SYSTEMS AND METHODS FOR INJECTING SUBSTANCES INTO A RESPIRATORY SYSTEM

A method for delivering a substance into an airway of a user via a respiratory system comprises receiving the substance within a receptacle; receiving physiological data; determining one or more sleep-related parameters based on the physiological data; and modifying the delivery of the substance into the airway of the user based at least in part on the one or more sleep-related parameters. The respiratory system includes a respiratory device configured to supply pressurized air to the airway of the user via a conduit and a user interface. The respiratory device, the user interface, and the conduit form an air pathway. The respiratory device is configured to include or engage the receptacle such that an outlet of the receptacle is in direct or indirect fluid communication with the air pathway.

TECHNICAL FIELD

The present disclosure relates generally to systems and methods for delivering medicine to a user, and more particularly, to systems and methods for delivering medicine to a user through an air pathway of a respiratory system.

BACKGROUND

Various systems exist for aiding users experiencing sleep apnea and related respiratory disorders. A range of respiratory disorders exist that can impact users. Certain disorders are characterized by particular events (e.g., apneas, hypopneas, hyperpneas, or any combination thereof). Examples of respiratory disorders include Obstructive Sleep Apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD), and Chest wall disorders. At least some of these events and disorders can be treated or at least ameliorated with medicine. Thus, a need exists for systems and methods for delivering medicine to the user utilizing the air pathway of the respiratory system. The present disclosure is directed to solving these and other problems.

SUMMARY

According to some implementations of the present disclosure, a method for delivering a substance into an airway of a user via a respiratory system comprises receiving the substance within a receptacle; receiving physiological data; determining one or more sleep-related parameters based on the physiological data; and modifying the delivery of the substance into the airway of the user based at least in part on the one or more sleep-related parameters.

According to some implementations of the present disclosure, a method for delivering a substance into an airway of a user via a respiratory system comprises receiving the substance within a receptacle; receiving physiological data; determining a current sleep stage of the user based on the physiological data, other data, or both; and modifying the delivery of the substance into the airway of the user based at least in part on the current sleep stage of the user.

According to some implementations of the present disclosure, a method for delivering a substance into an airway of a user via a respiratory system comprises receiving the substance within a receptacle; receiving physiological data; determining whether the user has experienced a predetermined event based on the physiological data; and modifying the delivery of the substance into the airway of the user based at least in part on the predetermined event.

According to some implementations of the present disclosure, a method for delivering a substance into an airway of a user via a respiratory system comprises receiving the substance within a receptacle; receiving physiological data based on exhaled breath of the user; determining the effectiveness of the substance based on the physiological data; and modifying the delivery of the substance into the airway of the user based at least in part on the determined effectiveness of the substance.

According to some implementations, a respiratory therapy system comprises a respiratory device and a receptacle. The respiratory device is configured to supply pressurized air to an airway of a user via a user interface coupled to the respiratory device via a conduit. The respiratory device, the user interface, and the conduit form an air pathway. The receptacle includes a substance therein, and is fluidly coupled to the air pathway so that the substance can be delivered into the air pathway.

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

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

DETAILED DESCRIPTION

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

Obstructive Sleep Apnea (OSA) is a form of Sleep Disordered Breathing (SDB), and is characterized by events including occlusion or obstruction of the upper air passage during sleep resulting from a combination of an abnormally small upper airway and the normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall. Central Sleep Apnea (CSA) is another form of SDB that results when the brain temporarily stops sending signals to the muscles that control breathing. More generally, an apnea generally refers to the cessation of breathing caused by blockage of the air or the stopping of the breathing function. Typically, the individual will stop breathing for between about 15 seconds and about 30 seconds during an obstructive sleep apnea event.

Other types of apneas include hypopnea, hyperpnea, and hypercapnia. Hypopnea is generally characterized by slow or shallow breathing caused by a narrowed airway, as opposed to a blocked airway. Hyperpnea is generally characterized by an increase depth and/or rate of breathing. Hypercapnia is generally characterized by elevated or excessive carbon dioxide in the bloodstream, typically caused by inadequate respiration.

Cheyne-Stokes Respiration (CSR) is another form of SDB. CSR is a disorder of a patient's respiratory controller in which there are rhythmic alternating periods of waxing and waning ventilation known as CSR cycles. CSR is characterized by repetitive de-oxygenation and re-oxygenation of the arterial blood.

Chronic Obstructive Pulmonary Disease (COPD) encompasses any of a group of lower airway diseases that have certain characteristics in common, such as increased resistance to air movement, extended expiratory phase of respiration, and loss of the normal elasticity of the lung.

Neuromuscular Disease (NMD) encompasses many diseases and ailments that impair the functioning of the muscles either directly via intrinsic muscle pathology, or indirectly via nerve pathology. Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the thoracic cage.

These and other disorders are characterized by particular events (e.g., snoring, an apnea, a hypopnea, a restless leg, a sleeping disorder, choking, an increased heart rate, labored breathing, an asthma attack, an epileptic episode, a seizure, or any combination thereof) that occur when the individual is sleeping.

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

Referring toFIG.1, a system100, according to some implementations of the present disclosure, is illustrated. The system100is for providing a variety of different sensors related to a user's use of a respiratory system, among other uses. The system100includes a control system110, a memory device114, an electronic interface119, one or more sensors130, and one or more external devices170. In some implementations, the system100further includes a respiratory system120that includes a respiratory device122, a blood pressure device181, an activity tracker191, or any combination thereof. The system100can be used to deliver a substance to the user's airway.

The control system110includes one or more processors112(hereinafter, processor112). The control system110is generally used to control (e.g., actuate) the various components of the system100and/or analyze data obtained and/or generated by the components of the system100. The processor112can be a general or special purpose processor or microprocessor. While one processor112is shown inFIG.1, the control system110can include any suitable number of processors (e.g., one processor, two processors, five processors, ten processors, etc.) that can be in a single housing, or located remotely from each other. The control system110can be coupled to and/or positioned within, for example, a housing of the external device170, and/or within a housing of one or more of the sensors130. The control system110can be centralized (within one such housing) or decentralized (within two or more of such housings, which are physically distinct). In such implementations including two or more housings containing the control system110, such housings can be located proximately and/or remotely from each other.

The memory device114stores machine-readable instructions that are executable by the processor112of the control system110. The memory device114can be any suitable computer readable storage device or media, such as, for example, a random or serial access memory device, a hard drive, a solid state drive, a flash memory device, etc. While one memory device114is shown inFIG.1, the system100can include any suitable number of memory devices114(e.g., one memory device, two memory devices, five memory devices, ten memory devices, etc.). The memory device114can be coupled to and/or positioned within a housing of any one or more of the sensors130. Like the control system110, the memory device114can be centralized (within one such housing) or decentralized (within two or more of such housings, which are physically distinct).

In some implementations, the memory device114(FIG.1) stores a user profile associated with the user. The user profile can include, for example, demographic information associated with the user, biometric information associated with the user, medical information associated with the user, self-reported user feedback, sleep parameters associated with the user (e.g., sleep-related parameters recorded from one or more earlier sleep sessions), or any combination thereof. The demographic information can include, for example, information indicative of an age of the user, a gender of the user, a race of the user, a family medical history, an employment status of the user, an educational status of the user, a socioeconomic status of the user, or any combination thereof. The medical information can include, for example, information indicative of one or more medical conditions associated with the user, medication usage by the user, or both. The medical information data can further include a multiple sleep latency test (MSLT) test result or score and/or a Pittsburgh Sleep Quality Index (PSQI) score or value. The self-reported user feedback can include information indicative of a self-reported subjective sleep score (e.g., poor, average, excellent), a self-reported subjective stress level of the user, a self-reported subjective fatigue level of the user, a self-reported subjective health status of the user, a recent life event experienced by the user, or any combination thereof.

The electronic interface119is configured to receive data (e.g., physiological and/or audio data) from the one or more sensors130such that the data can be stored in the memory device114and/or analyzed by the processor112of the control system110. The electronic interface119can communicate with the one or more sensors130using a wired connection or a wireless connection (e.g., using an RF communication protocol, a WiFi communication protocol, a Bluetooth communication protocol, an IR communication protocol, over a cellular network, over any other optical communication protocol, etc.). The electronic interface119can include an antenna, a receiver (e.g., an RF receiver), a transmitter (e.g., an RF transmitter), a transceiver, or any combination thereof. The electronic interface119can also include one more processors and/or one more memory devices that are the same as, or similar to, the processor112and the memory device114described herein. In some implementations, the electronic interface119is coupled to or integrated in the external device170. In other implementations, the electronic interface119is coupled to or integrated (e.g., in a housing) with the control system110and/or the memory device114.

As noted above, in some implementations, the system100optionally includes a respiratory system120(also referred to as a respiratory therapy system). The respiratory system120can include a respiratory device122(also referred to as a respiratory pressure therapy device), a user interface124, a conduit126(also referred to as a tube or an air circuit), a display device128, a humidification tank129, or any combination thereof. The respiratory device122, the user interface124, and the conduit126form an air pathway of the respiratory system120. In some implementations, the control system110, the memory device114, the display device128, one or more of the sensors130, and the humidification tank129are part of the respiratory device122. Respiratory pressure therapy refers to the application of a supply of air to an entrance to a user's airways at a controlled target pressure that is nominally positive with respect to atmosphere throughout the user's breathing cycle (e.g., in contrast to negative pressure therapies such as the tank ventilator or cuirass). The respiratory system120is generally used to treat individuals suffering from one or more sleep-related respiratory disorders (e.g., obstructive sleep apnea, central sleep apnea, or mixed sleep apnea), other respiratory disorders such as COPD, or other disorders leading to respiratory insufficiency, that may manifest either during sleep or wakefulness.

The respiratory device122is generally used to generate pressurized air that is delivered to a user (e.g., using one or more motors that drive one or more compressors). In some implementations, the respiratory device122generates continuous constant air pressure that is delivered to the user. In other implementations, the respiratory device122generates two or more predetermined pressures (e.g., a first predetermined air pressure and a second predetermined air pressure). In still other implementations, the respiratory device122is configured to generate a variety of different air pressures within a predetermined range. For example, the respiratory device122can deliver at least about 6 cm H2O, at least about 10 cm H2O, at least about 20 cm H2O, between about 6 cm H2O and about 10 cm H2O, between about 7 cm H2O and about 12 cm H2O, etc. The respiratory device122can also deliver pressurized air at a predetermined flow rate between, for example, about −20 L/min and about 150 L/min, while maintaining a positive pressure (relative to the ambient pressure). In some implementations, the control system110, the memory device114, the electronic interface119, or any combination thereof can be coupled to and/or positioned within a housing of the respiratory device122.

The user interface124engages a portion of the user's face and delivers pressurized air from the respiratory device122to the user's airway to aid in preventing the airway from narrowing and/or collapsing during sleep. This may also increase the user's oxygen intake during sleep. Depending upon the therapy to be applied, the user interface124may form a seal, for example, with a region or portion of the user's face, to facilitate the delivery of gas at a pressure at sufficient variance with ambient pressure to effect therapy, for example, at a positive pressure of about 10 cm H2O relative to ambient pressure. For other forms of therapy, such as the delivery of oxygen, the user interface may not include a seal sufficient to facilitate delivery to the airways of a supply of gas at a positive pressure of about 10 cm H2O.

The system also includes a receptacle300configured to receive and hold the substance. In the illustrated implementation, the receptacle300is shown as being separate from the respiratory system120. In these implementations, the receptacle300can be a physical separate component that can be added to the respiratory system120when in use, for example by physical coupling the receptacle300to any component of the respiratory system120. In other implementations, the receptacle300may be integrally built into any of the components of the respiratory system120, for example being positioned inside the respiratory device122, or as part of the user interface124or the conduit126.

As shown inFIG.2, in some implementations, the user interface124is or includes a facial mask that covers the nose and mouth of the user. Alternatively, the user interface124is or includes a nasal mask that provides air to the nose of the user or a nasal pillow mask that delivers air directly to the nostrils of the user. The user interface124can include a strap assembly that has a plurality of straps (e.g., including hook and loop fasteners) for positioning and/or stabilizing the user interface124on a portion of the user interface124on a desired location of the user (e.g., the face), and a conformal cushion (e.g., silicone, plastic, foam, etc.) that aids in providing an air-tight seal between the user interface124and the user. The user interface124can also include one or more vents for permitting the escape of carbon dioxide and other gases exhaled by the user210. In other implementations, the user interface124includes a mouthpiece (e.g., a night guard mouthpiece molded to conform to the user's teeth, a mandibular repositioning device, etc.).

The conduit126allows the flow of air between two components of a respiratory system120, such as the respiratory device122and the user interface124. In some implementations, there can be separate limbs of the conduit for inhalation and exhalation. In other implementations, a single limb conduit is used for both inhalation and exhalation.

One or more of the respiratory device122, the user interface124, the conduit126, the display device128, and the humidification tank129can contain one or more sensors (e.g., a pressure sensor, a flow rate sensor, or more generally any of the other sensors130described herein). These one or more sensors can be used, for example, to measure the air pressure and/or flow rate of pressurized air supplied by the respiratory device122.

The display device128is generally used to display image(s) including still images, video images, or both and/or information regarding the respiratory device122. For example, the display device128can provide information regarding the status of the respiratory device122(e.g., whether the respiratory device122is on/off, the pressure of the air being delivered by the respiratory device122, the temperature of the air being delivered by the respiratory device122, etc.) and/or other information (e.g., a sleep score or a therapy score (also referred to as a myAir™ score), the current date/time, personal information for the user210, etc.). In some implementations, the display device128acts as a human-machine interface (HMI) that includes a graphic user interface (GUI) configured to display the image(s) as an input interface. The display device128can be an LED display, an OLED display, an LCD display, or the like. The input interface can be, for example, a touchscreen or touch-sensitive substrate, a mouse, a keyboard, or any sensor system configured to sense inputs made by a human user interacting with the respiratory device122.

The humidification tank129is coupled to or integrated in the respiratory device122and includes a reservoir of water that can be used to humidify the pressurized air delivered from the respiratory device122. The respiratory device122can include a heater to heat the water in the humidification tank129in order to humidify the pressurized air provided to the user. Additionally, in some implementations, the conduit126can also include a heating element (e.g., coupled to and/or imbedded in the conduit126) that heats the pressurized air delivered to the user. In other implementations, the respiratory device122or the conduit126can include a waterless humidifier. The waterless humidifier can incorporate sensors that interface with other sensor positioned elsewhere in system100.

The respiratory system120can be used, for example, as a ventilator or a positive airway pressure (PAP) system, such as a continuous positive airway pressure (CPAP) system, an automatic positive airway pressure system (APAP), a bi-level or variable positive airway pressure system (BPAP or VPAP), or any combination thereof. The CPAP system delivers a predetermined air pressure (e.g., determined by a sleep physician) to the user. The APAP system automatically varies the air pressure delivered to the user based at least in part on, for example, respiration data associated with the user. The BPAP or VPAP system is configured to deliver a first predetermined pressure (e.g., an inspiratory positive airway pressure or IPAP) and a second predetermined pressure (e.g., an expiratory positive airway pressure or EPAP) that is lower than the first predetermined pressure.

Referring toFIG.2, a portion of the system100(FIG.1), according to some implementations, is illustrated. A user210of the respiratory system120and a bed partner220are located in a bed230and are laying on a mattress232. The user interface124(e.g., a full facial mask) can be worn by the user210during a sleep session. The user interface124is fluidly coupled and/or connected to the respiratory device122via the conduit126. In turn, the respiratory device122delivers pressurized air to the user210via the conduit126and the user interface124to increase the air pressure in the throat of the user210to aid in preventing the airway from closing and/or narrowing during sleep. The respiratory device122can be positioned on a nightstand240that is directly adjacent to the bed230as shown inFIG.2, or more generally, on any surface or structure that is generally adjacent to the bed230and/or the user210.

Referring to back toFIG.1, the one or more sensors130of the system100include a pressure sensor132, a flow rate sensor134, temperature sensor136, a motion sensor138, a microphone140, a speaker142, a radio-frequency (RF) receiver146, a radio-frequency (RF) transmitter148, a camera150, an infrared (IR) sensor152, a photoplethysmogram (PPG) sensor154, an electrocardiogram (ECG) sensor156, an electroencephalography (EEG) sensor158, a capacitive sensor160, a force sensor162, a strain gauge sensor164, an electromyography (EMG) sensor166, an oxygen sensor168, an analyte sensor174, a moisture sensor176, a light detection and ranging (LiDAR) sensor178, or any combination thereof. Generally, each of the one or sensors130are configured to output sensor data that is received and stored in the memory device114or one or more other memory devices. The sensors130can also include, an electrooculography (EOG) sensor, a peripheral oxygen saturation (SpO2) sensor, a galvanic skin response (GSR) sensor, a carbon dioxide (CO2) sensor, or any combination thereof.

While the one or more sensors130are shown and described as including each of the pressure sensor132, the flow rate sensor134, the temperature sensor136, the motion sensor138, the microphone140, the speaker142, the RF receiver146, the RF transmitter148, the camera150, the IR sensor152, the PPG sensor154, the ECG sensor156, the EEG sensor158, the capacitive sensor160, the force sensor162, the strain gauge sensor164, the EMG sensor166, the oxygen sensor168, the analyte sensor174, the moisture sensor176, and the LidAR sensor178, more generally, the one or more sensors130can include any combination and any number of each of the sensors described and/or shown herein.

The one or more sensors130can be used to generate, for example physiological data, audio data, or both. Physiological data generated by one or more of the sensors130can be used by the control system110to determine a sleep-wake signal associated with a user during the sleep session and one or more sleep-related parameters. The sleep-wake signal can be indicative of one or more sleep stages, including sleep, wakefulness, relaxed wakefulness, micro-awakenings, or distinct sleep stages such as a rapid eye movement (REM) stage, a first non-REM stage (often referred to as “N1”), a second non-REM stage (often referred to as “N2”), a third non-REM stage (often referred to as “N3”), or any combination thereof.

The sleep-wake signal can also be timestamped to indicate a time that the user enters the bed, a time that the user exits the bed, a time that the user attempts to fall asleep, etc. The sleep-wake signal can be measured one or more of the sensors130during the sleep session at a predetermined sampling rate, such as, for example, one sample per second, one sample per 30 seconds, one sample per minute, etc. Examples of the one or more sleep-related parameters that can be determined for the user during the sleep session based at least in part on the sleep-wake signal include a total time in bed, a total sleep time, a total wake time, a sleep onset latency, a wake-after-sleep-onset parameter, a sleep efficiency, a fragmentation index, an amount of time to fall asleep, a consistency of breathing rate, a fall asleep time, a wake time, a rate of sleep disturbances, a number of movements, or any combination thereof.

Physiological data and/or audio data generated by the one or more sensors130can also be used to determine a respiration signal associated with a user during a sleep session. the respiration signal is generally indicative of respiration or breathing of the user during the sleep session. The respiration signal can be indicative of, for example, a respiration rate, a respiration rate variability, an inspiration amplitude, an expiration amplitude, an inspiration-expiration amplitude ratio, an inspiration-expiration duration ratio, a number of events per hour, a pattern of events, pressure settings of the respiratory device122, or any combination thereof. The event(s) can include snoring, apneas, central apneas, obstructive apneas, mixed apneas, hypopneas, a mask leak (e.g., from the user interface124), a restless leg, a sleeping disorder, choking, an increased heart rate, a heart rate variation, labored breathing, an asthma attack, an epileptic episode, a seizure, a fever, a cough, a sneeze, a snore, a gasp, the presence of an illness such as the common cold or the flu, an elevated stress level, etc.

The pressure sensor132outputs pressure data that can be stored in the memory device114and/or analyzed by the processor112of the control system110. In some implementations, the pressure sensor132is an air pressure sensor (e.g., barometric pressure sensor) that generates sensor data indicative of the respiration (e.g., inhaling and/or exhaling) of the user of the respiratory system120and/or ambient pressure. In such implementations, the pressure sensor132can be coupled to or integrated in the respiratory device122. The pressure sensor132can 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, the pressure sensor132can be used to determine a blood pressure of the user.

The flow rate sensor134outputs flow rate data that can be stored in the memory device114and/or analyzed by the processor112of the control system110. In some implementations, the flow rate sensor134is used to determine an air flow rate from the respiratory device122, an air flow rate through the conduit126, an air flow rate through the user interface124, or any combination thereof. In such implementations, the flow rate sensor134can be coupled to or integrated in the respiratory device122, the user interface124, or the conduit126. The flow rate sensor134can be a mass flow rate sensor such as, for example, a rotary flow meter (e.g., Hall effect flow meters), a turbine flow meter, an orifice flow meter, an ultrasonic flow meter, a hot wire sensor, a vortex sensor, a membrane sensor, or any combination thereof.

The temperature sensor136outputs temperature data that can be stored in the memory device114and/or analyzed by the processor112of the control system110. In some implementations, the temperature sensor136generates temperatures data indicative of a core body temperature of the user210(FIG.2), a skin temperature of the user210, a temperature of the air flowing from the respiratory device122and/or through the conduit126, a temperature in the user interface124, an ambient temperature, or any combination thereof. The temperature sensor136can be, for example, a thermocouple sensor, a thermistor sensor, a silicon band gap temperature sensor or semiconductor-based sensor, a resistance temperature detector, or any combination thereof.

The motion sensor138outputs motion data that can be stored in the memory device114and/or analyzed by the processor112of the control system110. The motion sensor138can be used to detect movement of the user210during the sleep session, and/or detect movement of any of the components of the respiratory system120, such as the respiratory device122, the user interface124, or the conduit126. The motion sensor138can include one or more inertial sensors, such as accelerometers, gyroscopes, and magnetometers. The motion sensor138can be used to detect motion or acceleration associated with arterial pulses, such as pulses in or around the face of the user210and proximal to the user interface124, and configured to detect features of the pulse shape, speed, amplitude, or volume.

The microphone140outputs sound data that can be stored in the memory device114and/or analyzed by the processor112of the control system110. The audio data generated by the microphone140is reproducible as one or more sound(s) during a sleep session (e.g., sounds from the user210) to determine (e.g., using the control system110) one or more sleep-related parameters, as described in further detail herein. The audio data from the microphone140can also be used to identifying (e.g., using the control system110) an event experienced by the user during the sleep session, as described in further detail herein. The microphone140can be coupled to or integrated in the respiratory device122, the user interface124, the conduit126, or the external device170.

The speaker142outputs sound waves that are audible to a user of the system100(e.g., the user210ofFIG.2). The speaker142can be used, for example, as an alarm clock or to play an alert or message to the user210(e.g., in response to an event). In some implementations, the speaker142can be used to communicate the audio data generated by the microphone140to the user. The speaker142can be coupled to or integrated in the respiratory device122, the user interface124, the conduit126, or the external device170.

The microphone140and the speaker142can be used as separate devices. In some implementations, the microphone140and the speaker142can be combined into an acoustic sensor141, as described in, for example, WO 2018/050913, which is hereby incorporated by reference herein in its entirety. In such implementations, the speaker142generates or emits sound waves at a predetermined interval and the microphone140detects the reflections of the emitted sound waves from the speaker142. The sound waves generated or emitted by the speaker142have a frequency that is not audible to the human ear (e.g., below 20 Hz or above around 18 kHz) so as not to disturb the sleep of the user210or the bed partner220(FIG.2). Based at least in part on the data from the microphone140and/or the speaker142, the control system110can determine a location of the user210(FIG.2) and/or one or more of the sleep-related parameters described in herein. In some implementations, the speaker142is a bone conduction speaker. In some implementations, the one or more sensors130include (i) a first microphone that is the same or similar to the microphone140, and is integrated into the acoustic sensor141and (ii) a second microphone that is the same as or similar to the microphone140, but is separate and distinct from the first microphone that is integrated into the acoustic sensor141.

The RF transmitter148generates and/or emits radio waves having a predetermined frequency and/or a predetermined amplitude (e.g., within a high frequency band, within a low frequency band, long wave signals, short wave signals, etc.). The RF receiver146detects the reflections of the radio waves emitted from the RF transmitter148, and this data can be analyzed by the control system110to determine a location of the user210(FIG.2) and/or one or more of the sleep-related parameters described herein. An RF receiver (either the RF receiver146and the RF transmitter148or another RF pair) can also be used for wireless communication between the control system110, the respiratory device122, the one or more sensors130, the external device170, or any combination thereof. While the RF receiver146and RF transmitter148are shown as being separate and distinct elements inFIG.1, in some implementations, the RF receiver146and RF transmitter148are combined as a part of a radio-frequency (RF) sensor147. In some such implementations, the RF sensor147includes a control circuit. The specific format of the RF communication could be WiFi, Bluetooth, etc.

In some implementations, the RF sensor147is a part of a mesh system. One example of a mesh system is a WiFi mesh system, which can include mesh nodes, mesh router(s), and mesh gateway(s), each of which can be mobile/movable or fixed. In such implementations, the WiFi mesh system includes a WiFi router and/or a WiFi controller and one or more satellites (e.g., access points), each of which include an RF sensor that the is the same as, or similar to, the RF sensor147. The WiFi router and satellites continuously communicate with one another using WiFi signals. The WiFi mesh system can be used to generate motion data based at least in part on changes in the WiFi signals (e.g., differences in received signal strength) between the router and the satellite(s) due to an object or person moving partially obstructing the signals. The motion data can be indicative of motion, breathing, heart rate, gait, falls, behavior, etc., or any combination thereof.

The camera150outputs image data reproducible as one or more images (e.g., still images, video images, thermal images, or a combination thereof) that can be stored in the memory device114. The image data from the camera150can be used by the control system110to determine one or more of the sleep-related parameters described herein. For example, the image data from the camera150can be used to identify a location of the user, to determine a time when the user210enters the bed230(FIG.2), and to determine a time when the user210exits the bed230. The camera150can also be used to track eye movements, pupil dilation (if one or both of the user210's eyes are open), blink rate, or any changes during REM sleep. The camera150can also be used to track the position of the user, which can impact the duration and/or severity of apneic episodes in users with positional obstructive sleep apnea.

The IR sensor152outputs infrared image data reproducible as one or more infrared images (e.g., still images, video images, or both) that can be stored in the memory device114. The infrared data from the IR sensor152can be used to determine one or more sleep-related parameters during the sleep session, including a temperature of the user210and/or movement of the user210. The IR sensor152can also be used in conjunction with the camera150when measuring the presence, location, and/or movement of the user210. The IR sensor152can detect infrared light having a wavelength between about 700 nm and about 1 mm, for example, while the camera150can detect visible light having a wavelength between about 380 nm and about 740 nm.

The PPG sensor154outputs physiological data associated with the user210(FIG.2) that can be used to determine one or more sleep-related parameters, such as, for example, a heart rate, a heart rate pattern, a heart rate variability, a cardiac cycle, respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, estimated blood pressure parameter(s), or any combination thereof. The PPG sensor154can be worn by the user210, embedded in clothing and/or fabric that is worn by the user210, embedded in and/or coupled to the user interface124and/or its associated headgear (e.g., straps, etc.), etc.

The ECG sensor156outputs physiological data associated with electrical activity of the heart of the user210. In some implementations, the ECG sensor156includes one or more electrodes that are positioned on or around a portion of the user210during the sleep session. The physiological data from the ECG sensor156can be used, for example, to determine one or more of the sleep-related parameters described herein.

The EEG sensor158outputs physiological data associated with electrical activity of the brain of the user210. In some implementations, the EEG sensor158includes one or more electrodes that are positioned on or around the scalp of the user210during the sleep session. The physiological data from the EEG sensor158can be used, for example, to determine a sleep stage of the user210at any given time during the sleep session. In some implementations, the EEG sensor158can be integrated in the user interface124and/or the associated headgear (e.g., straps, etc.).

The capacitive sensor160, the force sensor162, and the strain gauge sensor164output data that can be stored in the memory device114and used by the control system110to determine one or more of the sleep-related parameters described herein. The EMG sensor166outputs physiological data associated with electrical activity produced by one or more muscles. The oxygen sensor168outputs oxygen data indicative of an oxygen concentration of gas (e.g., in the conduit126or at the user interface124). The oxygen sensor168can be, for example, an ultrasonic oxygen sensor, an electrical oxygen sensor, a chemical oxygen sensor, an optical oxygen sensor, or any combination thereof. In some implementations, the one or more sensors130also include a galvanic skin response (GSR) sensor, a blood flow sensor, a respiration sensor, a pulse sensor, a sphygmomanometer sensor, an oximetry sensor, or any combination thereof.

The analyte sensor174can be used to detect the presence of an analyte in the exhaled breath of the user210. The data output by the analyte sensor174can be stored in the memory device114and used by the control system110to determine the identity and concentration of any analytes in the user210's breath. In some implementations, the analyte sensor174is positioned near a mouth of the user210to detect analytes in breath exhaled from the user210's mouth. For example, when the user interface124is a facial mask that covers the nose and mouth of the user210, the analyte sensor174can be positioned within the facial mask to monitor the user210's mouth breathing. In other implementations, such as when the user interface124is a nasal mask or a nasal pillow mask, the analyte sensor174can be positioned near the nose of the user210to detect analytes in breath exhaled through the user210's nose. In still other implementations, the analyte sensor174can be positioned near the user210's mouth when the user interface124is a nasal mask or a nasal pillow mask. In this implementation, the analyte sensor174can be used to detect whether any air is inadvertently leaking from the user210's mouth. In some implementations, the analyte sensor174is a volatile organic compound (VOC) sensor that can be used to detect carbon-based chemicals or compounds, such as carbon dioxide. In some implementations, the analyte sensor174can also be used to detect whether the user210is breathing through their nose or mouth. For example, if the data output by an analyte sensor174positioned near the mouth of the user210or within the facial mask (in implementations where the user interface124is a facial mask) detects the presence of an analyte, the control system110can use this data as an indication that the user210is breathing through their mouth.

The moisture sensor176outputs data that can be stored in the memory device114and used by the control system110. The moisture sensor176can be used to detect moisture in various areas surrounding the user (e.g., inside the conduit126or the user interface124, near the user210's face, near the connection between the conduit126and the user interface124, near the connection between the conduit126and the respiratory device122, etc.). Thus, in some implementations, the moisture sensor176can be coupled to or integrated into the user interface124or in the conduit126to monitor the humidity of the pressurized air from the respiratory device122. In other implementations, the moisture sensor176is placed near any area where moisture levels need to be monitored. The moisture sensor176can also be used to monitor the humidity of the ambient environment surrounding the user210, for example the air inside the user210's bedroom. The moisture sensor176can also be used to track the user210's biometric response to environmental changes.

One or more LiDAR sensors178can be used for depth sensing. This type of optical sensor (e.g., laser sensor) can be used to detect objects and build three dimensional (3D) maps of the surroundings, such as of a living space. LiDAR can generally utilize a pulsed laser to make time of flight measurements. LiDAR is also referred to as 3D laser scanning. In an example of use of such a sensor, a fixed or mobile device (such as a smartphone) having a LiDAR sensor178can measure and map an area extending 5 meters or more away from the sensor. The LiDAR data can be fused with point cloud data estimated by an electromagnetic RADAR sensor, for example. The LiDAR sensor178may also use artificial intelligence (AI) to automatically geofence RADAR systems by detecting and classifying features in a space that might cause issues for RADAR systems, such a glass windows (which can be highly reflective to RADAR). LiDAR can also be used to provide an estimate of the height of a person, as well as changes in height when the person sits down, or falls down, for example. LiDAR may be used to form a 3D mesh representation of an environment. In a further use, for solid surfaces through which radio waves pass (e.g., radio-translucent materials), the LiDAR may reflect off such surfaces, thus allowing a classification of different type of obstacles.

While shown separately inFIG.1, any combination of the one or more sensors130can be integrated in and/or coupled to any one or more of the components of the system100, including the respiratory device122, the user interface124, the conduit126, the humidification tank129, the control system110, the external device170, or any combination thereof. For example, the acoustic sensor141and/or the RF sensor147can be integrated in and/or coupled to the external device170. In such implementations, the external device170can be considered a secondary device that generates additional or secondary data for use by the system100(e.g., the control system110) according to some aspects of the present disclosure. In some implementations, the pressure sensor132and/or the flow rate sensor134are integrated into and/or coupled to the respiratory device122. In some implementations, at least one of the one or more sensors130is not coupled to the respiratory device122, the control system110, or the external device170, and is positioned generally adjacent to the user210during the sleep session (e.g., positioned on or in contact with a portion of the user210, worn by the user210, coupled to or positioned on the nightstand, coupled to the mattress, coupled to the ceiling, etc.). More generally, the one or more sensors130can be positioned at any suitable location relative to the user210such that the one or more sensors130can generate physiological data associated with the user210and/or the bed partner220during one or more sleep session.

The data from the one or more sensors130can be analyzed to determine one or more sleep-related parameters, which can include a respiration signal, a respiration rate, a respiration pattern, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, an occurrence of one or more events, a number of events per hour, a pattern of events, an average duration of events, a range of event durations, a ratio between the number of different events, a sleep stage, an apnea-hypopnea index (AHI), or any combination thereof. The one or more events can include snoring, apneas, central apneas, obstructive apneas, mixed apneas, hypopneas, an intentional user interface leak, an unintentional user interface leak, a mouth leak, a cough, a restless leg, a sleeping disorder, choking, an increased heart rate, labored breathing, an asthma attack, an epileptic episode, a seizure, increased blood pressure, or any combination thereof. Many of these sleep-related parameters are physiological parameters, although some of the sleep-related parameters can be considered to be non-physiological parameters. Other types of physiological and non-physiological parameters can also be determined, either from the data from the one or more sensors130, or from other types of data.

The external device170(FIG.1) includes a display device172. The external device170can be, for example, a mobile device such as a smart phone, a tablet, a laptop, or the like. Alternatively, the external device170can be an external sensing system, a television (e.g., a smart television) or another smart home device (e.g., a smart speaker(s) such as Google Home, Amazon Echo, Alexa etc.). In some implementations, the user device is a wearable device (e.g., a smart watch). The display device172is generally used to display image(s) including still images, video images, or both. In some implementations, the display device172acts as a human-machine interface (HMI) that includes a graphic user interface (GUI) configured to display the image(s) and an input interface. The display device172can be an LED display, an OLED display, an LCD display, or the like. The input interface can be, for example, a touchscreen or touch-sensitive substrate, a mouse, a keyboard, or any sensor system configured to sense inputs made by a human user interacting with the external device170. In some implementations, one or more user devices can be used by and/or included in the system100.

The blood pressure device181is generally used to aid in generating physiological data for determining one or more blood pressure measurements associated with a user. The blood pressure device181can include at least one of the one or more sensors130to measure, for example, a systolic blood pressure component and/or a diastolic blood pressure component.

In some implementations, the blood pressure device181is a sphygmomanometer including an inflatable cuff that can be worn by a user and a pressure sensor (e.g., the pressure sensor132described herein). For example, as shown in the example ofFIG.2, the blood pressure device181can be worn on an upper arm of the user210. In such implementations where the blood pressure device181is a sphygmomanometer, the blood pressure device181also includes a pump (e.g., a manually operated bulb) for inflating the cuff. In some implementations, the blood pressure device181is coupled to the respiratory device122of the respiratory system120, which in turn delivers pressurized air to inflate the cuff. More generally, the blood pressure device181can be communicatively coupled with, and/or physically integrated in (e.g., within a housing), the control system110, the memory device114, the respiratory system120, the external device170, and/or the activity tracker191.

The activity tracker191is generally used to aid in generating physiological data for determining an activity measurement associated with the user. The activity measurement can include, for example, a number of steps, a distance traveled, a number of steps climbed, a duration of physical activity, a type of physical activity, an intensity of physical activity, time spent standing, a respiration rate, an average respiration rate, a resting respiration rate, a maximum respiration rate, a respiration rate variability, a heart rate, an average heart rate, a resting heart rate, a maximum heart rate, a heart rate variability, a number of calories burned, blood oxygen saturation, electrodermal activity (also known as skin conductance or galvanic skin response), or any combination thereof. The activity tracker191includes one or more of the sensors130described herein, such as, for example, the motion sensor138(e.g., one or more accelerometers and/or gyroscopes), the PPG sensor154, and/or the ECG sensor156.

In some implementations, the activity tracker191is a wearable device that can be worn by the user, such as a smartwatch, a wristband, a ring, or a patch. For example, referring toFIG.2, the activity tracker191is worn on a wrist of the user210. The activity tracker191can also be coupled to or integrated a garment or clothing that is worn by the user. Alternatively, still, the activity tracker191can also be coupled to or integrated in (e.g., within the same housing) the external device170. More generally, the activity tracker191can be communicatively coupled with, or physically integrated in (e.g., within a housing), the control system110, the memory device114, the respiratory system120, the external device170, and/or the blood pressure device181.

While the control system110and the memory device114are described and shown inFIG.1as being a separate and distinct component of the system100, in some implementations, the control system110and/or the memory device114are integrated in the external device170and/or the respiratory device122. Alternatively, in some implementations, the control system110or a portion thereof (e.g., the processor112) can be located in a cloud (e.g., integrated in a server, integrated in an Internet of Things (IoT) device, connected to the cloud, be subject to edge cloud processing, etc.), located in one or more servers (e.g., remote servers, local servers, etc., or any combination thereof.

While system100is shown as including all of the components described above, more or fewer components can be included in a system for canceling noises during use of the respiratory system120, according to implementations of the present disclosure. For example, a first alternative system includes the control system110, the memory device114, and at least one of the one or more sensors130. As another example, a second alternative system includes the control system110, the memory device114, at least one of the one or more sensors130, and the external device170. As yet another example, a third alternative system includes the control system110, the memory device114, the respiratory system120, at least one of the one or more sensors130, and the external device170. As a further example, a fourth alternative system includes the control system110, the memory device114, the respiratory system120, at least one of the one or more sensors130, the external device170, and the blood pressure device181and/or activity tracker191. Thus, various systems for delivering a substance into the user's airway can be formed using any portion or portions of the components shown and described herein and/or in combination with one or more other components.

As used herein, a sleep session can be defined in a number of ways based at least in part on, for example, an initial start time and an end time. In some implementations, a sleep session is a duration where the user is asleep, that is, the sleep session has a start time and an end time, and during the sleep session, the user does not wake until the end time. That is, any period of the user being awake is not included in a sleep session. From this first definition of sleep session, if the user wakes ups and falls asleep multiple times in the same night, each of the sleep intervals separated by an awake interval is a sleep session.

Alternatively, in some implementations, a sleep session has a start time and an end time, and during the sleep session, the user can wake up, without the sleep session ending, so long as a continuous duration that the user is awake is below an awake duration threshold. The awake duration threshold can be defined as a percentage of a sleep session. The awake duration threshold can be, for example, about twenty percent of the sleep session, about fifteen percent of the sleep session duration, about ten percent of the sleep session duration, about five percent of the sleep session duration, about two percent of the sleep session duration, etc., or any other threshold percentage. In some implementations, the awake duration threshold is defined as a fixed amount of time, such as, for example, about one hour, about thirty minutes, about fifteen minutes, about ten minutes, about five minutes, about two minutes, etc., or any other amount of time.

In some implementations, a sleep session is defined as the entire time between the time in the evening at which the user first entered the bed, and the time the next morning when user last left the bed. Put another way, a sleep session can be defined as a period of time that begins on a first date (e.g., Monday, Jan. 6, 2020) at a first time (e.g., 10:00 PM), that can be referred to as the current evening, when the user first enters a bed with the intention of going to sleep (e.g., not if the user intends to first watch television or play with a smart phone before going to sleep, etc.), and ends on a second date (e.g., Tuesday, Jan. 7, 2020) at a second time (e.g., 7:00 AM), that can be referred to as the next morning, when the user first exits the bed with the intention of not going back to sleep that next morning.

In some implementations, the user can manually define the beginning of a sleep session and/or manually terminate a sleep session. For example, the user can select (e.g., by clicking or tapping) one or more user-selectable element that is displayed on the display device172of the external device170(FIG.1) to manually initiate or terminate the sleep session.

Referring toFIG.3, an exemplary timeline301for a sleep session is illustrated. The timeline301includes an enter bed time (tbed), a go-to-sleep time (tGTS), an initial sleep time (tsleep), a first micro-awakening MA1, a second micro-awakening MA2, an awakening A, a wake-up time (twake), and a rising time (trise).

The enter bed time tbedis associated with the time that the user initially enters the bed (e.g., bed230inFIG.2) prior to falling asleep (e.g., when the user lies down or sits in the bed). The enter bed time tbedcan be identified based at least in part on a bed threshold duration to distinguish between times when the user enters the bed for sleep and when the user enters the bed for other reasons (e.g., to watch TV). For example, the bed threshold duration can 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. While the enter bed time tbedis described herein in reference to a bed, more generally, the enter time tbedcan refer to the time the user initially enters any location for sleeping (e.g., a couch, a chair, a sleeping bag, etc.).

The go-to-sleep time (GTS) is associated with the time that the user initially attempts to fall asleep after entering the bed (tbed). For example, after entering the bed, the user may engage in one or more activities to wind down prior to trying to sleep (e.g., reading, watching TV, listening to music, using the external device170, etc.). The initial sleep time (tsleep) is the time that the user initially falls asleep. For example, the initial sleep time (tsleep) can be the time that the user initially enters the first non-REM sleep stage.

The wake-up time twakeis the time associated with the time when the user wakes up without going back to sleep (e.g., as opposed to the user waking up in the middle of the night and going back to sleep). The user may experience one of more unconscious microawakenings (e.g., microawakenings MA1and MA2) having a short duration (e.g., 5 seconds, 10 seconds, 30 seconds, 1 minute, etc.) after initially falling asleep. In contrast to the wake-up time twake, the user goes back to sleep after each of the microawakenings MA1and MA2. Similarly, the user may have one or more conscious awakenings (e.g., awakening A) after initially falling asleep (e.g., getting up to go to the bathroom, attending to children or pets, sleep walking, etc.). However, the user goes back to sleep after the awakening A. Thus, the wake-up time twakecan be defined, for example, based at least in part on a wake 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.).

Similarly, the rising time triseis associated with the time when the user exits the bed and stays out of the bed with the intent to end the sleep session (e.g., as opposed to the user getting up during the night to go to the bathroom, to attend to children or pets, sleep walking, etc.). In other words, the rising time triseis the time when the user last leaves the bed without returning to the bed until a next sleep session (e.g., the following evening). Thus, the rising time trisecan be defined, for example, based at least in part on a rise threshold duration (e.g., the user has left the bed for at least 15 minutes, at least 20 minutes, at least 30 minutes, at least 1 hour, etc.). The enter bed time tbedtime for a second, subsequent sleep session can also be defined based at least in part on a rise threshold duration (e.g., the user has left the bed for at least 4 hours, at least 6 hours, at least 8 hours, at least 12 hours, etc.).

As described above, the user may wake up and get out of bed one more times during the night between the initial tbedand the final trise. In some implementations, the final wake-up time twakeand/or the final rising time trisethat are identified or determined based at least in part on a predetermined threshold duration of time subsequent to an event (e.g., falling asleep or leaving the bed). Such a threshold duration can be customized for the user. For a standard user which goes to bed in the evening, then wakes up and goes out of bed in the morning any period (between the user waking up (twake) or raising up (trise), and the user either going to bed (tbed), going to sleep (tGTS) or falling asleep (tsleep) of between about 12 and about 18 hours can be used. For users that spend longer periods of time in bed, shorter threshold periods may be used (e.g., between about 8 hours and about 14 hours). The threshold period may be initially selected and/or later adjusted based at least in part on the system monitoring the user's sleep behavior.

The total time in bed (TIB) is the duration of time between the time enter bed time tbedand the rising time trise. The total sleep time (TST) is associated with the duration between the initial sleep time and the wake-up time, excluding any conscious or unconscious awakenings and/or micro-awakenings therebetween. Generally, the total sleep time (TST) will be shorter than the total time in bed (TIB) (e.g., one minute short, ten minutes shorter, one hour shorter, etc.). For example, referring to the timeline301ofFIG.3, the total sleep time (TST) spans between the initial sleep time tsleepand the wake-up time twake, but excludes the duration of the first micro-awakening MA1, the second micro-awakening MA2, and the awakening A. As shown, in this example, the total sleep time (TST) is shorter than the total time in bed (TIB).

In some implementations, the total sleep time (TST) can be defined as a persistent total sleep time (PTST). In such implementations, the persistent total sleep time excludes a predetermined initial portion or period of the first non-REM stage (e.g., light sleep stage). For example, the predetermined initial portion can be between about 30 seconds and about 20 minutes, between about 1 minute and about 10 minutes, between about 3 minutes and about 5 minutes, etc. The persistent total sleep time is a measure of sustained sleep, and smooths the sleep-wake hypnogram. For example, when the user is initially falling asleep, the user may be in the first non-REM stage for a very short time (e.g., about 30 seconds), then back into the wakefulness stage for a short period (e.g., one minute), and then goes back to the first non-REM stage. In this example, the persistent total sleep time excludes the first instance (e.g., about 30 seconds) of the first non-REM stage.

In some implementations, the sleep session is defined as starting at the enter bed time (tbed) and ending at the rising time (trise), i.e., the sleep session is defined as the total time in bed (TIB). In some implementations, a sleep session is defined as starting at the initial sleep time (tsleep) and ending at the wake-up time (twake). In some implementations, the sleep session is defined as the total sleep time (TST). In some implementations, a sleep session is defined as starting at the go-to-sleep time (tGTS) and ending at the wake-up time (twake). In some implementations, a sleep session is defined as starting at the go-to-sleep time (tGTS) and ending at the rising time (trise). In some implementations, a sleep session is defined as starting at the enter bed time (tbed) and ending at the wake-up time (twake). In some implementations, a sleep session is defined as starting at the initial sleep time (tsleep) and ending at the rising time (trise).

Referring toFIG.4, an exemplary hypnogram400corresponding to the timeline301(FIG.3), according to some implementations, is illustrated. As shown, the hypnogram400includes a sleep-wake signal401, a wakefulness stage axis410, a REM stage axis420, a light sleep stage axis430, and a deep sleep stage axis440. The intersection between the sleep-wake signal401and one of the axes410-440is indicative of the sleep stage at any given time during the sleep session.

The sleep-wake signal401can be generated based at least in part on physiological data associated with the user (e.g., generated by one or more of the sensors130described herein). The sleep-wake signal can be indicative of one or more sleep stages, including wakefulness, relaxed wakefulness, microawakenings, a REM stage, a first non-REM stage, a second non-REM stage, a third non-REM stage, or any combination thereof. In some implementations, one or more of the first non-REM stage, the second non-REM stage, and the third non-REM stage can be grouped together and categorized as a light sleep stage or a deep sleep stage. For example, the light sleep stage can include the first non-REM stage and the deep sleep stage can include the second non-REM stage and the third non-REM stage. While the hypnogram400is shown inFIG.4as including the light sleep stage axis430and the deep sleep stage axis440, in some implementations, the hypnogram400can include an axis 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 can also be indicative of a respiration signal, a respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration amplitude ratio, an inspiration-expiration duration ratio, a number of events per hour, a pattern of events, or any combination thereof. Information describing the sleep-wake signal can be stored in the memory device114.

The hypnogram400can be used to determine one or more sleep-related parameters, such as, for example, a sleep onset latency (SOL), wake-after-sleep onset (WASO), a sleep efficiency (SE), a sleep fragmentation index, sleep blocks, or any combination thereof.

The sleep onset latency (SOL) is defined as the time between the go-to-sleep time (tGTS) and the initial sleep time (tsleep). In other words, the sleep onset latency is indicative of the time that it took the user to actually fall asleep after initially attempting to fall asleep. In some implementations, the sleep onset latency is defined as a persistent sleep onset latency (PSOL). The persistent sleep onset latency differs from the sleep onset latency in that the persistent sleep onset latency is defined as the duration time between the go-to-sleep time and a predetermined amount of sustained sleep. In some implementations, the predetermined amount of sustained sleep can include, for example, at least 10 minutes of sleep within the second non-REM stage, the third non-REM stage, and/or the REM stage with no more than 2 minutes of wakefulness, the first non-REM stage, and/or movement therebetween. In other words, the persistent sleep onset latency requires up to, for example, 8 minutes of sustained sleep within the second non-REM stage, the third non-REM stage, and/or the REM stage. In other implementations, the predetermined amount of sustained sleep can include at least 10 minutes of sleep within the first non-REM stage, the second non-REM stage, the third non-REM stage, and/or the REM stage subsequent to the initial sleep time. In such implementations, the predetermined amount of sustained sleep can exclude any micro-awakenings (e.g., a ten second micro-awakening does not restart the 10-minute period).

The wake-after-sleep onset (WASO) is associated with the total duration of time that the user is awake between the initial sleep time and the wake-up time. Thus, the wake-after-sleep onset includes short and micro-awakenings during the sleep session (e.g., the micro-awakenings MA1and MA2shown inFIG.4), whether conscious or unconscious. In some implementations, the wake-after-sleep onset (WASO) is defined as a persistent wake-after-sleep onset (PWASO) that only includes the total durations of awakenings having a predetermined length (e.g., greater than 10 seconds, greater than 30 seconds, greater than 60 seconds, greater than about 5 minutes, greater than about 10 minutes, etc.)

The sleep efficiency (SE) is determined as a ratio of the total time in bed (TIB) and the total sleep time (TST). For example, if the total time in bed is 8 hours and the total sleep time is 7.5 hours, the sleep efficiency for that sleep session is 93.75%. The sleep efficiency is indicative of the sleep hygiene of the user. For example, if the user enters the bed and spends time engaged in other activities (e.g., watching TV) before sleep, the sleep efficiency will be reduced (e.g., the user is penalized). In some implementations, the sleep efficiency (SE) can be calculated based at least in part on the total time in bed (TIB) and the total time that the user is attempting to sleep. In such implementations, the total time that the user is attempting to sleep is defined as the duration between the go-to-sleep (GTS) time and the rising time described herein. For example, if the total sleep time is 8 hours (e.g., between 11 PM and 7 AM), the go-to-sleep time is 10:45 PM, and the rising time is 7:15 AM, in such implementations, the sleep efficiency parameter is calculated as about 94%.

The fragmentation index is determined based at least in part on the number of awakenings during the sleep session. For example, if the user had two micro-awakenings (e.g., micro-awakening MA1and micro-awakening MA2shown inFIG.4), the fragmentation index can be expressed as 2. In some implementations, the fragmentation index is scaled between a predetermined range of integers (e.g., between 0 and 10).

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

In some implementations, the systems and methods described herein can include generating or analyzing a hypnogram including a sleep-wake signal to determine or identify the enter bed time (tbed), the go-to-sleep time (tGTS), the initial sleep time (tsleep), one or more first micro-awakenings (e.g., MA1and MA2), the wake-up time (twake), the rising time (trise), or any combination thereof based at least in part on the sleep-wake signal of a hypnogram.

In other implementations, one or more of the sensors130can be used to determine or identify the enter bed time (tbed), the go-to-sleep time (tGTS), the initial sleep time (tsleep), one or more first micro-awakenings (e.g., MA1and MA2), the wake-up time (twake), the rising time (trise), or any combination thereof, which in turn define the sleep session. For example, the enter bed time tbedcan be determined based at least in part on, for example, data generated by the motion sensor138, the microphone140, the camera150, or any combination thereof. The go-to-sleep time can be determined based at least in part on, for example, data from the motion sensor138(e.g., data indicative of no movement by the user), data from the camera150(e.g., data indicative of no movement by the user and/or that the user has turned off the lights), data from the microphone140(e.g., data indicative of the using turning off a TV), data from the external device170(e.g., data indicative of the user no longer using the external device170), data from the pressure sensor132and/or the flow rate sensor134(e.g., data indicative of the user turning on the respiratory device122, data indicative of the user donning the user interface124, etc.), or any combination thereof.

Continuous positive airway pressure (CPAP) systems are often used to treat individuals suffering from sleep-related respiratory disorders. Generally, the user of a CPAP system wears a user interface (such as a mask), which delivers pressurized air from a respiratory device into the throat of the user to aid in preventing the airway from narrowing and/or collapsing during sleep, thereby increasing the user's oxygen intake. Many CPAP systems generate audible noise during use that can interfere with or interrupt the user's sleep. This noise often arises from the operation of a motor within the respiratory device that generates the pressurized air. Further, noise can arise from air leaks in CPAP systems (e.g., from a mask of the CPAP system). Detecting and canceling such noises during operation of the CPAP system is useful in aiding users and their bed partners to have high quality sleep that is not interrupted by such noises.

System100can be used to deliver at least a portion of a substance from the receptacle300to the air pathway the user based at least in part on the physiological data, the sleep-related parameters, other data or information, or any combination thereof. Generally, modifying the delivery of the portion of the substance into the air pathway can include (i) initiating the delivery of the substance into the air pathway, (ii) ending the delivery of the portion of the substance into the air pathway, (iii) modifying an amount of the substance delivered into the air pathway, (iv) modifying a temporal characteristic of the delivery of the portion of the substance into the air pathway, (v) modifying a quantitative characteristic of the delivery of the portion of the substance into the air pathway, (vi) modifying any parameter associated with the delivery of the substance into the air pathway, or (vii) any combination of (i)-(vi). Modifying the temporal characteristic of the delivery of the portion of the substance into the air pathway can include changing the rate at which the substance is delivered, starting and/or finishing at different times, continuing for different time periods, changing the time distribution or characteristics of the delivery, changing the amount distribution independently of the time distribution, etc. The independent time and amount variation ensures that, apart from varying the frequency of the release of the substance, one can vary the amount of substance released each time. In this manner, a number of different combination of release frequencies and release amounts (e.g., higher frequency but lower release amount, higher frequency and higher amount, lower frequency and higher amount, lower frequency and lower amount, etc.) can be achieved. Other modifications to the delivery of the portion of the substance into the air pathway can also be utilized.

FIG.5Ashows a perspective view of the back side of the respiratory device122that includes a housing123, an air inlet180, and an air outlet190. The air inlet180includes an inlet cover182movable between a closed position and an open position. The air inlet cover182includes one or more air inlet apertures184defined therein. The respiratory device122includes a blower motor250(seeFIG.8B) configured to draw air in through the one or more air inlet apertures184defined in the air inlet cover182. The motor is further configured to cause pressurized air to flow through the humidification tank129and out of the air outlet190. The conduit126can be fluidly coupled to the air outlet190, such that the air flows from the air outlet190and into the conduit126. The air outlet190is partially formed by an internal conduit192extending through the housing123from the interior of the respiratory device122. A seal194is positioned around the end of the internal conduit192to ensure that substantially all of the air that exits through the air outlet190flows into the conduit126.

FIGS.5B and5Cshow a perspective view of an implementation of the receptacle300where the receptacle300is formed as part of an injection plug302, and the respiratory device122is configured to engage the receptacle300by coupling with the injection plug302. The injection plug302is used to deliver a substance into the air pathway of the respiratory system120so that the substance reaches the airway of the user210. As is discussed in more detail herein, the substance can be a medicament, such as anti-inflammatory medicine, medicine to treat an asthma attack, medicine to treat a heart attack, etc. Generally, any type of medicament that is used to treat any ailment, symptom, disease, etc. can be delivered to the airway of the user210using the injection plug302. When the substance is a medicament, the substance generally includes one or more active ingredients, and one or more excipients. The excipients serve as the medium for conveying the active ingredient, and can include substances such as bulking agents, fillers, diluents, antiadherents, binders, coatings, colors, disintegrants, flavors, glidants, lubricants, preservatives, sorbents, sweeteners, vehicles, or any combinations thereof. The active ingredient is generally the portion of the medicament that actually causes the effect brought on by the medicament.

The substance could also be an aroma compound (e.g., a substance that delivers scents and/or aromas to the airway of the user210), a sleep-aid (e.g., a substance that aids the user210in falling asleep), a consciousness-arousing compound (e.g., a substance that aids the user210in waking up, also referred to as a sleep inhibitor), a cannabidiol oil, an essential oil (such as lavender, valerian, clary sage, sweet marjoram, roman chamomile, bergamot, etc.). The substance can generally be a solid, a liquid, a gas, or any combination thereof. The substance can alternatively or additionally include one or more nanoparticles.

In some implementations, the substance is configured to aid in (i) opening the airway of the user210, (ii) managing (e.g., reducing, maintaining, or raising) a blood pressure of the user210, (iii) managing (e.g., reducing, maintaining, or raising) a heart rate of the user210, (iv) reducing a heart rate variability of the user210, (v) stabilizing a heart rate of the user210, (vi) managing (e.g., reducing, maintaining, or raising) an analyte (such as glucose) concentration in blood of the user210, (vii) reducing inflammation in one or more portions of the user210, (viii) managing (e.g., inducing or maintaining) sleep of the user210, (ix) waking up the user210, (x) reducing pain in one or more body parts of the user210, (xi) improving a perception of wellbeing of the user210(e.g., making the user feel better by using aromatherapy), or (xii) any combination thereof. In some implementations, if the user has insomnia and has trouble sleeping, the substance is configured aid the user in falling asleep and staying asleep. Generally, the injection plug302can be used to deliver any type of substance into the air pathway of the respiratory system120, such that the substance is delivered to the airway of the use along with the pressurized air.

As shown inFIGS.5B and5C, the injection plug302is positioned exterior to the respiratory device122, and can be placed in-line with the air outlet190of the respiratory device122and the conduit126. In this arrangement, the injection plug302is fluidly coupled between the air outlet190and the conduit126, such that the injection plug302is in fluid communication with the air pathway. As the pressurized air is caused to exit the air outlet190, the pressurized air flows through the injection plug302and into the conduit126. In other implementations however, the injection plug302can have different arrangements. For example, the injection plug302could be fluidly coupled between the conduit126and the user interface124. The injection plug302could also be fluidly coupled to the air inlet180of the respiratory device122. In this implementation, the injection plug302can be considered to be fluidly coupled between the air inlet180of the respiratory device122and the atmosphere outside of the respiratory device122. Thus, the injection plug302inFIGS.5B and5Cis generally placed in-line with the air pathway such that the pressurized air flows through the injection plug302and the receptacle300when the pressurized air is directed to the airway of the user210.

The injection plug302defines a receptacle300that is configured to receive and contain the substance therein. In the illustrated embodiment, the receptacle300is an open space that extends from the interior of the injection plug302to the periphery of the injection plug302. The injection plug302includes a movable cover304that controls access to the receptacle300.FIGS.3B and3Cshow the cover304in a first position. In the first position, the cover304is open, such that the substance can be inserted into the receptacle300. In a second position, the cover304is closed, such that the substance cannot be inserted into the receptacle300. The cover304is generally illustrated as being configured to pivot between the first position and the second position, for example via one or more hinges or one or more pivots. However, the cover304can be configured to be movable using any number of mechanisms or techniques. For example, the cover304could move in a single plane either horizontally or vertically between the first position and the second position. The cover304could also be configured to be twistable, such that rotation of the cover304moves the cover304between the first position and the second position. In still other implementations, the cover304could be attached to the injection plug302via a friction fit, a press fit, a snap fit, etc. In these implementations, opening the cover304to allow access to the receptacle300can include detaching the cover304from the injection plug302. Closing the cover304to prevent access to the receptacle300can include attaching the cover304to the injection plug302. The cover304can be manually movable by the user210, can be controlled by the control system110, or both.

The injection plug302may arranged to contain, and facilitate the injection of, the substance included in the receptacle300. While in some cases the injection plug302may include a controller for managing the functions and features of the injection plug302, in other cases the injection plug302may need to receive control signals from the control system110. When the injection plug302is disposed between the respiratory device122and the conduit126, the injection plug302may also need to transfer electrical signals (e.g., sensing signals) coming from the user interface124to the respiratory device122. To be able to effect all these functionalities, depending on its location, the injection plug302may need to be electrically connected to one or both of the respiratory device122and the user interface124, as well as mechanically. Thus, the injection plug302can include one or more sets of electrical contacts that electrically couple the injection plug302to the respiratory device122and the conduit126. A first set of electrical contacts306A is illustrated inFIG.5C. The first set of electrical contacts306A generally protrudes from the injection plug302, and is configured to mate with corresponding electrical contacts196recessed in the air outlet190of the respiratory device122. On the opposing side of the injection plug302where the injection plug302couples with the conduit126, the injection plug302can have a second set of electrical contacts306B recessed in the injection plug302(best shown inFIG.6A). The second set of electrical contacts306B of the injection plug302can electrically couple with a corresponding set of electrical contacts308on the conduit126.

The electrical contacts196,306A,306B,308on the respiratory device122, the injection plug302, and the conduit126can be used in a variety of different manners. In some implementations, one or more of the electrical contacts196,306A,306B,308are used to heat the air flowing through the injection plug302and the conduit126, either directly or by heating a separate heating element. One or more of the electrical contacts196,306A,306B,308can also act as a heater that is configured to heat the substance and cause some or all of the substance to evaporate, again either directly or by heating a separate heating element. The evaporation of the substance can be selectively controlled manually by the user210, and/or by the control system110.

In additional or alternative implementations, one or more of the electrical contacts196,306A,306B,308are used to electrically couple the injection plug302and/or the conduit126to the control system110. In these implementations, the control system110can control the injection plug302so as to selectively release the substance into the air pathway of the respiratory system120. As is discussed in more detail herein, the control system110can control the release of the substance into the air pathway based at least in part on a variety of different factors, including physiological data related to the user210and the sleep session. The control system110can also be used to control the movement of the cover304between the first (open) position and the second (closed) position.

FIGS.6A and6Bshow a first implementation of the injection plug302. In this implementation, air flowing through the injection plug302causes the substance to be delivered into the air pathway. The receptacle300and the injection plug302have an inlet312A (best shown inFIG.5C) and an outlet312B. In the implementation shown inFIGS.6A and6B, the inlet312A is formed generally from the open front end of the injection plug302and the apertures309defined in the front end of the receptacle300, while the outlet312B is formed generally from the open back end of the injection plug302and the apertures309defined in the back end of the receptacle300. However, the inlet312A and the outlet312B could be formed in any suitable fashion.

The apertures309are defined in the receptacle300where the substance is contained during use. In this implementation, both the inlet312A and the outlet312B are in direct or indirect fluid communication with the air pathway. The interior of the receptacle300where the substance is contained is also in direct or indirect fluid communication with the air pathway due to the presence of the apertures in the receptacle300. When the respiratory device122is in use, the pressurized air enters the injection plug302via the inlet312A, passes through the receptacle300via the apertures, and exits the injection plug302via the outlet312B. The pressurized air carries the substance out of the injection plug302and the receptacle300as the pressurized air flows through the injection plug302and the receptacle300. Thus, the injection plug302can act as a nebulizer that aerosolizes the substance.

In some implementations where the injection plug302is located between the respiratory device122and the conduit126, the inlet312A is in fluid communication with the air outlet190of the respiratory device122, and the outlet312B is in fluid communication with the conduit126. This implementation is illustrated inFIGS.5B and5C. In other implementations where the injection plug302is located between the conduit126and the user interface124, the inlet312A is in fluid communication with the conduit126, and the outlet312B is in fluid communication with the user interface124. In still other implementations where the injection plug is located adjacent to the air inlet180of the respiratory device122, the inlet312A is in fluid communication with the atmosphere outside of the respiratory device122, and the outlet312B is in fluid communication with the air inlet180of the respiratory device122. In still other implementations, the injection plug302could be located within the user interface124itself. In this implementation, the inlet312A is in fluid communication with the user interface124, and the outlet312B is in fluid communication with the sealed environment between the user interface124and the mouth of the user210. Thus, in some implementations, the substance could be delivered into the air pathway at or near the user interface124itself. In still further implementations, the injection plug302is located within the housing of the respiratory device122itself. In this implementations, the outlet312B is in fluid communication with an interior of the air outlet190of the respiratory device122, and the exterior of the air outlet190of the respiratory device122is in fluid communication the conduit126. In other implementations, the injection plug302is located within the conduit126. In these implementations, both the inlet312A and the outlet312B are in fluid communication with the conduit126.

As shown inFIGS.6A and6B, the substance can be contained within a separate pod310(e.g., a sachet) that is itself received by the receptacle300, such that the pod310is disposed within the injection plug302. In these implementations, the pod310must be able to release the substance into the receptacle300in order for the pressurized air to carry the substance along the air pathway. For example, the interior of the receptacle300could contain a mechanism that pierces or otherwise opens the pod310when the pod310is initially inserted into the receptacle300. The term pod is used herein to broadly describe any container containing the substance. The specific material and structure of the container will depend on the nature of the substance, which can be in liquid, solid, or gaseous form.

In some implementations, the injection plug302ofFIGS.6A and6Bincludes a bypass valve fluidly coupled to the injection plug302and the receptacle300. The bypass valve can be used to selectively alter the path of the pressurized air through the injection plug302. For example, the bypass valve can have and/or form a first pathway that bypasses the receptacle300, and a second pathway that is in fluid communication with the inlet312A. In this example, the first pathway can be pass outside of the entire injection plug302, or can pass through the interior of the injection plug302but not through the receptacle300(e.g., pass underneath the receptacle300with reference toFIGS.6A and6B). The second pathway passes through the receptacle300via the apertures defined by the receptacle300. Generally, the bypass valve includes a mechanical element that diverts the pressurized air into either the first pathway or the second pathway.

The bypass valve can be used to direct all of the pressurized air through either the first pathway or the second pathway. However, the bypass valve can also be used to direct a portion of the pressurized air through the first pathway and a portion of the pressurized air through the second pathway. This partial diversion of the pressurized air can be used to cause only some of the substance that is contained within the receptacle300to be delivered into the air pathway. The bypass valve can be manually operable by the user210, and/or can be controlled by the control system110, in order to move the bypass valve between open and closed configurations, and to control the amount of partial diversion.

FIGS.7A and7Bshow a second implementation of the injection plug302. The second implementation is generally similar to the first implementation, except that the injection plug302includes a separate injection mechanism314and nozzle316configured to deliver the substance into the air pathway. The injection plug302can generally be positioned in-line with the air pathway in any of the arrangements described above with reference to the injection plug302ofFIGS.6A and6B. The injection plug302can include electrical contacts that can be used to heat the pressurized air, heat the substance, and/or electrically connect the injection plug302to the control system110. The injection plug302also includes the movable cover304that controls access into the receptacle300. Finally, the substance can be contained in a pod310that is received by the receptacle300.

In the implementation ofFIGS.7A and7B, the injection plug302has an air inlet312A and an air outlet312B formed from the open ends of the injection plug302. However, the receptacle300is not directly open to the air pathway via apertures as inFIGS.6A and6B, but instead is fluidly coupled to the air pathway using a different mechanism or structure, such as via the injection mechanism314and the nozzle316. The end of the nozzle316thus acts as the outlet of the receptacle300in the implementation ofFIGS.7A and7B, while the receptacle300itself generally does not have an inlet via which pressurized air flows into the receptacle. The injection mechanism314is configured to pierce the pod310containing the substance to fluidly connect the pod310to the air pathway. The nozzle316is configured to control the release of the substance into the air pathway. The injection mechanism314can be a needle or other sharp object that is used to pierce the pod310and allow the substance to be delivered into the air pathway. The control system110is configured to control the injection mechanism314and the nozzle316so as to selectively deliver the substance into the air pathway. However, the injection mechanism314and/or the nozzle316could additionally or alternatively be manually operable by the user210. In this implementation, the injection plug302again acts as a nebulizer that can aerosolize the substance.

In still other implementations, the nozzle316is not controlled by the user210or the control system110. In these implementations, once the pod310is pierced by the injection mechanism314, the substance in the pod310is automatically released into the air pathway through the nozzle316. In these implementations, the injection mechanism314can be controlled by the user210or the control system110to pierce the pod310at a desired time, or the injection mechanism314can be configured to automatically pierce the pod310when the pod310is inserted into the receptacle300. In these implementations or any other implementations, the substance can be a solid, liquid, or a gas.

Referring now toFIGS.8A and8B, the receptacle300can also be disposed within the housing123of the respiratory device122, instead of being located external to the respiratory device122in a separate and distinct injection plug302. As shown inFIGS.8A and8B, the housing123can define a cover604that is similar to cover304of the injection plug302. Generally, all of the features of the cover304of the injection plug302can be present in the cover604of the housing123of the respiratory device122. The cover604thus controls access to the receptacle300inside the housing123, and can be controlled by the control system110and/or can be manually operable by the user210. The receptacle300is configured to receive a pod310that contains the substance. In this implementation, the pod310is thus disposed within the housing123of the respiratory device122when the receptacle300receives the pod310.

In the implementation illustrated inFIGS.8A and8B, the internal structure of the respiratory device122that forms the air pathway includes an injection plug302, in which the receptacle300is formed. In this manner, the implementation illustrated inFIGS.8A and8Bgenerally includes all of the features discussed herein with respect to the implementation inFIGS.5A-7B. However, in some implementations, the receptacle300could simply be a portion of or all of the internal structure of the respiratory device122that forms the air pathway (e.g., tubing), without any separate injection plug302.

The receptacle300inFIGS.8A and8Bis generally similar to the receptacle300inFIGS.6A-7B. The receptacle300can be positioned in-line with the air pathway inside the respiratory device122such that the pressurized air flowing through the receptacle300causes the substance to be delivered into the air pathway. In this implementation, the receptacle300is formed with apertures309similar to the receptacle300inFIGS.6A and6B, and has an inlet312A and an outlet312B that are in fluid communication with the air pathway. The receptacle300can alternatively have only an outlet312B that is in fluid communication with the air pathway. In this implementation, the receptacle300includes an injection mechanism314and nozzle316, which can be the same as or similar to the injection mechanism314and nozzle316of the receptacle300ofFIGS.7A and7B.

FIG.8Bshows one location of the receptacle300within the housing123of the respiratory device122. In the illustrated implementation, the respiratory device122includes a blower motor250with a motor inlet252and a motor outlet254. The motor inlet252is in fluid communication with the atmosphere through the air inlet180of the respiratory device122. The motor outlet254is in fluid communication with the interior of the humidification tank129. During operation of the respiratory device122, the blower motor250causes air to flow through the motor and through the humidification tank129.

The blower motor250is electrically connected to a control board256. In some implementations, the control board256contains the processor112, and thus forms the control system110. In other implementations, the control system110is separate from the control board256. In these implementations, the control board256includes a separate processor and a communication interface to allow the control board256to communicate with the control system110. The respiratory device122further includes a power converter258electrically connected to the control board256. The power converter258includes a receptacle that opens to the exterior of the respiratory device122that allows the respiratory device122to be connected to an external power source, such as an electrical outlet via an external electrical cable. The power converter258powers the blower motor250, the control board256, and any other electronic components of the respiratory device122.

WhileFIG.8Bshows the receptacle300positioned between the humidification tank129and the air outlet190of the respiratory device122, the internal receptacle300can be positioned elsewhere along the air pathway. For example, the receptacle300could be positioned between the air inlet180and the blower motor250, such that the inlet312A of the receptacle300/injection plug302is in fluid communication with the air inlet180and the outlet312B of the receptacle300/injection plug302is in fluid communication with the blower motor250. In another example, the receptacle300could be positioned between the blower motor250and the humidification tank129, such that the inlet312A is in fluid communication with the blower motor250and the outlet312B is in fluid communication with the humidification tank129.

Referring generally to the various receptacles300illustrated inFIGS.5B-8B, the receptacle300is generally separate and distinct from the humidification tank129, whether the receptacle300is formed as part of the injection plug302or is located within the housing of the respiratory device122. Thus, while the humidification tank129is configured to deliver water vapor into the air pathway and humidify the pressurized air, the receptacle300is distinct from the humidification tank129. As noted and shown herein, in some implementations, the receptacle300is in fluid communication with a point along the air pathway that is downstream from the humidification tank129and between the humidification tank129and the user210. However, in other implementations, the receptacle300can be in fluid communication with the air pathway at a point upstream from the humidification tank129.

In addition, while the implementation of the receptacle300having the injection mechanism314and the nozzle316is described as being formed so that the pressurized air does not flow through the receptacle300, it is contemplated that the receptacle300could have an inlet and an outlet, while still utilizing the injection mechanism314and the nozzle316to release the substance into the air pathway. Thus, while the pressurized air may generally flow into and through the receptacle300, it is the operation of the injection mechanism314and the nozzle316that operate to release the substance into the air pathway.

Other mechanisms can also be used to assist or cause the substance to be delivered into the air pathway. In some implementations, the receptacle300includes a membrane that regulates the delivery of the substance into the air pathway. In these implementations, the membrane can act as a timed release mechanism to ensure that an appropriate amount of the substance is delivered into the air pathway at an appropriate time. In other implementations, the receptacle300includes a barrier that is configured to break down in response to the pressurized air being directed to the airway of the user210. For example, the barrier could be configured to break down due to the force of the pressurized air flowing through the receptacle300, thereby releasing the substance into the air pathway. In another example, the barrier is configured to dissolve when the pressurized air is humidified prior to being directed to the air pathway.

In still other implementations, the packaging of the substance itself forms a membrane or dissolvable barrier, instead of the membrane or dissolvable barrier being located in the receptacle300. In these implementations, when the substance is inserted into the receptacle300, the packing of the substance regulates the release of the substance into the air pathway, as described above. The substance could also be inserted into the air pathway at any point within the system without the use of a separate receptacle300, such as being inserted directly into the humidification tank129.

In some implementations, the receptacle300can contain at least two different substances. The receptacle300can be configured to maintain the two substances separately, and allow the substances to be mixed together when needed.

Referring toFIG.9, a method700of delivering a substance into an air pathway of a user using a respiratory system (such as respiratory system120) is illustrated. A memory device (such as memory device114of system100) can be used to store machine-readable instructions and any type of data utilized in the steps of method700. A control system (such as control system110) can be used to execute the machine-readable instructions to cause the steps of method700to be performed. One or more of the steps of the method700described herein can be implemented using the system100(FIG.1), and are described using the various components of the system100. However, it is understood that the method700can be performed by appropriate systems other than system100.

Step702of the method700includes receiving the substance in the receptacle300. The receptacle300can be any of the implementations of the receptacle300described herein. The receptacle300can be formed as part of an external injection plug302, or can be disposed within the housing123of the respiratory device122. The receptacle300can be positioned in-line with the air pathway such that air flowing through the receptacle300causes the substance to be delivered into the air pathway, or the receptacle300can be configured to inject the substance into the air pathway. The receptacle300can directly receive the substance, or can receive the substance within the pod310. Step704of the method700includes receiving physiological data from the one or more sensors130. As noted herein, any number of the sensors130can be included as part of the respiratory system120.

Step706of the method700includes determining, using the control system110, one or more sleep-related parameters based at least in part on the received physiological data. As discussed herein, a large variety of sleep-related parameters can be determined based at least in part on the physiological data. The sleep-related parameters include a sleep score, a flow signal, a respiration signal, a respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, a number of events per hour, a pattern of events, a stage, pressure settings of the respiratory device122, a heart rate, a heart rate variability, movement of the user210, temperature, EEG activity, EMG activity, arousal, snoring, choking, coughing, whistling, wheezing, or any combination thereof. Step706can also include receiving other data, such as feedback data related to prior uses of the substance and/or the respiratory device122by the user210, or location data related to the location of the user or the ambient environment surrounding the user.

Finally, step708of the method700includes modifying the delivery of the substance into the air pathway based at least in part on the sleep-related parameters and/or the other data. The delivery of the substance into the air pathway can be modified in a variety of different ways, including by initiating the delivery of the substance into the air pathway, ending the delivery of the substance into the air pathway, modifying the amount of the substance that is currently being delivered into the air pathway, modifying a quantitative characteristic of the delivery, or modifying a temporal characteristic of the delivery (e.g., changing the rate at which the substance is delivered, starting and/or finishing at different times, continuing for different time periods, changing the time distribution or characteristics of the delivery, changing the amount distribution, independently of the time distribution, etc. The independent time and amount variation ensures that, apart from varying the frequency of substance release, one can vary the amount of substance released each time. So one can end up with different combination of release frequencies and release amount (e.g., higher frequency but lower release amount, higher frequency and higher amount, lower frequency and higher amount, lower frequency and lower amount, etc.). Generally, any parameters associated with the delivery of the substance in the air pathway can be modified, and multiple modifications can also be undertaken generally at the same time or step.

For example, the substance may cause the user210to have difficulty falling asleep. The sleep-related parameters could indicate that the user210is taking longer to fall asleep, or the user210could manually indicate that they are having trouble falling asleep. The control system110can then cause the substance to be injected into the air pathway at a later time, after the user210has fallen asleep.

In one implementation, the sleep-related parameters include a respiration rate, and the delivery of the substance into the air pathway is initiated if the respiration rate is above or below a first predetermined threshold respiration rate, or ended if the respiration rate is above or below a second predetermined threshold respiration rate different than the first predetermined threshold respiration rate. The substance can be configured to increase the respiration rate of the user210, in which case delivery is initiated if the respiration rate of the user210is too low, or ended if the respiration rate of the user210is too high or is appropriate. The substance could also be configured to decrease the respiration rate of the user210, in which case delivery is initiated if the respiration rate of the user210is too high, or ended if the respiration rate of the user210is too low or is appropriate.

In another implementation, the sleep-related parameter is a heart rate of the user210, and the delivery of the substance into the air pathway is initiated if the heart rate is above or below a first predetermined threshold heart rate, or ended if the heart rate is above or below a second predetermined threshold heart rate different than the first predetermined threshold heart rate. The substance can be configured to increase the heart rate of the user210, in which case delivery is initiated if the heart rate of the user210is too low, or ended if the heart rate of the user210is too high or is appropriate. The substance could also be configured to decrease the heart rate of the user210, in which case delivery is initiated if the heart rate of the user210is too high, or ended if the heart rate of the user210is too low or is appropriate.

In a further implementation, the sleep-related parameters are used to determine an effectiveness of the substance, and to modify the delivery of the substance into the air pathway based at least in part on the effectiveness. Generally, the substance can be a medicament, and the sleep-related parameters can be used to determine how effectively the medicament is treating the disease or ailment of the user210. The amount of the medicament being delivered into the air pathway could be increased in a larger dose is needed, or ended if the medicament is not effective.

In still another implementation, the other data is location data associated with the location of the user210. The location data can in this case be defined to also include environmental data about the ambient environment surrounding the respiratory device122and/or the user210(e.g., the user210's immediate surroundings such as their bedroom), or data about the user210's larger surroundings, such as the user210's house, neighborhood, etc. The location data could include sound or air pressure data in the user210's bedroom (and/or other room(s) where the respiratory device122or any components of system100are located). This data, as well as device data, such as, for example, airflow data obtained from the flow rate sensor134of respiratory device122, can be analyzed to determine whether any amount of the supplied pressurized air has escaped the user interface124or the conduit126or whether any amount of the portion of the substance has escaped the user interface124or the conduit126. If some of the air has escaped, the control system110can end the delivery of the substance into the air pathway, or reduce the amount of the substance being delivered into the air pathway. The control system110could additionally or alternatively adjust the pressure of the pressurized air being supplied to the air pathway, for example by increasing the pressure to account for the leak in the air pathway. The location data can also include other identifying information such as geographic coordinates; weather data about the user210's location (e.g., temperature, humidity, precipitation, wind); pollution data; or generally any other data about the user210's surroundings that may be beneficial (the temperature, sound/noise level and light intensity in the room, a chemical analysis of the air in the room, etc.).

The control system110can utilize the location data to generate a notification for the user210. The notification can be transmitted to the user210(for example, via the external device170), and/or recorded (e.g., by the control system110and the memory device114). For example, the control system110can generate a notification if it is detected that air is leaking from the air pathway. The notification could suggest to the user210a modification to the respiratory device122, the user interface124, or the conduit126, in order to reduce or end the leak. The control system110could also generate an alert if the leak is detected (and is unintentional), and delay the delivery of the substance into the air pathway if the leak is detected (and is unintentional) until the leak diminishes or stops.

In still other implementations, the other data is feedback data. The feedback data can be associated with a prior use of or experience with the substance by the user210, and can be used to modify the delivery of the substance into the air pathway to take into account the user210's experience during past uses of the substance. For example, if the feedback data indicates that the user210reacted to a substance in a specific way, the feedback data can be used to prevent that substance from being released into the air pathway, to ensure that an appropriate amount of the substance (e.g., a smaller amount of the substance) is released into the air pathway, or to ensure that the release has optimized dynamics (e.g., is sufficient in amount and flow properties to reach the user). In another example, the user can indicate that the scent of the substance was too strong, that the substance was delivered too quickly, or that the effect of medication lingered for too long. The control system110can then ensure that the amount of the substance released into the air pathway is reduced, such that the substance release period is prolonged or that the time and/or amount distribution for the release events is suitably amended.

In some implementations, the user210utilizes the external device170to input the feedback data. For example, the external device170can be a smart phone, and the user210can enter information related to past uses of the system via the external device170. The user210can also provide the feedback data in other ways (e.g., via a smart speaker). The feedback data can be objective (e.g., numerical data about the user210's reaction to the substance) or subjective (e.g., the user210's feelings about the substance, estimate of how the user feels before and after a release sequence, etc.) In some implementations, the physiological data and/or the sleep-related parameters can also be used as feedback data indicative of prior uses or experiences with the substance.

In an additional implementation, the other data is related to whether the user210is currently wearing the user interface124, what type of interface124the user is currently wearing, whether a treatment algorithm is running on the respiratory device, etc. In this implementation, the control system110can analyze this data to determine whether the user210is currently wearing the user interface124. If the control system110determines that the user210is not wearing the user interface124, the control system110can generate and/or transmit an alert indicating that the user is not wearing the user interface124. The control system110can also determine what type of interface124is currently being used, and adjust the delivery of the substance into the air pathway based at least in part on what type of interface124is being used. For example, if the type of user interface can affect the amount of released substance that is passed into the user210's airway(s), the amount of the substance that is being delivered into the air pathway may be adjusted based at least in part on what type of interface124is being used.

In another implementation, the one or more sleep-related parameters includes the user210's breathing pattern. The user210's breathing pattern is indicative of when the user is inhaling and when the user is exhaling. In this implementation, the control system110is configured to cause the substance to be delivered into the air pathway only when the user is inhaling. If the substance is delivered into the air pathway when the user exhales, some amount of the substance can be forced out of the respiratory system (for example via vents in the respiratory device120or other components), instead of being delivered into the user's airway. In implementations where the injection plug302includes a bypass valve, the control system110can close the bypass valve when the user is inhaling (or right before the user begins to inhale), so that the flow of pressurized air from the respiratory device120will flow through the receptacle300containing the substance. The control system110can open the bypass valve when the user is exhaling (or right before the user begins to exhale), so that the air flowing from the user's exhale bypasses the receptacle300. In implementations where the receptacle includes an injection mechanism314and a nozzle316, the control system110can control the nozzle316to deliver the substance into the air pathway when the user is inhaling, and to stop delivering the substance into the air pathway when the user is not inhaling. In another implementation, the user210can actively cause the substance to be delivered into the air pathway at a certain time. For example, the user210can trigger the release of the substance from the receptacle when the user210is ready to inhale.

As described herein, the control system110is configured to receive a variety of other data that is not direct physiological data from the sensors130. The other data can be received via the external device170, which can receive input from the user, or could be derived from additional sensors that generate and transmit the data. The other data can also be received via one or more of the sensors130, even if the other data is not direct physiological data about the user210. For example, the sensors130can be used to generate feedback data or environmental data, that while generated by the sensors130, is not physiological data about the user210. Generally, any of the physiological data, the other data, or any other information can be stored in the memory device114.

Referring toFIG.10, a method800of delivering a substance into an air pathway of a user using a respiratory system (such as respiratory system120) is illustrated. A memory device (such as memory device114of system100) can be used to store machine-readable instructions and any type of data utilized in the steps of method800. A control system (such as control system110) can be used to execute the machine-readable instructions to cause the steps of method800to be performed. One or more of the steps of the method800described herein can be implemented using the system100(FIG.1), and are described using the various components of the system100. However, it is understood that the method800can be performed by appropriate systems other than system100.

Step802of the method800includes receiving the substance in the receptacle300. The receptacle300can be any of the implementations of the receptacle300described herein. The receptacle300can be formed as part of an external injection plug302, or can be disposed within the housing123of the respiratory device122. The receptacle300can be positioned in-line with the air pathway such that air flowing through the receptacle300causes the substance to be delivered into the air pathway, or the receptacle300can be configured to inject the substance into the air pathway. The receptacle300can directly receive the substance, or can receive the substance within the pod310. The substance itself can be located within packaging. Step804of the method800includes receiving physiological data from the one or more sensors130. As noted herein, any number of the sensors130can be included as part of the respiratory system120.

Step806of the method800includes determining, using the control system110, the current sleep stage of the user210within the sleep session. At this step, it is generally determined whether the user210is asleep, and if the user210is asleep, what stage of sleep the user is in (e.g., light sleep, deep sleep, REM sleep, etc.). This determination can be based at least in part on the received physiological data and/or other data. In some implementations, the physiological data is used to determine one or more of the sleep-related parameters, which can be used to determine the current stage of the sleep session. Finally, step808of the method800includes modifying the delivery of the substance into the air pathway based at least in part on the current stage of the sleep session. Modifying the delivery of the substance into the air pathway can involve any modification discussed herein, including those modifications discussed herein with respect to step708of method700.

In one implementation, the control system110determines whether the user210has entered a predetermined or desired stage of the sleep session, and initiates the delivery of the portion of the substance into the air pathway, ends the delivery of the portion of the substance into the air pathway, modifies the amount of the substance being delivered into the air pathway, and/or modifies the frequency at which the substance is delivered. For example, the control system110can initiate the delivery of a medicament only once the user210has fallen asleep, or only once the user210has awakened after sleeping. In another example, the control system110can initiate the delivery of a medicament when the user210is initially awake at the beginning of the sleep session, and then reduce (in amount or frequency) or end the delivery of the medicament once the user210falls asleep.

In another implementation, the control system110can initiate the delivery of a first substance into the air pathway when the user210is in a first stage, and initiate the delivery of a second substance into the air pathway when the user210is in a second stage. The second substance can be delivered instead of or in addition to the first substance. In one example, the user210has a disease or ailment that can be treated while the user210is asleep. In this example, the first substance is a sleep aid that is delivered when the user210is awake, and the second substance is a medicament. In another example, the user210has a disease or ailment that preferably treated only while the user210is awake. In this example, the first substance is the medicament, and the second substance is configured to aid the user210in waking up that is only delivered when the user210is asleep.

In a further implementation, the control system110is configured to start and stop the delivery of the substance into the air pathway based at least in part on whether the user210is awake or asleep. In some cases, it is undesirable to deliver a medicament to the air pathway while the user210is asleep. Thus, if the control system110determines that the user210is awake the substance (which can be a medicament) can begin to be delivered into the air pathway. When the control system110determines at a later time that the user210is asleep, the system can end the delivery of the medicament into the air pathway. The control system110can also determine whether the user210is still asleep after a desired waking point, and initiate the delivery of the sleep inhibitor to aid the user210in waking up. Alternatively, the control system110can determine whether the user210is awake prior to a desired waking point, and initiate the delivery of a sleep aid to aid the user210in falling asleep.

In some implementations, the other data utilized by the control system110includes temporal data, such as an amount of time spent in the current stage of the sleep session. The modification of the delivery of the substance into the air pathway can be based at least in part on the temporal data. For example, if the time spent in the current stage is greater than or less than a threshold time, the control system110can initiate or end the delivery of the substance into the air pathway. If the current stage is a stage where the user210is awake, the delivery of a sleep aid or calming scents or aromas into the air pathway can be initiated if the user210is having difficulty falling asleep. If the current stage is a stage where the user210is asleep, the delivery of a consciousness-arousing compound (e.g., an anti-sleep aid) can be initiated if the user210is having difficulty waking up. In one example, if the user210has been in the current stage (such as being awake) for more than two hours, the substance (such as a sleep aid) could begin to be delivered into the air pathway. In another example, the delivery of the substance into the air pathway can be initiated based at last in part on the current time. In a further example, the system monitors the user210over a predetermined time period, determines whether the user210has been asleep or awake for at least a predetermined minimum amount of time within the time period, and only then initiates the delivery of the substance into the air pathway.

Referring toFIG.11, a method900of delivering a substance into an air pathway of a user using a respiratory system (such as respiratory system120) is illustrated. A memory device (such as memory device114of system100) can be used to store machine-readable instructions and any type of data utilized in the steps of method900. A control system (such as control system110) can be used to execute the machine-readable instructions to cause the steps of method900to be performed. One or more of the steps of the method900described herein can be implemented using the system100(FIG.1), and are described using the various components of the system100. However, it is understood that the method900can be performed by appropriate systems other than system100.

Step902of the method900includes receiving the substance in the receptacle300. The receptacle300can be any of the implementations of the receptacle300described herein. The receptacle300can be formed as part of an external injection plug302, or can be disposed within the housing123of the respiratory device122. The receptacle300can be positioned in-line with the air pathway such that air flowing through the receptacle300causes the substance to be delivered into the air pathway, or the receptacle300can be configured to inject the substance into the air pathway. The receptacle300can directly receive the substance, or can receive the substance within the pod310. Step904of the method900includes receiving physiological data from the one or more sensors130. As noted herein, any number of the sensors130can be included as part of the respiratory system120.

Step906of the method900includes determining, using the control system110, whether the user210has experienced an adverse event. An adverse event is generally any event that affects the user210in an adverse manner. For example, an adverse event could be a breathing event due to a sleep disorder, e.g., the cessation (apnea) or reduction (hypopnea) in breathing in a user210with sleep apnea. The adverse event can also include general health-related events, such as asthma attacks, heart attack or other cardiac events, coughing, snoring, etc. In some implementations, the user210waking up at an undesirable time (such as the middle of the night) is an adverse event.

The determination of whether the user210has experienced an adverse event can be based at least in part on the received physiological data which are used to determine sleep-related parameters, or any other data received (e.g., non-physiological data). For example, data about the user210's heart (such as a heart rate of the user210) can be used to determine whether the user210has suffered a heart attack. In another example, data about the user210's respiration (such as a respiration rate of the user210) can be used to determine whether the user210has suffered an asthma attack. Finally, step908of the method900includes modifying the delivery of the substance into the air pathway based at least in part on whether the user210has experienced an adverse event. Modifying the delivery of the substance into the air pathway can involve any modification discussed herein, including those modifications discussed herein with respect to step708of method700. Method900can also be utilized when the user210experiences any type of predetermined event, whether adverse or not.

In some implementations, the control system110detects that the user210has suffered or is suffering a heart attack, and can initiate the delivery of a medicament to treat the heart attack into the air pathway. Similarly, the control system110can detect that the user210has suffered or is suffering an asthma attack, and can initiate the delivery of a medicament to treat the asthma attack into the air pathway. Other adverse events can also be detected, such as a sleep apnea event, an event involving inflammation, or any event that causes the user210to cease breathing.

The control system110can also be configured to generate and/or transmit an alert (or cause an alert to be generated and/or transmitted) based at least in part on a determination that the user210has experienced an adverse event. For example, the control system110can alert an emergency services provider or an emergency contact when the user210experiences an adverse event.

In further implementations, the control system110can determine whether the user210undergoes a desired/expected motion pattern following the adverse event. Such a motion pattern can include one or more body movements of the user210. If the user210has not undergone the desired motion pattern within a desired time period, the control system110can initiate the delivery of a medicament into the air pathway, and/or can contact an emergency services provider.

In still other implementations, it is determined whether the user experiences any type of predetermined event, whether adverse or not. The delivery of the substance into the air pathway can then be modified in response. In some implementations, the predetermined event can include the user210being asleep for less than a predetermined length of time, the user being asleep for greater than a predetermined length of time, the user being awake for less than a predetermined length of time, or the user being awake for greater than a predetermined length of time.

In one implementation, the receptacle is configured to receive a first substance and a second substance different than the first substance. In response to determining that the user has experienced a first type of predetermined event (which could be a first type of adverse event), the control system110causes the first substance to be delivered into the air pathway of the user210. In response to determining that the user has experienced a second type of predetermined event (which could be a second type of adverse event), the control system110causes the second substance to be delivered into the air pathway of the user210. This implementation allows the system100to be prepared for multiple different types of events the user210may experience while they sleep, such as both a heart attack and an asthma attack. This implementation also allows the system100to deliver a non-medicament (such as an aromatherapy compound), while still being prepared to deliver a medicament if the user experiences an adverse event (such as a heart attack). In still another implementation, the first substance is a medicament configured to treat a medical condition or event, and the second substance is configured to counteract a potential adverse response to the first substance.

In these implementations, the physiological data can be analyzed to determine the user210's physiological response to the substance delivered into the air pathway. If the user210does not respond as strongly as desired, the amount of the substance being delivered into the air pathway can be increased. Conversely, of the user210responds more strongly than desired, the amount of the substance being delivered into the air pathway can be decreased. A summary of the user210's response to the substance can also be prepared and transmitted to the user210or to a third party, such as a caregiver or a healthcare provider.

Referring toFIG.12, a method1000of delivering a substance into an air pathway of a user using a respiratory system (such as respiratory system120) is illustrated. A memory device (such as memory device114of system100) can be used to store machine-readable instructions and any type of data utilized in the steps of method1000. A control system (such as control system110) can be used to execute the machine-readable instructions to cause the steps of method1000to be performed. One or more of the steps of the method1000described herein can be implemented using the system100(FIG.1), and are described using the various components of the system100. However, it is understood that the method1000can be performed by appropriate systems other than system100.

Step1002of the method1000includes receiving the substance in the receptacle300. The receptacle300can be any of the implementations of the receptacle300described herein. The receptacle300can be formed as part of an external injection plug302, or can be disposed within the housing123of the respiratory device122. The receptacle300can be positioned in-line with the air pathway such that air flowing through the receptacle300causes the substance to be delivered into the air pathway, or the receptacle300can be configured to inject the substance into the air pathway. The receptacle300can directly receive the substance, or can receive the substance within the pod310.

Step1004of the method1000includes receiving physiological data from the one or more sensors130associated with the exhaled breath of the user210before, during, and/or after the portion of the substance has been delivered into the air pathway of the user210. As noted herein, any number of the sensors130can be included as part of the respiratory system120. In this implementation, at least one of the sensors130is positioned in an exhalation path of the user210(e.g., adjacent to a mouth or a nose of the user210), and can be used to detect the presence and concentration of an analyte in the exhaled breath of the user210.

Step1006of the method1000includes determining, using the control system110, the effectiveness of the substance based at least in part on the physiological data. For example, the presence and concentration of the analyte can indicate whether a medicament that is being delivered to the user210is effective. In one example, the concentration of the analyte in the exhaled breath of the user210after the substance is delivered into the air pathway is used to determine the amount of the substance that has been absorbed by the user210. The absorbed amount of the substance can be compared to the amount of the substance that was delivered into the air pathway of the user210to determine the effectiveness of the substance. In another example, the concentration in the analyte in the exhaled breath of the user prior to delivering the substance into the air pathway of the user210is compared to the analyte concentration in the exhaled breath of the user after delivering the substance into the air pathway of the user210. This comparison can be used to determine the amount of the substance absorbed by the user210.

Finally, step1008of the method1000includes modifying the delivery of the substance into the air pathway based at least in part on the determined effectiveness of the substance medicament. Modifying the delivery of the substance into the air pathway can involve any modification discussed herein, including those modifications discussed herein with respect to step708of method700.

For example, if the substance is a medicament and the current amount is not effective, the control system110can increase the amount of the medicament that is delivered to the air pathway. The control system110can also end the delivery of the current medicament into the air pathway and initiate the delivery of a different medicament into the air pathway. In other implementations, the control system110can generate an alert if the medicament is not effective (for example following an adverse event).

In some implementations, the control system110is configured to compare the concentration of the analyte to a predetermined threshold to determine the effectiveness of the medicament. In some examples, the analyte is only present if the disease or ailment of the user210is not being treated, and thus a concentration larger than the threshold can indicate the medicament is not effective. Alternatively, the analyte may be a byproduct of the disease or ailment being treated by the medicament, in which case a concentration smaller than the threshold can indicate that the medicament is not effective.

In some implementations, determining the effectiveness of the medicament includes determining whether the user210has overdosed on the substance. This determination can be based at least in part on the physiological data indicating that one or more sleep-related parameters are above or below a desired threshold value. If the user210has overdosed on the medicament, the control system110can end the delivery of the medicament into the air pathway, and/or initiate the delivery of another substance into the air pathway that is configured to counteract the overdose.

As noted herein, the control system110can be configured to cause a notification to be sent in response to an overdose (or other adverse event). The notification could be sent to the user210and/or any desired third parties, such as family members, friends, emergency personnel (e.g., first responders, paramedics), or medical practitioner (e.g., the user210's doctor). In general, with any of the methods described inFIGS.9-12, the system100can generate a notification based at least in part on the physiological data or other data, and record and/or transmit the notification. The notification can be an indication of the effectiveness of the substance, adverse events caused by the substance, other adverse events unrelated to the substance, or generally any other phenomena or event that the user210or other desired third parties may want or need to be notified about.

According to some implementations of the present disclosure, the system100can be used to track cognitive function of the user210and/or detect cognitive decline in the user (e.g., a decrease in the user210's cognitive function). An impaired sense of smell can be an early predictor of cognitive decline, such as, for example, future development of Alzheimer's disease, other types of dementia, and/or other neurodegenerative disease. The system100can be used to detect and monitor how the user210reacts to various scents and/or aromas injected into the air pathway of the user210. One or more different scents can be injected by the system100in series and/or parallel for use in gauging a reaction of the user. Generally, the substance used with the system100for this purpose will have a specific aroma and/or scent that generally produces a detectable reaction in a person (e.g., a person with a standard cognitive function or a person without cognitive decline).

During and/or after the user210is exposed to the substance (e.g., before and/or during a sleep session with the respiratory device122), the system100can receive and store physiological data and/or information indicative of the user210's ability to detect or not detect the scent of the substance. In some implementations, one or more of the sensors130are used to generate such physiological data, which can then be transmitted to the control system110and stored in the memory device114. The physiological data can include (i) respiration data, which can be used to determine parameters such as respiration rate, inspiration amplitude, expiration amplitude, inspiration-expiration ratio, or a respiration signal; (ii) cardiac data, which can be used to determiner parameters such as heart rate, heart rate variability, or blood pressure; (iii) data related to dilation of the user210's pupils; (iv) electrical data associated with the user210's brain, which can be used to model brain activity (e.g., brain waves) of the user210; (v) electrical data associated with the user210's skin, such as galvanic skin response, or (vi) any combination thereof.

The physiological data can be generated using any one or more of the sensors130, such as the pressure sensor132, the flow rate sensor134, the temperature sensor136, the a motion sensor138, the microphone140, the speaker142, the acoustic sensor141, the radio-frequency (RF) receiver146, the RF transmitter148, the RF sensor147, the camera150, the infrared (IR) sensor152, the PPG sensor154, the ECG sensor156, the EEG sensor158, the capacitive sensor160, the force sensor162, the strain gauge sensor164, the EMG sensor166, a galvanic skin response (GSR) sensor, or any other sensor.

The physiological data can be indicative of how the user reacts to the scent of the substance(s). For example, specific brain activity may occur when the user detects the scent. The electrical data associated with the user210's brain can be used to monitor the user210's brain activity when the substance is delivered into the air pathway. In another example, the cardiac data can be utilized to determine if there is any distinct change in the user210's heart rate (for example a spike in the heart rate) when the substance is delivered into the air pathway. In still another example, the galvanic skin response of the user can change in response to the user210detecting the scent. In still other implementations, the control system110can use the data to determine sleep-related parameters, such as a sleep score, a number of respiration events per hours, a number of hours that the user is asleep during the sleep session, etc. These sleep-related parameters can also be used to determine how a user reacts to the scent of the substance. Furthermore, any or all of the various types of physiological data and resulting parameters may also be used to directly measure the cognitive functioning of the user210.

In additional or alternative implementations, usually applied during a pre-sleep session, the control system can receive information from the user210, for example via the external device170. This information is related to the user210's ability to smell the substance. In some implementations, the control system110is configured to ask the user210questions, such as through an application on the external device170(e.g., an app on a smartphone). The questions can be generally related to whether the user210is able to smell the substance that was injected into the air pathway. By providing answers to the questions, the user210provides feedback to the system indicative of their ability to detect the scent of various substances. The user210can input this information while the user210is wearing the user interface124and using the respiratory device122prior to falling asleep. The user210can additionally or alternatively input information once the user210has woken up, for example, after the sleep session has ended.

The system100can be used to monitor the user210's ability to detect scents, as well as how strong the scent is to the user210. This monitoring can be done in a variety of ways. For example, after delivery of a substance with a specific scent into the air pathway of the user210, the user210can indicate what kind of scent they were able to detect (e.g., strawberry scent, flower scent, bubble gum scent, skunk scent, etc.). In some implementations, the control system110can ask the user (for example, via an application running on the external device170) if they detected a scent, what kind of scent they detected, how many scents they detected, how long they detected the scent for, etc. The control system110could ask the user210to simply enter what kind of scent they detected, or ask the user210to choose from a variety of different options (e.g., via a multiple choice prompt). In some implementations, a different substance is used for successive sleep sessions, so as to deliver a different scent to the user210one night to the next.

The delivery of the substance for the purpose of cognitive testing may be different than the purpose associated with medication via aroma delivery (e.g., aromatherapy). In one example, delivering the substance for cognitive testing may include delivering a discrete amount of the substance to the user periodically, with a sufficient amount of time (e.g., one minute, five minutes, thirty minutes, one hour, two hours, three hours, four hours, five hours, etc., or any other amount of time) between the deliveries to collect physiological data or to receive feedback from the user. The amounts can progressively increase or decrease, depending, for example, on the response of the user210. For instance, if the user210reacts strongly, either physiologically and/or via direct response to a question, the amounts may be progressively reduced to test the limit of the user210's sensitivity. In contrast, when the user does not detect the substance, the amount can be progressively increased until an appreciable response is detected and/or received. The threshold where the user loses/gains sensitivity to the substance may provide a useful information of the cognitive state of the user.

In some implementations, the substance is continually delivered into the air pathway of the user210for substantially all of the sleep session, including when the user210is asleep. If the user210is able to detect the scent, it is likely that the user210will remember that scent once the user210wakes up. The user210can then provide that information to the control system110. In still other implementations, the user210can initiate a testing procedure (for example using the external device170) that prompts the user210for a variety of information related to detecting scents.

In some implementations, the control system110can also utilize non-physiological data. For example, the control system110can analyze the user210's medical records to determine if the user210or a family member has any history of cognitive disease, or if there is any other information that can assist in determining whether the user210may be suffering from decreased cognitive function. For example, the user210's medical records could indicate that there is some other reason that the user210is not able to detect scents as well as might be expected, for example, due to a medication that the user210is taking or another disease or condition that the user210is suffering from. In another example, medication that the user210is currently taking can indicate that the user210is suffering from cognitive decline. In still other implementations, the user210's medical records may indicate directly that the user is suffering from cognitive decline or other neurodegenerative disease. The control system110can use this information to assist in determining whether the user is suffering from decreased cognitive function. The user210's age can also be taken into account to assess any contribution that general deterioration of cognitive functions with age may have on the detected results. Absolute or relative values of the user210's detected state of cognitive functions can be used. For example, the user210's test results can be compared to a baseline associated with user210's earlier test results, with test results statistically derived for relevant population group, etc.

In still other implementations, the non-physiological data includes subjective information that can be inputted directly by the user210. The information can include information about the user210's current medical status (e.g., how are they feeling, what kinds of conditions or diseases do they have), information related to any medication currently being taken by the user210, information about the user210's ability to detect the scent of a substance, information about the user210's cognitive functioning, etc. In some implementations, the information includes an indication of the user210's ability to detect the scent of the substance that is unrelated to the user210's cognitive functioning level. In other implementations, the information includes an indication of the user210's cognitive functioning level that is unrelated to the user210's ability to detect the scent of the substance. Generally, the subjective information can include any relevant information that can be supplied by the user210, or by other persons or sources.

The control system110can also utilize data from games or other activities undertaken by the user210indicative of the user210's cognitive function. For example, the system100could deploy through the external device170a variety of different memory tests, puzzles, quizzes, etc., for the user210to complete. The results of these activities (e.g., how fast the user completed the test, how accurate the user was when taking the test, etc.) can be used by the control system110in its analysis of the user210's cognitive function. The user210could also input results from these memory tests, puzzles, quizzes, etc., via the external device170and/or by another method.

The control system110is configured to analyze the physiological data, the information provided by the user210, and any other data to generate one or more metrics related to the user210's ability to detect scents, which in turn can be used to determine a level of cognitive function of the user210. The system100can generate and store a time series of the one or more metrics to track the user210's cognitive function over time (e.g., over a period of minutes, hours, days, weeks, months, years, decades, etc.). In some implementations, values of the one or more metrics satisfying one or more threshold values (e.g., being greater than, less than, or equal to the one or more threshold values) can indicate that the user210has decreased cognitive functioning, or is otherwise at risk of developing a cognitive disease in the future. In other implementations, the system100can perform a variety of different statistical operations on the metrics to determine whether the user has decreased cognitive functioning, or is otherwise at risk of developing a cognitive disease in the future. In some implementations, the control system110utilizes running averages over a time period to analyze the user210's cognitive function. Using running averages over a time period can minimize the effect that unrelated temporary events may impact the values of one or more metrics.

In some implementations, the system100first establishes a baseline or initial level of cognitive functioning of the user210. The system100can then subsequently compare the real-time level of cognitive functioning of the user210to the baseline level, in order to determine that the user210's level of cognitive functioning has decreased below the baseline level.

When the system100determines that the user210's cognitive function has decreased, determines and/or finds an indication of potential cognitive decline or that the user210is at risk for developing a cognitive disease in the future, or generally determines that the cognitive functioning of the user210satisfies some threshold (e.g., the cognitive functioning level has dropped below some baseline cognitive functioning level, the amount of decrease in the cognitive functioning level has exceed a threshold decrease, etc.), a variety of different actions can be taken. In some implementations, the system100can notify the user210and suggest additional diagnostic tests to better diagnose the user210's cognitive function. In additional or alternative implementations, the system100can prompt the user210to input additional information about what types of events and/or other phenomena might be impacting the user210's sense of smell. This information can help the system100avoid false positives.

In still other implementations, the control system110is configured to cause a notification to be transmitted to one or more third parties (e.g., relatives, parents, children, friends, doctors, care providers, etc.) in response to determining that the user210is suffering from decreased cognitive function or developing a cognitive function-impacting disease. For example, the control system110can transmit a notification indicating this determination to a health care provider (such as a doctor or a nurse), emergency services personnel, a family member, a friend, a health insurance provider, etc.

The control system110can implement a training or learning process (e.g., training a cognitive decline detection algorithm, training a smell detection algorithm, etc.) to more accurately determine whether the user210is suffering from cognitive decline, and determine which types of scents are more indicative of cognitive functioning for a specific user210or group of users or all users generally. Generally, the control system110can compare any type of received data (physiological, non-physiological, subjective, etc.) to identify the values of the various metrics or trends in the various metrics that can indicate a decline in the user210's cognitive function. The control system110can thus rule out false positives, or other trends or values in the metrics that might be unrelated to the user210's cognitive functioning. This feature can be used to determine which types of substances/scents most accurately reflect the user210's cognitive functioning. For example, if there is a certain scent that the user is unable to detect (which could be indicated by physiological data and/or non-physiological data), the control system110can analyze any other data (such as the subjective information) to see if there is other any indication of cognitive decline. If there is no indication of cognitive decline from such an analysis (or an indication of level or even improved cognitive functioning), the control system110can ensure that that substance/scent is no longer used to test that specific user210's cognitive functioning, because the system100has learned that such a substance/scent will not provide accurate or reliable results.

Because the delivery of the substance into the air pathway can be controlled and based on physiological data and/or sleep-related parameters, the system100and methods700-1000aid in ensuring that the correct dosage of the substance is delivered into the air pathway, either as a single bolus or over a predetermined time period. Potential errors in dosage amounts due to manual control (e.g., asthma inhalers) can be avoided.

Generally, any of methods700,800,900, and1000can be implemented using a system having a control system with one or more processors, and a memory storing machine readable instructions. The controls system can be coupled to the memory, and methods700,800,900, and1000can be implemented when the machine readable instructions are executed by at least one of the processors of the control system. Methods700,800,900, and1000can also be implemented using a computer program product (such as a non-transitory computer readable medium) comprising instructions that when executed by a computer, cause the computer to carry out the steps of methods700,800,900, and1000.

One or more elements or aspects or steps, or any portion(s) thereof, from one or more of any of claims1-150below can be combined with one or more elements or aspects or steps, or any portion(s) thereof, from one or more of any of the other claims1-150or combinations thereof, to form one or more additional implementations and/or claims of the present disclosure.

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