Oral appliance for treating sleep apnea

Abstract

An oral appliance may include a mouthpiece configured to be disposed within an oral cavity of a user and an electronic component coupled to the mouthpiece. The electronic component may include an oxygen sensor oriented toward soft tissue of the user's oral cavity to determine a blood oxygen saturation level of the user. The electronic component may be disposed within an add-on extending away from the wall of the mouthpiece.

Description

[0001] Cross Reference to Related Applications

[0002] This application is a continuation-in-part of and claims priority to U.S. Patent Application No. 18 / 514,966, filed November 20, 2023, which is a continuation-in-part of U.S. Patent Application No. 18 / 209,298, filed June 13, 2023. This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 497,605, filed April 21, 2023, the entire contents of each of which are incorporated herein by reference. TECHNICAL BACKGROUND

[0003] Sleep apnea is a common medical condition in which a patient experiences one or more pauses in breathing during sleep, and in some cases, shallow breathing. There are multiple types of sleep apnea, but the most common is obstructive sleep apnea. In this medical condition, one or more of the patient’s throat muscles relax during sleep, causing the surrounding tissues in the back of the throat, mouth, and nose to collapse, creating a pharyngeal obstruction that can block the upper airway. Patients with obstructive sleep apnea do not exchange enough oxygen during sleep, which can lead to daytime fatigue, difficulty concentrating, and mood changes. If left untreated, obstructive sleep apnea can have significant effects on a patient’s health, often leading to cardiovascular disease, stroke, and metabolic disorders.

[0004] To reduce this risk, various non-surgical approaches are currently employed. One such non-surgical approach is the use of standardized oral appliances to progressively advance and / or protrude the maxilla (upper jaw) relative to the mandible (lower jaw). These standardized oral appliances, often referred to as mandibular advancement devices ("MADs"), generally include an upper dental tray and a lower dental tray, where the lower dental tray is designed to advance the mandible, thereby moving the tongue forward to increase the space in the posterior oropharynx and hypopharynx, which in turn can be used to increase airflow during sleep. The distance needed to advance and / or reposition the mandible (the degree of advancement) can depend, at least in part, on the severity of the individual's obstructive sleep apnea and psychological variables of the user. One drawback of using these standard oral appliances is that they can not adequately account for and / or address individualized anatomical differences, such as differences in dental arch, tooth alignment, and / or jaw flexibility. Another drawback is that in the event of excessive advancement, the appliance can cause long-term temporomandibular joint ("TMJ") disorders, increased muscle problems, dental discomfort, and / or myofascial disorders. As a result, the compliance rate for these standard appliances is approximately 75% within two years. For a detailed study on compliance with MADs, see Non-CPAP therapies in obstructive sleep apnoea: mandibular advancement device therapy, Eur Respir J 2012; 39: 1241-1247, which is incorporated by reference herein in its entirety. Thus, such oral appliances can not treat obstructive sleep apnea in a manner that prevents and / or limits the impact on an individual's health.

[0005] In view of the drawbacks of the currently available methods and devices for treating obstructive sleep apnea, there is a need for a device and method to treat obstructive sleep apnea while simultaneously storing patient behavior and / or medical data related to the user's blood oxygen saturation, breathing patterns, snoring patterns, and / or bruxism behavior to assist medical service providers in designing, improving, and / or modifying specialized treatment measures for individual patients. Furthermore, there is a need for a device and method that treats obstructive sleep apnea with a single movable oral appliance while preventing and / or limiting TMJ disorders, increased muscle problems, and / or myofascial disorders that can arise from long-term use of existing appliances. SUMMARY

[0006] According to one aspect of the disclosure, exemplary embodiments of an oral appliance can include a mouthpiece configured to be placed within a user's oral cavity. The mouthpiece can include a front wall configured to cover a labial surface of a user's dentition, a back wall configured to cover a lingual surface of the user's dentition, and a lateral wall extending between the front wall and the back wall. An electronic assembly can be coupled to the mouthpiece, and the electronic assembly can include an oxygen sensor coupled to the front wall and configured to be oriented toward soft tissue of the user's oral cavity to determine a blood oxygen saturation level of the user.

[0007] According to one aspect of the disclosure, exemplary embodiments of an oral appliance can include a mouthpiece configured to be placed within a user's oral cavity. The mouthpiece can include a front wall configured to cover a labial surface of a user's dentition, a back wall configured to cover a lingual surface of the user's dentition, and a lateral wall extending between the front wall and the back wall. An electronic assembly can be coupled to the mouthpiece. The electronic assembly can include an oxygen sensor coupled to the front wall and configured to be oriented toward soft tissue of the user's oral cavity to determine a blood oxygen saturation level of the user and to collect blood oxygen saturation (Sp02) and photoplethysmography (PPG) data.

[0008] According to one aspect of the disclosure, exemplary embodiments of an oral appliance can include a mouthpiece configured to be placed within a user's oral cavity. The mouthpiece can include a front wall configured to cover a labial surface of a user's dentition, a back wall configured to cover a lingual surface of the user's dentition, and a lateral wall extending between the front wall and the back wall. An additional portion can extend away from the front wall and toward soft tissue of the user's oral cavity, and a space can be defined within the additional portion. An electronic assembly can include an oxygen sensor, and can be at least partially located within the space in the additional portion, and the additional portion and the electronic assembly can be collectively configured to orient the oxygen sensor toward the soft tissue of the user's oral cavity. BRIEF DESCRIPTION OF DRAWINGS

[0009] A more particular description will be rendered by reference to specific embodiments illustrated in the drawings, which are presented for the purpose of providing exemplary embodiments and should not be considered as a limitation on the scope of the disclosure. It will be understood that the figures are presented for the purpose of illustration and description and are not intended as a definition of the limits of the disclosure.

[0010] FIG. 1 is a perspective view of an exemplary oral appliance according to various aspects of the disclosure;

[0011] FIG. 2 is a plan view of the oral appliance shown in FIG. 1 ;

[0012] FIG. 3 is a plan view of the oral appliance shown in FIG. 1, with a cross-section taken along a horizontal plane of a housing assembly of the oral appliance;

[0013] FIG. 4 is a rear view with a rear half of a housing removed, showing internal electronic components of the housing assembly of the oral appliance of FIG. 1 ;

[0014] FIG. 5 is a front view with the front half of the housing removed, showing the internal electronic components of the housing assembly of FIG. 4;

[0015] FIG. 6 is a side cross-sectional view of the housing assembly of the oral appliance of FIG. 1;

[0016] FIG. 7 is a plan view showing the internal electronic components of FIG. 6;

[0017] FIG. 8A is a front view of the internal electronic components of FIG. 6;

[0018] FIG. 8B is a top view of the internal electronic components;

[0019] FIG. 8C is a rear view of the internal electronic components;

[0020] FIG. 9 is a schematic view of the assembly of the oxygen sensor positioned between the isolation barriers in the oral appliance of FIG. 1;

[0021] FIG. 9A is an oxygen sensor of an example embodiment;

[0022] FIG. 10 is a side perspective view showing another aspect of the oral appliance including an upper dental tray, a lower dental tray, and a strut assembly;

[0023] FIG. 11 is a plan view showing the internal components of the upper dental tray of the oral appliance of FIG. 10;

[0024] FIG. 12A is a plan view showing the housing of the upper dental tray of FIG. 11;

[0025] FIG. 12B is a side perspective view showing the housing of FIG. 12A;

[0026] FIG. 12C is a side perspective view showing the cover of the upper dental tray of FIG. 10;

[0027] FIG. 13 is a perspective view showing the upper dental tray of the oral appliance of FIG. 10 positioned on the upper dentition of a user;

[0028] FIG. 14 is a side perspective view showing the oral appliance of FIG. 10 positioned on the upper dentition of a user;

[0029] FIG. 15 is a graph representing data related to snoring and normal breathing sounds collected by a sound measurement device according to an aspect of the present disclosure;

[0030] FIG. 16 is a graph representing data related to snoring and normal breathing sounds collected by a sound measurement device according to an aspect of the present disclosure;

[0031] FIG. 17 is a graph representing data related to normal breathing sounds collected by a sound measurement device according to an aspect of the present disclosure;

[0032] FIG. 18 is a graph representing data related to normal breathing sounds collected by a sound measurement device according to one aspect of the present disclosure;

[0033] FIG. 19 is a graph representing data related to snoring and normal breathing sounds collected by a sound measurement device according to one aspect of the present disclosure;

[0034] FIG. 20 is a graph representing data related to normal breathing sounds collected by a sound measurement device according to one aspect of the present disclosure;

[0035] FIG. 21 is a graph representing data related to snoring sounds collected by a sound measurement device according to one aspect of the present disclosure;

[0036] FIG. 22 is a graph representing data related to snoring sounds collected by a sound measurement device according to one aspect of the present disclosure;

[0037] FIG. 23 is a graph representing data related to normal breathing sounds collected by a sound measurement device according to one aspect of the present disclosure;

[0038] FIG. 24A is two graphs illustrating data collected by additional sensors (e.g., accelerometers and gyroscopes) of an oral appliance of the present disclosure with the mouth open and an inertial measurement unit (IMU) coupled to the oral appliance inside the mouth;

[0039] FIG. 24B is two graphs illustrating data collected by accelerometers and gyroscopes of an oral appliance of the present disclosure with the mouth open and an IMU coupled to the chin of the patient outside the mouth;

[0040] FIG. 25A is two graphs illustrating data collected by accelerometers and gyroscopes of an oral appliance of the present disclosure with the teeth side-to-side grinding and an IMU coupled to the oral appliance inside the mouth;

[0041] FIG. 25B is two graphs illustrating data collected by accelerometers and gyroscopes of an oral appliance of the present disclosure with the teeth side-to-side grinding and an IMU coupled to the chin of the patient outside the mouth;

[0042] FIG. 26A is two graphs illustrating data collected by accelerometers and gyroscopes of an oral appliance of the present disclosure with the patient swallowing and an IMU coupled to the oral appliance inside the mouth;

[0043] FIG. 26B is two graphs illustrating data collected by accelerometers and gyroscopes of an oral appliance of the present disclosure with the patient swallowing and an IMU coupled to the chin of the patient outside the mouth;

[0044] FIG. 27 is a perspective view illustrating an embodiment of another oral appliance including a sensor assembly;

[0045] FIG. 28 is a partial perspective view of the sensor assembly of FIG. 27 with its charging coil removed;

[0046] FIG. 29 is a partial perspective view of the sensor assembly of FIG. 27 with its charging coil and spacer removed;

[0047] FIG. 30 is another partial perspective view showing the printed circuit board and sensor of FIG. 29 placed in the housing;

[0048] FIG. 31 is a bottom perspective view of an oral appliance including an electromyography sensor, according to another embodiment of the disclosure;

[0049] FIG. 32 is a graph showing electromyography data collected during tongue muscle stimulation and as a user’s eyes move between open and closed configurations;

[0050] FIG. 33 is a graph showing the difference between electromyography data produced by tongue muscle activation and electromyography data without tongue muscle activation.

[0051] The various features, aspects and advantages of embodiments will be more apparent from the following detailed description, along with the accompanying figures in which like numerals represent similar components throughout the figures and text. The described features are not necessarily drawn to scale, but are intended to highlight certain features that are pertinent to certain embodiments. DETAILED DESCRIPTION

[0052] Various embodiments will be described in detail below. Each example is intended to explain a particular feature, aspect or implementation of the present disclosure, but not necessarily every implementation. Examples are not intended to limit the scope of the disclosure.

[0053] To illustrate the features of the embodiments, embodiments of the present disclosure will now be introduced and referred to throughout the disclosure. Those skilled in the art will recognize that the present embodiments are illustrative and not restrictive, and are provided solely for explanatory purposes.

[0054] As used herein, “coupled” can refer to any manner in which two components are assembled or connected together in any suitable way, such as, by way of example only: directly or indirectly connected (e.g., to a surface), disposed on, disposed within, substantially disposed within, formed with, embedded within, substantially embedded within, etc. “Coupled” can further include fixedly connecting two components (e.g., using a screw during manufacturing or embedding a first component within a second component), but need not necessarily do so. That is, two components can be coupled only by physical contact with one another.

[0055] In one embodiment, and with specific reference to FIGS. 1-6, an oral appliance 10 for treating sleep apnea in a user is provided. The oral appliance 10 generally includes a mouthpiece 20 and a housing assembly 30 coupled to the mouthpiece 20. In one embodiment, the mouthpiece 20 is "customizable," i.e., customized to an individual user's oral cavity so that it fits comfortably over and around the user's hard tissue (teeth / dental arch) and / or soft tissue (overall oral structure, including gums). When customized, the mouthpiece 20 can fit over a user's upper or lower dental arch, whether temporary, permanent, native, natural or artificial, in adult and / or child users. The mouthpiece 20 can be configured to receive a user's removable denture. According to one aspect, the mouthpiece 20 can be fabricated on a partially or completely edentulous maxilla or mandible. When customized, the mouthpiece 20 can be formed from any suitable self-adapting material that can accommodate differences and / or changes in the oral structure, or by using dental impressions of the individual user's dental arch as understood by those of ordinary skill in the art. In other words, a lower impression and / or a dental impression can be taken to create a positive replica (or cast) of the user's hard tissue and / or soft tissue using a negative impression of the user's oral structure. In some aspects, the lower impression and / or dental impression can be a digital dental impression taken by 3D scanning technology or other suitable technology.

[0056] The selection of the type of material used to form the mouthpiece 20 is known to those of ordinary skill in the art and includes polymers, thermoplastics, acrylic resins, silicones, rubbers, wires, or any other material that can be used to form a mouthpiece 20 that matches a user's dental arch. In one embodiment, these materials are medical grade, latex-free, bisphenol-A free, and any other materials known to minimize patient health risks. According to one aspect, the mouthpiece 20 can be formed from an impression made in a suitable impression material, such as alginate, polysulfide, polyvinylsiloxane, silicone, or similar materials. The mouthpiece material can also be selected, particularly from polymers, to ensure that it is capable of containing a pharmaceutical compound in a structural matrix.

[0057] The mouthpiece 20 includes a front wall 22 configured to cover the facial surface of the user's dentition, a rear wall 24 configured to cover the lingual surface of the user's dentition, and a transverse wall 26 interconnecting the front wall 22 and the rear wall 24 and configured to cover the occlusal surface of the user's dentition. The mouthpiece 20 defines a central passage 28 bounded by the front wall 22, the rear wall 24, and the transverse wall 26. The central passage 28 is configured to be positioned over one or more of the user's dentition such that the mouthpiece 20 is secured thereto. In use of the mouthpiece 20, the central passage 28 can receive the user's dentition and can extend over and / or cover the occlusal surface of the user's dentition. The rear wall 24 of the mouthpiece 20 extends between the user's dentition and the user's tongue. In one embodiment, the front wall 22 of the mouthpiece 20 is configured to extend between the user's dentition and the user's cheek.

[0058] The mouthpiece 20 can include a socket 32 coupled to the front wall 22 of the mouthpiece 20. The socket 32 is configured to be coupled to a strut assembly, such as one or more of the strut assemblies disclosed in U.S. Patent Application No. 17 / 737,470, filed May 5, 2022, the entirety of which is incorporated herein by reference. In combination with the strut assembly, the oral appliance 10 can be configured to position the user's lower jaw in a forward direction from the user's natural jaw position to assist in treating sleep apnea. The user's optimal lower jaw position can be determined by a dentist and implemented by a lab responsible for making the oral appliance 10.

[0059] The housing assembly 30 of the oral appliance 10 generally includes a housing 34 and a printed circuit board assembly 40 disposed within the housing 34 (Figs. 2 and 3). The housing 34 has a front portion 36 and a rear portion 38 coupled to the front wall 22 of the mouthpiece 20. The front portion 36 and the rear portion 38 can be integrally formed with one another to form the housing 34, and in other aspects, the front portion 36 and the rear portion 38 can be separate assemblies that are otherwise connected to one another. The rear portion 38 of the housing 34 conforms to the front wall 22 of the mouthpiece 20 and is coupled to the front wall 22 of the mouthpiece 20 by any suitable fastening engagement, such as adhesive, fasteners, heat treatment, etc. In other aspects, the rear portion 38 of the housing 34 can be integrally formed with the mouthpiece 20.

[0060] The posterior portion 38 projects vertically away from the mouthpiece 20 forwardly and away from the gumline 27 of the mouthpiece 20. The posterior portion 38 can be made of a light transmissive material, such as polycarbonate, acrylic, polyethylene terephthalate, amorphous copolyester (a modified form of polyester, such as combinations of diacids and diols), polyvinyl chloride, liquid silicone rubber, polyethylene, styrene methyl methacrylate, etc. In some aspects, as shown in FIG. 3, only a portion of the posterior portion 38 can be a light transmissive material, such as an optical window 42 located at the centerline of the posterior portion 38. With reference to FIG. 6, the optical window 42 is integrally formed with the posterior portion 38 and can project rearwardly from the posterior portion 38 to define a recess 44 for housing an optical assembly 50, described in detail below. As shown, the material forming the posterior portion 38 is different than the material forming the anterior portion 36.

[0061] With specific reference to FIGS. 8A-8C, an interior cavity 46 is defined in the housing 34 that extends along the length of the housing 34 to internally house a printed circuit board assembly 40. The printed circuit board assembly 40 includes a printed circuit board 48, an optical assembly 50, and, in some aspects, a microprocessor (not labeled) and other suitable electronic components. For example, the printed circuit board assembly 40 can also include a wireless charging coil 52 at a first end of the printed circuit board 48 and one or more batteries 54, such as lithium polymer (LiPo) rechargeable batteries, at the first and second ends of the printed circuit board 48.

[0062] The optical assembly 50 is located proximate the optical window 42 of the housing 34 and includes an optical housing 56 supported on the rear side of the printed circuit board 48 and an oxygen sensor 60 supported in the optical housing 56 and electrically connected with the microprocessor of the printed circuit board 48. In some aspects, the optical assembly 50 can be supported in a recess 44 (FIG. 6) defined by the optical window 42 such that the optical assembly 50 is oriented on the occlusal surface of the user’s mouth and oriented toward the user’s buccal gingiva when the oral appliance 10 is worn by the user.

[0063] Referring to FIGS. 7 and 9, the optical housing 56 can include a plurality of isolated baffles or barriers 58 coupled to the printed circuit board 48. The barriers 58 are arranged in parallel to one another. A first space 62 is defined between adjacent barriers (e.g., barriers 58a, 58b) in which one or more components of an oxygen sensor 60 are disposed. The oxygen sensor 60 can be a reflective pulse oximeter configured to monitor / sense the blood oxygen saturation of a user by analyzing color changes in the user's blood. The reflective pulse oximeter 60 can measure the pulse rate (typically expressed in beats per minute) of the user based on changes and / or deviations in the user's blood oxygen saturation. An exemplary pulse oximeter can utilize light-based technology to sense the actual oxygen saturation of the user's hemoglobin. According to one aspect, the pulse oximeter 60 includes a light emitting diode (LED) 60a and a photodiode (PD) 60b. The LED 60a is configured to emit red and infrared light toward the vascular surface of the user's gums "G", and the photodiode 60b receives light reflected from the gums "G" to determine changes in the oxygen level in the user's gums "G" (e.g., the buccal mucosa). In certain aspects, the emitted light can include blue or green light, or combinations of light consistent with the exemplary embodiments or otherwise consistent with the present disclosure.

[0064] The barriers 58 provide optical isolation between the LED 60a and the detection photodiode 60b to improve the signal-to-noise ratio through the tissue. For example, as shown in FIG. 9, the LED 60a can be received in the first space 62 between adjacent barriers 58a, 58b, and the photodiode 60b can be received in a second space 64 defined between adjacent barriers 58b, 58c. Each isolated barrier 58 can include a horizontal wall 66 extending perpendicularly therefrom to prevent laterally emitted light from escaping the spaces 62, 64 between the barriers 58. In this manner, the barriers 58 are configured to isolate the light emitted from the LED 60a. Moreover, optical reflection suppresses dc and ac ambient light interference while directly improving signal quality and effectively reducing errors in physiological data acquisition. The spacing between the LED 60a and the photodiode 60b is optimized to reduce backscattering of "no-blood" tissue, and the barriers 58 reduce cross-talk between the LED 60a and the photodiode 60b.

[0065] Current FDA-approved commercial pulse oximeter devices are used to measure the blood oxygen saturation of the body, for example, using an optical module. These devices are typically used externally to the skin surface and measure blood oxygen saturation using one LED and one photodiode using transmission or reflection techniques (one or more). According to the FDA, the Sp02 readings obtained by these devices should be considered an estimate of arterial blood oxygen saturation. For example, a commercial medical grade oximeter can record blood oxygen saturation values that differ from actual arterial blood oxygen readings by between about 4% to about 6%. For example, if an FDA-approved pulse oximeter reads 90%, the actual blood oxygen saturation in the blood is generally between 86-94%, or possibly between 84-96%.

[0066] Oral mucosa comprises a different histological structure than skin, and thus the optical module design of existing commercial pulse oximeter devices can not be suitable for intraoral blood oxygen saturation data collection. At least one reason that existing commercial pulse oximeter devices can not be suitable for intraoral use is the number of LEDs and photodiodes and their relative positions to each other. In intraoral applications, light intensity and the angle of light reflection on the tissue can cause light saturation (too high light intensity) or light scattering. Oral mucosa requires a smaller light penetration depth, and due to the high water content of intraoral tissue, and secondarily due to the smooth mucosal layer, it is prone to excessive light scattering. The epithelial thickness of oral mucosa is between about 0.3 mm to 0.5 mm, while the epithelial thickness of skin (i.e., a fingertip) is between about 1 mm to 3 mm.

[0067] FIG. 9A illustrates an intraoral oxygen sensor configured to minimize the effects of light scattering from oral mucosa, according to example embodiments of the present disclosure. The oxygen sensor 60 according to example embodiments is positioned on the optical assembly 50 and includes, but is not limited to, an LED 60b and two or more photodiodes 60a. The size and design of the oxygen sensor 60 is such that the two photodiodes 60a are positioned on opposite sides of the LED 60b, at distances d and d’ (e.g., centerline-to-centerline distances) from the LED 60b, respectively. In example configurations, the distances d and d’ are each in the range of about 3 mm to about 5 mm to achieve an optimal intraoral measurement depth of about 2 mm. This example configuration has been found to yield higher quality PPG waves with less scattering. This effect can be attributed in part to the fact that oral mucosa is thinner than finger skin and requires less depth to reach the blood vessel complex in the oral tissue to be measured. The example embodiments and configurations shown and described with reference to FIG. 9A have also been found to improve the quality of physiological data collection with lower LED power consumption because the mucosal thickness does not require as deep light penetration. This example configuration has also been found to improve the response speed of the sensor to changes in blood oxygen levels.

[0068] In other configurations, the distances d and d' can vary, and different configurations have been found to have optimal sensitivity in certain depth ranges. For example, distances in the range of about 6 to 8 millimeters have a peak sensitivity at about 2 millimeter depth, distances in the range of about 9 to about 14 millimeters have a peak sensitivity at about 3 to 4 millimeter depth, and distances on the order of about 20 to about 30 millimeters have a peak sensitivity at about 5 to about 6 millimeter depth.

[0069] In certain aspects and without limitation thereto, a biocompatible adhesive or viscous material can be applied to coat and hermetically seal the optical assembly (e.g., LED / photodiode) in any of the example embodiments of the present disclosure or embodiments consistent with the present disclosure. The biocompatible adhesive or viscous material can have a low refractive index. In another aspect, the biocompatible adhesive or viscous material can have a thickness of less than about 1 millimeter. The biocompatible adhesive or viscous material can be used in addition to or in place of the optical housing 56.

[0070] In certain aspects, the oral appliance 10 can also include one or more of the following additional components: a pressure sensor (not labeled), an airflow sensor (not labeled), a noise detector (not labeled), an actigraphy sensor (not labeled), a stimulator (not labeled), and an electroencephalogram (EEG) sensor 70 (FIG. 4) configured to distinguish various EEG rhythms and determine different states of consciousness and sleep of the user based on these detected rhythms. It is contemplated that the oral appliance 10 can aid in the diagnosis of health conditions related to the brain, such as epilepsy, by recording the brain activity of the user (such brain activity can be collected by a data logger (not labeled) for review and analysis). For more details regarding the EEG sensor 70, reference can be made to U.S. Patent Application No. 16 / 781,417 (now U.S. Patent No. 11,375,951), filed February 4, 2020, which is incorporated by reference herein in its entirety. The EEG sensor 70 can be located on a portion of the mouthpiece 20 proximate to the buccal side of the user’s maxilla when the oral appliance is worn. That is, the EEG sensor can be located on the alveolar mucosa between the user’s upper gingiva and the inner lip / buccal.

[0071] According to one aspect, the oral appliance 10 can include a transceiver (not labeled). The transceiver can be configured to remotely monitor any additional components on and / or within the mouthpiece 20. In one embodiment, the transceiver can be configured for use with a custom network-based application program of a handheld wireless communication device. The custom network-based application program can include features such as a graph of the user's sleep position, a graph and / or chart data related to hemoglobin oxygen saturation, and pressure applied to the user's occlusal surfaces. According to one aspect, the custom network-based application program can include data related to the user's heart rate. In one embodiment, the transceiver communicates with a handheld wireless communication device having Bluetooth functionality. The transceiver can communicate with a handheld wireless communication device such as a computer, smartwatch, smartphone, and the like.

[0072] In one embodiment, with particular reference to FIGS. 10-14, an oral appliance 100 for treating sleep apnea of a user is provided. The oral appliance 100 generally includes an upper mouthpiece 102 for positioning on the user's upper dentition, a lower mouthpiece 104 for positioning on the user's lower dentition, an electronic assembly 134 coupled to the upper mouthpiece 102, and a pair of bilateral struts 108, 110 for coupling the upper and lower mouthpieces 102, 104 together. The upper and lower mouthpieces 102, 104 each include a socket 112, 114 coupled to their opposing outer walls. In certain aspects, the sockets 112, 114 can be integrally formed with the upper and lower mouthpieces 102, 104.

[0073] Each strut 108, 110 includes an elongated first portion 116 having a first protrusion 118 configured to be received in the socket 112 of the upper mouthpiece 102, and an elongated second portion 120 extending perpendicularly from the elongated first portion 116 having a second protrusion 122 configured to be received in the socket 114 of the lower mouthpiece 104. The oral appliance 10, in combination with the struts 108, 110, can be configured to position the user's lower jaw in a forward direction from the user's natural jaw position to assist in treating sleep apnea of the user. The user's optimal lower jaw position can be determined by a dentist and executed by a lab responsible for fabricating the oral appliance 10. For more details regarding the sockets 112, 114 and the struts 108, 110, reference can be made to U.S. Patent Application No. 17 / 737,470, filed May 5, 2022, the entirety of which is incorporated herein by reference.

[0074] The upper dental tray 102 includes a housing 130, a cover 132, and an electronics assembly 134 coupled to the housing 130. The housing 130 has a first or occlusal portion 130a (e.g., a top portion) configured to contact the occlusal surface of the user's dentition and an opposing second portion 130b (e.g., a bottom portion) defining an internal cavity 136. The internal cavity 136 can extend along the entire arcuate length of the upper dental tray 102. The second portion 130b of the housing 130 has an outer periphery 138 defining a groove 140, and the cover 132 has an outer periphery or ridge 144 configured to complementarily engage the groove 140. The cover 132 of the housing 130 is secured to the second portion 130b of the housing 130 to isolate the internal cavity 136 from the external environment. It is contemplated that a sealing mechanism can be provided between at least a portion of the outer periphery or ridge 144 and the groove 140. A biocompatible adhesive can be provided between the groove 140 and the ridge 144 to secure the cover 132 and the housing 130 to one another. It is contemplated that the biocompatible adhesive can have a sealing function.

[0075] The cover 132 has a pair of posterior ends 132a, 132b (FIG. 13) defining ports 146a, 146b, respectively, therethrough that communicate with the internal cavity 136. In some aspects, the second portion 130b of the housing 130 can define a port at its posterior end. The ports 146a, 146b can each have a filter or impermeable mesh cover to prevent liquid or debris from entering the internal cavity 136 while allowing sound to pass through. The upper dental tray 102 can include a pair of microelectromechanical system ("MEMS") microphones (e.g., INFINEON MEMS microphones) positioned in the internal cavity 136 proximate the respective ports 146a, 146b. Alternatively, the microphones 148 can be located external to the housing 130. The microphones 148 can be covered and sealed with a biocompatible semi-permeable membrane (e.g., Gore-Tex A waterproof, breathable membrane) to prevent moisture and particles from contacting the MEMS microphones 148. The microphones 148 are configured to detect at least one of normal breathing of the user, changes in the intensity of the user's breathing sounds, and the quality of the user's snoring sounds. The microphones 148 can be configured to detect upper airway collapse at the time of obstructive sleep apnea. It is contemplated that the microphones 148 can be configured to recognize specific breathing patterns associated with sleep disordered breathing. A printed circuit board 150, and other electronic components, including one or more of a pressure sensor, an airflow sensor, a noise detector, an actigraphy sensor, a stimulator, a blood oxygen saturation (Sp02) sensor, a combination of a gyroscope and an accelerometer, and an electroencephalogram (EEG) sensor, can be provided in the internal cavity 136.

[0076] The microphones 148 can be pre-amplified and configured to record or sample sound at a frequency of about 10 kHz (to digitize the captured analog sound signals). According to one aspect, the microphones 148 are configured to filter the following signals:

[0077] High pass τ = 0.004 seconds [2ndorder];

[0078] Low pass τ = 0.0005 seconds [2ndorder],

[0079] Where the root mean square (RMS) signal (moving median 1 / 6) is calculated to capture the sound amplitude. The RMS calculates the root mean square of the signal instantaneous values. When applied to each sample of a continuous signal, this process only makes all negative values of the signal positive while leaving positive values positive. Subsequently, a moving time average can be performed to describe the RMS signal amplitude over time (i.e. within a single breath). Specifically, a moving median can be used which describes the median value within a 0.33 second window (window half-width w = 0.167 seconds; output signal at time t is the median of the input data points from time t-w to t+w seconds).

[0080] In at least one configuration, the microphone 148 comprises an S-VM3000-c Vesper - Mouser.

[0081] According to one aspect, the upper mouthpiece 102 comprises a processor operably coupled to the microphone 148. The processor, in combination with the microphone 148, is configured to identify a total sleep time of the user and a total number of sleep disturbances accompanied by arousal during a respiratory event. The microphone 148 is configured to detect a change in air exchange intensity of the user and the processor is configured to translate the detected change and trigger the stimulator to stimulate the muscles within the oral cavity of the user to reverse the obstruction of the upper airway.

[0082] The microphone 148, in combination with the processor, is configured to detect at least one of snoring during sleep of the user and a period of wakefulness or arousal.

[0083] According to one aspect, the upper mouthpiece 102 further comprises: a storage chip configured to store and record data; and a battery configured to power at least one of the sound measuring device, the processor, and the storage chip. According to one aspect, the data can also be streamed in real time and externally stored if required by the operator.

[0084] As shown in FIGS. 10, 13, and 14, the electronics assembly 134 can be located outside of the upper tray 102 and extend upwardly from the upper tray 102. In certain aspects, the electronics assembly 134 can be encased in a transparent housing (not explicitly shown). The electronics assembly 134 includes a substrate 152, an oxygen sensor 154, a printed circuit board 156, an optical housing (not labeled) supported on the printed circuit board 156, and a charging coil 158. The substrate 152 has a first end 152a coupled to the housing 130 and a second end 152b extending away from the housing 130 in a direction toward the user's gums. The first end 152a of the substrate 152 is coupled to the housing 130 of the upper tray 102, and the printed circuit board 156 is supported on the second end 152b of the substrate 152. The optical housing is supported on the printed circuit board 156, and the oxygen sensor 154 is supported in the optical housing and electrically coupled to the printed circuit board 156. The optical housing can be substantially identical or identical to the optical housing 56 (FIG. 7) described above.

[0085] The oxygen sensor 154 is configured to be oriented toward the user's alveolar mucosa or gums to determine the user's oxygen level. The oxygen sensor 154 can be a reflective pulse oximeter configured to monitor / sense the user's blood oxygen saturation by analyzing color changes in the user's blood. The reflective pulse oximeter 154 can measure the user's pulse rate (typically expressed in beats per minute) based on changes and / or deviations in the user's blood oxygen saturation. An exemplary pulse oximeter can sense the actual blood oxygen saturation of the user's hemoglobin using light-based technology. According to one aspect, the pulse oximeter 154 can be substantially identical or identical to the pulse oximeter 60 described above.

[0086] FIGS. 15-23 illustrate graphs representing sound results measured using a sound measurement device according to one aspect. The data shown in the graphs of FIGS. 15-23 were collected using a sound measurement device (e.g., a microphone) embedded in an oral appliance of the present disclosure at different time intervals during a snoring test. The sound measurement device used was a microphone embedded in an oral appliance. The sound measurement device used was placed in a sealed circular housing that was open to one side and coupled to the opposite side by adhesive. The sound measurement device was positioned under one of the user's upper molars.

[0087] The purpose of the test was to determine whether loud snoring sounds and quiet breathing sounds produced at the trachea could be clearly detected in the user's oral cavity using the oral appliance. The subject was tested in a conscious state with a series of inhaled snoring sounds followed by normal quiet breathing. The oral microphone signal was well captured - snoring sounds were detected without clipping, and breathing sounds were detected above background noise.

[0088] FIG. 15 is a graph representing data related to snoring and normal breathing sounds collected by the sound measurement device, according to one aspect. As shown, sound was measured from about 498 seconds into the user's sleep cycle. The user snored on inhalation and breathed normally on exhalation. The dotted line at about 512-516 seconds mark verifies the data collected from the sound measurement device, given that the data collected by the sound measurement device of the oral appliance is consistent with the standard reference data shown collected from an external (e.g., trachea) microphone.

[0089] FIG. 16 is a graph representing data related to snoring and normal breathing sounds collected by the sound measurement device, according to one aspect. As shown, sound was measured from about 512 seconds into the user's sleep cycle. The user snored on inhalation and breathed normally on exhalation.

[0090] FIG. 17 is a graph representing data related to normal breathing sounds collected by the sound measurement device, according to one aspect. As shown, sound was measured from about 230 seconds into the user's sleep cycle. The user breathed normally during this period and did not snore.

[0091] FIG. 18 is a graph representing data related to normal breathing sounds collected by the sound measurement device, according to one aspect. As shown, sound was measured from about 572 seconds into the user's sleep cycle. The user breathed normally during this period.

[0092] FIG. 19 is a graph representing data related to snoring and normal breathing sounds collected by the sound measurement device, according to one aspect. As shown, the user snored and then breathed normally.

[0093] FIG. 20 is a graph representing data related to normal breathing sounds collected by the sound measurement device, according to one aspect. As shown, sound was measured from about 533 seconds into the user's sleep cycle. The user breathed normally during this period.

[0094] FIG. 21 is a graph representing data related to snoring sounds collected by the sound measurement device, according to one aspect. The user snored during the test.

[0095] FIG. 22 is a graph representing data related to snoring sounds collected by the sound measurement device, according to one aspect. As shown, the user snored during the test.

[0096] FIG. 23 is a graph representing data related to normal breathing sounds collected by the sound measurement device, according to one aspect, in which signal amplitude is reduced due to saliva. As shown, the user breathed normally during the test.

[0097] In certain aspects, the present disclosure can provide an oral appliance comprising an inertial measurement unit (IMU) configured to measure three-axis acceleration and three-axis angular velocity, such as a BOSCH 6-axis accelerometer, gyroscope. According to one aspect, the IMU comprises a gyroscope and an accelerometer. The gyroscope is configured to output angular velocity signals for the three spatial axes, while the accelerometer is configured to output linear acceleration signals for the three spatial axes. According to one aspect, the IMU is a micro-IMU, sized to be coupled to a mouthpiece. The micro-IMU can be affixed to a wall of the buccal, lingual, or occlusal side of the mouthpiece. Placement of the IMU or micro-IMU can be at the most anterior segment of the user's mandible, i.e., at the location of the user's lower anterior incisors. It is contemplated that this can be the optimal location on the mouthpiece, at least because this anatomical location can exhibit the most detailed movements during recording. This is in accordance with the physics of the "fulcrum effect." The closer the point of action is to the fulcrum (the posterior jaw where the joint and associated muscles and ligaments are located), the less effort is required to produce movement at the point furthest from the fulcrum (the most anterior portion of the jaw), and thus this point is more sensitive to detecting movement.

[0098] It is contemplated that the oral appliance can be configured to detect mandibular movements. These mandibular movements can serve as surrogate biological signals for detecting respiratory effort, including snoring and arousals during sleep. According to one aspect, the mandibular movements can complement other biological signals that are indicative of the presence of sleep apnea in a user. The mandibular movement biological signals can identify specific breathing patterns that are associated with sleep disordered breathing, including obstructive sleep apnea ("OSA"). Use of the oral appliance comprising the IMU or micro-IMU can indicate sleep and wake stages, and can determine the severity level of OSA in these patients. Further analysis by specific algorithms can also identify the total sleep time, the total number of sleep disturbances with arousals during respiratory events or OSA events. According to one aspect, the algorithms can also be used as predictive models to predict future systemic issues, such as cardiovascular disease ("CVD"). It is contemplated that the IMU or accelerometer-gyroscope combination can determine bruxism and clenching, which are indicators of arousals during sleep disturbances. The IMU can also serve as an indicator of treatment compliance in patients undergoing OSA therapy.

[0099] FIGS. 24A-26B include data collected by the IMU described above.

[0100] FIGS. 24A and 24B compare data collected by an IMU coupled to an oral appliance of the present disclosure with data collected by an IMU coupled to the chin of a patient outside the mouth, where the patient is opening and closing their mouth and the head is in a straight, supine position. This data can be important in determining whether a patient is "mouth breathing" during sleep and in determining the degree of mouth breathing.

[0101] Figures 25A and 25B compare data collected by an intraoral IMU coupled to an oral appliance of the present disclosure with data collected by an IMU coupled to a patient's chin outside the mouth, where the patient's teeth are being ground side-to-side and the head is in a straight, supine position. This data can provide an indication of nocturnal bruxism secondary to obstructive sleep apnea.

[0102] Figures 26A and 26B compare data collected by an IMU coupled to an oral appliance of the present disclosure with data collected by an IMU coupled to a patient's chin outside the mouth, where the patient is swallowing.

[0103] Swallowing is a strong indicator of arousal during sleep, most commonly occurring in REM. The intraoral IMU of the present disclosure has a very unique and consistent waveform during swallowing compared to the external chin sensor.

[0104] Referring to Figures 27-30, another embodiment of an oral appliance 300 is provided, similar to the oral appliances 10, 100, 200 described above. The oral appliance 300 generally includes a mouthpiece 302 and a sensor assembly 350 disposed in an add-on or box 304 extending perpendicularly away from a rear end of the mouthpiece 302. The sensor assembly 350 can be located near an optical window 342 (Figure 30) of the add-on 304 and includes a charging coil 354, a printed circuit board 356, a spacer 358, and an oxygen sensor 360. The oxygen sensor 360 can be oriented on the occlusal plane of the user's mouth and oriented toward the user's buccal gingiva when the user wears the oral appliance 300. The oxygen sensor 360 can be similar to any of the oxygen sensors described above.

[0105] The charging coil 354 is stacked on the printed circuit board 356 and separated from the printed circuit board 356 by the spacer 358 to reduce heat generated by the charging coil 354 when charging. Thus, the spacer 358 keeps excess heat away from the printed circuit board 356. The add-on 304 is specifically designed to allow the charging coil 354 to fit in a recessed portion 306 of the add-on 304 that is about 0.6 millimeters in thickness relative to other portions of the add-on 304. This minimum thickness, such as about 0.6 millimeters, will allow more efficient contact between a charger (not explicitly shown) and the charging coil 354. The add-on 304 can have another recessed portion 362 (Figure 30) that is minimum in thickness relative to other portions of the walls of the add-on 304 to allow better emission of the photodiode and LED of the oxygen sensor 360.

[0106] Referring to FIGS. 31-33, the present disclosure provides another embodiment of an oral appliance 400 for treating and / or collecting data for treating sleep apnea. Electromyography (EMG) can be used as an indicator of the user's lack of tonus during REM and non-REM sleep (temporary paralysis of the legs and arms) during sleep. It is contemplated that an oral appliance 400 including an EMG sensor can provide data indicative of respiratory events, arousal caused by apnea, and bruxism during sleep disturbances. EMG activity in subjects with sleep disorders is typically more than twice as much as in subjects without sleep disorders. It is contemplated that measuring the EMG of the muscles within the user's mouth can provide a more sensitive and accurate data set than the EMG of external muscles (such as the lower jaw or tibia).

[0107] The tongue is the largest and most active muscle in the oral cavity. It is also the most closely associated upper airway muscle that controls airflow into the back of the throat during sleep. Therefore, detecting its contractility during sleep can provide valuable physiological data for monitoring and diagnostic purposes. Because of the tongue's important role in breathing, it is valuable to detect its electrical activity during obstructive sleep apnea. It is contemplated that an oral appliance 400 can detect such activity by placing EMG sensors along the left and right sides of the tongue's inferior-lateral sides and simultaneously coupling to a removable mouthpiece. It is contemplated that the EMG sensors can partially or completely cover the anterior and posterior portions of the user's tongue, thereby detecting expiratory and inspiratory motor units associated with the user's tongue muscle fibers.

[0108] As shown in FIG. 31, the exemplary oral appliance 400 includes a mouthpiece 402 configured to be placed within the user's oral cavity. According to one aspect, the mouthpiece 402 includes a lingual wall 404 configured to be disposed proximate to the user's tongue. The mouthpiece 402 can be made according to any of the methods described above and using any of the materials described above. The mouthpiece 402 is configured to be placed on the user's lower or upper jaw.

[0109] The oral appliance 400 also includes a pair of electromyography (EMG) sensors 406, 408 (e.g., MYOWARE muscle sensors). The EMG sensors 406, 408 are configured to provide physiological data for monitoring and diagnosing obstructive sleep apnea. According to one aspect, the EMG sensors 406, 408 are configured to detect electrical activity of a tongue of a user. The electrical activity can be indicative of muscle contractions of the tongue of the user. The EMG sensors 406, 408 are configured to contact both left and right sides of the tongue of the user so that the EMG sensors 406, 408 bilaterally detect twitches or contractions of the tongue of the user. The EMG sensors 406, 408 can be positioned on the mouthpiece 402 so that the EMG sensors 406, 408 contact both left and right sides of the tongue of the user inferior-laterally. It is contemplated that the EMG sensors 406, 408 can be sized to contact a portion of the side(s) of the tongue of the user. According to one aspect, the EMG sensors 406, 408 can be sized to contact the entire anterior and posterior sides of the tongue of the user. It is contemplated that by being positioned to contact the sides of the tongue of the user, the EMG sensors 406, 408 detect expiratory and inspiratory motor units associated with muscle fibers of the tongue of the user.

[0110] According to one aspect, the oral appliance 400 can include a single EMG sensor that contacts a single side of the tongue of the user. Alternatively, a plurality of EMG sensors can be positioned on a single side of the mouthpiece 400 so that all of the EMG sensors contact the same side (e.g., right or left side) of the tongue of the user. Although FIG. 31 illustrates that the oral appliance 400 can include wires 410 that extend from the EMG sensors 406, 408, it is contemplated that the oral appliance 400 can be wireless.

[0111] According to one aspect, the oral appliance 400 can include a processor (not explicitly shown). The processor can include a microprocessor. According to one aspect, the EMG sensors 406, 408 in combination with the microprocessor can be configured to identify respiratory events and arousals caused by obstructive sleep apnea. The EMG sensors 406, 408 in combination with the microprocessor can be configured to identify bruxism during sleep disturbances.

[0112] The oral appliance 400 can also include a memory chip (not explicitly shown) configured to store and record data collected by the EMG sensors 406, 408. According to one aspect, a battery (not explicitly shown) can be provided to power at least one of the EMG sensors 406, 408, the processor or microprocessor, and the memory chip. The battery can be a rechargeable battery. The oral appliance 400 can be positioned on a charging platform (not explicitly shown) so that the rechargeable battery can be charged and, thus, the oral appliance 400 can be powered.

[0113] When worn during sleep, the oral appliance 400 can provide information as an indicator of at least one of lack of tonus, respiratory events and arousal caused by apneas, and bruxism during sleep disturbances when the user is in REM sleep.

[0114] It is further contemplated that the oral appliance 400 can include additional sensors (not explicitly shown) in addition to the EMG sensors 406, 408. The additional sensors can be at least one of an oxygen sensor, a PPG sensor, and an inertial motion sensor. The EMG sensors 406, 408 and the additional sensor(s) can collectively gather physiological data over time to assist in diagnosing obstructive sleep apnea. The microprocessor and rechargeable battery(s) can be sealed within or otherwise coupled to the mouthpiece 400.

[0115] The information or data collected by the EMG sensors 406, 408 and the additional sensor(s) can be streamed in real-time, e.g., wirelessly (i.e., via Bluetooth), to a smart device. The data can also be downloaded the next day by placing the appliance on a fixed hub / charger combination (not shown). The data can then be transmitted to a cloud-based secure medium to be shared with the user and their care provider(s). Through deep learning / artificial intelligence (AI) system integration, these accumulated collective data can be built into predictive models to optimize accurate diagnosis and ongoing monitoring of continued treatment for patients with sleep breathing disorders, such as obstructive sleep apnea. Further, the predictive models can assist in determining the most statistically effective OSA prescription treatment with the highest probability of success prior to the user engaging in any treatment that can provide a substandard treatment response, such as positive airway pressure (i.e., CPAP), custom sleep oral appliances, hypoglossal nerve stimulators, and pharmacological treatments.

[0116] It is contemplated that the EMG sensors 406, 408 can be suitably coupled to any of the oral appliances described herein.

[0117] The additional sensor coupled to the oral appliance 400 can be an EEG sensor. Referring to FIG. 32, EMG data is acquired using the EEG sensor to determine when the user’s eyes are open and closed: (Stage 1) the user’s eyes are first opened and then closed; (Stage 2) the user’s eyes are open; and (Stage 3) the user’s eyes are again opened and then closed. During this test, EMG data is collected during Stages 1 and 3. A unique signal reflecting the electrical activity of the user’s tongue is obtained.

[0118] FIG. 33 is a graph showing the difference between EMG data indicative of tongue contractions and EMG data indicative of no tongue contractions. As shown, a unique signal is obtained that reflects the presence of muscle contractions or twitches in the user’s tongue indicating the moments in time when the user is not in REM sleep, while a signal reflecting relaxed tongue muscles indicates the user is in REM sleep. The unique signal is not generated when the user’s tongue muscles are not contracting or twitching.

[0119] The components of the illustrated devices are not limited to the particular embodiments described herein but, rather, can be used with other embodiments of well as in combinations of those embodiments. The devices are intended to encompass such modifications and changes.

[0120] While the devices and methods have been described with reference to particular embodiments, those skilled in the art will understand that various changes can be made and equivalents can be substituted for elements thereof without departing from the scope contemplated. In addition, many modifications can be made to adapt a particular situation or material to the teachings of the disclosure without departing from the central scope thereof.

[0121] In this specification and the appended claims, reference will be made to a number of terms, which shall have the following meanings. The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. In addition, 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, such as, for example, "about," "substantially," and the like, as used herein with respect to a given value or condition, means that the value or condition is within a reasonable expected range that would be understood by one of ordinary skill in the art to which the disclosure pertains. Accordingly, such a term should not be interpreted as excluding the presence of the recited value or condition in the value or condition itself. The term "coupled" as used herein, unless otherwise specified, means that the entities connected by the relation are in direct or indirect communication with each other to the extent that the entities remain individually operable. The term "connected" as used herein, unless otherwise specified, means that the entities connected by the relation are in direct communication with each other.

[0122] As used herein, the terms "may" and "can" mean the possibility in a set of circumstances; having a particular attribute, characteristic or function; and / or qualifying another verb with one or more abilities, capabilities or possibilities associated with the limiting verb. Thus, the use of "may" and "can" indicates that the modified term is apparently appropriate, capable or suitable in the indicated capacity, function or use, while taking into account that the modified term can sometimes be inappropriate, incapable or unsuitable in certain circumstances. For example, an event or capability can be expected in some circumstances, while the event or capability can not occur in other circumstances - this distinction is embodied by the terms "may" and "can."

[0123] As used in the claims, the word “comprise” and its grammatical variants are to be interpreted broadly to include both the strict inclusion of the listed elements and the inclusion of other elements not listed, such as by way of example only, “consisting essentially of” and “consisting of.” Where ranges are provided, the range includes all sub-ranges therebetween, unless otherwise indicated. Variations of the ranges are contemplated to be within the scope of the appended claims, if such variations are not already disclosed to the public. The disclosure of ranges includes endpoints.

[0124] Advances in science and technology can make equivalents and substitutes possible that are not presently contemplated due to imprecision in language; such changes are to be encompassed 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 skilled in the art to practice the methods, machines, and computer-readable media, including making and using any devices or systems and performing any incorporated methods. The patentable scope is defined by the claims, and can include other examples that are equivalent to the claims. If these other examples are not literal duplicates of the claims, but include equivalent structure that does not differ from the literal language of the claims in meaningful ways, then these other examples are intended to be within the scope of the claims.

Claims

1. An oral appliance comprising: a mouthpiece configured to be positioned in a user's mouth, the mouthpiece comprising: a front wall configured to cover a labial surface of a user's dentition; a back wall configured to cover a lingual surface of the user's dentition; a lateral wall extending between the front wall and the back wall; and an electronic assembly coupled to the mouthpiece, the electronic assembly comprising an oxygen sensor coupled to the front wall, the oxygen sensor configured to be oriented toward soft tissue of the user's mouth to determine a blood oxygen saturation level of the user.

2. The oral appliance of claim 1, further comprising a housing disposed on the mouthpiece, wherein the housing comprises / encloses / surrounds at least a portion of the electronic assembly.

3. The oral appliance of claim 1, wherein the electronic assembly further comprises: a printed circuit board; and an optical housing supported on the printed circuit board, wherein the oxygen sensor is supported within the optical housing and electrically coupled to the printed circuit board.

4. The oral appliance of claim 3, wherein the optical housing comprises at least two barriers defining a space therebetween, the oxygen sensor disposed in the space.

5. The oral appliance of claim 4, wherein the at least two barriers are arranged parallel to each other.

6. The oral appliance of claim 1, wherein the electronic assembly further comprises a charging coil in communication with the oxygen sensor. the oxygen sensor is a reflective pulse oximeter configured to emit light and determine an oxygen saturation level of the user's hemoglobin through the light.

7. The oral appliance of claim 1, wherein, 8. The oral appliance of claim 7, wherein the light comprises red light and infrared light.

9. The oral appliance of claim 1, wherein the electronic assembly has a first end connected to the mouthpiece and a second end extending away from the mouthpiece toward the user's gums, the second end of the electronic assembly supporting the oxygen sensor.

10. The oral appliance of claim 1, the electronic assembly comprising an electroencephalogram (EEG) electrode, wherein the EEG electrode is configured to be disposed proximate to the user's alveolar mucosa so that the EEG electrode detects brain wave signals. the oxygen sensor is a reflective pulse oximeter comprising one or more light emitting diodes (LEDs) configured to emit light, wherein the reflective pulse oximeter is configured to monitor an oxygen saturation level of the user's hemoglobin through the light emitted by the LEDs.

11. The oral appliance of claim 1, wherein, 12. The oral appliance of claim 1, further comprising a housing secured to the mouthpiece, the housing opposite the lateral wall, wherein the housing defines an internal cavity of the mouthpiece; and a microphone disposed in the internal cavity of the mouthpiece.

13. The oral appliance of claim 1, wherein a microphone is disposed on the mouthpiece and the microphone is covered by a semi-permeable membrane.

14. The oral appliance of claim 1, further comprising a strut, the strut comprising: an elongated first portion having a first protrusion configured to be received into a socket of the mouthpiece; and a second portion having a second protrusion configured to be received into a socket of the mouthpiece. ​ an elongated second portion extending perpendicularly from the elongated first portion and having a second protrusion configured to be received into a socket of another mouthpiece.

15. The oral appliance of claim 1, wherein the oxygen sensor is positioned above a top of the front wall.

16. An oral appliance comprising: a mouthpiece configured to be placed within a user's oral cavity, the mouthpiece comprising: a front wall configured to cover a labial surface of a user's dentition; a back wall configured to cover a lingual surface of a user's dentition; a lateral wall extending between the front wall and the back wall; and an electronic assembly coupled to the mouthpiece, the electronic assembly comprising an oxygen sensor coupled to the front wall and configured to be oriented toward soft tissue of the user's oral cavity to determine a blood oxygen saturation level of the user and collect blood oxygen saturation (Sp02) and photoplethysmography (PPG) data.

17. The oral appliance of claim 16, wherein the oxygen sensor comprises a light emitting diode (LED) and a barrier, wherein the LED is positioned between and within a space defined between the barrier.

18. The oral appliance of claim 17, further comprising a printed circuit board, the barrier coupled to the printed circuit board, wherein the oxygen sensor is a reflective pulse oximeter coupled to and in electrical communication with the printed circuit board.

19. The oral appliance of claim 16, wherein the light emitted by the LED comprises red light and infrared light.

20. An oral appliance comprising: a mouthpiece configured to be placed within a user's oral cavity, the mouthpiece comprising: a front wall configured to cover a labial surface of a user's dentition; a back wall configured to cover a lingual surface of a user's dentition; a lateral wall extending between the front wall and the back wall; an appendage extending away from the front wall in a direction of soft tissue of the user's oral cavity and defining a space within the appendage; and an electronic assembly comprising an oxygen sensor and positioned at least partially within the space in the appendage, wherein the appendage and the electronic assembly are collectively configured to orient the oxygen sensor toward the soft tissue of the user's oral cavity.

Images