User interface with integrated sensors

Abstract

The user interface of the respiratory treatment system includes a strap assembly, a frame, a connector, and a sensor. The strap assembly is positioned around a user's head when the user wears the user interface. The frame is physically and electrically connected to the strap assembly and defines an opening. The connector has a first end and a second end. The first end of the connector can be positioned within the opening of the frame such that the connector is physically and electrically connected to the frame. The sensor is coupled to the strap assembly or the frame such that the sensor abuts a target area of ​​the user when the user wears the user interface.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 001,273, filed March 28, 2020, the entire disclosure of which is incorporated herein by reference.

[0002] The present disclosure relates generally to systems and methods for analyzing data related to a user using a respiratory treatment system, and more particularly to systems and methods for positioning sensors on a user interface worn by a user while using a respiratory treatment system. [Background technology]

[0003] Many individuals suffer from sleep-related disorders, such as insomnia (e.g., difficulty falling asleep, frequent or prolonged awakenings after initially falling asleep, and early awakenings with inability to return to sleep), periodic limb movement disorder (PLMD), obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory failure, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disorders (NMD), hypertension, diabetes, and stroke. Many of these sleep-related disorders could be more effectively treated or managed if specific data regarding them were received and analyzed. However, utilizing sensors in a manner that can obtain desired data without interrupting the user's sleep or treatment can be difficult. For this reason, it would be advantageous to place sensors in a user interface that the user wears while sleeping and during treatment. The present disclosure is directed to solving these and other problems. Summary of the Invention

[0004] According to some implementations of the present disclosure, a user interface of a respiratory treatment system includes a strap assembly configured to be generally positioned around at least a portion of a user's head when the user interface is worn by the user; a frame defining an opening and physically and electrically connected to the strap assembly; a connector having a first portion and a second portion configured to be at least partially positioned within the opening of the frame such that the connector is physically and electrically connected to the frame; and a sensor coupled to the strap assembly or the frame such that the sensor abuts a target area of ​​the user when the user interface is worn by the user.

[0005] According to some implementations of the present disclosure, a respiratory treatment device includes a housing defining an inlet and an outlet, a blower motor positioned within the housing in fluid communication with the inlet and the outlet, a memory device storing machine-readable instructions, and a control system including one or more processors configured to execute the machine-readable instructions to cause the blower motor to discharge pressurized air through the outlet, wherein the respiratory treatment device does not include a pressure sensor positioned within the housing and does not include a flow sensor positioned within the housing.

[0006] According to some implementations of the present disclosure, a user interface of a respiratory treatment system includes a strap assembly configured to be generally positioned around at least a portion of a user's head when the user interface is worn by the user, a frame defining an opening and physically and electrically connected to the strap assembly, a cushion coupled to the frame and positioned between the frame and the strap assembly, a connector having a first portion and a second portion configured to be at least partially positioned within the opening of the frame such that the connector is physically and electrically connected to the frame, and a non-contact sensor positioned within the frame or within the cushion area of ​​the user.

[0007] The above summary is not intended to represent each implementation or every aspect of the present disclosure. Additional features and advantages of the present disclosure will be apparent from the detailed description and figures set forth below. [Brief explanation of the drawings]

[0008] [Figure 1] FIG. 1 is a functional block diagram of a respiratory treatment system according to some implementations of the present disclosure.

[0009] [Figure 2] FIG. 2 is a perspective view of the respiratory treatment system of FIG. 1, a user of the respiratory treatment system, and the user's bed partner, according to some implementations of the present disclosure.

[0010] [Figure 3] FIG. 3 illustrates an example timeline of a sleep session, according to some implementations of the present disclosure.

[0011] [Figure 4] FIG. 4 shows an example hypnogram associated with the sleep session of FIG. 3, according to some implementations of the present disclosure.

[0012] [Figure 5A] 5A is a perspective view of a first implementation of a user interface of the respiratory treatment system of FIG. 1 according to some implementations of the present disclosure.

[0013] [Figure 5B] FIG. 5B is a perspective exploded view of the user interface of FIG. 3A according to some implementations of the present disclosure.

[0014] [Figure 6A] FIG. 6A is a perspective view of the alignment of electrical contacts between a connector and a frame of the user interface of FIG. 5A according to some implementations of the present disclosure.

[0015] [Figure 6B]FIG. 6B is a close-up view of electrical contacts of the frame of the user interface of FIG. 5A according to some implementations of the present disclosure.

[0016] [Figure 6C] FIG. 6C is a cross-sectional view of an electrical connection between a connector and a frame of the user interface of FIG. 5A before the connector is inserted into the frame, according to some implementations of the present disclosure.

[0017] [Figure 6D] FIG. 6D is a cross-sectional view of the electrical connection between the connector and the frame of the user interface of FIG. 5A after the connector has been inserted into the frame, according to some implementations of the present disclosure.

[0018] [Figure 7] FIG. 7 is a perspective view of an electrical connection between the frame and strap of the user interface of FIG. 5A according to some implementations of the present disclosure.

[0019] [Figure 8] FIG. 8 is a perspective view of a user wearing the user interface of FIG. 5A according to some implementations of the present disclosure.

[0020] [Figure 9A] FIG. 9A is a perspective view of a second implementation of a user interface of the respiratory treatment system of FIG. 1 according to some implementations of the present disclosure.

[0021] [Figure 9B] FIG. 9B is an exploded view of the user interface of FIG. 9A according to some implementations of the present disclosure.

[0022] While the present disclosure is susceptible to various modifications and alternative forms, specific implementations thereof have been shown by way of example in the drawings and are herein described in detail. It is to be understood, however, that it is not intended to limit the disclosure to the particular forms disclosed, but rather, the disclosure is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure as defined by the appended claims. DETAILED DESCRIPTION OF THE INVENTION

[0023] Many individuals suffer from sleep-related and / or breathing-related disorders, including periodic limb movement disorder (PLMD), restless legs syndrome (RLS), sleep-disordered breathing (SDB), obstructive sleep apnea (OSA), central sleep apnea (CSA), other types of apnea, Cheyne-Stokes respiration (CSR), respiratory failure, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disorders (NMD), chest wall disorders, and rapid eye movement (REM) behavior disorder, also known as RBD.

[0024] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving obstruction or failure of the upper airway during sleep due to a combination of an abnormally small upper airway and loss of normal muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal wall.

[0025] Central sleep apnea (CSA) is another form of SDB that results when the brain temporarily stops sending signals to the muscles that control breathing. More generally, apnea refers to an interruption in breathing, usually caused by a blockage of air or a cessation of respiratory function. Typically, an individual stops breathing for about 15 to about 30 seconds during an obstructive sleep apnea event. Mixed sleep apnea is another form of SDB that is a combination of OSA and CSA.

[0026] Other types of apnea include hypopnea, hyperpnea, and hypercapnia. Hypopnea is generally characterized by slow or shallow breathing caused by narrowing of the airway rather than airway obstruction. Hyperpnea is generally characterized by an increase in the depth and / or rate of breathing. Hypercapnia is generally characterized by elevated or excess carbon dioxide in the bloodstream and is usually caused by insufficient breathing.

[0027] Cheyne-Stokes respiration (CSR) is another form of SDB. CSR is a disorder of a patient's respiratory control in which there are rhythmic alternating periods of increased and decreased ventilation, known as CSR cycles. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood.

[0028] Obesity-hypoventilation syndrome (OHS) is defined as the combination of severe obesity and chronic awake hypercapnia in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0029] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of diseases of the lower respiratory tract that share certain characteristics, such as increased resistance to air movement, a prolonged expiratory phase of breathing, and loss of normal elasticity of the lungs.

[0030] Neuromuscular disorders (NMDs) encompass a number of diseases and illnesses that impair muscle function either directly through intrinsic muscle pathology or indirectly through neuropathology. Chest wall disorders are a group of chest deformities that result in inefficient coupling between the respiratory muscles and the rib cage.

[0031] These and other disorders are characterized by specific events that occur while an individual is sleeping (e.g., snoring, apnea, hypopnea, restless legs, sleep disturbances, choking, increased heart rate, difficulty breathing, asthma attacks, epileptic episodes, seizures, or combinations thereof).

[0032] The apnea-hypopnea index (AHI) is an index used to indicate the severity of sleep apnea during a sleep session. The AHI is calculated by dividing the number of apnea and / or hypopnea events experienced by a user during a sleep session by the total number of hours of sleep during the sleep session. An event may be, for example, a pause in breathing lasting at least 10 seconds. An AHI of less than 5 is considered normal. An AHI of 5 or greater but less than 15 is considered to indicate mild sleep apnea. An AHI of 15 or greater but less than 30 is considered to indicate moderate sleep apnea. An AHI of 30 or greater is considered to indicate severe sleep apnea. In children, an AHI greater than 1 is considered abnormal. Sleep apnea may be considered "controlled" if the AHI is normal or if the AHI is normal or mild. The AHI may also be used in combination with oxygen desaturation levels to indicate the severity of obstructive sleep apnea.

[0033] A wide variety of types of data can be used to monitor the health of individuals with any of the above types of sleep-related disorders and / or breathing disorders (or other disorders). However, it is often difficult to collect accurate data in a manner that does not interrupt or disturb the user's sleep or interfere with any treatment the user may be receiving while sleeping. Therefore, it would be advantageous to utilize a therapeutic system that includes a variety of sensors for generating and collecting data without disturbing the user, their sleep, or their treatment.

[0034] 1 , a system 100 according to some implementations of the present disclosure is shown. The system 100 is intended, among other uses, to provide a variety of different sensors associated with a user's use of a respiratory treatment system. The system 100 includes a control system 110, a memory device 114, an electronic interface 119, one or more sensors 130, and one or more external devices 170. In some implementations, the system 100 further includes a respiratory treatment system 120 including a respiratory treatment device 122.

[0035] Control system 110 includes one or more processors 112 (hereinafter processors 112). Control system 110 is generally used to control (e.g., operate) various components of system 100 and / or analyze data obtained and / or generated by the components of system 100. Processor 112 may be a general-purpose or special-purpose processor or microprocessor. While one processor 112 is shown in FIG. 1 , control system 110 may include any suitable number of processors (e.g., one processor, two processors, five processors, ten processors, etc.), which may be located within a single housing or remotely from one another. Control system 110 (or any other control system), or a portion of control system 110, such as processor 112 (or any other processor or portion of any other control system), may be used to perform one or more steps of any method described and / or claimed herein. Control system 110 may be coupled to and / or positioned within the housing of external device 170 and / or within the housing of one or more sensors 130, for example. Control system 110 may be centralized (in one such housing) or distributed (in two or more such housings that are physically separate). In such implementations with two or more housings containing control system 110, such housings may be located proximate to and / or remote from one another.

[0036] Memory device 114 stores machine-readable instructions executable by processor 112 of control system 110. Memory device 114 may be any suitable computer-readable storage device or medium, such as, for example, a random or serial access memory device, a hard drive, a solid-state drive, a flash memory device, or the like. While one memory device 114 is shown in FIG. 1 , system 100 may include any suitable number of memory devices 114 (e.g., one memory device, two memory devices, five memory devices, ten memory devices, etc.). Memory device 114 may be coupled to and / or located within the housing of respiratory treatment device 122 of respiratory treatment system 120, within the housing of external device 170, within the housing of one or more sensors 130, or any combination thereof. Like control system 110, memory device 114 may be centralized (within one such housing) or distributed (within two or more such housings that are physically separate).

[0037] In some implementations, the memory device 114 (FIG. 1) stores a user profile associated with the user. The user profile may 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 may include, for example, information indicative of the user's age, the user's gender, the user's race, family medical history (such as a family history of insomnia or sleep apnea), the user's employment status, the user's educational status, the user's socioeconomic status, or any combination thereof. The medical information may include, for example, information indicative of one or more medical conditions associated with the user, medication use by the user, or both. The medical information data may further include a Multiple Sleep Latency Test (MSLT) result or score and / or a Pittsburgh Sleep Quality Index (PSQI) score or value. The self-reported user feedback may include information indicative of a self-reported subjective sleep score (e.g., poor, fair, good), a self-reported user's subjective stress level, a self-reported user's subjective fatigue level, a self-reported user's subjective health status, recent life events experienced by the user, or any combination thereof.

[0038] The electronic interface 119 is configured to receive data (e.g., physiological data and / or acoustic data) from one or more sensors 130 so that the data can be stored in the memory device 114 and / or analyzed by the processor 112 of the control system 110. The electronic interface 119 may communicate with the one or more sensors 130 using a wired or wireless connection (e.g., using an RF communication protocol, a WiFi communication protocol, a Bluetooth® communication protocol, an IR communication protocol, via a cellular network, via any other optical communication protocol, etc.). The electronic interface 119 may comprise an antenna, a receiver (e.g., an RF receiver), a transmitter (e.g., an RF transmitter), a transceiver, or any combination thereof. The electronic interface 119 may also comprise another processor and / or another memory device that are the same as or similar to the processor 112 and memory device 114 described herein. In some implementations, the electronic interface 119 is coupled to or integrated with the external device 170. In other implementations, the electronic interface 119 is coupled to or integrated with (eg, in the housing of) the control system 110 and / or the memory device 114 .

[0039] As mentioned above, in some implementations, system 100 optionally includes a respiratory treatment system 120 (also referred to as a respiratory pressure treatment system). Respiratory treatment system 120 may include a respiratory treatment device 122 (also referred to as a respiratory pressure treatment device), a user interface 124, a conduit 126 (also referred to as a tube or air circuit), a display device 128, a humidification tank 129, or any combination thereof. In some implementations, control system 110, memory device 114, display device 128, one or more sensors 130, and humidification tank 129 are part of respiratory treatment device 122. Respiratory pressure treatment refers to the application of a supply of air to the entrance of a user's airway at a controlled target pressure that is nominally positive relative to atmospheric pressure throughout the user's respiratory cycle (as opposed to negative pressure treatments such as a tank ventilator or cuirass, for example). Respiratory treatment system 120 is generally used to treat individuals suffering from one or more sleep-related breathing disorders (e.g., obstructive sleep apnea, central sleep apnea, or mixed sleep apnea), other breathing disorders such as COPD, or other disorders that lead to respiratory failure, which may manifest during sleep or wakefulness.

[0040] The respiratory treatment device 122 is generally used to generate pressurized air delivered to a user (e.g., using one or more motors driving one or more compressors). In some implementations, the respiratory treatment device 122 generates a continuous, constant air pressure delivered to a user. In other implementations, the respiratory treatment device 122 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 treatment device 122 is configured to generate a variety of different air pressures within a predetermined range. For example, the respiratory treatment device 122 may deliver at least about 6 cmH2O, at least about 10 cmH2O, at least about 20 cmH2O, between about 6 cmH2O and about 10 cmH2O, between about 7 cmH2O and about 12 cmH2O, etc. The respiratory treatment device 122 may also deliver pressurized air at a predetermined flow rate, e.g., between about -20 L / min and about 150 L / min, while maintaining a positive pressure (relative to ambient pressure). In some implementations, the control system 110 , the memory device 114 , the electronic interface 119 , or any combination thereof may be coupled to and / or positioned within the housing of the respiratory treatment device 122 .

[0041] The user interface 124 engages a portion of the user's face and delivers pressurized air from the respiratory treatment device 122 to the user's airways to help prevent narrowing and / or collapse of the airways during sleep. This may also increase the user's oxygen intake while sleeping. Depending on the treatment being applied, the user interface 124 may, for example, form a seal with an area or portion of the user's face to facilitate delivery of gas at a pressure sufficiently different from ambient pressure to effect treatment, for example, at a positive pressure of approximately 10 cmH2O relative to ambient pressure. For other forms of treatment, such as delivery of oxygen, the user interface may not include a seal sufficient to facilitate delivery of a gas supply to the airways at a positive pressure of approximately 10 cmH2O.

[0042] In some implementations, the user interface 124 is or includes a face mask that covers the user's nose and mouth (e.g., as shown in FIG. 2 ). Alternatively, the user interface 124 is or includes a nasal mask that provides air to the user's nose or a nasal pillows mask that delivers air directly to the user's nostrils. The user interface 124 may include a strap assembly having multiple straps (e.g., including hook-and-loop fasteners) for positioning and / or stabilizing the user interface 124 on a portion of the user's interface 124 in a desired position (e.g., on the face) and a conformal cushion (e.g., silicone, plastic, foam, etc.) that helps provide an airtight seal between the user interface 124 and the user. The user interface 124 may also include one or more vents 125 to allow carbon dioxide and other gases exhaled by the user to escape. In other implementations, the user interface 124 includes a mouthpiece (e.g., a night guard mouthpiece shaped to fit the user's teeth, a mandibular repositioning device, etc.).

[0043] The conduit 126 allows airflow between two components of the respiratory treatment system 120, such as the respiratory treatment device 122 and the user interface 124. In some implementations, there may be separate conduit limbs for inhalation and exhalation. In other implementations, a single limb conduit is used for both inhalation and exhalation. Generally, the respiratory treatment system 120 forms an air pathway extending between the motor of the respiratory treatment device 122 and the user and / or the user's airway. As such, the air pathway generally includes at least the motor of the respiratory treatment device 122, the user interface 124, and the conduit 126.

[0044] One or more of the respiratory treatment device 122, the user interface 124, the conduit 126, the display device 128, and the humidification tank 129 include one or more sensors (e.g., a pressure sensor, a flow sensor, or more generally, any of the other sensors 130 described herein) that may be used, for example, to measure the air pressure and / or flow rate of the pressurized air supplied by the respiratory treatment device 122.

[0045] The display device 128 is generally used to display images, including still images, video images, or both, and / or information about the respiratory treatment device 122. For example, the display device 128 may provide information about the status of the respiratory treatment device 122 (e.g., whether the respiratory treatment device 122 is on / off, the pressure of the air delivered by the respiratory treatment device 122, the temperature of the air delivered by the respiratory treatment device 122, etc.), and / or other information (e.g., a sleep score or a treatment score (also known as a myAir® score, such as that described in WO 2016 / 061629, the disclosure of which is incorporated herein by reference in its entirety), the current date and time, personal information about the user, etc.). In some implementations, the display device 128 functions as a human-machine interface (HMI) including a graphic user interface (GUI) configured to display images as an input interface. The display device 128 may be an LED display, an OLED display, an LCD display, etc. The input interface may be, for example, a touch screen or touch-sensitive board, a mouse, a keyboard, or any sensor system configured to sense input made by a human user interacting with the respiratory treatment device 122 .

[0046] Humidification tank 129 is coupled to or integrated with respiratory treatment device 122 and contains a reservoir of water that can be used to humidify the pressurized air delivered from respiratory treatment device 122. Respiratory treatment device 122 may include a heater that heats the water in humidification tank 129 to humidify the pressurized air provided to the user. Additionally, in some implementations, conduit 126 may also include a heating element (e.g., coupled to and / or embedded in conduit 126) that heats the pressurized air delivered to the user. In other implementations, respiratory treatment device 122 or conduit 126 may include a waterless humidifier. The waterless humidifier may incorporate a sensor that interfaces with other sensors positioned elsewhere in system 100.

[0047] Respiratory therapy system 120 may be used, for example, as a ventilator or a positive airway pressure (PAP) system, such as a continuous positive airway pressure (CPAP) system, an automatic positive airway pressure (APAP), a bilevel or variable positive airway pressure system (BPAP or VPAP), or any combination thereof. CPAP systems deliver a predetermined air pressure (e.g., determined by a sleep physician) to a user. APAP systems automatically vary the air pressure delivered to a user, for example, based at least in part on respiratory data related to the user. BPAP or VPAP systems are configured to deliver a first predetermined pressure (e.g., inspiratory positive airway pressure or IPAP) and a second predetermined pressure (e.g., expiratory positive airway pressure or EPAP) that is lower than the first predetermined pressure.

[0048] Referring to FIG. 2, a portion of system 100 (FIG. 1) is shown according to some implementations. A user 210 and bed partner 220 of respiratory treatment system 120 are positioned on bed 230, lying on mattress 232. A user interface 124 (e.g., a full-face mask) may be worn by user 210 during a sleep session. User interface 124 is fluidly coupled and / or connected to respiratory treatment device 122 via conduit 126. Respiratory treatment device 122 then delivers pressurized air to user 210 via conduit 126 and user interface 124, increasing air pressure in the user's 210's throat and helping to prevent airway closure and / or narrowing during sleep. Respiratory treatment device 122 may include a display device 128 that allows the user to interact with respiratory treatment device 122. Respiratory treatment device 122 may also include a humidification tank 129 that stores water used to humidify the pressurized air. The respiratory treatment device 122 may be positioned on a nightstand 234 directly adjacent to the bed 230, as shown in Figure 2, or more generally on any surface or structure generally adjacent to the bed 230 and / or the user 210. The user may also wear a blood pressure device 180 and an activity tracker 182 while lying on the mattress 232 of the bed 230.

[0049] 1 , the one or more sensors 130 of the system 100 include a pressure sensor 132, a flow sensor 134, a temperature sensor 136, a motion sensor 138, a microphone 140, a speaker 142, a radio frequency (RF) receiver 146, an RF transmitter 148, a camera 150, an infrared (IR) sensor 152, a photoplethysmogram (PPG) sensor 154, an electrocardiogram (ECG) sensor 156, an electroencephalogram (EEG) sensor 158, a capacitance sensor 160, a force sensor 162, a strain gauge sensor 164, an electromyogram (EMG) sensor 166, an oxygen sensor 168, an analyte sensor 174, a moisture sensor 176, a light detection and ranging (LiDAR) sensor 178, or any combination thereof. Generally, each of the one or more sensors 130 is configured to output sensor data that is received and stored in the memory device 114 or one or more other memory devices. The sensor 130 may also include an electrooculogram (EOG) sensor, a peripheral oxygen saturation (SpO2) sensor, a galvanic skin response (GSR) sensor, a carbon dioxide (CO2) sensor, or any combination thereof.

[0050] Although one or more sensors 130 are shown and described as including each of a pressure sensor 132, a flow sensor 134, a temperature sensor 136, a motion sensor 138, a microphone 140, a speaker 142, an RF receiver 146, an RF transmitter 148, a camera 150, an IR sensor 152, a PPG sensor 154, an ECG sensor 156, an EEG sensor 158, a capacitance sensor 160, a force sensor 162, a strain gauge sensor 164, an EMG sensor 166, an oxygen sensor 168, an analyte sensor 174, a moisture sensor 176, and a LiDAR sensor 178, more generally, one or more sensors 130 may include any combination and any number of each sensor described and / or shown herein.

[0051] One or more sensors 130 may be used to generate physiological data, acoustic data, or both, associated with, for example, a user of respiratory treatment system 120 (such as user 210 in FIG. 2 ), respiratory treatment system 120, both the user and respiratory treatment system 120, or other entities, objects, activities, etc. The physiological data generated by one or more sensors 130 may be used by control system 110 to determine a sleep-wake signal and one or more sleep-related parameters associated with the user during a sleep session. The sleep-wake signal may be indicative of one or more sleep stages and / or sleep states, including sleep, wakefulness, relaxed wakefulness, micro-arousal, or distinct sleep stages including rapid eye movement (REM) stages (which may include both typical and atypical REM stages), 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 any combination thereof. Methods for determining sleep stages and / or sleep states from physiological data generated by one or more sensors, such as sensor 130, are described, for example, in International Publication No. WO 2014 / 047310, U.S. Patent Application Publication No. 2014 / 0088373, International Publication No. WO 2017 / 132726, International Publication No. WO 2019 / 122413, and International Publication No. WO 2019 / 122414, the disclosures of each of which are incorporated herein by reference in their entirety.

[0052] The sleep-wake signal may also be time-stamped to indicate the time the user went to bed, the time the user left bed, the time the user attempted to fall asleep, etc. The sleep-wake signal may be measured by one or more sensors 130 during a sleep session at a predetermined sampling rate, such as, for example, one sample per second, one sample per 30 seconds, one sample per minute, etc. Examples of one or more sleep-related parameters that may be determined for a user during a sleep session based at least in part on the sleep-wake signal include total time in bed, total time asleep, total wake time, sleep onset latency, wake parameters after sleep onset, sleep efficiency, fragmentation index, time to sleep onset, breathing rate consistency, time to fall asleep, time to wake up, sleep disturbance rate, number of movements, or any combination thereof.

[0053] The physiological and / or acoustic data generated by one or more sensors 130 may also be used to measure respiratory signals associated with a user during a sleep session. The respiratory signals generally indicate the user's breathing or respiration during a sleep session. The respiratory signals may indicate, for example, respiration rate, respiration rate variability, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory amplitude ratio, inspiratory-expiratory duration ratio, number of events per hour, event patterns, pressure settings of the respiratory therapy device 122, or any combination thereof. The events may include snoring, apnea, central apnea, obstructive apnea, mixed apnea, hypopnea, mask leak (e.g., from the user interface 124), restless legs, sleep disorders, choking, increased heart rate, heart rate variability, dyspnea, asthma attack, epileptic episode, seizure, fever, coughing, sneezing, snoring, shortness of breath, presence of illness such as the common cold or flu, elevated stress levels, etc.

[0054] Pressure sensor 132 outputs pressure data that may be stored in memory device 114 and / or analyzed by processor 112 of control system 110. In some implementations, pressure sensor 132 is an air pressure sensor (e.g., a barometric sensor) that generates sensor data indicative of a user's breathing (e.g., inhalation and / or exhalation) and / or ambient pressure of respiratory treatment system 120. In such implementations, pressure sensor 132 may be coupled to or integrated with respiratory treatment device 122. Pressure sensor 132 may be, for example, a capacitive sensor, an electromagnetic sensor, an inductive sensor, a resistive sensor, a piezoelectric sensor, a strain gauge sensor, an optical sensor, a potentiometric sensor, or any combination thereof. In one example, pressure sensor 132 may be used to measure a user's blood pressure.

[0055] The flow sensor 134 outputs flow data that may be stored in the memory device 114 and / or analyzed by the processor 112 of the control system 110. In some implementations, the flow sensor 134 is used to measure the airflow rate from the respiratory treatment device 122, the airflow rate through the conduit 126, the airflow rate through the user interface 124, or any combination thereof. In such implementations, the flow sensor 134 may be coupled to or integrated with the respiratory treatment device 122, the user interface 124, or the conduit 126. The flow sensor 134 may be, for example, a mass flow sensor such as a rotary flow meter (e.g., a Hall effect flow meter), a turbine flow meter, an orifice flow meter, an ultrasonic flow meter, a hot wire sensor, a vortex sensor, a membrane sensor, or any combination thereof.

[0056] The temperature sensor 136 outputs temperature data that may be stored in the memory device 114 and / or analyzed by the processor 112 of the control system 110. In some implementations, the temperature sensor 136 generates temperature data indicative of the user's core body temperature, the user's skin temperature, the temperature of the air flowing from the respiratory treatment device 122 and / or through the conduit 126, the temperature of the user interface 124, the ambient temperature, or any combination thereof. The temperature sensor 136 may be, for example, a thermocouple sensor, a thermistor sensor, a silicon bandgap temperature sensor or semiconductor-based sensor, a resistance temperature detector, or any combination thereof.

[0057] The motion sensor 138 outputs motion data that may be stored in the memory device 114 and / or analyzed by the processor 112 of the control system 110. The motion sensor 138 may be used to detect the user's movement during a sleep session and / or to detect movement of any component of the respiratory treatment system 120, such as the respiratory treatment device 122, the user interface 124, or the conduit 126. The motion sensor 138 may include one or more inertial sensors, such as an accelerometer, a gyroscope, and a magnetometer. The motion sensor 138 may be used to detect movement or acceleration associated with an arterial pulse, such as a pulse, on or around the user's face and in the vicinity of the user interface 124, and may be configured to detect characteristics of the shape, rate, amplitude, or quantity of the pulse.

[0058] Microphone 140 outputs acoustic data that may be stored in memory device 114 and / or analyzed by processor 112 of control system 110. As described in further detail herein, the acoustic data generated by microphone 140 can be played as one or more sounds (e.g., sounds from the user) during a sleep session to determine one or more sleep-related parameters (e.g., using control system 110). As described in further detail herein, acoustic data from microphone 140 can also be used to identify events experienced by the user during a sleep session (e.g., using control system 110). In other implementations, acoustic data from microphone 140 is representative of noises associated with respiratory treatment system 120. Microphone 140 can be coupled to or integrated with respiratory treatment system 120 (or system 100) in generally any configuration. For example, microphone 140 can be located within respiratory treatment device 122, user interface 124, conduit 126, or other component. Microphone 140 may also be positioned adjacent to or coupled to the exterior of respiratory treatment device 122, the exterior of user interface 124, the exterior of conduit 126, or any other component. Microphone 140 may also be a component of external device 170 (e.g., microphone 140 is a smartphone microphone). Microphone 140 may be integrated into user interface 124, conduit 126, respiratory treatment device 122, or any combination thereof. In general, microphone 140 may be located at any point within or adjacent to the air path of respiratory treatment system 120, which includes at least the motor of respiratory treatment device 122, user interface 124, and conduit 126. As such, the air path is also referred to as the acoustic path.

[0059] The speaker 142 outputs sound waves audible to the user. The speaker 142 may be used, for example, as an alarm clock or to play alerts or messages to the user (e.g., in response to an event). In some implementations, the speaker 142 may be used to communicate acoustic data generated by the microphone 140 to the user. The speaker 142 may be coupled to or integrated with the respiratory treatment device 122, the user interface 124, the conduit 126, or the external device 170.

[0060] The microphone 140 and the speaker 142 may be used as separate devices. In some implementations, the microphone 140 and the speaker 142 may be combined into an acoustic sensor 141 (e.g., a SONAR sensor), as described, for example, in International Publication Nos. WO 2018 / 050913 and WO 2020 / 104465, each of which is incorporated herein by reference in its entirety. In such implementations, the speaker 142 generates or emits sound waves at predetermined intervals and / or frequencies, and the microphone 140 detects reflections of the sound waves emitted from the speaker 142. The sound waves generated or emitted by the speaker 142 have a frequency that is inaudible to the human ear (e.g., below 20 Hz or above about 18 kHz) so as not to disturb the sleep of the user or the user's bed partner (e.g., bed partner 220 in FIG. 2 ). Based at least in part on data from microphone 140 and / or speaker 142, control system 110 may determine the user's position and / or one or more sleep-related parameters described herein, such as, for example, a respiratory signal, a respiratory rate, an inhalation amplitude, an exhalation amplitude, an inhalation-exhalation ratio, a number of events per hour, an event pattern, a sleep stage, a pressure setting of respiratory therapy device 122, or any combination thereof. In this context, a SONAR sensor may be understood to relate to active acoustic sensing, such as by generating / transmitting an ultrasonic or low-frequency ultrasonic sensing signal through the air (e.g., in a frequency range of approximately 17-23 kHz, 18-22 kHz, or 17-18 kHz, etc.). Such systems may be considered in connection with WO 2018 / 050913 and WO 2020 / 104465, as discussed above. In some implementations, speaker 142 is a bone conduction speaker. In some implementations, the one or more sensors 130 include (i) a first microphone that is the same as or similar to microphone 140 and integrated into acoustic sensor 141, and (ii) a second microphone that is the same as or similar to microphone 140 but separate and different from the first microphone that is integrated into acoustic sensor 141.

[0061] The RF transmitter 148 generates and / or emits radio waves having a predetermined frequency and / or a predetermined amplitude (e.g., within a high-frequency band, within a low-frequency band, a long-wavelength signal, a short-wavelength signal, etc.). The RF receiver 146 detects reflections of the radio waves emitted from the RF transmitter 148, and this data may be analyzed by the control system 110 to determine the user's location and / or one or more sleep-related parameters described herein. The RF receiver (RF receiver 146 and RF transmitter 148, or other RF pair) may also be used for wireless communication between the control system 110, the respiratory treatment device 122, one or more sensors 130, the external device 170, or any combination thereof. Although the RF receiver 146 and the RF transmitter 148 are shown as separate and distinct elements in FIG. 1 , in some implementations, the RF receiver 146 and the RF transmitter 148 are combined as part of the RF sensor 147 (e.g., a RADAR sensor). In some such implementations, the RF sensor 147 comprises control circuitry. The particular form of RF communication may be WiFi, Bluetooth, or the like.

[0062] In some implementations, RF sensor 147 is part of a mesh system. One example of a mesh system is a WiFi mesh system that includes mesh nodes, mesh routers, and mesh gateways, each of which may be mobile / movable or fixed. In such implementations, the WiFi mesh system includes a WiFi router and / or a WiFi controller and one or more satellites (e.g., access points), each of which includes an RF sensor identical or similar to RF sensor 147. The WiFi router and satellites continuously communicate with each other using WiFi signals. The WiFi mesh system may be used to generate motion data based at least in part on changes in the WiFi signal between the router and the satellite (e.g., differences in received signal strength) due to moving objects or people that partially block the signal. The motion data may indicate movement, respiration, heart rate, gait, falls, activity, etc., or any combination thereof.

[0063] Camera 150 outputs image data playable as one or more images (e.g., still images, video images, thermal images, or a combination thereof) that may be stored in memory device 114. Image data from camera 150 may be used by control system 110 to determine one or more sleep-related parameters described herein. For example, image data from camera 150 may be used to identify a user's location, determine the time when the user enters the user's bed (such as bed 230 in FIG. 2 ), and determine the time when the user exits bed 230. Camera 150 may also be used to track eye movement, pupil dilation (if one or both of the user's eyes are open), blink rate, or any changes during REM sleep. Camera 150 may also be used to track a user's location, which may affect the duration and / or severity of apnea episodes in a user with obstructive sleep apnea.

[0064] The IR sensor 152 outputs infrared image data that can be played back as one or more infrared images (e.g., still images, video images, or both) that can be stored in the memory device 114. The infrared data from the IR sensor 152 can be used to determine one or more sleep-related parameters during a sleep session, including the user's body temperature and / or the user's movement. The IR sensor 152 can also be used in conjunction with the camera 150 when measuring the user's presence, location, and / or movement. For example, the camera 150 can detect visible light having a wavelength between about 380 nm and about 740 nm, while the IR sensor 152 can detect infrared light having a wavelength between about 700 nm and about 1 mm.

[0065] The IR sensor 152 outputs infrared image data that can be played back as one or more infrared images (e.g., still images, video images, or both) that can be stored in the memory device 114. The infrared data from the IR sensor 152 can be used to determine one or more sleep-related parameters during a sleep session, including the user's body temperature and / or the user's movement. The IR sensor 152 can also be used in conjunction with the camera 150 when measuring the user's presence, location, and / or movement. For example, the camera 150 can detect visible light having a wavelength between about 380 nm and about 740 nm, while the IR sensor 152 can detect infrared light having a wavelength between about 700 nm and about 1 mm.

[0066] The PPG sensor 154 outputs physiological data associated with the user that may be used to determine one or more sleep-related parameters, such as, for example, heart rate, heart rate pattern, heart rate variability, cardiac cycle, respiratory rate, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory ratio, estimated blood pressure parameters, or any combination thereof. The PPG sensor 154 may be worn by the user, embedded in clothing and / or fabric worn by the user, embedded in and / or coupled to the user interface 124 and / or its associated headgear (e.g., straps, etc.).

[0067] The ECG sensor 156 outputs physiological data related to the electrical activity of the user's heart. In some implementations, the ECG sensor 156 includes one or more electrodes that are positioned on or around a portion of the user during a sleep session. The physiological data from the ECG sensor 156 can be used, for example, to determine one or more sleep-related parameters described herein.

[0068] The EEG sensor 158 outputs physiological data related to the electrical activity of the user's brain. In some implementations, the EEG sensor 158 includes one or more electrodes positioned on or around the user's scalp during a sleep session. The physiological data from the EEG sensor 158 can be used, for example, to determine the user's sleep stage and / or sleep state at any given time during a sleep session. In some implementations, the EEG sensor 158 can be integrated into the user interface 124 and / or associated headgear (e.g., straps, etc.).

[0069] The capacitance sensor 160, the force sensor 162, and the strain gauge sensor 164 output data that can be stored in the memory device 114 and used by the control system 110 to determine one or more sleep-related parameters described herein. The EMG sensor 166 outputs physiological data related to electrical activity caused by one or more muscles. The oxygen sensor 168 outputs oxygen data indicative of the oxygen concentration of gas (e.g., in the conduit 126 or at the user interface 124). The oxygen sensor 168 may be, for example, an ultrasonic oxygen sensor, an electrical oxygen sensor, a chemical oxygen sensor, an optical oxygen sensor, or any combination thereof. In some implementations, the one or more sensors 130 may also include a galvanic skin response (GSR) sensor, a blood flow sensor, a respiration sensor, a pulse sensor, a sphygmomanometer sensor, an oximetry sensor, or any combination thereof.

[0070] The analyte sensor 174 may be used to detect the presence of analytes in the user's exhaled breath. Data output by the analyte sensor 174 may be stored in the memory device 114 and used by the control system 110 to determine the identity and concentration of any analytes in the user's breath. In some implementations, the analyte sensor 174 is positioned near the user's mouth to detect analytes in breath exhaled from the user's mouth. For example, if the user interface 124 is a face mask that covers the user's nose and mouth, the analyte sensor 174 may be positioned within the face mask to monitor the user's mouth breathing. In other implementations, such as when the user interface 124 is a nasal mask or nasal pillow mask, the analyte sensor 174 may be positioned near the user's nose to detect analytes in breath exhaled from the user's nose. In yet other implementations, the analyte sensor 174 may be positioned near the user's mouth when the user interface 124 is a nasal mask or nasal pillow mask. In this implementation, the analyte sensor 174 may be used to detect whether air is inadvertently leaking from the user's mouth. In some implementations, the analyte sensor 174 is a volatile organic compound (VOC) sensor that can be used to detect carbon-based chemicals or compounds, such as carbon dioxide. In some implementations, the analyte sensor 174 can also be used to detect whether a user is breathing through their nose or mouth. For example, if data output by an analyte sensor 174 positioned near the user's mouth or in a face mask (in implementations where the user interface 124 is a face mask) detects the presence of an analyte, the control system 110 can use this data as an indication that the user is breathing through their mouth.

[0071] The moisture sensor 176 outputs data that can be stored in the memory device 114 and used by the control system 110. The moisture sensor 176 can be used to detect moisture in various areas surrounding the user (e.g., inside the conduit 126 or the user interface 124, near the user's face, near the connection between the conduit 126 and the user interface 124, near the connection between the conduit 126 and the respiratory treatment device 122, etc.). Thus, in some implementations, the moisture sensor 176 can be coupled to or integrated with the user interface 124 or the conduit 126 to monitor the humidity of the pressurized air from the respiratory treatment device 122. In other implementations, the moisture sensor 176 is positioned near any area where humidity levels need to be monitored. The moisture sensor 176 can also be used to monitor the humidity of the air in the ambient environment surrounding the user, for example, inside the user's bedroom. The moisture sensor 176 can also be used to track the user's biometric response to environmental changes.

[0072] One or more LiDAR sensors 178 may be used for depth sensing. This type of optical sensor (e.g., a laser sensor) may be used to detect objects and create a three-dimensional (3D) map of an area, such as a living space. LiDAR typically utilizes a pulsed laser for time-of-flight measurements. LiDAR is also known as 3D laser scanning. In an example of such a sensor use, a stationary or mobile device (e.g., a smartphone) equipped with a LiDAR sensor 178 can measure and map an area extending more than five meters away from the sensor. LiDAR data may be fused with point cloud data estimated by, for example, an electromagnetic RADAR sensor. The LiDAR sensor 178 may use artificial intelligence (AI) for automatic geofencing of a RADAR system by detecting and classifying features in a space that may interfere with the RADAR system, such as glass windows (which may be highly reflective to the RADAR). LiDAR may also be used, for example, to estimate a person's height, as well as provide height changes when a person sits or falls. LiDAR may be used to create a 3D mesh representation of the environment. In a further application for solid surfaces (e.g., radio-transparent materials) through which radio waves pass, LiDAR may reflect off such surfaces, thereby enabling classification of various types of obstacles.

[0073] 1 , any combination of one or more sensors 130 may be integrated into and / or coupled to any one or more components of system 100, including respiratory treatment device 122, user interface 124, conduit 126, humidification tank 129, control system 110, external device 170, or any combination thereof. For example, acoustic sensor 141 and / or RF sensor 147 may be integrated into and / or coupled to external device 170. In such implementations, external device 170 may be considered a secondary device that generates additional or secondary data for use by system 100 (e.g., control system 110) according to some aspects of the present disclosure. In some implementations, pressure sensor 132 and / or flow sensor 134 are integrated into and / or coupled to respiratory treatment device 122. In some implementations, at least one of the one or more sensors 130 is not coupled to the respiratory treatment device 122, the control system 110, or the external device 170, but is positioned generally adjacent to the user during a sleep session (e.g., positioned on or in contact with a portion of the user, worn by the user, coupled to or positioned on a nightstand, coupled to a mattress, coupled to a ceiling, etc.). More generally, the one or more sensors 130 may be positioned in any suitable location relative to the user such that the one or more sensors 130 may generate physiological data related to the user and / or bed partner 220 during one or more sleep sessions.

[0074] Data from one or more sensors 130 may be analyzed to determine one or more sleep-related parameters, which may include a respiratory signal, a respiratory rate, a respiratory pattern, an inhalation amplitude, an exhalation amplitude, an inhalation-exhalation ratio, the occurrence of one or more events, the number of events per hour, an event pattern, the average duration of events, the range of event durations, the ratio between different event counts, a sleep stage, an apnea-hypopnea index (AHI), or any combination thereof. The one or more events may include snoring, apnea, central apnea, obstructive apnea, mixed apnea, hypopnea, an intentional user interface leak, an unintentional user interface leak, a mouth leak, coughing, restless legs, a sleep disorder, choking, an increased heart rate, dyspnea, an asthma attack, an epileptic episode, a seizure, an increase in blood pressure, or any combination thereof. While many of these sleep-related parameters are physiological parameters, some sleep-related parameters may be considered non-physiological parameters. Other types of physiological and non-physiological parameters may also be determined from data from one or more sensors 130 or from other types of data.

[0075] The external device 170 includes a display device 172. The external device 170 may be, for example, a mobile device such as a smartphone, tablet, or laptop. Alternatively, the external device 170 may be an external sensing system, a television (e.g., a smart television), or another smart home device (e.g., a smart speaker such as Google Home, Amazon Echo, or Alexa). In some implementations, the external device 170 is a wearable device (e.g., a smart watch). The display device 172 is generally used to display images, including still images, video images, or both. In some implementations, the display device 172 serves as a human-machine interface (HMI) that includes a graphical user interface (GUI) configured to display images and an input interface. The display device 172 may be an LED display, an OLED display, an LCD display, or the like. The input interface may be, for example, a touchscreen or touch-sensitive board, a mouse, a keyboard, or any sensor system configured to sense inputs made by a human user interacting with the external device 170. In some implementations, one or more external devices 170 may be used by and / or included with the system 100 .

[0076] The blood pressure device 180 is generally used to help generate physiological data for determining one or more blood pressure measurements associated with a user. The blood pressure device 180 may include at least one of the one or more sensors 130 to measure, for example, a systolic blood pressure component and / or a diastolic blood pressure component.

[0077] In some implementations, the blood pressure device 180 is a blood pressure monitor that includes an inflatable cuff that can be worn by a user and a pressure sensor (e.g., the pressure sensor 132 described herein). For example, as shown in the example of FIG. 2, the blood pressure device 180 can be worn on the user's upper arm. In such implementations in which the blood pressure device 180 is a blood pressure monitor, the blood pressure device 180 also includes a pump (e.g., a manually operated valve) for inflating the cuff. In some implementations, the blood pressure device 180 is coupled to the respiratory treatment device 122 of the respiratory treatment system 120 and then delivers pressurized air to inflate the cuff. More generally, the blood pressure device 180 can be communicatively coupled to and / or physically integrated (e.g., within a housing) with the control system 110, the memory device 114, the respiratory treatment system 120, the external device 170, and / or the activity tracker 182.

[0078] The activity tracker 182 is generally used to help generate physiological data for determining activity metrics related to the user. The activity metrics may include, for example, number of steps, distance traveled, number of steps climbed, duration of physical activity, type of physical activity, intensity of physical activity, time spent standing, respiration rate, average respiration rate, resting respiration rate, maximum respiration rate, respiration rate variability, heart rate, average heart rate, resting heart rate, maximum heart rate, heart rate variability, number of calories burned, blood oxygen saturation, electrodermal activity (also known as skin conductance or galvanic skin response), or any combination thereof. The activity tracker 182 includes one or more sensors 130 described herein, such as, for example, a motion sensor 138 (e.g., one or more accelerometers and / or gyroscope), a PPG sensor 154, and / or an ECG sensor 156.

[0079] In some implementations, activity tracker 182 is a wearable device that can be worn by a user, such as a smartwatch, wristband, ring, or patch. For example, referring to FIG. 2 , activity tracker 182 is worn on the user's wrist. Activity tracker 182 can also be coupled to or integrated with clothing or apparel worn by the user. Alternatively or additionally, activity tracker 182 can also be coupled to or integrated with external device 170 (e.g., within the same housing). More generally, activity tracker 182 can be communicatively coupled to and / or physically integrated (e.g., within the housing) with control system 110, memory device 114, respiratory treatment system 120, external device 170, and / or blood pressure device 180.

[0080] 1 as separate and distinct components of system 100, in some implementations control system 110 and / or memory device 114 are integrated into external device 170 and / or respiratory treatment device 122. Alternatively, in some implementations control system 110 or portions thereof (e.g., processor 112) may be located in the cloud (e.g., integrated into a server, integrated into an Internet of Things (IoT) device, connected to the cloud, subject to edge cloud processing, etc.), located on one or more servers (e.g., remote servers, local servers, etc., or any combination thereof).

[0081] Although system 100 is shown as including all of the above components, according to implementations of the present disclosure, a system for analyzing data associated with a user's use of respiratory treatment system 120 may include more or fewer components. For example, a first alternative system includes control system 110, memory device 114, and at least one of one or more sensors 130. As another example, a second alternative system includes control system 110, memory device 114, at least one of one or more sensors 130, and external device 170. As yet another example, a third alternative system includes control system 110, memory device 114, respiratory treatment system 120, at least one of one or more sensors 130, and external device 170. As a further example, a fourth alternative system includes control system 110, memory device 114, respiratory treatment system 120, at least one of one or more sensors 130, external device 170, and blood pressure device 180 and / or activity tracker 182. Thus, various systems for analyzing data related to a user's use of respiratory treatment system 120 may be formed using any portion of the components shown and described herein and / or in combination with one or more other components.

[0082] As used herein, a sleep session may be defined in several ways, for example, based at least in part on an initial start time and end time. In some implementations, a sleep session is a duration during which a user is asleep, i.e., a sleep session has a start time and an end time, and during a sleep session, the user does not wake up until the end time. That is, periods during which the user is awake are not included in a sleep session. From this first definition of a sleep session, if a user wakes up and falls asleep multiple times in the same night, each sleep interval separated by a wake interval is a sleep session.

[0083] Alternatively, in some implementations, a sleep session has a start time and an end time, and the user may wake up during a sleep session without the sleep session ending as long as the continuous duration the user is awake is less than a wakefulness duration threshold. The wakefulness duration threshold may be defined as a percentage of the sleep session. The wakefulness duration threshold may be, for example, about 20 percent of the sleep session, about 15 percent of the sleep session duration, about 10 percent of the sleep session duration, about 5 percent of the sleep session duration, about 2 percent of the sleep session duration, or any other threshold percentage. In some implementations, the wakefulness duration threshold is defined as a fixed amount of time, such as, for example, about 1 hour, about 30 minutes, about 15 minutes, about 10 minutes, about 5 minutes, about 2 minutes, or any other amount of time.

[0084] In some implementations, a sleep session may be defined as the entire time between the time in the evening when the user first gets into bed and the time the next morning when the user last leaves the bed. In other words, a sleep session may be defined as the time beginning at a first date (e.g., Monday, January 6, 2020) and a first time (e.g., 10:00 PM) when the user first gets into bed with the intention of sleeping (e.g., if the user does not intend to first watch TV or play on their smartphone before going to sleep), which may be referred to as this evening, and ending at a second date (e.g., Tuesday, January 7, 2020) and a second time (e.g., 7:00 AM), which may be referred to as the next morning, when the user first gets out of bed with the intention of not going back to sleep the next morning.

[0085] In some implementations, a user may manually define the start of a sleep session and / or manually end a sleep session. For example, a user may select (e.g., by clicking or tapping) one or more user-selectable elements displayed on display device 172 of external device 170 (FIG. 1) to manually start or end a sleep session.

[0086] 3, an exemplary timeline 240 of a sleep session is shown. The timeline 240 begins with the time of going to bed (t bed ), bedtime (t GTS ), first sleep time (t sleep ), the first micro-awakening MA1, the second micro-awakening MA2, the awakening A, the awakening time (t wake ), and wake-up time (t rise ) is included.

[0087] Bed time t bed is related to the time when the user first enters bed (e.g., bed 230 in FIG. 2) before falling asleep (e.g., when the user lies down or sits in bed). bed may be identified based at least in part on a bed threshold duration to distinguish between times when a user goes to bed to sleep and times when a user goes to bed for other reasons (e.g., to watch television). For example, the bed threshold duration may be at least about 10 minutes, at least about 20 minutes, at least about 30 minutes, at least about 45 minutes, at least about 1 hour, at least about 2 hours, etc. bed is described herein with reference to the bed, but more generally with reference to the time of bed entry t bed may refer to the time when a user first enters any location (e.g., couch, chair, sleeping bag, etc.) to sleep.

[0088] Bedtime (GTS) is the time when the user goes to bed (t bed ) relates to the time of first attempt to fall asleep after falling asleep. For example, after falling asleep, the user may engage in one or more activities to rest before attempting to fall asleep (e.g., reading, watching television, listening to music, using external device 170, etc.). Initial sleep time (t sleep ) is the time when the user first falls asleep. For example, the initial sleep time (t sleep ) may be the time when the user first enters the first non-REM sleep stage.

[0089] Awakening time t wakeis a time related to the time when the user wakes up without falling asleep again (as opposed to, for example, the user waking up in the middle of the night and going back to sleep). After the user initially falls asleep, they may experience one or more involuntary micro-awakenings (e.g., micro-awakenings MA1 and MA2) having short durations (e.g., 5 seconds, 10 seconds, 30 seconds, 1 minute, etc.). Awakening time t wake In contrast to the above, the user falls asleep again after each of the micro-awakenings MA1 and MA2. Similarly, the user may have one or more conscious awakenings (e.g., Awakening A) after initially falling asleep (e.g., getting up to go to the bathroom, caring for a child or pet, walking in their sleep, etc.). However, the user falls back asleep after Awakening A. Therefore, the awakening time t wake may be defined, for example, based at least in part on an arousal threshold duration (e.g., the user is awake for at least 15 minutes, at least 20 minutes, at least 30 minutes, at least 1 hour, etc.).

[0090] Similarly, the wake-up time t rise relates to the time when the user gets out of bed and is away from the bed with the intention of ending the sleep session (as opposed to, for example, the user getting up in the middle of the night to go to the bathroom, to care for a child or pet, or to walk in their sleep). In other words, the wake-up time t rise is the time when the user last left bed without returning to bed until the next sleep session (e.g., the next night). rise may be defined, for example, based at least in part on a wake-up threshold duration (e.g., the user has been out of bed for at least 15 minutes, at least 20 minutes, at least 30 minutes, at least 1 hour, etc.). bed may also be defined based at least in part on a wake threshold duration (e.g., the user has been out of bed for at least 4 hours, at least 6 hours, at least 8 hours, at least 12 hours, etc.).

[0091] As mentioned above, the user must first bed and the final t riseIn some implementations, the user may wake up and get out of bed again during the night between the last awakening time t wake and / or final wake-up time t rise The threshold duration may be identified or determined based at least in part on a predetermined threshold duration following an event (e.g., falling asleep or getting out of bed). Such threshold duration may be customized for the user. For a typical user who goes to bed at night and then wakes up and gets out of bed in the morning, the threshold duration may be anywhere between about 12 and about 18 hours (when the user wakes up). wake ) or wake up (t rise ) from the user's admission (t bed ), bedtime (t GTS ) or falling asleep (t sleep ) may be used. For users who spend more time in bed, a shorter threshold period may be used (e.g., between about 8 hours and about 14 hours). The threshold period may be initially selected and / or later adjusted based at least in part on the system monitoring the user's sleep behavior.

[0092] Total time in bed (TIB) is the time from bed entry time t bed From wake-up time t rise Total sleep time (TST) is the duration between the initial sleep time t and the wake time, excluding conscious or unconscious awakenings and / or microawakenings. Generally, total sleep time (TST) will be shorter than total time in bed (TIB) (e.g., 1 minute shorter, 10 minutes shorter, 1 hour shorter, etc.). For example, referring to timeline 240 of FIG. 3, total sleep time (TST) is the duration between the initial sleep time t and the wake time. sleep From wake-up time t wake , but excludes the duration of the first micro-arousal MA1, the second micro-arousal MA2, and the arousal A. As shown in this example, the total sleep time (TST) is shorter than the total time in bed (TIB).

[0093] In some implementations, total sleep time (TST) may be defined as continuous total sleep time (PTST). In such implementations, continuous total sleep time excludes a predetermined initial portion or a period of the first non-REM stage (e.g., a light sleep stage). For example, the predetermined initial portion may be between about 30 seconds and about 20 minutes, between about 1 minute and about 10 minutes, between about 3 minutes and about 5 minutes, etc. Continuous total sleep time is a measure of continuous sleep and smooths the sleep-wake hypnogram. For example, when a user first falls asleep, the user may be in the first non-REM stage for a very short time (e.g., about 30 seconds), then return to the wake stage for a short period (e.g., 1 minute), and then return to the first non-REM stage again. In this example, continuous total sleep time excludes the first stage (e.g., about 30 seconds) of the first non-REM stage.

[0094] In some implementations, a sleep session begins with a time to go to bed (t bed ) and wake-up time (t rise ), i.e., a sleep session is defined as the total time in bed (TIB). In some implementations, a sleep session is defined as the time from the initial sleep time (t sleep ) and wake-up time (t wake ) In some implementations, a sleep session is defined as total sleep time (TST). In some implementations, a sleep session is defined as ending at bedtime (t GTS ) and wake-up time (t wake ) In some implementations, a sleep session is defined as ending at bedtime (t GTS ) and wake-up time (t rise ) In some implementations, a sleep session is defined as ending at bedtime (t bed ) and wake-up time (t wake ) In some implementations, a sleep session is defined as ending at an initial sleep time (t sleep ) and wake-up time (t rise ) is defined as ending in

[0095] 4, an exemplary hypnogram 250 corresponding to the timeline 240 (FIG. 3) is shown, according to some implementations. As shown, the hypnogram 250 includes a sleep-wake signal 251, a wake stage axis 260, a REM stage axis 270, a light sleep stage axis 280, and a deep sleep stage axis 290. The intersection of the sleep-wake signal 251 with one of the axes 260-290 indicates the sleep stage at any given time during the sleep session.

[0096] The sleep-wake signal 251 may be generated based at least in part on physiological data associated with the user (e.g., generated by one or more sensors 130 described herein). The sleep-wake signal may indicate one or more sleep stages, including wakefulness, relaxed wakefulness, micro-arousal, REM stage, first non-REM stage, second non-REM stage, third non-REM stage, or any combination thereof. In some implementations, one or more of the first non-REM stage, second non-REM stage, and third non-REM stage may be grouped together and classified as a light sleep stage or a deep sleep stage. For example, a light sleep stage may include a first non-REM stage, and a deep sleep stage may include a second non-REM stage and a third non-REM stage. 4 as including a light sleep stage axis 280 and a deep sleep stage axis 290, in some implementations, the hypnogram 250 may include an axis for each of a first non-REM stage, a second non-REM stage, and a third non-REM stage. In other implementations, the sleep-wake signal may also indicate a respiration signal, a respiration rate, an inhalation amplitude, an exhalation amplitude, an inhalation-exhalation amplitude ratio, an inhalation-exhalation duration ratio, a number of events per time, a pattern of events, or any combination thereof. Information describing the sleep-wake signal may be stored in the memory device 114.

[0097] The hypnogram 250 may be used to determine one or more sleep-related parameters, such as, for example, sleep onset latency (SOL), wake after sleep onset (WASO), sleep efficiency (SE), sleep fragmentation index, sleep blocks, or any combination thereof.

[0098] Sleep onset latency (SOL) is the time to bed (t GTS ) to the initial sleep time (t sleep ) In other words, sleep onset latency refers to the time it takes from a user's first attempt to fall asleep to actually falling asleep. In some implementations, sleep onset latency is defined as sustained sleep onset latency (PSOL). Sustained sleep onset latency differs from sleep onset latency in that sustained sleep onset latency is defined as the duration between bedtime and a predetermined amount of sustained sleep. In some implementations, the predetermined amount of sustained sleep may include, for example, at least 10 minutes of sleep within the second non-REM stage, the third non-REM stage, and / or a REM stage with two minutes or less of wakefulness, the first non-REM stage, and / or movement therebetween. In other words, sustained sleep onset latency requires, for example, up to eight minutes of sustained sleep within the second non-REM stage, the third non-REM stage, and / or a REM stage. In other implementations, the predetermined amount of continuous sleep may include at least 10 minutes of sleep in a first non-REM stage, a second non-REM stage, a third non-REM stage, and / or a REM stage following the initial sleep time. In such implementations, the predetermined amount of continuous sleep may exclude microarousals (e.g., a 10-second microarousal does not resume for 10 minutes).

[0099] Awake after sleep onset (WASO) relates to the total duration a user is awake between the initial sleep time and the wake time. Thus, wake after sleep onset includes short micro-awakenings during a sleep session, whether conscious or unconscious (e.g., micro-awakenings MA1 and MA2 shown in FIG. 4). In some implementations, wake after sleep onset (WASO) is defined as persistent wake after sleep onset (PWASO), which includes only total durations of awakenings having a predetermined length (e.g., more than 10 seconds, more than 30 seconds, more than 60 seconds, more than about 5 minutes, more than about 10 minutes, etc.).

[0100] Sleep efficiency (SE) is determined as the ratio of total time in bed (TIB) to total sleep time (TST). For example, if the total time in bed is 8 hours and the total sleep time is 7.5 hours, the sleep efficiency for that sleep session is 93.75%. Sleep efficiency indicates a user's sleep hygiene. For example, if a user goes to bed and spends time engaging in other activities (e.g., watching TV) before going to sleep, sleep efficiency decreases (e.g., the user is penalized). In some implementations, sleep efficiency (SE) may be calculated based at least in part on the total time in bed (TIB) and the total time the user attempts to sleep. In such implementations, the total time the user attempts to sleep is defined as the duration between the Go To Bed (GTS) time and the wake-up time, as described herein. For example, if the total sleep time is 8 hours (e.g., from 11:00 PM to 7:00 AM), the bedtime is 10:45 PM, and the wake-up time is 7:15 AM, the sleep efficiency parameter is calculated to be approximately 94% in such implementations.

[0101] The fragmentation index is determined based at least in part on the number of arousals during a sleep session. For example, if a user has two micro-arousals (e.g., micro-arousals MA1 and MA2 shown in FIG. 4), the fragmentation index may be expressed as 2. In some implementations, the fragmentation index is scaled between a predetermined range of integers (e.g., between 0 and 10).

[0102] Sleep blocks relate to transitions between any stage of sleep (e.g., a first non-REM stage, a second non-REM stage, a third non-REM stage, and / or REM) and a wake stage. Sleep blocks may be calculated, for example, with a 30-second resolution.

[0103] In some implementations, the systems and methods described herein measure the time to bed (t bed ), bedtime (t GTS ), initial sleep time (t sleep ), one or more first micro-arousals (e.g., MA1 and MA2), and the awakening time (t wake ), wake-up time (t rise), or any combination thereof, based at least in part on the sleep-wake signals of the hypnogram.

[0104] In other implementations, one or more sensors 130 measure bedtime (t bed ), bedtime (t GTS ), initial sleep time (t sleep ), one or more first micro-arousals (e.g., MA1 and MA2), and the awakening time (t wake ), wake-up time (t rise ), or any combination thereof. For example, the time of bed admission t bed may be determined based at least in part on data generated by, for example, motion sensor 138, microphone 140, camera 150, or any combination thereof. Bedtime may be determined based at least in part on data from motion sensor 138 (e.g., data indicating no movement by the user), data from camera 150 (e.g., data indicating no movement by the user and / or data indicating the user has turned off the lights), data from microphone 140 (e.g., data indicating the user has turned off the TV), data from external device 170 (e.g., data indicating the user is no longer using external device 170), data from pressure sensor 132 and / or flow sensor 134 (e.g., data indicating the user has turned on respiratory treatment device 122, data indicating the user is wearing user interface 124, etc.), or any combination thereof.

[0105] User interface 300 is shown in Figures 5A and 5B. User interface 300 may be the same as or similar to user interface 124 described herein with respect to Figures 1 and 2 and may be used with any of the above-mentioned components or features of system 100, including respiratory treatment system 120 and respiratory treatment device 122. User interface 300 includes a strap assembly 310, a cushion 330, a frame 350, and a connector 370. Strap assembly 310 is configured to be generally positioned around at least a portion of a user's head when the user wears user interface 300. Strap assembly 310 may be coupled to frame 350 and positioned on a user's head such that the user's head is positioned between strap assembly 310 and frame 350.

[0106] In some implementations, the cushion 330 is positioned between the user's face and the frame 350 to form a seal with the user's face. A first end 372A of the connector 370 is coupled to the frame 350, while a second end 372B of the connector 370 may be coupled to a conduit (such as the conduit 126). The conduit may then be coupled to an air outlet of a respiratory treatment device (such as the respiratory treatment device 122). A blower motor of the respiratory treatment device is operable to generate a flow of pressurized air from the air outlet, thereby providing the pressurized air to the user. The pressurized air may flow from the respiratory treatment device through the conduit, the connector 370, the frame 350, and the cushion 330 until the air reaches the user's airway through the user's mouth, nose, or both.

[0107] The strap assembly 310 is formed from a rear portion 312, a pair of upper straps 314A and 314B, and a pair of lower straps 316A and 316B. The rear portion 312 of the strap assembly is positioned generally behind the user's head when the user wears the user interface 300. The upper straps 314A, 314B and lower straps 316A, 316B extend from the rear portion 312 toward the front of the user's face. In the illustrated implementation, the rear portion 312 is circular. However, the rear portion 312 may have other shapes. The rear portion 312, the upper straps 314A, 314B, and the lower straps 316A, 316B may be formed from a generally stretchable or resilient material, such as fabric, elastic, rubber, or any combination of materials, or may be woven. In some implementations, electrical wires or traces may pass through portions of the strap assembly 310. This portion of the strap assembly 310 may be generally formed around an electrical wire or trace, or may have a hollow interior or channel through which the electrical wire or trace extends, as described in more detail below.

[0108] Upper straps 314A, 314B and lower straps 316A, 316B each have a first end that originates at rear portion 312 and a second end that connects to frame 350. When a user wears user interface 300, tension applied by strap assembly 310 holds frame 350 against the user's face, thereby securing user interface 300 to the user's head.

[0109] In some implementations, a tension sensor may be embedded in one of the straps of the strap assembly. For example, FIG. 5B shows a tension sensor 313 embedded in the upper strap 314A. The tension sensor 313 is configured to measure tension in the strap of the user interface 124. As mentioned, the user interface 124 is generally secured to the head of the user 210 using a strap that is fastened using Velcro® or some other fastener. The tension sensor 313 can sense the tension in the strap, which can then be used to notify and / or instruct the user 210 about the correct fitting of the user interface 124. The tension sensor 313 may be integrated into threads, fibers, wires, carbon fibers, warp threads, webs, etc. As the tension in the strap increases or decreases, the sensor element of the tension sensor 313 deflects, causing a voltage change in the output signal. The tension sensor 313 may also have high elasticity and low resistance, and the ability to be washed. In some implementations, the tension sensor 313 measures the diameter of the inflated body by the principles of respiratory inductance plethysmography. The tension sensor 313 can also be an electrical impedance plethysmography sensor, a magnetometer, a strain gauge sensor, or can be made of a piezoresistive material displacement sensor.

[0110] Frame 350 is generally formed from a body 352 defining a first surface 354A and an opposite second surface 354B. When a user wears user interface 300, first surface 354A faces away from the user's face, while second surface 354B faces toward the user's face. The frame also defines an annular opening 356 through which cushion 330 and connector 370 can be inserted, thereby physically coupling cushion 330 and connector 370 to frame 350.

[0111] The cushion 330 may be coupled to an interior portion of the frame 350 adjacent the second surface 354B such that the cushion 330 is positioned between the user's face and the frame 350. The cushion 330 may be fabricated from the same or similar conformal material as the cushion of the user interface 124, and thus may be formed from a conformal material that forms an airtight seal with the user's face. The cushion 330 defines an opening 336 and includes an annular protrusion 338 extending from the cushion 330 around the opening 336 in the cushion. The annular protrusion 338 is inserted into the annular opening 356 in the frame 350 such that the annular opening 336 in the cushion 330 overlaps the annular opening 356 in the frame 350. In some implementations, the annular protrusion 338 of the cushion 330 is releasably secured to the body 352 of the frame 350 via a friction fit around the annular opening 356 between the annular protrusion 338 and the body 352.

[0112] In other implementations, the annular projection 338 and the frame 350 may have mating features that mate with each other to secure the cushion 330 to the frame 350. For example, the annular projection 338 of the cushion 330 may include an outwardly extending circumferential flange, and the body 352 of the frame 350 may include a corresponding inwardly extending circumferential flange about the annular opening 356. When the annular projection 338 of the cushion 330 is inserted into the annular opening 356 of the frame 350, the circumferential flanges can slide or snap together, thereby securing the cushion 330 to the frame 350. In additional implementations, the cushion 330 is held in place by tension applied by the strap assembly 310 and is not physically coupled to the frame 350. In still other implementations, the cushion 330 and the frame 350 may be formed as a single, integrated piece.

[0113] Connector 370 may be coupled to the opposite side of frame 350 as well as cushion 330. A first end portion 372A of connector 370 has a generally cylindrical shape and may be inserted into annular opening 356 of frame 350 such that a hollow interior 376 (see FIG. 6A ) of end portion 372A overlaps annular opening 356 and opening 336 of cushion 330. An opposite second end portion 372B of connector 370 is then coupled to a conduit such that the user's face (including the user's mouth and / or nose) is in fluid communication with the conduit through cushion 330, frame 350, and connector 370.

[0114] First end portion 372A of connector 370 is generally annular in shape and fits into annular opening 356 of frame 350. Frame 350 also includes an annular protrusion 358 extending from second surface 354B of frame 350 and formed around annular opening 356. When first end portion 372A is inserted into annular opening 356 of frame 350, the inner surface of annular protrusion 358 overlaps the outer surface of first end portion 372AA of connector 370.

[0115] In some implementations, a friction fit between the annular projection 358 and the first end portion 372A secures the connector 370 to the frame 350. In other implementations, the connector 370 may include a fastener configured to secure the connector 370 to the frame 350. In one example, the annular projection 358 has an outwardly extending circumferential flange, and the fastener is one or more deflectable latches formed on the first end portion 372A of the connector 370. When the first end portion 372A is inserted into the annular projection 358, the deflectable latch slides over the circumferential flange such that the deflectable latch is positioned outside the annular projection 358. As the deflectable latch clears the circumferential flange, the circumferential flange pushes the deflectable latch away from the annular projection 358. The deflectable latch then returns to its original position to prevent the connector 370 from disengaging from the frame 350 without manually deflecting the deflectable latch away from the annular projection 358.

[0116] The frame 350 includes a T-shaped extension strip 360 that extends upward from the upper end 351A of the main body 352. In some implementations, the extension strip 360 is integrally formed with the main body 352. In other implementations, the extension strip 360 is a separate component coupled to the main body 352. When the user wears the user interface 300, the extension strip 360 extends generally to the user's forehead. In some implementations, the extension strip 360 includes a cooling portion or mechanism that contacts and cools the forehead of the user 210, which can help users who suffer from insomnia fall asleep.

[0117] The lower straps 316A, 316B extend from the rear 312 of the strap assembly 310 toward the frame 350 and are coupled to either side of the lower end 351B of the body 352. The upper straps 314A, 314B extend from the rear 312 of the strap assembly 310 toward the frame 350 and are coupled to either side of the upper end 361 of the extension strip 360 (e.g., generally at the horizontal "cross" of the T). The frame 350 may include a variety of different strap attachment points for coupling with the upper straps 314A, 314B and lower straps 316A, 316B.

[0118] One type of strap attachment point is shown on extension strip 360. The top end 361 of extension strip 360 includes two openings 362A, 362B. These openings may be integrally formed in extension strip 360 itself or may be formed as part of a separate component or part that is coupled to extension strip 360. Openings 362A, 362B are formed to allow ends 315A, 315B of upper straps 314A, 314B to be inserted through openings 362A, 362B. Ends 315A, 315B may then be folded back and secured to the remainder of upper straps 314A, 314B via any suitable mechanism, such as Velcro®, adhesive, or the like. Thus, upper straps 314A, 314B are secured to extension strip 360 of frame 350.

[0119] Frame 350 is shown with different types of strap attachment points used to couple lower straps 316A, 316B to frame 350. Frame 350 includes two lateral strips 364A, 364B extending away from opposite ends of lower end 351B of body 352. A first end of each lateral strip 364A, 364B is coupled to body 352, and a corresponding magnet 366A, 366B is disposed at the second end of each lateral strip 364A, 364B. Magnet 318A is coupled to end 317A of lower strap 316A, while magnet 318B is coupled to end 317B of lower strap 316B. Magnet 318A may be secured to magnet 366A via magnetic attraction, while magnet 318B may be secured to magnet 366B via magnetic attraction, thereby coupling lower straps 316A, 316B to body 352 of frame 350.

[0120] In some implementations, the frame 350 does not include the extension strips 360, and instead the upper straps 314A, 314B are coupled to the frame over the lateral strips 364A, 364B. The upper straps 314A, 314B in these implementations extend past the temples of the user 210 and around the back of the head of the user 210. The frame 350 may include upper lateral strips to which the upper straps 314A, 314B are coupled.

[0121] The user interface 300 may also include one or more sensors 390. While FIG. 5B generally shows only a single sensor, any number of sensors may be coupled to the strap assembly 310. In some implementations, the one or more sensors 390 are coupled to the strap assembly 310 and configured to contact a target area of ​​the user when the user wears the user interface 300. The target area may be the user's forehead, temples, throat, neck, ears, etc. Generally, the one or more sensors 390 that contact the target area include sensors that directly contact the user's target area (e.g., the sensor touches the user's target area) and / or sensors that do not directly contact the user (e.g., the sensor is separated from the user's target area in some manner).

[0122] In some implementations, one or more sensors 390 are contact sensors and may include an electroencephalogram (EEG) sensor, an electrocardiogram (ECG) sensor, an electromyogram (EMG) sensor, an electrooculogram (EOG) sensor, an acoustic sensor, a peripheral oxygen saturation (SpO2) sensor, a galvanic skin response (GSR) sensor, or any combination thereof. The contact sensor may directly contact the target area of ​​the user or may contact a layer of material positioned between the contact sensor and the target area, such as fabric (which may be the strap assembly 310), silicone (which may be the cushion 330), foam (which may be the cushion 330), plastic (which may be the frame 350), etc. In some implementations, one or more sensors 390 are non-contact sensors and may include a carbon dioxide (CO2) sensor (to measure CO2 concentration), an oxygen (O2) sensor (to measure O2 concentration), a pressure sensor, a temperature sensor, a motion sensor, a microphone, an acoustic sensor, a flow sensor, a tension sensor, or any combination thereof. Generally, these non-contact sensors may be spaced apart from the target area such that there is air (or any other substance) located between one or more sensors 390 and the target area.

[0123] In other implementations, the one or more sensors 390 are not coupled to the strap assembly 310 but are instead located elsewhere in the user interface 300, such as in the connector 370. The one or more sensors 390 may be any one or more sensors 130 described herein with respect to FIG. 1 and may additionally or alternatively include other types of sensors. In some implementations, the one or more sensors 390 may include one or more non-contact sensors and one or more contact sensors. In some of these implementations, the non-contact sensors are not coupled to the strap assembly 310 but are instead located on the cushion 330, the frame 350, or the connector 370. Furthermore, the user interface 300 may include multiple non-contact sensors located in any combination of these locations. In one example, one of the one or more sensors 390 is coupled to the frame 350 and contacts the target area through the cushion 330. In this example, the sensor may be positioned on or near the surface of the cushion 330. Thus, the one or more sensors 390 may include any combination of sensors that (i) directly contact the target area, or (ii) are spaced apart from the target area and separated from the target area by air or some other substance. The one or more sensors 390 may include any combination of contact and non-contact sensors.

[0124] Generally, one or more sensors 390 of user interface 300 must be electrically connected to a control system and memory device (such as control system 110 and memory device 114 of system 100) to transmit data to the control system and memory device. This data may be used to modify the operation of the respiratory treatment device, or may be used for other purposes. To transmit data from one or more sensors 390 to the control system and memory device, one or more sensors 390 may be electrically connected to various portions of user interface 300, including frame 350 and connector 370. Data from one or more sensors 390 may be transmitted using electrical connections between one or more sensors 390, frame 350, and connector 370. Therefore, regardless of where one or more sensors 390 are located in user interface 300, one or more sensors 390 must be electrically connected to the control system and memory device.

[0125] 6A and 6B illustrate the electrical connection between frame 350 and connector 370. Frame 350 includes electrical contacts 368A, 368B, 368C, and 368D disposed within annular projection 358. Electrical contacts 368A-368D may be formed on the inner surface of annular projection 358 or may extend radially inward from the inner surface of annular projection 358. In FIGS. 6A and 6B, a portion of annular projection 358 has been removed to better show electrical contacts 368A-368D. Connector 370 includes corresponding electrical contacts 378A, 378B, 378C, and 378D disposed on the surface of annular end portion 372A.

[0126] When end portion 372A of connector 370 is inserted into annular opening 356 of frame 350, each electrical contact of frame 350 physically contacts one of the electrical contacts of connector 370, such that frame 350 electrically connects to connector 370. Thus, electrical contact 368A is physically and electrically connected to electrical contact 378A, electrical contact 368B is physically and electrically connected to electrical contact 378B, electrical contact 368C is physically and electrically connected to electrical contact 378C, and electrical contact 368D is physically and electrically connected to electrical contact 378D. Thus, connector 370 may be physically and electrically connected to frame 350.

[0127] In the illustrated implementation, each electrical contact 378A-378D of connector 370 is an annular electrical contact that forms a ring on the surface of end portion 372A of connector 370. Annular electrical contacts 378A-378D may be formed on the surface of end portion 372A or may extend radially outward from the surface of end portion 372A. Electrical contacts 368A-368D of frame 350 are formed as single electrical pads, each located at a location on the inner surface of annular protrusion 358. Electrical contacts 368A-368D may be formed on the inner surface of annular protrusion 358 or may be formed as pins that extend radially inward from the inner surface of annular protrusion 358. The annular shape of electrical connectors 378A-378D ensures that when end portion 372A is inserted into annular opening 356 of frame 350 and connector 370 is rotated relative to frame 350, some portion of each electrical contact 378A-378D is always in physical contact with a corresponding electrical contact 368A-368D on frame 350.

[0128] However, in other implementations, electrical contacts 368A-368D of frame 350 may have an annular shape forming a ring on the inner surface of annular protrusion 358, while electrical contacts 378A-378D of connector 370 are single electrical pads, each located at a location on the outer surface of end portion 372A. In still other implementations, electrical contacts 368A-368D and electrical contacts 378A-378D are all annular electrical contacts. In further implementations, electrical contacts 368A-368D and electrical contacts 378A-378D are all formed as a single electrical pad. In some implementations, electrical contacts 368A-368D and electrical contacts 378A-378D are at least partially annular, meaning they may form a partial ring. The ring can be a quarter ring (eg, 90°), a half ring (eg, 180°), a three-quarter ring (eg, 270°), or any other partially annular arrangement.

[0129] Connector 370 includes electrical contacts 382A-382D located on the other end portion 372B. Electrical contact 382A is electrically connected to electrical contact 378A via electrical path 380A formed in the hollow interior 376 of the connector. Electrical contact 382B is electrically connected to electrical contact 378B via electrical path 380B formed in the hollow interior 376 of the connector. Electrical contact 382C is electrically connected to electrical contact 378C via electrical path 380C formed in the hollow interior 376 of the connector. Electrical contact 382D is electrically connected to electrical contact 378D via electrical path 380D formed in the hollow interior 376 of the connector.

[0130] The electrical pathways 380A-380D can be formed in a variety of ways. In some implementations, the electrical pathways 380A-380D are electrical traces formed on the inner surface of the hollow interior 376 of the connector 370, or within the connector 370 itself. In other implementations, the electrical pathways 380A-380D are formed from wires positioned within the hollow interior 376 of the connector 370. The second end portion 372A of the connector 370 can be inserted into a conduit, which may have similar electrical contacts. In turn, when the conduit is coupled to the respiratory treatment device, the electrical contacts of the conduit may be electrically connected to the control system and memory device. Thus, the connector 370 can be physically and electrically coupled to the conduit.

[0131] Electrical contacts 368A-368D on annular projection 358 may be electrically connected to strap attachment points on frame 350. Electrical pathways 369A and 369B extend from electrical contacts 368A and 368B, respectively, through lateral strip 364A to magnet 366A. As described further herein, lateral strip 364A and magnet 366A may be electrically connected to one of the straps of strap assembly 310. Similarly, electrical pathways 369C and 369D extend upwardly from electrical contacts 368C and 368D, respectively, through extension strip 360. Although not shown in FIGS. 6A and 6B , one or more electrical pathways may also extend through lateral strip 364B to magnet 366B.

[0132] The electrical pathways 369A-369D can be formed in a variety of different ways. In some implementations, the electrical pathways 369A-369D are formed by wires positioned between the frame 350 and the cushion 330 adjacent the second surface of the body 352. In other implementations, the electrical pathways 369A-369D can be formed by electrical traces formed on the second surface of the body 352 or formed within the body 352 between the first and second surfaces.

[0133] 6A and 6B are exemplary implementations. In other implementations, any number of electrical paths may be formed between electrical contacts 368A-368D of annular projection 358 and any point on frame 350. For example, some of electrical contacts 368A-368D may be electrically connected to lateral strip 364B and magnet 366B instead of, or in addition to, electrical connections to lateral strip 364A and magnet 366A and extension strip 360.

[0134] FIG. 6C shows a cross-sectional view of annular projection 358 of frame 350 and first end portion 372A of connector 370 before first end portion 372A is inserted into annular opening 356 of frame 350. FIG. 6D shows a cross-sectional view of first end portion 372A after it has been inserted into annular opening 356 of frame 350. Electrical contacts 368A-368D of annular projection 358 are formed as single pads on the inner surface of annular projection 358. Electrical contacts 378A-378D of connector 370 are annular electrical contacts formed as rings on the outer surface of first end 372. Electrical paths 369A-369D of frame 350 are electrically connected to electrical contacts 368A-368D, respectively. Electrical paths 380A-380D of connector 370 are electrically connected to electrical contacts 378A-378D, respectively.

[0135] When first end portion 372A is inserted into annular opening 356 of frame 350, annular electrical contacts 378A-378D make contact with electrical contacts 368A-368D, thereby electrically connecting the two sets of electrical contacts. Electrical paths 369A-369D are then electrically connected to electrical paths 378A-378D. Because electrical contacts 378A-378D are annular, connector 370 can be rotated any number of times and connector 370 will remain electrically connected to frame 350.

[0136] 7A and 7B show implementations for electrically connecting strap attachment points on frame 350 to straps on strap assembly 310. Fig. 7A shows only the strap attachment points formed by lateral strips 364A. However, this implementation can be used for lateral strips 364B or other strap attachment points on frame 350.

[0137] As shown in FIG. 7A , electrical pathways 369A and 369B extend through transverse strip 364A and terminate at magnets 365A and 365B. Magnets 365A and 365B are generally the same as or similar to magnet 366A of FIGS. 6A and 6B , except that the magnet is formed from two smaller magnets 365A and 365B. Electrical pathway 369A terminates at electrical contact 371A adjacent to magnet 365A. Similarly, electrical pathway 369B terminates at electrical contact 371B adjacent to magnet 365B. In the illustrated implementation, electrical contact 371A is generally flush with the surface of magnet 365A, and electrical contact 371B is generally flush with the surface of magnet 365B.

[0138] End 317A of lower strap 316A is formed in generally the same manner. Magnets 319A and 319B are attached to end 317A of lower strap 316A. Magnets 319A and 319B are generally identical to magnet 318A shown in FIG. 5B, except that the magnet is formed from two smaller magnets 319A and 319B. Magnet 319A includes electrical contact 320A that is generally flush with the surface of magnet 319A. Similarly, magnet 319B includes electrical contact 320B that is generally flush with the surface of magnet 319B. Electrical contact 320A is electrically connected to electrical pathway 322A, and electrical contact 320B is electrically connected to electrical pathway 322B. Electrical pathways 322A, 322B extend through lower strap 316A to any desired point along strap assembly 310. Generally, electrical pathways 322A and 322B extend to a point along strap assembly 310 that is proximate to a target area on the user's face. As such, electrical pathways 322A and 322B generally have a first end positioned at electrical contacts 320A, 320B, respectively, and a second end positioned on another portion of strap assembly 310 near the target area on the user.

[0139] When end 317A of lower strap 316A is brought into proximity with horizontal strip 364A, magnets 319A and 319B are magnetically attracted to magnets 365A and 365B. The magnetic attraction secures end 317A of lower strap 316A to horizontal strip 364A, which places electrical contact 371A in physical contact with electrical contact 320A and electrical contact 371B in physical contact with electrical contact 320B. Electrical pathway 369A is thus electrically connected to electrical pathway 322A, while electrical pathway 369B is electrically connected to electrical pathway 322B. For electrical connection between horizontal strip 364A, annular protrusion 358 of frame 350, and connector 370, electrical pathways 322A, 322B (extending into strap assembly 310) are electrically connected to connector 370. Thus, the frame 350 may be physically and electrically connected to the strap assembly 310 .

[0140] End 317A of lower strap 316A includes a rotation locking feature, and horizontal strip 364A includes a corresponding rotation locking feature. In the illustrated implementation, the rotation locking feature on end 317A of lower strap 316A is a T-shaped protrusion 324 extending away from magnets 319A and 319B, and the rotation locking feature on horizontal strip 364A is a channel 373 defined between magnets 365A and 365B that is sized to receive at least a portion of T-shaped protrusion 324. Generally, a straight portion of T-shaped protrusion 324 can fit into channel 373 when end 317A of lower strap 316A is secured to horizontal strip 364A. T-shaped protrusion 324 is thus locked between magnets 365A and 365B, preventing magnets 365A and 365B from rotating relative to magnets 319A and 319B. This locked rotational turn ensures that electrical contact 371A remains in physical contact with electrical contact 320A, and electrical contact 371B remains in physical contact with electrical contact 320B. Additionally, the lower curved portion of T-shaped protrusion 324 fits generally below magnets 365A and 365B (relative to the plane of FIG. 7A ), preventing lower strap 316A from inadvertently being pulled away from lateral strip 364A.

[0141] The electrical pathways 322A and 322B extending from the end 317A of the lower strap 316A into the strap assembly 310 can be formed in a variety of different ways. In some implementations, the electrical pathways 322A and 322B are formed from wires that run generally through the hollow interior of the lower strap 316A and / or any other portion of the strap assembly 310. In other implementations, the strap assembly 310 is not hollow, and the wires that form the electrical pathways 322A and 322B are instead interwoven with the material that forms the strap assembly 310. In still other implementations, the electrical pathways 322A and 322B are formed by electrical traces that run along the surface of the lower strap 316A and the rest of the strap assembly 310.

[0142] By utilizing the electrical paths and electrical contacts of the user interface 300, one or more sensors 390 may be placed in any suitable location and electrically connected to the connector 370. By coupling the connector 370 with a conduit having its own electrical paths (e.g., wires or traces inside the conduit), the one or more sensors 390 may be electrically coupled to a control system and memory device located in or near the respiratory treatment device.

[0143] In some implementations, one or more sensors 390 are positioned near the connector 370. In this implementation, the one or more sensors 390 are electrically connected to one or more of the electrical contacts 378A-378D of the connector 370 so that data generated by the one or more sensors 390 can be transmitted via the electrical contacts 378A-378D. In these implementations, the one or more sensors 390 may be positioned inside the connector 370.

[0144] In other implementations, one or more sensors 390 are positioned near the frame 350. For example, the one or more sensors 390 can be positioned between the user's face and the cushion 330, between the cushion 330 and the frame 350, or within the annular opening 356 of the frame 350. In this implementation, the one or more sensors 390 are electrically connected to one or more of the electrical contacts 368A-368D of the frame 350, so that data generated by the one or more sensors 390 can be transmitted via the electrical contacts 368A-368D of the frame 350 and the electrical contacts 378A-378D of the connector 370.

[0145] In further implementations, one or more sensors 390 are positioned near any of the strap attachment points on frame 350. In some of these implementations, one or more sensors 390 are positioned in or near extension strips 360 and are electrically connected to frame 350 and connector 370 through extension strips 360. In other of these implementations, one or more sensors 390 may be positioned near magnet 366A on lateral strip 364A, for example, and electrically connected to one or both of electrical contacts 371A and 371B, such that data generated by one or more sensors 390 may be transmitted through electrical contacts 371A and 371B on lateral strip 364A, electrical contacts 368A-368D on frame 350, and electrical contacts 378A-378D on connector 370.

[0146] In yet other implementations, one or more sensors 390 are positioned near an end of one of the lower straps, such as near end 317A of lower strap 316A. One or more sensors 390 can be electrically connected to one or both of electrical contacts 320A and 320B, such that data generated by one or more sensors 390 can be transmitted via electrical contacts 320A and 320B, electrical contacts 371A and 371B on lateral strip 364A, electrical contacts 368A-368D on frame 350, and electrical contacts 378A-378D on connector 370.

[0147] In some implementations, one or more sensors 390 are positioned along the strap assembly 310 adjacent to the target area of ​​the user. In these implementations, the one or more sensors 390 may be electrically connected to electrical pathways extending through the strap assembly 310, such as electrical pathways 322A and 322B. As such, data generated by the one or more sensors 390 may be transmitted through electrical pathways 322A and 322B, electrical contacts 320A and 320B, electrical contacts 371A and 371B of the lateral strip 364A, electrical contacts 368A-368D of the frame 350, and contacts 378A-378D of the connector 370. Furthermore, the one or more sensors 390 may include a contact portion that contacts the target area of ​​the user and a wire that electrically connects the sensor's contact portion to an electrical pathway in the strap assembly 310, such as electrical pathways 322A and 322B.

[0148] In yet other implementations, instead of being electrically connected to a control system and memory device through conduits, one or more sensors 390 may be electrically connected to a processing device (such as a microprocessor) located within connector 370. In these implementations, the microprocessor is electrically connected to electrical contacts 378A-378D of connector 370 so that data generated by the sensors can be transmitted to the microprocessor via strap assembly 310, frame 350, and connector 370.

[0149] The user interface 124 and / or the conduits 126 may include one or more safety features to mitigate the risk of electric shock from excessive leakage current, which may result from worn or defective circuit parts or inadvertently exposed components. In some implementations, optical isolators or 1:1 transformers may be used to electrically isolate the various components. Additionally, heat generation in any of the electrical components may be mitigated using, for example, a variety of different insulators.

[0150] 8 illustrates a user (such as user 210) wearing a user interface 300 having three different sensors coupled to a strap assembly 310 and positioned adjacent to or against different parts of the user. As shown, strap assembly 310 is positioned around the user's head and coupled to a frame 350. A cushion 330 is attached to frame 350 and positioned between the user's face and frame 350. A connector 370 is coupled to frame 350.

[0151] 8 includes three sensors 402A, 402AB, and 402C that are positioned on or adjacent different areas of the strap assembly 310 and that contact different areas of the user. Sensor 402A is positioned adjacent the lower strap 316A, sensor 402B is positioned on the extension strip 360, and sensor 402C is positioned on the upper strap 314A.

[0152] In the illustrated implementation, the sensor 402A may be an SpO2 sensor that clips to the user's ear and is used to measure peripheral oxygen saturation. Clipping the SpO2 sensor to the user's ear rather than to another part of the user (such as a finger or toe) may result in more reliable peripheral oxygen saturation measurements. The sensor 402A is electrically connected to the connector 370 through the frame 350, a first electrical pathway 404A, a second electrical pathway 404B, and a third electrical pathway 404C. The first electrical pathway 404A is disposed within the frame 350 and may be a wire or an electrical trace. The first electrical pathway 404A extends to a strap attachment point on the frame 350 where the lower strap 316A is coupled to the frame 350. The second electrical pathway 404B extends through the lower strap 316A itself and may be a wire or an electrical trace positioned within or on the lower strap 316A. The first electrical pathway 404A and the second electrical pathway 404B may be electrically coupled using magnets disposed in the frame 350 and the lower strap 316A, as shown in FIG. 7. The third electrical pathway 404A extends from the lower strap 316A to the sensor 402A, which is attached to the user's ear. The third electrical pathway 404A is therefore generally formed as a wire. Thus, data generated by the sensor 402A may be transmitted via the lower strap 316A, the frame 350, and the connector 370.

[0153] In other implementations, the sensor 402A may be positioned adjacent to the user's neck or throat. In these implementations, the second electrical pathway 404B may extend downward from the lower strap 316A to the sensor 402A.

[0154] In the illustrated implementation, sensor 402B is a contact sensor (such as an EEG sensor) that rests against the user's forehead when user interface 300 is worn by the user. Sensor 402B may measure brain activity in the frontal lobe, which may be useful for determining the user's stage of sleep and for detecting wakefulness and micro-arousals during the user's sleep session. Sensor 402B is electrically connected to connector 370 through frame 350 and via electrical pathway 406. Electrical pathway 406 extends generally from frame 350 to extension strip 360 and may be a wire or electrical trace. Generally, sensor 402B is positioned outside extension strip 360 between extension strip 360 and the user's forehead. Sensor 402B may be electrically connected to electrical pathway 404 on the back surface of extension strip 360, or electrical pathway 404 may protrude slightly from the back surface (e.g., as a wire) to electrically connect to sensor 402B. Thus, data generated by sensor 402B can be transmitted through extension strip 360, frame 350, and connector 370.

[0155] In the illustrated implementation, the sensor 402C is a contact sensor (such as an EOG sensor) that contacts the user's temple when the user interface 300 is worn by the user. The sensor 402C is electrically connected to the connector 370 through the frame 350, a first electrical pathway 408A, and a second electrical pathway 408B. The first electrical pathway 408A may generally be the same as or similar to the electrical pathway 406 and thus extends from the frame 350 to the extension strip 360. However, the first electrical pathway 408A is connected to the second electrical pathway 408B, which extends through the upper strap 314A. In some implementations, the transition between the first and second electrical pathways 408B may utilize a magnet, as shown in FIG. 8 . In other implementations, the upper strap 314A is looped through an opening in the extension strip 360, and a magnet is not used. In these implementations, the first electrical pathway 408A may terminate in a wire that extends from the extension strip 360 toward the top strap 314A. The wire then extends into the top strap 314A, thus beginning the second electrical pathway 408B.

[0156] The second electrical pathway 408B extends toward the user's temple, where it electrically connects with sensor 402C. Similar to sensor 402B, sensor 402C may be positioned between the user's temple and the upper strap 316A. Sensor 402C may be electrically connected to the second electrical pathway 408B on the underside of the upper strap 316A, or the second electrical pathway 408B may protrude slightly from the underside (e.g., as a wire) to electrically connect with sensor 402C. Thus, data generated by sensor 402C may be transmitted via the upper strap 316A, extension strip 360, frame 350, and connector 370.

[0157] System 100 may also include a sensor configured to determine whether the user is sleeping on their back or side. In some implementations, the sensor may be located on user interface 124 or conduit 126 that measures the relative airflow between different sides of conduit 126. If the user is sleeping on their side, one of the sensors measures less airflow than the other, allowing system 100 to determine which side the user is sleeping on. If the air between the sensors is generally equal, system 100 may determine that the user is sleeping on their back. This information may be used in some examples to provide an estimate of mask integrity or wear.

[0158] In some implementations, existing electrical wires that may be internal to a conduit may be used in the user interface 300. For example, a conduit may include two wires coupled to a thermistor that may be used as a temperature sensor. To transmit data from one or more sensors 390, the thermistor may be removed and these two wires may be electrically connected to a connector. In another example, the thermistor is retained, but the connector is configured to bypass the thermistor and electrically connect to the two wires. In yet another example, a conduit may include wires used to heat air flowing through the conduit. These wires may instead be used as a voltage source (e.g., by installing a voltage regulator component such as a Zener diode) to power one or more sensors 390 or any other sensors or components in the user interface 300 that require power to operate.

[0159] In some implementations, the airflow through the conduits and connectors 370 can be used to power one or more sensors 390 and any other components. In these implementations, a small generator can be located within the conduits or connectors 370, in the path of the compressed air flowing through the conduits and connectors 370. The air flowing through the generator can be used to generate some or all of the required electrical power. In some of these implementations, the generator includes a turbine that rotates as air flows through the conduits and connectors 370, thereby generating electrical power. Other implementations can include a thermoelectric generator that converts heat flux into electricity. The generator can include nanomaterials.

[0160] The one or more sensors 390 (which may generally include one or more sensors 130 or other sensors) may be used for a variety of different purposes. In one implementation, the one or more sensors 390 are used to detect mouth leakage (e.g., pressurized air becoming noisy and exiting the mouth without entering the user's throat, trachea, or lungs). In this implementation, sensors located on the cushion 330 and / or frame 350 may be used to detect air leaking from the user's mouth. These sensors may include a pressure sensor (such as pressure sensor 132), a flow sensor (such as flow sensor 134), a CO2 sensor, an O2 sensor, an acoustic sensor, a microphone, or any other combination of sensors.

[0161] Typically, many respiratory treatment devices that can be used to provide respiratory treatment to a user during a sleep session include their own sensors for measuring various parameters. However, the user interface 300 can be used in conjunction with respiratory treatment devices that do not include separate sensors. In these implementations, the respiratory treatment device includes a housing defining an inlet and an outlet, and has a blower motor within the housing in fluid communication with the inlet and the outlet. The respiratory treatment device also includes a control system including one or more processors that execute machine-readable instructions stored in a memory device to cause the blower motor to discharge pressurized air through the outlet. However, the respiratory treatment device does not include its own sensors, as any necessary sensors can be located in the user interface 300.

[0162] For example, pressure and flow sensors are often used in respiratory treatment devices to monitor the operation of a blower motor and the volume of air delivered to a user. User interface 300 may include pressure and flow sensors so that the respiratory treatment device does not need its own pressure and flow sensors. The pressure and flow sensors of user interface 300 may generate data related to the respiratory treatment device and / or a user of the respiratory treatment device, which data may be transmitted via user interface 300 and conduits fluidly connecting user interface 300 and the respiratory treatment device. A control system of the respiratory treatment device may use data from the pressure and flow sensors to operate the blower motor.

[0163] In general, any of the above techniques or features for electrically connecting components may be used in other locations on the user interface 300. For example, the strap assembly 310 may only have straps that couple to the frame 350 using magnets. In another example, the strap assembly 310 may only have straps that couple to the frame 350 by looping them through openings in the frame 350 and extension strips 360. In yet another example, the lower straps 316A, 316B may be looped through openings in the frame 350, while the upper straps 314A, 314B may couple to the extension strips 360 using magnets. In yet another example, the frame 350 may not have extension strips 360, so that the upper straps 314A, 314B may be coupled to the body 352 of the frame 350, closer to the lower straps 316A, 316B.

[0164] Furthermore, user interface 300 is not limited to the particular number or arrangement of electrical contacts on connector 370, frame 350, or strap assembly 310 as shown. User interface 300 may generally include any arrangement of electrical contacts and electrical paths through the various components to position one or more sensors 390 in desired locations while simultaneously electrically connecting each of the one or more sensors 390 to connector 370. For example, frame 350 and connector 370 may each include a single electrical contact for a single sensor, multiple sets of electrical contacts for a single sensor, more or less than four electrical contacts for any number of sensors, etc. Finally, any of one or more sensors 390 may be located in any suitable location on strap assembly 310 or other portion of user interface 300.

[0165] In other implementations, the various electrical pathways are not formed by wires or traces on or within various portions of the user interface 124 or conduit 126, but instead are wireless or inductive electrical pathways. Wireless electrical pathways may use energy harvesting and wireless communication. Inductive electrical pathways may utilize magnetic and / or electric fields.

[0166] In some implementations, the strap assembly 310 comprises hollow tubes that extend around the face of the user 210. The hollow tubes may generally have all the same characteristics as the upper and lower straps 314A, 314B, 316A, 316B, except that they are hollow along their entire length. Any wires or sensors may then be positioned within the hollow tubes that make up the strap assembly 310.

[0167] 9A and 9B show perspective and exploded views, respectively, of a user interface 500 that may include a variety of different sensors according to embodiments of the present disclosure. The user interface 500 includes a strap assembly 510, a cushion 530, a frame 550, and a connector 570. The strap assembly 510 may be coupled to the frame 550, and when a user wears the user interface 500, the strap assembly 510 may be positioned generally around the back of the user's head such that the user's head is positioned between the strap assembly 510 and the frame 550. The cushion 530 may be attached to a lower end of the frame 550 such that when the user wears the user interface 500, the cushion 530 is positioned near the user's face, such that the cushion 530 forms a seal with the user's face. The connector 570 is configured to be inserted into an opening in the frame 550, thereby coupling the connector 570 to the frame 550. The conduit 126 of the respiratory treatment system 120 may be coupled to the other end of the connector 570, thereby connecting the respiratory treatment system 120 to the user interface 500. In other implementations, connector 570 may be optional, and frame 550 may instead connect directly to the conduits of a respiratory treatment system.

[0168] User interface 500 is configured to deliver pressurized air from conduit 126 of respiratory treatment system 120 through cushion 530 and frame 550 to a user, or more specifically, to a volume of space enclosed by cushion 530 around the user's mouth and / or nose. In the illustrated implementation, user interface 500 includes hollow portions 552A and 552B to provide two passageways for pressurized air that fluidly connect cushion 530 to connector 570. In this manner, cushion 530 is in fluid communication with the interior of connector 570. When a user wears user interface 500, hollow portions 552A and 552B are generally positioned on either side of the user's head / face. In other implementations, user interface 500 may include only one of hollow portions 552A and 552B to provide a single passageway for pressurized air, with the other portion being a solid portion that does not form a passageway for pressurized air. In yet other implementations, both portions 552A and 552B may be solid, and frame 550 may be one or more tubes (or other hollow portions) that form one or more passageways for pressurized air between connector 570 and the user's mouth and / or nose. Thus, in the implementation of Figures 9A and 9B, conduit 126 of respiratory treatment system 120 is attached to the frame of the user interface generally at the top of the user's head, instead of in front of the user's face.

[0169] User interface 500, like user interface 500, may include a variety of different electrical pathways. For example, connector 570 may be similar to connector 370 and may include electrical contacts at an end of connector 370 configured to mate with conduit 126 of respiratory treatment system 120. Connector 570 may also include annular electrical contacts at an opposite end of connector 370 configured to mate with frame 550. Frame 550, in turn, may be similar to frame 350 and may include electrical contacts near the end of frame 550 that mate with connector 570. Thus, the electrical contacts of frame 550 and connector 570 allow an electrical connection to be made between conduit 126 of respiratory treatment system 120 and frame 550. An electrical pathway may then be formed from frame 550 to the target area for the sensor via any desired route. For example, wires or traces may extend from frame 550 to the user's face, from frame 550 through strap assembly 510 to the user's face, from frame 550 through cushion 530 to the user's face, from frame 550 through strap assembly 510 and cushion 530 to the user's face, or from frame 550 through cushion 530 and strap assembly 510 to the user's face. In this manner, frame 550 may be physically and electrically connected to strap assembly 510, and connector 570 may be physically and electrically connected to frame 550. Similar to user interface 300, sensors may generally be positioned at any target area on or around the user, and electrical connections may be made to the sensors using any of the components of user interface 500.

[0170] The one or more sensors 390 of user interface 300 or user interface 500 may include a variety of different sensors in different locations to accomplish a variety of different sensing tasks. In some implementations, the one or more sensors 390 include one or more EEG sensors that contact a portion of the user's head, which may include the user's forehead and / or scalp. The EEG sensors measure electrical activity associated with the user's brain (e.g., brain activity) and may be used for sleep stage detection and / or micro-sleep arousal detection. The EEG sensors may also be implemented in earbuds positioned in the user's ears, which may further be used to monitor sound and temperature. The one or more sensors 390 may include multiple EEG sensors that contact various different areas of the user's scalp, which may be used for quantitative EEG, also known as brain mapping.

[0171] In some implementations, the one or more sensors 390 include one or more ECG sensors configured to measure electrical activity (e.g., cardiac activity) of the user's heart. The ECG sensors may measure differences in electrical activity between various parts of the user, such as between different parts of the user's head, between the user's ears, between the tip of the user's chin and the user's ears, etc.

[0172] In some implementations, the one or more sensors 390 include one or more EOG sensors configured to measure the user's eye movements. The EOG sensors can thus be used to detect when the user is moving their eyes, which can in turn help determine when the user is in a REM sleep stage.

[0173] In some implementations, the one or more sensors 390 include one or more EMG sensors configured to measure electrical activity of the user's muscles. The EMG sensors may be placed near the user's facial muscles to detect facial movements. For example, an EMG sensor may be placed near the user's jaw to detect jaw movements, which may indicate that the user is grinding their teeth, also known as bruxism, during sleep. The jaw movements (and / or other muscle activity) detected by the EMG sensors may help determine whether the user is having a seizure.

[0174] In some implementations, the one or more sensors 390 include one or more microphones that can be used to detect breathing sounds (e.g., mouth or nose breathing), noise from the user interface (which may occur if the user interface moves during a sleep session, such as when the user moves), background noise, noise due to air leaks from the user interface, etc. The microphones can also be used to determine whether a detected air leak is intentional and is due to manipulation of a vent in the user interface, or whether a detected air leak is unintentional and is due to a poor seal between the user and the user interface. A breathing signal can be derived from the microphone data, which can indicate the quality of the user's breathing (e.g., normal, slow, fast, hoarse, wheezing, whistling, etc.). In some implementations, the microphones can be implemented as earphones positioned in or near the user's ears, which can also be used as EEG and temperature sensors.

[0175] In some implementations, the one or more sensors 390 include an SpO2 sensor configured to measure the user's peripheral oxygen saturation. The SpO2 sensor may be placed in various locations, including near the user's ear, nose, lips, and / or forehead. The SpO2 sensor may be a reflective or transmissive sensor and, in some implementations, may utilize green and / or red LEDs.

[0176] In some implementations, the one or more sensors 390 include one or more GSR sensors configured to measure electrical properties of the user's skin (also known as electrodermal activity, or EDA). The GSR sensors may be positioned on the user's face and may be useful in determining the user's emotions, performing lie detection, and performing sleep analysis.

[0177] In some implementations, the one or more sensors 390 include one or more motion sensors, which may include an accelerometer, a gyroscope, a magnetometer, an inertial measurement unit (IMU), or any combination thereof. Motion sensors may be used to measure activity (such as movement during a sleep session), a user's gait while walking, fall detection (e.g., if the user is elderly and at risk of falling out of bed or falling while walking), etc. Motion sensors may be used to measure a user's movement due to their breathing (e.g., the rise and fall of the user's chest while breathing), which may then be used to derive a respiration signal. The motion sensors may measure the speed of movement to determine respiration rate, may indicate obstructive sleep apnea, may detect labored movement of the user's chest while breathing, and may detect when the chest is not moving at all due to central sleep apnea, in which the user's brain does not signal breathing. The respiration signal may indicate the quality of the user's breathing (e.g., normal, slow, fast, hoarse, wheezing, whistling, etc.). In some implementations, the motion sensor can be used to determine whether there is movement of the user interface on the user's head, which may indicate that the user interface is not fitting properly. This determination can be based on data from a tension sensor, which can indicate tension in the straps of the user interface and whether the user interface is properly fastened to the user's head. In some implementations, the motion sensor can be used to determine the user's position in bed, which can help determine whether the user interface is fitting improperly and causing leaks or poor airflow.

[0178] In some implementations, the one or more sensors 390 include one or more analyte sensors that can be used to detect analytes in a user's breath, such as ketones. The analyte sensors can thus be used to perform breath sampling and analysis. The analyte sensors can also detect analytes in the air, and thus can be used to perform air quality analysis.

[0179] In some implementations, the one or more sensors 390 include one or more pressure sensors that can be used to determine the pressure of the pressurized air delivered to the user's airway. These pressure sensors can be located in the user interface closer to the user's mouth and / or nose than pressure sensors in the conduit 126 or in the respiratory treatment device 122, and therefore, in some implementations, can provide a more accurate measurement of the pressure of the pressurized air.

[0180] In some implementations, the one or more sensors 390 include one or more RF sensors, one or more sonar sensors, one or more flow sensors (which may be in addition to or instead of any flow sensors of the respiratory treatment system 120), one or more temperature sensors (which may be used to measure the user's core body temperature at the user's temple or the user's ear, or the temperature of the user interface), one or more heart rate sensors (which may be used to measure the user's heart rate at the user's temple), etc. The temperature sensor may be implemented as an earphone positioned in or near the user's ear and may also be used as an EEG sensor and microphone. The heart rate sensor may include a PPG sensor, an RF sensor, or even a motion sensor capable of detecting movement due to the user's heartbeat (such as movement of the user's chest or movement due to venous or arterial pulsations).

[0181] The one or more sensors may be used for a variety of different applications. In some implementations, the one or more sensors 390 may be used to perform a polysomnogram (PSG), which measures various bodily functions while a user sleeps. PSG may use EEG sensors to measure brain activity, ECG sensors to measure heart activity, EOG sensors to measure eye movement, EMG sensors to measure muscle activity, and other sensors. Because PSG is typically performed during a sleep study, aspects of the present disclosure enable PSG to be performed using a user interface already worn by the user during a sleep session. Because of the electrical pathways formed in the user interface already worn by the user, the sensors needed to perform PSG can be attached and / or positioned near the patient as needed through the user interface.

[0182] In some implementations, one or more sensors 390 may be used for emotion mapping. The one or more sensors 390 may detect a variety of different characteristics, including facial expressions and body position, that may be associated with a user's emotional state. The one or more sensors 390 may also be used to detect spontaneous emotions versus forced emotions. The user's heart rate and breathing rate detected by the one or more sensors 390 may also be used to determine the user's emotional state, which may indicate the user's stress level. Speech detected by the one or more sensors 390 may also be used to help determine the user's emotional state. Data from a galvanic skin response sensor may also help determine the user's emotional state.

[0183] Data from one or more sensors 390 may be used to examine conditions other than the sleep-related conditions that the user is treating using the respiratory treatment system 120. For example, data may be used to determine whether the user has an underlying condition such as atrial fibrillation, which may be evidenced by intermittent cardiac abnormalities, breathing abnormalities, etc. Data from one or more sensors 390 may also be used to determine the user's level of cognitive function, including checking for signs of early-onset Alzheimer's disease, dementia, and other cognitive abnormalities. Data from one or more sensors 390 may also be used to determine the user's level of sleepiness, which may be associated with conditions such as a cold or flu, or other chronic illnesses. In some implementations, data from one or more sensors 390 may be used to detect any discomfort or pain the user is experiencing and to determine potential causes of the pain / discomfort (e.g., a particular body or neck position may be painful for the user during a sleep session). In some implementations, one or more sensors 390 may be used to detect various features of the user's bedroom (or other room in which the user may be present during a sleep session). For example, sonar sensors may be used to identify and map physical features of a room. In some implementations, data from one or more sensors 390 is used to provide feedback to the user after the user's sleep session. The feedback may include providing the user with the data itself and / or analysis based on the data. By using one or more sensors 390 to detect and monitor these other conditions, user interface 300 and / or user interface 500 may provide a more efficient mechanism for detecting and monitoring other conditions for users suffering from these other conditions and / or for whom other therapies are required to treat these other conditions.

[0184] In some implementations, the user interface may include one or more actuators configured to perform a function based on data from one or more sensors 390. The actuators may be used to adjust the fit of the user interface to the user (e.g., by tightening or loosening a strap assembly or by repositioning the user interface against the user's face), wake the user during a sleep session, or perform other desired functions.

[0185] In some implementations, the user interface may include components for powering one or more sensors 390 separately from any power provided by the respiratory treatment system 120. The user interface may also include one or more communication interfaces (e.g., transmitters, receivers, transceivers, data ports, etc.) that allow data generated by the one or more sensors 390 to be transferred and stored independently of the respiratory treatment system 120. Thus, in some implementations, the user interface may form a suite of independent sensors capable of independently generating and transferring data.

[0186] One or more elements, aspects, or steps, or any portion thereof, from any one or more of claims 1 to 69 below may be combined with one or more elements, aspects, or steps, or any portion thereof, from any one or more other claims 1 to 69, or any combination thereof, to form one or more additional implementations and / or claims of the present disclosure.

[0187] While the present disclosure has been described with reference to one or more particular implementations or implementations, those skilled in the art will recognize that many modifications may be made without departing from the spirit and scope of the present disclosure. Each of these implementations and obvious variations thereof is considered to be within the spirit and scope of the present disclosure. It is also contemplated that additional implementations according to aspects of the present disclosure may combine any number of features from any of the implementations described herein.

Claims

1. 1. A user interface for a respiratory treatment system, comprising: a strap assembly configured to be positioned generally around at least a portion of a user's head when the user interface is worn by the user; a frame defining an opening and coupled to the strap assembly; a connector having a first portion and a second portion configured to be at least partially coupled within the opening in the frame such that the connector is physically and electrically connected to the frame; a cushion coupled to the frame such that the cushion is in fluid communication with an interior of the connector; one or more sensors coupled to the user interface, the one or more sensors including at least a first radio frequency (RF) sensor coupled to the cushion or the frame and a second RF sensor coupled to the connector; Equipped with data from the first RF sensor can be communicated via a first electrical path, at least a portion of which is wireless or inductive, between the first RF sensor and the second RF sensor, and via a second electrical path between the second RF sensor and a control system and memory of the respiratory treatment system; User interface.

2. The user interface of claim 1 , wherein the first RF sensor is electrically connected to the frame such that data from the first RF sensor can be transmitted over the first electrical path through the frame.

3. 3. The user interface of claim 1 or claim 2, wherein the respiratory treatment system includes a respiratory treatment device, a conduit configured to be fluidly connected to the respiratory treatment device and the user interface, and the user interface, and the second portion of the connector is configured to be physically and electrically coupled to the conduit such that the connector is fluidly connected to the conduit.

4. 4. The user interface of claim 3, wherein the second electrical pathway includes the conduit, and the control system is configured to alter operation of the respiratory treatment device based at least in part on data from the first RF sensor.

5. 5. The user interface of claim 1, wherein the frame includes a body defining a first surface and an opposing second surface, and an annular protrusion formed around a periphery of the opening on the first surface and extending in a direction away from the first surface, such that the opening is further defined by an annular protrusion.

6. The user interface of claim 5 , wherein the connector includes one or more electrical contacts.

7. The user interface of claim 6 , wherein each of the one or more electrical contacts of the connector is an at least partially annular electrical contact.

8. 8. The user interface of claim 6 or claim 7, wherein the first RF sensor is electrically connected to at least one of the one or more electrical contacts of the connector, thereby electrically connecting the second RF sensor to the connector such that data from the first RF sensor can be transmitted via the electrical contacts of the connector.

9. A user interface according to claim 6 or claim 7, wherein the frame includes one or more electrical contacts.

10. The user interface of claim 9 , wherein each of the one or more electrical contacts of the frame is an at least partially annular electrical contact.

11. 11. A user interface as described in claim 9 or claim 10, wherein each of the one or more electrical contacts of the connector electrically connects the frame to the connector by contacting a corresponding one of the one or more electrical contacts of the frame when the connector is coupled to the frame, so that data from the first RF sensor can be transmitted via the electrical contacts of the frame.

12. 12. The user interface of claim 11, wherein the first RF sensor is electrically connected to at least one of the one or more electrical contacts of the frame such that data from the first RF sensor can be transmitted via the one or more electrical contacts of the frame and the one or more electrical contacts of the connector.

13. The user interface of claim 11 or claim 12, wherein the strap assembly includes a plurality of straps, and the user interface further includes an additional sensor coupled to at least one of the plurality of straps.

14. 14. The user interface of claim 13, wherein the frame includes a strap attachment point configured to couple to an end of one of the plurality of straps, the strap attachment point including one or more electrical contacts electrically connected to the one or more electrical contacts of the frame.

15. the additional sensor is electrically connected to the one or more electrical contacts of the strap attachment point such that data generated by the additional sensor can be transmitted via the one or more electrical contacts of the strap attachment point, the one or more electrical contacts of the frame, and the one or more electrical contacts of the connector; the one or more electrical contacts of the strap attachment points and the one or more electrical contacts of the frame are electrically connected by at least one wire connecting the one or more electrical contacts of the strap attachment points and the one or more annular contacts of the frame; at least one electrical trace formed on the second surface of the body of the frame, connecting the one or more electrical contacts of the strap attachment points with the one or more electrical contacts of the frame; and at least one electrical trace formed within the body of the frame between the first surface and the second surface, connecting the one or more electrical contacts of the strap attachment points with the one or more electrical contacts of the frame. The user interface of claim 14.

16. the additional sensor is electrically connected to one or more electrical contacts formed on the end of the one of the plurality of straps and to one or more electrical contacts at the strap attachment points, such that data generated by the additional sensor can be transmitted via the one or more electrical contacts at the end of the one of the plurality of straps, the one or more electrical contacts at the strap attachment points, the one or more electrical contacts at the frame, and the one or more electrical contacts at the connector; or the strap attachment point includes a first magnet adjacent to the one or more electrical contacts of the strap attachment point, and the end of the one of the plurality of straps includes a second magnet adjacent to the one or more electrical contacts of the end of the one of the plurality of straps; when the end of the one of the plurality of straps is coupled to the frame, the first magnet magnetically attracts and contacts the second magnet, thereby securing the one or more electrical contacts of the strap attachment point in physical contact with the one or more electrical contacts of the end of the one of the plurality of straps; or the strap assembly forms an electrical pathway having a first end positioned at the one or more electrical contacts of the end of the one of the plurality of straps and a second end positioned at a portion of the strap assembly adjacent a target area of ​​the user; the additional sensor is positioned adjacent to the target area of ​​the user and electrically connected to the second end of the electrical pathway of the strap assembly such that data generated by the additional sensor can be transmitted via the second end of the electrical pathway of the strap assembly, the one or more electrical contacts of the end of the one of the plurality of straps, the one or more electrical contacts of the strap attachment point, the one or more electrical contacts of the frame, and the one or more electrical contacts of the connector. The user interface of claim 14.

17. 17. The user interface of claim 1, wherein the strap assembly includes a rear portion configured to be positioned behind the user's head when the user interface is worn by the user, and a plurality of straps configured to extend from the rear portion toward the front of the user's head when the user interface is worn by the user.

18. 18. The user interface of claim 17, wherein the frame is configured to fit over the user's mouth, over the user's nose, or over both the user's mouth and nose when the user wears the user interface, and the user interface includes an extension strip configured to extend from a top end of the frame to the user's forehead when the user wears the user interface.

19. the one or more sensors include an additional sensor configured to contact the forehead of the user when the user interface is worn by the user, the temple of the user when the user interface is worn by the user, or the throat of the user when the user interface is worn by the user; the additional sensor is electrically connected to the connector through the extension strip and the frame such that data generated by the additional sensor can be transmitted via the extension strip, the frame, and the connector.

20. The user interface of claim 18.

20. 20. The user interface of claim 1, wherein the one or more sensors include an additional sensor coupled to the strap assembly, the cushion, or the frame, and wherein data generated by the additional sensor coupled to the strap assembly, the cushion, or the frame is transmitted to the at least one sensor coupled to the connector via an electrical path between the additional sensor and the connector.

21. A user interface described in any one of claims 1 to 20, wherein the first electrical path between the first RF sensor and the second RF sensor includes one or more wires electrically connected to the first RF sensor and extending within the frame toward the second RF sensor.

22. 22. The user interface of claim 21, wherein the first electrical pathway between the first RF sensor and the second RF sensor includes a first electrical connection between the first RF sensor and the frame formed by one or more wires, and a second electrical connection between the frame and the second RF sensor that does not include wires.

23. the frame includes a first hollow portion and a second hollow portion, each of which is coupled to the cushion and the connector and extends from the connector toward the opening in the frame, the first hollow portion and the second hollow portion being separated from each other to form two different passages that fluidly connect the cushion to the connector; 23. The user interface of claim 22, wherein the one or more wires of the first electrical path include: (i) at least one wire extending through or along the first hollow portion from the first RF sensor to the second RF sensor; (ii) at least one wire extending through or along the second hollow portion from the first RF sensor to the second RF sensor; or (iii) both (i) and (ii).

24. A user interface as described in any one of claims 1 to 23, wherein a first electrical path between the first RF sensor and the second RF sensor includes at least one wire extending from the first RF sensor at least partially through the frame.

25. A user interface described in any one of claims 1 to 24, wherein both the first RF sensor and the second RF sensor are non-contact sensors.

26. A user interface described in any one of claims 1 to 25, wherein the first RF sensor is an RF transmitter or an RF receiver.

27. ​​A user interface described in any one of claims 1 to 26, wherein the second RF sensor is an RF transmitter or an RF receiver.

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