Automatic oral appliance adjustment

Abstract

Automatic adjustments to oral appliances, such as mandibular repositioning devices, are disclosed. Sensor data can be received from one or more sensors external to a user using an oral appliance. Adjustments associated with the oral appliance are determined using the sensor data, and actions can be taken to facilitate application of the determined adjustments. Such actions can include sending a signal to the oral appliance to effectuate the adjustment (e.g., using an actuator or on-board electrical stimulator), presenting adjustment parameters to assist the user in making the adjustment manually, activating an actuator in an oral appliance storage receptacle when the oral appliance is next stored, or other such actions. Adjustments can be made dynamically in real-time or asynchronously (e.g., between sleep sessions).

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 090,004, filed on October 9, 2020, entitled “Automatic Oral Appliance Adjustment,” which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure generally relates to the treatment of sleep disorders, and more specifically to an oral appliance having an automatic adjustment mechanism for the treatment of sleep disorders. Background Technology

[0004] Many individuals suffer from sleep-related disorders associated with one or more events that occur during sleep, such as snoring, sleep apnea, hypopnea, restless legs, sleep disturbances, apnea, increased heart rate, difficulty breathing, asthma attacks, seizures, convulsions, or any combination thereof. These individuals are often treated with one or more medical devices to improve sleep and reduce the likelihood of events occurring during sleep. While some of these medical devices rely on providing positive airway pressure to the individual, some medical devices used to treat sleep disorders include oral appliances (e.g., dental appliances or jaw repositioning devices) that can be worn by the individual during sleep.

[0005] Orthodontic appliance therapy helps prevent collapse of the soft tissues at the back of the tongue and throat by supporting the jaw (mandible) in an anterior position, keeping the user's airway open during sleep. In some cases, orthodontic appliance therapy can be particularly suitable for individuals with a low body mass index (BMI) and a low apnea-hypopnea index (AHI). Orthodontic appliance therapy is especially effective for position-related (e.g., supine-dependent) obstructive sleep apnea.

[0006] When an individual wishes to use an orthodontic appliance to treat a sleep disorder, the appliance is typically fitted to the user with the assistance of a medical professional. Various adjustments can be made to the appliance to provide the most effective fit and function. In some cases, several 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 functions as expected. Because visits to the medical professional may be spaced one or more days apart, the current appliance may not be properly adjusted between such visits. Unfortunately, due to the need for multiple visits to the medical professional and the possibility that the appliance may not work as intended without proper adjustments, some individuals may abandon the appliance and therefore not adhere to their prescribed treatment, which can be detrimental to the individual. Summary of the Invention

[0007] According to some embodiments of this disclosure, a method for adjusting an orthodontic appliance includes receiving sensor data from one or more sensors external to a user using an orthodontic appliance for the treatment of sleep disorders. The method further includes automatically determining an adjustment associated with the orthodontic appliance based on the sensor data. The method also includes facilitating the application of the determined adjustment to the orthodontic appliance in response to the automatically determined adjustment.

[0008] The above overview is not intended to represent every embodiment or aspect of this disclosure. Additional features and benefits of this disclosure will become apparent from the following detailed description and accompanying drawings. Attached Figure Description

[0009] Figure 1 This is a functional block diagram of a system for automatically adjusting an orthodontic appliance, based on certain aspects of this disclosure.

[0010] Figure 2 Based on certain aspects of this disclosure Figure 1 A perspective of the system, users, and bed partners.

[0011] Figure 3 An example timeline of sleep periods according to certain aspects of this disclosure is illustrated.

[0012] Figure 4 The illustrations depict certain aspects of this disclosure. Figure 3 Example sleep graphs associated with different sleep periods.

[0013] Figure 5 It is a flowchart depicting a process for automatically adjusting an orthodontic appliance according to certain aspects of this disclosure.

[0014] While this disclosure allows for various modifications and alternatives, specific implementations and embodiments have been illustrated by example in the accompanying drawings and will be described in detail herein. However, it should be understood that this disclosure is not intended to be limited to the specific forms disclosed; rather, it will cover all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure as defined by the appended claims. Detailed Implementation

[0015] Certain aspects and features of this disclosure relate to the automatic adjustment of orthodontic appliances, such as mandibular repositioning devices. Sensor data can be received from one or more sensors external to the user using the orthodontic appliance. The sensor data is used to determine adjustments associated with the orthodontic appliance, and actions can be taken to facilitate the application of the determined adjustments. Such actions may include sending signals to the orthodontic appliance to achieve the adjustment (e.g., using an actuator or onboard electrical stimulator), presenting adjustment parameters to assist the user in making adjustments manually, activating an actuator in the orthodontic appliance storage reservoir the next time the orthodontic appliance is stored, or other such actions. Adjustments can be made dynamically, either in real time or asynchronously (e.g., between sleep periods).

[0016] Orthodontic treatment may include the use of orthodontic appliance systems to treat sleep disorders. This article describes examples of sleep disorders. Sleep disorders may include any known or unknown condition that affects a user during sleep. Sleep disorders may include any known or unknown condition that affects a user's ability to sleep and / or sleep quality. Sleep disorders may include any known or unknown condition that affects a user's ability to breathe during sleep.

[0017] Orthodontic appliance systems may include orthodontic appliances that can be used by a user (e.g., worn in the user's mouth). Orthodontic appliance systems may optionally include an orthodontic appliance reservoir for storing the orthodontic appliance when not in use. The orthodontic appliance reservoir may be a simple container or storage unit for receiving the orthodontic appliance, or may include additional components for charging, communicating with, and / or adjusting the orthodontic appliance.

[0018] Orthodontic appliances are typically fully removable (e.g., completely removable from the user's mouth), although this is not always the case. Orthodontic appliances may include one or more adjustments (e.g., adjustable aspects of the appliance), such as adjustable couplings for mandibular repositioning devices. In such instances, a mandibular repositioning device may include an upper and lower dental tray connected by an adjustable coupling. The upper tray is typically configured to engage the maxillary and / or maxillary teeth, while the lower tray is configured to engage the mandibular and / or mandibular teeth. The adjustable coupling can be adjusted to control the relative position of the upper tray relative to the lower tray, thereby controlling the relative position of the maxilla and mandible. For example, the adjustable coupling may include a post of adjustable length rotatably connected to the upper and lower trays at a fixed point. In another instance, the adjustable coupling may include a post of fixed length rotatably connected to the upper and lower trays at an adjustable point. In some cases, the adjustable connection can be adjusted to control the resistance and / or biasing force associated with the movement of the upper dental tray relative to the lower dental tray, which can be related to the amount of force required by the user to separate and bring their teeth together. Other adjustments may be made.

[0019] In some cases, adjustments to orthodontic appliances can be made manually, with or without the aid of tools. For example, an orthodontic appliance may be adjusted entirely by hand, or it may be adjusted using a screwdriver or other tools. In such cases, certain aspects of this disclosure may include presenting a display with adjustment parameters to the user or other individual (e.g., a medical professional). These adjustment parameters may indicate how to adjust the orthodontic appliance. For example, adjustment parameters may include instructions to shorten adjustable-length struts by 1 mm, 2 mm, 3 mm, etc.

[0020] In some cases, adjustments to orthodontic appliances can be made automatically at the appliance itself. Automatic adjustment at the appliance can include adjusting the appliance's software settings (e.g., adjusting the drive settings of an electrical stimulator within the appliance) or manipulating one or more physical adjustments to the appliance (e.g., actuating actuators within the appliance to change the relative position of the upper bracket relative to the lower bracket). In some cases, the orthodontic appliance may include actuators capable of manipulating one or more adjustments to the appliance. Any suitable actuator can be used, such as electromechanical actuators, piezoelectric actuators, linear actuators, rotary actuators, motors, servo mechanisms, pumps, screw drives, electromagnetic actuators, etc.

[0021] Adjusting an orthodontic appliance may involve sending a signal from a control system to the appliance. Once received by the appliance, the signal allows for adjustment. In some cases, the signal can be sent while the appliance is in use, allowing for dynamic, real-time adjustment. However, in other cases, the signal may be sent to the appliance when it is not in use (e.g., when it is in its storage compartment).

[0022] In some cases, adjustments to orthodontic appliances can be automated using external actuators, such as those within an appliance reservoir. In such cases, one or more sensors can detect that the appliance has been received by the appliance reservoir, and then one or more actuators in the reservoir can adjust one or more settings of the appliance. For example, a mandibular repositioning device can be placed in an associated reservoir, whereby the reservoir's actuators can manipulate an adjustable connection of the mandibular repositioning device to change the relative position of the upper bracket relative to the lower bracket.

[0023] The type and amount of adjustments to be made can be determined automatically by the system. The system can receive sensor data from one or more sensors and then use that data to determine the adjustments to be made. In some cases, 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 the incoming data (e.g., sensor data and stored data) and determine the desired adjustments. The determined adjustments can be designed to improve the treatment of a user's sleep disorders, reduce discomfort, reduce or minimize sleep events (e.g., sleep apnea events), or otherwise improve the user's sleep.

[0024] In some cases, the system determines adjustments dynamically (e.g., in real time), such as using real-time sensor data. In other cases, the system may determine adjustments asynchronously, such as using stored sensor data. In some cases, the system may cause adjustments to be applied dynamically (e.g., in real time or near real time), such as when the user is sleeping. In other cases, the system may cause adjustments to be applied asynchronously, such as when the user is not sleeping. In some cases, the system may control the adjustment of the orthodontic appliance to move slightly over time to help the user get used to the adjustment. Such small adjustments over time may occur within a single sleep period (e.g., slowly moving the orthodontic appliance from a comfort-priority state to a treatment-priority state) or over multiple sleep periods (e.g., slowly increasing a new orthodontic appliance user from a minimum treatment level to a desired treatment level over a multi-day process).

[0025] 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 orthodontic appliance, one or more sensors in the orthodontic appliance's storage, one or more sensors in the user's device (e.g., a smartphone or computer), or one or more sensors in another external device. In some cases, the sensor data comes from one or more sensors external to the user. In some cases, the system uses data associated with sleep periods when the user uses the orthodontic appliance. In some cases, the system may use data associated with sleep periods when the user does not use the orthodontic appliance. In such cases, the system can be used to determine differences associated with using the orthodontic appliance versus not using it, such as differences associated with the user's sleep disorders, comorbidities experienced by the user (e.g., hypertension, diabetes, insomnia, etc.), the occurrence of sleep events (e.g., sleep apnea events), sleep quality, or any combination thereof.

[0026] In some cases, determining adjustments may include analyzing sensor data to determine a sleep state or sleep stage associated with the user. Examples of determining sleep states and / or sleep stages are further described, for example, in WO 2014 / 047310, US 2014 / 0088373, WO 2015 / 006364, WO 2017 / 132726, WO 2019 / 122413, and WO 2019 / 122414, each of which is incorporated herein by reference in its entirety. In some cases, certain adjustments may be made based on the user's sleep state or sleep stage. For example, an orthodontic appliance may initially be adjusted to a comfort-priority sleep onset state (e.g., when the user is awake and begins to fall asleep), but once it is determined that the user is in a sleep state or sleep stage after sleep onset, the system may adjust the orthodontic appliance to a treatment-priority state. In a comfort-priority state, comfort may take precedence over treatment efficacy, and the orthodontic appliance may be more comfortable for the user, but may not provide effective treatment for the sleep disorder. In a treatment-priority setting, therapeutic efficacy takes precedence over comfort, and orthodontic appliances can be more effective in treating sleep disorders, though potentially more uncomfortable. Because the user is asleep when adjustments are made to prioritize the orthodontic appliance for treatment, they may not notice the reduced comfort but could benefit from the increased therapeutic efficacy.

[0027] In some cases, determining adjustments may include analyzing sensor data to identify and / or predict events, such as apnea events. Upon identifying or detecting an event, the system may adjust to place the orthodontic appliance in a post-event state. In the post-event state, the orthodontic appliance may apply corrections designed to counteract, reduce, minimize, and / or eliminate the event (e.g., apnea event) or an increase in the occurrence of subsequent events. In cases where future events are predicted based on sensor data, the system may adjust to place the orthodontic appliance in a pre-event state. In the pre-event state, which may be an enhancing state (e.g., a state designed for greater therapeutic effectiveness), the orthodontic appliance may apply certain corrections designed to avoid or minimize future events to the user. For example, entering a pre-event state may include adjusting the orthodontic appliance to improve the user's treatment effectiveness, potentially at the expense of reduced user comfort.

[0028] In some cases, orthodontic appliances can be used to drive other devices, such as implantable therapeutic devices. In such cases, adjustments to the orthodontic appliance may include tweaks to the software settings to adjust how the appliance controls the implantable therapeutic device.

[0029] In some cases, the system may interact with other external devices associated with the user's sleep phase. In one instance, a pillow, blanket, and / or mattress may include one or more inflatable air bladders that can be controlled by the system. In this instance, if the system detects that the user is sleeping while using an orthodontic appliance, the system may control one or more inflatable air bladders to induce the user into a desired position. For example, if the system detects that the user is sleeping with a mandibular repositioning device in place, the system may control one or more inflatable air bladders to induce the user into a side-lying position. In some cases, the system may induce the user into other sleeping positions, such as a supine position. Other external devices may be used. In some cases, the system may adjust the orthodontic appliance and one or more external devices together, such as to attempt and achieve a desired outcome (e.g., minimize, reduce, or eliminate an event or a series of events). For example, if adjustments to the orthodontic appliance are insufficient to achieve the desired outcome (e.g., if determined adjustments would exceed a threshold, such as a user comfort threshold or a system capability threshold), the system may additionally control the external devices to achieve the desired outcome. In other instances, if the system detects that a user is in bed and / or asleep without using an orthodontic appliance (e.g., if the user forgets to put the orthodontic appliance in their mouth before falling asleep), the system may alert the user, for example, via a notification from the user's device, or the system may control external devices to compensate for the absence of the orthodontic appliance and achieve the desired therapeutic outcome, such as by prompting the user to assume a side-lying or supine sleeping position.

[0030] In some cases, the process of receiving sensor data, determining adjustments, and applying those adjustments can create a feedback loop that can control various aspects of a user's sleep patterns to effectively treat sleep disorders.

[0031] In some cases, automatic adjustments of the orthodontic appliance occur continuously when the user is using it or when the user is determined to be asleep while using the appliance. In some cases, automatic adjustments occur occasionally (e.g., once per hour, once every few hours, once daily, once every few days, once weekly, once every few weeks, once monthly, once every few months, once a year, or once every few years). In some cases, automatic adjustments occur only a set number of times during each sleep period or each time the appliance is inserted (e.g., once). In some cases, automatic adjustments occur only after manual activation, such as by pressing a button or control on an external device associated with initiating the automatic adjustment of the orthodontic appliance. In some cases, automatic adjustments occur when one or more sensors determine that a new orthodontic appliance is being used.

[0032] These illustrative examples are given to introduce the reader to the general topics discussed herein, and are not intended to limit the scope of the disclosed concepts. Various additional features and examples are described below with reference to the accompanying drawings, in which the same numerals indicate the same elements, and the directional descriptions are used to describe illustrative embodiments, but as with the illustrative embodiments, should not be used to limit this disclosure. Elements included in the illustrations herein may be drawn out of scale.

[0033] refer to Figure 1 System 100 includes a control system 110, an orthodontic appliance treatment system 120, one or more sensors 130, a user device 170, and an external device 171. As described herein, system 100 is typically used to provide orthodontic appliance treatment to a user and to automatically adjust that treatment via adjustments to the orthodontic appliance 122.

[0034] The control system 110 includes one or more processors 112 (hereinafter referred to as processor 112). The control system 110 is typically used to control (e.g., actuate) 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 a microprocessor. Although in Figure 1 A processor 112 is shown, but the control system 110 may include any suitable number of processors (e.g., one processor, two processors, five processors, ten processors, etc.), which may be located in a single housing or positioned remotely from each other. The control system 110 may be coupled to and / or located within, for example, the housing of user device 170, the housing of external device 171, a portion (e.g., housing) of orthodontic treatment system 120 (e.g., orthodontic appliance 122 or orthodontic appliance storage 126), and / or the housing of one or more of sensors 130. The control system 110 may be centralized (within one such housing) or distributed (within two or more physically distinct such housings). In such embodiments including two or more housings containing the control system 110, such housings may be positioned adjacent to and / or remotely from each other.

[0035] Memory device 114 stores machine-readable instructions executable by processor 112 of control system 110. Memory device 114 can be any suitable computer-readable storage device or medium, such as random or serial access memory devices, hard disk drives, solid-state drives, flash memory devices, etc. Although Figure 1A memory device 114 is shown, but system 100 may include any suitable number of memory devices 114 (e.g., one memory device, two memory devices, five memory devices, ten memory devices, etc.). Memory devices 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 appliance storage 126), within the housing of the user device 170, within the housing of the external device 171, within the housing of one or more of the sensors 130, or any combination thereof. Similar to control system 110, memory devices 114 may be centralized (within one such housing) or distributed (within two or more physically different such housings).

[0036] 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, such that the data can be stored in memory device 114 and / or analyzed by processor 112 of control system 110. Electronic interface 119 can communicate with one or more sensors 130 using wired or wireless connections (e.g., using RF communication protocols, WiFi communication protocols, Bluetooth communication protocols, via cellular networks, etc.). 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. Electronic interface 119 may also include one or more processors and / or one or more memory devices that are the same as or similar to processor 112 and memory device 114 described herein. In some embodiments, electronic interface 119 is coupled to or integrated into user equipment 170. In some embodiments, electronic interface 119 is coupled to or integrated into external device 171. In other embodiments, electronic interface 119 is coupled to or integrated into control system 110 and / or memory device 114 (e.g., in a housing). In some cases, multiple electronic interfaces 119 can be used across multiple components of system 100 (e.g., orthodontic appliance 122, orthodontic appliance storage 126, user equipment 170, and external equipment 171).

[0037] Orthodontic appliance treatment system 120 includes an orthodontic appliance 122 (e.g., a mandibular repositioning device) and optionally an orthodontic appliance reservoir 126. The orthodontic appliance 122 may be a device that can be inserted into a user's mouth to apply orthodontic appliance treatment. The orthodontic appliance reservoir 126 may be any container or suitable reservoir for receiving the orthodontic appliance 122, such as for storage. The orthodontic appliance reservoir 126 may include receiving spaces for receiving the orthodontic appliance 122. Orthodontic appliance treatment refers to the use of an orthodontic appliance to treat sleep disorders, such as obstructive sleep apnea. Orthodontic appliance treatment may include one or more elements that apply force to a user's oral cavity (e.g., the mandible) to treat sleep disorders, such as those described herein.

[0038] Orthodontic appliance 122 may include one or more adjustments, also referred to as adjustable aspects. In some cases, orthodontic appliance 122 may optionally include one or more actuators 124 capable of inducing changes in one or more adjustments (e.g., adjusting the orthodontic appliance). In some cases, orthodontic appliance reservoir 126 may optionally include one or more actuators 128 capable of inducing changes in one or more adjustments of the orthodontic appliance (e.g., adjusting the orthodontic appliance) when the orthodontic appliance is received by the orthodontic appliance reservoir. One or more actuators 128 may be positioned to manipulate orthodontic appliance 122 when it is received in the receiving space of orthodontic appliance reservoir 126.

[0039] Oral appliance treatment systems 120 are typically used to treat individuals with one or more sleep-related breathing disorders (e.g., obstructive sleep apnea).

[0040] In some cases, the orthodontic appliance storage 126 may include a display device 129. The display device 129 is typically used to display images including still images, video images, or both, and / or information about the orthodontic appliance 122. For example, the display device 129 may provide information about the status of the orthodontic appliance 122 (e.g., whether the orthodontic appliance 122 is in use or has been cleaned since its last use, the current temperature of the orthodontic appliance 122, or other information associated with the orthodontic appliance 122), the current settings of one or more adjustable aspects of the orthodontic appliance 122, and / or other information (e.g., information about the latest sleep period, the current date / time, the user's personal information, etc.). In some embodiments, the display device 129 acts as a human-machine interface (HMI) including 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 substrate, a mouse, a keyboard, or any sensor system configured to sense input made by a human user interacting with the orthodontic appliance storage 126.

[0041] Reference Figure 2 The illustration shows a method according to some implementations. Figure 1 This is part of system 100. The user 210 and bed partner 220 of the oral appliance treatment system 120 are located in bed 230 and lie on mattress 232. The oral appliance 122 (e.g., mandibular repositioning device) can be used by the user 210 (e.g., worn in the mouth) during sleep.

[0042] In some cases, the orthodontic appliance treatment system 120 may include an orthodontic appliance storage device 126, which may be positioned such as Figure 2 The oral appliance treatment system 120 may be placed on a bedside table 240 directly adjacent to the bed 230, or more generally, on any surface or structure typically adjacent to the bed 230 and / or the user 210. In some cases, the oral appliance treatment system 120 may be placed in a location not adjacent to the bed 230 and / or the user 210, such as in a bathroom or other location.

[0043] Return to reference Figure 1The system 100 includes one or more sensors 130, such as 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 photoplethysmography (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 electromyography (EMG) sensor 166, an oxygen sensor 168, an analyte sensor 174, a humidity sensor 176, a LiDAR sensor 178, or any combination thereof. Typically, each of the one or more sensors 130 is configured to output sensor data received and stored in a memory device 114 or one or more other memory devices.

[0044] While one or more sensors 130 are shown and described as including each of the following: pressure sensor 132, flow sensor 134, temperature sensor 136, motion sensor 138, microphone 140, speaker 142, RF receiver 146, RF transmitter 148, camera 150, infrared sensor 152, photoplethysmography (PPG) sensor 154, electrocardiogram (ECG) sensor 156, electroencephalogram (EEG) sensor 158, capacitance sensor 160, force sensor 162, strain gauge sensor 164, electromyography (EMG) sensor 166, oxygen sensor 168, analyte sensor 174, humidity sensor 176, and LiDAR sensor 178, more generally, one or more sensors 130 may include any combination and any number of each of the sensors described and / or shown herein.

[0045] One or more sensors 130 can be used to generate, for example, physiological data, audio data, image data, other data, or any combination thereof. As described further in detail herein, sensor data from one or more sensors 130 can be used to automatically determine the adjustment of the orthodontic appliance 122. In some cases, the sensor data can identify information about the user, the user's sleep period, the orthodontic appliance 122, or another associated element.

[0046] In some cases, the control system 110 may use physiological data generated by one or more of the sensors 130 to determine sleep-wake signals and one or more sleep-related parameters associated with the user during a sleep period. Sleep-wake signals may indicate one or more sleep states, including wakefulness, relaxed wakefulness, micro-awakeness, rapid eye movement (REM) stage, first non-REM stage (commonly referred to as "N1"), second non-REM stage (commonly referred to as "N2"), third non-REM stage (commonly referred to as "N3"), or any combination thereof. Sleep-wake signals may also be timestamped to indicate the time the user went to bed, the time the user got out of bed, the time the user attempted to fall asleep, etc. Sleep-wake signals may be measured by the sensors 130 during a sleep period at a predetermined sampling rate, such as one sample per second, one sample every 30 seconds, one sample per minute, etc. Examples of one or more sleep-related parameters that may be determined for the user based on sleep-wake signals during a sleep period include total time in bed, total sleep time, sleep onset wait time, wakefulness parameters after sleep onset, sleep efficiency, segmentation index, or any combination thereof. Methods for determining sleep state and / or sleep stage based on physiological data generated by one or more sensors, such as WO 2014 / 047310, US 2014 / 0088373, WO 2017 / 132726, WO 2019 / 122413 and WO2019 / 122414, are described herein by reference in their entirety.

[0047] Physiological and / or audio data generated by one or more sensors 130 can also be used to determine respiratory signals associated with the user during sleep periods. Respiratory signals typically indicate the user's respiration / breathing during sleep periods. Respiratory signals can indicate, for example, respiratory rate, respiratory rate variability, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory ratio, number of events per hour, event pattern, setting of the oral appliance 122, effectiveness of the currently set oral appliance 122, or any combination thereof. Events may include snoring, sleep apnea, central sleep apnea, obstructive sleep apnea, mixed sleep apnea, hypopnea, restless legs, sleep disturbances, apnea, increased heart rate, dyspnea, asthma attack, seizure, convulsions, or any combination thereof. In some cases, the respiratory signal can be used to facilitate the determination of adjustments to the oral appliance.

[0048] Pressure sensor 132 outputs pressure data (e.g., pressure signals) that can be stored in memory device 114 and / or analyzed by processor 112 of control system 110. In some embodiments, pressure sensor 132 is an air pressure sensor (e.g., an atmospheric pressure sensor) that generates sensor data indicative of the user's breathing (e.g., inhalation and / or exhalation) and / or ambient pressure. In such embodiments, pressure sensor 132 can be coupled to or integrated into orthodontic appliance 122 and / or orthodontic appliance storage 126. 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, pressure sensor 132 can be used to determine a user's blood pressure.

[0049] The flow sensor 134 outputs flow data (e.g., flow signals) that can be stored in memory device 114 and / or analyzed by processor 112 of control system 110. In some embodiments, the flow sensor 134 is used to determine the airflow at or near orthodontic appliance 122. In such embodiments, the flow sensor 134 may be coupled to or integrated into orthodontic appliance 122. The flow sensor 134 may be a mass flow sensor, such as a rotary flow meter (e.g., Hall effect flow meter), turbine flow meter, orifice plate flow meter, ultrasonic flow meter, hot wire sensor, eddy current sensor, membrane sensor, or any combination thereof. Examples of flow sensors (such as flow sensor 134) are described in WO 2012 / 012835, which is incorporated herein by reference in its entirety.

[0050] Temperature sensor 136 outputs temperature data that can be stored in memory device 114 and / or analyzed by processor 112 of control system 110. In some embodiments, temperature sensor 136 generates instructions for user 210 ( Figure 2 Temperature data including core body temperature, user 210 skin temperature, temperature inside the user's mouth via orthodontic appliance 122, temperature in orthodontic appliance storage 126, ambient temperature, or any combination thereof. Temperature sensor 136 may be, for example, a thermocouple sensor, a thermistor sensor, a silicon bandgap temperature sensor or a semiconductor-based sensor, a resistance temperature detector, or any combination thereof.

[0051] The microphone 140 outputs audio data that can be stored in memory device 114 and / or analyzed by processor 112 of control system 110. The audio data generated by microphone 140 can be reproduced as one or more sounds (e.g., a sound from user 210) during sleep periods. The audio data from microphone 140 can also be used to identify (e.g., using control system 110) events experienced by the user during sleep periods, as described further in detail herein. Microphone 140 can be coupled to or integrated into orthodontic appliance 122, orthodontic appliance storage 126, user device 170, or external device 171.

[0052] The speaker 142 output can be controlled by a user of system 100 (e.g., Figure 2 The speaker 142 can be used as, for example, an alarm clock or to play alarms or messages to the user 210 (e.g., in response to an event). In some embodiments, the speaker 142 can be used to transmit audio data generated by the microphone 140 to the user. The speaker 142 can be coupled to or integrated into the orthodontic appliance 122, orthodontic appliance storage 126, user device 170, or external device 171.

[0053] Microphone 140 and speaker 142 can be used as separate devices. In some embodiments, microphone 140 and speaker 142 can be combined to form acoustic sensor 141 (e.g., sonar sensor), as described in, for example, WO 2018 / 050913 and WO2020 / 104465, each of which is incorporated herein by reference in its entirety. In such embodiments, speaker 142 generates or emits sound waves at predetermined intervals, and microphone 140 detects reflections of emitted sound waves from speaker 142. The sound waves generated or emitted by speaker 142 have frequencies inaudible to the human ear (e.g., below 20 Hz or above about 18 kHz) so as not to disturb the sleep of user 210 or bed partner 220. Figure 2 Based at least in part on data from microphone 140 and / or speaker 142, control system 110 can determine user 210 ( Figure 2The location of the body and / or one or more of the sleep-related parameters described herein (e.g., the identified body position and / or changes in body position) and / or the breathing-related parameters described herein, such as breathing patterns, breathing signals (e.g., breathing morphology can be determined from breathing signals), respiratory rate, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory ratio, number of events per hour, event pattern, sleep state, sleep stage, or any combination thereof. In this context, a sonar sensor can be understood to involve active acoustic sensing, such as by generating / transmitting ultrasonic or low-frequency ultrasonic sensing signals through the air (e.g., in the frequency range of about 17 to 23 kHz, 18 to 22 kHz, or 17 to 18 kHz). Such systems can be considered relative to WO2018 / 050913 and WO 2020 / 104465 above.

[0054] In some embodiments, sensor 130 includes (i) a first microphone that is the same as or similar to microphone 140 and is integrated in acoustic sensor 141; and (ii) a second microphone that is the same as or similar to microphone 140 but is separate from and different from the first microphone integrated in acoustic sensor 141.

[0055] RF transmitter 148 generates and / or transmits radio waves with a predetermined frequency and / or predetermined amplitude (e.g., in the high-frequency band, in the low-frequency band, long-wave signal, short-wave signal, etc.). RF receiver 146 detects the reflection of the radio waves emitted from RF transmitter 148, and this data can be analyzed by control system 110 to determine user 210 ( Figure 2 The location of the sensor and / or one or more of the sleep-related parameters described herein. The RF receiver (RF receiver 146 and RF transmitter 148 or another RF pair) may also be used for wireless communication between the control system 110, the orthodontic appliance 122, the orthodontic appliance storage 126, one or more sensors 130, the user equipment 170, the external device 171, or any combination thereof. Although the RF receiver 146 and RF transmitter 148 are in... Figure 1 While shown as separate and distinct components, 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 specific format of the RF communication may be WiFi, Bluetooth, etc.

[0056] In some implementations, RF sensor 147 is part of a mesh system. An 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 implementations, the WiFi mesh system includes WiFi routers and / or WiFi controllers and one or more satellites (e.g., access points), each of which includes the same or similar RF sensor as RF sensor 147. The WiFi routers and satellites communicate with each other continuously 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), caused by a moving object or person partially blocking the signal. The motion data may indicate movement, breathing, heart rate, gait, falls, behavior, etc., or any combination thereof.

[0057] Camera 150 outputs image data that can be reproduced as one or more images (e.g., still images, video images, thermal images, or combinations thereof) that can be stored in memory device 114. Image data from camera 150 can be used by control system 110 to determine one or more of the sleep-related parameters described herein. For example, image data from camera 150 can be used to identify the user's location, determine when user 210 has gone to bed 230 (…). Figure 2 The system can determine the time when the user 210 gets out of bed 230, and the time when the user 210 gets out of bed 230. In some cases, image data from camera 150 can be used by the control system 110 to detect or confirm the occurrence of an event.

[0058] The output of infrared (IR) sensor 152 is reproducible as infrared image data (e.g., still images, video images, or both) that can be stored in memory device 114. Infrared data from IR sensor 152 can be used to determine one or more sleep-related parameters during a sleep period, including the temperature of user 210 and / or the movement of user 210. IR sensor 152 can also be used in conjunction with camera 150 when measuring the presence, location, and / or movement of user 210. In some cases, infrared data from IR sensor 152 can be used to detect or confirm the occurrence of an event. IR sensor 152 can detect, for example, infrared light with wavelengths between about 700 nm and about 1 mm, while camera 150 can detect visible light with wavelengths between about 380 nm and about 740 nm.

[0059] PPG sensor 154 output and user 210 ( Figure 2The associated physiological data can be used to determine one or more sleep-related parameters, such as heart rate, heart rate variability, cardiac cycle, respiratory rate, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory ratio, estimated blood pressure parameters, or any combination thereof. The PPG sensor 154 can be worn by the user 210, embedded in clothing and / or fabric worn by the user 210, and / or embedded in and / or connected to the oral appliance 122.

[0060] ECG sensor 156 outputs physiological data associated with the electrical activity of the heart of user 210. In some embodiments, ECG sensor 156 includes one or more electrodes positioned on or around a portion of user 210 during sleep periods. The physiological data from ECG sensor 156 can be used, for example, to determine one or more sleep-related parameters as described herein.

[0061] EEG sensor 158 outputs physiological data associated with the electrical activity of the user 210's brain. In some embodiments, EEG sensor 158 includes one or more electrodes positioned on or around the user 210's scalp during sleep periods. The physiological data from EEG sensor 158 can be used, for example, to determine the user 210's sleep state at any given time during a sleep period.

[0062] The outputs of capacitive sensor 160, force sensor 162, and strain gauge sensor 164 can be stored in memory device 114 and used by control system 110 to determine data for one or more of the sleep-related parameters described herein. EMG sensor 166 outputs physiological data associated with electrical activity generated by one or more muscles. Oxygen sensor 168 outputs oxygen data indicating the oxygen concentration of a gas (e.g., gas in the user's mouth detected by a sensor in orthodontic appliance 122 or ambient gas detected by a sensor in orthodontic appliance reservoir 126). Oxygen sensor 168 can be, for example, an ultrasonic oxygen sensor, an electro-oxygen sensor, a chemical oxygen sensor, an optical oxygen sensor, or any combination thereof. In some embodiments, one or more sensors 130 also include a ground-skin response (GSR) sensor, a blood flow sensor, a respiration sensor, a pulse sensor, a blood pressure sensor, a blood oxygenation sensor, or any combination thereof.

[0063] Analyte sensor 174 can be used to detect the presence of analytes in the breath of user 210. Data output from analyte sensor 174 can be stored in memory device 114 and used by control system 110 to determine the identity and concentration of any analytes in the breath of user 210. In some embodiments, analyte sensor 174 is positioned inside the mouth of user 210 (e.g., coupled to and / or incorporated therein with an orthodontic appliance 122) to detect analytes in the breath exhaled from the mouth of user 210. In other embodiments, analyte sensor 174 can be positioned near the mouth of user 210, such as on an external device 171 located near the user's mouth. In some embodiments, analyte sensor 174 is a volatile organic compound (VOC) sensor that can be used to detect carbon-based chemicals or compounds. In some embodiments, analyte sensor 174 can also be used to detect whether user 210 is breathing through their nose or mouth. For example, if the presence of an analyte is detected by data output from the analyte sensor 174 located in or near the mouth of user 210, the control system 110 can use that data as an indication that user 210 is breathing through their mouth.

[0064] The humidity sensor 176 outputs data that can be stored in the memory device 114 and used by the control system 110. The humidity sensor 176 can be used to detect humidity in different areas inside or around the user (e.g., at the orthodontic appliance 122 or at the orthodontic appliance storage 126). Therefore, in some embodiments, the humidity sensor 176 can be coupled to or integrated into the orthodontic appliance 122 or the orthodontic appliance storage 126. In other embodiments, the humidity sensor 176 is placed near any area where humidity levels need to be monitored. The humidity sensor 176 can also be used to monitor the humidity of the surrounding environment around the user 210, for example, the humidity of the air inside a bedroom.

[0065] The Light Detection and Ranging (LiDAR) sensor 178 can be used for depth sensing. This type of optical sensor (e.g., a laser sensor) can be used to detect objects and construct a three-dimensional (3D) map of the surrounding environment, such as a living space. LiDAR typically utilizes pulsed lasers for time-of-flight measurements. LiDAR is also known as 3D laser scanning. In instances using such sensors, fixed or mobile devices (such as smartphones) with LiDAR sensor 166 can measure and map an area extending 5 meters or more from the sensor. For example, LiDAR data can be fused with point cloud data estimated by an electromagnetic RADAR sensor. The LiDAR sensor 178 can also use artificial intelligence (AI) to automatically geofence the RADAR system by detecting and classifying spatial features that may cause problems for the RADAR system, such as glass windows (which may be highly reflective of the RADAR). For example, LiDAR can also be used to provide an estimate of a person's height, and how that height changes when the person sits down or falls. LiDAR can be used to form a 3D mesh representation of the environment. In further applications, LiDAR can reflect radio waves away from solid surfaces (e.g., semi-transparent materials), allowing for the classification of different types of obstacles.

[0066] Although Figure 1 While shown separately, any combination of one or more sensors 130 may be integrated into and / or coupled to any one or more components of system 100, including orthodontic appliance 122, orthodontic appliance storage 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 appliance 122. In some embodiments, at least one of the one or more sensors 130 is not coupled to orthodontic appliance 122, control system 110, user device 170, or external device 171, and is typically positioned near user 210 during sleep (e.g., positioned on or in contact with a portion of user 210, worn by user 210, coupled to or positioned on a bedside table, coupled to a mattress, coupled to a ceiling, etc.). In some cases, one, some, or all of the one or more sensors 130 may be located outside the user. In some cases, one, some, or all of the one or more sensors 130 may be physically separate and not physically connected to the orthodontic appliance 122.

[0067] For example, such as Figure 2As shown, one or more of the sensors 130 may be located at a first position 250A on a bedside table 240 adjacent to the bed 230 and the user 210. Alternatively, one or more of the sensors 130 may be located at a second position on and / or within the mattress 232 (e.g., the sensors are attached to and / or integrated therein). Furthermore, one or more of the sensors 130 may be located at a third position on the bed 230 (e.g., attached to a headboard, footboard, or other location on the frame of the bed 230 and / or integrated therein). One or more of the sensors 130 may also be located at a fourth position on a wall or ceiling, typically adjacent to the bed 230 and / or the user 210. One or more of the sensors 130 may also be located in a fifth position, such that one or more of the sensors 130 are coupled to and / or positioned on and / or inside the housing of the orthodontic appliance 122 or orthodontic appliance storage 126 of the orthodontic appliance treatment system 120. Furthermore, one or more of the sensors 130 may be located in a sixth position, such that the sensors are coupled to and / or positioned on the user 210 (e.g., the sensors are embedded in or coupled to fabric or clothing worn by the user 210 during sleep periods). 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 sensor data (e.g., physiological data) associated with the user 210 and / or bed partner 220 during one or more sleep periods.

[0068] Return to reference Figure 1 User equipment 170 may include a processor (e.g., processor 112), memory (e.g., memory 114), and a display device 172. User equipment 170 may be, for example, a mobile device such as a smartphone, tablet, laptop, etc. Display device 172 is typically used to display images including still images, video images, or both. In some embodiments, display device 172 acts as a human-machine interface (HMI), which includes a graphical user interface (GUI) configured to display images and an input interface. Display device 172 may be an LED display, OLED display, LCD display, etc. Input interface may be, for example, a touchscreen or touch-sensitive substrate, a mouse, a keyboard, or any sensor system configured to sense input made by a human user interacting with user equipment 170.

[0069] In some cases, external device 171 may be a sleep-related device for receiving sensor data associated with sleep periods and / or controlling actions that affect sleep periods. As an example, external device 171 may be a smart pillow, smart mattress, smart bedding (e.g., sheets or blankets), etc. In some cases, such external device 171 may include one or more sensors 130 to receive sensor data associated with sleep periods. In some cases, such external device 171 may be an actuable or controllable device that can be controlled to affect sleep periods. For example, such devices may include one or more inflatable airbags that can be controlled to inflate to induce a user into or out of a specific sleeping position. For example, an inflatable airbag in a pillow or mattress may be used to induce a user to move from a supine to a side-lying position. Other types of controllable (e.g., via control system 110) external devices 171 may be used to influence a user's sleep periods in association with the automatic adjustment of orthodontic appliance 122.

[0070] Although the control system 110 and the memory device 114 are in Figure 1 While described and shown as separate and distinct components of system 100, in some embodiments, the control system 110 and / or memory device 114 are integrated into user device 170, external device 171, orthodontic appliance storage 126, or any combination thereof. Alternatively, in some embodiments, the control system 110 or a portion thereof (e.g., processor 112) may reside in the cloud (e.g., integrated into a server, integrated into an Internet of Things (IoT) device, connected to the cloud, subjected to edge cloud processing, etc.) or on one or more servers (e.g., remote servers, local servers, etc., or any combination thereof).

[0071] While system 100 is shown as including all of the aforementioned components, a system for automatically adjusting the orthodontic appliance 122 may include more or fewer components. For example, a first alternative system includes a control system 110, the orthodontic appliance 122, and at least one of one or more sensors 130. As another example, a second alternative system includes the orthodontic appliance 122, an orthodontic appliance storage 126, one or more sensors 130, and a user device 170. As yet another example, a third alternative system includes the orthodontic appliance 122, at least one of one or more sensors 130, and a user device 170. Therefore, any portion or multiple portions of the components shown and described herein and / or combined with one or more other components can be used to form various systems for determining sleep-related parameters associated with sleep periods.

[0072] As used in this article, sleep periods can be defined in several ways based on, for example, an initial start time and an end time. (See references.) Figure 3The diagram illustrates an example timeline 300 for sleep periods. Timeline 300 includes bedtime (t... 入床 ), time to fall asleep (t) GTS ), initial sleep time (t) 睡眠 ), first micro-awakening MA1 and second micro-awakening MA2, awakening time (t) 觉醒 ) and wake-up time (t 起床 ).

[0073] As used herein, sleep periods can be defined in several ways. For example, a sleep period can be defined by an initial start time and an end time. In some implementations, a sleep period is the duration during which a user falls asleep; that is, a sleep period has a start time and an end time, and during the sleep period, the user does not wake up until the end time. In other words, any period of time during which the user is awake is not included in a sleep period. According to this first definition of a sleep period, if a user wakes and falls asleep multiple times in the same night, each sleep interval separated by wakefulness intervals is a sleep period.

[0074] Alternatively, in some implementations, the sleep period has a start time and an end time, and during the sleep period, the user can wake up as long as the continuous duration of wakefulness is less than a wakefulness duration threshold, without the sleep period ending. The wakefulness duration threshold can be defined as a percentage of the sleep period. The wakefulness duration threshold can be, for example, about 20% of the sleep period, about 15% of the sleep period duration, about 10% of the sleep period duration, about 5% of the sleep period duration, about 2% of the sleep period duration, etc., or any other threshold percentage. In some implementations, the wakefulness duration threshold is defined as a fixed amount of time, such as about one hour, about thirty minutes, about fifteen minutes, about ten minutes, about five minutes, about two minutes, etc., or any other amount of time.

[0075] In some implementations, a sleep period is defined as the entire time between the time a user first goes to bed at night and the time the user last gets up the following morning. In other words, a sleep period can be defined as a time period that begins on the first date (e.g., Monday, January 6, 2020) when the user first goes to bed wanting to fall asleep (e.g., if the user does not intend to watch TV or use a smartphone before falling asleep), which can be referred to as the first time of the current night (e.g., 10:00 PM), and ends on the second date (e.g., Tuesday, January 7, 2020) when the user first gets out of bed and does not want to return to sleep the following morning, which can be referred to as the second time of the following morning (e.g., 7:00 AM).

[0076] refer to Figure 3The diagram illustrates an exemplary timeline 300 for a sleep period. Timeline 300 includes bedtime (t... 入床 ), time to fall asleep (t) GTS ), initial sleep time (t) 睡眠 First micro-awakening MA1, second micro-awakening MA2, awakening A, awakening time (t) 觉醒 ) and wake-up time (t 起床 ).

[0077] Bedtime t 入床 Initially getting into bed with the user before falling asleep (e.g., when the user lies down or sits on the bed). Figure 2 The time of bed admission (230) is associated with the bed's time. Bed admission time t can be identified based on the bed threshold duration. 入床 This is used to distinguish between the time a user goes to bed for sleep and the time a user goes to bed for other reasons (e.g., watching TV). For example, the bed threshold duration could 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. While this document refers to bed as the basis for describing bedtime t, it uses the term "bed" to describe bedtime t. 入床 But more often, bedtime t 入床 This can refer to the time a user initially enters any location (e.g., recliner, chair, sleeping bag, etc.) to sleep.

[0078] Going to sleep (GTS) and the time a user goes to bed (t) 入床 This is related to the initial attempt to fall asleep. For example, after going to bed, a user can engage in one or more activities to relax before attempting to sleep (e.g., reading, watching TV, listening to music, using user device 170, etc.). Initial sleep time (t) 睡眠 ) is the time when a user initially falls asleep. For example, initial sleep time (t) 睡眠 This could be the time when the user initially enters the first non-REM sleep stage.

[0079] Awakening Time t 觉醒 This is the time associated with when a user wakes up but does not return to sleep (e.g., the opposite of a user waking up in the middle of the night and returning to sleep). A user may experience one of several unconscious micro-awakenings (e.g., micro-awakenings MA1 and MA2) with short durations (e.g., 5 seconds, 10 seconds, 30 seconds, 1 minute, etc.) after initial sleep onset. This is related to the wakefulness time t. 觉醒 Conversely, the user returns to sleep after each of the micro-awakenings MA1 and MA2. Similarly, the user may have one or more conscious awakenings (e.g., awakening A) after initial sleep onset (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 wakefulness time t 觉醒It can be defined, for example, based on the duration of the arousal threshold (e.g., the user is awake for at least 15 minutes, at least 20 minutes, at least 30 minutes, at least 1 hour, etc.).

[0080] Similarly, wake-up time t 起床 This is associated with the time when a user gets out of bed and leaves the bed to end a sleep period (e.g., the opposite of when a user gets up at night to go to the bathroom, cares for a child or pet, or sleepwalks). In other words, wake-up time t 起床 This is the time a user last gets out of bed and doesn't return until the next sleep period (e.g., the next night). Therefore, wake-up time t 起床 The bedtime t for the second subsequent sleep period can be defined, for example, based on the duration of the wake-up threshold (e.g., at least 15 minutes, at least 20 minutes, at least 30 minutes, at least 1 hour, etc.). Alternatively, the bedtime t for the second subsequent sleep period can be defined based on the duration of the wake-up threshold (e.g., at least 4 hours, at least 6 hours, at least 8 hours, at least 12 hours, etc.). 入床 time.

[0081] As mentioned above, in the initial t 入床 With the final t 起床 During the night, a user may wake up and get out of bed more than once. In some implementations, the final wake-up time t is identified or determined based on a predetermined threshold duration following the event (e.g., falling asleep or getting out of bed). 觉醒 and / or final wake-up time t 起床 The duration of this threshold can be customized for the user. For a standard user who goes to bed at night and then wakes up and gets out of bed in the morning, any time period of approximately 12 to 18 hours can be used (during which time the user is awake). 觉醒 ) or get up (t 起床 ) and users going to bed (t 入床 ), entering sleep (t GTS ) or fall asleep (t 睡眠 For users who spend longer periods of time in bed, a shorter threshold time period can be used (e.g., between approximately 8 hours and approximately 14 hours). The threshold time period can be initially selected and / or adjusted later based on the system monitoring the user's sleep behavior.

[0082] Total time in bed (TIB) is the time to enter bed t 入床 and wake-up time t 起床 The duration between sleep and wake times. Total sleep time (TST) is the duration between the initial sleep time and wake time, excluding any conscious or unconscious awakenings and / or micro-awakenings in between. Typically, total sleep time (TST) will be shorter than total time in bed (TIB) (e.g., one minute shorter, ten minutes shorter, one hour shorter, etc.). For example, refer to... Figure 3Timeline 300, Total Sleep Time (TST) at initial sleep time t 睡眠 With awakening time t 觉醒 The duration spans between these periods, but does not include the durations of the first micro-wake (MA1), the second micro-wake (MA2), and wake-up A. As shown in the figure, in this example, the total sleep time (TST) is shorter than the total bed rest time (TIB).

[0083] In some implementations, total sleep time (TST) can be defined as total sustained sleep time (PTST). In such implementations, total sustained sleep time excludes a predetermined initial portion or a period of time in the first non-REM stage (e.g., a light sleep stage). For example, the predetermined initial portion could be about 30 seconds to about 20 minutes, about 1 minute to about 10 minutes, about 3 minutes to about 5 minutes, etc. Total sustained sleep time is a measure of sustained sleep and smooths the sleep-wake sleep graph. For example, when a user initially 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 very short period of time (e.g., one minute), and then return to the first non-REM stage. In this example, total sustained sleep time excludes the first instance of the first non-REM stage (e.g., about 30 seconds).

[0084] In some implementations, the sleep period is defined as the time from bedtime (t... 入床 Start at wake-up time (t) 起床 The sleep period ends at the beginning of the sleep period, i.e., the total time in bed (TIB) is defined as the total time in bed. In some implementations, the sleep period is defined as the time from the beginning of the sleep period (t...). 睡眠 ) begins and at the awakening time (t) 觉醒 The sleep period ends. In some implementations, the sleep period is defined as the total sleep time (TST). In some implementations, the sleep period is defined as the time from the onset of sleep (t). GTS ) begins and at the awakening time (t) 觉醒 The sleep period ends at the time of sleep onset (t). In some implementations, the sleep period is defined as the time from the onset of sleep (t). GTS Start at wake-up time (t) 起床 The sleep period ends at bedtime. In some implementations, the sleep period is defined as the time from bedtime (t...). 入床 ) begins and at the awakening time (t) 觉醒 The sleep period ends at the initial sleep time (t). In some implementations, the sleep period is defined as the time from the initial sleep time (t) to the end. 睡眠 Start at wake-up time (t) 起床 )Finish.

[0085] refer to Figure 4 The illustration shows the timeline 300 according to some implementation methods. Figure 3An exemplary sleep graph 400 is shown. As illustrated, sleep graph 400 includes a sleep-wake signal 401, a wakefulness stage axis 410, a REM stage axis 420, a light sleep stage axis 430, and a deep sleep stage axis 440. The intersection of the sleep-wake signal 401 with one of axes 410 to 440 indicates the sleep stage at any given time during a sleep period.

[0086] The sleep-wake signal 401 may 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 may indicate one or more sleep states, including wakefulness, relaxed wakefulness, micro-awakening, REM sleep, a first non-REM sleep stage, a second non-REM sleep stage, a third non-REM sleep stage, or any combination thereof. In some embodiments, one or more of the first non-REM sleep stage, the second non-REM sleep stage, and the third non-REM sleep stage may be grouped together and categorized as light sleep stages or deep sleep stages. For example, light sleep stages may include the first non-REM sleep stage, while deep sleep stages may include the second and third non-REM sleep stages. Although in Figure 4 The sleep graph 400 shown includes a light sleep stage axis 430 and a deep sleep stage axis 440, but in some embodiments, the sleep graph 400 may include axes for each of the first non-REM stage, the second non-REM stage, and the third non-REM stage. In other embodiments, sleep-wake signals may also indicate respiratory signals, respiratory rate, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory ratio, number of events per hour, event pattern, or any combination thereof. Information describing sleep-wake signals may be stored in memory device 114.

[0087] Sleep graph 400 can be used to determine one or more sleep-related parameters, such as sleep onset wait time (SOL), wakefulness onset after sleep (WASO), sleep efficiency (SE), sleep segmentation index, sleep blocks, or any combination thereof.

[0088] Sleep onset wait time (SOL) is defined as the time to enter sleep (t). GTS ) and initial sleep time (t 睡眠The sleep start wait time (PSOL) is the time between the initial attempt to fall asleep and the actual time it takes for the user to fall asleep. In some implementations, the sleep start wait time is defined as the continuous sleep start wait time (PSOL). The difference between PSOL and the initial sleep start wait time is that PSOL is defined as the duration between the time to fall asleep and a predetermined amount of continuous sleep. In some implementations, the predetermined amount of continuous sleep may include, for example, at least 10 minutes of sleep within a second non-REM phase, a third non-REM phase, and / or a REM phase, and a REM phase with wakefulness of no more than 2 minutes, a first non-REM phase, and / or movement between them. In other words, the PSOL requires continuous sleep for up to, for example, 8 minutes within the second non-REM phase, the third non-REM phase, and / or the REM phase. In other implementations, the predetermined amount of continuous sleep may include at least 10 minutes of sleep within a first non-REM phase, a second non-REM phase, a third non-REM phase, and / or a REM phase after the initial sleep time. In such implementations, the predetermined amount of continuous sleep may not include any micro-awakenings (e.g., a ten-second micro-awakening does not restart the 10-minute time period).

[0089] Post-sleep wakefulness onset (WASO) is associated with the total duration of a user's wakefulness between the initial sleep time and wake time. Therefore, WASO includes brief awakenings and micro-awakenings during the sleep period (e.g., Figure 4 Micro-awakenings (MA1 and MA2) are shown, whether conscious or unconscious. In some implementations, a sleep-onset awakening start (WASO) is defined as a sustained sleep-onset awakening start (PWASO) that includes only the total duration of awakenings having 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.).

[0090] Sleep efficiency (SE) is defined 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 that sleep period is 93.75%. Sleep efficiency indicates a user's sleep hygiene. For example, if a user goes to bed before sleep and spends time engaging in other activities (e.g., watching television), sleep efficiency will decrease (e.g., the user is penalized). In some implementations, sleep efficiency (SE) can be calculated based on the total time in bed (TIB) and the total time the user attempts to sleep. In such implementations, the total time the user attempts to sleep is defined as the duration between the time to fall asleep (GTS) and the wake-up time described herein. For example, if the total sleep time is 8 hours (e.g., 11 p.m. to 7 a.m.), the time to fall asleep is 10:45 p.m., and the wake-up time is 7:15 a.m., in such implementations, the sleep efficiency parameter is calculated to be approximately 94%.

[0091] The segmentation index is determined at least in part based on the number of awakenings during sleep periods. For example, if a user has two micro-awakenings (e.g., Figure 4 The segmentation index (MA1 and MA2 shown) can be represented as 2. In some implementations, the segmentation index is scaled between a predetermined range of integers (e.g., 0 to 10).

[0092] Sleep blocks are associated with the transition between any sleep stage (e.g., first non-REM stage, second non-REM stage, third non-REM stage, and / or REM stage) and the waking stage. Sleep blocks can be calculated at a resolution of, for example, 30 seconds.

[0093] In some embodiments, the systems and methods described herein may include generating or analyzing a sleep map including sleep-wake signals to determine or identify bedtime (t) based at least in part on the sleep-wake signals of the sleep map. 入床 ), time to fall asleep (t) GTS ), initial sleep time (t) 睡眠 ), one or more first micro-awakenings (e.g., MA1 and MA2), wake-up time (t) 觉醒 ), wake-up time (t) 起床 (or any combination thereof).

[0094] In other embodiments, one or more of the sensors 130 may be used to determine or identify the bed entry time (t). 入床 ), time to fall asleep (t) GTS ), initial sleep time (t) 睡眠 ), one or more first micro-awakenings (e.g., MA1 and MA2), wake-up time (t) 觉醒 ), wake-up time (t) 起床(or any combination thereof), which in turn define sleep periods. For example, bedtime t can be determined based on data generated, for example, by motion sensor 138, microphone 140, camera 150, or any combination thereof. 入床 The time to fall asleep can be determined based on, for example, 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 that the user has turned off the lights), data from microphone 140 (e.g., data indicating that the TV is turned off), data from user device 170 (e.g., data indicating that the user is no longer using user device 170), data from sensors in orthodontic appliance 122 (e.g., data indicating that orthodontic appliance 122 is inserted), data from sensors in orthodontic appliance storage 126 (e.g., data indicating that orthodontic appliance 122 is removed from orthodontic appliance storage 126), data from sensors in external device 171, or any combination thereof.

[0095] Figure 5 This is a flowchart depicting a process 500 for automatically adjusting an orthodontic appliance according to certain aspects of this disclosure. Process 500 can be... Figure 1 The process is executed by system 100, such as by control system 110 and other components of system 100. Process 500 can be used to provide respectively support to the orthodontic appliance, orthodontic appliance storage device, and optionally external devices (such as...). Figure 1 The process 500 is used for the adjustment of the oral appliance 122, the oral appliance storage 126, and the external device 171. The process 500 can be used to automatically adjust any oral appliance, such as a mandibular repositioning device.

[0096] At box 502, sensor data can be received. This data can be received from one or more sensors (such as...). Figure 1 One or more sensors 130) receive sensor data. Sensor data may be received from one or more sensors external to the user, although this is not always the case. Sensor data may include physiological data, audio data, video data, motion data, environmental data, or other data associated with the user of the orthodontic appliance (e.g., users who wear the orthodontic appliance in their mouth before, during, or after sleeping, and / or users who do not wear the orthodontic appliance in their mouth during these times).

[0097] Receiving sensor data at box 502 can occur continuously over time (e.g., when sensor data is collected by one or more sensors) or in batches (e.g., as a dataset representing sensor data from a time period such as an entire sleep period). Receiving sensor data at box 502 can occur in real time (e.g., during a sleep period when one or more sensors collect data associated with the sleep period) or asynchronously (e.g., receiving sensor data associated with past time periods, such as data associated with a sleep period from the previous night or sensor data with a delayed duration).

[0098] In some cases, optional box 518 may include receiving historical sensor data. Historical sensor data may include any sensor data collected prior to the collection of sensor data from box 502. In some cases, the historical sensor data at box 518 may include sensor data received in a previous occurrence of box 502, such as sensor data from an earlier sleep period or from a previous sleep period. In some cases, the historical sensor data received at box 518 may be compared with the sensor data received at box 502 to determine the effectiveness of previous orthodontic appliance treatment (e.g., the effectiveness of previous adjustments to the orthodontic appliance).

[0099] At box 504, adjustments associated with an orthodontic appliance can be determined based on sensor data. The system can use the sensor data received at box 502 to determine one or more adjustments associated with the orthodontic appliance (e.g., one or more adjustments to one or more adjustable aspects of the orthodontic appliance).

[0100] The adjustments identified at box 504 may be intended to achieve desired purposes, such as treating the user's sleep disorders, improving the user's sleep quality (e.g., increasing TST, reducing SOL, improving the time spent in different stages of wakefulness (e.g., reducing fatigue, improving alertness, etc.)), improving the comfort and / or efficacy of the orthodontic appliance, or other purposes. In some cases, the desired purpose of the adjustments identified at box 504 may depend on sensor data 502, the internal clock, and / or other data. For example, in some cases, the purpose of the identified adjustments may be to improve comfort before the onset of sleep, and adjustments identified afterward may be to improve the efficacy of the orthodontic appliance. Such examples may also be considered as improving the user's sleep quality by reducing SOL through increased comfort before the onset of sleep, and by increasing TST through improved therapeutic efficacy of the orthodontic appliance after the onset of sleep.

[0101] In some cases, determining the adjustment at box 504 may include determining the sleep state and / or sleep stage at box 506. The sleep state and / or sleep stage may be determined based on sensor data received from box 502. The system may make different adjustments depending on the sleep state and / or sleep stage. As an example, the process may place the orthodontic appliance in a comfort-priority state when it is determined that the user is awake or in light sleep (e.g., N1 sleep), and the process may place the orthodontic appliance in a treatment-priority state when it is determined that the user is in deep sleep, optionally specifically in REM sleep. In some cases, the adjustments to be made to place the orthodontic appliance in the desired state may be regulated to prior knowledge or detection of the user's non-REM relative REM probability. In some cases, the orthodontic appliance may be adjusted throughout the sleep cycle, relaxing when it is predicted that the user will move from slow-wave sleep (SWS) or REM to a light stage of sleep.

[0102] In one instance, if it is determined that the user is in a pre-sleep state (e.g., at t...), 睡眠 If the time frame is previously set (e.g., before sleep), the system can use preset pre-sleep adjustments. Preset pre-sleep adjustments can be preset adjustments or preset algorithms used to determine the adjustments. Pre-sleep adjustments can be designed to improve user comfort when the user attempts to fall asleep. Ideally, pre-sleep adjustments can reduce sleep apnea (SOL). Pre-sleep adjustments can prioritize the comfort of the orthodontic appliance.

[0103] As another example, if it is determined that the user is in a state after sleep has begun (e.g., at t...), 睡眠 After that time, the system can use preset sleep start adjustments. Preset sleep start adjustments can be preset adjustments or preset algorithms used to determine the adjustments. Sleep start adjustments can be designed to improve the therapeutic efficacy of the orthodontic appliance while the user is asleep. Ideally, sleep start adjustments can avoid, reduce, or minimize events such as sleep apnea. Sleep start adjustments can prioritize the orthodontic appliance for treatment.

[0104] In some cases, the system can use the determined sleep state and / or sleep stage to refuse, allow, suspend, or resume desired adjustments. For example, if the system attempts to adjust an orthodontic appliance over a period of time (e.g., tens or hundreds of seconds), and if it determines that the user is in a micro-awake state, the system can suspend any adjustments to the orthodontic appliance and resume adjustments after the micro-awake state ends. Such control over adjustments can reduce the risk of accidentally waking the user or otherwise negatively impacting the user's sleep period.

[0105] In some cases, determining an adjustment at box 504 may include applying subjective feedback at box 508. Subjective feedback may include any subjective feedback received by the user or another individual, such as a healthcare professional or caregiver. Subjective feedback may be voluntary or requested. In some cases, with or without orthodontic treatment, subjective feedback is associated with historical sleep periods. In one instance, the user may provide feedback as a response to a prompt, such as a positive response to a question about whether the user felt adequately rested after a sleep period. In this instance, the system may determine an adjustment based on that positive response.

[0106] In some cases, subjective feedback may be associated with the orthodontic appliance, with sleep periods, or not. In one instance, a user may provide feedback as a response to a prompt, such as a negative response to a question about whether the orthodontic appliance feels comfortable in the user's mouth. In this instance, the system may determine an adjustment based on the negative response. In another instance, a user may provide voluntary feedback by interacting with controls on their device (e.g., a smartphone) or on the orthodontic appliance's storage. Based on the selected control, the system may determine an adjustment. For example, if the user selects a control associated with "too tight" or "too loose," the system may determine an adjustment that makes the orthodontic appliance feel looser or tighter, respectively.

[0107] In some cases, similar controls can be used at box 504 to directly control adjustments to the orthodontic appliance. For example, a control associated with “lengthening struts” can be used to force the system at box 504 to determine an adjustment that will result in lengthening of the associated strut in the orthodontic appliance.

[0108] In some cases, determining an adjustment at box 504 may include identifying and / or predicting an event at box 510. Identifying an event at box 510 may include using sensor data received from box 502 to identify that an event has occurred, and optionally classifying the event or determining other information associated with it. Once the occurrence of an event is identified, the system can make desired adjustments, such as adjustments designed to stop, reduce, or minimize the event or its effects. In one instance, upon determining that a sleep apnea event has occurred, the system may use a preset post-apnea adjustment. This preset post-apnea adjustment may be a preset adjustment or a preset algorithm used to determine the adjustment. The post-apnea adjustment may be designed to enhance the therapeutic efficacy of the orthodontic appliance in a particularly effective or desired manner after an apnea event. For example, the post-apnea adjustment may place the orthodontic appliance in a post-event state (e.g., a post-apnea event state). In the post-event state, the orthodontic appliance is particularly effective in stopping, reducing, or minimizing the occurrence of the event or subsequent events. However, since the orthodontic appliance may be less comfortable in the post-event state, the system can be further adjusted to restore the orthodontic appliance to a more comfortable state (e.g., the previous state, such as the post-sleep state) after the event has passed (e.g., after the event is no longer detected or after a preset period of time when the event is no longer detected).

[0109] Predicting an event at box 510 may include using sensor data received from box 502 to determine that a future event is likely to occur, and optionally classifying the future event or determining other information associated with it. Predicting a future event may include determining that the probability of the future event occurring is higher 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 orthodontic appliance, or any combination thereof, and may be compared with current physiological data, current sleep state or sleep stage data, adjustments or settings of the orthodontic appliance, or any combination thereof to predict the future event. When predicting a future event, the system may make desired adjustments, such as adjustments designed to avoid, stop, reduce, or minimize the future event or its impact. In one example, when it is determined that a future apnea event is likely to occur, the system may use a preset pre-apnea adjustment. The preset pre-apnea adjustment may be a preset adjustment or preset algorithm used to determine the adjustment. The pre-apnea adjustment may be designed to improve the therapeutic efficacy of the orthodontic appliance in a particularly effective or desired manner to avoid, reduce, or minimize the future apnea event. For example, the pre-apnea adjustment may place the orthodontic appliance in a pre-event state (e.g., a pre-apnea event state). In the pre-event state, orthodontic appliances are particularly effective in avoiding, reducing, or minimizing future events. However, because orthodontic appliances may be less comfortable in the pre-event state, the system can be further adjusted to restore the orthodontic appliance to a previous state (e.g., the post-sleep state) after the future event has passed (e.g., after the future event is no longer detected or after a preset period of time when the future event is no longer detected) or after a specific duration has passed and no event has occurred (e.g., the duration after the predicted future event or the time when the predicted future event occurred or the duration after that time).

[0110] In some cases, determining an adjustment at box 504 may include accessing one or more historical adjustments (e.g., historical adjustment data) at box 512. One or more historical adjustments can be used to help determine the current adjustment to be made, such as the type and / or extent of the adjustment. In one instance, historical adjustment data may be compared with sensor data (e.g., sensor data received at box 502 and / or historical sensor data received at box 518) to determine the effect of a previous adjustment (e.g., the immediately preceding previous adjustment or other historical adjustments). If a previous adjustment was not as effective as expected or was too uncomfortable, the system may modify and determine an adjustment suitable for the desired outcome. For example, if a previous adjustment failed to reduce or increase the frequency of apnea events, the current adjustment may include reverting some or all of the previous adjustment.

[0111] In some cases, determining adjustments at box 504 may include determining physiological data at box 514 based on sensor data from box 502. The physiological data can be used to determine the desired adjustments. Determining the physiological data may include determining respiratory rate, heart rate, blood oxygen level, the number of apnea events, the frequency of apnea events, or other physiological data associated with the user. The physiological data may be associated with the user during or outside of sleep periods. For example, a particular adjustment may be particularly useful when it is determined that the user's blood oxygen level drops below a threshold when the user falls asleep. As another example, a particular adjustment may be particularly useful for improving the user's sleep period when it is determined that the user's average respiratory rate or heart rate exceeds a defined threshold during a period prior to sleep. In some cases, determining physiological data at box 514 may include determining whether the apnea event that has occurred is an obstructive apnea event or a central apnea event. If a central apnea event is determined to have occurred, an indication that a central apnea event has been detected may be presented to the user or another user (e.g., a healthcare professional or caregiver), and optionally, an indication that an orthodontic appliance may be unsuitable for treating central apnea.

[0112] In some cases, determining adjustments using the identified physiological data at box 514 may include identifying desired changes in the physiological data (e.g., the expectation of increasing blood oxygen levels) and then determining adjustments to achieve those desired changes. Since process 500 can operate as a feedback loop, as described further herein, the system can monitor the physiological data over time to determine whether the determined adjustments successfully achieve the desired changes in the physiological data. The adjustments made and the resulting changes in the physiological data can be used to train models (e.g., machine learning models) associated with individual sleep periods, individual users, individual orthodontic appliances, and / or individual orthodontic appliance styles. Therefore, as the system is used over time, it can more accurately and effectively determine the adjustments to be made.

[0113] In some cases, determining the adjustment at box 504 may include determining autonomic tension at box 516 based on sensor data from box 502. Autonomic tension can be used to determine the desired adjustment. For example, if a change in autonomic tension indicating increased sympathetic activity is detected (e.g., a change in autonomic tension associated with the fight-or-flight response), the system may use adjustments such as reverting to a previous adjustment, slowing down the rate of the current adjustment, or otherwise moving the orthodontic appliance to a more comfortable position. Therefore, determining autonomic tension at box 516 can help avoid unintentionally waking the user.

[0114] In some cases, determining an adjustment at box 504 may include any combination of one or more of boxes 506, 508, 510, 512, 514, and 516. In some cases, determining an adjustment at box 504 may include other boxes besides or alternatives to any of boxes 506, 508, 510, 512, 514, and 516.

[0115] At box 520, the system may facilitate the application of the determined adjustment to the orthodontic appliance. In some cases, facilitating the application of the determined adjustment includes taking direct actions to apply the determined adjustment to the orthodontic appliance. For example, such direct actions may include sending a signal to the orthodontic appliance to cause it to adjust, or sending a signal to the orthodontic appliance reservoir to cause it to adjust the appliance. However, in some cases, facilitating the application of the determined adjustment may include taking actions that indirectly cause the determined adjustment to be applied to the orthodontic appliance. For example, such indirect actions may include taking actions that help a user, another person (e.g., a healthcare professional or caregiver), or another system apply the determined adjustment.

[0116] In some cases, facilitating the adjustment determined by the application at box 520 may include sending a signal (e.g., an adjustment signal) to the orthodontic appliance. This signal can be sent to the orthodontic appliance via any suitable technology, such as wired or wireless transmission. Wireless transmission is often preferred. The signal may be sent to the orthodontic appliance when it is used by the user (e.g., worn in the user's mouth), although this is not always the case. In some cases, the signal may be sent to the orthodontic appliance when it is stored in an orthodontic appliance storage container.

[0117] In some cases, facilitating the adjustment determined by the application at box 520 may include presenting one or more adjustment parameters to facilitate manual adjustment at box 522. Adjustment parameters may include instructions on what adjustment must be made (e.g., “shorten the connecting strut by 1 mm”) and / or guidance on how to achieve the desired adjustment (e.g., “remove part A from slot A and then insert part A into slot B”) (e.g., step-by-step guidance). Presenting adjustment parameters may include displaying the adjustment parameters on a device (e.g., illuminating the area of ​​the orthodontic appliance to be adjusted), such as on a user device (e.g., a smartphone or computer), on a display of the orthodontic appliance storage device, and / or on the orthodontic appliance itself. In some cases, presenting adjustment parameters may include displaying the adjustment parameters as an overlay on a graphic of the orthodontic appliance and / or as an augmented reality overlay on an image of the orthodontic appliance (e.g., a live image or a non-live image of the orthodontic appliance). In some cases, presenting adjustment parameters may include generating a printed output of the adjustment parameters. As a result of presenting the adjustment parameters at box 522, it can prompt and guide the user or another person to manually adjust the orthodontic appliance, and the orthodontic appliance can be manually adjusted. As used herein, the term "automatic adjustment" regarding orthodontic appliances can include automatically presenting adjustment parameters to facilitate manual adjustment of the orthodontic appliance.

[0118] In some cases, facilitating the application of the determined adjustment at block 520 may include actuating actuators in the orthodontic appliance to apply the adjustment at block 524. At block 524, the system may cause a signal to be sent to the orthodontic appliance to actuate one or more actuators of the appliance. In the case where block 524 occurs while the user is currently using the orthodontic appliance, the technology used for sending the signal is typically wireless transmission. However, in some cases, block 524 may occur after the orthodontic appliance has been removed from the user's mouth, such as when the orthodontic appliance is placed in an appliance storage container. In such cases, actuators in the orthodontic appliance may be actuated to achieve the adjustment using a wired connection via a set of exposed contacts on the orthodontic appliance. However, wireless transmission may generally be preferred. In response to the transmitted signal, one or more actuators of the orthodontic appliance may be actuated, which may manipulate one or more adjustable aspects of the orthodontic appliance to achieve the determined adjustment.

[0119] In some cases, facilitating the application of the determined adjustment at box 520 may include actuating an actuator in the orthodontic appliance reservoir at box 526 to apply the adjustment. At box 526, the system may actuate one or more actuators within the orthodontic appliance reservoir to perform the determined adjustment on the orthodontic appliance. In some cases, box 526 includes waiting for a start command from the user and / or waiting for the orthodontic appliance to be accepted by the orthodontic appliance reservoir (e.g., receiving sensor data indicating that the orthodontic appliance is accepted by the orthodontic appliance reservoir). In some cases, box 526 includes, for example, automatically aligning the orthodontic appliance within the receiving space of the orthodontic appliance reservoir using sensor data. In some cases, box 526 may include using sensor data to determine whether the orthodontic appliance is correctly positioned within the receiving space of the orthodontic appliance reservoir, continuing adjustment only if the orthodontic appliance is correctly positioned, and optionally warning the user if the orthodontic appliance is not correctly positioned. In some cases, box 526 may include using sensor data to determine whether the adjustment was successful.

[0120] In some cases, facilitating the adjustments determined by the application at box 520 may include activating and / or adjusting an electrical stimulator in the orthodontic appliance at box 528. In some cases, the orthodontic appliance may include an optional electrical stimulator. The electrical stimulator may include a voltage source and electrodes for delivering voltage to the user's tissues. The electrical stimulator may be designed to stimulate muscles and / or tissues in the user's oral cavity, such as the tongue (e.g., via the tongue muscles or nerves). The electrical stimulator may be used to apply additional treatments to sleep disorders, such as stopping, avoiding, reducing, or minimizing tongue contractions during apnea events. Activating the electrical stimulator at box 528 may include sending a signal that is received by the orthodontic appliance and causes the appliance to initiate electrical stimulation. Adjusting the electrical stimulator at box 528 may include adjusting settings of the orthodontic appliance associated with the electrical stimulator (e.g., software settings). Settings associated with the electrical stimulator may control any suitable aspects of the electrical stimulator, including how and when electrical stimulation is generated and / or delivered to the user.

[0121] In some cases, the adjustments determined by the application at box 520 may include any combination of one or more of boxes 522, 524, 526, and 528. In some cases, the adjustments determined by the application at box 520 may include actions other than or alternative to any of boxes 522, 524, 526, and 528. For example, in some cases, the adjustments determined by the application at box 520 may include adjusting the software settings of the orthodontic appliance. Such software settings may be adjusted in a manner similar to adjusting the electrical stimulator at box 528, but may not involve the use of the electrical stimulator.

[0122] In some cases, after an adjustment is facilitated at box 520, such as after an adjustment has been implemented, process 500 can continue again at a new example at box 502 to receive additional sensor data, and at a new example at box 504 to determine one or more additional adjustments. Based on one or more additional adjustments, the new example at box 520 allows the system to facilitate the application of the determined additional adjustments to the orthodontic appliance. In this way, the system can dynamically adjust the orthodontic appliance in a feedback loop. Therefore, the system can continuously and repeatedly use feedback from one or more previous adjustments (e.g., immediately following a previous adjustment) to determine and implement new adjustments.

[0123] In some optional cases, in addition to applying the determined adjustments at box 520, process 500 may also include sending a signal to an external device at box 530. The signal sent at box 530 may adjust the settings of the external device, such as causing the external device to take actions that affect the user's sleep period, such as actions that affect the effectiveness of orthodontic appliance treatment. In some cases, the signal sent at box 530 occurs only after it is determined (e.g., based on analysis of sensor data received from box 502) that the user is using an orthodontic appliance. In some cases, the signal sent to the external device causes the external device to prompt the user to enter a desired sleeping position. In some cases, the signal sent to the external device at box 530 occurs only when other conditions are met, such as if it is determined (e.g., based on sensor data) that the user is sleeping in an undesirable sleeping position or if the user is in a specific sleep state or sleep stage.

[0124] In one example, when sensor data received at box 502 indicates that a user is using an orthodontic appliance and optionally indicates that the user is sleeping in a supine position, the system may send a signal at box 530 to an external device that is an inflatable air bladder (e.g., an inflatable air bladder in a pillow or mattress), which may cause the inflatable air bladder to inflate and prompt the user to assume a side-lying position. As other examples, sending a signal to an external device at box 530 may include sending a signal to increase or decrease the firmness of the mattress, increase or decrease the ambient temperature, increase or decrease the ambient light level, increase or decrease the ambient sound level (e.g., the level of white noise or other sounds), or take other actions.

[0125] While certain aspects and features of this disclosure are presented with regard to the use of oral appliances such as mandibular repositioning devices, such aspects and features can be used with regard to neurostimulation devices. Such neurostimulation devices can be incorporated into oral appliances (e.g., as described in reference box 528 above), although this is not always the case. In some cases, the neurostimulation device can be placed on or under the skin, such as at or near a nerve like the hypoglossal nerve (e.g., positioned such that the electrodes of the neurostimulation device are located at or near the nerve). Therefore, the above description of systems and methods including oral appliances and the appended claims also apply to neurostimulation devices.

[0126] In cases where a neurostimulation device is used as a supplement to or alternative to an orthodontic appliance, process 500 can be used to determine adjustments associated with the neurostimulation device and facilitate the application of such adjustments. For example, the determined adjustments may be the type, level, and / or location of the output stimulus (e.g., electrical stimulation supplied to elicit a response in a nerve or muscle). In one instance, the determined adjustments include hypoglossal nerve stimulation from a neurostimulation device implanted under the skin, which emits stimulation pulses synchronized with the patient's breathing and causes stimulation of the genioglossus muscle to move the user's tongue forward, thereby preventing or reversing airway obstruction. The determination of adjustments can occur similarly to that in box 504, but applied to the neurostimulation device.

[0127] The adjustments determined by the application can occur similarly to those in box 520, but are applied to a neurostimulation device. For example, the adjustments can be performed manually (e.g., by a user, physician, or technician) or remotely.

[0128] When sensor data (e.g., sensor data received at box 502) is supplied by a non-contact sensor including active and / or passive acoustic sensors (such as acoustic sensor 141 described herein), determining (and facilitating) adjustments to the neurostimulation device can be particularly useful. In such cases, non-contact sensors that do not disturb the user's sleep and do not interfere with the neurostimulation device can be used to accurately and intelligently control and / or adjust the neurostimulation device.

[0129] In instances where neurostimulation devices are used instead of orthodontic appliances as described herein, adjustments during the pre-sleep state may involve imperceptible stimuli designed to strengthen neck muscles to reduce the likelihood of sleep apnea or other events. For example, a neurostimulation device may generate stimuli to strengthen upper airway dilators such as the genioglossus and tensor veli palatini, which are innervated by the hypoglossal nerve. Similar to those using orthodontic appliances, systems using neurostimulation devices may also utilize and control external devices, such as inflatable balloons; adjustments may be determined based on physiological data, estimates of autonomic nerve tone, or the use of one or more sensors embedded in a smartphone or tablet; and, where appropriate, may function in other ways as described herein with respect to orthodontic appliances.

[0130] One or more elements or aspects or steps or any part thereof from the appended claims may be combined with one or more other elements or aspects or steps or any part thereof from the appended claims to form one or more additional embodiments of this disclosure.

[0131] While this disclosure has been described with reference to one or more specific embodiments or implementations, those skilled in the art will recognize that many changes can be made thereto without departing from the spirit and scope of this disclosure. Each of these implementations and their obvious variations is considered to fall within the spirit and scope of this disclosure. It is also contemplated that additional embodiments according to various aspects of this disclosure may combine any number of features of any of the embodiments described herein.

Claims

1. A system for adjusting an orthodontic appliance, comprising: Oral appliances configured for use by users to treat sleep disorders; One or more sensors; Orthodontic appliance storage device, configured to receive the orthodontic appliance when the user is not using it; A control system, the control system comprising one or more processors; as well as A memory, to which the control system is coupled, stores machine-readable instructions that, when executed on one or more processors, cause the one or more processors to perform operations, including: Receive sensor data from one or more sensors; Automatically determine adjustments associated with the orthodontic appliance based on the sensor data; and In response to automatically determining the adjustment, facilitating the application of the determined adjustment to the orthodontic appliance, wherein facilitating the application of the determined adjustment includes actuating one or more actuators of the orthodontic appliance reservoir to apply the determined adjustment to the orthodontic appliance.

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

3. The system according to claim 1, wherein the oral appliance is a mandibular repositioning device.

4. The system of claim 1, wherein facilitating the application of the determined adjustment includes sending an adjustment signal to the orthodontic appliance.

5. The system of claim 1, wherein facilitating the application of the determined adjustment includes dynamically or asynchronously adjusting the orthodontic appliance based on the determined adjustment.

6. The system of claim 1, wherein facilitating the application of the determined adjustment comprises dynamically or asynchronously adjusting the orthodontic appliance based on the determined adjustment, and wherein, The operation also includes: Additional sensor data is received from the one or more sensors, wherein the additional sensor data is associated with the use of the orthodontic appliance after the appliance has been dynamically or asynchronously adjusted based on the determined adjustments; Automatically determine additional adjustments associated with the orthodontic appliance based on the additional sensor data; and In response to automatically determining the additional adjustments, the determined additional adjustments are facilitated to be applied to the orthodontic appliance.

7. The system of claim 6, wherein automatically determining the adjustment associated with the orthodontic appliance based on the sensor data comprises: The user is determined to be in a pre-sleep state, wherein the determined adjustment is a preset pre-sleep adjustment for the pre-sleep state.

8. The system of claim 6, wherein automatically determining the adjustment associated with the orthodontic appliance based on the sensor data comprises: It is determined that the user is in a state after sleep has started, wherein the determined adjustment is a preset adjustment for the state after sleep has started.

9. The system of claim 6, wherein automatically determining the adjustment associated with the orthodontic appliance based on the sensor data comprises: Identify apnea events, wherein the determined adjustment is a preset apnea post-adjustment available after the apnea event is detected.

10. The system of claim 6, wherein automatically determining the adjustment associated with the orthodontic appliance based on the sensor data comprises: Predicting future apnea events, wherein the determined adjustments are pre-apnea adjustments for avoiding or minimizing the future apnea events.

11. The system of claim 1, wherein the orthodontic appliance includes an electrical stimulator for applying electrical stimulation to the user, and wherein applying the determined adjustment includes activating the electrical stimulator.

12. The system of claim 1, wherein the orthodontic appliance includes an electrical stimulator for applying electrical stimulation to the user, and wherein applying the determined adjustment includes adjusting the settings of the electrical stimulator.

13. The system of claim 11 or claim 12, wherein the electrical stimulator comprises one or more electrodes for directing the electrical stimulation to the user's tongue muscles or tongue nerves, and wherein, Applying the determined adjustment also includes directing the electrical stimulation to the user's tongue muscles or tongue nerves via the one or more electrodes.

14. The system of claim 1, wherein the operation further comprises: Based on the received sensor data, it is determined that the user is using the orthodontic appliance; as well as In response to determining that the user is using the orthodontic appliance, a signal is sent to an external device, wherein the signal, when received by the external device, adjusts the settings of the external device.

15. The system of claim 14, wherein the external device includes an inflatable airbag, and wherein adjusting the settings of the external device includes adjusting the inflatable airbag to induce the user into a desired sleeping position.

16. The system of claim 1, wherein the operation further includes accessing historical sensor data associated with the user's previous use of the orthodontic appliance, wherein the automatic determination of the adjustment is also based on the historical sensor data.

17. The system of claim 1, wherein the operation further comprises: Receive subjective feedback from the user; as well as The subjective feedback is correlated with the sensor data. The automatic determination of the adjustment is also based on the subjective feedback associated with the sensor data.

18. The system of claim 1, wherein the operation further comprises determining a sleep stage based on the sensor data, wherein automatically determining the adjustment includes using the determined sleep stage.

19. The system of claim 1, wherein automatically determining the adjustment comprises: Physiological data are determined based on the sensor data, wherein the physiological data includes respiratory rate, heart rate, or blood oxygen level; Identify the expected changes in the physiological data; as well as The adjustment is determined based on the expected changes in the physiological data.

20. The system of claim 1, wherein automatically determining the adjustment comprises: Estimate the user's autonomic nervous tension based on the sensor data; Identify the desired changes in autonomic nerve tension; as well as The adjustment is determined based on the expected change in autonomic nerve tension.

21. The system of claim 1, wherein the one or more sensors are housed in a smartphone or tablet.

22. The system of claim 1, wherein the one or more sensors include one or more sensors in the orthodontic appliance, one or more sensors in the orthodontic appliance storage, one or more sensors in the user device, one or more sensors in the external device, one or more sensors in the control system, one or more sensors positioned on or in contact with a portion of the user, one or more sensors worn by the user, one or more non-contact sensors spaced apart from the user, or any combination thereof.

23. The system of claim 22, wherein one or more sensors in the orthodontic appliance are configured to detect that the orthodontic appliance has been received by the orthodontic appliance storage unit.

24. The system of claim 22, wherein one or more sensors in the orthodontic appliance reservoir are configured to detect that the orthodontic appliance has been received by the orthodontic appliance reservoir.

25. The system of claim 1, wherein the sleep disorder is a sleep-disordered breathing disorder.

26. The system of claim 25, wherein the sleep disorder is obstructive sleep apnea.

27. The system of claim 1, wherein the operation further comprises: Access at least one historically determined adjustment associated with the orthodontic appliance based on historical sensor data from previous use of the appliance; as well as The validity of the at least one historical determination adjustment is determined based on at least one of the sensor data and the historical sensor data. The automatic determination of the adjustment also relies on the determined history to determine the validity of the adjustment.

28. The system of claim 1, wherein actuating the one or more actuators of the orthodontic appliance reservoir changes the position of the upper dental tray of the orthodontic appliance relative to the lower dental tray of the orthodontic appliance.

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