate portion 2760, which can include one or more sensors 2701. In some aspects, one or more wires 2725 can be configured on or embedded within one or more external or internal portions of the therapeutic oral appliance 2700. In some embodiments, the one or more wires 2725 can be embedded within at least one internal portion of the therapeutic oral appliance 2700 to prevent physical contact of the wires 2725 with one or more internal portions of the user's mouth, thereby reducing the likelihood of causing discomfort or injury to the user and extending the useful duration of the therapeutic oral appliance 2700. In some embodiments, the one or more wires 2725 can be attached to the one or more sensors 2701 to electronically couple the sensors 2701 to each other, to at least one power source 2735 (such as, for example and without limitation, at least one battery), to at least one transmission device 2745 (such as, for example and without limitation, an RF transmitter or a Bluetooth® transmitter), and / or to at least one receiving device (such as, for example and without limitation, an RF receiver or a Bluetooth® receiver).

[0188] In some non-limiting example embodiments, each of the one or more sensors 2701 can comprise at least one of the following: one or more acceleromyographic sensors, one or more piezoelectric myographic sensors, one or more temperature sensors, one or more peripheral arterial tonometry sensors, one or more photoplethysmographic sensors, one or more pulse oximetry sensors, one or more humidity 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 emission 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 can further comprise a clock or timer.

[0189] In some embodiments, the one or more sensors 2701 can be configured on or within one or more portions of the therapeutic oral appliance 2700 at one or more locations that can facilitate the utility or functionality of the sensors 2701. As a non-limiting example, one or more temperature sensors can be configured proximal to a deeper region within the user’s oral cavity, such as at or near the distal end of the tongue retainer portion 2770, thereby allowing the temperature sensors to obtain measurements closer to the core body region, increasing the accuracy of the measurements.

[0190] In some aspects, the therapeutic oral appliance 2700 can comprise one or more sensors 2701 that can comprise functionality that depends at least in part on emitting light and / or measuring light absorption, such as, for example and without limitation, one or more pulse oximetry sensors. By way of example and not limitation, such sensors can be configured proximal to one or more membranes of the user’s upper hard palate and / or soft palate by being positioned within or on one or more portions of the upper surface of the therapeutic oral appliance 2700, such as the tongue retainer portion 2770 and / or the hard palate portion 2760.

[0191] In some aspects, the therapeutic oral appliance 2700 can comprise one or more sensors 2701 configured to measure one or more muscle movements within the user’s mouth, throat, or oral cavity, wherein the sensors 2701 can be positioned on or within one or more portions of the tongue retainer portion 2770 to detect or measure any interaction between the therapeutic oral appliance 2700 and one or more portions of the user’s tongue and / or soft palate.

[0192] In some embodiments, one or more sensors 2701 can be configured to measure a user’s bite force, where the sensors 2701 can be positioned at or near one or more internal or external portions of the guard portion 2750 of the therapeutic oral appliance 2700 to detect and measure the amount of force applied to the guard portion 2750 when at least a portion of the guard portion experiences physical contact with 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 can be configured to detect or measure a user’s airway passage occlusion, where such sensors 2701 can be positioned at or near one or more internal or external portions of the guard portion 2750 of the therapeutic oral appliance 2700. Pressure or force sensors can be used to monitor bruxism or teeth grinding.

[0193] In some aspects, the therapeutic oral appliance 2700 can include one or more materials that can facilitate the performance and functionality of the sensors 2701. As a non-limiting example, the therapeutic oral appliance 2700 can include, at least in part, at least one optically transparent material so as to not interfere with the functionality of one or more sensors 2701 that can at least partially depend 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.

[0194] Referring now to FIG. 28A and FIG. 28B , an exemplary therapeutic oral appliance 2800 according to some embodiments of the present disclosure is shown. In some aspects, the therapeutic oral appliance 2800 can include one or more sensors 2801 and / or one or more electrodes 2880 configured within or on one or more internal or external portions of the tongue retainer portion 2810, the guard portion 2820, and / or the hard palate portion 2830 thereof. In some embodiments, one or more wires 2825 can be configured on or embedded within one or more internal or external portions of the therapeutic oral appliance 2800. As a non-limiting example, one or more wires 2825 can be embedded within one or more internal portions of the therapeutic oral appliance 2800 to prevent physical contact of the wires 2825 with one or more internal portions of a user’s mouth. In some embodiments, the wires and electrodes can be configured to facilitate diagnostic techniques including electroencephalography, magnetoencephalography, and electromyography.

[0195] In some embodiments, the electrical wire 2825 can be attached to the one or more sensors 2801, the one or more electrodes 2880, at least one transmission device 2845 (such as, for example and without limitation, an RF transmitter or a Bluetooth® transmitter), at least one power source 2835 (such as, for example and without limitation, a battery), and / or at least one receiving device (such as, for example and without limitation, an RF receiver or a Bluetooth® receiver). In some implementations, the at least one transmission device 2845 can include dual functionality in that it can also function as a receiving device.

[0196] In some embodiments, the therapeutic oral appliance 2800 can transmit data obtained from the one or more sensors 2801 and / or the 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 storage resource via the at least one transmission device 2845. In some implementations, the performance or functionality of the one or more sensors 2801 and / or the one or more electrodes 2880 can 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.

[0197] In some embodiments, by way of example and not limitation, the therapeutic oral appliance 2800 can include one or more sensors 2801 and / or one or more electrodes 2880 that can include at least one of the following: one or more electromyography electrodes, one or more acceleromyography sensors, one or more piezomyography sensors, one or more temperature sensors, one or more peripheral arterial tonometry sensors, one or more photoplethysmography sensors, one or more pulse oximetry sensors, one or more humidity 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 emission 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 can further include a clock or timer.

[0198] In some embodiments, the therapeutic oral appliance 2800 can include one or more sensors 2801 and / or electrodes 2880 that can be configured on or within one or more external or internal portions of the therapeutic oral appliance 2800 in order to optimize the performance or functionality of the sensors 2801 and / or electrodes 2880. By way of non-limiting example, one or more temperature sensors can be configured proximal to a deeper region within the user’s oral cavity, such as, for example and without limitation, by being positioned at or near the distal end of the tongue retainer portion 2810, thereby enabling the temperature sensors to obtain measurements closer to the user’s core body region, thereby increasing the accuracy of the measurements.

[0199] By further example and without limitation, the therapeutic oral appliance 2800 can include one or more sensors 2801 that can include functionality that depends at least in part on emitting light and / or measuring light absorption, such as, for example and without limitation, one or more pulse oximetry sensors. In some embodiments, such sensors 2801 can be positioned proximal to one or more membranes of the user’s hard and / or soft palate by being positioned at or near one or more portions of the upper surface of the tongue retainer portion 2810 and / or hard palate portion 2830 of the therapeutic oral appliance 2800.

[0200] In some aspects, the therapeutic oral appliance 2800 can include one or more sensors 2801 configured to measure one or more muscle movements of the user’s mouth, throat, or oral cavity, wherein the sensors 2801 can be configured on 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 without limitation, one or more interactions between the therapeutic oral appliance 2800 and the user’s tongue and / or soft palate. In some aspects, the therapeutic oral appliance 2800 can include one or more sensors 2801 configured to measure the user’s bite force by being positioned at, on, within, or proximal to one or more portions of the guard portion 2820 or any other appropriate portion of the therapeutic oral appliance 2800. In some aspects, the therapeutic oral appliance 2800 can include one or more sensors 2801 configured to detect and / or measure the user’s at least partial airway passage occlusion by being configured within, on, or proximal to one or more internal or external portions of the guard portion 2820 of the therapeutic oral appliance 2800, by way of example and without limitation.

[0201] In some aspects, the therapeutic oral appliance 2800 can include at least one material that can facilitate functionality and / or performance of the sensor 2801 and / or the electrode 2880. By way of non-limiting example, the therapeutic oral appliance 2800 can include, at least in part, at least one optically transparent material to minimize potential interference with the functionality of the at least one pulse oximetry sensor.

[0202] In some embodiments, the therapeutic oral appliance 2800 can include one or more electrodes 2880 configured to facilitate transcutaneous electrical nerve stimulation and / or muscle electrical stimulation. By way of non-limiting example, the one or more electrodes 2880 can be configured within, on, or proximal to one or more portions of the interior surface and / or the superior surface of the therapeutic oral appliance 2800 to help strengthen and tone one or more of the user's upper airway dilator muscles and / or tongue muscles. In some aspects, the one or more electrodes 2880 can include, at least in part, and / or be configured within, at least in part, one or more electrically conductive materials. By way of example and not limitation, the one or more electrodes 2880 can include, at least in part, and / or be configured within, at least in part, at least one material including one or more of: carbon infused medical grade silicone rubber, one or more carbon nanotube silicone composite materials, PDMS, or one or more PDMS composite materials including materials used in combination with nickel, carbon nanotubes, and / or silver.

[0203] In some embodiments, one or more portions of the tongue retainer portion 2810, such as, for example and without limitation, the at least one airway 2815, can include one or more electronic components. For example, the therapeutic oral appliance 2800 can include one or more electrodes 2880 that can be configured to provide transcutaneous electrical stimulation to one or more of the user's oropharyngeal muscles and / or tongue muscles. In some aspects, such stimulation can facilitate an increase in muscle tone, thereby facilitating opening of the user's oral airway passageway.

[0204] In some aspects, the therapeutic oral appliance 2800 can include one or more electrodes 2880 configured to facilitate neuromuscular electrical stimulation. By way of example and not limitation, such neuromuscular electrical stimulation can be implemented in conjunction with one or more sensors 2801 in the form of capnography sensors, respiration sensors, thoracic sensors, and / or other respiration sensors. In some embodiments, when one or more of these sensors 2801 detect that the user is not breathing or that the user’s breathing is at least partially obstructed, the one or more neuromuscular electrical stimulation electrodes 2880 can be configured to send at least one electrical pulse that can cause the user’s tongue muscles and / or upper airway dilator muscles to at least partially contract to facilitate opening of the user’s airway passage.

[0205] In some embodiments, the therapeutic oral appliance 2800 can be used to alleviate one or more health concerns of the user, such as sleep apnea. In some aspects, the neuromuscular electrical stimulation provided by the one or more electrodes 2880 of the therapeutic oral appliance 2800 can facilitate an increase in muscle tone within the user’s mouth, oral cavity, or throat, thereby reducing sleep apnea symptoms. In some non-limiting example embodiments, this increase in muscle tone can allow the size of the central portion (or web) of the airway passage 2815 and / or the cross-section of the tongue retainer portion 2810 to be progressively and gradually reduced over time, such as, for example and without limitation, by compressing or compacting in an adjustable manner, by replacing with a succession of one or more modular components, or by using multiple therapeutic oral appliances 2800 of different sizes. By way of example and not limitation, the gradual reduction in size of the airway passage 2815 or the central portion of the tongue retainer portion 2810 can result in increased user comfort.

[0206] In some embodiments, one or more electrodes 2880 for facilitating neuromuscular electrical stimulation can be configured within or on one or more portions of the therapeutic oral appliance 2800 at locations that can be advantageous to its purpose or functionality, which can be, as one non-limiting example, assisting the user in overcoming sleep apnea. In some aspects, one or more neuromuscular electrical stimulation electrodes 2880 can be positioned on any portion of the therapeutic oral appliance 2800 that can at least partially contact the user’s tongue, such as, for example and without limitation, the tongue retainer portion 2810. By way of example and not limitation, at least one neuromuscular electrical stimulation electrode 2880 can be placed on or near the user’s chin to facilitate stimulation of the genioglossus muscle. Stimulation of the genioglossus muscle can, as a non-limiting example, cause the tongue to tighten and at least partially protrude from the user’s mouth, thereby increasing the opening of the user’s airway passage. In some aspects, this direct stimulation of the genioglossus muscle can produce similar effects to those facilitated by a hypoglossal nerve stimulator without the need for any surgically implanted devices.

[0207] Referring now to FIG. 29 , a perspective view of an exemplary therapeutic oral appliance 2900 is shown, in accordance with some embodiments of the present disclosure. In some aspects, the therapeutic oral appliance 2900 can include at least some amount of a substantially hollow tube 2910. In some non-limiting exemplary embodiments, the hollow tube 2910 can be used to measure airflow inhaled or exhaled by the user. In some aspects, the hollow tube 2910 can be used to at least partially encase one or more wires 2920. In some aspects, the wires 2920 can be removably or securely attached to one or more sensors 2901 and / or one or more electrodes 2980.

[0208] In some aspects, the hollow tube 2910 can be attached or integrated with one or more gas flow meters and / or one or more gas analyzers, such as, for example and without 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 gas 2940 flowing into or out of the user’s body. In some embodiments, the hollow tube 2910 can be used to deliver one or more gases 2940 to the user, including but not limited to supplemental oxygen, nitric oxide, and / or humidification. In some embodiments, the hollow tube 2910 can be used to deliver one or more medicated gases 2940 to the user, such as, for example and without limitation, one or more aerosolized or misted medications within one or more gases 2940 in the form of air or oxygen.

[0209] Some embodiments of the therapeutic oral appliance can include an integrated computer processor. In some aspects, the therapeutic oral appliance can further include a non-volatile memory for storing data collected by the at least one sensor or electrode. In some embodiments, the data collected and stored in the non-volatile memory can be periodically transmitted or transferred to an external database through a wired or wireless connection. The integrated processor and / or non-volatile memory can be programmable in some implementations in order to instruct the at least one sensor or electrode to perform a sequence of therapeutic activities and / or monitor patient responses, such as performing periodic or patterned neuromuscular electrical stimulation and / or measuring responses through the at least one sensor. The integrated computer processor can cooperate with a clock or timer such that the integrated computer processor is able to track time. Further embodiments can include a physical computer interface, such as a USB or serial connection or wireless connection, for loading programs to the integrated processor and / or non-volatile memory and downloading data to an external computer or database. The data can be analyzed in real-time or offline. The integrated computer processor can be connected to a power source, such as a battery, preferably a rechargeable battery.

[0210] In some embodiments of the present 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., the hippocampus or other parts of the brain) without the need for surgically implanted electrodes within the brain. Furthermore, the magnetoencephalography sensors can be strategically positioned on or throughout the therapeutic oral appliance to optimize the measurement of brain electrical activity. Positioning the magnetoencephalography sensors on the inside of the mouth results in enhanced sensitivity of the hippocampal generators within the mouth, which is believed to improve the selectivity of the magnetoencephalography sensors to the human hippocampus both spectrally and spatially. Some embodiments of the therapeutic oral appliance include more than one electromyography electrode configured to perform electromyography, such as surface electromyography, in order to measure muscle responses or electrical activity, such as responses 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.

[0211] In some aspects, the therapeutic oral appliance can be used to assist in muscle function 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) that are aimed at improving the function of the muscles of the tongue or soft palate in order to maintain an open airway, thereby aiding in the treatment of sleep apnea. The muscles of the soft palate and tongue (including the uvular muscle, levator veli palatini muscle, tensor veli palatini muscle, palatopharyngeal muscle, palatoglossal muscle, genioglossal muscle, hyoglossal muscle, styloglossal muscle, superior longitudinal muscle of the tongue, inferior longitudinal muscle of the tongue, transverse muscle of the tongue, and vertical muscle of the tongue) can be strengthened and fortified with the oral appliance. The tongue can be used to squeeze the therapeutic oral appliance between the tongue and the hard palate and soft palate, thereby strengthening and fortifying the tongue. Conversely, the muscles of the soft palate can squeeze the therapeutic oral appliance against the tongue, thereby strengthening and fortifying the soft palate muscles. In this regard, some embodiments include pressure or force sensors positioned or embedded throughout the therapeutic oral appliance in order to measure the force or pressure exerted by the muscles of the tongue or soft palate against different regions of the therapeutic oral appliance. The effectiveness and progress of the muscle function therapy exercises can be measured by the pressure or force sensors. In particular, the measurements collected by the pressure or force sensors enable feedback to be provided to help the patient understand the target regions against which pressure is to be applied in order to ensure optimal muscle function therapy efficacy. A large number of pressure or force sensors will enable the patient to better understand whether they are performing the exercises correctly. Displaying the readings will allow the patient to track their progress in fortifying these oral muscles.

[0212] In further embodiments, electrodes can be placed on the tongue retainer portion and configured to perform neuromuscular electrical stimulation (NMES), particularly to the tongue and upper airway dilator muscles. NMES involves the application of electrical current through electrodes placed on the target muscle area in order to induce muscle contractions, particularly of muscle areas that are difficult to activate autonomously. By training the tongue and upper airway dilator muscles, breathing capacity can be improved and / or the muscles can be trained to react to various conditions, such as snoring and OSA, in order to improve airway space and patency. The muscles of the soft palate and tongue (including the uvular muscle, levator veli palatini muscle, tensor veli palatini muscle, palatopharyngeal muscle, palatoglossal muscle, genioglossal muscle, hyoglossal muscle, styloglossal muscle, superior longitudinal muscle of the tongue, inferior longitudinal muscle of the tongue, transverse muscle of the tongue, and vertical muscle of the tongue) can be stimulated, strengthened, and fortified with electrical stimulation of the therapeutic oral appliance.

[0213] Some embodiments of the therapeutic oral appliance can include one or more activity logging sensors for collecting data generated by the user's movements or activity. Activity logging can include data from an accelerometer or acceleromyography, as well as a clock or timer. The clock or timer can be programmable to start and stop the activity logger measurements at specific times, and maintain activity logger measurements for specific time frames. It can further include measurements of temperature, ambient light, sound or audio levels, motion or tremor, skin resistance, and electroencephalography data. The electronics for performing activity logging can further include a low pass filter configured to filter out external vibrations. As an example, the frequency range that can be allowed through the low pass filter is in the range of 2-3 Hz. In some aspects, a waterproof housing can be included to house the components provided for activity logging.

[0214] The sensors, monitors, and electrodes can be advantageously configured in or on different portions, regions, or zones of the therapeutic oral appliance according to their purpose. Preferably, heart rate monitors, pulse oximetry sensors, or other sensors that require transmission or absorption of light through body tissue are positioned on the upper surface of the therapeutic oral appliance so as to be in contact or engagement with the thinner tissues of the mouth and throat. For example, pulse oximetry sensors or heart rate monitors can be placed on the upper surface of the therapeutic oral appliance (e.g., on the upper surface of the hard palate portion) so as to transmit and absorb light through the hard palate tissue. Gas concentration sensors, gas pressure sensors, and capnography sensors are preferably positioned near the front or front portion of the appliance so as not to be obstructed by saliva and other fluids. Pressure sensors are preferably placed based on the desired pressure measurement. As an example, to measure pressure exerted by the tongue, palate, or upper airway dilator muscles, the pressure sensors should be placed at a location along the airway passage depending on the muscle movement to be measured. Acceleromyography and electromyography sensors are likewise preferably positioned proximal to the muscle sought to be monitored (e.g., along the airway passage). Pressure sensors can be placed on the upper or lower surface of the therapeutic oral appliance. As a further non-limiting example, pressure, force, or bite sensors for measuring bruxism, grinding, and clenching are preferably positioned in the mouth guard portion of the device.

[0215] Electrodes for NMES are preferably positioned at a location along the airway passage depending on the muscle to be stimulated. For example, stimulation electrodes for the tongue should be placed on the lower surface of the therapeutic oral appliance and in contact with the patient's tongue. As a further example, electrodes can be positioned on the upper surface of the therapeutic oral appliance in communication with the soft palate so as to stimulate the upper airway dilator muscles.

[0216] The temperature sensors are preferably positioned such that they provide accurate readings of core body temperature. For example, they can be placed behind the airway passageway, at the back of the therapeutic oral appliance, or at the distal end of the tongue retainer portion. The pH and humidity sensors are preferably positioned on the therapeutic oral appliance (e.g., at the back of the therapeutic oral appliance) so as to be proximate to the esophageal opening, providing the most accurate measurements, although other locations can be advantageous in context. The audio sensor, activity logging sensor, accelerometer, and sensors intended to provide data about, for example, gross motion or sound, can be placed anywhere on the appliance that does not impede their functionality.

[0217] The electroencephalography and magnetoencephalography sensors and electrodes are preferably positioned on the upper surface of the appliance and disposed toward (i.e., facing) the patient's brain.

[0218] CONCLUSION A number of embodiments of the disclosure have been described. While the specification contains many specifics, these should not be construed as limiting the scope of any disclosure or of any might claim, but as merely describing features that are specific to certain embodiments of the disclosure.

[0219] Some features described in the context of separate embodiments can also be implemented in combination, or in a single embodiment. Conversely, various features described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination. Although features can be described above as acting in particular combinations and even initially claimed as such, in some cases, the features from a claimed combination can be excised from the combination and the claimed combination can be directed to a sub-combination or variation of a sub-combination.

[0220] Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring such order, nor that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing can be advantageous.

[0221] 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 system typically can be integrated together in a single software product or packaged into multiple software products.

[0222] Thus particular embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims. In some cases, operations mentioned in the claims can be performed in a different order and still achieve the desired results. Additionally, the processes depicted in the accompanying figures do not necessarily require the particular order shown, or sequential order, to achieve the desired results. In certain implementations, multitasking and parallel processing can be advantageous. It will be appreciated that various modifications can be made within the spirit and scope of the disclosed subject matter.

Claims

1. A therapeutic oral appliance, comprising: Mouth guard portion, wherein the mouth guard portion is configured to engage at least partially with one or more of the user's teeth; The hard palate portion is configured to engage at least partially with the hard palate of the user's mouth, wherein the hard palate portion extends upward from the mouth guard portion; as well as At least one of a 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 according to 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 according to 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 according to 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 according to 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 according to any one of claims 3 to 6, wherein the at least one light-emitting sensor, the at least one light-absorbing sensor, the at least one pulse oximetry sensor, or the at least one heart rate monitor is positioned on the upper surface of the therapeutic oral appliance for contact with the hard palate of the user's mouth.

8. The therapeutic oral appliance according to any one of the preceding claims, wherein the at least one sensor is or includes at least one carbon dioxide recording 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 carbon dioxide chromatograph sensor, the at least one gas concentration sensor, or the at least one gas pressure sensor is located in front of or near the front of the appliance.

10. The therapeutic oral appliance according to 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 according to any one of the preceding claims, wherein the at least one sensor is or includes at least one peripheral arterial tension measuring sensor.

12. The therapeutic oral appliance according to any one of the preceding claims, wherein the at least one sensor is or includes at least one pressure sensor or force sensor.

13. The therapeutic oral appliance according to any one of the preceding claims, wherein the at least one sensor is or includes at least one occlusal sensor.

14. The therapeutic oral appliance of claim 12 or claim 13, wherein the at least one force sensor, pressure sensor or occlusal sensor is located in or on the mouthguard portion of the appliance.

15. The therapeutic oral appliance according to 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 myometry sensor.

16. The therapeutic oral appliance according to any one of the preceding claims, wherein the at least one sensor is or includes at least one activity recording sensor.

17. The therapeutic oral appliance according to 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 according to any one of the preceding claims, wherein the at least one sensor is or includes at least one humidity sensor.

19. The therapeutic oral appliance according to 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 according to 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 according to any one of claims 17 to 20, wherein the at least one sensor is preferably located at the rear of the therapeutic oral appliance.

22. The therapeutic oral appliance according to 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 according to 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 at least one neuromuscular electrical stimulation electrode is positioned on the lower surface of the therapeutic oral appliance for contact with the user's tongue, or on the upper surface of the therapeutic oral appliance for contact with the user's soft palate.

25. The therapeutic oral appliance according to 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 according to any one of the preceding claims, wherein the at least one electrode is or includes at least one electroencephalography (EEG) electrode.

27. The therapeutic oral appliance according to any one of the preceding claims, wherein the at least one electrode is or includes at least one magnetoencephalography (MEG) sensor.

28. The therapeutic oral appliance according to claim 26 or claim 27, wherein the at least one electrode is placed on the upper surface of the therapeutic oral appliance.

29. The therapeutic oral appliance of claim 28, wherein the at least one electrode is arranged to face the patient's brain during use.

30. The therapeutic oral appliance according to any one of the preceding claims, wherein the at least one sensor is or includes at least one accelerometer sensor.

31. The therapeutic oral appliance according to any one of the preceding claims, wherein the therapeutic oral appliance further comprises at least one delivery device.

32. The therapeutic oral appliance of claim 31, wherein the at least one transmission device is configured to transmit data obtained from 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 at least one of the at least one sensor and at least one electrode is transmitted to at least one database for storage.

34. The therapeutic oral appliance according to any one of the preceding claims, wherein the therapeutic oral appliance further comprises an integrated processor.

35. The therapeutic oral appliance according to 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 the at least one electrode.

36. The therapeutic oral appliance according to any one of the preceding claims, wherein the therapeutic oral appliance comprises at least a portion of at least one optically transparent material.

37. The therapeutic oral appliance according to any one of the preceding claims, wherein the therapeutic oral appliance comprises at least one material that becomes flexible when exposed to heat.

38. The therapeutic oral appliance according to any one of the preceding claims, wherein the therapeutic oral appliance further comprises at least one wire connected to 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 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 wire is disposed on one or more external surfaces of the therapeutic oral appliance.

41. The therapeutic oral appliance according to any one of the preceding claims, further comprising a timer.

42. The therapeutic oral appliance according to 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 the user's larynx, 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 grooves 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 airflow path following the user's natural anatomical airway pathway.

44. The therapeutic oral appliance of claim 42 or claim 43, wherein the tongue retainer portion is fixed to the distal end of the hard palate portion.

45. The therapeutic oral appliance of claim 43, wherein the at least one sensor or electrode comprises at least one neuromuscular electrical stimulation electrode, and the at least one neuromuscular electrical stimulation electrode is positioned on or along an airway passage.

46. ​​The therapeutic oral appliance of claim 43, wherein the at least one sensor or electrode comprises at least one pressure sensor, at least one electromyography electrode or at least one accelerometer sensor, and the at least one sensor or electrode is positioned on or along an airway.

47. The therapeutic oral appliance of claim 43, wherein the at least one sensor or electrode comprises at least one of the following: at least one temperature sensor, at least one humidity sensor, at least one audio sensor and at least one pH sensor, and the at least one sensor or electrode is positioned behind or posterior to the airway passage or positioned toward the rear or posterior to the airway passage.

48. The therapeutic oral appliance according to any one of the preceding claims, wherein the mouthpiece portion includes a universal adapter that can be used by a general user.

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