Identifying the work of breathing in respiratory gas delivery therapy systems

Abstract

A respiratory device configured to provide a gas flow to a user for respiratory therapy. The device includes a flow generator configured to generate a gas flow for the user, and one or more sensors configured to generate flow parameter data indicating or representing the gas flow. A controller is configured to receive the flow parameter data, identify an intranasal pressure variability value indicating the user's mean intranasal pressure, based at least partly on the received flow parameter data, identify a work-of-breathing (WOB) indicator based at least partly on the identified intranasal pressure variability value, and initiate one or more actions based at least partly on the identified WOB indicator.

Description

[Technical Field]

[0001] This disclosure relates to the determination of the work of breathing by a patient using an open-type ventilator (i.e., an open-type ventilator). [Background technology]

[0002] Respiratory support devices are used to deliver gas flow to users or patients in various environments such as hospitals, medical facilities, home care, or within the home. Respiratory support or respiratory therapy devices (collectively, "respiratory devices" or "ventilators") are used to deliver supplemental oxygen or other gases by gas flow and / or using humidifiers to deliver heated and humidified gases. Respiratory devices may allow for adjustment and control of gas flow characteristics, such as flow rate, temperature, gas concentration, humidity, and pressure. Sensors such as flow sensors and / or pressure sensors are used to measure gas flow characteristics. [Overview of the project] [Means for solving the problem]

[0003] In a first embodiment, the Disclosure broadly includes a respiratory device configured to provide a gas flow to a user for respiratory therapy, which includes a flow generator configured to generate a gas flow for the user, one or more sensors configured to generate flow parameter data indicating or representing the gas flow, and a controller configured to receive the flow parameter data, identify an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data, identify a work of breathing (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value, and initiate one or more actions based at least in part on the identified WOB indicator.

[0004] In a second embodiment, the Disclosure broadly includes a respiratory therapy system configured to provide a gas flow to a user for respiratory therapy, comprising: a flow generator configured to generate a gas flow for the user; one or more sensors configured to generate flow parameter data indicating or representing the gas flow; a respiratory conduit operationally coupled to the flow generator and configured to transport the gas flow from the flow generator to the user; a patient interface operationally coupled to the respiratory conduit; and a controller, the controller configured to receive the flow parameter data, identify an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data, identify a work-of-breath (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value, and initiate one or more actions based at least in part on the identified WOB indicator.

[0005] The respiratory apparatus of the first embodiment or the respiratory therapy system of the second embodiment may further have one or more of the following embodiments or features as defined in the following paragraphs:

[0006] In a certain configuration, the flow parameter data includes flow rate data that indicates or represents the flow rate of the gas flow provided by the flow generator.

[0007] In one configuration, the device includes one or more flow sensors configured to detect and generate flow data.

[0008] In a given configuration, one or more flow sensors are positioned or arranged within or inside the gas flow path.

[0009] In a particular configuration, one or more flow sensors are positioned or arranged at or near the outlet of the blower of the flow generator.

[0010] In a certain configuration, one or more flow sensors communicate electrically with the controller.

[0011] In one configuration, the controller is further configured to process the flow data to remove noise and / or signal components associated with the flow generator.

[0012] In one configuration, the controller is configured to remove noise related to the motor's influence on the flow rate data.

[0013] In one configuration, the controller is configured to receive data on motor speed, and when the motor speed falls below a preset threshold, the gas flow rate data is discarded.

[0014] In one configuration, the controller is configured to discard flow data when it determines that the gas flow data parameters are of insufficient quality.

[0015] In a certain configuration, flow rate data is considered to be of insufficient quality if it contains large transient peaks.

[0016] In a certain configuration, the flow parameter data includes pressure data that indicates or represents the pressure of the gas flow at the outlet of the flow generator's blower.

[0017] In one configuration, the device further includes one or more pressure sensors configured to detect and generate pressure data.

[0018] In a certain configuration, one or more pressure sensors are positioned or arranged within or inside the gas flow path.

[0019] In one configuration, one or more pressure sensors are positioned or arranged at or near the outlet of the blower of the flow generator.

[0020] In a given configuration, one or more pressure sensors communicate electrically with the controller.

[0021] In one configuration, the controller is further configured to identify an initial intranasal pressure estimate that indicates or represents the user's intranasal pressure, based at least in part on pressure data.

[0022] In one configuration, the controller is further configured to identify a flow path conductance estimate that indicates or represents an estimate of the flow path conductance for gas flow between the flow generator and the patient interface.

[0023] In one configuration, the controller is configured to determine the flow conductance estimate based at least in part on an initial intranasal pressure estimate that indicates or represents the user's intranasal pressure estimate.

[0024] In one configuration, the controller is configured to determine the flow path conductance estimate based at least in part on flow rate data indicating or representing the flow rate of the gas flow provided by the flow generator.

[0025] In one configuration, the controller is configured to determine the flow path conductance estimate based at least in part on pressure data indicating or representing the pressure of the gas flow at the outlet of the flow generator's blower.

[0026] In one configuration, the controller is configured to determine the flow path conductance estimate based at least in part on flow rate data indicating or representing the flow rate of the gas flow provided by the flow generator and the motor speed representing the motor speed of the blower of the flow generator.

[0027] In one configuration, the controller is configured to determine the flow path conductance estimate based at least in part on flow rate data indicating or representing the flow rate of the gas flow provided by the flow generator and pressure data indicating or representing the pressure of the gas flow at the outlet of the flow generator's blower.

[0028] In one configuration, the controller is configured to determine intranasal pressure fluctuations based at least in part on the estimation of flow path conductance.

[0029] In one configuration, the controller is configured to determine intranasal pressure fluctuations based at least in part on flow rate data indicating or representing the flow rate of the gas flow provided by the flow generator.

[0030] In one configuration, the controller is configured to determine intranasal pressure fluctuations based at least in part on minute ventilation data that indicates or represents the average volume of gas supplied per minute by the flow generator.

[0031] In one configuration, the controller is configured to identify minute ventilation data by fitting multiple splines to gas flow parameter data, the multiple splines are fitted using a least-squares criterion, and the minute ventilation data is identified by integrating along the multiple splines.

[0032] In one configuration, the controller is configured to identify minute ventilation data by identifying the integral of the absolute value of the first term of a line fitted to the gas flow parameter data.

[0033] In one configuration, the controller is configured to identify device minute ventilation data by identifying the integral of the absolute value of a line fitted to the gas flow parameter data, divided by the time range.

[0034] In one configuration, the controller is configured to identify device minute ventilation data by identifying the mean of the absolute values ​​of a line fitted to gas flow parameter data over a range of time points within a time range.

[0035] In a given configuration, the intranasal pressure fluctuation value is identified by a frequency selected within the range of 1 Hz to 20 Hz.

[0036] In a certain configuration, intranasal pressure fluctuations are continuously identified as rolling mean values.

[0037] In one configuration, the device further includes a non-temporary computer-readable medium that is accessible by a controller or communicates data with the controller, preferably the non-temporary computer-readable medium includes non-volatile memory, and preferably the device further includes a patient nostril model stored in the non-volatile memory.

[0038] In one configuration, the controller is further configured to determine a user respiratory flow rate estimate, which indicates or represents the user's respiratory flow rate, based at least in part on flow rate data indicating or representing the gas flow rate provided by the flow generator and the patient nostril model.

[0039] In one configuration, the controller is configured to determine the user respiratory flow rate estimate based at least in part on a flow path conductance estimate that indicates or represents an estimate of the conductance of the flow path for gas flow between the flow generator and the patient interface.

[0040] In one configuration, the controller is configured to determine the estimated user respiratory flow rate based at least in part on minute ventilation data that indicates or represents the average volume of gas supplied per minute by the flow generator.

[0041] In one configuration, the controller is configured to identify a nasal conductance estimate, which indicates or represents an estimate of the conductance of the flow path for gas flow between the patient interface and the user's nasal cavity, based at least in part on data indicating the size of the patient interface and an estimate of nasal obstruction by the patient interface.

[0042] In one configuration, the controller is configured to determine the user respiratory flow rate estimate based at least in part on a determined or calculated nasal conductance estimate.

[0043] In one configuration, the controller is configured to identify the work-of-respiratory indicator based at least in part on intranasal pressure fluctuations and the user respiratory flow estimation signal.

[0044] In one configuration, the controller is configured to identify a smoothness value that indicates or represents the smoothness of minute ventilation data, which indicates or represents the average volume of gas supplied per minute by the flow generator.

[0045] In one configuration, the controller is configured to identify the respiratory work indicator based at least in part on intranasal pressure fluctuations and smoothness values.

[0046] In one configuration, the device further includes a display screen, preferably which displays a graphical user interface and / or preferably which communicates with a controller.

[0047] In a certain configuration, the display screen is removable from the device or the device housing.

[0048] In one configuration, the controller is configured to display a graphical indicator on a display screen that represents a specified respiratory work indicator.

[0049] In a given configuration, a graphical indicator may include one or more of the following: numbers, text, waveforms, illustrations, or animations.

[0050] In a given configuration, a graphical indicator shows or represents whether a specified respiratory work indicator is increasing or decreasing.

[0051] In one configuration, the controller is configured to trigger or generate alerts, alarms, and / or notifications based at least in part on a specified respiratory work indicator and one or more thresholds.

[0052] In a given configuration, alerts, alarms, and / or notifications are triggered or generated at least in part based on the determination that a respiratory work indicator has risen above a certain threshold.

[0053] In a given configuration, alerts, alarms, and / or notifications are triggered or generated at least in part based on a determination that the respiratory work indicator has fallen below a certain threshold.

[0054] In a certain configuration, the threshold is the circuit out-of-circuit detection threshold.

[0055] In one configuration, alerts, alarms, and / or notifications are triggered or generated at least in part on the determination that a respiratory work indicator has continuously fallen below a threshold for a given sustained condition.

[0056] In one configuration, the controller is configured to generate alerts, alarms, and / or notifications in a form selected from one or more of the following: auditory, visual, and / or tactile.

[0057] In one configuration, the device further includes an audio output device that telecommunicates with a controller, and the controller is configured to audibly generate alerts, alarms, and / or notifications via the audio output device.

[0058] In one configuration, the controller is configured to visually generate alerts, alarms, and / or notifications via the device's display screen.

[0059] In one configuration, the controller is configured to send or transmit data representing alerts, alarms, and / or notifications to a remote device or system that telecommunicates with the device.

[0060] In a given configuration, the controller may be configured to set or adjust one or more parameters of a threshold, or any parameters associated therewith, based at least in part on user input via the graphical user interface of the device's display screen.

[0061] In one configuration, the controller is configured to generate or provide proposed thresholds and / or parameters associated with one or more thresholds based at least in part on a respiratory work indicator.

[0062] In one configuration, the controller is further configured to identify a ratio or percentage representing the user's respiratory work indicator relative to the nominal equivalent respiratory work indicator of a nominally average healthy person.

[0063] In a given configuration, a nominal equivalent respiratory work indicator is identified based at least in part on the amplitude of nominal fluctuations in nominal intranasal pressure in a nominally average healthy person.

[0064] In a given configuration, the amplitude of nominal variation in intranasal pressure in a nominally average healthy person is determined based at least in part on predetermined physiological parameters of a nominally average healthy person.

[0065] In a given configuration, the amplitude of nominal variation in nominal intranasal pressure for a nominally average healthy person is determined at least in part based on manually entered physiological parameters relating to the user.

[0066] In a given configuration, the amplitude of nominal fluctuations in nominal intranasal pressure in a nominally average healthy person is determined at least in part based on nominal numerical information of nasal obstruction due to nominal nasal cannula prongs in the patient interface.

[0067] In a given configuration, the amplitude of nominal fluctuations in nominal average healthy nasal pressure is determined at least in part based on manually entered numerical information of nasal obstruction via the nasal cannula prongs of the patient interface.

[0068] In one configuration, the controller is configured to generate one or more alerts, alarms, and / or notifications based at least in part on a ratio or percentage value representing the user's respiratory work indicator relative to the nominal equivalent respiratory work indicator of a nominal average healthy person, or related trend data of the ratio or percentage, and one or more thresholds.

[0069] In one configuration, the controller is configured to visually display ratio or percentage values ​​and / or trend data related to ratios or percentages on the device's display screen.

[0070] In one configuration, the controller is configured to generate alerts, alarms, and / or notifications containing data indicating suggested adjustments to one or more treatment settings and / or device settings, based at least in part on a ratio or percentage value representing the user's respiratory work indicator relative to the nominal equivalent respiratory work indicator of a nominal average healthy person, or related trend data of the ratio or percentage, and one or more thresholds.

[0071] In a given configuration, the treatment settings and / or device settings include flow rate settings and / or gas flow oxygen concentration settings (e.g., FiO2 settings or FdO2 settings).

[0072] In one configuration, the device or system further includes a housing which encloses or collectively houses a flow generator, a humidifier configured to heat and humidify the gas flow, a sensing block or sensor module including one or more sensors configured to generate flow parameter data indicating or representing the gas flow, and a controller.

[0073] In one configuration, the detection block or sensor module includes a flow sensor and a pressure sensor.

[0074] In a third embodiment, the Disclosure broadly includes a method for controlling a respiratory device configured to provide a gas flow to a user for respiratory therapy, the device including a flow generator configured to generate a gas flow for the user, one or more sensors configured to generate flow parameter data indicating or representing the gas flow, and a controller, the method being performed or implemented by the controller and including the following steps: receiving flow parameter data; identifying an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data; identifying a work-of-bodied (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value; and initiating one or more actions based at least in part on the identified WOB indicator.

[0075] In a certain configuration, the flow parameter data includes flow rate data that indicates or represents the flow rate of the gas flow provided by the flow generator.

[0076] In one configuration, the device includes one or more flow sensors configured to detect and generate flow data.

[0077] In a given configuration, one or more flow sensors are positioned or arranged within or inside the gas flow path.

[0078] In a particular configuration, one or more flow sensors are positioned or arranged at or near the outlet of the blower of the flow generator.

[0079] In a certain configuration, one or more flow sensors communicate electrically with the controller.

[0080] In one configuration, the controller is further configured to process the flow data to remove noise and / or signal components associated with the flow generator.

[0081] In one configuration, the controller is configured to remove noise related to the motor's influence on the flow rate data.

[0082] In one configuration, the method includes receiving data on motor speed and discarding gas flow rate data when the motor speed falls below a preset threshold.

[0083] In one configuration, the method includes discarding flow rate data when the gas flow rate data parameters are determined to be of insufficient quality.

[0084] In a certain configuration, flow rate data is considered to be of insufficient quality if it contains large transient peaks.

[0085] In a certain configuration, the flow parameter data includes pressure data that indicates or represents the pressure of the gas flow at the outlet of the flow generator's blower.

[0086] In one configuration, the device further includes one or more pressure sensors configured to detect and generate pressure data.

[0087] In a certain configuration, one or more pressure sensors are positioned or arranged within or inside the gas flow path.

[0088] In one configuration, one or more pressure sensors are positioned or arranged at or near the outlet of the blower of the flow generator.

[0089] In a given configuration, one or more pressure sensors communicate electrically with the controller.

[0090] In one configuration, the method further includes identifying an initial intranasal pressure estimate that indicates or represents an estimate of the user's intranasal pressure, based at least in part on pressure data.

[0091] In a given configuration, the method further includes identifying a channel conductance estimate that shows or represents an estimate of the conductance of a channel for gas flow between a flow generator and a patient interface.

[0092] In one configuration, the method includes determining the flow conductance estimate based at least in part on an initial intranasal pressure estimate that indicates or represents the user's intranasal pressure estimate.

[0093] In one configuration, the method includes determining the flow path conductance estimate based at least in part on flow rate data indicating or representing the flow rate of the gas flow provided by the flow generator.

[0094] In one configuration, the method includes determining the flow path conductance estimate based at least in part on pressure data indicating or representing the pressure of the gas flow at the outlet of the flow generator's blower.

[0095] In one configuration, the method includes determining the flow path conductance estimate based at least in part on flow rate data indicating or representing the flow rate of the gas flow provided by the flow generator and the motor speed representing the motor speed of the blower of the flow generator.

[0096] In one configuration, the method includes determining the flow path conductance estimate based at least in part on flow rate data indicating or representing the flow rate of the gas flow provided by the flow generator and pressure data indicating or representing the pressure of the gas flow at the outlet of the flow generator's blower.

[0097] In one configuration, the method includes determining the intranasal pressure fluctuation value based at least in part on the estimation of flow conductance.

[0098] In one configuration, the method includes determining intranasal pressure fluctuations based at least in part on flow rate data indicating or representing the flow rate of the gas flow provided by the flow generator.

[0099] In one configuration, the method includes determining intranasal pressure fluctuations based at least in part on minute ventilation data indicating or representing the average volume of gas supplied per minute by a flow generator.

[0100] In one configuration, the method involves identifying minute ventilation data by fitting multiple splines to gas flow parameter data, wherein the multiple splines are fitted using a least-squares criterion, and the minute ventilation data is identified by integrating along the multiple splines.

[0101] In one configuration, the method includes identifying minute ventilation data by identifying the integral of the absolute value of the first term of a line fitted to gas flow parameter data.

[0102] In one configuration, the method includes identifying device minute ventilation data by identifying the integral of the absolute value of a line fitted to the gas flow parameter data, divided by a time range.

[0103] In one configuration, the method includes identifying device minute ventilation data by identifying the mean of the absolute values ​​of a line fitted to gas flow parameter data over a range of time points within a time range.

[0104] In one configuration, the method includes identifying intranasal pressure fluctuations at a frequency selected within the range of 1 Hz to 20 Hz.

[0105] In one configuration, the method includes continuously identifying intranasal pressure fluctuations as a rolling mean value.

[0106] In one configuration, the device further includes a non-temporary computer-readable medium that is accessible by a controller or communicates data with the controller, preferably the non-temporary computer-readable medium includes non-volatile memory, and preferably the device further includes a patient nostril model stored in the non-volatile memory.

[0107] In one configuration, the method includes identifying a user respiratory flow rate estimate that indicates or represents the user's respiratory flow rate, based at least in part on flow rate data that indicates or represents the gas flow rate provided by a flow generator and a patient nostril model.

[0108] In one configuration, the method includes determining the user respiratory flow rate estimate based at least in part on a flow path conductance estimate that indicates or represents an estimate of the conductance of the flow path for gas flow between the flow generator and the patient interface.

[0109] In one configuration, the method includes determining the estimated user respiratory flow rate based at least in part on minute ventilation data indicating or representing the average volume of gas supplied per minute by the flow generator.

[0110] In one configuration, the method includes identifying a nasal conductance estimate that indicates or represents an estimate of the conductance of a flow path for gas flow between the patient interface and the user's nasal cavity, based at least in part on data indicating the size of the patient interface and an estimate of nasal obstruction by the patient interface.

[0111] In one configuration, the method includes determining the user respiratory flow rate estimate based at least in part on a determined or calculated nasal conductance estimate.

[0112] In one configuration, the method includes identifying a work-of-respiratory indicator based at least in part on intranasal pressure fluctuations and user respiratory flow estimation signals.

[0113] In one configuration, the method includes identifying a smoothness value that indicates or represents the smoothness of minute ventilation data, which indicates or represents the average volume of gas supplied per minute by a flow generator.

[0114] In one configuration, the method includes identifying a respiratory work indicator based at least in part on intranasal pressure fluctuations and smoothness values.

[0115] In one configuration, the device further includes a display screen, preferably which displays a graphical user interface and / or preferably which communicates with a controller.

[0116] In a certain configuration, the display screen is removable from the device or the device housing.

[0117] In one configuration, the method includes displaying a graphical indicator on a display screen that represents a specified respiratory work indicator.

[0118] In a given configuration, a graphical indicator may include one or more of the following: numbers, text, waveforms, illustrations, or animations.

[0119] In a given configuration, a graphical indicator shows or represents whether a specified respiratory work indicator is increasing or decreasing.

[0120] In one configuration, the method includes triggering or generating alerts, alarms, and / or notifications based at least in part on a specified respiratory work indicator and one or more thresholds.

[0121] In one configuration, the method includes triggering or generating alerts, alarms, and / or notifications based at least in part on the determination that a respiratory work indicator has risen above a certain threshold.

[0122] In one configuration, the method includes triggering or generating alerts, alarms, and / or notifications based at least in part on a determination that a respiratory work indicator has fallen below a certain threshold.

[0123] In a certain configuration, the threshold is the circuit out-of-circuit detection threshold.

[0124] In one configuration, the method includes triggering or generating alerts, alarms, and / or notifications based at least in part on a determination that a respiratory work indicator has continuously fallen below a threshold for a predetermined sustained condition in which it relates.

[0125] In one configuration, the method includes generating an alert, alarm, and / or notification in a form selected from one or more auditory, visual, and / or tactile senses.

[0126] In one configuration, the device further includes an audio output device that telecommunicates with a controller, and the method includes audibly generating alerts, alarms, and / or notifications via the audio output device.

[0127] In one configuration, the method includes visually generating alerts, alarms, and / or notifications via the display screen of the device.

[0128] In one configuration, the method includes transmitting or sending data representing alerts, alarms, and / or notifications to a remote device or system that telecommunicates with the device.

[0129] In one configuration, the method includes setting or adjusting one or more parameters of a threshold, or any parameters associated therewith, based at least in part on user input via the graphical user interface of the device's display screen.

[0130] In one configuration, the method includes generating or providing proposed thresholds and / or parameters associated with one or more thresholds based at least in part on a respiratory work indicator.

[0131] In one configuration, the method further includes identifying a ratio or percentage representing the user's respiratory work indicator with respect to the nominal equivalent respiratory work indicator of a nominally average healthy person.

[0132] In one configuration, the method includes identifying a nominal equivalent respiratory work indicator based at least in part on the amplitude of nominal fluctuations in nominal intranasal pressure in a nominally average healthy person.

[0133] In one configuration, the method includes identifying the amplitude of nominal fluctuations in nominal intranasal pressure in a nominally average healthy person based at least in part on predetermined physiological parameters of a nominally average healthy person.

[0134] In one configuration, the method includes identifying the amplitude of nominal variation in nominal intranasal pressure of a nominally average healthy person, based at least in part on manually entered physiological parameters relating to the user.

[0135] In one configuration, the method demonstrates how to identify the amplitude of nominal fluctuations in nominal intranasal pressure in a nominally average healthy person, based at least in part on nominal numerical information of nasal obstruction due to nominal nasal cannula prongs in the patient interface.

[0136] In one configuration, the method includes identifying the amplitude of nominal fluctuations in nominal intranasal pressure in a nominally average healthy person, based at least in part on manually entered numerical information of nasal obstruction via a patient interface nasal cannula prong.

[0137] In one configuration, the method includes generating one or more alerts, alarms, and / or notifications based at least in part on a ratio or percentage value representing the user's respiratory work indicator relative to a nominal equivalent respiratory work indicator for a nominal average healthy person, or related trend data of the ratio or percentage, and one or more thresholds.

[0138] In one configuration, the method includes visually displaying ratio or percentage values ​​and / or trend data relating to ratios or percentages on the display screen of the device.

[0139] In one configuration, the method includes generating alerts, alarms, and / or notifications, which include data indicating suggested adjustments to one or more treatment settings and / or device settings, based at least in part on a ratio or percentage value representing the user's respiratory work indicator relative to a nominal equivalent respiratory work indicator for a nominal average healthy person, or related trend data of the ratio or percentage, and one or more thresholds.

[0140] In a given configuration, the treatment settings and / or device settings include flow rate settings and / or gas flow oxygen concentration settings (e.g., FiO2 settings or FdO2 settings).

[0141] In one configuration, the device further includes a housing which encloses or collectively houses a flow generator, a humidifier configured to heat and humidify the gas flow, a sensing block or sensor module including one or more sensors configured to generate flow parameter data indicating or representing the gas flow, and a controller.

[0142] In one configuration, the detection block or sensor module includes a flow sensor and a pressure sensor.

[0143] In a fourth embodiment, the Disclosure broadly includes a respiratory device configured to provide a gas flow to a user for respiratory therapy, which includes a flow generator configured to generate a gas flow for the user, one or more sensors configured to generate flow parameter data indicating or representing the gas flow, and a controller configured to receive the flow parameter data, identify an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data, identify a work-of-breath (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value, and initiate one or more actions based at least in part on the identified WOB indicator.

[0144] In a fifth embodiment, the Disclosure broadly includes a respiratory therapy system configured to provide a gas flow to a user for respiratory therapy, comprising: a flow generator configured to generate a gas flow for a user; one or more sensors configured to generate flow parameter data indicating or representing the gas flow; a respiratory conduit operationally connected to the flow generator and configured to transport the gas flow from the flow generator to the user; a patient interface operationally connected to the respiratory conduit; and a controller, the controller configured to receive the flow parameter data, identify an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data, identify a user respiratory flow estimate indicating or representing the user's respiratory flow rate, identify a work-of-breathing (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value, and initiate one or more actions based at least in part on the identified WOB indicator.

[0145] In a sixth aspect, the disclosure broadly includes a method for controlling a respiratory device configured to provide a gas flow to a user for respiratory therapy, the device including a flow generator configured to generate a gas flow for a user, one or more sensors configured to generate flow parameter data indicating or representing the gas flow, and a controller, the method including the following steps: receiving flow parameter data; identifying an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data; identifying a user respiratory flow estimate indicating or representing the patient's respiratory flow rate; identifying a work-of-breathing (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value and the user respiratory flow estimate; and initiating one or more actions based at least in part on the identified WOB indicator.

[0146] In a seventh aspect, the Disclosure broadly includes a respiratory device configured to provide a gas flow to a user for respiratory therapy, comprising: a flow generator configured to generate a gas flow for the user; one or more sensors configured to generate flow parameter data indicating or representing the gas flow; and a controller, the controller being configured to receive the flow parameter data, identify an intranasal pressure variability value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data, identify a respiratory smoothness value indicating or representing the rate of change of the user's intranasal pressure variability, identify a work-of-breath (WOB) indicator based at least in part on the identified intranasal pressure variability value and respiratory smoothness value, and initiate one or more actions based at least in part on the identified WOB indicator.

[0147] In an eighth aspect, the Disclosure broadly includes a respiratory therapy system configured to provide a gas flow to a user for respiratory therapy, comprising: a flow generator configured to generate a gas flow for a user; one or more sensors configured to generate flow parameter data indicating or representing the gas flow; a respiratory conduit operationally connected to the flow generator and configured to transport the gas flow from the flow generator to the user; a patient interface operationally connected to the respiratory conduit; and a controller, the controller configured to receive the flow parameter data, identify an intranasal pressure variability value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data, identify a respiratory smoothness value indicating or representing the rate of change of the user's intranasal pressure variability, identify a user respiratory flow rate estimate indicating or representing the user's respiratory flow rate, identify a work-of-breathing (WOB) indicator based at least in part on the identified intranasal pressure variability value and respiratory smoothness value, and initiate one or more actions based at least in part on the identified WOB indicator.

[0148] In a ninth aspect, the Disclosure broadly includes a method for controlling a respiratory device configured to provide a gas flow to a user for respiratory therapy, the device including a flow generator configured to generate a gas flow for the user, one or more sensors configured to generate flow parameter data indicating or representing the gas flow, and a controller, the method being performed or implemented by the controller and including the following steps: receiving flow parameter data; identifying an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data; identifying a respiratory smoothness value indicating or representing the rate of change of the user's intranasal pressure fluctuation; identifying a work-of-breath (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value and respiratory smoothness value; and initiating one or more actions based at least in part on the identified WOB indicator.

[0149] The fourth to ninth aspects of this disclosure may further have one or more of the features described in the preceding paragraphs with respect to the first to third aspects.

[0150] In a tenth aspect, the Disclosure broadly includes a respiratory device configured to provide a gas flow to a user for respiratory therapy, which includes a flow generator configured to generate a gas flow for the user, one or more sensors configured to generate flow parameter data indicating or representing the gas flow, a display connected to or communicating data with the respiratory device, and a controller, the controller receiving the flow parameter data, identifying an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data, identifying a work-of-bodied (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value, and displaying, or being configured to display, WOB data based at least in part on the identified WOB indicator on the display.

[0151] In an eleventh aspect, the Disclosure broadly includes a respiratory therapy system configured to provide a gas flow to a user for respiratory therapy, comprising: a flow generator configured to generate a gas flow for a user; one or more sensors configured to generate flow parameter data indicating or representing the gas flow; a display connected to or communicating with the respiratory system; a respiratory conduit operationally connected to the flow generator and configured to transport the gas flow from the flow generator to the user; a patient interface operationally coupled to the respiratory conduit; and a controller, the controller receiving the flow parameter data, identifying an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data, identifying a work-of-respiratory (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value, and displaying, or being configured to display, WOB data on the display based at least in part on the identified WOB indicator.

[0152] A respiratory apparatus of the tenth aspect or a respiratory therapy system of the eleventh aspect may further have one or more of the following properties or features as defined in the following paragraphs:

[0153] In one configuration, the display includes the display screen of the respiratory device.

[0154] In one configuration, the display screen is detachable from the respiratory apparatus or the housing of the respiratory apparatus.

[0155] In one configuration, the display includes the user interface for the respiratory device.

[0156] In a certain configuration, the display includes a graphical user interface (GUI).

[0157] In one configuration, the display is provided on a remote device or system that communicates data with the respiratory apparatus.

[0158] In one configuration, the controller is further configured to send WOB data for display to a remote device or system for display.

[0159] In one configuration, the controller is configured to display one or more graphical indicators representing WOB data on the respiratory device's display screen.

[0160] In a given configuration, a graphical indicator may include one or more of the following: numbers, text, waveforms, illustrations, or animations.

[0161] In a given configuration, a graphical indicator shows or represents whether a specified WOB indicator is increasing or decreasing.

[0162] In a given configuration, the WOB data displayed on the screen includes data that represents raw or absolute WOB indicators.

[0163] In one configuration, the controller is further configured to process the identified WOB indicators to generate a ratio or percentage representing the user's identified WOB indicators relative to the nominal equivalent WOB indicators of a nominally average healthy person.

[0164] In a given configuration, the WOB data displayed on the screen includes data representing a ratio or percentage of the user's identified WOB indicator relative to the nominal equivalent WOB indicator of a nominally average healthy person.

[0165] In one configuration, the controller is further configured to process a portion or window of a specified WOB indicator over a certain period of time to generate one or more WOB indicator trends or trend data.

[0166] In a certain configuration, the WOB data displayed on the screen includes data that indicates one or more WOB indicator trends or trend data.

[0167] In a given configuration, the WOB data displayed on the screen includes WOB indicator trend or trend data that shows or represents one or more of the following: WOB increase, WOB decrease, and / or WOB stabilization.

[0168] In a given configuration, the WOB data displayed on the screen may include data representing one or more of the following data types: raw or absolute WOB indicator data, ratios or percentages representing the WOB indicator identified for a user relative to the nominal equivalent WOB indicator for a nominally average healthy person, and / or WOB indicator trends or trend data.

[0169] In a given configuration, one or more data types may be displayed on the display separately from or in combination with one or more other data types.

[0170] In one configuration, the data is displayed on a graphical user interface (GUI) of a display screen, and the GUI includes a first GUI element configured to display a first type of WOB data and a second GUI element configured to display a second type of WOB data.

[0171] In one exemplary configuration, the first GUI element includes a graphical indicator representing a ratio or percentage of a WOB indicator identified for a user with respect to raw or absolute WOB indicator data and / or nominal equivalent WOB indicators for a nominally average healthy person, and the second GUI element includes a graphical indicator representing a WOB indicator trend or trend data.

[0172] In a twelfth aspect, the Disclosure includes a method for controlling a respiratory device configured to provide a gas flow to a user for respiratory therapy, the device comprising: a flow generator configured to generate a gas flow for a user; one or more sensors configured to generate flow parameter data indicating or representing the gas flow; a display connected to or communicating data with the respiratory device; and a controller, the method being performed or implemented by the controller and comprising the following steps: receiving flow parameter data; identifying an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data; identifying a work-of-bodied (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value; and displaying or making displayable WOB data based at least in part on the identified WOB indicator on the display.

[0173] The method of the twelfth aspect may have one or more of the features described in the preceding paragraphs relating to the tenth or eleventh aspect of the present disclosure.

[0174] In a thirteenth aspect, the Disclosure broadly includes a respiratory device configured to provide a gas flow to a user for respiratory therapy, which includes a flow generator configured to generate a gas flow for the user, one or more sensors configured to generate flow parameter data indicating or representing the gas flow, and a controller, the controller being configured to receive the flow parameter data, identify an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data, identify a work-of-respiratory (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value, and generate one or more alerts, alarms, and / or notifications based at least in part on a comparison of the identified WOB indicator or associated WOB data with one or more thresholds.

[0175] In a fourteenth aspect, the Disclosure includes a respiratory therapy system configured to provide a gas flow to a user for respiratory therapy, comprising: a flow generator configured to generate a gas flow for the user; one or more sensors configured to generate flow parameter data indicating or representing the gas flow; a respiratory conduit operationally coupled to the flow generator and configured to transport the gas flow from the flow generator to the user; a patient interface operationally coupled to the respiratory conduit; and a controller, the controller configured to receive the flow parameter data, identify an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data, identify a work-of-respiratory (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value, and generate one or more alerts, alarms, and / or notifications based at least in part on a comparison of the identified WOB indicator or associated WOB data with one or more thresholds.

[0176] A respiratory apparatus of the thirteenth aspect or a respiratory therapy system of the fourteenth aspect may further have one or more of the following properties or features as defined in the following paragraphs:

[0177] In one configuration, the controller is configured to generate alerts, alarms, and / or notifications based at least in part on the determination that a WOB indicator or associated WOB data has risen above a certain threshold.

[0178] In one configuration, the controller is configured to generate alerts, alarms, and / or notifications based at least in part on the determination that a WOB indicator or associated WOB data has fallen below a certain threshold.

[0179] In one configuration, the controller is configured to generate alerts, alarms, and / or notifications in a form selected from one or more of the following: auditory, visual, and / or tactile.

[0180] In one configuration, the device or system further includes an audio output device that telecommunicates with a controller, and the controller is configured to audibly generate alerts, alarms, and / or notifications via the audio output device.

[0181] In one configuration, the device or system further includes a display that communicates electrically or data with a controller, and the controller is configured to visually generate alerts, alarms, and / or notifications via the display.

[0182] In one configuration, the controller is configured to send or transmit data representing alerts, alarms, and / or notifications to a remote device or system that communicates data with the device or system.

[0183] In one configuration, the controller is configured to transmit or send WOB indicators or associated WOB data to a remote data or system that transmits data to the device or system.

[0184] In a particular configuration, a remote device or system displays or presents data representing alerts, alarms, and / or notifications (whether visual, auditory, and / or tactile), and / or relays / transmits alarms, alerts, and / or notifications to other remote electronic devices or systems.

[0185] In one configuration, the display includes the display screen of the respiratory device.

[0186] In one configuration, the display screen is detachable from the respiratory apparatus or the housing of the respiratory apparatus.

[0187] In one configuration, the display includes the user interface for the respiratory device.

[0188] In a certain configuration, the display includes a graphical user interface (GUI).

[0189] In one configuration, the display is provided on a remote device or system that communicates data with the respiratory apparatus.

[0190] In one configuration, the controller is configured to display graphical indicators representing generated alerts, alarms, and / or notifications on the respiratory device's display screen.

[0191] In a given configuration, a graphical indicator includes one or more of the following: numerical data, text information, graphical form or format, trend lines, data plotted or graphed over a period of time, waveforms, illustrations, icons, animations, and / or color code information.

[0192] In one configuration, the controller is configured to simultaneously display data indicating or representing identified WOB indicators or associated WOB data, along with data indicating generated alerts, alarms, and / or notifications.

[0193] In a given configuration, the controller is configured to generate one or more different types of alerts, alarms, and / or notifications based at least in part on a comparison between identified WOB indicators or associated WOB data and one or more thresholds or threshold criteria.

[0194] In one configuration, the controller is configured to identify the user's WOB status based at least in part on a comparison between identified WOB indicators or associated WOB data and one or more thresholds or threshold criteria.

[0195] In a given configuration, the controller is configured to generate a first type of alert, alarm, and / or notification containing data indicating the user's identified WOB state (e.g., current state and / or trend state). In one exemplary configuration, the identified WOB state may be selected from one or more of the following: WOB increasing, WOB decreasing, WOB stable, high WOB, and / or low WOB.

[0196] In a given configuration, the controller is configured to generate a second type of alert, alarm, and / or notification containing data indicating suggested actions to remedy or in response to an identified WOB condition of the user. In one exemplary configuration, the suggested actions may be selected from one or more of the following: checking the patient, adjusting both settings, and / or suggesting changes to both settings (e.g., increasing or decreasing flow rate settings).

[0197] In a certain configuration, the controller may be configured such that a second type of alert, alarm, and / or notification can be triggered or generated in response to the generation or triggering of a first type of alert, alarm, and / or notification.

[0198] In a certain configuration, the controller may be configured to display a first type of alert, alarm, and / or notification simultaneously with a second type of alert, alarm, and / or notification.

[0199] In a given configuration, the displayed identified WOB indicator or associated WOB data includes, namely, raw or absolute WOB indicators, ratios or percentages representing the identified WOB indicator for a user relative to the nominal equivalent WOB indicator for a nominally average healthy person, and / or data showing one or more WOB indicator trends or trend data.

[0200] In one configuration, data is displayed on a graphical user interface (GUI) of a display screen, and the GUI includes one or more GUI elements or sections or regions for displaying one or more of the generated alerts, alarms, and / or notifications.

[0201] In one configuration, the data displayed on the GUI of the display screen includes a first GUI element or section or region for displaying a first type of alert, alarm, and / or notification indicating a specified WOB state of the user, and a second GUI element or section or region for displaying a second type of alert, alarm, and / or notification indicating a proposed action for repairing or responding to the specified WOB state of the user.

[0202] In one configuration, the controller may be configured to generate the first and / or second type of alerts, alarms, and / or notifications auditorily and / or with one or more voice cues or voice commands on an associated voice output device.

[0203] In a fifteenth aspect, the present disclosure includes a method of controlling a breathing device configured to provide a gas flow to a user for respiratory therapy, the device including a flow generator configured to generate a gas flow for the user, one or more sensors configured to generate flow parameter data indicative of or representing the gas flow, and a controller, the method being executed or implemented by the controller and including the following steps: receiving the flow parameter data; identifying an intranasal pressure variation value indicative of an average intranasal pressure of the user based at least in part on the received flow parameter data; identifying a work of breathing (WOB) indicator based at least in part on the identified intranasal pressure variation value; and generating one or more alerts, alarms, and / or notifications based at least in part on a comparison of the identified WOB indicator or associated WOB data with one or more thresholds.

[0204] The method of the fifteenth aspect may include any one or more of the features described for the thirteenth or fourteenth aspect of the present disclosure in the previous paragraphs.

[0205] In a sixteenth aspect, the present disclosure broadly includes a system including a breathing device configured to provide a gas flow to a user for respiratory therapy, the breathing device including a flow generator configured to generate a gas flow for the user, one or more sensors configured to generate flow parameter data indicative of or representing the gas flow, and a controller, the controller receiving the flow parameter data, identifying an intranasal pressure variation value indicative of the average intranasal pressure of the user based at least in part on the received flow parameter data, identifying a work of breathing (WOB) indicator based at least in part on the identified intranasal pressure variation value, and configured to transmit or convey the WOB indicator or associated WOB data to a remote device or system in data communication with the breathing device, the remote device or system being configured to generate one or more alerts, alarms, and / or notifications based at least in part on a comparison of the identified WOB indicator or associated WOB data with one or more thresholds.

[0206] In one configuration, the remote device or system is configured to present one or more generated alerts, alarms, and / or notifications (regardless of whether by visual, auditory, and / or tactile means).

[0207] In one configuration, the remote device or system is configured to push or transmit or relay the WOB indicator and / or associated WOB data and / or one or more generated alerts, alarms, and / or notifications to other electronic devices or systems.

[0208] A system of the sixteenth aspect may further include one or more of the features described in the preceding paragraphs with respect to aspects thirteenth to fifteenth of the present disclosure. For example, a remote device or system may be configured to perform one or more functions of a respiratory device or system controller, which include generating and / or presenting alarms, alerts, and / or notifications (e.g., display or auditory presentation).

[0209] In a seventeenth aspect, the Disclosure broadly includes a respiratory device configured to provide a gas flow to a user for respiratory therapy, comprising: a flow generator configured to generate a gas flow for the user; one or more sensors configured to generate flow parameter data indicating or representing the gas flow; and a controller, the controller configured to receive the flow parameter data, identify an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data, identify a work-of-breathing (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value, and generate one or more therapeutic parameter setting adjustment suggestions based at least in part on the identified WOB indicator or associated WOB data.

[0210] In an eighteenth aspect, the Disclosure includes a respiratory therapy system configured to provide a gas flow to a user for respiratory therapy, comprising: a flow generator configured to generate a gas flow for the user; one or more sensors configured to generate flow parameter data indicating or representing the gas flow; a respiratory conduit operationally coupled to the flow generator and configured to transport the gas flow from the flow generator to the user; a patient interface operationally coupled to the respiratory conduit; and a controller, the controller configured to receive the flow parameter data, identify an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data, identify a work-of-breath (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value, and generate one or more therapeutic parameter setting adjustment suggestions based at least in part on the identified WOB indicator or associated WOB data.

[0211] A respiratory apparatus of the seventeenth aspect or a respiratory therapy system of the eighteenth aspect may further have one or more of the following properties or features as defined in the following paragraphs:

[0212] In one configuration, the controller is configured to generate one or more therapeutic parameter setting adjustment suggestions based at least in part on a comparison between identified WOB indicators or associated WOB data and one or more thresholds.

[0213] In a given configuration, a WOB indicator or associated WOB data may include, namely, raw or absolute WOB indicators, ratios or percentages representing a WOB indicator identified for a user with respect to a nominally average healthy person's nominally equivalent WOB indicator, and / or data showing or representing one or more WOB indicator trends or trend data.

[0214] In one configuration, the controller may be configured to display or present the generated therapeutic parameter setting adjustment suggestions on the respiratory device's display screen.

[0215] In one configuration, the controller may be configured to transmit, send, or relay the generated therapeutic parameter setting adjustment suggestions to one or more remote devices or systems that communicate data with the respiratory device or system.

[0216] In one configuration, the controller may be configured to apply the generated therapeutic parameter setting adjustment suggestions to the therapeutic settings of the respiratory system (e.g., flow rate settings and / or gas flow oxygen concentration settings, e.g., FiO2 settings and / or FdO2 settings) in response to input or confirmation from the user or clinician via the user interface of the respiratory device and / or other remote device or system.

[0217] In a nineteenth aspect, the Disclosure includes a method for controlling a respiratory device configured to provide a gas flow to a user for respiratory therapy, the device including a flow generator configured to generate a gas flow for the user, one or more sensors configured to generate flow parameter data indicating or representing the gas flow, and a controller, the method being performed or implemented by the controller and including the following steps: receiving flow parameter data; identifying an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data; identifying a work-of-breath (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value; and generating one or more therapeutic parameter setting adjustment suggestions based at least in part on the identified WOB indicator or associated WOB data.

[0218] The nineteenth aspect of the method may include one or more of the features described in relation to the seventeenth or eighteenth aspect of the present disclosure as described in the preceding paragraphs.

[0219] In a 20th aspect, the Disclosure broadly includes a respiratory device configured to provide a gas flow to a user for respiratory therapy, which includes a flow generator configured to generate a gas flow for the user, one or more sensors configured to generate flow parameter data indicating or representing the gas flow, and a controller, the controller being configured to receive the flow parameter data, identify an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data, identify a work-of-bodied (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value, and process the WOB indicator or associated WOB data to detect a circuit break-out event.

[0220] In a 21st aspect, the Disclosure includes a respiratory therapy system configured to provide a gas flow to a user for respiratory therapy, comprising: a flow generator configured to generate a gas flow for the user; one or more sensors configured to generate flow parameter data indicating or representing the gas flow; a respiratory conduit operationally coupled to the flow generator and configured to transport the gas flow from the flow generator to the user; a patient interface operationally coupled to the respiratory conduit; and a controller, the controller configured to receive the flow parameter data, identify an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data, identify a work-of-breath (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value, and process the WOB indicator or associated WOB data to detect a circuit break-out event.

[0221] A respiratory apparatus of the 20th aspect or a respiratory therapy system of the 21st aspect may further have one or more of the following properties or features as defined in the following paragraphs:

[0222] In one configuration, a circuit disconnection event may indicate or represent that any part of the flow path (e.g., the patient breathing circuit and / or the patient interface) has come loose, and / or the user has disconnected or detached from the patient interface.

[0223] In one configuration, the controller may be configured to detect a circuit disconnection event based at least in part on whether a specified WOB indicator or associated WOB data has reached zero or fallen below a predetermined threshold (e.g., near zero) over a predetermined period.

[0224] In one configuration, the controller may further be configured to generate an alert, alarm, and / or notification in response to detecting a circuit disconnection event.

[0225] In one configuration, the controller may be configured to display or present the generated alert, alarm, and / or notification of the circuit disconnection event on a display of the breathing apparatus.

[0226] In one configuration, the controller may be configured to send, transmit, or relay the generated alert, alarm, and / or notification of the circuit disconnection event to a remote system.

[0227] In one configuration, the generated alert, alarm, and / or notification of the circuit disconnection event may further include data indicating a proposed repair or corrective action to resolve the circuit disconnection event.

[0228] In a 22nd aspect, the Disclosure includes a method for controlling a respiratory device configured to provide a gas flow to a user for respiratory therapy, the device including a flow generator configured to generate a gas flow for the user, one or more sensors configured to generate flow parameter data indicating or representing the gas flow, and a controller, the method being performed or implemented by the controller and including the following steps: receiving flow parameter data; identifying an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data; identifying a work-of-bodied (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value; and processing the WOB indicator or associated WOB data to detect a circuit break-out event.

[0229] The methods of the 22nd aspect may include one or more of the features described in relation to the 20th or 21st aspects of the present disclosure as described in the preceding paragraphs.

[0230] In a 23rd aspect, the Disclosure broadly includes a respiratory device configured to provide a gas flow to a user for respiratory therapy, which includes a flow generator configured to generate a gas flow for the user, one or more sensors configured to generate flow parameter data indicating or representing the gas flow, and a controller, the controller being configured to receive the flow parameter data, identify an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data, identify a work-of-respiratory (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value, and generate one or more alerts, alarms, and / or notifications based at least in part on a comparison of the identified WOB indicator or associated WOB data with one or more configurable thresholds.

[0231] In a twenty-fourth aspect, the Disclosure includes a respiratory therapy system configured to provide a gas flow to a user for respiratory therapy, comprising: a flow generator configured to generate a gas flow for the user; one or more sensors configured to generate flow parameter data indicating or representing the gas flow; a respiratory conduit operationally coupled to the flow generator and configured to transport the gas flow from the flow generator to the user; a patient interface operationally coupled to the respiratory conduit; and a controller, the controller being configured to receive the flow parameter data, to identify an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data, to identify a work-of-respiratory (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value, and to generate one or more alerts, alarms, and / or notifications based at least in part on a comparison of the identified WOB indicator or associated WOB data with one or more configurable thresholds.

[0232] A respiratory apparatus of the 23rd aspect or a respiratory therapy system of the 24th aspect may further have one or more of the following properties or features as defined in the following paragraphs:

[0233] In a certain configuration, the controller may also be capable of setting or adjusting one or more of the thresholds, or any of the parameters associated therewith, based at least in part on user input via the graphical user interface (GUI) of the device's display screen.

[0234] In one configuration, the controller is configured to generate or provide proposed thresholds and / or parameters associated with one or more thresholds, based at least in part on identified WOB indicators or associated WOB data.

[0235] In a given configuration, one or more configurable thresholds may include one or more of the following: a single threshold based on one or more parameters and / or conditions, a threshold range, upper and lower threshold limits, and / or a threshold function.

[0236] In one configuration, the device or system provides a GUI on a display screen that can be operated to adjust or set one or more thresholds associated with alerts, alarms, and / or notifications.

[0237] In one configuration, the GUI provides a first GUI element that presents alerts, alarms, notifications, and / or data indicating thresholds or parameters and / or conditions for adjusted thresholds, and a second GUI element that is user-interactive or operable to adjust one or more thresholds.

[0238] In one configuration, the second GUI element may include an interactive GUI with one or more users for adjusting one or more configurable thresholds via touch input or interaction force with a display screen.

[0239] In a given configuration, one or more user-interactive GUI elements for adjusting one or more configurable thresholds may include one or more of the following for entering a desired threshold: a toggle element, a dial, a slider scale element, a selectable discrete threshold element, and / or a numeric and / or classification input field.

[0240] In a given configuration, one or more WOB alerts, alarms, and / or notifications may be configured such that the comparison of identified WOB indicators or associated WOB data with thresholds effectively functions as surrogate alerts, alarms, and / or notifications for other respiratory parameters.

[0241] In a given configuration, WOB alerts, alarms, and / or notifications may be configured as surrogate alerts, alarms, and / or notifications relating to one or more respiratory parameters selected from respiratory rate, minute ventilation, and / or tidal volume.

[0242] In one configuration, the controller may be configured to compare identified WOB indicators or associated WOB data with multiple configurable thresholds, and may generate one or more different alerts, alarms, or notifications based on the results of each comparison.

[0243] In a given configuration, configurable thresholds can be pre-set to default or suggested values.

[0244] In a given configuration, a user interface may be provided on the device's display or system to accept or adjust default or suggested thresholds for one or more of the following: alerts, alarms, and / or notifications.

[0245] In a given configuration, the user interface may be provided on a remote device or system that communicates data with the respiratory apparatus or system, and the user interface may be operable by the user to accept or adjust default or suggested thresholds for one or more of the alerts, alarms, and / or notifications.

[0246] In a given configuration, alerts, alarms, and / or notifications are provided with multiple or numerous upper and lower limits or thresholds.

[0247] In a given configuration, alerts, alarms, and / or notifications may be provided with hierarchical or nested thresholds or threshold ranges, or inner and outer threshold ranges on a threshold scale, or multiple, consecutive, progressive, or hierarchical thresholds. In such a configuration, the generated alerts, alarms, and / or notifications associated with each of the thresholds may be a function of, or depend on, the nature, position, priority, or extrema of the thresholds on the entire threshold scale.

[0248] In a given configuration, when a high-priority threshold is met, a high-priority alert, alarm, or notification may be generated, and when a low-priority threshold is met, a low-priority alert, alarm, and / or notification may be generated.

[0249] In a given configuration, default or suggested thresholds associated with one or more alerts, alarms, and / or thresholds may be recalibrated and / or dynamically changed by the controller, at least in part, based on changes in a predetermined WOB indicator or associated WOB data (e.g., trend data) over a treatment session, multiple treatment sessions, and / or any other configurable period.

[0250] In a given configuration, one or more generated alerts, alarms, and / or notifications may be configured to be selectively presented on one or more devices or systems based at least in part on the alerts, alarms, or notifications and / or the thresholds that have been met.

[0251] In a given configuration, higher-priority alerts, alarms, and / or notifications may be configured to be presented on the respiratory device and one or more other remote devices or systems.

[0252] In a certain configuration, lower-priority alerts, alarms, and / or notifications may be configured to be presented only on the respiratory device.

[0253] In a twenty-fifth aspect, the Disclosure includes a method for controlling a respiratory device configured to provide a gas flow to a user for respiratory therapy, the device including a flow generator configured to generate a gas flow for the user, one or more sensors configured to generate flow parameter data indicating or representing the gas flow, and a controller, the method being performed or implemented by the controller and including the following steps: receiving flow parameter data; identifying an intranasal pressure fluctuation value indicating the user's mean intranasal pressure based at least in part on the received flow parameter data; identifying a work-of-breath (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value; and generating one or more alerts, alarms, and / or notifications based at least in part on comparing the identified WOB indicator or associated WOB data with one or more configurable thresholds.

[0254] The method of the 25th aspect may include one or more of the features described in relation to the 23rd or 24th aspect of the present disclosure as described in the preceding paragraphs.

[0255] In another embodiment, the Disclosure includes a respiratory device configured to generate a gas flow for a user; one or more sensors configured to generate flow parameter data indicating or representing characteristics or parameters of the gas flow; and a controller configured to control the flow generator to deliver a gas flow for nasal high-flow therapy, to identify a work-of-bodied (WOB) indicator based at least in part on the flow parameter data, and to initiate one or more actions based at least in part on the identified WOB indicator.

[0256] In a certain configuration, the flow parameter data includes pressure data that indicates or represents the pressure of the gas flow.

[0257] In a given configuration, pressure data is detected and generated by one or more pressure sensors that communicate with a controller.

[0258] In a particular configuration, one or more pressure sensors are configured to detect and generate pressure data that indicates or represents the pressure of the gas flow at the outlet of the blower of the flow generator.

[0259] In a certain configuration, the flow generator data includes flow rate data that indicates or represents the flow rate of the gas flow.

[0260] In a given configuration, flow rate data is detected and generated by one or more flow rate sensors that communicate with a controller.

[0261] In a particular configuration, one or more flow sensors are positioned or arranged at or near the outlet of the blower of the flow generator.

[0262] In one configuration, the WOB indicator is identified based at least in part on flow parameter data, including detected pressure and / or flow rate data related to the gas flow.

[0263] In another embodiment, the Disclosure includes a respiratory device configured to generate a gas flow for a user, and a controller configured to control the flow generator to deliver a gas flow for respiratory therapy or nasal high-flow therapy, to identify a Work of Breathing (WOB) indicator based at least in part on pressure and / or flow rate measurements relating to the gas flow, and to initiate one or more actions based at least in part on the identified WOB indicator.

[0264] In other embodiments, the Disclosure includes a respiratory device, which includes a flow generator configured to generate a gas flow for a user, and a controller configured to control the flow generator to deliver a gas flow for respiratory therapy or nasal high-flow therapy, and to identify a work-of-breath (WOB) indicator based at least in part on pressure and / or flow rate measurements relating to the gas flow.

[0265] In other embodiments, the Disclosure relates to electronically implemented methods, including software code or coded instructions, that are executable or implemented by a computer, processor, or controller to perform one or more of the methods of the embodiments described above.

[0266] In other embodiments, the disclosure broadly includes non-temporary computer-readable media that, when executed on one or more processing units, store computer-executable instructions thereon that cause one or more processing units to perform or execute any one or more of the methods or embodiments described above.

[0267] Any one of the embodiments of the disclosure described in the preceding paragraphs may further have one or more of the features described in relation to one or more of the other embodiments of the disclosure described in the preceding paragraph.

[0268] These and other features, aspects, and benefits of the Disclosure will be described with reference to drawings of specific embodiments, which are for illustrative purposes only and will not limit the Disclosure. [Brief explanation of the drawing]

[0269] [Figure 1] A schematic diagram of a respiratory system configured to provide respiratory therapy to a patient is shown. [Figure 2] This is an exemplary front view of a respiratory apparatus with the humidifying chamber in place and the handle / lever raised. [Figure 3] This is a top view corresponding to Figure 2. [Figure 4] This is a right side view corresponding to Figure 2. [Figure 5] This is a left side view corresponding to Figure 2. [Figure 6] This is a rear view corresponding to Figure 2. [Figure 7] This is a front-left perspective view corresponding to Figure 2. [Figure 8] This is a front-right perspective view corresponding to Figure 2. [Figure 9] This is a bottom view corresponding to Figure 2. [Figure 10] This shows an exemplary configuration of the air and oxygen inlet arrangement of a respiratory device. [Figure 11] Other exemplary configurations of the air and oxygen inlet arrangements of a respiratory device are shown. [Figure 12] Figure 11 is a cross-sectional view showing a more detailed view of the air and oxygen inlet arrangement. [Figure 13] This is another cross-sectional view showing a more detailed view of the air and oxygen inlet arrangement in Figure 11. [Figure 14] Figure 11 is a longitudinal section view showing a more detailed view of the air and oxygen-filled container arrangement. [Figure 15] This is an exploded view of the upper and lower chassis components of the main housing of the respiratory unit. [Figure 16] This is a front left perspective view of the lower chassis of the main housing, showing the housing for receiving the motor / sensor module subassembly. [Figure 17] This is a first lower perspective view of the main housing of the respiratory device, showing the internal recess for the motor / sensor module subassembly. [Figure 18] This is a second lower perspective view of the main housing of the respiratory unit, showing the recess for the motor / sensor module subassembly. [Figure 19A] A block diagram of a control system that interacts with and / or controls and directs components of the respiratory system is shown. [Figure 19B] A block diagram of an exemplary controller is shown. [Figure 20]A block diagram of the motor and sensor module is shown. [Figure 21] The detection chambers of the exemplary motor and sensor module are shown. [Figure 22A] A flowchart illustrating an embodiment of a method for estimating device minute ventilation is shown. [Figure 22B] Another embodiment of the flowchart for the method of estimating device minute ventilation is shown. [Figure 22C] Another embodiment of the flowchart for the method of estimating device minute ventilation is shown. [Figure 22D] Another embodiment of the flowchart for the method of estimating device minute ventilation is shown. [Figure 23] Another embodiment of the flowchart for the method of estimating device minute ventilation is shown. [Figure 24] This shows an exemplary configuration of a respiratory work monitor screen. It also shows a schematic example of a graphical user interface (GUI) display screen for a respiratory device. [Figure 25] Figures 25A-25F show schematic diagrams of the GUI display screens of a respiratory device, illustrating various examples of different respiratory work alert or notification screens. [Figure 26] A flowchart illustrating an embodiment of a method for estimating a work-of-bodied (WOB) indicator and generating suggestions for adjusting treatment parameters based on the generated WOB data is shown. [Figure 27] Figures 27A and 27B show schematic examples of the respiratory device's GUI display screen, illustrating various examples of circuit breaker alerts triggered in response to calculated WOB data. [Figure 28] Figures 28A and 28B show schematic examples of GUI display screens for adjusting thresholds related to notifications, alerts, and / or alarms based on WOB indicators or data. [Modes for carrying out the invention]

[0270] While specific examples are described below, those skilled in the art will understand that this disclosure goes beyond the specific examples and / or uses described herein, as well as obvious improvements and equivalents thereof. Therefore, the scope of this disclosure is not intended to be limited by any of the specific examples described below.

[0271] 1. Overview of Exemplary Respiratory Devices Examples of methods and / or processes for identifying the work of breathing (WOB), or an indicator or parameter indicating the work of breathing, are described with respect to an exemplary respiratory device 10 configured or operable to provide nasal high-flow therapy via an open-seal patient interface. This is intended to be a non-limiting example. It should be understood that the methods and processes may also be applicable to other respiratory devices or systems and / or other modes of operation and / or modes of therapy delivered to such devices.

[0272] A schematic diagram of an exemplary respiratory device 10 is shown in Figure 1.

[0273] The breathing apparatus 10 (or "breathing system") includes a flow source 50 for providing a high-flow gas 31 such as air, oxygen, oxygen-blended air, or a mixture of air and / or oxygen with one or more other gases. Alternatively, the breathing apparatus may have a connection for connecting to the flow source. Thus, the flow source may form part of the apparatus, or, depending on the situation, be separate from it, or part of the flow source may form part of the apparatus and part of the flow source may be outside the apparatus. In short, depending on the configuration (some components may be optional), the system may include a combination of components selected from: • Flow source, • Humidifier for humidifying gas flow • Conduit (e.g., dryline or heated breathing tube) • Patient interface, ·non-return valve, ·filter

[0274] Here, we will describe the device or system in more detail.

[0275] The flow source can be a high-flow device comprising a wall-mounted oxygen supply source, an oxygen tank 50A, a tank for other gases, and / or a flow generator 50B. Figure 1 shows a flow source 50 comprising a flow generator 50B, an optional air inlet 50C, and an optional connection means via a check valve and / or flow regulator and / or other gas flow control means 50D to an O2 source (tank or O2 generator, etc.) 50A, but this is only one option. The flow generator 50B can control the flow delivered to the patient 56 using one or more valves, or optionally, the flow generator 50B may include a blower. The flow source can be one or a combination of the flow generator 50B, O2 source 50A, and air source 50C, as shown in the figure. Although the flow source 50 is shown as part of the device 10, in the case of an external oxygen tank or wall-mounted supply source, it may be considered a separate component, in which case the device has a connection port to which such a flow source is connected. The flow source provides a (preferably high) flow of gas that can be delivered to the patient via the delivery conduit 16 and the patient interface 51.

[0276] The patient interface 51 may be a non-sealed interface (e.g., when used in high-flow therapy), such as a non-sealed cannula, or a sealed interface (e.g., when used in CPAP), such as a nasal mask, full-face mask, or nasal pillow mask. In some embodiments, the patient interface 51 is a non-sealed patient interface that helps prevent, for example, barotrauma to the patient (e.g., tissue damage to the lungs or other organs of the respiratory system due to pressure differences with respect to the atmosphere). In some embodiments, the patient interface 51 is a sealed mask that seals the patient's nose and / or mouth. The patient interface may be a nasal cannula with a manifold and nasal prongs, and / or a face mask, and / or a nasal pillow mask, and / or a nasal mask, and / or a tracheostomy interface, or any other suitable type of patient interface. The flow source can provide a basic gas flow rate, for example, 0.5 liters / min to 375 liters / min or any range within that range, or within a higher or lower limit. Details regarding the flow rate range and properties will be described later.

[0277] A humidifier 52 may optionally be provided between the flow source 50 and the patient to humidify the delivered gas. One or more sensors 53A, 53B, 53C, 53D, such as flow, oxygen fraction, pressure, humidity, temperature, or other sensors, may be installed in the system and / or on, on, or near the patient 56. Alternatively or additionally, sensors from which such parameters can be obtained may also be used. Additionally or alternatively, sensors 53A-53D may be one or more physiological sensors for detecting patient physiological parameters such as heart rate, oxygen saturation, blood oxygen partial pressure, respiratory rate, blood CO2 partial pressure. Alternatively or additionally, sensors from which such sensors can be obtained may also be used. Other patient sensors may include an EEG sensor, a torso band for detecting respiration, and any other suitable sensor. In some embodiments, the humidifier may be optional or may be preferred due to the advantage that the humidified gas helps maintain the condition of the airway. One or more sensors may form part of the device or be attached externally thereto, and the device has inputs for any of the external sensors. The sensors can be connected to the controller 19, or their outputs can be transmitted to the controller 19.

[0278] In some embodiments, the breathing system 10 may include a sensor 14 for measuring the oxygen fraction of the air inhaled by the patient. In some examples, the sensor 14 may be installed on the patient interface 51 to measure or otherwise identify the oxygen fraction near the patient's mouth and / or nose. In some configurations, the output from the sensor 14 is transmitted to a controller 19 to assist the control means of the breathing system 10 in modifying its operation accordingly. The controller 19 is connected to the flow source 50, the humidifier 52, and the sensor 14. In some embodiments, the controller 19 controls these and other properties of the breathing system 10 described herein. In some examples, the controller can operate the flow source 50 to provide a delivery gas flow at a desired flow rate high enough to meet or exceed the user's (i.e., patient's) inspiratory demand. The flow rate provided is sufficient to prevent ambient air from being taken in when the user (i.e., the patient) inhales. In some configurations, the sensor 14 can transmit measurements of oxygen fractions in the patient's mouth and / or nose to the user, who can then input this information into the respiratory system 10 / controller 19.

[0279] An optional check valve 23 may be provided within the breathing conduit 16. One or more filters may be provided at the air inlet 50C and / or the inlet to the flow generator 50B to filter the incoming gases before they are pressurized into high-flow gas 31 by the flow generator 50B.

[0280] The respiratory support device 10 can be integrated, as generally shown within the dashed box 100 in Figure 1, or it can be arranged in a configuration consisting of separate components. In some configurations, the device or system can be a modular arrangement of components. Furthermore, the device or system may include only some of the illustrated components, and not all of them are necessarily required. Also, the conduit and patient interface may not be part of the system and may be considered separately. Hereinafter, this will be referred to as a respiratory support device or respiratory system, but this should not be considered limiting. In this specification, respiratory support devices and respiratory systems are broadly considered to include anything that provides a patient with a certain flow rate of gas. Some such devices and systems may include a detection system that can be used to determine whether the gas flow rate meets the inspiratory demand.

[0281] The respiratory device 10 may include a main device housing 100. The main device housing 100 may include a flow generator 50B, which may take the form of a motor / impeller mechanism, an optional humidifier or humidification chamber 52, a controller 19, and an input / output I / O user interface 54. The user interface 54 may include a display and input device, such as buttons, a touchscreen (e.g., an LCD screen), a combination of a touchscreen and buttons, or the like. The controller 19 may include one or more hardware and / or software processors, which may be configured or programmed to control components of the system, including, but not limited to, operating the flow generator 50B to generate a gas flow for delivery to the patient, operating the humidifier or humidification chamber 52 (if present) to humidify and / or heat the gas flow, receiving user input from the user interface 54 for reconfiguration and / or user-defined operation of the respiratory device 10, and outputting information to the user (e.g., on a display). The user may be a patient, a healthcare worker, or the like.

[0282] In one configuration, the user interface 54 of the respiratory system 10 may include a removable display screen or touchscreen.

[0283] Continuing to refer to Figure 1, the patient respiratory conduit 16 can be connected to a gas flow outlet (gas outlet or patient outlet port) 21 in the main device housing 100 of the respiratory device 10, and can be connected to a patient interface 17, such as a nasal cannula with a manifold and nasal prongs. The patient respiratory conduit 16 can also be a tracheostomy interface or other non-sealed interface.

[0284] The gas flow can be generated by a flow generator 50B and may be humidified before being delivered to the patient through the patient interface 51 via the patient breathing conduit 16. The controller 19 can control the flow generator 50B to generate a gas flow of a desired rate, and / or control one or more valves to control the mixing of air with oxygen or other breathable gas. The controller 19 can also control a heating element in or associated with a humidification chamber 52, if present, to heat the gas to a desired temperature to achieve a desired level of temperature and / or humidity for delivery to the patient. The patient breathing conduit 16 may have a heating element, such as a heater wire, for heating the gas flow passing to the patient. The heating element may also be under the control of the controller 19.

[0285] The humidifier 52 of the device is configured to combine or introduce moisture into the gas flow. Various humidifier 52 configurations can be employed. In one configuration, the humidifier 52 may include a removable humidification chamber. For example, the humidification chamber may be partially or completely removed or disconnected from the flow path and / or the device. For example, the humidification chamber may be removed for refilling, cleaning, replacement, and / or repair. In one configuration, the humidification chamber may be received and held in or within the humidification compartment or bay of the device, or otherwise connected to or within the housing of the device.

[0286] The humidification chamber of the humidifier 52 may include a gas inlet and a gas outlet and can be connected to the gas flow path of the device. For example, the gas flow from the flow generator 50B is received into the humidification chamber through its gas inlet, heated and / or humidified, and then exits the chamber through its gas outlet.

[0287] A humidifying chamber contains a certain volume of liquid, typically water or a similar substance. During operation, the liquid in the humidifying chamber is controlled by one or more heaters or heating elements associated with the chamber to produce water vapor or steam, which increases the humidity of the gas flowing through the chamber.

[0288] In one configuration, the humidifier is a passover type humidifier. In other configurations, the humidifier is a non-passover type humidifier.

[0289] In one configuration, the humidifier may be associated with a humidification bay, for example, in which a chamber is placed for heating, or may include a heater plate within it. The chamber may have a heat transfer surface, such as a metal insert, plate, or similar, on its bottom or other surface that contacts or engages with the heater plate of the humidifier.

[0290] In other configurations, the humidification chamber may include an internal heater or heater element inside or within the chamber. The internal heater or heater element may be integrally mounted or provided inside the chamber, or it may be removable from the chamber.

[0291] The humidification chamber may be of any suitable shape and / or size. The location, number, size, and / or shape of the gas inlet and gas outlet of the chamber may vary as needed. In one configuration, the humidification chamber may have a bottom surface, one or more side walls extending upward from the bottom surface, and a top or upper surface. In one configuration, the gas inlet and gas outlet may be on the same face of the chamber. In other configurations, the gas inlet and gas outlet may be on different faces or positions of the chamber, for example, opposite faces or positions, or in other different locations.

[0292] In some configurations, the gas inlet and gas outlet may have parallel flow axes. In some configurations, the gas inlet and gas outlet may be located at the same height in the chamber.

[0293] The device 10 can communicate with the controller 19 to monitor gas flow characteristics and / or use flow sensors such as ultrasonic transducers and thermistor flow sensors, pressure sensors, temperature sensors, humidity sensors, or other sensors to operate the system 10 in a manner that provides appropriate treatment. Gas flow characteristics may include gas concentration, flow rate, pressure, temperature, humidity, or others. Sensors 53A, 53B, 53C, 53D, 14, such as pressure, temperature, humidity, and / or flow sensors, can be installed at various locations within the main device housing 100, patient conduit 16, and / or patient interface 51. The controller 19 can receive outputs from the sensors and help operate the respiratory device 10 to determine, for example, an appropriate target temperature, flow rate, and / or pressure of the gas flow in a manner that provides appropriate treatment. Providing appropriate treatment may include meeting or exceeding the patient's inspiratory demand. In the embodiment shown in the figure, sensors 53A, 53B, and 53C are located within the device housing, sensor 53D is located within the patient conduit 16, and sensor 14 is located within the patient interface 51.

[0294] The device 10 may include one or more communication modules, enabling data communication or connection with one or more external devices or servers, whether wired, wireless, or a combination thereof, over a data or communication link or data network. For example, in one configuration, the device 10 may include a wireless data transmitter and / or receiver, or transceiver 15, thereby enabling the controller 19 to wirelessly receive data signals from motion sensors and / or control various components of the system. The transceiver 15 or data transmitter and / or receiver module may have an antenna 15a as shown in the figure. In one example, the transceiver may include a Wi-Fi modem. Additionally or alternatively, the data transmitter and / or receiver 15 may transmit data to a remote patient management system (i.e., a remote server) or enable remote control of the system 10. The system 10 may include a wired connection, for example, using a cable or wire, thereby receiving data signals from motion sensors and controlling various components of the device 10. The device 10 may include one or more wireless communication modules. For example, the device may also include cellular communication modules such as 3G, 4G, or 5G modules. Module 15 is or may include a modem that enables the device to communicate with a remote patient management system (not shown in the figure) using an appropriate communication network. The remote management system may include a single server or multiple servers or computing devices implemented within a cloud computing network. The communication may be bidirectional between the device and the patient management system (e.g., a server) or other remote system. Device 10 may also include other wireless communication modules such as a Bluetooth module and / or a Wi-Fi module. The Bluetooth and / or Wi-Fi modules enable the device to wirelessly transmit information to other devices such as smartphones or tablets, or to operate on a LAN (Local Area Network) or Wireless LAN (WLAN).The device may additionally or alternatively include a Near Field Communication (NFC) module for enabling data transmission and / or data communication.

[0295] For example, a specific or calculated Work of Breathing (WOB) indicator or value, or other relevant WOB (e.g., WOB trend data), or notification data generated in response to WOB data (e.g., alerts, alarms, notifications) may be communicated to a remote patient management system (i.e., a remote server) and / or other remote electronic devices (e.g., smartphones, tablets, computers, laptops, wearable devices). The remote patient management system may be a single server or a network of servers or a cloud computing system, or other suitable architecture, for operating the remote patient management system. The remote patient management system (i.e., the remote server) further includes memory for storing received data and various shiftware applications or services that are executed to perform multiple functions. The remote patient management system (i.e., the remote server) may then communicate information and commands to system 10 depending on the received data. For example, the nature of the received data may trigger the remote server (or a software application running on the remote server) to communicate an alert, alarm, or notification to system 10. The remote patient management system may further store received data so that it can be accessed by authorized persons such as physicians or patients or other authorized persons. The remote patient management system may also be configured to generate reports (e.g., report data, displayed reports, edited reports, electronic reports, printable reports, numerical reports, graphical reports) in response to requests from authorized users, and the generated reports may include respiratory work data or related WOB data. The reports may further include other data or patient respiratory parameters, such as respiratory rate or SpO2 and / or device parameters, such as gas flow rate, oxygen concentration (e.g., gas concentration, and / or FiO2 and / or FdO2 parameter settings), humidity levels, or other such device parameters.

[0296] The respiratory device 10 may include a high-flow therapy device. The term "high-flow therapy" as used herein is given its typical and ordinary meaning, as will be understood by those skilled in the art, and refers to a respiratory system that delivers a target flow of humidified respiratory gas through a patient interface that is generally not intentionally sealed, at a flow rate generally intended to meet or exceed the user's inspiratory flow. Typical patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults are often in the range of approximately 15 liters / min to approximately 60 liters / min or higher. Typical flow rates for pediatric users (neonatal, infant, and child) are often in the range of approximately 1 liter / min / user's body weight in kilograms to approximately 3 liters / min / user's body weight in kilograms or higher, but are not limited to these.

[0297] High-flow therapy may also optionally include a gas mixture composition containing supplemental oxygen and / or a therapeutic agent to be administered.

[0298] High-flow therapy is often referred to by nasal high-flow (NHF), humidified high-flow nasal cannula (HHFNC), high-flow nasal oxygen (HFNO), high-flow therapy (HFT), or tracheal high-flow (THF), and other common names. For example, in some configurations, for adult patients, "high-flow therapy" may refer to the delivery of gas at a flow rate of approximately 10 liters / minute (10 LPM) or more to the patient, such as approximately 10 LPM to 100 LPM, or approximately 15 LPM to 95 LPM, or approximately 20 LPM to 90 LPM, or approximately 25 LPM to 85 LPM, or approximately 30 LPM to 80 LPM, or approximately 35 LPM to 75 LPM, or approximately 40 LPM to 70 LPM, or approximately 45 LPM to 65 LPM, or approximately 50 LPM to 60 LPM. In some configurations, for neonatal, infant, or child patients, "high-flow therapy" may refer to the delivery of gas to the patient at a flow rate of 1 LPM or more, for example, approximately 1 LPM to 25 LPM, or approximately 2 LPM to 25 LPM, or approximately 2 LPM to 5 LPM, or approximately 5 LPM to 25 LPM, or approximately 5 LPM to 10 LPM, or approximately 10 LPM to 25 LPM, or approximately 10 LPM to 20 LPM, or approximately 10 LPM to 15 LPM, or approximately 20 LPM to 25 LPM. High-flow therapy devices for adult patients, neonatal, infant, or child patients may deliver gas to the patient at a flow rate of approximately 1 LPM to 100 LPM, or at any of the partial ranges described above.

[0299] High-flow therapy can be effective in meeting or exceeding a patient's expiratory demand, increasing patient oxygenation, and / or reducing the work of breathing. In addition, high-flow therapy can produce a nasopharyngeal perfusion effect, where the anatomical dead space of the upper airway is perfused by a large inflow of gas. This perfusion effect can create a reservoir of fresh gas available for each breath, while minimizing rebreathing of carbon dioxide, nitrogen, etc. High-flow therapy can also extend the patient's expiratory time due to the pressure during exhalation, which in turn reduces the patient's respiratory rate.

[0300] The patient interface used in high-flow therapy may be an open interface to prevent barotrauma, which may include tissue damage to the lungs and other organs of the patient's respiratory system due to pressure changes related to the atmosphere. The patient interface may be a nasal cannula with a manifold and nasal prongs, and / or an open tracheostomy interface, or any other appropriate type of patient interface.

[0301] Figures 2-18 show an exemplary respiratory apparatus 10 having a main housing 100. The main housing 100 has a main housing upper chassis 102 and a main housing lower chassis 202. The main housing upper chassis 102 has a peripheral wall mechanism (see Figure 15). The peripheral wall mechanism defines a humidifier or humidification chamber bay 108 for receiving a removable humidification chamber 300. The removable humidification chamber 300 contains a suitable liquid, such as water, for humidifying a gas that can be delivered to a patient. The bottom portion of the humidification chamber bay 108 may have a recess for receiving a heater mechanism, such as a heater plate 140 or another suitable heating element suitable for heating the liquid in the humidification chamber 300 for use during the humidification process.

[0302] The humidifying chamber 300 can be fluidly connected to the device 10 so as to slide linearly from a position in front of the housing 100 toward the rear of the housing 100 in the direction toward the rear of the humidifying chamber 300 entering the chamber bay 108. The gas outlet port 322 can be fluidly connected to the motor.

[0303] The gas inlet port 340 (return of humidifying gas) shown in Figure 8 may include a removable L-shaped elbow. The removable elbow may further include a patient outlet port 344 connected to the patient conduit 16 to deliver the gas to the patient interface. The gas outlet port 322, gas inlet port 340, and patient outlet port 344 may each have a soft seal such as an O-ring seal or T-seal, thereby providing a sealed gas passage between the device 10, the humidifying chamber 300, and the patient conduit 16.

[0304] The humidification chamber gas inlet port 306 can be complementary to the gas outlet port 322, and the humidification chamber gas outlet port 308 can be complementary to the gas inlet port 340. The axes of these ports are parallel to each other, allowing the humidification chamber 300 to be inserted into the chamber bay 108 with linear movement.

[0305] The respiratory device may have air and oxygen (or alternative auxiliary gas) inlets that are in fluid communication with a motor, allowing the motor to deliver air, oxygen (or alternative auxiliary gas), or a mixture thereof to the humidification chamber 300 and thus to the patient. As shown in Figure 10, the device may have a combined air / oxygen (or alternative auxiliary gas) inlet mechanism 350. This mechanism may include a combined air / oxygen port 352 to the housing 100, a filter 354, and a cover 356 having a hinge 358. The gas tube may also optionally extend laterally or in other appropriate directions and be in fluid communication with the oxygen (or alternative auxiliary gas) source. The port 352 can be fluidly coupled to the motor 402. For example, the port 352 can be fluidly coupled to the motor / sensor module 400 via a gas flow passage that itself follows the motor, between the port 352 and the inlet opening or port of the motor and sensor module 400.

[0306] The device may have a mechanism, as shown in Figures 11-14, for enabling the blower to deliver air, oxygen (or an alternative auxiliary gas), or a suitable mixture thereof, to the humidification chamber 300 and thus to the patient. This mechanism may include an air inlet 356' in the rear wall 222 of the lower chassis 202 of the housing 100. The air inlet 356' includes a rigid plate with openings and / or slots in a suitable grille arrangement. Sound-absorbing foam may be provided on the inner surface of the plate, adjacent to the plate. An air filter box 354' may be located inside the main housing 100 near the air inlet 356' and may include an air outlet port 360 for delivering filtered air to the motor via an air inlet port 404 in the motor / sensor module 400. The air filter box 354' may include a filter configured to remove particles (e.g., dust) and / or pathogens (e.g., viruses or bacteria) from the gas flow. A flexible seal, such as an O-ring seal, can be provided between the air outlet port 360 and the air inlet port 404 to seal the components together. The device may include another oxygen inlet port 358' positioned adjacent to one side of the rear end of the housing 100, which receives oxygen from an oxygen source, such as an oxygen supply source using a tank or piping. The oxygen inlet port 358' is in fluid communication with a valve 362. The valve 362 may, in a suitable embodiment, be a solenoid valve capable of controlling the amount of oxygen added to the gas flow delivered to the humidification chamber 300. The oxygen port 358' and valve 362 can be used together with other auxiliary gases to control the addition of other auxiliary gases to the gas flow. Other auxiliary gases may include, but are not limited to, one or more of the various gases beneficial for gas therapy, including heliox and nitrogen oxides.

[0307] As shown in Figures 13-16, the lower housing chassis 202 may include a suitable electronic circuit board, such as a sensing circuit board. The electronic circuit board may be positioned adjacent to the respective outer side walls 210, 216 of the lower housing chassis 202. The electronic circuit board may include, or be able to communicate with, suitable electrical or electronic components, such as, but not limited to, a microprocessor, capacitor, resistor, diode, operational amplifier, comparator, and switch. A sensor can be used together with the electronic circuit board. Components of the electronic circuit board (for example, one or more microprocessors, but not limited to) may function as a controller 19 of the device.

[0308] One or more of the electronic circuit boards communicate electrically with the electrical components of the device 10, such as the display unit and user interface 54, the motor, the valve 362, and the heater plate 140, to operate the motor to provide a desired flow rate of gas, operate the humidification chamber 300 to humidify and heat the gas flow to an appropriate level, and supply an appropriate amount of oxygen (or an appropriate amount of alternative auxiliary gas) to the gas flow.

[0309] The electronic circuit board can communicate with a connector mechanism 274 that protrudes from the rear wall 122 of the upper housing chassis 102. The connector mechanism 274 can be connected to an alarm, pulse oximetry report, and / or other appropriate accessories. The electronic circuit board can also communicate with an electrical connector 276, which can also be mounted on the rear wall 122 of the upper housing chassis 102 and supply power to the equipment's components from an outlet or battery.

[0310] As described above, motion sensors such as flow rate, temperature, humidity, and / or pressure sensors can be installed at various locations on the ventilator, patient respiratory conduit 16, and / or cannula 51, as shown in Figure 1. An electronic circuit board can communicate with these sensors. Outputs from the sensors can be received by a controller 19, which helps the controller 19 operate the ventilator 10 in a manner that provides optimal therapy, such as by controlling a set flow rate. The set flow rate can be selected to provide perfusion of the patient's upper airway and / or meet or exceed the patient's expiratory demand and / or provide other benefits of high-flow therapy as described herein. In the embodiment shown in the figure, the sensors are located on an electronic circuit board located within a housing. The sensors are housed within the housing.

[0311] As outlined above, electronic circuit boards and other electrical and electronic components can be pneumatically isolated from gas passages to enhance safety. Sealing prevents water ingress.

[0312] 1.1 Control System Figure 19A shows a block diagram 900 of an exemplary control system 920 (which may be controller 19 in Figure 1) capable of detecting the patient's condition and controlling the operation of the respiratory system, including the gas source. The control system 920 can manage the flow rate of gas flowing through the respiratory system so that the gas is delivered to the patient. For example, the control system 920 can increase or decrease the flow rate by controlling the output 930 of the motor speed of the blower (hereinafter also referred to as the "blower motor") or the output 932 of the valve in the blender. The control system 920 can automatically determine a set value or a personalized value of the flow rate for a particular patient, as described later. The flow rate can be optimized by the control system 920 to improve patient comfort and treatment.

[0313] The control system 920 can also generate audio and / or display / visual outputs 938, 939. For example, the flow therapy device may include a display and / or audio output device (e.g., a speaker). The display can show the physician when warnings or alarms are generated by the control system 920. The display can also show control parameters that the physician can adjust. For example, the control system 920 can automatically recommend a flow rate for a particular patient. The control system 920 can also identify the patient's respiratory status, such as generating the patient's respiratory rate, and transmit this to the display, which will be described in more detail later.

[0314] The control system 920 can control one or more heating elements by changing the heater control output value (for example, to maintain the temperature setpoint of the gas delivered to the patient). The control system 920 can also change the operation or duty cycle of the heating elements. Heater control outputs may include heater plate control output 934 and heated breathing tube control output 936.

[0315] The control system 920 can identify outputs 930-939 based on one or more received inputs 901-916. Inputs 901-916 may correspond to sensor measurements (shown in Figure 19B) automatically received by the controller 600. The control system 920 can receive sensor inputs, including, but not limited to, a temperature sensor input 901, a flow sensor input 902, a motor speed input 903, a pressure sensor input 904, a gas fractionation sensor input 905, a humidity sensor input 906, a pulse oximeter (e.g., SpO2) sensor input 907, stored or user-defined parameters 908, a duty cycle or pulse width modulation (PWM) input 909, a voltage input 910, a current input 911, an acoustic sensor input 912, a power input 913, a resistance input 914, a CO2 sensor input 915, and / or a spirometer input 916. The control system 920 can receive input from the user or from parameter values ​​stored in memory 624 (shown in Figure 19B). The control system 920 can dynamically adjust the flow rate for the patient over the course of their treatment. The control system 920 can continuously detect system parameters and patient parameters. Those skilled in the art will see, based on the disclosure of this application, that any other suitable inputs and / or outputs can also be used with the control system 920.

[0316] 1.2 Controller Figure 19B shows a block diagram of one embodiment of controller 600 (which may be controller 19 in Figure 1). Controller 600 may include programming instructions for detecting input states and controlling output states. Programming instructions can be stored in the memory 624 of controller 600. Programming instructions can correspond to the methods, processes, and functions described herein. Programming instructions can be executed by one or more hardware processors 622 of controller 600. Programming instructions can be implemented in C, C++, Java®, or any other suitable programming language. Some or all of the programming instructions can be implemented in application-specific circuits 628 such as ASICs and FPGAs.

[0317] The controller 600 may also include a circuit 628 for receiving sensor signals. The controller 600 may further include a display 630 for transmitting the status of the patient and the respiratory support system. The display 630 may also show warnings and / or other alerts. The display 630 may be configured to display the characteristics of the detected gas in real time or otherwise. The controller 600 may also receive user input via a user interface such as a display 603. The user interface may include buttons and / or dials. The user interface may include a touchscreen.

[0318] 1.3 Motor and Sensor Modules Any of the features of the respiratory system described herein, including but not limited to the humidification chamber, flow generator, user interface, controller, and patient respiratory conduit, configured to connect the gas flow outlet of the respiratory system to the patient interface, can be combined with any of the sensor modules described herein.

[0319] Figure 20 shows a block diagram of the motor and sensor module 2000 (or "sensor block"), which may be received by a recess 250 in the ventilator (shown in Figures 17 and 18). The motor and sensor module may include a blower 2001, which captures room air delivered to the patient. The blower 2001 may be a centrifugal blower.

[0320] One or more sensors (e.g., Hall effect sensors) may be used to measure the motor speed of a blower motor. The blower motor may include a brushless DC motor from which the motor speed can be measured without the use of another sensor. For example, during the operation of a brushless DC motor, the back EMF can be measured from the motor's non-energized winding, from which the motor position can be determined, and then used to calculate the motor speed. In addition, a motor driver may be used to measure the motor current, which, along with the measured motor speed, can be used to calculate the motor torque. The blower motor may include a low-inertia motor.

[0321] Indoor air can enter the indoor air inlet 2002, which then enters the blower 2001 through the inlet port 2003. The inlet port 2003 may include a valve 2004 through which pressurized gas can enter the blower 2001. The valve 2004 can control the flow of oxygen to the blower 2001. The valve 2004 can be any type of valve, including a proportional valve or a binary valve. In some embodiments, the inlet port does not include a valve.

[0322] Blower 2001 can operate at motor speeds greater than 1,000 RPM, less than 30,000 RPM, greater than 2,000 RPM, less than 21,000 RPM, or any of these numbers. The operation of Blower 2001 mixes the gas entering Blower 2001 through the inlet port 2003. Using Blower 2001 as a mixer reduces the pressure drop that would otherwise occur in a system with another mixer, such as a static mixer with baffles, due to the energy required for mixing.

[0323] The mixed air can exit the blower 2001 through the conduit 2005 and enter the flow path 2006 in the sensor chamber 2007. A sensing circuit board equipped with sensors 2008 can be placed inside the sensor chamber 2007, thereby immersing the sensing circuit board at least partially in the gas flow. At least some of the sensors 2008 on the sensing circuit board are positioned within the gas flow to measure the gas characteristics in the flow. After passing through the flow path 2006 in the sensor chamber 2007, the gas can exit into the humidification chamber 2009.

[0324] By positioning the sensor 2008 downstream of the combined blower and mixer 2001, measurement accuracy, such as the measurement of gas fraction concentrations including oxygen concentration, can be improved compared to systems where the sensor is positioned upstream of the blower and / or mixer. Such positioning can provide a repeatable flow profile. Furthermore, positioning the sensor downstream of the combined blower and mixer avoids the pressure drop that would otherwise occur, because if detection were performed before the blower, another mixer, such as a baffled static mixer, would be required between the inlet and the detection system. A mixer can cause a pressure drop through it. By positioning detection after the blower, the blower can be used as a mixer, and while a static mixer lowers the pressure, the blower increases it. Furthermore, by immersing at least a portion of the detection circuit board and sensor 2008 in the flow path, measurement accuracy can be improved. This is because immersing the wires in the flow means they are more likely to be exposed to the same conditions as the gas flow, such as temperature and pressure, and therefore can better represent the characteristics of the gas flow.

[0325] Referring to Figure 21, the gas exiting the blower can enter a flow path 402 within the sensor chamber 400, which can be located within the motor and sensor module and may be the sensor chamber 2007 in Figure 20. The flow path 402 may have a curved shape. The flow path 402 can be configured to have a curved shape without sharp bends. The flow path 402 may have curved ends and straight sections between the curved ends. The curved flow path shape can reduce the pressure drop in the gas flow, and the sensitivity of the flow measurement is not reduced by partially coinciding the measurement area with the flow path to form the measurement portion of the flow path.

[0326] A detection circuit board 404, which includes an acoustic transmitter and / or receiver, a humidity sensor, a temperature sensor, a thermistor, and other sensors, can be positioned within the sensor chamber 400 such that the detection circuit board 404 is at least partially immersed in the flow path 402. Immersing at least a portion of the detection circuit board and sensors in the flow path improves measurement accuracy because sensors immersed in the flow are more likely to be exposed to the same temperature and pressure conditions as the gas flow, and therefore better represent the characteristics of the gas flow. After passing through the flow path 402 within the sensor chamber 400, the gas can exit the humidification chamber.

[0327] Gas flow rate can be measured using at least two different types of sensors. The first type of sensor may include a thermistor, which can determine the flow rate by monitoring the heat transfer between the gas flow and the thermistor. A thermistor flow sensor can operate the thermistor at a constant target temperature in the flow as the gas flows around and passes through it. The sensor can measure the power required to keep the thermistor at the target temperature. The target temperature can be set higher than the gas flow temperature, thereby requiring more power to keep the thermistor at the target temperature at a higher flow rate.

[0328] Thermistor flow sensors can also maintain multiple (e.g., two, three, or more) constant temperatures on the thermistor, preventing the difference between the target temperature and the gas flow temperature from being too small or too large. Multiple different target temperatures allow thermistor flow sensors to be accurate over a wide temperature range of the gas. For example, thermistor circuit can be configured to switch between two different target temperatures, thereby ensuring that the gas flow temperature always falls within a specific range (e.g., not too close or too far) with respect to one of the two target temperatures. Thermistor circuit can be configured to operate at a first target temperature of approximately 50°C to 70°C, or approximately 66°C. The first target temperature can be associated with a desired flow temperature range of approximately 0°C to 60°C, or approximately 0°C to 40°C. Thermistor circuit can be configured to operate at a second target temperature of approximately 90°C to 110°C, or approximately 100°C. The second target temperature can be associated with a desired flow temperature range of approximately 20°C to 100°C, or approximately 30°C to 70°C.

[0329] The controller can be configured to adjust the thermistor circuit to switch between at least a first and a second target temperature mode by connecting or bypassing a resistor within the thermistor circuit. The thermistor circuit can be arranged as a Wheatstone bridge configuration including a first voltage divider arm and a second voltage divider arm. The thermistor can be located on one of the voltage divider arms. Further details relating to the thermistor flow sensor are described in the brochure of PCT application publication WO2018 / 052320, filed on 3 September 2017, which is incorporated herein by reference in its entirety.

[0330] A second type of sensor may include an acoustic sensor assembly. Using an acoustic sensor, including an acoustic transmitter and / or receiver, the time of flight of an acoustic signal can be measured to determine the gas velocity and / or composition usable in a flow therapy device. In one ultrasonic sensing topology (including an ultrasonic transmitter and / or receiver), a driver causes a first sensor, such as an ultrasonic transducer, to generate an ultrasonic pulse in a first direction. A second sensor, such as a second ultrasonic transducer, receives this pulse and provides a measurement of the time of flight of the pulse between the first and second ultrasonic transducers. Using this time-of-flight measurement, the sound velocity of the gas flow between the ultrasonic transducers can be calculated by the respiratory system's processor or controller. The second sensor may transmit a pulse in a second direction opposite to the first direction, which the first sensor can receive, providing a second measurement of the time of flight and enabling the measurement of gas flow characteristics, such as flow rate and velocity. In other acoustic sensing topologies, an acoustic pulse transmitted by an acoustic transmitter, such as an ultrasonic transducer, can be received by an acoustic receiver, such as a microphone. Further details regarding the acoustic flow sensor are described in PCT application publication WO2017 / 095241, filed on 2 December 2016, which is incorporated herein by reference in its entirety.

[0331] One or more flow sensors, or a sensor assembly containing one or more flow sensors, may be positioned at various locations within the respiratory apparatus and / or along the gas flow path. In one configuration, one or more flow sensors or a sensor assembly may be installed or positioned after the flow generator 50B, i.e., the sensors are configured or positioned to detect or measure the flow rate of gas after the flow generator 50B in the flow path. In this configuration, the flow signal or flow data generated by one or more flow sensors may represent the output flow signal or data of the flow generator, i.e., the flow rate of the gas flow output from the flow generator 50B.

[0332] In one exemplary configuration, one or more sensors or sensor assemblies may be positioned before or after the humidifier 52 (if present) within the main device housing 100. For example, a flow sensor may be positioned or configured within the main device housing 100 to detect the flow rate of gas in the flow path, at a position between the flow generator 50B and the humidifier 52, or at a position after the humidifier in the flow path. In another exemplary configuration, one or more flow sensors or sensor assemblies may be positioned in or along the respiratory conduit 16 and / or patient interface 51. In this configuration, the sensor or sensor assembly is configured to detect or measure the flow rate of gas flow in the flow path including or formed by the respiratory conduit 17 and / or patient interface 51, i.e., in the flow path after the gas flow outlet 21 of the main device housing 100. In another exemplary configuration, the device may include any combination of the configurations or positions of the one or more flow sensors or sensor assemblies described above. For example, the device may include any combination of one or more flow sensors or sensor assemblies at any one or more locations along the gas flow path, whether in the main device housing 100, the respiratory conduit 1, and / or the patient interface 51.

[0333] In some configurations, readings from both the first and second types of sensors can be combined to determine a more accurate flow measurement. For example, the previously determined flow rate and one or more outputs from one of the sensor types can be used to determine the predicted current flow rate. The predicted current flow rate can then be updated using one or more outputs from the other of the first and second types of sensors to calculate the final flow rate.

[0334] 2. Exemplary Embodiments of the Respiratory Work Determination Process Methods and processes for identifying data indicating or representing the work of breathing will be described in reference to the above-described exemplary respiratory device 10, which is configured or operable to provide nasal high-flow therapy via an open-seal patient interface. As already described, methods and processes may also apply to other respiratory devices and / or other modes of operation and / or therapeutic modes delivered by such devices.

[0335] 2.1 Summary of the Work of Respiratory Absorption (WOB) Identification Process Work of breathing (WOB) is a clinical metric that provides a valuable indicator of the effectiveness of respiratory therapy. Estimating WOB or identifying indicators can be used to improve patient outcomes when using therapeutic devices. For example, in some configurations, WOB indicators can be used to assess whether adjustments are needed to the current respiratory device and / or therapeutic settings, which parameters should be adjusted, and / or by how much the settings should be adjusted.

[0336] As those skilled in the art will know, WOB has a generally accepted definition relating to the energy or work required or exerted by a person to breathe. One method for determining accurate WOB is to use a chest band that measures the force and depth of chest movement as a person breathes, but these are not always convenient or practical for all patients. There are also situations in which respiratory rate can be used as an indicator of WOB. This disclosure provides a method and process for identifying one or more alternative analogues, substitutes, or indicators of WOB for a given patient while receiving high-flow therapy delivered by a respiratory device. Alternative WOB indicators may be used to improve clinical decision-making, patient outcomes, and / or the operation of respiratory devices delivering improved high-flow therapy.

[0337] The embodiments described later aim to provide a method for reliably estimating a patient's WOB indicator using available sensor data from a respiratory device and / or algorithms performed on it.

[0338] This disclosure relates to methods and / or algorithms for identifying one or more patient or user WOB indicators or estimates based at least in part on detected flow parameter data indicating or representing gas flow in a respiratory device in use by a patient or user. For example, three different methods for identifying user WOB indicators or estimates are described below. Each of the three exemplary methods is ΔP nose This includes an estimate, which represents the intranasal pressure fluctuations indicating the average intranasal pressure of the user when receiving respiratory therapy with a respiratory device.

[0339] In an exemplary method, various WOB indicators are identified or calculated based at least in part on flow parameter data that indicates or represents the gas flow in the flow path of the respiratory device.

[0340] In one exemplary configuration, flow parameter data includes flow data indicating or representing the flow rate of gas supplied by the respiratory device during respiratory therapy. In one example, the flow data may be a flow signal generated by one or more flow sensors supplied or positioned within the flow path of the respiratory device. One or more flow sensors may be supplied within the flow path, downstream of the respiratory device's flow generator. Variations in the flow signal at a typical human respiratory rate are observed when using the respiratory device during respiratory therapy. The flow signal is highly noisy, and in this exemplary configuration, algorithms and / or signal preprocessing may be applied to the raw flow signal generated by the flow sensors to minimize the effects of noise. By analyzing the variations in the preprocessed flow signal, various useful WOB parameters or indicators associated with the patient can be extracted while receiving respiratory therapy with the respiratory device.

[0341] In some exemplary configurations, the flow parameter data used to generate the WOB indicator may additionally or alternatively include pressure data (e.g., pressure at the blower outlet in the breathing apparatus) that indicates or represents the gas flow provided by the flow generator.

[0342] As we will see later, in these exemplary configurations, there are several common steps to identify all three exemplary WOB indicators outlined below.

[0343] A method and / or algorithm for generating a WOB indicator can be executed or implemented on any suitable controller or processor. In this exemplary configuration, the method and / or algorithm for generating a WOB indicator can be executed or implemented on the main or primary controller of the respiratory device. As previously stated, the main controller of the respiratory device communicates electrically or data with flow and / or pressure sensors located within the respiratory device, main housing, respiratory conduit, and / or patient interface. In some exemplary configurations, a pressure sensing line may supply pressure samples from the patient interface to one or more pressure sensors located within the main housing of the respiratory device.

[0344] 2.2 First Exemplary WOB Indicator - ΔP nose Estimate Here, we describe a first exemplary WOB indicator method or algorithm for generating a first exemplary WOB indicator. The first exemplary WOB indicator is the intranasal pressure fluctuation value, i.e., ΔP nose Based on identifying or calculating estimates, this is explained below.

[0345] Generally, the flow through the respiratory conduit (Q tube ) can be determined by applying known fluid dynamics relationships. The result is the following equality:

number

[0346] In this exemplary configuration, without using direct intranasal pressure measurements, several approximations and trial values can be used to find the tube conductance value C tube In other configurations, the tube conductance can be derived or specified based on sensor data representing direct intranasal pressure measurements.

[0347] Regarding the NHF therapy delivered by the breathing apparatus, typically, P blower ≧10P nose (2) is known to be.

[0348] With this expression, an approximation of the tube conductance C tube can be specified by the following equation:

Equation

[0349] In this exemplary configuration, P blower This can be measured or detected by one or more pressure sensors or pressure sensing configurations in the respiratory apparatus. In one example, P blower The pressure data may be based on, or a function of, pressure data generated by one or more pressure sensors located at or near the outlet of the breathing apparatus's blower, or in the flow path downstream of the blower in the main housing of the breathing apparatus.

[0350] In one exemplary configuration, the pressure sensor may be a gauge pressure sensor, which includes a port to the ambient environment and is configured to detect and generate pressure data representing the difference between the pressure at or near the blower outlet and the pressure in the ambient environment. In this configuration, P blower The pressure data includes, is represented by, or may be a function of, the detected gauge pressure data generated by a gauge pressure sensor.

[0351] In other exemplary configurations, the pressure sensor may be an absolute pressure sensor, which is configured to detect and generate pressure data representing the absolute pressure at or near the blower outlet in the flow path. In this configuration, P blower The pressure data may include, be represented by, or be a function of, the detected absolute pressure data generated by an absolute pressure sensor.

[0352] In other exemplary configurations, the device may include an absolute pressure sensor configured to detect the absolute pressure at or near the blower outlet, and an ambient pressure sensor configured to detect the ambient pressure of the environment. In this configuration, P blowerPressure data may include pressure data representing the difference between absolute pressure data from an absolute pressure sensor and ambient pressure data from an ambient pressure sensor.

[0353] In this exemplary configuration, Q tube This can be based on the flow rate at the blower outlet of the respiratory apparatus, as detected by the apparatus's flow sensor. This assumes no malfunctions or unintended behavior, such as leaks in the tube due to improper connection between the gas outlet and tube inlet of the respiratory apparatus's main housing. For example, assuming no significant leaks along the flow path from the blower to the patient interface connected to the end of the respiratory conduit (e.g., tube), the flow rate Q tube This should be very close to the flow rate at the blower outlet.

[0354] As mentioned above, tube flow rate Q tube This may be based on a flow signal or data from a flow sensor downstream of the blower in the flow path of the main housing of the respiratory apparatus. In this exemplary configuration, Q tube The values ​​can be based on a pre-processed flow signal. For example, the raw flow signal or data from a flow sensor may be processed to remove and / or minimize the effects of noise in the signal. Examples of pre-processing of raw flow signals are described later in Section 2.5.

[0355] In one exemplary embodiment, P nose.guess (P nose The selection or calculation of the preliminary trial values ​​may be pre-programmed and / or based on known relationships between gas flow parameters. In one example, the controller sets the blower pressure P blower , in other words, the flow rate of the blower (as mentioned above, Q tube Corresponding value as an approximation for (equivalent to) and P nose Includes value, trial P nose Value (P nose.guess ) can be pre-programmed using numerical information or sensor data representing the blower output pressure and flow rate, or by a lookup table or other appropriate data structure or function that can select based on such information. In one exemplary configuration, trial P noseA lookup table, function, or data structure representing a relationship for selecting a value may be stored in memory associated with or accessible by the controller of the therapeutic device, for example, but not limited to, the device's non-volatile memory.

[0356] Trial intranasal pressure P nose.guess When a value is selected, the respiratory conduit conductance C tube The above C tube It can be estimated according to the following equation.

[0357] C tube The equation is: Intranasal pressure P nose This can be reorganized into an equation for estimating:

number

[0358] As shown above, in this example, the nasal pressure P nose The estimation is that the blower output pressure P blower , tube flow rate Q tube , and tube conductance C tube It is identified or calculated as a function of .

[0359] In this example, the intranasal pressure P nose The use of absolute estimation may, in some situations, be unreliable due to multiple noise sources in the flow and pressure measurements (e.g., blower motor noise, patient respiration, electronic noise, etc.) on which the preprocessing step may be largely, though not entirely, dependent. In light of this, the WOB indicator algorithm, in this configuration, considers the nasal pressure P nose Based on the variable values ​​or parameters derived from the absolute value of the estimation, a WOB indicator can be generated or represented, rather than the absolute value itself.

[0360] In this exemplary configuration, the WOB indicator is obtained based on the fluctuation amplitude (i.e., "delta") of the estimated intranasal pressure, which is ΔP nose This is expressed as: This nasal pressure fluctuation value ΔP noseThis correlates with the patient's respiratory effort and, since it depends only slightly on the aforementioned noise sources, can be seen as a WOB indicator.

[0361] In this exemplary configuration, the WOB indicator algorithm calculates the amplitude of intranasal pressure fluctuation (ΔP) at a given time point. nose ) can be configured to be identified using the following formula:

number

[0362] Mathematically, this equation is basically the same as the aforementioned P nose This is the derivative of the following equation: Variable value MV device The section is about device minute ventilation (MV) device ) represents or indicates. In this example, MV device This estimates the average volume of air / gas mixture output by the breathing apparatus per minute. MV device This relates to the gas flow output of the respiratory device, which is very closely related to patient respiration, and that is when the patient's inspiratory and expiratory volumes are MV device Because it is encoded within the signal. MV device Signal or MV device Methods for identifying data that indicates or represents this will be further described in Section 2.6.

[0363] C tube and Q tube Since it is almost constant, MV device The change is ΔP nose This is reflected in the value. MV device The change in ΔP is reflected in how difficult it is for the patient to breathe, that is, how much energy is used when the patient breathes. In this illustrative configuration, ΔP nose An increase in ΔP indicates an increase in WOB, and conversely, ΔP nose A decrease in WOB indicates a reduction in WOB.

[0364] Intranasal pressure fluctuation signal or value ΔP noseThis can be calculated periodically, arbitrarily, or in real time. In one exemplary configuration, the intranasal pressure fluctuation signal or value ΔP nose This can be calculated periodically at any suitable frequency using the WOB indicator algorithm. In one example, ΔP nose The value is calculated as a WOB indicator at a frequency selected from the range of approximately 1 Hz to approximately 20 Hz (i.e., every 1 second to approximately 5 ms). The application of the WOB indicator and / or the WOB indicator algorithm is ΔP nose It should be understood that any appropriate frequency may be selected depending on the characteristics of the input data stream used to calculate the WOB indicator.

[0365] ΔP nose One or more of the following properties of the WOB indicator may be applied in an exemplary construction of the WOB indicator algorithm: • In some configurations, ΔP nose WOB indicators may have advantages because they have relatively fewer potential sources of error compared to other disclosed WOB indicators. For example, in one configuration, ΔP nose The WOB indicator requires, or relies solely on, flow rate and pressure sensor data or signals from the respiratory device. • Tube conductance C tube While it is nearly constant, in some exemplary configurations, a filter is used to obtain ΔP nose It can be updated at the same rate. This is because, in some situations or applications, tube conductance may change if / when the position of the respiratory conduit (e.g., tube) changes during use of the respiratory device to deliver respiratory therapy to the patient. For example, if the tube becomes more bent or curved, the inductance decreases (because the impedance increases in these situations), or vice versa if the tube becomes straight during use. • In some exemplary configurations, the gas flow rate Q through the breathing conduit tube Ideally, the generated ΔP noseFor the accuracy / reliability of the WOB indicator to be maximized, it should generally be constant. This is generally true for periods longer than one minute. However, in some configurations, the WOB indicator algorithm may be configured to account for fluctuations / changes in gas flow. For example, in some configurations, the WOB indicator algorithm may be configured to account for fluctuations in gas flow by discarding spurious readings associated with transient flow changes and / or smoothing the data by applying an averaging filter (e.g., an exponential filter). • In several exemplary configurations, ΔP nose The WOB indicator value may depend on the size and fit of the patient interface used by the patient (e.g., the size and fit of the nasal cannula or other patient interface used by the patient). Additionally or alternatively, ΔP nose The WOB indicator value may depend on the physiological characteristics of the patient's respiratory effort, for example, but not limited to these.

[0366] 2.3 Second Exemplary WOB Indicator - ΔP nose *Q breath Estimate Next, a second exemplary WOB indicator method or algorithm for generating a second exemplary WOB indicator will be described. The second exemplary WOB indicator is the intranasal pressure fluctuation value ΔP of the first exemplary WOB indicator. nose Q is based on, or a function of, a variable value that represents or indicates a change in respiratory volume or the user's respiratory flow rate. In this example, the change in respiratory volume or the user's respiratory flow rate is Q breath It is represented by [this].

[0367] In one exemplary configuration, the second WOB indicator algorithm may be a variation of the first WOB indicator algorithm. For example, the second WOB indicator algorithm may be ΔP nose This may include additional steps or calculations beyond the calculation of the WOB indicator, which will be explained further later.

[0368] In a system where the volume changes, the work done can be expressed as follows: Work = Pressure * Volume (7)

[0369] In this second example, when the nasal pressure fluctuation value ΔP nose is substituted for Pressure, the actual Work value of WOB can be estimated by substituting the numerical information or value of the change in volume into the Volume term. In this example, as a result of these substitutions, an estimate of the actual Work value of WOB rather than an indicator of WOB is obtained. For example, a value in joules is obtained by estimating the actual Work.

[0370] In this second exemplary WOB indicator algorithm, the numerical information or value representing the change in respiratory volume or the respiratory flow rate of the user is Q breath and is represented as such. In this example, the respiratory flow rate Q breath of the user can be approximated by the following formula:

Equation

[0371] In this exemplary configuration, the respiratory flow rate Q breath of the user can be physically similar to the minute ventilation of the patient's nose, which is represented by MV nasal The minute ventilation volume MV nasalis a metric for estimating the minute ventilation of a patient's nasal cavity and is described in detail in PCT Patent Application Publication No. WO2022 / 167960, filed on February 3, 2022. However, MV nasal Unlike, the respiratory flow rate Q breath of the user can better account for the flow conductance within a high-flow therapy system (e.g., a respiratory device configured to deliver NHF therapy) and can thus be a more generalizable indicator of the average amount entering / leaving the patient's nasal cavity per minute. In this exemplary configuration, MV nasal may be similar to MV device but is different in that it incorporates information on the patient interface (e.g., size, type, etc.) and the fit of the patient interface (e.g., degree of nostril occlusion for a nasal cannula) and / or is transformed by a coefficient that is a function thereof.

[0372] In this exemplary configuration, the equation or function for the respiratory flow rate Q breath is derived by applying the flow-pressure equation to a conductance * pressure = flow 2 that is an appropriate patient nostril model. Alternatively, pressure = resistance * flow 2 can be used. In one example, the patient nostril model is based at least in part on three main flows, namely, the flow entering and leaving the nostrils via the nasopharynx due to the patient's respiration and the leakage flow exiting / around the nasal cannula. As a result, three simultaneous equations (9)-(11) are obtained, which can be rearranged and solved for the patient's respiratory flow rate. In this example, the resulting expression for Q breath can then be integrated (e.g., to average it). Therefore, the above equation (for specifying the average value of Q breath ) is reached.

[0373] For example, the three simultaneous equations can be as follows: C tube *(P device -P nose)=Q tube 2 (9) C nose *P nose =Q nose 2 (10) Q breath +Q tube =Q nose (11)

[0374] The three simultaneous equations (9)–(11) above are some examples of possible equations that can be used and solved for patient respiratory flow. In alternative configurations, one or more different and / or more complex equations with more parameters may be used if a more accurate modeling is desired or required for a particular application or situation.

[0375] In one exemplary configuration, C nose The calibration process for estimating or obtaining a value requires inserting a suitable nasal cannula into the patient's nostril, after which the respiratory device tests a predetermined flow rate range, simultaneously measuring or estimating intranasal pressure at each separate flow rate. Additionally or alternatively, in other exemplary configurations, the calibration process may be non-discrete, providing a flow rate sweep during which intranasal pressure is continuously measured or estimated.

[0376] In other alternative exemplary configurations, manual input from the user or physician is used, C nose The value of can be estimated based at least in part on the physiological elements or characteristics of one or more patients. For example, C nose The value may be estimated based on parameters or estimates relating to the patient's body size (e.g., their height) and / or cannula-nasal obstruction (e.g., estimation of the percentage of nasal obstruction by the cannula prongs), and / or one or more other appropriate parameters.

[0377] As a further explanation, regarding the patient's body size, taller (larger) patients can be expected to have larger nostrils (e.g., adults vs. children, and even infants). The size (e.g., cross-sectional area of ​​the nostril opening) is C nose This contributes to the fact that, without considering whether the nasal cannula is optimally fitted, larger patients generally wear larger cannulas than smaller patients, such as pediatric patients, and larger cannulas have wider prong holes and less flow resistance.

[0378] To further explain, with respect to cannula-nasal obstruction (or "nasal cavity obstruction"), a higher percentage of obstruction means that the space between the inside of the nasal cavity and the wall of the cannula prong is more closely fitted, while a lower percentage of obstruction means that there is a larger space between the cannula prong and the inside of the nasal cavity. Depending on the degree of obstruction, the amount / flow rate of gas expelled through the prong or the prong-nasal cavity "gap" changes, and therefore affects the flow conductance.

[0379] In this example, C nose The estimation may be based on relationships identified from past experimental tests.

[0380] The second exemplary WOB indicator algorithm shows that ΔP nose * Q breath A WOB indicator is generated that represents the estimation of ΔP, which, as mentioned above, can be considered the actual estimation of WOB. In this exemplary configuration, this ΔP nose * Q breath The WOB indicator is the first exemplary ΔP nose The WOB indicator may involve more calculation steps. In this example, the additional calculation steps are primarily for the patient's nasal conductance C. nose This may arise from the need to estimate or derive a numerical value of ΔP. nose * Q breathWOB indicators can provide a more familiar and practical estimate of WOB for physicians. In this example, the second exemplary ΔP nose * Q breath The accuracy and reliability of the WOB indicator are, at least in part, C nose It may depend on the accuracy of the value. In some configurations, C nose The accuracy of the values ​​may, at least in part, depend on or rely on additional inputs or parameters provided by the physician regarding the patient, as described above.

[0381] 2.4 A third exemplary WOB indicator - ΔP nose * Estimation of respiratory smoothness Next, a third exemplary WOB indicator method or algorithm for generating a third exemplary WOB indicator will be described. The third exemplary WOB indicator is the intranasal pressure fluctuation value ΔP of the first exemplary WOB indicator. nose This is based on, or a function of, a variable value that represents or indicates the respiratory smoothness coefficient. In this example, the respiratory smoothness coefficient is represented by σ.

[0382] In one exemplary configuration, the third WOB indicator algorithm may be a variation of the first WOB indicator algorithm. For example, the third WOB indicator algorithm may be ΔP nose This may include additional steps or calculations beyond calculating the WOB indicator, which will be further explained below.

[0383] In this third example, the WOB indicator algorithm uses the respiratory smoothness coefficient σ as ΔP nose Apply to the estimation, thereby ΔP nose * It is configured to generate a σ WOB indicator. In this example, the breathing smoothness is based on a mathematical concept that quantifies the number of possible continuous derivatives of a function over a given domain. ΔP nose In the case of data, respiratory smoothness is physically related to the rate of change in intranasal pressure fluctuations.

[0384] This numerical information σ of respiratory smoothness is useful because it indicates (or strongly correlates with) the patient's respiratory rate. For example, a higher respiratory rate may be evident as a rapid change in the intranasal pressure fluctuation signal or data, which is measured by the respiratory smoothness value σ (i.e., a value indicating a decrease in respiratory smoothness) and vice versa (i.e., an increase in respiratory smoothness may indicate a lower respiratory rate).

[0385] In one exemplary configuration, the third WOB indicator algorithm may identify or estimate the respiratory smoothness coefficient σ based at least in part on an estimate or value of patient minute ventilation (e.g., device minute ventilation). For example, the WOB indicator algorithm may be configured to estimate device minute ventilation by any one of the methods outlined below in Section 2.6 or any other suitable method. In this example, the calculated device minute ventilation estimate may then be normalized. For example, the device minute ventilation may be normalized according to or based on the number of available data points and then converted into a function that outputs numerical information or a coefficient σ of frequency-dependent respiratory smoothness. In this example, the function may be pre-identified through a mixture of analytic and numerical analysis.

[0386] The third WOB indicator algorithm then calculates the respiratory smoothness coefficient σ (for example, ΔP of the first exemplary WOB indicator) nose Applying to the WOB indicator, a third exemplary WOB indicator, ΔP nose * Generate σ. In this example, ΔP nose * The σ WOB indicator is the first exemplary ΔP nose Compared to the WOB indicator, it is mathematically dependent on the respiratory rate. In this configuration, the third exemplary WOB indicator may be more similar to other known WOB metrics, such as the well-established pressure-time product metric.

[0387] 2.5 Preprocessing of Flow Signals As described above, the exemplary WOB indicator method or algorithm and its respective output, the WOB indicator, are based at least in part on flow parameter data. In this example, the flow parameter data may include at least flow rate data from one or more flow sensors representing or indicating the flow rate of gas in the flow path. As will be further described, typically the WOB indicator algorithm receives and utilizes pre-processed flow signal or data; that is, the raw flow data or signal from the flow sensor is pre-processed to remove or minimize the effects of noise in the signal. In an alternative configuration, the WOB indicator algorithm may receive raw flow signal or data and perform a pre-processing step or stage as part of the WOB indicator algorithm.

[0388] Here are some examples of preprocessing applied to raw flow signals or data before they are further processed and / or used as input for generating WOB indicators.

[0389] As mentioned above, flow data (e.g., flow rate data) from open systems such as nasal high-flow systems can be difficult to interpret. Because the system is open, the signal-to-noise ratio is very low. For example, open interfaces (nasal cannulas) tend to have significant leakage and swirling flow around the patient's nostrils, which contributes to a substantial amount of noise in the detected flow signal (e.g., raw flow rate data). Any measured flow data may contain various irregularities and noise, which can obscure the flow data and must be taken into account to accurately identify the desired measurement. Flow data is important because it can contain a great deal of information about the open system, the patient's respiratory flow rate, and / or other device or patient metrics and / or parameters.

[0390] In this example, the flow signal can be supplied to a preprocessing step or stage to remove noise and other irregularities from any of the obtained flow data. Preprocessing allows the controller to remove certain distortions from the flow parameters, thereby enabling the flow parameter signal used to identify the device output and / or patient respiratory parameters (e.g., for generating a WOB indicator) to better reflect the effect that the gas flow parameters used to treat the patient have on the patient's respiration. Further details regarding the preprocessing of flow signals are described in the brochure of PCT application publication WO2020 / 178746, filed on March 4, 2020, which is incorporated herein by reference in its entirety.

[0391] When a patient is wearing a respiratory system and breathing through a patient interface, variations in pre-processed flow rate or other flow parameter data obtained from an open system (i.e., an open system that delivers the patient's gas flow through an open interface such as a nasal cannula) consist of random, uncorrelated noise and correlated respiratory signals generated from various sources. In particular, variations in flow parameter data may include noise (random and uncorrelated with the patient's respiration) and the patient's respiratory signal (correlated with the patient's respiration). Data preprocessing may begin with the controller receiving the flow parameter data (e.g., raw, unprocessed data). The controller can then perform preprocessing steps, for example, by determining whether the flow parameter data is good or suitable for use. If the data is unsuitable for use, the controller can discard it.

[0392] In determining the appropriateness of the data, the controller may receive second flow parameter data of a different type from the first flow parameter data. The second flow parameter data is assumed to have some correlation with the first parameter. The second flow parameter data may include, for example, motor speed, pressure, and / or oxygen flow rate or concentration, or any other parameter that has an effect on gas flow rate or can provide an indicator of gas flow rate other than the effect of patient respiration on gas flow rate. The controller may be configured to determine whether the second flow parameter data is useful as a parameter that correlates with the first flow parameter data. For example, the second flow parameter data may be a useful correlation metric if the second flow parameter data meets a threshold level. If the second flow parameter data does not meet the threshold level, it is assumed that the second flow parameter data does not correlate with the first flow parameter data. Therefore, the second flow parameter data can be ignored or discarded (i.e., deleted or not used by the controller). If there is insufficient second flow parameter data, the controller may determine that there is insufficient data to use the first flow parameter data and may discard the first parameter. If the second flow parameter data meets the minimum threshold level, the controller can determine that the first parameter data is suitable for use.

[0393] As an example, the second flow parameter data can represent motor speed. For patient respiration to be identified in the first flow parameter data, the motor needs to operate at a sufficient speed. If the motor speed is too slow, it may be impossible to accurately predict the effect or correlation of motor speed on the flow data (e.g., flow rate). Therefore, after the controller receives the motor speed data, it can compare the motor speed to a minimum motor speed threshold. If the motor speed is below the threshold, the controller can consider the first flow parameter data to be unsuitable and discard some or all of it. However, if the motor speed exceeds the threshold, the controller can calculate the recent change in motor speed. As a result of the change in motor speed, the first flow parameter data may also change, making it more difficult to identify patient respiration in the first flow parameter data. While the effect of motor speed can be removed to some extent from the first flow parameter data, if the change in motor speed is too large, the reliability of identifying patient respiration in the data may become too low. Therefore, the controller can generate a first value representing the recent relative change in motor speed by applying a running filter to the relative change in motor speed. The controller can then compare the first value to the first threshold. If the first value is higher than the first threshold, the controller can consider the flow parameter data unsuitable and discard the flow data point. If the first value is lower than the first threshold, the controller can consider the flow parameter data suitable for use.

[0394] As another example, the second flow parameter data may represent the concentration of an auxiliary gas from an auxiliary gas source. The first flow parameter data (e.g., flow rate) may be affected by the flow rate or concentration of the auxiliary gas from the auxiliary gas source. The controller may receive oxygen flow rate data or oxygen concentration data. The controller may calculate recent changes in oxygen flow rate or oxygen concentration. When the flow rate or oxygen concentration changes, the resulting change in total flow rate can make it more difficult to identify patient respiration in the flow signal or other flow parameter signal. The controller may therefore generate a second value representing recent changes in oxygen concentration or flow rate by applying a running filter to changes in the oxygen concentration or oxygen flow rate of the gas. The controller may compare the second value to a second threshold. If the second value is higher than the second threshold, the controller may identify the first flow parameter data as inappropriate and discard the first flow parameter data point. However, if the second flow parameter data is lower than the threshold, the controller may consider that the flow parameter data to be appropriate.

[0395] As mentioned above, if the controller deems the data appropriate, it may modify the primary flow parameter data (or any other flow parameter data) to eliminate the influence of the motor (or other factors such as oxygen concentration or flow rate). Modifying the primary flow parameter data may include removing the expected influence of other variable values ​​from the primary flow parameter data (such as motor speed). This expected influence is only valid if the gas flow parameter data meets certain criteria. As mentioned above, if the criteria are not met, the data may be discarded.

[0396] This process can eliminate the effect of motor speed by modifying the first flow parameter data. The motor effect can be estimated using motor speed and flow conductance. The controller can measure instantaneous flow conductance. Flow conductance can be calculated as follows:

number

[0397] In the above equation, C is the flow conductance, filt() is the filter function, Q is the flow parameter data, and ω motor is the motor speed. In some configurations, the filter function is a low-pass filter. In some examples, the flow parameter data is the flow signal generated by the respiratory device's flow sensor. Flow conductance is nearly constant over time and can therefore be estimated using a low-pass filter. The controller measures the instantaneous flow conductance in each iteration using the current motor speed and the measured flow rate. The controller can filter the instantaneous flow conductance to identify the filtered flow conductance.

[0398] The controller can compare the instantaneous flow conductance with the filtered flow conductance to determine if the difference is significant. If the difference is significant, it may indicate that something has changed in the physical system, such as the cannula being attached or removed. The instantaneous flow conductance can be compared with the filtered flow conductance by taking the difference between these two variable values ​​and comparing it to a minimum or maximum threshold. If the difference exceeds or falls below the threshold, the difference is considered significant, and the controller can reset the filtered flow conductance. The controller can also change the filter coefficients of the filter function in the filtered flow conductance calculation based on the difference between the instantaneous flow conductance and the filtered flow conductance. This allows the filtered flow conductance to change more quickly when the flow conductance fluctuation is large, for example, when the cannula is first attached.

[0399] If the difference between instantaneous flow conductance and filtered flow conductance does not exceed a threshold, the difference is considered unsignificant, and the controller can estimate the motor's effect on flow. The controller can output an effect value using the filtered flow conductance and motor speed. This value can be subtracted from the flow data or otherwise removed to obtain pre-processed flow data. Pre-processed flow data can better represent the patient's respiratory flow (however, pre-processed flow data may still contain signal noise).

[0400] The controller can also track recent changes in flow conductance. These changes can be tracked by adding the difference between the last two instantaneous flow conductance values ​​to the running total, which then decays over time. The decayed running total is filtered to obtain a filtered recent change in flow conductance. This filtered recent change in flow conductance, along with the pre-processed flow data, can be used in another part of the frequency analysis algorithm.

[0401] 2.6 Device minute ventilation MV device Identification As mentioned above, some of the exemplary WOB indicator algorithms and their respective WOB inductances are based on the respiratory device minute ventilation MV device It is based at least partially on, or is a function thereof.

[0402] Refer to Figures 22A-23, Device minute ventilation MV device Examples of various methods for identifying or calculating the estimate are described below, but it should be understood that alternative methods may also be used. In some configurations, the WOB indicator algorithm may perform such methods for estimating or identifying the device minute ventilation data. In other configurations, the device minute ventilation estimate or data may be calculated separately within the controller and fed into the WOB indicator algorithm running on the controller.

[0403] While inspiration and expiration are relatively easy to measure in closed systems, measuring respiratory parameters is far more difficult in open systems. In open systems such as nasal high-flow systems, the openness of the system (due to the use of an open patient interface) makes it significantly more difficult to identify patient respiratory parameters because the desired signal is often weak and / or obscured by noise.

[0404] This disclosure provides a reliable method for estimating key patient respiratory parameters (e.g., WOB indicators) in open-seal systems (e.g., open-seal nasal cannulas used in high-flow systems).

[0405] The controller controls the device minute ventilation (MV). device This may include a process configured to calculate an estimate of the device minute ventilation (MV). device ) represents the device minute ventilation (MV), which is numerical information about the average volume of air forced into and expelled from the respiratory apparatus (i.e., the device) per minute. In some configurations, the device minute ventilation (MV) is expressed as device minute ventilation (MV). device ) can be discrete values ​​or a series of discrete values ​​(e.g., a sequence of past estimates). In some examples, the series of discrete values ​​is the device minute ventilation (MV device It may start with the first estimate of ) and continue until the end of the respiratory device use (treatment) session. Alternatively, device minute ventilation (MV) device A series of discrete values ​​estimated can represent a specific time window and can be continuously overwritten as new values ​​are estimated. For example, device minute ventilation (MV deviceA series of discrete values ​​of the estimate can represent those values ​​over a recent period. In some configurations, this period can be 15 minutes, 20 minutes, 25 minutes, 30 minutes, 35 minutes, 40 minutes, 45 minutes, 50 minutes, 55 minutes, 60 minutes, 65 minutes, 70 minutes, 15-20 minutes, 20-25 minutes, 25-30 minutes, 30-35 minutes, 35-40 minutes, 40-45 minutes, 45-50 minutes, 50-55 minutes, 55-60 minutes, 60-65 minutes, 65-70 minutes, 15-30 minutes, 30-45 minutes, 45-60 minutes, and any value within the above ranges, including extreme values.

[0406] Figures 22A, 22B, 22C, and 22D show the device minute ventilation (MV). device Figure 22A shows four flowcharts for estimating the device minute ventilation (MV). device A simplified method for estimating minute ventilation (MV) is shown. Figures 22B, 22C, and 22D show minute ventilation (MV). device Examples of more detailed methods for estimating ) are shown in 1100, 1200, and 1300.

[0407] As shown in Figure 22A, the device minute ventilation (MV) device Method 1000 for estimating the device minute ventilation (MV) begins with obtaining raw flow data in step 1002. Raw flow data can be obtained from a flow sensor such as an ultrasonic flow sensor. deviceThe method for estimating the MV may include preprocessing the raw flow data in step 1004 to remove unwanted signal components. Removal of unwanted signal components has already been described in more detail. Unwanted signal components may originate from the flow generator motor. In some configurations, unwanted signal components may also be generated from other sources (e.g., noise), but they may primarily originate from the flow generator motor. For example, the preprocessed flow data may be a flow signal that includes components associated with the patient's respiratory activity. For example, components associated with the patient's respiratory activity may be included in the flow signal as changes in flow amplitude (e.g., as fluctuations). Once preprocessed, the flow data can represent the patient's respiratory data. Method 1000, assuming the data is of sufficient quality, can provide the preprocessed data to the device minute ventilation algorithm to estimate the device minute ventilation (MV). device This may include a step 1006 in which the following is calculated.

[0408] Refer to Figure 22B, Device minute ventilation (MV device A more detailed flowchart of method 1100 for estimating the flow rate is described below. Similar to method 1000, method 1100 begins with acquiring raw flow rate data in step 1102. Raw flow rate data can be obtained from a flow sensor such as an ultrasonic flow sensor. Method 1100 may include preprocessing the raw flow rate data in step 1104 to remove unwanted signal components. The removal of unwanted signal components has already been described in more detail. Unwanted signal components may originate from the motor of a flow generator. After preprocessing, the flow rate data can represent the patient's respiratory data. The processed flow rate data is then analyzed in step 1106 to determine whether the data quality is sufficiently good or not. If the quality is not sufficient, the flow data is discarded, and method 1100 returns to step 1102, waiting to receive the raw flow data.

[0409] However, once the data is identified as being of sufficient quality, the data proceeds to step 1112, where method 1100 uses the processed data to determine the device minute ventilation (MV device Calculate the device minute ventilation (MV). The data can be considered to be of sufficient quality if it does not contain large transient peaks (possibly due to interface adjustments). device ) is numerical information of the average volume that is pushed into and pushed out of the device per minute. As shown in step 1112, the device minute ventilation (MV) device The process for calculating tidal volume can first be performed by fitting a spline to flow data using a least-squares criterion. The flow data may be, for example, the most recent pre-filtered flow data points. In some configurations, using a least-squares criterion, the pre-processed flow data (e.g., respiratory signal) is first approximated, and then the tidal volume is estimated by integrating along the spline.

[0410] Method 1100 is the device minute ventilation (MV device Step 1116 may include a step in which an instantaneous estimate of the device minute ventilation (MV) is calculated using a spline. In some examples, the use of a spline may be more beneficial than another method (e.g., a set of filters configured to generate statistical numerical information of the data) because it can work better over a wider sampling frequency range (i.e., it fits / interpolates the data more accurately). This will be discussed in more detail later. Method 1100 calculates the device minute ventilation (MV). device This can include three methods for calculating the instantaneous estimate of the device minute ventilation (MV). device The estimation of the gas flow parameters is based on the data.

number

number

[0411] Device minute ventilation (MV) device The estimation of ) represents the mean of the absolute values ​​of the curve fitted to the gas flow parameter data (i.e., calculated without using splines for data interpolation). Both of the above estimations can be used as input in Method 1100, but each has its advantages and disadvantages depending on the random error of the sensor data and patient respiratory rate. Method 1100 represents the integral of the absolute value of the first term of the line fitted to the signal, and the device minute ventilation (MV) device The following estimation can be used. This estimation is the most resilient to random error and is hardly affected by it, but is most affected by respiratory rate.

[0412] Refer to Figure 22C, device minute ventilation (MV deviceA more detailed flowchart of Method 1200 for estimating the patient's respiratory data is described below. Similar to Methods 1000 and 1100, Method 1200 begins with acquiring raw flow data in step 1202. Raw flow data can be acquired from a flow sensor, such as an ultrasonic flow sensor. In some configurations, in step 1204, the raw flow data is first analyzed to determine whether the data quality is sufficiently good. If the raw flow data is determined to be of sufficient quality, the data can be preprocessed to remove unwanted signal components. If the raw flow data is of insufficient quality, the data is discarded, and Method 1200 returns to step 1202, waiting to receive additional raw flow data. In some examples, Method 1200 may include preprocessing the raw flow data in step 1206 to remove unwanted signal components. The removal of unwanted signal components has already been described in more detail. Unwanted signal components may originate from the motor of the flow generator. After preprocessing, the flow data can represent the patient's respiratory data. In some configurations, once the flow data is preprocessed, the data can proceed to step 1212, where method 1200 fits a curve to the flow data. The data can be considered to be of sufficient quality if it does not contain large transient peaks (possibly due to interface adjustments). Device minute ventilation (MV device This is numerical information indicating the average volume of air that is forced into and expelled from the device per minute. The process of fitting a curve to flow data can be done by first fitting a spline to the flow data using the least squares criterion. In some configurations, the fitted line can be (approximately) represented as follows:

number

[0413] In the above equation, m is the fitting parameter corresponding to the mean value of the flow data, s is the slope (i.e., gradient), and t *is the linear range of the normalized time parameter. In some configurations, t * is the linear range of the normalized time parameter, where the "oldest" point in time for the flow data is equal to -1 and the "most recent" point in time for the flow data is equal to 1.

[0414] In some configurations, other methods of function approximation may also be used. Flow data may be, for example, recent pre-filtered flow data points. In some examples, the least squares method may be used to approximate pre-processed flow data (e.g., respiratory signals), which are then integrated along a spline to estimate ventilation. In some configurations, the controller may use various line and / or curve fitting techniques to fit one or more functions to selected portions of flow parameter variation data. This may include, for example, regression analysis, interpolation, extrapolation, linear least squares, nonlinear least squares, composite least squares, linear simple regression, robust linear simple regression, polynomial regression, orthogonal regression, Temming regression, linear pieceline regression, regression dilution, and / or other non-limiting exemplary techniques. In some configurations, a curve may be generated by one or more functions, including at least the above. In some configurations, a curve may be a line. Lines or curves described herein may include multiple curves, vertices, and / or other features. Lines described herein may be straight, angled, and / or horizontal. In some cases, the lines described herein may be the best-fitting lines.

[0415] Method 1200 is the device minute ventilation (MV) device Method 1200 may include step 1214 in which an instantaneous estimate of the device minute ventilation (MV) is calculated using data from a curve composed of fitted splines. device This can include three methods for calculating the instantaneous estimate of the device minute ventilation (MV). device The estimation of the gas flow parameters is based on the data.

number

number

[0416] Device minute ventilation (MV) device The estimation of ) represents the mean of the absolute values ​​of the curve fitted to the gas flow parameter data (i.e., calculated without using splines for data interpolation). Both of the above estimations can be used as input in Method 1200, but each has its advantages and disadvantages depending on the random error of the sensor data and patient respiratory rate. Method 1200 represents the integral of the absolute value of the first term of the line fitted to the signal, and the device minute ventilation (MV) deviceThe estimation of ) can be used. This estimation is the most resilient to random errors and is hardly affected by them, but is most affected by respiratory rate. In some implementation examples, method 1200 can skip step 1212, the preprocessed flow data can proceed directly to step 1214, and method 1200 can directly calculate the average of selected preprocessed flow data points.

[0417] In one exemplary configuration, method 1200 also, in step 1216, instantaneous device minute ventilation (MV device The system may also be configured to apply a filter to average the estimates. In some configurations, each estimate, or a sequence of estimates captured in multiple iterations of the aforementioned step, can be averaged or "smoothed" using a filter (e.g., an exponential filter). In some examples, this step can be performed after the initial estimates but before any additional processing step.

[0418] In some configurations, the device minute ventilation (MV) device The estimation of the device minute ventilation (MV) is determined by taking an estimate, which involves taking the integral of the absolute value of the first term of a line fitted to the flow signal (e.g., zero-order spline). In some examples, the device minute ventilation (MV) is determined. device ) is estimated for each data point using all three methods described above. As described above, the three methods include: (1) Device minute ventilation (MV device The estimation of the gas flow parameters is based on data.

number

number

[0419] Refer to Figure 22D, device minute ventilation (MV device This describes another flowchart for estimating the device minute ventilation (MV). device ) is estimated for each data point using all three methods described above. Similar to methods 1000, 1100, and 1200, method 1300 begins with acquiring raw flow data in step 1302. Raw flow data can be obtained from a flow sensor such as an ultrasonic flow sensor. In some configurations, in step 1304, the raw flow data is first analyzed to determine whether the data quality is sufficiently good. If the raw flow data is determined to be of sufficient quality, the data can be preprocessed to remove unwanted signal components. If the raw flow data is of insufficient quality, the flow data is discarded, and method 1300 returns to step 1302, waiting to receive additional raw flow data. In some examples, method 1300 may include preprocessing the raw flow data in step 1306 to remove unwanted signal components. The removal of unwanted signal components has already been described in more detail. Unwanted signal components may originate from the motor of the flow generator. After preprocessing, the flow data can represent the patient's respiratory data. In some configurations, once the flow data is preprocessed, the data can proceed to step 1312, where method 1300 fits a curve to the flow data. The data can be considered to be of sufficient quality if it does not contain large transient peaks (possibly due to interface adjustments). Device minute ventilation (MV deviceThis is numerical information indicating the average volume of air that is forced into and expelled from the device per minute. The process of fitting a curve to flow data can be done by first fitting a spline to the flow data using the least squares criterion. In some configurations, the fitted line can be (approximately) represented as follows:

number

[0420] In the above equation, m is the fitting parameter corresponding to the mean value of the flow data, s is the slope (i.e., gradient), and t * is the linear range of the normalized time parameter. In some configurations, t * is the linear range of the normalized time parameter, where the "oldest" point in time for the flow data is equal to -1 and the "most recent" point in time for the flow data is equal to 1.

[0421] In some configurations, other methods of function approximation may also be used. Flow data may be, for example, recent pre-filtered flow data points. In some examples, the least squares method may be used to approximate pre-processed flow data (e.g., respiratory signals), which are then integrated along a spline to estimate ventilation. In some configurations, the controller may use various line and / or curve fitting techniques to fit one or more functions to selected portions of flow parameter variation data. This may include, for example, regression analysis, interpolation, extrapolation, linear least squares, nonlinear least squares, composite least squares, linear simple regression, robust linear simple regression, polynomial regression, orthogonal regression, Temming regression, linear pieceline regression, regression dilution, and / or other non-limiting exemplary techniques. In some configurations, a curve may be generated by one or more functions, including at least the above. In some configurations, a curve may be a line. Lines or curves described herein may include multiple curves, vertices, and / or other features. Lines described herein may be straight, angled, and / or horizontal. In some cases, the lines described herein may be the best-fitting lines.

[0422] Method 1300 is the device minute ventilation (MV device Method 1300 may include step 1314 in which an instantaneous estimate of the device minute ventilation (MV) is calculated using data from a curve composed of fitted splines. device This can include three methods for calculating instantaneous estimates of ). In some configurations, one of the three estimates is based on data of the gas flow parameters.

number

number

[0423] In some configurations, method 1300 can skip step 1312 and proceed directly to step 1314 with the pre-processed flow data, where method 1300 can directly calculate the average of the selected pre-processed flow data points.

[0424] Method 1300 is performed in step 1314 with a device minute ventilation rate (MV device Once you obtain three estimates of ), in step 1316, filter the device minute ventilation (MV) device ) applied to instantaneous device minute ventilation (MV device ) can be averaged. In some configurations, each estimate, or a sequence of estimates captured in multiple iterations of the aforementioned step, can be averaged or "smoothed" using a filter (e.g., an exponential filter). In some examples, this step can be performed after the initial estimate, but before any additional processing step.

[0425] Method 1300 uses three measurements (i.e., the first MV) device Presumably, the second music video device Estimated, and the third MV deviceThere are three unknown values ​​or signals that can constitute and / or contribute to the estimated device minute ventilation signal. These unknown values ​​and signal components may include, for example, noise, respiratory rate (e.g., patient-induced flow rate changes), and the underlying device minute ventilation signal. Thus, there is a set of three analytical expressions or equations that can be solved simultaneously to derive noise, respiratory rate, and device minute ventilation. In some configurations, solving three analytical expressions or equations simultaneously is computationally very costly and therefore places a high demand on processing hardware in embedded device applications such as medical devices. In some configurations, in Method 1300, the algorithm of Method 1300 first proceeds to step 1318, and the three MV device The estimations are normalized according to the number of data points used in each estimation. In some examples, method 1300 may include step 1320 in which a noise correction coefficient can be calculated, the noise correction coefficient having a relationship to the signal-to-noise ratio. The calculation of the noise correction coefficient in step 1320 may be similar to any of those disclosed in PCT application publication WO2020 / 178746, filed on March 4, 2020, which is incorporated herein by reference in its entirety. In some configurations, the normalized MV device A noise correction coefficient related to one or more of the estimations can be calculated.

[0426] In some configurations, method 1300 may include step 1322, in which the algorithm normalizes minute ventilation estimates and noise correction coefficients for the device minute ventilation (MV device A predefined fitted curve can be used to relate to one of the estimates. In some configurations, the fitting function may include several numerically derived terms, at least in part. In some configurations, this corrected curve can relate to the device minute ventilation (MV). device This allows us to approximate the output of the analytical representation regarding ). This allows us to find the device minute ventilation (MV) with the least noise and respiratory rate dependence. device ) can be provided.

[0427] In some configurations of Method 1300, each device minute ventilation (MV) device The estimations, or the sequence of estimations captured over multiple iterations of the aforementioned steps, can be averaged or "smoothed" using a filter (e.g., an exponential filter). In some examples, this step can be performed after the initial estimation and before any additional processing steps.

[0428] Referring to Figure 23, a flowchart of Method 1400 for estimating normalized device minute ventilation is illustrated. Unlike the methods shown in Figures 22B-22D, the respiratory device takes a corrected device minute ventilation and normalizes it using the respiratory device flow rate. In some configurations, this can yield a device flow rate-independent estimate of device minute ventilation that does not change with flow. In some examples, the estimated device minute ventilation can also be independent of the nasal cannula fit and can provide a general indicator of patient minute ventilation.

[0429] Method 1400 begins with acquiring raw flow data in step 1402. Raw flow data can be obtained from a flow sensor, such as an ultrasonic flow sensor. In some configurations, in step 1404, the raw flow data is first analyzed to determine whether the data quality is sufficiently good. If the raw flow data is determined to be of sufficient quality, the data can be preprocessed to remove unwanted signal components. If the raw flow data is of insufficient quality, the data is discarded, and Method 1400 returns to step 1402, waiting to receive additional raw flow data. In some examples, Method 1400 may include preprocessing the raw flow data in step 1406 to remove unwanted signal components. The removal of unwanted signal components has already been described in more detail. Unwanted signal components can originate from the flow generator motor.

[0430] In some configurations, once the flow data has been preprocessed, the data can proceed to step 1408, where method 1400 fits a curve to the flow data. The data can be considered to be of sufficient quality if it does not contain large transient peaks (possibly due to interface adjustments). Device minute ventilation (MV device This is numerical information indicating the average volume of air that is forced into and expelled from the device per minute. The process of fitting a curve to flow data can be done by first fitting a spline to the flow data using the least squares criterion. In some configurations, the fitted line can be (approximately) represented as follows:

number

[0431] In the above equation, m is the fitting parameter corresponding to the mean value of the flow data, s is the slope (i.e., gradient), and t * is the linear range of the normalized time parameter. In some configurations, t * is the linear range of the normalized time parameter, where the "oldest" point in time for the flow data is equal to -1 and the "most recent" point in time for the flow data is equal to 1.

[0432] In some configurations, other methods of function approximation may also be used. Flow data may be, for example, recent pre-filtered flow data points. In some examples, the least squares method may be used to approximate pre-processed flow data (e.g., respiratory signals), which are then integrated along a spline to estimate ventilation. In some configurations, the controller may use various line and / or curve fitting techniques to fit one or more functions to selected portions of flow parameter variation data. This may include, for example, regression analysis, interpolation, extrapolation, linear least squares, nonlinear least squares, composite least squares, linear simple regression, robust linear simple regression, polynomial regression, orthogonal regression, Temming regression, linear pieceline regression, regression dilution, and / or other non-limiting exemplary techniques. In some configurations, a curve may be generated by one or more functions, including at least the above. In some configurations, a curve may be a line. Lines or curves described herein may include multiple curves, vertices, and / or other features. Lines described herein may be straight, angled, and / or horizontal. In some cases, the lines described herein may be the best-fitting lines.

[0433] Method 1400 uses data from a curve composed of fitted splines to calculate the device minute ventilation (MV). device Method 1400 may include step 1410 in which three instantaneous estimates of the device minute ventilation (MV) are calculated. device This can include three methods for calculating instantaneous estimates of ). In some configurations, one of the three estimates is based on data of the gas flow parameters.

number

number

[0434] In some configurations, method 1400 can skip step 1408 and proceed directly to step 1410, where method 1400 can directly calculate the average of the selected pre-processed flow data points.

[0435] Method 1400 is performed in step 1410 with the device minute ventilation (MV device Once you obtain three estimates of ), in step 1412, filter the device minute ventilation (MV) device ) applied to instantaneous device minute ventilation (MV device ) can be averaged. In some configurations, each estimate, or a sequence of estimates captured in multiple iterations of the aforementioned step, can be averaged or "smoothed" using a filter (e.g., an exponential filter). In some examples, this step can be performed after the initial estimate, but before any additional processing step.

[0436] Method 1400 uses three measurements (i.e., the first MV) device Presumably, the second music video device Estimated, and the third MV deviceThere are three unknown values ​​or signals that can constitute and / or contribute to the estimated device minute ventilation signal. These unknown values ​​and signal components may include, for example, noise, respiratory rate (e.g., patient-induced flow rate changes), and the underlying device minute ventilation signal. Thus, there is a set of three analytical expressions or equations that can be solved simultaneously to derive noise, respiratory rate, and device minute ventilation. In some configurations, solving three analytical expressions or equations simultaneously is computationally very costly and therefore places a high demand on processing hardware in embedded device applications such as medical devices. In some configurations, in Method 1400, the algorithm of Method 1400 first proceeds to step 1414, and the three MV device The estimation is normalized according to the number of data points used in each estimation. In some examples, method 1400 may include a step 1416 in which a noise correction coefficient can be calculated, the noise correction coefficient having a relationship to the signal-to-noise ratio. The calculation of the noise correction coefficient in step 1416 may be similar to any of those disclosed in PCT application publication WO2020 / 178746, filed on March 4, 2020, which is incorporated herein by reference in its entirety. In some configurations, the normalized MV device A noise correction coefficient related to one or more of the estimations can be calculated.

[0437] In some configurations, method 1400 may include step 1418, in which the algorithm normalizes minute ventilation estimates and noise correction coefficients for the device minute ventilation (MV device A predefined fitted curve can be used to relate to one of the estimates. In some configurations, the fitting function may include several numerically derived terms, at least in part. In some configurations, this corrected curve can relate to the corrected device minute ventilation (MV). device This allows us to approximate the output of the analytical representation regarding ). This is the device minute ventilation (MV) with the least noise and respiratory rate dependence. device ) can be provided.

[0438] In some configurations, Method 1400 uses a corrected device minute ventilation (MV) device This may include step 1420 in which the corrected device minute ventilation (MV) is normalized using the device flow rate. In some examples, the same data previously used in a previous step (i.e., good quality pre-processed flow rate data) is used to normalize the corrected device minute ventilation (MV). device It is used to reach the corrected device minute ventilation (MV) and provides an estimate of device minute ventilation that does not change with flow and is independent of device flow rate. device This can be independent of the nasal cannula fit and provides a versatile indicator of patient minute ventilation.

[0439] 2.7 WOB Indicators - As a function of, or relative to, the numerical information of a healthy person. In some configurations, either the WOB indicator or numerical information described above can be transformed into metrics or numerical information that are presented or represented as a function of the numerical information of a conceptual healthy person, or as metrics or numerical information relative to such numerical information of a healthy person. In such configurations, the respiratory device controller or other processing device implementing or executing the WOB indicator algorithm may take extra steps to transform, modify, or otherwise represent the WOB indicator or numerical information as a function of, or correlated with, the numerical information of a healthy person, based on comparative data of a healthy person stored (e.g., in the device's memory) or otherwise accessible.

[0440] In one configuration, any of the exemplary WOB indicators are presented or represented as ratios or percentages of what is expected of an "average healthy person." For example, WOB indicator data may be modified, transformed, or presented to express a patient's respiratory performance as a ratio of ideal health values. In some configurations, this representation of disclosed WOB indicators may have the advantage of being familiar to physicians, thereby making them more intuitive to use.

[0441] In some configurations, one or more of the WOB indicators described above for a nominal "average healthy person" are calculated from nominal people (or a range of nominal people of various body sizes) who use an average cannula in a controlled environment, either pre-programmed, otherwise stored in, or otherwise accessible from the respiratory device's memory.

[0442] In an alternative configuration, the WOB indicator can estimate the body size of a particular patient using a mixture of estimated, detected, and / or manually entered parameters. For example, measurable flow and pressure parameters (e.g., Q tube , P blower This can be used in combination with numerical information or estimates of the patient's size and a percentage estimate of nasal obstruction manually entered by the physician. Alternatively or additionally, in other examples, the patient's body size may be estimated by the device based on the flow rate setting, and nasal obstruction may be estimated or approximated using the cannula size (which may be manually entered, for example) and knowledge of the patient's body size.

[0443] In other exemplary configurations, a table (or other suitable data structure) of patient parameters and corresponding WOB numerical information may also be stored in the respiratory device's memory, if they represent a healthy state, and can be accessed as needed to enable the generation of WOB indicators or numerical information as a function of, or correlated with, the numerical information of a healthy person.

[0444] In one exemplary configuration, a respiratory device or its controller may be configured to periodically or continuously calculate or determine the ratio or percentage of the patient's WOB measurement to the nominal healthy WOB measurement. Any of the applications described in the following sections may be applicable not only to individual WOB numerical information but also to this ratio or percentage.

[0445] 2.8 Uses of the WOB Indicator overview Any patient WOB indicators, data, or trend data disclosed herein, including patient WOB indicators expressed as ratios or percentages relative to data from healthy individuals, may be generated and used by a respiratory device in one or more different applications or functions, examples of which are further discussed below. In some configurations, these WOB indicators are generated and used by one or more applications or functions during respiratory therapy sessions in which a patient is receiving using a respiratory device. In some configurations, the application or function may utilize and / or process the WOB indicator data generated and stored during respiratory therapy sessions for post-treatment processing and / or storage, for example, by transmitting or transferring the WOB indicator data and / or associated treatment data to a remote or cloud computing system, such as a patient and / or device management platform.

[0446] Here, we further elaborate on various examples of uses and / or functions that may utilize and / or process the WOB indicators generated by the algorithms described above and / or disclosed above. In some of the examples described later, one or more WOB indicators or associated data may also be used for one or more of the following actions: Display of WOB indicator data and / or WOB trend data on the respiratory device or related device (for example, on the device's display screen and / or GUI, or transmitted for display on related devices or devices that communicate with the device for data). - Triggering or generating alarms, notifications, or suggestions (visual, auditory, and / or tactile) on a display device or related devices that communicate with the device. - Trigger or generate one or more alerts, alarms, and / or notifications based at least in part on identified WOB indicator data and / or WOB trend data, and one or more thresholds. Alerts, alarms, and / or notifications may be auditory, visual, and / or tactile. • Triggering or generating one or more alerts, alarms, and / or notifications that include WOB indicator data and / or WOB trend data, and data indicating suggested adjustments or changes to treatment settings and / or device settings based at least in part on one or more thresholds. • Generate reports based on WOB indicator data and / or WOB trend data.

[0447] Any one or more of the exemplary uses and / or functions described above or below may be used in conjunction with a respiratory apparatus.

[0448] First exemplary use - Displaying WOB data In this example, the WOB indicators generated by the respiratory device may be displayed on the respiratory device's display screen or user interface (e.g., a graphical user interface - GUI), or transmitted to be displayed on an associated remote device or system communicating data with the device. As previously stated, raw or absolute patient WOB indicators may be displayed, and / or patient WOB ratio or percentage indicators with respect to WOB data in a healthy state may be displayed. Additionally or alternatively, one or more WOB trends or trend data (e.g., "WOB increase," "WOB decrease," "WOB stable") with respect to WOB data may be displayed separately from or concurrently with the WOB indicator data.

[0449] Referring to Figure 24, an exemplary GUI 2100 is shown, which includes a WOB monitor screen. In this example, the WOB monitor screen includes a first GUI element 2102 configured to display WOB indicator data. In this example, the WOB indicator data may be a patient WOB ratio or percentage indicator with respect to nominal healthy WOB data, but alternatively, it may be raw or absolute WOB indicator data. In this example, the WOB monitor screen also includes a second GUI element 2104 that is displayed simultaneously, which is configured to display corresponding WOB trend data with respect to the WOB data displayed in the first GUI element 1202. GUI elements 2102, 2014 may display their respective data in any appropriate format or combination of formats, which may include, but are not limited to, numbers, graphics, text, icons, colors, and / or animations.

[0450] In one configuration, the respiratory device may be configured to display WOB data (e.g., WOB indicator data and / or WOB trend data) on the respiratory device's display or user interface at the end of each treatment session or at any other configurable or predetermined time.

[0451] In a given configuration, the respiratory device may be configured to process WOB data over multiple treatment sessions or periods for a given patient, and may generate comparative and / or aggregated and / or statistical data representing or indicating statistics, changes, and / or trends in WOB data for that patient over multiple treatment sessions and / or other desired capture data periods (e.g., days or weeks). The comparative, aggregated, and / or statistical data may be stored on the respiratory device and / or transmitted to a remote device or server for storage and / or further processing. Additionally or alternatively, the comparative, aggregated, and / or statistical data may be displayed or presented on the respiratory device's display at the end of a treatment session and / or at any other configurable or predetermined time and / or based on certain conditions or events.

[0452] Second exemplary use - display of notices and / or proposals In this example, WOB data and / or related notifications and / or suggestions generated or triggered based on WOB data may be displayed for the user, patient, and / or physician or medical staff (e.g., respiratory therapist, nurse, etc.). WOB data, notifications, and / or suggestions may be displayed on the display screen or user interface (e.g., GUI) of the respiratory device and / or transmitted to be displayed on a remote device or system that communicates data with the device (e.g., patient and / or device management systems, and / or portable electronic devices such as smartphones, tablets, laptops, wearable smart devices, etc.).

[0453] In one configuration, the respiratory device GUI may be configured to display or present one or more live or real-time generated WOB indicators based on any of the above. This may also prompt the user to check in real time whether changes to the respiratory device's therapeutic settings or therapeutic settings (e.g., flow rate settings and / or gas flow oxygen concentration settings, e.g., FiO2 and / or FdO2 settings) will favorably change the patient's WOB (e.g., result in a lower, more severe, or decreasing WOB). This configuration may allow the user or physician to fine-tune the respiratory device's therapeutic settings for the patient with the aim of reducing WOB.

[0454] In other configurations, one or more auditory and / or visual alerts, warnings, notifications, prompts, or similar features may be presented or displayed on a display screen or GUI simultaneously with the WOB indicator or data. Auditory alerts, alarms, and / or notifications may be provided via the device's audio output device. For example, if the patient WOB is increasing due to a new flow setting, an appropriate alert may be generated or delivered. Refer to Figures 25A–25F for examples of various GUIs and / or notifications and / or alerts in such configurations.

[0455] Figure 25A shows a first exemplary GUI 2110 in which WOB data has detected a high work of breathing and triggered message 2112 indicating that the patient should be checked.

[0456] Figure 25B shows a second exemplary GUI 2120 in which WOB data triggers a first GUI element 2122 that displays a trend notification indicating an increase in the patient's respiratory work, and a second GUI element 2124 that includes a notification or suggestion for adjusting treatment settings. The notification data may include, for example, data indicating how to adjust one or more of the respiratory device treatment settings to reduce the respiratory work.

[0457] Figure 25C shows a third exemplary GUI 2130 in which WOB data has triggered a first GUI element 2132 for displaying a message indicating that a high work of breathing has been detected, and a second GUI element 2134 including a notification or corrective suggestion to the user or physician to increase the respiratory device flow rate setting. In this example, the GUI displays the WOB alert and corresponding corrective or suggested data, and provides information on how to clear or correct the alert, for example, increasing the flow rate setting may help reduce the patient's current work of breathing as represented by the calculated WOB data.

[0458] Figure 25D shows a fourth exemplary GUI 2140 in which WOB data has detected a trend of increasing respiratory work and a message or trend notification 2142 indicating that the patient should be checked.

[0459] Figure 25E shows a fifth exemplary GUI 2150 in which WOB data triggers a first GUI element 2152 that displays a notification or message indicating that low work of breathing has been detected, and a second GUI element 2154 that includes a notification or corrective suggestion for adjusting treatment settings. The notification data may include data indicating how one or more of the respiratory device's treatment settings should be adjusted in response to the detected low work of breathing.

[0460] Figure 25F shows a sixth exemplary GUI 2160 in which WOB data triggers a first GUI element 2162 that displays a trend notification indicating an increasing patient's work of breathing, and a second GUI element 2164 that includes a notification or corrective suggestion to the user or physician to increase the respiratory device flow rate setting. In this example, the GUI displays the WOB alert and corresponding corrective or suggested data, provides information on how to clear or correct the alert, for example, increasing the flow rate setting may help stop and / or reverse the current trend of the patient's increasing work of breathing.

[0461] As described above, notification data or information provided on the WOB notification, alert, and / or suggestion display screen may be provided or presented in any appropriate form, or in combination of visual forms including, but not limited to, numerical data, text information, graphic form or format, continuous trend lines, time-series plots or graphs, icons, animations, and / or color-coded information. Additionally or alternatively, notification data may be provided, for example, aurally, and / or by aural cues or voice commands.

[0462] Third exemplary use - Reporting and generating reports on WOB data or notification data. In some configurations, the generated WOB data (e.g., WOB indicator data and / or WOB trend data) and / or notification data (e.g., alerts, alarms, and notifications triggered based on a comparison of WOB data with one or more thresholds) may be reported or transmitted by the respiratory device to one or more remote devices or systems (e.g., patient and / or device management systems, and / or other personal or portable electronic devices such as smartphones, tablets, laptops, and wearable devices). In one configuration, the respiratory device may be configured to report or transmit WOB data and / or notification data in real time, instantaneously, periodically, on demand, on request, at configurable intervals, or automatically in response to specific events or actions.

[0463] In one exemplary configuration, the respiratory device is configured to report or transmit WOB data and / or notification data at the end of each treatment session or thereafter. In one example, the respiratory device is configured to report or transmit WOB data and / or notification data while the device is operating in dry mode after a treatment session, or at any other appropriate time after the end of a treatment session. In one configuration, the dry mode of the treatment device refers to a mode in which the device dries after a treatment session, for example, by the controller operating a blower or flow generator but not a humidifier.

[0464] In one exemplary configuration, the respiratory device may be configured to report or transmit WOB data and / or notification data from the previous treatment session during the warm-up mode of the next treatment session. For example, during the warm-up mode of a new treatment session, the respiratory device may be configured to report or transmit WOB data and / or notification data generated from the previous treatment session or previous sessions. In one configuration, the warm-up mode of the respiratory device refers to the mode of the device in which the controller brings the device's humidifier (if any) to operating temperature before the start of a treatment session.

[0465] Any of the aforementioned notification data (e.g., alerts, notifications, suggestions, etc.) triggered in response to calculated or identified WOB data may, additionally or alternatively, be transmitted for display or presentation on a remote device or system that communicates directly or indirectly with the respiratory apparatus. Additionally or alternatively, WOB data generated by the respiratory apparatus may trigger such notification data to be presented on a remote device or system, for example, a remote device or system may trigger the display or presentation of notification data in response to receiving and processing WOB data from the respiratory apparatus. For example, a remote device or system may be any suitable electronic device or system having a visual (e.g., display screen), auditory, and / or tactile user interface, including, but not limited to, mobile phones, smartphones, tablets, laptops, pagers, personal computers, wearable devices, or any other suitable electronic device.

[0466] In some configurations, WOB data and / or associated triggered notification data may be transmitted by the respiratory device to a remote device or system for presentation. In some configurations, WOB data and / or associated triggered notification data may be transmitted to a patient and / or device management system by a remote cloud or server, which may process the received data and then relay or push the WOB and / or notification data to one or more other electronic devices or systems (e.g., a physician's electronic devices or systems, e.g., smartphones, tablets, laptops, computers, wearable devices, or others). In some configurations, the patient and / or device management system may be configured to receive WOB data from the respiratory device, process the WOB data, and present (e.g., push, trigger, or generate) notification data on one or more remote electronic devices or systems (e.g., a physician's electronic devices or systems).

[0467] In some configurations, a remote server or device (e.g., a patient and / or device management system) that receives WOB data and / or notification data from a respiratory device may be configured to generate one or more patient reports based on the received WOB data (e.g., WOB indicator data and / or trend data). The generated reports may be of any appropriate report type and / or format, including, but not limited to, report data, displayed reports, edited reports, electronic reports, printable reports, numerical reports, and graphical reports. The reports may include data representing WOB data and / or notification data for a single treatment session and / or across multiple treatment sessions and / or over a selectable or configurable period (e.g., days or weeks).

[0468] In some configurations, the generated report may include comparative and / or aggregated and / or statistical data regarding WOB data and / or notification data received by a patient, based on one or more treatment sessions and / or over a desired period (e.g., days or weeks).

[0469] Fourth exemplary use – Proposal for adjusting treatment parameter settings in response to WOB indicators Referring to Figure 26, an exemplary method 2200 performed by a respiratory device (e.g., the controller of the respiratory device) to calculate a WOB indicator in accordance with the above disclosure is described, in which case the respiratory device generates suggestions for adjusting the settings of therapeutic parameters in response to the calculated WOB indicator. The order of the steps described is not important in all configurations, and some steps may be performed in parallel rather than sequentially. Details and alternatives for each step have already been described and will not be repeated for the sake of brevity.

[0470] In this exemplary method 2200, the process begins in step 2202, and in step 2204, the respiratory device controller receives pressure data from, for example, one or more pressure sensors of the device. In this configuration, the pressure data is the pressure P at the output of the blower. blower This is shown. Next, the controller receives flow data indicating the output flow rate of the device from, for example, one or more flow sensors in the device's flow path, as shown in step 2206. The controller then receives the conduit or tube flow Q as shown in step 2208. tube The device minute ventilation MV is configured to be calculated or estimated based at least in part on the received device output flow rate data. In this example, the controller is also configured to calculate the device minute ventilation MV as shown in step 2210. device The estimation is configured to be generated based at least in part on the device output flow rate data.

[0471] In this example, the controller then proceeds to the trial intranasal pressure value P, as shown in step 2212. nose.guess Identify or calculate the estimate of the tube flow conductance C, as shown in step 2214. tube The estimation is Q tube , P blower , P nose.guess It is identified based at least in part on the data or value of the following. Subsequently, the controller uses the intranasal pressure fluctuation WOB indicator ΔP as shown in step 2216. nose Q tube , C tube , and MV device It is configured to calculate based on at least part of the value of . Additionally or alternatively, the controller may perform further steps to generate one or more of the other WOB indicators, as already described in Sections 2.3 and 2.4.

[0472] In this exemplary method 2200, the controller then optionally controls ΔP noseThe controller is configured to process WOB indicators or other calculated WOB data and may generate suggestions for changing or adjusting the treatment parameter set. As shown in step 2218, the generated suggestions for changing or adjusting the treatment parameter setting may be based at least in part on, or in response to, the generated WOB data, or on further processing of the WOB data with respect to one or more thresholds or similar. For example, if the WOB data is outside the setting limits or shows an unfavorable trend, the controller may generate suggestions for changing or adjusting, as described above.

[0473] When a therapeutic parameter setting change is proposed or triggered in step 2218, the controller may optionally be configured to display or present these proposed therapeutic parameter setting changes on the respiratory device's display screen, as shown in step 2220, and / or transmit them to be displayed on one or more remote devices or systems as described above. In one configuration, the respiratory device may be configured to have an additional optional step that allows the user or physician to acknowledge receipt of the proposed therapeutic parameter setting changes and to accept or reject the proposed settings changes, which will be applied by the controller, as they wish. For example, the user or physician may accept or reject the proposed settings changes through user interaction via the user interface of the respiratory device and / or remote devices or systems.

[0474] In a given configuration, the controller may be configured to process WOB data (e.g., WOB indicator data and / or WOB trend data) and subsequently generate notifications, alerts, or alarms suggesting adjustments to treatment parameter settings based on a comparison of the WOB data with one or more thresholds. The controller may suggest changes to one or more treatment settings or device settings, including but not limited to flow rate settings and gas flow oxygen concentration settings (e.g., FiO2 and / or FdO2 settings that control the oxygen concentration in the gas flow provided to the patient). Suggestions for adjusting treatment parameter settings may include instructions such as "increase flow rate," "decrease flow rate," or "increase oxygen concentration," or "decrease oxygen concentration," depending on the necessary response or corrective change in light of the comparison of WOB data with one or more thresholds. As described above, the suggested treatment setting adjustments may be presented or displayed on the respiratory device and / or transmitted to a remote device or system for processing and / or display.

[0475] Fifth exemplary use - circuit breaker alarm or notification In other examples, the controller may be configured to process one or more of the calculated WOB indicators described above to detect a disconnection of any part of the flow path (e.g., the patient breathing circuit and / or the patient interface) and / or a disconnection or detachment of the patient interface (e.g., the nasal cannula) from the patient.

[0476] For example, in one configuration, ΔP nose WOB indicator (and by extension, ΔP nose * Q breath WOB indicator or ΔP nose *If the σ WOB indicator (or similar) reaches zero or exceeds a predetermined threshold (e.g., near zero) for a sufficient period of time (i.e., patient respiration is not detected), a circuit breaker may have occurred. When such a circuit breaker is detected based on WOB data, any appropriate response may be initiated or triggered. For example, the controller may suggest corrective action by triggering the presentation of auditory and / or visual alarms and / or the display of notifications (e.g., text and / or animation) on a display screen. Alternatively or additionally, alarms (visual, auditory, and / or tactile) may be triggered on a remote device or system such as a mobile phone, tablet, laptop, pager, or other suitable device (other examples have already been mentioned).

[0477] Referring to Figures 27A and 27B, several examples of GUI screen circuit disconnection alert notifications that may be displayed on the display screen of a respiratory device or remote device are shown.

[0478] Figure 27A shows a first exemplary GUI 2300, in which WOB data indicates that a potential disconnection event has been detected, triggering a disconnection alert notification screen containing information prompting the user or physician to check the connection of the patient circuit (e.g., breathing tube and / or patient interface) along the air circuit and / or check for patient disconnection from the patient interface.

[0479] Figure 27B shows a second exemplary GUI 2310, in which, as in the example in Figure 27A, a circuit break alert notification screen is triggered, which includes a first GUI element 2312 containing text information indicating that a potential circuit break event has been detected by WOB data and prompting the user or physician to check the patient circuit. In addition, a second GUI element 2314 may be displayed next to or simultaneously with the first GUI element, which may include an animation or other image that prompts the user to check the patient's breathing circuit or otherwise visually alerts them to a potential circuit break event.

[0480] Sixth exemplary use - configurable alarm settings In another example, the respiratory device controller may consist of one or more configurable alarm or trigger thresholds from which generated WOB data can be compared, and from which actions can be taken based on these comparisons.

[0481] For example, either a WOB indicator or data may be compared against one or more thresholds associated with one or more respective notification, alert, and / or alarm events. For example, a controller may consist of one or more specific notification, alert, or alarm events that are triggered when WOB data meets or satisfies threshold requirements or threshold rules. Threshold rules or requirements for each notification, alert, and / or alarm event may be based on one threshold, a threshold range with upper and lower threshold limits, or a threshold function based on one or more parameters and / or conditions (for example, an alert / alarm / notification may be triggered when WOB data exceeds the upper limit over a specific period of time, or when WOB data exceeds the upper limit more than x times within a specific time). Whether a notification, alert, and / or alarm event is triggered may depend on whether the threshold rules or functions are met after the WOB data or indicator has been compared against the threshold rules or functions and associated threshold limits.

[0482] In some configurations, or for some notification, alert, or alarm events, one or more threshold limits or threshold function parameters may be pre-programmed or pre-configured. In other configurations, or for some notification, alert, or alarm events, one or more threshold limits or threshold function parameters may be configurable by the user or physician. In such configurations, threshold limits or threshold function parameters may be configurable and / or adjustable via a user interface (e.g., GUI) presented on the respiratory device's display screen.

[0483] Referring to Figures 28A and 28B, several examples of possible GUI screens that can be operated to adjust threshold parameters for specific notifications, alerts, and / or alarm events are shown.

[0484] Figure 28A shows a first exemplary GUI 2400 presenting a parameter alert threshold setting or adjustment screen. In this exemplary GUI 2400, a first GUI element 2402 provides notifications or information regarding the parameter alert or notification threshold being adjusted. For example, the parameter alert or notification or alarm may be selected from examples including, but not limited to, "high WOB," "low WOB," and / or "potential out-of-circuit." In this exemplary GUI 2400, a second GUI element 2404 is also provided, which may be a user-interactive or operable GUI element or interface that allows adjustment of one or more thresholds related to parameter alerts. In this example, the GUI may be presented on a touchscreen user interface, and the user may interact with the GUI elements to set thresholds via touch input or interactively. A user-interactive GUI element for adjusting one or more configurable thresholds may include, but is not limited to, any suitable form of adjustment, such as a toggle element for increasing or decreasing a threshold limit, a dial or slider scale for adjusting a threshold, a selectable discrete threshold element for selecting from a range of discrete threshold levels, or a numerical or categorical input field for entering a desired threshold.

[0485] In the example shown in Figure 28A, the thresholds are adjusted via a user-interactive GUI 2404 having plus ("+") and minus ("-") GUI elements or buttons that can be interacted with to gradually increase or decrease the alert parameter thresholds, respectively. In this example, the upper slider element 2406 may represent the upper parameter threshold, and the lower slider element 2408 may represent the lower parameter threshold. In one configuration, the user may tap, select, or touch either the upper or lower slider element 2406, 2408, and then adjust the selected threshold by moving the selected slider element and operating the plus ("+") and minus ("-") GUI elements or buttons. Additionally or alternatively, the user may adjust the respective upper and / or lower parameter thresholds by directly interacting with the upper and / or lower slider elements 2406, 2408 by sliding and / or dragging the slider elements along the slider bar / range.

[0486] The second exemplary GUI 2400a shown in Figure 28B is the same as the one shown and described in Figure 28A, but differs in that it includes a different user interface GUI 2404a, which includes qualitative adjustment of threshold limits by manipulating “High” and “Low” GUI elements to increase or decrease the limits, respectively. Similar to the example described for Figure 28A, the user can adjust the selected parameter threshold by selecting either the upper and / or lower slider elements 2406a, 2408a and then interacting with the “High” or “Low” GUI element, or the user can adjust the relevant parameter threshold by manipulating either the slider element 2406a, 2408a by directly sliding the slider element along the slider bar / range and / or dragging it.

[0487] In other exemplary configurations, it should be understood that the GUIs in Figures 28A and 28B may instead provide a single interactive slider bar on a slider scale for adjusting one upper or lower parameter alert threshold.

[0488] In one exemplary configuration, the WOB indicator or data may serve as background parameters used as input to set or guide the setting of one or more common respiratory device alarm thresholds (e.g., respiratory rate alarm, minimum ventilation alarm, tidal volume alarm, and / or others). In other exemplary configurations, WOB alarms may be set based on the WOB indicator or data and may serve as alternative alarms for other parameters, such as respiratory rate, minute ventilation, tidal volume, and / or others, but not limited to these. For example, in some configurations, the WOB indicator may be closely related to some of these other parameters. For instance, as the patient's respiratory rate or minute ventilation increases, the WOB indicator should generally increase in response. Similarly, as the patient's respiratory rate or minute ventilation decreases, the WOB indicator should generally decrease. This may be advantageous in some configurations because detecting some respiratory parameters can be quite difficult in the case of open-circuit respiratory systems (e.g., nasal high-flow systems). The WOB indicators described can be calculated with greater confidence in some cases, but they still depend on the underlying patient respiratory parameters. Therefore, they are useful as alternative or surrogate indicators, which can be used to trigger one or more respiratory parameter alarms, as will be explained later.

[0489] In one exemplary configuration, after the respiratory device is set up and a respiratory therapy session is performed on the patient, initial WOB indicators or data may be calculated. The respiratory device may then display or visualize the WOB indicators or data or other relevant parameters (e.g., minute ventilation) on its display and, based at least in part on the WOB indicators or data, provide suggestions for upper and lower boundaries or threshold limits.

[0490] In one example, ΔP noseAn alarm may be provided that is triggered based on a WOB indicator or a comparison of data with associated thresholds. nose The WOB indicator alarm can be considered as an alternative to a patient minute ventilation alarm (actual patient minute ventilation compared to device or nasal minute ventilation numerical information, as described above) or a respiratory rate alarm. ΔP nose Alarm thresholds based on WOB indicators, which function as an alternative to patient minute ventilation or respiratory rate alarms, may have advantages in several configurations. ΔP nose WOB indicator estimations are likely to be more accurate and / or may contain more information about changes in the patient's respiration.

[0491] In one example, ΔP is used as an alarm. nose The WOB indicator can be similar to a minute ventilation alarm. In this example, ΔP nose The WOB indicator is proportional to and closely related to the patient's minute ventilation (MV).

number

[0492] In other examples, ΔP nose Since it is proportional to MV and closely related to it, ΔP nose The WOB indicator alarm can be configured to function as a respiratory rate (RR) alarm. For example,

number

number

[0493] In other examples, the aforementioned WOB indicator example (for example, ΔP nose ΔP nose * Q breath , and / or ΔP nose * One or more of σ) can be monitored against a threshold for use as an alternative alarm for patient minute ventilation or respiratory rate. For example, one or more of the example WOB indicators can be compared against one or more thresholds set or calibrated for patient minute ventilation alarms and / or respiratory rate alarms. In some such configurations, the WOB indicator can be compared against a threshold without considering any temporal phase (e.g., the alarm is triggered when the WOB indicator exceeds the threshold at any point). In other such configurations, the WOB indicator can be compared against a threshold in conjunction with one or more related additional trigger conditions, such as time, trend, or other conditions. For example, an alarm threshold can be set to trigger only when the WOB indicator is above or below the threshold over a predetermined or configurable period, or when the WOB indicator exceeds the threshold a certain number of times within a predetermined or configurable period, or under other such conditions.

[0494] In some configurations, with respect to WOB indicator alarms, the upper and lower boundaries or thresholds may correspond to undesirably high WOBs that require changes to treatment parameters (at least in part). Similarly, the lower limit or lower threshold may correspond to undesirably low WOBs (at least in part), but as mentioned above, it can also be used as a circuit breaker alarm trigger. Therefore, one or more WOB indicators or data may be compared to one or more thresholds to trigger different alarms, alerts, or notifications (depending on the threshold function or criterion) depending on whether the WOB indicator is above or below the threshold.

[0495] In one exemplary configuration, the physician may choose to accept the default or suggested notifications, alerts, and / or alarm thresholds of the respiratory device, ignore them entirely, use them with their own preferred thresholds or other alert triggers (e.g., SpO2 alarms), or adjust the default or suggested thresholds before accepting them. In this example, the physician may perform these alarm threshold adjustments, threshold settings, or acceptances remotely via the respiratory device's user interface (e.g., GUI) or via the user interface of other electronic devices or systems that communicate with the respiratory device.

[0496] In some configurations, WOB indicator alarms, alerts, or notifications may be configured with multiple or numerous upper and lower boundaries or thresholds. For example, alarms, alerts, or notifications may be configured with hierarchical or nested thresholds or threshold ranges, or inner and outer threshold ranges, or with multiple or a series of progressive or hierarchical thresholds such that the nature of the triggered alarm, alert, or notification associated with each of the thresholds is a function of or depends on the nature, position, priority, or extremum of the threshold on an overall threshold scale. In one exemplary configuration, a first upper boundary or threshold may simply trigger a notification or suggestion to adjust treatment parameters, while a second, higher upper boundary or threshold may trigger a higher-priority alert because this higher upper boundary or threshold may correspond to a WOB indicator magnitude indicating, for example, severe hyperventilation or other serious medical event.

[0497] In one exemplary configuration, the default or proposed upper / lower boundary or threshold limits of the respiratory device may be recalibrated or dynamically changed for each treatment session after a certain period of time has elapsed or after a certain number of treatment sessions have been completed. In other words, the threshold proposal may change daily, weekly, monthly, or at other appropriate intervals (which may also be configurable). In one example, the recalibration of the proposed threshold may be based at least in part on changes in one or more calculated WOB indicators or data, and / or WOB trend data. For example, if a downtrend continues in one or more WOB indicators or data across one or more treatment sessions, the controller may thereby narrow the proposed upper / lower boundary or threshold (i.e., make the acceptable range narrower), shift down, shift up, or otherwise change it in any combination thereof.

[0498] In several exemplary scenarios, the default values ​​for upper / lower boundaries or thresholds may be set or configured for the entire respiratory device group according to hospital, healthcare system, or clinical protocols. In one configuration, the default thresholds may be pre-programmed during manufacturing or set remotely, for example, via a cloud or server-based patient and / or device management system or platform.

[0499] In one configuration, the default values ​​for the upper / lower boundary or threshold may be stored in the memory of the respiratory device or in the memory of a remote device or system used to configure the respiratory device.

[0500] In some exemplary configurations, alerts, notifications, and / or alarms may be configured to be selectively presented on different devices or systems based on the thresholds exceeded. For example, as described above, a first upper boundary or threshold may trigger a notification to adjust treatment parameters and may be displayed only on the respiratory device's display. A second upper boundary or threshold corresponds to a more critical threshold and, in addition to being displayed on the respiratory device, may trigger an alarm or notification to be presented on multiple devices or systems, such as one or more remote devices.

[0501] While the upper and lower boundaries or thresholds were discussed together above, in some configurations these may be set individually or selectively. For example, a physician or user may selectively set a lower boundary or threshold for a circuit breaker alarm, but may not adjust higher boundaries or thresholds associated with other alarms or notifications (e.g., high WOB).

[0502] 3. Terms and Definitions As used herein and in the claims, the terms “computer-readable medium” or “machine-readable medium” should be interpreted to include one medium or multiple mediums unless the context suggests otherwise. Examples of multiple mediums include centralized or distributed databases and / or associated caches. These multiple mediums store one or more computer-executable instruction sets. The terms “computer-readable medium” or “machine-readable medium” should also be interpreted to include any medium that can store, encode, or carry instruction sets for execution by a processor of a computing device, causing the processor to execute one or more of the methods described herein. Computer-readable mediums can also store, encode, or carry data structures used by or associated with these instruction sets. The terms “computer-readable medium” and “machine-readable medium” include, but are not limited to, portable or fixed-storage devices, solid-state memory, optical media or optical storage devices, magnetic media, and / or other types of media that can store, store, or carry instructions and / or data. "Computer-readable media" or "machine-readable media" may be non-temporary.

[0503] As used herein and in the claims, the term "comprising" means "including, but not limited to, at least in part," or "including, but not limited to." It shall be interpreted in an inclusive, not exclusive or exhaustive, sense. When interpreting each statement containing the term "comprising" within this specification and in the claims, other features may also exist besides those that follow the term. Related terms (comprise, comprises, etc.) shall be interpreted similarly.

[0504] The range of numbers disclosed herein (e.g., 1 to 10) is also intended to include references to all rational numbers within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, 10) and to all ranges of rational numbers within that range (e.g., 2 to 8, 1.5 to 5.5, 3.1 to 4.7), and therefore all subranges of all ranges expressly disclosed herein are also expressly disclosed here. These are merely examples of what is expressly intended, and all conceivable combinations of numbers between the listed minimum and maximum values ​​are considered as expressly stated herein.

[0505] The term "and / or" means "and" or "or" or both.

[0506] The use of "(s)" following a noun indicates the plural and / or singular form of that noun.

[0507] Conditional language, such as "can, could" or "might, may," is generally intended to convey that a particular embodiment includes certain features, elements, and / or steps, while other embodiments do not, unless otherwise specified or understood in the context in which they are used. Therefore, such conditional language is generally not intended to include logic for determining whether the features, elements, and / or steps are required in any one or more embodiments, or whether one or more embodiments necessarily include, or will perform, these features, elements, and / or steps in any particular embodiment, with or without user input or prompting.

[0508] The terms used herein to indicate degree, such as “approximately,” “about,” “generally,” and “substantially,” represent values, quantities, or characteristics close to the specified value, quantity, or characteristic that perform the desired function or achieve the desired result. For example, the terms “approximately,” “about,” “generally,” and “substantially” may refer to quantities that are less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the specified quantity.

[0509] Where references are made herein to patent specifications, other external documents, or other sources, these are generally intended to provide context for discussing the features of the present invention. Unless otherwise specified, references to such external documents shall not be construed as an acknowledgment that such documents or sources are prior art or within the scope of the general knowledge of those skilled in the art in any jurisdiction.

[0510] In the above description, specific details are provided to ensure a thorough understanding of the embodiments. However, those skilled in the art will understand that the embodiments can be implemented without these specific details. For example, software modules, functions, circuits, etc., may be shown in block diagrams to avoid obscuring the embodiments with unnecessary details. In other examples, well-known modules, structures, and techniques may not be described in detail to avoid obscuring the embodiments.

[0511] Furthermore, it should be noted that embodiments may be described as processes depicted as flowcharts, flow diagrams, structural diagrams, or block diagrams. While flowcharts describe operations as a continuous process, many operations can be performed in parallel or simultaneously. In addition, the order of operations may be rearranged. A process terminates when its operations are complete. A process may correspond to a method, function, procedure, subroutine, subprogram, etc., within a computer program. If a process corresponds to a function, its termination corresponds to returning the function to the calling function or the main function.

[0512] The embodiments of the systems and methods described above may operate on any type of general-purpose computer system or computing device, including but not limited to desktops, laptops, notebooks, tablets, smart televisions, game consoles, or portable devices. The term "portable device" includes, but is not limited to, wireless devices, mobile phones, smartphones, mobile communication devices, user communication devices, personal digital assistants, portable handheld computers, laptop computers, wearable electronic devices such as smartwatches and head-mounted devices, e-book readers and reading devices capable of reading electronic content, and / or other types of portable devices that are typically carried by an individual and / or have any form of communication function (e.g., wireless, infrared, short-range wireless, cellular, etc.).

[0513] The embodiments of the aforementioned systems and methods may operate on or be implemented on any type of purpose-specific or dedicated computer, or any machine, computer, server, or electronic device comprising a microprocessor, processor, microcontroller, programmable controller, or other, or on a cloud-based platform or other network of processors and / or servers, whether local or remote, or on any combination of such devices.

[0514] Furthermore, embodiments may be implemented in hardware, software, firmware, middleware, microcode, or any combination thereof. When implemented in software, firmware, middleware, or microcode, program code or code segments for performing the required tasks may be stored in a machine-readable medium such as a storage medium or other storage. The processor may then perform the required tasks. Code segments may represent any combination of procedures, functions, subprograms, programs, routines, subroutines, modules, software packages, classes, or instructions, data structures, or program statements. Code segments, information, data, arguments, parameters, or memory contents may be coupled to other code segments or hardware circuits by passing and / or receiving them. Information, arguments, parameters, data, etc., may be passed, transmitted, or transmitted via any suitable means, including memory sharing, message passing, token passing, network transmission, etc.

[0515] In the above description, a storage medium may include one or more devices for storing data, including read-only memory (ROM), random access memory (RAM), magnetic disk storage media, optical storage media, flash memory devices, and / or other machine or computer-readable media for storing information.

[0516] The various exemplary logical block modules, circuits, elements, and / or components described in relation to the examples disclosed herein may be implemented or run as general-purpose processors, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or other programmable logic components, discrete gate or transistor logic, discrete hardware components, or any combination thereof, designed to perform the functions described herein. A general-purpose processor may be a microprocessor, but alternatively, the processor may be any conventional processor, controller, microcontroller, circuit, and / or state machine. The processor may also be implemented as a combination of computing components, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors working with a DSP core, or other such configurations.

[0517] The methods or algorithms described in relation to the examples disclosed herein may be directly embodied in hardware, processor-executable software modules, or a combination thereof, in the form of processing units, programming instructions, or other instructions, and may be included in a single device or distributed among multiple devices. The software modules may reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disks, removable disks, CD-ROMs, or any other form of storage medium known in the art. The storage medium may be coupled to a processor, thereby enabling the processor to read information from and write information to the storage medium. Alternatively, the storage medium may be embedded within the processor.

[0518] One or more components or functions shown in the figures may be rearranged and / or combined into one component, or implemented in several components, without departing from the scope of this disclosure. Additional elements or components may also be added, without departing from the scope of this disclosure. In addition, the features described herein may be implemented in software, hardware, as business models, and / or combinations thereof.

[0519] In various embodiments, embodiments of the present disclosure can be embodied in computer implementation processes, machines (e.g., electronic devices or general-purpose computers or other devices that provide a platform on which computer programs can be executed), processes performed by such machines, or manufactured articles. Such articles may include computer program products or digital information products that include computer program instructions or computer-readable data stored on a computer-readable storage medium, as well as processes and machines that manufacture and use such manufactured articles.

[0520] While this disclosure describes specific embodiments and examples, those skilled in the art will understand that this disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as obvious modifications and equivalents thereof. In addition, while several variations of the embodiments of this disclosure are illustrated and described in detail, other modifications included within the scope of this disclosure will also be readily apparent to those skilled in the art. It is also conceivable that various combinations or partial combinations of the specific features and aspects of the embodiments may be devised and also included within the scope of this disclosure. For example, the aforementioned features relating to one embodiment may be used in a different embodiment described herein, and the combination remains within the scope of this disclosure. It should be understood that the various features and aspects of the disclosed embodiments can be combined or substituted for each other to form different modes of the embodiments of this disclosure. Therefore, the scope of this disclosure should not be limited by the specific embodiments described above. Accordingly, unless otherwise stated and unless explicitly stated otherwise, and unless explicitly stated otherwise, each embodiment of this disclosure may include, in addition to its basic features described herein, one or more features of other embodiments of the invention disclosed herein.

[0521] This disclosure may be broadly said to consist of the parts, elements, and features that are individually or collectively referred to or shown herein, as well as any combination of any two or more such parts, elements, or features. Where a specific integer having an equivalent known in the industry to which this disclosure relates is expressed herein, such known equivalent shall be deemed incorporated herein as if it were individually stated.

[0522] Any features, materials, properties, or groups described in particular aspects, embodiments, or examples should be understood to apply to any other aspects, embodiments, or examples described in this section or elsewhere in this specification, to the extent that they do not contradict each other. All features disclosed herein (including all of the accompanying claims, abstract, and drawings) and / or all of the steps of any method or process disclosed herein may be combined in any combination, except for any combination in which at least some of such features and / or steps are mutually exclusive. The protection is not limited to the details of any of the embodiments described above. The protection extends to any novel one or any novel combination of features disclosed herein (including all of the accompanying claims, abstract, and drawings), or to any novel one or any novel combination of any of the steps of any method or process disclosed herein.

[0523] Furthermore, certain features described in this disclosure in relation to separate embodiments can also be implemented in a single embodiment. Conversely, various features described in relation to a single embodiment can be implemented separately or in any suitable partial combination in multiple embodiments. Moreover, even if features are described in the foregoing as functioning in a particular combination, one or more features may be optionally removed from the claimed combination, and the combination may be claimed as a partial combination or a variation of a partial combination.

[0524] Furthermore, while operations may be depicted in a specific order in the drawings and described in the specification, these operations do not need to be performed in that specific order or sequentially shown, or not all operations need to be performed, in order to achieve the desired result. Other operations not shown or described may be included in explicit methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the described operations. Furthermore, operations may be rearranged or changed in order in other embodiments. Those skilled in the art will see that in some embodiments, the actual steps taken in the illustrated and / or disclosed processes may differ from those shown in the drawings. Depending on the embodiment, certain steps described above may be omitted or others added. Furthermore, the features and characteristics of the specific embodiments disclosed above may be combined in different ways to form yet another embodiment, all of which are within the scope of this disclosure. Also, while various system components are separated in the above embodiments, it should not be understood that such separation is necessary in all embodiments; the described components and systems can generally be integrated into one product or packaged into multiple products.

[0525] For the purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not all such advantages are necessarily achieved in any particular embodiment. Therefore, for example, a person skilled in the art will understand that this disclosure may be implemented or performed in a manner that achieves one advantage or set of advantages taught herein, and not necessarily other advantages taught or proposed herein.

[0526] The scope of this disclosure is not intended to be limited by the specific disclosure of embodiments in this section or elsewhere in this specification, but may be defined by the claims presented in this section or elsewhere in this specification, or to be presented in the future. The language of the claims shall be interpreted broadly on the basis of the language used in the claims, and shall not be limited to the examples described herein or presented during the examination proceedings of this application, and such examples shall be construed as non-exclusive.

Claims

1. A respiratory device configured to provide a gas flow to a user for respiratory therapy, A flow generator configured to generate the gas flow for the user, One or more sensors configured to generate flow parameter data indicating or representing the gas flow, A controller, including, Upon receiving the aforementioned flow parameter data, The intranasal pressure fluctuation value representing the average intranasal pressure of the user is identified based at least in part on the received flow parameter data. The work of breathing (WOB) indicator is identified based at least in part on the identified intranasal pressure fluctuation value, Initiate one or more actions based at least in part on the identified WOB indicator. A respiratory apparatus configured in such a way.

2. The breathing apparatus according to claim 1, wherein the flow parameter data includes flow rate data indicating or representing the flow rate of the gas flow provided by the flow generator.

3. The breathing apparatus according to claim 2, comprising one or more flow sensors configured to detect and generate the aforementioned flow rate data.

4. The breathing apparatus according to claim 3, wherein the one or more flow sensors are positioned or arranged within or inside the gas flow path.

5. The breathing apparatus according to claim 3 or 4, wherein the one or more flow sensors are positioned or arranged at or near the outlet of the blower of the flow generator.

6. The breathing apparatus according to any one of claims 3 to 5, wherein one or more flow sensors communicate electrically with the controller.

7. The breathing apparatus according to any one of claims 3 to 6, wherein the controller is further configured to process the flow rate data to remove noise and / or signal components associated with the flow generator.

8. The breathing apparatus according to claim 7, wherein the controller is configured to remove noise related to the influence of the motor on the flow rate data.

9. The breathing apparatus according to claim 7 or 8, wherein the controller is configured to receive data relating to the motor speed, and when the motor speed falls below a preset threshold, the flow rate data of the gas flow is discarded.

10. The breathing apparatus according to any one of claims 7 to 9, wherein the controller is configured to discard the flow rate data when the controller determines that the flow rate data parameter of the gas flow is of insufficient quality.

11. The breathing apparatus according to claim 10, wherein the flow rate data is identified as being of insufficient quality if it contains a large transient peak.

12. The breathing apparatus according to any one of claims 1 to 11, wherein the flow parameter data includes pressure data indicating or representing the pressure of the gas flow at the outlet of the blower of the flow generator.

13. The breathing apparatus according to claim 12, further comprising one or more pressure sensors configured to detect and generate the aforementioned pressure data.

14. The breathing apparatus according to claim 13, wherein the one or more pressure sensors are located or arranged in or within the gas flow path.

15. The breathing apparatus according to claim 13 or 14, wherein the one or more pressure sensors are located or arranged at or near the outlet of the blower of the flow generator.

16. The breathing apparatus according to any one of claims 13 to 15, wherein one or more pressure sensors communicate electrically with the controller.

17. The breathing apparatus according to any one of claims 12 to 16, wherein the controller is further configured to identify an initial intranasal pressure estimate indicating or representing the user's intranasal pressure estimate, based at least in part on the pressure data.

18. The respiratory apparatus according to any one of claims 1 to 17, wherein the controller is further configured to identify a flow path conductance estimate that indicates or represents an estimate of the flow path conductance for the gas flow between the flow generator and the patient interface.

19. The respiratory device according to claim 18, wherein the controller is configured to determine the flow path conductance estimation based at least in part on an initial intranasal pressure estimate that indicates or represents the user's intranasal pressure estimation.

20. The breathing apparatus according to claim 18 or 19, wherein the controller is configured to determine the flow path conductance estimation based at least in part on flow rate data indicating or representing the flow rate of the gas flow provided by the flow generator.

21. The breathing apparatus according to any one of claims 18 to 20, wherein the controller is configured to determine the flow path conductance estimation based at least in part on pressure data indicating or representing the pressure of the gas flow at the outlet of the blower of the flow generator.

22. The breathing apparatus according to claim 18, wherein the controller is configured to determine the flow path conductance estimation based at least in part on flow rate data indicating or representing the flow rate of the gas flow provided by the flow generator and a motor speed representing the motor speed of the blower of the flow generator.

23. The breathing apparatus according to claim 18, wherein the controller is configured to determine the flow path conductance estimation based at least in part on flow rate data indicating or representing the flow rate of the gas flow provided by the flow generator and pressure data indicating or representing the pressure of the gas flow at the outlet of the blower of the flow generator.

24. The respiratory device according to any one of claims 18 to 23, wherein the controller is configured to determine the intranasal pressure fluctuation value based at least in part on the estimation of the flow path conductance.

25. The respiratory apparatus according to any one of claims 18 to 24, wherein the controller is configured to determine the intranasal pressure fluctuation value based at least in part on flow rate data indicating or representing the flow rate of the gas flow provided by the flow generator.

26. The respiratory apparatus according to any one of claims 18 to 25, wherein the controller is configured to determine the intranasal pressure fluctuation value based at least in part on minute ventilation data indicating or representing the average volume of gas supplied per minute by the flow generator.

27. The respiratory apparatus according to claim 26, wherein the controller is configured to identify minute ventilation data by fitting a plurality of splines to the flow parameter data of the gas flow, the plurality of splines are fitted using a least-squares criterion, and the minute ventilation data is identified by integrating along the plurality of splines.

28. The respiratory apparatus according to claim 26, wherein the controller is configured to identify minute ventilation data by identifying the integral of the absolute value of the first term of a line fitted to the flow parameter data of the gas flow.

29. The respiratory apparatus according to claim 26, wherein the controller is configured to identify the device minute ventilation data by identifying the integral of the absolute value of a line fitted to the flow parameter data of the gas flow, divided by a time range.

30. The respiratory apparatus according to claim 26, wherein the controller is configured to identify device minute ventilation data by identifying the mean of absolute values ​​of a line fitted to the flow parameter data of the gas flow over a range of time points within a time range.

31. The aforementioned intranasal pressure fluctuation value is determined by a frequency selected within the range of 1 Hz to 20 Hz. A breathing apparatus according to any one of claims 1 to 30.

32. The respiratory apparatus according to any one of claims 1 to 30, wherein the intranasal pressure fluctuation value is continuously specified as a rolling average value.

33. The respiratory device according to any one of claims 1 to 32, further comprising a non-temporary computer-readable medium accessible by or communicating data with the controller, preferably the non-temporary computer-readable medium comprising a non-volatile memory, and preferably the device further comprising a patient nostril model stored in the non-volatile memory.

34. The respiratory device according to claim 33, wherein the controller is further configured to determine a user respiratory flow rate estimate indicating or representing the user's respiratory flow rate based at least in part on flow rate data indicating or representing the gas flow rate provided by the flow generator and the patient nasal model.

35. The respiratory device according to claim 34, wherein the controller is configured to determine the user respiratory flow rate estimate based at least in part on a flow path conductance estimate that indicates or represents an estimate of the conductance of the flow path for the gas flow between the flow generator and the patient interface.

36. The breathing apparatus according to claim 34 or 35, wherein the controller is configured to determine the estimated user breathing flow rate based at least in part on minute ventilation data indicating or representing the average volume of gas supplied per minute by the flow generator.

37. The respiratory device according to any one of claims 34 to 36, wherein the controller is configured to specify a nasal conductance estimate that indicates or represents an estimate of the conductance of the flow path for the gas flow between the patient interface and the user's nasal cavity, based at least in part on data indicating the size of the patient interface and an estimate of nasal obstruction by the patient interface.

38. The breathing apparatus according to claim 37, wherein the controller is configured to determine the estimated user respiratory flow rate based at least in part on the determined or calculated nasal conductance estimate.

39. The respiratory device according to any one of claims 34 to 38, wherein the controller is configured to identify the respiratory work indicator based at least in part on the intranasal pressure fluctuation value and the user respiratory flow rate estimation signal.

40. The breathing apparatus according to any one of claims 1 to 39, wherein the controller is configured to indicate or specify a smoothness value that indicates or represents the average volume of gas supplied per minute by the flow generator.

41. The respiratory apparatus according to claim 40, wherein the controller is configured to determine the respiratory work indicator based at least in part on the intranasal pressure fluctuation value and the smoothness value.

42. The breathing apparatus according to any one of claims 1 to 41, further comprising a display screen, preferably the display screen displaying a graphical user interface, and / or preferably the display screen communicating with the controller.

43. The respiratory apparatus according to claim 42, wherein the display screen is removable from the apparatus or the housing of the apparatus.

44. The respiratory apparatus according to claim 42 or 43, wherein the controller is configured to display a graphical indicator representing the identified respiratory work indicator on the display screen.

45. The respiratory apparatus according to claim 44, wherein the graphical indicator includes one or more of the following: numbers, text, waveforms, illustrations, or animations.

46. The respiratory apparatus according to claim 44 or 45, wherein the graphical indicator indicates or represents whether the identified respiratory work indicator is increasing or decreasing.

47. The respiratory device according to any one of claims 1 to 46, wherein the controller is configured to trigger or generate alerts, alarms, and / or notifications based at least in part on the identified respiratory work indicator and one or more thresholds.

48. The respiratory device according to claim 47, wherein the alert, alarm, and / or notification is triggered or generated at least in part on the identification that the respiratory work indicator has increased above a certain threshold.

49. The respiratory device according to claim 47 or 48, wherein the alert, alarm, and / or notification is triggered or generated at least in part on the identification that the respiratory work indicator has fallen below a certain threshold.

50. The respiratory device according to claim 49, wherein the threshold is a circuit disconnection detection threshold.

51. The respiratory device according to claim 50, wherein the alert, alarm, and / or notification is triggered or generated at least in part on the identification that the respiratory work indicator has continuously fallen below the threshold for a predetermined duration condition relating to the alert, alarm, and / or notification.

52. The breathing apparatus according to any one of claims 47 to 51, wherein the controller is configured to generate the alert, alarm, and / or notification in a form selected from one or more of auditory, visual, and / or tactile.

53. The breathing apparatus according to claim 52, further comprising an audio output device that telecommunicates with the controller, wherein the controller is configured to audibly generate the alerts, alarms, and / or notifications via the audio output device.

54. The respiratory device according to claim 52 or 53, wherein the controller is configured to visually generate the alerts, alarms, and / or notifications via the display screen of the device.

55. The breathing apparatus according to any one of claims 52 to 54, wherein the controller is configured to transmit or transmit data representing the alerts, alarms, and / or notifications to a remote device or system that communicates data with the apparatus.

56. The respiratory device according to any one of claims 47 to 55, wherein the controller is operable to set or adjust any parameter of one or more of the thresholds, or any parameter associated with one or more of the thresholds, based at least in part on user input via the graphical user interface of the display screen of the device.

57. The respiratory apparatus according to any one of claims 47 to 56, wherein the controller is configured to generate or provide proposed thresholds and / or parameters associated with the one or more thresholds based at least in part on the respiratory work indicator.

58. The breathing apparatus according to any one of claims 1 to 57, wherein the controller is further configured to identify a ratio or percentage representing the user's respiratory work indicator with respect to the nominal equivalent respiratory work indicator of a nominally average healthy person.

59. The respiratory apparatus according to claim 58, wherein the nominal equivalent respiratory work indicator is identified at least in part on the amplitude of nominal fluctuations in the nominal intranasal pressure of the nominal average healthy person.

60. The respiratory apparatus according to claim 59, wherein the amplitude of the nominal fluctuation of the intranasal pressure of the nominally average healthy person is determined based at least in part on predetermined physiological parameters of the nominally average healthy person.

61. The amplitude of the nominal variation in the intranasal pressure of the nominally average healthy person is determined at least in part based on manually entered physiological parameters relating to the user. The respiratory apparatus according to claim 59 or claim 60.

62. The respiratory device according to any one of claims 59 to 61, wherein the amplitude of the nominal fluctuation of the nominal intranasal pressure in the nominally average healthy person is determined at least in part based on nominal numerical information of nasal obstruction by the nominal nasal cannula prong of the patient interface.

63. The respiratory device according to any one of claims 59 to 62, wherein the amplitude of the nominal fluctuation of the nominal intranasal pressure of the nominally average healthy person is determined at least in part based on manually entered numerical information of nasal obstruction by the nasal cannula prong of the patient interface.

64. The respiratory device according to any one of claims 58 to 63, wherein the controller is configured to generate one or more alerts, alarms, and / or notifications based at least in part on a ratio or percentage value representing the user's respiratory work indicator with respect to a nominal equivalent respiratory work indicator for a nominal average healthy person, or related trend data of the ratio or percentage, and one or more thresholds.

65. The respiratory apparatus according to any one of claims 58 to 64, wherein the controller is configured to visually display the value of the ratio or percentage and / or trend data relating to the ratio or percentage on the display screen of the apparatus.

66. The respiratory device according to any one of claims 58 to 65, wherein the controller is configured to generate alerts, alarms, and / or notifications including data indicating suggested adjustments to one or more treatment settings and / or device settings, based at least in part on the ratio or percentage value representing the user's respiratory work indicator with respect to the nominal equivalent respiratory work indicator of a nominal average healthy person, or related trend data of the ratio or percentage, and one or more thresholds.

67. The respiratory apparatus according to claim 66, wherein the treatment settings and / or device settings include flow rate settings and / or gas flow oxygen concentration settings.

68. Further including a housing, the housing is The aforementioned flow generator, A humidifier configured to heat and humidify the aforementioned gas flow, A detection block or sensor module including one or more sensors configured to generate flow parameter data indicating or representing the gas flow, Controller and A breathing apparatus according to any one of claims 1 to 67, which surrounds or occupies together.

69. The breathing apparatus according to claim 68, wherein the detection block or sensor module includes a flow sensor and a pressure sensor.

70. A control method for a respiratory device configured to provide a gas flow to a user for respiratory therapy, wherein the device A flow generator configured to generate the gas flow for the user, One or more sensors configured to generate flow parameter data indicating or representing the gas flow, The method includes a controller, and is performed or implemented by the controller, namely, the following steps: The steps include receiving the aforementioned flow parameter data, The steps include identifying the intranasal pressure fluctuation value representing the average intranasal pressure of the user based at least in part on the received flow parameter data, The steps include identifying a work-of-bodied (WOB) indicator based at least in part on the identified intranasal pressure fluctuation value, A step of initiating one or more actions based at least in part on the identified WOB indicator, A control method including

71. In a respiratory therapy system configured to provide a gas flow to a user for respiratory therapy, A flow generator configured to generate the gas flow for the user, One or more sensors configured to generate flow parameter data indicating or representing the gas flow, A respiratory conduit, which is operationally connected to the flow generator and configured to transport the gas flow from the flow generator to the user, A patient interface operationally connected to the aforementioned respiratory conduit, A controller, including, Upon receiving the aforementioned flow parameter data, The intranasal pressure fluctuation value representing the average intranasal pressure of the user is identified based at least in part on the received flow parameter data. The work of breathing (WOB) indicator is identified based at least in part on the identified intranasal pressure fluctuation value, Initiate one or more actions based at least in part on the identified WOB indicator. A respiratory therapy system configured in such a way.

72. In respiratory devices, A flow generator configured to generate gas flow for the user, One or more sensors configured to generate flow parameter data that indicates or represents the characteristics or parameters of the gas flow, It is a controller, The flow generator is controlled to deliver the gas flow for nasal high-flow therapy, The work of breathing (WOB) indicator is identified based at least in part on the flow parameter data, A controller configured to initiate one or more actions based at least in part on the identified WOB indicators, A respiratory apparatus including a respiratory device.

73. The breathing apparatus according to claim 72, wherein the flow parameter data includes pressure data indicating or representing the pressure of the gas flow.

74. The breathing apparatus according to claim 73, wherein the pressure data is detected and generated by one or more pressure sensors that communicate with the controller.

75. The breathing apparatus according to claim 74, wherein the one or more sensors are configured to detect and generate pressure data indicating or representing the pressure of the gas flow at the outlet of the blower of the flow generator.

76. The breathing apparatus according to any one of claims 72 to 75, wherein the flow parameter data includes flow rate data indicating or representing the flow rate of the gas flow.

77. The respiratory apparatus according to claim 76, wherein the flow rate data is detected and generated by one or more flow rate sensors that communicate with the controller.

78. The breathing apparatus according to claim 77, wherein the one or more flow sensors are positioned or arranged at or near the outlet of the blower of the flow generator.

79. The breathing apparatus according to any one of claims 72 to 78, wherein the WOB indicator is identified at least in part on flow parameter data including detected pressure and / or flow rate data relating to the gas flow.

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