Systems and methods for analyzing individual physical characteristics

Abstract

This invention discloses a method for analyzing the physical characteristics of an individual, the method comprising: receiving data generated by one or more sensors of a handheld device, the data indicating structural features of the individual's head, neck, or both; generating a structural profile of the individual's head, neck, or both based at least in part on the data; determining, in response to generating the structural profile, risk factors for the individual to have sleep-disordered breathing, to develop sleep-disordered breathing, or both; and generating recommendations for the individual for a treatment type based at least in part on the structural profile, wherein the recommendations for the treatment type include recommendations for using a mandibular repositioning device, recommendations for using a respiratory therapy device, or both.

Description

[0001] Divisional application statement

[0002] This application is a divisional application of Chinese invention patent application filed on April 30, 2021, with application number 2021800469794 and invention title "System and method for analyzing the physical characteristics of an individual".

[0003] Cross-references to related applications

[0004] This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 018,449, filed April 30, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0005] The present invention generally relates to systems and methods for analyzing a user’s physical characteristics, and more specifically to systems and methods for generating structural profiles of a user’s head, neck and mouth in order to identify risk factors associated with the development of sleep-disordered breathing. Background Technology

[0006] Many individuals suffer from sleep-related and / or breathing disorders, such as periodic limb movement disorder (PLMD), restless legs syndrome (RLS), sleep-disordered breathing (SDB), obstructive sleep apnea (OSA), respiratory effort-related arousal (RERA), central sleep apnea (CSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity-related hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), rapid eye movement (REM) behavior disorder (also known as RBD), dream-like behavior (DEB), insomnia, and chest wall disorders. Individuals with certain physical characteristics associated with their head and neck are generally at increased risk of developing these conditions, including SBD and OSA. However, measuring and tracking these characteristics over long periods can be difficult, and for most individuals, it may be challenging to determine how these physical characteristics relate to their risk of developing these conditions. Therefore, it would be advantageous to be able to accurately monitor an individual's physical characteristics and determine the individual's risk of developing any of these conditions. This invention relates to systems, apparatus, and methods that allow for easier tracking of an individual's physical characteristics and, based on said physical characteristics, determine the risk of developing any of these or other conditions. Summary of the Invention

[0007] According to some implementations of the present invention, a method for analyzing the body characteristics of an individual includes using an acoustic sensor to direct an acoustic signal toward the mouth of the individual, the acoustic signal being configured to reflect away from at least a portion of the interior of the individual's mouth; using the acoustic sensor to receive the reflected acoustic signal from the interior of the individual's mouth, the reflected acoustic signal indicating structural features of the individual's mouth; generating a structural profile of at least the interior of the mouth of the individual based at least in part on the reflected acoustic signal; and in response to generating the structural profile, causing an action to be performed.

[0008] According to some implementations of the invention, an apparatus for positioning a handheld device adjacent to the mouth of an individual includes a mouth portion configured to be at least partially inserted into the mouth of the individual; and a handheld device portion configured to securely accommodate at least a portion therein, such that when the mouth portion is at least partially inserted into the mouth of the individual, an acoustic sensor of the handheld device is in fluid communication with the interior of the mouth of the individual.

[0009] According to some implementations of the present invention, a system for analyzing the body characteristics of an individual includes: a handheld device including an acoustic sensor; and a device configured to be inserted into a user's mouth. The device includes a mouth portion and a handheld device portion. The mouth portion is configured to be at least partially inserted into the mouth of the individual. The handheld device portion is configured to securely receive the handheld device such that when the mouth portion of the device is at least partially inserted into the mouth of the individual, the acoustic sensor of the handheld device is in fluid communication with the interior of the individual's mouth, and the handheld device is configured to perform a method. The method includes directing an acoustic signal towards the mouth of the individual using the acoustic sensor. The acoustic signal is configured to reflect away from at least a portion of the interior of the individual's mouth. The method further includes receiving the reflected acoustic signal from the interior of the individual's mouth using the acoustic sensor. The reflected acoustic signal represents a structural feature of the individual's mouth. The method further includes generating a structural profile of at least the interior of the individual's mouth based at least partially on the reflected acoustic signal. The method further includes: in response to generating the structural profile, causing an action to be performed.

[0010] The above overview is not intended to represent every implementation or aspect of the invention. Additional features and advantages of the invention will become apparent from the detailed description and accompanying drawings. Attached Figure Description

[0011] Figure 1 This is a functional block diagram of a system for monitoring sleep periods according to some implementations of the present invention;

[0012] Figure 2 This is according to some implementations of the present invention. Figure 1A perspective view of the system, the system's users, and the users' bed partners;

[0013] Figure 3 An exemplary timeline of sleep periods according to some implementations of the present invention is shown;

[0014] Figure 4 It is based on some implementations of the present invention and Figure 3 An exemplary hypnosis diagram associated with sleep periods;

[0015] Figure 5 This is a flowchart illustrating a method for analyzing an individual's physical characteristics according to some implementations of the present invention;

[0016] Figure 6A It is a perspective view of a user holding a smartphone to generate image data associated with the user's head and / or neck;

[0017] Figure 6B It is when the user keeps their smartphone on Figure 6A When the position shown is Figure 6A The view of a smartphone's display;

[0018] Figure 7A It is a perspective view of a user holding a smartphone to generate image data associated with the inside of the user's mouth;

[0019] Figure 7B It is when the user keeps their smartphone on Figure 7A When the position shown is Figure 7A The view of a smartphone's display;

[0020] Figure 8 It is a side view of the user holding a smartphone with the first device to generate acoustic data associated with the inside of the user's mouth;

[0021] Figure 9A yes Figure 8 Front perspective view of the device;

[0022] Figure 9B yes Figure 8 Rear perspective view of the device;

[0023] Figure 9C yes Figure 8 An exploded view of the device, the smartphone, and the user's mouth;

[0024] Figure 10A yes Figure 8 Top cross-sectional view of the device;

[0025] Figure 10B Is it to keep your smartphone Figure 8 Top cross-sectional view of the device;

[0026] Figure 11 It is a side view of a user holding a smartphone with a second device to generate image data associated with the exterior of the user's head and / or neck and acoustic data associated with the interior of the user's mouth;

[0027] Figure 12A A perspective cross-sectional view showing a user biting down on a third device to hold the smartphone in place when it transmits sound signals into their mouth.

[0028] Figure 12B It is when the smartphone transmits sound signals into the user's mouth and the user bites down. Figure 12A A side cross-sectional view of the device;

[0029] Figure 13A It is when the smartphone receives an acoustic signal reflected from the user's mouth and the user bites down. Figure 12A A perspective cross-sectional view of the device;

[0030] Figure 13B It is when the smartphone receives an acoustic signal reflected from the user's mouth and the user bites down. Figure 12A A side cross-sectional view of the device.

[0031] While the present invention is susceptible to various modifications and substitutions, its specific implementations and embodiments have been illustrated by way of example in the accompanying drawings and will be described in detail herein. However, it should be understood that this is not intended to limit the invention to the specific forms disclosed, but rather, the invention is intended to cover all modifications, equivalents, and substitutions falling within the spirit and scope of the invention as defined by the appended claims. Detailed Implementation

[0032] Many individuals suffer from sleep-related and / or breathing disorders, such as periodic limb movement disorder (PLMD), restless legs syndrome (RLS), sleep-disordered breathing (SDB), obstructive sleep apnea (OSA), respiratory effort-related arousal (RERA), central sleep apnea (CSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity-related hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), rapid eye movement (REM) behavior disorder (also known as RBD), dream-disordered behavior (DEB), insomnia, and chest wall disorder.

[0033] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events during sleep that result in closure or obstruction of the upper airway caused by a combination of abnormally small upper airway and loss of normal muscle tone in the areas of the tongue, soft palate and posterior oropharyngeal wall.

[0034] Central sleep apnea (CSA) is another form of sleep apnea-drowsiness (SDB) that occurs when the brain temporarily stops sending signals to the muscles that control breathing. More generally, apnea generally refers to the cessation of breathing caused by air blockage (or cessation of breathing function). Typically, during an obstructive sleep apnea event, an individual will stop breathing for about 15 to 30 seconds. Mixed sleep apnea is another form of SDB, which is a combination of obstructive sleep apnea (OSA) and CSA.

[0035] Other types of apnea include hypoventilation, hyperventilation, and hypercapnia. Hypoventilation is typically characterized by slow or shallow breathing caused by a narrowed airway, rather than airway obstruction. Hyperventilation is typically characterized by increased respiratory depth and / or rate. Hypercapnia is typically characterized by an excess of carbon dioxide in the bloodstream and is usually caused by hypoventilation.

[0036] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a dysregulation of the patient's respiratory controller, in which there is a rhythmic alternation of waxing and waning ventilation called the CSR cycle. CSR is characterized by repetitive hypoxia and reoxygenation of arterial blood.

[0037] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness, without other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0038] Chronic obstructive pulmonary disease (COPD) includes any of the lower airway diseases that share certain common characteristics, such as increased resistance to air movement, prolonged expiratory phase of breathing, and loss of normal lung elasticity.

[0039] Neuromuscular diseases (NMD) encompass a wide range of conditions and ailments that impair muscle function directly through intrinsic muscular pathology or indirectly through neuropathology. The chest wall is a group of thoracic deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity.

[0040] A respiratory effort-related awakening (RERA) event is typically characterized by an increased respiratory effort lasting ten seconds or longer, resulting in an awakening from sleep, and does not meet the criteria for apnea or hypopnea events. RERA is defined as a respiratory sequence characterized by increased respiratory effort leading to a sleep awakening, but not meeting the criteria for apnea or hypopnea. These events must meet two criteria: (1) a pattern of progressively more negative esophageal pressure, culminating in a sudden change in pressure to a lower negative level and termination of the awakening, and (2) the event lasting ten seconds or longer. In some implementations, a nasal cannula / pressure transducer system is sufficient and reliable for detecting RERA. The RERA detector can be based on an actual flow signal derived from a respiratory therapy device. For example, a flow restriction measure can be determined based on the flow signal. An awakening measure can then be derived from the flow restriction measure and the measure of the sudden increase in ventilation. One such method is described in WO 2008 / 138040, assigned to ResMed Ltd, the disclosure of which is incorporated herein by reference in its entirety.

[0041] RBD is a condition characterized by a lack of muscle tone during REM sleep, and in more severe cases, by motor and vocal disturbances that occur during REM sleep. RBD can sometimes be accompanied by DEB, in which individuals have dreams they might have, sometimes leading to injury to themselves or their partners.

[0042] These and other conditions are characterized by specific events that occur when an individual is sleeping (such as snoring, sleep apnea, insufficiency of breathing, restless legs, sleep disorders, suffocation, increased heart rate, difficulty breathing, asthma attacks, seizures, epilepsy, or any combination thereof).

[0043] The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea during sleep. An AHI is calculated by dividing the number of apnea and / or hypopnea events experienced by the user during a sleep period by the total number of hours of sleep in that period. An event can be, for example, an apnea lasting at least 10 seconds. An AHI less than 5 is considered normal. An AHI greater than or equal to 5 but less than 15 is considered an indicator of light sleep apnea. An AHI greater than or equal to 15 but less than 30 is considered an indicator of moderate sleep apnea. An AHI greater than or equal to 30 is considered an indicator of severe sleep apnea. In children, an AHI greater than 1 is considered abnormal. When the AHI is normal, or when the AHI is normal or mild, sleep apnea can be considered “controlled.” The AHI can also be used in conjunction with oxygen desaturation levels to indicate the severity of obstructive sleep apnea.

[0044] Various types of data can be used to monitor the health of individuals suffering from any of the aforementioned types of sleep-related and / or breathing disorders (or other disorders). However, it is often difficult to collect accurate data in a manner that does not interrupt or interfere with the user's sleep or any treatment the user may be undergoing during sleep. Therefore, it is advantageous to utilize therapeutic systems that incorporate various sensors to generate and collect data without interfering with the user, the user's sleep, or the user's treatment.

[0045] Reference Figure 1 This describes a system 100 according to some implementations of the invention. System 100 can be used to analyze a user's physical characteristics to determine an individual's risk of developing sleep-related and / or respiratory-related conditions, including those discussed herein. System 100 includes a control system 110, a memory device 114, an electronic interface 119, one or more sensors 130, and one or more user devices 170. In some implementations, system 100 may further optionally include a respiratory therapy system 120 (which includes a respiratory therapy device 122), a blood pressure device 180, an activity tracker 182, or any combination thereof.

[0046] Control system 110 includes one or more processors 112 (hereinafter, processor 112). Control system 110 is typically used to control various components of system 100 and / or analyze data acquired and / or generated by the components of system 100. 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 remotely to each other. The control system 110 (or any other control system) or a portion thereof, such as processor 112 (or any other processor or a portion thereof), may be used to perform one or more steps of any of the methods described herein and / or claimed. The control system 110 may be coupled to and / or located within, for example, the housing of user device 170, and / or the housing of one or more sensors 130. The control system 110 may be centralized (within one such housing) or distributed (within two or more physically different such housings). In this embodiment, which includes two or more housings containing the control system 110, such housings may be located close to and / or far from each other.

[0047] 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 storage devices, hard disk drives, solid-state drives, flash memory devices, etc. Although Figure 1 A 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.). The memory device 114 may be coupled to and / or located within the housing of the respiratory therapy device 122, the housing of the external device 170, the housing of one or more sensors 130, or any combination thereof. Similar to control system 110, the memory device 114 may be centralized (within one such housing) or distributed (within two or more physically different such housings).

[0048] In some implementations, memory device 114 stores a user profile associated with the user. The user profile may include, for example, user-associated demographic information, user-associated biostatistics, user-associated medical information, self-reported user feedback, user-associated sleep parameters (e.g., sleep-related parameters recorded from one or more earlier sleep periods), or any combination thereof. Demographic information may include, for example, information indicating the user's age, gender, ethnicity, geographic location, relationship status, family history (e.g., family history of sleep-related and / or respiratory-related illnesses), employment status, education status, socioeconomic status, or any combination thereof. Medical information may include, for example, information indicating one or more medical conditions associated with the user, the user's medication use, or both. Medical information data may further include Multisleep Latency Test (MSLT) results or scores and / or Pittsburgh Sleep Quality Index (PSQI) scores or values. Self-reported user feedback may include information indicating the following items in self-report: subjective sleep rating (e.g., poor, average, excellent), user's self-reported subjective stress level, user's self-reported subjective fatigue level, user's self-reported subjective health status, user's recent life events, or any combination thereof.

[0049] Electronic interface 119 is configured to receive data (e.g., physiological data and / or acoustic data) 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, IR communication protocols, via cellular networks, via any other optical communication protocols, 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 implementations, electronic interface 119 is coupled to or integrated into user device 170. In other implementations, electronic interface 119 is coupled to or integrated with control system 110 and / or memory device 114 (e.g., within a housing).

[0050] As described above, in some embodiments, system 100 may optionally include a therapeutic respiratory therapy system 120 (also known as a respiratory pressure therapy system). The respiratory therapy system 120 may include a respiratory therapy device 122 (also known as a respiratory pressure therapy device), a user interface 124, a conduit 126 (also known as a tube or air circuit), a display device 128, a humidifier canister 129, or any combination thereof. In some implementations, a control system 110, a memory device 114, a display device 128, one or more sensors 130, and a humidifier canister 129 are part of the respiratory therapy device 122. Respiratory pressure therapy refers to supplying air to the user's airway inlet at a controlled target pressure that is nominally positive relative to the atmosphere throughout the user's respiratory cycle (e.g., opposite to the negative pressure therapy of a canister ventilator or duct ventilator). The respiratory therapy system 120 is typically used to treat individuals who have one or more sleep-related breathing disorders (e.g., obstructive sleep apnea, central sleep apnea, or mixed sleep apnea), other breathing disorders such as COPD, or other disorders that result in respiratory insufficiency that may be present during sleep or wakefulness.

[0051] The respiratory therapy device 122 includes a blower motor (not shown), which is typically used to generate pressurized air delivered to the user (e.g., using one or more motors driving one or more compressors). In some implementations, the respiratory therapy device 122 generates a continuous, constant air pressure that is delivered to the user. In other implementations, the respiratory therapy device 122 generates two or more predetermined pressures (e.g., a first predetermined air pressure and a second predetermined air pressure). In yet another implementation, the respiratory therapy device 122 is configured to generate a variety of different air pressures within a predetermined range. For example, the respiratory therapy device 122 may deliver at least about 6 cm H2O, at least about 10 cm H2O, at least about 20 cm H2O, between about 6 cm H2O and about 10 cm H2O, between about 7 cm H2O and about 12 cm H2O, etc. The respiratory therapy device 122 may also deliver pressurized air at predetermined flow rates, for example, between about -20 L / min and about 150 L / min, while maintaining positive pressure (relative to ambient pressure). In some implementations, the control system 110, memory device 114, electronic interface 119, or any combination thereof may be coupled to the housing of the respiratory therapy device 122 and / or located within the housing of the respiratory device.

[0052] User interface 124 engages with a portion of the user's face and delivers pressurized air from respiratory therapy device 122 to the user's airway to help prevent airway narrowing and / or collapse during sleep. This also increases the user's oxygen intake during sleep. Typically, user interface 124 engages with the user's face such that pressurized air is delivered to the user's airway via the user's mouth, the user's nose, or both the user's mouth and nose. Respiratory therapy device 122, user interface 124, and conduit 126 together form an air passage fluidly connected to the user's airway. Pressurized air also increases the user's oxygen intake during sleep. Depending on the treatment to be applied, user interface 124 may form a seal with, for example, an area or portion of the user's face, thereby facilitating the delivery of air at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cm H2O relative to ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the user interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of approximately 10 cm H2O to the airway.

[0053] like Figure 2As shown, in some implementations, user interface 124 is or includes a mask (e.g., a full-face mask) covering the nose and mouth of user 210. Alternatively, user interface 124 is or includes a nasal mask that supplies air to the nose of user 210 or a nasal pillow mask that supplies air directly to the nostrils of user 210. User interface 124 may include a strap assembly having multiple straps (e.g., including hook and loop fasteners) and conformal pads (e.g., silicone, plastic, foam, etc.) for helping to position and / or stabilize user interface 124 on a portion of user 210 (e.g., face), and conformal pads for helping to provide an airtight seal between user interface 124 and user 210. In some implementations, user interface 124 may include a connector 127 and one or more vents 125. One or more vents 125 may be used to allow the escape of carbon dioxide and other gases exhaled by the user. In other implementations, the user interface 124 includes a suction nozzle (e.g., a night-protective suction nozzle molded to conform to the user's teeth, a mandibular repositioning device, etc.). In some implementations, the connector 127 differs from the user interface 124 (and / or the conduit 126) but can be connected to the user interface (and / or the conduit).

[0054] The conduit 126 (also referred to as an air circuit or tube) allows air to flow between two components of the respiratory therapy system 120, such as the respiratory therapy device 122 and the user interface 124. In some implementations, there may be separate branches for inspiratory and expiratory conduits 126. In other implementations, a single-branch air conduit is used for both inspiratory and expiratory processes.

[0055] One or more of the respiratory therapy device 122, user interface 124, conduit 126, display device 128, and humidifier 129 may include one or more sensors (e.g., pressure sensor, flow sensor, or any other sensor 130 described more generally herein). These one or more sensors can be used, for example, to measure the air pressure and / or flow rate of the pressurized air supplied by the respiratory therapy device 122.

[0056] Display device 128 is typically used to display images including still images, video images, or both, and / or information about the respiratory therapy device 122. For example, display device 128 may provide information about the status of the respiratory therapy device 122 (e.g., whether the respiratory therapy device 122 is on / off, the pressure of the air delivered by the respiratory therapy device 122, the temperature of the air delivered by the respiratory therapy device 122, etc.) and / or other information (e.g., sleep score or therapy score (also known as myAir)). TMScores, such as those described in WO 2016 / 061629, are incorporated herein by reference in their entirety; the current date / time; individual information of user 210, etc.). In some implementations, the display device 128 acts as a human-machine interface (HMI) including a graphical user interface (GUI) configured to display images as input. The display device 128 may be an LED display, an OLED display, an LCD display, etc. The 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 the respiratory therapy device 122.

[0057] The humidifier canister 129 is connected to or integrated into the respiratory therapy device 122 and includes a water reservoir for humidifying pressurized air delivered from the respiratory therapy device 122. The respiratory therapy device 122 may include one or more vents (not shown) and a heater for heating the water in the humidifier canister 129 to humidify the pressurized air supplied to the user 210. Additionally, in some implementations, the conduit 126 may include a heating element (e.g., coupled to and / or embedded in the conduit 126) that heats the pressurized air delivered to the user 210. The humidifier canister 129 may be fluidly coupled to a water vapor inlet of the air passage and deliver water vapor into the air passage via the water vapor inlet, or it may be formed in a straight line with the air passage as part of the air passage itself. In some implementations, the respiratory therapy device 122 and / or the conduit 126 may include a waterless humidifier. The waterless humidifier may include a sensor that interfaces with other sensors located elsewhere in the system 100.

[0058] The respiratory therapy system 120 can be used, for example, as a ventilator or as a positive airway pressure (PAP) system, such as a continuous positive airway pressure (CPAP) system, an automated positive airway pressure (APAP) system, a bilevel or variable positive airway pressure (BPAP or VPAP) system, or any combination thereof. The CPAP system delivers air to the user 210 at a predetermined pressure (e.g., determined by a sleep physician). The APAP system automatically changes the air pressure delivered to the user 210 based at least in part on respiratory data, for example, associated with the user 210. The BPAP or VPAP system is configured to deliver a first predetermined pressure (e.g., inspiratory positive airway pressure or IPAP) and a second predetermined pressure below the first predetermined pressure (e.g., expiratory positive airway pressure or EPAP).

[0059] Refer again Figure 2 The system 100 is shown according to some implementation methods. Figure 1As part of the respiratory therapy system 120, the user 210 and bed partner 212 are located in bed 230 and lie on mattress 232. A user interface 124 (also referred to herein as a mask, e.g., a full mask) can be worn by the user 210 during sleep. The user interface 124 is fluidly coupled and / or connected to the respiratory therapy device 122 via conduit 126. The respiratory therapy device 122, in turn, delivers pressurized air to the user 210 via conduit 126 and user interface 124 to increase air pressure in the user 210's throat, thereby helping to prevent airway closure and / or narrowing during sleep. The respiratory therapy device 122 may include a display device 128 that allows the user to interact with the respiratory therapy device 122. The respiratory therapy device 122 may also include a humidifier canister 129 that stores water for humidifying the pressurized air. The respiratory therapy device 122 may be positioned as follows: Figure 2 The device is located on a bedside table 234 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. The user may also wear a blood pressure monitor 180 and an activity tracker 182 while lying on the mattress 232 within the bed 230.

[0060] See again Figure 1 The 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, a radio frequency (RF) transmitter 148, a camera 150, an infrared (IR) sensor 152, a photoplethysmography (PPG) sensor 154, an electrocardiogram (ECG) sensor 156, an 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 (LiDAR) sensor 178, or any combination thereof. Typically, each of the one or more sensors 130 is configured to output sensor data that is received and stored in a memory device 114 or one or more other memory devices. Sensor 130 may also include an electrooculogram (EOG) sensor, a peripheral oxygen saturation (SpO2) sensor, a skin conductance response (GSR) sensor, a carbon dioxide (CO2) sensor, or any combination thereof.

[0061] Although 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, IR sensor 152, PPG sensor 154, ECG sensor 156, EEG sensor 158, capacitance sensor 160, force sensor 162, strain gauge sensor 164, 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.

[0062] One or more sensors 130 can be used to generate, for example, physiological data, acoustic data, or both, which are communicated with the user of the respiratory therapy system 120 (such as...). Figure 2 The user 210, the respiratory therapy system 120, both the user and the respiratory therapy system 120, or other entities, objects, or activities are associated with the user 210. The control system 110 may use physiological data generated by one or more sensors 130 to determine sleep-wake signals and one or more sleep-related parameters associated with the user 210 during sleep periods. Sleep-wake signals may indicate one or more sleep stages and / or sleep states (used interchangeably herein), including wakefulness, relaxed wakefulness, micro-wakefulness, or different sleep stages such as rapid eye movement (REM) stages (which may include typical REM stages and atypical REM periods), a first non-REM stage (commonly referred to as "N1"), a second non-REM stage (commonly referred to as "N2"), a third non-REM stage (commonly referred to as "N3"), or any combination thereof. Methods for determining sleep state and / or sleep stage based on physiological data generated by one or more sensors (e.g., one or more sensors 130) are described in, for example, WO 2014 / 047310, US 2014 / 0088373, WO2017 / 132726, WO 2019 / 122413 and WO 2019 / 122414, each of which is incorporated herein by reference in its entirety.

[0063] In some implementations, the sleep-wake signals described herein can be timestamped to indicate the time a user enters the bed, the time a user leaves the bed, the time a user attempts to fall asleep, etc. The sleep-wake signals can be measured by one or more sensors 130 during sleep periods at a predetermined sampling rate, such as one sample per second, one sample every 30 seconds, one sample per minute, etc. In some implementations, the sleep-wake signals can also indicate respiratory signals, respiratory rate, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory ratio, number of events per hour, event pattern, pressure setting of breathing device 122, or any combination thereof. Events can include snoring, sleep apnea, central sleep apnea, obstructive sleep apnea, mixed sleep apnea, hypopnea, mask leakage (e.g., from user interface 124), restless legs, sleep disturbance, suffocation, increased heart rate, difficulty breathing, asthma attack, seizure, epilepsy, fever, cough, sneezing, snoring, wheezing, the presence of illnesses such as the common cold or influenza, increased stress levels, etc. One or more sleep-related parameters that can be determined for a user during a sleep period based on sleep-wake signals include, for example, total time in bed, total sleep time, sleep onset wait time, wakefulness parameters after sleep onset, sleep efficiency, segmentation index, or any combination thereof. As described further in detail herein, physiological data and / or sleep-related parameters can be analyzed to determine one or more sleep-related scores.

[0064] Physiological and / or acoustic 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 represent the user's breathing during sleep periods. Other sleep-related parameters (or other parameters or measurements in general) can be determined from the physiological and / or acoustic data, and in some implementations, they can be determined from the respiratory signals themselves. One or more sleep-related parameters that can be determined for the user 210 during sleep periods include, for example, apnea-hypopnea index (AHI) score, sleep fraction, flow signal, respiratory signal, respiratory rate, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory ratio, occurrence of one or more times, number of events per hour, event pattern, sleep stage (also known as sleep state), pressure setting of the respiratory therapy device 122, heart rate, heart rate variability, user 210's movement, temperature, EEG activity, EMG activity, awakening, snoring, choking, coughing, whistling, wheezing, or any combination thereof. One or more events may include snoring, apnea, central apnea, obstructive apnea, mixed apnea, hypopnea, intentional mask leakage (e.g., from user interface 124), unintentional mask leakage, mouth leakage, coughing, restless legs, sleep disturbance, apnea, tachycardia, dyspnea, asthma attack, seizure, epilepsy, elevated blood pressure, or any combination thereof. Many of the described sleep-related parameters are physiological parameters, although some sleep-related parameters may be considered non-physiological parameters. Other types of physiological and / or non-physiological parameters may also be determined based on data from one or more sensors 130 or based on other types of data.

[0065] Pressure sensor 132 outputs pressure data that can be stored in memory device 114 and / or analyzed by processor 112 of control system 110. In some implementations, pressure sensor 132 is an air pressure sensor (e.g., an atmospheric pressure sensor) that generates sensor data indicating the breathing (e.g., inhalation and / or exhalation) and / or ambient pressure of the user of respiratory therapy system 120. In such implementations, pressure sensor 132 can be coupled to or integrated into respiratory therapy device 122. Pressure sensor 132 can be, for example, a capacitive sensor, an inductive sensor, a resistive sensor, an electromagnetic sensor, a piezoelectric sensor, a strain gauge sensor, an optical sensor, a potential sensor, or any combination thereof. In some implementations, pressure sensor 132 can be used to determine the user's blood pressure.

[0066] The flow sensor 134 outputs flow data that can be stored in memory device 114 and / or analyzed by processor 112 of control system 110. An example of a flow sensor (e.g., flow sensor 134) is described in International Publication No. WO 2012 / 012835, which is incorporated herein by reference in its entirety. In some implementations, flow sensor 134 is used to determine the airflow rate from respiratory therapy device 122, the airflow rate through conduit 126, the airflow rate through user interface 124, or any combination thereof. In such implementations, flow sensor 134 can be coupled to or integrated into respiratory therapy device 122, user interface 124, or conduit 126. Flow sensor 134 can be a mass flow sensor, such as a rotary flow meter (e.g., a Hall effect flow meter), turbine flow meter, orifice flow meter, ultrasonic flow meter, hot wire sensor, eddy current sensor, membrane sensor, or any combination thereof. In some implementations, the flow sensor 134 is configured to measure ventilation flow (e.g., intentional “leakage”), unintentional leakage (e.g., mouth leak and / or mask leak), patient flow (e.g., air entering and / or leaving the lungs), or any combination thereof. In some implementations, flow data can be analyzed to determine a user’s cardiogenic oscillations. In one example, the pressure sensor 132 can be used to determine a user’s blood pressure.

[0067] 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 implementations, temperature sensor 136 generates temperature data indicating: user 210 ( Figure 2 The temperature sensor 136 may be, for example, the core body temperature of the user 210, the skin temperature of the user 210, the temperature of the air flowing from the respiratory therapy device 122 and / or through the conduit 126, the temperature in the user interface 124, the ambient temperature, or any combination thereof. The temperature sensor 136 may be, for example, a thermocouple sensor, a thermistor sensor, a silicon bandgap temperature sensor or a semiconductor-based sensor, a resistance temperature detector, or any combination thereof.

[0068] Motion sensor 138 outputs motion data that can be stored in memory device 114 and / or analyzed by processor 112 of control system 110. Motion sensor 138 can be used to detect movement of user 210 during sleep, and / or movement of any component of respiratory therapy system 120, such as respiratory therapy device 122, user interface 124, or catheter 126. Motion sensor 138 may include one or more inertial sensors, such as accelerometers, gyroscopes, and magnetometers. In some implementations, motion sensor 138 alternatively or additionally generates one or more signals representing the user's body movements, from which signals representing the user's sleep state can be obtained; for example, through the user's breathing movements. In some implementations, motion data from motion sensor 138 can be combined with additional data from another sensor 130 to determine the user's sleep stage. Motion sensor 138 can be used to detect motion or acceleration associated with an arterial pulse, such as a pulse in or around the user's face and near user interface 124, and is configured to detect characteristics of the pulse shape, velocity, amplitude, or volume.

[0069] The output of microphone 140 may be stored in memory device 114 and / or analyzed by processor 112 of control system 110. The acoustic data generated by microphone 140 can be reproduced as one or more sounds (e.g., sounds from the user) during a sleep period to determine (e.g., using control system 110) one or more sleep-related parameters, as described further herein. The acoustic data from microphone 140 can also be used to identify (e.g., using control system 110) events experienced by the user during a sleep period, as described further herein. In other implementations, the acoustic data from microphone 140 represents noise associated with respiratory therapy system 120. In some implementations, system 100 includes multiple microphones (e.g., two or more microphones and / or a microphone array with beamforming), such that sound data generated by each of the multiple microphones can be used to distinguish sound data generated by another of the multiple microphones. Microphone 140 can generally be coupled to or integrated into respiratory therapy system 120 (or system 100) in any configuration. For example, microphone 140 may be disposed within respiratory therapy device 122, user interface 124, conduit 126, or other components. Microphone 140 may also be positioned adjacent to or connected to the exterior of respiratory therapy device 122, user interface 124, conduit 126, or any other component. Microphone 140 may also be a component of user device 170 (e.g., microphone 140 is a smartphone microphone). Microphone 140 may be integrated into user interface 124, conduit 126, respiratory therapy device 122, or any combination thereof. Typically, microphone 140 may be located anywhere within or near the air passage of respiratory therapy system 120, which includes at least the motor of respiratory therapy device 122, user interface 124, and conduit 126. Therefore, the air passage may also be referred to as an acoustic passage.

[0070] The speaker 142 outputs to the user of the system 100 (e.g., Figure 2 The speaker 142 can be used to transmit audible sound waves to the user 210. 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 implementations, the speaker 142 can be used to transmit acoustic data generated by the microphone 140 to the user. The speaker 142 can be coupled to or integrated into the respiratory therapy device 122, user interface 124, catheter 126, or user device 170. In some implementations, the speaker 142 is a bone conduction speaker.

[0071] Microphone 140 and speaker 142 can be used as separate devices. In some implementations, microphone 140 and speaker 142 can be combined into acoustic sensor 141 (e.g., a sonar sensor), as described in, for example, WO2018 / 050913 and WO2020 / 104465, which are incorporated herein by reference in their entirety. In this implementation, speaker 142 generates or emits sound waves at predetermined intervals and / or frequencies, and microphone 140 detects reflections of the 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 212. Figure 2 Based at least in part on data from microphone 140 and / or speaker 142, control system 110 can determine user 210 ( Figure 2 The location of the sleep and / or one or more of the sleep-related parameters described herein, such as respiratory signal, respiratory rate, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory ratio, number of events per hour, event pattern, sleep state, sleep stage, pressure setting of the respiratory therapy device 122, or any combination thereof. In this document, a sonar sensor can be understood to involve active acoustic sensing, such as by generating and / or transmitting ultrasonic and / or low-frequency ultrasonic sensing signals through the air (e.g., in a frequency range of, for example, about 17-23 kHz, 18-22 kHz, or 17-18 kHz). Such a system can be considered in relation to WO2018 / 050913 and WO2020 / 104465 mentioned above, each of which is incorporated herein by reference in its entirety.

[0072] In some embodiments, one or more sensors 130 include (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.

[0073] 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 the user 210 (…). Figure 2The location of the device and / or one or more of the sleep-related parameters described herein. An 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 respiratory therapy device 122, one or more sensors 130, the user device 170, or any combination thereof. While RF receiver 146 and RF transmitter 148 are in... Figure 1 While shown as separate and distinct components, in some implementations, the RF receiver 146 and RF transmitter 148 are combined as part of the RF sensor 147 (e.g., a radar sensor). In some such implementations, the RF sensor 147 includes control circuitry. The specific format of the RF communication can be Wi-Fi, Bluetooth, etc.

[0074] In some implementations, RF sensor 147 is part of a mesh system. An example of a mesh system is a Wi-Fi mesh system, which may include mesh nodes, mesh routers, and mesh gateways, each of which may be mobile / movable or fixed. In such an implementation, the Wi-Fi mesh system includes Wi-Fi routers and / or Wi-Fi controllers, and one or more satellites (e.g., access points), each satellite including the same or similar RF sensor as RF sensor 147. The Wi-Fi routers and satellites communicate continuously with each other using Wi-Fi signals. The Wi-Fi mesh system can be used to generate motion data based at least in part on variations in the Wi-Fi signals between the routers and satellites (e.g., differences in received signal strength), said variations being 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.

[0075] Camera 150 outputs image data that can be reproduced as one or more images (e.g., still images, video images, thermal images, or any combination 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, such as one or more events (e.g., periodic limb movements or restless legs syndrome), respiratory 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. Furthermore, image data from camera 150 can be used, for example, to identify the user's location and determine chest movement of user 210. Figure 2 ), determine the airflow from user 210's mouth and / or nose, and determine the time when user 210 enters bed 230 ( Figure 2The camera 150 can also be used to track eye movements, pupil dilation (if one or both eyes of the user are open), blink rate, or any changes during REM sleep. The camera 150 can also be used to track the user's position, which can affect the duration and / or severity of apnea events in users with obstructive sleep apnea. In some implementations, the camera 150 can detect visible radiation that may be emitted due to swelling and / or redness of the user's tonsils and / or gums.

[0076] The output of IR sensor 152 is reproducible as one or more infrared images (e.g., still images, video images, or both) that can be stored in memory device 114. IR sensor 152 can be a passive or active sensor. Passive IR sensor 152 can measure natural infrared emission or reflection from a distant surface, for example, measuring IR energy radiated from a surface to determine the surface temperature. Active IR sensor 152 can include an IR transmitter that generates an IR signal, which is then received by an IR receiver. Such active IR sensor 152 can be used to measure IR reflected from and / or transmitted through an object. For example, an IR transmitter acting as a dot projector can use IR light to project an identifiable array of dots onto a user's face, the reflection of which can then be detected by an IR receiver to determine ranging data (e.g., data associated with the distance between IR sensor 152 and a distant surface such as a portion of the user's face) or contour data associated with the user's face (e.g., data associated with a relative height characteristic of the surface relative to its nominal height).

[0077] Infrared data from IR sensor 152 can be used to determine one or more physiological and / or sleep-related parameters during sleep periods, 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 (including movement associated with RBD or DEB). For example, IR sensor 152 can detect 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. In some implementations, IR sensor 152 can be used to detect localized temperatures at, near, or inside the user's head, mouth, and / or neck. For example, inflammation in the user's mouth (e.g., swelling and / or redness of the user's tonsils and / or gums) can generate heat, which can be detected by IR sensor 152. IR sensor 152 can also be used in conjunction with camera 150, for example, by correlating IR data (e.g., temperature data or ranging data) with camera data (e.g., localized features or color). Therefore, IR sensor 152 can be used as a thermal sensor and a ranging sensor.

[0078] PPG sensor 154 output and user 210 ( Figure 2 The associated physiological data can be used to determine one or more sleep-related parameters, such as heart rate, heart rate pattern, 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, embedded in and / or coupled to the user interface 124 and / or its associated helmet (e.g., straps, etc.).

[0079] ECG sensor 156 outputs physiological data associated with the electrical activity of the heart of user 210. In some implementations, ECG sensor 156 includes one or more electrodes located above or around a portion of user 210 during sleep periods. Physiological data from ECG sensor 156 can be used, for example, to determine one or more of the sleep-related parameters described herein.

[0080] EEG sensor 158 outputs physiological data associated with the electrical activity of the user's brain. In some implementations, EEG sensor 158 includes one or more electrodes positioned on or around the user's scalp during sleep. The physiological data from EEG sensor 158 can be used, for example, to determine the sleep stage of the user at any given time during a sleep period. In some implementations, EEG sensor 158 may be integrated into user interface 124 and / or an associated helmet (e.g., a strap, etc.).

[0081] The capacitive sensor 160, force sensor 162, and strain gauge sensor 164 output data that can be stored in memory device 114 and used by control system 110 to determine one or more of the sleep-related parameters described herein. EMG sensor 166 outputs physiological data related to electrical activity generated by one or more muscles. Oxygen sensor 168 outputs oxygen data indicating the oxygen concentration of a gas (e.g., in catheter 126 or at user interface 124). Oxygen sensor 168 can be, for example, an ultrasonic oxygen sensor, an electro-oxygen sensor, a chemical oxygen sensor, an optical oxygen sensor, a pulse oximeter (e.g., an SpO2 sensor), or any combination thereof. In some embodiments, one or more sensors 130 also include a skin conductance response (GSR) sensor, a blood flow sensor, a respiration sensor, a pulse sensor, a blood pressure sensor, a blood oxygen sensor, or any combination thereof.

[0082] Analyte sensor 174 can be used to detect the presence of analytes in the exhaled 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 characteristics and concentration of any analytes in the user's breath. In some implementations, analyte sensor 174 is located near the mouth of user 210 to detect analytes in the breath exhaled from the mouth of user 210. For example, when user interface 124 is a mask covering the nose and mouth of user 210, analyte sensor 174 can be located inside the mask to monitor mouth breathing of user 210. In other implementations, such as when user interface 124 is a nasal mask or nasal pillow mask, analyte sensor 174 can be positioned near the nose of user 210 to detect analytes in the breath exhaled through the nose of user 210. In other implementations, when user interface 124 is a nasal mask or nasal pillow mask, analyte sensor 174 can be located near the mouth of user 210. In this implementation, the analyte sensor 174 can be used to detect whether any air is unintentionally leaking from the mouth of user 210. In some implementations, the analyte sensor 174 is a volatile organic compound (VOC) sensor that can be used to detect carbon-based chemicals or compounds such as carbon dioxide. In some embodiments, the 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 near the mouth of user 210 or inside a mask (in the implementation where user interface 124 is a mask), the control system 110 can use that data as an indication that user 210 is breathing through their mouth.

[0083] The humidity sensor 176 outputs data that can be stored in the storage device 114 and used by the control system 110. The humidity sensor 176 can be used to detect humidity in various areas surrounding the user (e.g., inside the conduit 126 or user interface 124, near the user 210's face, near the connection between the conduit 126 and the user interface 124, near the connection between the conduit 126 and the respiratory therapy device 122, etc.). Therefore, in some implementations, the humidity sensor 176 can be coupled to or integrated into the user interface 124 or the conduit 126 to monitor the humidity of pressurized air from the respiratory therapy device 122. In other implementations, 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, such as the air in a bedroom. The humidity sensor 176 can also be used to track the user's biometric response to environmental changes.

[0084] The lidar sensor 178 can be used for depth and distance sensing, and can also be used to generate structural contours of the user 210's head, mouth, and / or neck. 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 (e.g., a living space). LiDAR typically utilizes pulsed lasers for time-of-flight measurements. LiDAR is also known as 3D laser scanning. In examples using this sensor, a fixed or mobile device (such as a smartphone) with lidar sensor 178 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. 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 to 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, for solid surfaces through which radio waves pass (e.g., transmissive materials), lidar can reflect them away from such surfaces, thereby allowing for the classification of different types of obstacles. Furthermore, while lidar sensor 178 is described herein, in some cases one or more other ranging sensors may be used in place of lidar sensor 178 or as a supplement to lidar sensor, such as ultrasonic ranging sensors, electromagnetic radiation radar sensors, IR sensors 152, etc.

[0085] In some implementations, one or more sensors 130 may also include a skin conductance response (GSR) sensor, a blood flow sensor, a respiration sensor, a pulse sensor, a blood pressure sensor, a pulse oximeter sensor, a sonar sensor, a radar sensor, a blood glucose sensor, a color sensor, a pH sensor, an air quality sensor, a tilt sensor, a rain sensor, a soil moisture sensor, a water flow sensor, an alcohol sensor, or any combination thereof.

[0086] 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 respiratory therapy device 122, user interface 124, catheter 126, humidifier 129, control system 110, external device 170, activity tracker 182, or any combination thereof. For example, microphone 140 and speaker 142 may be integrated into and / or coupled to external device 170, and pressure sensor 130 and / or flow sensor 134 may be integrated into and / or coupled to respiratory therapy device 122. For example, acoustic sensor 141 and / or RF sensor 147 may be integrated into and / or coupled to user device 170. In such an implementation, user device 170 can be considered as an auxiliary device for generating additional or auxiliary data for use by system 100 (e.g., control system 110) according to some aspects of the invention.

[0087] In some implementations, at least one of the one or more sensors 130 is not coupled to the respiratory therapy device 122, the control system 110, or the user device 170, and is typically positioned near or in contact with the user 210 during sleep periods (e.g., positioned on or in contact with a portion of the user 210, worn by the user 210, coupled to or positioned on a bedside table, coupled to a mattress, coupled to a ceiling, etc.). More generally, the one or more sensors 130 may be positioned relative to the user in any suitable location such that the one or more sensors 130 can generate physiological data associated with the user and / or bed partner 212 during one or more sleep periods.

[0088] User equipment 170 ( Figure 1The system 100 may include a display device 172. The user device 170 may be, for example, a mobile device such as a smartphone, tablet, game console, smartwatch, laptop, etc. Alternatively, the user device 170 may be an external sensing system, a television (e.g., a smart TV), or another smart home device (e.g., a smart speaker such as Google Home, Amazon Echo, Alexa, etc.). In some implementations, the user device 170 is a wearable device (e.g., a smartwatch). The display device 172 is typically used to display images including still images, video images, or both. In some implementations, the display device 172 acts as a human-machine interface (HMI) including a graphical user interface (GUI) configured to display images and provide input interfaces. The display device 172 may be an LED display, OLED display, LCD display, etc. The 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 the user device 170. In some implementations, the system 100 may use and / or include one or more user devices 170.

[0089] Blood pressure device 180 is typically used to help generate physiological data (such as cardiovascular data) to determine one or more blood pressure measurements associated with user 210. Blood pressure device 180 may include at least one of one or more sensors 130 to measure, for example, systolic blood pressure components and / or diastolic blood pressure components.

[0090] In some implementations, the blood pressure device 180 is a blood pressure monitor that includes an inflatable cuff that can be worn by a user 210 and a pressure sensor (e.g., pressure sensor 132 described herein). For example, as Figure 2 As shown in the example, the blood pressure device 180 can be worn on the upper arm of the user 210. In this implementation where the blood pressure device 180 is a blood pressure monitor, the blood pressure device 180 also includes a pump (e.g., a manually operated light bulb) for inflating the cuff. In some implementations, the blood pressure device 180 is coupled to a respiratory therapy device 122 of the respiratory system 120, which in turn delivers pressurized air to inflate the cuff. More generally, the blood pressure device 180 can be communicatively coupled to the respiratory therapy system 120 and / or optionally physically integrated with the respiratory therapy system (e.g., within a housing). Additionally or optionally, the blood pressure device 180 can be communicatively coupled to a control system 110, a memory device 114, a user device 170, and / or an activity tracker 182, which in turn are communicatively coupled to the respiratory therapy system 120.

[0091] In some implementations, the blood pressure device 180 is an invasive device that continuously monitors the arterial blood pressure of the user 210 and collects arterial blood samples as needed to analyze the gas content of the arterial blood. In other implementations, the blood pressure device 180 is a non-invasive continuous blood pressure monitor using: a radio frequency (RF) sensor, a radio detection and ranging (RADAR) sensor, a sound navigation and ranging (SONAR) sensor, an infrared (IR) sensor, a pressure sensor, a displacement sensor, or a combination thereof. The RF sensor is capable of measuring the user 210's blood pressure once per second (e.g., 3 seconds, 5 seconds, 7 seconds, etc.). The RF sensor can use continuous waves; frequency modulated continuous waves (FMCW) with ramp chirp, triangular waves, sine waves, and other modulation schemes such as phase shift keying (PSK), frequency shift keying (FSK); pulsed continuous waves; and / or wave spreads in the ultra-wideband (UWB) range (which may include spreads, pseudo-random noise (PRN) codes, or pulse systems).

[0092] When using RADAR or sonar sensors, in some implementations, the mattress on bed 230 can calculate cardiac impaction (BCG), and optical sensors located on the user's body (e.g., a smartwatch, smart eye mask, etc.) or remotely (e.g., a camera) can calculate optical volumetric plethysmography (PPG). The BCG and PPG values ​​can then be used to measure the time delay between these two signals in order to calculate systolic and diastolic blood pressure.

[0093] In some implementations, a PPG with automatic gain and signal-to-noise ratio (SNR) management can be used to calculate pulse conduction time (PTT), pulse wave analysis, and a PPG with appropriate calibration parameters (demographic or personalized) can be used to estimate the blood pressure of user 210. For example, an optical sensor can emit coherent light into the skin of user 210 and then collect and capture reflected light from red blood cells in blood vessels in the skin beneath the optical sensor. Thus, the optical sensor and associated software can detect the pulse wave to determine the blood pressure measurement of user 210. Other techniques can directly use video, such as using transcutaneous optical imaging (e.g., via a custom camera system or via a smartphone) to measure blood pressure from video of the user's face (e.g., using ambient light, or light from sources such as LEDs or infrared sources). Other sensors can include ultrasound sensors, thereby using pulses and echoes to map the anterior and posterior walls of arteries.

[0094] In other implementations, the blood pressure device 180 is an ambulatory blood pressure monitor communicatively coupled to the respiratory therapy system 120. An ambulatory blood pressure monitor includes: a portable recording device connected to a strap or band worn by a user 210; and an inflatable cuff connected to the portable recording device and worn around the user 210's arm. The ambulatory blood pressure monitor is configured to measure blood pressure approximately every fifteen minutes to approximately thirty minutes over a 24-hour or 48-hour period. The ambulatory blood pressure monitor can simultaneously measure the user 210's heart rate. These multiple readings are averaged over a 24-hour period. The ambulatory blood pressure monitor determines any variations in the user 210's measured blood pressure and heart rate, as well as any distribution and / or trend patterns of the blood pressure and heart rate data during the user 210's sleep and wake cycles. The measured data and statistics can then be transmitted to the respiratory therapy system 120.

[0095] Activity tracker 182 is typically used to help generate physiological data for determining activity measurements associated with user 210. Activity tracker 182 may include one or more sensors 130 described herein, such as motion sensors 138 (e.g., one or more accelerometers and / or gyroscopes), PPG sensors 154, and / or ECG sensors 156. Physiological data from activity tracker 182 can be used to determine, for example, steps, distance traveled, number of steps climbed, duration of physical activity, type of physical activity, intensity of physical activity, time spent standing, respiratory rate, average respiratory rate, resting respiratory rate, maximum respiratory rate, respiratory rate variability, heart rate, average heart rate, resting heart rate, maximum heart rate, heart rate variability, calories burned, blood oxygen saturation, electrodermal activity (also known as skin conductance or skin response), or any combination thereof. In some implementations, activity tracker 182 is coupled (e.g., electronically or physically) to user device 170.

[0096] In some implementations, the activity tracker 182 is a wearable device that can be worn by the user 210, such as a smartwatch, wristband, ring, or patch. For example, see reference... Figure 2 The activity tracker 182 is worn on the wrist of user 210. The activity tracker 182 may also be coupled to or integrated into clothing or garments worn by user 210. Alternatively, the activity tracker 182 may also be coupled to or integrated into user device 170 (e.g., within the same housing). More generally, the activity tracker 182 may be communicatively coupled to control system 110, memory device 114, respiratory therapy system 120, user device 170, and / or blood pressure device 180, or physically integrated into the control system, memory device, respiratory therapy system, user device, and / or blood pressure device (e.g., within a housing).

[0097] 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 implementations, control system 110 and / or memory device 114 are integrated into user device 170 and / or respiratory therapy device 122. Alternatively, in some implementations, 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 in one or more servers (e.g., remote servers, local servers, etc., or any combination thereof).

[0098] While system 100 is shown as including all of the components described above, a system according to an implementation of the invention may include more or fewer components. For example, a first alternative system includes a control system 110, a memory device 114, and at least one of one or more sensors 130, but does not include a respiratory therapy system 120. As another example, a second alternative system includes a control system 110, a memory device 114, at least one of one or more sensors 130, and a user device 170. As yet another example, a third alternative system includes a control system 110, a memory device 114, a respiratory therapy system 120, at least one of one or more sensors 130, and a user device 170. As yet another example, a fourth alternative system includes a control system 110, a memory device 114, a respiratory therapy system 120, at least one of one or more sensors 130, a user device 170, and a blood pressure device 180 and / or an activity tracker 182. Thus, various systems can be formed using any part or multiple parts of the components shown and described herein and / or in combination with one or more other components.

[0099] As used here, sleep periods can be defined in various ways based on, for example, initial start and end times. (See reference) Figure 3 An exemplary timeline 240 for a sleep period is shown. Timeline 240 includes bedtime (t... 入床 ), sleep onset time (t) GTS ), initial sleep time (t) 睡眠 ), First micro-wake-up MA1 and second micro-wake-up MA2, wake-up time (t) 觉醒 ) and wake-up time (t 起床 ).

[0100] 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 of a user's sleep; that is, a sleep period has a start time and an end time, and the user does not wake up until the end time during the sleep period. In other words, any period 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 up and falls asleep multiple times during the same night, each sleep interval separated by the wake-up intervals is a sleep period.

[0101] Alternatively, in some implementations, the sleep period has a start and end time, and during the sleep period, the user can remain awake 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, approximately 20 percent of the sleep period, approximately 15 percent of the sleep period duration, approximately 10 percent of the sleep period duration, 5 percent of the sleep period duration, approximately 2 percent of the sleep period duration, or any other threshold percentage. In some implementations, the wakefulness duration threshold is defined as a fixed amount of time, such as approximately one hour, approximately thirty minutes, approximately fifteen minutes, approximately ten minutes, approximately five minutes, approximately two minutes, or any other amount of time.

[0102] 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 leaves bed the following morning. In other words, a sleep period can be defined as the time period that begins at a first time (e.g., 10:00 PM) on a first date (e.g., Monday, January 6, 2020), which can be referred to as the current night, when the user first enters bed intending to go to sleep (e.g., if the user does not intend to watch TV or use their smartphone before going to sleep), and ends at a second time (e.g., 7:00 AM) on a second date (e.g., Tuesday, January 7, 2020), which can be referred to as the following morning, when the user first leaves bed with the intention of not returning to sleep the following morning.

[0103] In some implementations, users can manually define the start and / or end of sleep periods. For example, a user can select (e.g., by clicking or tapping) on ​​an external device 170 ( Figure 1 One or more user-selectable elements are displayed on the user device 172 to manually initiate or terminate a sleep period.

[0104] Typically, a sleep period includes any point in time after the user 210 has already lay down or sat in bed 230 (or another area or object where they intend to sleep) and has turned on the breathing therapy device 122 and put on the user interface 124. A sleep period can therefore include time intervals (i) when the user 210 is using the CPAP system, but before the user 210 attempts to fall asleep (e.g., when the user 210 is lying in bed 230 reading a book); (ii) when the user 210 begins to try to fall asleep but is still awake; (iii) when the user 210 is in light sleep (also known as stages 1 and 2 of non-rapid eye movement (NREM) sleep); (iv) when the user 210 is in deep sleep (also known as slow-wave sleep, SWS, or stage 3 of NREM sleep); (v) when the user 210 is in rapid eye movement (REM) sleep; (vi) when the user 210 periodically wakes up between light sleep, deep sleep, or REM sleep; or (vii) when the user 210 wakes up without falling back asleep.

[0105] A sleep period is typically defined as ending once user 210 removes user interface 124, shuts off respiratory therapy device 122, and leaves bed 230. In some implementations, a sleep period may include additional time periods, or may be limited to only some of the aforementioned time periods. For example, a sleep period may be defined as a time period that begins when respiratory therapy device 122 begins supplying pressurized air to the airway or user 210, ends when respiratory therapy device 122 stops supplying pressurized air to the airway of user 210, and includes some or all of the time points between when user 210 is asleep or awake.

[0106] refer to Figure 3 Timeline 240, bed entry time t 入床 Before the user falls asleep (e.g., when the user lies down or sits in bed), the user initially gets into bed (e.g., 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 distinguishes between when a user goes to bed for sleep and when they go to bed for other reasons (e.g., watching television). For example, the bed threshold duration could be at least approximately 10 minutes, at least approximately 20 minutes, at least approximately 30 minutes, at least approximately 45 minutes, at least approximately 1 hour, at least approximately 2 hours, etc. While this document describes bedtime t... 入床 But more generally, bedtime t 入床 This can refer to the time when a user initially enters any location intended for sleeping (e.g., sofa, chair, sleeping bag, etc.).

[0107] Time to Fall Asleep (GTS) and the time it takes for a user to first fall asleep after getting into bed (t) 入床This is related to [the concept of sleep duration]. 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.

[0108] Wake-up time t 觉醒 This is the time associated with when a user wakes up without returning to sleep (e.g., the opposite of when a user wakes up at night and returns 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 initially falling asleep. This is related to the wake-up 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 initially falling asleep (e.g., getting up to go to the bathroom, caring for a child or pet, sleepwalking, etc.). However, the user returns to sleep after awakening A. Therefore, the awakening time t 觉醒 It can be defined, for example, based on the duration of the wake-up 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.).

[0109] Similarly, wake-up time t 起床 This is associated with the time a user leaves the bed and gets out of bed to end a sleep period (e.g., the opposite of a user getting up at night to go to the bathroom, care for a child or pet, or sleepwalk). In other words, wake-up time t 起床 This is the time a user last leaves bed and does not 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.

[0110] As mentioned above, in the initial t 入床 And the last t 升 During the night, a user can wake up and get out of bed more than once. In some implementations, the final wake-up time t 觉醒 and / or final wake-up time t 起床It is identified or determined based on a predetermined threshold duration following an event (e.g., falling asleep or getting out of bed). This threshold duration can be customized for the user. For any time period after getting out of bed at night and then waking up and getting out of bed in the morning (when the user wakes up (t...)...) 觉醒 ) or get up (t 升 ) and users going to bed (t 入床 ), fall asleep (t GTS ) or fall asleep (t 睡眠 For standard users (between approximately 8 and 14 hours), the threshold period can be used for approximately 12 to approximately 18 hours. For users who spend longer periods in bed, a shorter threshold period can be used (e.g., between approximately 8 and approximately 14 hours). The threshold period can be initially selected and / or adjusted later based on the system monitoring the user's sleep behavior.

[0111] Total time in bed (TIB) is the time to bed entry t 入床 and wake-up time t 起床 The duration between the initial sleep time and wake time. 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 3 Timeline 240, Total Sleep Time (TST) spanning initial sleep time t 睡眠 and wake-up time t 觉醒 The duration of sleep is between, but does not include, the duration of the first micro-awake MA1, the second micro-awake MA2, and awakening A. As shown in the figure, in this example, the total sleep time (TST) is shorter than the total time in bed (TIB).

[0112] In some implementations, Total Sleep Time (TST) can be defined as Persistent Total Sleep Time (PTST). In this implementation, Persistent Total Sleep Time excludes a predetermined initial portion or period of the first non-REM stage (e.g., a light sleep stage). For example, the predetermined initial portion could be between approximately 30 seconds and approximately 20 minutes, between approximately 1 minute and approximately 10 minutes, between approximately 3 minutes and approximately 5 minutes, etc. Persistent Total 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., approximately 30 seconds), then return to the wakeful stage for a very short time (e.g., one minute), and then return to the first non-REM stage. In this example, Persistent Total Sleep Time excludes the first instance of the first non-REM stage (e.g., approximately 30 seconds).

[0113] 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 initial sleep time (t), meaning the sleep period is defined as the total time to bed (TIB). In some implementations, the sleep period is defined as the time to bed (t). 睡眠 ) starts and at wake-up time (t 觉醒 End. 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 start of sleep (t... GTS ) starts and at wake-up time (t 觉醒 The sleep period ends at the time of falling asleep (t). In some implementations, the sleep period is defined as the time from falling asleep to falling asleep (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 ) starts and at wake-up 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 start of sleep (t). 觉醒 Start at wake-up time (t) 起床 )Finish.

[0114] Reference Figure 4 This shows the corresponding timeline 240 according to some implementation methods. Figure 3 An exemplary sleep graph 250 is provided. As shown, sleep graph 250 includes a sleep-wake signal 251, a wakefulness stage axis 260, a REM stage axis 270, a light sleep stage axis 280, and a deep sleep stage axis 290. The intersection of the sleep-wake signal 251 and one of axes 260-290 represents a sleep stage at any given time during a sleep period.

[0115] The sleep-wake signal 251 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-wakefulness, 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 implementations, 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 non-REM sleep stage and the third non-REM sleep stage. Although in Figure 4The sleep graph 250 shown includes a light sleep stage axis 280 and a deep sleep stage axis 290, but in some implementations, the sleep graph 250 may include axes for each of the first non-REM stage, the second non-REM stage, and the third non-REM stage. In other implementations, the sleep-wake signal may also indicate respiratory signals, respiratory rate, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory amplitude ratio, inspiratory-expiratory duration ratio, number of events per hour, event pattern, or any combination thereof. Information describing the sleep-wake signal may be stored in the memory device 114.

[0116] Sleep graph 250 can be used to determine one or more sleep-related parameters, such as sleep onset wait time (SOL), wakefulness after sleep onset (WASO), sleep efficiency (SE), sleep segmentation index, sleep blockage, or any combination thereof.

[0117] 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 (SOL) represents the time it takes for a user to actually fall asleep after their initial attempt 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 (with no more than 2 minutes of wakefulness), and / or movement between the first non-REM phase. In other words, continuous sleep of up to, for example, 8 minutes within the second non-REM phase, the third non-REM phase, and / or the 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 the first non-REM phase, the second non-REM phase, the third non-REM phase, and / or the REM phase after the initial sleep time. In this way, a predetermined amount of continuous sleep can exclude any micro-awakening (e.g., a ten-second micro-awakening does not restart the 10-minute session).

[0118] Post-sleep wake-onset (WASO) is associated with the total duration of a user's wakefulness between the initial sleep time and wake-up time. Therefore, WASO includes brief and micro-awakenings during sleep (e.g., Figure 4The micro-awakenings MA1 and MA2 shown are either conscious or unconscious. In some implementations, a sleep-wake attack (WASO) is defined as a sustained sleep-wake attack (PWASO) that consists only of the total duration of arousal 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.).

[0119] Sleep efficiency (SE) is defined as the ratio of total time spent in bed (TIB) to total sleep time (TST). For example, if the total time spent in bed is 8 hours and the total sleep time is 7.5 hours, then the sleep efficiency for that sleep period is 93.75%. Sleep efficiency reflects 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 total time spent 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 here. For example, if the total sleep time is 8 hours (e.g., between 11 pm and 7 am), the time to fall asleep is 10:45 pm, and the wake-up time is 7:15 am, then in such an implementation, the sleep efficiency parameter is calculated to be approximately 94%.

[0120] 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-awakes (e.g., Figure 4 As shown in the micro-awakenings MA1 and MA2, the segmentation index can be represented as 2. In some implementations, the segmentation index is scaled between a predetermined range of integers (e.g., between 0 and 10).

[0121] 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.

[0122] In some implementations, 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 ), sleep onset time (t) GTS ), initial sleep time (t) 睡眠 ), one or more first micro-awakenings (e.g., MA1 and MA2), awakening time (t) 觉醒 ), wake-up time (t) 起床(or any combination thereof). Sleep maps can be generated in real time during a sleep period or after the sleep period has ended.

[0123] In other implementations, one or more of the sensors 130 can be used to determine or identify the bed entry time (t). 入床 ), sleep onset time (t) GTS ), initial sleep time (t) 睡眠 ), one or more first micro-awakenings (e.g., MA1 and MA2), awakening time (t) 觉醒 ), wake-up time (t) 起床 (e.g., motion sensor 138, microphone 140, camera 150, or any combination thereof), which in turn defines the sleep period. 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 being turned off), data from user device 170 (e.g., data indicating that the user is no longer using user device 170), data from pressure sensor 132 and / or flow sensor 134 (e.g., data indicating that the user turns on the breathing therapy device 122, data indicating that the user wears user interface 124, etc.), or any combination thereof.

[0124] Now for reference Figure 5 This paper illustrates a method 500 for analyzing the physical characteristics of a user (such as user 210). Typically, there are certain physical characteristics, traits, or features of a user associated with sleep apnea and / or obstructive sleep apnea. These physical characteristics may include the size of the user's neck and / or cervical circumference; the structure of the user's jaw; the shape and size of various internal structures, including the top of the user's mouth, the user's tongue, the user's tonsils, the user's teeth, and the user's uvula; the overall shape of the user's mouth; and other characteristics.

[0125] Certain values ​​of these characteristics, such as certain sizes and shapes, can be associated with an increased risk of developing sleep-disordered breathing and / or obstructive sleep apnea, including: neck / neck circumference exceeding threshold sizes (which may be an indicator of excess body fat); a user's mandible tilted backward relative to the user's maxilla; the shape of the user's mouth that may lead to airway collapse; the size of the user's tongue exceeding the baseline size for the user's age and sex; the shape of the user's mouth that typically changes over time; deviations in the shape of the user's skull from the expected shape (e.g., reduced anterior and / or posterior skull measurements can indicate the presence of brachycephaly); and others. Regarding the shape of the user's mouth, upper airway restriction or collapse is typically seen at the soft palate, larynx, lateral pharyngeal walls, and tongue. If the user has a narrow larynx, they are at increased risk of these tissues “closing” each other and obstructing the airway when the muscles in the upper larynx relax during sleep. Additionally, large tonsils can cause airway collapse, and a large tongue can also relax and curl up during sleep.

[0126] Therefore, external and internal features of a user's head, neck, and mouth can be analyzed to track these temporal characteristics of the body in order to identify and update one or more risk factors for the development of sleep-disordered breathing and / or obstructive sleep apnea.

[0127] Method 500 can be implemented using a control system (e.g., control system 110 of system 100) and any number of sensors (e.g., any sensor 130). A storage device (e.g., storage device 114 of system 100) can be used to store any type of data used in the steps of method 500. In some implementations, method 500 can be implemented using at least one handheld device (e.g., a user's smartphone, which may be user device 170).

[0128] Step 502 of method 500 includes generating first image data reproducible as an image of the exterior of a user's head via one or more image sensors. The first image data may be associated with various aspects of the exterior of the user's head, including the mouth, jawline, skull, eyes, nose, etc. Step 502 therefore includes generating data on at least various body features that can be used to identify the exterior of the user's head 214, such as the user's neck circumference, the size and shape of the user's jaw, the size and shape of the user's skull, etc. As used herein, the user's head may include the user's mouth, eyes, nose, skull, face, etc.

[0129] The image sensor can be any suitable image sensor, such as camera 150 of system 100. In some implementations, camera 150 is integrated into a handheld device, and the user's mobile device (e.g., the image sensor) is the camera of the user's smartphone. The image sensor can be the front-facing camera of the user's smartphone, such that the smartphone's display (which can be display device 172 of user device 170) displays the user's live view. The user can use the live view to properly position the image sensor to generate first image data. In other implementations, the image sensor is the rear camera of the user's smartphone, and the user can view the smartphone's display, for example, by means of a mirror.

[0130] Figure 6A and 6B The illustration shows a user 210 using a smartphone 402 with a camera 404 to generate first image data of the exterior of the user 210's head 214 and / or neck 216. In the illustrated implementation, the image sensor is the camera 404 of the user 210's smartphone 402. In other implementations, the image sensor may be a camera of a different handheld device, such as a tablet computer. In other implementations, the image sensor may not be a component of the handheld device. Therefore, the image sensor may be integrated into the handheld device or may be part of other devices.

[0131] The display of smartphone 402 can be used to display a real-time video image 211 of at least a portion of user 210 and illuminate at least a portion of user 210. For example, in Figure 6A and 6B In this display, a first portion 406A of the smartphone 402 displays a live video image 211 of the user 210. Various features of the user 210's head 214 are visible in the live video image 211, including the user's neck 216, eyes 218, mouth 220, and nose 222. The first portion 406A is the part of the display closest to the camera 404 and the user 210's eyes 218. The user 210 can view the live video image 211 to properly position the smartphone 402 to obtain first image data of the exterior of their head 214 and / or neck 216. A second portion 406B of the smartphone 402's display is used to illuminate a portion of the user 210's head 214 and / or neck 216. The second portion 406B is the part furthest from the camera 404 and the user 210's eyes 218 and closer to the user 210's neck 216 and mouth 220. Typically, the second portion 406B can display any suitable screen, image, object, etc., to illuminate this portion of the user 210. In one example, the second part 406B of the display shows a blank screen that can be white or other colors.

[0132] Refer again Figure 5 Step 504 of method 500 includes generating second image data via one or more image sensors that can be reproduced as an image of the interior of the mouth 220 of user 210. Therefore, step 502 includes generating data that can at least be used to identify various characteristics or features of the interior of the mouth 220 of user 210, such as the size and shape of the user 210's tongue, tonsils, teeth, palate, uvula, etc.

[0133] Figure 7A and 7B This illustrates how user 210 uses smartphone 402 to generate second image data of the interior of user 210's mouth 220. (See image below.) Figure 7A As shown, user 210 holds smartphone 402 to their mouth 220 to generate second image data using smartphone 402's camera 404. Smartphone 402 can display a real-time video image 219 of user 210's mouth 220. In the illustrated implementation, smartphone 402 is flipped so that the first portion 406A and the second portion 406B of the display are inverted. In this orientation, the first portion 406A remains closer to camera 404, while the second portion 406B remains further away from camera 404. However, the first portion 406A and camera 404 are now positioned below the second portion 406B, closer to user 210's mouth 220 than user 210's eyes 218. Then, the second portion 406B is now positioned below the first portion 406A and camera 404, closer to user 210's eyes 218 than user 210's mouth 220. A real-time video image 219 of the user 210's mouth 220 is displayed on the second part 406B of the display, while the first part 406A of the display is used for illumination.

[0134] By flipping the smartphone 402, the camera 404 can focus on the user 210's mouth 220 without rotating it out of the user 210's line of sight. Without flipping the smartphone 402, when the user 210 moves the smartphone 402 closer to their mouth 220, the smartphone 402 would need to be rotated downwards so that the camera 404 remains focused on the user 210's mouth 220. However, this rotation would also cause the first portion 406A of the display and the displayed live video image 211 to rotate downwards and out of the user 210's line of sight. Therefore, the user would not be able to view the live video image 211 to properly guide the placement of the smartphone 402. Because the smartphone 402 has been flipped, the camera 404 can focus on the user 210's mouth 220 without having to rotate the second portion 406B of the display and the displayed live video image 211 of the user 210 out of the user 210's line of sight. The smartphone 402 can also be flipped to obtain first image data of the exterior of the user 210's head 214 and / or neck 216, or it can be kept in the correct orientation, such as Figure 6A and 6B As shown.

[0135] The second portion 406B of the display may display one or more augmented reality markers to assist the user 210 in moving the smartphone 402 to a desired location. Typically, when the smartphone 402 is in the desired location, the camera 404 appropriately focuses on the inside of the user 210's mouth 220 to generate second image data of the inside of the user 210's mouth 220. In some implementations, the augmented reality markers may include markers indicating the direction in which the smartphone 402 needs to move or the direction in which the user 210 needs to move their head 214 and / or mouth 220.

[0136] In some implementations, smartphone 402 may include a rear image sensor (e.g., a rear camera) located on the rear of smartphone 402 (e.g., on the side of smartphone 42 opposite to display portions 406A and 406B). When using the rear image sensor, the user cannot view the augmented reality markers on the second portion 406B of the display because they are facing away from them; instead, an additional device must be used to view the second portion 406B. In one example, the user can use smartphone 402 while facing a mirror, allowing the user to see the reflection of the augmented reality markers in the mirror. Smartphone 402 will invert the augmented reality markers on the second portion 406B of the display so that the augmented reality markers appear in the mirror with the correct orientation. In a second example, the content of the second portion 406B of the display (such as images, videos, augmented reality markers, etc.) can be sent to an external device (such as user device 170), such as a tablet, bedside monitor, or smartwatch, that the user can easily view.

[0137] exist Figure 7B In the implementation shown, the real-time video image 219 is located in the upper left quadrant of the second portion 406B of the display. The marker is an arrow 408 pointing to the upper left quadrant, indicating that the user 210 needs to move the smartphone 402 up and to the left to properly position the camera 404 of the smartphone 402. Therefore, arrow 408 points in the direction in which the user 210 needs to move the smartphone 402. In other implementations, arrow 408 could point down and to the left, indicating that the user 210 needs to move their mouth 220 down and to the left so that their mouth 220 is properly positioned relative to the camera 404.

[0138] Augmented reality markers may also include one or more outlines of various body features of the user 210. These outlines typically have shapes corresponding to the body features to aid in alignment with the smartphone 402 and camera 404. See, for example. Figure 7BThe second portion 406B of the display shows the outline 410 of the user's lips. Because the second portion 406B of the display also shows a live video image 211 of the user 210, including the user 210's lips, the outline 410 provides alignment guidance for the smartphone 402 and the camera 404. By aligning the outline 410 with the corresponding feature in the live video image 211, the user 210 ensures that the camera 404 is positioned to focus on the inside of the user 210's mouth 220. Although the outline 410 is the outline of the user's lips, the outline can be the outline of any feature of the user 210, such as the user 210's eyes 218, tongue, teeth, uvula, tonsils, or any other feature, or combination of features.

[0139] In some implementations, smartphone 402 is configured to indicate to user 210 when smartphone 402 and camera 404 are in the desired position for capturing second image data inside user 210's mouth 220. In some implementations, smartphone 402 may display an indicator in a first portion 406A or a second portion 406B of the display. The indicator may include images, symbols, text, etc. The indicator may be displayed continuously or may be displayed in a flashing manner. Augmented reality markers such as arrow 408 or outline 410 may also be modified when smartphone 402 and camera 404 are correctly positioned. For example, smartphone 402 may cause the augmented reality marker to change color, shape, size, or any combination thereof. In other implementations, audible sounds indicating that smartphone 402 and camera 404 are correctly positioned may be generated (e.g., via the speaker of smartphone 402). Generally, smartphone 402 may take any appropriate action to indicate to user 210 in any appropriate manner that smartphone 402 and camera 404 are in the correct position.

[0140] The smartphone 402 can also generate audible sounds to help the user 210 correctly position the smartphone 402 and camera 404. For example, when the smartphone 402 is not in the correct position, it may initially play a sound, and then gradually modify certain characteristics of the sound as the user moves the smartphone 402 closer to the correct position. For example, the volume or pitch of the sound may be increased or decreased as the user 210 moves the smartphone 402 and camera 404. In another example, the audible sound repeats continuously at a certain repetition rate. As the user 210 moves the smartphone 402 and camera 404, the repetition rate of the audible sound may be increased or decreased (e.g., the sound may play faster or slower).

[0141] Refer again Figure 5In method 500, step 506 includes directing an acoustic signal toward the interior of the mouth 220 of user 210, and step 508 includes receiving reflected acoustic signals from the interior of the mouth 220 of user 210. The result of steps 506 and 508 is obtaining acoustic data associated with structural characteristics or features of the interior of the mouth 220 of user 210. Typically, smartphone 402 includes an acoustic sensor comprising one or more speakers and one or more microphones. Smartphone 402 is configured to cause the speakers to emit acoustic signals (e.g., sound waves) that are directed toward the interior of the mouth 220 of user 210. The acoustic signals are reflected from various structures within the mouth 220 of user 210 and propagate back to smartphone 402. The one or more microphones can then detect the reflected acoustic signals, thereby generating acoustic data.

[0142] The sound signals indicate the structural features of the user's mouth 220 and can be analyzed to determine the size and / or location of various structures within the user's mouth 220, such as the user's tongue, teeth, jaw, tonsils, uvula, the top of the user's mouth 220, the back of the user's throat, etc. The smartphone 402 is configured to monitor the amount of time elapsed between sound signals emitted by the speaker, and the reflected acoustic signals are detected by the microphone. Based on the elapsed time, the distance between the smartphone 402 and the structure that reflected the acoustic signals can be determined.

[0143] Various techniques can be used to analyze acoustic signals. In a frequency-hopping range gating (FHRG) implementation, the frame / tone-to-frame modulator is controlled by the processor (utilizing implicit multi-frequency operations using frames, etc.). In adaptive implementations such as Adaptive FHRG (AFHRG) or Adaptive Time-of-Flight (AToF), the system also includes modules for fading detection and explicit frequency shift operations not present in the FHRG implementation. The fading detector module provides a feedback mechanism to adjust system parameters (including frequency shift, modulation type, frame parameters such as tone count, time, and frequency interval) to optimally detect motion and provide detailed distance information to map the mouth under varying channel conditions.

[0144] Fading can be detected directly from changes in amplitude modulation (extracted via envelope detection) and / or from changes in specific pitch pairs in the reflected acoustic signal. The fading detector can also receive auxiliary information from subsequent baseband signal processing, although this may add some processing latency; this can be used to correlate the quality / morphology of the actually extracted respiratory signal with current channel conditions to provide better adaptation to maximize the useful signal. The fading detector can also process I / Q pairs (baseband pre-breathing / heart rate analysis). By using a configuration of the non-fading Tx (transmit) waveform, the limited transmit signal power of the loudspeaker can also be optimized / optimally used to maximize the useful information received by the sound sensor / receiver Rx (receive) and demodulated / further processed to baseband. In some cases, if the system is found to be more stable over longer time periods (e.g., to avoid multipath variations in fading at timescales similar to respiratory rate, which could introduce "noise" / artifacts in the desired demodulated respiratory rate band), the system can select a slightly suboptimal set of frequencies for Tx (in terms of short-term SNR).

[0145] The transmitted sound pressure signal generated by the smartphone speaker is reflected by the target and returned to be sensed at the smartphone microphone. For an omnidirectional source, the sound pressure (SPL) The level will decrease with distance. for The speaker of smartphone 402 can be 18kHz directional, and therefore: ,in It is the speaker gain, and has a value between 0 and 2, and is usually greater than 1.

[0146] The target (e.g., user 210) has a specific cross-section and reflectance coefficient. Reflections from user 210 are also directional: . It is the reflector attenuation and has a value between 0 and 1, and is usually greater than 0.1. It is the reflector gain, and has a value between 0 and 2, and is usually greater than 1. It is the sonar cross section.

[0147] As a result, the transmitted sound pressure signal is reflected at a distance d. Will at a reduced power level Returning to smartphone 402: The microphone of smartphone 402 will only receive a portion of the reflected sound pressure signal. The percentage will depend on the effective area of ​​the microphone. : In this way, a small portion of the transmitted sound signal is reflected by the user 210 and returned to be received by the microphone of the smartphone 402.

[0148] FHRG system distance from acoustic sensor The acoustic signal will be reflected by users within range. This is because it is used at any frequency. The sound generated by the smartphone 402, which is a model signal, is:

[0149] For any single frequency, at a distance The acoustic signal arriving at the target is given as:

[0150] The acoustic signal reflected from the microphone of smartphone 402 is given as:

[0151] However, if the target distance changes sinusoidally, the distance is modified. , making ,in It's frequency. It's the range of breathing. It is a phase, and It is the nominal target distance.

[0152] In these cases, distance from the target Compared to, maximum respiratory displacement The amplitude is small, and its effect on the reflected acoustic signal can be ignored. As a result, the acoustic signal received by the microphone becomes:

[0153]

[0154] Because an idealized respiratory motion signal can be considered a sine of a sine function, it can be analogous to a cardiac motion signal, albeit at different frequencies and displacements. For the same peak-to-peak amplitude at that displacement, the respiratory motion signal will have regions of maximum and minimum sensitivity. To accurately recover this signal, it is beneficial to utilize a quadrature phase receiver or similar device to mitigate the zero-sensitivity point.

[0155] The I and Q baseband signals can then be used as phasors I+jQ to: (i) recover the RMS and phase of the respiratory signal, (ii) recover the direction of motion (phasor direction), and (iii) recover folding information by detecting when the phasor changes direction. Analysis of reflected acoustic signals (e.g., sonar techniques) is known in the art, and additional details relating to reflected acoustic signals can be found at least in WO2018 / 050913 and WO2020 / 104465, the entire contents of each of which are incorporated herein by reference.

[0156] In other implementations, a similar architecture can be used to implement an adaptive continuous wave (ACW) system if one or more individual tones are used instead of tone pairs.

[0157] In some implementations, the smartphone 402 uses acoustic sensors to perform a scan of the user 210's mouth 220. For example, the acoustic sensors can repeatedly emit acoustic signals and measure their reflections in multiple different directions to determine the positions of various structures within the user 210's mouth 220. Therefore, the acoustic sensors can be used to identify various structures within the user 210's mouth 220 and determine the distances between each structure and between each structure and the acoustic sensor. Thus, acoustic sensors are typically used to map the interior of the user 210's mouth 220.

[0158] Acoustic signals emitted by acoustic sensors can primarily have a single frequency or a frequency within a narrow bandwidth, or they can have frequencies spanning a large bandwidth. In some implementations, the acoustic signal takes the form of "white noise." In these implementations, the acoustic signal is formed by multiple sound waves with frequencies spanning a specific frequency band. The spectral power density of the acoustic signal is constant, causing the acoustic signal to have approximately equal intensity at different frequencies, thus forming white noise.

[0159] In other embodiments, the frequency of the acoustic signal can be scanned back and forth within a frequency band. For example, when the acoustic sensor continuously introduces an acoustic signal into the mouth 220 of the user 210, the frequency can be modulated between a first frequency and a second frequency. Thus, at a first time, the frequency of the acoustic signal is equal to the first frequency. At a second time after the first time, the frequency of the acoustic signal has increased or decreased and is equal to the second frequency. At a third time after the second time, the frequency of the acoustic signal decreases or increases again and is equal to the first frequency again.

[0160] In some implementations, the acoustic sensor can be calibrated before use. For example, user 210 can place smartphone 402 in front of a flat surface such as a wall or table. Smartphone 402 can cause the acoustic sensor to emit an acoustic signal at the flat surface, and then measure the reflected acoustic signal. Typically, the flat surface will have known or estimated reflection characteristics, allowing the actually received reflected acoustic signal to be compared with the expected reflected acoustic signal. This comparison can then be used to determine a calibration factor for adjusting the reflected acoustic signal measured within user 210's mouth 220.

[0161] Step 510 of method 500 includes generating a structural profile of the user based at least in part on (i) image data of the exterior of the user 210's head 214 and / or neck 216, (ii) image data of the interior of the user's mouth 220, (iii) reflected acoustic signals from the interior of the user 210's mouth 220, or (iv) any combination of (i)-(iii). The image data and reflected acoustic signals can be analyzed to identify various body features of the user 210, such as neck size, jaw position, mouth shape, tongue shape, etc., as explained herein. A structural profile containing information about the user 210 can then be generated. The structural profile contains all information about the user 210's body features, determined by any combination of the first image data, the second image data, and the reflected acoustic signals.

[0162] To generate the structural profile, smartphone 402 can use first image data to locate the user's head, face, and mouth 220, for example, using eye detection, ear detection, nose detection, etc. As smartphone 402 moves around the head 214 and neck 216, the dimensions of the head 214 and neck 216 can be estimated. Smartphone 402 can also detect whether the user's mouth 220 is open, allowing the image and sound sensors to have a clear "view" of the mouth 220, and smartphone 402 can process the available sensor data / signals to obtain information about the interior of the mouth 220. For example, smartphone 402 can also map the tongue position, estimate the tongue size (e.g., based on the user moving their tongue in response to a command or instruction), and use second image and acoustic data to provide a "view" of the back of the mouth 220.

[0163] In some implementations, the structural profile is based solely on acoustic signals reflected from inside the mouth 220 of user 210. Therefore, in these implementations, steps 502 and 504 of method 500 do not need to be performed. In other implementations, the structural profile may additionally or alternatively be based on first image data and / or second image data. In these implementations, one or both of steps 502 and 504 may be performed in addition to the remaining steps. Therefore, although in Figure 5 The steps of method 500 shown include obtaining first image data, second image data, and reflected acoustic signals. Various implementations of method 500 can be practiced, which utilize only one or both of the first image data, second image data, and reflected acoustic signals.

[0164] In some implementations, the structural profile may additionally or alternatively be based on thermal data generated by sensors (such as IR sensors, which may be IR sensors 152 of system 100) of camera 404 and / or smartphone 402. For example, a thermal sensor (active or passive) can be used to detect inflammation in the user's mouth. This inflammation may be the result of an infection, stimulation from the user of the respiratory therapy device 122 and / or user interface 124, etc. The inflammation may be located in the user's tonsils and / or gums (e.g., swelling or redness of the tonsils and / or gums), and / or other locations. The heat generated by the inflammation may manifest as the emission of a certain amount of electromagnetic radiation in the infrared and / or visible range. Camera 404 and / or IR sensors can be used as thermal sensors to detect this emitted electromagnetic radiation and determine the local temperature and / or any temperature difference in the user's mouth. The data generated by camera 404 and / or IR sensors can then be used to form the user's structural profile. These techniques can also be used to monitor changes in inflammation in the user's mouth over time.

[0165] In other implementations, the structural profile may additionally or alternatively be based on ranging data generated by one or more ranging sensors, such as lidar sensors (e.g., lidar sensor 178), RADAR sensors (which can be implemented using RF receiver 146 and RF transmitter 148 to form RF sensor 147), ultrasonic ranging sensors, etc. The ranging data from the ranging sensors can be used to generate structured data about the user's head, mouth, and / or neck, including the position, size, orientation, etc., of any body features. In some implementations, IR sensor 152 can be used as the ranging sensor. The ranging sensors can also be used to track various features of the user's head, mouth, and / or neck over time.

[0166] The structural profile can be based on any combination of image data from an image sensor, acoustic data from an acoustic sensor, thermal data from a thermal sensor, and ranging data from a ranging sensor. The structural profile can identify features on the user's head, including features in the user's mouth and / or throat. The structural profile can also include measured distances between any combination of features. The structural profile can be two-dimensional, three-dimensional, or a combination of both. In some implementations, the thermal sensor and / or ranging sensor can be used as alternatives to the camera 404 and / or speaker of the smartphone 404. In other implementations, the thermal sensor and / or ranging sensor can be used in addition to the camera 404 and / or speaker of the smartphone 404 to enhance the image data and / or acoustic data.

[0167] Step 512 of method 500 includes causing an action to be performed in response to generating a structural profile. In some implementations, the action to be performed includes identifying risk factors. In some implementations, the risk factors indicate the percentage probability that user 210 will develop sleep apnea and / or obstructive sleep apnea at some future time, and / or the percentage probability that user 210 has already developed sleep apnea and / or obstructive sleep apnea. The risk factors in these implementations may include an estimated timeline for the development of sleep apnea and / or obstructive sleep apnea. The risk factors may be based at least in part on the physical characteristics of user 210.

[0168] For example, if analysis of user 210 shows that the user has a large neck circumference and a large tongue size (which can be achieved through symptoms of obesity), then user 210's risk factors, compared to users with average neck circumference and tongue size, could indicate that user 210 is at higher risk of developing sleep-disordered breathing and / or obstructive sleep apnea. In some implementations, the risk profile may also consider additional information about user 210. This information may include demographic data such as age, sex, gender, ethnicity, location, etc. This information may also include other physiological data such as height, weight, other medical conditions, etc. In some implementations, data from user 210's use of system 100 may be used. For example, if user 210 has used a respiratory therapy device (such as respiratory therapy device 122) during their sleep periods, method 500 can be used to determine whether user 210's risk factors are decreasing, for example, whether the treatment with the respiratory therapy device is effective (e.g., better sleep quality, weight loss and / or need for lower pressure during use of the respiratory therapy device).

[0169] In some implementations, this action includes sending a notification or report to user 210 and / or to a third party (such as a healthcare provider, caregiver, friend, family member, etc.). The notification or report may include information about identified risk factors, such as the percentage probability that user 210 will develop or has already developed sleep-disordered breathing and / or obstructive sleep apnea.

[0170] In other implementations, this action may include providing the user with recommendations for treatment. Treatment can be any type of therapy designed to reduce the likelihood that the user 210 will develop sleep-disordered breathing and / or obstructive sleep apnea in the future, or to reduce the severity of sleep-disordered breathing and / or obstructive sleep apnea if the user 210 has already developed it. This treatment may include recommending that the user 210 wear a mandibular repositioning device (used to help reposition the user 210's maxilla and mandible), that the user begin using a respiratory therapy device (such as a positive airway pressure device), or any other suggested treatment. Recommendations for treatment may also include suggestions that the user visit a doctor and / or dentist for further analysis or treatment, or that the user participate in a sleep study.

[0171] In other implementations, the action may include generating a three-dimensional (3D) model of at least a portion of the exterior of the user 210's head 214, a three-dimensional (3D) model of at least a portion of the interior of the user 210's mouth 220, or a three-dimensional (3D) model of both. The 3D model can be used as a template to create a custom device to aid in the handling of the user 210. In some implementations, the custom device is a mouthguard worn by the user 210 during sleep periods, which can help prevent events during sleep periods. In other implementations, the custom device is a client-user interface used with a respiratory therapy device, such as a positive airway pressure device. In yet another implementation, the custom device is a mandibular repositioning device used to aid in the repositioning of the user 210's maxilla and mandible.

[0172] In any step of method 500, instructions may be provided for performing the various steps of method 500 (or other steps of other methods). These provided instructions may include instructions for properly positioning smartphone 402 to generate first image data of the exterior of user 210's head 214, generating second image data of the interior of user 210's mouth 220, or guiding acoustic signals and receiving reflected acoustic signals from the interior of user 210's mouth 220. For example, smartphone 402 may play audio instructions via its speaker, or display visual instructions on its display. In some implementations, smartphone 402 provides the instructions. In other implementations, other devices (such as tablets, laptops, desktop computers, smart speakers, etc.) may provide the instructions.

[0173] In some implementations, the instructions are specifically designed for user 210. For example, if smartphone 402 needs to move to the left relative to user 210, the instructions could include a command to move smartphone 402 to the left, since the user will be holding smartphone 402 in their hand. In other implementations, these instructions are intended for use by a third party to assist user 210 in performing the steps of method 500. Thus, referring back to the example above, instructions given to a third party could include a command to move the phone to the third party's right. Because the third party is facing user 210, following the instructions will cause smartphone 402 to move in the same direction relative to user 210. Therefore, while these instructions may differ depending on who they are addressed to, they are designed to help place the phone in a desired position or perform any other steps.

[0174] The augmented reality markers discussed herein in conjunction with step 504 can typically be used in any step to aid in the positioning of smartphone 402. For example, smartphone 402 may display augmented reality markers such as arrow 408 or outline 410 to indicate the correct positioning of smartphone 402 to obtain first image data of the exterior of user 210's head 214 and / or neck 216. Augmented reality markers can also be used to indicate the correct positioning of smartphone 402 to direct acoustic signals toward the interior of user 210's mouth 220. In some implementations, the desired locations for generating the first image data (the exterior of user 210's head 214 and / or neck 216), generating the second image data (the interior of user 210's mouth 220), and directing acoustic signals toward the interior of user 210's mouth 220 are different. In other implementations, any two desired locations may be the same location. In other implementations, all three desired locations are the same location.

[0175] In some implementations, additional sensors may be used to generate additional data, which can be used to augment image and acoustic data to help generate structural profiles. These additional sensors may include depth sensors (to perform time-of-flight processing applied to acoustic or any optical signals to help estimate the distance to the outside or inside of the user 210's mouth 220), proximity sensors (to determine if the smartphone 402 has been brought close to the user's face), infrared (IR) sensors (which may include a dot matrix IR sensor optionally combined with a camera to map the user 210's face and open mouth 220), radio frequency (RF) sensors (e.g., ultra-wideband RF (UWB-RF) sensors) for imaging the face and mouth 220 in 3D, millimeter-wave frequency-modulated continuous wave (FMCW) RF sensors for imaging the face and mouth in 3D, or any combination thereof. These sensors may be integrated into the smartphone 402 or other handheld device, or may be part of another device. In some implementations, some of these additional sensors may be integrated into the smartphone 402 or other handheld device, while others are implemented on separate devices.

[0176] Typically, method 500 can be implemented using a control system having one or more processors and a memory storing machine-readable instructions. The control system can be coupled to the memory, and method 500 can be implemented when the machine-readable instructions are executed by at least one processor of the control system. Method 500 can also be implemented using a computer program product (e.g., a non-transitory computer-readable medium) comprising instructions that, when executed by a computer, cause the computer to perform the steps of method 500.

[0177] Now for reference Figure 8 User 210 can use device 600 to place smartphone 402 in the correct position to direct sound signals into the mouth 220 of user 210. For example... Figure 8 As shown, a smartphone 402 can be inserted into a device 600, and the user can bite onto the device 600. In doing so, the acoustic sensor of the smartphone 402 is typically located inside or just outside the mouth 220 of the user 210. In this location, the smartphone 402 can use the acoustic sensor to direct acoustic signals into the mouth 220 of the user 210 and receive reflected acoustic signals reflected from structural features within the mouth 220 of the user 210.

[0178] Now refer to the appendix Figure 9A , 9BIn conjunction with 9C, device 600 is formed by a handheld device portion 602A and a mouth portion 602B. The handheld device portion 602A is configured to securely receive some or all of a handheld device such as smartphone 402. The mouth portion 602B is configured to be gripped in the user's mouth 220, such that smartphone 402 is positioned by the user's mouth 220. The user can hold device 600 in their mouth 220 by biting down on the mouth portion 602B with their teeth. The user can bite down on the mouth portion 602B by inserting their teeth into a recess 603 formed by the mouth, and actively apply pressure to the mouth portion 602B with their teeth or passively rest their teeth in the recess 603. The user can additionally or alternatively grip the mouth portion 602B with their gums and / or lips to hold device 600 in their mouth 220. In some implementations, a user may grasp the mouth portion 602B by inserting their gums and / or lips into the recess 603, and either actively apply pressure to the mouth portion 602B with their gums and / or lips, or passively rest their gums and / or lips in the recess 603. As used herein, an individual's teeth may include a single tooth, multiple teeth, a portion of a single tooth, or a portion of multiple teeth. As used herein, an individual's gums may include the upper gum, lower gum, both the upper and lower gums, a portion of the upper gum, a portion of the lower gum, or a portion of both the upper and lower gums. As used herein, an individual's lips may include the upper lip, lower lip, both the upper and lower lip, a portion of the upper lip, a portion of the lower lip, or a portion of both the upper and lower lip.

[0179] In some implementations, the handheld device portion 602A defines a slot 604 for receiving the smartphone 402. For example, Figure 9A , 9B Figure 9C shows a handheld device portion 602A including a top wall, a bottom wall, a first side wall coupled to a first end of the top and bottom walls, and a second side wall coupled to a second end of the top and bottom walls. The four walls together define a slot 604 for receiving a smartphone 402. In other implementations, the slot 604 may be defined by fewer walls. For example, the handheld device portion 602A may include only the top and bottom walls, or only two side walls. In these implementations, the smartphone 402 is held in place by the two walls forming the slot 604.

[0180] When the smartphone 402 is received by the slot 604 of the handheld device portion 602A, the acoustic sensor is located within the slot 604. Typically, the area within the slot 604 opens to the opposite side of the mouth portion 602B opposite to the handheld device portion 602A. Therefore, when the mouth portion 602B is inserted into the user's mouth 220, the acoustic sensor is in fluid communication with the interior of the user's mouth 220. Thus, the acoustic sensor is able to guide acoustic signals into the interior of the user's mouth 220 and receive reflected acoustic signals after reflections from various structures within the user's mouth 220.

[0181] Figure 10A A top view of device 600 is shown, while Figure 10B A top view of a device 600 holding a smartphone 402 is shown. It can be seen that the mouth portion 602B has a generally curved shape that conforms to the user's teeth, gums, lips, etc., when the user grasps the mouth portion 602B. The mouth portion 602B is formed by an outer curved wall 608A and an inner curved wall 608B. When the user holds the mouth portion 602B, the inner curved wall 608B is typically behind the user's teeth, for example, between the user's teeth and the back of the user's mouth. The outer curved wall 608A is positioned in front of the user's teeth, such that the user's teeth are located between the outer curved wall 608A and the inner curved wall 608B. The user's gums and / or lips may also be positioned between the outer curved wall 608A and the inner curved wall 608B (e.g., Figure 8 (as shown), or on the outside of the outer curved wall 608A.

[0182] In some implementations, the outer curved wall 608A and the inner curved wall 608B define two channels 606A and 606B. Channels 606A and 606B open the interior of the slot 604 to the opposite side of the mouth portion 602B. When the smartphone 402 is inserted into the handheld device portion 602A, the speaker 412A can be positioned near channel 606A, and the microphone can be positioned near channel 606B. Channel 606A helps guide sound signals from the speaker 412A to the interior of the user's mouth, while channel 606B helps guide reflected sound signals from the interior of the user's mouth to the microphone 412B. In some implementations, channels 606A and 606B are simply one or more portions of the slot 604 extending from the handheld device portion 602A to the mouth portion 602B. In other implementations, channels 606A and 606B are separate openings defined in the device 600. Therefore, the design of the mouth portion provides for more efficient transmission of sound signals to the user's mouth and more efficient reception of reflected sound signals from the user's mouth. In an embodiment, the region of the outer curved wall 608A can be shaped to facilitate the collection of reflected acoustic signals. For example, the outer curved wall 608A may include tapered protrusions that facilitate more efficient collection of reflected acoustic signals.

[0183] In some embodiments, device 600 includes a tongue depressor 610. The tongue depressor extends inward from the inner curved wall 608B toward the rear of the user's mouth. When the user inserts the mouth portion 602B into their mouth and bites down, the tongue depressor 610 is positioned on top of the user's tongue. When the speaker 412A emits an acoustic signal and the microphone 412B receives the reflected acoustic signal, the tongue depressor 610 prevents the user's tongue from moving upward. Therefore, the tongue depressor 610 helps prevent the user's tongue from blocking the acoustic signal emitted by the speaker 412A and helps prevent the user's tongue from blocking the reflected acoustic signal.

[0184] In an implementation where channels 606A and 606B are defined by slot 604, the tongue depressor 610 may also serve as a blocking structure to prevent acoustic signals emitted by speaker 412A from being directly received by microphone 412B, and to ensure that the acoustic signals are reflected from one or more physical structures of user 210's mouth 220 before being received by microphone 412B. In an embodiment where channels 606A and 606B are separately defined by device 600, the portion of device 600 located between channels 606A and 606B (which may originate from outer curved wall 608A, inner curved wall 608B, or any other portion) serves as a blocking structure to prevent acoustic signals emitted by speaker 412A from being directly received by microphone 412B, and to ensure that the acoustic signals are reflected from one or more physical structures of user 210's mouth 220 before being received by microphone 412B.

[0185] The device 600 may also include calibration markers 612A and 612B. Calibration markers 612A and 612B are configured to help determine the location of various features in the user's mouth. Both calibration generators 612A and 612B extend a known distance away from the device 600, and are positioned a known distance apart from each other. Therefore, when analyzing reflected acoustic signals, any portion of the acoustic signal associated with the reflection of calibration markers 612A and 612B can be used as a reference to determine other distances and locations, since the positions of calibration markers 612A and 612B relative to each other and relative to the inner curved wall 608 are known. In some implementations, the device 600 may include only a single calibration generator. In other implementations, the device 600 may include three or more calibration generators.

[0186] Figure 11 A device 900 for holding a smartphone 402 is shown. The device 900 is similar to the device 600 and includes a handheld portion 902A and a mouth portion 902B. The handheld portion 902A securely accommodates the smartphone 402, while the mouth portion 902B is inserted into the mouth of a user 210. However, in this implementation, the handheld portion 902A is angled at approximately 90°, such that the smartphone 402 is held vertically in front of the user 210's face. Therefore, the device 900 holds the smartphone 402 in a position where the smartphone 402 can generate first image data of the exterior of the user 210's head using the smartphone's camera. However, because the end of the smartphone 402, which has a speaker and microphone, is inserted into a slot defined by the handheld portion 902A, the speaker and microphone of the smartphone 402 are in fluid communication with the interior of the user 210's mouth in this position. Therefore, while the camera of the smartphone 402 is acquiring first image data, the speaker can direct acoustic signals into the user 210's mouth while the microphone receives reflected acoustic signals.

[0187] Figures 12A-13B A device 1000 for holding a smartphone 402 is shown, having a camera 404, a speaker 412A, and a microphone 412B, all located at one end of the smartphone 402. Device 1000 is similar to device 900. However, device 1000 is configured to hold the smartphone 402 such that the interior of a user's mouth 220 is within the field of view of the camera 404, and that both the speaker 412A and the microphone 412B are in fluid communication with the interior of the user's mouth 220.

[0188] Device 1000 includes a front wall 1004A and a rear wall 1004B defining an opening of mobile phone 402. Device 1000 also includes an outer curved wall 1008A and an inner curved wall 1008B that contact the user's mouth 220. In the illustrated implementation, the user bites onto device 1000 such that the user's teeth 224 are located between the outer curved wall 1008A and the inner curved wall 1008B.

[0189] An opening in the device 1000, defined between the front wall 1004A and the rear wall 1004B, leads to the interior of the user's mouth 220. Therefore, as... Figure 12A and 12B As shown, speaker 412A can emit acoustic signals (represented by sound wave 416A) that propagate into the user's mouth 220. Simultaneously, camera 404 of smartphone 402 can generate image data that can be reproduced as an image of the inside of the user's mouth 220. Furthermore, because smartphone 402 extends into the opening defined between front wall 1004A and rear wall 1004B, the first portion 406A of the display of smartphone 402 is positioned adjacent to the inside of the user's mouth 220. The first portion 406A of the display of smartphone 402 can be used to illuminate the inside of the user's mouth 220 and generate higher quality image data. When the sound signal (represented by sound wave 416A) is emitted by speaker 412A, the sound signal is reflected from various structures or features within the user's mouth 220. The reflected acoustic signal (represented by sound wave 416B) propagates back to smartphone 402, where it is received by microphone 412B.

[0190] While the disclosure herein generally pertains to smartphones, any device or combination of devices can be used to perform the steps of method 500, and generally captures image and audio data from the user. For example, user 210 can use a tablet, laptop, desktop computer, other device, or any combination thereof to acquire image and acoustic data and generate a structural profile. In some implementations, a handheld device is used to acquire image and audio data, but an external device (such as user device 170) is used to perform some or all of the data processing to generate the structural profile.

[0191] In some implementations, the device for holding the smartphone 402 is configured to allow controlled use of the camera 404 to generate image data. For example, the device may include a shutter configured to selectively block and unlock the camera 404, such that the camera 404 generates image data only when needed. The device may also include a calibration generator used with the camera 404 to provide a positional reference in the image data. The calibration marks may be the same calibration marks 612A, 612B used with the acoustic sensor, or they may be additional or alternative calibration marks. In some implementations, a portion of the device defining a slot may extend the length of the smartphone 402 such that all or almost all of the smartphone 402, including the camera 404, is arranged within the slot. The shutter may be constructed within the portion of the device defining the slot to block and unlock the camera 404.

[0192] A handheld device (such as a smartphone 402) and a device for receiving the handheld device (such as device 600, device 900, or device 600) can form a system for analyzing the body characteristics of a user's mouth, throat, neck, head, etc. By using a device that can be partially inserted into their own mouth, the user can obtain more accurate measurements, analyses, etc., of their own body characteristics. By inserting the handheld device into a device that is partially inserted into the user's mouth, the user can achieve consistent positioning of the handheld device and avoid any incorrect positioning that could lead to inaccurate measurements and analyses.

[0193] One or more elements or aspects or steps or any part thereof from the claims may be combined with one or more other elements or aspects or steps or any part thereof from the claims to form one or more additional embodiments of the invention.

[0194] While the invention 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 the invention. Each of these implementations and their obvious variations is considered to fall within the spirit and scope of the invention. Additional implementations of aspects of the invention are also contemplated that can combine any number of features from any of the implementations described herein.

Claims

1. A method for analyzing the physical characteristics of an individual, the method comprising: Receive data generated by one or more sensors of the handheld device, the data indicating structural features of the individual's head, the individual's neck, or both; Based at least in part on the data, the structural outline of the individual's head, the individual's neck, or both is generated; In response to generating the structural profile, risk factors for the individual to have sleep-disordered breathing, to develop sleep-disordered breathing, or both are identified; and Based at least in part on the structural profile, recommendations for treatment types are generated for the individual, including recommendations for the use of a mandibular repositioning device, recommendations for the use of a respiratory therapy device, or both.

2. The method of claim 1, wherein the data indicates structural features of the interior of at least the mouth of the individual, and wherein the structural profile includes at least a portion of the interior of the mouth of the individual.

3. The method of claim 1, wherein the one or more sensors include an image sensor of the handheld device, and wherein the data includes image data reproducible as one or more images of: (i) the interior of the mouth of the individual; (ii) the exterior of the head of the individual; (iii) the neck of the individual; or (iv) any combination of (i)-(iii).

4. The method of claim 3, wherein the structural profile includes at least a portion of the exterior of the head of the individual, at least a portion of the neck of the individual, or both.

5. The method of claim 3, wherein the method further comprises: A real-time view of the individual is displayed on at least a first portion of the display of the handheld device based on the image data; as well as At least a portion of the individual is illuminated by at least a second portion of the display of the handheld device, such that the display of the handheld device is used simultaneously to display the real-time view of the individual and to illuminate the individual.

6. The method of claim 5, further comprising displaying one or more augmented reality (AR) markers on the first portion of the display of the handheld device, the AR markers being configured to help guide the handheld device to a desired location to generate the image data.

7. The method of claim 6, wherein the one or more augmented reality markers comprise (i) at least one marker configured to indicate a direction of movement of the handheld device toward the desired location; (ii) at least one contour configured to overlap with a real-time view of features of the individual on the first portion of the display when the handheld device is at the desired location; or (iii), both (i) and (ii).

8. The method of claim 7, wherein the at least one contour has a shape corresponding to the characteristics of the individual.

9. The method of claim 6, wherein the handheld device is configured to indicate when the handheld device is in the desired position.

10. The method of claim 9, wherein in response to the handheld device being in the desired position, the handheld device is configured to (i) display an indicator on the display of the handheld device; (ii) generate an audible sound; (iii) modify the one or more augmented reality markers; (iv) change the color of at least one of the one or more augmented reality markers; (v) change the shape of at least one of the one or more augmented reality markers; (vi) change the size of at least one of the one or more augmented reality markers; or any combination of (vii) and (i)-(vi).

11. The method of claim 6, wherein the image data includes first image data reproducible as one or more images of the interior of the mouth of the individual, and second image data reproducible as one or more images of the exterior of the head of the individual, the neck of the individual, or both, and wherein the desired location used to generate the first image data is different from the desired location used to generate the second image data.

12. The method of claim 5, wherein the image sensor is disposed at the upper end of the handheld device, wherein the first portion of the display is the lower end of the display spaced apart from the image sensor, and wherein the second portion of the display is the upper end of the display adjacent to the image sensor and located between the image sensor and the first portion of the display.

13. The method of claim 12, wherein the image data is reproducible as one or more images of the interior of the individual's mouth, and wherein during the generation of the image data, the first portion of the image sensor and the display is aligned with the individual's mouth, and the second portion of the display is aligned with the individual's eyes.

14. The method of claim 3, wherein the method further comprises: On an external display separate from the handheld device, a real-time view of the individual is displayed based on the image, thereby helping to locate the handheld device to generate the image data.

15. The method of claim 1, wherein the structural profile includes information associated with the individual's neck circumference, the individual's jaw position, the individual's mouth shape, the individual's tongue shape, the individual's tongue size, or any combination thereof.

16. The method of claim 1, wherein the risk factor is further based on demographic data associated with the individual, physiological data associated with the individual, or both.

17. The method of claim 1, wherein the structural profile is further based on data generated by at least one sensor not integrated into the handheld device.

18. The method of claim 1, wherein the one or more sensors include a LiDar sensor, an ultrasonic ranging sensor, a depth sensor, a proximity sensor, an infrared (IR) sensor, a radio frequency (RF) sensor, or any combination thereof.

19. The method of claim 1, further comprising generating at least a three-dimensional (3D) model of the interior of the mouth of the individual based at least in part on the data, the three-dimensional model being configured as a template for creating a custom mandibular repositioning device or a custom user interface for use with the respiratory therapy device.

20. A system for analyzing the physical characteristics of an individual, the system comprising: Memory on which machine-readable instructions are stored; as well as A control system, coupled to the memory, includes one or more processors that execute the machine-readable instructions to: Receive data generated by one or more sensors of the handheld device, the data indicating structural features of the individual's head, the individual's neck, or both; Based at least in part on the data, the structural outline of the individual's head, the individual's neck, or both is generated; In response to generating the structural profile, risk factors for the individual to have sleep-disordered breathing, to develop sleep-disordered breathing, or both are identified; and Based at least in part on the structural profile, recommendations for treatment types are generated for the individual, including recommendations for the use of a mandibular repositioning device, recommendations for the use of a respiratory therapy device, or both.

21. A means for positioning a handheld device toward the mouth of an adjacent individual, the means comprising: The mouth portion is configured to be at least partially inserted into the mouth of the individual; as well as The handheld device portion is configured to securely house at least a portion therein, such that when the mouth portion is at least partially inserted into the mouth of the individual, the acoustic sensor of the handheld device is in fluid communication with the interior of the mouth of the individual.

22. The device of claim 21, wherein the mouth portion is a mouth piece configured to be held by the individual's teeth, the individual's gums, the individual's lips, or any combination thereof.

23. The apparatus of claim 21, further comprising a tongue depressor extending from the mouth portion, the tongue depressor being configured to help hold the tongue of the individual in a depressed position, wherein the acoustic sensor of the handheld device is configured to generate an acoustic signal, and wherein when the tongue is in the depressed position, the tongue is prevented from (i) blocking the acoustic signal from entering the interior of the mouth of the individual; and (ii) blocking the reflection of the acoustic signal from leaving the interior of the mouth of the individual.

24. The device of claim 23, wherein the mouth portion includes an inner curved wall and an outer curved wall, and wherein when the first portion is inserted into the mouth of the individual, the individual's teeth, the individual's gums, the individual's lips, or any combination thereof are located between the inner curved wall and the outer curved wall, and wherein the mouth portion includes at least one channel defined at least through the outer curved wall, and wherein when the handheld device is secured by the handheld device portion, the acoustic sensor of the handheld device is positioned adjacent to the channel such that the acoustic sensor is in fluid communication with the interior of the mouth of the individual through the at least one channel.

25. The device of claim 23, wherein the mouth portion includes a blocking structure positioned adjacent to the acoustic sensor when the handheld device is secured by the handheld device portion, the blocking structure being configured to prevent acoustic signals emitted by the one or more speakers from being received by the acoustic sensor before the acoustic signals are reflected away from the interior of the mouth of the individual.

26. The apparatus of claim 23, further comprising a calibration mark extending a known distance from the first portion, the calibration mark being configured to help determine the position of a feature within the interior of the individual's mouth relative to the acoustic sensor.

27. A method for analyzing the physical characteristics of an individual, the method comprising: Calibrate acoustic sensors; The acoustic sensor is used to direct an acoustic signal toward the mouth of the individual, the acoustic signal being configured to reflect away from at least a portion of the interior of the mouth of the individual; The acoustic sensor is used to receive reflected acoustic signals from inside the mouth of the individual, the reflected acoustic signals indicating the structural features of the mouth of the individual; The structural contour of at least the interior of the mouth of the individual is generated, based at least in part on the reflected acoustic signal; as well as In response to generating the structural contour, an action is performed.

28. A method for analyzing the physical characteristics of an individual, the method comprising: An acoustic signal is directed at the mouth of the individual using an acoustic sensor. The acoustic signal is configured to reflect off at least a portion of the interior of the mouth of the individual. The acoustic signal comprises multiple sound waves spanning a frequency band and has approximately equal intensity at different frequencies within the frequency band, such that the acoustic signal has a constant power spectral density. The acoustic sensor is used to receive reflected acoustic signals from inside the mouth of the individual, the reflected acoustic signals indicating the structural features of the mouth of the individual; The structural contour of at least the interior of the mouth of the individual is generated, based at least in part on the reflected acoustic signal; as well as In response to generating the structural contour, an action is performed.

29. A method for analyzing the physical characteristics of an individual, the method comprising: For a period of time, an acoustic signal is continuously directed at the mouth of the individual using an acoustic sensor, the acoustic signal being configured to reflect off at least a portion of the interior of the mouth of the individual, the acoustic signal having a varying frequency during the period of time; The acoustic sensor is used to receive reflected acoustic signals from inside the mouth of the individual, the reflected acoustic signals indicating the structural features of the mouth of the individual; The structural contour of at least the interior of the mouth of the individual is generated, based at least in part on the reflected acoustic signal; as well as In response to generating the structural contour, an action is performed.

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