Apparatus and method for treating sleep apnea

Abstract

Apparatus for treating sleep apnea and methods for use include a wearable housing having a contact surface configured to removably engage a wearer's chin, a stimulator enclosed in the housing and configured to produce a magnetic field directed through the contact surface, and a control unit in communication with the stimulator and sensor(s), each sensor configured to produce signals indicative of i) biometric measurements of the wearer or ii) environmental measurements corresponding to an environment of the wearer. The control unit may be configured to analyze the sensor signals to detect an apneic event or a hypoxic condition of the wearer, and, responsive to the detecting, activate the stimulator to produce a magnetic field configured to deliver stimulation to targeted tissues(s) and / or nerve(s), thereby causing contraction of the wearer's pharyngeal tissue, tongue, and / or other dilator muscle.

Description

APPARATUS AND METHOD FOR TREATING SLEEP APNEACROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to, and the benefit of, U.S. Provisional App. No. 63 / 486,350, filed February 22, 2023, the entirety of which is incorporated herein.TECHNICAL FIELD

[0002] The present disclosure relates to sleep apnea treatment devices, systems, and methods. In particular, the present disclosure describes the use of time varying magnetic fields at a distance to induce electricity in the neuromuscular tissues that control the airway opening of an individual. Through the use of time varying magnetic fields, devices and treatment therapies described herein may actively open / manage the airway during sleep. Active management of the airway may allow for increased muscle tone to reduce and eliminate the constriction / collapse of the airway.BACKGROUND

[0003] The sleep disorders commonly referred to as sleep apnea each involve periods of breathing cessation and restarting during sleep. The symptoms can include gasping for air during sleep, loud snoring, and insomnia. Sleep apnea frequently causes hypersomnia - excessive sleepiness throughout the day. There are two general medical causes for sleep apnea. Obstructive sleep apnea (OSA) involves the relaxing of throat muscles which leads to air flow blockage into the lungs. Central sleep apnea (CSA) is caused by the brain failing to properly signal the muscles that control breathing.

[0004] Sleep apnea sufferers today often feel trapped into reliance on continuous positive airway pressure (CPAP) machines due to lack of another viable solution. The CPAP apparatus includes a face mask which covers the nose and mouth and straps firmly to the head so that it retains position while pressurized air is delivered to the wearer through a bulky tube delivering air from a nearby main unit. The mask frequently causes discomfort and / or skin irritation, while the strap can damage the wearer’s hair. Wearers may suffer headaches, sinus irritation, and / or dry mouth produced in part by the delivery of dry air throughout the night. Due to being tethered to a nearby blower by a tube, CPAP wearers experience difficulty in moving into different sleeping positions, in particular with side sleepers due to the mask getting in the way of desired positioning. Certain CPAP wearers even experience symptoms of claustrophobia due to the coverage of the mask about the nose and mouth. Meanwhile, when CPAP wearers are notsleeping alone, even their partners may experience sleep disruption due to the noisiness of the blower unit. Further, when in bed but not asleep, the CPAP unit must be removed to effectively speak with one’s partner. User compliance is a serious issue with CPAP machines due to the many downsides of the device, leading to untreated or insufficiently treated sleep apnea.SUMMARY OF THE DISCLOSURE

[0005] Certain embodiments of treatment devices described herein fit comfortably underneath the chin without the use of a face mask and / or a skin-tight seal to hold the device in place. Thus, various systems and devices described herein provide the advantage of improving wearer compliance by avoiding the bulkiness, discomfort, and difficulty of use of currently marketed systems, ultimately allowing individuals to breathe better, live healthier, and feel more well-rested. Devices, systems, and methods described herein may use pulsed electromagnetic fields that generate an electromagnetic force that does not require physical contact with tissues and / or nerves of and / or involved in the control of the wearer’s airway (e.g., the hypoglossal nerve, posterior pharyngeal tissue, soft palate, tongue, dilator muscle(s), etc.). In certain embodiments, systems described herein may include a wearable device connected (e.g., via a flexible wire) to a remote (e.g., bedside) unit (e.g., small box) for powering and / or control of the wearable device. The distributed design may further improve the comfort to the wearer by reducing bulk and / or weight from the wearable portion. In other embodiments, the device may be rechargeable such that it may remain untethered at night. The bedside control unit, further, may include a wireless transmitter for providing control signals to the wearable device.

[0006] In one aspect, the present disclosure relates to a device for treating sleep apnea through delivering neuromuscular stimulation. The device includes a housing having a contact surface, designed to removably engage with skin of a user (e.g. under the chin). The housing includes at lease one stimulator for producing a magnetic field that is configured to deliver stimulation therapy to tissues and / or nerves of and / or involving the control of the wearer’s airway (e.g., the hypoglossal nerve, posterior pharyngeal tissue, soft palate, tongue, dilator muscle(s), etc.). The device may include at least one sensor configured to detect biological signals indicative of an apneic event (e.g. processing circuitry, application, and / or control login) in communication with the at least one stimulator and the sensor(s). The controller may be configured to receive the biological signal from the sensor(s) and analyze the biological signals to detect the apneic event and / or hypoxic condition. Responsive to detecting the apneic event and / or hypoxic condition, the controller may issue signals and / or commands configured toactivate at least one stimulator to deliver electrical stimulation through magnetic field generation, thereby causing adjustment of the wearer’s airway. The signals and / or commands may include one or more parameters for producing an electromagnetic field, such as pulsed electromagnetic fields (PEMF), configured to deliver the electrical stimulation. The stimulation parameters, in some examples, may include a length of time (e.g., duration of stimulation, durations of pulses of stimulation, etc.), at least one frequency, a frequency pattern (e.g., a timevarying frequency), one or more powers, strengths, amplitudes, and / or pulse parameters. The airway may be adjusted, in some examples by causing contraction, by the electrical stimulation, of the pharyngeal tissue, tongue, or other dilator muscle.

[0007] In an aspect, the present disclosure relates to a method of treating sleep apnea is using a sleep apnea device including a housing having a contact surface configured to removably engaging with skin of a user. The method may include securing the sleep apnea device to a user so that the contact surface is disposed against the neck, chin, and / or jaw region of the user. The method may include activating the sleep apnea device to cause at least one sensor to collect biological signals of the user. The method may include analyzing, by a controller of and / or in communication with the sleep apnea device, the biological signals to identify an apneic event and / or hypoxic condition. The method may include determining, by the controller based at least in part on the biological signals, one or more stimulation parameters for producing, by at least one stimulator of the sleep apnea device, a magnetic field configured to deliver stimulation of the user. The stimulation parameters, in some examples, may include a length of time and / or a frequency. The method may include causing at least one stimulator to stimulate a pharyngeal tissue, a tongue, or other dilator muscle of the user with a magnetic field. The magnetic field, for example, may be produced according to the one or more stimulation parameters.

[0008] In an aspect, a device for treating sleep apnea is presented. The device includes a housing having a contact surface. The housing is configured to removably engage with skin of a user through the contact surface. The housing includes a bottom surface and a curved surface connecting the contact surface to the bottom surface. The housing includes a single stimulator located more proximate to the contact surface relative to the bottom surface. The single stimulator is configured to produce a magnetic field that contracts a pharyngeal tissue, a tongue, or other dilator muscle of the user or a combination thereof. The device includes a sensor configured to detect a biological signal indicative of an apneic event of the user. The device includes a control suite in communication with the single stimulator and the sensor. The controlsuite is configured to receive the biological signal from the sensor and active the single stimulator based on the biological signal, thereby contracting the pharyngeal tissue, tongue, or other dilator muscle.

[0009] The control suite may be stored within the housing. The control suite may be located external to the housing. The control suite may be further configured to adjust a frequency of the magnetic field based on the biological signal. The magnetic field produced by the single stimulator may interact with a hypoglossal nerve of the user. The control suite may be configured to select a remedy mode based on the biological signal and activate the single stimulator based on the selected remedy mode. The magnetic field may have a frequency of about 0 Hz to about 30 KHz. The control suite may be in communication with an external computing device through a wireless connection. The control suite may be further configured to communicate the biological signal and parameters of the single stimulator to the external computing device though the wireless connection. The control suite may be further configured to utilize a machine learning model to select parameters of operation of the single stimulator. The housing may include a butterfly structure, the butterfly structure including a first housing element and a second housing element joined to the first housing element. The single stimulator may be a coil. A diameter of the contact surface or the bottom surface may be greater than a height of the curved surface.

[0010] In another aspect, a method of treating sleep apnea is presented. The method includes securing a sleep apnea device to a user. The sleep apnea device is positioned on a neck region of the user. The sleep apnea device includes a housing having a contact surface. The housing is configured to removably engage with skin of a user through the contact surface. The housing includes a bottom surface and a curved surface connecting the contact surface to the bottom surface. The housing includes a single stimulator located more proximate to the contact surface relative to the bottom surface. The single stimulator is configured to produce a magnetic field that contracts a pharyngeal tissue, a tongue, or other dilator muscle of the user or a combination thereof. The method includes receiving, through a sensor, a biological signal indicative of an apneic event of the user. The method includes determining, by a control suite, a parameter of stimulation based on the biological signal. The method includes stimulating, by the stimulator, a pharyngeal tissue, a tongue, or other dilator muscle of the user through a magnetic field produced by the stimulator.

[0011] The control suite may be stored within the housing. The control suite may be located external to the housing. Securing may further comprise apply an adhesive of the sleep apneadevice to the neck region of the user an the single stimulator may be positioned underneath a chin of the user. The method may further include adjusting a frequency of the magnetic field based on the biological signal through the control suite. The magnetic field produced by the single stimulator may interact with a hypoglossal nerve of the user. The method may further include selecting a remedy mode based on the biological signal and activating the single stimulator based on the selected remedy mode through the control suite. The magnetic field may have a frequency of about 0 Hz to about 30 KHz. The control suite may be in communication with an external computing device through a wireless connection. The method may further include communicating the biological signal and parameters of the single stimulator to the external computing device through the wireless connection by the control suite.

[0012] In another embodiment, an apparatus for treating sleep apnea is presented. The apparatus includes a first portion. The first portion includes a first housing comprising a top tooth tray form factor, the first housing having an outer surface, an inner surface, and an interior. The inner surface is proximate to teeth when in use. The outer surface has an interior outer surface proximate to the interior of the mouth and an exterior outer surface proximate to at least one of a cheek, upper lips, or both when in use. The first portion includes an electromagnetic stimulator disposed within the interior of the first housing and configured to contract a pharyngeal tissue, a tongue, or other dilator muscle, or a combination thereof. The contraction is configured to cause an opening if an upper airway by wirelessly stimulating a soft palate. The first portion includes a first protrusion extending from the outer surface of the first housing. The apparatus includes a second portion including a second housing comprising a bottom tooth tray form factor. The second portion includes a second protrusion extending externally from an outer surface of the second housing. The second protrusion is configured to at least one of mechanically fix or adjust a positioning of the lower jaw of the user in cooperation with the first protrusion. Th apparatus includes a biological sensor configured to detect a biological signal indicative of an apneic event. The apparatus includes a control suite in communication with the electromagnetic simulator and configured to receive the biological signal from the biological sensor and stimulate the soft palate or the tongue by adjusting or activating the electromagnetic stimulator.

[0013] In another aspect, another apparatus for treating sleep apnea is presented. The apparatus include a first portion. The first portion includes a first housing shaped as a top tooth tray and having an outer surface, an inner surface, and an interior. The inner surface is proximate to teeth when in use and the outer surface has an interior outer surface proximate to the interiorof the mouth and an exterior outer surface proximate to a check and / or upper lips when in use. The first portion has a first protrusion extending from the outer surface of the first housing and comprising a magnet. The apparatus includes a second portion. The second portion has a second housing shaped as a bottom tooth tray. The second portion has a second protrusion extending from the outer surface of the second housing and comprising a magnet oriented towards the first position. The magnets of the first and second protrusions are configured to at least one of magnetically adjust or fix a position of a lower jaw relative to a relaxed jaw position of the lower jaw. The apparatus includes a control suite electronically connected to the magnets. The control suite is adapted to adjust the magnet of the second protrusion to move the second protrusion in any one or more directions relative to the first protrusion. The apparatus includes a biological sensor configured to detect a biological signal indicative of an apneic event, wherein the adjustment of the magnets is based on the apneic event.

[0014] The control suite may be further configured to activate a remedy mode based on the detected biological signal. The biological sensor may be located on any one of the first portion, second portion, or control suite. The control suite may be positioned outside the exterior of the first portion through a sensor extension removably attachable to the first portion. The control suite may be further adapted to vibrate a portion of a jaw of the user through the first protrusion or the second protrusion based on the detected biological signal. The control suite may be further configured to communicate the biological signal to a computing device. The computing device may be configured to determine a remedy mode and communicate the remedy mode to the control suite. The computing device may be configured to determine the remedy mode utilizing a remedy mode machine learning model. Utilizing a remedy mode machine learning model may include receiving training data correlating biological signals to remedy modes, training the remedy mode machine learning model with the training data, and determining a remedy mode based on the trained remedy mode machine learning model. The first portion may include a respiratory sensor in electronic communication with the control suite. The control suite may be further configured to determine a sleep stage of the user based on the biological signal and active a remedy mode based on the determined sleep stage of the user.

[0015] In another aspect, another method of treating sleep apnea is presented. The method includes detecting, through a sending device of a first portion of a mouth retainer, a biological signal of a user. The method includes calculating, through a control suite of the mouth retainer, a remedy mode for the user. The method includes activating, through the control suite, the remedy mode for the user. Activation of the remedy mode includes one or more of wirelesslystimulating a soft palate of an upper jaw of the user through an electromagnetic stimulator of the first portion of the mouth retainer, adjusting an upper jaw positioning of the user through a first protrusion positioned on an exterior of an upper portion of the mouth retainer, adjusting a lower jaw positioning of the user through a second protrusion positioned on an exterior of a lower portion of the mouth retainer, and vibrating a potion of a jaw of the user through the upper portion of the mouth retainer or the lower portion of the mouth retainer.

[0016] Activation of the remedy mode may include adjusting an upper jaw positioning of the user through a protrusion positioned on an outer surface of the first portion of the mouth retainer. Activation of the remedy mode may include adjusting a lower jaw positioning of the user through a second protrusion positioned on an outer surface of a second portion of the mouth retainer. Activating the remedy mode may include vibrating a portion of a jaw of the user through a first protrusion located on an outer surface of the first portion of the mouth retainer or a second protrusion located on an outer surface of a second portion of the mouth retainer. Calculating the remedy mode may include receiving training data correlating biological signals to activity modes, training a remedy mode machine learning model with the training data, and determining a remedy mode based on the trained remedy mode machine learning model. The training data may be generated from data of previous users. Calculating the remedy mode may further include determining , through the control suite, a sleep stage of the user based on the biological signal and activating the remedy mode based on the determined sleep stage of the user. The method may further include determining a remedy mode for the user base don the biological signal. The method may further include communicating the biological parameter to a computing device, wherein the computing device determines a remedy mode for the user base don the biological parameter. Activating the remedy mode for the user may include calculating a respiratory rhythm of the user based on the biological parameter an activating the remedy mode based on the respiratory rhythm of the user.

[0017] In another aspect, a system for treating sleep apnea is presented. The system includes a mouth retainer having a first portion including a first housing shaped as a top tooth tray having an outer surface, an inner surface, and an interior. The inner surface is proximate to teeth when in use and the outer surface has an interior outer surface proximate to the interior of the mouth and an exterior outer surface proximate to a check and / or upper lips when in use. The system includes an electromagnetic stimulate in the interior of the first housing configured to contract a user’s pharyngeal tissue thereby opening an upper airway of the user by wirelessly stimulating the soft palate of the user. The system includes a first protrusion extending from the exteriorouter surface of the first housing. The second portion includes a second housing shaped as a bottom tooth tray having an outer surface, an inner surface, and an interior. The inner surface is proximate to teeth when in use. The outer surface has an interior outer surface proximate to the tongue and an exterior outer surface proximate to the check and / or lower lips when in use. The system includes a second protrusion extending from the outer surface of the second housing. The system includes a biological sensor configured to detect a biological signal indicative of an apneic event. The system includes a control suite electronically connected to the electromagnetic stimulator configured to receive the biological signal from the biological sensor and stimulate the user’s soft palate by adjusting or activating the electromagnetic stimulator. The system includes a computing device in communication with the control suite. The computing device is configured to receive the biological signal from the control suite, determine a remedy mode based on the biological signal, and communicate the remedy mode to the control suite.

[0018] A remedy mode may include one of activating the electromagnetic stimulator, fixing and / or adjusting a positioning of the lower jaw of the user through cooperation of the second protrusion with the first protrusion relative to a relaxed jaw position of the lower jaw of the user, or vibrating the lower jaw of the user through the second protrusion. The biological signal may include one of blood oxygen level, noise, blood pressure, blood glow, pulse, position, monitoring of body structures, temperature, electromagnetic flux, muscular activity, air flow, air pressure, moisture content, mineral / chemical content, or movement of a user. The remedy mode may be configured to assist with one of dysphagia, muscle rehabilitation, muscle toning, oral / head / neck cancer rehabilitation, TMJ surgery rehabilitation, TMJ rehabilitation, or salivary function. The mouth retainer may be 3-D printed. The first housing may include a microfluid channel.

[0019] In particular embodiments, a device disclosed herein represents an improved device that, unlike with CPAP, 1) does not force air in the wear’s airway, 2) allows the wearer to talk while wearing the device, 3) avoids claustrophobic feelings since no element of the device or system will touch the mouth / nose area of the face, 4) is likely less noisy since there is no generation of airflow, 5) permits wearers the option to sleep on their side or face, enabling an increased range body positions during sleep.

[0020] In another aspect, another apparatus for treating sleep apnea is presented. The apparatus includes a wearable housing. The wearable housing includes a contact surface. The wearable housing is configured to removably engage with skin of a chin and / or neck of a wear at least at the contact surface. The apparatus includes a stimulator configured to produce amagnetic field directed through the contact surface of the wearable housing. The apparatus includes a control unit in communication with the stimulator and at least one sensor. Each sensor of the at least one sensor is configured to produce a plurality of signals indicative of one or more biometrics measurements of the wearer or one or more environmental measurements corresponding to an environment of the wearer. The control unit is configured to analyze the plurality of signals of each respective sensor of the at least one sensor to detect at least one of an apneic event or a hypoxic condition of the wearer. The control unit is configured to, responsive to detecting the at least one of the apneic event or the hypoxic condition, activate the stimulator to produce the magnetic field. The magnetic field is configured to deliver functional electrical stimulation to at least one of one or more tissues or one or more nerves of the wearer thereby causing contraction of at least one of a pharyngeal tissue, a tongue, or another dilator muscle of the user. At least a portion of the control unit may be disposed within the wearable housing. The control unit may be located external to the wearable housing. The wearable housing may be connected to a control unit by a wired connection. The control unit may be further configured to determine, based at least in part on the plurality of signals, one or more stimulation parameters for producing the magnetic field. One or more stimulation parameters comprise at least one of one or more frequencies, a frequency rage, a frequency pattern, a pulse duration, a duration of stimulation therapy, a power, a strength, an amplitude, a collapsible size of a coil of the stimulator, a focal point adjustment, a transmission range, a depth of penetration and / or one or more pulse parameters. Activating the stimulator may include causing the stimulator to produce the magnetic field according to the one or mor stimulation parameters.

[0021] The control unit may be configured to receive from each sensor of one or more sensors of the at least one sensor a respective further plurality of signals, analyze the further plurality of signals from each sensor of the one or more sensors, responsive to the analyzing, adjust at least one simulation parameter of the one or more stimulation parameters, and cause the stimulator to produce an adjusted magnetic field according to the at least one adjusted stimulation parameter. Determining the one or more stimulation parameters includes applying one or more artificial intelligence and / or machine learning models to the plurality of signals to determine at least one stimulation parameter of the one or more stimulation parameters. The functional electric stimulation may stimulate a hypoglossal nerve of the wearer. The control unit may be further configured to select, based at least in part on the plurality of signals, a remedy mode of a set of remedy modes. Activating the simulator may include causing the stimulator to produce the magnetic field according to the remedy mode. The magnetic field may have afrequency of about 5 Hz to about 40 KHz. The magnetic field may have a frequency of about 2 MHz to about 8 MHz. An external computing device may include one or more sensors of the at least one sensor. The control unit may be in communication with the external computing device through a wireless connection to receive the plurality of signals of each respective sensor of the one or more sensors. At least a portion of the control unit may be configured to execute on one or more processors of a remote networked computing system. The wearable housing may include a first housing portion adjacent to a second housing portion. The first hosing portion may include a first contact region of the contact surface and the second housing portion may include a second contact region of the contact surface. The stimulator may include a butterfly coil having a first lobe of coil disposed in the first housing portion and a second lobe of coil disposed in the second housing portion. The stimulator may include a first emitting element and a second emitting element. Each emitting element may include a coil. The coil of the first emitting element may be disposed in the first housing portion. The coil of the second emitting element may be disposed in the second housing portion.

[0022] In another aspect, a method of treating sleep apnea is presented. The method includes by one or more processors, receiving, from each respective sensor of at least one sensor, a respective plurality of sensor signals. Each respective sensor is configured to monitor a biometric parameter of a wearer of a sleep apnea device or an environmental parameter. The method includes analyzing by the one or more processors the plurality of signals of each respective sensor of the at least one sensor to identify an indication of an apneic event or a hypoxic condition. The method includes, responsive to detecting the at least one of the apneic events or the hypoxic condition, activating, by the one or more processors, a simulator disposed in a housing of the sleep apnea device to produce a magnetic field directed through a contact surface of the housing. The contact surface is disposed against skin of a neck and / or a chin of the wearer. The magnetic field is configured to deliver functional electric stimulation to at least one of one or more tissues or one or more nerves of the wearer, thereby causing contraction of at least one of a pharyngeal tissue, a tongue, or another dilator muscle of the wearer.

[0023] The method may include determining, based on at least a portion of the plurality of signals of one or more sensors of the at least one sensor and by the one or more processors, at least one stimulation parameter. Activating the simulator may include activating the stimulator to produce the magnetic field according to the at least one stimulation parameter. The environmental parameters may include ambient noise or ambient temperature. The biometric parameter may include blood oxygen level, pulse, pulse oximetry, heart rate, or respiratory rate.The simulator may be a first stimulator. The sleep apnea device may include a second stimulator. The method may include selecting the first stimulator and / or the second simulator for activating. The method may include determining a remedy mode of a set of remedy modes based at least in part on a portion of the plurality of signals of one or more sensors of the at least one sensor. The first stimulator and / or the second stimulator may be selected based at least in part on the remedy mode. The magnetic field may have a frequency of about 2 MHz to about 8 MHz.

[0024] These and other aspects and features of non-limiting embodiments of the present document will become apparent to those skilled in the art upon review of the following description of specific non-limiting embodiments of the subject matter in conjunction with the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0025] FIGS. 1 A and IB illustrate a cross-sectional profile view of a human sleeping according to the present disclosure;

[0026] FIG. 1C illustrates genioglossus muscle activation in an endoscopic view with the tongue base at the bottom of the image according to embodiments of the present disclosure;

[0027] FIG. ID illustrates a hypoglossal nerve anatomy and related innervation of the genioglossus according to the present disclosure;

[0028] FIG. IE illustrates a glossopharyngeal nerve anatomy and pathway through upper airway according to the present disclosure;

[0029] FIGS. 2 A and 2B illustrate a sleep apnea treatment system according to embodiments of the present disclosure;

[0030] FIGS. 3A through 3D illustrate a sleep apnea treatment device according to embodiments of the present disclosure;

[0031] FIG. 4 illustrates a sleep apnea treatment control unit according to embodiments of the present disclosure;

[0032] FIGS. 5 A and 5B illustrate a mandibular treatment device according to embodiments of the present disclosure;

[0033] FIG. 6 illustrates a communication pathway and sensing system of a sleep apnea treatment - device according to embodiments of the present disclosure;

[0034] FIG. 7 illustrates a network for sleep apnea treatment according to embodiments of the present disclosure;

[0035] FIG. 8 illustrates a sleep treatment process according to embodiments of the present disclosure;

[0036] FIG. 9 illustrates another sleep treatment process according to embodiments of the present disclosure;

[0037] FIGS. 10 and 11 illustrate a bottom view of a first portion of the sleep apnea device according to embodiments of the present disclosure;

[0038] FIGS. 12 and 13 illustrate a profile view of the sleep apnea device according to embodiments of the present disclosure;

[0039] FIGS. 14A and 14B illustrate respective views of an sleep apnea device according to embodiments of the present disclosure;

[0040] FIG. 15 illustrates a side view of another embodiment of the sleep apnea device according to embodiments of the present disclosure;

[0041] FIGS. 16A and 16B illustrate views of another sleep apnea device according to embodiments of the present disclosure;

[0042] FIGS. 17A and 17B illustrate another sleep apnea device according to embodiments of the present disclosure; and

[0043] FIG. 18 illustrates another example a first portion of the sleep apnea device according to embodiments of the present disclosure.DETAILED DESCRIPTION

[0044] In the following description, for the purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the present subject matter. It will be apparent, however, that the present subject matter may be practiced without these specific details. As used herein, the word "exemplary" or "illustrative" means "serving as an example, instance, or illustration." Any implementation described herein as "exemplary" or "illustrative" is not necessarily to be construed as preferred or advantageous over other implementations. As used herein, the term “and / or” means that the features or aspects connected thereby may exist or be provided individually or in any combination. All of the implementations described below are exemplary implementations provided to enable persons skilled in the art to make or use the embodiments of the disclosure and are not intended to limit the scope of the disclosure, which is defined by the claims.

[0045] At a high level, provided herein are apparatuses, methods, and systems for treating sleep apnea and / or other conditions and diseases that may debilitate muscles of the upper respiratory region (e.g. jaw, throat, tongue, and / or soft palate). In an embodiment, aspects of the present disclosure are used to deliver functional electrical stimulation (FES) wirelessly to a nerve and / or tissues (e.g. tongue, soft palate) of the upper respiratory region of a user.Wirelessly stimulating the nerves and / or tissues of a user, for example, may result in constricting one or more tissues which may open an airway of the user.

[0046] Aspects of the present disclosure are used to adjust a jaw positioning of a user, such as through protrusions extending from a first portion and / or second portion of a sleep apnea apparatus. The protrusions may be moveable relative to each other not just for initial setting of the upper jaw (maxilla) relative to the lower jaw (mandible), but actively for comfort before, during or after use, or in response to or to avoid or lessen the likelihood of an apneic event, or to adapt to the user in another manner while in use. The protrusions may be configured to change the maxilla and mandible positioning during, before, or after an apneic event, by changing the relative position of the protrusions using software based on sensor output of the apparatus or of another sensor.

[0047] Certain aspects of the present disclosure utilize Artificial Intelligence (Al) and / or machine learning model(s) to identify sleep apnea parameters and / or remedies for a user. In some embodiments, the Al and / or machine learning may be configured to identify functional parameters of a treatment device for treating sleep apnea. The functional parameters, for example, may be configured to instruct the treatment device to change the mandible position relative to the maxilla (e.g. using the protrusions before, during, and / or after sleep, before during and / or after an apneic event, etc.). In another example, the functional parameters may be configured to instruct the treatment device to deliver neurostimulation to the soft palate and / or tongue of the user (e.g., wirelessly) to cause the airway of the user to open.

[0048] FIGS. 1 A and IB illustrate a cross-sectional profile view of a human sleeping according to the present disclosure. In the example shown in FIG. 1A, a human is asleep and experiencing typical breathing during sleep. The tongue 105 is at rest at a position away from the soft palate 110 and posterior pharyngeal wall (which includes the midline projection referenced as the “uvula”) providing an un-obstructed airway 115.

[0049] In the example shown in FIG. IB, while the human is asleep, the tongue 105 is at rest at a rear position in which it substantially contacts the soft palate 110 and posterior pharyngeal wall, blocking the airway 115.Based on the findings with the visualization of endoscopic opening of the airway (depicted in FIG. 1C) it is possible that additional nerves besides just the hypoglossal nerve 125 are being activated. The hypoglossal nerve 125 protrudes the tongue 105, yet embodiments of the present disclosure further provide lateral expansion of the airway during activation of the disclosed device. Likely additional nerves are recruited from the superior branches of theGlossopharyngeal Nerve 135, as shown in FIG. IE. In other embodiments soft palate 110 activation occurs through Glossopharyngeal Nerve 135 and then subsequent expansion of the airway.

[0050] FIGS. 2 A and 2B illustrate a system 200 for treating sleep apnea according to embodiments of the present disclosure. FIG. 2A illustrates a block diagram of system 200 and FIG. 2B illustrates an example of system 200 according to embodiments of the present disclosure.

[0051] In some embodiments, system 200 includes an emitting element 205 and a control unit 210. An “emitting element” as used in this disclosure refers to a device capable of producing electromagnetic fields, including purely electric or purely magnetic fields. Emitting element 205 may be configured to produce one or more magnetic fields at various frequencies, strengths, and / or time periods, as explained in further detail below.

[0052] The emitting element 205 can be coupled to the control unit 210 via a wired or wireless communication link 215. The control unit 210 may include processing circuitry and / or storage circuitry (e.g., one or more processors, memories, etc.). In some embodiments, the control unit 210 performs various processing tasks. Tasks may include, without limitation, operating the emitting element 205, analyzing sensor signals, performing data calculations, cleansing data, aggregating data, and / or other operations. In some embodiments, the emitting element 205 and the control unit 210 are contained within the same housing 235. In other embodiments, at least a portion of the operations of the control unit 210 are performed on a device disposed remotely from the treatment device. For example, portions of the functionality of the control unit 210 may be executed on a peripheral device in a wired or wireless communication with the treatment device.

[0053] The emitting element 205 may include a stimulator 220. The stimulator 220 may include an electromagnetic transmitter, such as one or more conductive coils, and a power source 225. The stimulator 220 may be configured to emit an electromagnetic signal at a specified frequency towards a region of the human body. For example, the stimulator 220 can be configured to perform functional electrical stimulation (FES) of one or more nerves or tissues by emitting the electromagnetic signal towards a region of the human body, which may induce an electrical current in one or more tissues of the human body. The stimulator 220 may be disposed such that the stimulator 220 may be physically isolated from contacting a skin of a subject. For instance and without limitation, housing 235 of the device 200 may maintain a physical separation between the stimulator 220 and the subject such that the stimulator 220 operates in anon-contact manner. In certain embodiments, the stimulator 220 is disposed such that an emitting portion of the stimulator 220 is proximate to, or includes, a portion of a first surface 230 of a housing 235 of the emitting element 205. The specified frequency of an electromagnetic signal generated by the stimulator 220 can be preset or variable under the control of control unit 210. The specified frequency can be in the range of up to and including 8 MHz. In certain embodiments, the specified frequency is set at a value configured to stimulate the hypoglossal nerve to inhibit or prevent the tongue from blocking the airway 115.

[0054] System 200 may include a treatment device housing 235, which may store one or more components of system 200. The treatment device housing 325 can be made of a rigid material or a flexible material. The treatment device housing 235 may be adapted to store one or more components of system 200, such as stimulator 220, emitting element 205, and / or control unit 210. An exterior portion of the treatment device housing 235 may provide physical isolation of the stored components from external or environmental factors (e.g. a user’s skin, a surrounding environment, etc.). The elements contained within the treatment device housing 235 may similarly be isolated from the user of the device, since the magnetic stimulation does not require physical contact with skin. The magnetic field produced by the stimulator 220, for example, will be passed through the treatment device housing 235.

[0055] The treatment device housing 235, whether rigid or flexible, may include first surface 230 adapted to physically contact a region of a skin of a user. For instance and without limitation, the first surface 230 may be adapted to contact a neck region of a user, a chin region of a user, and / or other regions therebetween. The first surface 230 may be adapted to physically isolate the stimulator 220 and / or the emitting element 205 from physically contacting a skin of the subject. In certain embodiments, the first surface 230 is configured to adhere to the skin via one or more adhesive means, such as a glue or other adhesives. For example, the first surface 230 can include an adhesive surface or can be adapted to couple to an adhesive material. The first surface 230 can be formed to comfortably couple to a body part, such as the chin or neck, of the subject. For example, the first surface 230 can have a concave or convex shape, such as, but not limited to, circular, rectangular, ovular, conical, and / or other shapes. In certain embodiments, the first surface 230 includes curved protrusions designed to provide a smooth transition from the housing 235 to the skin of the subject. In certain embodiments, all or a portion of the treatment device housing 235 is form-fitting or formed to conform to a portion of the body of the subject wearer so as to make the contact surface portion and subject’s body surface contiguous. For example, the first surface 230 can be formed from a molded material tosmoothly couple to a chin of the subject wearer. In certain embodiments, an outer layer of the first surface 230 or an attachment to the housing 235 connected to the first surface 230 is removable to be cleaned or replaced, such as due to excessive wear or a change in subject wearer.

[0056] In other implementations, rather than being used as a treatment device, the device housing 235 is configured to be positioned remotely to and in electrical communication with the emitting element 205, while the emitting element 205 may be configured to be held, temporarily affixed, or coupled to a skin or external surface of a subject for use in treating sleep apnea or the related conditions. In certain embodiments, the emitting element 205 is configured to be held comfortably by a human hand or configured to be strapped, temporarily glued, taped, or otherwise placed on the skin of a body portion of the subject while in use. That is, the emitting element 205 is configured to externally engage the skin of the user and emit an electromagnetic field through the skin towards a region within the human body. The emitting element 205 and / or stimulator 220 may be positioned on a region of skin of a user, such as a neck or chin region of the user, underneath a chin of the user, and / or regions therebetween. An electromagnetic field emitted by the emitting element 205 may be configured to cause a contraction of one or more tissues within the human body and either open the airway 115 or relax one or more tissues (muscles) controlling the jaw. In certain embodiments, the emitting element 205 is configured to be retractably (i.e., non-surgically) inserted into the mouth of the subject. The emitting element 205, for example, may be placed against one or both of the upper jaw (maxillae) or lower jaw (mandible) of the subject. The housing 235, meanwhile, may be tethered to the emitting element 205 and / or the stimulator 220 by a cable or wire. The housing 235, further to these implementations, may house the power source 225, the control unit 210, and / or the stimulator 220, in some examples.

[0057] In certain embodiments, the power source 225 includes a receiver configured to receive external power from the control unit 210. In certain embodiments, the power source 225 includes a converter configured to convert alternating current (AC) electrical energy into direct current (DC) electrical energy. In certain embodiments, the power source 225 includes an inverter configured to change DC electrical energy into AC electrical energy. The power source 225 may be configured to provide electrical energy to the emitting element 205. In certain embodiments, the power source 225 is configured to output a first type of electrical energy to the stimulator 220 and a second type of electrical energy to a different electronic component, suchas a sensor, indicator, or display. For example, the power source 225 can provide AC electrical energy to the stimulator 220 and provide DC electrical energy to a sensor or indicator.

[0058] In certain embodiments, the control unit 210 includes processor(s) 240, memory 245, transmitter(s) 250, receiver(s) 255, and / or corresponding circuitry. The processor(s) 240 may be configured to control operations of the control unit 210 or emitting element 205 to provide a sleep apnea inhibiting treatment for the subject wearer. The processor(s) 240 may be configured to execute instructions stored in the memory 245 to control an operation of the control unit 210 and the emitting element 205. In certain embodiments, the processor(s) 240 is configured to operate the stimulator 220 in response to data received from one or more sensors. The sensors can be included in the control unit 210, in the treatment device housing 235, and / or in an external device. The processor(s) 240, in some embodiments, monitor signals from the sensors and determine when the stimulator 220 needs to be operated. For example, the processor(s) 240 can identify that the subject is snoring but determine, for example based on signals from the same or other sensors, that the subject is not experiencing an apneic event or hypoxic condition. At a different time, the processor(s) 240 may determine, for example based on the identified snoring and additional sensor signals, that the subject is likely to be experiencing a blocked or slightly blocked airway 115 and, in response, operate the stimulator 220. The processor(s) 240, further, may analyze signals from one or more sensors to determine stimulation parameters for activating the stimulator 220, such as, in some examples, one or more frequencies or frequency ranges and / or a time period for delivering therapy. Accordingly, the processor(s) 240 may be configured to monitor signals from sensors corresponding to one or more biometric parameters to identify a current state of the subject wearer. The biometric parameters, in some examples, can include blood oxygen level, pulse, pulse oximetry, heart rate, electrocardiogram, electroencephalogram, electromyography, acoustic, body position, body temperature, and / or plethysmography. The blood oxygen level, for example, may provide indication of a hypoxic condition, while pulse and / or heart rate, in some examples, may be indicative of a sleep stage and / or stress level of the subject.

[0059] In certain embodiments, the processor 240 identifies when: (i) each of a number of sensor signals exceeds a threshold value; (ii) each of a number of sensor signals is within a specified range; (iii) each of a number of sensor signals is within a specified range relative to the ranges of other signals. For example, the processor 240 can identify a volume of snoring relative to: a duration of snoring, a degree of muscle tension, a heart rate, a chest movement and / or a blood oxygen level.

[0060] In certain embodiments, the processors 240 are configured to utilize one or more artificial intelligence (Al) and / or machine learning models to recognize sleep apnea characteristics and identify one or more corresponding remedies for a wearer. The remedies, for example, may include operating the emitting element 205 according to one or more stimulation parameters such as, in some examples, one or more determined frequencies and / or durations of stimulation. The remedies, further, may include a timing such as, in some examples, one or more of the following: before, during, and / or after sleep the wearer is determined to be asleep; upon detection of sleep apnea characteristics corresponding to the build-up towards an apneic event, upon identifying sleep apnea characteristics corresponding the ongoing occurrence of an apneic event, and / or beyond identifying sleep apnea characteristics corresponding to cessation of the apneic event; and / or upon detection of sleep apnea characteristics corresponding to the build-up towards a hypoxic condition, upon identifying sleep apnea characteristics corresponding the ongoing occurrence of a hypoxic condition, and / or beyond identifying sleep apnea characteristics corresponding to cessation of the hypoxic condition. The stimulation parameters, further may include identifying a focal point of stimulation, such as by stimulating tissues proximate to the jaw or stimulating the soft palate and / or tongue of the user wirelessly to open the airway of the user, or by a combination of these. In certain embodiments, the processors 240 are configured to utilize an Al or machine learning to vary one or more of the parameters after each use. In certain embodiments, the processors 240 are configured to automatically control operation of the stimulator 220. Herein, automatically refers to a condition or operation in which the processor performs a function without human intervention. For example, the processors 240, upon identifying a specified condition, perform a corresponding, subsequent or dependent action without a human instructing the processor to perform the corresponding, subsequent or dependent action.

[0061] In some implementations, the Al or machine learning is configured to continuously or periodically learn and / or adapt based on feedback received related to the stimulation therapy. The Al and / or machine learning, for example, may be configured to anticipate, based on one or more historic sensor values and / or metrics derived therefrom, when a subject is about to experience a symptom such as an obstructed airway. In another example, the Al and / or machine learning may be configured to learn, based on one or more sensor values gathered during a period of active stimulation therapy, how the subject responds to different stimulation parameters, such as frequencies or power intensity levels of the tissue / never stimulator. In a further example, the Al and / or machine learning may be configured to derive one or moretypical time periods (e.g., times of the night) and / or time durations (e.g., elapsed time after falling asleep, elapsed time after entering a particular sleep stage, etc.) in which the subject typically experiences symptoms, such as those of sleep apnea. In another example, the Al and / or machine learning may be configured to fine-tune one or more stimulation parameters (e.g., a duration of treatment and / or duty cycle of treatment, etc.) that have been demonstrated to cease recurrence of one or more symptoms for a significant period of time (e.g., prolong an open airway of the subject, etc.).

[0062] In the example shown in FIG. 2B, system 200 includes a control unit 210 configured as a bed-side box and the emitting element 205 configured with a strap to secure the emitting element 205 (e.g., active element) to a head of the wearer. The control unit 210, as a bed-side box, may be placed in proximity to the patient (i.e., wearer), such as near the bed or on a nightstand, where the control unit 210 can be connected via a cable 260 to the emitting element 205 that delivers pulsed electromagnetic fields (PEMF) to the patient. The emitting element 205 may be placed underneath the chin in the submental region. The straps 265 may be configured to hold the emitting element 205 in place during sleep.

[0063] FIG. 3A illustrates a sleep apnea treatment device 300 according to embodiments of the present disclosure. The device 300 can be the same as, or similar to, the device 200 as described above with reference to FIG. 2A. The device 300 may include a flexible or rigid housing 305. The housing 305 may be the same as or similar to the housing 235 as described above with reference to FIG. 2 A, without limitation. In certain embodiments, the housing 305 is formed from a flexible material and configured to be removably engage a skin of a subject. For example, the housing 305 can include one or more of: an elastic strap, belt, bandage, a patch, or adhesive material. For example, the housing 305 can be in the form of a patch configured to flexibly adhere to the skin of a wearer such that key elements in the device 300. In certain embodiments, the housing 305 includes a flexible structure, such as a patch or fabric, configured to conform to a body portion of the subject. For example, the device 300 may be configured as a flexible adhesive patch configured to attach to the subject. In certain embodiments, an adhesive surface of the device 300 is a smooth or rough surface configured to receive a liquid or gelatinous adhesive, which can be removed or dissolved by a water or other non-toxic dissolving agent. In certain embodiments, an adhesive surface of the device 300 includes an adhesive patch including a contact surface configured to removably couple to the housing 305 and a second surface including an adhesive configured to stick to or otherwise couple to a skin of a wearer. In certain embodiments, an adhesive patch of the device 300 and the housing 305 include acoupling means such as one or more of: tape, a bandage, buttons, fasteners, clips, or a hook and loop connection (such as VELCRO). In certain embodiments, the housing 305 is composed of a rigid or hardened material. The housing 305 may include a contact surface portion that is adapted to engage a skin of the subject wearer. For example, a contact surface portion of the housing 305 is configured to adhere to the skin via one or more adhesive means, such as a glue. For example, the contact surface portion can include the adhesive surface or can be adapted to couple to an adhesive material. The contact surface portion can be formed to comfortably couple to a body part, such as the chin or neck, of the subject. For example, the contact surface portion can have a concave or convex shape. In certain embodiments, the contact surface portion includes curved protrusions designed to provide a smooth transition from the housing 305 to the skin of the subject. In certain embodiments, all or a portion of the housing 305 is form-fitting or formed to conform to a portion of the body of the subject wearer so as to make the contact surface portion and subject’s body surface contiguous. For example, the contact surface portion can be formed from a molded material to smoothly couple to a chin of the subject wearer. In certain embodiments, the contact surface portion is removable to be cleaned or replaced, such as due to excessive wear or a change in subject wearer.

[0064] The device 300 may include an electromagnetic stimulator 310. The electromagnetic stimulator 310 may be disposed proximate to the contact surface portion and positioned within or at least partially within an interior of the housing 305. The electromagnetic stimulator 310 may be configured to emit one or more electromagnetic signals. For example, the electromagnetic stimulator 310 can be a transducer or transmitter that transmits one or more electromagnetic signals at one or more frequencies. The signals emitted by the electromagnetic stimulator 310 may be preset or variable in response to a user input or controller. The signals can be in the range of up to 8 MHz. The signals may be configured to perform a functional electrical stimulation (FES) and cause a contraction of one or more tissues or stimulation of one or more nerves of the subject. In certain embodiments, the signals can be set to a frequency value configured to stimulate the hypoglossal nerve to prevent the tongue of a subject from blocking the airway 115. The electromagnetic stimulator 310 may include one or more conductive materials, such as, but not limited to, copper, silver, or aluminum. The electromagnetic stimulator 310 may include one or more electrodes, transmissive coils, and / or power cells. A transmissive coil of the electromagnetic stimulator 310 may include a conductive wire wrapped in one or more loops. The electromagnetic stimulator device 310 can be shaped in a form of a circle, disk, or other shape.

[0065] The electromagnetic stimulator 310 may transmit one or more magnetic signals, electrical signals, electromagnetic signals, or waves. The electromagnetic stimulator 310 may be disposed within housing 305 and physically isolated from contacting a skin of the subject by the housing 305. That is, the housing 305 may be disposed between the electromagnetic stimulator 310 and the skin of the subject such that the housing 305 prevents the electromagnetic stimulator 310 from physically contacting the skin of the subject when in used. In some embodiments, the electromagnetic stimulator 310 is configured to stimulate one or more nerves or tissues of the subject without physically contacting the subject through induction of electric fields and / or currents via a changing magnetic field. The electromagnetic stimulator 310 may be configured to emit one or more electromagnetic signals to wirelessly stimulate a proximate tissue or nerve of the subject. The proximate tissue can include a soft palate or tongue of a subject’s mouth. The proximate nerve can include the hypoglossal nerve of the subject. It is noted that other tissues or nerves can be stimulated, such as by a different placement of device 300 underneath the chin in the neck area, without departing from the scope of the present disclosure.

[0066] In certain embodiments, the electromagnetic stimulator 310 produces a varying magnetic field, which may induce a local electric field or current in a proximate tissue and / or nerve. A magnetic field can be generated by the electromagnetic stimulator 310 through an AC energy or DC energy source, hi certain embodiments, the electromagnetic stimulator 310 can wirelessly contract one or more tissues or stimulate one or more nerves through time-varying magnetic fields. For example, the electromagnetic stimulator 10 can produce a magnetic field, which may have a frequency, such as within a range up to 8 MHz. In certain embodiments, the magnetic field produced by the electromagnetic stimulator 310 has a frequency of about 30 KHz. In certain embodiments, the magnetic field produced by electromagnetic stimulator 310 has a frequency greater than about 30 KHz. The electromagnetic stimulator 310 may contract one or more tissues, such as one or more tissues within a mouth of a subject, or stimulate one or more nerves coupled to respective tissues in the mouth of subject, which can inhibit an obstruction of the airway 115 or enable an opening of the airway 115.

[0067] In certain embodiments, the device 300 includes a processor 315 communicatively coupled to the electromagnetic stimulator 10. The processor 315 may include one or more of processing circuitry, a central processing unit (CPU), an application processor (AP), or a communication processor (CP). Example types of processing circuitry include microprocessors, microcontrollers, digital signal processors, field programmable gate arrays, application specific integrated circuits, and discrete circuitry.

[0068] The processor 315 may be configured to control operation of the electromagnetic stimulator 310. For example, the processor 315 can execute programmed instructions or instructions stored in a memory 320 (if so equipped). In certain embodiments, the device 300 includes a receiver or transceiver configured to communicate with an external processor via a wired or wireless communication. For example, in certain embodiments, the processor 315 is disposed within a control unit and configured to remotely operate the electromagnetic stimulator 310. The processor 315 is configured to control one or more parameters of the electromagnetic stimulator 310, such as one or more of: a frequency, a field, a power and a strength, an amplitude, a pulse duration or frequency, a duty cycle (i.e., period(s) of operation of the electromagnetic stimulator 310), or any other variable of the electromagnetic stimulator 310. In certain embodiments, the processor 315 is configured to receive a signal from one or more sensors 325 that are positioned and configured to detect and analyze the subject’s sleep patterns and biometric signals to identify a potential and / or actual apneic event, directly or indirectly by proxy through software that has interpreted or made decisions based on such signal to be transmitted to the processor 315 and ultimately to instruct the electromagnetic stimulator 310 to emit a signal at a specified or determined frequency, field, power, strength, amplitude, pulse parameters such as frequency, duration, or other variable, with the ultimate effect of opening the airway 115 through wireless energy delivered to one or more of: the hard palate, the soft palate, a tongue of the user, other muscles or tissues, or nerves of the subject.

[0069] In certain embodiments, the sensor(s) 325 is a sound sensor, such as a microphone, configured to provide audio signals to the processor 315. In certain embodiments, the sound sensor may be part of a smartphone, tablet, and / or other device that may be in communication with the processor 315. In certain embodiments, the sound sensor is one of a number of additional sensors coupled to the processor 315. The additional sensors can be included in the device 300, the smartphone, in different external electronic devices, or a combination thereof such that each of multiple different devices provides different sensor signals to the processor 315.

[0070] The processor 315, in some embodiments, is configured to identify and determine a snoring episode of an individual based on the audio signal received from the sensor 325, such as sound levels, sound duration, and / or sound frequency. The processor 315 can correlate the snoring episode with signals from additional biometric sensors. The processor 315 can determine one or more remedies to treat a potential sleep apnea being experienced by the subject based on audio or other signals from the sensor 325. That is, the processor 315 can monitorsignals from the sensors 325 and determine when the electromagnetic stimulator 310 needs to be operated. For example, the processor 315 can identify that the subject is snoring but determine, based on signals from other sensors, that the subject is not experiencing an apneic event or hypoxic condition. At a different time, the processor 315 can determine, based on the identified snoring and additional sensor values, that the subject is experiencing a blocked or slightly blocked airway 115 and, in response, operate the electromagnetic stimulator 310 at the specified stimulation parameter(s). The processor 315 may be configured to monitor signals from sensors corresponding to a biometric parameters to identify a current state of the subject wearer. In certain embodiments, the processor 315 identifies when: (i) each of a number of sensor signals exceeds a threshold value; (ii) each of a number of sensor signals is within a specified range; (iii) each of a number of sensor signals is within a specified range relative to the ranges of other signals. For example, the processor 315 can identify a volume of snoring relative to one or more of a duration of snoring, a degree of muscle tension as measured through electromyography, a heart rate, a chest movement as measured through plethysmography and / or gyroscope / accelerometer, or a blood oxygen level. In certain embodiments, the processor 315 is configured to utilize one or more Al and / or machine learning models to identify sleep apnea parameters and remedies for a wearer. The remedies may include operating the emitting element at one or more determined frequencies before, during, and / or after sleep, before during and / or after an apneic event, such as by stimulating tissues proximate to the jaw or stimulating the soft palate and / or tongue of the user wirelessly to open the airway of the user, or by a combination of these. In certain embodiments, the processor 315 is configured to utilize the Al or machine learning to vary one or more of the parameters after each use. In certain embodiments, the processor 315 is configured to automatically control operation of the electromagnetic stimulator 310. Herein, automatically refers to a condition or operation in which the processor performs a function without human intervention. For example, the processor 315, upon identifying a specified condition, performs a corresponding, subsequent or dependent action without a human instructing the processor to perform the corresponding, subsequent or dependent action. The actions performed could be completed within a closed-loop system on the device.

[0071] The device 300 may include a power source 330 electrically coupled to the electromagnetic stimulator 310 and the processor 315. In some embodiments, the power source 330 is internal to device 300. The power source 330 may be external to device 300. For instance and without limitation, the power source 330 may be a battery strapped to a user’s arm, chest, or other body part. The power source 330 may be configured to provide AC or DC power to theelectromagnetic stimulator 310 and the processor 315. In certain embodiments, the power source 330 includes an independent power source, such as a battery, solar cell, or the like. In certain embodiments, the power source 330 includes a wired or wireless coupling configured to electronically couple the electromagnetic stimulator 310 and the processor 315 to an external power supply. In certain embodiments, the power source 330 includes an inverter configured to change DC electrical energy into AC electrical energy. The power source 330 is configured to provide electrical energy to the electromagnetic stimulator 310. In certain embodiments, the power source 330 is configured to output a first type of electrical energy to the electromagnetic stimulator 310 and a second type of electrical energy to a different electronic component, such as a processor 315. For example, the power source 330 can provide AC electrical energy to the electromagnetic stimulator 310 and provide DC electrical energy to the processor 315.

[0072] In certain embodiments, the device 300 includes an input interface configured to receive a user input. The input interface can be one or more of a toggle switch, one or more buttons, a keypad, a display, touchscreen display, or a combination thereof. The input interface can receive one or more inputs from a user to set functional parameters such as, in some examples, the frequency, hours of operation, and / or user profile settings.

[0073] FIGS. 3B through 3D illustrate example form factors of the device 300 according to embodiments of the present disclosure.. The device 300 may include two or more housing elements, such as first housing element 305A and / or second housing element 305B. The first and second housing elements 305a, 305b may be separately designed or interconnected. For example, the device 300 can include a small butterfly coil design with each butterfly “wing” disposed in a separate housing section 305a, 305b, for example as shown in FIG. 3B. The transmissive butterfly coil design, for example, may include a “figure 8” style of wrapping of a single coil of the emitting element. The benefits of a butterfly coil reside in the shape of the time varying magnetic field. The butterfly coil can produce a more localized field of flux and increased strength at a distance. The benefit of a circular coil is ease in manufacturing / simulation and more distributed time varying magnetic field. In another example, each housing element 305a, 305b may be isolated and housing a separate circular coil transmission element. The transmission elements may be controlled by a single control unit (e.g., residing in one of the housing elements 305a, 305b or separately, such as in a bedside box unit. The device 300 may be positioned underneath a chin of a user and / or on a neck region 350 of a user. In certain embodiments, the device 300 can be attached to a wearer via an adhesive means. Device 300 is described in greater detail below with reference to FIG. 3C.

[0074] FIG. 3C illustrates a perspective view of the device 300. The device 300 may have a first housing element 305A and / or a second housing element 305B. The first housing element 305A may include an interior volume that may house one or more components of device 300. The interior volume of the first hosing element 305A may be made from an exterior surface of the first housing element 305A, such as the first curved surface 344A, joined together with one or more interior surfaces of the first housing element 305A. For instance and without limitation, the first curved surface 344A may form a circle or ovular shape, which may create an interior volume. The first curved surface 344A may have a thickness of about 1 cm. The first curved surface 344A may have an exterior surface and an interior surface opposite the exterior surface. An exterior surface and interior surface of the first curved surface 344A may provide an interior volume of the first housing element 305A. The first curved surface 344A may encompass first housing element 305A, which may give first housing element 305A a substantially circular form. The first curved surface 344A may wrap around an entirety of the first housing element 305 A. In some embodiments, the first curved surface 344A wraps around at least a portion of the first housing element 305 A. The dimensions of the device 300 as illustrated in FIG. 3C, for example, may include an approximate length of around 95mm, an approximate height of around 18mm, and / or an approximate width of around 40mm. The curvature of the curved surfaces 344a, 344b may be approximately 10 degrees. The first curved surface 344a may have a curvilinear surface length of approximately 85mm on the contact and bottom surface. The curvilinear width may be similar to or the same as the width (e.g., approximately 40mm) The thickness of the device 300 may be approximately 18mm in a curved fashion.

[0075] The first housing element 3O5A may include first contact surface 348A. The first contact surface 348 A may be adapted to contact a user’s chin and / or neck region, such as neck region 350 depicted above with reference to FIG. 3B. The first contact surface 348a may have an approximate diameter of about 40mm. In some embodiments, the first contact surface 348A is made of a material differing from that of the first curved surface 344A. For instance, the first curved surface 348A may be made of a plastic, silicon, or rubber material while the first contact surface 348A may be made of a foam or other cushioned material. In some embodiments, an additional layer may be disposed on top of the first contact surface 348 A, such as, but not limited to, padding, cushioning, and / or adhesives. In some embodiments, the first contact surface 348A has an incline and / or gradient with respect to the top of the first curved surface 344A. An incline and / or gradient of the first contact surface 348A may include an increasing height of the first contact surface 348A extending out radially from a center point of the firstcontact surface 348A. As a non-limiting example, the first contact surface 348A may have a short conical shape that may be adapted to fit at least a portion of a user’ s chin. In some embodiments, the first contact surface 348A is substantially flat.

[0076] The first housing element 3O5A may include a first bottom surface 352A. The first bottom surface 352A may be positioned opposite the first contact surface 348A. The first bottom surface 352A may have a same radius as the first contact surface 348A. In other embodiments, the first bottom surface 352A has a radius greater or smaller than that of the first contact surface 348A. The first bottom surface 352A may have a thickness, such as, but not limited to, about 1 cm, less than 1 cm, or greater than 1 cm. In some embodiments, the first bottom surface 352A has a thickness differing from that of the first contact surface 348A. The first bottom surface 352A may have a similar or same thickness as that of the first contact surface 348A. The first bottom surface 352A may be circularly or ovulary shaped. The first bottom surface 352A may be shaped similar to that or the same of a shape of the first contact surface 348A. As a nonlimiting example, both the first contact surface 348A and the first bottom surface 352A may be circular. In some embodiments, a height of the first curved surface 344A separates the first contact surface 348A from the first bottom surface 352A. The first curved surface 344A may have a height of about 5 cm, less than 5cm, or greater than 5 cm, without limitation.

[0077] The first contact surface 348A and the first bottom surface 352A may be joined by the first curved surface 344A. The first contact surface 348A may be joined perpendicularly to a height of the first curved surface 344A. Likewise, the first bottom surface 352A may be joined perpendicularly to a bottom height of the first curved surface 344A. In some embodiments, the first contact surface 348A has an angle with respect to an edge of a height of the first curved surface 344A. For example, and without limitation, the first contact surface 348A has an angle of about 15 degrees with respect to an edge of the first curved surface 344A. In embodiments where there may be an angle between the first contact surface 348A and the first curved surface 344A, the first contact surface 348A may have a concave or convex shape such that the first contact surface is able to join all edges of the first curved surface 344A. An angle between the first curved surface 344A and the first contact surface 348A may be about 15 degrees, 30 degrees, 45 degrees, and / or other measurements. In some embodiments, there is an angle between the first bottom surface 352A and the first curved surface 344 A. An angle between the first bottom surface 352A and the first curved surface 344A may be about 15 degrees, 30 degrees, 45 degrees, or other measurements. In embodiments where there is an angle between the first curved surface 344A and the first bottom surface 352A, the first bottom surface 352Amay have a concave or convex shape such that the first bottom surface 352A is able to join every edge of the first curved surface 344 A. For instance, the first bottom surface 352 A may have a spherical or semi- spherical shape, extending beyond a height of a bottom of the first curved surface 344A, which may provide for a larger interior volume of the first housing element 3O5A that may be used to store one or more components of device 300.

[0078] The first curved surface 344A may be physically coupled to both the first contact surface 348A and the first bottom surface 352A. The first curved surface 344A, the first contact surface 348A, and / or the first bottom surface 352A may join to form the first housing element 305 A. One or more components may be stored within an interior volume that may be formed by a joining of the first curved surface 344A, the first contact surface 348 A, and / or the first bottom surface 352A. In some embodiments, the electromagnetic simulator 310 may be stored within an interior volume of the first hosing element 305A just below an interior side of the first contact surface 348A, which may allow for a stronger electromagnetic signal to reach a neck and / or chin region of a user. Likewise, the power source 330 may be positioned in an interior volume of the first housing element 305A near the first bottom surface 352A.

[0079] The first housing element 3O5A may include first connector 335 A. The first connector 335A may be located at a side of the first housing element 305A. The first connector 335A may be located near a top height of the first curved surface 344A, such as adjacent to the first contact surface 348A. For instance and without limitation, the first connector 335A may be positioned vertically about 5 cm away from the first bottom surface 352A. The first connector 335A may be made of plastic or other materials. The first connector 335A may be circular, rectangular, or another shape. The first connector 335A may provide a space between a surface of the first connector 335A and a portion of the first curved surface 344A. A space between the first connector 334A and a portion of the first curved surface 344A may allow for a securing device, such as a strap, rope, or other device, to wrap around the first connector 334A.The first connector 334a may be approximately 10mm in width, 7mm in height, and 24mm in length. In some embodiments, the first connector 335A is adapted to fasten a strap, such as, but not limited to, a VELCRO strap, to the first housing element 305 A.

[0080] Referring still to FIG. 3C, the device 300 may have second housing element 3O5B. Second housing element 305B may include second curved surface 344B, second contact surface 348B, second bottom surface 352B, and / or second connector 335B, each of which may be the same as described above with reference to first curved surface 344A, first contact surface 348A, and / or first bottom surface 352A. The second housing element 305B may have the samedimensions of each of it’s components as that of the first housing element 305 A. In some embodiments, the second housing element 305B may have differing dimensions than that of the first housing element 305 A. For instance, the second curved surface 344B may have a larger circumference or a smaller circumference than that of the first curved surface 344A, a thickness of the second contact surface 348B may be greater or less than that of a thickness of the first contact surface 348 A, a height of the second curved surface 344B may be greater or less than a height of the first curved surface 344 A, and / or a radius of the second bottom surface 352B may be greater or less than that of a radius of the first bottom surface 352A. The second housing element 3O5B may be made from a same material as that of the first housing element 305A or may be made of a different material than that of the first housing element 305A. As a nonlimiting example, the second housing element 305B may be made from rubber while the first housing element 305A may be made from plastic, or vice versa.

[0081] In some embodiments, the first housing element 305A and the second housing element 3O5B may be joined together by a contacting segment between the first curved surface 344A and the second curved surface 344B. A contacting segment between the first curved surface 344A and the second curved surface 344B may include a joined portion of the first curved surface 344A and the second curved surface 344B. For instance, the first curved surface 344A may be physically coupled to at least a portion of the second curved surface 344B, such as at a certain circumference of the first curved surface 344A and / or the second curved surface 344B. The first housing element 305 A and the second housing element 305B may be joined together at an angle, such as, but not limited to, about 10 degrees, about 15 degrees, about 20 degrees, and / or other measurements. An angle between the first housing element 305A and the second housing element 305B may allow the first contact surface 348A and / or the second contact surface 348B to better conform to a user’s neck, chin, or other region of their body. In some embodiments, an angle between the first housing element 305A and the second housing element 3O5B may be adjustable, such as through a pivot device. In embodiments where an angle between the first housing element 305A and the second housing element 305B is adjustable, a user may be able to select an angle that conforms best to their anatomy.

[0082] In some embodiments, second housing element 305B stores additional components of device 300. For instance, second housing element 3O5B may store a second electromagnetic stimulator 310, a second processor 315, and / or a second power source 330. For instance, first housing element 305A may be adapted to provide a first electromagnetic signal towards a region of a user through a first electromagnetic stimulator 310 and the second housing element 305Bmay be adapted to provide a second electromagnetic signal towards a region of a user through a second electromagnetic stimulator 310. First and second electromagnetic signals may overlap or alternate between emissions. In some embodiments, an overlapping of two or more electromagnetic signals may allow for increased stimulation of a specific target anatomy of a user.

[0083] In certain embodiments, the device 300 includes a circular coil design 340 and housing as shown in FIG. 3D. Device 300 may include first curved surface 344A, first contact surface 348A, and / or first bottom surface 352A as described above with reference to FIG. 3C. In certain embodiments, the circular device 300 can be attached to a wearer via an adhesive means. In certain embodiments, the housing 305 of the circular device 300 includes connector 335, such as described above with reference to FIG. 3C. The embodiments of the device 300 shown in FIGS. 3B through 3D are for illustration only. Other embodiments could be used without departing from the scope of the present disclosure.

[0084] The device 300 may be a non-contact technology using pulsed electromagnetic tissue stimulation. In certain embodiments, the electromagnetic stimulator 310 includes a coil and does not require a conductive fluid. The electromagnetic stimulator 310 can operate below 50 microseconds or above 1000 microseconds. Additionally, the electromagnetic stimulator 310 can operate below 15Hz or about 50Hz in frequency.

[0085] Although FIGS. 3A through FIGS. 3D illustrates one example of device 300, various changes may be made to FIG. 3A-3D. For example, the device 300 could include one or more of each component in varying arrangements. In addition, in embodiments in which the housing 305 is formed from a flexible material, one or more of the aforementioned elements (namely, the electromagnetic stimulator 310, processor 315, memory 320, sensor 325, or power source 330, or combination thereof) are stored within the flexible housing 310. In general, computing and signal systems come in a wide variety of configurations, and FIGs. 3A-3D do not limit the scope of this disclosure to any particular configuration. Also, while FIGs. 3A-3D illustrates operational environments in which various features disclosed therein can be used, these features could be used in other systems or operational environments. In various embodiments, the device shown in FIG. 3D includes a single stimulator (e.g., a single electromagnetic stimulator) within the housing 305. The single stimulator may be embodied as a circular coil design (e.g., a circular coil positioned between first contact surface 348A and first bottom surface 352A such that a magnetic signal can be provided through the skin of the user to the target tissue). For example,the circular coil can be positioned such that the longitudinal portion of the coil extends from the first contact surface 348 A to the first bottom surface 352 A.

[0086] In some embodiments, the device shown in FIG. 3D includes a two or more stimulators (e.g., two or more electromagnetic stimulators) within the housing 305. In various embodiments, the device includes two, three, four, five, six, seven, eight, nine, or ten stimulator within the housing 305. For example, the housing 305 may contain two or more stimulators such that the two or more stimulators produce overlapping magnetic fields that increase a focality of the produced magnetic fields. Thus, an overlap of the magnetic fields may increase the overall magnetic field strength at a specified location of a user. In particular embodiments, a first electromagnetic stimulator of the housing 305 and a second electromagnetic stimulator of the housing 305 work together. In various embodiments, a first and second electromagnetic simulator 310 of the first and second housing elements 305 A and 305B, may act independently.

[0087] FIG. 4 illustrates a sleep apnea treatment control unit according to embodiments of the present disclosure. The embodiment of the control unit 400 shown in FIG. 4 is for illustration only. Other embodiments could be used without departing from the scope of the present disclosure. The control unit 400 can be the same as, or similar to, control unit 210 as described above with reference to FIG. 2A.

[0088] The control unit 400 includes a housing, a processor 410, a memory 415, and a transceiver 420. The transceiver 420 includes a transmitter function and receiver function. In certain embodiments, the control unit 400 does not include a transceiver 420 and, instead, includes a transmitter, a receiver, or both. In certain embodiments, the transceiver 420 is coupled to one or more antenna 425. In certain embodiments, the transceiver 420 is coupled to one or more input / output (I / O) ports. In certain embodiments, the control unit 400 includes one or more sensors 430. In certain embodiments, the control unit 400 includes an input interface configured to receive a user input. The input interface can be one or more of a dial, a toggle switch, one or more buttons, a keypad, a display, touchscreen display, or a combination thereof. In certain embodiments, the control unit 400 is a smartphone, a tablet, smart-watch, health-monitoring device, other computing device, or included in one of a smartphone, a tablet, smart-watch, health-monitoring device, other computing device. In certain embodiments, the control unit 400 and device 300 combine to form a sleep apnea treatment system.

[0089] In certain embodiments, the control unit 400 is configured to couple to device 300 via a wired or wireless communication medium. For example, the control unit 400 is configured to control operation of the device 300, such as by controlling an operation of the electromagneticstimulator 310. For example, the processor 410 can execute programmed instructions or instructions stored in a memory 415. The processor 410 is configured to control one or more of: frequency, field, power, and strength, amplitude, pulse duration or frequency, or any other variable of the electromagnetic stimulator 310. In certain embodiments, the processor 410 is configured to receive a signal from one or more sensors 430 that are positioned and configured to detect and analyze the subject’s sleep patterns and identify a potential or actual apneic event, or hypoxic condition, directly or indirectly by proxy through software that has interpreted or made decisions based on such signal to be transmitted to the processor 410 and ultimately to instruct the electromagnetic stimulator 310 to emit a signal at a specified or determined frequency, field, power, strength, amplitude, pulse parameters such as frequency, duration, or other variable, with the ultimate effect of opening the airway 115 through wireless energy delivered to one or more of: the hard palate, the soft palate, a tongue of the user, other muscles or tissues, or nerves of the subject.

[0090] In certain embodiments, the sensor 430 is a sound sensor, such as a microphone, configured to provide an audio signal to the processor 410. The processor 410 is configured to identify and determine a snoring episode of an individual based on the audio signal received from the sensor 430, such as, in some examples, sound levels, sound duration, and / or sound frequency. In certain embodiments, the processor 410 can correlate the snoring episode with readings from additional biometric sensors. The additional biometric sensors can be included in either the control unit 400, an external electronic device, a number of external electronic devices, or a combination thereof. The processor 410 can determine one or more remedies to treat a potential sleep apnea being experienced by the subject based on audio or other signals from the sensor 430 and the additional biometric sensors. That is, the processor 410 can monitor signals from sensors and determine when the electromagnetic stimulator 310 needs to be operated. For example, the processor 410 can identify that the subject is snoring based on the sensor 430, but determine, based on signals from the additional biometric sensors, that the subject is not experiencing an apneic event or hypoxic condition. At a different time, the processor 410 can determine, based on the identified snoring and additional sensor values, that the subject is experiencing a blocked or slightly blocked airway 115 and, in response, operate the electromagnetic stimulator 310 at the specified frequency. Accordingly, the processor 410 is configured to monitor signals from sensors corresponding to biometric parameters to identify a current state of the subject wearer. In certain embodiments, the processor 410 identifies when: (i) each of a number of sensor signals exceeds a threshold value; (ii) each of a number of sensorsignals is within a specified range; (iii) each of a number of sensor signals is within a specified range relative to the ranges of other signals. For example, the processor 410 can identify a volume of snoring relative to one or more of: a duration of snoring, a degree of muscle tension, a heart rate, a chest movement; or a blood oxygen level. In certain embodiments, the processor 410 is configured to utilize an Al to and / or machine learning model to identify sleep apnea parameters and remedies for a wearer that include operating the emitting element at one or more determined frequencies before, during, and / or after sleep, before during and / or after an apneic event, such as by stimulating tissues proximate to the jaw or stimulating the soft palate and / or tongue of the user wirelessly to open the airway of the user, or by a combination of these. In certain embodiments, the processor 410 is configured to utilize the Al or machine learning to vary one or more of the parameters after each use. The processor 410 can determine one or more remedies to treat a potential sleep apnea being experienced by the subject based on audio or other signals from one or more of: the sensor 430, the additional biometric sensors, or a combination thereof.

[0091] The control unit includes a power source 435 electrically coupled to the processor 410 and transceiver 420. The power source 435 is configured to provide AC or DC power to the processor 410 and transceiver 420. In certain embodiments, the power source 435 includes an independent power source, such as a battery, solar cell, or the like. In certain embodiments, the power source 435 includes a wired or wireless coupling configured to receive power from an external power supply, such as via an electrical plug removable coupled to an electrical outlet. In certain embodiments, the power source 435 includes a converter configured to convert AC electrical energy into DC electrical energy. In certain embodiments, the power source 435 includes an inverter configured to change DC electrical energy into AC electrical energy. In certain embodiments, the power source 435 is configured to output a first type of electrical energy to the transceiver 420 and a second type of electrical energy to a different electronic component, such as a sensor, indicator, or display. For example, the power source 435 can provide AC electrical energy to the transceiver 420 and provide DC electrical energy to the processor 410.

[0092] Although FIG. 4 illustrates one example of a control unit 400, various changes may be made to FIG. 4. For example, the control unit 400 could include different numbers of certain components, and or a different arrangement of the components. In general, computing and signal systems come in a wide variety of configurations, and FIG. 4 does not limit the scope of this disclosure to any particular configuration. Also, while FIG. 4 illustrates one operationalenvironment in which various features disclosed therein can be used, these features could be used in other systems and / or environments.

[0093] Referring now to FIG. 5A, a left side external view showing an exemplary embodiment of an exterior of a top and second portion of an apparatus 500 for treating sleep apnea is presented. Apparatus 500a may include first portion 505a and / or second portion 505b of housing 505. First portion 505 a may be made of a flexible material, such as rubber or a polymer, without limitation. First portion 505a may alternatively be made of a rigid structure, such as plastic. First portion 505a may be hollow, allowing entry of a user’s teeth into a mold of first portion 505a. In some embodiments, first portion 505a includes indentations, wherein each indentation is being sized and shaped for a specific tooth of an upper row of teeth of a user. In other embodiments, first portion 505a includes a uniform space throughout a shape of first portion 505a, which allows more varieties of user teeth to be positioned in first portion 505a. First portion 505a may be 3-D printed or milled to match a user’s upper jaw. In some embodiments, first portion 505a is sized and / or shaped to fit within a user’s mouth. First portion 505a may be shaped as a top tooth tray. First portion 505a may be shaped to conform to an upper part of a user’s mouth, such as a top row of teeth. First portion 505a may be shaped as a tooth tray, part of a mouth retainer, and / or other oral appliances. First portion 505 a may be configured to contact one or more teeth of the top (or upper) teeth of the user. First portion 505a may be configured to contact one or more teeth of the bottom (or lower) teeth of the user. First portion 505a may include outer surface 520a, which may include an interior portion, and an exterior portion, an inner surface, and an interior. An inner surface of first portion 505a may be configured to be opposite the outer surface 520a with an interior therebetween. The interior of first portion 505a may contain and / or house (in whole or in part) electronics, circuitry, one or more magnets, one or more electromagnets, one or more antenna, one or more motors, one or more rotatable shafts, or any other element of the top portion or bottom portion mentioned herein, and any combinations of these. An inner surface of first portion 505a may be proximate to and / or contact one or more teeth of the maxilla of a user when in use. An inner surface of first portion 505a may be proximate to and / or contact one or more teeth of the mandible of a user when in use. The outer surface 520a of first portion 505a may be configured to contact the cheek, lips and / or interior of the mouth (behind the teeth and / or adjacent the tongue) when in use. The outer surface 520a of a first portion 505a may have an interior outer surface that is configured to contact the interior of the mouth (behind the teeth and / or adjacent the tongue) when in use — i.e. the interior outer surface is proximate to an interior of a mouth of a user. Theouter surface 520a of first portion 505a may have an exterior outer surface proximate to a check and / or lips of a user when in use. In embodiments where first portion 505a is configured for the upper teeth, the inner surface would include a portion that contacts at least one upper tooth. In embodiments where first portion 505 a is configured for the bottom (lower) teeth, the inner surface would include a portion that contacts at least one lower tooth.

[0094] Still referring to FIG. 5A, apparatus 500 may include second portion 505b. Second portion 505b may be shaped as a tooth tray, mouth retainer, and / or other oral appliance, and is configured to be on the opposite jaw (or teeth thereof) relative to the first portion. Second portion 505b may include outer surface 520b, an inner surface, an interior, and any one or more of the features, functions, and advantages as described previously with relation to first portion 505a. An inner surface second portion 505b may be proximate to one or more teeth of a user when in use. The outer surface 520b of second portion 505b may be configured to have an interior outer surface proximate to a tongue of a user and an exterior outer surface proximate to a check and / or lips of a user when in use. Second portion 505b may be shaped to contact or be proximate to the opposite jaw (or tooth or teeth thereof) as that of the first portion, such as to one or more bottom teeth of the user when the first portion is configured to contact or be proximate to one or more upper teeth of the user. Second portion 505b may include a mold of a bottom row of a user’s teeth. Second portion 505b may be made of a flexible, or elastic material, such as rubber or a polymer, without limitation. In an embodiment, second portion 505b is made of a rigid structure such as plastic. Second portion 505b may include indentations, wherein each indentation being sized specific to a tooth of a user’s bottom teeth. In other embodiments, second portion 505b includes a uniform space throughout a shape of second portion 505b which allows second portion 505b to fit within a variety of user’s mouths. Second portion 505b may be shaped as a bottom tooth tray. Second portion 505b may have outer surface 520b, an inner surface, and / or an interior. An inner surface of second portion 505b may be proximate to one or more teeth of a user when in use. For instance, second portion 505b may rest on a row of lower teeth of a user, positioning the lower teeth between an interior of second portion 505b and an inner surface of second portion 505b. Second portion 505b may have an exterior outer surface proximate to a check and / or lower lips of a user when in use. For instance, an exterior outer surface may be positioned between a cheek of a user and one or more teeth of a user when second portion 505b is placed on a bottom jaw of the user. Second portion 505b may be separate from that of first portion 505a. In an embodiment, second portion 505b is connected to firstportion 505a, such as through one or more snap elements, locks, and / or fastening elements, as previously described, herein.

[0095] Apparatus 500 may include protrusions 550a, 550b which may extend from the exterior outer surface 520b of the outer surface of second portion 505b and / or the outer surface 520a of first portion 505a in a direction away from an inner surface (which is toward a cheek of a user in use). Protrusions 550a, 550b may include an elastic or inelastic material such as, but not limited to, rubber, silicon, or plastic. Protrusions 550a, 550b may extend downwards, upwards, or in however direction appropriate from second portion 505b and / or first portion 505a. First portion 505a may include protrusion 550a. Protrusions 550a may extend from an outer exterior surface of the exterior surface 520a of first portion 505a. In some embodiments, first portion 505a includes a first set of protrusions 550a and second portion 505b includes a second set of protrusions 550b. A first set of protrusions 550a of first portion 505a may extend downwards relative from a highest exterior surface 520a of first portion 505a. A first set of protrusions 550a of first portion 505a may be angled downwards relative from a highest exterior surface 520a of first portion 505a, such as at an angle of about 15 degrees, without limitation. A first set of protrusions 550a may be positioned behind or in front of a second set of protrusions 550b of second portion 505b. A second set of protrusions 550b of second portion 505b may extend upwards relative from a lowest surface of the exterior surface 520b of second portion 505b. In some embodiments, a second set of protrusions 550b extend upwards relative to a lowest surface of exterior surface 520b of second portion 505b at an angle, such as at an angle of about 15 degrees, without limitation. A first set of protrusions 550a, and a second set of protrusions 550b may be touching in an initial state. In some embodiments, a first set of protrusions 550a and a second set of protrusions 550b, are spaced apart, such as, but not limited to, by about 3 cm. In some embodiments, protrusions 550a, b include a magnet.

[0096] While still referring to FIG. 5 A, first portion 505 a may include a slot. A slot may include a hole in a portion of first portion 505a. A slot may be rectangular, square, circular, and / or any other shape. In some embodiments, a slot of first portion 505a includes a width of about 2 cm and a height of about 1.5 cm, without limitation. A slot may include a snap element to secure a sensor extension in first portion 505a, such as sensor extension 580.

[0097] FIG. 5A illustrates a first portion 505a and a second portion 505b of the sleep apnea device 500, having a housing 305. The second portion 505b includes an outer surface 510, an inner surface 525, an interior 530, and any one or more of the features, functions, and advantages as described previously with relation to the first portion 505a. An inner surface 525of the second portion 505b is disposed to be proximate to one or more teeth of the subject when in use. The outer surface 510 of the second portion 505b is configured to have an interior oral surface 515 proximate to a tongue of a subject and an exterior oral surface 520 configured to be proximate to a check and / or lips of a subject when in use. The second portion 505b may be formed and dimensioned to contact or be proximate to the opposite jaw (or tooth or teeth thereof) as that of the first portion 505a, such as to one or more bottom teeth of the user when the first portion 505 a is configured to contact or be proximate to one or more upper teeth of the subject.

[0098] In certain embodiments, the first portion 505a and a second portion 505b of housing 505 are separatable pieces, or are integrally formed in a unitary piece. In certain embodiments, the first portion 505a and the second portion 505b may be removably attachable to each other. “Removably attachable” as used in this disclosure refers to a form of connection between two or more objects that can be undone and / or reconnected without creating an irreversible change in the structure or function of either object. The first portion 505a and a second portion of housing 505b may connect through a connection means, such as a linking element, fastener, bracket, or the like. The linker may include a first surface on the first portion 505a, a second surface on the second portion 505b, and a linkage connecting the first surface with the second surface. The linkage may be based on coordinating shapes, ridges, lips, edges, buttons, hooks, lock, latch, or other linking means. A linker may include a receiving end on the first portion that receives a hook, latch, or both, from a locking end of the second portion of the housing 505, or vice-versa. The first surface and / or the second surface of a linker may be moveable about an axis of rotation. For instance, a first surface and / or a second surface of a linker may be moveable about one or more axes (e.g. x-axis, y-axis, z-axis) to link or unlink the first surface to the second surface, or vice versa.

[0099] The first portion 505a and second portion 505b can be configured to couple together or engage the subject independently. In certain embodiments, the housing 505 includes three or more parts. In certain embodiments, the housing 505 includes a single part adapted to contact both the top and bottom teeth of the subject. A first portion 505a of the housing 505 can be shaped to conform to an upper part of a user’s mouth, such as a top row of teeth. The first portion 505a can be shaped as a tooth tray, part of a mouth retainer, other oral appliances, or a combination thereof. The first portion 505a may be configured to contact one or more teeth of the top (or upper) teeth of the subject. That is, the first portion 505a can be configured to contact one or more teeth of the maxillae. In certain embodiments, the first portion 505a is configured tocontact one or more teeth of the bottom (or lower) teeth of the user. That is, the first portion 505a can be configured to contact one or more teeth of the mandible.

[0100] The housing 505 and / or one or more portions of housing 505 may include indentations forming the inner surface 525. The indentations may include one or more spaces along a path of housing 505. For example, indentations may include tooth-sized indentations running along a middle portion of housing 505. Each indentation of the indentations of housing 505 can be spaced apart such that the indentations fit a row of teeth of an individual. In certain embodiments, the housing 505 is custom formed to accommodate a particular fit for an individual. As a non-limiting example, the housing 505 may be dimensioned to have or fit with a length, diameter, and / or surface dimensions, of a roof of a subject’s mouth such that the sleep apnea device 500 fits the subject’s mouth with minimum discomfort. In certain embodiments, the housing 505 includes an average or typical diameter, length, and / or placement of surface features of a population of people, which allows the housing 505 to fit within a variety of differing mouth shapes. The housing 505, additionally or alternatively, may be 3-D printed for a user.

[0101] In embodiments in which the first portion 505a is configured for the upper teeth, the first portion 505a of the housing 305 includes a surface that is dimensioned to contact at least one upper tooth. In embodiments in which the first portion is configured for the bottom (lower) teeth, the first portion 505 a of the housing 505 includes a surface that is dimensioned to contact at least one lower tooth.

[0102] In certain embodiments, the housing 505 includes a second portion 505b. In certain embodiments, the second portion 505b can be configured to removably couple to the first portion 505a of the housing 505. The second portion 505b may be shaped as a tooth tray, mouth retainer, and / or other oral appliance, and is configured to be on the opposite jaw (or teeth thereof) relative to the first portion.

[0103] FIG. 5B is a bottom view of an exemplary embodiment of an apparatus 500 for treating sleep apnea. Apparatus 500 may include housing 505. The housing 505 can be made of a flexible material. In certain embodiments, the flexible materials for housing 505 can include, in some examples, rubber, polymer, elastic materials, and / or plastics. In certain embodiments, the housing 505 can be composed of, or include, a rigid material, such as an inelastic, plastic, or other material. In certain embodiments, the housing 505 includes an ovular, “U” form factor. In certain embodiments, the housing 505 is configured or shaped to have a different shape. In certain embodiments, the housing 505 is shaped and dimensioned to fit inside of a person’smouth. For example, the housing 505 can be shaped to conform along at least portions of the top teeth and / or the bottom teeth of an individual. In certain embodiments, the housing 505 can be configured as or to include a retainer, mouthguard, tooth tray, another oral appliance, or any combinations or portions thereof that rests at least partially or fully inside a user’s mouth.

[0104] Referring still to FIG. 5B, housing 505 may include an outer surface 510 with a form factor having an interior oral surface 515 and an exterior oral surface 520, an inner surface 525, and an interior 530. The inner surface 525 can be configured to be opposite outer surface 510 with the interior 530 therebetween. The interior 530 is dimensioned to contain, in whole or in part, electronics, circuitry, one or more magnets, one or more electromagnets, one or more antenna, one or more motors, one or more rotatable shafts, or any other element of the first portion 505a or second portion 505b as described above with reference to FIG. 5A, or any combinations of these. The inner surface 525 of the housing 505 may be proximate to, or contact with, or both, one or more teeth of the maxilla of a wearer when in use. In certain embodiments, the inner surface 525 of the housing 505 may be proximate to, or contact with, or both, one or more teeth of the mandible of a wearer when in use. In certain embodiments, the outer surface 510 is configured to contact one or more of: a cheek, lips, or interior of the mouth (behind the teeth and / or adjacent the tongue) when in use. The outer surface 510 of the housing 505 includes an interior oral surface 515 that is configured to be disposed at, or proximate to, an interior of the mouth (behind the teeth and / or adjacent the tongue) when in use — that is, the interior oral surface 515 is proximate to an interior of a mouth of the wearer. The outer surface 510 of the housing 505 may have an exterior oral surface 520 proximate to a check and / or lips of the wearer when in use

[0105] Apparatus 500 may include an electromagnetic stimulator 535. The electromagnetic stimulator 535 can be the same as, or similar to, the electromagnetic stimulator 310 described with reference to FIG. 3. The electromagnetic stimulator 535 may be positioned within, or at least partially within, the interior 530 of the housing 505. The housing 505 can include a space in its interior 530 designed to accommodate and maintain the electromagnetic stimulator 535 in a secure position. The electromagnetic stimulator 535 can include one or more conductive materials, such as, but not limited to, copper, silver, and / or aluminum. The electromagnetic stimulator 535 may include one or more electrodes, transmissive coils, and / or power cells. A current of an electrode of electromagnetic stimulator 535 can pass from an anode to a cathode of an electrode and / or from the cathode to the anode of the electrode. The transmissive coil ofelectromagnetic stimulator 535 can include a conductive wire wrapped in one or more loops. The electromagnetic stimulator 535 can be shaped in a form of a circle, disk, and / or other shape.

[0106] The electromagnetic stimulator 535 is configured to transmit one or more electromagnetic signals or waves. The electromagnetic stimulator 535 is configured to emit the electromagnetic signals to wirelessly stimulate a proximate tissue or nerve of the subject. The proximate tissue can include a soft palate and / or tongue of a subject’s mouth. A proximate nerve can include the hypoglossal nerve of the subject. It is noted that other tissues or nerves can be stimulated, such as by a different placement of the device 500, without departing from the scope of the present disclosure. In certain embodiments, electromagnetic stimulator 535 produces a varying magnetic field, which may induce a local electric field or current in a proximate tissue. The magnetic field may be generated by the electromagnetic stimulator 535 through an alternating current (AC) or direct current (DC). In certain embodiments, the electromagnetic stimulator 535 can wirelessly contract one or more tissues or stimulate one or more nerves through time-varying magnetic fields. For example, the electromagnetic stimulator 535 can produce a magnetic field, which may have a frequency, such as between 0 Hz to about 30 KHz. In certain embodiments, a magnetic field produced by electromagnetic stimulator 535 has a frequency of 30 KHz. In certain embodiments, a magnetic field produced by electromagnetic stimulator 535 has a frequency greater than 30KHz. The electromagnetic stimulator 535 may contract one or more tissues, such as one or more tissues within a mouth of the subject, or stimulate one or more nerves coupled to respective tissues in the mouth of subject, which can inhibit an obstruction of the airway 115 or enable an opening of the airway 115.

[0107] The device 500 may include a power source 540 electrically coupled to the electromagnetic stimulator 535. The power source 540 may be configured to provide AC or DC power to the electromagnetic stimulator 535. In certain embodiments, the power source 540 includes an independent power source, such as a battery, solar cell, or the like. In certain embodiments, the power source 540 includes a wired or wireless coupling configured to electronically couple the electromagnetic stimulator 535 to an external power supply.

[0108] In certain embodiments, the device 500 includes a control unit 545 configured to control one or more operations of the electromagnetic stimulator 535. The control unit 545 can include one or more of: processor(s), memory, and / or sensors configured to perform a task. In certain embodiments, the control unit 545 includes control circuitry including, in some examples, one or more processors, microprocessors, and / or microcontrollers. In certain embodiments, the control unit 545 includes the power source 540. The power source 540 is anelectric element capable of delivering power. The power source 540 can include one or more batteries, such as, but not limited to, lithium-ion batteries. The power source 540 can be configured to deliver one or more voltages / currents, to electromagnetic stimulator 535 and / or one or more magnets of the protrusions 550a, 550b, 550c, or 550d.

[0109] For example, the control unit 545 can control one or more of: a frequency, field, power, and strength, amplitude, pulse duration or frequency, or any other variable of the electromagnetic stimulator 535. The control unit 545 can receive a signal from a sensor that is positioned and configured to detect one or more sleep patterns. The control unit 545 can analyze the received sensor signal to identify a potential or actual apneic event of the subject. The control unit 545 can execute instructions or software to analyze and determine the potential or actual apneic even based on such signal. The control unit 545 can instruct the electromagnetic stimulator 535 to generate a specified frequency, field, power, strength, amplitude, pulse parameters such as frequency, duration, or other variables with the ultimate effect of opening the airway 115 through wireless energy delivered to one or more of the hard palate, soft palate, tissue of the subject, a tongue of the subject, other muscles or tissues of the subject, or one or more nerves of the subject. In some embodiments, the control unit 545 receives a signal from a sound sensor, such as a microphone. A sound sensor may be part of a smartphone, tablet, and / or other device that may be in communication with the control unit 545. In certain embodiments, the sound sensor is part of additional sensors of the control unit 545. The control unit 545 can identify a snoring episode of an individual from a signal of the sound sensor, such as, in some examples, sound levels, sound duration, and / or sound frequency. The control unit 545 may determine one or more remedies for a user based on analysis of the signals from the sound sensor.

[0110] In certain embodiments, the device 500 includes one or more protrusions. In certain embodiments, the device 500 includes a single protrusion located on an exterior outside surface of housing 505. In certain embodiments, the device 500 includes at least two protrusions, such as a first protrusion 550a disposed on a left side of the housing 505 and second protrusion 550b disposed on a right side of the housing 505 opposite the first protrusion 550a. In certain embodiments, the first portion 505a as described above with reference to FIG. 5A includes a first set of protrusions 550a, and the second portion 505b as described above with reference to FIG. 5A includes a second set of protrusions 550b. Protrusions 550a, 550b may extend from the exterior oral surface 520 of the outer surface 510 of the housing 505 in a direction away from the inner surface 525. In certain embodiments, the protrusions move a jaw of a user forward,such as by using magnetic forces to move the protrusions 550a, 550b further from each other. Device 500 may have three mechanisms of action: 1) PEMF muscle activation of tongue / soft palate; 2) Mandibular protrusion; and 3) Mandibular muscle activation through vibration (increasing muscle tone to stabilize jaw which increases muscle tone of the airway). Protrusions 550a, 550b, can cause movement outward / forward such that a jaw is moving away from a throat of a user. In certain embodiments, protrusions 550a, 550b include an elastic or inelastic material such as, but not limited to, rubber, plastic, and / or silicon. In certain embodiments, the first portion 505a of the housing 505 as described above with refence to FIG. 5A includes a first set of protrusions 550a, 550b and the second portion 505b as described above with reference to FIG. 5A of the housing 505 includes a second set of protrusions 550c, 550d. Protrusions 550a, 550b of the first portion 505a can extend downwards, upwards, or in a first direction from the first portion 505a toward the second portion 505b (depending on their relative positions) or toward the second set of protrusions 550c, 550d, to ensure that the first set of protrusions 550a, 550b, are proximate to the second set of protrusions 550c, 550d, respectively. In embodiments in which there is only one protrusion 550a extending from the first portion 505a, and only one protrusion 550b extending from the second portion 505b, the first protrusion 505a of the first portion extends downwards, upwards, or in a first direction from the first portion 505a toward the second portion 505b (depending on their relative positions) or toward the second protrusion 550b of the second portion 505b to ensure that the first protrusion 550a is proximate to the second protrusion 505b, when in use. In certain embodiments, the second set of protrusions 550c, 550d extend from the exterior oral surface 520 of the outer surface 510 of the second portion 505b of the housing 505 in a direction away from the inner surface 525 (which is disposed toward a cheek of a user in use). The second set of protrusions 550c, 550d of the second portion 505b extend downwards, upwards, or in a second direction (which may be opposite to the first direction) from the second portion 505b toward the first portion 505a (depending on their relative positions) or toward the first set of protrusions 550a, 550b, to ensure that the second set of protrusions 550c, 550d, are proximate to the first set protrusions 550a, 550b, respectively. In certain embodiments, in which there is only one protrusion 550a in the first portion 505a, and only one protrusion 550c in the second portion 505b, the protrusion 550a of the second portion 505b extends downwards, upwards, or in however direction appropriate from the second portion 505b toward the first portion 505a (depending on their relative positions) or toward the first protrusions 550a, of the first portion 505a in order to ensure that the second protrusion 550c is proximate to the first protrusion 550a, when in use. In certainembodiments, one or more of the protrusions 550a, 550b, 550c, or 550d are angled. For example, protrusions 550a, 550b, 550c, or 550d may be angled upwards and / or downwards at an angle equal to or greater than fifteen degrees (i.e., > 15°). In certain embodiments, the protrusions 550a, 550b, 550c, or 550d are angled at an angle less than fifteen degrees (i.e., < 15°). As shown in the example depicted in FIG. 5B, the protrusions 550a, 550b, 550c, or 550d can be located on either side of the housing 505 of the sleep apnea device 500. The protrusions 550a, 550b, 550c, or 550d can be symmetrically located on either side of the housing 505. In certain embodiments, only one side of the housing 505 includes protrusions. In certain embodiments, both sides of the housing 505 include protrusions 550a, 550b, 550c, or 550d in which the protrusions 550a, 550b, 550c, or 550d are asymmetrically located (e.g., to account for the jaw structure of the user). The protrusions proximate to each other (namely, one on top and one on a bottom portion of the housing) may be configured to interfere or engage with each other mechanically. In embodiments with or without the adjustment features described herein, the protrusions serve to prevent the bottom portion from moving in at least one direction (i.e. x-, y-, and / or z-direction) relative to the top portion when the protrusions are proximate and contacting one another. For example, when the protrusions 550a, 550b, 550c, or 550d extend vertically, the protrusions 550a, 550b, 550c, or 550d inhibit or prevent lateral movement. The magnetic features noted herein may provide additional maneuverability regarding the relative positions of the top and bottom portion of the housing 505 in various directions in use.

[0111] In certain embodiments, the first protrusions 550a, 550b are configured to adjust a positioning of an upper, or lower jaw, or both, of a subject in cooperation with the second set of protrusions 550c, 550d, respectively. While this method, and the apparatuses and devices enabling such methods may be equally achieved using a single protrusion 550a, in coordination with a second protrusion 550c, (for example if positioned substantially in the front of the housing 505, or positioned on either side of the housing (left or right), the figures generally refer to and show embodiments having two sets of protrusions, that have two protrusions each and that coordinate on both the left and right side of the housing 505). Nevertheless, the advantages and improvements may equally be achieved with a single protrusion on the first portion and a single protrusion on the second portion of the housing 505.

[0112] For a nonlimiting example, the first set of protrusions 550a, 550b, and a second set of protrusions of protrusions 550c, 550d may adjust and / or fix a subject’s jaw positioning relative to a relaxed jaw position of the subject’s jaw. At least one protrusion 550a of the first portion 505a of the housing 505 proximate to a protrusion 550c of the second portion 505b includes amagnet or magnetic material. Similarly, the protrusion 550c of the second portion 505b can include a magnet or magnetic material. A positioning of the subject’s jaw may be adjusted through adjustment and / or activation and / or inactivation of magnets (electromagnets and / or permanent magnets) of the protrusions. The magnets of the protrusions can include one or more magnetic materials, such as ferro-magnetic materials, paramagnetic materials, and / or diamagnetic materials. In certain embodiments, the magnet is a square and / or rectangular mass of iron. The magnet may be positioned on an outer surface or at least partially or fully within a protrusion. Each magnet may be responsive to one or more magnetic fields. For example, a magnetic field of one protrusion may push or pull the magnet of a cooperating protrusion proximate thereto, which may move such cooperating protrusion and thereby move the lower jaw (mandible) relative to the upper jaw (maxilla).

[0113] In some embodiments, protrusions 550a, 550b, 550c, or 550d may be adjusted through a magnetic field produced by electromagnetic stimulator 535. The electromagnetic stimulator 535 can generate a magnetic field that may push, pull, or otherwise move at least one magnet and / or magnetic material such as a linear actuator, such as, in one or more of the protrusions 550a, 550b, 550c, or 550d through magnetic forces. In certain embodiments, only one of such protrusions 550a, 550b, 550c, or 550d includes such magnet or magnetic material to be effective. In some embodiments, the first magnet in the first protrusion 550a, for nonlimiting example, may magnetically oppose a second magnet or magnetic material in the third protrusion 550c proximate thereto, which may result in a repulsive force to push apart the first set of protrusions 550a, 550c (relative to each other). In certain embodiments, the second magnet in a second protrusion 550b magnetically opposes a second magnet or magnetic material in a fourth protrusion 550d proximate thereto, which may result in a repulsive force to push apart the second set of protrusions 550b, 550d (relative to each other). In certain embodiments, a first set of protrusions 550a, 550b having magnets or magnetic materials therein magnetically attracts a second set of protrusions elements 550c, 550d having magnets or magnetic materials therein. In certain embodiments, each protrusion 550a, 550b of the first portion 505a includes a magnet or magnetic material, which can be a permanent magnet or electromagnet. In certain embodiments, each protrusion 550c, 550d of the second portion 505b includes a magnet or magnetic material, which can be a permanent magnet or electromagnet.

[0114] In certain embodiments, a processor 555, such as in the control suite 545, may adjust each magnetic field of each magnet of any protrusion 550a, 550b, 550c, or 550d individually. The control unit 545 can send a current, such as an AC or DC current, to each magnet throughone or more wires, which can change a magnetic field of each magnet. In this way, the control unit 545 can individually modify each magnetic field of each magnet, which enables precise movements of protrusions 550a, 550b, 550c, or 550d. Thereby, the movements of the protrusions using magnetic interactions of the protrusion 550a, 550b, 550c, or 550d with each other or with the electromagnetic stimulator 535 is adapted to adjust the lower jaw, any one or more of the protrusions 550a, 550b, 550c, or 550d, and / or the first portion in increments of 0.1mm to 20mm in any of an x, y, or z direction relative to the upper jaw, relative to another protrusion, 550a, 550b, 550c, or 550d, and / or relative to the second portion of the housing 505. That is, the protrusions 550a, 550b, 550c, or 550d thereby, can adjust a subject’s lower jaw leftwards, rightwards, upwards, and / or downwards. Adjusting a subject’s lower jaw through protrusions 1 12a. 112b, 1 14a, and / or 114b. in such a manner can open a user’s air pathway to avoid or prevent, circumvent, stop, or otherwise alleviate an apneic event and overall, improve sleep for the user.

[0115] In certain embodiments, the control unit 545 includes a communication module 560. The communication module 560 is configured to transmit and receive electromagnetic signals. The communication module 560 can be configured to communicate over a WI-FI, BLUETOOTH, ZIGBEE, near field communication (NFC), Global System for Mobile communication (GSM), 3G, 4G, 5G, WLMAX, infrared, optic, or other standard of signal communication. The power source 540 is coupled to, and provides power to, the communication module 560. A communication module may communicate with one or more external computing devices, such as, but not limited to, smartphones, tablets, servers, laptops, and / or desktops.

[0116] In certain embodiments, the control unit 545 includes a biological sensor 565. The biological sensor 565 is configured to detect one or more of: biometric or environmental parameters. Although FIG. 5B depicts a biological sensor 565 located within the control suite 545, in various embodiments, the biological sensor 545 may be differently located, such as on the first portion or second portion of the housing 505. In certain embodiments, the biological sensor 565 is disposed within an external device, such as within a smartphone, a smartwatch, or a health-monitoring device. In certain embodiments, the biological sensor 565 is configured to detect one or more of: a temperature, resistivity, blood oxygen level, or other parameters. In certain embodiments, the biological sensor 565 includes a blood oxygen monitor. In certain embodiments, the biological sensor 565 is configured to detect a biological signal indicative of an apneic event of a subject. The biological signals indicative of apneic events may include, without limitation, blood oxygen levels, sound, and / or movement. A biological parameter mayinclude, but is not limited to, a body temperature, resistivity, and / or blood oxygen level. In certain embodiments, the control unit 545 includes one or more additional sensors 570. The additional sensors 570 include, but are not limited to, respiratory sensors, blood oxygen sensors, and the like. The control unit 545 is configured to activate or deactivate additional sensors 570. For example, the control unit 545 can determine that more data is required, that data may be inaccurate, or the like; and, in response to such determination, the control unit 545 may active additional sensor 570. In certain embodiments, the additional sensor 570 is configured as a backup sensor to biological sensor 565. In certain embodiments, the biological sensor 565 and the additional sensors 570 work in parallel, which allows the control unit 545 to receive more accurate data, such as sleep data. The biological sensor 565 can communicate a biological parameter to the control unit 545. The control unit 545 can determine a remedy mode for a user based on a biological parameter. The remedy mode includes an operation that alleviates a subject’s affliction. The remedy mode may include adjusting a jaw of a subject through movable protrusions 550a-550d, stimulating a tissue of the subject through electromagnetic stimulator 535, vibrating the subject’s jaw through protrusions 550, and / or a combination thereof. The control unit 545 can calculate, identify, and / or otherwise determine a remedy mode on-board the sleep apnea device 500. In certain embodiments, the control unit 545 communicates, through the communication module 560, one or more biological parameters to an external computing device. For example, and without limitation, the control unit 545 is configured to communicate a biological parameter detected from the biological sensor 565 to a smartphone, or other electronic device, through a BLUETOOTH connection. Thereafter, the smartphone can calculate a remedy mode and communicate the remedy mode back to the control suite 565. A computing device, such as the smartphone, and the control suite 565 can communicate through a mobile application, such as an iOS or ANDROID application. The mobile application may also provide a user interface for displaying functional parameters such as, in some examples, sleep data, and / or remedy modes. The sleep data may include, without limitation, a quantity of sleep, an actual time asleep, a time in bed, a quantity of times awake, and / or one or more snoring episodes, which may be calculated through the control unit 545 based on the biological parameters received through biological sensor 565. The sleep data may include an overall quality of sleep of a user, which may be calculated through the external computing device in communication with the control unit 545. A quality of sleep may be scored on a scale such as, in some examples, a range between 1-10, 1-100, and / or a number of stars out of 5 stars, without limitation. The quality of sleep may be calculated through an amount of movement detectedthroughout the night, one or more biological parameters such as, in some examples, temperatures and / or blood oxygen levels, detected stages of sleep, and / or length of sleep. The biological sensor(s) 565 may include one or more of an accelerometer, a microphone, temperature sensor, muscular activity sensor, moisture sensor, air flow sensor, pressure sensor, optical sensor, body structure position / movement / action sensor, and / or a heart rate sensor and communicate detected movements of a user to the control unit 545, which can determine an impact to a sleep quality score based on the movements detected. In some embodiments, control unit 545 is configured to determine a stage of sleep of a subject. The stage of sleep may include, but is not limited to, stage 1, stage 2, and / or stage 3. Stage 1 sleep may last between 1-5 minutes and may be non-rapid eye movement (NREM) sleep. Stage 2 sleep may last between about 10- 60 minutes and be NREM sleep. Stage 3 may include slow-wave, delta, and / or deep sleep, and may last between about 20-40 minutes. Stage 3 sleep may include rapid eye movement (REM) sleep and last about 10-60 minutes. An individual may go into and out of REM sleep multiple times per night, such as in one or more sleep cycles. The control unit 545 is configured to determine sleep parameters (e.g. one or more stages of sleep, interruptions of stages of sleep, etc.) through biological parameters detected through the biological sensor 565. The control suite 545 may calculate and / or determine a remedy mode based on one or more sleep modes. For example, and without limitation, the control unit 545 is configured to determine whether the subject is in stage 4 sleep and activate one or more protrusions 550a, 550b, 550c, or 550d. to adjust a lower jaw position of the subject.

[0117] In certain embodiments, the device 500 includes a respiratory sensor 575. The respiratory sensor 575 can include one or both of: a breath or pressure sensor. The respiratory sensor 575 is configured to detect a respiration rate of a subject wearer. The respiration rate refers to the cyclic breathing patterns of a person, such as inhalation period and / or exhalation period. The control unit 545 can be in communication with respiratory sensor 575 and is configured to calculate a respiration rate based on data from the respiratory sensor 575. The control unit 545 is configured to calculate, determine, identify, or activate, or a combination thereof, a remedy mode for the subject based on a respiration rate determined through the respiratory sensor 575. The control unit 545 is configured to record or measure a time an activation of a remedy mode to synchronize with a respiration rate of a user. For example, and without limitation, the subject wearer may inhale every six seconds, to which the control unit 545 is configured to activate electromagnetic stimulator 535 to open an airway 115 of the subject using activation of the hypoglossal nerve, or a stimulation of the soft palate, the tongue,through protrusion 550a, 550b, 550c, or 550d, or combination thereof, movement as previously described herein.

[0118] In certain embodiments, the housing 505 includes a sensor extension 580. The sensor extension 580 is configured to connect the control suite 545 to a first portion 505a or second portion 505b. In some embodiments, the sensor extension 580 is removably coupled to one or both of the first portion 505a or second portion 505b. The housing 505 may include a slot, via, or other hole configured to receive an end of sensor extension 580. In certain embodiments, the control unit 545 is removably coupled to the sensor extension 580. In certain embodiments, the control unit 545 is included in, or permanently affixed to, part of an end of the sensor extension 132. The sensor extension 580 is configured to securely position the control unit 545 outside of a subject’s mouth, when in use, and exterior to the first portion 505a and second portion 505b, which may help prevent potential electrical, or thermal hazards to the subject wearer.

[0119] Referring back to FIG. 5A, the first portion 505a may be made of a flexible material, such as rubber or a polymer, without limitation. The first portion 505a may alternatively be made of a rigid structure, such as plastic. In certain embodiments, the first portion 505a is hollow, enabling entry of a subject’s teeth into a mold of the first portion 505a. In certain embodiments, the first portion 505a includes indentations in which each indentation is dimensioned (i.e., sized and shaped) for a specific tooth of an upper row of teeth of a subject. In certain embodiments, the first portion 505a includes a uniform space throughout a shape of the first portion 505a, which enables more variations of teeth to be positioned in the first portion 505a. The first portion 505a may be 3-D printed or milled to match a subject’s upper jaw. In certain embodiments, the first portion 505a is dimensioned to fit within a subject’s mouth. The first portion 505a can be configured and formed as a top tooth tray. The first portion 505a can be dimensioned to conform to an upper part of a subject’s mouth, such as a top row of teeth. The first portion 505a can be configured and formed as a tooth tray, part of a mouth retainer, or other oral appliances. In certain embodiments, the first portion 505a is configured to contact one or more teeth of the top (or upper) teeth of the user. In certain embodiments, the first portion 505a is configured to contact one or more teeth of the bottom (or lower) teeth of the user. The first portion 505a includes exterior oral surface 520a, which may include an interior portion, and an exterior portion, an inner surface, and an interior cavity. The inner surface of first portion 505a may be configured to be opposite the exterior oral surface 520a with the interior portion therebetween. The interior of first portion 505a may contain and / or house (in whole or in part) electronics, circuitry, one or more magnets, one or more electromagnets, one or more antenna,one or more motors, one or more rotatable shafts, or any other element of the top portion or bottom portion mentioned herein, and any combinations of these. The inner surface of first portion 505a may be proximate to and / or contact one or more teeth of the maxilla of a subject when in use. The inner surface of first portion 505a may be proximate to and / or contact one or more teeth of the mandible of the subject when in use. The exterior oral surface 520a of first portion 505a is configured to contact the cheek, lips and / or interior of the mouth (behind the teeth and / or adjacent the tongue) when in use. The exterior oral surface 520a of a first portion 505a may have an interior outer surface that is disposed to contact the interior of the mouth (behind the teeth and / or adjacent the tongue) when in use — i.e., the interior outer surface is proximate to an interior of a mouth of a subject. The exterior oral surface 520a of first portion 505a may have an exterior outer surface disposed to be proximate to a check and / or lips of a user when in use. In embodiments in which the first portion 505a is configured for the upper teeth, the inner surface includes a portion that contacts at least one upper tooth. In embodiments in which the first portion 505a is configured for the bottom (lower) teeth, the inner surface includes a portion that contacts at least one lower tooth.

[0120] In certain embodiments, the second portion 505b is shaped as a tooth tray, mouth retainer, and / or other oral appliance, and is configured to be on the opposite jaw (or teeth thereof) relative to the first portion 505a. The second portion 505b includes exterior oral surface 520b, an inner surface, an interior, and any one or more of the features, functions, and advantages as described previously with relation to the first portion 505a. An inner surface of the second portion 505b is disposed to be proximate to one or more teeth of a user when in use. The exterior oral surface 520b of the second portion 505b is configured to have an interior outer surface disposed to be proximate to a tongue of a subject and an exterior outer surface 520b proximate to a cheek and / or lips of a subject when in use. The second portion 505b is dimensioned to contact or be proximate to the opposite jaw (or tooth or teeth thereof) as that of the first portion 505a, such as to one or more bottom teeth of the subject when the first portion 505a is configured to contact or be proximate to one or more upper teeth of the subject. The second portion 505b can include a mold of a bottom row of a subject’s teeth. The second portion 505b can be made of a flexible, or elastic material, such as rubber or a polymer, without limitation. In certain embodiments, the second portion 505b is made of a rigid structure, such as plastic. In certain embodiments, the second portion 505b includes indentations in which each indentation is dimensioned specifically to one of a user’s bottom teeth. In certain embodiments, the second portion 505b includes a uniform space throughout a shape of the second portion505b, which allows the second portion 505b to fit within a variety of different subject’s mouths. The second portion 505b can be shaped as a bottom tooth tray. The second portion 505b can have outer surface 220, an inner surface, and / or an interior cavity. The inner surface of the second portion 505b is disposed to be proximate to one or more teeth of a subject when in use. For example, the second portion 505b can be configured to rest on a row of lower teeth of a user, positioning the lower teeth between an interior of the second portion 505b and an inner surface of the second portion 505b. The second portion 505b can have the exterior oral surface 520b disposed to be proximate to a check and / or lower lips of a user when in use. For example, the exterior oral surface 520b is configured to be positioned between a cheek of a user and one or more teeth of a user when the second portion 505b is placed on a bottom jaw of the subject. The second portion 505b can be separate from that of the first portion 505b. Tn certain embodiments, the second portion 505b is connected to the first portion 505a, such as through one or more couples, fasteners, snap elements, and / or locks, as previously described, herein.

[0121] As noted herein above with respect to FIG. 5B, the device 500 may include protrusions 550a, 550c which may extend from the exterior oral surface 520a of the first portion 505a and the exterior oral surface 520b of the second portion 505b, respectively, in a direction away from an inner surface (which is toward a cheek of a user in use). In certain embodiments, the protrusions 550a, 550c include an elastic or inelastic material such as, but not limited to, rubber, plastic and / or silicon. The protrusions 550a, 550c may extend vertically downwards, upwards, or in first direction between the second portion 505b and the first portion 505a. The first portion 505a includes protrusion 550a. The protrusions 550a extend from an exterior oral surface 520a of the first portion 505a. In certain embodiments, the first portion 505a includes the first set of protrusions 550a and the second portion 505b includes the second set of protrusions 550c. The first set of protrusions 550a of the first portion 505a extend downwards relative from the highest exterior surface of the first portion 505a. In certain embodiments, the first set of protrusions 550a of the first portion 505a are angled downwards relative from the highest exterior surface of the first portion 505a, such as at an angle of about fifteen degrees, without limitation. The first set of protrusions 550a can be positioned behind or in front of a second set of protrusions 550c of the second portion 505b. The second set of protrusions 550c of the second portion 505b extend upwards relative from the lowest surface of the exterior oral surface 520b of the second portion 505b. In certain embodiments, the second set of protrusions 550c extend upwards relative to the lowest surface of exterior oral surface 520b of the second portion 505b at an angle, such as at an angle of about fifteen degrees, without limitation. The first set ofprotrusions 550a, and the second set of protrusions 550c may be touching in an initial state. In certain embodiments, the first set of protrusions 520a and the second set of protrusions 550c, are spaced apart, such as, but not limited to, by about 3cm. In certain embodiments, one or more of the protrusions 550a-550d include a magnet.

[0122] In certain embodiments, the first portion 505a includes a slot. The slot may include a hole or via in the first portion 505a. The slot may be rectangular, square, circular, or any other shape. In certain embodiments, the slot of the first portion 505a includes a width of about 2 cm and a height of about 1.5 cm, without limitation. The slot can include a coupling means such as a fastener, interlock, or snap elements to secure a sensor extension in first portion 505a, such as sensor extension 580.

[0123] FIG. 6 illustrates a communication pathway and sensing system 605 of a sleep apnea treatment - device according to embodiments of the present disclosure. The embodiment of the network 600 shown in FIG. 6 is for illustration only. Other embodiments could be used without departing from the scope of the present disclosure. The network 600 shown in FIG. 6 could be used with any of the devices, control units, or systems described throughout this disclosure.

[0124] In the example shown in FIG. 6, the system 605 includes an emitting device 610 that is in communication with a control unit 615. The emitting device 610 can be the same as, or similar to, emitting device 205 as described above with reference to FIG. 2. The control unit 615 can be the same as, or similar to, one or more of, control unit 210 as described above with reference to FIG. 2. In certain embodiments, the control unit 615 and emitting device 605 are contained within a same housing such that system 605 is a single unit.

[0125] The emitting device 610 includes an electromagnetic stimulator 620. In certain embodiments, the emitting device 610 also includes one or more variable or lockable protrusions 625. The control unit 615 includes a processor 630 and one or more of: a biological sensor 635 and power source 640. In certain embodiments, the power source 640 in the control unit is configured to provide AC or DC power to the electromagnetic stimulator 620 in the emitting device 610. In certain embodiments, the emitting device 610 includes its own power source. In certain embodiments, the processor 630 controls one more operations of the electromagnetic stimulator 620 or protrusions 625 in the emitting device 610. In certain embodiments, the emitting device 610 includes a processor and memory configured to control the operations of the electromagnetic stimulator 620 or protrusions 625 in the emitting device 610. In certain embodiments, the STS 600 is configured to couple to an external measurement device 645. The external measurement device 645 includes one or more sensors configured tomeasure one or more biological parameters 650 of a subject. The external measurement device 645 can be one or more of: a smartwatch, a smartphone, a sleep tracking device (such as a FITBIT or smart ring), or other fitness or health monitoring device that includes sensors to monitor one or more biometric parameters of an individual.

[0126] In certain embodiments, the emitting device 610 is attached to a body part of a subject (such as a human person) that may be experiencing apneic episodes. For example, the emitting device 610 may be placed on a skin surface corresponding to a lower jaw or neck of the subject. More specifically, the emitting device 610 can be placed on a skin surface proximate to a hypoglossal nerve of the subject, such as under a chin of the subject. In certain embodiments, the emitting device 610 is configured to be inserted into a mouth of the subject and be disposed between the upper and lower teeth (jaws) of the subject. For example, the emitting device 610 can be configured as the first portion 505a and second portion 505b of the device 500 and the control unit 615 can be configured as the control unit 545. More specifically, a first portion of the emitting device 610 can be positioned on an upper jaw of the subject and a second portion of the emitting device 610 can be positioned on a bottom jaw of the subject.

[0127] In certain embodiments, the biological sensor 635 is configured to detect one or more biological parameters of the subject. The biological sensor 635 can be housed or otherwise disposed inside (in full or in part) the emitting device 610 or control unit 615. In certain embodiments, the biological sensor 635 is positioned on a surface of the emitting device 610. In certain embodiments, the biological sensor 635 includes a sensor included in the external measurement device 645. The biological parameter may include, but is not limited to, a blood oxygen value, and / or temperature value. The control unit 615 is configured to determine a remedy mode of operation based on the biological parameter. For example, the control unit 615 is configured to analyze the biological parameter(s), identify a potential apneic, and select and activate a particular remedy mode configured to treat the particular apneic event. The remedy mode can include one of a set of remedy modes, such as, but not limited to, jaw movement, electromagnetic stimulation, and / or jaw vibration. The remedy mode for a jaw movement may include adjusting one or both of first set of protrusions and second set of protrusions in a sleep apnea device 500. The remedy mode for an obstruction resulting from tongue contacting the soft palate may include stimulating one or more nerves to relax the tongue and open the airway 115. In certain embodiments, one or more portions of the emitting device 610, such as first portion 505a or second portion 505b of the device 500, includes an accelerometer and / or gyroscope in communication with the control unit 615. The control unit 615 is configured to assess amovement of a jaw or tongue of the subject more precisely through an accelerometer, gyroscope, or other sensor measurement (such as sonic measurement) by the emitting device 610.

[0128] In certain embodiments, the remedy mode includes activating electromagnetic stimulator 620. For example, the control unit 615 is configured to determine that a subject’s jaw is in a corrective position, but a blood oxygen value in the biological parameters signal 84%. Based on the jaw position and blood oxygen value in biological parameters 650 detected by biological sensor 635 or by the external measurement device 645, the control unit 615 determines a respective remedy mode for treatment of the corresponding event. For example, the control unit 615 may be configured to determine respiratory rates, blood oxygen levels, jaw positioning, and / or tongue position, and calculate a corresponding remedy mode. As an additional non-limiting example, the control unit 615 may receive biological parameters 650 regarding a respiratory rate and a blood oxygen level of 92%, to which the control unit 615 calculates the remedy mode to include activating electromagnetic stimulator 620 to wirelessly contract the soft palate of the subject. The control unit 615 can input or receive any combination of biological parameters 650 and output a single remedy mode or one or more combinations of remedy modes, without limitation. For example, the control unit 615 determines that contracting one or more portions of a soft palate of the subject may enable more air to enter the airway 115 of the subject. The control unit 615 can send electrical transmissions including, in some examples, one or more signals, currents, and / or voltages to electromagnetic stimulator 620. The electromagnetic stimulator 650 is configured to generate one or more magnetic fields, which are generated to stimulate a nerve or contract a soft palate or other tissues of the subject. In certain embodiments, the remedy mode includes a vibration mode. For example, the vibration mode can include shaking a jaw of the subject through first set of protrusions 625. For example, the control unit 615 can send an AC current to one or more magnetic elements of first set of protrusions 650, second set of protrusions 650, or both. One or more magnetic elements of the first set of protrusions 650, the second set of protrusions 650, or both, can generate or modify one or more magnetic fields, which may push or pull the first set of protrusions 650, the second set of protrusions 650, or both, which can cause a vibration of the jaw of the subject. The control unit 615 may be configured to determine a pattern of sleep data and remedy modes. The pattern can include an historical trend of remedy modes employed, trends of sleep data, or a combination thereof. The control unit 615 is configured to determine the remedy mode based on a sleep pattern of the subject. The sleep pattern of the subject can be determined through one ormore biological sensors 635, such as, but not limited to, accelerometers, gyroscopes, microphones, and the like. The control unit 615 is configured to determine a positioning of a subject’s head, body, or both, based on data from one or more accelerometers, gyroscopes, and the like, of biological sensor 635. For example, a sleep pattern of the subject may show that the subject tends to sleep on a left side with a lower jaw of the subject slightly moved to a right side. The control unit 615 is configured to activate the remedy mode for adjusting a jaw of the subject, through first set of protrusions 650, the second set of protrusions 650, or both, to a leftside to accommodate a detected sleep pattern of the jaw of subject slightly to the right.

[0129] FIG. 7 illustrates a system and environment 700 for sleep apnea treatment according to embodiments of the present disclosure. The embodiment of the environment 700 shown in FIG. 7 is for illustration only. Other embodiments could be used without departing from the scope of the present disclosure.

[0130] The system and environment 700 includes a wireless communication device 705. The wireless communication device 705, in some examples, can be one of: a smartphone, smartwatch, tablet, laptop, or electronic computing device. The wireless communication device 705 may be configured to run one or more mobile applications, including a health application such as a sleep treatment application 710. The wireless communication device 705 can execute sleep treatment application 710. In certain embodiments, the sleep treatment application 710 is a software application, such as an iOS or ANDROID application, that may enable a user to control a sleep apnea device, such as any sleep apnea device as described throughout this disclosure, without limitation. The sleep treatment application 710 may be programed or configured to enable one or more features, such as, but not limited to, sleep tracking, snore sensing, stimulator controls, jaw controls, vibration controls, and / or other features. The sleep tracking feature may include an operation of a sleep apnea device to track biological parameters and determine sleep data, such as described above with reference to FIGS. 3-6. The snore sensing feature may include controlling an operation of a sleep apnea device, such as any sleep apnea device described throughout this disclosure, without limitation, to detect and track snoring of an individual, which may be indicative of sleep apnea. The stimulator control feature may include generating a user interface through sleep treatment application 710 that may enable a user to adjust one or more settings of an electromagnetic stimulator, such as electromagnetic stimulator of one of the devices 300 or 500, as described above with reference to FIGS. 3-5B. The stimulator control feature may enable the user to adjust one or more stimulation parameters such as, in some examples, an intensity of stimulation, duration of stimulation, and / or frequency ofstimulation. A jaw control feature may enable the user to adjust one or more moveable protrusion elements, such as those described above, to modify a positioning of the subject’s jaw. For example, the jaw control feature enables the user to activate one or more moveable protrusion elements to move a lower jaw left, right, forward, backward, or a combination thereof. A vibration control feature may enable the user to operate a vibration of a sleep apnea device, such as any sleep apnea device as described throughout this disclosure, without limitation. For example, and without limitation, the vibration control feature may enable the user to modify one or more vibration parameters such as, in some examples, an intensity of vibration, duration of vibration, and / or a delivery pattern of vibration.

[0131] In certain embodiments, the wireless communication device 705 communicates with cloud-computing network 715. The cloud-computing network 715 includes one or more computing devices wirelessly communicating with each other. In certain embodiments, the cloud-computing network 715 includes one or more servers. The cloud-computing network 715, for example, may support communication between computing device 720 and sleep treatment application 710 operating on wireless communication device 705. The computing device 720 can be a personal user device or can be a computing device of a medical practitioner or other health assistance company or personnel.

[0132] The cloud-computing network 720, in some implementations, includes a portion of the functionality of a control unit, as discussed above. The cloud-computing network 720, for example, may execute one or more engines, applications, and / or algorithms to calculate one or more remedy modes, store user data, sleep data, and / or synchronize sleep treatment application 710 with the computing device 720.

[0133] FIG. 8 illustrates a sleep treatment process 800 according to embodiments of the present disclosure. While the flow chart depicts a series of sequential steps, unless explicitly stated, no inference should be drawn from that sequence regarding specific order of performance, performance of steps or portions thereof serially rather than concurrently or in an overlapping manner, or performance of the steps depicted exclusively without the occurrence of intervening or intermediate steps. The process depicted in the example depicted is implemented by a sleep treatment system.

[0134] In operation 805, an emitting device is coupled to a subject potentially experiencing one or more sleep related issues, such as sleep apnea. For example, the emitting device can be adhesively affixed to a chin of the subject, strapped to the neck and / or chin area of the subject, or the emitting device can be inserted into a mouth of the subject. The glue can be a removableadhesive that can be washed off or removed via alcohol or other reactive agent. In certain embodiments, the emitting device is strapped, or taped, to the subject and maintained in a position under the chin. In certain embodiments, the emitting device includes a coupling means, such as an adhesive configured to adhere to the skin of the subject. In certain embodiments, the emitting device is configured as a mouth-piece configured to be disposed between the upper teeth and lower teeth of the subject when inserted.

[0135] In operation 810, one or more nerve / tissue stimulators in the emitting device are activated to perform functional electric stimulation. In certain embodiments, one or more nerve / tissue stimulators are activated by activating a power source configured to provide power to the nerve / tissue stimulator(s). In certain embodiments, the nerve / tissue stimulators are activated by a processor in response to the processor determining a specified condition has been met, such as in response to data received from one or more sensors.

[0136] In operation 815, one or more of a nerve or tissue are stimulated through generation of the functional electric stimulation. The stimulation, for example, may be delivered according to one or more stimulation parameters configured to cause an airway of the subject to open or to cause one and / or more jaw muscles of the subject to relax. In certain embodiments, the stimulation parameters (duty cycle, clock frequency, signal frequency, or a combination thereof) of the electromagnetic stimulator are set or adjusted to cause a stimulation of proximate nerves or contraction of proximate tissue. In certain embodiments, the tissue / nerve stimulators are attenuated by the processor in response to the processor determining a current condition, such as in response to data received from one or more sensors (e.g. audio, biometric, and / or environmental sensors). In certain embodiments, the processor is configured to utilize one or more Al or machine learning models to learn and adjust one or more parameters of the tissue / nerve stimulators to more precisely treat an apneic or potentially apneic event.

[0137] FIG. 9 illustrates another sleep treatment process 900 according to embodiments of the present disclosure. While the flow chart depicts a series of sequential steps, unless explicitly stated, no inference should be drawn from that sequence regarding specific order of performance, performance of steps or portions thereof serially rather than concurrently or in an overlapping manner, or performance of the steps depicted exclusively without the occurrence of intervening or intermediate steps. The process depicted in the example depicted is implemented by a sleep treatment system, such as accomplished by processing circuitry and stimulators in, for example, any sleep apnea device or system as described throughout this disclosure, without limitation.

[0138] In operation 905, one or more biometric parameters are obtained. The biological parameters can be detected through one or more biological sensors configured to monitor one or more aspects of a subject. The biometric sensors can include, in some examples a blood oxygen sensor, a temperature sensor, an ohmmeter, an accelerometer, and / or a gyroscope. In certain embodiments, the biometric sensor is included in one of: a smart-watch, smartphone, sleep tracking device (such as a FITBIT or SMART RING), or other health monitoring device. The biological parameters, in some examples, can include one or more of: blood oxygen levels, movement, and / or temperatures.

[0139] In operation 910, data including the biological parameter is transmitted to a computing device. The data including the biological parameter can be transmitted from the biological sensor to a processor, or other computing device. The data including the biological parameter may also be transmitted, or otherwise communicated, to an external computing device. The computing device may include, but is not limited to, a smartphone, smart-watch, laptop, or other computing device. The communication can include a wired or wireless communication utilizing a cloud-computing network. In certain embodiments, communication occurs between a sleep apnea device and a cloud-computing network.

[0140] In operation 915, the data is cleaned and processed by a processor in the computing device. Cleaning and processing data, in some examples, may include sorting, filtering, and / or aggregating data. For example, sensor signals from one or more sensors may be combined according to one or more algorithms to calculate one or more sensor metrics. In certain embodiments, cleaning and processing data includes classifying data to one or more categories, such as, but not limited to, firmware data, geolocational data, software data, and / or sleep apnea device data.

[0141] In operation 920, one or more of treatment parameters are determined through analyzing the biological parameter(s) and / or metrics derived therefrom. In certain embodiments, a processor or external computing device, is configured to utilize machine learning models (and / or other Al) to calculate, identify, or determine a one or more of the treatment parameters. The treatment parameters may include, but are not limited to, jaw positioning, blood oxygen levels, or other indicators, characteristics, and / or symptoms indicative of the treated condition, such as sleep apnea. The treatment parameters may be analyzed to determine one or more stimulation parameters and / or one or more remedy modes. The machine learning model (or Al) can be trained with training data correlating sensor data (e.g. biological parameters) to one or more treatment parameters. The training data can be received via user input, external computingdevices, and / or previous iterations of processing. The Al and / or machine learning model(s) may be configured to receive one or more biological parameters and output one or more remedy modes and / or other stimulation parameters. The Al and / or machine learning model(s) can be used to identify and alleviate problems related to sleep apnea, such as jaw movement, tongue positioning, and / or airway constriction. The machine learning model can include a clustering model. The clustering model can be configured to input biological and / or demographic data related to a pool of subjects and output classifications and / or categories of users to one or more groupings, such as, without limitation, by age, weight, height, gender, and / or pregnancy status. The machine learning model can include a supervised, unsupervised, and / or other machine learning model.

[0142] In some embodiments, the machine learning model(s) is any one of a regression model (e.g., linear regression, logistic regression, or polynomial regression), decision tree, random forest, support vector machine, Naive Bayes model, k-means cluster, or neural network (e.g., feed-forward networks, convolutional neural networks (CNN), deep neural networks (DNN), autoencoder neural networks, generative adversarial networks, or recurrent networks (e.g., long short-term memory networks (LSTM), bi-directional recurrent networks, deep bidirectional recurrent networks).

[0143] The machine learning model can be trained using a machine learning implemented method, such as any one of a linear regression algorithm, logistic regression algorithm, decision tree algorithm, support vector machine classification, Naive Bayes classification, K-Nearest Neighbor classification, random forest algorithm, deep learning algorithm, gradient boosting algorithm, and dimensionality reduction techniques such as manifold learning, principal component analysis, factor analysis, autoencoder regularization, and independent component analysis, or combinations thereof. In certain embodiments, the machine learning model is trained using supervised learning algorithms, unsupervised learning algorithms, semi- supervised learning algorithms (e.g., partial supervision), weak supervision, transfer, multi-task learning, or any combination thereof.

[0144] In certain embodiments, the machine learning model has one or more parameters, such as hyperparameters or model parameters. Hyperparameters are generally established prior to training. Examples of hyperparameters include the learning rate, depth or leaves of a decision tree, number of hidden layers in a deep neural network, number of clusters in a k-means cluster, penalty in a regression model, and a regularization parameter associated with a cost function. Model parameters are generally adjusted during training. Examples of model parameters includeweights associated with nodes in layers of neural network, support vectors in a support vector machine, and coefficients in a regression model. Generally, model parameters can be adjusted to improve the machine learning models’ ability to select a remedy method.

[0145] The aforementioned machine learning models, in some embodiments, are configured to use the training data from an individual patient and adapt overtime to improve the accuracy of the remedy method.

[0146] The Al may include one or more neural networks for performing automated analysis of data. The Al neural networks, in some examples, can include a synaptic neural network, a deep neural network, a transformer neural network, and / or a generative adversarial network (GAN). The Al neural network(s) may be trained using one or more machine learning techniques and / or classifiers such as, in some examples, anomaly detection, clustering, and / or supervised and / or association. In one example, the Al neural networks may be developed and / or based on a bidirectional encoder representations for transformers (BERT) model by Google of Mountain View, CA.

[0147] The systems described herein may communicate with one or more foundational model systems (e.g., artificial intelligence neural networks). The foundational model system(s), in some examples, may be developed, trained, tuned, fine-tuned, and / or prompt engineered to evaluate data inputs such as sensor signals and / or metrics derived therefrom. The foundational model systems, in some examples, may include or be based off of the generative pre-trained transformer (GPT) models available via the Open Al platform by OpenAI of San Francisco, CA (e.g., GPT-3, GPT-3.5, and / or GPT-4) and / or the generative Al models available through Azure OpenAI or Vertex Al by Google of Mountain View, CA (e.g., PaLM 2).

[0148] Certain foundational models may be fine-tuned as Al models trained for performing particular tasks required by the systems described herein. Training material, for example, may be submitted to certain foundational models to adjust the training of the foundational model for performing types of analyses described herein.

[0149] Multiple foundational model systems may be applied by the systems and methods described herein depending on context. The context, for example, may include type(s) of data and / or type(s) of response output desired. In another example, the context can include userbased context such as demographic information and / or medical diagnosis information. In some embodiments, a single foundational model system may be dynamically adapted to different forms of analyses requested by the systems and methods described herein using prompt engineering.

[0150] In operation 925, a remedy mode (e.g. one or more stimulation parameters) is selected (or identified) and communicated to a sleep apnea treatment device, such as any sleep apnea device or system as described throughout this disclosure, without limitation. A remedy mode includes, but is not limited to, electromagnetic stimulation, jaw vibration, jaw movement, or a combination thereof. The communication can occur over a wired communication link or a wireless communication link, such as via WI-FI, BLUETOOTH, ZIGBEE, NFC, or other wireless communication protocol. The sleep apnea device may be configured to active a remedy mode upon receiving the remedy mode from a wireless communication. The sleep apnea device can receive a remedy mode from, one or more of: a smart-watch, a smartphone, sleep tracking device (such as a FITBIT or SMART RING), other health monitoring device, laptop, server, and / or cloud-computing network.

[0151] FIG. 10 illustrates a bottom view of a first portion 1000 of the a sleep apnea device according to embodiments of the present disclosure. The embodiment of the first portion 1000 shown in FIG. 10 is for illustration only. Other embodiments can be used without departing from the scope of the present disclosure. The first portion 1000 of the sleep apnea device can be configured the same as, or similar to, the first portion 505a of the device 500.

[0152] The first portion 1000 includes an interior surface 1005 and an exterior surface 1010. The interior surface 1005 is disposed to be opposite the exterior surface 1010. In certain embodiments, the first portion 1000 includes microfluid injections 1015. The microfluid injections 1015 traverse a path between the interior surface 1005 and the exterior surface 1010 towards a front side of the first portion 1000. In certain embodiments, the microfluid injections 1015 are 3-D printed within a 3- D printed solid. In certain embodiments, the microfluid injections 1015 are injected or inserted into the first portion 1000. In certain embodiments microfluid injections 1015 include one or more conductive materials, such as copper, and / or aluminum. The microfluid injections 1015 can include one or more patterns such as, but not limited to, swirls, curves, and / or lines. In certain embodiments, the microfluid injections 1015 form a set of three swirls on a left side of the first portion 1000 and another set of three swirls on a right side of the first portion 1000, with a curved line connecting the two sets of three swirls. The sets of threes swirls can include conductive or magnetic material configured to generate, or interact with, one or more magnetic fields. In certain embodiments, the microfluid injections 1015 include four or more swirls. In certain embodiments, the microfluid injections 1015 include two or less swirls. Each swirl can be configured to act as an electromagnetic coil or magnetic component. Each swirl of microfluid injections 1015 can be configured to interact withone or more magnets of a second portion a sleep apnea device. For example, a second portion of the sleep apnea device can include one or more magnets that care configured to attract or repel one or more swirls of the microfluid injections 1015.

[0153] FIG. 11 illustrates a bottom view of another first portion 1100 of the sleep apnea device according to embodiments of the present disclosure. The embodiment of the first portion 1100 shown in FIG. 11 is for illustration only. Other embodiments can be used without departing from the scope of the present disclosure. The first portion 1100 of the sleep apnea device can be configured the same as, or similar to, the first portion 505a of the device 500.

[0154] The first portion 1100 includes an exterior surface 1105 and an interior surface 1110. In certain embodiments, the first portion 1 100 includes magnet 1115a and magnet 1115b. The magnet 1 1 15a can include a permanent, electromagnet, or other magnet. The magnet 1 115a can be positioned on a left side of the first portion 1100. The magnet 1115a can be angled or oriented to be parallel to the interior surface 1105 of the left side of the first portion 1100. The magnet 1115a can be shaped as a rectangle, square, circle, or other shape. In certain embodiments, first portion 1100 includes magnet 1115b. The magnet 1115b can be similar to that of magnet 1115a. In certain embodiments, the magnet 11 15b is positioned on a right side of the first portion 1100. The magnet 1115b can be oriented or angled to be parallel with an interior surface 1105 of the right side of the first portion 1100. The magnets 1115a-b can be positioned on a bottom surface of the first portion 1100. In certain embodiments, the magnets 1115a-b protrude from a bottom surface of the first portion 1 100. In certain embodiments, the magnets 1115a-b are enclosed by the bottom surface of the first portion 1100. The magnets 1115a-b can be configured to interact with one or more magnetic elements of a second portion of the sleep apnea device.

[0155] FIG. 12 illustrates a profile view of the sleep apnea device according to embodiments of the present disclosure. The embodiment of the sleep apnea device 1200 shown in FIG. 12 is for illustration only. Other embodiments can be used without departing from the scope of the present disclosure. The sleep apnea device 1200 can be configured the same as, or similar to, the sleep apnea device 500.

[0156] In certain embodiments, the sleep apnea device 1200 includes a first portion 1205 and a second portion 1210. The first portion 1205 can be the same as, or similar to, the first portion 1000 or the first portion 505a; and the second portion 1210 can be the same as, or similar to, the second portion 505b. The first portion 1205 can include magnet 1215a. The magnet 1215a can be shaped as a rectangle, square, circle, or other shape. In certain embodiments, themagnet 1215a is shaped rectangularly, with a long side running across an x-axis (i.e., a length of the first portion 1205) and a short side running across a y-axis (i.e., traverse to a length of the first portion 1205). The magnet 1215a can be positioned on a lateral surface of the first portion 1205, such as a left or right side. The magnet 1215a can be positioned on an exterior outer surface 1220 of the first portion 1205 and disposed to be proximate to a subject’s cheek when inserted in the subject’s mouth. In certain embodiments, the magnet 1215a is positioned towards a rear area of the first portion 1205 relative to a subject’s mouth.

[0157] In certain embodiments, the sleep apnea device 1200 includes magnet 1215b, which can be similar to that of magnet 1215a. For example, the magnet 1215b can have a rectangular shape similar to that of magnet 1215a. In certain embodiments, each of the magnets 1215a, 1215b have a same shape. In certain embodiments, a shape of the first magnet 1215a is different than a shape of the second magnet 1215b. The magnet 1215b can be disposed at a top surface of an exterior surface 1225 of the second portion 1210. The magnet 1215b can be positioned on an exterior outer surface 1225 of the second portion 1210 to be proximate to a subject’s cheek when inserted in the subject’s mouth. In certain embodiments, the magnet 1215b is positioned at a bottom, middle, or other surface of exterior surface 1225 of the second portion 1210. The magnet 1215b can be proximate to the magnet 1215a. For example, a top long side of magnet 1215b may be proximate to a bottom long side of magnet 1215a. The magnets 1215a, 1215b, are configured to adjust a positioning of the first portion 1205, the second portion 1210, or both, through magnetic forces.

[0158] FIG. 13 illustrates a profile view of the sleep apnea device according to embodiments of the present disclosure. The embodiment of the sleep apnea device 1300 shown in FIG. 13 is for illustration only. Other embodiments can be used without departing from the scope of the present disclosure. The sleep apnea device 1300 can be configured the same as, or similar to, the sleep apnea device 500 or sleep apnea device 1200.

[0159] In certain embodiments, the sleep apnea device 1300 includes a first portion 1305 and a second portion 1310. In certain embodiments, each of the first portion 1305 and the second portion 1310 may include a magnet, such as a magnet 1315a on the first portion 1305 and magnet 1315b on the second portion 1310. In certain embodiments, the magnet 1315a extends from the first portion 1305 towards the second portion 1310. The magnet 1315a can be positioned on an exterior surface 1320 of the first portion 1305 and the magnet 1315b can be positioned on the exterior surface 1325 of the second portion 1310. In certain embodiments, the magnet 1315b extends from the exterior portion 1320 of the first portion 1305 towards theexterior portion 1325 of the second portion 1310. In certain embodiments, the magnet 1315a and the magnet 1315b share an interface. In certain embodiments, the magnet 1315a and the magnet 1315b are housed within a shared interface. In certain embodiments, one or both of the magnet 1315a or the magnet 1315b is an electromagnet that is configured to generate one or more magnetic fields. In certain embodiments, the magnet 1315a is an electromagnet and the magnet 1315b is a permanent magnet, both of which are configured to repel or attract to one another. In certain embodiments, the magnet 1315b is an electromagnet and the magnet 1315a is a permanent magnet, both of which are configured to repel or attract to one another. For example, the magnet 1315a and the magnet 1315b share a magnetic interface. Such an interface can traverse along a length of the magnet 1315a and a length of the magnet 1315b.

[0160] In certain embodiments, the first portion 1305 includes magnet 1315a. In certain embodiments, the magnet 1315a has a triangular shape. In certain embodiments, the magnet 1315a has a right triangle shape. The magnet 1315a can be positioned on an exterior outer surface 1320 of the first portion 1305. In certain embodiments, the magnet 1315a is positioned between a front and rear of the exterior surface 1320 of the first portion 1305. The magnet 1315a can extend from the exterior surface 1320 of first portion 1305 to an exterior surface 1325 of the second portion 1310. For example, the magnet 1315a, having a triangular shape with one of its vertices directed toward the exterior surface 1325 of the second portion 1310 and a lateral edge opposite the at least one vertex disposed at the outer surface 1320 of the first portion 1305. In certain, the magnet 1315a is partially connected to the first portion 1 05 and the second portion 1310. The magnet 1315a can be fully connected to both the first portion 1305 and second portion 1310.

[0161] In certain embodiments, the second portion 1310 includes a magnet 1315b, which can be similar to that of magnet 1315a. In certain embodiments, the magnet 1315b has a triangular shape, such as a right triangle. The magnet 1315b can be oriented to be opposite to magnet 1315a, such as in a “flipped” position. The magnet 1315b can be positioned on an exterior outer surface 1325 of the second portion 1310. In certain embodiments, the magnet 1315b extends from the second portion 1310 to the first portion 1315. For example, the magnet 1315b can have a lateral leg edge of its right triangle disposed along a top portion of the second portion 1310 and extending to a vertex (opposite the lateral leg edge) positioned at a middle to lower portion of exterior surface 1325 of the first portion 1305. Each ninety-degree side of each right triangle of magnets 1315a, 1315b, can be positioned proximate to each other. In certainembodiments, magnets 1315a, 1315b, are spaced apart. In certain embodiments, the magnets 1315a, 1315b, are disposed to be in physical contact with each other when in use.

[0162] FIGS. 14A and 14B illustrate respective views of a sleep apnea device 1400 according to embodiments of the present disclosure. FIG. 14A illustrates a bottom of a top portion of the sleep apnea device 1400. FIG. 14B illustrates a rear perspective view of the top portion of the sleep apnea device 1400. The embodiment of the sleep apnea device 1400 shown in FIGS. 14A-14D are for illustration only. Other embodiments could be used without departing from the scope of the present disclosure. The sleep apnea device 1400 can be the same as, or similar to, the sleep apnea device 500, the sleep apnea device 1200, or the sleep apnea device 1300.

[0163] The sleep apnea device 1400 includes an interior surface 1405 and an exterior surface 1410, which may be similar to the interior oral surface 515 and the exterior oral surface 520 as described with reference to FIGS. 5A and 5B. In certain embodiments, the sleep apnea device 1400 includes a magnetic interface 1415. The magnetic interface 1415 can include a strip of magnet that may be oriented along a curve of a front end of the sleep apnea device 1400.

[0164] In certain embodiments, the sleep apnea device 1400 includes an exterior surface 1420 and an interior surface 1425. The exterior surface 1420 and the interior surface 1425 can be the same as the exterior oral surface 520 and the interior oral surface 515 as described above with reference to FIGS. 5A and 5B. In certain embodiments, the sleep apnea device 1400 includes a magnetic interface 1430. The magnetic interface 1430 can be shaped in a disk, circle, and / or other shape. In certain embodiments, the magnetic interface 1430 is positioned at a front of the sleep apnea device 1400 relative to a subject’s mouth. For example, the magnetic interface 1430 can be disposed to be at a front of the sleep apnea device 1400 and proximate to a front of the subject’s mouth, when inserted, such as at the point at which a left side and right side of the sleep apnea device 1400 convene. The magnetic interface 1430 is configured to generate one or more magnetic fields that can stimulate surrounding tissue of the subject’s mouth.

[0165] FIG. 15 illustrates a side view of another embodiment of the sleep apnea device 1500 according to embodiments of the present disclosure. The embodiment of the sleep apnea device 1500 shown in FIG. 15 is for illustration only. Other embodiments could be used without departing from the scope of the present disclosure. The sleep apnea device 1500 can be the same as, or similar to, the sleep apnea device 500, the sleep apnea device 1200, the sleep apnea device 1300, or the sleep apnea device 1400.

[0166] In certain embodiments, the sleep apnea device 1500 includes a first portion 1505 and the second portion 1510. The first portion 1505 and the second portion 1510 can be the same as the first portion 505a and the second portion 505b as described above with reference to FIGS. 5A and 5B. In certain embodiments, the sleep apnea device 1500 includes arm 1515. The arm 1515 can be disposed on an exterior surface 1520 of the first portion 1505. In certain embodiments, the arm 1515 has at least two components including: a sphere- like base 1525 and an extension 1530 (e.g., a rectangular extension). The arm 1515 can be formed from a rigid material. The arm 1515 can extend downwards relative to a top section of the exterior surface 1520 of the first portion 1505 such that a rectangular extensions 1530 of the arm 1515 extends downwards towards an exterior surface 1535 of the second portion 1510. In certain embodiments, the arm 1515 is moveable. For example, the arm 1515 enables a movement of a rectangular extension 1530 relative to the sphere-like base 1525. The arm 1515 can connect to magnet 1540. The magnet 1540 can include a magnetized element, such as, but not limited to, iron, copper, and / or other magnetic elements. The magnet 1540 can pass through rings 1545. The rings 1545 can include two or more rings. In certain embodiments, the sleep apnea device 1500 includes a single ring 1545. The rings 1545 can include a set of three rings that are disposed on the exterior surface 1535 of the second portion 1510. In certain embodiments, the rings 1545 are composed of or include a conductive material. In certain embodiments, the rings 1545 are electromagnetically controlled through the magnet 1540 or arm 1515, or both. For example, the arm 1515 can provide a current to magnet 1540, which can induce an electric current or magnetic field, or both, in rings 1545.

[0167] FIGS. 16A and 16B illustrate views of another sleep apnea device 1600 according to embodiments of the present disclosure. The embodiments of the sleep apnea device 1600 shown in FIG. 16A and 16B are for illustration only. Other embodiments could be used without departing from the scope of the present disclosure. The sleep apnea device 1600 can be the same as, or similar to, the sleep apnea device 500, the sleep apnea device 1200, the sleep apnea device 1300, the sleep apnea device 1400, or the sleep apnea device 1500.

[0168] Referring now to FIG. 16 A, in certain embodiments, the sleep apnea device 1600 includes the first portion 1605 and a second portion 1610. The first portion 1605 and the second portion 1610 can be the same as the first portion 505a and the second portion 505b as described above with reference to FIGS. 5 A and 5B. In certain embodiments, the first portion 1605 includes a linear actuator 1615. The linear actuator 1615 can be positioned on an exterior surface 1620 of the first portion 1605. In certain embodiments, the linear actuator 1615 includes anelectromechanical device configured to push or pull an element. The linear actuator 1615 can be connected to arm 1625. The arm 1625 can be made of a rigid material. The arm 1625 can be configured to extend and retract in response to forces applied by the linear actuator 1615. The second portion 1610 can include plate 1630. The plate 1630 can be positioned on an exterior surface 1635 of the second portion 1610. The plate 1630 can be positioned perpendicularly to the exterior surface 1635 of the second portion 1610. The plate 1630 can be configured to receive forces, such as mechanical forces, applied to the arm 1625 from the linear actuator 1615.

[0169] Referring now to FIG. 16B, in certain embodiments, the sleep apnea device includes the first portion 1605, the second portion 1610, the linear actuator 1615, arm 1625, and plate 1216B, each of which may operate as described above with reference to FIG. 16 A. The linear actuator 1615 can push against plate 1630, which can adjust a positioning between the first portion 1605 and the second portion 1610.

[0170] FIGS. 17A and 17B illustrate another sleep apnea device 1700 according to embodiments of the present disclosure. The embodiments of the sleep apnea device 1700 shown in FIG. 17A and 17B are for illustration only. Other embodiments could be used without departing from the scope of the present disclosure. The sleep apnea device 1700 can be the same as, or similar to, the sleep apnea device 500, the sleep apnea device 1200, the sleep apnea device 1300, the sleep apnea device 1400, the sleep apnea device 1500, or the sleep apnea device 1600.

[0171] In certain embodiments, the sleep apnea device 1700 includes an interior surface 1705 and an exterior surface 1710. The interior surface 1705 and the exterior surface 1710 can be the same as exterior oral surface 520 and interior oral surface 515 as described above with reference to FIGS. 5A and 5B. In certain embodiments, the sleep apnea device 1700 includes a bridge 1715. The bridge 1715 can be a rigid structure. The bridge 1715 is positioned at a front of the sleep apnea device 1700 relative to a subject’s mouth. The sleep apnea device 1700 includes a base that extends across a perimeter of a front surface of the sleep apnea device 1700. The sleep apnea device 1700 includes a top portion that extends away from the base portion. In certain embodiments, the sleep apnea device 1700 includes a first string 1720 and a second string 1725. The first string 1720 is positioned on a left side of the bridge 1715 and can connect a top portion of the bridge 1715 to a bottom portion of the sleep apnea device 1700. The second string 1725 is positioned on a right side of the bridge 1715 and can connect a top of the bridge 1715 to a second portion of the sleep apnea device 1700. The first string 1720 and second string 1725 are composed of or include an elastic material, such as rubber. In certain embodiments, the bridge 1715 includes tightener 1730. The tightener 1730 is configured to tighten strings 1720and 1725. The tightener 1730 is positioned near a top of bridge 1715. In certain embodiments, the tightener 1730 is configured to pull an end of one or both of the first string 1720 or the second string 1725.

[0172] In certain embodiments, the bridge 1715 is positioned on an external surface 1735 of the first portion 1705. The second portion 1705 includes anchor 1740. The anchor 1740 can include a loop, hook, adhesive, or other element configured to attach, string 1720 to anchor 1740. The anchor 1740 is positioned on exterior surface 1745 of the second portion 1710. Although not depicted, the second portion 1705 can include an additional anchor on the other side of the second portion configured to receive and secure the second string 1725. The first string 1720 is configured to travel from tightener 1730 or bridge 1715 downwards towards the external surface 1745 of the second portion 1710. The bridge 1715 extends away from the exterior surface 1735 of the first portion 1705. The bridge 1715 can be positioned at a center of a circumference of the first portion 1705. The bridge 1715 can be connected to the first string 1720. The second string 1720 can connect a portion of bridge 1715 to the second portion 1710. The bridge 1715 includes tightener 1730. The tightener 1730 can tighten string 1720, which may cause a movement of the second portion 1710 towards the first portion 1705.

[0173] FIG. 18 illustrates another example a first portion 1800 of the sleep apnea device according to embodiments of the present disclosure. The embodiment of the first portion 1800 shown in FIG. 18 is for illustration only. Other embodiments can be used without departing from the scope of the present disclosure. The first portion 1800 of the sleep apnea device can be configured the same as, or similar to, the first portion 505a of the sleep apnea device 500.

[0174] The first portion 1800 includes a first surface 1805, which can be form molded to match the teeth or bite of the wearer. The first surface includes a wire or conductor 1810. In certain embodiments, the conductor 1810 is enclosed within a housing 1815 of the first portion 1800. In certain embodiments, the conductor 1810 is disposed on a surface of the housing 1815.

[0175] The conductor 1810 is configured to receive a signal, such as electrical energy, and emit a stimulating signal, such as a pulsed electromagnetic field (PEMF) 1820. In certain embodiments, the conductor 1810 is oriented or configured to direct the PEMF 1820 to a particular region, such as the hypoglossal nerve or other muscle tissue of the wearer. The first portion 1800, as well as any other first portion described throughout this disclosure, may have interior outer surface 1825 and / or exterior outer surface 1830, each of which may be as described above with reference to FIG. 5 A. For instance, the interior outer surface 1825 may be disposed to contact the interior of the mouth (behind the teeth and / or adjacent the tongue) whenin use — i.e., the interior outer surface 1825 is proximate to an interior of a mouth of a subject.The exterior outer surface 1830 may be disposed to be proximate to a check and / or lips of a user when in use.Examples

[0176] The following is meant to provide high level examples of use cases and workings of the above described midcourse and is not meant to limit the disclosure as described above.Operation

[0177] In some embodiments, the device described above uses inductively coupled pulsed electromagnetic stimulation using noncontact coils to activate the hypoglossal nerve tissue. The device creates a magnetic field following the principles of Faraday’s Law. Therefore, the magnetic flux created by the device changes (pulsed) through time to produce maximal electrical induction. The device may interrupt the flow of current in the coil to disrupt the magnetic field. This momentary decrease and / or depletion of magnetic field may create an environment in which the magnetic flux is in constant change. This time varying magnetic field is able to induce an electrical change without contact in distance biological tissue.

[0178] An electrical field is induced in the nerve tissue by magnetic stimulation. Peripheral axons can be stimulated through a depolarizing event caused by the magnetic stimulation. In this depolarization event the electrical field (induced by magnetic stimulation) leads voltage-gated sodium channels to open for intracellular sodium leading to a further depolarization of downstream activated neurons in this case towards the muscular tissue of a motor neuron. This depolarization of motor neurons will lead to a supramaximal contraction. Since other body tissue has weak conductive properties (like that of skin, fat, bone) the electromagnetic field induces a current selective for the muscle layer. The individual field strength required for each nerve will depend on the individuals’ nerve. Additionally, a decay in the field strength occurs with increasing distance from the coil.

[0179] The magnitude of the time varying magnetic field declines as the distance to the hypoglossal nerve increases. As the anatomy of each patient is different from the hypoglossal nerve to the outer surface of the submental / neck area, the device has varying degrees of strength output. The final output strength from the device is the magnitude of the time varying magnetic field. This strength variable is able to be controlled by the patient and / or the treating physician. A manual or electronic control (ie. on smartphone / digital device) can allow the range of strength to be limited to a specific amount. Likely a physician can identify a range that is optimal on a per patient basis, yet still allow the patient to control fine tuning of the strength. For example,sleep apnea is known to be worse if patients consume alcohol, gain weight, lose muscle tone, or take sedative / hypnotic medications. These transient conditions will lead to changes in night-to- night variability of sleep apnea. In addition, for comfort patients will be able to have the perceived control and ability to fine tune to their personal preferences. Ultimately, the final output strength will be a key variable that the patient and / or clinical provider can access and change.

[0180] Using DC or AC current, the pulses of electricity through a coil will lead to the time varying magnetic field. The properties of the coil are an important consideration of the output strength to affect the neuromuscular tissue. Following Maxwell’s equations, coil material and thickness and ferromagnetically active core material have been tested. The coil has a comfortable housing around it to ensure patient safety and comfort.

[0181] The device can be tethered to a bedside box (coil tethered to stimulation generator) or standalone (coil with stimulation generator in same housing). The tethered version could be a box place on the bedside or the box could be situated or strapped to the patient around a limb or facial / head area or chest. Any or all versions may be configured to provide biometric sensing data from patients while device is in use. The biometric sensing data may be used to provide the device with specific frequency and stimulation controls that are based on the biometric sensing data and sleep patterns of the patient.Data Capture and Processing

[0182] Data can he captured by the device to personalize the treatment, reduce battery consumption, improve comfort, and increase effectiveness of the treatment. Pulse oximetry may be built into the device to take measurements from underneath the chin. In another embodiment the device that has the coil tethered to the stimulation generator placed on the arm / hand may take pulse oximetry data from the gold standard method on the finger using traditional methods. The pulse oximetry signals may be high resolution (<ls time points of data capture) to lower resolution (10s time points of data capture). Another specific data source may be audio taken from a microphone within the device or from a smart phone or dedicated bedside box. This information after data processing can allow for the timing of respiration and identification of hypopnea / apneic events. Another specific data source is heart rate and pulse that will be captured from the device. Other biometric sensors may be placed on the device or smart phone or dedicated box. The data will be collated on the cloud, smart phone, or dedicated box. To conserve energy the device may intermittently transmit data to be collated and later processed. Raw data will be pre-processed to improve data management and accuracy / validity of data.Steps to processing may include data cleaning, integrating, altering, and organizing. Al and other data processing will be used to provide stimulation patterns and / or real-time stimulation control to activate the device.Additional Embodiments

[0183] Additional embodiments of the present disclosure may include the following:1. A device for treating a sleep disorder, the device comprising: a stimulator configured to emit a magnetic field towards a neck region within a human body , the magnetic field configured to cause a reaction of one or more tissues within the human body; a housing storing the stimulator, wherein the housing includes a first surface configured to externally engage the neck region of the human body and physically isolate the stimulator from contacting the human body; and at least one sensor configured to monitor a biometric parameter of the human body.2. The device of claim 1, further comprising: a processor in communication with the stimulator and the at least one sensor, wherein the processor is configured to control an operation of the stimulator based on the biometric parameter.3. The device of claim 2, wherein the processor is configured to set a mode of operation of the stimulator based on the biometric parameter.4. The device of claim 2, wherein processor is configured to utilize an artificial intelligence (Al) or machine learning to adjust at least one operational parameter of the stimulator based on a result of a previous treatment.5. The device of claim 1, wherein the stimulator is configured to emit the signal at a specified range between 0 Hz and 30 KHz.6. The device of claim 1, further comprising: an interface configured to transmit and receive data via a wired or wireless communication from at least one of: an external computing device; a health monitoring device; a sleep monitoring device; a fitness tracker; a smartphone, a smart watch, or smart ring.7. The device of claim 1, wherein the housing comprises flexible or rigid material and a form factor that is at least one of: dimensioned to be held by a human hand; dimensioned to couple to a chin of the human body; or dimensioned to be inserted into a mouth of the human body.8. A system for treating a sleep disorder, the system comprising:a signal emitting device configured to externally engage a first portion of a human body and to emit an electronic signal towards a region within the human body proximate to the first portion, the electronic signal configured to cause a reaction of one or more tissues within the human body; one or more sensors configured to monitor a number of biometric parameters of the human body before, after, and while the signal emitting device is emitting the electronic signal; and a control device configured to control an operation of the signal emitting device.9. The system of claim 8, wherein the control device comprises: a processor configured to control an operation of the signal emitting device.10. The system of claim 9, wherein at least one of: the processor is configured to set a mode of operation of the signal emitting device based on the biometric parameter; or the processor is configured to control operation of the signal emitting device based on a plurality of different types of biometric values.11. The system of claim 9, wherein processor is configured to utilize an artificial intelligence (Al) or machine learning to adjust at least one operational parameter of the signal emitting device based on a result of a previous treatment.12. The system of claim 9, further comprising a communication circuit configured to communicatively couple the control device to the signal emitting device and to relay signals from the processor to the signal emitting device, wherein the wired or wireless communication comprises at least one of: a cloud based communication;WI-FI;BLUETOOTH;ZIGBEE; near field communication (NFC);Global System for Mobile communication (GSM); or optical.13. The system of claim 8, wherein at least one of the one or more sensors is contained within one of: the signal emitting device; the control device; a smartphone; a smart-watch; ora health monitoring device.14. The system of claim 8, wherein the emitting device comprises a housing configured to isolate the signal emitting device from physically contacting the human body; and wherein the housing comprises a form factor that is at least one of: dimensioned to be held by a human hand; dimensioned to couple to a chin of the human body; or dimensioned to be inserted into a mouth of the human body.15. A method for treating a sleep disorder, the method comprising: externally engaging a first portion of a human body; monitoring at least one biometric parameter of the human body; and in response to the at least one biometric parameter exceeding a threshold, automatically emitting an electronic signal, from a stimulator physically isolated from the human body, towards a region within the human body proximate to the first portion, the electronic signal configured to cause a reaction of one or more tissues within the human body.16. The method of claim 15, further comprising: controlling an operation of the stimulator by controlling at least one of: a duty cycle; a clock frequency; or a signal frequency.17. The method of claim 15, further comprising: measuring a biological parameter related to the human body; and setting a mode of operation of the stimulator based on the biological parameter.18. The method of claim 17, further comprising: using an artificial intelligence (Al) or machine learning to adjust at least one operational parameter of the stimulator based on a result of a previous treatment.19. The method of claim 15, further comprising: communicating data via a wired or wireless communication from an external computing device.20. The method of claim 15, wherein emitting an electronic signal to cause the reaction of one or more tissues comprises at least one of: stimulating a hypoglossal nerve; stimulating one or more tissues to move a jaw of the human body; or causing muscles corresponding to the jaw to relax.21. Software related implementations of the techniques described herein may include, but are not limited to, firmware, application specific software, or any other type of computer readable instructions that may be executed by one or more processors. Hardware relatedimplementations of the techniques described herein may include, but are not limited to, integrated circuits (ICs), application specific ICs (ASICs), field programmable arrays (FPGAs), and / or programmable logic devices (PLDs). In some examples, the techniques described herein, and / or any system or constituent component described herein may be implemented with a processor executing computer readable instructions stored on one or more memory components.

[0184] Certain examples of the present disclosure were described above. It is, however, expressly noted that the present disclosure is not limited to those examples, but rather the intention is that additions and modifications to what was expressly described herein are also included within the scope of the disclosed examples. Moreover, it is to be understood that the features of the various examples described herein were not mutually exclusive and may exist in various combinations and permutations, even if such combinations or permutations were not made express herein, without departing from the spirit and scope of the disclosed examples. In fact, variations, modifications, and other implementations of what was described herein will occur to those of ordinary skill in the art without departing from the spirit and the scope of the disclosed examples. As such, the disclosed examples are not to be defined only by the preceding illustrative description.

[0185] Program aspects of the technology may be thought of as “products” or “articles of manufacture” typically in the form of executable code and / or associated data that is carried on or embodied in a type of non-transitory, machine readable medium. Storage type media include any or all of the tangible memory of the computers, processors or the like, or associated modules thereof, such as various semiconductor memories, tape drives, disk drives and the like, which may provide non-transitory storage at any time for the software programming. It is emphasized that the Abstract of the Disclosure is provided to allow a reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, various features are grouped together in a single example for streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed examples require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed example. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate example. In the appended claims, the terms "including" and "in which" are used as the plain-English equivalents of the respective terms "comprising" and "wherein," respectively. Moreover, the terms "first," "second," "third,"and so forth, are used merely as labels and are not intended to impose numerical requirements on their objects.

[0186] Although the present disclosure has been described with an exemplary embodiment, various changes and modifications may be suggested to one skilled in the art. It is intended that the present disclosure encompass such changes and modifications as fall within the scope of the appended claims. None of the description in this application should be read as implying that any particular element, step, or function is an essential element that must be included in the claims scope.

[0187] Software related implementations of the techniques described herein may include, but are not limited to, firmware, application specific software, or any other type of computer readable instructions that may be executed by one or more processors. Hardware related implementations of the techniques described herein may include, but are not limited to, integrated circuits (ICs), application specific ICs (ASICs), field programmable arrays (FPGAs), and / or programmable logic devices (PLDs). In some examples, the techniques described herein, and / or any system or constituent component described herein may be implemented with a processor executing computer readable instructions stored on one or more memory components.

[0188] Some examples of the disclosed device may be implemented, for example, using a storage medium, a computer-readable medium, or an article of manufacture which may store an instruction or a set of instructions that, if executed by a machine (i.e., processor or microcontroller), may cause the machine to perform a method and / or operation in accordance with examples of the disclosure. Such a machine may include, for example, processing platform, computing platform, computing device, processing device, computing system, processing system, computer, and / or processor and may be implemented using various combination of hardware and / or software. The computer-readable medium or article may include, for example, one or more types type of memory unit, memory (e.g. non-transitory and / or non-volatile memory), memory article, memory medium, storage device, storage article, storage medium and / or storage unit, removable or non-removable media, erasable or non-erasable media, writeable or re-writeable media, digital or analog media, hard disk, floppy disk, Compact Disk Read Only Memory (CD-ROM), Compact Disk Recordable (CD-R), Compact Disk Rewriteable (CD-RW), optical disk, magnetic media, magneto-optical media, removable memory cards or disks, various types of Digital Versatile Disk (DVD), a tape, and / or a cassette. The instructions may include any suitable type of code, such as source code, compiled code, interpreted code, executable code, static code, dynamic code, encrypted code, programming code, and the like,implemented using, in some examples, a high-level, low-level, object-oriented, visual, compiled and / or interpreted programming language. The non-transitory computer readable medium embodied programming code may cause a processor when executing the programming code to perform functions, such as those described herein.

[0189] Certain examples of the present disclosure were described above. It is, however, expressly noted that the present disclosure is not limited to those examples, but rather the intention is that additions and modifications to what was expressly described herein are also included within the scope of the disclosed examples. Moreover, it is to be understood that the features of the various examples described herein were not mutually exclusive and may exist in various combinations and permutations, even if such combinations or permutations were not made express herein, without departing from the spirit and scope of the disclosed examples. In fact, variations, modifications, and other implementations of what was described herein will occur to those of ordinary skill in the art without departing from the spirit and the scope of the disclosed examples. As such, the disclosed examples are not to be defined only by the preceding illustrative description.

[0190] Program aspects of the technology may be thought of as “products” or “articles of manufacture” typically in the form of executable code and / or associated data that is carried on or embodied in a type of non-transitory, machine readable medium. Storage type media include any or all of the tangible memory of the computers, processors or the like, or associated modules thereof, such as various semiconductor memories, tape drives, disk drives and the like, which may provide non-transitory storage at any time for the software programming. It is emphasized that the Abstract of the Disclosure is provided to allow a reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, various features are grouped together in a single example for streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed examples require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed example. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate example. In the appended claims, the terms "including" and "in which" are used as the plain-English equivalents of the respective terms "comprising" and "wherein," respectively. Moreover, the terms "first," "second," "third,"and so forth, are used merely as labels and are not intended to impose numerical requirements on their objects.

Claims

CLAIMSWhat is claimed is:

1. A device for treating sleep apnea, comprising: a housing comprising: a contact surface, wherein the housing is configured to removably engage with skin of a user through the contact surface; a bottom surface; a curved surface connecting the contact surface to the bottom surface; a single stimulator located more proximate to the contact surface relative to the bottom surface, the single stimulator configured to produce a magnetic field that contracts a pharyngeal tissue, a tongue, or other dilator muscle of the user or a combination thereof; a sensor configured to detect a biological signal indicative of an apneic event of the user; and a control suite in communication with the single stimulator and the sensor, wherein the control suite is configured to receive the biological signal from the sensor and activate the single stimulator based on the biological signal, thereby contracting the pharyngeal tissue, tongue, or other dilator muscle.

2. The device of claim 1 , wherein the control suite is stored within the housing.

3. The device of claim 1, wherein the control suite is located external to the housing.

4. The device of claim 1, wherein the control suite is further configured to adjust a frequency of the magnetic field based on the biological signal.

5. The device of claim 1, wherein the magnetic field produced by the single stimulator interacts with a hypoglossal nerve of the user.

6. The device of claim 1, wherein the control suite is further configured to select a remedy mode based on the biological signal and activate the single stimulator based on the selected remedy mode.

7. The device of claim 1, wherein the magnetic field has a frequency of about 0 Hz to about 30 KHz.

8. The device of claim 1, wherein the control suite is in communication with an external computing device through a wireless connection.

9. The device of claim 8, wherein the control suite is further configured to communicate the biological signal and parameters of the single stimulator to the external computing device through the wireless connection.

10. The device of claim 1, wherein the control suite is further configured to utilize a machine learning model to select parameters of operation of the single stimulator.

11. The device of claim 1 , wherein the housing comprises: a butterfly structure, the butterfly structure including a first housing element and a second housing element joined to the first housing element.

12. The device of claim 1, wherein the single stimulator is a coil.

13. The device of claim 1, wherein a diameter of the contact surface or the bottom surface is greater than a height of the curved surface.

14. A method of treating sleep apnea, comprising: securing a sleep apnea device to a user, wherein the sleep apnea device is positioned on a neck region of the user, the sleep apnea device comprising: a housing comprising: a contact surface, wherein the housing is configured to removably engage with skin of a user through the contact surface; a bottom surface; a curved surface connecting the contact surface to the bottom surface; a single stimulator located more proximate to the contact surface relative to the bottom surface, the single stimulator configured to produce a magnetic field that contracts a pharyngeal tissue, a tongue, or other dilator muscle of the user or a combination thereof; receiving, through a sensor, a biological signal indicative of an apneic event of the user; determining, by a control suite, a parameter of stimulation based on the biological signal; and stimulating, by the simulator, a pharyngeal tissue, a tongue, or other dilator muscle of the user or a combination thereof through a magnetic field produced by the stimulator.

15. The method of claim 14, wherein the control suite is stored within the housing.

16. The method of claim 14, wherein the control suite is located external to the housing.

17. The method of claim 14, wherein securing further comprises applying an adhesive of the sleep apnea device to the neck region of the user and the single simulator is positioned underneath a chin of the user.

18. The method of claim 14, further comprising adjusting, by the control suite, a frequency of the magnetic field based on the biological signal.

19. The method of claim 14, wherein the magnetic field produced by the single stimulator interacts with a hypoglossal nerve of the user.

20. The method of claim 14, further comprising selecting, by the control suite, a remedy mode based on the biological signal and activating the electromagnetic stimulator based on the selected remedy mode.21 . The method of claim 14, wherein the magnetic field has a frequency of about 0 Hz to about 30 KHz.

22. The method of claim 14, wherein the control suite is in communication with an external computing device through a wireless connection.

23. The method of claim 22, further comprising communicating, by the control suite, the biological signal and parameters of the single stimulator to the external computing device through the wireless connection.

24. The method of claim 14, further comprising selecting, by the control suite, parameters of operation of the single stimulator through a machine learning model.

25. An apparatus for treating sleep apnea, the apparatus comprising: a first portion comprising: a first housing comprising a top tooth tray form factor, the first housing having an outer surface, an inner surface, and an interior, the inner surface proximate to teeth when in use, the outer surface having an interior outer surface proximate to the interior of the mouth and an exterior outer surface proximate to at least one of a cheek, upper lips, or both, when in use; an electromagnetic stimulator disposed within the interior of the first housing and configured to contract a pharyngeal tissue, a tongue, or other dilator muscle, or a combination thereof, wherein the contraction is configured to cause an opening of an upper airway by wirelessly stimulating a soft palate; and a first protrusion extending from the outer surface of the first housing; a second portion, comprising:a second housing comprising a bottom tooth tray form factor; and a second protrusion extending externally from an outer surface of the second housing, wherein the second protrusion is configured to at least one of mechanically fix or adjust a positioning of the lower jaw of the user in cooperation with the first protrusion; a biological sensor configured to detect a biological signal indicative of an apneic event; and a control suite in communication with the electromagnetic stimulator and configured to receive the biological signal from the biological sensor and stimulate the soft palate or the tongue by adjusting or activating the electromagnetic stimulator.

26. An apparatus for treating sleep apnea, the apparatus comprising: a first portion comprising: a first housing shaped as a top tooth tray and having an outer surface, an inner surface, an interior, the inner surface proximate to teeth when in use, and the outer surface having an interior outer surface proximate to the interior of the mouth and an exterior outer surface proximate to a cheek and / or upper lips when in use; and a first protrusion extending from the outer surface of the first housing and comprising a magnet; a second portion comprising: a second housing shaped as a bottom tooth tray; and a second protrusion extending from the outer surface of the second housing and comprising a magnet oriented towards the first protrusion, wherein the magnets of the first and second protrusions are configured to at least one of magnetically adjust or fix a positioning of a lower jaw relative to a relaxed jaw position of the lower jaw; a control suite electronically connected to the magnets, the control suite adapted to adjust the magnet of the second protrusion to move the second protrusion in any one or more directions relative to the first protrusion; and a biological sensor configured to detect a biological signal indicative of an apneic event, wherein the adjustment of the magnets is based on the apneic event.

27. The apparatus of claim 25 or claim 26, wherein the control suite is further configured to: activate a remedy mode based on the detected biological signal.

28. The apparatus of any of claims 25-27, wherein the biological sensor is located on any one of the first portion, second portion, or control suite.

29. The apparatus of any of claims 25-28, wherein the control suite is positioned outside the exterior of the first portion through a sensor extension removably attachable to the first portion.

30. The apparatus of any of claims 25-29, wherein the control suite is further adapted to vibrate a portion of a jaw of the user through the first protrusion or the second protrusion based on the detected biological signal.

31. The apparatus of any of claims 29-30, wherein the control suite is further configured to communicate the biological signal to a computing device, wherein the computing device is configured to: determine a remedy mode; and communicate the remedy mode to the control suite.

32. The apparatus of claim 31, wherein the computing device is configured to determine the remedy mode utilizing a remedy mode machine learning model, wherein utilizing a remedy mode machine learning model comprises: receiving training data correlating biological signals to remedy modes; training the remedy mode machine learning model with the training data; and determining a remedy mode based on the trained remedy mode machine learning model.

33. The apparatus of any of claims 25-32, wherein the first portion further comprises a respiratory sensor positioned in an interior of the housing of the first portion, the respiratory sensor in electronic communication with the control suite.

34. The apparatus of any of claims 25-33, wherein the control suite is further configured to: determine a sleep stage of the user based on the biological signal; and activate a remedy mode based on the determined sleep stage of the user.

35. A method of treating sleep apnea, the method comprising: detecting, through a sensing device of a first portion of a mouth retainer, a biological signal of a user; calculating, through a control suite of the mouth retainer, a remedy mode for the user; and activating, through the control suite, the remedy mode for the user, wherein activation of the remedy mode includes one or more of:wirelessly stimulating a soft palate of an upper jaw of the user through an electromagnetic stimulator of the first portion of the mouth retainer; adjusting an upper jaw positioning of the user through a first protrusion positioned on an exterior of an upper portion of the mouth retainer; adjusting a lower jaw positioning of the user through a second protrusion positioned on an exterior of a lower portion of the mouth retainer; and vibrating a portion of a jaw of the user through the upper portion of the mouth retainer or the lower portion of the mouth retainer.

36. The method of claim 35, wherein activation of the remedy mode includes adjusting an upper jaw positioning of the user through a protrusion positioned on an outer surface of the first portion of the mouth retainer.

37. The method of any of claims 35-36, wherein activation of the remedy mode includes adjusting a lower jaw positioning of the user through a second protrusion positioned on an outer surface of a second portion of the mouth retainer.

38. The method of any of claims 35-37, activating the remedy mode includes vibrating a portion of a jaw of the user through a first protrusion located on an outer surface of the first portion of the mouth retainer or a second protrusion located on an outer surface of a second portion of the mouth retainer.

39. The method of any of claims 37-38, wherein calculating the remedy mode further comprises: receiving training data correlating biological signals to activity modes; training a remedy mode machine learning model with the training data; and determining a remedy mode based on the trained remedy mode machine learning model.

40. The method of claim 39, wherein the training data is generated from data of previous users.

41. The method of any of claims 35-40, wherein calculating the remedy mode further comprises: determining, through the control suite a sleep stage of the user based on the biological signal; and activating the remedy mode based on the determined sleep stage of the user.

42. The method of any of claims 35-41, further comprising determining a remedy mode for the user based on the biological signal.

43. The method of any of claims 35-42, further comprising communicating a biological parameter to a computing device, wherein the computing device determines a remedy mode for the user based on the biological signal.

44. The method of any of claims 35-43, wherein activating the remedy mode for the user further comprises: calculating a respiratory rhythm of the user based on the biological parameter; and activating the remedy mode based on the respiratory rhythm of the user.

45. A system for treating sleep apnea, the system comprising: a mouth retainer having a first portion comprising a first housing shaped as a top tooth tray having an outer surface, an inner surface, an interior, the inner surface proximate to teeth when in use, and the outer surface having an interior outer surface proximate to the interior of the mouth and an exterior outer surface proximate to a cheek and / or upper lips when in use; an electromagnetic stimulator in the interior of the first housing configured to contract a user’s pharyngeal tissue thereby opening an upper airway of the user by wirelessly stimulating the a soft palate of the user; and a first protrusion extending from the exterior outer surface of the first housing; a second portion comprising a second housing shaped as a bottom tooth tray having an outer surface, an inner surface, an interior, the inner surface proximate to teeth when in use, and the outer surface having an interior outer surface proximate to the tongue and an exterior outer surface proximate to the cheek and / or lower lips when in use; a second protrusion extending from the outer surface of the second housing; a biological sensor configured to detect a biological signal indicative of an apneic event; a control suite electronically connected to the electromagnetic stimulator configured to receive the biological signal from the sensor and stimulate the user’ s soft palate by adjusting or activating the electromagnetic stimulator; and a computing device in communication with the control suite, wherein the computing device is configured to: receive the biological signal from the control suite; determine a remedy mode based on the biological signal; and communicate the remedy mode to the control suite.

46. The system of claim 45, wherein a remedy mode includes one of activating the electromagnetic stimulator, fixing and / or adjust a positioning of the lower jaw of the user through cooperation of the second protrusion with the first protrusion relative to a relaxed jaw position of the lower jaw of the user, or vibrating the lower jaw of the user through the second protrusion.

47. The system of any of claims 45-46, wherein the biological signal includes one of blood oxygen levels, noise, blood pressure, blood flow, pulse, position, monitoring of body structures, temperature, electromagnetic flux, muscular activity, air flow, air pressure, moisture content, mineral / chemical content, or movement of a user.

48. The system of any of claims 41-43, wherein the mouth retainer comprises any of the apparatuses of claims 21 -30.

49. The system of any of claims 41-44, wherein the remedy mode is configured to assist with one of dysphagia, muscle rehabilitation, muscle toning, oral / head / neck cancer rehabilitation, TMJ surgery rehabilitation, TMJ rehabilitation, or salivary function.

50. The system of any of claims 41-45, wherein the mouth retainer is 3-D printed.

51. The system of any of claims 41-46, wherein the first housing further comprises a microfluid channel.

52. An apparatus for treating sleep apnea, the apparatus comprising: a wearable housing comprising a contact surface, wherein the wearable housing is configured to removably engage with skin of a chin and / or neck of a wearer at least at the contact surface, and a stimulator configured to produce a magnetic field directed through the contact surface of the wearable housing; and a control unit in communication with the stimulator and at least one sensor, wherein each sensor of the at least one sensor is configured to produce a plurality of signals indicative of i) one or more biometric measurements of the wearer or ii) one or more environmental measurements corresponding to an environment of the wearer, wherein the control unit is configured to analyze the plurality of signals of each respective sensor of the at least one sensor to detect at least one of an apneic event or a hypoxic condition of the wearer, and responsive to detecting the at least one of the apneic event or the hypoxic condition, activate the stimulator to produce the magnetic field, whereinthe magnetic field is configured to deliver functional electric stimulation to at least one of a) one or more tissues or b) one or more nerves of the wearer, thereby causing contraction of at least one of a phalangeal tissue, a tongue, or another dilator muscle of the wearer.

53. The apparatus of claim 52, wherein at least a portion of the control unit is disposed within the wearable housing.

54. The apparatus of claim 52, wherein the control unit is located external to the wearable housing.

55. The apparatus of claim 54, wherein the wearable housing is connected to the control unit by a wired connection.

56. The apparatus of claim 52, wherein the control unit is further configured to determine, based at least in part on the plurality of signals, one or more stimulation parameters for producing the magnetic field, wherein: the one or more stimulation parameters comprise at least one of one or more frequencies, a frequency range, a frequency pattern, a pulse duration, a duration of stimulation therapy, a power, a strength, an amplitude, a collapsible size of a coil of the stimulator, a focal point adjustment, a transmission range, a depth of penetration, and / or one or more pulse parameters; and activating the stimulator comprises causing the stimulator to produce the magnetic field according to the one or more stimulation parameters.

57. The apparatus of claim 56, wherein the control unit is further configured to: receive, from each sensor of one or more sensors of the at least one sensor, a respective further plurality of signals; analyze the further plurality of signals from each sensor of the one or more sensors; responsive to the analyzing, adjust at least one stimulation parameter of the one or more stimulation parameters; and cause the stimulator to produce an adjusted magnetic field according to the at least one adjusted stimulation parameter.

58. The apparatus of claim 56, wherein determining the one or more stimulation parameters comprises applying one or more artificial intelligence and / or machine learning models to the plurality of signals to determine at least one stimulation parameter of the one or more stimulation parameters.

59. The apparatus of claim 52, wherein the functional electric stimulation stimulates a hypoglossal nerve of the wearer.

60. The apparatus of claim 52, wherein the control unit is further configured to select, based at least in part on the plurality of signals, a remedy mode of a set of remedy modes, wherein activating the stimulator comprises causing the stimulator to produce the magnetic field according to the remedy mode.

61. The apparatus of claim 52, wherein the magnetic field has a frequency of about 5 Hz to about 30 KHz.

62. The apparatus of claim 52, wherein the magnetic field has a frequency of about 2 MHz to about 8 MHz.

63. The apparatus of claim 52, further comprising the at least one sensor.

64. The apparatus of claim 52, wherein: an external computing device comprises one or more sensors of the at least one sensor; and the control unit is in communication with the external computing device through a wireless connection to receive the plurality of signals of each respective sensor of the one or more sensors.

65. The apparatus of claim 52, wherein at least a portion of the control unit is configured to execute on one or more processors of a remote networked computing system.

66. The apparatus of claim 52, wherein the wearable housing comprises a first housing portion adjacent to a second housing portion, wherein: the first housing portion comprises a first contact region of the contact surface; and the second housing portion comprises a second contact region of the contact surface.

67. The apparatus of claim 66, wherein the stimulator comprises a butterfly coil having a first lobe of coil disposed in the first housing portion and a second lobe of coil disposed in the second housing portion.

68. The apparatus of claim 66, wherein the stimulator comprises a first emitting element and a second emitting element, each emitting element comprising a coil, wherein: the coil of the first emitting element is disposed in the first housing portion; and the coil of the second emitting element is disposed in the second housing portion.

69. A method of treating sleep apnea, the method comprising:by one or more processors, receiving, from each respective sensor of at least one sensor, a respective plurality of sensor signals, each respective sensor configured to monitor a biometric parameter of a wearer of a sleep apnea device or an environmental parameter; analyzing, by the one or more processors, the plurality of signals of each respective sensor of the at least one sensor to identify an indication of an apneic event or a hypoxic condition; and responsive to detecting the at least one of the apneic event or the hypoxic condition, activating, by the one or more processors, a stimulator disposed in a housing of the sleep apnea device to produce a magnetic field directed through a contact surface of the housing, wherein the contact surface is disposed against skin of a neck and / or a chin of the wearer, and the magnetic field is configured to deliver functional electric stimulation to at least one of a) one or more tissues or b) one or more nerves of the wearer, thereby causing contraction of at least one of a phalangeal tissue, a tongue, or another dilator muscle of the wearer.

70. The method of claim 69, further comprising, based on at least a portion of the plurality of signals of one or more sensors of the at least one sensor, determining, by the one or more processors, at least one stimulation parameter, wherein activating the stimulator comprises activating the stimulator to produce the magnetic field according to the at least one stimulation parameter.

71. The method of claim 69, wherein the environmental parameter comprises ambient noise or ambient temperature.

72. The method of claim 69, wherein the biometric parameter comprises blood oxygen level, pulse, pulse oximetry, heart rate, or respiratory rate.

73. The method of claim 69, wherein: the stimulator is a first stimulator; the sleep apnea device comprises a second stimulator; and the method further comprises selecting the first stimulator and / or the second stimulator for the activating.

74. The method of claim 69, further comprising determining, based at least in part on a portion of the plurality of signals of one or more sensors of the at least one sensor, a remedy mode of a set of remedy modes, wherein the first stimulator and / or the second stimulator is selected based at least in part on the remedy mode.

75. The method of claim 69, wherein the magnetic field has a frequency of about 2 MHz to about 8 MHz.

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