Automatic adjustment of oral orthodontic treatment devices

Abstract

Automatic adjustment of an orthodontic treatment device (such as a mandibular repositioning device) is disclosed. Sensor data can be received from one or more sensors external to a user using the orthodontic treatment device. The sensor data can be used to determine adjustments associated with the orthodontic treatment device and to take actions to facilitate application of the determined adjustments. Such actions can include sending a signal to the orthodontic treatment device to effect the adjustment (e.g., using an actuator or an on-board electrical stimulator), presenting adjustment parameters to assist the user in manual adjustments, activating an actuator in an orthodontic treatment device storage reservoir the next time the orthodontic treatment device is stored, or other such actions. Adjustments can be made dynamically in real time or asynchronously (e.g., between sleep sessions).

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 090,004, filed October 9, 2020, entitled "AUTOMATIC ORAL APPLIANCE ADJUSTMENT," which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates generally to the treatment of sleeping sickness, and more particularly to an orthodontic treatment device with automatic adjustment for the treatment of sleeping sickness. [Background technology]

[0003] Many individuals suffer from sleep-related disorders associated with one or more events occurring during sleep, such as snoring, apnea, hypopnea, restless legs, sleeping sickness, choking, increased heart rate, labored breathing, asthma attacks, epileptic seizures, seizures, or any combination thereof. These individuals are typically treated with one or more medical devices to improve sleep and reduce the likelihood of the events occurring during sleep. Some such medical devices rely on providing positive airway pressure to the individual, while some medical devices for the treatment of sleeping sickness include oral orthodontic appliances (e.g., dental braces or mandibular repositioning devices) that can be worn by the individual while sleeping.

[0004] Oral orthodontic treatment can support the jaw (mandible) in an anterior position and prevent the tongue and soft tissues at the back of the throat from collapsing by maintaining an open airway during sleep. In some implementations, oral orthodontic treatment can be particularly effective for individuals with a relatively low body mass index (BMI) and a relatively low apnea-hypopnea index (AHI). Oral orthodontic treatment is particularly effective for position-related (e.g., supine-dependent) obstructive sleep apnea.

[0005] When using an oral orthodontic appliance to treat sleeping sickness is desired, the appliance is often fitted to the user with the assistance of a medical professional. The appliance can be adjusted in various ways to provide the most effective fit and function. In some implementations, multiple visits may be required to achieve the desired fit and function. At each visit, the medical professional may need to make minor adjustments to the appliance to ensure it operates as desired. Because visits to a medical professional may be one or more days apart, the current orthodontic appliance may not be properly adjusted between such visits. Unfortunately, without multiple visits to a medical professional and proper adjustments, the appliance may not have a chance to operate as expected, and non-compliant treatment may be harmful to the individual, as some individuals may abandon the appliance. Summary of the Invention [Means for solving the problem]

[0006] According to some implementations of the present disclosure, a method for adjusting an oral orthodontic treatment device for treating sleeping sickness is disclosed, the method including receiving sensor data from one or more sensors external to a user, automatically determining adjustments associated with the oral orthodontic treatment device based on the sensor data, and facilitating application of the determined adjustments to the oral orthodontic treatment device in response to the automatically determined adjustments.

[0007] The above summary is not intended to represent each embodiment or every aspect of the present disclosure. Additional features and benefits of the present disclosure will be apparent from the following detailed description and drawings. [Brief explanation of the drawings]

[0008] [Figure 1] FIG. 1 is a functional block diagram of a system for automatically adjusting an orthodontic treatment appliance, according to some implementations of the present disclosure. [Figure 2] FIG. 2 is a perspective view of the system, user, and bed companion of FIG. 1 according to some implementations of the present disclosure. [Figure 3] FIG. 1 illustrates an example timeline of a sleep session, according to some implementations of the present disclosure. [Figure 4] FIG. 4 illustrates an example sleep diagram associated with the sleep session of FIG. 3 in accordance with some implementations of the present disclosure. [Figure 5] 1 is a flowchart illustrating a process for automatically adjusting an orthodontic treatment appliance, according to some implementations of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0009] While the present disclosure is susceptible to various modifications and alternative forms, specific implementations and embodiments of the present disclosure have been shown by way of example in the drawings and are herein described in detail. It is to be understood, however, that it is not intended to limit the disclosure to the particular forms disclosed, but that the present disclosure is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.

[0010] Some aspects and features of the present disclosure relate to automatic adjustment of an oral orthodontic treatment appliance (e.g., a mandibular repositioning appliance). Sensor data can be received from one or more sensors external to a user using the oral orthodontic treatment appliance. The sensor data can be used to determine adjustments associated with the oral orthodontic treatment appliance and take actions to facilitate application of the determined adjustments. Such actions can include sending a signal to the oral orthodontic treatment appliance to effect the adjustment (e.g., using an actuator or an on-board electrical stimulator), presenting adjustment parameters to assist the user in manual adjustments, activating an actuator in an orthodontic treatment appliance storage reservoir the next time the oral orthodontic treatment appliance is stored, or other such actions. Adjustments can be made dynamically in real time or asynchronously (e.g., between sleep sessions).

[0011] Treatment with the oral orthodontic treatment device may include treating sleeping sickness using an oral orthodontic treatment device system. Examples of sleeping sickness are described herein. Sleeping sickness may include any known or unknown illness that affects a user during sleep. Sleeping sickness may include any known or unknown illness that affects a user's ability to sleep and / or sleep quality. Sleeping sickness may include any known or unknown illness that affects a user's ability to breathe during sleep.

[0012] An oral orthodontic treatment device system may include an oral orthodontic treatment device usable by a user (e.g., worn in the user's mouth (e.g., oral cavity)). The oral orthodontic treatment device system may optionally include an oral orthodontic treatment device reservoir for storing the oral orthodontic treatment device when not in use. The oral orthodontic treatment device reservoir may be a single container or reservoir for receiving the oral orthodontic treatment device or may include additional elements for charging, communicating with, and / or adjusting the oral orthodontic treatment device.

[0013] Oral orthodontic treatment appliances are typically, though not always, fully removable (e.g., completely removable from a user's oral cavity). Oral orthodontic treatment appliances may include one or more adjustments (e.g., adjustable aspects of the oral orthodontic treatment appliance), such as an adjustable connection for a mandibular repositioning device. In such an example, the mandibular repositioning device may include an upper impression tray and a lower impression tray connected by an adjustable connection. The upper impression tray is typically configured to interface with the teeth of the upper jaw and / or maxilla, and the lower impression tray is configured to interface with the teeth of the mandibular and / or maxilla. The adjustable connection can be adjusted to control the relative position of the upper impression tray with the lower impression tray to control the relative positions of the upper and lower jaws. For example, the adjustable connection may include adjustable-length posts rotatably connected to the upper and lower impression trays at fixed points. In another example, the adjustable connection can include fixed-length posts rotatably connected to the upper and lower impression trays at adjustable points. In some implementations, the adjustable connection can be adjusted to control the resistance and / or biasing force associated with movement of the upper impression tray relative to the lower impression tray, which can be related to the amount of force required by a user to separate and gather their teeth. Other adjustments can be made.

[0014] In some implementations, adjustment of the oral orthodontic treatment appliance is accomplished manually, with or without the aid of tools. For example, the oral orthodontic treatment appliance can be adjusted entirely by hand or with a screwdriver or other tool. In such implementations, some aspects of the present disclosure may include presenting a display with adjustment parameters to a user or other individual (e.g., a medical professional). These adjustment parameters may instruct how to adjust the oral orthodontic treatment appliance. For example, the adjustment parameters may include instructions to shorten an adjustable-length post by 1 mm, 2 mm, 3 mm, etc.

[0015] In some implementations, adjustments to the orthodontic treatment device can be automatically implemented in the orthodontic treatment device. Automatically implementing adjustments in the orthodontic treatment device can include adjusting software settings of the orthodontic treatment device (e.g., adjusting drive settings of an electrical stimulator within the orthodontic treatment device) or one or more physical adjustments that operate the orthodontic treatment device (e.g., driving an actuator within the orthodontic treatment device to change the relative position of the upper impression tray with respect to the lower impression tray). In some implementations, the orthodontic treatment device can include one or more adjustment actuators that can operate the orthodontic treatment device. Any suitable actuators can be used, such as electromechanical actuators, piezoelectric actuators, linear actuators, rotary actuators, motors, servo mechanisms, pumps, screw actuators, electromagnetic actuators, etc.

[0016] Adjusting the orthodontic treatment appliance in the orthodontic treatment appliance may include transmitting a signal from the control system to the orthodontic treatment appliance. When received by the orthodontic treatment appliance, this signal may effectuate adjustment of the orthodontic treatment appliance. In some implementations, transmitting the signal when the orthodontic treatment appliance is in use may enable dynamic, real-time adjustment of the orthodontic treatment appliance. However, in some implementations, this signal may be transmitted to the orthodontic treatment appliance when the orthodontic treatment appliance is not in use (e.g., when the orthodontic treatment appliance is in an orthodontic treatment appliance reservoir).

[0017] In some implementations, adjusting the orthodontic treatment appliance can be accomplished automatically using an external actuator, such as an actuator in the orthodontic treatment appliance reservoir. In such implementations, one or more sensors can detect that the orthodontic treatment appliance is received by the orthodontic treatment appliance reservoir, and one or more actuators in the orthodontic treatment appliance reservoir can adjust one or more adjustments of the orthodontic treatment appliance. For example, a mandibular repositioning appliance can be placed in an associated reservoir, and the reservoir's actuator can then operate an adjustable linkage of the mandibular repositioning appliance to change the relative position of the upper impression tray with respect to the lower impression tray.

[0018] The type and amount of adjustment to be made can be automatically determined by the system. The system can receive sensor data from one or more sensors and use the sensor data to determine the adjustment to be made. In some implementations, the system can also receive stored data, such as historical sensor data, historical adjustments, preset settings, or routines. The system can operate using one or more algorithms, machine learning models (e.g., neural networks), or other techniques to interpret input data (e.g., sensor data and stored data) and determine the desired adjustment. The determined adjustment may be designed to improve the user's treatment of sleep sickness, reduce discomfort, reduce or minimize sleep events (e.g., apnea events), or otherwise improve the user's sleep.

[0019] In some implementations, the system determines adjustments dynamically (e.g., in real time), such as using real-time sensor data. In some implementations, the system can determine adjustments asynchronously, such as using stored sensor data. In some implementations, the system can cause adjustments to be applied dynamically (e.g., in real time or near real time), such as when the user is sleeping. In other implementations, the system can cause adjustments to be applied asynchronously, such as when the user is not sleeping. In some implementations, the system can control the adjustment of the oral orthodontic treatment appliance to move small amounts over time to help the user get used to the adjustment. Such small adjustments over time may be during a single sleep session (e.g., gradually moving the oral orthodontic treatment appliance from a comfort-first state to a treatment-first state) or over multiple sleep sessions (e.g., gradually improving a new oral orthodontic treatment appliance user from a minimum treatment level to a desired treatment level over a multi-day process).

[0020] The sensor data used by the system may include sensor data from one or more sensors on one or more devices. For example, the sensor data may include sensor data from one or more sensors in the oral orthodontic treatment device, one or more sensors in the oral orthodontic treatment device reservoir, one or more sensors on a user device (e.g., a smartphone or computer), or one or more sensors on another external device. In some implementations, the sensor data is from one or more sensors external to the user. In some implementations, the system uses data related to sleep sessions in which the user uses the oral orthodontic treatment device. In some implementations, the system uses data related to sleep sessions in which the user does not use the oral orthodontic treatment device. In such implementations, the system can be used to determine differences associated with using an oral orthodontic treatment device versus not using an oral orthodontic treatment device, such as differences related to the user's sleep pathology, comorbidities experienced by the user (e.g., hypertension, diabetes, insomnia, etc.), occurrence of sleep events (e.g., apnea events), sleep quality, or any combination thereof.

[0021] In some implementations, determining the adjustments may include analyzing the sensor data to determine a sleep state or sleep stage associated with the user. Examples of determining sleep states and / or sleep stages are described in WO 2014 / 047310, US 2014 / 0088373, WO 2015 / 006364, WO 2017 / 132726, WO 2019 / 122413, and WO 2019 / 122414, e.g., each of which is incorporated by reference in its entirety. In some implementations, some adjustments may be made depending on the user's sleep state or sleep stage. For example, the oral orthodontic treatment appliance may initially be adjusted to a comfort-first sleep-onset state (e.g., when the user wakes and begins to fall asleep), but upon determining that the user is in a post-sleep-onset sleep state or sleep stage, the system may adjust the oral orthodontic treatment appliance to a treatment-first state. In the comfort-first state, comfort may be prioritized over therapeutic effectiveness, and the oral treatment device may be more comfortable for the user but may not provide effective treatment for sleeping sickness. In the treatment-first state, therapeutic effectiveness may be prioritized over comfort, and the oral treatment device may be more effective in treating sleeping sickness but may be less comfortable. Because the user was asleep when the oral treatment device was adjusted to the treatment-first state, the user may not notice the reduced comfort but may benefit from the increased therapeutic effectiveness.

[0022] In some implementations, determining an adjustment may include analyzing the sensor data to identify and / or predict an event, such as an apnea event. If an event is identified or detected, the system may adjust the oral orthodontic treatment appliance to place it in a post-event state. In the post-event state, the oral orthodontic treatment appliance may apply modifications designed to offset, reduce, minimize, and / or eliminate an increase in the occurrence of the event (e.g., an apnea event) or subsequent events. If a future event is predicted based on the sensor data, the system may adjust the oral orthodontic treatment appliance to place it in a pre-event state. In the pre-event state, which may be an enhanced state (e.g., designed to be more therapeutically effective), the oral orthodontic treatment appliance may apply modifications to the user designed to avoid or minimize future events. For example, entering a pre-event state may adjust the oral orthodontic treatment appliance to improve the user's treatment effectiveness, which may be at the expense of reduced comfort for the user.

[0023] In some implementations, the oral orthodontic treatment appliance can be used to drive other devices, such as implantable treatment devices. In such implementations, adjustments to the oral orthodontic treatment appliance can include adjusting software settings to adjust how the oral orthodontic treatment appliance controls the implantable treatment device.

[0024] In some implementations, the system can interact with other external devices related to the user's sleep session. In one example, a pillow, blanket, and / or mattress may include one or more inflatable airbags controllable by the system. In this example, if the system detects that the user is sleeping while using the oral orthodontic treatment appliance, the system can control the one or more inflatable airbags to encourage the user to enter a desired position. For example, if the system detects that the user is sleeping with the mandibular repositioning appliance in place, the system can control the one or more inflatable airbags to encourage the user to enter a lateral sleeping position. In some implementations, the system can encourage the user to enter other sleeping positions, such as a supine sleeping position. Other external devices can be used. In some implementations, the system can adjust the oral orthodontic treatment appliance and one or more external devices together to attempt and achieve a desired result (e.g., minimize, reduce, or eliminate an event or series of events). For example, if adjustments to the oral orthodontic treatment appliance are not sufficient to achieve the desired result (e.g., if the determined adjustments exceed a threshold, such as a user comfort threshold or a system capability threshold), the system can further control the external device to achieve the desired result. In other examples, if the system detects that the user has gone to bed and / or is sleeping without using the oral orthodontic treatment device (e.g., if the user forgets to place the oral orthodontic treatment device in their mouth before going to sleep), the system may alert the user, for example, via a notification from the user device, or the system may control an external device to compensate for the deficiency in the oral orthodontic treatment device and achieve the desired treatment result, for example, by prompting the user to sleep on their side or on their back.

[0025] In some implementations, the process of receiving sensor data, determining adjustments, and applying the adjustments can create a feedback circuit to control various aspects of a user's sleep session to effectively treat sleeping sickness.

[0026] In some implementations, automatic adjustment of the oral orthodontic treatment device occurs continuously when the user uses the oral orthodontic treatment device or when the user is determined to fall asleep while using the oral orthodontic treatment device. In some implementations, automatic adjustment occurs frequently (e.g., hourly, every few hours, daily, every few days, weekly, weekly, monthly, monthly, monthly, yearly, or every few years). In some implementations, automatic adjustment occurs a set number of times (e.g., once) only while sleeping or whenever the oral orthodontic treatment device is inserted. In some implementations, automatic adjustment occurs only after manual turn-on by pressing a button or control on an external device associated with initiating automatic adjustment of the oral orthodontic treatment device. In some implementations, automatic adjustment occurs when one or more sensors determine that a new oral orthodontic treatment device is being used.

[0027] These illustrative examples are intended to introduce the reader to the general themes discussed herein and are not intended to limit the scope of the disclosed concepts. The following sections describe various additional features and examples with reference to the drawings, in which like numerals refer to like elements and directional illustrations are provided to illustrate the illustrative examples, but as with the illustrative examples, are not intended to limit the disclosure. Elements included in the illustrations herein may be plotted out of scale.

[0028] 1 , system 100 includes a control system 110, an orthodontic treatment system 120, one or more sensors 130, a user device 170, and an external device 171. As described herein, system 100 may generally be used to provide orthodontic treatment to a user and automatically adjust the treatment by adjusting orthodontic treatment device 122.

[0029] The control system 110 includes one or more processors 112 (hereinafter referred to as processors 112). The control system 110 is generally used to control (e.g., operate) various components of the system 100 and / or analyze data acquired and / or generated by the components of the system 100. The processor 112 may be a general-purpose or special-purpose processor or microprocessor. While one processor 112 is shown in FIG. 1 , the control system 110 may include any suitable number of processors (e.g., one processor, two processors, five processors, ten processors, etc.), which may reside in a single housing or may be located remotely from one another. The control system 110 may be coupled to and / or located within the housing of the user device 170, the housing of the external device 171, within a portion (e.g., the housing) of the orthodontic treatment system 120 (e.g., the orthodontic treatment device 122 or the orthodontic treatment reservoir 126), and / or within the housing of one or more of the sensors 130. Control system 110 can be centralized (in one such enclosure) or distributed (in two or more such enclosures that are physically distinct). In such implementations that include two or more enclosures housing control system 110, such enclosures may be located proximate to and / or far from one another.

[0030] The storage device 114 stores machine-readable instructions executable by the processor 112 of the control system 110. The storage device 114 may be any suitable computer-readable storage device or medium, such as, for example, a random or serial access memory device, a hard drive, a solid-state drive, a flash memory device, etc. Although one storage device 114 is shown in FIG. 1 , the system 100 may include any suitable number of storage devices 114 (e.g., one storage device, two storage devices, five storage devices, ten storage devices, etc.). The storage device 114 may be coupled to and / or located within the housing of the orthodontic treatment system 120 (e.g., within the housing of the orthodontic treatment reservoir 126), within the housing of the user device 170, within the housing of the external device 171, within the housing of one or more sensors 130, or any combination thereof. Like the control system 110, the storage device 114 may be centralized (within one such housing) or distributed (within two or more such housings that are physically distinct).

[0031] The electronic interface 119 is configured to receive data (e.g., physiological data, environmental data, audio data, motion data, etc.) from one or more sensors 130 so that the data can be stored in the storage device 114 and / or analyzed by the processor 112 of the control system 110. The electronic interface 119 can communicate with the one or more sensors 130 using a wired or wireless connection (e.g., an RF communication protocol, a WiFi communication protocol, a Bluetooth communication protocol, a cellular network, etc.). The electronic interface 119 may include an antenna, a receiver (e.g., an RF receiver), a transmitter (e.g., an RF transmitter), a transceiver, or any combination thereof. The electronic interface 119 may further include one or more processors and / or one or more storage devices the same as or similar to the processor 112 and storage device 114 described herein. In some embodiments, the electronic interface 119 is coupled to or integrated with the user device 170. In some embodiments, the electronic interface 119 is coupled to or integrated with the external device 171. In other embodiments, the electronic interface 119 is coupled to or integrated with (e.g., within the housing of) the control system 110 and / or the memory device 114. In some implementations, multiple electronic interfaces 119 can be used across multiple components of the system 100 (e.g., the orthodontic treatment appliance 122, the orthodontic treatment appliance reservoir 126, the user device 170, and the external device 171).

[0032] The oral orthodontic treatment system 120 includes an oral orthodontic treatment device 122 (e.g., a mandibular repositioning device) and, optionally, an oral orthodontic treatment device reservoir 126. The oral orthodontic treatment device 122 may be a device that can be inserted into a user's oral cavity to apply orthodontic treatment. The oral orthodontic treatment device reservoir 126 may be any container or suitable reservoir, such as a storage container, for receiving the oral orthodontic treatment device 122. The oral orthodontic treatment device reservoir 126 may include a receiving space for receiving the oral orthodontic treatment device 122. Orthodontic treatment refers to treating a sleeping disorder, such as obstructive sleep apnea, using an oral orthodontic treatment device. Oral orthodontic treatment may include applying a force to one or more elements of the user's oral cavity (e.g., the mandible) to treat the sleeping disorder, as described herein.

[0033] The oral orthodontic treatment appliance 122 may include one or more adjustments, also referred to as adjustable aspects. In some implementations, the oral orthodontic treatment appliance 122 may include one or more actuators 124 that can selectively initiate one or more adjustment changes (e.g., adjusting the oral orthodontic treatment appliance). In some implementations, the oral orthodontic treatment appliance reservoir 126 optionally includes one or more actuators 128 that can initiate one or more adjustment changes of the oral orthodontic treatment appliance (e.g., adjust the oral orthodontic treatment appliance) when the oral orthodontic treatment appliance is received by the oral orthodontic treatment appliance reservoir. The one or more actuators 128 can be positioned to manipulate the oral orthodontic treatment appliance 122 when the oral orthodontic treatment appliance 122 is received within the receiving space of the oral orthodontic treatment appliance reservoir 126.

[0034] Orthodontic treatment system 120 is typically used to treat individuals with one or more sleep-related breathing disorders (eg, obstructive sleep apnea).

[0035] In some implementations, the orthodontic treatment reservoir 126 may include a display device 129. The display device 129 is generally used to display images and / or information, including still images, moving images, or both, related to the orthodontic treatment device 122. For example, the display device 129 may provide information regarding the status of the orthodontic treatment device 122 (e.g., whether the orthodontic treatment device 122 is in use or has been cleaned since last use, the current sound of the orthodontic treatment device 122, or other information related to the orthodontic treatment device 122), the current settings of one or more adjustable aspects of the orthodontic treatment device 122, and / or other information (e.g., information regarding the most recent sleep session, the current date / time, personal user information, etc.). In some embodiments, the display device 129 functions as a human-machine interface (HMI) that includes a graphical user interface (GUI) configured to display images as an input interface. The display device 129 may be an LED display, an OLED display, an LCD display, etc. The input interface may be, for example, a touch screen or touch-sensitive board, a mouse, a keyboard, or any sensor system configured to sense inputs made by a human user interacting with the orthodontic treatment reservoir 126 .

[0036] 2, a portion of the system 100 of FIG. 1 is shown, according to some embodiments. A user 210 and a bed partner 220 of the oral orthodontic treatment system 120 are positioned in a bed 230 and lying on a mattress 232. An oral orthodontic treatment device 122 (e.g., a mandibular repositioning device) may be worn by the user 210 (e.g., worn intraorally) during a sleep session.

[0037] In some implementations, the oral orthodontic treatment system 120 may include an oral orthodontic treatment reservoir 126 that may be positioned on a nightstand 240 directly adjacent to the bed 230, as shown in FIG. 2, or more generally, on any surface or structure adjacent to the bed 230 and / or user 210. In some implementations, the oral orthodontic treatment system 120 may be positioned in a location not adjacent to the bed 230 and / or user 210, such as in a bathroom or other location.

[0038] 1 , the one or more sensors 130 of the system 100 may include a pressure sensor 132, a flow sensor 134, a temperature sensor 136, a motion sensor 138, a microphone 140, a speaker 142, a radio frequency (RF) receiver 146, an RF transmitter 148, a camera 150, an infrared sensor 152, a photoplethysmogram (PPG) sensor 154, an electrocardiogram (ECG) sensor 156, an electroencephalogram (EEG) sensor 158, a capacitance sensor 160, a force sensor 162, a strain gauge sensor 164, an electromyogram (EMG) sensor 166, an oxygen sensor 168, an analyte sensor 174, a moisture sensor 176, a LiDAR sensor 178, or a combination thereof. Generally, each of the one or more sensors 130 is configured to output sensor data that is received and stored by the storage device 114 or one or more other storage devices.

[0039] Although the one or more sensors 130 are illustrated and described as including each of a pressure sensor 132, a flow sensor 134, a temperature sensor 136, a motion sensor 138, a microphone 140, a speaker 142, an RF receiver 146, an RF transmitter 148, a camera 150, an infrared sensor 152, a photoplethysmogram (PPG) sensor 154, an electrocardiogram (ECG) sensor 156, an electroencephalogram (EEG) sensor 158, a capacitance sensor 160, a force sensor 162, a strain gauge sensor 164, an electromyogram (EMG) sensor 166, an oxygen sensor 168, an analyte sensor 174, a moisture sensor 176, and a LiDAR sensor 178, more generally, the one or more sensors 130 may include any combination and number of the sensors described and / or illustrated herein.

[0040] The one or more sensors 130 may be used to generate, for example, physiological data, audio data, image data, other data, or any combination thereof. The sensor data from the one or more sensors 130 may be used to automatically determine adjustments to the oral orthodontic treatment appliance 122, as disclosed in further detail herein. In some implementations, the sensor data may identify information about the user, the user's sleep session, the oral orthodontic treatment appliance 122, or another related factor.

[0041] In some implementations, the control system 110 can use physiological data generated by one or more of the sensors 130 to determine a sleep-wake signal and one or more sleep-related parameters associated with the user during a sleep session. The sleep-wake signal can indicate one or more sleep states, including wakefulness, relaxed wakefulness, micro-arousal, rapid eye movement (REM) stage, first non-REM stage (often referred to as “N1”), second non-REM stage (often referred to as “N2”), third non-REM stage (often referred to as “N3”), or any combination thereof. The sleep-wake signal can also be time-stamped to indicate the time the user goes to bed, the time the user gets out of bed, the time the user attempts to fall asleep, etc. The sleep-wake signal can be measured by the sensors 130 at a predetermined sampling rate during the sleep session, such as one sample per second, one sample per 30 seconds, one sample per minute, etc. The one or more sleep-related parameters that can be determined for the user during a sleep session based on the sleep-wake signal include total time in bed, total sleep time, sleep onset latency, a wake-after-sleep parameter, sleep efficiency, a fragmentation index, or any combination thereof. Methods for determining sleep states and / or sleep stages based on physiological data generated by one or more sensors (e.g., sensor 130) are described, for example, in WO 2014 / 047310, US 2014 / 0088373, WO 2017 / 132726, WO 2019 / 122413, and WO 2019 / 122414, each of which is incorporated herein by reference in its entirety.

[0042] Physiological and / or audio data generated by one or more sensors 130 can be used to determine a respiratory signal associated with the user during a sleep session. The respiratory signal generally indicates the user's respiration / breathing during a sleep session. The respiratory signal can indicate, for example, respiration rate, respiration rate variability, inspiratory amplitude, expiratory amplitude, inspiratory-to-expiratory ratio, number of events per hour, pattern of events, position of the oral orthodontic treatment device 122, effect of the currently configured oral orthodontic treatment device 122, or any combination thereof. Events can include snoring, apnea, central apnea, obstructive apnea, mixed apnea, hypopnea, restless legs, sleep disorder, choking, increased heart rate, labored breathing, asthma attack, epileptic seizure, seizure, or any combination thereof. In some implementations, the respiratory signal can be used to facilitate adjustments to the oral orthodontic treatment device.

[0043] The pressure sensor 132 outputs pressure data (e.g., a pressure signal) that can be stored in the memory device 114 and / or analyzed by the processor 112 of the control system 110. In some embodiments, the pressure sensor 132 is an air pressure sensor (e.g., a barometric sensor) that generates sensor data indicative of the user's breathing (e.g., inhalation and / or exhalation) and / or ambient pressure. In such embodiments, the pressure sensor 132 can be coupled to or integrated with the oral orthodontic treatment device 122 and / or the oral orthodontic treatment device reservoir 126. The pressure sensor 132 can be, for example, a capacitive sensor, an electromagnetic sensor, a piezoelectric sensor, a strain gauge sensor, an optical sensor, a potentiometric sensor, or any combination thereof. In one example, the pressure sensor 132 can be used to determine the user's blood pressure.

[0044] The flow sensor 134 outputs flow data (e.g., a flow signal) that can be stored in the memory device 114 and / or analyzed by the processor 112 of the control system 110. In some embodiments, the flow sensor 134 is used to determine the airflow rate at or adjacent to the oral orthodontic treatment device 122. In such embodiments, the flow sensor 134 can be coupled to or integrated with the oral orthodontic treatment device 122. The flow sensor 134 can be, for example, a mass flow sensor such as a rotary flow meter (e.g., a Hall effect flow meter), a turbine flow meter, an orifice flow meter, an ultrasonic flow meter, a hot wire sensor, a vortex sensor, a membrane sensor, or any combination thereof. An example of a flow sensor (e.g., the flow sensor 134) is described in WO 2012 / 012835, which is incorporated herein by reference.

[0045] The temperature sensor 136 outputs temperature data that may be stored in the memory device 114 and / or analyzed by the processor 112 of the control system 110. In some embodiments, the temperature sensor 136 generates temperature data indicative of the core body temperature of the user 210 (FIG. 2), the skin temperature of the user 210, the temperature in the user's mouth via the oral orthodontic treatment appliance 122, the temperature within the oral orthodontic treatment appliance reservoir 126, the ambient temperature, or any combination thereof. The temperature sensor 136 may be, for example, a thermocouple sensor, a thermistor sensor, a silicon bandgap temperature sensor or semiconductor-based sensor, a resistance temperature detector, or any combination thereof.

[0046] The microphone 140 outputs audio data that may be stored in the memory device 114 and / or analyzed by the processor 112 of the control system 110. The audio data generated by the microphone 140 may be played back as one or more sounds (e.g., sounds from the user 210) during a sleep session. As described in further detail herein, the audio data from the microphone 140 may also be used to identify events experienced by the user during a sleep session (e.g., using the control system 110). The microphone 140 may be coupled to or integrated with the oral orthodontic treatment appliance 122, the oral orthodontic treatment appliance reservoir 126, the user device 170, or an external device 171.

[0047] The speaker 142 can output sound waves that can be heard by a user of the system 100 (e.g., user 210 of FIG. 2 ). The speaker 142 can be used, for example, as an alarm clock or to play alerts or messages to the user 210 (e.g., in response to an event). In some embodiments, the speaker 142 can be used to communicate audio data generated by the microphone 140 to the user. The speaker 142 can be coupled to or integrated with the oral orthodontic treatment appliance 122, the oral orthodontic treatment appliance reservoir 126, the user device 170, or the external device 171.

[0048] The microphone 140 and the speaker 142 can be used as independent devices. In some embodiments, the microphone 140 and the speaker 142 can be combined into an acoustic sensor 141 (e.g., a sonar sensor), for example, as described in WO 2018 / 050913 and WO 2020 / 104465, which are incorporated herein by reference in their entireties. In such embodiments, the speaker 142 generates or emits sound waves at predetermined intervals, and the microphone 140 detects reflections of the sound waves emitted from the speaker 142. The sound waves generated or emitted by the speaker 142 have a frequency that is inaudible to the human ear (e.g., below 20 Hz or above about 18 kHz) so as not to disturb the sleep of the user 210 or bedmate 220 ( FIG. 2 ). Based at least in part on data from microphone 140 and / or speaker 142, control system 110 can determine the position of user 210 (FIG. 2) and / or one or more of the sleep-related parameters described herein (e.g., identified body position and / or change in body position), and / or respiration-related parameters described herein, such as breathing pattern, respiration signal (e.g., respiration morphology can be determined from the respiration signal), respiration rate, inspiration amplitude, expiration amplitude, inspiration-to-expiration ratio, number of events per hour, event pattern, sleep state, sleep stage, or any combination thereof. In this regard, sonar sensors can be understood to relate to active acoustic sensing, such as by generating / transmitting ultrasonic or low-frequency ultrasonic sensing signals through the air (e.g., within a frequency range of approximately 17-23 kHz, 18-22 kHz, or 17-18 kHz). Such systems can be considered with respect to WO 2018 / 050913 and WO 2020 / 104465, as discussed above.

[0049] In some embodiments, sensor 130 includes (i) a first microphone that is the same as or similar to microphone 140 and integrated into acoustic sensor 141, and (ii) a second microphone that is the same as or similar to microphone 140 but is independent and separate from the first microphone that is integrated into acoustic sensor 141.

[0050] The RF transmitter 148 generates and / or emits radio waves having a predetermined frequency and / or a predetermined amplitude (e.g., within a high frequency band, within a low frequency band, a long wave signal, a short wave signal, etc.). The RF receiver 146 detects reflections of the radio waves emitted from the RF transmitter 148, and this data can be analyzed by the control system 110 to determine the location of the user 210 ( FIG. 2 ) and / or one or more of the sleep-related parameters described herein. The RF receiver (either the RF receiver 146 and RF transmitter 148 or another RF pair) can also be used for wireless communication between the control system 110, the oral orthodontic treatment appliance 122, the oral orthodontic treatment appliance reservoir 126, one or more sensors 130, the user device 170, the unit device 171, or any combination thereof. Although the RF receiver 146 and the RF transmitter 148 are shown in FIG. 1 as separate and distinct elements, in some embodiments, the RF receiver 146 and the RF transmitter 148 are combined as part of the RF sensor 147. In some such embodiments, the RF sensor 147 includes control circuitry. The particular form of RF communication may be WiFi, Bluetooth, or the like.

[0051] In some embodiments, RF sensor 147 is part of a mesh system. One example of a mesh system is a WiFi mesh system, which may include mesh nodes, mesh routers, and mesh gateways, each of which may be mobile / movable or fixed. In such embodiments, the WiFi mesh system includes a WiFi router and / or a WiFi controller, and one or more satellites (e.g., access points), each of which includes an RF sensor identical or similar to RF sensor 147. The WiFi router and satellites continuously communicate with each other using WiFi signals. The WiFi mesh system can be used to generate motion data based on changes in the WiFi signal between the router and the satellite (e.g., differences in received signal strength) due to the movement of an object or person partially obstructing the signal. This motion data can indicate movement, breathing, heart rate, gait, falls, behavior, etc., or any combination thereof.

[0052] Camera 150 outputs image data that can be played back as one or more images (e.g., still images, video images, thermal images, or a combination thereof) that can be stored in storage device 114. The image data from camera 150 can be used by control system 110 to determine one or more sleep-related parameters described herein. For example, image data from camera 150 can be used to identify a user's location, determine the time when user 210 enters bed 230 ( FIG. 2 ), and determine the time when user 210 leaves bed 230. In some implementations, image data from camera 150 can be used by control system 110 to detect or confirm the occurrence of an event.

[0053] The infrared (IR) sensor 152 outputs infrared image data that can be played back as one or more infrared images (e.g., still images, moving images, or both) that can be stored in the storage device 114. The infrared data from the IR sensor 152 can be used to determine one or more sleep-related parameters during a sleep session, including the temperature of the user 210 and / or the movement of the user 210. The IR sensor 152 can also be used in combination with the camera 150 in measuring the presence, location, and / or movement of the user 210. In some implementations, the infrared data from the IR sensor 152 can be used to detect or confirm the occurrence of an event. The IR sensor 152 can detect infrared light having a wavelength between about 700 nm and about 1 mm, for example, while the camera 150 can detect visible light having a wavelength between about 380 nm and about 740 nm.

[0054] The PPG sensor 154 outputs physiological data associated with the user 210 (FIG. 2) that can be used to determine one or more sleep-related parameters, such as, for example, heart rate, heart rate variability, cardiac cycle, respiratory rate, inspiration amplitude, expiration amplitude, inspiration-to-expiration ratio, estimated blood pressure parameters, or any combination thereof. The PPG sensor 154 is worn by the user 210, can be embedded in clothing and / or fabric worn by the user 210, and / or embedded in and / or coupled to the oral orthodontic treatment appliance 122.

[0055] The ECG sensor 156 outputs physiological data associated with the electrical activity of the heart of the user 210. In some embodiments, the ECG sensor 156 includes one or more electrodes placed on or around a portion of the user 210 during a sleep session. The physiological data from the ECG sensor 156 can be used to determine, for example, one or more sleep-related parameters described herein.

[0056] The EEG sensor 158 outputs physiological data associated with the electrical activity of the brain of the user 210. In some embodiments, the EEG sensor 158 includes one or more electrodes placed on or around the scalp of the user 210 during a sleep session. The physiological data from the EEG sensor 158 can be used, for example, to determine the sleep state of the user 210 at any given time during the sleep session.

[0057] The capacitance sensor 160, the force sensor 162, and the strain gauge sensor 164 output data that may be stored in the memory device 114 and used by the control system 110 to determine one or more sleep-related parameters described herein. The EMG sensor 166 outputs physiological data associated with electrical activity produced by one or more muscles. The oxygen sensor 168 outputs oxygen data indicative of the oxygen concentration of a gas (e.g., gases in the user's mouth detected by a sensor in the oral orthodontic treatment appliance 122 or ambient gases detected by a sensor in the oral orthodontic treatment appliance reservoir 126). The oxygen sensor 168 may be, for example, an ultrasonic oxygen sensor, an electrical oxygen sensor, a chemical oxygen sensor, an optical oxygen sensor, or any combination thereof. In some embodiments, the one or more sensors 130 further include a galvanic skin response (GSR) sensor, a blood flow sensor, a respiration sensor, a pulse sensor, a sphygmomanometer sensor, an oximetry sensor, or any combination thereof.

[0058] The analyte sensor 174 can be used to detect the presence of analytes in the exhaled breath of the user 210. Data output by the analyte sensor 174 can be stored in the memory device 114 and used by the control system 110 to determine the identity and concentration of any analytes in the user's 210 breath. In some embodiments, the analyte sensor 174 is positioned in the user's 210 mouth (e.g., coupled to and / or integrated with the oral orthodontic treatment appliance 122) to detect analytes in the breath exhaled from the user's 210 mouth. In other embodiments, the analyte sensor 174 can be located near the user's 210 mouth, for example, on an external device 171 positioned near the user's mouth. In some embodiments, the analyte sensor 174 is a volatile organic compound (VOC) sensor that can be used to detect carbon-based chemicals or compounds. In some embodiments, the analyte sensor 174 can also be used to detect whether the user 210 is breathing through their nose or mouth. For example, if the presence of an analyte is detected by data output by an analyte sensor 174 placed in or near the mouth of the user 210, the control system 110 can use this data as an indicator that the user 210 is mouth breathing.

[0059] The moisture sensor 176 outputs data that can be stored in the memory device 114 and used by the control system 110. The moisture sensor 176 can be used to detect moisture in different areas in or around the user (e.g., in the oral orthodontic treatment appliance 122 or in the oral orthodontic treatment appliance reservoir 126). Thus, in some embodiments, the moisture sensor 176 is coupled to or integrated with the oral orthodontic treatment appliance 122 or the oral orthodontic treatment appliance reservoir 126. In other embodiments, the moisture sensor 176 is placed near any area where moisture levels need to be monitored. The moisture sensor 176 can also be used to monitor the ambient environment surrounding the user 210, for example, the moisture of the air in a bedroom.

[0060] A light detection and ranging (LiDAR) sensor 178 can be used for depth sensing. Such optical sensors (e.g., laser sensors) can be used to detect objects and create three-dimensional (3D) maps of surrounding environments, such as living spaces. LiDAR typically uses a pulsed laser to measure time of flight. LiDAR is also known as 3D laser scanning. In one use case of such sensors, a fixed or mobile device (such as a smartphone) equipped with a LiDAR sensor 178 can measure and map an area more than five meters away from the sensor. LiDAR data can be fused with point cloud data estimated, for example, by an electromagnetic RADAR sensor. The LiDAR sensor 178 can also automatically create geofences for RADAR systems by using artificial intelligence (AI) to detect and classify spatial features that may pose problems for RADAR systems, such as glass windows (which may be highly reflective to RADAR). For example, LiDAR can also be used to estimate a person's height and changes in height that occur when a person sits, falls, etc. LiDAR can be used to create a 3D mesh representation of the environment. In a further application, solid surfaces through which radio waves pass (e.g., radio-transparent materials) allow LiDAR to reflect off such surfaces, thereby enabling classification of different types of obstacles.

[0061] 1 , any combination of one or more sensors 130 may be integrated into and / or coupled to any one or more of the components of system 100, including orthodontic treatment appliance 122, orthodontic treatment appliance reservoir 126, control system 110, user device 170, external device 171, or any combination thereof. For example, microphone 140 and speaker 142 are integrated into and / or coupled to user device 170, and temperature sensor 136 and / or motion sensor 138 are integrated into and / or coupled to orthodontic treatment appliance 122. In some embodiments, at least one of the one or more sensors 130 is not coupled to orthodontic treatment appliance 122, control system 110, user device 170, or external device 171, but is positioned generally adjacent to user 210 during a sleep session (e.g., positioned on or in contact with a portion of user 210, worn by user 210, coupled to or positioned on a nightstand, coupled to a mattress, coupled to a ceiling, etc.). In some implementations, one, some, or all of the one or more sensors 130 may be located external to the user. In some implementations, one, some, or all of the one or more sensors 130 may be physically separate and not physically coupled to the oral orthodontic treatment appliance 122.

[0062] 2, one or more of the sensors 130 can be positioned at a first location 250A on a nightstand 240 adjacent to the bed 230 and user 210. Alternatively, one or more of the sensors 130 can be positioned at a second location on and / or within the mattress 232 (e.g., the sensors are coupled to and / or integrated into the mattress 232). Also, one or more of the sensors 130 can be positioned at a third location on the bed 230 (e.g., coupled to and / or integrated into the headboard, footboard, or other location on the frame of the bed 230). One or more of the sensors 130 can be positioned at a fourth location, typically on a wall or ceiling adjacent to the bed 230 and / or user 210. One or more of the sensors 130 may be positioned at a fifth location such that one or more of the sensors 130 are coupled to and / or disposed on and / or within the housing of the orthodontic treatment device 122 or orthodontic treatment device reservoir 126 of the orthodontic treatment system 120. One or more of the sensors 130 may also be positioned at a sixth location such that one or more of the sensors 130 are coupled to and / or disposed on the user 210 (e.g., the sensors are embedded in or coupled to fabric, clothing worn by the user 210 during a sleep session). More generally, one or more of the sensors 130 may be positioned at any suitable location relative to the user 210 such that the sensors 140 can generate physiological data related to the user 210 and / or bed companion 220 during one or more sleep sessions.

[0063] Returning to FIG. 1 , user device 170 includes a processor (e.g., processor 112), a memory (e.g., memory 174), and a display device 172. User device 170 may be, for example, a mobile device such as a smartphone, a tablet, a laptop computer, etc. Display device 172 is typically used to display images, including still images, moving images, or both. In some embodiments, display device 172 functions as a human-machine interface (HMI) that includes a graphical user interface (GUI) configured to display images and an input interface. Display device 172 may be an LED display, an OLED display, an LCD display, etc. The input interface may be, for example, a touchscreen or touch-sensitive board, a mouse, a keyboard, or any sensor system configured to sense inputs made by a human user interacting with user device 170.

[0064] In some implementations, the external device 171 may be a sleep-related device for receiving sensor data related to a sleep session and / or controlling operations that affect a sleep session. By way of example, the external device 171 may be a smart pillow, a smart mattress, smart bedding (e.g., a sheet or blanket), etc. In some implementations, such an external device 171 may include one or more sensors 130 for receiving sensor data related to a sleep session. In some implementations, such an external device 171 may be an actuatable or controllable device that can be controlled to affect a sleep session. For example, such a device may include one or more inflatable airbags that can be controlled to inflate a user into or away from a particular sleeping position. For example, an inflatable airbag in a pillow or mattress may be used to prompt a user from a supine sleeping position toward a side sleeping position. Other types of controllable external devices 171 (e.g., via the control system 110) may be used to affect a user's sleep session in connection with automatic adjustments of the oral orthodontic treatment appliance 122.

[0065] 1 as separate and distinct components of system 100, in some embodiments, control system 110 and / or storage 114 are integrated into user device 170, external device 171, orthodontic treatment appliance reservoir 126, or any combination thereof. Alternatively, in some embodiments, control system 110 or portions thereof (e.g., processor 112) can be located in the cloud (e.g., integrated into a server, integrated into an Internet of Things (IoT) device, connected to the cloud, subject to edge cloud processing), located on one or more servers (e.g., remote servers, local servers, etc., or any combination thereof).

[0066] Although system 100 is shown as including all of the above components, a system for automatically adjusting the oral orthodontic treatment appliance 122 may include more or fewer components. For example, a first alternative system includes control system 110, the oral orthodontic treatment appliance 122, and at least one of the one or more sensors 130. As another example, a second alternative system includes the oral orthodontic treatment appliance 122, the oral orthodontic treatment appliance reservoir 126, the one or more sensors 130, and the user device 170. As yet another example, a third alternative system includes the oral orthodontic treatment appliance 122, at least one of the one or more sensors 130, and the user device 170. Thus, any portion of the components shown and described herein can be used and / or combined with one or more other components to form various systems for determining sleep-related parameters associated with a sleep session.

[0067] As used herein, a sleep session can be defined in a variety of ways, for example, based on an initial start time and an end time. Referring to FIG. 3, an example timeline 300 of a sleep session is shown. The timeline 300 includes a time from bedtime (t ベッド ), sleep onset time (t GTS ), initial sleep time (t 睡眠), the first micro-arousal MA1 and the second micro-arousal MA2, the awakening time (t 覚醒 ) and wake-up time (t 起床 ) is included.

[0068] As used herein, a sleep session can be defined in various ways. For example, a sleep session can be defined by an initial start time and an end time. In some embodiments, a sleep session is the duration during which a user is asleep, i.e., a sleep session has a start time and an end time, and the user is awake during the sleep session until the end time. That is, any time period during which the user is awake is not included in the sleep session. According to this first definition of a sleep session, if a user wakes up and falls asleep multiple times in the same night, each sleep interval separated by a wake interval is considered a sleep session.

[0069] Alternatively, in some embodiments, a sleep session has a start time and an end time, and if the continuous duration during which the user is awake in a sleep session is less than a wakefulness duration threshold, the user can wake up but the sleep session does not end. The wakefulness duration threshold can be defined as a percentage of the sleep session. The wakefulness duration threshold can be, for example, about 20% of the sleep session, about 15% of the sleep session duration, about 10% of the sleep session duration, about 5% of the sleep session duration, about 2% of the sleep session duration, etc., or any other threshold percentage. In some embodiments, the wakefulness duration threshold is defined as a fixed amount of time, such as about 1 hour, about 30 minutes, about 15 minutes, about 10 minutes, about 5 minutes, about 2 minutes, or any other amount of time.

[0070] In some embodiments, a sleep session is defined as the total time between the time the user first goes to bed in the evening and the time the user last wakes up the following morning. In other words, a sleep session can be defined as the period starting when the user first wants to fall asleep (e.g., the user has no intention of first watching television or using their smartphone before attempting to fall asleep), which may be referred to as a first date (e.g., Monday, January 6, 2020) at a first time (e.g., 10:00 PM) of the current night), and ending when the user first gets out of bed because they do not want to go back to sleep the following morning, which may be referred to as a second date (e.g., Tuesday, January 7, 2020) at a second time (e.g., 7:00 AM) the following morning).

[0071] Referring to Figure 3, an exemplary timeline 300 of a sleep session is shown. The timeline 300 begins with bedtime (t ベッド ), sleep onset time (t GTS ), initial sleep time (t 睡眠 ), the first micro-awakening MA1, the second micro-awakening MA2, the awakening A, the awakening time (t 覚醒 ) and wake-up time (t 起床 ) is included.

[0072] bedtime t ベッド is associated with the time of initial bedtime (e.g., bed 230 in FIG. 2) before the user falls asleep (e.g., when the user lies or sits in bed). ベッド can be identified based on a bed threshold duration to distinguish between the time when a user goes to bed to sleep and the time when a user goes to bed for other reasons (e.g., to watch TV). For example, the bed threshold duration can be at least about 10 minutes, at least about 20 minutes, at least about 30 minutes, at least about 45 minutes, at least about 1 hour, at least about 2 hours, etc. As used herein, the bedtime t refers to the time when a user goes to bed with reference to a bed. ベッド More generally, the bedtime t ベッド can refer to the time when a user first goes to sleep in any position (e.g., couch, chair, sleeping bag, etc.).

[0073] The time of sleep onset (GTS) is the time when the user goes to bed (t ベッド ) and then associated with the time of the first sleep attempt. For example, after going to bed, the user may engage in one or more activities to relax before attempting to fall asleep (e.g., reading a book, watching television, listening to music, using the user device 170, etc.). The initial sleep time (t 睡眠 ) is the time when the user first falls asleep. For example, the initial sleep time (t 睡眠 ) may be the time when the user first enters the first non-REM sleep stage.

[0074] Awakening time t 覚醒 is the time associated with the time the user awakens without returning to sleep (e.g., as opposed to the user waking up in the middle of the night and returning to sleep). After initial sleep onset, the user may experience one of multiple unconscious micro-awakenings (e.g., micro-awakenings MA1 and MA2) having short durations (e.g., 5 seconds, 10 seconds, 30 seconds, 1 minute, etc.). Awakening time t 覚醒 Conversely, the user returns to sleep after each of the micro-arousals MA1 and MA2. Similarly, the user may have one or more conscious arousals (e.g., Awakening A) after initially falling asleep (e.g., getting up to go to the bathroom, caring for a child or pet, sleepwalking, etc.). However, the user returns to sleep after Awakening A. Therefore, the awakening time t 覚醒 can be defined, for example, based on an awakening threshold duration (e.g., the user has been awakened for at least 15 minutes, at least 20 minutes, at least 30 minutes, at least 1 hour, etc.).

[0075] Similarly, the time t 離床 is associated with the time when the user gets out of bed and ends their sleep session (e.g., as opposed to getting up during the night to go to the bathroom, care for a child or pet, sleepwalking, etc.). In other words, the bed exit time t 離床 is the time when the user finally gets out of bed without returning to bed until the next sleep period (e.g., the next night). 離床can be defined, for example, based on a bed exit threshold duration (e.g., the user has already been out of bed for at least 15 minutes, at least 20 minutes, at least 30 minutes, at least 1 hour, etc.). ベッド The time may also be defined based on a bed ambulation threshold duration (eg, the user has been out of bed for at least 4 hours, at least 6 hours, at least 8 hours, at least 12 hours, etc.).

[0076] As mentioned above, the initial t ベッド and final t 離床 During the night between t and t, the user may be awakened and get out of bed one or more times. In some embodiments, the last awakening time t 覚醒 and / or last time of getting out of bed t 離床 The threshold duration may be identified or determined based on a predetermined threshold duration after an event (e.g., falling asleep or getting out of bed). Such threshold duration may be user-customized. For a typical user who goes to bed at night and then wakes and gets out of bed in the morning, the threshold duration may be any period (user wake (t)) between about 12 and about 18 hours. 覚醒 ) or getting out of bed (t 離床 ) and user bedtime (t ベッド ), falling asleep (t GTS ) or sleep (t 睡眠 ) and (between ) can be used. For users who spend longer periods in bed, a shorter threshold period (e.g., about 8 hours to about 14 hours) can be used. The threshold period may be initially selected and / or later adjusted based on the system monitoring the user's sleep movements.

[0077] Total time in bed (TIB) is the time from bedtime t ベッド and time t 離床t ... 睡眠 and awakening time t 覚醒 The figure spans between MA1 and MA2, but does not include the duration of the first micro-awakening MA1, the second micro-awakening MA2, and Awakening A. As shown, in this example, the total time asleep (TST) is less than the total time in bed (TIB).

[0078] In some embodiments, total sleep time (TST) can be defined as continuous total sleep time (PTST). In such implementations, continuous total sleep time does not include the period of the predetermined initial portion or the first non-REM stage (e.g., light sleep stage). For example, the predetermined initial portion can be about 30 seconds to about 20 minutes, about 1 minute to about 10 minutes, about 3 minutes to about 5 minutes, etc. Continuous total sleep time is a measure of continuous sleep and smooths out the sleep-wake sleep diagram. For example, when a user first falls asleep, the user may be in the first non-REM stage for a very short time (e.g., about 30 seconds), then return to the wake stage for a short period (e.g., 1 minute), and then return to the first non-REM stage. In this example, continuous total sleep time does not include the first instance of the first non-REM stage (e.g., about 30 seconds).

[0079] In some embodiments, a sleep session is based on time to bed (t ベッド ) and the time to get out of bed (t 離床 ), i.e., total time in bed (TIB). In some embodiments, a sleep session is defined as a time period ending at initial sleep time (t 睡眠 ) and wake-up time (t 覚醒 ) In some embodiments, a sleep session is defined as total sleep time (TST). In some embodiments, a sleep session is defined as ending at sleep onset time (t GTS ) and wake-up time (t覚醒 In some embodiments, a sleep session is defined as ending at sleep onset time (t GTS ) and the time to get out of bed (t 離床 In some embodiments, a sleep session is defined as ending at bedtime (t ベッド ) and wake-up time (t 覚醒 In some embodiments, a sleep session is defined as ending at an initial sleep time (t 睡眠 ) and the time to get out of bed (t 離床 ) is defined as ending in

[0080] 4, an exemplary hypnogram 400 corresponding to timeline 300 (FIG. 3) is shown, according to some embodiments. As shown, hypnogram 400 includes a sleep-wake signal 401, a wake stage axis 410, a REM stage axis 420, a light sleep stage axis 430, and a deep sleep stage axis 440. The intersection between sleep-wake signal 401 and one of axes 410-440 indicates the sleep stage at any given time during a sleep session.

[0081] The sleep-wake signal 401 can be generated based on physiological data associated with the user (e.g., generated by one or more of the sensors 130 described herein). The sleep-wake signal can indicate one or more sleep states, including wakefulness, relaxed wakefulness, micro-arousal, REM stage, first non-REM stage, second non-REM stage, third non-REM stage, or any combination thereof. In some embodiments, one or more of the first non-REM stage, second non-REM stage, and third non-REM stage can be grouped and categorized as a light sleep stage or a deep sleep stage. For example, a light sleep stage may include the first non-REM stage, while a deep sleep stage may include the second non-REM stage and the third non-REM stage. While the hypnogram 400 shown in FIG. 4 includes a light sleep stage axis 430 and a deep sleep stage axis 440, in some embodiments, the hypnogram 400 can include an axis for each of the first non-REM stage, the second non-REM stage, and the third non-REM stage. In other embodiments, the sleep-wake signal may indicate a respiratory signal, a respiratory rate, an inhalation amplitude, an exhalation amplitude, an inhalation-to-exhalation ratio, a number of events per hour, a pattern of events, or any combination thereof. Information describing the sleep-wake signal may be stored in memory device 114.

[0082] The hypnogram 400 can be used to determine one or more sleep-related parameters, such as sleep onset latency (SOL), wake after sleep onset (WASO), sleep efficiency (SE), sleep fragmentation index, sleep blocks, or any combination thereof.

[0083] Sleep onset latency (SOL) is the time of sleep onset (t GTS ) and initial sleep time (t 睡眠) in order to fall asleep. In other words, sleep onset latency indicates the time it takes for a user to actually fall asleep after an initial sleep attempt. In some embodiments, sleep onset latency is defined as sustained sleep onset latency (PSOL). The difference between sustained sleep onset latency and sleep onset latency is that sustained sleep onset latency is defined as the duration between the time of sleep onset and a predetermined amount of continuous sleep. In some embodiments, the predetermined amount of continuous sleep may include, for example, at least 10 minutes of sleep in the second NREM stage, the third NREM stage, and / or the REM stage, and no more than 2 minutes of awake REM stage, the first NREM stage, and / or movement therebetween. In other words, sustained sleep onset latency requires, for example, up to 8 minutes of continuous sleep in the second NREM stage, the third NREM stage, and / or the REM stage. In other embodiments, the predetermined amount of continuous sleep may include at least 10 minutes of sleep in the first NREM stage, the second NREM stage, the third NREM stage, and / or the REM stage after the initial sleep time. In such embodiments, the predetermined amount of continuous sleep may not include any micro-arousals (eg, a 10 second micro-arousal that does not resume for a 10 minute period).

[0084] The wake-up after sleep onset (WASO) is associated with the total duration of the user's wake between the initial sleep time and the wake time. Thus, the wake-up after sleep onset includes transient and micro-awakenings during a sleep session, whether conscious or unconscious (e.g., micro-awakenings MA1 and MA2 shown in FIG. 4). In some embodiments, the wake-up after sleep onset (WASO) is defined as the persistent wake-up after sleep onset (PWASO), which includes only total durations with awakenings of a predetermined length (e.g., greater than 10 seconds, greater than 30 seconds, greater than 60 seconds, greater than about 5 minutes, greater than about 10 minutes, etc.).

[0085] Sleep efficiency (SE) is determined as the ratio of total time in bed (TIB) to total sleep time (TST). For example, if the total time in bed is 8 hours and the total sleep time is 7.5 hours, the sleep efficiency for this sleep session is 93.75%. Sleep efficiency indicates the user's sleep hygiene. For example, if the user goes to bed before sleep and spends time doing other activities (e.g., watching TV), sleep efficiency will decrease (e.g., the user will be penalized). In some embodiments, sleep efficiency (SE) can be calculated based on total time in bed (TIB) and the total length of the user's sleep attempts. In such embodiments, the total length of the user's sleep attempts is defined as the duration between the time of sleep onset (GTS) and the time of getting out of bed as described herein. For example, if the total sleep time is 8 hours (e.g., 11:00 PM - 7:00 AM), the time of sleep onset is 10:45 PM, and the time of getting out of bed is 7:15 AM, in such embodiments, the sleep efficiency parameter is calculated to be approximately 94%.

[0086] The fragmentation index is determined based at least in part on the number of arousals during a sleep session. For example, if a user has two micro-arousals (e.g., micro-arousals MA1 and MA2 shown in FIG. 4), the fragmentation index may be expressed as 2. In some embodiments, the fragmentation index scales between a predetermined range of integers (e.g., 0 to 10).

[0087] Sleep blocks are associated with the transitions between any sleep stage (e.g., first non-REM stage, second non-REM stage, third non-REM stage, and / or REM) and wake stages. Sleep blocks can be calculated, for example, at a 30-second resolution.

[0088] In some embodiments, the systems and methods described herein generate or analyze a hypnogram including a sleep-wake signal to determine time to bed (t ベッド ), sleep onset time (t GTS ), initial sleep time (t 睡眠 ), one or more first micro-arousals (e.g., MA1 and MA2), and the awakening time (t 覚醒 ), bed leaving time (t 離床), or any combination thereof, based at least in part on the sleep-wake signal of a hypnogram.

[0089] In other embodiments, one or more sensors 130 may measure time to bed (t ベッド ), sleep onset time (t GTS ), initial sleep time (t 睡眠 ), one or more first micro-arousals (e.g., MA1 and MA2), and the awakening time (t 覚醒 ), bed leaving time (t 離床 ), or a combination thereof, and further define a sleep session. For example, a bedtime t based on data generated by the motion sensor 138, the microphone 140, the camera 150, or a combination thereof, can be used to determine or recognize a sleep session. ベッド For example, the time of sleep onset may be determined based on data from motion sensor 138 (e.g., data indicating that the user is not moving), data from camera 150 (e.g., data indicating that the user is not moving and / or data indicating that the user has turned off a lamp), data from microphone 140 (e.g., data indicating that the TV is off), data from user device 170 (e.g., data indicating that the user is not using user device 170), data from a sensor in orthodontic treatment appliance 122 (e.g., data indicating that orthodontic treatment appliance 122 has been inserted), data from a sensor in orthodontic treatment appliance reservoir 126 (e.g., data indicating that orthodontic treatment appliance 122 has been removed from orthodontic treatment appliance reservoir 126), data from a sensor in external device 171, or any combination thereof.

[0090] 5 is a flowchart illustrating a process 500 for automatically adjusting an orthodontic treatment appliance, according to some implementations of the present disclosure. Process 500 can be performed by system 100 of FIG. 1, as can be performed by control system 100 and other components of system 100. Process 500 can be used to provide adjustments to an orthodontic treatment appliance, an orthodontic treatment appliance reservoir, and optionally an external device (such as orthodontic treatment appliance 122, orthodontic treatment appliance reservoir 126, and external device 171 of FIG. 1), respectively. Process 500 can be used to automatically adjust any orthodontic treatment appliance, such as a mandibular repositioning appliance.

[0091] At block 502, sensor data may be received. The sensor data may be received from one or more sensors (e.g., one or more sensors 130 of FIG. 1). The sensor data may be received from one or more sensors external to the user, although this is not necessarily the case. The sensor data may include physiological data, audio data, video data, mobile data, environmental data, or other data related to a user of the oral orthodontic appliance (e.g., a user who wears the oral orthodontic appliance in their mouth before, during, or after sleeping, and / or a user who does not wear the oral orthodontic appliance in their mouth during these times).

[0092] In block 502, receiving sensor data can occur continuously over time (e.g., as sensor data is collected by one or more sensors) or in bulk (e.g., as a data set representing sensor data from a period such as an entire sleep session). In block 502, receiving sensor data can occur in real time (e.g., receiving sensor data during a sleep session as one or more sensors collect data related to the sleep session) or asynchronously (e.g., receiving sensor data related to a past period, such as data related to a previous night's sleep session or sensor data that has been delayed in duration).

[0093] In some implementations, optional block 518 may include receiving historical sensor data. The historical sensor data may include any sensor data collected prior to collecting sensor data from block 502. In some implementations, the historical sensor data in block 518 may include sensor data received in a previous occurrence of block 502, such as sensor data from earlier in a sleep session or sensor data from a previous sleep session. In some implementations, the historical sensor data received in block 518 may be compared to the sensor data received in block 502 to determine the effectiveness of previous orthodontic treatment appliances (e.g., the effectiveness of previous adjustments to the orthodontic treatment appliance).

[0094] At block 504, adjustments associated with the oral orthodontic treatment appliance can be determined based on the sensor data. The system can use the sensor data received at block 502 to determine one or more adjustments associated with the oral orthodontic treatment appliance (e.g., one or more adjustments of one or more adjustable aspects of the oral orthodontic treatment appliance).

[0095] The adjustments determined in block 504 may be intended to treat the user's sleep sickness, improve the user's quality of sleep (e.g., increasing TST, decreasing SOL, improving the time spent in different stages of wakefulness (e.g., reducing fatigue, improving alertness, etc.), improve the comfort and / or effectiveness of the oral orthodontic treatment appliance, or achieve other objectives. In some implementations, the desired objective of the adjustments determined in block 504 may be determined using sensor data 502, an internal clock, and / or other data. For example, in some implementations, the objective of the determined adjustments may be to improve comfort before sleep onset, and the subsequent determined adjustments may be to improve the effectiveness of the oral orthodontic treatment appliance. Such an example might be improving the user's quality of sleep by improving comfort before sleep onset thereby decreasing SOL, and improving the treatment effectiveness of the oral orthodontic treatment appliance after sleep onset thereby increasing TST.

[0096] In some implementations, determining an adjustment in block 504 may include determining a sleep state and / or sleep stage in block 506. The sleep state and / or sleep stage can be determined based on the sensor data received from block 502. Depending on the sleep state and / or sleep stage, the system can make different adjustments. As an example, the process can place the oral orthodontic treatment device in a comfort-first state if it determines that the user is awake or in light sleep (e.g., N1 sleep), and the process can place the oral orthodontic treatment device in a treatment-first state if it determines that the user is in deep sleep, and optionally specifically in REM sleep. In some implementations, the adjustment to place the oral orthodontic treatment device in a desired state can be adjusted to prior knowledge or detection of the user's non-REM state relative to REM likelihood. In some implementations, adjustments can be made to the oral orthodontic treatment device throughout a sleep period if the user is predicted to relax as they move from slow-wave sleep (SWS) or REM to lighter stages of sleep.

[0097] In one example, the user may be in a pre-sleep state (e.g., t 睡眠 If it is determined that the sleep time is within the predetermined time (previous time), the system may use a preset pre-sleep adjustment. The preset pre-sleep adjustment may be a preset adjustment or a preset algorithm for determining the adjustment. The pre-sleep adjustment may be designed to improve the user's comfort when the user wishes to fall asleep. Preferably, the pre-sleep adjustment may reduce SOL. The pre-sleep adjustment may place the oral orthodontic treatment appliance in a comfort-first state.

[0098] As another example, if a user is in a post-sleep state (e.g., t 睡眠 If it is determined that the user is in a sleep state (later), the system may use a preset post-sleep onset adjustment. The preset post-sleep onset adjustment may be a preset adjustment or a preset algorithm for determining an adjustment. The post-sleep onset adjustment may be designed to improve the treatment effect of the oral orthodontic treatment device when the user is sleeping. Preferably, the post-sleep onset adjustment may avoid, reduce, or minimize the occurrence of an event, such as an apnea event. The post-sleep onset adjustment may place the oral orthodontic treatment device in a treatment-priority state.

[0099] In some implementations, the system can use the determined sleep state and / or sleep stage to deny, allow, pause, or restore any adjustments that are desirable to make. For example, if the system attempts to adjust an oral orthodontic treatment appliance within a period (e.g., tens or hundreds of seconds) and determines that the user is in a micro-arousal state, the system can pause any adjustments to the oral orthodontic treatment appliance and resume the adjustments after the micro-arousal state ends. Controlling such adjustments can reduce the risk of unexpectedly waking the user or otherwise negatively impacting the user's sleep session.

[0100] In some implementations, determining the adjustment in block 504 may include applying subjective feedback in block 508. The subjective feedback may include any subjective feedback received by the user or another individual (e.g., a medical professional or caregiver). The subjective feedback may be spontaneous or requested. In some implementations, with or without treatment with an oral orthodontic treatment appliance, the subjective feedback is related to historical sleep sessions. In one example, the user may provide feedback in response to a prompt, such as a positive response to a question regarding whether the user felt sufficiently rested after a sleep session. In this example, the system may determine the adjustment based on this positive response.

[0101] In some implementations, the subjective feedback is related to the oral orthodontic treatment appliance, and may or may not be related to the sleep session. In one example, the user may provide feedback in response to a prompt, such as a negative response to a question regarding whether the oral orthodontic treatment appliance is comfortable in the user's mouth. In this example, the system may determine an adjustment based on this negative response. In another example, the user may provide feedback voluntarily by interacting with a control on a user device (e.g., a smartphone) or on the oral orthodontic treatment appliance reservoir. The system may determine an adjustment based on the selected control. For example, if the user selects a control related to "too tight" or "too loose," the system may determine an adjustment to make the oral orthodontic treatment appliance feel looser or tighter, respectively.

[0102] In some implementations, similar controls may generally be used to directly control adjustments to the oral orthodontic appliance in block 504. For example, a control associated with a "lengthened post" may be used by the system to determine an adjustment in block 504 to lengthen the associated post in the oral orthodontic appliance.

[0103] In some implementations, determining an adjustment in block 504 may include identifying and / or predicting an event in block 510. Identifying an event in block 510 may include identifying that an event has occurred using the sensor data received from block 502 and, optionally, classifying the event or determining other information related to the event. Once the occurrence of an event is identified, the system may make desired adjustments, such as adjustments designed to stop, reduce, or minimize the event or its effects. In one example, if an apnea event is determined to have occurred, the system may use a preset post-apnea adjustment. The preset post-apnea adjustment may be a preset adjustment or a preset algorithm for determining an adjustment. The post-apnea adjustment may be designed to enhance the treatment effect of the oral orthodontic treatment device in a particularly effective or desired manner after an apnea event. For example, the post-apnea adjustment may place the oral orthodontic treatment device in a post-event state (e.g., a post-apnea event state). In the post-event state, the oral orthodontic treatment device is particularly effective at stopping, reducing, or minimizing the event or the occurrence of a subsequent event. However, because the oral orthodontic treatment device may not be as comfortable in the post-event state, the system may further adjust the oral orthodontic treatment device to return to a more comfortable state (e.g., a previous state, such as a post-sleep onset state) after the event has passed (e.g., after the event is no longer detected or after a preset period of time during which the event is no longer detected).

[0104] Predicting an event in block 510 may include using the sensor data received from block 502 to determine that a future event is likely to occur and, optionally, classify the future event or determine other information related to the future event. Predicting a future event may include determining that the likelihood of the future event occurring is greater than a threshold amount. Predicting a future event may be based on historical physiological data, historical sleep state or sleep stage data, historical adjustments or settings of the oral orthodontic treatment device, or any combination thereof, which may be compared with current physiological data, current sleep state or sleep stage data, adjustments or settings of the oral orthodontic treatment device, or any combination thereof to predict the future event. Upon predicting a future event, the system may make desired adjustments, such as adjustments designed to avoid, stop, reduce, or minimize the future event or the effects of the future event. In one example, if a future apnea event is determined to be likely to occur, the system may use a preset pre-apnea adjustment. The preset pre-apnea adjustment may be a preset adjustment or a preset algorithm for determining the adjustment. The pre-apnea adjustment can be designed to enhance the therapeutic effect of the oral orthodontic treatment device in a particularly effective or desired manner to avoid, reduce, or minimize future apnea events. For example, the pre-apnea adjustment can place the oral orthodontic treatment device in a pre-event state (e.g., a pre-apnea event state). In the pre-event state, the oral orthodontic treatment device is particularly effective at avoiding, reducing, or minimizing future events. However, because the oral orthodontic treatment device may not be as comfortable in the pre-event state, the system can further adjust the oral orthodontic treatment device to return to this previous state (e.g., a post-sleep onset state) after the future event has passed (e.g., after the future event is no longer detected or after a preset period of time during which the future event is no longer detected), or after a specified duration has passed and no event has occurred (e.g., a duration after predicting a future event, or a duration ending at or after the time when the future event was predicted to occur).

[0105] In some implementations, determining an adjustment in block 504 may include accessing one or more historical adjustments (e.g., historical adjustment data) in block 512. The one or more historical adjustments may be used to facilitate determining the need for a current adjustment, such as the type and / or extent of the adjustment needed. In one example, the historical adjustment data may be compared to sensor data (e.g., the sensor data received in block 502 and / or the historical sensor data received in block 518) to determine the impact of a previous adjustment (e.g., the immediately preceding adjustment or another historical adjustment). If the previous adjustment was not as effective as desired or was too uncomfortable, the system may determine a different adjustment appropriate for the desired result. For example, if the previous adjustment failed to reduce or increase the frequency of apnea events, the current adjustment may include restoring some or all of the previous adjustment.

[0106] In some implementations, determining the adjustment in block 504 may include determining physiological data based on the sensor data from block 502 in block 514. The physiological data can be used to determine the desired adjustment. Determining the physiological data may include determining a respiration rate, a heart rate, a blood oxygen level, a number of apnea events, a frequency of apnea events, or other physiological data associated with the user. The physiological data can be associated with the user during a sleep session or outside of a sleep session. For example, if it is determined that the user's blood oxygen level dropped below a threshold when the user fell asleep, a particular adjustment may be particularly useful. As another example, if it is determined that the user's average respiration rate or heart rate exceeded a defined threshold within a period prior to the sleep session, a particular adjustment may be particularly useful for improving the user's sleep session. In some implementations, determining the physiological data in block 514 may include determining whether the apnea event that occurred was an obstructive apnea event or a central apnea event. If it is determined that a central apnea event has occurred, an indication may be presented to the user or another user (e.g., a medical professional or caregiver) that a central apnea event has been detected, and optionally, an indication may be presented that the oral orthodontic treatment device may not be suitable for treating central apnea.

[0107] In some implementations, determining adjustments using the determined physiological data in block 514 may include identifying a desired change in the physiological data (e.g., a desire to improve blood oxygen levels) and determining adjustments expected to achieve the desired change in the physiological data. Process 500 can operate as a feedback loop, as described further herein, so that the system can monitor the physiological data over time to determine whether the determined adjustments were successful in achieving the desired change in the physiological data. The adjustments made and the resulting changes in the physiological data can be used to train a model (e.g., a machine learning model) related to an individual's sleep session, an individual user, an individual oral orthodontic treatment appliance, and / or the individual's oral orthodontic treatment appliance patterns. Thus, as the system is used over time, it can more accurately and effectively determine adjustments to make.

[0108] In some implementations, determining the adjustment in block 504 may include determining an autonomous tone based on the sensor data from block 502 in block 516. The autonomous tone can be used to determine the desired adjustment. For example, if a change in autonomous tone indicative of increased sympathetic activity (e.g., a change in autonomous tone associated with a fight-or-escape response) is detected, the system can use an adjustment to restore a previous adjustment, slow the rate of a current adjustment, or otherwise move the oral orthodontic treatment appliance to a more comfortable state. Thus, determining the autonomous tone in block 516 can help avoid unintentionally waking the user.

[0109] In some implementations, determining the adjustment in block 504 may include any combination of one or more of blocks 506, 508, 510, 512, 514, and 516. In some implementations, determining the adjustment in block 504 may include other blocks in addition to or as an alternative to any of blocks 506, 508, 510, 512, 514, and 516.

[0110] At block 520, the system may facilitate applying the determined adjustment to the oral orthodontic treatment appliance. In some implementations, facilitating application of the determined adjustment includes taking a direct action to apply the determined adjustment to the oral orthodontic treatment appliance. For example, such a direct action may include sending a signal to the oral orthodontic treatment appliance to cause an adjustment of the oral orthodontic treatment appliance, or sending a signal to an orthodontic treatment appliance reservoir to adjust the oral orthodontic treatment appliance. However, in some implementations, facilitating application of the determined adjustment may include taking an action to indirectly apply the determined adjustment to the oral orthodontic treatment appliance. For example, such an indirect action may include taking an action that can facilitate the determined adjustment by a user, another individual (e.g., a medical professional or caregiver), or another system application.

[0111] In some implementations, facilitating application of the adjustment determined in block 520 may include transmitting a signal (e.g., an adjustment signal) to the oral orthodontic treatment device. The signal can be transmitted to the oral orthodontic treatment device via any suitable technique (e.g., wired or wireless transmission), although wireless transmission is generally preferred. The signal can be transmitted to the oral orthodontic treatment device when the oral orthodontic treatment device is being used by a user (e.g., worn in the user's mouth), although this is not necessarily the case. In some implementations, the signal can be transmitted to the oral orthodontic treatment device when the oral orthodontic treatment device is housed in an oral orthodontic treatment reservoir.

[0112] In some implementations, facilitating application of the adjustment determined in block 520 may include presenting one or more adjustment parameters to facilitate manual adjustment in block 522. The adjustment parameters may include instructions on what adjustment is needed (e.g., “shorten the connecting post by 1 mm”) and / or guides (e.g., step guides) on how to achieve the desired adjustment (e.g., “remove part A from slit A, then insert part A into slit B”). Presenting the adjustment parameters may include displaying the adjustment parameters on the device (e.g., illuminating the area of ​​the orthodontic treatment appliance to be adjusted), for example, on a user device (e.g., a smartphone or computer), on a display of the orthodontic treatment appliance reservoir, and / or on the orthodontic treatment appliance. In some implementations, presenting the adjustment parameters may include displaying the adjustment parameters as an overlay on a graphic of the orthodontic treatment appliance and / or as an augmented reality overlay on an image of the orthodontic treatment appliance (e.g., a live image of the orthodontic treatment appliance or a non-live image of the orthodontic treatment appliance). In some implementations, presenting the adjustment parameters may include generating a printout of the adjustment parameters. Presenting the adjustment parameters in block 522 may result in presenting and instructing a user or another individual to manually adjust the oral orthodontic treatment appliance, which may be manually adjusted. As used herein, the term "automatic adjustment" with respect to an oral orthodontic treatment appliance may include automatically presenting adjustment parameters to facilitate manual adjustment of the oral orthodontic treatment appliance.

[0113] In some implementations, facilitating application of the adjustment determined in block 520 may include actuating an actuator within the oral orthodontic treatment appliance to apply the adjustment in block 524. In block 524, the system may cause a signal to be sent to the oral orthodontic treatment appliance to cause actuation of one or more actuators of the oral orthodontic treatment appliance. Currently, if block 524 occurs while a user is using the oral orthodontic treatment appliance, the technology for sending the signal is typically wireless transmission. However, in some implementations, block 524 may occur after the oral orthodontic treatment appliance is removed from the user's oral cavity, such as when the oral orthodontic treatment appliance is housed in an orthodontic treatment appliance reservoir. In such implementations, actuation of an actuator within the oral orthodontic treatment appliance may achieve the adjustment by using a wired connection of a set of exposed contacts on the oral orthodontic treatment appliance. However, wireless transmission is generally preferred. In response to the transmitted signal, one or more actuators of the oral orthodontic treatment appliance may be actuated, which may operate one or more adjustable aspects of the oral orthodontic treatment appliance to achieve the determined adjustment.

[0114] In some implementations, facilitating application of the determined adjustment in block 520 may include actuating an actuator in an orthodontic treatment device reservoir to apply the adjustment in block 526. In block 526, the system can cause the orthodontic treatment device reservoir to actuate one or more actuators in the orthodontic treatment device reservoir to implement the determined adjustment on the orthodontic treatment device. In some implementations, block 526 includes waiting for a start command from a user and / or waiting for an indication that the orthodontic treatment device has been received by the orthodontic treatment device reservoir (e.g., receiving sensor data indicating that the orthodontic treatment device has been received by the orthodontic treatment device reservoir). In some implementations, block 526 includes automatically aligning the orthodontic treatment device within a receiving space of the orthodontic treatment device reservoir using the sensor data. In some implementations, block 526 can include using the sensor data to determine whether the oral orthodontic treatment appliance is properly positioned within the receiving space of the oral orthodontic treatment appliance reservoir, and can include only continuing with the adjustment if the oral orthodontic treatment appliance is properly positioned, and optionally, alerting the user if the oral orthodontic treatment appliance is not properly positioned. In some implementations, block 526 can include using the sensor data to determine whether the adjustment was successful.

[0115] In some implementations, facilitating application of the adjustments determined in block 520 may include activating and / or adjusting an electrical stimulator within the oral orthodontic treatment device in block 528. In some implementations, the oral orthodontic treatment device may include any electrical stimulator. The electrical stimulator may include a voltage source and electrodes for supplying voltage to user tissue. The electrical stimulator may be designed to stimulate muscles and / or tissues within the user's oral cavity, such as the tongue (e.g., via the tongue muscle or lingual nerve). The electrical stimulator may be used to apply additional treatments for sleep sickness, such as stopping, avoiding, reducing, or minimizing tongue contractions of apneic events. Activating the electrical stimulator in block 528 may include transmitting a signal received by the oral orthodontic treatment device that causes the oral orthodontic treatment device to begin electrical stimulation. Adjusting the electrical stimulator in block 528 may include adjusting settings (e.g., software settings) of the oral orthodontic treatment device associated with the electrical stimulator. The settings associated with the electrical stimulator may control any suitable aspect of the electrical stimulator, including how and when electrical stimulation is generated and / or delivered to the user.

[0116] In some implementations, facilitating application of the determined adjustments in block 520 may include any combination of one or more of blocks 522, 524, 526, and 528. In some implementations, facilitating application of the determined adjustments in block 520 may include other operations in addition to or as an alternative to any of blocks 522, 524, 526, and 528. For example, in some implementations, facilitating application of the determined adjustments in block 520 may include adjusting software settings of an orthodontic treatment appliance. Adjusting an electrical stimulator in block 528 may be similar to adjusting such software settings, but may not involve use of the electrical stimulator.

[0117] In some implementations, after facilitating an adjustment in block 520, e.g., after realizing an adjustment, process 500 may continue in a new instance of block 502 to receive additional sensor data and in a new instance of block 540 to determine one or more additional adjustments. Based on the one or more additional adjustments, the new instance of block 520 may enable the system to facilitate applying the determined additional adjustments to the oral orthodontic treatment appliance. In this manner, the system may dynamically adjust the oral orthodontic treatment appliance in a feedback loop. Thus, the system may continuously and repeatedly use feedback from one or more previous adjustments (e.g., immediately preceding adjustments) to determine and implement new adjustments.

[0118] In some optional implementations, in addition to applying the adjustments determined in block 520, process 500 may include sending a signal to an external device in block 530. The signal sent in block 530 may adjust settings on the external device to cause the external device to take an action that affects the user's sleep session, such as an action that affects the effectiveness of the orthodontic treatment device treatment. In some implementations, the signal sent in block 530 occurs only after determining (e.g., based on analysis of sensor data received from block 502) that the user is using the orthodontic treatment device. In some implementations, the signal sent to the external device causes the external device to cause the user to assume a desired sleeping position. In some implementations, sending the signal to the external device in block 530 occurs only if other conditions are met, such as if the user is sleeping in an undesirable sleeping position or if the user is determined (e.g., based on sensor data) to be in a particular sleep state or stage.

[0119] In one example, when the sensor data received in block 502 indicates that the user is using an orthodontic treatment appliance and optionally indicates that the user is sleeping in a supine sleeping position, the system can send a signal to an external device that is an inflatable airbag (e.g., an inflatable airbag in a pillow or mattress) in block 530, which can inflate the inflatable airbag and cause the user to assume a side sleeping position. As another example, sending a signal to an external device in block 530 can include sending a signal to increase or decrease mattress firmness, increase or decrease ambient temperature, increase or decrease ambient lighting levels, increase or decrease ambient sound levels (e.g., white noise or other sound levels), or take other action.

[0120] Although some aspects and features of the present disclosure are disclosed for use with an oral orthodontic treatment device, such as a mandibular repositioning device, such aspects and features can be used for a neurostimulation device. Such a neurostimulation device can be incorporated into an oral orthodontic treatment device (e.g., as described above with reference to block 528), although this is not necessarily the case. In some implementations, the neurostimulation device may be placed on or under the skin to be positioned on or near a nerve similar to the hypoglossal nerve (e.g., positioned so that an electrode of the neurostimulation device is located on or near the nerve). Accordingly, the above description of systems and methods including an oral orthodontic treatment device and the claims below also apply to the neurostimulation device.

[0121] When a neurostimulator is used as a supplement or alternative to an oral orthodontic treatment appliance, process 500 can be used to determine adjustments associated with the neurostimulator and facilitate application of such adjustments. For example, the determined adjustments can be the type, level, and / or location of output stimulation (e.g., electrical stimulation delivered to elicit a response in a nerve or muscle). In one example, the determined adjustments include hypoglossal nerve stimulation with a neurostimulator implanted under the skin, which emits stimulation pulses synchronized with the patient's respiration and causes genioglossus muscle stimulation to move the user's tongue forward, thereby preventing or reversing airway obstruction. Determining the adjustments can occur similar to block 504, but applied to the neurostimulator.

[0122] Facilitating application of the determined adjustments may occur similar to block 520, but applied to the neurostimulator. For example, the adjustments may be performed manually (e.g., by a user, physician, or technician) or remotely.

[0123] Determining (and facilitating) adjustments to the neurostimulator may be particularly useful when the sensor data (e.g., the sensor data received in block 502) is provided by non-contact sensors, including active and / or passive acoustic sensors (such as acoustic sensor 141 described herein). In such implementations, the neurostimulator can be accurately and intelligently controlled and / or adjusted by using non-contact sensors that do not interfere with the user's sleep and do not interfere with the neurostimulator.

[0124] In examples using a neurostimulator rather than the oral orthodontic appliance described herein, adjustments during the pre-sleep state may be undetected stimulation that strengthens the neck muscles to reduce the likelihood of apnea or other events. For example, the neurostimulator may generate stimulation to strengthen upper airway dilator muscles, such as the genioglossus and tensor palatini, which are innervated by the hypoglossal nerve. Systems using a neurostimulator, like those using an oral orthodontic appliance, may also be controlled using an external device, such as an inflatable airbag, and may determine adjustments based on determining physiological data, estimating subjective intonation, using one or more sensors located on a smartphone or tablet computer, and may function in other ways as described herein with respect to the oral orthodontic appliance, as needed.

[0125] One or more elements, aspects, steps or any portion thereof from any one or more of the following claims 1-56 may be combined with one or more elements, aspects, steps or any portion thereof from any one or more other claims 1-56 or combinations thereof to form one or more further implementations and / or claims of the present disclosure.

[0126] While the present disclosure has been described with reference to one or more particular examples or implementations, those skilled in the art will recognize that many modifications are possible without departing from the spirit and scope of the present disclosure. Each of these implementations and obvious variations thereof is considered to be within the spirit and scope of the present disclosure. It is also contemplated that additional implementations according to aspects of the present disclosure may combine any number of features from any of the implementations described herein.

Claims

1. An oral orthodontic treatment device for use by a user to treat sleeping sickness, the oral orthodontic treatment device including an electrical stimulation device having one or more electrodes for applying electrical stimulation to the tongue muscles or tongue nerves of the user; one or more sensors external to the user; a control system including one or more processors; a memory storing machine-readable instructions; A system comprising: the control system is coupled to the memory; The machine-readable instructions, when executed on the one or more processors, cause the one or more processors to perform operations, including: receiving sensor data from at least one of the one or more sensors; automatically determining adjustments associated with the orthodontic treatment appliance based on the sensor data; and facilitating, in response to the automatically determined adjustment, applying the determined adjustment to the orthodontic treatment appliance, wherein applying the determined adjustment includes activating the electrical stimulation device or adjusting a setting of the electrical stimulation device; Including, the system.

2. 10. The system of claim 1, wherein facilitating application of the determined adjustments includes presenting a display of one or more adjustment parameters to facilitate manual adjustment of the oral orthodontic treatment appliance based on the one or more adjustment parameters.

3. 3. The system of claim 1 or 2, wherein facilitating application of the determined adjustments includes actuating one or more actuators of an oral orthodontic treatment device reservoir to apply the determined adjustments to the oral orthodontic treatment device, the oral orthodontic treatment device reservoir being configured to receive the oral orthodontic treatment device when the user is not using the oral orthodontic treatment device.

4. The system according to any one of claims 1 to 3, wherein the oral orthodontic treatment device is a mandibular repositioning device.

5. The system of any one of claims 1 to 4, wherein facilitating application of the determined adjustment comprises transmitting an adjustment signal to the orthodontic treatment appliance.

6. 6. The system of claim 1, wherein facilitating application of the determined adjustments comprises dynamically adjusting the oral orthodontic treatment appliance based on the determined adjustments while the user is sleeping.

7. The operation is receiving additional sensor data from at least one of the one or more sensors, the additional sensor data relating to use of the orthodontic treatment appliance after dynamically adjusting the orthodontic treatment appliance based on the determined adjustment; automatically determining additional adjustments associated with the orthodontic treatment appliance based on the additional sensor data; and 7. The system of claim 6, further comprising: in response to automatically determining the additional adjustments, facilitating application of the determined additional adjustments to the orthodontic treatment appliance.

8. 8. The system of claim 5, wherein automatically determining the adjustment associated with the oral orthodontic treatment appliance based on the sensor data includes determining that the user is in a pre-sleep state, and the determined adjustment is a pre-sleep adjustment for the pre-sleep state.

9. 8. The system of claim 5, wherein automatically determining the adjustment associated with the oral orthodontic treatment appliance based on the sensor data includes determining that the user is in a post-sleep onset state, and the determined adjustment is a pre-set post-sleep onset adjustment for the post-sleep onset state.

10. 8. The system of claim 5, wherein automatically determining the adjustment associated with the oral orthodontic treatment appliance based on the sensor data includes identifying an apnea event, and the determined adjustment is a pre-set post-apnea adjustment to be used after the apnea event is detected.

11. 8. The system of claim 5, wherein automatically determining the adjustment associated with the oral orthodontic treatment appliance based on the sensor data includes predicting a future apnea event, and the determined adjustment is a pre-apnea adjustment to avoid or minimize the future apnea event.

12. The operation is determining that the user is using the orthodontic treatment appliance based on the received sensor data; 12. The system of claim 1, further comprising: in response to determining that the user is using the oral orthodontic treatment appliance, sending a signal to an external device, the signal adjusting a setting of the external device when received by the external device.

13. 13. The system of claim 12, wherein the external device includes an inflatable airbag, and adjusting the settings of the external device includes adjusting the inflatable airbag to place the user in a desired sleeping position.

14. 14. The system of claim 1, wherein the operations further include accessing historical sensor data related to the user's previous use of the oral orthodontic treatment appliance, and wherein automatically determining the adjustment is further based on the historical sensor data.

15. The operation is receiving subjective feedback from the user; and associating the subjective feedback with the sensor data; The system of any one of claims 1 to 14, wherein automatically determining the adjustment is further based on the subjective feedback related to the sensor data.

16. 16. The system of claim 1, wherein the operations further include determining a sleep stage based on the sensor data, and wherein automatically determining the adjustment includes using the determined sleep stage.

17. automatically determining the adjustment determining physiological data including a respiration rate, a heart rate, or a blood oxygen level based on the sensor data; identifying a desired change in the physiological data; and determining the adjustment based on the desired change in the physiological data.

18. The system of any one of claims 1 to 17, wherein the one or more sensors are located in a smartphone or tablet.

19. The system of any preceding claim, wherein the one or more sensors include a non-contact sensor spaced apart from the user.

20. The system according to any one of claims 1 to 19, wherein the sleeping sickness is sleep-disordered breathing.

21. 21. The system of claim 20, wherein the sleep disordered breathing disorder is obstructive sleep apnea.

22. The operation is accessing at least one historically determined adjustment associated with the orthodontic treatment appliance based on previously used historical sensor data from the orthodontic treatment appliance; determining a validity of the at least one historically determined adjustment based on at least one of the sensor data and the historical sensor data; The system of any one of claims 1 to 21, wherein automatically determining the adjustment is further based on a determined effectiveness of the historically determined adjustment.

23. A system described in any one of claims 1 to 22, wherein the lingual nerve of the user includes the hypoglossal nerve of the user.

24. receiving sensor data from one or more sensors external to a user using an orthodontic treatment device for treating sleeping sickness; automatically determining adjustments associated with the orthodontic treatment appliance based on the sensor data; and responsive to automatically determining the adjustment, facilitating application of the determined adjustment to the orthodontic treatment appliance. causing a computer to execute a process for adjusting an oral orthodontic treatment appliance, the orthodontic treatment device includes an electrical stimulation device having one or more electrodes for applying electrical stimulation to the user's tongue muscles or tongue nerves; applying the determined adjustment includes activating the electrical stimulation device or adjusting a setting of the electrical stimulation device. Computer program.

25. A computer program as described in claim 24, which causes the computer to function as a system as described in any one of claims 2 to 23.

26. A non-transitory computer readable medium storing a computer program according to claim 24 or 25.

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