Systems and methods for predicting face mask leakage

Abstract

A method for predicting unintentional leaks in a respiratory system during a sleep period includes delivering pressurized air from a breathing device to a user via a conduit connected to a user interface during the sleep period. The method also includes receiving historical first data associated with pressurized air delivered from the breathing device during one or more previous sleep periods; receiving current first data associated with pressurized air delivered from the breathing device during the sleep period; receiving historical second data associated with the user during one or more previous sleep periods; and receiving current second data associated with the user during the current sleep period via one or more second sensors. The method determines the likelihood of an unintentional leak occurring in the respiratory system within a predetermined time period.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 032,325, filed on May 29, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates generally to respiratory systems, and more specifically to systems and methods for predicting unintentional mask leaks in respiratory systems. Background Technology

[0004] Many people suffer from sleep-related and / or respiratory disorders, such as periodic limb tic disorder (PLMD), restless legs syndrome (RLS), sleep-disordered breathing (SDB), obstructive sleep apnea (OSA), sleep apnea, Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity-related hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD), and chest wall diseases. These conditions are often treated with respiratory therapy systems. People with respiratory disorders may have sleep problems, but systems designed to alleviate the physical symptoms of respiratory disorders do not address issues beyond the symptoms of the disease itself, which can disrupt sleep. Therefore, there is a need for alternative systems and methods to address sleep-disordered or unintended features of current respiratory therapy systems that may reduce the intended quality of sleep therapy. This invention aims to address these problems and other needs. Summary of the Invention

[0005] According to some implementations of the present invention, a method for predicting unintentional leakage in a respiratory system during a current sleep period includes delivering pressurized air from a respiratory device to a user via a conduit coupled to a user interface during the current sleep period. The user interface is worn around a portion of the user's face to assist the user in receiving at least a portion of the pressurized air. Historical first data related to pressurized air delivered from the respiratory device during one or more previous sleep periods is received. Current first data related to pressurized air delivered from the respiratory device during the current sleep period is received via one or more first sensors. Historical second data related to one or more orientations of the user during one or more previous sleep periods is received. Current second data related to one or more orientations of the user during the current sleep period is received via one or more second sensors. The probability of an unintentional leakage in the respiratory system occurring within a predetermined time period is determined based at least in part on (i) the historical first data, (ii) the current first data, (iii) the historical second data, and (iv) the current second data.

[0006] According to some implementations of the present invention, a method for predicting unintentional leaks in the respiratory system during a current sleep period includes determining an unintentional leak prediction value for a user of the respiratory system. The determined unintentional leak prediction value represents the probability that the user will experience an unintentional leak within a predetermined amount of time during the current sleep period. The unintentional leak prediction value is determined using an unintentional leak prediction algorithm configured to receive location data as input and output an unintentional leak prediction value for the individual.

[0007] The above overview is not intended to represent every implementation or aspect of the invention. Additional features and benefits of the invention will become apparent from the following detailed description and accompanying drawings. Attached Figure Description

[0008] Figure 1 This is a functional block diagram of a system according to some implementations of the present invention.

[0009] Figure 2 This is according to some implementations of the present invention. Figure 1 A perspective view of at least a portion of the system, user, and bed partner.

[0010] Figure 3 This is a flowchart of a method for determining the likelihood of unintentional leakage according to some implementations of the present invention.

[0011] Figure 4 This is a graph of pressure and flow data according to some implementations of the present invention.

[0012] While the invention is open to various modifications and alternatives, specific implementations and embodiments thereof have been shown 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

[0013] Many individuals suffer from sleep-related and / or breathing disorders. Examples of sleep-related and / or respiratory disorders include periodic limb tic disorder (PLMD), restless legs syndrome (RLS), sleep-disordered breathing (SDB), obstructive sleep apnea (OSA), sleep apnea, Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity-related hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD), and chest wall diseases.

[0014] To mitigate some of these sleep-related and / or breathing disorders, the user may be prescribed the use of a breathing device or system. For example, a continuous positive airway pressure (CPAP) machine may be used to increase the air pressure in the throat of the breathing device user (e.g., the user) and prevent airway closure and / or narrowing during sleep. While these breathing devices or systems can improve the user's sleep quality, some problems beyond the symptoms of the condition itself may be the opposite of what is sought after the improvement in sleep quality. For example, noise generated by the system, such as noise caused by unintentional leaks. Besides potentially reducing the user's sleep quality, this noise may also interfere with the quality of sleep for the sleeping partner. In some implementations of the invention, a method for predicting unintentional leaks in the breathing system used by a subject during a current sleep period is described. Predicting unintentional leaks allows for mitigation measures to prevent them.

[0015] Reference Figure 1 The diagram illustrates a system 100 according to some implementations of the present invention. System 100 includes a control system 110, a storage device 114, an electronic interface 119, one or more sensors 130, and one or more user devices 170. In some implementations, system 100 may also optionally include a respiratory system 120.

[0016] The control system 110 includes one or more processors 112 (hereinafter referred to as processors 112). The control system 110 is typically used to control various components of the system 100 and / or analyze data acquired and / or generated by the components of the system 100. The processor 112 may be a general-purpose or special-purpose processor or a microprocessor. Although in Figure 1 A processor 112 is shown, but the control system 110 may include any suitable number of processors (e.g., one processor, two processors, five processors, ten processors, etc.), which may be located in a single housing or positioned remotely from each other. The control system 110 may be coupled to and / or located within, for example, the housing of user equipment 170, and / or within 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 implementation, which includes two or more housings containing the control system 110, such housings may be positioned close to and / or far from each other.

[0017] Storage device 114 stores machine-readable instructions executable by processor 112 of control system 110. Storage 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 storage devices, etc. Although Figure 1The diagram shows one storage device 114, but system 100 may include any suitable number of storage devices 114 (e.g., one storage device, two storage devices, five storage devices, ten storage devices, etc.). Storage devices 114 may be coupled to and / or located within the housing of the breathing device 122, the housing of the user device 170, the housing of one or more sensors 130, or any combination thereof. Similar to control system 110, storage devices 114 may be centralized (within one such housing) or distributed (within two or more physically different such housings).

[0018] In some implementations, storage device 114 ( Figure 1 The system stores user profiles related to the user. User profiles may include, for example, user-related demographic information, user-related biostatistics, user-related medical information, self-reported user feedback, user-related 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, race, family history of insomnia, employment status, education level, socioeconomic status, or any combination thereof. Medical information may include, for example, information indicating one or more medical conditions related to the user, medication use, or both. Medical information data may also include polyphasic sleep latency measurement (MSLT) test results or scores and / or Pittsburgh Sleep Quality Index (PSQI) scores or values. Self-reported user feedback may include information indicating self-reported subjective sleep scores (e.g., poor, average, excellent), the user's self-reported subjective stress level, the user's self-reported subjective fatigue level, the user's self-reported subjective health status, recent life events experienced by the user, or any combination thereof.

[0019] Electronic interface 119 is configured to receive data (e.g., physiological data) from one or more sensors 130, such that the data can be stored in storage device 114 and / or analyzed by processor 112 of control system 110. Electronic interface 119 can communicate with one or more sensors 130 using wired or wireless connections (e.g., using RF communication protocols, WiFi communication protocols, Bluetooth communication protocols, via cellular networks, etc.). Electronic interface 119 may include an antenna, a receiver (e.g., an RF receiver), a transmitter (e.g., an RF transmitter), a transceiver, or any combination thereof. Electronic interface 119 may also include one or more processors and / or one or more processors that are the same as or similar to one or more processors 112 and / or one or more storage devices 114. In some implementations, electronic interface 119 is coupled to or integrated into user equipment 170. In other implementations, electronic interface 119 is coupled to or integrated with control system 110 and / or storage device 114 (e.g., in a housing).

[0020] As described above, in some implementations, system 100 may optionally include a respiratory system 120 (also referred to as a respiratory therapy system). The respiratory system 120 may include a respiratory pressure therapy device 122 (referred to herein as respiratory device 122), a user interface 124, a catheter 126 (also referred to as a tube or air circuit), a display device 128, a humidifier canister 129, a reservoir 180, or any combination thereof. In some implementations, a control system 110, a storage device 114, a display device 128, one or more sensors 130, and a humidifier canister 129 are part of the respiratory device 122. Respiratory pressure therapy refers to the application of supplying air to the inlet of a user's airway at a controlled target pressure that is nominally positive relative to the atmosphere throughout the user's respiratory cycle (e.g., as opposed to negative pressure therapy, such as a canister ventilator or a thoracic ventilator). The respiratory system 120 is typically used to treat individuals suffering from one or more sleep-related breathing disorders (e.g., obstructive sleep apnea, central sleep apnea, or mixed sleep apnea).

[0021] Breathing device 122 is typically used to generate pressurized air to be delivered to a user (e.g., using one or more motors driving one or more compressors). In some implementations, breathing device 122 generates a continuous, constant air pressure that is delivered to the user. In other implementations, breathing device 122 generates two or more predetermined pressures (e.g., a first predetermined air pressure and a second predetermined air pressure). In other implementations, breathing device 122 is configured to generate a variety of different air pressures within a predetermined range. For example, breathing 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. Breathing 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).

[0022] User interface 124 engages with a portion of the user's face and delivers pressurized air from breathing device 122 to the user's airway to help prevent airway narrowing and / or collapse during sleep. This can also increase the user's oxygen intake during sleep. Depending on the treatment to be applied, user interface 124 may form a seal with an area or portion of the user's face to deliver gas at a pressure sufficiently variable to the ambient pressure, such as a positive pressure of about 10 cm H2O relative to the 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 deliver gas at a positive pressure of about 10 cm H2O to the airway.

[0023] like Figure 2 As shown, in some implementations, the user interface 124 is a mask (e.g., a full-face mask) covering the user's nose and mouth. The user interface 124 may include multiple straps (e.g., including hook and loop fasteners) for positioning and / or securing the interface to a portion of the user (e.g., the face) and conformal padding (e.g., silicone, plastic, foam, etc.) designed to provide an airtight seal between the user interface 124 and the user. The user interface 124 may also include one or more vents for allowing carbon dioxide and other gases exhaled by the user 210 to escape.

[0024] The conduit 126 (also referred to as an air circuit or tube) allows air to flow between two components of the respiratory system 120, such as the breathing device 122 and the user interface 124. In some implementations, there may be separate branches of the conduit for inhalation and exhalation. In other implementations, a single branch conduit is used for both inhalation and exhalation.

[0025] One or more of the breathing device 122, user interface 124, tubing 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 may be used, for example, to measure the air pressure and / or flow rate of the pressurized air supplied by the breathing device 122.

[0026] Display device 128 is typically used to display images, including still images, video images, or both, and / or information about breathing apparatus 122. For example, display device 128 may provide information about the status of breathing apparatus 122 (e.g., whether breathing apparatus 122 is on / off, the pressure of the air delivered by breathing apparatus 122, the temperature of the air delivered by breathing apparatus 122, etc.) and / or other information (e.g., sleep score, current date / time, personal information of user 210, etc.). In some implementations, display device 128 acts as a human-machine interface (HMI) including a graphical user interface (GUI) configured to display images as an input interface. Display device 128 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 breathing apparatus 122.

[0027] A humidifier canister 129 is coupled to or integrated into a breathing apparatus 122. The humidifier canister 129 includes a water reservoir for humidifying pressurized air delivered from the breathing apparatus 122. The breathing apparatus 122 may include a heater to heat the water in the humidifier canister 129 to humidify the pressurized air supplied to the user. 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. The humidifier canister 129 may be fluidly coupled to a water vapor inlet of an 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.

[0028] In some implementations, system 100 may be used to deliver at least a portion of a substance from seat 180 to the user's airway, at least in part based on physiological data, sleep-related parameters, other data or information, or a combination thereof. Typically, modifying the delivery of a portion of the substance into the airway may include (i) initiating delivery of the substance into the airway, (ii) terminating delivery of a portion of the substance into the airway, (iii) modifying the amount of substance delivered into the airway, (iv) modifying the temporal characteristics of delivery of a portion of the substance into the airway, (v) modifying the quantitative characteristics of delivery of a portion of the substance into the airway, (vi) modifying any parameters associated with delivery of the substance into the airway, or (vii) a combination of (i)-(vi).

[0029] Altering the temporal characteristics of the delivery of a portion of the substance entering the air channel can include changing the delivery rate, starting and / or ending at different times, lasting for different periods, changing the temporal distribution or characteristics of the delivery, and changing the quantity distribution independently of the time distribution. Independent temporal and quantity variations ensure that, in addition to changing the frequency of substance release, the amount of substance released each time can be altered. In this way, various combinations of release frequency and release quantity can be achieved (e.g., higher frequency but lower release quantity, higher frequency and higher release quantity, lower frequency and higher release quantity, lower frequency and lower release quantity, etc.). Other variations that deliver a portion of the substance into the air channel can also be utilized.

[0030] The respiratory system 120 can be used as, for example, a positive airway pressure (PAP) system, 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, a ventilator, or a combination thereof. A CPAP system delivers a predetermined pressure (e.g., determined by a sleep physician) to the user. An APAP system automatically changes the pressure delivered to the user based on, for example, breathing data relevant to the user. A 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 lower than the first predetermined pressure (e.g., expiratory positive airway pressure or EPAP).

[0031] Still referencing Figure 1The system 100 includes one or more sensors 130, such as a pressure sensor 132, a flow sensor 134, a temperature sensor 136, a motion sensor 138, a microphone 140, a speaker 142, a radio frequency (RF) receiver 146, an RF transmitter 148, a camera 150, an infrared sensor 152, a photoplethysmography (PPG) sensor 154, an electrocardiogram (ECG) sensor 156, an electroencephalogram (EEG) sensor 158, a capacitance sensor 160, a force sensor 162, a strain gauge sensor 164, an electromyography (EMG) sensor 166, an oxygen sensor 168, an analyte sensor 174, a humidity sensor 176, a light detection and ranging (LiDAR) sensor 178, or combinations thereof. Typically, each of the one or more sensors 130 is configured to output sensor data that is received and stored in storage device 114 or one or more other storage devices.

[0032] 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, infrared sensor 152, photoplethysmography (PPG) sensor 154, electrocardiogram (ECG) sensor 156, electroencephalogram (EEG) sensor 158, capacitance sensor 160, force sensor 162, strain gauge sensor 164, electromyography (EMG) sensor 166, oxygen sensor 168, analyte sensor 174, humidity sensor 176, and light detection and ranging (LiDAR) sensor 178. More generally, one or more sensors 130 may include combinations and any number of each of the sensors described and / or shown herein.

[0033] As described herein, system 100 can typically be used to generate interactions with the user (e.g., during sleep periods) Figure 2 Physiological data related to the user of the respiratory system 120 shown. Physiological data can be analyzed to generate one or more sleep-related parameters, which may include any parameters, measurements, etc., related to the user during sleep periods. 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 score, flow signal, respiratory signal, respiratory rate, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory ratio, number of events per hour, event pattern, stage, pressure setting of the respiratory device 122, heart rate, heart rate variability, user 210 movement, temperature, EEG activity, EMG activity, arousal, snoring, choking, coughing, whistling, wheezing, or combinations thereof.

[0034] In some implementations, 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 states, including wakefulness, relaxed wakefulness, micro-wakefulness, rapid eye movement (REM) stage, first non-REM stage (commonly referred to as "N1"), second non-REM stage (commonly referred to as "N2"), third non-REM stage (commonly referred to as "N3"), or combinations thereof.

[0035] The sleep-wake signal can also be time-stamped to determine the time when the user enters the bed, the time when the user leaves the bed, and the time when the user attempts to fall asleep. The sleep-wake signal can be measured by one or more sensors 130 during the sleep period at a predetermined sampling rate, such as one sample per second, one sample every 30 seconds, one sample per minute, etc. The sleep-wake signal 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 combinations thereof, during the sleep period. 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, apnea, increased heart rate, difficulty breathing, asthma attack, seizure, epileptic seizure, or combinations thereof. One or more sleep-related parameters that can be determined for the user based on the sleep-wake signal during the sleep period include, for example, total time in bed, total sleep time, sleep onset wait time, wakefulness parameters after sleep onset, sleep efficiency, segmentation index, or combinations thereof.

[0036] 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 / or has turned on the breathing device 122 and / or put on the user interface 124. A sleep period can therefore include time periods (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 asleep again.

[0037] A sleep period is typically defined as ending once the user 210 removes the user interface 124, shuts off the breathing device 122, and / or leaves the 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 the breathing device 122 begins supplying pressurized air to the airway or the user 210, ends when the breathing device 122 stops supplying pressurized air to the user 210's airway, and includes some or all of the time points between when the user 210 is asleep or awake.

[0038] Pressure sensor 132 outputs pressure data that can be stored in storage 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 system 120. In such implementations, pressure sensor 132 can be coupled to or integrated into respiratory device 122. Pressure sensor 132 can be, for example, a capacitive sensor, an electromagnetic sensor, a piezoelectric sensor, a strain gauge sensor, an optical sensor, a potential sensor, or a combination thereof.

[0039] The flow sensor 134 outputs flow data that can be stored in storage device 114 and / or analyzed by processor 112 of control system 110. In some implementations, the flow sensor 134 is used to determine the airflow rate from breathing device 122, the airflow rate through conduit 126, the airflow rate through user interface 124, or a combination thereof. In this implementation, the flow sensor 134 can be coupled to or integrated into breathing device 122, user interface 124, or conduit 126. The 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 a combination thereof.

[0040] Temperature sensor 136 outputs temperature data that can be stored in storage device 114 and / or analyzed by processor 112 of control system 110. In some implementations, temperature sensor 136 generates instructions for user 210 ( Figure 2 Temperature data including the user's core body temperature, the user's skin temperature, the temperature of the air flowing from the breathing device 122 and / or through the conduit 126, the temperature in the user interface 124, the ambient temperature, or a combination thereof. Temperature sensor 136 may be, for example, a thermocouple sensor, a thermistor sensor, a silicon bandgap temperature sensor, or a semiconductor-based sensor, a resistance temperature detector, or a combination thereof.

[0041] Motion sensor 138 outputs motion data that can be stored in storage 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 periods, and / or movement of any component of respiratory system 120, such as breathing 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 state.

[0042] The microphone 140 output can be stored in storage device 114 and / or analyzed by processor 112 of control system 110. Microphone 140 can be used to record sounds during sleep periods (e.g., sounds from user 210) to determine (e.g., using control system 110) one or more sleep-related parameters, as described further herein. Microphone 140 can be coupled to or integrated into breathing device 122, user interface 124, catheter 126, or user device 170. 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.

[0043] The user of the speaker 142 output system 100 (e.g., Figure 2 The speaker 142 can be used as, for example, an alarm clock or to play warnings or messages to the user 210 (e.g., in response to an event such as an unintentional mask leak). The speaker 142 can be attached to or integrated into the breathing device 122, user interface 124, catheter 126, or external device 170.

[0044] 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, as described, for example, in WO 2018 / 050913, which is incorporated herein by reference in its entirety. In this implementation, speaker 142 generates or emits sound waves at predetermined intervals, 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 user 210 or bed partner 220. Figure 2 The control system 110 can determine the sleep of user 210, based at least in part on data from microphone 140 and / or speaker 142. Figure 2 The location or orientation of the sleep and / or one or more of the sleep-related parameters described herein.

[0045] 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 the data can be analyzed by control system 110 to determine the user 210 (…). Figure 2 The 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 breathing device 122, one or more sensors 130, the user device 170, or a 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 the RF transmitter 148 are combined as part of the RF sensor 147. In some such implementations, the RF sensor 147 includes control circuitry. The specific format for RF communication may be Wi-Fi, Bluetooth, etc.

[0046] 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 / mobile 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 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 activity data based on changes in the Wi-Fi signals between the routers and satellites (e.g., differences in received signal strength), caused by moving objects or people partially blocking the signal. The activity data may indicate activity, respiration, heart rate, behavior, etc., or combinations thereof.

[0047] Camera 150 outputs image data that can be reproduced as one or more images (e.g., still images, video images, thermal images, or combinations thereof) that can be stored in storage device 114. Control system 110 can use the image data from camera 150 to determine one or more sleep-related parameters, such as one or more events (e.g., changes in the position of object 210), respiratory signals, respiratory rate, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory ratio, number of events per hour, event pattern, sleep state, sleep stage, or combinations thereof. Furthermore, the image data from camera 150 can be used, for example, to identify the user's position and orientation, determine the user 210's chest movements, determine the airflow through the user 210's mouth and / or nose, determine the time the user 210 enters bed 230, and determine the time the user 210 leaves bed 230.

[0048] Infrared (IR) sensor 152 outputs infrared image data that can be reproduced as one or more infrared images (e.g., still images, video images, or both) that can be stored in storage device 114. The infrared data from IR sensor 152 can be used to determine one or more sleep-related parameters during a sleep period, including the user 210's temperature and / or the user 210's movement. IR sensor 152 can also be used in conjunction with camera 150 when measuring the presence, location, and / or movement of user 210. 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.

[0049] PPG sensor 154 output and user 210 ( Figure 2The PPG sensor 154 can be worn by the user 210, embedded in clothing and / or textiles worn by the user 210, embedded in and / or connected to the user interface 124 and / or its associated headband (e.g., strap, etc.).

[0050] ECG sensor 156 output and user 210 ( Figure 2 The ECG sensor 156 provides physiological data related to the electrical activity of the heart. In some implementations, the ECG sensor 156 includes one or more electrodes located above or around a portion of the user 210 during sleep periods. Physiological data from the ECG sensor 156 can be used, for example, to determine one or more sleep-related parameters as described herein.

[0051] EEG sensor 158 outputs physiological data relating to the electrical activity of the user 210's brain. In some implementations, EEG sensor 158 includes one or more electrodes positioned on or around the user 210's scalp during sleep periods. Physiological data from EEG sensor 158 can be used, for example, to determine the user 210's sleep state at any given time during a sleep period. In some implementations, EEG sensor 158 may be integrated into user interface 124 and / or an associated headband (e.g., a strap, etc.).

[0052] The capacitive sensor 160, force sensor 162, and strain gauge sensor 164 output data that can be stored in storage device 114 and used by control system 110 to determine one or more of the sleep-related parameters described herein. The EMG sensor 166 outputs physiological data related to the electrical activity generated by one or more muscles. The oxygen sensor 168 outputs oxygen data indicating the oxygen concentration of a gas (e.g., in catheter 126 or at user interface 124). The oxygen sensor 168 can be, for example, an ultrasonic oxygen sensor, an electro-oxygen sensor, a chemical oxygen sensor, an optical oxygen sensor, or a combination thereof.

[0053] 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 storage device 114 and used by control system 110 to determine the identity and concentration of any analytes in the breath of user 210. In some 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 some implementations, analyte sensor 174 is a volatile organic compound (VOC) sensor that can be used to detect carbon-based chemicals or compounds. In some implementations, 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 inside the face mask of user 210, the processor 112 can use the data as an indication that user 210 is breathing through their mouth.

[0054] 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 user interface 124, near the connection between the conduit 126 and breathing device 122, etc.). Therefore, in some implementations, the humidity sensor 176 can be positioned in the user interface 124 or the conduit 126 to monitor the humidity of pressurized air from the breathing device 122. In other implementations, the humidity sensor 176 is placed near any area where the humidity level needs 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 inside the user 210's bedroom.

[0055] One or more light detection and ranging (LiDAR) sensors 178 can be used for depth sensing. This type of optical sensor (e.g., a laser sensor) can be used to detect objects and construct a three-dimensional (3D) map of the surrounding environment (e.g., a living space). LiDAR typically utilizes pulsed lasers for time-of-flight measurements. LiDAR is also known as 3D laser scanning. In instances using this sensor, fixed or mobile devices (such as smartphones) with LiDAR sensors 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 a radar (RADAR) sensor. LiDAR sensors 178 can also use artificial intelligence (AI) to automatically geofence radar systems by detecting and classifying features in space 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, lidar can reflect radio waves off solid surfaces (e.g., transmissive materials) to allow for the classification of different types of obstacles.

[0056] 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 blood oxygen 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 a combination thereof.

[0057] Although Figure 1While shown separately, combinations of one or more sensors 130 may be integrated into and / or coupled to any one or more components of system 100, including breathing device 122, user interface 124, catheter 126, humidifier 129, control system 110, user device 170, or combinations thereof. For example, acoustic sensor 141 and / or RF sensor 147 may be integrated into and / or coupled to user device 170. In such implementations, according to some aspects of the invention, user device 170 may be considered as an auxiliary device that generates additional or auxiliary data for use by system 100 (e.g., control system 110). In some implementations, at least one of the one or more sensors 130 is not coupled to breathing device 122, control system 110, or user device 170, and is typically positioned near user 210 during sleep periods (e.g., positioned on or in contact with a portion of user 210, worn by user 210, coupled to or positioned on a bedside table, coupled to a mattress, coupled to a ceiling, etc.).

[0058] Data from one or more sensors 130 can be analyzed to determine one or more sleep-related parameters, which may include respiratory signals, respiratory rate, breathing pattern, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory ratio, occurrence of one or more events, number of events per hour, event pattern, sleep state, apnea-hypopnea index (AHI), or any combination thereof. One or more events may include snoring, apnea, central apnea, obstructive apnea, mixed apnea, hypopnea, mask leakage, coughing, restless legs, sleep disturbance, apnea, increased heart rate, dyspnea, asthma attack, seizure, epileptic seizure, elevated blood pressure, or any combination thereof. Many of these sleep-related parameters are physiological parameters, although some may be considered non-physiological parameters. Other types of physiological and non-physiological parameters may also be determined based on data from one or more sensors 130 or based on other types of data.

[0059] User equipment 170 ( Figure 1The system includes a display device 128. User device 170 may be, for example, a mobile device such as a smartphone, tablet, game console, smartwatch, laptop, etc. Alternatively, 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 is a wearable device (e.g., a smartwatch). Display device 172 is typically used to display images including still images, video images, or both. In some implementations, display device 172 acts as a human-machine interface (HMI) including a graphical user interface (GUI) configured to display images and an input interface. Display device 172 may be an LED display, OLED display, LCD display, etc. 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 user device 170. In some implementations, one or more user devices may be used by and / or included in system 100.

[0060] Although the control system 110 and the storage 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 storage device 114 are integrated into user device 170 and / or breathing 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 combinations thereof).

[0061] Although system 100 is shown as including all of the components described above, according to implementations of the invention, a system for generating physiological data and determining a user's recommended bedtime may include more or fewer components. For example, a first alternative system includes a control system 110, a storage device 114, and at least one of one or more sensors 130. As another example, a second alternative system includes a control system 110, a storage 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 storage device 114, a respiratory system 120, at least one of one or more sensors 130, and a user device 170. Therefore, various systems for determining a user's recommended bedtime can be formed using any portion of the components shown and / or combined with one or more other components.

[0062] Overall reference Figure 2 The system 100 is shown according to some implementation methods. Figure 1 Part of the breathing system 120. The user 210 and bed partner 220 are located in the bed 230 and lie on the mattress 232. The user interface 124 (e.g., a full-face mask) can be worn by the user 210 during sleep. The user interface 124 is fluidly coupled and / or connected to the breathing device 122 via a conduit 126. The breathing device 122, in turn, delivers pressurized air to the user 210 via the conduit 126 and the user interface 124 to increase the air pressure in the user 210's throat, thereby helping to prevent airway closure and / or narrowing during sleep. The breathing device 122 may be positioned such as Figure 2 The bedside table 240 shown is directly adjacent to the bed 230, or more generally, is positioned on any surface or structure that is typically adjacent to the bed 230 and / or the user 210.

[0063] In some implementations, the control system 110, memory 214, and any one or more sensors 130, or a combination thereof, may be located on and / or in any surface and / or structure typically adjacent to the bed 230 and / or the user 210. For example, in some implementations, at least one of the one or more sensors 130 may be located on and / or in one or more components of the respiratory system 120 adjacent to a first position 255A of the bed 230 and / or the user 210. The one or more sensors 130 may be coupled to the respiratory system 120, user interface 124, catheter 126, display device 128, humidifier 129, or a combination thereof.

[0064] Alternatively or additionally, at least one of the one or more sensors 130 may be located at a second position 255B on and / or within the bed 230 (e.g., one or more sensors 130 are coupled to and / or integrated into the bed 230). Furthermore, additionally or alternatively, at least one of the one or more sensors 130 may be located at a third position 255C on and / or within the mattress 232, adjacent to the bed 230 and / or the user 210 (e.g., one or more sensors 130 are coupled to and / or integrated into the mattress 232). Alternatively or additionally, at least one of the one or more sensors 130 may be located at a fourth position 255D on and / or within the pillow, generally adjacent to the bed 230 and / or the user 210.

[0065] Alternatively or additionally, at least one of the one or more sensors 130 may be positioned on the bed seat 240 and / or at a fifth position 255E within the bed seat 240, generally adjacent to the bed 230 and / or the user 210. Alternatively or additionally, at least one of the one or more sensors 130 may be positioned at a sixth position 255F, such that at least one of the one or more sensors 130 is coupled to and / or positioned on the user 215 (e.g., one or more sensors 130 are embedded in or coupled to textiles, clothing 212, and / or a smart device worn by the user 210). More generally, at least one of the one or more sensors 130 may be located at any suitable position relative to the user 210, such that one or more sensors 130 can generate sensor data associated with the user 210.

[0066] Typically, compared to not using the breathing system 120 (especially when the user suffers from sleep apnea or other sleep-related conditions), users designated to use the breathing system 120 will tend to experience higher quality sleep and less fatigue throughout the day following the use of the breathing system 120. For example, user 210 may suffer from obstructive sleep apnea and relies on the user interface 124 (e.g., a full-face mask) to deliver pressurized air from the breathing device 122 via the tube 126. The breathing device 122 may be a continuous positive airway pressure (CPAP) machine used to increase the air pressure in the user 210's throat to prevent the airway from closing and / or narrowing during sleep. For a person with sleep apnea, her airway may narrow or collapse during sleep, reducing oxygen intake and forcing her to wake up and / or otherwise interrupting her sleep. The CPAP machine prevents airway narrowing or collapse, thereby minimizing awakenings or disturbances due to reduced oxygen intake.

[0067] The breathing device 122 strives to maintain medically prescribed air pressure during sleep, but in some cases, the user interface 124 may be moved or repositioned while the user 210 is asleep. Movement of the interface 124 may cause and / or allow pressurized air from the breathing system 120 to leak at the interface between the user interface 124 and the user 210's face / head. For example, with the user interface 124 open, the user 210 may lie supine while sleeping, but during the night, the user 210 may unintentionally change position so that her cheek is flush with the pillow 260. In such a position, the user interface 124 can be moved from a relatively tight position without unintentional air leakage to a new position that allows and / or causes unintentional air leakage from the breathing system 120. Unintentional air leakage from the user interface 124 can generate audible noise that disturbs the user 210 and / or bed partner 220, thereby interfering with and / or negatively impacting the sleep periods of both. Furthermore, unintentional air leakage can cause the user's skin to dry out, leading to dry mouth, dry eyes, or any combination thereof.

[0068] Other sources of unintentional air leakage at the interface between user interface 124 and the face / head of user 210 are possible. For example, over time, user interface 124 or a portion thereof may become worn, making the seal at the interface less complete than when user interface 124 was new. As another example, the strip or strip segment holding user interface 124 in place may loosen over time, resulting in a poor seal that may lead to unintentional leakage.

[0069] As used throughout this invention, the term unintentional leakage refers to the unintentional flow of air from the respiratory system 120 to the surrounding environment. In some implementations, the user interface 124 includes vents designed to allow exhaled gas and airflow from the respiratory system 120, which are referred to as intentional leakage or vent flow because such flow is designed to occur and intentionally occur. That is, gas escaping through a vent is not considered an unintentional leakage because the gas includes the intended airflow from the respiratory system 120. In contrast to the intended airflow from the respiratory system 120, as described above, unintentional leakage may occur due to an imperfect seal between the user interface 124 (e.g., a mask) and the face / head of the user 210. In some implementations, some flow out of the respiratory system 120 occurs due to an imperfect seal between the user interface 124 and the face / head of the user 210, for example, where the user interface or a portion thereof (e.g., padding) needs to be sufficiently loose for user comfort or where the user has facial features (e.g., a beard), where this is not considered unintentional. In another instance, unintentional leaks or air leaks can occur anywhere in the air circuit of the breathing system 120 to the environment. For example, in some implementations, some airflow from the breathing system 120 can occur anywhere in the circuit of the breathing system 120. For example, a leak may occur at the junction between the duct 126 and the user interface 124 due to design requirements and / or tolerances, such as when there is easy movement between the duct 126 and the user interface 124. In some implementations, a threshold is set for unintentional leaks, wherein action is not taken until the unintentional leak exceeds the set threshold.

[0070] In some implementations, unintentional airflow leaving the respiratory system 120 may be considered acceptable and not serious enough to require action (e.g., a new user interface or pad, a change in treatment pressure, or any combination thereof). In such implementations, an acceptable amount of unintentional leakage or airflow from the respiratory system 120 may be defined as a certain percentage or less of the total volume of air flowing through the respiratory system 120. For example, unintentional flow may be considered acceptable when the unintentional leakage is about 20% or less, or about 10% or less, or about 5% or less, or about 3% or less, or about 2% or less, or about 1% or less. Regarding airflow, an acceptable unintentional leakage may also be determined when the airflow is less than, for example, about 5 liters / minute, about 4 liters / minute, about 3 liters / minute, about 2 liters / minute, about 1 liter / minute, etc. For example, in cases where unintentional leakage occurs while the user 210 is changing from one sleep position to another, or when the user 210 is in a position that causes unintentional leakage for a short period of time. For example, in some implementations, an unintentional leak can be considered acceptable if it lasts for less than about 1 second, less than about 5 seconds, less than about 10 seconds, less than about 30 seconds, or less than about 1 minute. In some implementations, a combination of flow rate and time can be considered when determining an acceptable unintentional leak. For example, an unintentional leak can be considered acceptable if the total volume of air released due to the unintentional leak during its duration is less than about 5 liters, less than about 4 liters, less than about 3 liters, less than about 2 liters, or less than about 1 liter.

[0071] In some implementations, unintentional leaks and intentional leaks are grouped and referred to as total leaks of the respiratory system 120. In some such implementations, total leaks can be considered acceptable when they are below a threshold. For example, the acceptability of total leaks can also be based in part on the amount of time during which the total leak is below a threshold when the total leak is below approximately 30 liters / minute, or below approximately 29 liters / minute, or below approximately 28 liters / minute, or below approximately 27 liters / minute, or below approximately 26 liters / minute, or below approximately 25 liters / minute, or below approximately 24 liters / minute, or below approximately 23 liters / minute, or below approximately 22 liters / minute, or below approximately 21 liters / minute, or below approximately 20 liters / minute. For example, in some implementations, total leaks below 24 liters / minute can be considered acceptable for at least 70% of the measured time (e.g., during sleep).

[0072] Reference Figure 3 The diagram shows a flowchart of a method for predicting unintentional leaks in the respiratory system during the current sleep period, according to some implementations of this specification.

[0073] In step 310, pressurized air is delivered from a breathing device (e.g., breathing device 122) to the user (e.g., user 210) during the current sleep period. The sleep period is as described above and is defined, for example, by the time between when user 210 has lay down or sat in bed 230 / turned on breathing device 122 / put on user interface 124, and when user 210 removes user interface 124, turns off breathing device 122, and / or leaves bed 230. The current sleep period refers to the sleep period being monitored to predict unintentional leaks.

[0074] After pressurized air delivery from the breathing device begins in step 310, the method includes four additional steps. In step 320, historical first data related to the delivered pressurized air is received. In step 330, current first data related to the delivered pressurized air is received. In step 340, historical second data related to the user's orientation is received. In step 350, current second data related to the user's orientation is received. Steps 320, 330, 340, and 350 can be performed in any order. Steps 320 and 340 can also be performed before step 310.

[0075] Historical first data or historical second data refers to data collected or obtained during a previous sleep period (i.e., not the current sleep period). In some implementations, the previous sleep period ends immediately before the start of the current sleep period, such as on a night when the user 210 wants to sleep. For example, in some implementations, the time between the end of the previous sleep period and the start of the current sleep period is less than about 30 seconds, less than about 1 minute, less than about 30 minutes, less than about 1 hour, less than about 4 hours, less than about 12 hours, or less than about 18 hours. In some implementations, the previous sleep period ends and a longer period occurs before the start of the current sleep period, such as spanning the period between the end of the first night and the start of the second night. For example, in some implementations, the time between the end of the previous sleep period and the start of the current sleep period is greater than about 18 hours, greater than about 24 hours, greater than about 2 days, greater than about 3 days, greater than about 4 days, greater than about 5 days, greater than about 6 days, greater than about a week, or greater than about a month. In some implementations, previous historical data is the average of one or more sleep periods that occurred before the current sleep period. In some implementations, the average number of sleep periods is 1 to 1000, 1 to 500, 1 to 100, 1 to 50, 1 to 10, 1 to 3, or 2.

[0076] Optionally, and according to some implementations, receiving historical or current first data related to pressurized air delivered from the breathing device includes receiving first data via one or more first sensors, wherein the one or more first sensors include one or more pressure sensors, one or more flow sensors, one or more humidity sensors, one or more microphones, or any combination thereof. For example, according to Figure 1 and 2 The system 100 shown includes one or more sensors. In some implementations, the one or more sensors include one or more pressure sensors, one or more flow sensors, or at least one pressure sensor and at least one flow sensor.

[0077] In some implementations, receiving historical or current second data related to one or more user orientations includes receiving the second data via one or more second sensors, including one or more cameras, one or more video cameras, one or more pressure sensors, one or more microphones, one or more speakers, one or more accelerometers, one or more gyroscopes, one or more radio frequency sensors, one or more acoustic sensors, or any combination thereof. Optionally, the radio frequency sensor may be one or more ultra-wideband sensors, one or more pulse radar ultra-wideband sensors, or one or more frequency-modulated continuous wave radar sensors. For example, according to... Figure 1 and 2 One or more sensors of the system 100 shown.

[0078] In step 360, the likelihood of an unintentional leak occurring in the respiratory system is determined. The likelihood of an unintentional leak may be limited to an unintentional leak occurring within a predetermined time period. For example, the likelihood may be associated with an unintentional leak that will occur within ten seconds, thirty seconds, one minute, five minutes, ten minutes, or any other time period. In some implementations, the likelihood is determined using historical first pressure data (step 320), historical second data related to the user's orientation (step 340), current first pressure data related to the delivered pressurized air (step 330), current second data related to the user's orientation, or any combination thereof.

[0079] In step 370, a mitigation action is initiated to mitigate the unintentional leakage, wherein the mitigation action is in response to the probability satisfying a threshold for the unintentional leakage to occur. Likelihood can be expressed as, for example, a probability, such as an integer selected from 1 and 10 (e.g., 1 to 5, 1 to 3, or any range), where 1 is the least likely and 10 is the most likely. In some other implementations, probability is expressed as a rating: extremely unlikely, impossible, moderately likely, likely, and very likely. Other implementations may express probability as a percentage probability. According to some implementations, probability is a percentage likelihood of an unintentional leakage occurring, where the threshold is at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, or at least about 99%.

[0080] In some implementations, mitigation actions include causing a sound to be emitted, causing a change in treatment pressure, causing a change in expiratory pressure reduction (EPR) settings, causing a change in humidification levels, causing the equipment to be modified or moved, causing a light to be turned on or its brightness to be increased, causing a fan to be turned on or its output to be increased, or any combination thereof. In some implementations, the type of mitigation action that occurs depends on the percentage probability of an unintentional leak occurring. For example, if a 60% threshold leads to a first mitigation action, and a second mitigation action occurs because the first mitigation action is ineffective or even causes the probability to increase to 90%. If the probability of an unintentional leak still increases, a third or more mitigation measures may be taken. In some implementations, mitigation actions can be implemented even after an unintentional leak has occurred. In some implementations, a second mitigation may occur even if the probability remains the same or even decreases after the first mitigation action, for example, if the probability remains above a threshold.

[0081] Sounds that can be used to mitigate movement may include, but are not limited to, white noise, pink noise, brown noise, violet noise, soothing sounds, music, alarms, warnings, beeps, or combinations thereof. As used herein, some variations of flattened white noise sounds are referred to as pink noise, brown noise, violet noise, etc. In some implementations, sounds (e.g., white noise, pink noise, brown noise, violet noise, etc.) help mask noise from which unintentional leakage is predicted to occur. In some implementations, sounds (e.g., soothing sounds and music) help a user or bed partner remain asleep, or can gently wake them or cause them to change sleeping positions, such as to positions where unintentional leakage is unlikely or will not occur.

[0082] In some implementations, sound may be provided by one or more speakers 142 of system 100. Optionally, system 100 includes multiple speakers 142 to provide localized sound emission. Speakers 142 may include in-ear speakers, over-ear speakers, near-ear speakers, earbuds, Apple headphones, or any combination thereof. Speakers 142 may be wired or wireless speakers (e.g., headphones, bookshelf speakers, floorstanding speakers, TV speakers, wall speakers, ceiling speakers, etc.). In some implementations, speakers 142 are worn by user 210 and / or bed partner 220. In some such implementations, the provided speakers 142 may provide noise masking without affecting the bed partner, as sound will be localized by the type of speaker 142. In such an approach, appropriate localized speakers 142 may be provided for the breathing user and / or bed partner.

[0083] Optionally, speaker 142 is attached to one or more bands or segments of user interface 124. Thus, user 210 and / or bed partner 220 have the option to perceive a relatively flat shape of white noise or a quieter (lower level and / or low-pass filtered) shape of noise signal. In some such implementations, higher frequency sounds / noise (e.g., “more harsh” sounds) are reduced while still providing masking sound to ambient noise. System 100 can select an optimized set of fill sound frequencies to achieve a target noise distribution. For example, if certain components of the sound are already present in the spectrum (e.g., associated with a box fan, CPAP blower motor, etc. in a room), system 100 can select fill sounds with sound parameters / characteristics filled, for example, in a quieter frequency band reaching a target amplitude level. Therefore, system 100 is able to adaptively attenuate higher and / or lower frequency components using active adaptive masking and / or adaptive noise cancellation, making the perceived sound more pleasant and relaxing to the ear (the latter being better suited for slower-changing and predictable sounds).

[0084] In some implementations, the sound is emitted in a gradual manner. For example, control system 100 may cause speaker 142 to emit sound at a first volume, and then gradually increase the volume from the first volume to a second volume over a period of time. For example, speaker 142 may initially emit sound at a relatively low volume, and then gradually increase the volume so as not to wake and / or disturb user 210 and / or bed partner 220 due to the sudden introduction of a new sound. The time period for increasing the volume may be 1 second, 5 seconds, 10 seconds, 20 seconds, 30 seconds, etc., or any other amount of time. In some implementations, in response to the probability meeting a threshold, the sound may start at a low volume, and if the probability does not decrease, for example due to user 210 changing orientation, the sound may gradually increase until the probability decreases. In some implementations, once the probability no longer meets the threshold (e.g., it is below the threshold), the sound may stop immediately, or the sound may gradually decrease, for example, until no sound is emitted. The time period for the volume to decrease may be about 1 second, about 5 seconds, about 10 seconds, about 20 seconds, about 30 seconds, etc., or any other amount of time.

[0085] Pressure therapy variations that can be used to alleviate movement may include, but are not limited to, increasing or decreasing the air pressure delivered to user 210. The increase or decrease in pressure may be related to the orientation of user 210. For example, if user 210 moves to an orientation that increases the likelihood of unintended leakage (e.g., against mattress 232 or pillow 260), the pressure may be reduced to decrease the likelihood of unintended leakage. In some implementations, the pressure may be increased to arouse user 210 or cause mild discomfort, thereby causing user 210 to change orientation without waking the user.

[0086] The expiratory pressure relief (EPR) setting can be changed in response to predictions of unintentional leakage. Typically, EPR is a feature on some respiratory devices (e.g., CPAP machines) that allows users to adjust between different comfort settings to alleviate some users' experience of shortness of breath. For example, a 2 cm H2O droplet between inhalation and exhalation. Where the feature can be manual, according to the implementation described in this specification, the EPR setting can be changed by system 100 without manual user input to mitigate the occurrence of unintentional leakage.

[0087] In some implementations, the change in humidification level used to mitigate the action is an increase in the humidity of the air delivered to user 210. For example, the percentage probability of unintentional leakage increases because the user 210's skin becomes drier, leading to a reduced seal efficiency between interface 123 and user 210. User 210 may also experience discomfort due to dryness of the nose or mouth at lower humidification levels, which leads to an orientation change that is expected to increase the probability of unintentional leakage. In some implementations, the change in humidification level is a decrease in humidification. For example, a change in orientation, predicted to increase the probability of unintentional leakage, occurs when user 210 experiences discomfort due to moisture or water buildup (e.g., at the seal of user interface 124).

[0088] Devices actuated or moved to mitigate movement may include, but are not limited to, smart pillows, adjustable bed frames, adjustable mattresses, fans, adjustable blankets, or any combination thereof. For example, the device is controlled by controller 110. In some implementations, a smart pillow, smart mattress, or adjustable blanket may include one or more inflatable compartments or air bladders that can be inflated or deflated. The actuation device can thus change the user's orientation. For example, pillow 260 may be a smart pillow including one or more inflatable air bladders that change the user's orientation if the user's head is in an orientation that increases the likelihood of unintentional leakage above a threshold. In another implementation, the adjustable bed frame may include multiple sections that can be raised or lowered by a motor and cause the user 210 to change orientation, for example, by forcing the user 210 to roll from their side to their back. In some implementations, a fan (e.g., a fan placed on bedside table 240, a fan in a window, or a ceiling fan) turns on in response to the possibility of unintentional leakage and blows air toward the user 210 to cause or cause them to change orientation. Alternatively, the fan may shut off in response to a threshold indicating that the likelihood of unintentional leakage has been determined. In some implementations, the fan may be turned on or off to provide a more soothing environment for the user 210, who is anticipated to change orientation toward a location where unintentional leakage may occur due to discomfort or lack of airflow associated with the airflow. In some implementations, the fan generates white noise. The fan may gradually increase the speed and movement of the air so as not to wake and / or disturb the user 210 and / or bed partner 220 due to sudden changes in air movement or sound from the fan.

[0089] In some implementations, the leakage mitigation action that causes the leak is to inject a substance into the pressurized air to be delivered to the user interface 124. For example, the container 180 may be filled with the substance, and the container may have an outlet in direct or indirect fluid communication with the conduit 126. The substance may be configured or selected to elicit a physical response from the user 210. For example, the user 210 may change orientation.

[0090] Optionally, the substance may include a drug, such as an anti-inflammatory drug, a drug for treating an asthma attack, a drug for treating a heart attack, etc. Generally, any type of drug used to treat any disease, symptom, condition, etc., can be delivered to the airway of the user 210. For example, in cases where symptoms cause agitation or changes in orientation and movement in the user 210, increasing the likelihood of unintentional leakage, injecting a drug can reduce the likelihood of unintentional leakage. When the substance is a drug, it typically includes one or more active ingredients and one or more excipients. Excipients, as a medium for delivering the active pharmaceutical ingredient, may include substances such as swelling agents, fillers, diluents, anti-adhesion agents, adhesives, coatings, pigments, disintegrants, fragrances, flow aids, lubricants, preservatives, adsorbents, sweeteners, carriers, or any combination thereof. The active ingredient is typically the portion of the drug that actually causes the effects produced by the drug.

[0091] The substance may also optionally be an aromatic compound (e.g., a substance that delivers fragrance and / or aroma to the airways of the user 210), a sleep aid (e.g., a substance that helps the user 210 fall asleep), a consciousness-awakening compound (e.g., a substance that helps the user 210 wake up, also known as a sleep depressant), cannabidiol oil, or essential oils (e.g., lavender, valerian, sage, sweet marjoram, Roman chamomile, bergamot, etc.). The substance can typically be a solid, liquid, gas, or any combination thereof. The substance may optionally or additionally include one or more nanoparticles.

[0092] In some implementations, the current second data indicates that the user moves from a first position to a second position. For example, the first position is any one of supine, lateral, prone, and fetal positions. The second position is one of supine, lateral, prone, and fetal positions other than the first position. Optionally, the first position includes the user supine, and the second position includes the user lateral. Optionally, the first position includes the user supine, and the second position includes the user prone. Optionally, the first position includes the user lateral, and the second position includes the user in a fetal position.

[0093] Alternatively or optionally, after the unintentional leakage mitigation action occurs in step 370, the likelihood of an unintentional leakage is reassessed. For example, by repeating... Figure 3One or more of steps 330, 340, 350, 360, and 360 are outlined in the document. During repetition, if the probability of unintentional leakage does not meet a threshold after the reassessment at step 360, additional mitigation actions, such as step 370, may occur. These steps can be repeated to predict and mitigate unintentional leakage during sleep periods, for example, more than 3 times, more than 10 times, more than 20 times, or more than 30 times. In some implementations, the number of times mitigation actions are used is tracked and stored, for example, in storage device 114. In some implementations, the information can be displayed to, for example, a user 210 or a caregiver. This can be displayed, for example, after one or more sleep periods using an external device 170 such as a smartphone.

[0094] The data received in any of steps 320, 330, 334, and 335 can be processed by the respiratory system 100. For example, the control system may include an unintentional leak prediction algorithm stored as machine-readable instructions in a memory such as storage device 114. For example, the unintentional leak prediction algorithm may be activated when a sleep period begins. For example, the start of a sleep period may be detected by one or more sensors 130. In some implementations, the sleep period begins and the algorithm starts when pressurized air is delivered to the user (step 310). In some implementations, the algorithm may be activated, but in sleep or monitoring modes, it is considered activated only after the start of a sleep period. In some implementations, the sleep period is manually started by the user 210, and the algorithm is activated, such as by turning on the respiratory device 122, wearing the user interface 124, or lying in bed. Once pressurized air is delivered to the user, data from one or more of steps 320, 330, 340, and 350 can be received as input to the algorithm. The algorithm may output an unintentional leak prediction value, for example, based on the likelihood calculated for the individual by the algorithm in step 360. The determined unintentional leakage prediction value represents the probability that a user will experience an unintentional leakage within a predetermined time period during the current sleep period. In some implementations, the predetermined time period is less than about 5 seconds, less than about 10 seconds, less than about 20 seconds, less than about 30 seconds, less than about 40 seconds, less than about 50 seconds, less than about 60 seconds, less than about 2 minutes, less than about 5 minutes, less than about 10 minutes, or less than about 1 hour. Steps prior to processing using the unintentional leakage prediction algorithm may include receiving data via one or more sensors 130 as described above, and transmitting or sending the data to a control system, including storing the data in storage device 114. In some implementations, system 100 may activate or actuate devices to mitigate the occurrence of leaks.

[0095] In some implementations, the method for predicting unintentional leakage also includes identifying the type of user interface. For example, in some implementations, the method includes identifying user interfaces such as full-face masks, nasal masks, or nasal pillows. In some implementations, determining the likelihood of unintentional leakage is further based at least in part on the type of user interface identified. In some other implementations, the user interface is identified from diagrams such as referenced models and styles.

[0096] It predicts unintentional leaks and identifies user interfaces, and can optionally be based on measurements of pressure and flow in the respiratory system 120. Pressure and flow data are used to generate data with... Figure 4 The curve 400 is shown as the characteristic curve 410 for intentional leakage. Typically, unintentional leakage can be predicted by the deviation of pressure and flow rate from the characteristic curve 410. Furthermore, the shape of the characteristic curve 410 can typically identify the user interface.

[0097] exist Figure 4 The average total flow is described in the text. (in liters per minute) and average equipment pressure The relationship (in cmH2O) is given, where the average value is the average of multiple respiratory cycles. The shape of curve 410 depends on the mask, such as its shape and volume (e.g., whether it surrounds the user's face and the mask) and the size and construction of the mask's airway. Therefore, the type of mask can be determined by the shape of curve 410. The average flow rate described by curve 410 is... This corresponds to the outflow from a device system (e.g., respiratory system 120), where the flow is intentional, such as the outflow from the vent in a mask (e.g., user interface 124). Therefore, the deviation from curve 410 involves unintended flow.

[0098] When the user 210 breathes outside an interface such as the user interface 124, a device 122, such as a CPAP, attempts to maintain a constant pressure. However, some small fluctuations occur around the target pressure or set pressure, corresponding to the average pressure. Slightly increase and decrease. For expected traffic (i.e., no unexpected traffic), when During the up-and-down oscillation, the average flow rate value Precisely follow curve 410. Unintentional leakage corresponds to a rightward shift of curve 410, such as mean pressure and flow rate ( , Point 420. At point 420, the average pressure... With an average flow rate of approximately 11 (cmH2O), if an expected leak occurs, the average flow rate is... It will be approximately 30 LPM. However, due to the average flow rate... The actual measurement was almost 40 LPM, indicating an unintentional leak. The Δd derived from the characteristic curve was approximately 40 LMP.

[0099] If a blockage exists in the system, such as if the user's position obstructs the mask vent or if the conduit 126 becomes blocked (e.g., bent or kinked), another unintentional flow, referred to herein as unintentional blockage, may occur. In these cases, the flow rate will be lower than the flow rate predicted by the intentional leakage curve 410. The unintentional block will appear as a point or offset to the left of curve 410. In some implementations, the unintentional block data can be used to receive historical second data related to one or more orientations of the user during one or more previous sleep periods. In some implementations, the unintentional block data can be used to receive current data related to one or more orientations of the user during the current sleep period.

[0100] Increasing the pressure applied to the user interface can increase the likelihood of unintentional leaks. For example, increased pressure can cause a poorer seal between the mask (e.g., user interface 124) and the user's face, allowing air to escape. Although the user can increase and improve the seal between the user and the mask by tightening the straps of the user interface, at sufficiently high pressures, some unintentional leaks will occur.

[0101] In some implementations, such as Figure 4 The intended flow rate curve 410 shown is derived below. The flow path is formed by a breathing device (e.g., breathing device 122), a mask (e.g., user interface 124) with one or more ventilation ports, and a catheter (e.g., catheter 126). The catheter generates a first impedance Z1, which in turn causes a flow rate as a percentage of the total flow rate. voltage drop of the function Interface pressure It is equipment pressure Subtract the pressure drop through the catheter ,in The pressure drop characteristics of the catheter:

[0102] (1)

[0103] The vent of the mask generates a second impedance Z2. Ventilation flow rate. The relationship between the ventilation characteristic f and the interface pressure Pm is as follows:

[0104] (2)

[0105] Combining equations (1) and (2), the equipment pressure Pd can be written as:

[0106] (3)

[0107] Unintentional leakage, which is unknown and unpredictable, generates a third impedance Z3. A fourth impedance Z4, capacitance Clung, and a variable pressure source Plung represent the user's characteristics. Therefore, the total flow rate... equal to ventilation flow rate Leakage flow and respiratory flow sum:

[0108] (4)

[0109] In some implementations, respiratory flow The average value is zero over multiple respiratory cycles (e.g., respiratory cycles) because the average flow rate entering or leaving the lungs must be zero. Therefore, by averaging the flow rate over multiple respiratory cycles, the tidal flow rate can be approximated as:

[0110] (5)

[0111] The tilde (~) represents the average of multiple respiratory cycles. The averaging process can be achieved using a low-pass filter with a sufficiently long time constant to encompass multiple respiratory cycles. The time constant can be any suitable duration, such as 5 seconds, 10 seconds, 30 seconds, 1 minute, etc. However, other time intervals can also be considered.

[0112] Combining equations (3) and (5), the average equipment pressure It can be written as

[0113] (6)

[0114] Average total traffic without any leakage (e.g., Q leakage = 0) This can be referred to as the bias flow rate Qb. Equation (6) can then be written to reflect the bias flow rate Qb and mean device pressure characterizing the respiratory therapy system. The relationship between them:

[0115] (7)

[0116] The relationship between the intentional leakage characteristic curve of the system and the ventilation characteristics is... and catheter pressure drop characteristics Sure.

[0117] For at least two pressures or two average flow rates, the average total flow rate can be measured. (in liters per minute) relative to average equipment pressure (in cmH2O units) to make such Figure 4 The features shown are intentional flow plots. (Drawn) and Data points can be fitted and described by equations. For example, in some implementations, a polynomial equation, such as a quadratic equation, can be used to approximate the intentionally leaky characteristic curve 410:

[0118] (8)

[0119] The parameters of the intentional leakage characteristic curve, in the quadratic equation, are two non-zero constants (or coefficients), k1 and k2, which characterize the ventilation characteristics. and air circuit pressure drop characteristics The series connection. In some implementations, the polynomial equations define the intentional leakage of the system (e.g., the system's ventilation flow) by providing a corresponding flow rate for the intentional leakage at a given pressure.

[0120] In some implementations, polynomial equations can have more than two non-zero constants, such as three, four, or five. For example, a polynomial equation can be represented as:

[0121] (9)

[0122] In some implementations, polynomial equations can involve powers of three, four, five, etc. For example, a polynomial equation can be expressed as:

[0123] (10)

[0124] In some implementations, polynomial equations can involve powers of three, four, five, etc. For example, a polynomial equation can be expressed as:

[0125] (11)

[0126] As described herein, the respiratory therapy system discussed typically includes components such as a breathing device 122, a catheter 126, and a user interface 124. Various different models capable of influencing pressure and flow characteristics can be used. For example, models may include different vents in a mask and catheters of different lengths and diameters. To provide improved control over the therapy delivered to the user interface, estimating therapy parameters such as pressure, ventilatory flow rate, and unintentional flow rate at the user interface can be advantageous. In systems using therapy parameter estimation, knowledge of the types of components used by the user can improve the accuracy of the therapy parameter estimation and thus enhance the efficacy of the therapy.

[0127] To obtain information about component types, some respiratory devices include menu systems that allow users to input and / or select the type of system component, including the user interface used (e.g., brand, manufacturer, type, model, serial number, mask series, size, etc.). Once the user inputs and / or selects the component type, the respiratory device can select the appropriate operating parameters of the flow generator that best coordinates with the selected component, and can more accurately monitor treatment parameters during therapy. However, in some cases, the user may not have selected the component type correctly, or may not have selected the component type correctly at all, causing the respiratory device to err or be unaware of the type of component being used.

[0128] Accordingly, in some implementations, the unintentional leakage prediction algorithm may include code or subroutines for the user interface. For example, if the catheter pressure drop characteristic ΔP is known (e.g., because the type of catheter that makes up the catheter is known, or through previous calibration operations), the parameters of the intentional leakage characteristic curve effectively characterize the vent, which in turn indicates the type of user interface.

[0129] In some implementations, historical first data and historical second data are received by user 210 using the same user interface 124. In some implementations, user 210 receives historical first data, historical second data, current first data, and current second data using a first user interface 124, and receives current first data and current second data using a second user interface 124. In some such implementations, the unintentional leakage prediction algorithm can adjust for or compensate for changes caused by changes in the user interface.

[0130] In some implementations, when used with a known conduit, user interface identification can be accomplished by comparing the computed parameters k1 and k2 with a data structure such as an array or database containing pairs (k1, k2) associated with a known user interface type. The type of the user interface associated with the stored pair (k1, k2) that most closely matches the computed parameters k1 and k2 can be taken as the type of the user interface.

[0131] Alternatively, before fitting the quadratic equation to the resulting characteristic curve of intentional leakage in the mask, the average equipment pressure can be used. Subtract the pressure drop from each value The obtained parameters k1 and k2 can then be compared with a data structure of (k1, k2) pairs associated with a known user interface type to identify the user interface or access data for the operation of the respiratory device that is associated with the use of a specific user interface.

[0132] Therefore, detected parameters can be compared with expected parameters over a period of time, collecting longitudinal and cross-sectional data. In some implementations, the system can determine production variations by understanding a batch of masks and use this information for production quality improvement.

[0133] In some implementations, the system can examine changes over time and understand whether the mask seal itself has degraded over time (because the system can determine how long a particular mask has been used based on features such as acoustic characteristics), and what conditions caused the unintentional leak (e.g., whether it is location-related, has been changed based on recommendations to tighten or loosen the headband, the seal has followed a pre-defined degradation cycle (assuming regular cleaning), whether it shows accelerated wear, etc.).

[0134] In some implementations, the user interface used can be determined by: user input, optical detection of the user interface, detection of the user interface via RFID, detection of the user interface via echo characteristics, detection of the conduit via a connector with a heating element having electronics, or any combination thereof. Therefore, an initial profile describing the correct functioning of this type of new mask can be selected. The initial profile can be specific to the breathing device, operating mode, operating parameters, other settings such as expiratory pressure release (EPR) or dual-level, user interface (e.g., brand, manufacturer, type, model, serial number, mask series, size, etc.), or any combination thereof.

[0135] In some implementations, the system can also select, over time, a model of the expected behavior of this type of partially or completely worn mask as an initial curve, such as from a lookup table or from a cloud system. These expected models can describe different levels of airflow obstruction, duct obstruction (e.g., for masks with airflow through a hose around the head), and different levels of seal wear, headband stretching, etc. Therefore, by selecting an appropriate initial model, the system can detect intentional and unintentional leaks through sleep periods and / or through multiple sleep periods.

[0136] In some implementations, the system provides output to an external device 170, such as a smartphone, which provides user data related to the amount of a predicted unintentional leak or the percentage probability of a detected unintentional leak. For example, during sleep periods or over several sleep periods.

[0137] One or more elements or aspects or steps or any part thereof from the appended claims may be combined with one or more other elements or aspects or steps or any part thereof from the appended claims or combinations thereof to form one or more additional implementations of the invention.

[0138] 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 its obvious variations, is considered to fall within the spirit and scope of the invention. It is also contemplated that additional implementations of various aspects of the invention can combine any number of features from any implementation described herein.

Claims

1. A system for predicting unintentional leaks in the respiratory system during a current sleep period, comprising: A control system, which includes one or more processors; as well as Memory on which machine-readable instructions are stored; The control system is coupled to the memory, and when the machine-executable instructions in the memory are executed by at least one of the one or more processors of the control system, a method is implemented comprising: During the current sleep period, pressurized air is delivered from the breathing device to the user via a conduit connected to a user interface worn around a portion of the user's face to help the user receive at least a portion of the pressurized air; Receive historical first data related to pressurized air delivered from the breathing device during one or more previous sleep periods; Receive current first data related to the pressurized air delivered from the breathing device during the current sleep period via one or more first sensors; Receive historical second data relating to one or more orientations of the user during one or more previous sleep periods; Receive current second data related to one or more orientations of the user during the current sleep period via one or more second sensors; and Based at least in part on (i) the historical first data, (ii) the current first data, (iii) the historical second data, and (iv) the current second data, the probability of an unintentional leak occurring in the respiratory system within a predetermined time period is determined.

2. A system for predicting unintentional leaks in the respiratory system during a current sleep period, the system comprising a control system having one or more processors configured to perform a method comprising: During the current sleep period, pressurized air is delivered from the respiratory system to the user via a conduit connected to a user interface worn around a portion of the user's face to help the user receive at least a portion of the pressurized air; Receive historical first data related to pressurized air delivered from the respiratory system during one or more previous sleep periods; Receive current first data related to the pressurized air delivered from the respiratory system during the current sleep period via one or more first sensors; Receive historical second data relating to one or more orientations of the user during one or more previous sleep periods; Receive current second data related to one or more orientations of the user during the current sleep period via one or more second sensors; as well as Based at least in part on (i) the historical first data, (ii) the current first data, (iii) the historical second data, and (iv) the current second data, the probability of an unintentional leak occurring in the respiratory system within a predetermined time period is determined.

3. The system according to claim 2, wherein, The method further includes emitting a sound in response to the probability satisfying a threshold.

4. The system according to claim 3, wherein, The sounds include white noise, pink noise, brown noise, purple noise, soothing sounds, music, alarms, warnings, beeps, or any combination thereof.

5. The system according to claim 2 or 3, wherein, To produce sounds in a gradual manner.

6. The system according to claim 2 or 3, wherein, The method further includes: changing one or more pressure settings of the respiratory system in response to the possibility meeting a threshold.

7. The system according to claim 6, wherein, The method also includes changing the expiratory pressure reduction (EPR) setting in response to the possibility meeting a threshold.

8. The system according to claim 2 or 3, wherein, The method further includes changing the humidification level in response to the possibility satisfying a threshold.

9. The system according to claim 2 or 3, wherein, The method further includes moving the device in response to the possibility satisfying a threshold.

10. The system according to claim 9, wherein, The device is a smart pillow, an adjustable bed frame, an adjustable mattress, a fan, an adjustable blanket, or any combination thereof.

11. The system according to claim 2 or 3, wherein, The method further includes, in response to the possibility satisfying a threshold, delivering the substance to be injected into the pressurized air to the user interface.

12. The system according to claim 11, wherein, The substance is configured to elicit a bodily response from the user.

13. The system according to claim 2 or 3, wherein, The one or more first sensors include one or more pressure sensors, one or more flow sensors, one or more humidity sensors, one or more microphones, or any combination thereof.

14. The system according to claim 2 or 3, wherein, The one or more second sensors include one or more cameras, one or more video cameras, one or more pressure sensors, one or more microphones, one or more speakers, one or more accelerometers, one or more gyroscopes, one or more radio frequency sensors, one or more acoustic sensors, or any combination thereof.

15. The system according to claim 14, wherein, The one or more radio frequency sensors include one or more ultra-wideband sensors, one or more frequency-modulated continuous wave radar sensors, or any combination thereof.

16. The system according to claim 2 or 3, wherein, The method also includes identifying the type of the user interface.

17. The system according to claim 16, wherein, The identified user interface type is a full-face interface, a nose interface, or a nose pillow interface.

18. The system according to claim 17, wherein, The determination of the probability is also based at least in part on the identification type of the user interface.

19. The system according to claim 2 or 3, wherein, The current second data indicates that the user moves from the first position to the second position.

20. The system according to claim 19, wherein, The first position involves the user lying supine and the second position involves the user lying on their side.

21. The system according to claim 19, wherein, The first position involves the user lying supine and the second position involves the user lying prone.

22. The system according to claim 2 or 3, wherein, The probability mentioned is a percentage probability.

23. The system according to claim 2 or 3, wherein, The scheduled time is less than 1 hour.

24. A computer program product comprising instructions that, when executed by a computer, cause the computer to perform: During the current sleep period, pressurized air is delivered from the breathing device to the user via a conduit connected to a user interface worn around a portion of the user's face to help the user receive at least a portion of the pressurized air; Receive historical first data related to pressurized air delivered from the breathing device during one or more previous sleep periods; Receive current first data related to the pressurized air delivered from the breathing device during the current sleep period via one or more first sensors; Receive historical second data relating to one or more orientations of the user during one or more previous sleep periods; Receive current second data related to one or more orientations of the user during the current sleep period via one or more second sensors; as well as Based at least in part on (i) the historical first data, (ii) the current first data, (iii) the historical second data, and (iv) the current second data, the processor determines the likelihood of an unintentional leak occurring in the respiratory system within a predetermined time period.

25. The computer program product according to claim 24, wherein, The computer program product is a non-transitory computer-readable medium.

26. A system for predicting unintentional leaks in the respiratory system during a current sleep period, comprising: A control system, which includes one or more processors; as well as Memory on which machine-readable instructions are stored; The control system is coupled to the memory, and when the machine-executable instructions in the memory are executed by at least one of the one or more processors of the control system, a method is implemented comprising: An unintentional leakage prediction value is determined for the user of the respiratory system. The determined unintentional leakage prediction value indicates the probability that the user will experience an unintentional leakage within a predetermined amount of time during the current sleep period. The unintentional leakage prediction value is determined using an unintentional leakage prediction algorithm configured to receive location data of the user's sleep location as input and output the unintentional leakage prediction value for the user.

27. A system for predicting unintentional leaks in the respiratory system during a current sleep period, the system comprising a control system having one or more processors configured to: An unintentional leakage prediction value is determined for the user of the respiratory system. The determined unintentional leakage prediction value indicates the probability that the user will experience an unintentional leakage within a predetermined amount of time during the current sleep period. The unintentional leakage prediction value is determined using an unintentional leakage prediction algorithm configured to receive location data of the user's sleep location as input and output the unintentional leakage prediction value for the user.

28. The system according to claim 27, wherein, The algorithm is also configured to receive physiological data related to the user of the respiratory system as input.

29. The system according to claim 27 or 28, wherein, The scheduled time is less than 1 hour.

30. The system according to claim 27 or 28, wherein, The one or more processors are configured to cause an action in response to the unintentional leak prediction value meeting a threshold.

31. The system according to claim 30, wherein, The actions include emitting a sound, changing the treatment pressure, changing the humidification level, modifying the device, turning on the light, turning on the fan, or any combination thereof.

32. The system according to claim 27 or 28, wherein, It also includes a microphone and a speaker, wherein the location data of the user's sleeping position is determined based on the microphone detecting reflections of emitted sound waves generated by the speaker at predetermined intervals.

33. A computer program product comprising instructions that, when executed by a computer, cause the computer to perform: An unintentional leakage prediction value is determined for a user of the respiratory system. The determined unintentional leakage prediction value indicates the likelihood that the user will experience an unintentional leakage within a predetermined amount of time during the current sleep period. The unintentional leakage prediction value is determined using an unintentional leakage prediction algorithm configured to receive location data of the user's sleep location as input and output the unintentional leakage prediction value for the user.

34. The computer program product according to claim 33, wherein, The computer program product is a non-transitory computer-readable medium.

Images