CN114641235A

CN114641235A - Intraoral electroencephalographic apparatus and method

Info

Publication number: CN114641235A
Application number: CN202080077113.5A
Authority: CN
Inventors: R·拉德曼德
Original assignee: INVENTIVE MEDICAL DEVICES LLC
Current assignee: INVENTIVE MEDICAL DEVICES LLC
Priority date: 2019-11-04
Filing date: 2020-02-04
Publication date: 2022-06-17
Also published as: EP4054420A1; WO2021091583A1; CA3156309A1; AU2020378954A1; EP4054420A4

Abstract

An oral device for wearing on the upper dentition of a user includes electrodes and a microprocessor which function as an electroencephalograph for detecting electrical activity in the brain of the user. The oral device can be used in a variety of applications such as sports, games and personal preferences.

Description

Intraoral electroencephalographic apparatus and method

Cross Reference to Related Applications

This application is a continuation-in-part application of U.S. application No.16/673,077 filed on day 4, 11, 2019, No.16/673,077 is a continuation-in-part application of U.S. application No.16/202,204 filed on day 28, 11, 2018, No.16/202,204 is a continuation-in-part application of U.S. application No.15/479,737 filed on day 5, 4, 2017, and No.15/479,737 claims the benefit of U.S. provisional No.62/319,443 filed on day 7, 4, 2016. Each of these applications is incorporated by reference herein in its entirety.

Background

Sleep apnea is a common medical condition during which a person experiences one or more apneas, and in some cases, shallow breaths during sleep. Although there are several types of sleep apnea, the most common type is obstructive sleep apnea. In such medical conditions, one or more of the throat muscles of the patient relax during sleep, causing the surrounding tissues of the mouth, nasal cavity, and back of the throat to collapse, creating a pharyngeal obstruction that can obstruct the upper airway. People with obstructive sleep apnea have insufficient oxygen exchange during sleep, which can lead to daytime fatigue, inattention and mood changes. If not treated in time, obstructive sleep apnea can have a significant impact on human health, often leading to cardiovascular, stroke, and metabolic disease.

Known methods of treating obstructive sleep apnea include surgical and non-surgical means. One popular surgical procedure is uvula-palatopharynoplasty, which may be performed on patients whose anatomy is abnormal, leading to their obstructive sleep apnea and/or making them less likely to tolerate non-surgical means. Uvula palatopharynoplasty may be a complex procedure during which a portion of the soft palate is resected to prevent unwanted tissue from blocking the airway during sleep. However, a disadvantage of this procedure is that the procedure is often expensive and may damage the throat muscles required to swallow and/or cause other undesirable conditions such as nasal reflux and lower incisor numbness.

To reduce this risk, various non-surgical approaches have been taken. One non-surgical method involves using standardized oral appliances to incrementally advance and/or protrude the mandible (lower jaw) relative to the maxilla (upper jaw). These standardized oral appliances, commonly referred to as Mandibular Advancement Devices (MADs), typically include upper and lower dental brackets intended to advance the mandible, thereby moving the tongue forward to increase the space behind the throat and oropharynx, which in turn may increase air flow during sleep. The distance (degree of advancement) required to protrude and/or reposition the mandible may depend, at least in part, on the severity of the individual's obstructive sleep apnea, as well as psychological factors of the user. A drawback to using these standard oral appliances is that they may not adequately provide and/or address individualized anatomical differences, such as differences in dental arch, dentition alignment, and/or jaw flexibility. Another disadvantage is that in cases of excessive propulsion, the appliance may cause long-term temporomandibular joint (TMJ) disease, muscle deterioration, dentition discomfort and/or myofascial disease. Thus, within 2 years, compliance with these standard devices is about 75%. For a detailed study of compliance with MAD, see Non-CPAP therapies in structural sleep ultrasound, manual advance device therapy, Eur Respir J2012; 39: 1241-1247, which is incorporated herein by reference in its entirety. Thus, such oral appliances may not be able to treat obstructive sleep apnea in a manner that prevents and/or limits the effects on human health.

Fig. 1 depicts a system 1 comprising an intra-oral stimulation device 2 for providing sleep disorder treatment. The intraoral stimulator device 2 is powered by a rechargeable battery and includes a housing for a hollow dental fixture wireframe or mouthguard (in the case of a bilateral configuration) or molar clamp (in the case of a unilateral configuration) for positioning over the lower teeth. The housing 4 includes one or two pairs of bilateral electrodes 5a, 5b for positioning at the ventral and sublingual locations posterior to the sublingual mid-tongue for stimulating a substantial portion of the genioglossus muscle and tongue root to restore muscle tone during sleep. The system 1 comprises an external inductive charger subsystem 6 configured to receive power from a wall socket 7 and use that power to charge a rechargeable battery (not shown) provided in the oral stimulator device 2 by transferring power by electromagnetic induction.

The oral appliance 1 also includes a non-rechargeable battery-powered hand-held appliance 3 that communicates instructions to the intraoral stimulator device 2. The non-rechargeable battery powered hand piece 3 is used by the patient's sleeping doctor to program the stimulation and set system parameters in the intraoral stimulator device 2. The stimulation may be pre-programmed or may occur in response to changes in the user's breathing pattern as measured by the accelerometer, temperature, piezoelectric film and EMG. Alternatively, the stimulation therapy may be programmed and set by the physician so that the treatment starts immediately after the device is activated and stops when the device is deactivated, regardless of changes in the user's breathing pattern. One problem with continuous stimulation is that over-stimulation can lead to nerve and/or muscle fatigue/injury. Further, while the physician may set and/or send instructions to the intraoral stimulator, the physician may not be able to store and/or evaluate the patient's breathing and/or snoring patterns in a manner that allows the physician to modify the therapy as desired. The lack of specialized treatment measures in individual patients with unique medical needs can be problematic, particularly because they are unable to store patient behavior and/or medical data to assist medical service providers in designing and/or improving specialized treatment measures for individual patients. Thus, such an intraoral stimulator device may not be able to treat obstructive sleep apnea in a manner that prevents and/or limits the impact on human health.

Other methods of treating obstructive sleep apnea include administration of positive air pressure by a Continuous Positive Airway Pressure (CPAP) machine. CPAP machines are typically assembled for use in conjunction with various face or nasal masks, and may provide continuous pressurized and/or forced air during a patient's sleep. A disadvantage of this assembly is that it may lead to dryness of the nasal and/or oral mucosa due to the continuous forced air and may also lead to claustrophobia due to the presence of the mask on the patient's face. Thus, compliance with these components was approximately 50% over 5 years. For a detailed study of the compliance of CPAP machines, see Long-term compliance with continuous positive air pressure in properties with obstractive sheet attach, Can Respir J.2008 Oct; 15(7) 365-. Another disadvantage is that standard masks are not properly adapted to accommodate people with unique and/or variable facial anatomy that may be natural or caused by loss of muscle tone secondary to facial paralysis and/or stroke. A poorly fitting mask may result in air leakage and/or insufficient air intake. Additionally, masks used with CPAP machines have been found to be a breeding ground for bacteria and fungi. Despite the conventional washing and cleaning measures, bacteria and fungi on these masks grow exponentially and cause respiratory infections, such as pneumonia, in the person using them. Furthermore, such an assembly may not adequately treat obstructive sleep apnea and may not promote patient compliance with the treatment regimen.

The above-described treatment techniques may not provide adequate treatment for obstructive sleep apnea, may cause and/or promote other negative health conditions for the user, and may not promote compliance with treatment regimens.

In view of the shortcomings of currently available methods and devices for treating obstructive sleep apnea, there is a need for a device and method for treating obstructive sleep apnea while storing patient behavior and/or medical data related to the user's breathing patterns, snoring patterns, and/or teeth biting/grinding behavior to assist medical providers in designing, improving, and/or modifying professional treatment measures for individual patients. In addition, there is a need for an apparatus and method for treating obstructive sleep apnea and preventing and/or limiting long-term TMJ disease, muscle deterioration, and/or myofascial disease, which may occur with continuous use of existing appliances, in a single detachable oral appliance.

Electroencephalography is a technique for recording and interpreting electrical activity occurring within the brain. Electroencephalography is based on the generation of nerve cells of the brain that produce electrical impulses that fluctuate in a specific pattern. Patterns produced by electroencephalographic machines that can be recorded are called electroencephalograms (EEGs).

Obtaining an electroencephalogram typically begins with connecting a number of electrode pairs to the scalp of a subject. Each pair of electrodes sends a signal to one of several recording channels of the electroencephalogram; the signal is a measure of the voltage difference between the pair of electrodes. This voltage difference may be rhythmic and displayed as a wave on a line graph by the recording channel. For a normal fully awake adult in a relaxed state, the electroencephalogram shows regularly oscillating waves called alpha waves. Exciting or frightening the person results in the alpha wave being replaced by a rapidly irregular low voltage wave relative to the alpha wave. The brain waves of a sleeping adult become very slow. This is also true for unconscious people. Other abnormal conditions have a known electroencephalogram pattern. For example, a delta wave is an irregular slow wave near a brain injury area. While electroencephalograms are certainly not useful in all situations, they are useful as diagnostic aids in cases of severe head injury, brain tumors, sleep disorders, brain infection, epilepsy, some degenerative diseases of the nervous system, and brain death.

In a sleep laboratory, the depth of sleep may be estimated using a delta wave. The stronger the delta rhythm, the deeper the sleep. Increased delta power (delta wave recording increments) was also found to be associated with an increase in the concentration of internal working memory tasks.

As previously described, the collection of electroencephalographic data is performed with electrodes attached to the scalp of the subject. One reason for this placement is to bring the electrodes as close to the brain as possible, with as few intervening structures as possible. Except for bald subjects, it is not possible to actually "attach" the electrodes to the scalp. This presents a problem because the movement of the electrodes can interfere with the quality of the received voltage. Furthermore, because muscle cells also produce electrical potentials, electroencephalographic machines typically attempt to avoid muscle interference between electrodes and the brain.

In addition to the foregoing, there is a need for an apparatus and method that can determine when a user is awake or waking from deep sleep, entering or being in an obstructive sleep apnea state. Such monitoring devices and methods may be combined with an active treatment regime. That is, determining that the user is waking from sleep or waking from sleep, entering or being in an obstructive sleep apnea state, may be used as a trigger for an active treatment regimen.

Disclosure of Invention

According to one aspect, an embodiment is associated with an oral appliance for treating sleep apnea of a user. Embodiments may include an oral device (mouthpiece) configured to be held in a mouth of a user, a plurality of electrodes, a microprocessor, and at least one stimulator. The oral cavity of the user contains oral tissue, and the oral device has a lingual wall and a buccal wall. A plurality of electrodes attached to the oral device and electrically connected to the microprocessor; the electrodes and microprocessor are configured to determine an electroencephalographic rhythm of the brain of the user. The microprocessor is configured to evaluate the rhythm of the user's immediate occurrence of sleep apnea. The at least one stimulator is also attached to the oral device and is configured to respond to an immediate occurrence of sleep apnea of the user by stimulating the genioglossus muscle of the user. The oral device of the oral appliance can have an upper portion and a lower portion.

Embodiments of the present disclosure are also associated with an oral appliance for treating sleep apnea of a user, comprising an oral device, a plurality of electrodes, at least one electrical stimulator, a microprocessor. The oral device is configured to be retained in a mouth of a user and may have an upper portion and a lower portion, each portion having a lingual wall and a buccal wall. The user's mouth has oral tissue. The plurality of electrodes are attached to the oral device and the microprocessor is configured to receive signals from the electrodes such that the electrodes and microprocessor together operate as an electroencephalograph and detect an electrical rhythm from the brain of the user. The electrical rhythm may indicate an immediate occurrence of arousal from deep sleep, or sleep apnea of the user. The at least one electrical stimulator is attached to the oral device and the microprocessor; the stimulator is configured to emit an electric current or field in response to the immediate occurrence of sleep apnea of the user according to an electrical rhythm.

Embodiments of the present disclosure are also associated with an oral device for wearing on the upper dentition and jaw (or upper jaw, toothless) of a user. The oral device includes electrodes for detecting the electrical rhythm of the user's brain. The oral device can be used in a variety of applications such as sports, games and personal preferences. It is contemplated that the oral device may be used to detect traumatic blows to a user's head in real time to be detected in athletic activities while the athlete is wearing the oral device. The user's electroencephalogram may also be monitored on the sideline by a trained operator. This technique can detect the early onset of acute brain trauma or concussion prior to any clinical occurrence and helps protect the user from the potentially future devastating side effects of this trauma.

Drawings

A more particular description will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments and are not therefore to be considered to be limiting of its scope, the exemplary embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

FIG. 1 is a perspective view of a prior art oral device;

fig. 2 is a top view of an oral appliance according to an embodiment;

fig. 3 is a perspective view of an oral appliance according to an embodiment;

fig. 4 is a perspective view of an oral appliance according to an embodiment;

fig. 5 is a perspective view of an oral appliance kit according to an embodiment;

FIG. 6 is a schematic diagram of a method of providing genioglossus stimulation, according to an embodiment;

FIG. 7 is a bottom view of a top oral device of an oral appliance according to an embodiment;

FIG. 8A is a lower left perspective view of an oral device of an oral appliance according to an embodiment;

FIG. 8B is a lower right perspective view of the oral device of the oral appliance shown in FIG. 8A;

FIG. 9 is a front underside perspective view of an oral device of an oral appliance according to an embodiment; and

fig. 10 is a schematic diagram of a method of providing genioglossus stimulation according to an embodiment.

Various features, aspects, and advantages of the embodiments will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings in which like numerals represent like components throughout the drawings and text. The various features described are not necessarily drawn to scale, emphasis instead being placed upon particular features of certain embodiments.

Detailed Description

Reference will now be made in detail to various embodiments. Each example is provided by way of explanation, not meant as a limitation, and does not constitute a definition of all possible embodiments.

Embodiments of the present disclosure generally relate to devices/apparatus and methods for treating obstructive sleep apnea, devices for providing electrical stimulation to the tongue of a user to suppress and/or limit snoring that may be caused by obstructive sleep apnea, and devices including a drug delivery reservoir for delivering a drug for treating obstructive sleep apnea. Such devices provide particular utility in providing electrical stimulation to the user's tongue so that the stimulation is not awakened during the user's sleep. Alternatively or in addition to electrical stimulation, the device may include a pharmaceutical compound, such as an ionising drug, for the treatment of obstructive sleep apnea. The drug compound may be provided in a reservoir/drug reservoir separate from the device or as part of the physical matrix of the device. In particular in the former option, the reservoir may be refilled or replaced on a daily or less frequent schedule.

Contemplated oral appliances include oral devices configured to receive at least temporary, permanent, and/or artificial dentition of a user. The oral device may include various electronic components including one or more of the following: oxygen sensors, pressure sensors, airflow sensors, noise detectors, actigraphy sensors, stimulators, data loggers, batteries, and microprocessors. The oral device may also include a material, such as a polymer matrix, into which the pharmaceutical compound may be incorporated for delivery to the user. Alternatively, one or more reservoirs containing a drug compound may be attached to the oral device. Each reservoir is capable of delivering a drug directly to one or more oral membrane surfaces of a user. The oral device can include customizable materials that provide a comfortable fit for the user while retrieving data related to the user's blood saturation level, clenching and/or abrasion of the dentition surfaces, actual airflow level, and noise level related to snoring, analyzing the data, and preparing a set of instructions to the stimulator.

When used in combination with a pharmaceutical compound, the stimulator assembly may be used to effectively transfer a drug from the device to the oral mucosa of a user. This drug delivery function may be in addition to, or in place of, the electrical stimulation of the user's oral musculature, i.e. the electrical stimulation may only function as a drug release/delivery mechanism. The stimulator may operate upon receiving the operating instructions to break or pierce a drug reservoir attached to or otherwise associated with the oral device. Alternatively, the stimulator may be used in combination with a drug with a charged surface, as will be further explained. In the event that the microprocessor sends a signal causing the drug reservoir to rupture, a user notification may be communicated to the user via the microprocessor that the reservoir needs to be replaced. Such notification may take the form of a smartphone notification to the user, or a visual notification, such as activating an LED light that the user can then see.

According to one aspect, the oral device is customized to be receivably positioned and/or secured to the user's mandible. According to one aspect, the oral device is customized to receive the user's lower dentition. In any event, the oral device can be customized such that it provides a comfortable fit, thereby increasing the comfort of the user and enhancing the likelihood of the user repeatedly wearing the oral device, i.e., the compliance rate of the user.

To illustrate the features of the embodiments, embodiments will now be described and referenced throughout this disclosure. Those skilled in the art will recognize that this example is illustrative, not limiting, and is provided purely for purposes of explanation.

In one embodiment, and with particular reference to fig. 2-4, an oral appliance 10 for treating sleep apnea of a user is provided. The oral appliance 10 is illustrated with an oral device 20 and several components. In one embodiment, the oral device 20 is "customizable," that is, customized to the oral cavity of an individual user such that it provides a comfortable fit on and around the surfaces of the hard tissue (teeth/dentition) and/or soft tissue (oral structures in general, including the gums) of the user. When customized, the oral device 20 may fit into the temporary, permanent, natural and/or artificial lower dentition of a human and/or child user. The oral device 20 may be configured to receive a removable denture of a user. According to one aspect, the oral device 20 is manufactured on the lower jaw, i.e., the mandible, partially or completely without dentition. When customized, the oral device 20 may be formed from any self-conforming material that can accommodate variations and/or changes in oral structure, or by using a dental impression of the dentition of an individual user, as will be understood by those of ordinary skill in the art. In other words, a mandibular and/or dental impression may be taken to create a positive replica (or cast) that is customized for the user using a negative impression of the user's hard and/or soft tissue.

The types of materials selected for forming the oral device 20 are well known to those of ordinary skill in the art and include polymers, thermoplastics, acrylics, silicones, rubbers, wires, or any other material that may be used to form the oral device 20 to conform to the dentition of the user. In one embodiment, the material is medical grade, latex-free, BPA-free, and any other material known to minimize patient health risks. According to one aspect, the oral device 20 can be formed from a stamp made in a thin elastomeric material. The oral device material may also be selected in particular from polymers, as they are capable of incorporating the pharmaceutical compound into the structural matrix.

In one embodiment and as shown in fig. 2 and 3, the oral device 20 includes a central channel 29 defined by a tongue 24 and a cheek 23. Central channel 29 may be configured to be receivably positioned over and/or receive one or more user dentitions such that oral device 20 is secured thereto. When the oral device 20 is in use, the central channel 29 can receive the dentition of the user and can extend to and/or cover the biting or biting surfaces of the user's teeth. The tongue 24 of the oral device 20 extends between the user's teeth and the user's tongue. In one embodiment and as shown in fig. 2 and 3, the cheek portion 23 of the oral device 20 extends between the teeth of the user and the cheek of the user.

According to one aspect, the oral device 20 is configured to be secured to the dentition of a user. In one embodiment and as shown in fig. 4, the oral device 20 includes a tongue portion 24 and a dentition attachment member 28 coupled to the tongue portion 24. The dentition attachment members 28, as well as the tongue 24, may be customizable such that the dentition attachment members 28 have a shape and size that substantially conforms to a user's dentition, thereby providing the user with an oral device 20 having a secure and customized fit. Typically, the dentition attachment members 28 are provided in the form of a wire frame in a manner extending from the tongue 24 to wrap around or over the dentition of the individual user and anchor the tongue 24 between the lingual surface of the teeth and the tongue. According to one aspect, at least a portion of dentition attachment members 28 are shaped to form a retaining ring around one or more teeth of a user.

Similar to the dentition receiving cavities 25 described with respect to the oral device 20 of fig. 2 and 3, the tongue 24 depicted in fig. 4 may also be customized to have a shape that is substantially the same as the shape of the individual user's dentition that it has been molded and/or shaped to conform to, thereby assisting in the retention function of the dentition attachment members 28. In any event, the oral device 20 can be at least temporarily secured in place because it has been molded and fitted (formed to) the user's dentition and/or provided with dentition attachment members 28 to provide a customized fit. Thus, the oral device 20 may provide a retention function, allowing the oral appliance 10 to remain in place during a user's sleep, particularly if the user is likely to make a mild to moderate action during sleep and/or when the user is likely to be awake. Thus, the oral device 20 can be substantially immovable unless a positive effort is applied to remove the oral device 20. In other words, the user can remove the oral device 20 at any time as desired by applying a slight amount of pressure to remove the oral device 20. Because the oral device 20 is not permanently affixed to the dentition, it may be worn by the user at any time and/or removed later. Thus, oral appliance 10 may be used for different lengths of time.

According to one aspect and as shown in fig. 2-4, the components located and/or embedded within the oral device 20 include one or more of the following components: oxygen sensor 30, pressure sensor 32, air flow sensor 34, noise detector 35, actigraphy sensor 36, stimulator 40, drug reservoir 42, microprocessor 50, data logger 60 and battery 70. According to one aspect, the oral device 20 includes a desiccation protection area or covering for these electronic components that substantially inhibits and/or limits water and/or tissue damage to the components (not shown). Such a desiccation/protection zone may be formed as a result of the components being embedded within the oral device 20 itself.

As shown in fig. 2-4, the oxygen sensor 30 may be disposed near the front 21 of the oral device 20, i.e., toward the user's lips and away from the user's pharynx. According to one aspect, the oxygen sensor 30 is configured to monitor and/or determine an actual oxygen saturation level of hemoglobin of the user. The oxygen sensor 30 may be adapted to monitor and/or determine the pulse and/or heart rate of the user. The oxygen sensor 30 may be positioned on or in the tongue 24 of the oral device 20. In one embodiment, the oxygen sensors 30 are positioned primarily toward the sides of the tongue (which are generally understood to be the most vascular regions of the tongue, i.e., having many blood vessels) as well as the buccal regions of the upper jaw. According to one aspect, the oxygen sensor 30 is a transceiver, such as a pulse oximeter, configured to monitor/sense the oxygen saturation level of the user by analyzing the color changes of the user's blood. Pulse oximeters may measure a user's pulse rate, typically beats per minute, based on changes and/or deviations in the user's oxygen saturation level. For example, an exemplary pulse oximeter may include a light emitting diode configured to transmit red and infrared light to the vascular surface of the user's tongue and to sense changes in oxygen levels in the user's tongue. According to one aspect, two oxygen sensors 30 are provided on the tongue 24 of the oral device 20. It is contemplated that the oxygen sensor 30 may be placed in other locations of the oral cavity, such as the cheekbones, such that the oxygen sensor collects oxygen saturation data from the gum surface overlying the cheekbones. Two oxygen sensors 30 may be positioned on either side of the oral device 20. While fig. 2-4 show two oxygen sensors 30 positioned on the oral device 20, it is to be understood that the number of oxygen sensors provided may be 3, 4, 5, 6, or more.

According to one aspect and as shown in fig. 2 and 3, the oral appliance 10 can include one or more pressure sensors 32. According to one aspect, the one or more pressure sensors 32 are configured to detect signs of user biting and/or grinding teeth, such as occurs while the user is asleep. The pressure sensor 32 may be located in or on the central passage 29. In one embodiment, the pressure sensor 32 is positioned in the dentition receiving cavities 25 such that the pressure sensor 32 is positioned substantially adjacent to the mandibular biting and/or biting surface of the user. According to one aspect, the pressure sensors 32 are located on an outer surface of the central channel 29, wherein the central channel 29 has an inner surface configured to receive the dentition receiving cavities 25, and the outer surface is located opposite the inner surface such that the pressure sensors 32 are positioned substantially adjacent to the user's maxillary biting and/or biting surfaces. In some embodiments (not shown), a pressure sensor may be provided on the dentition attachment member 28, for example under the trade mark FlexiForce^TMForce Sensors are manufactured by Tekscan. Such signs of biting may include force sensors configured to measure forces exerted on the biting and/or biting surfaces of the user's teeth. According to one aspect, the pressure sensor 32 is a thin bulletAnd (3) a material. The one or more pressure sensors 32 may be electrically sealed and/or non-infiltrated by liquid, saliva, and/or oral tissue. The number of pressure sensors 32 provided on the oral device 20 may be selected based on the user's propensity to molar and/or bite. According to one aspect, the number of pressure sensors 32 provided is 2, 3, 4, 5, 6 or more.

In one embodiment, the oral device 20 includes one or more airflow sensors 34 configured to measure the actual airflow and/or respiratory rate of the user, i.e., the rate of air inhaled and/or exhaled by the user through the oral device 20. According to one aspect, airflow sensor 34 is configured to detect any reduction and/or cessation of airflow during sleep. The airflow sensor 34 may be disposed anywhere on the oral device 20 that is in the general flow path of air inhaled and/or exhaled by the user. As shown in FIG. 2, the airflow sensor 34 may be positioned near the rear portion 22 of the oral device 20. According to one aspect, the airflow sensors 34 are positioned symmetrically on both sides of the oral device 20. As shown in fig. 2 and 3, one airflow sensor 34 may be positioned to the left of the tongue 24, while another airflow sensor 34' may be positioned to the right of the tongue 24. In any case, the two

airflow sensors

34, 34' may work in conjunction to measure the airflow rate of the user. The airflow sensor 34 may be disposed in/on at least one of the tongue 24 and the cheek 23 of the oral device 20. The number of airflow sensors 34 provided on the oral device can be selected according to the needs of the user. According to one aspect, the number of air flow sensors provided is 2, 3, 4, 5 or more.

According to one aspect and as shown in fig. 2-4, the oral device 20 may include a actigraph sensor 36 configured to monitor and capture data related to sleep activity, including sleep position and movement of the user during sleep. The actigraphy sensor 36 may be embedded or otherwise connected to the oral device 20 at any desired location. According to one aspect and as shown in fig. 2 and 3, the actigraphy sensor 36 is positioned on a cheek portion 23 of the oral device 20. In an alternative embodiment and as shown in fig. 4, actigraph sensor 36 may be positioned on tongue 24 of oral device 20. The actigraphy sensor 36 may determine a sleeping position of the user, for example, a supine position during which the user is supine, a prone position during which the user is lying face down, and/or a lateral position during which the user is lying left or right. Actigraph sensor 36 may measure the time the user sleeps in each recognized posture and/or the frequency with which the user changes from one sleep posture to another.

The oral appliance 10 may include a noise detector 35 configured to detect actual noise and/or vibration caused by snoring of the user. According to one aspect, the noise detector 35 is internally hardwired to one or more components coupled to or otherwise embedded in the oral device 20, such as the stimulator 40, the microprocessor 50, and the data logger 60, so that the noise detector 40 can communicate with these components. The noise detector 35 may be configured to wirelessly communicate with at least one of the stimulator 40, the microprocessor 50, and the data recorder 60. The noise detector 35 may be positioned or otherwise embedded in the oral device 20 at any desired location. According to one aspect, the noise detector 35 is located at the rear 22 of the oral device 20 so that the associated snoring information can be detected close to the sound source (i.e., the user's pharynx). In one embodiment, the noise detector 34 is located at the front 21 of the oral device 20. As shown in fig. 3, the noise sensor 35 may be positioned on the cheek portion 23 of the oral device 20. In one embodiment and as shown in fig. 4, the noise sensor 35 is positioned at the tongue 24 of the oral device 20. While fig. 3 and 4 show a single noise detector 35 disposed on the oral device 20, it is to be understood that 2, 3, 4, or more noise detectors 35 may be provided.

According to one aspect and as shown in fig. 2-4, at least one stimulator 40 is disposed near the rear portion 22 of the oral device 20, i.e., generally near the rear of the user's mouth. The stimulator 40 is configured to provide mild stimulation to the tongue of the user, as will be described in more detail below. In one embodiment, the stimulator 40 is positioned on the tongue 24 of the oral device 20 adjacent to the tongue. The stimulator 40 may be positioned symmetrically on both sides of the oral device 20 such that symmetrical bilateral stimulation may be provided to both sides of the user's tongue. The stimulator 40 may be positioned substantially near the base of the user's tongue, for example, near the user's genioglossus muscle. Thus, the stimulator 40 may be configured to provide stimulation to the genioglossus muscle of the tongue of the user in a manner that allows for restoration of muscle tension of the genioglossus muscle. Such stimulation may be an electrical pulse that causes the genioglossus muscle to contract and/or causes the user to reduce the amount of force exerted on the biting and/or biting surfaces of the user's teeth. In some embodiments, contraction of the genioglossus muscle may cause the tongue of the user to protrude, thereby creating more space in the pharynx of the user and helping the user to breathe more easily in a manner that increases the oxygen saturation level of the hemoglobin of the user. The stimulus may be a response to the actual saturation level of the user's hemoglobin as measured by the at least one oxygen sensor 30.

According to one aspect, the stimulator 40 is activated based on measurements received from the oxygen sensor 30, the pressure sensor 32, the airflow sensor 34, and/or the noise detector 35. The stimulator 40 may be activated if the oxygen sensor 30 determines that the actual oxygen saturation level of the user's hemoglobin is at a predetermined oxygen level, i.e. a certain oxygen level has been predetermined as insufficient. The stimulator 40 may at least intermittently stimulate the genioglossus muscle of the tongue of the user until the oxygen saturation level of hemoglobin rises above a predetermined oxygen level. In one embodiment, the stimulator 40 is activated if the oxygen sensor 30 determines that the actual oxygen saturation level of the user's hemoglobin is below about 95% oxygen saturation. Stimulating the genioglossus muscle of the user may facilitate increasing the respiratory flow of the user, thereby increasing the oxygen availability of the user and increasing the oxygen saturation level of hemoglobin. According to one aspect, the stimulator 40 is not activated when the oxygen sensor 30 determines that the oxygen saturation level of the hemoglobin of the user is above about 95% oxygen saturation. In one embodiment, the stimulator 40 is activated if the pressure sensor 32 detects that the user is grinding and/or biting teeth. According to one aspect, the stimulator 40 provides stimulation until the force applied to the biting and/or biting surfaces of the user's teeth is below a predetermined force level. The stimulator 40 may cease stimulation once the pressure sensor 32 detects that the molars and/or bites have substantially decreased and/or ceased, as evidenced by the detected force level. According to one aspect, the stimulator 40 is activated when the airflow sensor 34 determines that the frequency of air inhaled and/or exhaled by the user is below a predetermined airflow level. In one embodiment, the stimulator 40 is activated when the airflow sensor 34 determines that the airflow is at or below 30% of the user's natural airflow or breathing rate (i.e., the air inhaled and/or exhaled by the user while the user is awake (natural airflow) has been reduced by 30%). The stimulator 40 may provide stimulation to the genioglossus muscle until a predetermined airflow level is reached and/or the airflow to the user is at least about 30% of the user's natural airflow rate. In one embodiment, the stimulator 40 is activated if the noise detector 35 detects that the actual noise and/or vibration is above a predetermined noise level. In this embodiment, the stimulator 40 provides mild electrical stimulation to the genioglossus muscle of the user's tongue until the actual noise and/or vibration is below a predetermined noise level.

In one embodiment, the stimulator 40 is configured to provide a constant stimulation to the genioglossus muscle of the tongue of the user. Alternatively, the stimulator 40 may provide variable stimulation to the genioglossus muscle of the tongue of the user. The variable stimulation may incrementally stimulate the genioglossus muscle of the tongue until the oxygen saturation level is at a predetermined oxygen level, for example, at or above 95%. In one embodiment, the variable stimulus incrementally stimulates the genioglossus muscle until the force applied to the clenching and/or occlusal surfaces is below a predetermined force level. The variable stimulation provided by the stimulator 40 may incrementally stimulate the genioglossus muscle until a predetermined airflow level is reached and/or until the actual noise and/or vibration is below a predetermined noise level. According to one aspect, the intensity and frequency of the electrical pulses in the variable mode will depend on the speed at which the oxygen saturation of hemoglobin and/or the predetermined force level is reached. The constant or variable stimulus may be a mild stimulus that does not disturb and/or wake the user during sleep. According to one aspect, the constant or variable stimulus is sufficiently mild that when the user is at least slightly awake, the user is unaware of it while wearing it. The stimulator 40 may alternate between a constant stimulation mode and a variable stimulation mode. In one embodiment, at least one stimulator 40 is an electrode configured to provide a mild electrical pulse. The gentle electrical pulse may be provided to the genioglossus muscle of the user's tongue in a non-invasive manner and in this manner does not wake the user while sleeping.

In one embodiment, the oral device 20 or structure associated with the oral device 20 allows for the delivery of a pharmaceutical compound to facilitate the maintenance or restoration of the muscle tone of the genioglossus muscle. Such pharmaceutical compounds may cause contraction of the genioglossus muscle. Activation of the genioglossus muscle can be achieved using a cholinergic drug, such as neostigmine. Other stimulants and/or drugs that activate and/or increase calcium ion release/activation to affect muscle contraction may also be used to activate the genioglossus muscle, including norepinephrine and caffeine.

In another example, genetically engineered light can be used to stimulate nerves and muscles specific to the desired site. This concept is called optogenetics. Optogenetics allows for stimulation of neurons with light by inserting a gene from a protein called channelrhodopsin-2 from green algae. When the modified neuron is exposed to blue light, the protein initiates electrical activity within the cell, and then diffuses from neuron to neuron. Optical control methods offer advantages over electrical stimulation for the biomechanics of muscle and body movements. That is, the oral device 20 releases photons rather than charges/current.

In one embodiment, the pharmaceutical compound may be incorporated into the material of the oral device 20 for active or passive release. Passive release may be triggered by environmental factors in the user's mouth, such as changes in temperature, pH, or similar variables. Active delivery may involve electrical stimulation controlled by the microprocessor 50 in response to input from one or more sensors associated with the oral device 50. The electrical stimulation that results in the release of the drug will be discussed further below.

Iontophoresis (ionophoresis) is a drug delivery process that utilizes a voltage gradient. Molecules are transported through semipermeable materials or barriers by electrophoresis and/or electroosmosis. Electrophoresis is the movement of charged particles, ions or anions in the presence of an electric field. Surface-charged particles present in liquids or gels (i.e. capable of being transferred with respect to the medium in which they are contained)Performs substantial motion) is most amenable to electrophoresis, although motion through other materials is also possible. Electroosmosis is the movement of a liquid caused by an electrical potential applied to a porous material, capillary, membrane, microchannel, or any other fluid conduit. Iontophoresis is the active transport of substances caused by an applied current. This transport is measured in units of chemical flux, usually μmol/(cm)²Hours).

The material selected for the oral device 20 can be, for example, a polymer that acts as a semipermeable retainer for the selected pharmaceutical compound. That is, the material of the oral device 20 will retain the pharmaceutical compound during storage and other conditions, while releasing the pharmaceutical compound under certain passive or active conditions. In the case of active delivery, an electrical charge or field may be applied to certain portions of the oral device 20, causing the pharmaceutical compound to flow out of the oral device 20 and be absorbed across the oral mucosa of the user, precisely by the tissue for which the pharmaceutical compound is designed to be treated. Whether active or passive, once reservoir 42 is empty, a user notification of the need to replace reservoir 42 may be communicated to the user via microprocessor 50. Such notification may take the form of a user smartphone notification or a visual notification, such as activating an LED light that the user can then see. The replacement reservoir 42 can be provided to the user and have means such as friction or adhesive (e.g., pressure sensitive adhesive/PSA) to attach to the oral device 20 when the user is notified that replacement is required.

In one embodiment, a reservoir 42 containing a liquid, gel, or similar state of matter may be associated with the oral device 20. For example, the reservoir 42 may comprise a bag attached to a surface of the oral device 20 and containing a pharmaceutical compound. In one embodiment, the pocket is formed of a material that ruptures when subjected to an electrical charge or field by activation of the stimulator 40. Such activation may be the result of the microprocessor 31 responding to inputs from one or more sensors, as previously described. The pocket of reservoir 42 is typically attached to the oral device 20 at a surface that is less likely to withstand as much force as would be associated with a user's bite or rubbing against the oral device 10. Thus, either the lingual wall 24 or the buccal wall 23 is the ideal choice for placement of the reservoir 42. Reservoir 42 may be removed after use or simply dissolved during use; either way, placement of a new reservoir 42 can be accomplished by the user before the oral device 20 is inserted, if desired.

In one embodiment, the material forming the pouch wall 44 of the reservoir 42 may be a semipermeable polymer through which the drug compound may pass under specified passive conditions, or through which the drug may pass when an electrical stimulus or field is applied to the pouch of the reservoir 42. In addition to considering the location of the reservoir 42 discussed above, when iontophoresis requires electrical stimulation, it is also important to consider the location relative to the electrical stimulator 40. One feature of the stimulation reservoir 42 to dispense the pharmaceutical compound is that delivery of the compound can be initiated, stopped, and restarted based on readings communicated to the microprocessor 50 by the

sensors

30, 32, 34, and/or 36. Thus, instead of delivering the drug compound as a pill, it can be delivered closer to the needs of the user.

Another semi-permeable barrier through which molecules of a pharmaceutical compound can be transported is the outermost layer of human skin, namely the stratum corneum and other oral mucosal layers. Thus, regardless of how released from the oral device 20, the pharmaceutical compound is absorbed by the oral mucosa of the user. In some embodiments, the drug-induced contraction of the genioglossus muscle may cause the tongue of the user to protrude, thereby creating more space in the pharynx of the user and helping the user to breathe more easily in a manner that increases the oxygen saturation level of the hemoglobin of the user. The stimulus may be responsive to an actual saturation level of the user's hemoglobin as measured by the at least one oxygen sensor 30. The release of the pharmaceutical compound that results in stimulation of the genioglossus muscle of the user's tongue may continue until the oxygen saturation level of hemoglobin rises above a predetermined oxygen level. In one embodiment, the stimulator 40 is activated if the oxygen sensor 30 determines that the actual oxygen saturation level of the user's hemoglobin is below about 95% oxygen saturation. Stimulating the genioglossus muscle of the user may facilitate increasing respiratory flow to the user, thereby increasing the oxygen availability of the user and increasing the oxygen saturation level of hemoglobin. According to one aspect, if the oxygen sensor 30 determines that the oxygen saturation level of the user's hemoglobin is above about 95% oxygen saturation, the stimulator 40 is not activated and does not iontophoretically or otherwise cause the reservoir 42 to dispense the pharmaceutical compound. In one embodiment, the stimulator 40 is activated if the pressure sensor 32 detects a user's molars and/or bites. According to one aspect, the stimulator 40 provides an electrical stimulus or field to the reservoir 42 as directed by the microprocessor 50 which acts in response to input from one or more of the

sensors

30, 32, 34 and 36.

As shown in fig. 2-4, the microprocessor 50 may be disposed on the oral device 20 and/or embedded within the oral device 20. As shown in fig. 2 and 3, the microprocessor 50 may be located on or in the cheek 23. Alternatively and as shown in fig. 4, the microprocessor 50 may be located on or in the tongue 24 of the oral device 20. In other words, the microprocessor 50 can be placed anywhere on the oral device 20 where available space can be found. Thus, when more than one component, e.g., the oxygen sensor 30 and the stimulator 40, are positioned at the lingual portion 24 of the oral device 20, the microprocessor 50 may be positioned on the buccal portion 23 away from these areas. In some embodiments and as shown in fig. 4, the microprocessor 50 is positioned on the tongue 24 of the oral device 20 and may be embedded therein. It should be understood that the microprocessor 50 may be positioned in any location that enables it to communicate with the components contained in the oral appliance 10, e.g., the oxygen sensor 30, the pressure sensor 32, the airflow sensor 34, the noise detector 35, the actigraph sensor 36, the stimulator 40, the data logger 60, and/or the battery 70, while ensuring that the location of the microprocessor 50 helps maintain a comfortable fit and/or maintains the wearability of the oral device 20 to a user. The microprocessor 50 can be attached to and/or positioned at any desired location on the oral device 20, e.g., the front, the back, and anywhere therebetween. According to one aspect, the microprocessor 50 is sized and/or positioned to comfortably fit a user. It will be appreciated that the microprocessor 50 can be positioned at any location that does not interfere with the comfortable fit of the oral device 20 to the user. The microprocessor 50 may be configured to receive data from the at least one oxygen sensor 30 corresponding to the actual oxygen saturation level of hemoglobin, as well as data relating to the user's molar and/or biting behavior, actual airflow level, actual noise and/or snoring level. In one embodiment, the microprocessor 50 is configured to activate the stimulator 40 if the oxygen sensor 30 determines that the actual oxygen saturation level of the user's hemoglobin is at a predetermined level. According to one aspect, if the pressure sensor 32 determines that the user is clenching and/or grinding his/her dentition at an unacceptable level, the microprocessor 50 activates the stimulator 40. If the airflow sensor 34 determines that the user's airflow rate is below a predetermined airflow level, the microprocessor 50 may activate the stimulator 40. According to one aspect, the microprocessor 50 activates the stimulator if the noise detector 35 determines that the actual noise and/or vibration of the user during sleep is above a predetermined noise level.

As shown in fig. 2-4 and in one embodiment, the oral appliance 10 includes a data logger 60. The data logger 60 may be positioned, for example, at the cheek 23 of the oral device 20 (see, e.g., fig. 2). According to one aspect and as shown in fig. 3, the data logger 60 is located on the tongue 24 of the oral device 20. In one embodiment, the data logger 60 is configured to receive and/or store information provided from the microprocessor 50. According to one aspect, the data logger 60 receives and/or stores the actual oxygen saturation level of hemoglobin, the predetermined force level applied to the user of the biting and/or biting surface, and/or the predetermined airflow level provided by the oxygen sensor 30, the pressure sensor 32, and the airflow sensor 34, respectively. The data logger 60 may also receive and/or store information regarding the number and/or frequency of stimuli provided by the stimulator 40. The data logger 60 may also store drug compound dispense information such as the volume/dose dispensed from the reservoir 42 at each dispense event and the total volume dispensed and therefore remaining in the reservoir 42. This remaining drug compound data can be used to signal the user regarding replacement of reservoir 42.

According to one aspect, the appliance 10 includes a transceiver (not shown). The transceiver may be configured to remotely monitor any other component provided on and/or within the device 20. In one embodiment, theThe transceiver may be configured for use with a customized web-based application for a handheld wireless communication device. The customized Web-based application may include features such as a chart of the user's sleep posture and/or graphical data related to the oxygen saturation level of hemoglobin and pressure applied to the occlusal surfaces of the user's dentition. According to one aspect, the customized Web-based application may include data related to a heart rate of the user. In one embodiment, a transceiver and a transceiver having

The functional handheld wireless communicator communicates. The transceiver may communicate with a handheld wireless communication device, such as a computer, smart watch, smart phone, and the like.

The oral appliance 10 may include a battery 70. Although it is contemplated that battery 70 is rechargeable, it may be disposable. The battery 70 may be configured to provide power to at least one of the oxygen sensor 30, the pressure sensor 32, the airflow sensor 34, the noise detector 35, the actigraph sensor 36, the stimulator 40, the microprocessor 50, the data logger 60, and the transceiver. According to one aspect, the battery 70 includes an energy storage and contact element (not shown) sealingly disposed on the oral device 20. In one embodiment, the battery 70 is embedded within the oral device 20 such that the battery 70 is not exposed to liquid, saliva, and/or oral tissue. The battery 70 may be positioned proximate the cheek 23 (see, e.g., fig. 2). According to one aspect, the battery 70 is positioned proximate the tongue 24 of the oral device 20 (see, e.g., fig. 4).

As shown in fig. 5, the oral appliance may include a data transmission box 80. The data transfer box 80 may be configured to charge and/or provide power to the rechargeable battery 70. According to one aspect, the data transfer box 80 is configured to retrieve and/or store information collected by the data logger 60 so that a user and/or healthcare provider can track and/or evaluate the collected information. According to one aspect, the transceiver may include a power amplifier (not shown) configured to reduce the power requirements of the oral appliance 10, thereby helping to conserve the life of the rechargeable battery 70. The data transfer box 80 may be provided with an electrical contact assembly that can access a plug (not shown) of the power supply unit.

As shown in fig. 5 and in one embodiment, an oral appliance kit 100 for treating sleep apnea of a user is provided. In one embodiment, the oral appliance kit 100 includes an oral appliance 10, the oral appliance 10 including various electronic components, as substantially described above and shown in fig. 2-4, and a data transmission box 80.

Fig. 6 is a flow chart illustrating exemplary operations 200 of the oral appliance 10. Optionally, a custom oral device is created 201 and various electronic components are assembled to form the oral appliance. The oral device of the oral appliance is positioned 210 in the mouth of the user. The oxygen sensor measures 220 an oxygen saturation level of hemoglobin of the user, the pressure sensor measures 222 a pressure applied to an occlusal surface of the customized mandibular oral device, the airflow sensor measures 224 an actual airflow and/or respiration rate of the user, the actigraphy sensor measures 226 data related to sleep activity including a sleep posture and movement of the user during sleep, and/or the noise detector measures 228 an actual noise and/or vibration generated by the user during sleep. The microprocessor collects, records and analyzes 230 data relating to oxygen saturation, pressure, airflow, sleep activity and actual noise levels. In the event that the actual oxygen saturation level of hemoglobin is below a predetermined level, or the actual pressure applied to the bite portion of the oral device is above a predetermined pressure level, the stimulator sends a pulse 240 to stimulate the genioglossus muscle of the tongue of the user. The oxygen sensor re-measures 250 the oxygen saturation level of hemoglobin, the pressure sensor re-measures 252 the pressure applied to the occlusal surface of the customized mandibular oral device, the air flow sensor re-measures 254 the actual air flow of the user, the actigraph sensor re-measures 256 the sleep activity of the user, and the noise detector re-measures 258 the actual noise and/or vibration generated by the user during sleep. If a predetermined level is reached, stimulation is stopped. According to one aspect, if the predetermined level is not reached, the stimulus is continued, increased, decreased, or otherwise varied according to the measured value.

According to one aspect, the superior oral device 120 is configured to be secured to/worn on the upper dentition of the user. As shown in FIG. 7, the oral device 120 includes a dentition attachment member 128 (or, collectively, dentition attachment portion 128, which has the general arch shape of the upper dentition). The dentition attachment section 128 has a buccal surface/wall 130a facing the user's lips and/or cheeks, and a lingual surface/wall 130b opposite the buccal surface 130a facing the user's tongue. The oral device 120 also includes a palatal portion 122 adjacent to and integrally connected with the lingual surface 130b of the dentition attachment portion 128. The oral device 120 further includes a gingival portion 132 (shown in fig. 8A-9) that is integral with and extends upwardly from the buccal surface 130a of the dentition attachment section 128 such that the gingival portion 132 is positioned along the upper gingiva of the user adjacent the maxilla of the user. The dentition attachment portion 128, the palate portion 122 and the gum portion 132 are a unitary component.

The gingival portion 132, dentition attachment portion 128, and oral device 120 may be generally described as having (when viewed in a top plan view) a left/wing 134a (i.e., generally on the user's left dentition), a right/wing 134b (i.e., generally on the user's right dentition), a front or front end 136a (i.e., generally on the user's front/front dentition), and a rear or back end 136b (i.e., generally on the user's back/back dentition), respectively. The palate portion 122 therefore extends between and is partially enclosed by the left side of the dentition attachment portion and the right side of the dentition attachment portion.

As shown in fig. 7, the dentition attachment members 128 (each and collectively) have a shape and size that substantially matches the user's upper dentition. The palate portion 122 of the upper oral device 120 substantially matches the user's palate. Thus, the user is presented with the oral device 120 having a secure and customized fit. The dentition attachment members 128 may be provided in the form of a wire frame for support, or, as shown in fig. 7, support may stem from the presence of the palate part 122 and the material selected for forming the superior oral device 120. According to one aspect, a portion of the dentition attachment members 128 may be shaped to form a retaining ring around one or more teeth of a user. The dentition attachment members 128 and the palate portion 122 enable the upper oral device 120 to be at least temporarily fixed in position due to a customized fit. Thus, the oral device 120 may provide a hold function, allowing it to remain in place during a user's sleep, particularly if the user may make a slight to moderate movement during sleep and/or when the user may be awake.

Thus, the oral device 120 may be substantially immovable unless a positive effort is applied to remove the oral device 120. In other words, the user can remove the oral device 120 by applying a little pressure to remove the oral device 120 at any time as desired. Because the oral device 120 is not permanently affixed to the dentition, it may be worn and/or subsequently removed by the user at any time.

As with the oral device 20, the components can be positioned on the oral device 120 and/or embedded within the oral device 120. The components in or on the upper oral device 120 can include any components associated with the oral device 20. The assembly shown in fig. 7 includes a first pair of

electrodes

112a, 112b, a second pair of

electrodes

114a, 114b, a microprocessor 118, and electrical leads 116 connecting each electrode to the microprocessor 118. The microprocessor 118 can have a data logger 60 and/or battery 70 associated therewith and/or integrated therewith that can be embedded within the oral device 120 such that any components on any surface of the oral device 120 are covered to eliminate tissue damage and damage to such components. The placement of these components should not interfere with the fit of the oral device 120 in the user's mouth or cause pain to the user's gums or palate. The electrical leads 116 are also embedded within the material of the oral device 120 or, if placed on the surface of the oral device, are covered to eliminate some of the obvious problems of lead loosening. Figure 9 shows how the electrical leads 116 follow the shape of the oral device 120, either within the oral device material or on top of the oral device material, from each electrode to the microprocessor 118.

The microprocessor 118 of the oral device 120 may also be provided with a wireless transceiver enabling it to communicate with an external wireless communication device, such as a computer, smart watch, smart phone, etc., like the oral appliance 10. Further, the wireless transceivers of the oral device 120 and the oral appliance 10 may communicate with each other. Thus, the microprocessor 118 of the oral device 120 can provide information to the oral appliance 10 in much the same way that the oral appliance receives information from external sources and their constituent components. Alternatively, it is contemplated that the upper oral device 120 and the oral appliance 10 can be connected together in a manner that is not inconvenient or uncomfortable to the user.

Fig. 7 illustrates an arrangement in which the

first electrode pair

112a, 112b, the

second electrode pair

114a, 114b, and the microprocessor 118 are all located in or on the palate part 122 of the superior device 120. Electrical leads 116 carry electrical signals from each electrode 112a, 112b, 114a, 114b to a microprocessor 118. Although there is sufficient room for the posterior palate part 122 of the oral device 120 to be oriented, it may be difficult to obtain a strong electroencephalogram signal when the electrodes are located only below the palate part.

Fig. 8A and 8B illustrate an arrangement in which the first electrode pair 112a, 112B and the second electrode pair 114a, 114B are located on the gum portion 132 of the oral device 120 adjacent to the buccal side of the maxilla of the user. That is, the

first electrode pair

112a, 112b and the

second electrode pair

114a, 114b are located between the upper gum and the inner lip/cheek of the user. The upper jaw, which comprises the maxilla of the user, is a continuous extension of the skull, i.e. on the underside of the brain. Therefore, the electrodes in close contact with the maxilla (i.e., the bones in contact with the cheek and the inside of the upper lip of the user) on the cheek side of the user will receive brain waves in the same manner as the scalp.

Electrodes

112a and 114a (e.g., left side electrodes) are positioned along the left side of gum portion 132/oral device 120 (i.e., along the left buccal side of the user's maxilla), and their

counter electrodes

112b and 114b (e.g., right side electrodes) are positioned along the right side of gum portion 132/oral device 120 (i.e., along the right buccal side of the user's maxilla). The location of the electrodes in fig. 8A and 8B allows for a good electroencephalographic signal to be achieved by the electrodes and the microprocessor 118, which can be clearly read and interpreted. The microprocessor 118, although not visible in fig. 8A and 8B, may be located in or on the palatal portion 122 of the superior device 120, i.e., in substantially the same location as on the palatal portion 122 of fig. 7. The electrical leads 116 carry the electrical signals from each electrode 112a, 112b, 114a, 114b to the microprocessor 118 by a most direct route along or within the material of the superior device 120. For example, the electrical lead 116 may follow the contour of the dentition attachment member 128 down, over and then to the palatal portion 122, where the electrical lead 116 then continues to the microprocessor 118. The paths of the electrical leads in fig. 8A and 8B are similar to those in fig. 9, and fig. 9 illustrates these paths more clearly.

Fig. 9 illustrates an arrangement in which the first electrode pair 112a, 112B and the second electrode pair 114a, 114B are positioned on the gingival portion 132 of the upper oral device 120 adjacent the buccal side of the palatal bone of the user as in fig. 8A and 8B. The

electrodes

112a and 114a (e.g., posterior electrodes) are positioned along the posterior portion of the gingival portion 132 (and oral device 120), and their

mating electrodes

112b and 114b (e.g., anterior electrodes) are positioned along the anterior portion of the gingival portion 132 (and oral device 120). The electrode locations in fig. 9 allow for good electroencephalographic signals to be achieved through the electrodes and the microprocessor 118. The microprocessor 118, although not visible in fig. 9, is located in or on the palatal portion 122 of the upper oral device 120, i.e., in approximately the same position as on the palatal portion 122 in fig. 7. The electrical leads 116 carry the electrical signals from each electrode 112a, 112b, 114a, 114b to the microprocessor 118 by a most direct route along or within the material of the superior device 120. That is, the electrical lead 116 will follow the contour of dentition attachment members 128 down, over and then to palatal portion 122, with electrical lead 116 then continuing to microprocessor 118.

Each of the first and

second electrode pairs

112a, 112B, 114a, 114B may be configured with the microprocessor 118 as an electroencephalograph of sufficient sensitivity to detect rhythmic changes in electrical signals in the brain, by any of the electrode arrangements of the electrodes shown in fig. 7, 8A, 8B and 9.

Electrodes

112a, 112b and 114a, 114b record the voltage difference between the paired "a" and "b" electrodes resulting from electrical signals in the brain. The signals detected by the electrodes are provided via electrical leads 116 to a signal processor which is part of a microprocessor 118.

As with any electroencephalogram, some psychological/conscious state causes the voltage difference detected between the

first electrode pair

112a, 112b and the

second electrode pair

114a, 114b to be rhythmic, with the recorded channels appearing as waves on the graph. The electroencephalographic signal of a conscious adult in a relaxed state is typically an oscillating wave known as an alpha wave. The brain waves of a sleeping adult become very slow. These slow waves are called delta waves and can be used not only to identify sleep but also to assess sleep depth. That is, the varying intensity of the delta wave may indicate a deeper sleep state. The signal processor and other microprocessor 118 components are capable of distinguishing between the various electroencephalogram rhythms and determining the various states of consciousness and sleep of the user based on these detected rhythms. It is contemplated that the oral device 120 may diagnose epilepsy by recording the user's brain activity, which may be collected by the data logger 60.

Fig. 10 is a flow chart illustrating exemplary operations 300 of the oral appliance 10 in cooperative communication with the upper oral device 120. Optionally, a custom fit oral device 120 and oral device of the oral appliance 10 are created 201, and the various electronic components are assembled to form a complete cooperative appliance. The upper oral device 120 and the oral device portion 210 of the oral appliance 10 are positioned 210 in the mouth of the user. The first 112a, 112b and second 114a, 114b electrode pairs collect voltage data and the microprocessor evaluates the electroencephalogram rhythm 212 from the data. The upper oral device microprocessor 118 can utilize the electroencephalographic rhythm to assess the sleep state 214 of the user and communicate the determination of the sleep state to the oral appliance 10. Alternatively, the raw electroencephalographic rhythm may be communicated to the oral appliance 10 for evaluation at step 230. In the event that the electroencephalographic data indicates that the user may be waking from sleep or exiting the sleep state in an untimely manner, the microprocessor of the oral appliance may cause the stimulator to send pulses 240 to stimulate the genioglossus muscle of the tongue of the user. The oral device 120 continuously evaluates the user's electroencephalographic rhythm 262 and sleep state 264 and provides data to the oral appliance. If the appropriate sleep state is reached, stimulation is stopped. According to one aspect, if the predetermined electroencephalographic rhythm is not restored, the stimulation continues, increases, decreases, or otherwise varies according to the measurement.

The flowchart shown in fig. 10 may be used independently of the flowchart shown in fig. 6 or in combination with the flowchart shown in fig. 6. Thus, the electroencephalography data can be used in conjunction with or in addition to the oxygen sensor measurement 220, the pressure sensor measurement 222, the airflow sensor measurement 224, the actigraph sensor measurement 226, and/or the noise detector measurement 228.

The various oral devices described above (e.g., the oral device 120 described in connection with fig. 7, 8A, 8B, and 9) may be used in various other applications. For example, the oral device may be used as a mouthguard suitable for athletic activities. In such applications, the oral device may be used to assess potential medical conditions or injuries, such as concussions or other head trauma. The data and/or results may be transmitted to the smart device via Bluetooth or may be transmitted to a remote application (e.g., a cloud application) via the internet. Other possibilities as understood by those skilled in the art are also contemplated. These data can also be used to study head trauma occurring in athletic activities in general.

As another example, various oral devices may be used for amateur or gaming applications, such as personal meditation devices, virtual reality games, video games, learning/education devices, or other personal activities that are centered on brain activity.

The superior oral device may or may not be used with the inferior oral device (e.g., the oral device 10).

The components of the illustrated apparatus are not limited to the specific embodiments described herein, but rather, features illustrated or described as part of one embodiment can be used on or in conjunction with other embodiments to yield yet a further embodiment. It is intended that the device include such modifications and variations. Further, the steps described in the methods may be used independently of other steps described herein.

While the apparatus and methods have been described with reference to specific embodiments, it will be understood by those skilled in the art that various changes may be made and elements thereof may be substituted without departing from the intended scope. In addition, many modifications may be made to adapt a particular situation or material to the teachings herein without departing from the essential scope thereof.

In this specification and the claims which follow, reference will be made to a number of terms which shall be defined to have the following meanings. The singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. Furthermore, references to "one embodiment," "some embodiments," "an embodiment," etc., are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features. Approximating language, as used herein throughout the specification and claims, may be applied to modify any quantitative representation that could permissibly vary without resulting in a change in the basic function to which it is related. Accordingly, a value modified by a term or terms, such as "about," should not be limited to the precise value specified. In some cases, the approximating language may correspond to the precision of an instrument for measuring the value. Terms such as "first," "second," "upper," "lower," and the like are used to distinguish one element from another and, unless otherwise specified, are not intended to refer to a particular order or quantity of elements.

As used herein, the terms "may" and "may" mean: the likelihood of occurrence in a series of situations; possess a specified attribute, feature or function; and/or qualify another verb by expressing one or more of an ability, capacity, or possibility associated with qualifying the verb. Thus, use of "may" and "may" indicate that the modified term is apparently appropriate, capable, or suitable for the indicated capacity, function, or use, while taking into account that in some instances the modified term may sometimes not be appropriate, capable, or suitable. For example, in some cases, an event or capacity may be expected, while in other cases, an event or capacity may not occur, such distinction being denoted by the terms "may" and "may".

The term "comprising" and grammatical variations thereof as used in the claims also logically encompasses varying degrees and different degrees of phrase such as, but not limited to, "consisting essentially of. . . Make up of. . . Composition ". Where necessary, ranges have been provided and include all subranges therebetween. It is anticipated that variations in these ranges will suggest themselves to practitioners of ordinary skill in the art, and where not already dedicated to the public, these variations are intended to be covered by the appended claims.

Scientific and technological advances may make equivalents and alternatives now left out due to language inaccuracies possible; such variations are intended to be covered by the appended claims. This written description uses examples to disclose the methods, machines, and computer-readable media, including the best mode, and also to enable any person having ordinary skill in the art to practice the methods, including making and using any devices or systems and performing any incorporated methods. The patentable scope thereof is defined by the claims, and may include other examples that occur to those of ordinary skill in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal languages of the claims.

Claims

1. An oral device for detecting electrical activity in a user's brain, the oral device comprising:

a dentition attachment portion for receiving the user's upper dentition, the dentition attachment portion having a buccal surface;

a gum portion extending upwardly from the buccal surface of the dentition attachment portion such that the gum portion is positioned along the upper gum of the user;

an electrode positioned along the gingival portion of the oral device; and

a microprocessor connected to the electrode, wherein the electrode and microprocessor are operative to detect electrical activity in the brain of the user.

2. The oral device of claim 1 wherein the electrodes are embedded within the gingival portion of the oral device.

3. The oral device of claim 1, wherein the gingival portion has a left side and a right side, and wherein the electrodes comprise a first pair of electrodes comprising a left electrode positioned along the left side of the gingival portion and a right electrode positioned along the right side of the gingival portion.

4. The oral device of claim 3, wherein the electrodes further comprise a second pair of electrodes comprising a left electrode positioned along the left side of the gingival portion and a right electrode positioned along the right side of the gingival portion.

5. The oral device of claim 1, wherein the gingival portion has an anterior portion and a posterior portion, and wherein the electrodes comprise a first pair of electrodes comprising an anterior electrode positioned along the anterior portion of the gingival portion and a posterior electrode positioned along the posterior portion of the gingival portion.

6. The oral device of claim 5, wherein the electrodes further comprise a second pair of electrodes comprising an anterior electrode positioned along the anterior portion of the gingival portion and a posterior electrode positioned along the posterior portion of the gingival portion.

7. The oral device of claim 1 wherein the dentition attachment section has a lingual surface opposite the buccal surface, and wherein the oral device further comprises a palatal portion extending from the lingual surface of the dentition attachment section.

8. An oral device as in claim 7, wherein the microprocessor is disposed along the palate portion of the oral device.

9. The oral device of claim 1, further comprising electrical leads connecting the electrodes to the microprocessor.

10. An oral device as claimed in claim 1, which comprises a mouthguard for athletic activities.

11. The oral device of claim 1, comprising an oral device for gaming activities.

12. An oral device for detecting electrical activity in a user's brain, the oral device comprising:

a dentition attachment portion configured to conform to at least a portion of the user's upper dentition;

a palatal portion integral with the dentition attachment portion, the palatal portion configured to conform to at least a portion of the user's palate;

a gingival portion integral with the dentition attachment portion, the gingival portion configured to conform to at least a portion of a gingiva of the user;

a plurality of electrodes positioned along the gingival portion; and

a microprocessor connected to the electrodes, wherein the electrodes and microprocessor operate as an electroencephalograph for detecting electrical activity in the brain of the user.

13. The oral device of claim 12, wherein the dentition attachment portion has a buccal surface and the gingival portion extends from the buccal surface of the dentition attachment portion.

14. The oral device of claim 12, wherein the plurality of electrodes comprises a plurality of pairs of electrodes, and for each pair of electrodes, a first electrode is positioned along a left side of the gingival portion and a second electrode is positioned along a right side of the gingival portion.

15. The oral device of claim 12, wherein the plurality of electrodes comprises a plurality of pairs of electrodes, and for each pair of electrodes, a first electrode is positioned along an anterior portion of the gingival portion and a second electrode is positioned along a posterior portion of the gingival portion.

16. The oral device of claim 12, wherein the microprocessor is embedded within the palate part of the oral device.

17. An oral device for detecting electrical activity in a user's brain, the oral device comprising:

a dentition attachment portion for positioning on a user's upper dentition, the dentition attachment portion having a buccal surface and a lingual surface;

a gingival portion extending from the buccal surface of the dentition attachment portion such that the gingival portion is positioned along an upper gum of the user;

a palatal portion extending from the lingual surface of the dentition attachment portion;

a plurality of electrode pairs positioned along the gingival portion; and

a microprocessor connected to the plurality of electrode pairs, wherein the microprocessor connected to the plurality of electrode pairs operates as an electroencephalograph.

18. The oral device of claim 17, wherein for each pair of electrodes, a first electrode is positioned along a left side of the gingival portion and a second electrode is positioned along a right side of the gingival portion.

19. The oral device of claim 17, wherein for each pair of electrodes, a first electrode is positioned along an anterior portion of the gingival portion and a second electrode is positioned along a posterior portion of the gingival portion.

20. The oral device of claim 17, wherein the microprocessor is embedded within the palate part of the oral device.