Intraoral electroencephalogram device and method

Abstract

An oral device for wearing on a user's upper dentition includes electrodes and a microprocessor that function as an electroencephalograph for detecting electrical activity in the user's brain. The oral device can be used for various applications such as sports, gaming, and personal hobbies.

Description

[0001] Cross - Reference to Related Applications

[0002] This application is a partial continuation of U.S. Application No. 16 / 673,077, filed on November 4, 2019, which is a partial continuation of U.S. Application No. 16 / 202,204, filed on November 28, 2018, which is a partial continuation of U.S. Application No. 15 / 479,737, filed on April 5, 2017, which claims the benefit of U.S. Provisional No. 62 / 319,443, filed on April 7, 2016. Each of these applications is incorporated herein by reference in its entirety. Background of the Invention

[0003] Sleep apnea is a common medical condition during which a person experiences one or more apneas and, in some cases, shallow breathing during sleep. Although there are several types of sleep apnea, the most common type is obstructive sleep apnea. In this medical condition, one or more throat muscles of the patient relax during sleep, causing the surrounding tissues in the mouth, nasal cavity, and back of the throat to collapse, thereby creating a pharyngeal obstruction that blocks 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 left untreated, obstructive sleep apnea can have a significant impact on a person's health, typically leading to cardiovascular, stroke, and metabolic diseases.

[0004] Known methods for treating obstructive sleep apnea include surgical and non - surgical means. One popular surgical procedure is uvulopalatopharyngoplasty, which can be performed on patients whose anatomical abnormalities cause their obstructive sleep apnea and / or make them less likely to tolerate non - surgical means. Uvulopalatopharyngoplasty can be a complex surgery during which a portion of the soft palate is removed to prevent excess tissue from blocking the airway during sleep. However, the drawbacks of this surgery are that it is usually expensive and may damage the throat muscles required for swallowing and / or cause other adverse conditions such as nasal reflux and numbness of the lower front teeth.

[0005] To reduce this risk, various non-surgical methods have been employed. One non-surgical method involves the use of a standardized oral appliance that progressively advances and / or protrudes 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 trays, where the lower dental tray is designed to advance the mandible, thereby moving the tongue forward to increase the space in the posterior pharynx and oropharynx, which in turn can increase airflow 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 an individual's obstructive sleep apnea and the user's psychological factors. A disadvantage of using these standard oral appliances is that they may not adequately provide for and / or address individualized anatomical differences, such as differences in dental arch, dental alignment, and / or jaw flexibility. Another disadvantage is that in cases of excessive advancement, the appliance may cause long-term temporomandibular joint (TMJ) disorders, muscle deterioration, dental discomfort, and / or myofascial disorders. Thus, within 2 years, the compliance rate for using these standard appliances is approximately 75%. For a detailed study on the compliance of using MADs, see Non-CPAP therapies in obstructive sleep apnoea: mandibular advancement device therapy, see Eur Respir J 2012; 39: 1241-1247, which is incorporated herein by reference in its entirety. Thus, such oral appliances may not treat obstructive sleep apnea in a manner that prevents and / or limits the impact on a person's health.

[0006] Figure 1 Depicted is a system 1 that includes an intraoral stimulation device 2 for providing treatment of sleep disorders. The intraoral stimulator device 2 is powered by a rechargeable battery and includes a housing for a hollow tooth retainer wireframe or mouthguard (in the case of a bilateral configuration) or molar clip (in the case of a unilateral configuration) for positioning on the lower teeth. The housing 4 includes one or two pairs of bilateral electrodes 5a, 5b for positioning on the ventral surface of the tongue and sublingual positions posterior to the midline of the tongue for stimulating the majority of the genioglossus muscle and the base of the tongue to restore muscle tone during sleep. The system 1 includes an external inductive charger subsystem 6 configured to receive power from a wall outlet 7 and use that power to transfer power by electromagnetic induction to charge a rechargeable battery (not shown) provided in the intraoral stimulator device 2.

[0007] The oral appliance 1 further includes a non-rechargeable battery-powered handheld appliance 3 that conveys instructions to the intraoral stimulator device 2. The non-rechargeable battery-powered handheld appliance 3 is used by the patient's sleep doctor to program the stimulation and set system parameters in the intraoral stimulator device 2. The stimulation can be pre-programmed or can occur based on changes in the user's breathing pattern as sensed by an accelerometer, temperature, piezoelectric film, and EMG. Alternatively, the stimulation therapy can be programmed and set by the doctor so that the treatment begins 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 overstimulation can cause nerve and / or muscle fatigue / injury. Additionally, while the doctor can set and / or send instructions to the intraoral stimulator, the doctor cannot store and / or evaluate the patient's breathing and / or snoring patterns in a way that would allow the doctor to modify the treatment as needed. The lack of specialized treatment for individual patients with unique medical needs can be problematic, especially since they cannot store patient behavior and / or medical data to help healthcare providers design and / or improve specialized treatment for individual patients. Thus, such an intraoral stimulator device may not be able to treat obstructive sleep apnea in a way that prevents and / or limits the impact on a person's health.

[0008] Other methods for treating obstructive sleep apnea include delivering positive air pressure via a continuous positive airway pressure (CPAP) machine. CPAP machines are typically assembled for use in conjunction with various face masks or nasal masks and can provide continuous pressurized and / or forced air during a patient's sleep. A drawback of this assembly is that due to the continuous forced air, it can cause dryness of the nasal and / or oral mucosa and can also cause claustrophobia due to the presence of the mask on the patient's face. As a result, within 5 years, the compliance rate for using these components is approximately 50%. For a detailed study on CPAP machine use compliance, see Long-term compliance with continuous positive airway pressure in patients with obstructive sleep apnea, Can Respir J. 2008 Oct;15(7):365-369, which is incorporated herein by reference in its entirety. Another drawback is that standard masks are not properly adjusted to fit people with unique and / or variable facial anatomies, which may be natural or caused by a loss of muscle tone secondary to facial paralysis and / or stroke. A poorly fitting mask can lead to air leakage and / or insufficient air intake. In addition, masks used with CPAP machines have been found to be breeding grounds for bacteria and fungi. Despite routine cleaning and disinfection measures, the bacteria and fungi on these masks can grow exponentially and cause respiratory infections, such as pneumonia, in the people using them. Furthermore, this assembly may not adequately treat obstructive sleep apnea and may not promote patient compliance with the treatment method.

[0009] The above-described treatment techniques may not provide adequate treatment for obstructive sleep apnea, may cause and / or contribute to other negative health conditions in the user, and may not promote compliance with the treatment method.

[0010] Given the drawbacks of current methods and devices available for treating obstructive sleep apnea, there is a need for a device and method that treats obstructive sleep apnea while storing patient behavior and / or medical data related to the user's breathing pattern, snoring pattern, and / or teeth grinding / clenching behavior to assist healthcare providers in designing, improving, and / or modifying customized treatment measures for individual patients. In addition, there is a need for a device and method that treats obstructive sleep apnea in a single removable oral appliance and prevents and / or limits long-term temporomandibular joint (TMJ) disorders, muscle deterioration, and / or myofascial disorders that may occur with continuous use of existing appliances.

[0011] Electroencephalogram is a technique for recording and interpreting the electrical activity occurring within the brain. Electroencephalogram technology is based on the nerve cells of the brain that generate electrical impulses fluctuating in a specific pattern. The patterns generated by an electroencephalogram machine that can be recorded are called electroencephalograms (EEGs).

[0012] Obtaining an electroencephalogram usually begins with connecting many 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 that pair of electrodes. This voltage difference can be rhythmic and is displayed as waves 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. Becoming excited or being startled causes the alpha waves to be replaced by low-voltage waves that are fast and irregular relative to the alpha waves. The brain waves of a sleeping adult become very slow. This is also the case for a person in a coma. Other abnormal conditions have known electroencephalogram patterns. For example, delta waves are irregular slow waves near an area of brain damage. Although electroencephalograms are certainly not useful in all cases, they are useful as a diagnostic aid in cases of severe head injury, brain tumor, sleep disorder, brain infection, epilepsy, some neurodegenerative diseases of the nervous system, and brain death.

[0013] In a sleep laboratory, delta waves can be used to evaluate the depth of sleep. The stronger the delta rhythm, the deeper the sleep. An increased delta power (an increment in delta wave recording) has also been found to be related to an increased concentration in an internal working memory task.

[0014] As mentioned above, the collection of electroencephalogram data is carried out using electrodes connected to the scalp of a subject. One reason for this placement is to bring the electrodes as close as possible to the brain and with as few intervening structures as possible. Except for bald subjects, it is not really possible to "attach" the electrodes to the scalp. This poses a problem because the movement of the electrodes interferes with the quality of the received voltage. In addition, since muscle cells also generate electrical potentials, electroencephalogram machines usually try to avoid muscle interference between the electrodes and the brain.

[0015] In addition to the above, there is a need for a device and method that can determine when a user has a wake-up or wakes up from deep sleep and enters or is in an obstructive sleep apnea state. Such a monitoring device and method can be combined with an active treatment regimen. That is, determining that a user is waking up from sleep or becoming awake from sleep and entering or being in an obstructive sleep apnea state can be used as a trigger for an active treatment regimen. Summary of the Invention

[0016] According to one aspect, embodiments are associated with an oral appliance for treating a user's sleep apnea. An embodiment can include a mouthpiece configured to be retained in the user's mouth, a plurality of electrodes, a microprocessor, and at least one stimulator. The user's mouth contains oral tissues, and the mouthpiece has a tongue wall and a buccal wall. The plurality of electrodes are attached to the mouthpiece and electrically connected to the microprocessor; the electrodes and the microprocessor are configured to determine an electroencephalogram rhythm of the user's brain. The microprocessor is configured to evaluate an immediately occurring rhythm of the user's sleep apnea. The at least one stimulator is also attached to the mouthpiece and is configured to respond to an immediately occurring user sleep apnea by stimulating the user's genioglossus muscle. The mouthpiece of the oral appliance can have an upper portion and a lower portion.

[0017] Embodiments of the present disclosure are also associated with an oral appliance for treating a user's sleep apnea, including a mouthpiece, a plurality of electrodes, at least one electrical stimulator, and a microprocessor. The mouthpiece is configured to be retained in the user's mouth and can have an upper portion and a lower portion, each having a tongue wall and a buccal wall. The user's mouth has oral tissues. The plurality of electrodes are attached to the mouthpiece, and the microprocessor is configured to receive signals from the electrodes such that the electrodes and the microprocessor operate together as an electroencephalograph and detect an electrical rhythm from the user's brain. The electrical rhythm may indicate an immediate occurrence of arousal from deep sleep or the user's occurrence of sleep apnea. The at least one electrical stimulator is attached to the mouthpiece and the microprocessor; the stimulator is configured to emit an electric current or an electric field in response to an immediate occurrence of the user's sleep apnea based on the electrical rhythm.

[0018] Embodiments of the present disclosure are also associated with a mouthpiece for being worn on a user's upper dentition and jaw (or maxilla, edentulous). The mouthpiece includes electrodes that detect an electrical rhythm of the user's brain. The mouthpiece can be used for various applications such as sports, gaming, and hobbies. It is contemplated that the mouthpiece can be used to detect in real time a traumatic blow to the user's head during a competitive sport when the athlete wears the mouthpiece. The user's electroencephalogram can also be monitored by a trained operator on the sidelines. The technology can detect an early onset of acute brain injury or concussion before any clinical manifestation and help protect the user from potential future damaging side effects of the trauma. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] A more specific description will be presented by reference to specific embodiments shown in the drawings. It should be understood that these drawings only depict typical embodiments therein and thus should not be considered as limiting its scope. The exemplary embodiments will be described and explained with additional specificity and detail by using the drawings, wherein:

[0020] Figure 1Is a perspective view of an oral device of the prior art;

[0021] Figure 2 Is a top view of an oral appliance according to an embodiment;

[0022] Figure 3 Is a perspective view of an oral appliance according to an embodiment;

[0023] Figure 4 Is a perspective view of an oral appliance according to an embodiment;

[0024] Figure 5 Is a perspective view of a kit of oral appliances according to an embodiment;

[0025] Figure 6 Is a schematic diagram of a method for providing electrical genioglossus muscle stimulation according to an embodiment;

[0026] Figure 7 Is a bottom view of the top oral device of an oral appliance according to an embodiment;

[0027] Figure 8A Is a perspective view of the lower left side of the oral device of an oral appliance according to an embodiment;

[0028] Figure 8B Is Figure 8A A perspective view of the lower right side of the oral device of the illustrated oral appliance;

[0029] Figure 9 Is a perspective view of the lower front side of the oral device of an oral appliance according to an embodiment; and

[0030] Figure 10 Is a schematic diagram of a method for providing electrical genioglossus muscle stimulation according to an embodiment.

[0031] The various features, aspects, and advantages of the embodiments will become more apparent from the following detailed description in conjunction with the accompanying drawings, where the same numerals represent the same components throughout the drawings and the text. The various features described are not necessarily drawn to scale but are drawn to emphasize specific features relevant to certain embodiments. Detailed Description

[0032] Reference will now be made in detail to various embodiments. Each example is provided by way of explanation and is not meant to be limiting, nor does it constitute a definition of all possible embodiments.

[0033] Embodiments of the present disclosure generally relate to devices / appliances and methods for treating obstructive sleep apnea, devices for providing electrical stimulation to a user's tongue to inhibit 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 a particular utility in providing electrical stimulation to the user's tongue such that the stimulation does not wake the user during sleep. As an alternative or supplement to electrical stimulation, the device may include a pharmaceutical compound for treating obstructive sleep apnea, such as an ionized drug. The pharmaceutical compound may be disposed in a reservoir / drug reservoir that is separate from the device or as part of the physical matrix of the device. Particularly in the former option, the reservoir may be refilled or replaced on a daily or less frequent schedule.

[0034] The envisioned oral appliance includes an oral device configured to receive at least the user's temporary, permanent, and / or artificial mandibular dentition. The oral device may include a variety of electronic components, including one or more of the following: an oxygen sensor, a pressure sensor, an airflow sensor, a noise detector, an actigraphy sensor, a stimulator, a data recorder, a battery, and a microprocessor. The oral device may also include a material such as a polymer matrix into which a pharmaceutical compound may be incorporated for delivery to the user. Alternatively, one or more reservoirs containing the pharmaceutical compound may be attached to the oral device. Each reservoir is capable of delivering the drug directly to one or more oral mucosal surfaces of the user. The oral device may include a customizable material to provide a comfortable fit for the user while retrieving data related to the user's blood saturation level, clenching and / or grinding of the dentition surface, actual airflow level, and noise level related to snoring, analyzing the data, and preparing a set of instructions for the stimulator.

[0035] When used in combination with a pharmaceutical compound, the stimulator assembly may be used to effectively transfer the drug from the device to the oral mucosa of the user. This drug delivery function may be supplementary to or an alternative to the electrical stimulation of the user's oral muscle tissue, i.e., the electrical stimulation may only serve as a drug release / delivery mechanism. The stimulator may operate to rupture or pierce a drug reservoir attached to or otherwise associated with the oral device upon receipt of an operating instruction. Alternatively, the stimulator may be used in combination with a drug having a charged surface, which will be further explained. In the case where the microprocessor sends a signal causing the drug reservoir to rupture, the user may be notified by the microprocessor that the reservoir needs to be replaced. Such notification may take the form of a notification on the user's smartphone or in the form of a visual notification, e.g., activating an LED light that the user can then see.

[0036] According to one aspect, the oral device is customized to be receivably positioned and / or secured to a user's mandible. According to one aspect, the oral device is customized to receive a user's lower dentition. In any case, the oral device can be customized to provide a comfortable fit, thereby enhancing user comfort and increasing the likelihood of the user repeatedly wearing the oral device, i.e., the user's compliance rate.

[0037] To illustrate the features of the embodiments, embodiments will now be introduced and referred to throughout the disclosure. Those skilled in the art will recognize that the examples are illustrative and not restrictive and are provided purely for explanatory purposes.

[0038] In one embodiment, and with particular reference to Figures 2 to 4 , an oral appliance 10 for treating a user's sleep apnea is provided. The oral appliance 10 is shown as having an oral device 20 and several components. In one embodiment, the oral device 20 is "customizable", that is, customized for an individual user's oral cavity such that it provides a comfortable fit on and around the surfaces of the user's hard tissues (teeth / dentition) and / or soft tissues (general oral structures, including gums). When customized, the oral device 20 can conform to the temporary, permanent, native natural, and / or artificial lower dentition of adult and / or child users. The oral device 20 can be configured to receive a user's removable dentures. According to one aspect, the oral device 20 is fabricated on a mandible with partial or no dentition, i.e., the mandible. When customized, the oral device 20 can be formed from any self-compliant material that can accommodate variations and / or changes in the oral structure, or by using an impression of the teeth of an individual user's dentition, as will be understood by those of ordinary skill in the art. In other words, a mandibular impression and / or a dental impression can be taken, such that a positive replica (or casting) customized for the user is created using a negative impression of the user's hard and / or soft tissues.

[0039] 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 materials that can be used to form an oral device 20 that conforms to a user's dentition. 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 an impression made in a thin elastic material. The oral device material can also be specifically selected from polymers due to their ability to incorporate pharmaceutical compounds into the structural matrix.

[0040] In one embodiment and as Figure 2 and Figure 3As shown, the oral device 20 includes a central channel 29 defined by a tongue portion 24 and a buccal portion 23. The central channel 29 may be configured to be positioned receivably over and / or receive one or more user dentitions such that the oral device 20 is secured thereto. When the oral device 20 is in use, the central channel 29 may receive the user's dentition and may extend to and / or cover the occlusal or biting surfaces of the user's teeth. The tongue portion 24 of the oral device 20 extends between the user's teeth and the user's tongue. In one embodiment and as Figure 2 and Figure 3 shown, the buccal portion 23 of the oral device 20 extends between the user's teeth and the user's cheek.

[0041] According to one aspect, the oral device 20 is configured to be secured to a user's dentition. In one embodiment and as Figure 4 shown, the oral device 20 includes a tongue portion 24 and a dentition attachment member 28 coupled to the tongue portion 24. The dentition attachment member 28 and the tongue portion 24 may be customizable such that the dentition attachment member 28 has a shape and size that substantially conforms to the user's dentition, thereby providing the user with an oral device 20 with a secure and customized fit. Generally, the dentition attachment member 28 is provided in the form of a wireframe that extends from the tongue portion 24 to wrap around or surround an individual user's dentition and anchor the tongue portion 24 between the lingual surface of the teeth and the tongue. According to one aspect, at least a portion of the dentition attachment member 28 is shaped to form retention loops around one or more of the user's teeth.

[0042] Similar to the dentition receiving cavity 25 described for the oral device 20 of Figure 2 and Figure 3 Figure 4 ​The tongue portion 24 depicted therein can also be customized to have a shape substantially the same as the shape of the individual user's dentition for which it has been contoured and / or shaped to conform, thereby assisting the retention function of the dentition attachment member 28. In any case, the oral appliance 20 is capable of being at least temporarily secured in place because it has been contoured and conformed to the user's dentition and / or is provided with the dentition attachment member 28, thereby providing a customized fit. Accordingly, the oral appliance 20 can provide a retention function that allows the oral appliance 10 to remain in place during user sleep, particularly in cases where the user may make slight to moderate movements during sleep and / or when the user may be awake. Thus, the oral appliance 20 can be substantially immovable unless a positive effort is exerted to remove the oral appliance 20. In other words, the user can remove the oral appliance 20 at any time as needed by exerting a bit of pressure for removing the oral appliance 20. Since the oral appliance 20 is not permanently fixed to the dentition, the user can wear and / or subsequently remove it at any time. Accordingly, the oral appliance 10 can be used for different lengths of time.

[0043] According to one aspect and as Figures 2 to 4 shown, the components located within and / or embedded in the oral appliance 20 include one or more of the following components: an oxygen sensor 30, a pressure sensor 32, an airflow sensor 34, a noise detector 35, an actigraphy sensor 36, a stimulator 40, a drug reservoir 42, a microprocessor 50, a data recorder 60, and a battery 70. According to one aspect, the oral appliance 20 includes a dry protection area or covering for these electronic components that substantially inhibits and / or limits damage to the components by water and / or tissue (not shown). Such a dry / protected area can be formed as a result of the components being embedded within the oral appliance 20 itself.

[0044] As Figures 2 to 4As shown, the oxygen sensor 30 may be disposed near the front portion 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 the actual oxygen saturation level of the user's hemoglobin. The oxygen sensor 30 may be adapted to monitor and / or determine the user's pulse and / or heart rate. The oxygen sensor 30 may be positioned on or within the tongue portion 24 of the oral device 20. In one embodiment, the oxygen sensor 30 is primarily positioned 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) and the buccal regions of the maxilla. According to one aspect, the oxygen sensor 30 is a transceiver such as a pulse oximeter that is configured to monitor / sense the user's oxygen saturation level by analyzing color changes in the user's blood. The pulse oximeter may measure the user's pulse rate, typically in beats per minute, based on changes and / or deviations in the user's oxygen saturation level. For example, an exemplary pulse oximeter may include light emitting diodes that are configured to transmit red and infrared light to the vascular surface of the user's tongue and sense changes in the oxygen level in the user's tongue. According to one aspect, two oxygen sensors 30 are provided on the tongue portion 24 of the oral device 20. It is contemplated that the oxygen sensor 30 may be placed in other locations in the oral cavity, such as the cheekbones, such that the oxygen sensor collects oxygen saturation data from the gum surface covering the cheekbones. The two oxygen sensors 30 may be positioned on opposite sides of the oral device 20. Although Figures 2 to 4 two oxygen sensors 30 are shown positioned on the oral device 20, it is understood that the number of oxygen sensors provided may be 3, 4, 5, 6 or more.

[0045] According to one aspect and as Figure 2 and Figure 3 shown, the oral appliance 10 may 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 bruxism and / or clenching, such as may occur when the user is asleep. The pressure sensor 32 may be located in or on the central channel 29. In one embodiment, the pressure sensor 32 is positioned within the dentition receiving cavity 25 such that the pressure sensor 32 is positioned substantially adjacent to the user's mandibular clenching and / or occlusal surfaces. According to one aspect, the pressure sensor 32 is located on the outer surface of the central channel 29, wherein the central channel 29 has an inner surface configured to receive the dentition receiving cavity 25, and the outer surface location is opposite the inner surface such that the pressure sensor 32 is positioned substantially adjacent to the user's maxillary clenching and / or occlusal surfaces. In some embodiments (not shown), the pressure sensor may be provided on the dentition attachment member 28, such as under the trademark FlexiForce TMForce Sensors Pressure sensors manufactured by Tekscan. Such bruxism signs may include force sensors configured to measure forces applied to the occluding and / or biting surfaces of the user's teeth. According to one aspect, the pressure sensor 32 is a thin elastic material. One or more pressure sensors 32 may be electrically sealed and / or not wetted by liquids, saliva, and / or oral tissues. The number of pressure sensors 32 provided on the oral device 20 may be selected according to the user's tendency to grind and / or clench their teeth. According to one aspect, the number of pressure sensors 32 provided is 2, 3, 4, 5, 6 or more.

[0046] In one embodiment, the oral device 20 includes one or more airflow sensors 34 configured to measure the user's actual airflow and / or respiratory rate, i.e., the rate of air inhaled and / or exhaled by the user through the oral device 20. According to one aspect, the airflow sensor 34 is configured to detect any reduction and / or cessation of airflow during sleep. The airflow sensor 34 may be arranged at any position on the oral device 20 that is in the general flow path of the air inhaled and / or exhaled by the user. As Figure 2 shown, the airflow sensor 34 may be positioned near the rear 22 of the oral device 20. According to one aspect, the airflow sensors 34 are symmetrically positioned on both sides of the oral device 20. As Figure 2 and Figure 3 shown, 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 together to measure the user's airflow rate. The airflow sensor 34 may be arranged in and / or 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 may be selected according to the user's needs. According to one aspect, the number of airflow sensors provided is 2, 3, 4, 5 or more.

[0047] According to one aspect and as Figures 2 to 4 shown, the oral device 20 may include an actigraphy sensor 36 configured to monitor and capture data related to sleep activities, including the user's sleep position and movement during sleep. The actigraphy sensor 36 may be embedded or otherwise connected to the oral device 20 at any desired position. According to one aspect and as Figure 2 and Figure 3 shown, the actigraphy sensor 36 is positioned in the cheek 23 of the oral device 20. In an alternative embodiment and as Figure 4As shown, the body movement recorder sensor 36 can be positioned on the tongue 24 of the oral device 20. The body movement recorder sensor 36 can determine the user's sleeping posture, for example, the supine position during which the user lies on their back, the prone position during which the user lies face down, and / or the lateral position during which the user lies on their left or right side. The body movement recorder sensor 36 can measure the time the user sleeps in each identified posture and / or the frequency at which the user changes from one sleeping posture to another.

[0048] The oral appliance 10 can include a noise detector 35 configured to detect the actual noise and / or vibrations caused by the user's snoring. According to one aspect, the noise detector 35 is internally hardwired to one or more components that are coupled to or otherwise embedded in the oral device 20, such as the stimulator 40, the microprocessor 50, and the data recorder 60, such that the noise detector 40 can communicate with these components. The noise detector 35 can be configured to communicate wirelessly with at least one of the stimulator 40, the microprocessor 50, and the data recorder 60. The noise detector 35 can be positioned at 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 such that relevant 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 Figure 3 shown, the noise sensor 35 can be positioned on the cheek 23 of the oral device 20. In one embodiment and as Figure 4 shown, the noise sensor 35 is positioned on the tongue 24 of the oral device 20. Although Figure 3 and Figure 4 show a single noise detector 35 being provided on the oral device 20, it is understood that 2, 3, 4, or more noise detectors 35 can be provided.

[0049] According to one aspect and as Figures 2 to 4As shown, 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 oral cavity. The stimulator 40 is configured to provide a gentle stimulation to the user's tongue, which will be described in more detail below. In one embodiment, the stimulator 40 is located on the tongue portion 24 of the oral device 20, adjacent to the tongue. The stimulator 40 may be symmetrically positioned on both sides of the oral device 20 such that symmetrical bilateral stimulation can 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, e.g., near the user's genioglossus muscle. Thus, the stimulator 40 may be configured to provide stimulation to the genioglossus muscle of the user's tongue in a manner that allows restoration of the muscle tone of the genioglossus muscle. Such stimulation may be an electrical pulse, which causes the genioglossus muscle to contract and / or causes the user to reduce the amount of force applied on the biting and / or occlusal surfaces of the user's teeth. In some embodiments, the contraction of the genioglossus muscle may cause the user's tongue to protrude, thereby creating more space in the user's pharynx and helping the user to breathe more easily in a manner that increases the oxygen saturation level of the user's hemoglobin. The stimulation may be in response to the actual saturation level of the user's hemoglobin as measured by the at least one oxygen sensor 30.

[0050] 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. 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 pre-determined to be insufficient, the stimulator 40 can be activated. The stimulator 40 can at least intermittently stimulate the genioglossus muscle of the user's tongue until the oxygen saturation level of the hemoglobin rises above the predetermined oxygen level. In one embodiment, if the oxygen sensor 30 determines that the actual oxygen saturation level of the user's hemoglobin is below about 95% oxygen saturation, the stimulator 40 is activated. Stimulating the genioglossus muscle of the user can promote an increase in the user's respiratory flow, thereby increasing the user's oxygen availability and increasing the oxygen saturation level of the hemoglobin. According to one aspect, when 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. In one embodiment, if the pressure sensor 32 detects that the user is grinding and / or clenching their teeth, the stimulator 40 is activated. According to one aspect, the stimulator 40 provides stimulation until the force applied to the biting and / or occlusal surfaces of the user's teeth is below a predetermined force level. Once the pressure sensor 32 detects that the grinding and / or clenching of the teeth has been significantly reduced and / or stopped, as evidenced by the detected force level, the stimulator 40 can stop stimulating. According to one aspect, when the airflow sensor 34 determines that the frequency at which the user inhales and / or exhales air is below a predetermined airflow level, the stimulator 40 is activated. In one embodiment, 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 (natural airflow) inhaled and / or exhaled by the user when awake has been reduced by 30%), the stimulator 40 is activated. The stimulator 40 can 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, if the noise detector 35 detects that the actual noise and / or vibration is above a predetermined noise level, the stimulator 40 is activated. 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 the predetermined noise level.

[0051] In one embodiment, the stimulator 40 is configured to provide a constant stimulation to the genioglossus muscle of the user's tongue. Alternatively, the stimulator 40 can provide a variable stimulation to the genioglossus muscle of the user's tongue. The variable stimulation can incrementally stimulate the genioglossus muscle of the tongue until the oxygen saturation level is at a predetermined oxygen level, e.g., at or above 95%. In one embodiment, the variable stimulation incrementally stimulates the genioglossus muscle until the force applied to the clenching and / or occlusal surface is below a predetermined force level. The variable stimulation provided by the stimulator 40 can 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 rate of achieving the oxygen saturation of hemoglobin and / or the predetermined force level. The constant or variable stimulation can be a mild stimulation that does not disturb and / or wake the user during sleep. According to one aspect, the constant or variable stimulation is mild enough that the user is not aware of it when worn while the user is at least slightly awake. The stimulator 40 can 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 mild electrical pulses. The mild electrical pulses can be provided to the genioglossus muscle of the user's tongue in a non-invasive manner and in such a way that the user in sleep is not awakened.

[0052] In one embodiment, the oral device 20 or structures associated with the oral device 20 allow for the delivery of a pharmaceutical compound to facilitate the maintenance or restoration of the muscle tone of the genioglossus muscle. Such a pharmaceutical compound can cause the genioglossus muscle to contract. A cholinergic drug (such as neostigmine) can be used to effect the activation of the genioglossus muscle. Other stimulants and / or drugs that activate and / or increase the release / activation of calcium ions that affect muscle contraction can also be used to activate the genioglossus muscle, and these compounds include norepinephrine and caffeine.

[0053] In another embodiment, genetically engineered light can be used to stimulate nerves and muscles, specific to the desired site. This concept is known as optogenetics. Optogenetics enables the use of light to stimulate neurons by inserting the gene for a protein called channelrhodopsin-2 from green algae. When the modified neurons are exposed to blue light, the protein initiates electrical activity within the cell and then spreads from neuron to neuron. The optical control method offers advantages over electrical stimulation for the biomechanics of muscles and human movement. That is, the oral device 20 emits photons rather than charges / currents.

[0054] In one embodiment, a pharmaceutical compound can be incorporated into the material of the oral device 20 for active or passive release. Passive release can be triggered by environmental factors in the user's oral cavity, such as changes in temperature, pH, or similar variables. Active release can involve electrical stimulation controlled by a microprocessor 50 in response to input from one or more sensors associated with the oral device 50. The electrical stimulation that causes drug release will be discussed further below.

[0055] Iontophoresis is a drug delivery process that utilizes a voltage gradient. Molecules are transported across a semipermeable material or barrier by electrophoresis and / or electroosmosis. Electrophoresis is the movement of charged particles, ions, or anions in the presence of an electric field. Particles with a surface charge present in a liquid or gel (i.e., capable of substantial movement relative to the medium containing them) are most amenable to electrophoresis, although movement through other materials is also possible. Electroosmosis is the movement of liquid caused by an electric potential applied across 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, typically μmol / (cm 2 *h).

[0056] The material selected for the oral device 20 can be, for example, a polymer that acts as a semipermeable reservoir for the selected pharmaceutical compound. That is, the material of the oral device 20 will retain the pharmaceutical compound under storage and other conditions, while releasing the pharmaceutical compound under certain passive or active conditions. In the case of active release, a charge or electric field can be applied to certain parts of the oral device 20, causing the pharmaceutical compound to flow out of the oral device 20 and be absorbed by the tissue that the pharmaceutical compound is designed to treat, precisely through the user's oral mucosa. Whether it is active release or passive release, once the reservoir 42 is empty, a user notification indicating the need to replace the reservoir 42 can be communicated to the user by the microprocessor 50. Such notification can take the form of a user smartphone notification or a visual notification, for example, activating an LED light that the user can then see. A replacement reservoir 42 can be provided to the user and have means such as friction or an adhesive (e.g., a pressure-sensitive adhesive / PSA) to attach to the oral device 20 when the user is notified of the need for replacement.

[0057] In one embodiment, a reservoir 42 containing a liquid, gel, or similar state of matter can be associated with the oral device 20. For example, the reservoir 42 can comprise a pouch attached to the surface of the oral device 20 and containing a pharmaceutical compound. In one embodiment, the pouch is formed of a material that will rupture when subjected to an electric charge or electric field by activating the stimulator 40. Such activation can be the result of the microprocessor 31 responding to inputs from one or more sensors, as previously described. The pouch of the reservoir 42 is typically attached to the oral device 20 at a surface that is not likely to be subjected to as much force associated with the user's tooth biting or rubbing against each other or rubbing against the oral device 10. Thus, the tongue wall 24 or the cheek wall 23 is an ideal location to place the reservoir 42. The reservoir 42 can be removed after use or simply dissolved during use; either way, a new reservoir 42 can be placed by the user before inserting it into the oral device 20 as needed.

[0058] In one embodiment, the material forming the pouch wall 44 of the reservoir 42 can be a semipermeable polymer through which the pharmaceutical compound can pass under specified passive conditions or through which the drug can pass when an electric stimulus or electric field is applied to the pouch of the reservoir 42. In addition to considering the location of the reservoir 42 discussed above, it is also important to consider the location relative to the stimulator 40 when iontophoresis requires an electric stimulus. One feature of stimulating the reservoir 42 to dispense the pharmaceutical compound is that the delivery of the compound can be initiated, stopped, and restarted based on readings transmitted by the sensors 30, 32, 34, and / or 36 to the microprocessor 50. Thus, instead of delivering the pharmaceutical compound as a pill, it can be delivered closer to the needs of the user.

[0059] Another semipermeable barrier through which a pharmaceutical compound molecule can be transported is the outermost layer of the human skin, namely, the stratum corneum and other oral mucosal layers. Thus, regardless of how the pharmaceutical compound is released from the oral device 20, it is absorbed by the user's oral mucosa. In some embodiments, a drug-induced genioglossus muscle contraction can cause the user's tongue to protrude, thereby creating more space in the user's pharynx and helping the user to breathe more easily in a manner that increases the oxygen saturation level of the user's hemoglobin. This stimulation can be in response to the actual saturation level of the user's hemoglobin measured by at least one oxygen sensor 30. The release of the pharmaceutical compound that stimulates the genioglossus muscle of the user's tongue can continue until the oxygen saturation level of the hemoglobin rises above a predetermined oxygen level. In one embodiment, if the oxygen sensor 30 determines that the actual oxygen saturation level of the user's hemoglobin is below about 95% oxygen saturation, the stimulator 40 is activated. Stimulating the genioglossus muscle of the user can promote an increase in the respiratory flow to the user, thereby increasing the user's oxygen availability and increasing the oxygen saturation level of the 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 the reservoir 42 is not caused to dispense the pharmaceutical compound by iontophoresis or other means. In one embodiment, if the pressure sensor 32 detects that the user is grinding and / or clenching their teeth, the stimulator 40 is activated. According to one aspect, the stimulator 40 provides an electrical stimulus or an electric field to the reservoir 42 in accordance with an indication of a microprocessor 50 that acts in response to an input from one or more of the sensors 30, 32, 34, and 36.

[0060] As Figures 2 to 4 shown, the microprocessor 50 can be disposed on and / or embedded within the oral device 20. As Figure 2 and Figure 3 shown, the microprocessor 50 can be located on or within the buccal portion 23. As an alternative and as Figure 4 shown, the microprocessor 50 can be located on or within the tongue portion 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 located at the tongue portion 24 of the oral device 20, the microprocessor 50 can be located on the buccal portion 23 away from these areas. In some embodiments and as Figure 4As shown, the microprocessor 50 is positioned in the tongue portion 24 of the oral device 20 and may be embedded therein. It should be understood that the microprocessor 50 may be positioned at any location that enables it to communicate with components included in the oral appliance 10, such as, for example, an oxygen sensor 30, a pressure sensor 32, an airflow sensor 34, a noise detector 35, an actigraphy sensor 36, a stimulator 40, a data recorder 60, and / or a battery 70, while ensuring that the position of the microprocessor 50 contributes to maintaining a comfortable fit and / or maintaining the wearability of the oral device 20 for the user. The microprocessor 50 may be attached to and / or positioned at any desired location on the oral device 20, such as, for example, the front, the back, and any location therebetween. According to one aspect, the size and / or positioning of the microprocessor 50 is for a comfortable fit for the user. It is certain that the microprocessor 50 may 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 corresponding to the actual oxygen saturation level of hemoglobin from at least one oxygen sensor 30, as well as data related to the user's grinding and / or clenching 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, if the noise detector 35 determines that the actual noise and / or vibration of the user during sleep is higher than a predetermined noise level, the microprocessor 50 activates the stimulator.

[0061] As Figures 2 to 4 shown in and in one embodiment, the oral appliance 10 includes a data recorder 60. The data recorder 60 may be positioned, for example, at the buccal portion 23 of the oral device 20 (see, for example, Figure 2 ). According to one aspect and as Figure 3As shown, the data recorder 60 is located in the tongue portion 24 of the oral appliance 20. In one embodiment, the data recorder 60 is configured to receive and / or store information provided from the microprocessor 50. According to one aspect, the data recorder 60 receives and / or stores the actual oxygen saturation level of hemoglobin, the predetermined force level applied to the clenching and / or occlusal surface of the user, and / or the predetermined airflow level provided by the oxygen sensor 30, the pressure sensor 32, and the airflow sensor 34, respectively. The data recorder 60 may also receive and / or store information regarding the quantity and / or frequency of the stimulation provided by the stimulator 40. The data recorder 60 may also store drug compound dispensing information, such as the volume / dose dispensed from the reservoir 42 at each dispensing event and the total volume dispensed and thus remaining in the reservoir 42. This remaining drug compound data can be used to signal the user to replace the reservoir 42.

[0062] According to one aspect, the appliance 10 includes a transceiver (not shown). The transceiver may be configured to remotely monitor any other components provided on and / or inside the oral appliance 20. In one embodiment, the transceiver may be configured to be used with a customized web-based application for a handheld wireless communication device. The customized web-based application may include features such as graphs of the user's sleep posture and / or graphical data related to the oxygen saturation level of hemoglobin and the pressure applied to the occlusal surface of the user's dentition. According to one aspect, the customized web-based application may include data related to the user's heart rate. In one embodiment, the transceiver communicates with a handheld wireless communication device having function. The transceiver may communicate with a handheld wireless communication device such as a computer, a smartwatch, a smartphone, etc.

[0063] The oral appliance 10 may include a battery 70. Although it is contemplated that the 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 recorder 60, and the transceiver. According to one aspect, the battery 70 includes an energy storage and contact element (not shown) disposed sealingly on the oral appliance 20. In one embodiment, the battery 70 is embedded within the oral appliance 20 such that the battery 70 is not exposed to liquid, saliva, and / or oral tissue. The battery 70 may be positioned adjacent to the buccal portion 23 (see, for example, Figure 2 ). According to one aspect, the battery 70 is positioned adjacent to the tongue portion 24 of the oral appliance 20 (see, for example, Figure 4 ).

[0064] As Figure 5As shown, the oral appliance may include a data transfer case 80. The data transfer case 80 may be configured to charge and / or provide power to a rechargeable battery 70. According to one aspect, the data transfer case 80 is configured to retrieve and / or store information collected by the data recorder 60 such that the user and / or healthcare provider can track and / or evaluate the information collected. According to one aspect, the transceiver may include a power amplifier (not shown) that is 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 case 80 may be provided with an electrical contact assembly that is accessible to a plug (not shown) of a power unit.

[0065] As Figure 5 shown and in one embodiment, there is provided an oral appliance kit 100 for treating a user's sleep apnea. In one embodiment, the oral appliance kit 100 includes an oral appliance 10 that includes various electronic components as generally described above and Figures 2 to 4 shown, and a data transfer case 80.

[0066] Figure 6 is a flow chart showing an exemplary operation 200 of the oral appliance 10. Optionally, a customized 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 user's oral cavity. An oxygen sensor measures 220 the oxygen saturation level of the user's hemoglobin, a pressure sensor measures 222 the pressure applied to the occlusal surface of the customized mandibular oral device, an airflow sensor measures 224 the user's actual airflow and / or respiratory rate, an actigraphy sensor measures 226 data related to sleep activity, including the user's sleep posture and movement during sleep, and / or a noise detector measures 228 the actual noise and / or vibration generated by the user during sleep. A microprocessor collects, records, and analyzes 230 data related to oxygen saturation, pressure, airflow, sleep activity, and actual noise level. In the case where the actual oxygen saturation level of the hemoglobin is below a predetermined level, or in the case where the actual pressure applied to the occlusal portion of the oral device is higher than a predetermined pressure level, a stimulator sends a pulse 240 to stimulate the genioglossus muscle of the user's tongue. The oxygen sensor re-measures 250 the oxygen saturation level of the hemoglobin, the pressure sensor re-measures 252 the pressure applied to the occlusal surface of the customized mandibular oral device, the airflow sensor re-measures 254 the user's actual airflow, the actigraphy sensor re-measures 256 the user's sleep activity, 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, the stimulation stops. According to one aspect, if the predetermined level is not reached, the stimulation will continue, increase, decrease, or otherwise vary according to the measured values.

[0067] According to one aspect, the upper oral appliance 120 is configured to be fixed to / worn on a user's upper dentition. As Figure 7 shown, the oral appliance 120 includes a dentition attachment member 128 (or collectively the dentition attachment portion 128, which has the general arch of the upper dentition). The dentition attachment portion 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 and facing the user's tongue. The oral appliance 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 appliance 120 also includes a gingival portion 132 (as Figures 8A to 9 shown), which is integrated with the buccal surface 130a of the dentition attachment portion 128 and extends upward from the buccal surface 130a such that the gingival portion 132 is placed along the user's upper gum adjacent to the user's maxilla. The dentition attachment portion 128, the palatal portion 122, and the gingival portion 132 are integral components of a single body.

[0068] The gingival portion 132, the dentition attachment portion 128, and the oral appliance 120 as a whole can be described respectively (when viewed in a top planar view) as having a left side / left portion / left wing 134a (i.e., generally located on the user's left dentition), a right side / right portion / right wing 134b (i.e., generally located on the user's right dentition), a front or front end 136a (i.e., generally located on the user's front / anterior dentition), and a rear or rear end 136b (i.e., generally located on the user's rear / posterior dentition). The palatal portion 122 thus extends between and is partially surrounded by the left side of the dentition attachment portion and the right side of the dentition attachment portion.

[0069] As Figure 7 shown, the dentition attachment member 128 (each and overall) has a shape and size that substantially match the user's upper dentition. The palatal portion 122 of the upper oral appliance 120 substantially matches the user's palate. Thus, an oral appliance 120 is presented to the user with a secure and customized fit. The dentition attachment member 128 can be provided in a wireframe form for support, or, as Figure 7 shown, the support can result from the presence of the palatal portion 122 and the material selected for forming the upper oral appliance 120. According to one aspect, a portion of the dentition attachment member 128 can be shaped to form a retention loop around one or more of the user's teeth. The dentition attachment member 128 and the palatal portion 122 enable the upper oral appliance 120 to be at least temporarily fixed in place due to the customized fit. Thus, the oral appliance 120 can provide a retention function, allowing it to remain in place during the user's sleep, particularly in situations where the user may make minor to moderate movements during sleep and / or when the user may be awake.

[0070] Accordingly, the oral device 120 can be substantially immovable unless positive effort is exerted to remove the oral device 120. In other words, the user can remove the oral device 120 at any time as needed by exerting a little pressure for removing the oral device 120. Since the oral device 120 is not permanently fixed to the dentition, the user can wear and / or subsequently remove it at any time.

[0071] Similar to the oral device 20, components can be positioned on and / or embedded within the upper oral device 120. The components in or on the upper oral device 120 can include any components associated with the oral device 20. Figure 7 The components shown include a first pair of electrodes 112a, 112b, a second pair of electrodes 114a, 114b, a microprocessor 118, and electrical wires 116 that connect each electrode to the microprocessor 118. The microprocessor 118 can have a data recorder 60 and / or a battery 70 associated with and / or integrated therewith that can be embedded within the upper oral device 120 such that any components on any surface of the oral device 120 are covered to eliminate tissue damage and damage to these components. The placement of these components should not interfere with the fit of the upper oral device 120 in the user's mouth or cause pain to the user's gums or palate. The electrical wires 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 associated with loose wires. Figure 9 Shown is how the electrical wires 116 follow the shape of the upper oral device 120, either within or on top of the oral device material, from each electrode to the microprocessor 118.

[0072] The microprocessor 118 of the upper oral device 120 can also be provided with a wireless transceiver to enable it to communicate with external wireless communication devices such as a computer, smartwatch, smartphone, etc., similar to the oral appliance 10. Additionally, the wireless transceivers of the upper oral device 120 and the oral appliance 10 can communicate with each other. Accordingly, the microprocessor 118 of the upper oral device 120 can provide information to the oral appliance 10 in substantially the same manner as the oral appliance receives information from an external source and its components. Alternatively, it is contemplated that the upper oral device 120 and the oral appliance 10 can be connected together in a manner that does not inconvenience or discomfort the user.

[0073] Figure 7Shows 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 palatal portion 122 of the upper oral appliance 120. Electrical wires 116 transmit electrical signals from each of the electrodes 112a, 112b, 114a, 114b to the microprocessor 118. Although there is sufficient space towards the posterior palatal portion 122 of the upper oral appliance 120, it may be difficult to obtain strong electroencephalogram signals when the electrodes are only located under the palatal portion.

[0074] Figure 8A and Figure 8B Shows an arrangement in which the first electrode pair 112a, 112b and the second electrode pair 114a, 114b are located on the gingival portion 132 of the upper oral appliance 120 adjacent to the buccal side of the user's maxilla. That is, the first electrode pair 112a, 112b and the second electrode pair 114a, 114b are located between the user's upper gingiva and the inner lip / cheek. The maxilla, which includes the user's maxilla bone, is a continuous extension of the skull, i.e., on the lower side of the brain. Therefore, electrodes in intimate contact with the buccal side of the user's maxilla (i.e., the bone in contact with the user's cheek and the inner side of the upper lip) will receive brain waves in the same manner as the scalp. Electrodes 112a and 114a (e.g., the left electrodes) are positioned along the left side of the gingival portion 132 / oral appliance 120 (i.e., along the left buccal side of the user's maxilla), and their paired electrodes 112b and 114b (e.g., the right electrodes) are positioned along the right side of the gingival portion 132 / oral appliance 120 (i.e., along the right buccal side of the user's maxilla). Figure 8A and Figure 8B The position of the electrodes in allows for good electroencephalogram signals to be achieved through the electrodes and the microprocessor 118, which can be clearly read and interpreted. Although the microprocessor 118 is not visible in Figure 8A and Figure 8B it can be located in or on the palatal portion 122 of the upper oral appliance 120, i.e., at a position approximately the same as that on the palatal portion 122 in Figure 7 Electrical wires 116 transmit electrical signals from each of the electrodes 112a, 112b, 114a, 114b to the microprocessor 118 through the most direct route along the material of the upper oral appliance 120 or inside it. For example, the electrical wires 116 can follow the contour of the dentition attachment member 128 downwards, cross over and then reach the palatal portion 122, where the electrical wires 116 then continue to the microprocessor 118. Figure 8A and Figure 8B The path of the electrical wires in is similar to the path in Figure 9 and Figure 9 illustrates these paths more clearly.

[0075] Figure 9 Shows the first electrode pair 112a, 112b and the second electrode pair 114a, 114b asFigure 8A and Figure 8B the arrangement as in Figure 8A located on the gingival portion 132 of the upper oral appliance 120 adjacent to the buccal side of the user's palatine bone. The electrodes 112a and 114a (e.g., the posterior electrodes) are positioned along the rear of the gingival portion 132 (and the oral appliance 120), and their paired electrodes 112b and 114b (e.g., the anterior electrodes) are positioned along the front of the gingival portion 132 (and the oral appliance 120). Figure 9 The electrode positions in Figure 8B allow for good electroencephalogram signals to be achieved through the electrodes and the microprocessor 118. Although the microprocessor 118 is not visible in Figure 9 Figure 8A , it is located in or on the palatal portion 122 of the upper oral appliance 120, i.e., at a position substantially the same as on the palatal portion 122 in Figure 7 Figure 8A . The electrical wires 116 transmit the electrical signals from each of the electrodes 112a, 112b, 114a, 114b to the microprocessor 118 through the most direct route along or within the material of the upper oral appliance 120. That is, the electrical wires 116 will follow the contour of the dentition attachment member 128 downward, cross over and then reach the palatal portion 122, where the electrical wires 116 then continue to the microprocessor 118.

[0076] Through Figure 7 , Figure 8A , Figure 8B and Figure 9 any of the electrode arrangements of the electrodes shown in Figure 7 , Figure 8A , Figure 8B , each pair of the first electrode pair 112a, 112b and the second electrode pair 114a, 114b can form an electroencephalograph with sufficient sensitivity together with the microprocessor 118 to detect the rhythmic changes of electrical signals in the brain. The electrodes 112a, 112b and 114a, 114b record the voltage difference between the paired "a" electrodes and "b" electrodes generated by the electrical signals in the brain. The signals detected by the electrodes are provided to the signal processor through the electrical wires 116, and the processor is part of the microprocessor 118.

[0077] With any electroencephalogram Figure 1Similarly, some mental / consciousness states result in a rhythmic voltage difference detected between the first electrode pair 112a, 112b and the second electrode pair 114a, 114b, and the recorded channels are shown as waves on the graph. The electroencephalogram signals of a conscious adult in a relaxed state are usually oscillatory waves called alpha waves. The brain waves of a soundly sleeping adult become very slow. These slow waves are called delta waves and can be used not only to identify sleep but also to evaluate the depth of sleep. That is, the intensity of the change in delta waves can indicate a deeper sleep state. The signal processor and other microprocessor components 118 are capable of distinguishing various electroencephalogram rhythms and determining various consciousness and sleep states of the user based on these detected rhythms. It is conceivable that the oral device 120 can diagnose epilepsy by recording the brain activity of the user, which can be collected by the data recorder 60.

[0078] Figure 10 FIG. 4 is a flow chart showing an exemplary operation 300 of the upper oral device 120 communicating in cooperation with the oral appliance 10. Optionally, a customized upper oral device 120 and the oral appliance part of the oral appliance 10 are created, and various electronic components are assembled to form a complete cooperative appliance. The upper oral device 120 and the oral appliance part of the oral appliance 10 are positioned 210 in the user's oral cavity. The first electrode pair 112a, 112b and the second electrode pair 114a, 114b collect voltage data, and the microprocessor evaluates the electroencephalogram rhythm 212 from this data. The upper oral device microprocessor 118 can utilize this electroencephalogram rhythm to evaluate the sleep state 214 of the user and communicate the determination of the sleep state to the oral appliance 10. Alternatively, the raw electroencephalogram rhythm can be communicated to the oral appliance 10 for evaluation in step 230. In the case where the electroencephalogram data indicates that the user may be waking up from sleep or exiting the sleep state in an inappropriate manner, the microprocessor of the oral appliance can cause the stimulator to send pulses 240 to stimulate the genioglossus muscle of the user's tongue. The upper oral device 120 continuously evaluates the electroencephalogram rhythm 262 and the sleep state 264 of the user and provides data to the oral appliance. If an appropriate sleep state is reached, the stimulation stops. According to one aspect, if the predetermined electroencephalogram rhythm does not recover, the stimulation continues, increases, decreases, or otherwise varies according to the measurement.

[0079] Figure 10 The flow chart shown in FIG. 4 can be independent of Figure 6 the flow chart shown in FIG. Figure 6 or used in combination with the flow chart shown in FIG. Thus, the electroencephalogram data can be used in combination with or as a supplement to oxygen sensor measurements 220, pressure sensor measurements 222, airflow sensor measurements 224, actigraph sensor measurements 226, and / or noise detector measurements 228.

[0080] The various upper oral devices described above (e.g., in combination withFigure 7 , Figure 8A , Figure 8B and Figure 9 The upper oral device 120) described can be used for various other applications. For example, the oral device can be used as a mouthguard suitable for sports activities. In such an application, the oral device can be used to evaluate potential medical conditions or injuries, such as concussions or other head traumas. Data and / or results can be transmitted to a smart device via Bluetooth, or can also be transmitted to a remote application (e.g., a cloud application) via the Internet. Other possibilities understood by those skilled in the art are also contemplated. This data can also be used generally to study head traumas that occur in sports.

[0081] As another example, various upper oral devices can be used for hobbyist or gaming applications, such as personal meditation devices, virtual reality games, video games, learning / educational devices, or other personal activities centered around brain activity.

[0082] The upper oral device can be used with or without a lower oral device (e.g., oral device 10).

[0083] The components of the device shown are not limited to the specific embodiments described herein, but rather features shown or described as part of one embodiment are used in other embodiments or combined with other embodiments to yield yet another embodiment. The device is intended to include such modifications and variations. Additionally, the steps described in the method can be used independently of the other steps described herein.

[0084] Although the device and method have been described with reference to specific embodiments, those skilled in the art will understand that various changes can be made and elements can be substituted without departing from the scope contemplated. Additionally, many modifications can be made to adapt a particular situation or material to the teachings herein without departing from its basic scope.

[0085] In this specification and the appended claims, certain terms will be referenced that have the following meanings. The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Additionally, references to "one embodiment," "some embodiments," "an embodiment," etc. are not to be construed as precluding the existence of additional embodiments that also incorporate the recited features. Approximating language, as used herein, may apply to modify any quantitative representation that could permissibly vary without resulting in a change in the basic function associated therewith. Accordingly, a value modified by a term such as "about" is not to be limited to the precise value specified. In some instances, the approximating language may correspond to the precision of the instrument used to measure the value. Terms such as "first," "second," "above," "below," etc. are used to distinguish one element from another, and unless otherwise stated, they do not imply a particular order or number of the elements.

[0086] As used herein, the terms "can" and "may" mean: the likelihood of occurring in a series of circumstances; having a specified attribute, characteristic, or function; and / or qualifying another verb by expressing one or more of the ability, capacity, or likelihood associated with the qualified verb. Thus, the use of "can" and "may" indicates that the term being modified is apparently appropriate, capable, or suitable for the indicated capacity, function, or use, while allowing for the possibility that in some circumstances, the term being modified may sometimes be inappropriate, incapable, or unsuitable. For example, in some cases, an event or capacity is to be expected, while in other cases, the event or capacity does not occur, and this distinction is denoted by the terms "can" and "may."

[0087] The word "comprising" as used in the claims and its grammatical variants logically also encompass varying degrees and phrases of inclusion, such as but not limited to, "consisting essentially of" and "consisting of." Where ranges are provided, and these ranges include all sub-ranges therebetween. It is contemplated that variations within these ranges will be apparent to practitioners of ordinary skill in the art, and the appended claims should cover such variations where they have not been dedicated to the public.

[0088] Advances in science and technology may render equivalents and alternatives possible that are not currently contemplated due to linguistic imprecision; these changes should be covered by the appended claims. The written description uses examples to disclose methods, machines, and computer-readable media, including the best mode, and also enables any person of ordinary skill in the art to practice these methods, including making and using any device or system and performing any method included. Its patentable scope is defined by the claims and may include other examples that occur to a person of ordinary skill in the art. If the structural elements of these other examples do not differ from the literal language of the claims, or if they include equivalent structural elements that do not materially differ from the literal language of the claims, then these other examples are intended to be within the scope of the claims.

Claims

1. An oral device for detecting electrical activity in a user's brain, the oral device comprising: an upper portion including a dentition attachment portion configured to receive the user's upper dentition, the dentition attachment portion having a buccal surface; a gingival portion extending upwardly from the buccal surface of the dentition attachment portion such that the gingival portion is configured to be placed along the user's upper gingiva, wherein the gingival portion includes a left side and a right side; a plurality of electroencephalogram electrodes, i.e., a plurality of EEG electrodes, positioned on or embedded within the gingival portion of the oral device, the plurality of EEG electrodes including: a first EEG electrode positioned on the left side of the gingival portion, a second EEG electrode positioned on the left side of the gingival portion, wherein the first EEG electrode is spaced apart from and in front of the second EEG electrode, a third EEG electrode positioned on the right side of the gingival portion, wherein the first EEG electrode and the third EEG electrode form a first pair of EEG electrodes, and a fourth EEG electrode positioned on the right side of the gingival portion, wherein the third EEG electrode is spaced apart from and in front of the fourth EEG electrode, wherein the second EEG electrode and the fourth EEG electrode form a second pair of EEG electrodes; and a microprocessor electrically connected to each of the plurality of EEG electrodes, wherein the microprocessor is configured to: identify an electroencephalogram signal through the user's oral cavity based on a voltage difference measured between the first pair of EEG electrodes and a voltage difference measured between the second pair of EEG electrodes, detect an EEG rhythm based on the electroencephalogram signal detected through the user's oral cavity, and determine the mental state of the user based on the EEG rhythm.

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

3. The oral device according to claim 1, wherein the dentition attachment portion has a lingual surface opposite the buccal surface, and wherein the oral device further includes a palatal portion extending from the lingual surface of the dentition attachment portion.

4. The oral device according to claim 3, wherein the microprocessor is disposed along or embedded within the palatal portion of the oral device.

5. The oral device according to claim 1, further comprising electrical wires connecting the electrodes to the microprocessor.

6. The oral device according to claim 1, which includes a mouthguard for sports activities.

7. The oral device according to claim 1, which includes an oral device for gaming activities.

8. An oral device for detecting electrical activity in a user's brain, the oral device comprising: an upper portion including 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 gum portion integral with the dentition attachment portion, the gum portion being configured to conform to at least a portion of the user's gums and placed along the user's upper gums, wherein the gum portion includes a left side and a right side; A plurality of electrodes positioned along or embedded within the gum portion of the oral device, the plurality of electrodes including: A first electrode positioned on the left side of the gum portion, A second electrode positioned on the left side of the gum portion, wherein the first electrode is spaced apart from and in front of the second electrode, A third electrode positioned on the right side of the gum portion, wherein the first electrode and the third electrode form a first pair of electrodes, and A fourth electrode positioned on the right side of the gum portion, wherein the third electrode is spaced apart from and in front of the fourth electrode, wherein the second electrode and the fourth electrode form a second pair of electrodes; And A microprocessor electrically connected to each of the plurality of electrodes, wherein the microprocessor is configured to: Identify an electroencephalogram (EEG) signal through the user's oral cavity based on a voltage difference measured between the first pair of electrodes and a voltage difference measured between the second pair of electrodes, Detect an EEG rhythm based on the EEG signal detected through the user's oral cavity, and Determine the mental state of the user based on the EEG rhythm.

9. The oral device according to claim 8, wherein the dentition attachment portion has a buccal surface and a lingual surface opposite the buccal surface, and the gum portion extends from the buccal surface of the dentition attachment portion, and the palatal portion extends from the lingual surface of the dentition attachment portion.

10. The oral device according to claim 8, wherein the microprocessor is disposed along or embedded within the palatal portion of the oral device.

11. The oral device according to claim 8, wherein the electrodes are embedded within the gum portion of the oral device.

12. The oral device according to claim 8, further comprising electrical wires connecting the electrodes to the microprocessor.

13. The oral device according to claim 8, which includes a mouthguard for sports.

14. The oral device according to claim 8, which includes an oral device for gaming activities.

15. An oral device for detecting electrical activity in a user's brain, the oral device comprising: An upper portion including a dentition attachment portion for positioning on the user's upper dentition, the dentition attachment portion having a buccal surface and a lingual surface; A gum portion extending from the buccal surface of the dentition attachment portion such that the gum portion is configured to be placed along the user's upper gums, wherein the gum portion includes a left side and a right side; A palatal portion extending from the lingual surface of the dentition attachment portion; A plurality of electrodes positioned on or embedded within the gum portion of the oral device, the plurality of electrodes including: A first electrode positioned on the left side of the gum portion, A second electrode, which is positioned on the left side of the gingival portion, wherein the first electrode is spaced apart from the second electrode and is located in front of the second electrode, A third electrode, which is positioned on the right side of the gingival portion, wherein the first electrode and the third electrode form a first pair of electrodes, and A fourth electrode, which is positioned on the right side of the gingival portion, wherein the third electrode is spaced apart from the fourth electrode and is located in front of the fourth electrode, wherein the second electrode and the fourth electrode form a second pair of electrodes; And A microprocessor connected to the plurality of pairs of electrodes, wherein the microprocessor is configured to: Identify an electroencephalogram (EEG) signal through the user's oral cavity based on the voltage difference measured between the first pair of electrodes and the voltage difference measured between the second pair of electrodes, Detect an EEG rhythm based on the EEG signal detected through the user's oral cavity, and Determine the mental state of the user based on the EEG rhythm.

16. The oral device according to claim 15, wherein the microprocessor is disposed along the palatal portion of the oral device or embedded within the palatal portion of the oral device.

17. The oral device according to claim 15, wherein the electrodes are embedded within the gingival portion of the oral device.

18. The oral device according to claim 15, further comprising electrical wires connecting the electrodes to the microprocessor.

19. The oral device according to claim 15, which comprises a mouthguard for sports activities.

20. The oral device according to claim 15, which comprises an oral device for gaming activities.

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