User interface with integrated sensor

Abstract

A user interface of a respiratory therapy system includes a strap assembly, a frame, a connector, and a sensor. The strap assembly is positioned around a head of a user when the user interface is worn by the user. The frame is physically and electrically connected to the strap assembly and defines an aperture. The connector has a first end and a second end. The first end of the connector can be positioned within the aperture 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 region of the user when the user interface is worn by the user.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 001,273, filed on March 28, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to systems and methods for analyzing data related to users of a respiratory therapy system, and more specifically, to systems and methods for positioning sensors in a user interface worn by the user during use of the respiratory therapy system. Background Technology

[0004] Many individuals suffer from sleep-related disorders such as insomnia (e.g., difficulty falling asleep, frequent or prolonged awakenings after initial sleep onset, and early awakenings that prevent sleep recovery), periodic limb movement disorder (PLMD), obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity, hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMDA), hypertension, diabetes, stroke, etc. If some data about these sleep-related disorders is received and analyzed, many of these disorders can be treated or managed more effectively. However, utilizing sensors in a way that captures the desired data without interrupting the user's sleep or treatment can be challenging. Therefore, it would be advantageous to position sensors within a user interface worn by the user during sleep and treatment. This disclosure aims to address these and other issues. Summary of the Invention

[0005] According to some implementations of this disclosure, a user interface for a respiratory therapy system includes a strap assembly configured to be positioned approximately around at least a portion of a user's head when the user wears the user interface; a frame physically and electrically connected to the strap assembly, the frame defining an aperture; a connector having a first portion and a second portion, the first portion being configured to be at least partially positioned within the aperture 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 when the user wears the user interface, the sensor is adjacent to a target area of ​​the user.

[0006] According to some implementations of this disclosure, a respiratory therapy device includes a housing defining an inlet and an outlet; a blower motor located within the housing and in fluid communication with the inlet and the outlet; a storage 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 expel pressurized air from the outlet, wherein the respiratory therapy device does not include a pressure sensor located within the housing, and wherein the respiratory therapy device does not include a flow sensor located within the housing.

[0007] According to some implementations of this disclosure, a user interface for a respiratory therapy system includes a strap assembly configured to be positioned approximately around at least a portion of a user's head when the user wears the user interface; a frame physically and electrically connected to the strap assembly, the frame defining an aperture; a pad coupled to the frame and positioned between the frame and the strap assembly; a connector having a first portion and a second portion, the first portion being configured to be at least partially positioned within the aperture 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 user's pad area.

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

[0009] Figure 1 This is a functional block diagram of a respiratory therapy system based on some implementations of this disclosure;

[0010] Figure 2 This is based on some implementation methods of this disclosure. Figure 1 A perspective view of the respiratory therapy system, the user of the respiratory therapy system, and the user's bed partner;

[0011] Figure 3 The illustration shows an exemplary timeline of sleep periods according to some implementations of this disclosure;

[0012] Figure 4 The diagram illustrates some implementations of this disclosure. Figure 3 An exemplary sleep graph associated with sleep periods;

[0013] Figure 5A This is based on some implementation methods of this disclosure. Figure 1 A perspective view of the first implementation of the user interface of the respiratory therapy system;

[0014] Figure 5B This is based on some implementation methods of this disclosure. Figure 5AA perspective breakdown of the user interface;

[0015] Figure 6A The electrical contacts of the connector according to some implementations of this disclosure are... Figure 5A The user interface framework is aligned with the perspective;

[0016] Figure 6B This is based on some implementation methods of this disclosure. Figure 5A A magnified view of the electrical contacts within the framework of the user interface;

[0017] Figure 6C According to some implementations of this disclosure, before inserting the connector into the frame, the connector is in contact with... Figure 5A A cross-sectional view of the electrical connections between the frames of the user interface;

[0018] Figure 6D According to some implementations of this disclosure, after the connector is inserted into the frame, the connector and... Figure 5A A cross-sectional view of the electrical connections between the frames of the user interface;

[0019] Figure 7 This is based on some implementation methods of this disclosure. Figure 5A A perspective view of the electrical connection between the user interface framework and the strap; and

[0020] Figure 8 Wearing is based on some implementation methods of this disclosure. Figure 5A The user's perspective of the user interface.

[0021] Figure 9A This is based on some implementation methods of this disclosure. Figure 1 A perspective view of the second implementation of the user interface of the respiratory therapy system.

[0022] Figure 9B This is based on some implementation methods of this disclosure. Figure 9A A breakdown diagram of the user interface.

[0023] While this disclosure allows for various modifications and alternatives, specific implementations and embodiments thereof have been illustrated by way of example in the accompanying drawings and will be described in detail herein. However, it should be understood that this is not intended to limit this disclosure to the specific forms disclosed, but rather, this disclosure will cover all modifications, equivalents, and substitutions falling within the spirit and scope of this disclosure as defined by the appended claims. Detailed Implementation

[0024] Many individuals suffer from sleep-related and / or breathing-related disorders. Examples of sleep-related and / or breathing-related disorders include periodic limb movement disorder (PLMD), restless lower extremities syndrome (RLS), sleep-disordered breathing (SDB), obstructive sleep apnea (OSA), central sleep apnea (CSA), other types of apnea, Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity-related hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), chest wall disorders, and rapid eye movement (REM) behavioral disorder, also known as RBD.

[0025] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events of obstruction or blockage of the upper airway during sleep, resulting from a combination of abnormally small upper airway and loss of normal muscle tone in the areas of the tongue, soft palate and posterior oropharyngeal wall.

[0026] Central sleep apnea (CSA) is another form of sleep apnea-drowsiness (SDB) that occurs when the brain temporarily stops sending signals to the muscles that control breathing. More generally, apnea refers to the cessation of breathing caused by air obstruction or cessation of breathing function. Typically, during an obstructive sleep apnea event, an individual will stop breathing for about 15 to 30 seconds. Mixed sleep apnea is another form of SDB, which is a combination of obstructive sleep apnea (OSA) and CSA.

[0027] Other types of apnea include hypoventilation, hyperventilation, and hypercapnia. Hypoventilation is typically characterized by slow or shallow breathing caused by a narrowed airway, rather than airway obstruction. Hyperventilation is usually characterized by an increased depth and / or rate of breathing. Hypercapnia is typically characterized by an excess of carbon dioxide in the bloodstream and is usually caused by hypoventilation.

[0028] Cheyne-Stokes respiration (CSR) is another form of SDB disorder. CSR is a dysregulation of the patient's respiratory controller, in which there is a rhythmic alternation of waxing and waning ventilation known as the CSR cycle. CSR is characterized by repetitive hypoxia and reoxygenation of arterial blood.

[0029] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness, without other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0030] Chronic obstructive pulmonary disease (COPD) includes any of the lower airway diseases that share certain common characteristics, such as increased resistance to air movement, prolonged expiratory phase of breathing, and loss of normal lung elasticity.

[0031] Neuromuscular diseases (NMDs) encompass a wide range of conditions and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. The chest wall is a group of thoracic deformities that result in inefficient connection between the respiratory muscles and the thorax.

[0032] These and other disorders are characterized by specific events that occur when an individual is sleeping (such as snoring, sleep apnea, insufficiency of breathing, restless legs, sleep disturbances, apnea, increased heart rate, difficulty breathing, asthma attacks, seizures, epileptic seizures, or any combination thereof).

[0033] The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea during sleep. An AHI is calculated by dividing the number of apnea and / or hypopnea events experienced by the user during a sleep period by the total number of hours of sleep in that period. An event can be, for example, an apnea lasting at least 10 seconds. An AHI less than 5 is considered normal. An AHI greater than or equal to 5 but less than 15 is considered an indicator of light sleep apnea. An AHI greater than or equal to 15 but less than 30 is considered an indicator of moderate sleep apnea. An AHI greater than or equal to 30 is considered an indicator of severe sleep apnea. In children, an AHI greater than 1 is considered abnormal. When the AHI is normal, or when the AHI is normal or mild, sleep apnea can be considered “controlled.” The AHI can also be used in conjunction with oxygen desaturation levels to indicate the severity of obstructive sleep apnea.

[0034] Various types of data can be used to monitor the health of individuals suffering from any of the aforementioned types of sleep-related and / or breathing disorders (or other disorders). However, it is often difficult to collect accurate data in a manner that does not interrupt or interfere with the user's sleep or any treatment the user may undergo during sleep. Therefore, it is advantageous to utilize treatment systems that include various sensors to generate and collect data without interfering with the user, the user's sleep, or the user's treatment.

[0035] refer to Figure 1 The diagram illustrates a system 100 according to some implementations of the present disclosure. System 100 is used to provide various sensors related to user use and other uses of the respiratory therapy system. System 100 includes a control system 110, a storage device 114, an electronic interface 119, one or more sensors 130, and one or more external devices 170. In some implementations, system 100 also includes a respiratory therapy system 120, which includes a respiratory therapy device 122.

[0036] The control system 110 includes one or more processors 112 (hereinafter referred to as processors 112). The control system 110 is typically used to control various components of the system 100 and / or analyze data acquired and / or generated by the components of the system 100. The processor 112 may be a general-purpose or special-purpose processor or a microprocessor. Although in Figure 1 A processor 112 is shown, but the control system 110 may include any suitable number of processors (e.g., one processor, two processors, five processors, ten processors, etc.), which may be located in a single housing or remotely to each other. The control system 110 (or any other control system) or a portion thereof, such as processor 112 (or any other processor or a portion thereof), may be used to perform one or more steps of any of the methods described herein and / or claimed. The control system 110 may be coupled to and / or located within a housing, for example, an external device 170, and / or within a housing of one or more sensors 130. The control system 110 may be centralized (within one such housing) or distributed (within two or more physically distinct such housings). In such implementations including two or more housings containing the control system 110, such housings may be located close to and / or far from each other.

[0037] Storage device 114 stores machine-readable instructions executable by processor 112 of control system 110. Storage device 114 can be any suitable computer-readable storage device or medium, such as, for example, random or serial access memory devices, hard disk drives, solid-state drives, flash memory devices, etc. Although Figure 1 A memory device 114 is shown, but system 100 may include any suitable number of memory devices 114 (e.g., one memory device, two memory devices, five memory devices, ten memory devices, etc.). Memory devices 114 may be coupled to and / or located within the housing of the respiratory therapy device 122 of the respiratory therapy system 120, within the housing of the external device 170, within the housing of one or more sensors 130, or any combination thereof. Similar to control system 110, storage devices 114 may be centralized (within one such housing) or distributed (within two or more physically different such housings).

[0038] In some implementations, memory device 114 ( Figure 1The system stores user profiles associated with each user. User profiles may include, for example, user-associated demographic information, user-associated biostatistics, user-associated medical information, self-reported user feedback, user-associated sleep parameters (e.g., sleep-related parameters recorded from one or more earlier sleep periods), or any combination thereof. Demographic information may include, for example, information indicating the user's age, gender, ethnicity, family medical history (such as a family history of insomnia or sleep apnea), employment status, education status, socioeconomic status, or any combination thereof. Medical information may include, for example, information indicating one or more medical conditions associated with the user, medication use, or both. Medical information data may also include Multisleep Latency Test (MSLT) results or scores and / or Pittsburgh Sleep Quality Index (PSQI) scores or values. Self-reported user feedback may include information indicating self-reported subjective sleep scores (e.g., poor, average, excellent), user's self-reported subjective stress levels, user's self-reported subjective fatigue levels, user's self-reported subjective health status, recent life events experienced by the user, or any combination thereof.

[0039] Electronic interface 119 is configured to receive data (e.g., physiological data and / or acoustic data) from one or more sensors 130, such that the data can be stored in storage device 114 and / or analyzed by processor 112 of control system 110. Electronic interface 119 can communicate with one or more sensors 130 using wired or wireless connections (e.g., using RF communication protocols, WiFi communication protocols, Bluetooth communication protocols, IR communication protocols, via cellular networks, via any other optical communication protocol, etc.). Electronic interface 119 may include an antenna, a receiver (e.g., an RF receiver), a transmitter (e.g., an RF transmitter), a transceiver, or any combination thereof. Electronic interface 119 may also include one or more processors and / or one or more storage devices that are the same as or similar to processor 112 and storage device 114 described herein. In some implementations, electronic interface 119 is coupled to or integrated into external device 170. In other implementations, the electronic interface 119 is coupled to or integrated with the control system 110 and / or the storage device 114 (e.g., in a housing).

[0040] As described above, in some implementations, system 100 may optionally include a respiratory therapy system 120 (also referred to as a respiratory therapy system). The respiratory therapy system 120 may include a respiratory therapy device 122 (also referred to as a respiratory pressure therapy device), a user interface 124, a catheter 126 (also referred to as a tube or air circuit), a display device 128, a humidifier 129, or any combination thereof. In some implementations, one or more of the control system 110, storage device 114, display device 128, sensor 130, and humidifier 129 are part of the respiratory therapy device 122. Respiratory pressure therapy refers to applying an air supply to the inlet of a user's airway at a controlled target pressure that is nominally positive relative to the atmosphere throughout the user's respiratory cycle (e.g., in contrast to negative pressure therapy such as a cannula ventilator or thoracic brace). The respiratory therapy system 120 is typically used to treat individuals with one or more sleep-related breathing disorders (such as obstructive sleep apnea, central sleep apnea, or mixed sleep apnea), other breathing disorders (such as COPD), or other disorders that cause respiratory insufficiency, which may occur during sleep or wakefulness.

[0041] The respiratory therapy device 122 is typically used to generate pressurized air to be delivered to a user (e.g., using one or more motors driving one or more compressors). In some implementations, the respiratory therapy device 122 generates a continuous, constant air pressure that is delivered to the user. In other implementations, the respiratory therapy device 122 generates two or more predetermined pressures (e.g., a first predetermined air pressure and a second predetermined air pressure). In still other implementations, the respiratory therapy device 122 is configured to generate a variety of different air pressures within a predetermined range. For example, the respiratory therapy device 122 may deliver at least about 6 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 therapy device 122 may also deliver pressurized air at predetermined flow rates, for example, between about -20 L / min and about 150 L / min, while maintaining positive pressure (relative to ambient pressure). In some implementations, the control system 110, memory device 114, electronic interface 119, or any combination thereof may be connected to and / or located within the housing of the respiratory therapy device 122.

[0042] User interface 124 engages with a portion of the user's face and delivers pressurized air from respiratory therapy device 122 to the user's airway to help prevent airway narrowing and / or collapse during sleep. This can also increase the user's oxygen intake during sleep. Depending on the treatment to be applied, user interface 124 may, for example, form a seal with an area or portion of the user's face to facilitate the delivery of gas at a pressure sufficiently varied relative to ambient pressure, such as a positive pressure of about 10 cmH2O relative to ambient pressure to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of about 10 cmH2O to the airway.

[0043] In some implementations, user interface 124 is or includes a mask that covers the user's nose and mouth (e.g., as shown in the image). Figure 2 (As shown). Alternatively, the user interface 124 may be a nasal mask that delivers air to the user's nose or a nasal pillow mask that delivers air directly to the user's nostrils. The user interface 124 may include a strap assembly and a conformal pad (e.g., silicone, plastic, foam, etc.), the strap assembly having multiple straps (e.g., including hook-and-loop fasteners) for positioning and / or stabilizing the user interface 124 at a desired location (e.g., face) of the user on a portion of the user interface 124, and the conformal pad facilitating an airtight seal between the user interface 124 and the user. The user interface 124 may also include one or more vents 125 for allowing the user's exhaled carbon dioxide and other gases to escape. In other implementations, the user interface 124 includes a mouthpiece (e.g., a night-time protective mouthpiece molded to conform to the user's teeth, a mandibular repositioning device (MRD), etc.).

[0044] The conduit 126 allows air to flow between two components of the respiratory therapy system 120, such as the respiratory therapy device 122 and the user interface 124. In some implementations, there may be separate branches of the conduit for inhalation and exhalation. In other implementations, a single branch conduit is used for both inhalation and exhalation. Typically, the respiratory therapy system 120 forms an air passage extending between the motor of the respiratory therapy device 122 and the user and / or the user's airway. Therefore, the air passage typically includes at least the motor of the respiratory therapy device 122, the user interface 124, and the conduit 126.

[0045] One or more of the respiratory therapy device 122, user interface 124, catheter 126, display device 128, and humidifier 129 may include one or more sensors (e.g., pressure sensors, flow sensors, or any other sensors 130 described more generally herein). These one or more sensors may be used, for example, to measure the air pressure and / or flow rate of the pressurized air supplied by the respiratory therapy device 122.

[0046] Display device 128 is typically used to display images including still images, video images, or both, and / or information about the respiratory therapy device 122. For example, display device 128 may provide information about the status of the respiratory therapy device 122 (e.g., whether the respiratory therapy device 122 is on / off, the pressure of the air delivered by the respiratory therapy device 122, the temperature of the air delivered by the respiratory therapy device 122, etc.) and / or other information (e.g., sleep score or treatment score (also known as myAir)). TM Scores, such as those described in WO2016 / 061629 (incorporated herein by reference in its entirety), current date / time, user's personal information, etc. In some implementations, the display device 128 acts as a human-machine interface (HMI) including a graphical user interface (GUI) configured to display images as input. The display device 128 may be an LED display, an OLED display, an LCD display, etc. The input interface may be, for example, a touchscreen or touch-sensitive substrate, a mouse, a keyboard, or any sensor system configured to sense input made by a human user interacting with the respiratory therapy device 122.

[0047] The humidification tank 129 is coupled to or integrated into the respiratory therapy device 122 and includes a water reservoir for humidifying pressurized air delivered from the respiratory therapy device 122. The respiratory therapy device 122 may include a heater to heat the water in the humidification tank 129 to humidify the pressurized air supplied to the user. Additionally, in some implementations, the conduit 126 may include a heating element (e.g., coupled to and / or embedded in the conduit 126) that heats the pressurized air delivered to the user. In other implementations, the respiratory therapy device 122 or the conduit 126 may include a waterless humidifier. This waterless humidifier may include sensors that interface with other sensors located elsewhere in the system 100.

[0048] The respiratory therapy system 120 can be used as, for example, a ventilator or a positive airway pressure (PAP) system, such as a continuous positive airway pressure (CPAP) system, an automated positive airway pressure (APAP) system, a bilevel or variable positive airway pressure (BPAP or VPAP) system, or any combination thereof. A CPAP system delivers a predetermined pressure (e.g., determined by a sleep physician) to the user. An APAP system automatically changes the pressure delivered to the user, at least in part, based on, for example, respiratory data associated with the user. A BPAP or VPAP system is configured to deliver a first predetermined pressure (e.g., inspiratory positive airway pressure or IPAP) and a second predetermined pressure below the first predetermined pressure (e.g., expiratory positive airway pressure or EPAP).

[0049] refer to Figure 2 The diagram illustrates system 100 according to some implementation methods. Figure 1As part of the respiratory therapy system 120, the user and bed partner 220 are located in bed 230 and lie on mattress 232. A user interface 124 (e.g., a full-face mask) can be worn by the user during sleep. The user interface 124 is fluidly connected and / or connected to the respiratory therapy device 122 via conduit 126. The respiratory therapy device 122, in turn, delivers pressurized air to the user via conduit 126 and user interface 124 to increase air pressure in the user's throat, thereby helping to prevent airway closure and / or narrowing during sleep. The respiratory therapy device 122 may include a display device 128 that allows the user to interact with the respiratory therapy device 122. The respiratory therapy device 122 may also include a humidification tank 129 that stores water for humidifying the pressurized air. The respiratory therapy device 122 may be positioned such as... Figure 2 The device is positioned on a bedside table 234 directly adjacent to the bed 230, or more generally, on any surface or structure typically adjacent to the bed 230 and / or the user 210. The user may also wear a blood pressure monitor 180 and an activity tracker 182 while lying on the mattress 232 within the bed 230.

[0050] Return to reference Figure 1 The system 100 includes one or more sensors 130, such as a pressure sensor 132, a flow sensor 134, a temperature sensor 136, a motion sensor 138, a microphone 140, a speaker 142, a radio frequency (RF) receiver 146, an RF transmitter 148, a camera 150, an infrared (IR) sensor 152, a photoplethysmography (PPG) sensor 154, an electrocardiogram (ECG) sensor 156, an electroencephalogram (EEG) sensor 158, a capacitance sensor 160, a force sensor 162, a strain gauge sensor 164, an electromyography (EMG) sensor 166, an oxygen sensor 168, an analyte sensor 174, a humidity sensor 176, a light detection and ranging (LiDAR) sensor 178, or any combination thereof. Typically, each of the one or more sensors 130 is configured to output sensor data received and stored in storage device 114 or one or more other storage devices. Sensor 130 may also include an electrooculogram (EOG) sensor, a peripheral oxygen saturation (SpO2) sensor, a skin conductance response (GSR) sensor, a carbon dioxide (CO2) sensor, or any combination thereof.

[0051] While one or more sensors 130 are shown and described as including each of the following: pressure sensor 132, flow sensor 134, temperature sensor 136, motion sensor 138, microphone 140, speaker 142, RF receiver 146, RF transmitter 148, camera 150, IR sensor 152, PPG sensor 154, ECG sensor 156, EEG sensor 158, capacitance sensor 160, force sensor 162, strain gauge sensor 164, EMG sensor 166, oxygen sensor 168, analyte sensor 174, humidity sensor 176, and LiDAR sensor 178, more generally, one or more sensors 130 may include any combination and any number of each of the sensors described and / or shown herein.

[0052] One or more sensors 130 can be used to generate, for example, data with a user of the respiratory therapy system 120 (such as...). Figure 2 The physiological data, acoustic data, or both, associated with the user, the respiratory therapy system 120, both the user and the respiratory therapy system 120, or other entities, objects, activities, etc., generated by one or more sensors 130 can be used by the control system 110 to determine sleep-wake signals associated with the user during sleep and one or more sleep-related parameters. Sleep-wake signals can indicate one or more sleep stages and / or sleep states, including sleep, wakefulness, relaxed wakefulness, micro-awakeness, or different sleep stages, including rapid eye movement (REM) stages (which may include typical REM stages and atypical REM stages), a first non-REM stage (commonly referred to as "N1"), a second non-REM stage (commonly referred to as "N2"), a third non-REM stage (commonly referred to as "N3"), or any combination thereof. For example, methods for determining sleep stages and / or sleep states based on physiological data generated by one or more sensors, such as sensor 130, are described in WO 2014 / 047310, US 2014 / 0088373, WO2017 / 132726, WO 2019 / 122413 and WO 2019 / 122414, the entire contents of which are incorporated herein by reference.

[0053] Sleep-wake signals can also be timestamped to indicate the time a user enters bed, the time a user leaves bed, the time a user attempts to fall asleep, etc. Sleep-wake signals can be measured on one or more sensors 130 during sleep at a predetermined sampling rate (e.g., one sample per second, one sample every 30 seconds, one sample per minute, etc.). Examples of one or more sleep-related parameters that can be determined for a user, at least in part, based on sleep-wake signals during sleep include total sleep onset time, total sleep time, total wake time, sleep onset latency, wake time after sleep onset parameter, sleep efficiency, fragmentation index, amount of sleep onset time, consistency of respiratory rate, sleep onset time, wake time, sleep disturbance rate, number of movements, or any combination thereof.

[0054] Physiological and / or acoustic data generated by one or more sensors 130 may also be used to determine breathing signals associated with the user during sleep. Breathing signals typically represent the user's breathing during sleep. Breathing signals may indicate, for example, respiratory rate, respiratory rate variability, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory amplitude ratio, inspiratory-expiratory duration ratio, number of events per hour, event pattern, pressure setting of the respiratory therapy device 122, or any combination thereof. Events may include snoring, sleep apnea, central sleep apnea, obstructive sleep apnea, mixed sleep apnea, hypopnea, mask leakage (e.g., from user interface 124), restless legs, sleep disturbance, apnea, increased heart rate, heart rate variability, satiety breathing, asthma attack, seizure, fever, cough, sneezing, snoring, wheezing, presence of illness such as the common cold or flu, elevated stress levels, etc.

[0055] Pressure sensor 132 outputs pressure data that can be stored in storage device 114 and / or analyzed by processor 112 of control system 110. In some implementations, pressure sensor 132 is an air pressure sensor (e.g., an atmospheric pressure sensor) that generates sensor data indicating the breathing (e.g., inhalation and / or exhalation) and / or ambient pressure of the user of respiratory therapy system 120. In such implementations, pressure sensor 132 can be coupled to or integrated into respiratory therapy device 122. Pressure sensor 132 can be, for example, a capacitive sensor, an 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 can be used to determine the user's blood pressure.

[0056] The flow sensor 134 outputs flow data that can be stored in storage device 114 and / or analyzed by processor 112 of control system 110. In some implementations, the flow sensor 134 is used to determine the airflow rate from respiratory therapy device 122, the airflow rate through conduit 126, the airflow rate through user interface 124, or any combination thereof. In such implementations, the flow sensor 134 may be coupled to or integrated into respiratory therapy device 122, user interface 124, or conduit 126. The flow sensor 134 may be a mass flow sensor, such as a rotary flow meter (e.g., a Hall effect flow meter), turbine flow meter, orifice flow meter, ultrasonic flow meter, hot wire sensor, eddy current sensor, membrane sensor, or any combination thereof.

[0057] Temperature sensor 136 outputs temperature data that can be stored in storage device 114 and / or analyzed by processor 112 of control system 110. In some implementations, temperature sensor 136 generates temperature data indicating the user's core body temperature, the user's skin temperature, the temperature of air flowing from respiratory therapy device 122 and / or flowing through conduit 126, the temperature in user interface 124, ambient temperature, or any combination thereof. Temperature sensor 136 can be, for example, a thermocouple sensor, a thermistor sensor, a silicon bandgap temperature sensor or a semiconductor-based sensor, a resistance temperature detector, or any combination thereof.

[0058] Motion sensor 138 outputs motion data that can be stored in storage device 114 and / or analyzed by processor 112 of control system 110. Motion sensor 138 can be used to detect user movement during sleep periods and / or the movement of any component of respiratory therapy system 120 (such as respiratory therapy device 122, user interface 124, or catheter 126). Motion sensor 138 may include one or more inertial sensors, such as accelerometers, gyroscopes, and magnetometers. Motion sensor 138 can be used to detect motion or acceleration associated with an arterial pulse, such as a pulse in or around the user's face and near user interface 124, and is configured to detect characteristics of pulse shape, velocity, amplitude, or volume.

[0059] The output of microphone 140 may be stored in memory device 114 and / or analyzed by processor 112 of control system 110. The acoustic data generated by microphone 140 can be reproduced as one or more sounds (e.g., sounds from the user) during a sleep period to determine (e.g., using control system 110) one or more sleep-related parameters, as further described herein. The acoustic data from microphone 140 can also be used to identify (e.g., using control system 110) events experienced by the user during a sleep period, as further described herein. In other implementations, the acoustic data from microphone 140 represents noise associated with respiratory therapy system 120. Microphone 140 can typically be coupled to or integrated into respiratory therapy system 120 (or system 100) in any configuration. For example, microphone 140 may be disposed within respiratory therapy device 122, user interface 124, catheter 126, or other components. Microphone 140 may also be positioned adjacent to or attached to the exterior of the respiratory therapy device 122, the user interface 124, the conduit 126, or any other component. Microphone 140 may also be a component of an external device 170 (e.g., microphone 140 is a microphone for a smartphone). Microphone 140 may be integrated into the user interface 124, the conduit 126, the respiratory therapy device 122, or any combination thereof. Typically, microphone 140 may be located anywhere within or near the air passage of the respiratory therapy system 120, which includes at least the motor of the respiratory therapy device 122, the user interface 124, and the conduit 126. Therefore, the air passage may also be referred to as the acoustic passage.

[0060] Speaker 142 outputs sound waves that are audible to the user. Speaker 142 can be used as, for example, an alarm clock or to play alarms or messages to the user (e.g., in response to an event). In some implementations, speaker 142 can be used to send acoustic data generated by microphone 140 to the user. Speaker 142 can be coupled to or integrated into respiratory therapy device 122, user interface 124, catheter 126, or external device 170.

[0061] Microphone 140 and speaker 142 can be used as separate devices. In some implementations, microphone 140 and speaker 142 can be combined into acoustic sensor 141 (e.g., a SONAR sensor), as described in, for example, WO 2018 / 050913 and WO2020 / 104465, each of which is incorporated herein by reference in its entirety. In such implementations, speaker 142 generates or transmits sound waves at predetermined intervals and / or frequencies, and microphone 140 detects reflections of the transmitted sound waves from speaker 142. The sound waves generated or emitted by speaker 142 have frequencies inaudible to the human ear (e.g., below 20 Hz or above approximately 18 kHz) so as not to disturb the user or the user's bed partner (such as...). Figure 2 The sleep of the bed partner (220) is monitored. Based at least in part on data from microphone 140 and / or speaker 142, control system 110 can determine the user's position and / or one or more of the sleep-related parameters described herein, such as respiratory signal, respiratory rate, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory ratio, number of events per hour, pattern of events, sleep stage, pressure setting of respiratory therapy device 122, or any combination thereof. In this document, SONAR sensor can be understood to involve active acoustic sensing, such as by generating / transmitting ultrasound or low-frequency ultrasound sensing signals (e.g., in the frequency range of approximately 17-23 kHz, 18-22 kHz, or 17-18 kHz) through the air. Such systems can be considered relative to WO 2018 / 050913 and WO 2020 / 104465 described above. In some implementations, speaker 142 is a bone conduction speaker. In some implementations, one or more sensors 130 include (i) a first microphone that is the same as or similar to microphone 140 and is integrated into acoustic sensor 141; and (ii) a second microphone that is the same as or similar to microphone 140 but is different from the first microphone integrated into acoustic sensor 141.

[0062] RF transmitter 148 generates and / or transmits radio waves having a predetermined frequency and / or predetermined amplitude (e.g., in the high-frequency band, in the low-frequency band, long-wave signal, short-wave signal, etc.). RF receiver 146 detects the reflection of the radio waves transmitted from RF transmitter 148, and this data can be analyzed by control system 110 to determine one or more of the user's location and / or the sleep-related parameters described herein. RF receivers (RF receiver 146 and RF transmitter 148 or another RF pair) can also be used for wireless communication between control system 110, respiratory therapy device 122, one or more sensors 130, external device 170, or any combination thereof. Although RF receiver 146 and RF transmitter 148 are in... Figure 1While shown as separate and distinct components, in some implementations, the RF receiver 146 and RF transmitter 148 are combined as part of the RF sensor 147 (e.g., a RADAR sensor). In some such implementations, the RF sensor 147 includes control circuitry. The specific format of the RF communication may be WiFi, Bluetooth, etc.

[0063] In some implementations, the RF sensor 147 is part of a mesh system. An example of a mesh system is a Wi-Fi mesh system, which may include mesh nodes, one or more mesh routers, and one or more mesh gateways, each of which may be mobile / movable or fixed. In such an implementation, the Wi-Fi mesh system includes Wi-Fi routers and / or Wi-Fi controllers, and one or more satellites (e.g., access points), each satellite including the same or similar RF sensor as the RF sensor 147. The Wi-Fi routers and satellites communicate continuously with each other using Wi-Fi signals. The Wi-Fi mesh system can be used to generate motion data, at least in part, based on variations in the Wi-Fi signals between the routers and satellites (e.g., differences in received signal strength), caused by a moving object or person partially blocking the signal. The motion data may indicate movement, breathing, heart rate, gait, falls, behavior, etc., or any combination thereof.

[0064] Camera 150 outputs image data that can be reproduced as one or more images (e.g., still images, video images, thermal images, or combinations thereof) that can be stored in storage device 114. The image data from camera 150 can be used by control system 110 to determine one or more of the sleep-related parameters described herein. For example, image data from camera 150 can be used to identify the user's location, determine when the user enters the user's bed (such as...). Figure 2 The camera 150 can also be used to track the time the user spends in bed 230, and to determine when the user leaves bed 230. The camera 150 can also be used to track eye movements, pupil dilation (if one or both of the user's eyes are open), blink rate, or any changes during REM sleep. The camera 150 can also be used to track the user's position, which can affect the duration and / or severity of apnea events in users with obstructive sleep apnea.

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

[0066] The output of IR sensor 152 is reproducible as one or more infrared images (e.g., still images, video images, or both) that can be stored in memory device 114. The infrared data from IR sensor 152 can be used to determine one or more sleep-related parameters during a sleep period, including the user's temperature and / or the user's movement. IR sensor 152 can also be used in conjunction with camera 150 when measuring the user's presence, location, and / or movement. For example, IR sensor 152 can detect infrared light with wavelengths between about 700 nm and about 1 mm, while camera 150 can detect visible light with wavelengths between about 380 nm and about 740 nm.

[0067] The PPG sensor 154 outputs physiological data associated with the user, which can be used to determine one or more sleep-related parameters, such as heart rate, heart rate pattern, heart rate variability, cardiac cycle, respiratory rate, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory ratio, estimated blood pressure parameters, or any combination thereof. The PPG sensor 154 can be worn by the user, embedded in clothing and / or fabric worn by the user, embedded in and / or connected to the user interface 124 and / or its associated head-mounted device (e.g., a strap, etc.).

[0068] ECG sensor 156 outputs physiological data associated with the electrical activity of the user's heart. In some implementations, ECG sensor 156 includes one or more electrodes located on or around a portion of the user during sleep. The physiological data from ECG sensor 156 can be used, for example, to determine one or more of the sleep-related parameters described herein.

[0069] ECG sensor 158 outputs physiological data associated with the electrical activity of the user's brain. In some implementations, ECG sensor 158 includes one or more electrodes positioned on or around the user's scalp during sleep periods. The physiological data from ECG sensor 158 can be used, for example, to determine the user's sleep stage and / or sleep state at any given time during sleep stages. In some implementations, ECG sensor 158 may be integrated into user interface 124 and / or an associated helmet (e.g., a strap, etc.).

[0070] The capacitive sensor 160, force sensor 162, and strain gauge sensor 164 output data that can be stored in storage device 114 and used by control system 110 to determine one or more of the sleep-related parameters described herein. The EMG sensor 166 outputs physiological data associated with electrical activity generated by one or more muscles. The oxygen sensor 168 outputs oxygen data indicating the oxygen concentration of a gas (e.g., in conduit 126 or at user interface 124). The oxygen sensor 168 can be, for example, an ultrasonic oxygen sensor, an electro-oxygen sensor, a chemical oxygen sensor, an optical oxygen sensor, or any combination thereof. In some implementations, one or more sensors 130 also include a skin conductance response (GSR) sensor, a blood flow sensor, a respiration sensor, a pulse sensor, a blood pressure sensor, a blood oxygenation sensor, or any combination thereof.

[0071] Analyte sensor 174 can be used to detect the presence of analytes in a user's exhaled breath. Data output by analyte sensor 174 can be stored in memory device 114 and used by control system 110 to determine the identity and concentration of any analyte in the user's breath. In some implementations, analyte sensor 174 is located near the user's mouth to detect analytes in the breath exhaled from the user's mouth. For example, when user interface 124 is a mask covering the user's nose and mouth, analyte sensor 174 can be located inside the mask to monitor the user's mouth breathing. In other implementations, such as when user interface 124 is a nasal mask or nasal pillow mask, analyte sensor 174 can be positioned near the user's nose to detect analytes in the breath exhaled through the user's nose. In other implementations, when user interface 124 is a nasal mask or nasal pillow mask, analyte sensor 174 can be located near the user's mouth. In this implementation, analyte sensor 174 can be used to detect any unintentional leakage of air from the user's mouth. In some implementations, the analyte sensor 174 is a volatile organic compound (VOC) sensor, which 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 the presence of an analyte is detected by data output from the analyte sensor 174 located near the user's mouth or inside a mask (in the implementation where the user interface 124 is a mask), the control system 110 can use that data as an indication that the user is breathing through their mouth.

[0072] The humidity sensor 176 outputs data that can be stored in the storage device 114 and used by the control system 110. The humidity sensor 176 can be used to detect humidity in various areas surrounding the user (e.g., within the conduit 126 or user interface 124, near the user's face, near the connection between the conduit 126 and user interface 124, near the connection between the conduit 126 and the respiratory therapy device 122, etc.). Therefore, in some implementations, the humidity sensor 176 can be coupled to or integrated into the user interface 124 or the conduit 126 to monitor the humidity of pressurized air from the respiratory therapy device 122. In other implementations, the humidity sensor 176 is placed near any area where the humidity level needs to be monitored. The humidity sensor 176 can also be used to monitor the humidity of the surrounding environment around the user, such as the air in the user's bedroom. The humidity sensor 176 can also be used to track the user's biometric response to environmental changes.

[0073] One or more LiDAR sensors 178 can be used for depth sensing. Optical sensors of this type (e.g., laser sensors) can be used to detect objects and construct a three-dimensional (3D) map of the surrounding environment (such as a living space). LiDAR typically utilizes pulsed lasers for time-of-flight measurements. LiDAR is also known as 3D laser scanning. In examples using such sensors, a fixed or mobile device (such as a smartphone) with LiDAR sensors 178 can measure and map an area extending 5 meters or more from the sensor. For example, LiDAR data can be fused with point cloud data estimated by an electromagnetic RADAR sensor. LiDAR sensors 178 can also use artificial intelligence (AI) to automatically geofence the RADAR system by detecting and classifying features in the space that may cause problems for the RADAR system, such as glass windows (which may be highly reflective of RADAR). For example, LiDAR can also be used to provide an estimate of a person's height, and how that height changes when the person sits down or falls. LiDAR can be used to form a 3D mesh representation of the environment. In further applications, LiDAR can reflect radio waves off solid surfaces (e.g., transmissive materials), allowing for the classification of different types of obstacles.

[0074] Although Figure 1 While shown separately, any combination of one or more sensors 130 may be integrated into and / or coupled to any one or more components of system 100, including respiratory therapy device 122, user interface 124, catheter 126, humidifier 129, control system 110, external device 170, 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 an implementation, external device 170 can be considered as an auxiliary device for generating additional or auxiliary data for use by system 100 (e.g., control system 110) according to some aspects of this disclosure. In some implementations, pressure sensor 132 and / or flow sensor 134 are integrated into and / or coupled to respiratory therapy device 122. In some implementations, at least one of the one or more sensors 130 is not coupled to the respiratory therapy device 122, the control system 110, or the external device 170, and is positioned substantially near the user during sleep periods (e.g., positioned on or in contact with a part of the user, worn by the user, coupled to or positioned on a bedside table, coupled to a mattress, coupled to a ceiling, etc.). More generally, the one or more sensors 130 may be located at any suitable position relative to the user, such that the one or more sensors 130 can generate physiological data associated with the user and / or bed partner 220 during one or more sleep periods.

[0075] Data from one or more sensors 130 can be analyzed to determine one or more sleep-related parameters, which may include respiratory signals, respiratory rate, respiratory pattern, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory ratio, occurrence of one or more events, number of events per hour, event pattern, average duration of events, range of event durations, ratio between different event numbers, sleep stage, apnea-hypopnea index (AHI), or any combination thereof. The one or more events may include snoring, apnea, central apnea, obstructive apnea, mixed apnea, hypopnea, intentional user interface leakage, unintentional user interface leakage, oral leakage, coughing, restless legs, sleep disturbance, apnea, increased heart rate, dyspnea, asthma attack, seizure, increased blood pressure, or any combination thereof. Many of these sleep-related parameters are physiological parameters, although some may be considered non-physiological parameters. Other types of physiological and non-physiological parameters may also be determined based on data from one or more sensors 130 or based on other types of data.

[0076] External device 170 includes display device 172. External device 170 may be, for example, a mobile device such as a smartphone, tablet, laptop, etc. Alternatively, external device 170 may be an external sensing system, a television (e.g., a smart TV), or another smart home device (e.g., a smart speaker such as Google Home, Amazon Echo, Alexa, etc.). In some implementations, external device 170 is a wearable device (e.g., a smartwatch). Display device 172 is typically used to display images including still images, video images, or both. In some implementations, display device 172 acts as a human-machine interface (HMI) including a graphical user interface (GUI) configured to display images and an input interface. Display device 172 may be an LED display, OLED display, LCD display, etc. The input interface may be, for example, a touchscreen or touch-sensitive substrate, a mouse, a keyboard, or any sensor system configured to sense input from a human user interacting with external device 170. In some implementations, one or more external devices 170 may be used by system 100 and / or included in system 100.

[0077] Blood pressure device 180 is typically used to help generate physiological data for determining one or more blood pressure measurements associated with a user. Blood pressure device 180 may include at least one of one or more sensors 130 to measure, for example, systolic blood pressure components and / or diastolic blood pressure components.

[0078] 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., pressure sensor 132 described herein). For example, as Figure 2 As shown in the example, the blood pressure device 180 can be worn on a user's upper arm. In this implementation where the blood pressure device 180 is a blood pressure monitor, the blood pressure device 180 also includes a pump (e.g., a manually operated light bulb) for inflating the cuff. In some implementations, the blood pressure device 180 is coupled to a respiratory therapy device 122 of a respiratory therapy system 120, which in turn delivers pressurized air to inflate the cuff. More generally, the blood pressure device 180 may be communicatively coupled to and / or physically integrated therein (e.g., within a housing) with a control system 110, a memory device 114, a respiratory therapy system 120, an external device 170, and / or an activity tracker 182.

[0079] Activity tracker 182 is typically used to help generate physiological data for determining activity measurements associated with a user. Activity measurements may include, for example, steps, distance traveled, number of steps climbed, duration of physical activity, type of physical activity, intensity of physical activity, time spent standing, respiratory rate, average respiratory rate, resting respiratory rate, maximum HE respiratory rate, respiratory rate variability, heart rate, average heart rate, resting heart rate, maximum heart rate, heart rate variability, calories burned, blood oxygen saturation, electrical skin activity (also known as skin conductance or skin response), or any combination thereof. Activity tracker 182 includes one or more of the sensors 130 described herein, such as, for example, motion sensor 138 (e.g., one or more accelerometers and / or gyroscopes), PPG sensor 154, and / or ECG sensor 156.

[0080] In some implementations, the activity tracker 182 is a wearable device that can be worn by a user, such as a smartwatch, wristband, ring, or patch. For example, see reference... Figure 2 The activity tracker 182 is worn on the user's wrist. The activity tracker 182 can also be attached to or integrated into the user's clothing or garments. Alternatively, the activity tracker 182 can also be attached to or integrated into an external device 170 (e.g., within the same housing). More generally, the activity tracker 182 can be communicatively attached to or physically integrated therein (e.g., within a housing) with or within a control system 110, a memory device 114, a respiratory therapy system 120, an external device 170, and / or a blood pressure device 180.

[0081] Although the control system 110 and the memory device 114 are in Figure 1While described and shown as separate and distinct components of system 100, in some implementations, control system 110 and / or memory device 114 are integrated into external device 170 and / or respiratory therapy device 122. Alternatively, in some implementations, control system 110 or a portion thereof (e.g., processor 112) may reside in the cloud (e.g., integrated into a server, integrated into an Internet of Things (IoT) device, connected to the cloud, subjected to edge cloud processing, etc.) or in one or more servers (e.g., remote server, local server, etc., or any combination thereof).

[0082] While system 100 is shown as including all of the aforementioned components, according to implementations of this disclosure, a system for analyzing data associated with user use of the respiratory therapy system 120 may include more or fewer components. For example, a first alternative system includes a control system 110, a storage device 114, and at least one of one or more sensors 130. As another example, a second alternative system includes a control system 110, a storage device 114, at least one of one or more sensors 130, and an external device 170. As yet another example, a third alternative system includes a control system 110, a storage device 114, a respiratory therapy system 120, at least one of one or more sensors 130, and an external device 170. As yet another example, a fourth alternative system includes a control system 110, a storage device 114, a respiratory therapy system 120, at least one of one or more sensors 130, an external device 170, and a blood pressure device 180 and / or an activity tracker 182. Therefore, various systems for analyzing data associated with user use of the respiratory therapy system 120 can be formed using any part of the components shown and described herein and / or in combination with one or more other components.

[0083] As used herein, sleep periods can be defined in several ways, at least in part, based on, for example, an initial start time and an end time. In some implementations, a sleep period is the duration of a user's sleep; that is, a sleep period has a start time and an end time, and during a sleep period, the user does not wake up until the end time. In other words, any period during which the user is awake is not included in a sleep period. According to this first definition of a sleep period, if a user wakes up and falls asleep multiple times in the same night, each sleep interval separated by the wake-up intervals is a sleep period.

[0084] Alternatively, in some implementations, the sleep period has a start time and an end time, and during the sleep period, the user can remain awake as long as the continuous duration of wakefulness is less than a wakefulness duration threshold, without the sleep period ending. The wakefulness duration threshold can be defined as a percentage of the sleep period. The wakefulness duration threshold can be, for example, approximately 20% of the sleep period, approximately 15% of the sleep period duration, approximately 10% of the sleep period duration, approximately 5% of the sleep period duration, approximately 2% of the sleep period duration, etc., or any other threshold percentage. In some implementations, the wakefulness duration threshold is defined as a fixed amount of time, such as approximately one hour, approximately thirty minutes, approximately fifteen minutes, approximately ten minutes, approximately five minutes, approximately two minutes, etc., or any other amount of time.

[0085] In some implementations, a sleep period is defined as the entire time between the time a user first goes to bed at night and the time the user last gets up the following morning. In other words, a sleep period can be defined as a time period that begins on the first date (e.g., Monday, January 6, 2020) when the user first goes to bed wanting to fall asleep (e.g., if the user does not intend to watch TV or use a smartphone before falling asleep), which can be called the first time of the current night (e.g., 10:00 PM), and ends on the second date (e.g., Tuesday, July 7, 2020) when the user first gets out of bed and does not want to sleep the following morning, which can be called the second time of the following morning (e.g., 7:00 AM).

[0086] In some implementations, users can manually define the start and / or end of sleep periods. For example, a user can select (e.g., by clicking or tapping) on ​​an external device 170 ( Figure 1 One or more user-selectable elements are displayed on the display device 172 to manually initiate or terminate a sleep period.

[0087] refer to Figure 3 An exemplary timeline 240 for sleep periods is shown. Timeline 240 includes bedtime (t... 入床 ), time to fall asleep (t) GTS ), initial sleep time (t) 睡眠 ), First micro-awakening MA1, Second micro-awakening MA2, Awakening A, Awakening time (t) 觉醒 ) and wake-up time (t 起床 ).

[0088] Time to enter bed t 入床 Before the user falls asleep (e.g., when the user lies down or sits in bed), they initially enter the bed (e.g., Figure 2The time of going to bed (230) is associated with the time of bed use. Bedtime t can be identified at least in part based on the bed threshold duration. 入床 This is used to distinguish between the time a user goes to bed and the time a user goes to bed for other reasons (e.g., watching TV). For example, the bed threshold duration could be at least about 10 minutes, at least about 20 minutes, at least about 30 minutes, at least about 45 minutes, at least about 1 hour, at least about 2 hours, etc. Although the term "bed" is used to describe bed entry time t in this document... 入床 However, more generally, bedtime t 入床 This can refer to the time when a user initially enters any location to sleep (e.g., a sleeping chair, a chair, a sleeping bag, etc.).

[0089] Sleep onset time (GTS) and the time it takes for a user to first attempt to fall asleep after getting into bed (t) 入床 This is related to [the concept of sleep]. For example, after going to bed, a user can engage in one or more activities to relax before attempting sleep (e.g., reading, watching TV, listening to music, using external devices, etc.). Initial sleep time (t) 睡眠 ) is the time when a user initially falls asleep. For example, initial sleep time (t) 睡眠 This could be the time when the user initially enters the first non-REM sleep stage.

[0090] Awakening Time t 觉醒 This is the time associated with when a user wakes up without returning to sleep (e.g., the opposite of when a user wakes up at night and returns to sleep). A user may experience one of several unconscious micro-awakenings (e.g., micro-awakenings MA1 and MA2) with short durations (e.g., 5 seconds, 10 seconds, 30 seconds, 1 minute, etc.) after initially falling asleep. This is related to the wakefulness time t. 觉醒 Conversely, the user returns to sleep after each of the micro-awakenings MA1 and MA2. Similarly, the user may have one or more conscious awakenings (e.g., awakening A) after initial sleep onset (e.g., waking up to go to the bathroom, caring for a child or pet, sleepwalking, etc.). However, the user returns to sleep after awakening A. Therefore, the awakening time t can be defined, for example, at least in part, based on an awakening 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.). 觉醒 .

[0091] Similarly, wake-up time t 起床 This is associated with the time a user wakes up and gets out of bed to end a sleep period (e.g., the opposite of a user waking up at night to go to the bathroom, care for a child or pet, or sleepwalk). In other words, wake-up time t 起床This refers to the time a user last gets up and doesn't return to bed until the next sleep period (e.g., the next night). Therefore, the wake-up time t can be defined, for example, based on a rising threshold duration (e.g., the user has been awake for at least 15 minutes, at least 20 minutes, at least 30 minutes, at least 1 hour, etc.). 起床 The bedtime t for the second subsequent sleep period can also be defined, at least in part, based on the duration of the rise threshold (e.g., the user has been awake for at least 4 hours, 6 hours, 8 hours, 12 hours, etc.). 入床 time.

[0092] As mentioned above, in the initial t 入床 And the last t 起床 During the night, a user can wake up and get up more than once. In some implementations, the final wake-up time t 觉醒 and / or final wake-up time t 起床 It is identified or determined, at least in part, based on a predetermined threshold duration following an event (e.g., falling asleep or waking up). This threshold duration can be customized for the user. For a standard user who sleeps at night and then wakes up and gets out of bed in the morning, any time period between approximately 12 and approximately 18 hours can be used (the time between the user waking up and waking up). 觉醒 ) or get up (t 起床 Between ), and users going to bed (t) 入床 ), entering sleep (t GTS ) or fall asleep (t 睡眠 For users who spend longer periods in bed, shorter threshold periods can be used (e.g., between approximately 8 and 14 hours). The threshold period can be initially selected and / or adjusted later, at least in part, based on a system that monitors the user's sleep behavior.

[0093] Total time in bed (TIB) is the time spent in bed (t). 入床 and wake-up time t 起床 The duration between the initial sleep time and wake time. Total sleep time (TST) is associated with the duration between the initial sleep time and wake time, excluding any conscious or unconscious awakenings and / or micro-awakenings in between. Typically, total sleep time (TST) will be shorter than total time in bed (TIB) (e.g., one minute shorter, ten minutes shorter, one hour shorter, etc.). For example, refer to... Figure 3 Timeline 240, Total Sleep Time (TST) spanning initial sleep time t 睡眠 and awakening time t 觉醒 The duration of sleep is between, but does not include, the duration of the first micro-awake MA1, the second micro-awake MA2, and awakening A. As shown in the figure, in this example, the total sleep time (TST) is shorter than the total time in bed (TIB).

[0094] In some implementations, Total Sleep Time (TST) can be defined as Total Persistent Sleep Time (PTST). In these implementations, PTST excludes a predetermined initial portion or period of the first non-REM stage (e.g., a light sleep stage). For example, the predetermined initial portion could be between approximately 30 seconds and approximately 20 minutes, between approximately 1 minute and approximately 10 minutes, between approximately 3 minutes and approximately 5 minutes, etc. PTST is a measure of persistent sleep and smooths the sleep-wake sleep graph. For example, when a user initially falls asleep, they might be in the first non-REM stage for a very short time (e.g., approximately 30 seconds), then return to the wakeful stage for a very short time (e.g., one minute), and then return to the first non-REM stage. In this example, PTST excludes the first instance of the first non-REM stage (e.g., approximately 30 seconds).

[0095] In some implementations, the sleep period is defined as the time from bedtime (t... 入床 ) start and at wake-up time (t 起床 The sleep period ends at the initial sleep time (t), meaning the sleep period is defined as the total time to bed (TIB). In some implementations, the sleep period is defined as the time to bed (t). 睡眠 ) begins and at the awakening time (t) 觉醒 End. In some implementations, the sleep period is defined as the total sleep time (TST). In some implementations, the sleep period is defined as the time from the start of sleep (t... GTS ) begins and at the awakening time (t) 觉醒 The sleep period ends at the time of falling asleep (t). In some implementations, the sleep period is defined as the time from falling asleep to falling asleep (t). GTS ) start and at wake-up time (t 起床 The sleep period ends at bedtime. In some implementations, the sleep period is defined as the time from bedtime (t...). 入床 ) begins and at the awakening time (t) 觉醒 The sleep period ends at the initial sleep time (t). In some implementations, the sleep period is defined as the time from the start of sleep (t). 睡眠 ) start and at wake-up time (t 起床 )Finish.

[0096] refer to Figure 4 The diagram illustrates the timeline 240 based on various implementation methods. Figure 3 An exemplary sleep graph 250 is provided. As shown, sleep graph 250 includes a sleep-wake signal 251, a wakefulness stage axis 260, a REM stage axis 270, a light sleep stage axis 280, and a deep sleep stage axis 290. The intersection of the sleep-wake signal 251 with one of axes 260-290 indicates the sleep stage at a given time during a sleep period.

[0097] The sleep-wake signal 251 may be generated at least in part based on physiological data associated with the user (e.g., generated by one or more of the sensors 130 described herein). The sleep-wake signal may indicate one or more sleep states, including wakefulness, relaxed wakefulness, micro-wakefulness, REM sleep, a first non-REM sleep stage, a second non-REM sleep stage, a third non-REM sleep stage, or any combination thereof. In some implementations, one or more of the first non-REM sleep stage, the second non-REM sleep stage, and the third non-REM sleep stage may be grouped together and categorized as light sleep stages or deep sleep stages. For example, light sleep stages may include the first non-REM sleep stage, while deep sleep stages may include the second and third non-REM sleep stages. Although in Figure 4 The sleep graph 250 shown includes a light sleep stage axis 280 and a deep sleep stage axis 290, but in some implementations, the sleep graph 250 may include axes for each of the first non-REM stage, the second non-REM stage, and the third non-REM stage. In other implementations, the sleep-wake signal may also indicate respiratory signals, respiratory rate, inspiratory amplitude, expiratory amplitude, inspiratory-expiratory amplitude ratio, inspiratory-expiratory duration ratio, number of events per hour, event pattern, or any combination thereof. Information describing the sleep-wake signal may be stored in the storage device 114.

[0098] Sleep graph 250 can be used to determine one or more sleep-related parameters, such as sleep onset latency (SOL), wake-up time after sleep onset (WASO), sleep efficiency (SE), sleep segmentation index, sleep blocks, or any combination thereof.

[0099] Sleep onset latency (SOL) is defined as the time to enter sleep (t). GTS ) and initial sleep time (t 睡眠The sleep onset latency is the time between the initial attempt to fall asleep and the actual time it takes for a user to fall asleep. In some implementations, the sleep onset latency is defined as the sustained sleep onset latency (PSOL). The difference between sustained sleep onset latency and sleep onset latency is that sustained sleep onset latency is defined as the duration between the time of falling asleep 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 a second non-REM stage, a third non-REM stage, and / or a REM stage, with wakefulness not exceeding 2 minutes, a first non-REM stage, and / or movement between them. In other words, sustained sleep of up to, for example, 8 minutes within a second non-REM stage, a third non-REM stage, and / or a REM stage. In other implementations, the predetermined amount of sustained sleep may include at least 10 minutes of sleep within a first non-REM stage, a second non-REM stage, a third non-REM stage, and / or a REM stage after the initial sleep time. In this type of implementation, a predetermined amount of continuous sleep can exclude any micro-awakening (e.g., a ten-second micro-awakening does not restart the 10-minute period).

[0100] Waiting-on-Sleep (WASO) is associated with the total duration of a user's wakefulness between the initial sleep time and wakefulness time. Therefore, WASO includes brief and micro-awake periods during sleep (e.g., Figure 4 The micro-awake moments (MA1 and MA2) shown are either conscious or unconscious. In some implementations, the sleep onset wake time (WASO) is defined as the continuous sleep onset wake time (PWASO), which includes only wake times with a total duration of a predetermined length (e.g., greater than 10 seconds, greater than 30 seconds, greater than 60 seconds, greater than about 5 minutes, greater than about 10 minutes, etc.).

[0101] Sleep efficiency (SE) is defined as the ratio of total time spent in bed (TIB) to total sleep time (TST). For example, if the total time spent in bed is 8 hours and the total sleep time is 7.5 hours, then the sleep efficiency for that sleep period is 93.75%. Sleep efficiency indicates a user's sleep hygiene. For example, if a user goes to bed before sleep and spends time engaging in other activities (e.g., watching television), sleep efficiency will decrease (e.g., the user is punished). In some implementations, sleep efficiency (SE) can be calculated at least in part based on the total time spent in bed (TIB) and the total time the user attempts to sleep. In such implementations, the total time the user attempts to sleep is defined as the duration between the time to fall asleep (GTS) and the wake-up time described herein. For example, if the total sleep time is 8 hours (e.g., between 11 PM and 7 AM), the time to fall asleep is 10:45 PM, and the wake-up time is 7:15 AM, then in such implementations, the sleep efficiency parameter is calculated to be approximately 94%.

[0102] The segmentation index is determined at least in part based on the number of awakenings during sleep periods. For example, if a user has two micro-awakes (e.g., Figure 4 As shown in the micro-awakenings MA1 and MA2, the segmentation exponent can be represented as 2. In some implementations, the segmentation exponent is scaled between a predetermined range of integers (e.g., between 0 and 10).

[0103] Sleep blocks are associated with the transition between any sleep stage (e.g., first non-REM stage, second non-REM stage, third non-REM stage, and / or REM stage) and the wakefulness stage. Sleep blocks can be calculated at a resolution of, for example, 30 seconds.

[0104] In some implementations, the systems and methods described herein may include generating or analyzing a sleep map that includes sleep-wake signals to determine or identify bedtime (t) based at least in part on the sleep-wake signals of the sleep map. 入床 ), time to fall asleep (t) GTS ), initial sleep time (t) 睡眠 ), one or more first micro-awakenings (e.g., MA1 and MA2), awakening time (t) 觉醒 ), wake-up time (t) 起床 (or any combination thereof).

[0105] In other implementations, one or more of the sensors 130 can be used to determine or identify the bed entry time (t). 入床 ), time to fall asleep (t) GTS ), initial sleep time (t) 睡眠 ), one or more first micro-awakenings (e.g., MA1 and MA2), awakening time (t) 觉醒), wake-up time (t) 起床 (or any combination thereof), which in turn define sleep periods. For example, bedtime t can be determined at least in part based on data generated, for example, by motion sensor 138, microphone 140, camera 150, or any combination thereof. 入床 For example, the time to fall asleep can be determined at least in part based on data from motion sensor 138 (e.g., data indicating that the user is not moving), data from camera 150 (e.g., data indicating that the user is not moving and / or that the user has turned off the lights), data from microphone 140 (e.g., data indicating that the TV is off), data from external device 170 (e.g., data indicating that the user is no longer using external device 170), data from pressure sensor 132 and / or flow sensor 134 (e.g., data indicating that the user turns on breathing therapy device 122, data indicating that the user puts on user interface 124, etc.), or any combination thereof.

[0106] exist Figure 5A and 5B User interface 300 is shown in the diagram. User interface 300 can be used with the interface described here. Figure 1 and 2 The user interface 124 discussed is the same as or similar to any of the aforementioned components or features of system 100, including respiratory therapy system 120 and respiratory therapy device 122. User interface 300 includes a strap assembly 310, a pad 330, a frame 350, and a connector 370. The strap assembly 310 is configured to be positioned generally around at least a portion of the user's head when the user wears the user interface 300. The strap assembly 310 is attachable to the frame 350 and positioned on the user's head such that the user's head is positioned between the strap assembly 310 and the frame 350.

[0107] In some implementations, the pad 330 is positioned between the user's face and the frame 350 to form a seal on the user's face. A first end portion 372A of the connector 370 is coupled to the frame 350, while a second end portion 372B of the connector 370 may be coupled to a conduit (such as conduit 126). The conduit may in turn be coupled to the air outlet of a respiratory therapy device (such as respiratory therapy device 122). A blower motor in the respiratory therapy device is operable to generate a pressurized airflow exiting the air outlet, thereby providing pressurized air to the user. The pressurized air may flow from the respiratory therapy device through the conduit, connector 370, frame 350, and pad 330 until the air reaches the user's airway through the user's mouth, nose, or both.

[0108] The strap assembly 310 is formed by a rear portion 312, a pair of upper straps 314A and 314B, and a pair of lower straps 316A and 316B. When a user wears the user interface 300, the rear portion 312 of the strap assembly is typically located behind the user's head. The upper straps 314A, 314B and the 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 has a circular shape. However, the rear portion 312 may also have other shapes. The rear portion 312, the upper straps 314A, 314B, and the lower straps 316A, 316B may be formed or woven from generally stretchable or elastic materials, such as fabric, elastic materials, rubber, etc., or any combination of materials. In some implementations, wires or traces may extend through the interior of a portion of the strap assembly 310. This portion of the strap assembly 310 may typically be formed around a wire or trace, or may have a hollow interior or channel through which the wire or trace extends, as discussed in further detail below.

[0109] The upper straps 314A, 314B and the lower straps 316A, 316B each have a first end originating from the rear portion 312 and a second end connected to the frame 350. When the user wears the user interface 300, the tension provided by the strap assembly 310 holds the frame 350 to the user's face, thereby securing the user interface 300 to the user's head.

[0110] In some implementations, the tension sensor can be embedded in one of the straps of the strap assembly. For example, Figure 5B The diagram illustrates a tension sensor 313 embedded in the upper strap 314A. The tension sensor 313 is configured to measure the tension in the strap of the user interface 124. As discussed, the user interface 124 is typically fastened to a user's head using a strap, which can be secured 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 indicate to the user regarding the correct fit of the user interface 124. The tension sensor 313 can be integrated into yarn, fiber, wire, carbon fiber, warp, fabric, etc. When the tension in the strap increases or decreases, the sensor element of the tension sensor 313 deflects, causing a change in the voltage of the output signal. The tension sensor 313 can have high elasticity, low resistance, and be washable. In some implementations, the tension sensor 313 measures the diameter of the inflatable body using the principle of breath-sensory plethysmography. The tension sensor 313 can also be an impedance volumetric sensor, a magnetometer, a strain gauge sensor, or a displacement sensor made of piezoresistive material.

[0111] The frame 350 is typically formed of a body 352 defining a first surface 354A and an opposing second surface 354B. When a user wears the user interface 300, the first surface 354A faces away from the user's face, while the second surface 354B faces the user's face. The frame also defines an annular aperture 356 into which a pad 330 and a connector 370 can be inserted, thereby physically connecting the pad 330 and the connector 370 to the frame 350.

[0112] The pad 330 may be coupled to the interior of the frame 350 adjacent to the second surface 354B, such that the pad 330 is positioned between the user's face and the frame 350. The pad 330 may be made of the same or similar material as the pad of the user interface 124, and therefore may be formed of a conformal material that forms an airtight seal with the user's face. The pad 330 defines an orifice 336 and includes an annular protrusion 338 extending from the pad 330 around the orifice 336 of the pad. The annular protrusion 338 is inserted into the annular orifice 356 of the frame 350 such that the annular orifice 336 of the pad 330 overlaps with the annular orifice 356 of the frame 350. In some implementations, the annular protrusion 338 of the pad 330 is releasably secured to the body 352 of the frame 350 via a frictional engagement between the annular protrusion 338 and the body 352 around the annular orifice 356.

[0113] In other implementations, the annular protrusion 338 and the frame 350 may have mating features that engage with each other to secure the pad 330 to the frame 350. For example, the annular protrusion 338 of the pad 330 may include an outwardly extending peripheral flange, and the body 352 of the frame 350 may include a corresponding inwardly extending peripheral flange surrounding an annular aperture 356. When the annular protrusion 338 of the pad 330 is inserted into the annular aperture 356 of the frame 350, the peripheral flanges may slide or snap against each other, thereby securing the pad 330 to the frame 350. In another implementation, the pad 330 is held in place by tension provided by the strap assembly 310 and is not physically coupled to the frame 350. In other implementations, the pad 330 and the frame 350 may be formed as a single integral piece.

[0114] Connector 370 can be coupled to the opposite side of frame 350 in a similar manner to gasket 330. The first end portion 372A of connector 370 has a generally cylindrical shape and can be inserted into an annular aperture 356 of frame 350, such that the hollow interior 376 of end portion 372A (see...) Figure 6A The connector 370 overlaps with the annular orifice 356 and the orifice 336 of the gasket 330. The opposite second end portion 372B of the connector 370 is then coupled to the conduit, such that the user's face (including the user's mouth and / or nose) is in fluid communication with the conduit through the gasket 330, the frame 350 and the connector 370.

[0115] The first end portion 372A of the connector 370 is generally annular and fits into the annular aperture 356 of the frame 350. The frame 350 also includes an annular protrusion 358 extending from the second surface 354B of the frame 350 and forming around the annular aperture 356. When the first end portion 372A is inserted into the annular aperture 356 of the frame 350, the inner surface of the annular protrusion 358 overlaps with the outer surface of the first end portion 372A of the connector 370.

[0116] In some implementations, a frictional engagement between the annular protrusion 358 and the first end portion 372A secures the connector 370 to the frame 350. In other implementations, the connector 370 may include fasteners configured to secure the connector 370 to the frame 350. In one example, the annular protrusion 358 has an outwardly extending peripheral flange, and the fasteners are one or more deflectable latches formed on the first end portion 372A of the connector 370. When the first end portion 372A slides into the annular protrusion 358, the deflectable latch slides on the peripheral flange, such that the deflectable latch is locked outside the annular protrusion 358. As the deflectable latch passes the peripheral flange, the peripheral flange pushes the deflectable latch away from the annular protrusion 358. The deflectable latch then returns to its original position, such that the connector 370 cannot be removed from the frame 350 without manually deflecting the deflectable latch away from the annular protrusion 358.

[0117] The frame 350 includes a T-shaped extension 360 extending upward from the upper end 351A of the body 352. In some implementations, the extension 360 is integrally formed with the body 352. In other implementations, the extension 360 is a separate component attached to the body 352. When a user wears the user interface 300, the extension 360 typically extends upward to the user's forehead. In some implementations, the extension 360 includes a cooling portion or mechanism that contacts and cools the user's forehead, which can help a user with insomnia fall asleep.

[0118] Lower straps 316A and 316B extend from the rear portion 312 of the strap assembly 310 toward the frame 350 and attach to the opposite side of the lower end 351B of the body 352. Upper straps 314A and 314B extend from the rear portion 312 of the strap assembly 310 toward the frame 350 and attach to the opposite side of the upper end 361 extension 360 (e.g., a generally horizontal "cross" of the T). The frame 350 may include various strap attachment points for attachment to the upper straps 314A and 314B and the lower straps 316A and 316B.

[0119] A type of strap attachment point is shown in the extension strip 360. The upper end 361 of the extension strip 360 includes two openings 362A and 362B. These openings may be integrally formed in the extension strip 360 itself, or they may be formed as part of a separate component or part attached to the extension strip 360. The openings 362A and 362B are shaped to allow end portions 315A and 315B of the upper straps 314A and 314B to be inserted through the openings 362A and 362B. The end portions 315A and 315B can then be secured by any suitable mechanism, such as Velcro. TM Adhesives, etc., are used to loop back and secure the upper straps 314A and 314B to the remaining portions. The upper straps 314A and 314B are thus secured to the extension strip 360 of the frame 350.

[0120] The frame 350 is shown having different types of strap attachment points for attaching lower straps 316A, 316B to the frame 350. The frame 350 includes two lateral straps 364A, 364B extending from opposite ends of the lower end 351B of the body 352. A first end of each lateral strap 364A, 364B is attached to the body 352, and corresponding magnets 366A, 366B are disposed at the second end of each lateral strap 364A, 364B. Magnet 318A is attached to the end portion 317A of the lower strap 316A, while magnet 318B is attached to the end portion 317B of the lower strap 316B. Magnet 318A can be secured to magnet 366A by magnetic attraction, and magnet 318B can be secured to magnet 366B by magnetic attraction, thereby attaching the lower straps 316A, 316B to the body 352 of the frame 350.

[0121] In some implementations, frame 350 does not include extension strip 360, and the upper straps 314A and 314B are instead attached to the frame above the lateral straps 364A and 364B. In these implementations, the upper straps 314A and 314B extend past the user 210's temples and around the back of the user 210's head. Frame 350 may include upper lateral straps attached to the upper straps 314A and 314B.

[0122] The user interface 300 may also include one or more sensors 390. Although Figure 5BTypically, only a single sensor is shown, but any number of sensors can be coupled to the strap assembly 310. In some implementations, one or more sensors 390 are coupled to the strap assembly 310 and configured to be adjacent to a target area of ​​the user when the user interface 300 is worn. The target area may be the user's forehead, temples, throat, neck, ears, etc. Typically, the one or more sensors 390 adjacent to the target area may include sensors that directly contact the user's target area (e.g., sensors touch the user's target area) and / or sensors that do not directly contact the user (e.g., sensors are separated from the user's target area in some way).

[0123] In some implementations, one or more sensors 390 are contact sensors, which may include electroencephalogram (EEG) sensors, electrocardiogram (ECG) sensors, electromyogram (EMG) sensors, electrooculogram (EOG) sensors, acoustic sensors, peripheral oxygen saturation (SpO2) sensors, skin conductance response (GSR) sensors, or any combination thereof. The contact sensors may directly contact the user's target area or may contact a material layer between the contact sensor and the target area, such as fabric (which may be a strip assembly 310), silicone (which may be a pad 330), foam (which may be a pad 330), plastic (which may be a frame 350), etc. In some implementations, one or more sensors 390 are non-contact sensors, which may include carbon dioxide (CO2) sensors (measuring CO2 concentration), oxygen (O2) sensors (measuring O2 concentration), pressure sensors, temperature sensors, motion sensors, microphones, acoustic sensors, flow sensors, tension sensors, or any combination thereof. Typically, these non-contact sensors may be spaced apart from the target area, such that air (or any other material) is positioned between one or more sensors 390 and the target area.

[0124] In other implementations, one or more sensors 390 are not coupled to the strap assembly 310, but are located elsewhere within the user interface 300, such as within the connector 370. The one or more sensors 390 may be as described above. Figure 1The sensor 390 described may include any one or more of the following, 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 disposed in the pad 330, frame 350, or connector 370. Furthermore, the user interface 300 may include multiple non-contact sensors disposed in any combination of these locations. In one example, one or more sensors 390 are coupled to the frame 350 and contact the target area via the pad 330. In this example, the sensor may be positioned on or near the surface of the pad 330. Therefore, 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 material. The one or more sensors 390 may include any combination of contact and non-contact sensors.

[0125] Typically, one or more sensors 390 of the user interface 300 need to be electrically connected to a control system and memory device (such as the control system 110 and memory device 114 of system 100) to transmit data to the control system and memory device. This data can be used to modify the operation of the respiratory therapy device and can also 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 can be electrically connected to various parts of the user interface 300, including the frame 350 and connector 370. The electrical connection between the one or more sensors 390, the frame 350, and the connector 370 can be used to transmit data from the one or more sensors 390. Therefore, regardless of where the one or more sensors 390 are located in the user interface 300, the one or more sensors 390 need to be able to be electrically connected to the control system and memory device.

[0126] Figure 6A and 6B An electrical connection between frame 350 and connector 370 is shown. Frame 350 includes electrical contacts 368A, 368B, 368C, and 368D disposed on the inner side of annular protrusion 358. Electrical contacts 368A-368D may be formed on the inner surface of annular protrusion 358, or may extend radially inward from the inner surface of annular protrusion 358. Figure 6A and 6B In the middle, a portion of the annular protrusion 358 has been removed to better show the electrical contacts 368A-368D. Connector 370 includes corresponding electrical contacts 378A, 378B, 378C, and 378D disposed on the surface of the annular end portion 372A.

[0127] When the end portion 372A of connector 370 is inserted into the annular aperture 356 of frame 350, each electrical contact of frame 350 physically contacts one of the electrical contacts of connector 370, thereby electrically connecting frame 350 to connector 370. Therefore, 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 can be physically and electrically connected to frame 350.

[0128] In the illustrated implementation, each electrical contact 378A-378D of connector 370 is an annular electrical contact, forming a ring on the surface of end portion 372A of connector 370. The annular electrical contacts 378A-378D can be formed on the surface of end portion 372A, or can extend radially outward from the surface of end portion 372A. The electrical contacts 368A-368D of frame 350 are formed as individual solder pads, each solder pad located at a position on the inner surface of annular protrusion 358. The electrical contacts 368A-368D can be formed on the inner surface of annular protrusion 358, or can be formed as pins extending radially inward from the inner surface of annular protrusion 358. The annular shape of the electrical connectors 378A-378D ensures that if the connector 370 is rotated relative to the frame 350 once the end portion 372A is inserted into the annular aperture 356 of the frame 350, some portions of each electrical contact 378A-378D will always physically contact its corresponding electrical contact 368A-368D of the frame 350.

[0129] However, in other implementations, the electrical contacts 368A-368D of frame 350 may have an annular shape forming a ring on the inner surface of the annular protrusion 358, while the electrical contacts 378A-378D of connector 370 are single electrical pads, each located at a position on the outer surface of end portion 372A. In other implementations, both electrical contacts 368A-368D and 378A-378D are annular electrical contacts. In yet another implementation, both electrical contacts 368A-368D and 378A-378D are formed as single electrical pads. In some implementations, electrical contacts 368A-368D and 378A-378D are at least partially annular, meaning they can form partial rings. These rings can be quarter rings (e.g., 90°), half rings (e.g., 180°), three-quarter rings (e.g., 270°), or any other partially annular arrangement.

[0130] Connector 370 includes electrical contacts 382A-382D located at its other end portion 372B. Electrical contact 382A is electrically connected to electrical contact 378A via an electrical passage 380A formed in the hollow interior 376 of the connector. Electrical contact 382B is electrically connected to electrical contact 378B via an electrical passage 380B formed in the hollow interior 376 of the connector. Electrical contact 382C is electrically connected to electrical contact 378C via an electrical passage 380C formed in the hollow interior 376 of the connector. Electrical contact 382D is electrically connected to electrical contact 378D via an electrical passage 380D formed in the hollow interior 376 of the connector.

[0131] Electrical pathways 380A-380D can be formed in various ways. In some implementations, electrical pathways 380A-380D are electrical traces formed on the inner surface of the hollow interior 376 of connector 370 or within connector 370 itself. In other implementations, electrical pathways 380A-380D are formed by wires positioned inside the hollow interior 376 of connector 370. The second end portion 372A of connector 370 can be inserted into a catheter, which may have similar electrical contacts. Furthermore, when the catheter is connected to a respiratory therapy device, the electrical contacts of the catheter can be electrically connected to a control system and a memory device. Therefore, connector 370 can be physically and electrically connected to the catheter.

[0132] Electrical contacts 368A-368D of the annular protrusion 358 can be electrically connected to the strap attachment points of the frame 350. Electrical paths 369A and 369B extend from electrical contacts 368A and 368B, respectively, through the transverse strip 364A, and extend to the magnet 366A. As discussed further herein, the lateral strap 364A and the magnet 366A can be electrically connected to one of the straps of the strap assembly 310. In a similar manner, electrical paths 369C and 369D extend upward from electrical contacts 368C and 368D, respectively, through the extension strip 360. Although in Figure 6A and 6B Not shown, but one or more electrical pathways may extend through the lateral strap 364B to the magnet 366B.

[0133] Electrical pathways 369A-369D can be formed in various different ways. In some implementations, electrical pathways 369A-369D are formed by wires positioned between the second surfaces adjacent to the body 352, between the frame 350 and the pad 330. In other implementations, electrical pathways 369A-369D may 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.

[0134] Figure 6A and 6BThe electrical pathways 3689-369D shown are exemplary implementations. In other implementations, any number of electrical pathways can be formed between the electrical contacts 368A-368D of the annular protrusion 358 and any point on the frame 350. For example, some of the electrical contacts 368A-368D can be electrically connected to the lateral strap 364B and the magnet 366B, instead of being electrically connected to the lateral strap 364A, the magnet 366A, and the extension strip 360, or they can be electrically connected to the lateral strap 364B and the magnet 366B in addition to being electrically connected to the lateral strap 364A, the magnet 366A, and the extension strip 360.

[0135] Figure 6C A cross-sectional view of the annular protrusion 358 of the frame 350 and the first end portion 372A of the connector 370 is shown before the first end portion 372A is inserted into the annular aperture 356 of the frame 350. Figure 6D A cross-sectional view is shown after the first end portion 372A is inserted into the annular aperture 356 of the frame 350. The electrical contacts 368A-368D of the annular protrusion 358 are formed as individual pads on the inner surface of the annular protrusion 358. The electrical contacts 378A-378D of the connector 370 are annular electrical contacts formed as a ring on the outer surface of the first end portion 372. The electrical paths 369A-369D of the frame 350 are electrically connected to the electrical contacts 368A-368D, respectively. The electrical paths 380A-380D of the connector 370 are electrically connected to the electrical contacts 378A-378D, respectively.

[0136] Once the first end portion 372A is inserted into the annular aperture 356 of the frame 350, the annular electrical contacts 378A-378D 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 the electrical contacts 378A-378D are annular, the connector 370 can rotate any number of times, and the connector 370 will remain electrically connected to the frame 350.

[0137] Figure 7 An implementation for electrically connecting the strap attachment points of the frame 350 to the strap assembly 310 is shown. Figure 7 Only the strap attachment point formed by the lateral strap 364A is shown. However, this implementation can be used for the lateral strap 364B, or for other strap attachment points of the frame 350.

[0138] like Figure 7 As shown, electrical pathways 369A and 369B extend through lateral straps 364A and terminate at magnets 365A and 365B. Magnets 365A and 365B are typically connected to... Figure 6A and 6BThe magnet 366A is the same as or similar to the magnet 365A, except that the magnet is formed by two smaller magnets 365A and 365B. Electrical path 369A terminates at electrical contact 371A adjacent to magnet 365A. Similarly, electrical path 369B terminates at electrical contact 371B adjacent to magnet 365B. In the illustrated implementation, electrical contact 371A is typically flush with the surface of magnet 365A, while electrical contact 371B is typically flush with the surface of magnet 365B.

[0139] The end portion 317A of the lower strap 316A is generally formed in the same manner. Magnets 319A and 319B are mounted at the end portion 317A of the lower strap 316A. Magnets 319A and 319B are generally... Figure 5B The magnet 318A shown is identical, except that it is formed by two smaller magnets 319A and 319B. Magnet 319A includes an electrical contact 320A that is generally flush with the surface of magnet 319A. Similarly, magnet 319B includes an electrical contact 320B that is generally flush with the surface of magnet 319B. Electrical contact 320A is electrically connected to electrical path 322A, while electrical contact 320B is electrically connected to electrical path 322B. Electrical paths 322A and 322B extend through the lower strap 316A to any desired point along the strap assembly 310. Typically, electrical paths 322A and 322B extend along the strap assembly 310 to a point near a target area on the user's face. Therefore, electrical paths 322A and 322B typically have first end positions located at electrical contacts 320A and 320B, respectively, and second end positions located at some other portion of the strap assembly 310 near the user's target area.

[0140] When the end portion 317A of the lower strap 316A approaches the lateral strap 364A, magnets 319A and 319B are magnetically attracted to magnets 365A and 365B. This magnetic attraction secures the end portion 317A of the lower strap 316A to the lateral strap 364A, causing electrical contact 371A to physically contact electrical contact 320A, and electrical contact 371B to physically contact electrical contact 320B. Therefore, electrical path 369A is electrically connected to electrical path 322A, and electrical path 369B is electrically connected to electrical path 322B. Due to the electrical connection between the lateral strap 364A, the annular protrusion 358 of the frame 350, and the connector 370, electrical paths 322A and 322B (which extend into the strap assembly 310) are electrically connected to the connector 370. Therefore, the frame 350 can be physically and electrically connected to the strap assembly 310.

[0141] The end portion 317A of the lower strap 316A includes a rotation-locking feature, and the lateral strap 364A includes a corresponding rotation-locking feature. In the illustrated implementation, the rotation-locking feature of the end portion 317A of the lower strap 316A is a T-shaped protrusion 324 extending away from magnets 319A and 319B, and the rotation-locking feature of the lateral strap 364A is a channel 373 defined between magnets 365A and 365B, the channel being sized to receive at least a portion of the T-shaped protrusion 324. Typically, when the end portion 317A of the lower strap 316A is secured to the lateral strap 364A, the straight portion of the T-shaped protrusion 324 can engage in the channel 373. The 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. The locking swivel ensures that electrical contact 371A maintains physical contact with electrical contact 320A, and electrical contact 371B maintains physical contact with electrical contact 320B. Additionally, the downward-curved portion of the T-shaped protrusion 324 is typically fitted below magnets 365A and 365B (relative to...). Figure 7 (the plane), which prevents the lower strap 316A from being unintentionally pulled away from the lateral strap 364A.

[0142] Electrical pathways 322A and 322B extending from the end portion 317A of the lower strap 316A into the strap assembly 310 can be formed in various different ways. In some implementations, electrical pathways 322A and 322B are formed by wires passing through the generally 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 forming electrical pathways 322A and 322B are instead braided together with the material forming the strap assembly 310. In other implementations, electrical pathways 322A and 322B are formed by electrical traces extending along the surface of the lower strap 316A and the remainder of the strap assembly 310.

[0143] By utilizing the electrical pathways and contacts of the user interface 300, one or more sensors 390 can be placed in any suitable location and can be electrically connected to the connector 370. By connecting the connector 370 to a conduit having its own electrical pathway (e.g., wires or traces within the conduit), one or more sensors 390 can be electrically connected to a control system and memory device arranged in or near the respiratory therapy device.

[0144] In some implementations, the 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 electrical contacts 378A-378D of the connector 370, such 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 within the connector 370.

[0145] In other implementations, the one or more sensors 390 are positioned near the frame 350. For example, the one or more sensors 390 may be positioned between the user's face and the pad 330, between the pad 330 and the frame 350, or within the annular aperture 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, such 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.

[0146] In another implementation, one or more sensors 390 are positioned near any of the strap attachment points of the frame 350. In some of these implementations, one or more sensors 390 are positioned in or near an extension strip 360 and electrically connected to the frame 350 and connector 370 via the extension strip 360. In other implementations, the one or more sensors 390 may be positioned, for example, near a magnet 366A of a lateral strap 364A and electrically connected to one or both of electrical contacts 371A and 371B, such that data generated by the one or more sensors 390 can be transmitted via electrical contacts 371A and 371B of the lateral strap 364A, electrical contacts 368A-368D of the frame 350, and electrical contacts 378A-378D of the connector 370.

[0147] In other implementations, one or more sensors 390 are positioned near the end of one of the lower straps, such as near the end portion 317A of the lower strap 316A. The one or more sensors 390 may be electrically connected to one or both of electrical contacts 320A and 320B, such that data generated by the one or more sensors 390 can be transmitted via electrical contacts 320A and 320B, electrical contacts 371A and 371B of the lateral strap 364A, electrical contacts 368A-368D of the frame 350, and electrical contacts 378A-378D of the connector 370.

[0148] In some implementations, one or more sensors 390 are positioned along the strap assembly 310 adjacent to a target area of ​​the user. In these implementations, the one or more sensors 390 may be electrically connected to electrical pathways, such as electrical pathways 322A and 322B, extending through the strap assembly 310. Therefore, data generated by the one or more sensors 390 can be transmitted via electrical pathways 322A and 322B, electrical contacts 320A and 320B, electrical contacts 371A and 371B of the lateral strap 364A, electrical contacts 368A-368D of the frame 350, and electrical contacts 378A-378D of the connector 370. Furthermore, the one or more sensors 390 may include contact portions that contact the target area of ​​the user, and wires that electrically connect the contact portions of the sensors to electrical pathways (such as electrical pathways 322A and 322B) in the strap assembly 310.

[0149] In a further implementation, one or more sensors 390 may be electrically connected to a processing device (such as a microprocessor) located in connector 370, rather than being electrically connected to a control system and storage device via conduits. In these implementations, the microprocessor is electrically connected to electrical contacts 378A-378D of connector 370, such that data generated by the sensors can be transmitted to the microprocessor via strap assembly 310, frame 350, and connector 370.

[0150] User interface 124 and / or conduit 126 may also include one or more safety features to mitigate the risk of electric shock due to excessive leakage current, which may be caused by worn or defective circuitry or unintentionally exposed components. In some implementations, opto-isolators or 1:1 transformers may be used to electrically isolate various components. Furthermore, various different insulators may be used, for example, to mitigate heating of any electrical components.

[0151] Figure 8 The illustration depicts a user (such as a user) wearing a user interface 300 with three different sensors attached to a strap assembly 310 and positioned adjacent to or adjacent to different parts of the user's body. As shown, the strap assembly 310 is positioned around the user's head and attached to a frame 350. A pad 330 is attached to the frame 350 and positioned between the user's face and the frame 350. A connector 370 is attached to the frame 350.

[0152] Figure 8 The user interface 300 includes three sensors 402A, 402AB, and 402C, which are located in or adjacent to different areas of the strap assembly 310. Sensor 402A is located near the lower strap 316A, sensor 402B is located in the extension strip 360, and sensor 402C is located in the upper strap 314A.

[0153] In the illustrated implementation, sensor 402A is clipped onto the user's ear and can be an SpO2 sensor for measuring peripheral oxygen saturation. A more reliable measurement of peripheral oxygen saturation can be obtained by clipping the SpO2 sensor onto the user's ear instead of another part of the user's body (such as a finger or toe). Sensor 402A is electrically connected to connector 370 via frame 350, a first electrical path 404A, a second electrical path 404B, and a third electrical path 404C. The first electrical path 404A is disposed within frame 350 and can be a wire or trace. The first electrical path 404A extends to a strap attachment point of frame 350, where lower strap 316A is attached to frame 350. The second electrical path 404B extends through lower strap 316A itself and can be a wire or trace located within or on the surface of lower strap 316A. The first electrical path 404A and the second electrical path 404B can be electrically connected using magnets located in frame 350 and lower strap 316A, such as… Figure 7 As shown. The third electrical path 404A extends from the lower strap 316A to the sensor 402A clipped on the user's ear. Therefore, the third electrical path 404A is typically formed as a wire. Thus, data generated by the sensor 402A can be transmitted through the lower strap 316A, frame 350, and connector 370.

[0154] In other implementations, sensor 402A may be located near the user's neck or throat. In these implementations, the second electrical pathway 404B may extend from the lower strap 316A and extend downwards to sensor 402A.

[0155] In the illustrated implementation, sensor 402B is a contact sensor (such as an ECG sensor) adjacent to the user's forehead when the user wears user interface 300. Sensor 402B can measure brain activity in the frontal lobe, which can help determine which stage of sleep the user is in, and detect wakefulness and micro-wakefulness during the user's sleep. Sensor 402B is electrically connected to connector 370 via frame 350 and electrical pathway 406. Electrical pathway 406 typically extends upward from frame 350 to extension bar 360 and can be a wire or trace. Typically, sensor 402B is located on the outside of extension bar 360, between extension bar 360 and the user's forehead. Sensor 402B may be electrically connected to electrical pathway 404 at the dorsal surface of extension bar 360, or electrical pathway 404 may protrude slightly from the dorsal surface (e.g., as a wire) to be electrically connected to sensor 402B. Therefore, data generated by sensor 402B can be transmitted via extension bar 360, frame 350, and connector 370.

[0156] In the illustrated implementation, sensor 402C is a contact sensor (such as an EOG sensor) that contacts the user's temple when the user interface 300 is worn. Sensor 402C is electrically connected to connector 370 via frame 350, a first electrical path 408A, and a second electrical path 408B. The first electrical path 408A can typically be the same as or similar to electrical path 406, and thus extends upward from frame 350 to extension strip 360. However, the first electrical path 408A connects to the second electrical path 408B, which extends through upper strap 314A. In some implementations, the transition between the first and second electrical paths 408B can utilize a magnet, such as... Figure 8 As shown in the diagram. In other implementations, the upper strap 314A loops through the opening in the extension strip 360 and does not use a magnet. In these implementations, the first electrical path 408A may terminate in a wire extending from the extension strip 360 toward the upper strap 314A. The wire may then extend into the upper strap 314A to initiate the second electrical path 408B.

[0157] The second electrical path 408B extends toward the user's temple, where it is electrically connected to the 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 path 408B at the back surface of the upper strap 316A, or the second electrical path 408B may protrude slightly from the back surface (e.g., as a wire) to be electrically connected to sensor 402C. Therefore, data generated by sensor 402C can be transmitted via the upper strap 316A, extension strip 360, frame 350, and connector 370.

[0158] System 100 may also include sensors configured to determine whether the user is sleeping on their back or on either side. In some implementations, the sensors may be placed in the user interface 124 or the duct 126, measuring the relative airflow between different sides of the duct 126. If the user is sleeping on one side, one of the sensors will measure less airflow relative to the other side, allowing system 100 to determine which side the user is sleeping on. If the airflow between the sensors is approximately equal, system 100 can determine that the user is sleeping on their back. In some examples, this information can be used to provide an estimate of the integrity or wear of the face shield.

[0159] In some implementations, existing wiring within the conduit can be used with the user interface 300. For example, the conduit may include two wires connected to a thermistor, which can be used as a temperature sensor. The thermistor can be removed, and the two wires can be electrically connected to a connector to transmit data from one or more sensors 390. In another example, the thermistor is retained, but the connector is configured to bypass the thermistor and be electrically connected to both wires. In yet another example, the conduit may include wires for heating air flowing through it. These wires can alternatively be used as a voltage source (e.g., by connecting 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 electrical power to operate.

[0160] In some implementations, airflow through the duct and connector 370 can be used to power one or more sensors 390 and any other components. In these implementations, a small generator can be placed within the duct or connector 370, in the path of pressurized air flowing through it. Air flowing through and passing over the generator can be used to generate some or all of the required power. In some of these implementations, the generator includes a turbine that rotates as air flows through the duct and connector 370, thereby generating power. Other implementations may include a thermoelectric generator that converts heat flux into electricity. The generator may include nanomaterials.

[0161] One or more sensors 390 (which may typically include one or more sensors 130 or other sensors) may be used for a variety of different purposes. In one implementation, one or more sensors 390 are used to detect mouth leaks (e.g., pressurized air entering a noisy area and being expelled through the mouth without entering the user's throat, trachea, or lungs). In this implementation, sensors located in the pad 330 and / or frame 350 may be used to detect air leaking from the user's mouth. These sensors may include pressure sensors (such as pressure sensor 132), flow sensors (e.g., flow sensor 134), CO2 sensors, O2 sensors, acoustic sensors, microphones, or any other combination of sensors.

[0162] Typically, many respiratory therapy devices used to provide breathing therapy to a user during sleep include their own sensors to measure various parameters. However, the user interface 300 can be used in conjunction with a respiratory therapy device that does not include any individual sensor. In these implementations, the respiratory therapy device includes a housing defining an inlet and an outlet, and within the housing is a blower motor in fluid communication with the inlet and outlet. The respiratory therapy device also includes a control system having one or more processors that execute machine-readable instructions stored in a memory device to cause the blower motor to direct compressed air out of the outlet. However, because any desired sensor can be placed in the user interface 300, the respiratory therapy device does not include its own sensor.

[0163] For example, pressure and flow sensors are frequently used in respiratory therapy devices to monitor the operation of the blower motor and the amount of air delivered to the user. Because the user interface 300 can include pressure and flow sensors, the respiratory therapy device does not need its own. The pressure and flow sensors in the user interface 300 can generate data relevant to the respiratory therapy device and / or its user, and this data can be transmitted via the user interface 300 and a conduit fluidly connecting the user interface 300 and the respiratory therapy device. The control system of the respiratory therapy device can use the data from the pressure and flow sensors to operate the blower motor.

[0164] Typically, any of the aforementioned techniques or features used for electrical connection components can be used in other locations on the user interface 300. For example, the strap assembly 310 may only have a strap that is magnetically attached to the frame 350. In another example, the strap assembly 310 may only have a strap that is looped through openings in the frame 350 and the extension strip 360. In yet another example, the lower straps 316A, 316B may loop through openings in the frame 350, while the upper straps 314A, 314B are magnetically attached to the extension strip 360. In yet another example, the frame 350 may not have the extension strip 360, and therefore the upper straps 314A, 314B are attached closer to the body 352 of the frame 350 to the lower straps 316A, 316B.

[0165] Furthermore, the user interface 300 is not limited to the specific number or arrangement of electrical contacts in the connector 370, frame 350, or strap assembly 310, as shown in the figure. The user interface 300 can typically include any arrangement of electrical contacts and electrical paths through various components to place one or more sensors 390 in their desired locations while electrically connecting each of the one or more sensors 390 back to the connector 370. For example, the 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, or more or fewer than four electrical contacts for any number of sensors, etc. Finally, any of the one or more sensors 390 can be located in any suitable position within the strap assembly 310 or in other parts of the user interface 300.

[0166] In other implementations, the various electrical paths are not formed by wires or traces on or within various portions of the user interface 124 or conduit 126, but rather by radio paths or inductive electrical paths. Radio paths may utilize energy harvesting and wireless communication. Inductive circuits may utilize magnetic and / or electric fields.

[0167] In some implementations, the strap assembly 310 includes a hollow tube extending around the face of the user 210. The hollow tube may typically have all the same features as the upper strap 314A and the lower straps 314B, 316A, 316B, except that they are hollow along their entire length. Any wires or sensors can then be positioned within the hollow tube constituting the strap assembly 310.

[0168] Figure 9A and 9B Perspective and exploded views of a user interface 500, which may include various sensors, are illustrated according to various aspects of this disclosure. The user interface 500 includes a strap assembly 510, a pad 530, a frame 550, and a connector 570. The strap assembly 510 is attachable to the frame 550 and, when a user wears the user interface 500, is positioned approximately 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 pad 530 can be attached to the lower end of the frame 550 such that, when the user wears the user interface 500, the pad 530 is positioned near the user's face, forming a seal on the user's face. The connector 570 is configured to insert into an opening in the frame 550, thereby attaching the connector 570 to the frame 550. A conduit 126 of a respiratory therapy system 120 can be attached to the other end of the connector 570, thereby connecting the respiratory therapy system 120 to the user interface 500. In other implementations, connector 570 may be optional and frame 550 may alternatively be directly connected to the catheter of the respiratory therapy system.

[0169] User interface 500 is configured to deliver pressurized air from conduit 126 of respiratory therapy system 120 through pad 530 and frame 550 to a user, or more specifically, to a volume of space surrounding the user's mouth and / or nose and enclosed by pad 530. In the illustrated implementation, user interface 500 includes hollow portions 552A and 552B to provide two channels for pressurized air, which fluidly connect pad 530 to connector 570. In this way, pad 530 is in fluid communication with the interior of connector 570. When a user wears user interface 500, hollow portions 552A and 552B are typically located 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 passage for pressurized air, while the other portion is a solid portion that does not form a passage for pressurized air. In other implementations, portions 552A and 552B may both be solid, and frame 550 may be one or more tubes (or other hollow portions) forming one or more channels for pressurized air between connector 570 and the user's mouth and / or nose. Therefore, in Figure 9A and 9B In this implementation, the conduit 126 of the respiratory therapy system 120 is typically attached to the user interface frame at the top of the user's head rather than in front of the user's face.

[0170] User interface 500 may include various electrical pathways similar to user interface 500. For example, connector 570 may be similar to connector 370 and include electrical contacts at the ends of connector 370 configured to mate with conduit 126 of respiratory therapy system 120. Connector 570 may also include annular electrical contacts at the opposite ends of connector 370 configured to mate with frame 550. Frame 550 may, in turn, be similar to frame 350 and include electrical contacts near its ends that mate with connector 570. Thus, the electrical contacts in frame 550 and connector 570 allow for the formation of an electrical connection between conduit 126 of respiratory therapy system 120 and frame 550. An electrical path from frame 550 to a target area of ​​the sensor can then be formed via any desired path. For example, wires or traces can extend from frame 550 to the user's face; pass through strap assembly 510 from frame 550 to the user's face; pass through padding 530 from frame 550 to the user's face; pass through strap assembly 510 and padding 530 from frame 550 to the user's face; or pass through padding 530 and strap assembly 510 from frame 550 to the user's face. In this way, frame 550 can be physically and electrically connected to strap assembly 510, and connector 570 can be physically and electrically connected to frame 550. Similar to using interface 300, the sensor can typically be positioned on or around the user in any target area, and an electrical connection to the sensor can be formed using any component of user interface 500.

[0171] One or more sensors 390 of user interface 300 or user interface 500 may include various different sensors in different locations to perform various different sensing tasks. In some implementations, one or more sensors 390 include one or more ECG sensors that contact a portion of the user's head, which may include the user's forehead and / or scalp. The ECG sensors measure electrical activity associated with the user's brain (e.g., brain activity) and can be used to detect sleep stages and / or detect microsleep awakenings. ECG sensors may also be implemented in earplugs located in the user's ear, which can be additionally used to monitor sound and temperature. One or more sensors 390 may include multiple ECG sensors that contact various different areas on the user's scalp, which can then be used for quantitative EEG, also known as brain mapping.

[0172] In some implementations, one or more sensors 390 include one or more ECG sensors configured to measure the electrical activity of the user's heart (e.g., heart activity). The ECG sensors can measure differences in electrical activity between different parts of the user, such as between different parts of the user's head, between the user's ears, between the user's chin and one of the user's ears, etc.

[0173] In some implementations, one or more sensors 390 include one or more EOG sensors configured to measure the movement of a user's eyes. Therefore, the EOG sensors can be used to detect when a user moves their eyes, which in turn helps determine when the user is in REM sleep.

[0174] In some implementations, the one or more sensors 390 include one or more EMG sensors configured to measure the electrical activity of a user's muscles. The EMG sensors can be placed near the muscles of the user's face to detect facial movements. For example, an EMG sensor can be placed near the user's jaw to detect jaw movements, which can indicate that the user grinds their teeth during sleep, also known as bruxism. Jaw movements (and / or other muscle activity) detected by the EMG sensors can also be used to help determine if the user is experiencing a seizure.

[0175] In some implementations, the one or more sensors 390 include one or more microphones that can be used to detect a variety of different sounds, such as breathing sounds (e.g., mouth or nose breathing), noise from the user interface (which may occur if the user interface is moved during sleep periods, such as when the user moves), background noise, and noise caused by air leakage from the user interface. The microphones can also be used to determine whether any detected air leakage is intentional and due to the operation of any vent in the user interface, or whether the detected air leakage is unintentional and due to a poor seal between the user and the user interface. Breathing signals can be derived from the microphone data, which can indicate the quality of the user's breathing (e.g., normal, slow, fast, wheezing, whistling, etc.). In some implementations, the microphone can be implemented as an earplug located in or near the user's ear, and can also be used as an ECG sensor and a temperature sensor.

[0176] In some implementations, one or more sensors 390 include an SpO2 sensor configured to measure the user's peripheral oxygen saturation. The SpO2 sensor can be placed in various locations, including near the user's ears, nose, lips, and / or forehead. The SpO2 sensor can be a reflective or transmissive sensor, and in some implementations, green and / or red LEDs can be utilized.

[0177] In some implementations, one or more sensors 390 include one or more GSR sensors configured to measure the electrical properties of a user's skin (also known as electrical skin activity or EDA). The GSR sensors can be located on the user's face and can help determine the user's mood, perform lie detection, and perform sleep analysis.

[0178] In some implementations, the one or more sensors 390 include one or more motion sensors, which may include accelerometers, gyroscopes, magnetometers, inertial measurement units (IMUs), or any combination thereof. Motion sensors can be used to measure activities (such as movement during sleep), 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 can be used to measure user movement caused by breathing (e.g., the user's chest rising and falling during breathing), which can then be used to derive a breathing signal. The motion sensor can measure the rate of this movement to determine the breathing rate; can detect chest movement during breathing that indicates obstructive sleep apnea; and can detect when the chest does not move at all due to central sleep apnea, in which case the user's brain does not send a breathing signal. This breathing signal can indicate the quality of the user's breathing (e.g., normal, slow, fast, wheezing, stridor, whistling, etc.). In some implementations, motion sensors can be used to determine if the user interface is moving arbitrarily over the user's head, which can indicate that the user interface is not properly fitted. This determination can also be based on data from a tension sensor, which can indicate the tension in the user interface straps and whether the user interface is properly tightened over the user's head. In some implementations, motion sensors can be used to determine the user's position on the bed, which can help determine if the user interface is improperly assembled, resulting in leaks or poor airflow.

[0179] In some implementations, one or more sensors 390 include one or more analyte sensors that can be used to detect analytes, such as ketones, in a user's breath. The analyte sensors can therefore be used for breath sampling and analysis. The analyte sensors can also detect analytes in the air, and thus can be used for air quality analysis.

[0180] 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 placed closer to the user's mouth and / or nose in a user interface compared to pressure sensors in the catheter 126 or the respiratory therapy device 122, and thus, in some implementations, can provide a more accurate measurement of the pressurized air pressure.

[0181] 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 supplement or replace any flow sensor in the respiratory therapy system 120), one or more temperature sensors (which may be used to measure the user's core temperature at the temples or in the 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, for example, at the temporal region), etc. The temperature sensor may be implemented as an earplug located in or near the user's ear, and may also be used as an ECG sensor and microphone. The heart rate sensor may include a PPG sensor, an RF sensor, or even a motion sensor capable of detecting motion caused by the user's heartbeat (such as movement of the user's chest or movement caused by a pulse in a vein or artery).

[0182] One or more sensors can be used for a variety of different applications. In some implementations, one or more sensors 390 can be used to perform polysomnography (PSG), which measures various bodily functions while the user is asleep. PSG can use an ECG sensor to measure brain activity, an ECG sensor to measure cardiac activity, an EOG sensor to measure previous-moment movement, an EMG sensor to measure muscle activity, and other sensors. PSG is typically performed during sleep studies, therefore aspects of this disclosure allow for PSG to be performed using a user interface already worn by the user during their sleep period. Since electrical pathways can be formed in a user interface already worn by the user, the sensors required to perform PSG can be attached to and / or positioned near the patient as needed via the user interface.

[0183] In some implementations, one or more sensors 390 can be used for emotion mapping. The one or more sensors 390 can detect various characteristics that may be associated with a user's emotional state, including facial expressions and body position. The one or more sensors 390 can also be used to detect spontaneous emotions versus compulsive emotions. The user's heart rate and respiratory rate detected by the one or more sensors 390 can also be used to determine the user's emotional state, as they can indicate the user's stress level. Speech detected by the one or more sensors 390 can be used to help determine the user's emotional state. Data from an electrodermal response sensor can also help determine the user's emotional state.

[0184] Data from one or more sensors 390 can be used to test conditions other than those related to sleep during the user's treatment with the respiratory therapy system 120. For example, the data can be used to determine if the user has any underlying conditions, such as atrial fibrillation, which can be evidenced by intermittent cardiac abnormalities, breathing abnormalities, etc. Data from one or more sensors 390 can 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 can also be used to determine the user's level of drowsiness, which may be related to conditions such as a cold or flu or other chronic illnesses. In some implementations, data from one or more sensors 390 can be used to detect any discomfort or pain the user is experiencing and to determine the potential cause of the pain / discomfort (e.g., a specific body or neck position may cause pain to the user during sleep). In some implementations, one or more sensors 390 can be used to detect various characteristics of the user's bedroom (or any other room the user may be in during sleep). For example, sonar sensors can be used to identify and map the physical features of the room. In some implementations, data from one or more sensors 390 can be used to provide feedback to the user after a period of sleep. This feedback may include providing the user with the data itself and / or data-based analysis. By using one or more sensors 390 to detect and monitor these additional conditions, user interface 300 and / or user interface 500 provide a more efficient mechanism for detecting and monitoring additional conditions in users suffering from these additional conditions and / or requiring additional treatment.

[0185] In some implementations, the user interface may include one or more actuators configured to perform functions based on data from one or more sensors 390. The actuators may be used to adjust the user interface's fit on the user (e.g., by tightening or loosening the strap assembly, or by repositioning the user interface relative to the user's face) to wake the user during sleep, or to perform any other desired function.

[0186] In some implementations, the user interface may include components that power one or more sensors 390 separately from the arbitrary power provided by the respiratory therapy 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 transmitted and stored independently of the respiratory therapy system 120. Therefore, in some implementations, the user interface may form a standalone sensor suite capable of independently generating and transmitting data.

[0187] One or more elements or aspects or steps or any portion thereof from the appended claims may be combined with one or more other elements or aspects or steps or any portion thereof from the appended claims to form one or more additional implementations of this disclosure.

[0188] While this disclosure has been described with reference to one or more specific embodiments or implementations, those skilled in the art will recognize that many changes can be made thereto without departing from the spirit and scope of this disclosure. Each of these implementations and its obvious variations are considered to fall within the spirit and scope of this disclosure. It is also contemplated that further implementations of aspects of this disclosure may combine any number of features from any of the implementations described herein.

Claims

1. A user interface for a respiratory therapy system, the user interface comprising: A strap assembly configured to be positioned generally around at least a portion of the user's head when the user wears the user interface; A frame connected to the strap assembly, the frame defining an opening; A connector having a first portion and a second portion, the first portion being configured to be at least partially positioned within the aperture of the frame, such that the connector is physically and electrically connected to the frame. A gasket, which is connected to the frame, such that the gasket is in fluid communication with the interior of the connector; and One or more sensors are coupled to the user interface, the one or more sensors including at least a first radio frequency sensor coupled to the pad or the frame, and a second radio frequency sensor coupled to the connector. The data from the first radio frequency sensor is transmittable via a first electrical path between the first radio frequency sensor and the second radio frequency sensor, the first electrical path being at least partially wireless and / or inductive, and the data from the first radio frequency sensor is transmittable via a second electrical path between the second radio frequency sensor and the control system and storage device of the respiratory therapy system.

2. The user interface according to claim 1, wherein, The first radio frequency sensor is electrically connected to the frame, so that data from the first radio frequency sensor can be transmitted through the frame via the first electrical path.

3. The user interface according to claim 2, wherein, The frame is releasably connected to the strap assembly.

4. The user interface according to claim 1, wherein, The frame is configured to be near the user's face when the strap assembly is positioned approximately around a portion of the user's head.

5. The user interface according to claim 1, wherein, The connector is releasably coupled to the frame.

6. The user interface according to claim 1, wherein, The respiratory therapy system includes a respiratory therapy device, a catheter, and the user interface, the catheter being configured to be in fluid communication with the respiratory therapy device and the user interface.

7. The user interface according to claim 1, wherein, The second portion of the connector is configured to be physically and electrically coupled to the conduit, such that the connector is in fluid communication with the conduit.

8. The user interface according to claim 7, wherein, The conduit is configured to be in fluid communication with the air outlet of a respiratory therapy device, which includes a blower motor operable to generate a pressurized airflow exiting the air outlet.

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

10. The user interface according to claim 9, wherein, The first portion of the connector is annular and configured to be inserted into the aperture of the frame.

11. The user interface according to claim 10, wherein, The connector includes a fastener configured to secure the connector to the frame.

12. The user interface according to claim 11, wherein, The annular protrusion includes a peripheral flange, and the fastener of the connector includes a deflectable latch configured to slide on the peripheral flange of the annular protrusion to secure the connector to the frame.

13. The user interface according to claim 9, wherein, The connector includes one or more electrical contacts.

14. The user interface according to claim 13, wherein, Each of the one or more electrical contacts of the connector is at least a partially annular electrical contact.

15. The user interface according to claim 13, wherein, The first radio frequency sensor is electrically connected to at least one of the one or more electrical contacts of the connector to electrically connect the first radio frequency sensor to the connector, such that data generated by the sensor can be transmitted via the electrical contacts of the connector.

16. The user interface according to claim 13, wherein, The frame includes one or more electrical contacts.

17. The user interface according to claim 16, wherein, Each of the one or more electrical contacts in the frame is at least a partially annular electrical contact.

18. The user interface according to claim 16, wherein, When the connector is attached to the frame, each of the one or more electrical contacts of the connector contacts a corresponding one of the one or more electrical contacts of the frame, thereby electrically connecting the frame to the connector so that data from the first radio frequency sensor can be transmitted via the electrical contacts of the frame.

19. The user interface according to claim 18, wherein, Each of one or more electrical contacts of the connector is an annular electrical contact disposed on the outer surface of the annular first portion of the connector.

20. The user interface according to claim 19, wherein, Each of the one or more electrical contacts of the frame is disposed on the inner surface of the annular protrusion of the frame.

21. The user interface according to claim 18, wherein, Each of the one or more electrical contacts of the frame is an annular electrical contact disposed on the inner surface of the annular protrusion of the frame.

22. The user interface according to claim 21, wherein, Each of one or more electrical contacts of the connector is disposed on the outer surface of the annular first portion of the connector.

23. The user interface according to claim 18, wherein, The first radio frequency sensor is electrically connected to at least one of the one or more electrical contacts of the frame, such that data from the first radio frequency sensor can be transmitted via the one or more electrical contacts of the frame and the one or more electrical contacts of the connector.

24. The user interface according to claim 18, wherein, The strap assembly includes a plurality of straps, and the one or more sensors include an additional sensor coupled to at least one of the plurality of straps.

25. The user interface according to claim 24, wherein, The frame includes a strap attachment point configured to connect to the end of one of the plurality of straps, the strap attachment point including one or more electrical contacts electrically connected to one or more electrical contacts of the frame.

26. The user interface according to claim 25, wherein: The additional sensor is electrically connected to one or more electrical contacts of the strap attachment point, such that data generated by the additional sensor can be transmitted via one or more electrical contacts of the strap attachment point, one or more electrical contacts of the frame, and one or more electrical contacts of the connector. as well as The one or more electrical contacts of the strap attachment point and the one or more electrical contacts of the frame are electrically connected by: (i) at least one wire connecting the one or more electrical contacts of the strap attachment point and the one or more annular contacts of the frame; (ii) at least one electrical trace formed on the second surface of the body of the frame and connecting the one or more electrical contacts of the strap attachment point and the one or more electrical contacts of the frame; or (iii) at least one electrical trace formed in the body of the frame between the first surface and the second surface and connecting the one or more electrical contacts of the strap attachment point and the one or more electrical contacts of the frame.

27. The user interface according to claim 26, wherein: The additional sensor is electrically connected to one or more electrical contacts formed at the end of one of the plurality of straps, 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 of the strap attachment point, the one or more electrical contacts of the frame, and the one or more electrical contacts of the connector. or The strap attachment point includes a first magnet adjacent to one or more electrical contacts of the strap attachment point, and wherein the end of one of the plurality of straps includes a second magnet adjacent to one or more electrical contacts of the end of the one of the plurality of straps, wherein when the end of the one of the plurality of straps is attached to the frame, the first magnet magnetically attracts and contacts the second magnet, thereby fixing the one or more electrical contacts of the strap attachment point into 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 path having a first end at one or more electrical contacts at the end of one of the plurality of straps, and a second end at a portion of the strap assembly adjacent to the user's target area. The electrical path of the strap assembly is formed by at least one wire extending through the interior of one of the plurality of straps, and / or by electrical traces on the surface of the strap assembly. The additional sensor is positioned adjacent to the user's target area and electrically connected to the second end of the electrical path of the strap assembly, such that data generated by the additional sensor can be transmitted via the second end of the electrical path of the strap assembly, the one or more electrical contacts at the end of 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.

28. The user interface according to claim 27, wherein, The additional sensor includes a contact portion and a wire, the contact portion being configured to contact the user's target area, the wire electrically connecting the contact portion of the sensor to a second end of the electrical path of the strap assembly, and wherein the user's target area is the user's face, the user's forehead, the user's temple, the user's throat, or any combination thereof.

29. The user interface according to claim 28, wherein, The one or more sensors include contact sensors configured to contact the user's target area and non-contact sensors disposed in the frame or the connector.

30. The user interface according to claim 29, wherein, The contact sensor is 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 skin conductance response (GSR) sensor, or any combination thereof.

31. The user interface according to claim 29 or 30, wherein, The non-contact sensor is a carbon dioxide (CO2) sensor, an oxygen (O2) sensor, a pressure sensor, a temperature sensor, a motion sensor, an acoustic sensor, a microphone, or any combination thereof.

32. The user interface according to claim 1, wherein, The user interface includes an extension strip configured to extend from the upper end of the frame to the user's forehead when the user wears the user interface, and wherein the strap assembly includes: a rear portion configured to be positioned at the rear of the user's head when the user wears the user interface; a pair of lower straps extending from the rear portion and configured to connect to opposite sides of the lower end of the frame; and a pair of upper straps extending from the rear portion and configured to connect to opposite sides of the lower end of the frame.

33. The user interface according to claim 32, wherein, The one or more sensors include an additional sensor configured to be adjacent to the user's forehead when the user wears the user interface, the additional sensor being electrically connected to the connector via 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.

34. The user interface according to claim 32, wherein, The one or more sensors include an additional sensor configured to be adjacent to the user's temple when the user interface is worn by the user. The additional sensor is electrically connected to the connector via one of the pair of upper straps, the extension strip, and the frame, such that data generated by the additional sensor can be transmitted via one of the pair of upper straps, the extension strip, the frame, and the connector.

35. The user interface according to claim 32, wherein, The one or more sensors include an additional sensor configured to be adjacent to the user's throat when the user wears the user interface, the additional sensor being electrically connected to the connector via one of the pair of lower straps and the frame, such that data generated by the additional sensor can be transmitted via one of the pair of lower straps, the frame, and the connector.

36. The user interface according to claim 1, wherein, The first electrical path between the first radio frequency sensor and the second radio frequency sensor includes one or more wires that are electrically connected to the first radio frequency sensor and extend toward the second radio frequency sensor into the frame.

37. The user interface according to claim 36, wherein, The first electrical path between the first radio frequency sensor and the second radio frequency sensor includes: a first electrical connection between the first radio frequency sensor and the frame formed by the one or more wires, and a second electrical connection between the frame and the second radio frequency sensor that does not include any wires.

38. The user interface according to claim 37, wherein, The frame includes a first hollow portion and a second hollow portion, each connected to the pad and the connector and extending from the connector toward the opening of the frame, the first hollow portion and the second hollow portion being separate from each other such that the first hollow portion and the second hollow portion each form two different channels for fluidly connecting the pad to the connector; And the one or more wires of the first electrical path include: (i) at least one wire passing through or extending along the first hollow portion from the first radio frequency sensor to the second radio frequency sensor, (ii) at least one wire passing through or extending along the second hollow portion from the first radio frequency sensor to the second radio frequency sensor, or both (iii), (i) and (ii).

39. The user interface according to claim 1, wherein, The first electrical path between the first radio frequency sensor and the second radio frequency sensor includes at least one wire extending from the first radio frequency sensor and at least partially passing through the frame.

40. The user interface according to claim 1, wherein, Both the first radio frequency sensor and the second radio frequency sensor are non-contact sensors.

41. The user interface according to claim 1, wherein, The first radio frequency sensor is a radio frequency transceiver or a radio frequency transmitter.

42. The user interface according to claim 1, wherein, The second radio frequency sensor is a radio frequency transceiver or a radio frequency receiver.

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