Patent Description:
The present disclosure relates generally to respiratory systems and more particularly to systems and methods for predicting unintentional mask leaks in respiratory systems.

Many individuals suffer from sleep-related and/or respiratory disorders such as, for example, Periodic Limb Movement Disorder (PLMD), Restless Leg Syndrome (RLS), Sleep-Disordered Breathing (SDB), Obstructive Sleep Apnea (OSA), apneas, Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD), and chest wall disorders. These disorders are often treated using a respiratory therapy system. <CIT> relates to such a respiratory system with an auto- fit patient interface, such as a mask, worn during sleep that fits a user with automatic adjustments in case of unintentional leak.

A person with respiratory disorder can have trouble sleeping, but systems designed to mitigate physical symptoms of the respiratory disorder do not address issues outside of the symptoms of the disorder itself that can keep the person from sleeping well. Thus, a need exists for alternative systems and methods for addressing sleep disturbances or unintentional features of current respiratory therapy systems that can degrade the quality of the intended sleep therapy. The present disclosure is directed to solving these problems and addressing other needs.

According to some implementations of the present disclosure, a method (not claimed) of predicting an unintentional leak in a respiratory system during a current sleep session includes causing, during the current sleep session, pressurized air to be delivered from a respiratory device to a user via a conduit coupled to a user interface. The user interface is worn about a portion of a face of the user to aid in the user receiving at least a portion of the pressurized air. Historical first data associated with pressurized air delivered from the respiratory device during one or more prior sleep sessions is received. Current first data associated with the pressurized air being delivered from the respiratory device during the current sleep session is received, via one or more first sensors. Historical second data associated with one or more orientations of the user during one or more prior sleep sessions is received. Current second data associated with one or more orientations of the user during the current sleep session is received, via one or more second sensors. Based at least in part on the (i) historical first data, (ii) the current first data, (iii) the historical second data, and (iv) the current second data, a likelihood that an unintentional leak in the respiratory system will occur within a predetermined amount of time is determined.

According to some implementations of the present disclosure, a method (not claimed) of predicting an unintentional leak in a respiratory system during a current sleep session includes determining, for a user of the respiratory system, an unintentional leak prediction value. The determined unintentional leak prediction value is indicative of a likelihood that the user will experience an unintentional leak within a pre-determined amount of time in the current sleep session. The unintentional leak prediction value is determined using an unintentional leak prediction algorithm that is configured to receive, as an input, positional data, and output the unintentional leak prediction value for the individual.

The above summary is not intended to represent each implementation or every aspect of the present disclosure. Additional features and benefits of the present disclosure are apparent from the detailed description and figures set forth below.

While the present disclosure is susceptible to various modifications and alternative forms, specific implementations and embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that it is not intended to limit the present disclosure to the particular forms disclosed, but on the contrary, the present disclosure is to cover all modifications, equivalents, and alternatives falling within the scope of the present disclosure.

The present invention is defined by the appended claims Subject-matter referred as embodiments, disclosures, aspects and/or implementations, which does not fall under the scope of the claims is not part of the invention.

Many individuals suffer from sleep-related and/or respiratory disorders. Examples of sleep-related and/or respiratory disorders include Periodic Limb Movement Disorder (PLMD), Restless Leg Syndrome (RLS), Sleep-Disordered Breathing (SDB), Obstructive Sleep Apnea (OSA), apneas, Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD), and chest wall disorders.

In order to mitigate some of these sleep-related and/or respiratory disorders, a user can be prescribed usage of a respiratory device or system. For example, a continuous positive airway pressure (CPAP) machine can be used to increase air pressure in the throat of the respiratory device user (e.g., user) and to prevent the airway from closing and/or narrowing during sleep. While these respiratory devices or systems can improve the sleep quality of the user some issues outside of the symptoms of the disorder itself that can work counter to the sought after sleep quality improvement. For example, noises due to the system such as produced by unintentional leaks. As well as possibly reducing the sleep quality of the user, such noises can also disturb the quality of a sleep partner. In some implementations of the present disclosure, a method for predicting an unintentional leak in a respiratory system used by a subject during a current sleep session is described. Prediction of an unintentional leak allows a mitigating action to stop an unintentional leak can be implemented.

Referring to <FIG>, a system <NUM>, according to some implementations of the present disclosure, is illustrated. The system <NUM> includes a control system <NUM>, a memory device <NUM>, an electronic interface <NUM>, one or more sensors <NUM>, and one or more user devices <NUM>. In some implementation, the system <NUM> further optionally includes a respiratory system <NUM>.

The control system <NUM> includes one or more processors <NUM> (hereinafter, processor <NUM>). The control system <NUM> is generally used to control (e.g., actuate) the various components of the system <NUM> and/or analyze data obtained and/or generated by the components of the system <NUM>. The processor <NUM> can be a general or special purpose processor or microprocessor. While one processor <NUM> is shown in <FIG>, the control system <NUM> can include any suitable number of processors (e.g., one processor, two processors, five processors, ten processors, etc.) that can be in a single housing, or located remotely from each other. The control system <NUM> can be coupled to and/or positioned within, for example, a housing of the user device <NUM>, and/or within a housing of one or more of the sensors <NUM>. The control system <NUM> can be centralized (within one such housing) or decentralized (within two or more of such housings, which are physically distinct). In such implementations including two or more housings containing the control system <NUM>, such housings can be located proximately and/or remotely from each other.

The memory device <NUM> stores machine-readable instructions that are executable by the processor <NUM> of the control system <NUM>. The memory device <NUM> can be any suitable computer readable storage device or media, such as, for example, a random or serial access memory device, a hard drive, a solid state drive, a flash memory device, etc. While one memory device <NUM> is shown in <FIG>, the system <NUM> can include any suitable number of memory devices <NUM> (e.g., one memory device, two memory devices, five memory devices, ten memory devices, etc.). The memory device <NUM> can be coupled to and/or positioned within a housing of the respiratory device <NUM>, within a housing of the user device <NUM>, within a housing of one or more of the sensors <NUM>, or any combination thereof. Like the control system <NUM>, the memory device <NUM> can be centralized (within one such housing) or decentralized (within two or more of such housings, which are physically distinct).

In some implementations, the memory device <NUM> (<FIG>) stores a user profile associated with the user. The user profile can include, for example, demographic information associated with the user, biometric information associated with the user, medical information associated with the user, self-reported user feedback, sleep parameters associated with the user (e.g., sleep-related parameters recorded from one or more earlier sleep sessions), or any combination thereof. The demographic information can include, for example, information indicative of an age of the user, a gender of the user, a race of the user, a family history of insomnia, an employment status of the user, an educational status of the user, a socioeconomic status of the user, or any combination thereof. The medical information can include, for example, including indicative of one or more medical conditions associated with the user, medication usage by the user, or both. The medical information data can further include a multiple sleep latency test (MSLT) test result or score and/or a Pittsburgh Sleep Quality Index (PSQI) score or value. The self-reported user feedback can include information indicative of a self-reported subjective sleep score (e.g., poor, average, excellent), a self-reported subjective stress level of the user, a self-reported subjective fatigue level of the user, a self-reported subjective health status of the user, a recent life event experienced by the user, or any combination thereof.

The electronic interface <NUM> is configured to receive data (e.g., physiological data) from the one or more sensors <NUM> such that the data can be stored in the memory device <NUM> and/or analyzed by the processor <NUM> of the control system <NUM>. The electronic interface <NUM> can communicate with the one or more sensors <NUM> using a wired connection or a wireless connection (e.g., using an RF communication protocol, a WiFi communication protocol, a Bluetooth communication protocol, over a cellular network, etc.). The electronic interface <NUM> can include an antenna, a receiver (e.g., an RF receiver), a transmitter (e.g., an RF transmitter), a transceiver, or any combination thereof. The electronic interface <NUM> can also include one more processors and/or one more memory devices that are the same as, or similar to, the processor <NUM> and the memory device <NUM> described herein. In some implementations, the electronic interface <NUM> is coupled to or integrated in the user device <NUM>. In other implementations, the electronic interface <NUM> is coupled to or integrated (e.g., in a housing) with the control system <NUM> and/or the memory device <NUM>.

As noted above, in some implementations, the system <NUM> optionally includes a respiratory system <NUM> (also referred to as a respiratory therapy system). The respiratory system <NUM> can include a respiratory pressure therapy device <NUM> (referred to herein as respiratory device <NUM>), a user interface <NUM>, a conduit <NUM> (also referred to as a tube or an air circuit), a display device <NUM>, a humidification tank <NUM>, a receptacle <NUM> or any combination thereof. In some implementations, the control system <NUM>, the memory device <NUM>, the display device <NUM>, one or more of the sensors <NUM>, and the humidification tank <NUM> are part of the respiratory device <NUM>. Respiratory pressure therapy refers to the application of a supply of air to an entrance to a user's airways at a controlled target pressure that is nominally positive with respect to atmosphere throughout the user's breathing cycle (e.g., in contrast to negative pressure therapies such as the tank ventilator or cuirass). The respiratory system <NUM> is generally used to treat individuals suffering from one or more sleep-related respiratory disorders (e.g., obstructive sleep apnea, central sleep apnea, or mixed sleep apnea).

The respiratory device <NUM> is generally used to generate pressurized air that is delivered to a user (e.g., using one or more motors that drive one or more compressors). In some implementations, the respiratory device <NUM> generates continuous constant air pressure that is delivered to the user. In other implementations, the respiratory device <NUM> generates two or more predetermined pressures (e.g., a first predetermined air pressure and a second predetermined air pressure). In still other implementations, the respiratory device <NUM> is configured to generate a variety of different air pressures within a predetermined range. For example, the respiratory device <NUM> can deliver at least about <NUM> H<NUM>O, at least about <NUM> H<NUM>O, at least about <NUM> H<NUM>O, between about <NUM> H<NUM>O and about <NUM> H<NUM>O, between about <NUM> H<NUM>O and about <NUM> H<NUM>O, etc. The respiratory device <NUM> can also deliver pressurized air at a predetermined flow rate between, for example, about -<NUM>/min and about <NUM>/min, while maintaining a positive pressure (relative to the ambient pressure).

The user interface <NUM> engages a portion of the user's face and delivers pressurized air from the respiratory device <NUM> to the user's airway to aid in preventing the airway from narrowing and/or collapsing during sleep. This may also increase the user's oxygen intake during sleep. Depending upon the therapy to be applied, the user interface <NUM> may form a seal, for example, with a region or portion of the user's face, to facilitate the delivery of gas at a pressure at sufficient variance with ambient pressure to effect therapy, for example, at a positive pressure of about <NUM> H<NUM>O relative to ambient pressure. For other forms of therapy, such as the delivery of oxygen, the user interface may not include a seal sufficient to facilitate delivery to the airways of a supply of gas at a positive pressure of about <NUM> H<NUM>O.

As shown in <FIG>, in some implementations, the user interface <NUM> is a facial mask (e.g., a full face mask) that covers the nose and mouth of the user. The user interface <NUM> can include a plurality of straps (e.g., including hook and loop fasteners) for positioning and/or stabilizing the interface on a portion of the user (e.g., the face) and a conformal cushion (e.g., silicone, plastic, foam, etc.) intended to provide an air-tight seal between the user interface <NUM> and the user. The user interface <NUM> can also include one or more vents for permitting the escape of carbon dioxide and other gases exhaled by the user <NUM>.

The conduit <NUM> (also referred to as an air circuit or tube) allows the flow of air between two components of a respiratory system <NUM>, such as the respiratory device <NUM> and the user interface <NUM>. In some implementations, there can be separate limbs of the conduit for inhalation and exhalation. In other implementations, a single limb conduit is used for both inhalation and exhalation.

One or more of the respiratory device <NUM>, the user interface <NUM>, the conduit <NUM>, the display device <NUM>, and the humidification tank <NUM> can contain one or more sensors (e.g., a pressure sensor, a flow rate sensor, or more generally any of the other sensors <NUM> described herein). These one or more sensors can be used, for example, to measure the air pressure and/or flow rate of pressurized air supplied by the respiratory device <NUM>.

The display device <NUM> is generally used to display image(s) including still images, video images, or both and/or information regarding the respiratory device <NUM>. For example, the display device <NUM> can provide information regarding the status of the respiratory device <NUM> (e.g., whether the respiratory device <NUM> is on/off, the pressure of the air being delivered by the respiratory device <NUM>, the temperature of the air being delivered by the respiratory device <NUM>, etc.) and/or other information (e.g., a sleep score, the current date/time, personal information for the user <NUM>, etc.). In some implementations, the display device <NUM> acts as a human-machine interface (HMI) that includes a graphic user interface (GUI) configured to display the image(s) as an input interface. The display device <NUM> can be an LED display, an OLED display, an LCD display, or the like. The input interface can be, for example, a touchscreen or touch-sensitive substrate, a mouse, a keyboard, or any sensor system configured to sense inputs made by a human user interacting with the respiratory device <NUM>.

The humidification tank <NUM> is coupled to or integrated in the respiratory device <NUM>. The humidification tank <NUM> includes a reservoir of water that can be used to humidify the pressurized air delivered from the respiratory device <NUM>. The respiratory device <NUM> can include a heater to heat the water in the humidification tank <NUM> in order to humidify the pressurized air provided to the user. Additionally, in some implementations, the conduit <NUM> can also include a heating element (e.g., coupled to and/or imbedded in the conduit <NUM>) that heats the pressurized air delivered to the user. The humidification tank <NUM> can be fluidly coupled to a water vapor inlet of the air pathway and deliver water vapor into the air pathway via the water vapor inlet, or can be formed in-line with the air pathway as part of the air pathway itself.

In some implementations, the system <NUM> can be used to deliver at least a portion of a substance from a receptacle <NUM> to the air pathway the user based at least in part on the physiological data, the sleep-related parameters, other data or information, or a combination thereof. Generally, modifying the delivery of the portion of the substance into the air pathway can include (i) initiating the delivery of the substance into the air pathway, (ii) ending the delivery of the portion of the substance into the air pathway, (iii) modifying an amount of the substance delivered into the air pathway, (iv) modifying a temporal characteristic of the delivery of the portion of the substance into the air pathway, (v) modifying a quantitative characteristic of the delivery of the portion of the substance into the air pathway, (vi) modifying any parameter associated with the delivery of the substance into the air pathway, or (vii) a combination of (i)-(vi).

Modifying the temporal characteristic of the delivery of the portion of the substance into the air pathway can include changing the rate at which the substance is delivered, starting and/or finishing at different times, continuing for different time periods, changing the time distribution or characteristics of the delivery, changing the amount distribution independently of the time distribution, etc. The independent time and amount variation ensures that, apart from varying the frequency of the release of the substance, one can vary the amount of substance released each time. In this manner, a number of different combination of release frequencies and release amounts (e.g., higher frequency but lower release amount, higher frequency and higher amount, lower frequency and higher amount, lower frequency and lower amount, etc.) can be achieved. Other modifications to the delivery of the portion of the substance into the air pathway can also be utilized.

The respiratory system <NUM> can be used, for example, as a positive airway pressure (PAP) system, a continuous positive airway pressure (CPAP) system, an automatic positive airway pressure system (APAP), a bi-level or variable positive airway pressure system (BPAP or VPAP), a ventilator, or a combination thereof. The CPAP system delivers a predetermined air pressure (e.g., determined by a sleep physician) to the user. The APAP system automatically varies the air pressure delivered to the user based on, for example, respiration data associated with the user. The BPAP or VPAP system is configured to deliver a first predetermined pressure (e.g., an inspiratory positive airway pressure or IPAP) and a second predetermined pressure (e.g., an expiratory positive airway pressure or EPAP) that is lower than the first predetermined pressure.

Still referring to <FIG>, the one or more sensors <NUM> of the system <NUM> include a pressure sensor <NUM>, a flow rate sensor <NUM>, temperature sensor <NUM>, a motion sensor <NUM>, a microphone <NUM>, a speaker <NUM>, a radio-frequency (RF) receiver <NUM>, a RF transmitter <NUM>, a camera <NUM>, an infrared sensor <NUM>, a photoplethysmogram (PPG) sensor <NUM>, an electrocardiogram (ECG) sensor <NUM>, an electroencephalography (EEG) sensor <NUM>, a capacitive sensor <NUM>, a force sensor <NUM>, a strain gauge sensor <NUM>, an electromyography (EMG) sensor <NUM>, an oxygen sensor <NUM>, an analyte sensor <NUM>, a moisture sensor <NUM>, a Light Detection and Ranging (LiDAR) sensor <NUM>, or a combination thereof. Generally, each of the one or more sensors <NUM> are configured to output sensor data that is received and stored in the memory device <NUM> or one or more other memory devices.

While the one or more sensors <NUM> are shown and described as including each of the pressure sensor <NUM>, the flow rate sensor <NUM>, the temperature sensor <NUM>, the motion sensor <NUM>, the microphone <NUM>, the speaker <NUM>, the RF receiver <NUM>, the RF transmitter <NUM>, the camera <NUM>, the infrared sensor <NUM>, the photoplethysmogram (PPG) sensor <NUM>, the electrocardiogram (ECG) sensor <NUM>, the electroencephalography (EEG) sensor <NUM>, the capacitive sensor <NUM>, the force sensor <NUM>, the strain gauge sensor <NUM>, the electromyography (EMG) sensor <NUM>, the oxygen sensor <NUM>, the analyte sensor <NUM>, the moisture sensor <NUM>, and the Light Detection and Ranging (LiDAR) sensor <NUM> more generally, the one or more sensors <NUM> can include a combination and any number of each of the sensors described and/or shown herein.

As described herein, the system <NUM> generally can be used to generate physiological data associated with a user (e.g., a user of the respiratory system <NUM> shown in <FIG>) during a sleep session. The physiological data can be analyzed to generate one or more sleep-related parameters, which can include any parameter, measurement, etc. related to the user during the sleep session. The one or more sleep-related parameters that can be determined for the user <NUM> during the sleep session include, for example, an Apnea-Hypopnea Index (AHI) score, a sleep score, a flow signal, a respiration signal, a respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, a number of events per hour, a pattern of events, a stage, pressure settings of the respiratory device <NUM>, a heart rate, a heart rate variability, movement of the user <NUM>, temperature, EEG activity, EMG activity, arousal, snoring, choking, coughing, whistling, wheezing, or a combination thereof.

In some implementations, the physiological data generated by one or more of the sensors <NUM> can be used by the control system <NUM> to determine a sleep-wake signal associated with the user <NUM> during the sleep session and one or more sleep-related parameters. The sleep-wake signal can be indicative of one or more sleep states, including wakefulness, relaxed wakefulness, micro-awakenings, a rapid eye movement (REM) stage, a first non-REM stage (often referred to as "N1"), a second non-REM stage (often referred to as "N2"), a third non-REM stage (often referred to as "N3"), or a combination thereof.

The sleep-wake signal can also be timestamped to determine a time that the user enters the bed, a time that the user exits the bed, a time that the user attempts to fall asleep, etc. The sleep-wake signal can be measured by the one or more sensors <NUM> during the sleep session at a predetermined sampling rate, such as, for example, one sample per second, one sample per <NUM> seconds, one sample per minute, etc. In some implementations, the sleep-wake signal can also be indicative of a respiration signal, a respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, a number of events per hour, a pattern of events, pressure settings of the respiratory device <NUM>, or a combination thereof during the sleep session. The event(s) can include snoring, apneas, central apneas, obstructive apneas, mixed apneas, hypopneas, a mask leak (e.g., from the user interface <NUM>), a restless leg, a sleeping disorder, choking, an increased heart rate, labored breathing, an asthma attack, an epileptic episode, a seizure, or a combination thereof. The one or more sleep-related parameters that can be determined for the user during the sleep session based on the sleep-wake signal include, for example, a total time in bed, a total sleep time, a sleep onset latency, a wake-after-sleep-onset parameter, a sleep efficiency, a fragmentation index, or a combination thereof.

Generally, the sleep session includes any point in time after the user <NUM> has laid or sat down in the bed <NUM> (or another area or object on which they intend to sleep), and/or has turned on the respiratory device <NUM> and/or donned the user interface <NUM>. The sleep session can thus include time periods (i) when the user <NUM> is using the CPAP system but before the user <NUM> attempts to fall asleep (for example when the user <NUM> lays in the bed <NUM> reading a book); (ii) when the user <NUM> begins trying to fall asleep but is still awake; (iii) when the user <NUM> is in a light sleep (also referred to as stage <NUM> and stage <NUM> of non-rapid eye movement (NREM) sleep); (iv) when the user <NUM> is in a deep sleep (also referred to as slow-wave sleep, SWS, or stage <NUM> of NREM sleep); (v) when the user <NUM> is in rapid eye movement (REM) sleep; (vi) when the user <NUM> is periodically awake between light sleep, deep sleep, or REM sleep; or (vii) when the user <NUM> wakes up and does not fall back asleep.

The sleep session is generally defined as ending once the user <NUM> removes the user interface <NUM>, turns off the respiratory device <NUM>, and/or gets out of bed <NUM>. In some implementations, the sleep session can include additional periods of time, or can be limited to only some of the above-disclosed time periods. For example, the sleep session can be defined to encompass a period of time beginning when the respiratory device <NUM> begins supplying the pressurized air to the airway or the user <NUM>, ending when the respiratory device <NUM> stops supplying the pressurized air to the airway of the user <NUM>, and including some or all of the time points in between, when the user <NUM> is asleep or awake.

The pressure sensor <NUM> outputs pressure data that can be stored in the memory device <NUM> and/or analyzed by the processor <NUM> of the control system <NUM>. In some implementations, the pressure sensor <NUM> is an air pressure sensor (e.g., barometric pressure sensor) that generates sensor data indicative of the respiration (e.g., inhaling and/or exhaling) of the user of the respiratory system <NUM> and/or ambient pressure. In such implementations, the pressure sensor <NUM> can be coupled to or integrated in the respiratory device <NUM>. The pressure sensor <NUM> can be, for example, a capacitive sensor, an electromagnetic sensor, a piezoelectric sensor, a strain-gauge sensor, an optical sensor, a potentiometric sensor, or a combination thereof.

The flow rate sensor <NUM> outputs flow rate data that can be stored in the memory device <NUM> and/or analyzed by the processor <NUM> of the control system <NUM>. In some implementations, the flow rate sensor <NUM> is used to determine an air flow rate from the respiratory device <NUM>, an air flow rate through the conduit <NUM>, an air flow rate through the user interface <NUM>, or a combination thereof. In such implementations, the flow rate sensor <NUM> can be coupled to or integrated in the respiratory device <NUM>, the user interface <NUM>, or the conduit <NUM>. The flow rate sensor <NUM> can be a mass flow rate sensor such as, for example, a rotary flow meter (e.g., Hall effect flow meters), a turbine flow meter, an orifice flow meter, an ultrasonic flow meter, a hot wire sensor, a vortex sensor, a membrane sensor, or a combination thereof.

The temperature sensor <NUM> outputs temperature data that can be stored in the memory device <NUM> and/or analyzed by the processor <NUM> of the control system <NUM>. In some implementations, the temperature sensor <NUM> generates temperatures data indicative of a core body temperature of the user <NUM> (<FIG>), a skin temperature of the user <NUM>, a temperature of the air flowing from the respiratory device <NUM> and/or through the conduit <NUM>, a temperature in the user interface <NUM>, an ambient temperature, or a combination thereof. The temperature sensor <NUM> can be, for example, a thermocouple sensor, a thermistor sensor, a silicon band gap temperature sensor or semiconductor-based sensor, a resistance temperature detector, or a combination thereof.

The motion sensor <NUM> outputs motion data that can be stored in the memory device <NUM> and/or analyzed by the processor <NUM> of the control system <NUM>. The motion sensor <NUM> can be used to detect movement of the user <NUM> during the sleep session, and/or detect movement of any of the components of the respiratory system <NUM>, such as the respiratory device <NUM>, the user interface <NUM>, or the conduit <NUM>. The motion sensor <NUM> can include one or more inertial sensors, such as accelerometers, gyroscopes, and magnetometers. In some implementations, the motion sensor <NUM> alternatively or additionally generates one or more signals representing bodily movement of the user, from which may be obtained a signal representing a sleep state of the user; for example, via a respiratory movement of the user. In some implementations, the motion data from the motion sensor <NUM> can be used in conjunction with additional data from another sensor <NUM> to determine the sleep state of the user.

The microphone <NUM> outputs sound data that can be stored in the memory device <NUM> and/or analyzed by the processor <NUM> of the control system <NUM>. The microphone <NUM> can be used to record sound(s) during a sleep session (e.g., sounds from the user <NUM>) to determine (e.g., using the control system <NUM>) one or more sleep-related parameters, as described in further detail herein. The microphone <NUM> can be coupled to or integrated in the respiratory device <NUM>, the user interface <NUM>, the conduit <NUM>, or the user device <NUM>. In some implementations, the system <NUM> includes a plurality of microphones (e.g., two or more microphones and/or an array of microphones with beamforming) such that sound data generated by each of the plurality of microphones can be used to discriminate the sound data generated by another of the plurality of microphones.

The speaker <NUM> outputs sound waves that are audible to a user of the system <NUM> (e.g., the user <NUM> of <FIG>). The speaker <NUM> can be used, for example, as an alarm clock or to play an alert or message to the user <NUM> (e.g., in response to an event such as an unintentional mask leak). The speaker <NUM> can be coupled to or integrated in the respiratory device <NUM>, the user interface <NUM>, the conduit <NUM>, or the external device <NUM>.

The microphone <NUM> and the speaker <NUM> can be used as separate devices. In some implementations, the microphone <NUM> and the speaker <NUM> can be combined into an acoustic sensor <NUM>, as described in, for example, <CIT>, which is hereby incorporated by reference herein in its entirety. In such implementations, the speaker <NUM> generates or emits sound waves at a predetermined interval and the microphone <NUM> detects the reflections of the emitted sound waves from the speaker <NUM>. The sound waves generated or emitted by the speaker <NUM> have a frequency that is not audible to the human ear (e.g., below <NUM> or above around <NUM>) so as not to disturb the sleep of the user <NUM> or the bed partner <NUM> (<FIG>). Based at least in part on the data from the microphone <NUM> and/or the speaker <NUM>, the control system <NUM> can determine a location or orientation of the user <NUM> (<FIG>) and/or one or more of the sleep-related parameters described in herein.

The RF transmitter <NUM> generates and/or emits radio waves having a predetermined frequency and/or a predetermined amplitude (e.g., within a high frequency band, within a low frequency band, long wave signals, short wave signals, etc.). The RF receiver <NUM> detects the reflections of the radio waves emitted from the RF transmitter <NUM>, and this data can be analyzed by the control system <NUM> to determine a location of the user <NUM> (<FIG>) and/or one or more of the sleep-related parameters described herein. An RF receiver (either the RF receiver <NUM> and the RF transmitter <NUM> or another RF pair) can also be used for wireless communication between the control system <NUM>, the respiratory device <NUM>, the one or more sensors <NUM>, the user device <NUM>, or a combination thereof. While the RF receiver <NUM> and RF transmitter <NUM> are shown as being separate and distinct elements in <FIG>, in some implementations, the RF receiver <NUM> and RF transmitter <NUM> are combined as a part of an RF sensor <NUM>. In some such implementations, the RF sensor <NUM> includes a control circuit. The specific format of the RF communication could be Wi-Fi, Bluetooth, etc..

In some implementations, the RF sensor <NUM> is a part of a mesh system. One example of a mesh system is a Wi-Fi mesh system, which can include mesh nodes, mesh router(s), and mesh gateway(s), each of which can be mobile/movable or fixed. In such implementations, the Wi-Fi mesh system includes a Wi-Fi router and/or a Wi-Fi controller and one or more satellites (e.g., access points), each of which include an RF sensor that the is the same as, or similar to, the RF sensor <NUM>. The Wi-Fi router and satellites continuously communicate with one another using Wi-Fi signals. The Wi-Fi mesh system can be used to generate motion data based on changes in the Wi-Fi signals (e.g., differences in received signal strength) between the router and the satellite(s) due to an object or person moving partially obstructing the signals. The motion data can be indicative of motion, breathing, heart rate, behavior, etc., or a combination thereof.

The camera <NUM> outputs image data reproducible as one or more images (e.g., still images, video images, thermal images, or a combination thereof) that can be stored in the memory device <NUM>. The image data from the camera <NUM> can be used by the control system <NUM> to determine one or more of the sleep-related parameters described herein, such as, for example, one or more events (e.g., position change of subject <NUM>), a respiration signal, a respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, a number of events per hour, a pattern of events, a sleep state, a sleep stage, or a combination thereof. Further, the image data from the camera <NUM> can be used to, for example, identify a position and orientation of the user, to determine chest movement of the user <NUM>, to determine air flow of the mouth and/or nose of the user <NUM>, to determine a time when the user <NUM> enters the bed <NUM>, and to determine a time when the user <NUM> exits the bed <NUM>.

The infrared (IR) sensor <NUM> outputs infrared image data reproducible as one or more infrared images (e.g., still images, video images, or both) that can be stored in the memory device <NUM>. The infrared data from the IR sensor <NUM> can be used to determine one or more sleep-related parameters during a sleep session, including a temperature of the user <NUM> and/or movement of the user <NUM>. The IR sensor <NUM> can also be used in conjunction with the camera <NUM> when measuring the presence, location, and/or movement of the user <NUM>. The IR sensor <NUM> can detect infrared light having a wavelength between about <NUM> and about <NUM>, for example, while the camera <NUM> can detect visible light having a wavelength between about <NUM> and about <NUM>.

The PPG sensor <NUM> outputs physiological data associated with the user <NUM> (<FIG>) that can be used to determine one or more sleep-related parameters, such as, for example, a heart rate, a heart rate variability, a cardiac cycle, respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, estimated blood pressure parameter(s), or a combination thereof. The PPG sensor <NUM> can be worn by the user <NUM>, embedded in clothing and/or fabric that is worn by the user <NUM>, embedded in and/or coupled to the user interface <NUM> and/or its associated headgear (e.g., straps, etc.), etc..

The ECG sensor <NUM> outputs physiological data associated with electrical activity of the heart of the user <NUM> (FIG. In some implementations, the ECG sensor <NUM> includes one or more electrodes that are positioned on or around a portion of the user <NUM> during the sleep session. The physiological data from the ECG sensor <NUM> can be used, for example, to determine one or more of the sleep-related parameters described herein.

The EEG sensor <NUM> outputs physiological data associated with electrical activity of the brain of the user <NUM>. In some implementations, the EEG sensor <NUM> includes one or more electrodes that are positioned on or around the scalp of the user <NUM> during the sleep session. The physiological data from the EEG sensor <NUM> can be used, for example, to determine a sleep state of the user <NUM> at any given time during the sleep session. In some implementations, the EEG sensor <NUM> can be integrated in the user interface <NUM> and/or the associated headgear (e.g., straps, etc.).

The capacitive sensor <NUM>, the force sensor <NUM>, and the strain gauge sensor <NUM> output data that can be stored in the memory device <NUM> and used by the control system <NUM> to determine one or more of the sleep-related parameters described herein. The EMG sensor <NUM> outputs physiological data associated with electrical activity produced by one or more muscles. The oxygen sensor <NUM> outputs oxygen data indicative of an oxygen concentration of gas (e.g., in the conduit <NUM> or at the user interface <NUM>). The oxygen sensor <NUM> can be, for example, an ultrasonic oxygen sensor, an electrical oxygen sensor, a chemical oxygen sensor, an optical oxygen sensor, or a combination thereof.

The analyte sensor <NUM> can be used to detect the presence of an analyte in the exhaled breath of the user <NUM>. The data output by the analyte sensor <NUM> can be stored in the memory device <NUM> and used by the control system <NUM> to determine the identity and concentration of any analytes in the user <NUM>'s breath. In some implementations, the analyte sensor <NUM> is positioned near a mouth of the user <NUM> to detect analytes in breath exhaled from the user <NUM>'s mouth. For example, when the user interface <NUM> is a facial mask that covers the nose and mouth of the user <NUM>, the analyte sensor <NUM> can be positioned within the facial mask to monitor the user <NUM>'s mouth breathing. In some implementations, the analyte sensor <NUM> is a volatile organic compound (VOC) sensor that can be used to detect carbon-based chemicals or compounds. In some implementations, the analyte sensor <NUM> can also be used to detect whether the user <NUM> is breathing through their nose or mouth. For example, if the data output by an analyte sensor <NUM> positioned within the facial mask of the user <NUM> detects the presence of an analyte, the processor <NUM> can use this data as an indication that the user <NUM> is breathing through their mouth.

The moisture sensor <NUM> outputs data that can be stored in the memory device <NUM> and used by the control system <NUM>. The moisture sensor <NUM> can be used to detect moisture in various areas surrounding the user (e.g., inside the conduit <NUM> or the user interface <NUM>, near the user <NUM>'s face, near the connection between the conduit <NUM> and the user interface <NUM>, near the connection between the conduit <NUM> and the respiratory device <NUM>, etc.). Thus, in some implementations, the moisture sensor <NUM> can be positioned in the user interface <NUM> or in the conduit <NUM> to monitor the humidity of the pressurized air from the respiratory device <NUM>. In other implementations, the moisture sensor <NUM> is placed near any area where moisture levels need to be monitored. The moisture sensor <NUM> can also be used to monitor the humidity of the ambient environment surrounding the user <NUM>, for example the air inside the user <NUM>'s bedroom.

One or more Light Detection and Ranging (LiDAR) sensors <NUM> can be used for depth sensing. This type of optical sensor (e.g., laser sensor) can be used to detect objects and build three dimensional (3D) maps of the surroundings, such as of a living space. LiDAR can generally utilize a pulsed laser to make time of flight measurements. LiDAR is also referred to as 3D laser scanning. In an example of use of such a sensor, a fixed or mobile device (such as a smartphone) having a LiDAR sensor <NUM> can measure and map an area extending <NUM> meters or more away from the sensor. The LiDAR data can be fused with point cloud data estimated by an electromagnetic RADAR sensor, for example. The LiDAR sensor(s) <NUM> may also use artificial intelligence (AI) to automatically geofence RADAR systems by detecting and classifying features in a space that might cause issues for RADAR systems, such a glass windows (which can be highly reflective to RADAR). LiDAR can also be used to provide an estimate of the height of a person, as well as changes in height when the person sits down, or falls down, for example. LiDAR may be used to form a 3D mesh representation of an environment. In a further use, for solid surfaces through which radio waves pass (e.g., radio-translucent materials), the LiDAR may reflect off such surfaces, thus allowing a classification of different type of obstacles.

In some implementations, the one or more sensors <NUM> also include a galvanic skin response (GSR) sensor, a blood flow sensor, a respiration sensor, a pulse sensor, a sphygmomanometer sensor, an oximetry 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.

While shown separately in <FIG>, a combination of the one or more sensors <NUM> can be integrated in and/or coupled to any one or more of the components of the system <NUM>, including the respiratory device <NUM>, the user interface <NUM>, the conduit <NUM>, the humidification tank <NUM>, the control system <NUM>, the user device <NUM>, or a combination thereof. For example, the acoustic sensor <NUM> and/or the RF sensor <NUM> can be integrated in and/or coupled to the user device <NUM>. In such implementations, the user device <NUM> can be considered a secondary device that generates additional or secondary data for use by the system <NUM> (e.g., the control system <NUM>) according to some aspects of the present disclosure. In some implementations, at least one of the one or more sensors <NUM> is not coupled to the respiratory device <NUM>, the control system <NUM>, or the user device <NUM>, and is positioned generally adjacent to the user <NUM> during the sleep session (e.g., positioned on or in contact with a portion of the user <NUM>, worn by the user <NUM>, coupled to or positioned on the nightstand, coupled to the mattress, coupled to the ceiling, etc.).

The data from the one or more sensors <NUM> can be analyzed to determine one or more sleep-related parameters, which can include a respiration signal, a respiration rate, a respiration pattern, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, an occurrence of one or more events, a number of events per hour, a pattern of events, a sleep state, an apnea-hypopnea index (AHI), or any combination thereof. The one or more events can include snoring, apneas, central apneas, obstructive apneas, mixed apneas, hypopneas, a mask leak, a cough, a restless leg, a sleeping disorder, choking, an increased heart rate, labored breathing, an asthma attack, an epileptic episode, a seizure, increased blood pressure, or any combination thereof. Many of these sleep-related parameters are physiological parameters, although some of the sleep-related parameters can be considered to be non-physiological parameters. Other types of physiological and non-physiological parameters can also be determined, either from the data from the one or more sensors <NUM>, or from other types of data.

The user device <NUM> (<FIG>) includes a display device <NUM>. The user device <NUM> can be, for example, a mobile device such as a smart phone, a tablet, a gaming console, a smart watch, a laptop, or the like. Alternatively, the user device <NUM> can be an external sensing system, a television (e.g., a smart television) or another smart home device (e.g., a smart speaker(s) such as Google Home, Amazon Echo, Alexa etc.). In some implementations, the user device is a wearable device (e.g., a smart watch). The display device <NUM> is generally used to display image(s) including still images, video images, or both. In some implementations, the display device <NUM> acts as a human-machine interface (HMI) that includes a graphic user interface (GUI) configured to display the image(s) and an input interface. The display device <NUM> can be an LED display, an OLED display, an LCD display, or the like. The input interface can be, for example, a touchscreen or touch-sensitive substrate, a mouse, a keyboard, or any sensor system configured to sense inputs made by a human user interacting with the user device <NUM>. In some implementations, one or more user devices can be used by and/or included in the system <NUM>.

While the control system <NUM> and the memory device <NUM> are described and shown in <FIG> as being a separate and distinct component of the system <NUM>, in some implementations, the control system <NUM> and/or the memory device <NUM> are integrated in the user device <NUM> and/or the respiratory device <NUM>. Alternatively, in some implementations, the control system <NUM> or a portion thereof (e.g., the processor <NUM>) can be located in a cloud (e.g., integrated in a server, integrated in an Internet of Things (IoT) device, connected to the cloud, be subject to edge cloud processing, etc.), located in one or more servers (e.g., remote servers, local servers, etc., or a combination thereof.

While system <NUM> is shown as including all of the components described above, more or fewer components can be included in a system for generating physiological data and determining a recommended bedtime for the user according to implementations of the present disclosure. For example, a first alternative system includes the control system <NUM>, the memory device <NUM>, and at least one of the one or more sensors <NUM>. As another example, a second alternative system includes the control system <NUM>, the memory device <NUM>, at least one of the one or more sensors <NUM>, and the user device <NUM>. As yet another example, a third alternative system includes the control system <NUM>, the memory device <NUM>, the respiratory system <NUM>, at least one of the one or more sensors <NUM>, and the user device <NUM>. Thus, various systems for determining a recommended bedtime for the user can be formed using any portion or portions of the components shown and described herein and/or in combination with one or more other components.

Referring generally to <FIG>, a portion of the system <NUM> (<FIG>), according to some implementations, is illustrated. A user <NUM> of the respiratory system <NUM> and a bed partner <NUM> are located in a bed <NUM> and are laying on a mattress <NUM>. The user interface <NUM> (e.g., a full facial mask) can be worn by the user <NUM> during a sleep session. The user interface <NUM> is fluidly coupled and/or connected to the respiratory device <NUM> via the conduit <NUM>. In turn, the respiratory device <NUM> delivers pressurized air to the user <NUM> via the conduit <NUM> and the user interface <NUM> to increase the air pressure in the throat of the user <NUM> to aid in preventing the airway from closing and/or narrowing during sleep. The respiratory device <NUM> can be positioned on a nightstand <NUM> that is directly adjacent to the bed <NUM> as shown in <FIG>, or more generally, on any surface or structure that is generally adjacent to the bed <NUM> and/or the user <NUM>.

In some implementations, the control system <NUM>, the memory <NUM>, any of the one or more sensors <NUM>, or a combination thereof can be located on and/or in any surface and/or structure that is generally adjacent to the bed <NUM> and/or the user <NUM>. For example, in some implementations, at least one of the one or more sensors <NUM> can be located at a first position 255A on and/or in one or more components of the respiratory system <NUM> adjacent to the bed <NUM> and/or the user <NUM>. The one or more sensors <NUM> can be coupled to the respiratory system <NUM>, the user interface <NUM>, the conduit <NUM>, the display device <NUM>, the humidification tank <NUM>, or a combination thereof.

Alternatively or additionally, at least one of the one or more sensors <NUM> can be located at a second position 255B on and/or in the bed <NUM> (e.g., the one or more sensors <NUM> are coupled to and/or integrated in the bed <NUM>). Further, alternatively or additionally, at least one of the one or more sensors <NUM> can be located at a third position 255C on and/or in the mattress <NUM> that is adjacent to the bed <NUM> and/or the user <NUM> (e.g., the one or more sensors <NUM> are coupled to and/or integrated in the mattress <NUM>). Alternatively or additionally, at least one of the one or more sensors <NUM> can be located at a fourth position 255D on and/or in a pillow that is generally adjacent to the bed <NUM> and/or the user <NUM>.

Alternatively or additionally, at least one of the one or more sensors <NUM> can be located at a fifth position 255E on and/or in the nightstand <NUM> that is generally adjacent to the bed <NUM> and/or the user <NUM>. Alternatively or additionally, at least one of the one or more sensors <NUM> can be located at a sixth position 255F such that the at least one of the one or more sensors <NUM> are coupled to and/or positioned on the user <NUM> (e.g., the one or more sensors <NUM> are embedded in or coupled to fabric, clothing <NUM>, and/or a smart device worn by the user <NUM>). More generally, at least one of the one or more sensors <NUM> can be positioned at any suitable location relative to the user <NUM> such that the one or more sensors <NUM> can generate sensor data associated with the user <NUM>.

Generally, a user who is prescribed usage of the respiratory system <NUM> will tend to experience higher quality sleep and less fatigue during the day after using the respiratory system <NUM> during the sleep compared to not using the respiratory system <NUM> (especially when the user suffers from sleep apnea or other sleep related disorders). For example, the user <NUM> may suffer from obstructive sleep apnea and rely on the user interface <NUM> (e.g., a full face mask) to deliver pressurized air from the respiratory device <NUM> via conduit <NUM>. The respiratory device <NUM> can be a continuous positive airway pressure (CPAP) machine used to increase air pressure in the throat of the user <NUM> to prevent the airway from closing and/or narrowing during sleep. For someone with sleep apnea, her airway can narrow or collapse during sleep, reducing oxygen intake, and forcing her to wake up and/or otherwise disrupt her sleep. The CPAP machine prevents the airway from narrowing or collapsing, thus minimizing the occurrences where she wakes up or is otherwise disturbed due to reduction in oxygen intake.

The respiratory device <NUM> strives to maintain a medically prescribed air pressure or pressures during sleep, but in some cases, the user interface <NUM> may move or become repositioned while the user <NUM> is asleep. The movement of the interface <NUM> can cause and/or allow pressurized air from the respiratory system <NUM> to leak at an interface between the user interface <NUM> and face/head of the user <NUM>. For example, the user <NUM> may sleep on her back while sleeping with the user interface <NUM> on, but during the course of a night's sleep, the user <NUM> can unconsciously change position such that her cheek becomes flush against the pillow <NUM>. In such a position, the user interface <NUM> can move from a relatively snug position with no unintentional air leakage to a new position that allows and/or causes air to unintentionally leak from the respiratory system <NUM>. Unintentional air leaking from the user interface <NUM> can make audible noise that disturbs the user <NUM> and/or the bed partner <NUM>, thus interfering with and/or negatively influencing both parties' sleeping session. Further, unintentional air leaking can dry the user's skin, cause dry mouth, cause dry eye(s), etc., or any combination thereof.

Other sources of unintentional air leaks at the interface between the user interface <NUM> and face/head of the user <NUM> are possible. For example, over time, the user interface <NUM> or a portion thereof may become worn such that the seal at the interface is not as complete as when the user interface <NUM> was new. As another example, straps or strap segments holding a user interface <NUM> in place can become loosened over time resulting in a poor seal that may cause unintentional leaks.

As used throughout the present disclosure, the term unintentional leak means an unintended flow of air from the respiratory system <NUM> to ambient. In some implementations, the user interface <NUM> includes vents designed to allow exhaled gases and air flow from the respiratory system <NUM>, which is referred to as intentional leak or vent flow, as such flow is designed to occur and intended to occur. That is, the gases escaping via the vents are not considered unintentional leaks because the gases comprise an intended flow of air out of the respiratory system <NUM>. In contrast to the intended vent flow out of the respiratory system <NUM>, an unintentional leak may occur, as described above, as the result of an incomplete seal between the user interface <NUM> (e.g., a mask) and the face/head of the user <NUM>. In some implementations, some flow out of the respiratory system <NUM> occurs due to an incomplete seal between the user interface <NUM> and the face/head of user <NUM>, such as where the user interface or a portion thereof (e.g., the cushion) needs to be loose enough for comfort of the user or the user has facial features (e.g., a beard), wherein this is not considered unintentional. In another example, an unintentional leak or air may occur anywhere in the air circuit of the respiratory system <NUM> to ambient. For example, in some implementations, some flow of air out of the respiratory system <NUM> can occur anywhere in the circuit of respiratory system <NUM>. For example, a leak at a joint between the conduit <NUM> and the user interface <NUM>, due to design requirements and/or tolerances, such as ease of movement between the conduit <NUM> and user interface <NUM>. In some implementations a threshold is set for an unintentional leak where no action is taken until the unintentional leak is greater than the set threshold.

In some implementations, unintentional flow of air out of the respiratory system <NUM> can be considered acceptable and not deemed to be severe enough to require action (e.g., requiring a new user interface or a new cushion, requiring a change in therapy pressure(s), etc., or any combination thereof). In such implementations, the acceptable amount of unintentional leak or air flow from the respiratory system <NUM> can be when the volume of the unintentional leak is a certain percentage or less of the total volume of air being flowed by the respiratory system <NUM>. For example, when the unintentional leak is about <NUM>% or less, or about <NUM>% or less, or about <NUM>% or less, or about <NUM>% or less, or about <NUM>% or less, or about <NUM>% or less, etc., the unintentional flow can be deemed acceptable. In terms of air flow, the acceptable unintentional leak can be when the flow of air is less than, for example, about <NUM> liters per minute, about <NUM> liters per minute, about <NUM> liters per minute, about <NUM> liters per minute, about <NUM> liter per minute, etc. The amount of time an unintentional lack lasts can also determine if the unintentional leak is acceptable. For example, where the user <NUM> is transitioning from one sleep position to another causing an unintentional leak, or the user <NUM> is for a short period of time is in a position that causes an unintentional leak. For example, in some implementations, an unintentional leak can be considered acceptable if it lasts for less than about <NUM> second, less than about, <NUM> seconds, less than about <NUM> seconds, less than about <NUM> seconds, or less than about one minute. In some implementations, the combination flow rate and time can be considered when determining an acceptable unintentional leak. For example, the unintentional leak can be considered acceptable where during the time of an unintentional leak the total volume of air released due to an unintentional leak is less than about <NUM> liters, less than about <NUM> liters, less than about <NUM> liters, less than about <NUM> liters, less than about <NUM> liter.

In some implementations, the unintentional leak is grouped with the intentional leak and referred to as the total leak of the respiratory system <NUM>. In some such implementations, the total leak can be deemed acceptable when below a threshold. For example, when the total leak is below about <NUM> liters/minute, or below about <NUM> liters per minute, or below about <NUM> liters per minute, or below about <NUM> liters per minute, or below about <NUM> liters per minute, or below about <NUM> liters per minute, or below about <NUM> liters per minute, or below about <NUM> liters per minute, or below about <NUM> liters per minute, or below about <NUM> liters per minute, or below about <NUM> liters per minute, etc. The acceptableness of the total leak can also be based in part on an amount of time that the total leak is below a threshold. For example, in some implementations, the total leak being below <NUM> liters per minute for at least <NUM> percent of a measured amount of time (e.g., a sleep session) can be deemed acceptable.

Referring to <FIG>, a flow diagram illustrating a method for predicting an unintentional leak in a respiratory system during a current sleep session is shown according to some implementations of the description.

At step <NUM>, pressurized air is delivered from a respiratory device (e.g., the respiratory device <NUM>) to a user (e.g., the user <NUM>) during the current sleep session. A sleep session is as previously described, and for example, is bounded by the time between when the user <NUM> has laid or sat down in the bed <NUM>/ turned on the respiratory device <NUM>/donned the user interface <NUM>, and when the user <NUM> removes the user interface <NUM>, turns off the respiratory device <NUM>, and/or gets out of bed <NUM>. The current sleep session refers to the sleep session that is being monitored for prediction of an unintentional leak.

After commencing delivery of pressurized air from the respiratory device in step <NUM> the method includes four additional steps. At step <NUM>, historical first data associated with the delivered pressurized air is received. At step <NUM>, current first data associated with pressured air delivered is received. At step <NUM>, historical second data associated with orientation of the user is received. At step <NUM>, current second data associated with the orientation of the user is received. The steps <NUM>, <NUM>, <NUM> and <NUM> can be made in any order. The steps <NUM> and <NUM> can also be implemented before step <NUM>.

Historical first data or historical second data refers to data collected or obtained during a previous sleep session, i.e., not the current sleep session. In some implementation the previous sleep session ends immediately before the beginning of current sleep session, for example during one night or period of time the user <NUM> intends to sleep. For example, in some implementations the time between the end of previous sleep session and the beginning of the current sleep session is less than about <NUM> seconds, less than about one minute, less than about <NUM> minutes, less than about one hour, less than about <NUM> hours, less than about <NUM> hours, less than about <NUM> hours. In some implementation the previous sleep session ends and a longer period of time, such as a period of time spanning the end of a first night and beginning of a second night, occurs before the beginning of current sleep session. For example, in some implementations, the time between the end of the previous sleep session and beginning of the current sleep session is more than about <NUM> hours, more than about <NUM> hours, more than about <NUM> days, more than about <NUM> days, more than about <NUM> days, more than <NUM> days, more than about <NUM> days, more than about a week, or more than about a month. In some implementations, the previous historical data is an average of one or more sleep sessions that occurred prior to the current sleep session. In some implementations the average is of <NUM> to <NUM> sleep sessions, <NUM> to <NUM> sleep sessions, <NUM> to <NUM> sleep sessions, <NUM> to <NUM> sleep sessions, <NUM> to <NUM> sleep sessions, <NUM> to <NUM> sleep sessions, or <NUM> sleep sessions.

Optionally, and according to some implementations, receiving the historical or current first data associated with pressurized air delivered from the respiratory device comprises receiving the 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 sensor, one or more microphones, or any combination thereof. For example, one or more sensors according to system <NUM> shown in <FIG> and <FIG>. In some implementations the one or more sensors include one or more pressure sensor, one or more flow sensors, or at least one pressure sensor and at least one flow sensor.

In some implementations, receiving the historical or current second data associated with one or more orientations of the user comprises 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 sensors can be one or more ultra-wideband sensors, one or more impulse radar ultra-wideband sensors or one or more frequency modulated continuous wave radar sensors. For example, one or more sensors according to system <NUM> shown in <FIG> and <FIG> can be used.

At step <NUM>, a likelihood that an unintentional leak in the respiratory system will occur is determined. The likelihood that the unintentional leak will occur can be limited to unintentional leaks that will occur within a predetermined amount of time. For example, the likelihood can be associated with an unintentional leak that will occur within ten seconds, within thirty second, within one minute, within five minutes, within ten minutes, etc., or any other amount(s) of time. In some implementations, the likelihood is determined using the historical first pressure data (step <NUM>), the historical second data associated with the orientation of the user (step <NUM>), the current first pressure data associated with pressurized air delivered (step <NUM>), the current second data associated with the orientation of the user, or any combination thereof.

At step <NUM>, an unintentional leak mitigation action is caused to occur, where the mitigation action is responsive to the likelihood satisfying a threshold that an unintentional leak occurs. The likelihood can be expressed, for example, as a probability e.g., as express with integers selected from <NUM> and <NUM> (e.g., <NUM> to <NUM>, <NUM> to <NUM>, or any range), such as where <NUM> is least likely and <NUM> is most likely. In some other implementations, the likelihood is expressed as a rating such as, very unlikely, unlikely, medium likely, likely, and very likely. Other implementations may express the likelihood as a percentage likelihood. According to some implementations, the likelihood is percentage likelihood that an unintentional leak occurs with a threshold is at least about <NUM>%, at least about <NUM>%, at least about <NUM>%, at least about <NUM>%, at least about <NUM>% or at least about <NUM>%.

In some implementations the mitigation action includes causing a sound to be emitted, causing a therapy pressure to change, cause an Expiratory Pressure Relief (EPR) setting to change, causing a humidification level to change, causing a device to be modified or move, causing a light to turn on or increase in brightness, causing a fan to turn on or increase in output, or any combination thereof. In some implementations the kind of mitigation action that occurs depends on the percent likelihood that an unintentional leak will occur. For example, if a threshold of <NUM>% causes a first mitigation action to occur, and the likelihood increases to <NUM>% because the first mitigation action is not effective or even causes an increase in the likelihood, a second mitigation action can occur. If the likelihood of an unintentional leak still increases escalation by a third or more mitigation actions can occur. In some implementations a mitigation action can be implemented even after an unintentional leak has occurred. In some implementations a second mitigation might occur even if the likelihood stays the same or even decreases after a first mitigation action, for example where a likelihood remains above a threshold.

Sounds that can be used as mitigation action can include, without limitation, white noise, pink noise, brown noise, violet noise a soothing sound, music, an alarm, an alert, beeping, or a combination thereof. As used herein, some variants of the flat shaped white noise sound are referred to as pink noise, brown noise, violet noise, etc. In some implementations the sounds (e.g., white noise, pink noise, brown noise, violet, etc.) aid in masking noises from an unintentional leak that is predicted to occur. In some implementations, the sounds (e.g., soothing sounds and music) aid the user or bed partner to remain in a sleep state or can gently awaken or cause the user to change sleeping position, e.g., to a position where an unintentional leak will not or is less likely to occur.

In some implementations the sound can be provide by the one or more speakers <NUM> of system <NUM>. Optionally, the system <NUM> includes multiple speakers <NUM> to provide localized sound emission. The speakers <NUM> can include in the ear speakers, over the ear speakers, adjacent to the ear speakers, ear buds, ear pods, or any combination thereof. The speakers <NUM> can be wired or wireless speakers (e.g., headphones, bookshelf speakers, floor standing speakers, television speakers, in-wall speakers, in-ceiling speakers, etc.). In some implementations, the speakers <NUM> are worn by the user <NUM> and/or the bed partner <NUM>. In some such implementations, the provided speakers <NUM> can supply the masking noise without impacting the bed partner as the sound would be localized via the type of the speakers <NUM>. In such implementations, respective localized speakers <NUM> could be provided for the respiration user and/or the bed partner.

Optionally, the speaker <NUM> is attached to one or more of a strap or strap segments of the user interface <NUM>. Thus, the user <NUM> and/or the bed partner <NUM> has the choice to perceive a relatively flat shaped white noise sound, or for a quieter (lower level and/or low pass filtered) shaped noise signal. In some such implementations, the higher frequency sounds/noises (e.g., "harsher" sounds) are reduced, while still providing masking sounds to the environmental noise. The system <NUM> can select an optimized set of fill-in sound frequencies to achieve a target noise profile. For example, if certain components of sound already exist in the frequency spectrum (e.g., related to a box fan in the room, a CPAP blower motor, etc.), then the system <NUM> can select fill-in sounds with sound parameters/characteristics that fill in the quieter frequency bands, for example, up to a target amplitude level. Thus, the system <NUM> is able to adaptively attenuate the higher and/or lower frequency components using active adaptive masking and/or as adaptive noise canceling such that the perceived sound is more pleasant and relaxing to the ear (the latter being more suited to more slowly varying and predictable sounds).

In some implementations, the sound is caused to be emitted in a gradual fashion. For example, the control system <NUM> can cause the speaker <NUM> to emit the sound at a first volume and then incrementally increase the volume from the first volume to a second louder volume over a period of time. For example, the speaker <NUM> can emit sound at a relatively low volume initially then gradually increase the volume so as to not wake and/or disturb the user <NUM> and/or the bed partner <NUM> with a sudden introduction of a new sound. The time period for the ramping up the volume can be <NUM> second, <NUM> seconds, <NUM> seconds, <NUM> seconds, <NUM> seconds, etc. or any other amount of time. In some implementations, the sound can start at a low volume responsive to the likelihood satisfying a threshold, and, if the likelihood does not decrease, for example due to the user <NUM> changing orientation, then the sound can gradually increase until the likelihood decreases. In some implementations, once the likelihood no longer satisfied the threshold (e.g., it is below a threshold) the sound can stop instantaneously or the sound can gradually decrease, e.g., until no sound is emitted. The time period for the ramping down the volume can be about one second, about five seconds, about ten seconds, about twenty seconds, about thirty seconds, etc., or any other amount of time.

Pressure therapy changes that can be used as a mitigation action can include, without limitation, increasing the pressure of air delivered to the user <NUM> or decreasing the pressure delivered to the user <NUM>. The increase and decrease in pressure can be related to the orientation of the user <NUM>. For example, where a user <NUM> shifts to an orientation where the user interface <NUM> is moved so that the likelihood of an unintended leak increases (e.g., against a mattress <NUM> or pillow <NUM>), the pressure can be decreased to reduce the likelihood of an unintended leak occurs. In some implementations the pressure can be increased to arouse the user <NUM> or cause a slight discomfort causing the user <NUM> to change orientation, without necessarily waking the user up.

Expiratory Pressure Relief (EPR) settings can be changed in response to an unintentional leak prediction. In general, EPR is a feature on some respiratory devices (e.g., CPAP machines) that allows users to adjust between different comfort settings to alleviate feelings of breathlessness some users experience. For example, a drop of <NUM> H<NUM>O between inspiration and expiration. Where this feature can be manual, the EPR setting can be changed by the system <NUM> without manual user input according to implementations of this description to mitigate against an unintentional leak occurring.

In some implementations the change in humidification level used as a mitigation action is an increase in the humidity of the air delivered to the user <NUM>. For example, where the percent likelihood of an unintentional leak increases due to a drying out of the skin of user <NUM> causing a seal between the interface <NUM> and user <NUM> to be less efficient. The user <NUM> might also experience discomfort due to dryness of the nose or mouth at a lower humidification level, the discomfort leading to orientation changes that are predicted to increase the likelihood of an unintentional leak. In some implementations the change in humidification level is a reduction in humidification. For example, where the user <NUM> experiences discomfort due to moistness or water accumulation (e.g., at the seal of the user interface <NUM>) leading to orientation changes that are predicted to increase the likelihood of an unintentional leak.

A device that is actuated or moved as a mitigation action can include, without limitation, a smart pillow, an adjustable bed frame, an adjustable mattress, a fan, an adjustable blanket, or any combination thereof. For example, the device is under control of controller <NUM>. In some implementations the smart pillow, smart mattress, or adjustable blanket can include one or more inflatable compartments or bladders that can inflate or deflate. The actuated device can thereby change the orientation of user. For example, a pillow <NUM> can be a smart pillow including one or more inflatable bladders that change the orientation of user <NUM> if the user's head is in an orientation that increases the likelihood of an unintentional leak above a threshold. In another or additional implementation, an adjustable bed frame can include sections that can rise or lower as driven by a motor and cause the user <NUM> to change orientation, e.g., forcing user <NUM> to roll from their side to their back. In some implementations, the fan, for example a fan placed on nightstand <NUM>, a fan in a window or a ceiling fan, turns on responsive to the likelihood of an unintentional leak and blows air towards user <NUM> to induce or cause them to change orientation. As another option, the fan turns off responsive to the likelihood of an unintentional leak satisfies a threshold. In some implementations, the fan turns on or off to provide a more soothing environment to the user <NUM> who is predicted to change orientations to a position where an unintentional leak occurs due to discomfort associated with an air current or lack thereof. In some implementations, the fan generates white noise. The fan can increase in speed and movement of air gradually, so as to not wake and/or disturb the user <NUM> and/or the bed partner <NUM> with a sudden change of air movement or sound from the fan.

In some implementations the leak mitigation action caused to occur is injection of a substance into the pressurized air to be being delivered to the user interface <NUM>. For example, receptacle <NUM> can be charged with a substance, the receptacle having an outlet that is in direct or indirect fluid communication with the conduit <NUM>. The substance can be configured or selected to invoke a physical reaction by the user <NUM>. For example, the user <NUM> may change orientation.

Optionally, the substance can include a medicament, such as anti-inflammatory medicine, medicine to treat an asthma attack, medicine to treat a heart attack, etc. Generally, any type of medicament that is used to treat any ailment, symptom, disease, etc. can be delivered to the airway of the user <NUM>. For example, where symptoms cause agitation or orientation changes and movement of the user <NUM> that increase the likelihood of an unintentional leak, injecting the medicament can reduce the likelihood of an unintentional leak. When the substance is a medicament, the substance generally includes one or more active ingredients, and one or more excipients. The excipients serve as the medium for conveying the active ingredient, and can include substances such as bulking agents, fillers, diluents, antiadherents, binders, coatings, colors, disintegrants, flavors, glidants, lubricants, preservatives, sorbents, sweeteners, vehicles, or any combinations thereof. The active ingredient is generally the portion of the medicament that actually causes the effect brought on by the medicament.

The substance can also optionally be an aroma compound (e.g., a substance that delivers scents and/or aromas to the airway of the user <NUM>), a sleep-aid (e.g., a substance that aids the user <NUM> in falling asleep), a consciousness-arousing compound (e.g., a substance that aids the user <NUM> in waking up, also referred to as a sleep inhibitor), a cannabidiol oil, an essential oil (such as lavender, valerian, clary sage, sweet marjoram, roman chamomile, bergamot, etc.). The substance can generally be a solid, a liquid, a gas, or any combination thereof. The substance can alternatively or additionally include one or more nanoparticles.

In some implementations, the current second data is indicative that the user moved from a first position to a second position. For example, wherein the first position is any of resting on its back, resting on its side, resting on its stomach and resting in a fetal position. The second position is one of resting on its back, resting on its side, resting on its stomach and resting in a fetal position different from the first position. Optional the first position involves the user resting on its back and the second position involves the user resting on its side. Optionally, the first position the user resting on its back and the second position involves the user resting on its stomach. Optionally, the first position involves the user resting on its side and the second position involves the user resting in a fetal position.

Alternatively or optionally, after an unintentional leak mitigation action occurs at step <NUM>, the likelihood that an unintentional leak occurs is re-evaluated. For example, by repeating one or more of the steps <NUM>, <NUM>, <NUM>, <NUM> and <NUM> outlined in <FIG>. Where, upon repetition, the likelihood of an unintentional leak does not satisfy a threshold after the re-evaluation at step <NUM>, additional mitigation actions can occur e.g., step <NUM>. These steps can be implemented repeatedly for predicting and mitigating an unintentional leak through the sleep session, such as more than <NUM> times, more than <NUM> time, more than <NUM> times, more than <NUM> times. In some implementations, the number of times a mitigation action is used is tracked and stored, e.g., in memory device <NUM>. In some implementations, this information can be displayed, for example, to the use <NUM> or a caregiver. This can be displayed, for example, after one or more sleep sessions using an external device <NUM> such as a smart phone.

The data received in any one of the steps <NUM>, <NUM>, <NUM>, <NUM> can be processed by a respiratory system <NUM>. For example, the control system can include an unintentional leak prediction algorithm stored in a memory such as memory device <NUM> as machine-readable instructions. The unintentional leak prediction algorithm can be initiated, for example, when a sleep session is started. For example, a start of a sleep session is detected by one or more sensors <NUM>. In some implementations, the sleep session starts, and the algorithm initiates, when pressurized air is delivered to the user (step <NUM>). In some implementations, the algorithm can be started but in a sleep or monitoring mode until a sleep session starts, after which it is considered initiated. In some implementations, the sleep session is started manually by the user <NUM>, and the algorithm is initiated, such as by turning on the respiratory device <NUM>, donning user interface <NUM> or reclining in bed. Once pressurized air is delivered to the user, data from one or more of steps <NUM>, <NUM>, <NUM>, and <NUM>, can be received by the algorithm as input. The algorithm can output an unintentional leak prediction value, for example based on the likelihood calculated, by the algorithm, at step <NUM> for the individual. The determined unintentional leak prediction value is indicative of a likelihood that the user will experience an unintentional leak within a predetermined amount of time in the current sleep session. In some implementations, the pre-determined amount of time is less than about <NUM> seconds, less than about <NUM> seconds, less than about <NUM> seconds, less than about <NUM> seconds, less than about <NUM> seconds, less than about <NUM> seconds, less than about <NUM> seconds, less than about <NUM> minutes, less than about <NUM> minutes, less than about <NUM> minutes, or less than about one hour. Steps prior to processing using the unintentional leak prediction algorithm can include receiving data via one or more sensors <NUM> as previously described, and transferring or sending the data to the control system, including storing the data in memory device <NUM>. In some implementations, the system <NUM> can active or actuate a device to mitigate an unintentional leak from occurring.

In some implementations the method for predicting an unintentional leak further includes identifying a type of the user interface. For example, in some implementations, the method includes identifying the user interface such as a full face mask, a nasal face mask or nasal pillow. In some implementations determining the likelihood of an unintentional leak is further based at least in part on the identified type of the user interface. In some other implementations the user interface is identified from a chart such as a model and make that is referred to.

Predicting an unintentional leak and identifying a user interface and can optionally be based on measuring pressure and flow in respiratory system <NUM>. The pressure and flow data are used for generating a plot <NUM> having an intentional leak characteristic curve <NUM> as shown by <FIG>. Generally, an unintentionally leak can be predicted by an excursion in pressure and flow from characteristic curve <NUM>. Also, in general, the shape of the characteristic curve <NUM> can identify the user interface.

In <FIG> the average total flow rate Q̃t (in liters per minute) versus average device pressure P̃d (in cmH<NUM>O) is depicted, where the average values are averages over a plurality of respiratory cycles. The shape of curve <NUM> depends on the mask such as the shape and volume (e.g., enclosed by the users face and the mask) and the mask vent size and configuration. Accordingly, the type of mask can be determined by the shape of curve <NUM>. The average flow Q̃t as described by curve <NUM> corresponds to the flow out of the device system, such as respiratory system <NUM>, where the flow is the intentional flow, such as flows out of vents in a mask (e.g., user interface <NUM>). Accordingly, excursions away from curve <NUM> relate to unintended flow.

As a user <NUM>, breaths in an out wearing an interface, such as user interface <NUM>, the device <NUM>, such as a CPAP, tries to maintain a constant pressure. However, some small fluctuations occur around the targeted or set pressure, which correspond to the average pressure P̃d increasing and decreasing slightly. With intended flow (i.e., no unintended flow), as P̃d oscillates up and down, the average flow value Q̃t follows curve <NUM> exactly. Unintentional leaks correspond to excursions off of and to the right of the curve <NUM>, such as average pressure and flow (P̃d, Q̃t) point <NUM>. At point <NUM>, with an average pressure P̃d of about <NUM> (cmH<NUM>O), if an expected leak occurred the average flow Q̃t would be about <NUM> LPM. However, since the average flow Q̃t is actually measured at almost <NUM> LPM an unintentional leak is indicated, with a delta d of about <NUM> LMP from the characteristic curve.

Another unintended flow, herein referred to an unintentional block, can also occur if there is a blockage in the system, such as where a user's position blocks a mask vent or conduit <NUM> becomes blocked (e.g., bent, or kinked). In these instances, the flow will be lower than predicted by the intentional leak plot <NUM>. An unintentional block would appear as a point or excursion to the left of curve <NUM>. In some implementations, unintentional block data can be used to receive the historical second data associated with one or more orientations of the user during one or more prior sleep sessions. In some implementations the unintentional block data can be used to receive current data associated with one or more orientations of the user during the current sleep session.

Increasing the pressure applied to a user interface can increase the incidences of unintentional leaks. For example, the increase in pressure can cause the seal between a mask (e.g., user interface <NUM>) and the user's face to be degraded and allow air to escape. Although a user might increase and improve a seal between user and mask by tightening straps of a user interface, at some high enough pressure, some amount of unintentional leak will occur.

In some implementations the intentional flow curve <NUM> as depicted in <FIG> is derived as follows. A flow pathway is formed by a respiratory device (e.g., the respiratory device <NUM>), a mask (e.g., the user interface <NUM>) having one or more vents, and a conduit (e.g., the conduit <NUM>). The conduit creates a first impedance Z1, which in turn causes a pressure drop ΔP that is a function of the total flow rate Qt. The interface pressure Pm is the device pressure Pd less the pressure drop ΔP through the conduit, where ΔP(Q) is the pressure drop characteristic of the conduit: <MAT>.

The vent of the mask creates a second impedance Z2. The vent flow Qv is related to the interface pressure Pm via the vent characteristic f <MAT>.

Combining equation (<NUM>) with equation (<NUM>), the device pressure Pd may be written as <MAT>.

The unintentional leak, which is unknown and unpredictably variable, creates a third impedance Z3. The fourth impedance Z4, the capacitance Clung, and the variable pressure source Plung represent characteristics of the user. Thus, the total flow rate Qt is equal to the sum of the vent flow rate Qv, the leak flow rate Qleak, and the respiratory flow rate Qr: <MAT>.

In some implementations, the respiratory flow rate Qr averages to zero over a plurality of respiratory cycles (e.g., breathing cycles), because the average flow into or out of the lungs must be zero. As such, taking an average of each flow rate over the plurality of respiratory cycles, the vent flow rate may be approximated as: <MAT>.

The tilde (~) indicates the average value over the plurality of respiratory cycles. The process of averaging may be implemented by low-pass filtering with a time constant long enough to contain the plurality of respiratory cycles. The time constant can be of any suitable duration, such as five seconds, ten seconds, thirty seconds, one minute, etc. However, other time intervals are also contemplated.

Combining equations (<NUM>) and (<NUM>), the average device pressure P̃d may be written as <MAT>.

Absent any leak flow (e.g., Qleak = <NUM>), the average total flow rate Q̃t may be referred to as the bias flow rate Qb. Equation (<NUM>) can then be written to reflect the relationship between bias flow rate Qb and average device pressure P̃d that characterizes the respiratory therapy system: <MAT>.

The relationship, which is the intentional leak characteristic curve for the system, is determined by the vent characteristic f(Q) and the conduit pressure drop characteristic ΔP(Q).

The characteristic intentional flow plot as shown in <FIG> can be made by measuring average total flow rate Q̃t (in liters per minute) versus average device pressure P̃d (in cmH<NUM>O) for at least two pressures, or two average flows. The plotted P̃d and Q̃t data points can be fitted and described by an equation. For example, in some implementations, the intentional leak characteristic curve <NUM> may be approximated using a polynomial equation, such as a quadratic equation: <MAT>.

The parameters of the intentional leak characteristic curve, in this quadratic equation, two non-zero constants (or coefficients), k<NUM> and k<NUM>, characterize the series concatenation of the vent characteristic f and the air circuit pressure drop characteristic ΔP. In some implementations, the polynomial equation defines an intentional leak of the system (e.g., vent flow of the system) by providing a corresponding flow rate of intentional leak for a given pressure.

In some implementations, the polynomial equation may have more than two non-zero constants, such as three non-zero constants, four non-zero constants, five non-zero constants, etc. For example, the polynomial equation may be expressed as: <MAT>.

In some implementations, the polynomial equation may involve a power of three, four, five, etc. For example, the polynomial equation may be expressed as: <MAT>.

As discussed herein, a respiratory therapy system typically includes components such as a respiratory device <NUM>, a conduit <NUM>, and a user interface <NUM>. A variety of different models may be used which can impact the pressure and flow characteristics. For example, models can include different vents in a face mask and different lengths and diameters of conduits. In order to provide improved control of therapy delivered to the user interface, it may be advantageous to estimate treatment parameters such as the pressure in the user interface, the vent flow rate, and the unintentional flow rate. In systems using estimation of treatment parameters, knowledge of the type of component being used by a user can enhance the accuracy of treatment parameter estimation, and therefore the efficacy of therapy.

To obtain knowledge of component type, some respiratory devices include a menu system that allows the user to enter and/or select the type of system components, including the user interface being used (e.g., brand, manufacturer, form, model, serial number, mask family, size etc.). Once the types of the components are entered and/or selected by the user, the respiratory device can select appropriate operating parameters of the flow generator that best coordinate with the selected components, and can more accurately monitor treatment parameters during therapy. However, in some instances, the user may not select the type of component correctly, or at all, leaving the respiratory device in error or ignorant about the type of component in use.

As such, in some implementations, an unintentional leak prediction algorithm can include code or sub routine used to identify the user interface. For example, if the conduit pressure drop characteristic ΔP is known, (e.g., because the type of conduit making up the conduit is known, or through a prior calibration operation), then the parameters of the intentional leak characteristic curve effectively characterize the vent, which in turn is indicative of the type of user interface.

In some implementations, the historical first data and historical second data are received with a user <NUM> using the same user interface <NUM>. In some implementations, the historical first data, historical second data, current first data, and current second data are received with a user <NUM> using a first user interface <NUM>, and the current first data, and current second data are received with a user <NUM> using a second user interface <NUM>. In some such implementations, the unintentional leak prediction algorithm can adjust or compensate to changes due to the user interface change.

In some implementations, the identification of user interface may be done by comparing the computed parameters k<NUM> and k<NUM> to a data structure such as an array or database having pairs (k<NUM>, k<NUM>) associated with known user interface types, when used with the known conduit. The type of user interface associated with the stored pair (k<NUM>, k<NUM>) that most closely matches the computed parameters k<NUM> and k<NUM> may be taken as the type of the user interface.

Alternatively, the pressure drop ΔP(Q̃t) may be subtracted from each value of the average device pressure P̃d before fitting the quadratic equation to the resulting mask intentional leak characteristic curve. The resulting parameters k<NUM> and k<NUM> may then be compared to a data structure of pairs (k<NUM>, k<NUM>) associated with known user interface types to identify the user interface or access data for operations of the respiratory device that is associated with use of particular user interfaces.

Thus, the detected parameters can be compared to the expected parameters over a period of time, collecting longitudinal data and cross-sectional data. In some implementations, the system may be able to determine production variation by understanding a batch of masks, and use this for production quality improvement.

In some implementations, the system can check for variation over time, and understand if the mask seal itself is degrading over time (as the system can determine how long a specific mask has been in use based on a signature such as an acoustic signature), and what are the conditions that are giving rise to unintentional leak (e.g., is it position dependent, has it changed based on recommendation to tighten or loosen headgear, has the seal followed an expected degradation cycle (assuming regular washing), is it showing accelerated wear, etc.).

In some implementations, the user interface being used can be determined by: user input, detecting the user interface optically, detecting the user interface via RFID, detecting the user interface via echo signature, detecting the conduit via connector of heated tube that has electronics, or any combination thereof. Thus an initial curve can be selected that describes a correctly functioning new mask of this type. The initial curve may be specific to the respiratory device, the operating mode, the operating parameters, other settings such as Expiratory Pressure Relief (EPR) or bi-level, the user interface (e.g., brand, manufacturer, form, model, serial number, mask family, size etc.), or any combination thereof.

In some implementations, overtime, the system may also be able to select models of expected behavior of partially worn or fully worn out masks of this type as the initial curve, such as from a look up table, or from a cloud system. These expected models may describe different levels of vent occlusion, conduit occlusion (such as for masks that have airflow through soft tubing around the head) and different levels of seal wear, headgear stretching and so forth. Thus, by selecting an appropriate initial model, the system can detect intentional leak and unintentional leak through a sleep session, and/or across multiple sleep sessions.

In some implementation the system provides an output to an external device <NUM> such as a smart phone that provides the user data related to the amount of predicted unintentional leaks detected or the % likelihood of unintentional leaks detected. For example, during a sleep session or over several sleep sessions.

While the present disclosure has been described with reference to one or more particular embodiments or implementations, those skilled in the art will recognize that many changes may be made thereto without departing from the scope of the present disclosure. Each of these implementations and obvious variations thereof is contemplated as falling within the scope of the present disclosure. It is also contemplated that additional implementations according to aspects of the present disclosure may combine any number of features from any of the implementations described herein.

Claim 1:
A system (<NUM>) for predicting an unintentional leak in a respiratory system (<NUM>) during a current sleep session, the system (<NUM>) including a respiratory system (<NUM>), a control system (<NUM>) having one or more processors (<NUM>) and sensors (<NUM>), the control system (<NUM>) being configured to:
cause, during the current sleep session, pressurized air to be delivered from a respiratory device (<NUM>) via a conduit (<NUM>) coupled to a user interface (<NUM>), the user interface (<NUM>) configured to being worn about a portion of a face of a user to aid in the user receiving at least a portion of the pressurized air;
receive historical first data associated with pressurized air delivered from the respiratory device (<NUM>) during one or more prior sleep sessions;
receive, via one or more first sensors (<NUM>), current first data associated with the pressurized air being delivered from the respiratory device during the current sleep session;
receive historical second data associated with one or more orientations of the user during one or more prior sleep sessions;
receive, via one or more second sensors (<NUM>), current second data associated with one or more orientations of the user during the current sleep session; and
determine,based at least in part on the (i) historical first data, (ii) the current first data, (iii) the historical second data, and (iv) the current second data, a likelihood that an unintentional leak in the respiratory system will occur within a predetermined amount of time.