Determining respiratory work in respiratory flow therapy system

Abstract

A respiratory apparatus configured to provide a flow of gas to a user for respiratory therapy. The apparatus comprises: a flow generator configured to generate a flow of gas for a user; and one or more sensors configured to generate flow parameter data indicative of or representative of the gas flow. The controller is configured to: receive flow parameter data; determining a nasal pressure change value indicative of an average nasal pressure of the user based at least in part on the received flow parameter data; determining a work of breathing (WOB) indicator based at least in part on the determined nasal pressure change value; and initiating one or more actions based at least in part on the determined WOB metrics.

Description

[0001] This application is a divisional application of the invention patent application filed on October 27, 2023, with application number 202380072694.7 (PCT international application number PCT / IB2023 / 060841) and entitled "Determining the Work of Breathing in a Respiratory Flow Therapy System". Technical Field

[0002] This disclosure relates to determining the work of breathing during a patient’s use of an unsealed breathing device (i.e., an open breathing device). Background Technology

[0003] Respiratory assist devices are used in various environments (e.g., hospitals, medical facilities, inpatient care, or home environments) to deliver a flow of gas to a user or patient. Respiratory assist or respiratory therapy devices (collectively referred to as "respiratory equipment" or "respiratory apparatus") can be used to deliver supplemental oxygen or other gases using a gas flow, and / or to deliver heated and humidified gases using a humidifier. Respiratory equipment allows for the adjustment and control of the characteristics of the gas flow, including flow rate, temperature, gas concentration, humidity, and pressure. Sensors (e.g., flow sensors and / or pressure sensors) are used to measure the characteristics of the gas flow. Summary of the Invention

[0004] In a first aspect, this disclosure broadly includes a respiratory device configured to provide a gas flow to a user for respiratory therapy, the respiratory device 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 configured to: receive the flow parameter data; determine, at least in part, a nasal pressure change value indicating the user's average nasal pressure based on the received flow parameter data; determine a work of breathing (WOB) index based at least in part on the determined nasal pressure change value; and initiate one or more actions based at least in part on the determined WOB index.

[0005] In a second aspect, this disclosure broadly includes a respiratory therapy system configured to provide a gas flow to a user for respiratory therapy, the respiratory therapy system 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 breathing tube operatively coupled to the flow generator and configured to deliver the gas flow from the flow generator to the user; a patient interface operatively coupled to the breathing tube; and a controller configured to: receive the flow parameter data; determine, at least in part, a nasal pressure change value indicating the user's mean nasal pressure based on the received flow parameter data; determine a work of breathing (WOB) index based at least in part on the determined nasal pressure change value; and initiate one or more actions based at least in part on the determined WOB index.

[0006] The respiratory device of the first aspect or the respiratory therapy system of the second aspect may further have any one or more of the following aspects or features defined in the following paragraphs.

[0007] In the configuration, flow parameter data includes velocity data that indicates or represents the flow rate of the gas flow provided by the flow generator.

[0008] In the configuration, the device includes one or more flow rate sensors configured to sense and generate flow rate data.

[0009] In the configuration, the one or more flow rate sensors are positioned within or in the flow path of the gas flow.

[0010] In the configuration, the one or more flow rate sensors are located at or near the outlet of the blower of the flow generator.

[0011] In the configuration, the one or more flow rate sensors communicate electrically with the controller.

[0012] In the configuration, the controller is further configured to process flow rate data to remove noise and / or signal components associated with the flow generator.

[0013] In the configuration, the controller is set to remove noise that affects the flow rate data due to the motor.

[0014] In the configuration, the controller is set to receive data about the motor speed and discard the gas flow rate data if the motor speed is below a preset threshold.

[0015] In the configuration, the controller is set to discard the flow rate data if it determines that the flow rate data parameters of the gas flow are of insufficient quality.

[0016] In the configuration, if the flow rate data includes large transient peaks, the flow rate data is determined to be of insufficient quality.

[0017] In the configuration, the flow parameter data includes pressure data that indicates or represents the pressure of the gas flow at the outlet of the blower of the flow generator.

[0018] In the configuration, the device further includes one or more pressure sensors configured to sense and generate pressure data.

[0019] In the configuration, the one or more pressure sensors are positioned within or in the flow path of the gas flow.

[0020] In the configuration, the one or more pressure sensors are located at or near the outlet of the blower of the flow generator.

[0021] In the configuration, the one or more pressure sensors communicate electrically with the controller.

[0022] In the configuration, the controller is further configured to determine an initial nasal pressure estimate that indicates or represents an estimate of the user's nasal pressure, based at least in part on pressure data.

[0023] In the configuration, the controller is further configured to determine a flow path conductivity estimate, which indicates or represents an estimate of the conductivity of the flow path of the gas flow between the flow generator and the patient interface.

[0024] In the configuration, the controller is configured to determine the flow path conductivity estimate based at least in part on an initial nasal pressure estimate that indicates or represents the user's nasal pressure.

[0025] In the configuration, the controller is configured to determine the flow path conductivity estimate based at least in part on flow rate data that indicates or represents the flow rate of the gas flow provided by the flow generator.

[0026] In the configuration, the controller is configured to determine the flow path conductivity estimate based at least in part on pressure data that indicates or represents the pressure of the gas flow at the outlet of the blower of the flow generator.

[0027] In the configuration, the controller is configured to determine the flow path conductivity 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 motor speed representing the motor speed of the blower of the flow generator.

[0028] In the configuration, the controller is configured to determine the flow path conductivity estimate based at least in part on flow rate data that indicates or represents the flow rate of the gas flow provided by the flow generator and pressure data that indicates or represents the pressure of the gas flow at the outlet of the blower of the flow generator.

[0029] In the configuration, the controller is configured to determine the nose pressure change value based at least in part on the flow path conductivity estimate.

[0030] In the configuration, the controller is configured to determine the nasal pressure change value based at least in part on flow rate data that indicates or represents the flow rate of the gas flow provided by the flow generator.

[0031] In the configuration, the controller is configured to determine the nasal pressure change value based at least in part on minute ventilation data that indicates or represents the average gas volume provided per minute by the flow generator.

[0032] In the configuration, the controller is configured to determine the minute ventilation data by fitting multiple splines to the flow parameter data of the gas flow, wherein the multiple splines are fitted using the least squares criterion, and the minute ventilation data is determined by integrating along the multiple splines.

[0033] In the configuration, the controller is configured to determine the minute ventilation data by integrating the absolute value of the first term of the line fitted to the flow parameter data of the gas flow.

[0034] In the configuration, the controller is configured to determine the device's per-minute ventilation data by dividing the integral of the absolute value of the line of flow parameter data fitted to the gas flow by the time range.

[0035] In the configuration, the controller is configured to determine the device's minute ventilation data by averaging the absolute values ​​of a line fitted to the flow parameter data of the gas flow over a series of time points spanning a time range.

[0036] In the configuration, the nasal pressure variation value is determined at a frequency selected within the range of 1 Hz to 20 Hz.

[0037] In the configuration, the nasal pressure change value is continuously determined as a rolling average.

[0038] In the configuration, the device further includes a non-transitory computer-readable medium accessible or capable of data communication with a controller, and preferably wherein the non-transitory computer-readable medium includes non-volatile memory, and preferably wherein the device further includes a patient nostril model stored in the non-volatile memory.

[0039] In the configuration, the controller is further configured to determine 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 flow rate of the gas flow provided by the flow generator and a patient nostril model.

[0040] In the configuration, the controller is configured to determine the user's respiratory flow rate estimate based at least in part on a flow path conductivity estimate, which indicates or represents an estimate of the conductivity of the flow path of the gas flow between the flow generator and the patient interface.

[0041] In the 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 gas volume provided per minute by the flow generator.

[0042] In the configuration, the controller is configured to determine a nostril conductance estimate based at least in part on data indicating the size of the patient interface and an estimate of the patient interface’s nasal obstruction, the nostril conductance estimate indicating or representing an estimate of the conductance of the flow path of gas flow between the patient interface and the user’s nostrils.

[0043] In the configuration, the controller is configured to determine the user's respiratory flow rate estimate based at least in part on the determined or calculated nasal conductance estimate.

[0044] In the configuration, the controller is configured to determine the work of breathing index based at least in part on nasal pressure change values ​​and user respiratory flow rate estimation signals.

[0045] In the configuration, the controller is configured to determine a smoothness value that indicates or represents the smoothness of the minute ventilation data, which indicates or represents the average gas volume provided per minute by the flow generator.

[0046] In the configuration, the controller is configured to determine the work of breathing index based at least in part on nasal pressure change values ​​and smoothness values.

[0047] In the configuration, the device further includes a display screen, and preferably wherein the display screen displays a graphical user interface, and / or preferably wherein the display screen is in electrical communication with the controller.

[0048] In this configuration, the display screen can be removed from the device or the device housing.

[0049] In the configuration, the controller is set to display a graphical representation of the determined work of breathing on the screen.

[0050] In the configuration, graphical metrics include any one or more of the following: numerical values, text, waveforms, illustrations, or animations.

[0051] In the configuration, the graphical indicators show or represent whether the determined work of breathing index is increasing or decreasing.

[0052] In the configuration, the controller is configured to trigger or generate warnings, alarms, and / or notifications based at least in part on a determined work of breathing metric and one or more thresholds.

[0053] In the configuration, warnings, alerts, and / or notifications are triggered or generated at least in part based on the determination that the work of breathing index has increased above a threshold.

[0054] In the configuration, warnings, alerts, and / or notifications are triggered or generated based at least in part on the determination that the work of breathing index has decreased below a threshold.

[0055] In the configuration, the threshold is the disconnection detection threshold.

[0056] In the configuration, warnings, alerts, and / or notifications are triggered or generated at least in part based on the determination that the work of breathing index has continuously decreased below a threshold for an associated predetermined duration condition.

[0057] In the configuration, the controller is configured to generate warnings, alarms, and / or notifications in the form of any one or more of the following: auditory, visual, and / or tactile.

[0058] In the configuration, the device further includes an audio output device that is in electrical communication with the controller, and wherein the controller is configured to audibly generate warnings, alarms and / or notifications via the audio output device.

[0059] In the configuration, the controller is set to visually generate warnings, alarms, and / or notifications via the device's display screen.

[0060] In the configuration, the controller is configured to send or transmit data representing warnings, alarms, and / or notifications to a remote device or system that is in data communication with the device.

[0061] In the configuration, the controller is operable to configure or adjust one or more of the thresholds or any parameters associated with one or more of the thresholds based at least in part on user input via a graphical user interface through the device’s display screen.

[0062] In the configuration, the controller is configured to generate or provide suggested thresholds and / or parameters associated with one or more thresholds, based at least in part on the work of breathing index.

[0063] In the configuration, the controller is further configured to determine a ratio or percentage representing the user’s work of breathing relative to the nominal equivalent work of breathing of a nominal average healthy person.

[0064] In this configuration, the nominal equivalent work of breathing is determined at least in part based on the magnitude of the nominal nasal pressure change in a nominal average healthy person.

[0065] In the configuration, the magnitude of the nominal nasal pressure change of the nominal average healthy person is determined at least in part based on predetermined physiological parameters of the nominal average healthy person.

[0066] In the configuration, the nominal nasal pressure variation of the nominal average healthy person is determined at least in part based on physiological parameters manually entered by the user.

[0067] In the configuration, the nominal nasal pressure variation of the nominal average healthy person is determined at least in part based on the nominal measurement of nasal obstruction by the nominal nasal cannula fork of the patient interface.

[0068] In the configuration, the nominal nasal pressure variation of the nominal average healthy person is determined at least in part based on the measurement of nasal obstruction manually input by the nasal cannula fork of the patient interface.

[0069] In the configuration, the controller is configured to generate one or more warnings, alerts and / or notifications based at least in part on: a value representing the ratio or percentage of a user’s work of breathing relative to the nominal equivalent work of breathing of a nominal average healthy person, or associated trend data of that ratio or percentage, and one or more thresholds.

[0070] In the configuration, the controller is set to visually display the value of a ratio or percentage and / or trend data involving ratios or percentages on the device's display screen.

[0071] In the configuration, the controller is configured to generate warnings, alarms, and / or notifications based at least in part on the following: a value representing the ratio or percentage of a user’s work of breathing relative to the nominal equivalent work of breathing of a nominal average healthy person, or associated trend data of such ratio or percentage, and one or more thresholds.

[0072] In the configuration, treatment settings and / or device settings include flow rate settings and / or gas flow oxygen concentration settings (e.g., FiO2 settings or FdO2 settings).

[0073] In the configuration, the device or system further includes a housing, wherein the housing includes or integrates the following: 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.

[0074] In the configuration, the sensing block or sensor module includes a flow rate sensor and a pressure sensor.

[0075] In a third aspect, this disclosure broadly 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 the user; one or more sensors configured to generate flow parameter data indicating or representing the gas flow; and a controller, wherein the method is executed or implemented by the controller and includes the steps of: receiving the flow parameter data; determining, at least in part, a nasal pressure change value indicating the user's average nasal pressure based on the received flow parameter data; determining a work of breathing (WOB) index based at least in part on the determined nasal pressure change value; and initiating one or more actions based at least in part on the determined WOB index.

[0076] In the configuration, flow parameter data includes velocity data that indicates or represents the flow rate of the gas flow provided by the flow generator.

[0077] In the configuration, the device includes one or more flow rate sensors configured to sense and generate flow rate data.

[0078] In the configuration, the one or more flow rate sensors are positioned within or in the flow path of the gas flow.

[0079] In the configuration, the one or more flow rate sensors are located at or near the outlet of the blower of the flow generator.

[0080] In the configuration, the one or more flow rate sensors communicate electrically with the controller.

[0081] In the configuration, the method further includes: processing flow rate data to remove noise and / or signal components associated with the flow generator.

[0082] In the configuration, the method includes: removing noise that affects the flow rate data related to the motor.

[0083] In the configuration, the method includes: receiving data about the motor speed, and discarding the gas flow rate data if the motor speed is lower than a preset threshold.

[0084] In the configuration, the method includes: if the flow rate data of the gas flow is determined to be of insufficient quality, then discarding the flow rate data.

[0085] In the configuration, if the flow rate data includes large transient peaks, the flow rate data is determined to be of insufficient quality.

[0086] In the configuration, the flow parameter data includes pressure data that indicates or represents the pressure of the gas flow at the outlet of the blower of the flow generator.

[0087] In the configuration, the device further includes one or more pressure sensors configured to sense and generate pressure data.

[0088] In the configuration, the one or more pressure sensors are positioned within or in the flow path of the gas flow.

[0089] In the configuration, the one or more pressure sensors are located at or near the outlet of the blower of the flow generator.

[0090] In the configuration, the one or more pressure sensors communicate electrically with the controller.

[0091] In the configuration, the method further includes: determining an initial nasal pressure estimate that indicates or represents an estimate of the user's nasal pressure based at least in part on pressure data.

[0092] In the configuration, the method further includes: determining a flow path conductivity estimate, which indicates or represents an estimate of the conductivity of the flow path of the gas flow between the flow generator and the patient interface.

[0093] In the configuration, the method includes: determining a flow path conductivity estimate based at least in part on an initial nasal pressure estimate that indicates or represents an estimate of the nasal pressure of a user.

[0094] In the configuration, the method includes: determining a flow path conductivity estimate based at least in part on velocity data that indicates or represents the velocity of the gas flow provided by the flow generator.

[0095] In this configuration, the method includes determining an estimate of the flow path conductivity based at least in part on pressure data that indicates or represents the pressure of the gas flow at the outlet of the blower of the flow generator.

[0096] In the configuration, the method includes: determining a flow path conductivity estimate based at least in part on flow velocity data indicating or representing the flow rate of the gas flow provided by the flow generator and motor speed representing the motor speed of the blower of the flow generator.

[0097] In the configuration, the method includes: determining a flow path conductivity estimate based at least in part on flow velocity data that indicates or represents the flow rate of the gas flow provided by the flow generator and pressure data that indicates or represents the pressure of the gas flow at the outlet of the blower of the flow generator.

[0098] In the configuration, the method includes determining the nasal pressure change value based at least in part on the flow path conductivity estimate.

[0099] In the configuration, the method includes: determining the nasal pressure change value based at least in part on flow rate data that indicates or represents the flow rate of the gas flow provided by the flow generator.

[0100] In the configuration, the method includes determining the nasal pressure change value based at least in part on minute ventilation data that indicates or represents the average gas volume provided per minute by the flow generator.

[0101] In the configuration, the method includes determining minute ventilation data by fitting multiple splines to flow parameter data of the gas flow, wherein the multiple splines are fitted using a least squares criterion, and the minute ventilation data is determined by integrating along the multiple splines.

[0102] In this configuration, the method includes determining minute ventilation data by integrating the absolute value of the first term of a line fitted to flow parameter data of the gas flow.

[0103] In this configuration, the method includes determining the device's per-minute ventilation data by dividing the integral of the absolute value of a line of flow parameter data fitted to the gas flow by a time range.

[0104] In the configuration, the method further includes determining the device's per-minute ventilation data by averaging the absolute values ​​of a line fitted to the flow parameter data of the gas flow over a series of time points spanning a time range.

[0105] In the configuration, the method includes determining the nasal pressure variation value at a frequency selected in the range of 1 Hz to 20 Hz.

[0106] In the configuration, the method includes: continuously determining the nasal pressure change value as a rolling average.

[0107] In the configuration, the device further includes a non-transitory computer-readable medium accessible or capable of data communication with a controller, and preferably wherein the non-transitory computer-readable medium includes non-volatile memory, and preferably wherein the device further includes a patient nostril model stored in the non-volatile memory.

[0108] In the configuration, the method further includes: determining 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 flow rate of the gas flow provided by the flow generator and a patient nostril model.

[0109] In the configuration, the method includes: determining a user respiratory flow rate estimate based at least in part on a flow path conductivity estimate, the flow path conductivity estimate indicating or representing an estimate of the conductivity of the flow path of the gas flow between the flow generator and the patient interface.

[0110] In the configuration, the method includes: determining a user's respiratory flow rate estimate based at least in part on minute ventilation data that indicates or represents the average gas volume provided per minute by the flow generator.

[0111] In the configuration, the method includes: determining a nostril conductance estimate based at least in part on data indicating the size of the patient interface and an estimate of nostril obstruction by the patient interface, the nostril conductance estimate indicating or representing an estimate of the conductance of the flow path of gas flow between the patient interface and the user's nostrils.

[0112] In the configuration, the method includes: determining a user's respiratory flow rate estimate based at least in part on a determined or calculated estimate of nasal conductance.

[0113] In the configuration, the method includes determining a work of breathing index based at least in part on nasal pressure change values ​​and user respiratory flow rate estimation signals.

[0114] In the configuration, the method includes: determining a smoothness value that indicates or represents the smoothness of minute ventilation data, which indicates or represents the average gas volume provided per minute by the flow generator.

[0115] In the configuration, the method includes determining the work of breathing index based at least in part on nasal pressure change values ​​and smoothness values.

[0116] In the configuration, the device further includes a display screen, and preferably wherein the display screen displays a graphical user interface, and / or preferably wherein the display screen is in electrical communication with the controller.

[0117] In this configuration, the display screen can be removed from the device or the device housing.

[0118] In the configuration, the method includes: displaying a graphical representation of the determined work of breathing index on a display screen.

[0119] In the configuration, graphical metrics include any one or more of the following: numerical values, text, waveforms, illustrations, or animations.

[0120] In the configuration, the graphical indicators show or represent whether the determined work of breathing index is increasing or decreasing.

[0121] In the configuration, the method includes triggering or generating warnings, alarms, and / or notifications based at least in part on a determined work of breathing indicator and one or more thresholds.

[0122] In the configuration, the method includes triggering or generating warnings, alerts, and / or notifications based at least in part on determining that the work of breathing index has increased above a threshold.

[0123] In the configuration, the method includes triggering or generating warnings, alarms, and / or notifications based at least in part on determining that the work of breathing index has decreased below a threshold.

[0124] In the configuration, the threshold is the disconnection detection threshold.

[0125] In the configuration, the method includes triggering or generating warnings, alarms, and / or notifications based at least in part on determining that the work of breathing index has continuously decreased below a threshold for an associated predetermined duration condition.

[0126] In the configuration, the method includes generating warnings, alerts, and / or notifications in the form of any one or more of the following: auditory, visual, and / or tactile.

[0127] In the configuration, the device further includes an audio output device that is in electrical communication with the controller, and wherein the method includes: audibly generating warnings, alarms and / or notifications via the audio output device.

[0128] In the configuration, the method includes: visually generating warnings, alerts, and / or notifications via the device's display screen.

[0129] In the configuration, the method includes sending or transmitting data representing warnings, alarms, and / or notifications to a remote device or system that is in data communication with the device.

[0130] In the configuration, the method includes: configuring or adjusting one or more of the thresholds or any parameters associated with the one or more of the thresholds based at least in part on user input via a graphical user interface of the device's display screen.

[0131] In the configuration, the method includes: generating or providing suggested thresholds and / or parameters associated with the one or more thresholds, at least in part based on the work of breathing index.

[0132] In the configuration, the method further includes: determining a ratio or percentage representing the user's work of breathing index relative to the nominal equivalent work of breathing index of a nominal average healthy person.

[0133] In the configuration, the method includes: determining a nominal equivalent work of breathing index based at least in part on the magnitude of the nominal nasal pressure change in a nominal average healthy person.

[0134] In the configuration, the method includes: determining the magnitude of the nominal nasal pressure change of a nominal average healthy person based at least in part on predetermined physiological parameters of a nominal average healthy person.

[0135] In the configuration, the method includes: determining a magnitude of the nominal nasal pressure change in a nominal average healthy person based at least in part on physiological parameters manually entered by the user.

[0136] In the configuration, the method includes: determining a magnitude of the nominal nasal pressure change in a nominal average healthy person based at least in part on a nominal measure of nasal obstruction by a nominal nasal cannula fork of the patient interface.

[0137] In the configuration, the method includes: determining a magnitude of the nominal nasal pressure change of a nominal average healthy person based at least in part on a measure of the nasal cannula fork of the patient interface that is manually input to indicate nasal obstruction.

[0138] In the configuration, the method includes generating one or more warnings, alerts, and / or notifications based at least in part on: a value representing the ratio or percentage of a user's work of breathing relative to the nominal equivalent work of breathing of a nominal average healthy person, or associated trend data of such ratio or percentage, and one or more thresholds.

[0139] In the configuration, the method includes: visually displaying the value of a ratio or percentage and / or trend data involving the ratio or percentage on the device's display screen.

[0140] In the configuration, the method includes generating warnings, alerts, and / or notifications based at least in part on the following: a value representing a ratio or percentage of a user’s work of breathing relative to a nominal equivalent work of breathing of a nominal average healthy person, or associated trend data of such ratio or percentage, and one or more thresholds.

[0141] In the configuration, treatment settings and / or device settings include flow rate settings and / or gas flow oxygen concentration settings (e.g., FiO2 settings or FdO2 settings).

[0142] In the configuration, the device further includes a housing, wherein the housing includes or integrates the following: 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.

[0143] In the configuration, the sensing block or sensor module includes a flow rate sensor and a pressure sensor.

[0144] In a fourth aspect, this disclosure broadly includes a respiratory device configured to provide a gas flow to a user for respiratory therapy, the respiratory device 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 configured to: receive the flow parameter data; determine, at least in part, a nasal pressure change value indicating the user's average nasal pressure based on the received flow parameter data; determine a user respiratory flow rate estimate indicating or representing the user's respiratory flow rate; determine a work of breathing (WOB) index at least in part based on the determined nasal pressure change value and the user respiratory flow rate estimate; and initiate one or more actions at least in part based on the determined WOB index.

[0145] In a fifth aspect, this disclosure broadly includes a respiratory therapy system configured to provide a gas flow to a user for respiratory therapy, the respiratory therapy system 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 breathing tube operatively coupled to the flow generator and configured to deliver the gas flow from the flow generator to the user; a patient interface operatively coupled to the breathing tube; and a controller configured to: receive the flow parameter data; determine, at least in part, a nasal pressure change value indicating the user's average nasal pressure based on the received flow parameter data; determine a user respiratory flow rate estimate indicating or representing the user's respiratory flow rate; determine a work of breathing (WOB) index based at least in part on the determined nasal pressure change value and the user respiratory flow rate estimate; and initiate one or more actions based at least in part on the determined WOB index.

[0146] In a sixth aspect, this disclosure broadly 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 the user; one or more sensors configured to generate flow parameter data indicating or representing the gas flow; and a controller, wherein the method is executed or implemented by the controller and includes the steps of: receiving the flow parameter data; determining, at least in part, a nasal pressure change value indicating the user's average nasal pressure based on the received flow parameter data; determining a user respiratory flow rate estimate indicating or representing the user's respiratory flow rate; determining a work of breathing (WOB) index at least in part based on the determined nasal pressure change value and the user respiratory flow rate estimate; and initiating one or more actions at least in part based on the determined WOB index.

[0147] In a seventh aspect, this disclosure broadly includes a respiratory device configured to provide a gas flow to a user for respiratory therapy, the respiratory device 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 configured to: receive the flow parameter data; determine, at least in part, a nasal pressure change value indicating the user's average nasal pressure based on the received flow parameter data; determine a breathing smoothness value indicating or representing the rate of change of nasal pressure fluctuations in the user; determine a work of breathing (WOB) index at least in part based on the determined nasal pressure change value and the breathing smoothness value; and initiate one or more actions at least in part based on the determined WOB index.

[0148] In the eighth aspect, this disclosure broadly includes a respiratory therapy system configured to provide a gas flow to a user for respiratory therapy, the respiratory therapy system 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 breathing tube operatively coupled to the flow generator and configured to deliver the gas flow from the flow generator to the user; a patient interface operatively coupled to the breathing tube; and a controller configured to: receive the flow parameter data; determine, at least in part, a nasal pressure change value indicating the user's average nasal pressure based on the received flow parameter data; determine a breathing smoothness value indicating or representing the rate of change of nasal pressure fluctuations in the user; determine a work of breathing (WOB) index at least in part based on the determined nasal pressure change value and the breathing smoothness value; and initiate one or more actions at least in part based on the determined WOB index.

[0149] In a ninth aspect, this disclosure broadly includes a method of 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 the user; one or more sensors configured to generate flow parameter data indicating or representing the gas flow; and a controller, wherein the method is executed or implemented by the controller and includes the steps of: receiving the flow parameter data; determining, at least in part, a nasal pressure change value indicating the user's average nasal pressure based on the received flow parameter data; determining a breathing smoothness value indicating or representing the rate of change of nasal pressure fluctuations in the user; determining a work of breathing (WOB) index at least in part based on the determined nasal pressure change value and the breathing smoothness value; and initiating one or more actions at least in part based on the determined WOB index.

[0150] The fourth to ninth aspects of this disclosure may further have any one or more of the features described in the first to third aspects of the preceding paragraphs.

[0151] In a tenth aspect, this disclosure broadly includes a respiratory device configured to provide a gas flow to a user for respiratory therapy, the respiratory device 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 display connected to or in data communication with the respiratory device; and a controller configured to: receive the flow parameter data; determine, at least in part, a nasal pressure change value indicating the user's average nasal pressure based on the received flow parameter data; determine a work of breathing (WOB) index based at least in part on the determined nasal pressure change value; and display or cause to display WOB data at least in part on the display based on the determined WOB index.

[0152] In the eleventh aspect, this disclosure includes: a respiratory therapy system configured to provide a gas flow to a user for respiratory therapy, the respiratory therapy system 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 display connected to or in data communication with the respiratory system; a breathing tube operatively coupled to the flow generator and configured to deliver a gas flow from the flow generator to the user; a patient interface operatively coupled to the breathing tube; and a controller configured to: receive the flow parameter data; determine, at least in part, a nasal pressure change value indicating the user's average nasal pressure based on the received flow parameter data; determine a work of breathing (WOB) index based at least in part on the determined nasal pressure change value; and display or cause to display WOB data at least in part on the display based on the determined WOB index.

[0153] The respiratory device of aspect ten or the respiratory therapy system of aspect eleven may further have any one or more of the following aspects or features defined in the following paragraphs.

[0154] In the configuration, the display includes the screen of the breathing device.

[0155] In this configuration, the display screen can be removed from the breathing device or the housing of the breathing device.

[0156] In the configuration, the display includes the user interface for the breathing device.

[0157] In the configuration, the display includes a graphical user interface (GUI).

[0158] In the configuration, the display is set on a remote device or system that communicates data with the respiratory equipment.

[0159] In the configuration, the controller is further configured to transmit the WOB data to be displayed to a remote device or system for display.

[0160] In the configuration, the controller is set to display one or more graphical indicators representing WOB data on the respiratory device's display screen.

[0161] In the configuration, graphical metrics include any one or more of the following: numerical values, text, waveforms, illustrations, or animations.

[0162] In the configuration, graphical indicators can indicate or represent whether the determined WOB indicator is increasing or decreasing.

[0163] In the configuration, the WOB data displayed on the monitor includes data indicating the raw or absolute WOB metric.

[0164] In the configuration, the controller is further configured to process the determined WOB metric to generate a ratio or percentage representing the user's determined WOB metric relative to the nominal equivalent WOB metric of the nominal average healthy person.

[0165] In the configuration, the WOB data displayed on the monitor includes data indicating the ratio or percentage of the user's determined WOB index relative to the nominal equivalent WOB index of the nominal average healthy person.

[0166] In the configuration, the controller is further configured to process a portion or window of the determined WOB metric over time to generate one or more WOB metric trends or trend data.

[0167] In the configuration, the WOB data displayed on the monitor includes data indicating the trend or trend data of one or more WOB indicators.

[0168] In the configuration, the WOB data displayed on the monitor includes WOB indicator trends or trend data that indicate or represent any one or more of the following: WOB increasing, WOB decreasing, and / or WOB stabilizing.

[0169] In the configuration, the WOB data displayed on the display may include data indicating any one or more of the following data types: raw or absolute WOB metric data, a ratio or percentage of the user's determined WOB metric relative to the nominal equivalent WOB metric of the nominal average healthy person, and / or WOB metric trend or trend data.

[0170] In the configuration, one or more data types can be displayed on the display in isolation or in combination with any one or more other data types.

[0171] In the configuration, the data is displayed on the graphical user interface (GUI) of the display screen, and the GUI includes a first GUI element configured to display WOB data of a first type and a second GUI element configured to display WOB data of a second type.

[0172] In one example configuration, the first GUI element includes a graphical indicator representing: raw or absolute WOB indicator data; and / or a ratio or percentage representing the user's determined WOB indicator relative to the nominal equivalent WOB indicator of the nominal average healthy person, and the second GUI element includes a graphical indicator representing: WOB indicator trend or trend data.

[0173] In a twelfth aspect, this disclosure includes a method of 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 the user; one or more sensors configured to generate flow parameter data indicating or representing the gas flow; a display connected to or in data communication with the respiratory device; and a controller, wherein the method is executed or implemented by the controller and includes the steps of: receiving the flow parameter data; determining, at least in part, a nasal pressure change value indicating the user's mean nasal pressure based on the received flow parameter data; determining a work of breathing (WOB) index based at least in part on the determined nasal pressure change value; and displaying or causing the display to show WOB data based at least in part on the determined WOB index.

[0174] The method of the twelfth aspect may include any one or more of the features mentioned in the tenth or eleventh aspect of this disclosure as described in the preceding paragraphs.

[0175] In the thirteenth aspect, this disclosure broadly includes a respiratory device configured to provide a gas flow to a user for respiratory therapy, the respiratory device 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 configured to: receive the flow parameter data; determine, at least in part, a nasal pressure change value indicating the user's average nasal pressure based on the received flow parameter data; determine a work of breathing (WOB) index based at least in part on the determined nasal pressure change value; and generate one or more warnings, alarms, and / or notifications based at least in part on comparing the determined WOB index or associated WOB data with one or more thresholds.

[0176] In the fourteenth aspect, this disclosure includes: a respiratory therapy system configured to provide a gas flow to a user for respiratory therapy, the respiratory therapy system 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 breathing tube operatively coupled to the flow generator and configured to deliver the gas flow from the flow generator to the user; a patient interface operatively coupled to the breathing tube; and a controller configured to: receive the flow parameter data; determine, at least in part, a nasal pressure change value indicating the user's average nasal pressure based on the received flow parameter data; determine a work of breathing (WOB) index based at least in part on the determined nasal pressure change value; and generate one or more warnings, alarms, and / or notifications based at least in part on comparing the determined WOB index or associated WOB data with one or more thresholds.

[0177] The respiratory device of aspect thirteen or the respiratory therapy system of aspect fourteen may further have any one or more of the following aspects or features defined in the following paragraphs.

[0178] In the configuration, the controller is configured to generate warnings, alerts, and / or notifications based at least in part on determining that a WOB metric or associated WOB data has increased above a threshold.

[0179] In the configuration, the controller is configured to generate warnings, alerts, and / or notifications based at least in part on determining that the WOB metric or associated WOB data has decreased below a threshold.

[0180] In the configuration, the controller is configured to generate warnings, alarms, and / or notifications in the form of any one or more of the following: auditory, visual, and / or tactile.

[0181] In the configuration, the device or system further includes an audio output device that is in electrical communication with the controller, and wherein the controller is configured to audibly generate warnings, alarms and / or notifications via the audio output device.

[0182] In the configuration, the device or system further includes a display that communicates electricalally or data with the controller, and the controller is configured to visually generate warnings, alarms, and / or notifications via the display.

[0183] In the configuration, the controller is configured to send or transmit data representing generated warnings, alarms, and / or notifications to a remote device or system that is in data communication with the device or system.

[0184] In the configuration, the controller is configured to send or transmit the determined WOB metrics and / or associated WOB data to a remote device or system that is communicating with the device or system.

[0185] In the configuration, a remote device or system displays or presents data representing warnings, alarms, and / or notifications (e.g., whether visual, auditory, and / or tactile), and / or relays / transmits warnings, alarms, and / or notifications to another remote electronic device or system.

[0186] In the configuration, the display includes the screen of the breathing device.

[0187] In this configuration, the display screen can be removed from the breathing device or the housing of the breathing device.

[0188] In the configuration, the display includes the user interface for the breathing device.

[0189] In the configuration, the display includes a graphical user interface (GUI).

[0190] In the configuration, the display is set on a remote device or system that communicates data with the respiratory equipment.

[0191] In the configuration, the controller is set to display graphical indicators representing generated warnings, alarms, and / or notifications on the respiratory device's display screen.

[0192] In the configuration, graphical indicators include any one or more of the following: numerical values, textual information, graphical forms or formats, trend lines, data plotted or represented in charts over time, waveforms, illustrations, icons, animations, and / or color-coded information.

[0193] In the configuration, the controller is configured to simultaneously display data indicating or representing the determined WOB metrics or associated WOB data, as well as data indicating generated warnings, alarms, and / or notifications.

[0194] In the configuration, the controller is configured to generate one or more different types of warnings, alerts, and / or notifications, at least in part, based on comparing determined WOB metrics or associated WOB data with one or more thresholds or threshold criteria.

[0195] In the configuration, the controller is configured to determine a user's WOB status at least in part based on comparing the determined WOB metric or associated WOB data with one or more thresholds or threshold criteria.

[0196] In the configuration, the controller is configured to generate a first type of warning, alarm, and / or notification, which includes data indicating a determined WOB state (e.g., current state and / or trend state) for the user. In one example configuration, the determined WOB state can be selected from any one or more of the following: WOB increasing, WOB decreasing, WOB stable, high WOB, and / or low WOB.

[0197] In the configuration, the controller is configured to generate a second type of warning, alarm, and / or notification, which includes data indicating a suggested remedial action or in response to a user-determined WOB state. In one example configuration, the suggested action may be selected from any one or more of the following: checking the patient, adjusting treatment settings, and / or suggested changes to treatment settings (e.g., increasing or decreasing flow rate settings).

[0198] In the configuration, the controller can be configured such that a second type of warning, alarm, and / or notification can be triggered or generated in response to the generation or triggering of a first type of warning, alarm, and / or notification.

[0199] In the configuration, the controller can be configured to display data indicating a first type of warning, alarm, and / or notification simultaneously with data indicating a second type of warning, alarm, and / or notification.

[0200] In the configuration, the identified WOB metric or associated WOB data displayed includes data indicating any one or more of the following: raw or absolute WOB metric, a ratio or percentage representing the user's identified WOB metric relative to the nominal equivalent WOB metric of the nominal average healthy person, and / or one or more WOB metric trends or trend data.

[0201] In the configuration, data is displayed on the graphical user interface (GUI) of the display screen, and the GUI includes one or more GUI elements, panes, or areas for displaying one or more of the generated warnings, alerts, and / or notifications.

[0202] In the configuration, the data displayed on the GUI of the display screen includes: a first GUI element or pane or area for displaying a first type of warning, alarm, and / or notification indicating the WOB status determined by the user; and a second GUI element or pane or area for displaying a second type of warning, alarm, and / or notification indicating the suggested remedial action or in response to the WOB status determined by the user.

[0203] In the configuration, the controller can be configured to generate first and / or second types of warnings, alarms and / or notifications audibly and / or using one or more audible prompts or voice commands via an associated audio output device.

[0204] In the fifteenth aspect, this disclosure includes a method of 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 the user; one or more sensors configured to generate flow parameter data indicating or representing the gas flow; and a controller, wherein the method is executed or implemented by the controller and includes the steps of: receiving the flow parameter data; determining, at least in part, a nasal pressure change value indicating the user's average nasal pressure based on the received flow parameter data; determining a work of breathing (WOB) index based at least in part on the determined nasal pressure change value; and generating one or more warnings, alarms, and / or notifications based at least in part on comparing the determined WOB index or associated WOB data with one or more thresholds.

[0205] The approach in aspect fifteen may include any one or more of the features mentioned in aspect thirteen or fourteen of this disclosure as described in the preceding paragraphs.

[0206] In a sixteenth aspect, this disclosure broadly includes a system comprising: a respiratory device configured to provide a gas flow to a user for respiratory therapy, the respiratory device 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 configured to: receive the flow parameter data; determine, at least in part, a nasal pressure change value indicating the user's average nasal pressure based on the received flow parameter data; determine a work of breathing (WOB) index based at least in part on the determined nasal pressure change value; and send or transmit the WOB index or associated WOB data to a remote device or system in data communication with the respiratory device, wherein: the remote device or system is configured to generate one or more warnings, alarms, and / or notifications based at least in part on comparing the determined WOB index or associated WOB data with one or more thresholds.

[0207] In the configuration, the remote device or system is configured to present one or more generated warnings, alarms and / or notifications (e.g., whether visual, auditory and / or tactile).

[0208] In the configuration, a remote device or system is configured to push, transmit, or relay WOB metrics and / or associated WOB data and / or one or more generated warnings, alarms, and / or notifications to another electronic device or system.

[0209] The system of aspect sixteen may further include any one or more of the features mentioned in aspects thirteen through fifteen of this disclosure with respect to the preceding paragraphs. In one example, the remote device or system may be configured to implement any one or more of the functions of a controller for a respiratory device or system, including generating and / or presenting (e.g., displaying or audibly presenting) alarms, warnings, and / or notifications.

[0210] In the seventeenth aspect, this disclosure broadly includes a respiratory device configured to provide a gas flow to a user for respiratory therapy, the respiratory device 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 configured to: receive the flow parameter data; determine, at least in part, a nasal pressure change value indicating the user's mean nasal pressure based on the received flow parameter data; determine a work of breathing (WOB) index based at least in part on the determined nasal pressure change value; and generate one or more treatment parameter setting adjustment suggestions based at least in part on the determined WOB index or associated WOB data.

[0211] In the eighteenth aspect, this disclosure includes: a respiratory therapy system configured to provide a gas flow to a user for respiratory therapy, the respiratory therapy system 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 breathing tube operatively coupled to the flow generator and configured to deliver the gas flow from the flow generator to the user; a patient interface operatively coupled to the breathing tube; and a controller configured to: receive the flow parameter data; determine, at least in part, a nasal pressure change value indicating the user's mean nasal pressure based on the received flow parameter data; determine a work of breathing (WOB) index based at least in part on the determined nasal pressure change value; and generate one or more treatment parameter setting adjustment suggestions based at least in part on the determined WOB index or associated WOB data.

[0212] The respiratory device of aspect seventeen or the respiratory therapy system of aspect eighteen may further have any one or more of the following aspects or features defined in the following paragraphs.

[0213] In the configuration, the controller is configured to generate one or more treatment parameter setting adjustment recommendations based at least in part on comparing the determined WOB metric or associated WOB data with one or more thresholds.

[0214] In the configuration, the WOB metric or associated WOB data may include data that indicates or represents any one or more of the following: raw or absolute WOB metric, a ratio or percentage of the user's determined WOB metric relative to the nominal equivalent WOB metric of the nominal average healthy person, and / or one or more WOB metric trends or trend data.

[0215] In the configuration, the controller can be set to display or present the generated treatment parameter setting adjustment suggestions on the respiratory device's display screen.

[0216] In the configuration, the controller can be configured to transmit, send, or relay the generated treatment parameter setting adjustment suggestions to one or more remote devices or systems that are in data communication with the respiratory equipment or system.

[0217] In the configuration, the controller can be configured to apply generated treatment parameter setting adjustment suggestions to the treatment settings of the respiratory device (e.g., flow rate setting and / or gas flow oxygen concentration setting, such as FiO2 setting and / or FdO2 setting) in response to input or confirmation from the user or clinician via the user interface of the respiratory device and / or remote device or system.

[0218] In a nineteenth aspect, this disclosure includes a method of 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 the user; one or more sensors configured to generate flow parameter data indicating or representing the gas flow; and a controller, wherein the method is executed or implemented by the controller and includes the steps of: receiving the flow parameter data; determining, at least in part, a nasal pressure change value indicating the user's mean nasal pressure based on the received flow parameter data; determining a work of breathing (WOB) index based at least in part on the determined nasal pressure change value; and generating one or more treatment parameter setting adjustment suggestions based at least in part on the determined WOB index or associated WOB data.

[0219] The method of the nineteenth aspect may include any one or more of the features mentioned in the seventeenth or eighteenth aspects of this disclosure as described in the preceding paragraphs.

[0220] In a twentieth aspect, this disclosure broadly includes a respiratory device configured to provide a gas flow to a user for respiratory therapy, the respiratory device 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 configured to: receive the flow parameter data; determine, at least in part, a nasal pressure change value indicating the user's average nasal pressure based on the received flow parameter data; determine a work of breathing (WOB) index based at least in part on the determined nasal pressure change value; and process the WOB index or associated WOB data to detect a disconnection event.

[0221] In the twenty-first aspect, this disclosure includes: a respiratory therapy system configured to provide a gas flow to a user for respiratory therapy, the respiratory therapy system 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 breathing tube operatively coupled to the flow generator and configured to deliver a gas flow from the flow generator to the user; a patient interface operatively coupled to the breathing tube; and a controller configured to: receive the flow parameter data; determine, at least in part, a nasal pressure change value indicating the user's average nasal pressure based on the received flow parameter data; determine a work of breathing (WOB) index based at least in part on the determined nasal pressure change value; and process the WOB index or associated WOB data to detect a disconnection event.

[0222] The respiratory device of aspect 20 or the respiratory therapy system of aspect 21 may further have any one or more of the following aspects or features defined in the following paragraphs.

[0223] In the configuration, a disconnection event can indicate or represent the disconnection of any part of the flow path (e.g., the patient breathing circuit and / or the patient interface), and / or the disconnection or detachment of the user from the patient interface.

[0224] In the configuration, the controller can be configured to detect disconnection events based at least in part on whether a determined WOB metric or associated WOB data reaches zero or falls below a predetermined threshold (e.g., approaches zero) for a predetermined period of time.

[0225] In the configuration, the controller can be further configured to generate warnings, alarms, and / or notifications in response to the detection of a disconnection event.

[0226] In the configuration, the controller can be configured to display or present warnings, alarms, and / or notifications generated by the disconnection event on the respiratory device's display.

[0227] In the configuration, the controller can be configured to send, transmit, or relay warnings, alarms, and / or notifications generated by disconnection events to remote systems.

[0228] In the configuration, the warnings, alarms, and / or notifications generated by a disconnection event may further include data indicating suggested remedial or corrective actions to resolve the disconnection event.

[0229] In a twenty-second aspect, this 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 the user; one or more sensors configured to generate flow parameter data indicating or representing the gas flow; and a controller, wherein the method is executed or implemented by the controller and includes the steps of: receiving the flow parameter data; determining, at least in part, a nasal pressure change value indicating the user's average nasal pressure based on the received flow parameter data; determining a work of breathing (WOB) index based at least in part on the determined nasal pressure change value; and processing the WOB index or associated WOB data to detect a disconnection event.

[0230] The method of aspect 22 may include any one or more of the features mentioned in aspect 20 or 21 of this disclosure as described in the preceding paragraphs.

[0231] In the twenty-third aspect, this disclosure broadly includes a respiratory device configured to provide a gas flow to a user for respiratory therapy, the respiratory device 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 configured to: receive the flow parameter data; determine, at least in part, a nasal pressure change value indicating the user's average nasal pressure based on the received flow parameter data; determine a work of breathing (WOB) index based at least in part on the determined nasal pressure change value; and generate one or more warnings, alarms, and / or notifications based at least in part on comparing the determined WOB index or associated WOB data with one or more configurable thresholds.

[0232] In its twenty-fourth aspect, this disclosure includes: a respiratory therapy system configured to provide a gas flow to a user for respiratory therapy, the respiratory therapy system 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 breathing tube operatively coupled to the flow generator and configured to deliver a gas flow from the flow generator to the user; a patient interface operatively coupled to the breathing tube; and a controller configured to: receive the flow parameter data; determine, at least in part, a nasal pressure change value indicating the user's average nasal pressure based on the received flow parameter data; determine a work of breathing (WOB) index based at least in part on the determined nasal pressure change value; and generate one or more warnings, alarms, and / or notifications based at least in part on comparing the determined WOB index or associated WOB data with one or more configurable thresholds.

[0233] The respiratory device of aspect 23 or the respiratory therapy system of aspect 24 may further have any one or more of the following aspects or features defined in the following paragraphs.

[0234] In the configuration, the controller is further operable to configure or adjust one or more of the thresholds or any parameters associated with one or more of the thresholds based at least in part on user input via a graphical user interface (GUI) of the device’s display screen.

[0235] In the configuration, the controller is configured to generate or provide suggested thresholds and / or parameters associated with the one or more thresholds, based at least in part on the determined WOB metrics or associated WOB data.

[0236] In the configuration, the one or more configurable thresholds may include any one or more of the following: a single threshold, a threshold range, an upper threshold and a lower threshold, and / or a threshold function based on one or more parameters and / or conditions.

[0237] In the configuration, the device or system provides a GUI on the display screen that is operable to adjust or configure one or more thresholds associated with warnings, alarms and / or notifications.

[0238] In the configuration, the GUI provides: a first GUI element that presents data indicating conditions such as warnings, alerts, notifications, and / or thresholds or parameters, and / or thresholds being adjusted; and a second GUI element that is interactive or operable for the user to adjust the one or more thresholds.

[0239] In the configuration, the second GUI element may include one or more user-interactive GUI elements that are used to adjust the one or more configurable thresholds via touch input or interaction with the display screen.

[0240] In the configuration, the one or more user-interactive GUI elements used to adjust the one or more configurable thresholds may include any one or more of the following: a bi-state trigger element, a dial, a slider scaling element, a selectable discrete threshold element, and / or a numerical and / or categorical input field for inputting the desired threshold.

[0241] In the configuration, the one or more WOB warnings, alarms, and / or notifications can be configured with thresholds such that comparisons of determined WOB metrics or WOB data with these thresholds effectively serve as alternative warnings, alarms, and / or notifications for other respiratory parameters.

[0242] In the configuration, WOB warnings, alarms and / or notifications can be configured as alternative warnings, alarms and / or notifications for one or more of the following respiratory parameters: respiratory rate, minute ventilation and / or tidal volume.

[0243] In the configuration, the controller can be configured to compare the determined WOB metric or associated WOB data with multiple configurable thresholds, and can generate one or more different warnings, alerts or notifications depending on the result of each corresponding comparison.

[0244] In the configuration, these configurable thresholds can be pre-configured with default or recommended values.

[0245] In the configuration, the user interface can be set on the device or system's display to accept or adjust default or recommended thresholds for one or more of warnings, alerts, and / or notifications.

[0246] In the configuration, the user interface can be set on a remote device or system that communicates data with the respiratory equipment or system, and the user interface can be user-operable to accept or adjust default or recommended thresholds for one or more of the warnings, alarms and / or notifications.

[0247] In the configuration, warnings, alerts and / or notifications can be set with multiple or more upper limits or threshold limits and lower limits or threshold limits.

[0248] In the configuration, warnings, alerts, and / or notifications can be set with cascading or nested thresholds or threshold ranges, or inner and outer threshold ranges, or multiple or a series of progressive or gradually increasing thresholds on the threshold scale. In such a configuration, the nature of the generated warnings, alerts, and / or notifications associated with each corresponding threshold can depend on the nature, position, priority, or extremes of that threshold on the overall threshold scale.

[0249] In the configuration, if a high-priority threshold is met, a high-priority warning, alert, or notification can be generated, and if a low-priority threshold is met, a low-priority warning, alert, and / or notification can be generated.

[0250] In the configuration, the default or recommended thresholds associated with any one or more of the warnings, alerts and / or thresholds can be recalibrated and / or dynamically changed by the controller based at least in part on changes in WOB metrics or associated WOB data (e.g., trend data) determined over a treatment period, multiple treatment periods and / or some other configurable time period.

[0251] In the configuration, the one or more generated warnings, alarms and / or notifications can be configured to be selectively presented on one or more devices or systems, at least in part based on the nature of the warning, alarm or notification and / or the thresholds met.

[0252] In the configuration, higher-priority warnings, alarms, and / or notifications can be configured to be displayed on the respiratory device and one or more other remote devices or systems.

[0253] In the configuration, lower-priority warnings, alerts, and / or notifications can be configured to appear only on the respiratory device.

[0254] In a twenty-fifth aspect, this disclosure includes a method of 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 the user; one or more sensors configured to generate flow parameter data indicating or representing the gas flow; and a controller, wherein the method is executed or implemented by the controller and includes the steps of: receiving the flow parameter data; determining, at least in part, a nasal pressure change value indicating the user's average nasal pressure based on the received flow parameter data; determining a work of breathing (WOB) index based at least in part on the determined nasal pressure change value; and generating one or more warnings, alarms, and / or notifications based at least in part on comparing the determined WOB index or associated WOB data with one or more configurable thresholds.

[0255] The method of aspect 25 may include any one or more of the features mentioned in aspect 23 or 24 of this disclosure as described in the preceding paragraphs.

[0256] In another aspect, this disclosure includes a breathing 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 characteristics or parameters of the gas flow; and a controller configured to: control the flow generator to deliver the gas flow for high-flow nasal therapy; determine a work of breathing (WOB) index based at least in part on the flow parameter data; and initiate one or more actions based at least in part on the determined WOB index.

[0257] In the configuration, flow parameter data includes pressure data that indicates or represents the pressure of the gas flow.

[0258] In the configuration, pressure data is sensed and generated by one or more pressure sensors that communicate with the controller.

[0259] In the configuration, the one or more pressure sensors are configured to sense and generate pressure data that indicates or represents the pressure of the gas flow at the outlet of the blower of the flow generator.

[0260] In the configuration, flow parameter data includes velocity data that indicates or represents the flow rate of the gas flow.

[0261] In the configuration, flow rate data is sensed and generated by one or more flow rate sensors that communicate with the controller.

[0262] In the configuration, the one or more flow rate sensors are located at or near the outlet of the blower of the flow generator.

[0263] In the configuration, the WOB metric is determined at least in part based on flow parameter data, which includes sensed pressure and / or flow rate data relating to the gas flow.

[0264] In another aspect, this disclosure includes a breathing device comprising: a flow generator configured to generate a gas flow for a user; and a controller configured to: control the flow generator to deliver the gas flow for respiratory therapy or high-flow nasal therapy; determine a work of breathing (WOB) index based at least in part on pressure and / or flow rate measurements relating to the gas flow; and initiate one or more actions based at least in part on the determined WOB index.

[0265] In another aspect, this disclosure includes a breathing device comprising: a flow generator configured to generate a gas flow for a user; and a controller configured to: control the flow generator to deliver the gas flow for respiratory therapy or high-flow nasal therapy; and to determine a work of breathing (WOB) index based at least in part on pressure and / or flow rate measurements relating to the gas flow.

[0266] In another aspect, this disclosure relates to an electronically implemented method comprising software code or coded instructions that can be executed by or implemented by a computer, processor, or controller to implement any one or more of the methods or aspects described above.

[0267] In another aspect, this disclosure broadly includes a non-transitory computer-readable medium storing computer-executable instructions that, when executed on one or more processing devices, cause the one or more processing devices to perform or implement any one or more of the methods or aspects described above.

[0268] Any aspect of this disclosure described in the foregoing paragraphs may further have any one or more of the features described in any one or more of the other aspects of this disclosure described in the foregoing paragraphs. Attached Figure Description

[0269] These and other features, aspects, and advantages of this disclosure are described with reference to the accompanying drawings of certain embodiments, which are intended to illustrate certain embodiments and not to limit the scope of this disclosure.

[0270] Figure 1 A respiratory system configured to provide respiratory therapy to a patient is illustrated schematically.

[0271] Figure 2 This is a front view of an example breathing device with a humidification chamber in the proper position and a raised handle / rod.

[0272] Figure 3 It corresponds to Figure 2 Top view.

[0273] Figure 4 It corresponds to Figure 2 The right-side view.

[0274] Figure 5 It corresponds to Figure 2 The left-side view.

[0275] Figure 6 It corresponds to Figure 2 Rear view.

[0276] Figure 7 It corresponds to Figure 2 Left front 3D view.

[0277] Figure 8 It corresponds to Figure 2 The right front 3D view.

[0278] Figure 9 It corresponds to Figure 2 A bottom view.

[0279] Figure 10 An example configuration of the air and oxygen inlet arrangement structure of a breathing device is shown.

[0280] Figure 11 Another example configuration of the air and oxygen inlet arrangement structure of the breathing device is shown.

[0281] Figure 12 It shows Figure 11 A cross-sectional view showing further details of the air and oxygen inlet arrangement structure.

[0282] Figure 13 It is shown Figure 11 Another cross-sectional view showing further details of the air and oxygen inlet arrangement structure.

[0283] Figure 14 It is shown Figure 11 A longitudinal sectional view showing further details of the air and oxygen inlet arrangement structure.

[0284] Figure 15 This is an exploded view of the upper and lower housing components of the main housing of the breathing apparatus.

[0285] Figure 16 This is a left front perspective view of the lower housing of the main housing, showing the housing used to receive the motor / sensor module sub-assembly.

[0286] Figure 17 This is a first bottom perspective view of the main housing of the breathing device, showing the recess inside the housing for the motor / sensor module subassembly.

[0287] Figure 18 This is a second bottom perspective view of the main housing of the breathing device, showing the recess for the motor / sensor module subassembly.

[0288] Figure 19A A block diagram of a control system is shown, which interacts with and / or provides control and instructions to components of the respiratory system.

[0289] Figure 19B A block diagram of the example controller is shown.

[0290] Figure 20 A block diagram of the motor and sensor modules is shown.

[0291] Figure 21 The sensing chamber of the example motor and sensor module is shown.

[0292] Figure 22A An embodiment of a method for estimating the ventilation rate per minute of a device is shown in the flowchart.

[0293] Figure 22B Another embodiment of a flowchart illustrating a method for estimating the ventilation rate per minute of a device is shown.

[0294] Figure 22C Another embodiment of a flowchart illustrating a method for estimating the ventilation rate per minute of a device is shown.

[0295] Figure 22D Another embodiment of a flowchart illustrating a method for estimating the ventilation rate per minute of a device is shown.

[0296] Figure 23 Another embodiment of a flowchart illustrating a method for estimating the ventilation rate per minute of a device is shown.

[0297] Figure 24 A schematic example of a graphical user interface (GUI) display for a respiratory device is shown, illustrating an example configuration of a respiratory work monitoring screen.

[0298] Figure 25A-25F A schematic example of a GUI display for a breathing device is shown, illustrating examples of different breathing function warning or notification screens.

[0299] Figure 26 An example flowchart illustrates a method for estimating work of breathing (WOB) indices and generating recommendations for adjusting treatment parameters based on the generated WOB data.

[0300] Figure 27A and Figure 27B A schematic example of a GUI display for a breathing device is shown, illustrating various examples of disconnection warnings triggered in response to calculated WOB data.

[0301] Figure 28A and Figure 28B A schematic example of a GUI display is shown, which is used to adjust thresholds associated with notifications, warnings, and / or alerts triggered by WOB metrics or data. Detailed Implementation

[0302] While certain examples are described below, those skilled in the art will understand that this disclosure extends beyond the specific examples and / or uses disclosed herein, as well as their obvious modifications and equivalents. Therefore, it is intended that the scope of this disclosure should not be limited to any particular example described below.

[0303] 1. Overview of Example Respiratory Equipment

[0304] Examples of methods and / or procedures for determining the work of breathing (WOB) or an indicator or parameter indicative of the work of breathing will be described in the context of an example respiratory device 10 configured or operable to deliver high-flow nasal therapy via an unsealed patient interface. This is intended as a non-limiting example. It will be understood that these methods and procedures can be applied to other respiratory devices or systems and / or other modes of operation and / or modes of therapy delivered by such devices.

[0305] Figure 1 A schematic representation of an example breathing device 10 is provided.

[0306] The breathing device 10 (or 'breathing system') includes a flow source 50 for providing a high-flow-rate gas 31, such as air, oxygen, air mixed with oxygen, or a mixture of air and / or oxygen with one or more other gases. Alternatively, the breathing aid may have a connector for attachment to the flow source. Thus, the flow source may be considered part of the device or separate from the device (depending on the context), or even a portion of the flow source may be part of the device, and a portion of the flow source may not be part of the device. In short, depending on the configuration (some components may be optional), the system may include a combination of components selected from the following:

[0307] •Source of the stream

[0308] • A humidifier used to humidify gas streams.

[0309] • Catheters (e.g., drying tubing or heated breathing tubes).

[0310] • Patient interface,

[0311] • Check valve,

[0312] • Filter

[0313] The device or system will now be described in more detail.

[0314] The flow source can be an in-wall oxygen supply source, an oxygen cylinder 50A, other gas cylinders and / or a high-flow device with a flow generator 50B. Figure 1A flow source 50 is shown, having a flow generator 50B, an optional air inlet 50C, and an optional connection via a shut-off valve and / or regulator and / or other gas flow control 50D to an O2 source (e.g., a canister or O2 generator) 50A, but this is only one option. The flow generator 50B may use one or more valves to control the flow delivered to the patient 56, or alternatively, the flow generator 50B may include a blower. As described, the flow source may be one or a combination of the flow generator 50B, the O2 source 50A, and the air source 50C. The flow source 50 is shown as part of the device 10, however, in the case of an external oxygen canister or an in-wall source, it may be considered a separate component, in which case the device has connection ports for connecting to such a flow source. The flow source provides a gas flow (preferably high-flow gas) that can be delivered to the patient via a delivery conduit 16 and a patient interface 51.

[0315] Patient interface 51 can be an unsealed (non-sealed) interface (e.g., when used in high-flow therapy), such as an unsealed nasal cannula, or a sealed (sealed) interface (e.g., when used in CPAP), such as a nasal mask, full face mask, or nasal pillow. In some embodiments, patient interface 51 is an unsealed patient interface that will, for example, help prevent barotrauma (e.g., tissue damage to the lungs or other organs of the respiratory system due to pressure differences relative to the atmosphere). In some embodiments, patient interface 51 is a sealing shield that seals against the patient's nose and / or mouth. Patient interface can be a nasal cannula with a manifold and nasal fork, and / or a face mask, and / or a nasal pillow, and / or a nasal mask, and / or a tracheostomy interface, or any other suitable type of patient interface. The flow source can provide a base gas flow rate between, for example, 0.5 L / min and 375 L / min, or any range within that range, or even a range with higher or lower limits. Details of the range and nature of the flow rate will be described later.

[0316] A humidifier 52 may be optionally positioned between the flow source 50 and the patient to humidify the delivered gas. One or more sensors 53A, 53B, 53C, 53D (e.g., flow rate, oxygen fraction, pressure, humidity, temperature, or other sensors) may be placed throughout the system and / or on or near the patient 56. Alternatively or additionally, sensors from which such parameters are derived may be used. Additionally or alternatively, sensors 53A-53D may be one or more physiological sensors for sensing patient physiological parameters such as heart rate, oxygen saturation, partial pressure of oxygen in the blood, respiratory rate, and partial pressure of CO2 in the blood. Alternatively or additionally, sensors from which such parameters are derived may be used. Other patient sensors may include an EEG sensor, a trunk band for detecting respiration, and other suitable sensors. In some configurations, a humidifier may be optional, or it may be preferred due to the advantage of humidifying the gas in maintaining airway condition. One or more of these sensors may be part of the device or may be external to the device, wherein the device has inputs for any external sensors. These sensors can be connected to controller 19 or their outputs can be sent to the controller.

[0317] In some configurations, the respiratory 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 placed on the patient interface 51 to measure or otherwise determine the oxygen fraction very close to (at / near / close to) the patient's mouth and / or nose. In some configurations, the output of the sensor 14 is sent to a controller 19 to assist in controlling the respiratory system 10 to change its operation accordingly. The controller 19 is coupled to the flow source 50, the humidifier 52, and the sensor 14. In some configurations, the controller 19 controls these and other aspects of the respiratory system 10 as described herein. In some examples, the controller may operate the flow source 50 to provide a delivered gas flow at a desired flow rate, high enough to meet or exceed the user's (i.e., the patient's) inhalation needs. The provided flow rate is sufficient such that ambient gases are not entrained during the user's (i.e., the patient's) inhalation. In some configurations, sensor 14 can transmit measurements of the oxygen fraction at the patient's mouth and / or nose to the user, who can then input the information into the respiratory system 10 / controller 19.

[0318] An optional check valve 23 may be provided in the breathing duct 16. One or more filters may be provided at one and / or more air inlets 50C of the flow generator 50B to filter the incoming gas before it is pressurized into a high-flow-rate gas 31 to the flow generator 50B.

[0319] The respiratory assist device 10 can be an integral or separate component-based arrangement, which generally... Figure 1 The device or system is shown in dashed box 100. In some configurations, the device or system may be a modular arrangement of components. Furthermore, the device or system may include only some of the components shown, and not necessarily all of them are essential. Moreover, catheters and patient interfaces need not be part of the system, but can be considered separate. Hereinafter, it will be referred to as a respiratory assist device or respiratory system, but this should not be considered limiting. Respiratory assist devices and respiratory systems will be broadly considered herein to include anything that delivers a certain flow rate of gas to the patient. Some such devices and systems include a detection system that can be used to determine whether the gas flow rate meets the inspiratory requirement.

[0320] The respiratory device 10 may include a main housing 100. The main housing 100 may include a flow generator 50B, which may be in the form of a motor / impeller arrangement, 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 devices, such as buttons, a touchscreen (e.g., an LCD screen), and combinations of touchscreens and buttons. The controller 19 may include one or more hardware and / or software processors and may be configured or programmed as a component of the control system, including but not limited to operating the flow generator 50B to generate a gas flow for delivery to a 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 operations of the respiratory device 10, and outputting information to the user (e.g., on a display). The user may be a patient, a healthcare professional, or someone else.

[0321] In one configuration, the user interface 54 of the breathing device 10 may include a removable display screen or touchscreen.

[0322] Continue to refer to Figure 1 The patient breathing tube 16 can be connected to the gas outlet (gas outlet or patient outlet port) 21 in the main housing 100 of the breathing device 10, and to the patient interface 17 (e.g., an unsealed interface like a nasal cannula with a manifold and nasal fork). The patient breathing tube 16 can also be a tracheostomy interface or other unsealed interface.

[0323] A gas flow can be generated by a flow generator 50B and humidified before being delivered to the patient via a patient breathing tube 16 through a patient interface 51. A controller 19 can control the flow generator 50B to generate a gas flow at a desired rate and / or control one or more valves to control the mixing of air and oxygen or other breathable gases. The controller 19 can control a heating element in or associated with a humidification chamber 52 (if present) to heat the gas to a desired temperature that achieves the desired level of temperature and / or humidity for delivery to the patient. The patient breathing tube 16 may have a heating element (e.g., a heating wire) to heat the gas flow traveling to the patient. The heating element may also be controlled by the controller 19.

[0324] The humidifier 52 of the device is configured to combine with or introduce humidity into a gas flow. Various humidifier 52 configurations are possible. 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 instance, the humidification chamber may be removed, for example, for refilling, cleaning, replacement, and / or repair. In one configuration, the humidification chamber may be received and secured by or within a humidification compartment or niche of the device, or may be otherwise coupled to or within the housing of the device.

[0325] The humidification chamber of humidifier 52 may include a gas inlet and a gas outlet to enable connection to the gas flow path of the device. For example, a gas flow from flow generator 50B, after being heated and / or humidified, is received into the humidification chamber via its gas inlet and exits the chamber via its gas outlet.

[0326] A humidification chamber contains a volume of liquid, typically water or the like. In operation, the liquid in the humidification chamber is controllably heated by one or more heaters or heating elements associated with the chamber to generate water vapor or steam, thereby increasing the humidity of the gas flowing through the chamber.

[0327] In one configuration, the humidifier is a pass-over humidifier. In another configuration, the humidifier can be a non-pass-over humidifier.

[0328] In one configuration, the humidifier may include a heating plate, for example, associated with or within a humidification compartment (on which the chamber is seated) for heating. The chamber may be provided with a heat transfer surface (e.g., a metal insert, plate, or the like in the base surface or other surface of the chamber) that abuts or engages with the heating plate of the humidifier.

[0329] In another configuration, the humidification chamber may include an internal heater or heater element inside the chamber. This internal heater or heater element may be integrally mounted or disposed within the chamber, or it may be removable from the chamber.

[0330] The humidification chamber can be of any suitable shape and / or size. The location, number, size, and / or shape of the gas inlet and outlet of the chamber can vary as needed. In one configuration, the humidification chamber may have a base surface, one or more sidewalls extending upward from the base surface, and a top or crown surface. In one configuration, the gas inlet and outlet may be located on the same side of the chamber. In another configuration, the gas inlet and outlet may be on different surfaces of the chamber, such as on opposite sides or locations, or in other different locations.

[0331] In some configurations, the gas inlet and gas outlet may have parallel flow axes. In other configurations, the gas inlet and gas outlet may be located at the same height on the chamber.

[0332] Device 10 may use an ultrasonic transducer, flow sensor (e.g., a thermistor flow sensor), pressure sensor, temperature sensor, humidity sensor, or other sensors that communicate with controller 19 to monitor the characteristics of the gas flow and / or operate device 10 in a manner that provides appropriate therapy. Gas flow characteristics may include gas concentration, flow rate, pressure, temperature, humidity, or other properties. Sensors 53A, 53B, 53C, 53D, and 14 (e.g., pressure, temperature, humidity, and / or flow sensors) may be placed in various locations within the main device housing 100, the patient catheter 16, and / or the patient interface 51. Controller 19 may receive output from the sensors to assist it in operating the respiratory device 10 in a manner that provides appropriate therapy, in order to determine appropriate target temperatures, flow rates, and / or pressures for the gas flow. Providing appropriate therapy may include meeting or exceeding the patient's inspiratory needs. In the illustrated embodiment, sensors 53A, 53B, and 53C are located within the device housing, sensor 53D is located within the patient catheter 16, and sensor 14 is located within the patient interface 51.

[0333] Device 10 may include one or more communication modules to enable data communication or connection with one or more external devices or servers via a data or communication link or data network (whether wired, wireless, or a combination thereof). In one configuration, for example, device 10 may include a wireless data transmitter and / or receiver or transceiver 15 to enable controller 19 to wirelessly receive data signals from operating sensors and / or control various components of system 10. Transceiver 15 or data transmitter and / or receiver module may have an antenna 15a as shown. In one example, the transceiver may include a Wi-Fi modem. Additionally or alternatively, data transmitter and / or receiver 15 may deliver data to a remote patient management system (i.e., a remote server) or enable remote control of system 10. System 10 may include wired connections (e.g., using cables or wires) to enable controller 19 to receive data signals from operating sensors and / or control various components of device 10. Device 10 may include one or more wireless communication modules. For example, the device may include a cellular communication module, such as a 3G, 4G, or 5G module. Module 15 may be or may include a modem that enables the device to communicate with a remote patient management system (not shown) using a suitable communication network. The remote management system may include a single server or multiple servers or multiple computing devices implemented in a cloud computing network. The communication may be bidirectional communication between the device and the patient management system (e.g., a server) or other remote systems. Device 10 may also include other wireless communication modules, such as a Bluetooth module and / or a Wi-Fi module. Bluetooth and / or Wi-Fi modules allow the device to wirelessly transmit information to another device (e.g., a smartphone or tablet) or operate via a LAN (Local Area Network) or wireless LAN (WLAN). Additionally or alternatively, the device may include a Near Field Communication (NFC) module to allow data transfer and / or data communication.

[0334] For example, data representing a determined or calculated work of breathing (WOB) indicator or value, or other associated WOB data (e.g., WOB trend data), or notification data generated in response to WOB data (e.g., warnings, alarms, notifications), can be transmitted to a remote patient management system (i.e., a remote server) and / or another remote electronic device (e.g., a personal electronic device, such as a smartphone, tablet, computer, laptop, or wearable device). The remote patient management system can be a single server, a network of servers, 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 a memory for storing received data and various software applications or services executed to perform multiple functions. Then, for example, the remote patient management system (i.e., the remote server) can transmit information or instructions to system 10, at least in part, depending on the received data. For example, the nature of the received data can trigger the remote server (or a software application running on the remote server) to transmit a warning, alarm, or notification to system 10. The remote patient management system can further store the received data for access by an authorized party (e.g., a clinician or patient, or another authorized party). The remote patient management system can be further configured to generate reports (e.g., report data, displayed reports, compiled reports, electronic reports, printable reports, numerical reports, graphical reports) in response to requests from authorized parties, and work of breathing data or associated WOB data can be included in the generated reports. These reports may further include: other data or patient respiratory parameters, such as respiratory rate or SpO2; and / or device parameters, such as flow rate, oxygen concentration of the gas flow (e.g., sensed oxygen concentration and / or FiO2 and / or FdO2 parameter settings), humidity level, or other such device parameters.

[0335] Breathing device 10 may include a high-flow-rate therapeutic device. As discussed herein, high-flow-rate therapeutic is intended to be given its typical, general meaning as understood by those skilled in the art; it generally refers to a respiratory system delivering a target flow rate of humidified breathing gas via an intentionally unsealed patient interface at a flow rate generally designed to meet or exceed the user's inspiratory flow rate. Typical patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults often range from, but are not limited to, about 15 liters per minute to about 60 liters per minute or more. Typical flow rates for pediatric users (e.g., newborns, infants, and children) often range from, but are not limited to, about 1 liter per minute per kilogram of user body weight to about 3 liters per minute or more.

[0336] High-flow therapy may also optionally include gas mixture components, which may include supplemental oxygen and / or administration of therapeutic drugs.

[0337] High-flow therapy is often referred to as nasal high-flow (NHF), humidified high-flow nasal cannula (HHFNC), nasal high-flow oxygen therapy (HFNO), high-flow therapy (HFT), or tracheal high-flow (THF), among other common names. For example, in some configurations, for adult patients, 'high-flow therapy' can refer to delivering gas to the patient at a flow rate greater than or equal to approximately 10 liters per minute (10 LPM), such as between approximately 10 LPM and approximately 100 LPM, or between approximately 15 LPM and approximately 95 LPM, or between approximately 20 LPM and approximately 90 LPM, or between approximately 25 LPM and approximately 85 LPM, or between approximately 30 LPM and approximately 80 LPM, or between approximately 35 LPM and approximately 75 LPM, or between approximately 40 LPM and approximately 70 LPM, or between approximately 45 LPM and approximately 65 LPM, or between approximately 50 LPM and approximately 60 LPM. In some configurations, for neonatal, infant, or pediatric patients, 'high-flow-rate therapy' may refer to delivering gas to the patient at a flow rate greater than 1 LPM, such as between about 1 LPM and about 25 LPM, or between about 2 LPM and about 25 LPM, or between about 2 LPM and about 5 LPM, or between about 5 LPM and about 25 LPM, or between about 5 LPM and about 10 LPM, or between about 10 LPM and about 25 LPM, or between about 10 LPM and about 20 LPM, or between about 10 LPM and 15 LPM, or between about 20 LPM and 25 LPM. For adult, neonatal, infant, or pediatric patients, high-flow-rate therapy devices may deliver gas to the patient at a flow rate between about 1 LPM and about 100 LPM, or at any of the subranges outlined above.

[0338] High-flow-rate therapy can effectively meet or exceed a patient's inspiratory needs, improve oxygenation, and / or reduce the work of breathing. Additionally, high-flow-rate therapy can create a flushing effect in the nasopharynx, flushing the anatomically dead spaces of the upper airway with a high inflow of gas. This flushing effect creates a reservoir of usable fresh gas with each breath while minimizing rebreathing of carbon dioxide, nitrogen, etc. High-flow-rate therapy can also increase the patient's expiratory time due to pressure during expiration. This, in turn, reduces the patient's respiratory rate.

[0339] Patient interfaces used in high-flow therapy may be unsealed interfaces to prevent barotrauma, which can include tissue damage to the lungs or other organs of the patient's respiratory system due to pressure differences relative to the atmosphere. Patient interfaces may be nasal cannulas with manifolds and nasal forks, and / or unsealed tracheostomy interfaces, or any other suitable type of patient interface.

[0340] Figures 2 to 18 An example breathing apparatus 10 with a main housing 100 is shown. The main housing 100 has an upper main housing 102 and a lower main housing 202. The upper main housing 102 has an outer wall arrangement structure 106 (see...). Figure 15 The outer wall arrangement defines a humidifier or humidification chamber compartment 108 for receiving a removable humidification chamber 300. The removable humidification chamber 300 contains a suitable liquid (e.g., water) for humidifying gases that can be delivered to a patient. The base portion of the humidification chamber compartment 108 may have a recess to receive a heater arrangement (e.g., a heating plate 140 or other suitable heating element) for heating the liquid in the humidification chamber 300 for use during the humidification process.

[0341] The humidification chamber 300 can be fluidly connected to the device 10 as follows: the humidification chamber 300 slides linearly into the compartment 108 in a rearward direction from a position at the front of the housing 100 toward the rear of the housing 100. The gas outlet port 322 can be in fluid communication with the motor.

[0342] like Figure 8 The gas inlet port 340 (humidifying gas return) shown may include a removable L-shaped bend. The removable bend may further include a patient outlet port 344 for coupling to the patient catheter 16 to deliver 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 (e.g., an O-ring seal or a T-seal) to provide a sealed gas passage between the device 10, the humidification chamber 300, and the patient catheter 16.

[0343] 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 those ports can be parallel to each other so that the humidification chamber 300 can be inserted into the compartment 108 with linear movement.

[0344] The breathing device may have air and oxygen (or alternative assist gas) inlets in fluid communication with a motor, enabling the motor to deliver air, oxygen (or alternative assist gas), or a mixture thereof to the patient via the humidification chamber 300. Figure 10As shown, the device may have a combined air / oxygen (or alternative auxiliary gas) inlet arrangement 350. This arrangement may include a combined air / oxygen port 352 entering the housing 100, a filter 354, and a cover 356 with a hinge 358. The gas line may also optionally extend laterally or in another suitable direction and be in fluid communication with an oxygen (or alternative auxiliary gas) source. Port 352 may be fluidly coupled to motor 402. For example, port 352 may be coupled to motor / sensor module 400 via a gas flow path between port 352 and an inlet or port in motor and sensor module 400 (which in turn leads to motor).

[0345] The device can have Figures 11 to 14 The arrangement shown enables a blower to deliver air, oxygen (or an alternative auxiliary gas), or a suitable mixture thereof to the humidification chamber 300 and thereby to the patient. This arrangement may include an air inlet 356' located in the rear wall 222 of the lower housing 202 of the housing 100. The air inlet 356' comprises a rigid plate with a suitable grille arrangement having orifices and / or slots. Sound-absorbing foam may be disposed adjacent to the plate on its inner side. An air filter box 354' may be positioned adjacent to the air inlet 356' inside the main housing 100 and includes an air outlet port 360 to deliver 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 particulate matter (e.g., dust) and / or pathogens (e.g., viruses or bacteria) from the gas stream. A soft seal (e.g., an O-ring seal) may be disposed between the air outlet port 360 and the air inlet port 404 to provide a seal between these components. The device may include a separate oxygen inlet port 358' located on a side adjacent to the housing 100 at the rear end of the housing, the oxygen inlet port 358' being used to receive oxygen from an oxygen source (e.g., a canister or source of piped oxygen). The oxygen inlet port 358' is in fluid communication with a valve 362. The valve 362 may suitably be a solenoid valve, enabling control of the amount of oxygen added to the gas stream delivered to the humidification chamber 300. The oxygen port 358' and valve 362 may be used with other auxiliary gases to control the addition of other auxiliary gases to the gas stream. Other auxiliary gases may include any one or more of several gases useful for gas therapy, including but not limited to helium-oxygen mixtures and nitric oxide.

[0346] like Figures 13 to 16As shown, the lower housing 202 may include a suitable electronic component board, such as a sensing circuit board. The electronic component board may be positioned adjacent to corresponding outer sidewalls 210, 216 of the lower housing 202. The electronic component board may contain or be electrically connected to suitable electrical or electronic components, such as, but not limited to, microprocessors, capacitors, resistors, diodes, operational amplifiers, comparators, and switches. Sensors may be used in conjunction with the electronic component board. Components of the electronic component board (such as, but not limited to, one or more microprocessors) may act as the controller 19 of the device.

[0347] One or more of the electronic components board can be electrically connected to the electrical components of device 10 (including display unit and user interface 54, motor, valve 362 and heating plate 140) to operate the motor to provide gas at the desired flow rate, operate the humidification chamber 300 to humidify and heat the gas flow to an appropriate level, and supply the gas flow with an appropriate amount of oxygen (or an appropriate amount of alternative auxiliary gas).

[0348] The electronic component board can be electrically connected to a connector arrangement 274 protruding from the rear wall 122 of the upper housing 102. The connector arrangement 274 can be coupled to an alarm, pulse oximeter port, and / or other suitable accessories. The electronic component board can also be electrically connected to an electrical connector 276 (which may also be located in the rear wall 122 of the upper housing 102) to provide trunk power or battery power to components of the device.

[0349] As mentioned above, the operating sensors (e.g., flow, temperature, humidity, and / or pressure sensors) can be placed in various locations within the breathing apparatus, the patient breathing tube 16, and / or the cannula 51 (e.g., Figure 1 (as shown in the diagram). The electronics board can be electrically connected to those sensors. The output from the sensors can be received by the controller 19 to assist the controller 19 in operating the respiratory device 10 in a manner that provides optimal therapy (e.g., control to a set flow rate). The set flow rate can be selected such that it provides flushing of the patient's upper airway and / or meets or exceeds the patient's inspiratory needs and / or provides other advantages of high-flow therapy described herein. In the illustrated embodiment, the sensors are positioned on the electronics board, which is located within the housing. The sensors are encapsulated within the housing.

[0350] As outlined above, electronic component boards and other electrical and electronic components can be pneumatically isolated from gas flow paths to improve safety. Sealing also prevents water ingress.

[0351] 1.1 Control System

[0352] Figure 19A An example control system 920 is shown (which can be...) Figure 1 The block diagram 900 of the controller 19 in this example control system can detect the patient's condition and control the operation of a respiratory system including a gas source. The control system 920 can manage the flow rate of gas flowing through the respiratory system as it is delivered to the patient. For example, the control system 920 can increase or decrease the flow rate by controlling the output of the motor speed of a blower (hereinafter also referred to as a "blower motor") 930 or the output of a valve 932 in a mixer. The control system 920 can automatically determine a setpoint or personalized flow rate for a specific patient, as discussed below. The flow rate can be optimized by the control system 920 to improve patient comfort and treatment.

[0353] The control system 920 may 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 may indicate any alerts or alarms generated by the control system 920 to the physician. The display may also indicate control parameters that the physician can adjust. For example, the control system 920 may automatically recommend a flow rate for a specific patient. The control system 920 may also determine the patient's respiratory status (including, but not limited to, generating the patient's respiratory rate) and send it to the display, which will be described in more detail below.

[0354] The control system 920 can modify the heater control output to control one or more of the heating elements (e.g., to maintain a temperature setpoint for the gas delivered to the patient). The control system 920 can also modify the operation or duty cycle of the heating elements. The heater control output may include a heating plate control output 934 and a heated breathing tube control output 936.

[0355] The control system 920 can determine the outputs 930-939 based on one or more received inputs 901-916. Inputs 901-916 can correspond to those determined by the controller 600 (in...). Figure 19B (As shown in the diagram) Automatically received sensor measurements. The control system 920 can receive sensor inputs, including but not limited to temperature sensor input 901, flow rate sensor input 902, motor speed input 903, pressure sensor input 904, gas fraction sensor input 905, humidity sensor input 906, pulse oximeter (e.g., SpO2) sensor input 907, stored or user parameters 908, duty cycle or pulse width modulation (PWM) input 909, voltage input 910, current input 911, acoustic sensor input 912, power input 913, resistance input 914, CO2 sensor input 915, and / or spirometer input 916. The control system 920 can receive sensor measurements from memory 624 (in... Figure 19BThe system receives input from the user or stored parameter values ​​(as shown in the diagram). The control system 920 can dynamically adjust the flow rate for the patient during treatment. The control system 920 can continuously monitor system parameters and patient parameters. Based on the disclosure herein, those skilled in the art will understand that any other suitable inputs and / or outputs can be used with the control system 920.

[0356] 1.2 Controller

[0357] Figure 19B The controller 600 (which can be) was demonstrated. Figure 1 A block diagram of an embodiment of controller 600 (19). Controller 600 may include programming instructions for detecting input conditions and controlling output conditions. The programming instructions may be stored in memory 624 of controller 600. The programming instructions may correspond to the methods, processes, and functions described herein. The programming instructions may be executed by one or more hardware processors 622 of controller 600. The programming instructions may be implemented in C, C++, JAVA, or any other suitable programming language. Some or all of the programming instructions may be implemented in a special-purpose circuit system 628 (e.g., ASIC and FPGA).

[0358] The controller 600 may also include circuitry 628 for receiving sensor signals. The controller 600 may further include a display 630 for transmitting the status of the patient and the ventilator. The display 630 may also display alerts and / or other warnings. The display 630 may be configured to display, in real-time or otherwise, the characteristics of (multiple) sensed gases. The controller 600 may also receive user input via a user interface (e.g., the display 630). The user interface may include buttons and / or dials. The user interface may include a touchscreen.

[0359] 1.3 Motor and Sensor Module

[0360] Any feature of the respiratory system described herein (including, but not limited to, humidification chamber, flow generator, user interface, controller, and patient breathing tubing configured to connect the gas outlet of the respiratory system to the patient interface) may be combined with any sensor module described herein.

[0361] Figure 20 A block diagram of a motor and sensor module 2000 (or 'sensing block') is shown, which can be supplied by a breathing device (in... Figure 17 and Figure 18 The recess 250 (shown in the diagram) receives the air. The motor and sensor module may include a blower 2001 that carries indoor air for delivery to the patient. The blower 2001 may be a centrifugal blower.

[0362] One or more sensors (e.g., Hall effect sensors) can be used to measure the motor speed of a blower motor. The blower motor can include a brushless DC motor from which the motor speed can be measured without the need for a separate sensor. For example, during operation of a brushless DC motor, the back EMF can be measured from the unenergized windings of the motor, from which the motor position can be determined, which can then be used to calculate the motor speed. Alternatively, a motor driver can be used to measure the motor current, which can be used in conjunction with the measured motor speed to calculate the motor torque. The blower motor can also include a low-inertia motor.

[0363] Indoor air can enter through indoor air inlet 2002, which then enters blower 2001 through inlet port 2003. Inlet port 2003 may include valve 2004 through which pressurized gas enters blower 2001. Valve 2004 can control the oxygen flow into blower 2001. Valve 2004 can be any type of valve, including proportional valves or two-position valves. In some embodiments, the inlet port does not include a valve.

[0364] Blower 2001 can operate at motor speeds greater than 1,000 RPM and less than 30,000 RPM, greater than 2,000 RPM and less than 21,000 RPM, or any of the foregoing values. The operation of blower 2001 mixes the gas entering blower 2001 through inlet port 2003. Using blower 2001 as a mixer reduces pressure drops that would otherwise occur in systems with separate mixers (e.g., static mixers including baffles), as mixing requires energy.

[0365] The mixed air can exit the blower 2001 through duct 2005 and enter the flow path 2006 in the sensor chamber 2007. A sensing circuit board with sensors 2008 can be positioned in the sensor chamber 2007 such that the sensing circuit board is at least partially immersed in the gas flow. At least some of the sensors 2008 on the sensing circuit board can be positioned within the gas flow to measure the gas properties within the flow. After passing through the flow path 2006 in the sensor chamber 2007, the gas can exit 2009 to reach the humidification chamber.

[0366] Positioning the sensor 2008 downstream of the combined blower and mixer 2001 improves measurement accuracy (e.g., for measuring gas fractional concentrations, including oxygen concentration) compared to systems where the sensor is positioned upstream of the blower and / or mixer. Such positioning provides repeatable flow profiles. Furthermore, positioning the sensor downstream of the combined blower and mixer avoids pressure drops that would otherwise occur, since a separate mixer (e.g., a static mixer with baffles) is required between the inlet and the sensing system in cases where sensing occurs before the blower. The mixer introduces pressure drops across its ends. Positioning the sensor downstream of the blower allows the blower to act as a mixer, whereas a static mixer would reduce pressure, whereas the blower would increase it. Moreover, immersing at least a portion of the sensing circuit board and sensor 2008 in the flow path improves measurement accuracy because sensor immersion in the flow means they are more likely to experience the same conditions (e.g., temperature and pressure) as the gas flows, thus providing a better representation of the gas flow characteristics.

[0367] refer to Figure 21 The gas leaving the blower can enter the flow path 402 in the sensor chamber 400, which can be located within the motor and sensor module and can be... Figure 20 The sensor chamber 2007. The flow path 402 can have a curved shape. The flow path 402 can be configured to have a curved shape without sharp turns. The flow path 402 can have curved ends, with straighter sections between these curved ends. The curved flow path shape can reduce the pressure drop in the gas flow without reducing the sensitivity of the flow measurement by partially aligning the measurement area with the flow path to form the measurement portion of the flow path.

[0368] A sensing circuit board 404, incorporating sensors (e.g., acoustic transmitters and / or receivers, humidity sensors, temperature sensors, thermistors, etc.), can be positioned within a sensor chamber 400 such that the sensing circuit board 404 is at least partially immersed in a flow path 402. Immersing at least a portion of the sensing circuit board and the sensors in the flow path improves measurement accuracy because sensors immersed in the flow are more likely to experience the same conditions (e.g., temperature and pressure) as the gas flows, thus providing a better representation of the characteristics of the gas flow. After passing through the flow path 402 in the sensor chamber 400, the gas can exit to reach the humidification chamber.

[0369] At least two different types of sensors can be used to measure gas flow rate. The first type of sensor may include a thermistor, allowing the flow rate to be determined by monitoring heat transfer between the gas flow and the thermistor. As the gas flows around and past the thermistor, the thermistor flow sensor can keep the thermistor operating at a constant target temperature within the flow. The sensor can measure the electrical charge required to maintain the thermistor at the target temperature. The target temperature can be configured to be higher than the temperature of the gas flow, such that more electrical charge is required at higher flow rates to maintain the thermistor at the target temperature.

[0370] The thermistor flow rate sensor can also maintain multiple (e.g., two, three, or more) constant temperatures on the thermistor to avoid the difference between the target temperature and the gas flow temperature being too small or too large. These multiple different target temperatures allow the thermistor flow rate sensor to be accurate across a large temperature range of the gas. For example, the thermistor circuit can be configured to switch between two different target temperatures such that the temperature of the gas flow will always fall within a certain range (e.g., not too close but not too far) relative to one of the two target temperatures. The thermistor circuit can be configured to operate at a first target temperature of about 50°C to about 70°C or about 66°C. The first target temperature can be associated with a desired flow temperature range between about 0°C and about 60°C or between about 0°C and about 40°C. The thermistor circuit can be configured to operate at a second target temperature of about 90°C to about 110°C or about 100°C. The second target temperature can be associated with a desired flow temperature range between about 20°C and about 100°C or between about 30°C and about 70°C.

[0371] The controller can be configured to adjust the thermistor circuit by connecting or bypassing a resistor within the thermistor circuit to change between at least a first target temperature mode and a second target temperature mode. The thermistor circuit can be arranged in 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 of the thermistor flow rate sensor are described in PCT application publication number WO 2018 / 052320, filed September 3, 2017, which is incorporated herein by reference in its entirety.

[0372] The second type of sensor may include acoustic sensor components. Acoustic sensors, including acoustic transmitters and / or receivers, can be used to measure the time of flight of acoustic signals to determine gas velocity and / or composition; these acoustic sensors can be used in flow therapy devices. In one ultrasonic sensing topology (including an ultrasonic transmitter and / or receiver), a driver causes a first sensor (e.g., an ultrasonic transducer) to generate an ultrasonic pulse in a first direction. A second sensor (e.g., 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 velocity of sound of the gas flow between the ultrasonic transducers can be calculated by a processor or controller of the respiratory system. The second sensor may emit the pulse in a second direction opposite to the first direction, and the first sensor may receive the pulse to provide a second measurement of the time of flight, thereby allowing the determination of characteristics of the gas flow (e.g., flow velocity or flow rate). In another acoustic sensing topology, the acoustic pulse emitted by an acoustic transmitter (e.g., an ultrasonic transducer) may be received by an acoustic receiver (e.g., a microphone). Further details of the acoustic flow velocity sensor are described in PCT application publication number WO 2017 / 095241, filed on December 2, 2016, which is incorporated herein by reference in its entirety.

[0373] The one or more flow rate sensors, or sensor assemblies including one or more flow rate sensors, can be located in various positions within the breathing device and / or along the gas flow path. In one configuration, the one or more flow rate sensors or sensing assemblies can be located or arranged downstream of the flow generator 50B, i.e., the sensors are configured or arranged to sense or measure the flow rate of gas in the flow path downstream of the flow generator 50B. In this configuration, the flow rate signal or flow rate data generated by the one or more flow rate sensors can represent the flow rate signal or data output by the flow generator, i.e., the flow rate of the gas flow output from the flow generator 50B.

[0374] In one example configuration, one or more flow rate sensors or sensor assemblies may be located within the main housing 100, in front of or behind the humidifier 52 (if present). For example, a flow rate sensor may be arranged or configured within the main housing 100 to sense the flow rate of gas in a flow path located between the flow generator 50B and the humidifier 52, or in a flow path behind the humidifier. In another example configuration, one or more flow rate sensors or sensor assemblies may be located within or along the breathing tube 16 and / or the patient interface 51. In this configuration, the sensor or sensor assembly is configured to sense or measure the flow rate of gas in a flow path including the breathing tube 16 and / or the patient interface 51 or formed by the breathing tube and / or the patient interface (i.e., the flow path following the gas outlet 21 of the main housing 100). In yet another example configuration, the device may include any combination of the aforementioned configurations or locations of one or more flow rate sensors or sensor assemblies. For example, the device may include one or more flow rate sensors or any combination of sensor assemblies at any one or more locations along the gas flow path, whether in the main housing 100 or in the breathing tube 16 and / or patient interface 51.

[0375] In some configurations, readings from both the first type of sensor and the second type of sensor can be combined to determine a more accurate flow measurement. For example, a previously determined flow rate and one or more outputs from a sensor of one of these types can be used to determine a predicted current flow rate. The predicted current flow rate can then be updated using one or more outputs from a sensor of the other type of sensor to calculate the final flow rate.

[0376] 2. Example Implementation of the Breathing Work Determination Process

[0377] Methods and procedures for determining data indicating or representing the work of breathing will be described in the context of the example respiratory device 10 described above, which is configured or operable to deliver high-flow nasal therapy via an unsealed patient interface. As previously explained, these methods and procedures may also be applied to other respiratory devices and / or other modes of operation and / or modes of therapy delivered by such devices.

[0378] 2.1 Overview of the process for determining Work of Breath (WOB)

[0379] Work of breathing (WOB) is a valuable clinical measure that provides insights into the efficacy of respiratory therapy. Determining an estimated WOB value or index can be used to improve patient outcomes when using respiratory equipment. For example, in some configurations, the WOB index can be used to assess whether adjustments to the current respiratory equipment and / or treatment settings are needed, which parameters need to be adjusted, and / or by how much.

[0380] As those skilled in the art will understand, WOB has a generally accepted definition involving the energy or work required or exerted by a person during respiration. One way to determine true WOB is using a chest strap that measures the force and depth of chest movement during respiration; however, these are not always convenient or practical for some patients. In some scenarios, respiratory rate can be used as an indicator of WOB. This disclosure provides methods and procedures for determining one or more alternative analogues, substitutes, or indicators of WOB in a patient undergoing high-flow therapy delivered by a ventilator. Alternative WOB indicators can be used to enhance clinical decision-making, patient outcomes, and / or the operation of ventilator equipment to deliver improved high-flow therapy.

[0381] The embodiments described below are intended to provide a method for reliably estimating a patient's WOB index using sensor data available from a respiratory device and / or algorithms implemented thereon.

[0382] This disclosure relates to methods and / or algorithms for determining one or more patient or user WOB indices or estimates based at least in part on sensed flow parameter data that indicate or represent gas flow in a respiratory device during patient or user use. For example, methods for determining three different user WOB indices or estimates are described below. Each of these three example methods involves... The estimate represents the change in nasal pressure, which indicates the average nasal pressure of a user while the user is undergoing respiratory therapy with a breathing device.

[0383] In the example method, various WOB metrics are determined or calculated, at least in part, based on flow parameter data that indicate or represent the gas flow in the flow path of the breathing device.

[0384] In the example configuration, the flow parameter data includes flow rate data that indicates or represents the rate of gas flow provided by the respiratory device during respiratory therapy. In one example, the flow rate data may be a flow signal generated by one or more flow sensors set or located in the flow path of the respiratory device. These flow sensors may be positioned downstream of the flow generator of the respiratory device. When a patient uses the respiratory device during respiratory therapy, fluctuations in the flow rate signal around a typical human respiratory rate will be observed. The flow rate signal can be very noisy, and in the example configuration, algorithms and / or signal preprocessing may be applied to the raw flow signal generated by the flow sensors to minimize the impact of noise. By analyzing the fluctuations in the preprocessed flow rate signal, various useful WOB parameters or indicators associated with the patient can be extracted while the patient is undergoing respiratory therapy with the respiratory device.

[0385] In some example configurations, the flow parameter data used to generate the WOB index may additionally or alternatively include pressure data (e.g., the pressure at the blower outlet in a breathing apparatus) that indicates or represents the gas flow provided by the flow generator.

[0386] As will be seen, in these example configurations, there are some common steps used to determine all three example WOB metrics, which will be outlined below.

[0387] The methods and / or algorithms used to generate the WOB metric can be executed or implemented on any suitable controller or processor. In the example configuration, the methods and / or algorithms used to generate the WOB metric can be executed or implemented on the main controller or primary controller of the respiratory device. As explained above, the main controller of the respiratory device communicates electrically or data with flow sensors and / or pressure sensors located in the main housing of the respiratory device, the breathing tubing, and / or the patient interface. In some example configurations, a pressure sensing line can feed pressure samples from the patient interface to one or more pressure sensors located in the main housing of the respiratory device.

[0388] 2.2 First Example WOB Indicator – estimated value

[0389] The method or algorithm for generating the first example WOB indicator will now be described. The first example WOB indicator is based on determining or calculating the change in nasal pressure, i.e. Estimates, as will be explained below.

[0390] Generally, the flow rate through a breathing tube can be determined by applying known fluid dynamics relationships. The result is the following equation:

[0391] (1)

[0392] in:

[0393] It is the conductivity of the breathing tube – a measure of how easily / unimpeded gas can flow through the tube.

[0394] It refers to the gas flow rate through the breathing tube.

[0395] It is the output pressure of the blower in the breathing equipment.

[0396] It is the pressure at or inside the patient's nostrils ('nasal pressure').

[0397] In this example configuration, the tube conductivity value can be found using approximations and experimental values ​​without access to direct nasal pressure measurements. In other configurations, tubular conductivity can be derived or determined based on sensor data representing direct nasal pressure measurements.

[0398] In the context of NHF treatment delivered by respiratory devices, it has been found that typically:

[0399] (2)

[0400] This expression allows the determination of tube conductivity based on the following equation. Approximate value:

[0401] (3)

[0402] in yes The preliminary test values. In this example, This can be an initial estimate or guess of the nasal pressure. In one example, the initial estimate or guess may be at least partially based on preliminary estimates of the measured blower pressure and / or flow rate and / or conductance. In one example, the initial estimate or guess may be a mathematical guess, i.e., not a completely arbitrary choice of values, but a taught choice of appropriate initial values ​​that are likely to be close to the true values. In the example configuration, this can be derived or determined from one or more stored functions, prior relations, equations, models, or lookup tables based on one or more input parameters, such as, but not limited to, preliminary estimates of blower pressure, flow rate, and / or conductance. Value. In one example, based on prior knowledge of the expected or estimated pressure drop between the blower and the patient interface (e.g., nasal cannula), The value can be determined by the blower output pressure. The value depends on the pressure drop. In some configurations, for example, a large portion of the pressure drop is caused by the breathing tube.

[0403] In this example configuration, Pressure can be measured or sensed by one or more pressure sensors or pressure sensing configurations in the breathing device. In one example... Pressure data may be based on pressure data generated by one or more pressure sensors located at or near the outlet of the blower of the breathing device or in the flow path downstream of the blower of the main housing of the breathing device.

[0404] In one example configuration, the pressure sensor may be a gauge pressure sensor, which includes a port to the ambient environment and is configured to sense 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, Pressure data may include, or be represented by, gauge pressure data sensed by a gauge pressure sensor, or depend on the gauge pressure data.

[0405] In another example configuration, the pressure sensor can be an absolute pressure sensor, configured to sense and generate pressure data representing the absolute pressure at or near the blower outlet in the flow path. In this configuration, Pressure data may include, or be represented by, absolute pressure data generated by an absolute pressure sensor.

[0406] In another example configuration, the device may include: an absolute pressure sensor configured to sense the absolute pressure at or near the blower outlet; and an ambient pressure sensor configured to sense the ambient pressure. In this configuration, Pressure 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.

[0407] In this example configuration, The flow rate can be based on the flow rate at the outlet of the blower of the respiratory device (e.g., sensed by the device's flow sensor). This assumes there is no malfunction or unexpected behavior, such as tubing leakage due to improper connection between the gas outlet and tubing inlet of the main housing of the respiratory device. For example, assuming there is no significant leakage along the flow path from the blower to the patient interface connected to the end of the breathing tubing (e.g., tube), the flow rate... It should be very close to the flow rate at the blower outlet.

[0408] As explained above, pipe flow velocity The flow rate signal or data can be based on a flow rate sensor in the flow path downstream of the blower from the main housing of the breathing device. In this example configuration, The values ​​are based on the preprocessed flow velocity signal. For example, raw flow velocity signals or data from flow velocity sensors can be processed to remove and / or minimize the effects of noise in the signal. An example of preprocessing raw flow velocity signals will be explained later in Section 2.5.

[0409] In one example configuration, for ( The selection or calculation of the preliminary test values ​​can be pre-programmed and / or based on known relationships between gas flow parameters. In one example, the controller can be pre-programmed using a lookup table or other suitable data structure or function that contains information about the blower pressure. Blower flow rate (equivalent to that described above) ),as well as A series of approximate corresponding values ​​make it possible to select tests using or based on measurements or sensor data representing the blower's output pressure and flow rate. value( In one example configuration, this represents the option used to select a trial. The lookup table, function, or data structure of the value relationship can be stored in memory associated with or accessible by the controller of the breathing device (such as, but not limited to, the device's non-volatile memory).

[0410] Once you have selected or chosen the nasal pressure test The value can be determined based on the information provided above. The equation is used to estimate the transmissibility of the breathing tube. .

[0411] The equation can be rearranged into a single equation to estimate nasal pressure. :

[0412] (4)

[0413] (5)

[0414] As shown above, in this example, nasal pressure The estimated value depends on the blower output pressure. Pipe flow velocity and tube conductivity It is determined or calculated.

[0415] In this example, nasal pressure is used. The absolute estimate may be unreliable under some conditions due to multiple noise sources in flow and pressure measurements (e.g., blower motor noise, patient breathing, electronic noise, etc.) that the pretreatment steps can largely, but not completely, account for. Therefore, in this configuration, the WOB index algorithm can rely on nasal pressure... The WOB index is generated or represented by variables or parameters derived from the absolute value of the estimated value, rather than relying on the absolute value itself.

[0416] In this example configuration, the WOB metric can be based on the fluctuation value (i.e., 'delta') in the nasal pressure estimate, which is represented as This nasal pressure change value It is related to the patient’s breathing effort and can be observed as a WOB indicator because it depends only slightly on the noise source mentioned.

[0417] In this example configuration, the WOB index algorithm can be configured to use the following equation to determine the magnitude of nasal pressure fluctuation at a given time point ( ):

[0418] (6)

[0419] Mathematically, this equation is essentially what is shown above. The derivative of the equation. Variables The item indicates or indicates the ventilation rate per minute ( In this example, Estimate the average volume of air / gas mixture output per minute by the breathing device. Although Related to the gas flow output of the respiratory device, but because the patient's inspiratory and expiratory volumes are encoded in The signal is therefore very closely related to the patient's breathing. The methods for identifying the indication or representative are further described below in section 2.6. of Examples of methods for using signals or data.

[0420] because and Approximately constant, therefore in The value reflects The changes. The change is due to a change in the patient's respiratory effort (i.e., how much energy the patient expends when breathing). In this example configuration, increasing... The indicator WOB increases, and conversely, decreases. The WOB value decreases.

[0421] Nasal pressure change signal or value It can be calculated periodically or on an arbitrary or specific basis. In one example configuration, the nasal pressure change signal or value... The WOB metric can be calculated periodically at any suitable frequency using the WOB metric algorithm. In one example, The value is calculated as the WOB metric at a frequency selected from approximately 1 Hz to approximately 20 Hz (i.e., between approximately every 1 second and approximately every 5 ms). It will be understood that any suitable frequency can be chosen for calculation, depending on the application of the WOB metric and / or the characteristics of the incoming data stream used by the WOB metric algorithm. WOB indicator.

[0422] The WOB metric algorithm can be applied in the example configuration. Any one or more of the following aspects of the WOB indicator:

[0423] • In some configurations, compared to other disclosed WOB metrics, there are fewer potential sources of error. The WOB metric can be beneficial. For example, in one configuration, The WOB metric requires or relies solely on flow and pressure sensor data or signals from the respiratory device.

[0424] • Pipe conductivity It is approximately constant, but in some example configurations, filters can be used to... The same rate of update. This is because, in some scenarios or applications, the conductivity of the breathing tube (e.g., the tubing) may change if / when the position of the breathing tube changes during the delivery of respiratory therapy to the patient using a breathing device. For example, if the tubing becomes more curved or coiled, the conductivity will decrease (because the impedance increases in these cases), or vice versa if the tubing straightens during use.

[0425] • In some example configurations, the flow rate of gas through the breathing tube Ideally, it should be roughly constant to achieve the generated The WOB metric offers maximum accuracy / reliability. This is typically the case over time periods of one minute or longer. Nevertheless, in some configurations, the WOB metric algorithm can be configured to account for variations / changes in gas flow rate. For example, in some configurations, the WOB metric algorithm can be configured to account for variations in gas flow rate by: discarding spurious readings associated with transient flow rate changes and / or applying an averaging filter (e.g., an exponential filter) to smooth the data.

[0426] • In some example configurations The value of the WOB metric can 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, The value of the WOB index can depend on the patient's physiological characteristics, such as, but not limited to, their breathing effort.

[0427] 2.3 Second Example WOB Indicator – estimated value

[0428] The method or algorithm for generating the second example WOB indicator will now be described. The second example WOB indicator is based on the nasal pressure change value of the first example WOB indicator. And variables that represent or indicate changes in respiratory volume or the user's respiratory flow rate, or depending on both. In this example, changes in respiratory volume or the user's respiratory flow rate are determined by... express.

[0429] In one example configuration, the second WOB metric algorithm can be a variation of the first WOB metric algorithm. For example, the second WOB metric algorithm may include calculations other than... Additional steps or calculations beyond the WOB indicator will be explained further below.

[0430] In a system with a change in volume, the work done can be expressed as:

[0431] (7)

[0432] In this second example, if we use the nasal pressure change value replace Then it can be replaced by a measure or value of volume change. To estimate the actual WOB The value. In this example, the result of these substitutions provides the actual value of the WOB. The estimated value, not the WOB metric. For example, the estimated value of actual work provides a value in joules.

[0433] In this second example WOB metric algorithm, the measure or value representing the change in respiratory volume or the user's respiratory flow rate is expressed as: In this example, the user's respiratory flow rate can be roughly estimated using the following equation. :

[0434] (8)

[0435] All of these terms have the same physical meaning as previously described. This indicates the conductivity of the patient's nostrils / nares and can depend at least on the size of the patient's nostrils, as well as the size and fit of the nasal cannula. Although it can be easily estimated roughly... (As discussed earlier), but in this example configuration, The parameters may require calibration or learning processes to obtain accurate estimates.

[0436] In this example configuration, the user's breathing flow rate It can be physically similar to the patient's nasal ventilation per minute, which is caused by Indicates the nasal minute ventilation rate. It is a measure used to estimate the minute ventilation of a patient's nasal cavity, and is explained in detail in PCT patent application publication WO 2022 / 167960, filed February 3, 2022, which is incorporated herein by reference in its entirety. However, unlike Measurement, user's respiratory flow rate It can better take into account the flow guiding components in high-flow-rate treatment systems (e.g., respiratory devices configured to deliver NHF therapy), and therefore can be a more general indicator of the average amount of air entering / leaving the patient's nasal cavity per minute. In this example configuration, in addition to being transformed by some factor, It can be similar to This factor combines information and / or depends on the patient interface (e.g., size, type, etc.) and the adaptability of the patient interface (e.g., the degree of nasal obstruction in the context of nasal intubation).

[0437] In this example configuration, the user's breathing flow rate The equation or function is derived by applying the flow-pressure equation to a suitable patient nostril model: conductivity * pressure = flow. 2 Alternatively, pressure can be calculated as pressure = resistance * flow rate. 2 In one example, the patient's nostril model is based at least in part on three key flows: the flow into the nostril via the nasopharynx due to the patient's breathing, the flow out of the nostril, and the leakage flow from / around the nasal cannula. This yields three simultaneous equations (9)-(11), which can be rearranged and solved for the patient's respiratory flow. In this example, then... Integrate the resulting expression (e.g., take its average). Thus, the above equation is derived (used to determine...). (average).

[0438] For example, these three simultaneous equations could be:

[0439] (9)

[0440] (10)

[0441] (11)

[0442] The three simultaneous equations (9) - (11) above are some examples of possible equations that can be used and solved for the patient's respiratory flow. In alternative configurations, if more accurate modeling is desired or required for a particular application or situation, one or more different and / or more complex equations with more parameters can be used.

[0443] In one example configuration, it is used to obtain The calibration process for the estimated value or value may require inserting a suitable nasal cannula into the patient's nostril, followed by testing the respiratory device at a series of predetermined flow rates while simultaneously measuring or estimating the nasal pressure at each discrete flow rate. Additionally or alternatively, in another example configuration, the calibration process can be non-discrete, involving providing flow rate scans while continuously measuring or estimating nasal pressure.

[0444] In another alternative configuration, estimation can be made, at least in part, based on one or more patient physiological factors or characteristics, using manual input from the user or clinician. The value can be estimated, for example, based on parameters or estimates relating to patient size (e.g., body length) and / or intubation-nasal obstruction (e.g., the estimated percentage obstruction of the intubation fork tube to the nasal cavity), and / or one or more other suitable parameters. The value of .

[0445] To further explain, regarding patient size, it can be expected that longer (larger) patients will have larger nostrils (e.g., adult patients compared to pediatric or even infant patients). Size (e.g., the cross-sectional area of ​​the nostril opening) will contribute to... Regardless of whether the nasal cannula fits optimally, larger patients will typically be fitted with larger cannulas than smaller patients (e.g., children), and the larger cannulas will have a forked tube with a wider orifice that provides less flow resistance.

[0446] To further explain, regarding intubation-nasal obstruction (or 'nasal blockage'), a higher percentage of obstruction means a tighter fit between the inside of the nostril and the wall of the intubation fork, and conversely, a lower percentage of obstruction means there is more space between the intubation fork and the inside of the nostril. Depending on the degree of obstruction, the amount / rate of airflow exhaled through the fork or fork-nasal 'gap' will vary and thus affect flow conduction.

[0447] In this example, The estimate can be based on the relationship determined by previous empirical testing.

[0448] This second example of the WOB metric algorithm generates a representation. The estimated value of the WOB index can be considered as the actual estimate of the WOB, as described above. In this example configuration, this... The WOB metric may involve more than the first example. The WOB index involves more computational steps. In this example, the additional computational steps are likely primarily due to the need to estimate or derive the conduction rate of the patient's nostrils. This is generated based on the value. This second example... The WOB metric can provide a practical estimate of WOB that clinicians may be more familiar with. In this example, the second example... The accuracy and reliability of the WOB metric can at least partially depend on The accuracy of the value. In some configurations, The accuracy of the values ​​may depend at least in part on or depend on additional inputs or parameters about the patient provided by the clinician, as described above.

[0449] 2.4 Third Example: WOB Indicator – estimated value

[0450] The method or algorithm for generating the third example WOB indicator will now be described. The third example WOB indicator is based on the nasal pressure change value of the first example WOB indicator. And variables that represent or indicate the breathing ease factor, or, depending on both. In this example, the breathing ease factor is represented by σ.

[0451] In one example configuration, the third WOB metric algorithm can be a variation of the first WOB metric algorithm. For example, the third WOB metric algorithm may include calculations other than... Additional steps or calculations beyond the WOB indicator will be explained further below.

[0452] In this third example, the WOB index algorithm is configured to apply the breathing smoothness factor σ. The estimated value is generated from this. The WOB metric. In this example, breathing ease is a mathematical concept based on the number of possible continuous derivatives of a quantized function over a domain. In the case of data, breathing ease physically involves the rate of change of nasal pressure fluctuations.

[0453] This measure of breathing ease It is useful because it can indicate a patient's respiratory rate (or be strongly correlated with it). For example, a higher respiratory rate will be evident in nasal pressure fluctuation signals or data as a steeper rate of change, which will be reflected in the breathing smoothness value. (That is, a value representing a decrease in breathing ease) is used for measurement, and vice versa (that is, an increase in breathing ease value can represent a lower breathing rate).

[0454] In one example configuration, the third WOB index algorithm can determine or calculate the breathing smoothness factor based at least in part on an estimate or value of the patient's minute ventilation (e.g., device minute ventilation). For example, the WOB metric algorithm can be configured to estimate device minute ventilation (WFM) according to any of the methods outlined below in Section 2.6 or any other suitable method. In this example, the calculated WFM estimate can then be normalized. For example, the WFM can be normalized based on or according to the number of available data points, and then passed to an output frequency-independent measure or factor of breathing smoothness. The function. In this example, the function can be predetermined through a combination of analytical and numerical analysis.

[0455] Then, the third WOB index algorithm is configured to use the calculated breathing smoothness factor. Applied to (e.g., the WOB metric in the first example) The WOB indicator was used to generate a third example WOB indicator. In this example, compared to the first example... Compared to the WOB indicator, The WOB metric can be mathematically more dependent on the respiratory rate. In this configuration, the third example WOB metric can be more closely resembled the confirmed pressure-time product metric, which is another known WOB measure.

[0456] 2.5 Preprocessing of Flow Velocity Signals

[0457] As explained above, the example WOB index methods or algorithms and their respective output WOB indices are at least partially based on flow parameter data. In the examples, the flow parameter data may include at least flow velocity data from one or more flow velocity sensors, which represent or indicate the flow velocity of the gas in the flow path. As further explained, typically, the WOB index algorithm receives and utilizes preprocessed flow velocity signals or data; that is, the raw flow velocity data or signals from the flow sensors are preprocessed to remove or minimize the effects of noise in the signal. In alternative configurations, it will be understood that the WOB index algorithm may receive raw flow velocity signals or data and perform preprocessing steps or stages as part of the WOB index algorithm.

[0458] Examples of some forms of preprocessing that can be applied to raw flow velocity signals or data, which are then further processed and / or used as input to generate WOB indicators, will now be described below.

[0459] As discussed above, flow data (e.g., flow rate data) in unsealed systems (e.g., high-flow nasal systems) can be difficult to determine. The open nature of the system results in a very low signal-to-noise ratio. For example, unsealed interfaces (nasal cannulas) tend to generate significant leakage and vortex flows around the patient's nostrils, contributing substantial amounts of noise to the sensed flow rate signal (e.g., raw flow rate data). Any flow data measured may include various irregularities and noise that can obscure the flow data and must be resolved to accurately determine the desired measurement. Flow data is important because it informs the unsealed system, the patient's respiratory flow, and / or other device or patient measurements and / or parameters.

[0460] In this example, to remove noise and other irregularities from any acquired flow data, the flow signal can be fed through a preprocessing step or stage. Preprocessing allows the controller to remove certain distortions from the flow parameters, so that the flow parameter signals used to determine device output and / or patient respiratory parameters (e.g., WOB indices) better reflect the impact of the gas flow parameters used in the patient's treatment on the patient's respiration. Further details regarding the preprocessing of the flow signal are described in PCT application publication WO / 2020 / 178746, filed March 4, 2020, which is incorporated herein by reference in its entirety.

[0461] If a patient is attached to a respiratory system and breathes through a patient interface, the fluctuations in preprocessed flow rate or other flow parameter data obtained in an open system (i.e., an unsealed system that delivers a flow of gas to a patient via an unsealed interface, such as a nasal cannula) consist of random, unrelated noise and relevant respiratory signals generated from various sources. Specifically, fluctuations in the flow parameter data can include noise (random and unrelated to the patient's breathing) and patient respiratory signals (related to the patient's breathing). Data preprocessing can begin with the controller receiving flow parameter data (e.g., unprocessed or raw data). The controller can then perform preprocessing steps, such as determining whether the flow parameter data is good or suitable for use. If the data is unsuitable for use, the controller can discard the data.

[0462] In determining the suitability of data, the controller may receive second flow parameter data of a different type than 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 may affect or provide an indication of gas flow rate, separate from the effect of the patient's breathing on gas flow rate. The controller may be configured to determine whether the second flow parameter data can be used as a correlation parameter with the first flow parameter data. For example, if the second flow parameter data meets a threshold level, then the second flow parameter data may be a useful correlation measure. If the second flow parameter data does not meet the threshold level, then it is assumed that the second flow parameter data is unrelated to the first flow parameter data. Therefore, the second flow parameter data may be ignored or discarded (i.e., deleted or not used by the controller). If insufficient second flow parameter data exists, the controller may determine that it does not have enough data to use the first flow parameter data and may discard the first parameter data. If the second flow parameter data meets a minimum threshold level, the controller may determine that the first parameter data is suitable for use.

[0463] As an example, the second flow parameter data could represent motor speed. For the motor to operate at a sufficient speed to identify a patient's breathing in the first flow parameter data, it might not accurately predict the effect or correlation of motor speed on flow data (e.g., flow rate). Therefore, after receiving the motor speed data, the controller 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 unsuitable and discard part or all of it. However, if the motor speed is above the threshold, the controller can calculate the most recent change in motor speed. Changes in motor speed can cause changes in the first flow parameter data, making it more difficult to identify a patient's breathing in the first flow parameter data. While the effect of motor speed can be removed from the first flow parameter data to some extent, large changes in motor speed can make the data too unreliable for identifying a patient's breathing. Therefore, the controller can apply a running filter to the relative change in motor speed to generate a first value representing the most recent relative change in motor speed. The controller can then compare the first value to a first threshold. If the first value is above 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 to be suitable for use.

[0464] As another example, the second flow parameter data could represent the concentration of the supplemental gas from the supplemental gas source. The first flow parameter data (e.g., flow rate) may be affected by the flow rate or concentration of the supplemental gas from the supplemental gas source. The controller can receive oxygen flow rate data or oxygen concentration data. The controller can calculate the most recent change in oxygen flow rate or oxygen concentration. If the oxygen flow rate or concentration changes, the resulting change in the total flow rate may make it more difficult to identify the patient's breathing in the flow rate signal or other flow parameter signals. Therefore, the controller can apply a running filter to the change in the oxygen concentration or oxygen flow rate of the gas to generate a second value representing the most recent change in oxygen concentration or flow rate. The controller can compare the second value to a second threshold. If the second value is higher than the second threshold, the controller can determine that the first flow parameter data is inappropriate and can discard the first flow parameter data point. However, if the second flow parameter data is lower than the threshold, the controller can consider the flow parameter data appropriate.

[0465] As described above, if the controller deems the data appropriate, the first flow parameter data (or any other flow parameter data) can also be modified to remove the influence of the motor (or other factors, such as oxygen concentration or flow rate). Modifying the first flow parameter data may involve removing assumed influences of other variables from the first flow parameter data (e.g., motor speed). Such assumed influences are only valid if the gas flow parameter data meets certain criteria. As described above, if these criteria are not met, the data can be discarded.

[0466] This process can modify the initial flow parameter data to remove the influence of motor speed. The motor's influence can be estimated using motor speed and flow conductance. The controller can measure instantaneous flow conductance. Flow conductance can be calculated as described below:

[0467]

[0468] In the equations provided above, C is the flow conductance, filt() is the filter function, and Q is the flow parameter data. This refers to the motor speed. In some configurations, the filtering function is a low-pass filter. In some examples, the flow parameter data is a flow velocity signal generated by the flow velocity sensor of the breathing device. The flow conductance is approximately constant over time and can therefore be estimated using a low-pass filter. The controller uses the current motor speed and the measured flow velocity to measure the instantaneous flow conductance at each iteration. The controller can filter the instantaneous flow conductance to determine the filtered flow conductance.

[0469] The controller can compare the instantaneous conductance with the filtered conductance to see if the difference is significant. If the difference is significant, something may have altered the physical system, such as a cannula being attached or detached. The instantaneous conductance can be compared with the filtered conductance by taking the difference between the two variables 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 conductance. The controller can also adjust the filter coefficients of the filter function in the filtered conductance calculation based on the difference between the instantaneous and filtered conductance. This allows the filtered conductance to change more rapidly when the variance of the conductance is high (e.g., when the cannula is first attached).

[0470] If the difference between the instantaneous conductance and the filtered conductance does not exceed a threshold, the difference is considered insignificant, and the controller can estimate the motor's effect on flow rate. The controller can use the filtered conductance and motor speed to output a value for this effect. This value can be subtracted from or otherwise removed from the flow rate data to obtain preprocessed flow rate data. Preprocessed flow rate data can be more indicative of the patient's respiratory flow (although preprocessed flow rate data may still include signal noise).

[0471] The controller can also track recent changes in flow conductance. This can be done by adding the difference between the last two instantaneous flow conductance values ​​to the total number of runs, which then decays over time. The decaying total number of runs is filtered to obtain a filtered recent change in flow conductance. This filtered recent change in flow conductance, along with preprocessed velocity data, can be used in further parts of the frequency analysis algorithm.

[0472] 2.6 Determine the ventilation rate per minute of the device.

[0473] As explained above, the example WOB index algorithms and some of their respective WOB indices are at least in part based on the device minute ventilation of the respiratory equipment. Or it depends on the ventilation rate of the device per minute.

[0474] refer to Figure 22A-23 The following section describes the methods used to determine or calculate the ventilation rate per minute of the device. Examples of various methods for estimating the device's minute ventilation (WBO) are provided, though it will be understood that alternative methods may be used. In some configurations, the WBO index algorithm may implement such a method for determining the device's minute ventilation estimate or data. In other configurations, the device's minute ventilation estimate or data may be calculated separately in the controller and then fed to the WBO index algorithm executed on the controller.

[0475] While measuring inspiration and expiration is relatively easy in sealed systems, measuring respiratory parameters is much more difficult in unsealed systems. In unsealed systems (e.g., high-flow nasal systems), the open nature of the system (due to the use of unsealed patient interfaces) makes determining patient respiratory parameters significantly more difficult, as the expected signals are often weak and / or masked by noise.

[0476] This disclosure provides a reliable method for estimating key patient respiratory parameters (e.g., WOB indices) in unsealed systems (e.g., unsealed nasal cannulas used in high-flow systems).

[0477] The controller may include a device configured to calculate the ventilation rate per minute (V / V). The process of estimating the value of ). The ventilation rate per minute of the device ( Device ventilation per minute (DMF) is a measure of the average volume of air propelled out of the breathing apparatus (i.e., the device) per minute. In some configurations, device ventilation per minute (DMF) is... () can be a discrete value or a series of discrete values ​​(e.g., a series of previously estimated values). In some examples, this series of discrete values ​​can be derived from the device's ventilation rate per minute ( The first estimate of the ventilation rate (tidal volume) begins and continues until the end of the respiratory device use (treatment) period. Alternatively, the device minute ventilation (tidal volume) is used. A series of discrete values ​​for the estimate can represent a specific time window and are continuously rewritten when estimating new values. For example, the device's ventilation rate per minute (VPR). A series of discrete values ​​for the estimated value can represent their values ​​over a recent period of time. In some configurations, this time 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, between 15 and 20 minutes, between 20 and 25 minutes, between 25 and 30 minutes, between 30 and 35 minutes, between 35 and 40 minutes, between 40 and 45 minutes, between 45 and 50 minutes, between 50 and 55 minutes, between 55 and 60 minutes, between 60 and 65 minutes, between 65 and 70 minutes, between 15 and 30 minutes, between 30 and 45 minutes, between 45 and 60 minutes, and any value (including endpoints) between those listed ranges.

[0478] Figure 22A , Figure 22B , Figure 22C and Figure 22D This demonstrates the estimated ventilation rate per minute of the device ( The four flowcharts of the method. Figure 22A This demonstrates the estimated ventilation rate per minute of the device ( The simplified method of 1000 is 1000. Figure 22B , Figure 22C and Figure 22D This demonstrates the estimated ventilation rate per minute of the device ( Examples of more detailed methods 1100, 1200, and 1300.

[0479] like Figure 22A As shown, the estimated ventilation rate per minute of the device ( Method 1000 begins by obtaining raw flow rate data at step 1002. The raw flow rate data can be obtained from a flow rate sensor (e.g., an ultrasonic flow sensor). The estimated ventilation rate per minute (VPM) of the device is then calculated. The method may include, at step 1004, preprocessing the raw flow rate data to remove unwanted signal components. The removal of unwanted signal components has been described in more detail above. Unwanted signal components may be present from the flow generator motor. In some configurations, unwanted signal components may be generated from other sources (e.g., noise), and may primarily originate from the flow generator motor. For example, the preprocessed flow data may be a flow rate 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 rate signal as magnitudes of flow rate changes (e.g., as fluctuations). Once preprocessed, the flow data can represent the patient's respiratory data. Method 1000 may include step 1006, where, assuming the data has sufficient quality, the preprocessed data may be passed to a device minute ventilation algorithm to calculate the device minute ventilation (DMV). ).

[0480] refer to Figure 22B The description will estimate the ventilation rate per minute of the device ( A more detailed flowchart of method 1100 is provided below. Similar to method 1000, method 1100 begins by obtaining raw flow rate data at step 1102. The raw flow rate data can be obtained from a flow rate sensor (e.g., an ultrasonic flow sensor). Method 1100 may include, at step 1104, preprocessing the raw flow rate data to remove unwanted signal components. The removal of unwanted signal components is described in more detail above. Unwanted signal components may be present from the flow generator motor. Once preprocessed, the flow data can represent the patient's respiratory data. The processed flow rate data can then be analyzed at step 1106 to determine if the data quality is good enough. If not, the flow data is discarded, and method 1100 returns to step 1102 and waits to receive the raw flow data.

[0481] However, if the data is determined to be of sufficient quality, it can proceed to step 1112, where method 1100 uses the processed data to calculate the device's ventilation rate per minute. If the data does not include large transient peaks (which may be due to interface adjustments), the data can be considered to have sufficient quality. Device ventilation per minute ( ) Measure the average volume of air propelled out of the device per minute. As shown in step 1112, this is used to calculate the device's per-minute airflow rate ( The process can be accomplished by first fitting splines to the streaming data using a least-squares criterion. The streaming data can be, for example, the most recent pre-filtered velocity data points. In some configurations, the least-squares criterion first approximates the pre-processed streaming data (e.g., a respiratory signal) and then integrates along the splines to estimate the ventilation.

[0482] Method 1100 may include step 1116, in which splines are used to calculate the device's ventilation rate per minute. The instantaneous estimate of the ventilation rate per minute (VPM). In some examples, the use of splines may be more useful than alternative methods (e.g., a series of filters configured to generate statistical measures of the data) because it can perform better across a wider range of sampling frequencies (i.e., fit / interpolate the data more accurately). This is described in more detail below. Method 1100 may include calculating the ventilation rate per minute (VPM). Three different methods for instantaneous estimation of the ventilation rate per minute (VOC). The estimated value represents the value fitted to the gas flow parameter data. The integral of the absolute value of the first term of the line is divided by the time range covered by the selected filtered velocity data points (i.e., the zero-order spline). The device's ventilation rate per minute ( The estimated value of ) is represented by the following: fitted to the gas flow parameter data ( The integral of the absolute value of the line is divided by the time range covered by the selected filtered velocity data points (i.e., the first-order spline). This is used to calculate the device's ventilation rate per minute (V / V). The instantaneous estimate of ) can be obtained within 1 second, or 20 estimates can be obtained within 1 second (i.e., the sampling frequency is 20 Hz). The time period used to calculate the estimate can be any of the following ranges: between at least 1 and 120 seconds, between 1 and 60 seconds, between 60 and 120 seconds, between 1 and 10 seconds, between 10 and 20 seconds, between 20 and 30 seconds, between 30 and 40 seconds, between 40 and 50 seconds, between 50 and 60 seconds, between 60 and 70 seconds, between 70 and 80 seconds, between 80 and 90 seconds, between 90 and 100 seconds, between 100 and 110 seconds, between 110 and 120 seconds, or can be at least one of the following: 1 second, 10 seconds, 20 seconds, 30 seconds, 40 seconds, 50 seconds, 60 seconds, 70 seconds, 80 seconds, 90 seconds, 100 seconds, 110 seconds, and 120 seconds.

[0483] The ventilation rate per minute of the device ( The estimated value represents the average of the absolute values ​​of the curve fitted to the gas flow parameter data (i.e., calculated without data interpolation using splines). Any of the aforementioned estimates can be used as input in Method 1100; however, each estimate has advantages and disadvantages depending on the sensor data and random errors in the patient's respiratory rate. Method 1100 can use the device minute ventilation (MMV) The estimate is the integral of the absolute value of the first term of the line fitted to the signal. This estimate is likely the most resilient to random errors and least affected by them, but also most affected by the respiratory rate.

[0484] refer to Figure 22C The description will estimate the ventilation rate per minute of the device ( A more detailed flowchart of method 1200 is provided below. Similar to methods 1000 and 1100, method 1200 begins by obtaining raw flow rate data at step 1202. The raw flow rate data can be obtained from a flow rate sensor (e.g., an ultrasonic flow sensor). In some configurations, at step 1204, the raw flow rate data is first analyzed to determine if the data quality is sufficient. If the raw flow rate data is determined to be of sufficient quality, the data can be preprocessed to remove unwanted signal components. If the raw flow rate data is of insufficient quality, the flow rate data is discarded, and method 1200 returns to step 1202 and waits to receive additional raw flow data. In some examples, method 1200 may include: at step 1206, preprocessing the raw flow rate data to remove unwanted signal components. The removal of unwanted signal components is described in more detail above. Unwanted signal components may be present from the flow generator motor. Once preprocessed, the flow data can represent the patient's respiratory data. In some configurations, once the streaming data has been preprocessed, it can proceed to step 1212, where method 1200 curve-fits the streaming data. If the data does not include large transient peaks (potentially due to interface tuning), it can be considered to have sufficient quality. Device ventilation per minute ( The average volume of air propelled out of the device per minute is measured. The process of fitting a curve to the streaming data can be accomplished by first fitting a spline to the streaming data using the least squares criterion. In some configurations, the fitted line can be (approximately) represented by the following equation:

[0485]

[0486] In the equations provided above, m is the fitting parameter corresponding to the mean of the streaming data, s is the slope (i.e., the 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 "earliest" time point in the streaming data is equal to -1 and the "most recent" time point in the streaming data is equal to 1.

[0487] In some configurations, other function approximation methods may also be used. Flow data may be, for example, the most recent pre-filtered flow velocity data points. In some examples, least squares methods may be used to approximate preprocessed flow data (e.g., respiratory signals) and then integrated along splines to estimate ventilation. In some configurations, the controller may perform various line and / or curve fitting techniques to fit the one or more functions to selected portions of the flow parameter variation data. This may include, for example, regression analysis, interpolation, extrapolation, linear least squares, nonlinear least squares, total least squares, simple linear regression, robust simple linear regression, polynomial regression, orthogonal regression, Deming regression, linear piecewise regression, regression dilution, and / or other non-limiting example techniques. In some configurations, the one or more functions (which include at least those described above) may generate a curve. In some configurations, the curve may be a line. The line or curve described herein may include multiple curves, vertices, and / or other features. The line described herein may be straight, angled, and / or horizontal. In some examples, the line described herein may be a best-fit line.

[0488] Method 1200 may include step 1214, in which data from a curve constructed from fitted splines are used to calculate the device ventilation rate per minute. The instantaneous estimate of the ventilation rate per minute (VPM). Method 1200 may include calculating the ventilation rate per minute (VPM). Three different methods for instantaneous estimation of the ventilation rate per minute (VOC). The estimated value of ) is represented by the following: fitted to the gas flow parameter data ( The integral of the absolute value of the first term of the line is divided by the time range covered by the selected filtered velocity data points (i.e., the zero-order spline). The device's ventilation rate per minute ( The estimated value of ) is represented by the following: fitted to the gas flow parameter data ( The integral of the absolute value of the line is divided by the time range covered by the selected filtered velocity data points (i.e., the first-order spline). This is used to calculate the device's ventilation rate per minute (V / V). The instantaneous estimate of ) can be obtained within 1 second, or 20 estimates can be obtained within 1 second (i.e., the sampling frequency is 20Hz). The time period used to calculate the estimate can be any of the following ranges: between at least 1 and 120 seconds, between 1 and 60 seconds, between 60 and 120 seconds, between 1 and 10 seconds, between 10 and 20 seconds, between 20 and 30 seconds, between 30 and 40 seconds, between 40 and 50 seconds, between 50 and 60 seconds, between 60 and 70 seconds, between 70 and 80 seconds, between 80 and 90 seconds, between 90 and 100 seconds, between 100 and 110 seconds, between 110 and 120 seconds, or can be at least one of the following: 1 second, 10 seconds, 20 seconds, 30 seconds, 40 seconds, 50 seconds, 60 seconds, 70 seconds, 80 seconds, 90 seconds, 100 seconds, 110 seconds, and 120 seconds.

[0489] The ventilation rate per minute of the device ( The estimated value represents the average of the absolute values ​​of the curve fitted to the gas flow parameter data (i.e., calculated without data interpolation using splines). Any of the aforementioned estimates can be used as input in Method 1200; however, each estimate has advantages and disadvantages depending on the sensor data and random errors in the patient's respiratory rate. Method 1200 can use the device minute ventilation (MMV)... The estimated value is represented by the integral of the absolute value of the first term of the line fitted to the signal. This estimated value is likely to be most resilient to random errors and least affected by them, while also being most affected by the respiratory rate. In some embodiments, method 1200 may skip step 1212, and the preprocessed flow data may proceed directly to step 1214, in which method 1200 may directly calculate the average value of selected preprocessed flow rate data points.

[0490] In one example configuration, method 1200 can also be configured to apply a filter at step 1216 to the instantaneous device ventilation per minute ( The average is then calculated. In some configurations, a filter (e.g., an exponential filter) may be used to average or "smooth" each estimate or sequence of estimates captured through multiple repetitions of the previously described steps. In some examples, this step may occur after the initial estimate but before any additional processing steps.

[0491] In some configurations, the device's ventilation rate per minute ( The estimate of the flow rate is determined by obtaining an estimate, which involves taking the integral of the absolute value of the first term of the line fitted to the flow rate signal (e.g., a zero-order spline). In some examples, all three methods discussed above are used to estimate the device ventilation rate per minute for each data point. As previously mentioned, these three methods include: (1) where the device provides ventilation per minute ( The estimated value of ) is represented by the following: fitted to the gas flow parameter data ( (2) The integral of the absolute value of the first term of the line divided by the time range covered by the selected filtered velocity data points (i.e., the zero-order spline); where the device ventilation rate per minute ( The estimated value of ) is represented by the following: fitted to the gas flow parameter data ( The integral of the absolute value of the line divided by the time range covered by the selected filtered velocity data points (i.e., the first-order spline); and (3) the device's ventilation rate per minute ( The estimated value represents the average of the absolute values ​​of the curve fitted to the gas flow parameter data (i.e., calculated without using splines for data interpolation).

[0492] refer to Figure 22D The description will estimate the ventilation rate per minute of the device ( Another flowchart of method 1300. In this method 1300, all three methods discussed above are used to estimate the device ventilation per minute for each data point. Similar to methods 1000, 1100, and 1200, method 1300 begins by obtaining raw flow rate data at step 1302. The raw flow rate data can be obtained from a flow rate sensor (e.g., an ultrasonic flow sensor). In some configurations, at step 1304, the raw flow rate data is first analyzed to determine if the data quality is sufficient. 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 and waits to receive additional raw flow rate data. In some examples, method 1300 may include: at step 1306, preprocessing the raw flow data to remove unwanted signal components. The removal of unwanted signal components is described in more detail above. Unwanted signal components may be present from the flow generator motor. Once preprocessed, the flow rate data can represent the patient's respiratory data. In some configurations, once the flow rate data has been preprocessed, it can proceed to step 1312, where method 1300 curve-fits the flow rate data. If the data does not include large transient peaks (potentially due to interface adjustments), it can be considered to have sufficient quality. Ventilation rate per minute (V / V) The average volume of air propelled out of the device per minute is measured. The process of fitting a curve to the streaming data can be accomplished by first fitting a spline to the streaming data using the least squares criterion. In some configurations, the fitted line can be (approximately) represented by the following equation:

[0493]

[0494] In the equations provided above, m is the fitting parameter corresponding to the mean of the streaming data, s is the slope (i.e., the 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 "earliest" time point in the streaming data is equal to -1 and the "most recent" time point in the streaming data is equal to 1.

[0495] In some configurations, other function approximation methods may also be used. Flow data may be, for example, the most recent pre-filtered flow velocity data points. In some examples, least squares methods may be used to approximate preprocessed flow data (e.g., respiratory signals) and then integrated along splines to estimate ventilation. In some configurations, the controller may perform various line and / or curve fitting techniques to fit the one or more functions to selected portions of the flow parameter variation data. This may include, for example, regression analysis, interpolation, extrapolation, linear least squares, nonlinear least squares, total least squares, simple linear regression, robust simple linear regression, polynomial regression, orthogonal regression, Deming regression, linear piecewise regression, regression dilution, and / or other non-limiting example techniques. In some configurations, the one or more functions (which include at least those described above) may generate a curve. In some configurations, the curve may be a line. The line or curve described herein may include multiple curves, vertices, and / or other features. The line described herein may be straight, angled, and / or horizontal. In some examples, the line described herein may be a best-fit line.

[0496] Method 1300 may include step 1314, in which data from a curve constructed from fitted splines are used to calculate the device ventilation rate per minute. The instantaneous estimate of the ventilation rate per minute (VPM). Method 1300 may include calculating the ventilation rate per minute (VPM). There are three different methods for instantaneous estimation of the ventilation rate per minute. In some configurations, one of the three estimates is represented by the device ventilation rate per minute (VPM). Estimates of the gas flow parameter data: fitted to the gas flow parameter data ( The integral of the absolute value of the first term of the line is divided by the time range covered by the selected filtered velocity data points (i.e., the zero-order spline). In some examples, another of the three estimates is the device ventilation rate per minute, expressed as follows: Estimates of the gas flow parameter data: fitted to the gas flow parameter data ( The integral of the absolute value of the line is divided by the time range covered by the selected filtered velocity data points (i.e., the first-order spline). This is used to calculate the device's ventilation rate per minute (V / V). The instantaneous estimate of ) can be obtained within 1 second, or 20 estimates can be obtained within 1 second (i.e., the sampling frequency is 20 Hz). The time period used to calculate the estimate can be any of the following ranges: between at least 1 and 120 seconds, between 1 and 60 seconds, between 60 and 120 seconds, between 1 and 10 seconds, between 10 and 20 seconds, between 20 and 30 seconds, between 30 and 40 seconds, between 40 and 50 seconds, between 50 and 60 seconds, between 60 and 70 seconds, between 70 and 80 seconds, between 80 and 90 seconds, between 90 and 100 seconds, between 100 and 110 seconds, between 110 and 120 seconds, or can be at least one of the following: 1 second, 10 seconds, 20 seconds, 30 seconds, 40 seconds, 50 seconds, 60 seconds, 70 seconds, 80 seconds, 90 seconds, 100 seconds, 110 seconds, and 120 seconds. In some configurations, another of the three estimates is the device ventilation rate per minute (VPR) expressed as follows: The estimated value of MV is the average of the absolute values ​​of the curves fitted to the gas flow parameter data (i.e., calculated without data interpolation using splines). In some configurations, the first MV... 装置 The estimated value (i.e., the zero-order spline) is most resilient to noise / least dependent on noise and is most affected by the patient's respiratory rate. In some examples, the second MV 装置 The estimates (i.e., the first-order splines) are significantly dependent on noise, but less dependent on respiration rate. In some configurations, the third MV... 装置 The estimates (i.e., where there is no spline / interpolation and the estimates are a direct average of a series of instantaneous absolute values) are significantly affected by noise and independent of the breathing rate. It should be further noted that all three estimates are flow-dependent, meaning they will vary depending on the blower flow output.

[0497] In some configurations, method 1300 may skip step 1312 and proceed directly to step 1314, in which method 1300 may directly calculate the average value of selected preprocessed flow rate data points.

[0498] Once method 1300 obtains the device ventilation rate per minute at step 1314 ( The three estimated values ​​can be used to apply the filter to the device's minute ventilation rate at step 1316. ) to the instantaneous device ventilation rate per minute ( The average is then calculated. In some configurations, a filter (e.g., an exponential filter) may be used to average or "smooth" each estimate or sequence of estimates captured through multiple repetitions of the previously described steps. In some examples, this step may occur after the initial estimate but before any additional processing steps.

[0499] In method 1300, there are three measurements (i.e., the first MV). 装置 Estimated value, second MV 装置 Estimated value and third MV 装置 The estimated device minute ventilation (MVV) is composed of three unknown values ​​or signal components, which can then form 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., the rate of change in flow induced by the patient), and the potential device minute ventilation signal. Therefore, there exists a set of three analytical expressions or equations that can be solved simultaneously to derive expressions for noise, respiratory rate, and device minute ventilation. In some configurations, solving these three analytical expressions or equations simultaneously can be computationally very expensive and therefore place high demands on the processing hardware in embedded device applications, such as in medical devices. In some configurations, in method 1300, the algorithm first proceeds to step 1318 to normalize the three MVVs according to the number of data points used in each estimate. 装置 Estimated value. In some examples, method 1300 may include step 1320, in which a noise correction factor can be calculated, wherein the noise correction factor is related to the signal-to-noise ratio. The calculation of the noise correction factor in step 1320 may be similar to any noise correction factor disclosed in PCT application publication WO / 2020 / 178746 filed March 4, 2020, which is incorporated herein by reference in its entirety. In some configurations, the normalized MV can be calculated. 装置 One or more relevant noise correction factors in the estimated value.

[0500] In some configurations, method 1300 may include step 1322, in which the algorithm may use a predefined fitting curve that matches the normalized minute ventilation estimate and the noise correction factor with the device minute ventilation (MPV). This is related to one of the estimated values. In some configurations, the fitting function may include at least some numerically derived terms. In some configurations, this calibration curve can approximate the device's minute ventilation (…). The output of the analytical expression for ) can provide the device minute ventilation (FMV) with minimal noise and respiratory rate dependence. ).

[0501] In some configurations of method 1300, a filter (e.g., an exponential filter) may be used to filter the ventilation per minute of each device captured by multiple repetitions of the previously described steps. This involves averaging or "smoothing" the estimated values ​​or the sequence of estimated values. In some examples, this step may occur after the initial estimation but before any additional processing steps.

[0502] refer to Figure 23 The flowchart describes a method 1400 for estimating the normalized device ventilation per minute. (Compared to...) Figure 22B-22D The methods shown differ; the respiratory device acquires a calibrated device minute ventilation (DMV) and normalizes it using the respiratory device flow rate. In some configurations, this can present an estimate of the DMV that is independent of flow rate and device flow rate. In some examples, the estimated DMV is also independent of nasal cannula fit and can provide a general metric for patient minute ventilation.

[0503] Method 1400 begins by obtaining raw flow velocity data at step 1402. The raw flow velocity data can be obtained from a flow velocity sensor (e.g., an ultrasonic flow sensor). In some configurations, at step 1404, the raw flow velocity data is first analyzed to determine if the data quality is sufficient. If the raw flow velocity data is determined to be of sufficient quality, the data can be preprocessed to remove unwanted signal components. If the raw flow velocity data is of insufficient quality, the flow velocity data is discarded, and method 1400 returns to step 1402 and waits to receive additional raw flow velocity data. In some examples, method 1400 may include: at step 1406, preprocessing the raw flow velocity data to remove unwanted signal components. The removal of unwanted signal components is described in more detail above. Unwanted signal components may be present from the flow generator motor.

[0504] In some configurations, once the streaming data has been preprocessed, it can proceed to step 1408, where method 1400 curve-fits the streaming data. If the data does not include large transient peaks (potentially due to interface tuning), it can be considered to have sufficient quality. Device ventilation per minute ( The average volume of air propelled out of the device per minute is measured. The process of fitting a curve to the streaming data can be accomplished by first fitting a spline to the streaming data using the least squares criterion. In some configurations, the fitted line can be (approximately) represented by the following equation:

[0505]

[0506] In the equations provided above, m is the fitting parameter corresponding to the mean of the streaming data, s is the slope (i.e., the 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 "earliest" time point in the streaming data is equal to -1 and the "most recent" time point in the streaming data is equal to 1.

[0507] In some configurations, other function approximation methods may also be used. Flow data may be, for example, the most recent pre-filtered velocity data points. In some examples, least squares methods may be used to approximate preprocessed flow data (e.g., respiratory signals) and then integral along splines to estimate ventilation. In some configurations, the controller may perform various line and / or curve fitting techniques to fit the one or more functions to selected portions of the flow parameter variation data. This may include, for example, regression analysis, interpolation, extrapolation, linear least squares, nonlinear least squares, total least squares, simple linear regression, robust simple linear regression, polynomial regression, orthogonal regression, Deming regression, linear piecewise regression, regression dilution, and / or other non-limiting example techniques. In some configurations, the one or more functions (which include at least those described above) may generate a curve. In some configurations, the curve may be a line. The line or curve described herein may include multiple curves, vertices, and / or other features. The line described herein may be straight, angled, and / or horizontal. In some examples, the line described herein may be a best-fit line.

[0508] Method 1400 may include step 1410, in which data from a curve constructed from fitted splines are used to calculate the device ventilation rate per minute. The instantaneous estimate of the ventilation rate per minute (VPM). Method 1400 may include calculating the ventilation rate per minute (VPM). There are three different methods for instantaneous estimation of the ventilation rate per minute. In some configurations, one of the three estimates is represented by the device ventilation rate per minute (VPM). Estimates of the gas flow parameter data: fitted to the gas flow parameter data ( The integral of the absolute value of the first term of the line is divided by the time range covered by the selected filtered velocity data points (i.e., the zero-order spline). In some examples, another of the three estimates is the device ventilation rate per minute, expressed as follows: Estimates of the gas flow parameter data: fitted to the gas flow parameter data ( The integral of the absolute value of the line is divided by the time range covered by the selected filtered velocity data points (i.e., the first-order spline). This is used to calculate the device's ventilation rate per minute (V / V). The instantaneous estimate of ) can be obtained within 1 second, or 20 estimates can be obtained within 1 second (i.e., the sampling frequency is 20 Hz). The time period used to calculate the estimate can be any of the following ranges: between at least 1 and 120 seconds, between 1 and 60 seconds, between 60 and 120 seconds, between 1 and 10 seconds, between 10 and 20 seconds, between 20 and 30 seconds, between 30 and 40 seconds, between 40 and 50 seconds, between 50 and 60 seconds, between 60 and 70 seconds, between 70 and 80 seconds, between 80 and 90 seconds, between 90 and 100 seconds, between 100 and 110 seconds, between 110 and 120 seconds, or can be at least one of the following: 1 second, 10 seconds, 20 seconds, 30 seconds, 40 seconds, 50 seconds, 60 seconds, 70 seconds, 80 seconds, 90 seconds, 100 seconds, 110 seconds, and 120 seconds. In some configurations, another of the three estimates is the device ventilation rate per minute (VPR) expressed as follows: The estimated value of MV is the average of the absolute values ​​of the curves fitted to the gas flow parameter data (i.e., calculated without data interpolation using splines). In some configurations, the first MV... 装置 The estimated value (i.e., the zero-order spline) is most resilient to noise / least dependent on noise and is most affected by the patient's respiratory rate. In some examples, the second MV 装置 The estimates (i.e., the first-order splines) are significantly dependent on noise, but less dependent on respiration rate. In some configurations, the third MV... 装置 The estimates (i.e., where there is no spline / interpolation and the estimates are a direct average of a series of instantaneous absolute values) are significantly affected by noise and independent of the breathing rate. It should be further noted that all three estimates are flow-dependent, meaning they will vary depending on the blower flow output.

[0509] In some configurations, method 1400 may skip step 1408, and the preprocessed stream data may proceed directly to step 1410, in which method 1400 may directly calculate the average value of selected preprocessed stream data points.

[0510] Once method 1400 obtains the device ventilation rate per minute at step 1410 ( The three estimated values ​​of ) can be used to apply the filter to the device's minute ventilation rate () at step 1412. ) to the instantaneous device ventilation rate per minute ( The average is then calculated. In some configurations, a filter (e.g., an exponential filter) may be used to average or "smooth" each estimate or sequence of estimates captured through multiple repetitions of the previously described steps. In some examples, this step may occur after the initial estimate but before any additional processing steps.

[0511] In method 1400, there are three measurements (i.e., the first MV). 装置 Estimated value, second MV 装置 Estimated value and third MV 装置 The estimated device minute ventilation (MVV) is composed of three unknown values ​​or signal components, which can then form 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., the rate of change in flow induced by the patient), and the potential device minute ventilation signal. Therefore, there exists a set of three analytical expressions or equations that can be solved simultaneously to derive expressions for noise, respiratory rate, and device minute ventilation. In some configurations, solving these three analytical expressions or equations simultaneously can be computationally very expensive and therefore place high demands on the processing hardware in embedded device applications, such as in medical devices. In some configurations, in method 1400, the algorithm first proceeds to step 1414 to normalize the three MVVs according to the number of data points used in each estimate. 装置 Estimated value. In some examples, method 1400 may include step 1416, in which a noise correction factor can be calculated, wherein the noise correction factor is related to the signal-to-noise ratio. The calculation of the noise correction factor in step 1416 may be similar to any noise correction factor disclosed in PCT application publication WO / 2020 / 178746 filed March 4, 2020, which is incorporated herein by reference in its entirety. In some configurations, the normalized MV can be calculated. 装置 One or more relevant noise correction factors in the estimated value.

[0512] In some configurations, method 1400 may include step 1418, in which the algorithm may use a predefined fitting curve that matches the normalized minute ventilation estimate and the noise correction factor with the device minute ventilation (MPV). This relates to one of the estimated values. In some configurations, the fitting function may include at least some numerically derived terms. In some configurations, this calibration curve can approximate the calibrated device minute ventilation (FMV). The output of the analytical expression for ) can provide the corrected device minute ventilation (FMV) with minimal noise and respiratory rate dependence. ).

[0513] In some configurations, method 1400 may include step 1420, in which the device flow rate is used to determine the calibrated device ventilation rate per minute (MPa). Normalization is performed. In some examples, the same data used in previous steps (i.e., high-quality, pre-processed flow rate data) is used to achieve the corrected device ventilation rate per minute (V / min). It provides an estimate of the device's ventilation rate per minute, which is independent of flow rate and device velocity. As previously mentioned, the corrected device ventilation rate per minute ( It can be independent of nasal intubation fit and provides a universal indicator of patient minute ventilation.

[0514] 2.7 WOB Indicator – Depends on the measurement of healthy individuals or relative to the measurement of healthy individuals

[0515] In some configurations, any of the WOB indices or measures described above can be converted into a measure or measure dependent on, or presented or represented as a measure or measure relative to, a nominally healthy person. In such configurations, the respiratory device controller or other processing device that implements or executes the WOB index algorithm may take additional steps to convert, transform, or otherwise represent the WOB indices or measures dependent on or relative to the healthy person's measure based on stored (e.g., stored in the device's memory) or otherwise accessible comparative data involving healthy persons.

[0516] In one configuration, any of the example WOB metrics can be presented or represented as a ratio or percentage expected from the 'average healthy person'. For example, WOB metric data can be transformed, converted, or presented to represent a patient's respiratory performance as a ratio to ideal health values. In some configurations, this representation of the disclosed WOB metrics can have the advantage of being familiar to clinicians, making them more intuitive.

[0517] In some configurations, one or more of the WOB metrics described above relating to the nominal 'average healthy person' can be calculated from a nominal person (or a range of nominal persons of different sizes) with an average intubation in a controlled environment, and are pre-programmed or otherwise stored in the respiratory device’s memory or in memory accessible to the respiratory device.

[0518] In alternative configurations, a mixture of estimated, detected, and / or manually entered parameters can be used to estimate WOB metrics for a specific patient size. For example, measurable flow and pressure parameters (e.g., , This can be used in combination with measurements or estimates of patient dimensions manually entered by the clinician and an approximate percentage of nasal obstruction. Alternatively or additionally, in another example, patient dimensions can be estimated by the device based on flow rate settings, and nasal obstruction can be estimated or roughly estimated using knowledge of cannula size (e.g., which can be manually entered) and patient dimensions.

[0519] In another example configuration, a table (or other suitable data structure) of patient parameters and corresponding WOB measures (if they are healthy) can also be stored in the memory of the respiratory device and accessed when needed to allow the generation of WOB indicators or measures that depend on or are relative to the measures of healthy individuals.

[0520] In one example configuration, the respiratory device or its controller can be configured to periodically or continuously calculate or account for the ratio or percentage of a patient's WOB measurement to a nominal healthy WOB measurement. This ratio or percentage can be applied to any of the applications described in the following sections, and not just to the WOB measurement alone.

[0521] 2.8 Application of the WOB Indicator

[0522] Overview

[0523] Any of the patient WOB metrics, data, or trend data disclosed herein (including patient WOB metrics expressed as a ratio or percentage relative to data from healthy individuals) can be generated and used by the respiratory device in one or more various applications or functions, examples of which are further discussed below. In some configurations, these WOB metrics are generated and used by one or more applications or functions during a respiratory therapy session initiated by the patient using the respiratory device. In some configurations, the applications or functions may utilize and / or process the WOB metric data generated and stored during the respiratory therapy session for post-treatment processing and / or storage, such as sending or transmitting the WOB metric data and / or related treatment data to a remote or cloud computing system, such as a patient and / or device management platform.

[0524] The following will explain in further detail examples of various applications and / or functions that can utilize and / or process the WOB indicator discussed above and / or generated by the algorithms disclosed above. In some examples further explained below, the one or more WOB indicators or associated data can be used for any one or more of the following actions:

[0525] • Display WOB index data and / or WOB trend data on the respiratory device or associated device (e.g., on the device's display screen and / or GUI, or transmit it for display on the associated device or device that communicates with the device).

[0526] • Trigger or generate alarms, notifications, or suggestions (visual, auditory, and / or tactile) on respiratory equipment or associated devices that communicate data with the equipment.

[0527] • Trigger or generate one or more warnings, alerts, and / or notifications based at least in part on identified WOB metric data and / or WOB trend data, and one or more thresholds. Warnings, alerts, and / or notifications may be audible, visual, and / or tactile.

[0528] • Trigger or generate one or more warnings, alerts and / or notifications based at least in part on WOB indicator data and / or WOB trend data, and one or more thresholds, wherein the one or more warnings, alerts and / or notifications include data indicating suggested adjustments or changes to treatment settings and / or device settings.

[0529] • Reports are generated based on WOB indicator data and / or WOB trend data.

[0530] Any one or more of the example applications and / or functions discussed above or below can be used in combination with respiratory devices.

[0531] First Example Application – Displaying WOB Data

[0532] In this example, WOB index data generated by the respiratory device can be displayed on the respiratory device's screen or user interface (e.g., a graphical user interface - GUI), or it can be transmitted for display on an associated remote device or system communicating with the device. As discussed above, raw or absolute patient WOB indices can be displayed, and / or patient WOB ratios or percentage indices relative to healthy WOB data can be displayed. Additionally or alternatively, one or more WOB trends or trend data (e.g., 'WOB increasing', 'WOB decreasing', 'WOB stable') related to the WOB data can be displayed in isolation or simultaneously with the WOB index data.

[0533] refer to Figure 24The illustration shows an example GUI 2100 including a WOB monitoring screen. In this example, the WOB monitoring 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 relative to nominal healthy WOB data, but alternatively may be raw or absolute WOB indicator data. In this example, the WOB monitoring screen also includes a second GUI element 2104 displayed simultaneously, which is configured to display corresponding WOB trend data relating to the WOB data displayed in the first GUI element 2102. GUI elements 2102 and 2104 may display their respective data in any suitable format or combination of formats, such as, but not limited to, numerical, graphical, textual, icon, color, and / or animation.

[0534] In the configuration, the respiratory device can be configured to display WOB data (e.g., WOB metric data and / or WOB trend data) on the respiratory device’s display or user interface at the end of each treatment period or at some other configurable or predetermined time.

[0535] In the configuration, the respiratory device can be configured to process WOB data across multiple treatment periods or time intervals for a patient, and can generate comparative and / or aggregated and / or statistical data representing or indicating statistics, variations, and / or trends in the patient's WOB data over multiple treatment periods and / or with respect to other desired time intervals (e.g., days or weeks) of the captured data. The comparative, aggregated, and / or statistical data can 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 can be displayed or presented on the respiratory device's display at the end of a treatment period and / or at some other configurable or predetermined time and / or based on conditions or events.

[0536] Second example application – Displaying notifications and / or suggestions

[0537] In this example, WOB data and / or related notifications and / or suggestions generated or triggered based on WOB data can be displayed to users, patients, and / or clinicians or clinical personnel (e.g., respiratory therapists, nurses, etc.). WOB data, notifications, and / or suggestions can be displayed on the respiratory device's display screen or user interface (e.g., GUI) and / or transmitted for display on remote devices or systems communicating 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.).

[0538] In one configuration, the GUI of the respiratory device can be configured to display or present one or more live or real-time generated WOB metrics based on any of those disclosed above. This can also prompt the user to review whether changes to the respiratory device's treatment settings or settings (e.g., flow rate settings and / or gas flow oxygen concentration-related settings, such as FiO2 and / or FdO2 settings) have beneficially altered the patient's WOB in real time (e.g., causing WOB to be low, even lower, or reduced). This configuration allows users or clinicians to fine-tune the respiratory device's treatment settings for patients to reduce WOB.

[0539] In another configuration, one or more auditory and / or visual warnings, alerts, notifications, prompts, or similar items may be presented simultaneously with WOB metrics or data or displayed on a screen or GUI. Audible warnings, alarms, and / or notifications can be provided via the device's audio output. For example, if a patient's WOB increases / has increased with a new flow rate setting, an appropriate warning can be presented or delivered. Reference Figure 25A-25F This section will describe various GUI examples of such configurations and / or notifications and / or warnings.

[0540] Figure 25A The first example GUI 2110 is shown, in which WOB data has triggered message 2112, which indicates that a high work of breathing has been detected and the patient should be examined.

[0541] Figure 25B A second example GUI 2120 is shown, where WOB data has been triggered: a first GUI element 2122 displays a trend notification indicating that the patient's work of breathing is increasing; and a second GUI element 2124 includes notification or suggestion data for adjusting treatment settings. For example, the notification data may include data instructing how to adjust one or more treatment settings of the breathing device to reduce the work of breathing.

[0542] Figure 25C A third example GUI 2130 is shown, where WOB data has been triggered: a first GUI element 2132 displays a message indicating that a high work of breathing has been detected; and a second GUI element 2134 includes a notification or remedial suggestion to the user or clinician to increase the flow rate setting of the breathing device. In this example, the GUI displays a WOB warning and corresponding remedial or suggested data, which provides information on how to interpret or remedy the warning, for example, increasing the flow rate setting may help reduce the patient's current work of breathing, as represented by the calculated WOB data.

[0543] Figure 25DA fourth example GUI 2140 is shown, in which WOB data has triggered a message or trend notification 2142 indicating that a trend that increases the work of breathing has been detected and the patient should be examined.

[0544] Figure 25E A fifth example GUI 2150 is shown, where WOB data has been triggered: a first GUI element 2152 for displaying a notification or message indicating that low work of breathing has been detected; and a second GUI element 2154 including a notification or remedial suggestion for adjusting treatment settings. The notification data may include data indicating how to adjust one or more of the treatment settings of the breathing device in response to the detected low work of breathing.

[0545] Figure 25F A sixth example GUI 2160 is shown, where WOB data has been triggered: a first GUI element 2162 displays a notification indicating a trend of increasing work of breathing in the patient; and a second GUI element 2164 includes a notification or remedial suggestion to the user or clinician to increase the flow rate setting of the breathing device. In this example, the GUI displays a WOB warning and corresponding remedial or suggested data, which provides information on how to interpret or remedy the warning; for example, increasing the flow rate setting could help stop and / or reverse the current trend of increasing work of breathing in the patient.

[0546] As discussed above, notification data or information provided in WOB notification, warning, and / or suggestion displays may be provided or presented in any suitable form or combination of visual forms, including but not limited to, numerical values, text information, graphical forms or formats, continuous trend lines, data plotted or represented in charts over time, icons, animations, and / or color-coded information. Additionally or alternatively, for example, notification data may be provided audibly and / or using audible prompts or voice commands.

[0547] Third example application – Reporting WOB data or notification data and generating reports

[0548] In some configurations, the generated WOB data (e.g., WOB metric data and / or WOB trend data) and / or notification data (e.g., warnings, alarms, notifications triggered based on comparisons of WOB data with one or more thresholds) can be reported by the respiratory device to or transmitted 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, wearable devices). In one configuration, the respiratory device can be configured to report or transmit WOB data and / or notification data immediately in real time, periodically, on demand, or upon request, at configurable intervals, or automatically in response to a specific event or action.

[0549] In one example configuration, the respiratory device is configured to report or transmit WOB data and / or notification data at or after the end of each treatment period. In one example, the respiratory device is configured to report or transmit WOB data and / or notification data when the device operates in a drying mode after a treatment period or at any other suitable time after the treatment period has ended. In one configuration, the drying mode of the respiratory device refers to a mode in which the respiratory device dries after a treatment period, for example, by operating a blower or flow generator via a controller instead of a humidifier.

[0550] In one example configuration, the respiratory device is configured to report or transmit WOB data and / or notification data from previous treatment periods during a preheating mode for a subsequent treatment period. For example, during a preheating mode for a new treatment period, the respiratory device may be configured to report or transmit WOB data and / or notification data generated from previous treatment periods or multiple previous periods. In one configuration, the preheating mode of the respiratory device refers to a mode in which the device's humidifier (if present) is raised to the operating temperature by the controller before the start of the treatment period.

[0551] Any of the above notification data (e.g., warnings, notifications, suggestions, etc.) triggered in response to calculated or determined 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 device. Additionally or alternatively, WOB data generated by the respiratory device may trigger the presentation of such notification data on the remote device or system; for example, the remote device or system may trigger the display or presentation of notification data in response to receiving and processing WOB data from the respiratory device. For example, the remote device or system may be any suitable electronic device or system with 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.

[0552] In some configurations, WOB data and / or associated triggered notification data can be transmitted from the respiratory device to a remote device or system for presentation. In some configurations, WOB data and / or associated triggered notification data can be transmitted to a remote, cloud-based or server-based patient and / or device management system that can process the incoming data and then relay or push the WOB and / or notification data to one or more other electronic devices or systems (e.g., clinician electronic devices or systems, such as smartphones, tablets, laptops, computers, wearable devices, etc.). In some configurations, the patient and / or device management system can be configured to receive WOB data from the respiratory device, process the WOB data, and cause (e.g., push, trigger, or generate) notification data to be presented on one or more remote electronic devices or systems (e.g., clinician electronic devices or systems).

[0553] 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 can 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 can be of any suitable type and / or format, including but not limited to report data, displayed reports, compiled reports, electronic reports, printable reports, numerical reports, and graphical reports. Reports may include data representing WOB data and / or notification data for a single treatment period and / or across multiple treatment periods and / or across selectable or configurable time periods (e.g., days or weeks).

[0554] In some configurations, the generated reports may include comparative and / or aggregated data and / or statistics relating to WOB data and / or notification data received by the patient based on one or more treatment periods and / or within a desired time period (e.g., days or weeks).

[0555] Fourth example application – Treatment parameter setting adjustment recommendations in response to WOB index

[0556] refer to Figure 26 This section describes an example method 2200 for calculating the WOB index, implemented by a respiratory device (e.g., a controller of the respiratory device) according to the previously disclosed information above, and how the method causes the respiratory device to generate recommendations for adjusting treatment parameter settings in response to the calculated WOB index. The order of the described steps is not critical in all configurations, and some steps may occur in parallel rather than sequentially. Details and alternatives associated with each of these steps have been described above and will not be repeated for the sake of brevity.

[0557] In this example method 2200, the process begins at step 2202, where the controller of the breathing device receives pressure data, for example, from one or more pressure sensors of the device at step 2204. In this configuration, the pressure data indicates the pressure at the blower output. The controller then receives flow rate data, indicating the output flow rate of the device, from one or more flow rate sensors in the flow path of the device, as shown at step 2206. The controller is then configured to calculate or estimate the flow rate of the conduit or pipe, at least in part, based on the received device output flow rate data. As shown in step 2208. In this example, the controller is also configured to generate the device's ventilation rate per minute based at least in part on the device output flow rate data. The estimated value is as shown in step 2210.

[0558] In this example, the controller then determines or calculates the nasal pressure test value. The estimated value is as shown in step 2212. Then, at least in part, based on... , and Data or values ​​to determine pipe flow conductance The estimated value is as shown at step 2214. Thereafter, the controller is configured to be at least partially based on... , and The value is used to calculate the nasal pressure fluctuation WOB index. As shown at step 2216, and as previously described. Additionally or alternatively, the controller may undertake further processing steps to generate one or more of the other WOB metrics described above in sections 2.3 and 2.4.

[0559] In this example method 2200, the controller is then configured to optionally handle... The controller can generate recommendations for changing or adjusting treatment parameter settings, based on or in response to the generated WOB data or to further processing of the WOB data relative to one or more thresholds or the like, as shown at step 2218. For example, if the WOB data is outside configurable limits or is demonstrating an adverse trend, the controller can generate a change or adjustment recommendation as described above.

[0560] If a treatment parameter setting change is suggested or triggered at step 2218, the controller may optionally be configured to display or present those suggested treatment parameter setting changes on the respiratory device's display screen and / or transmit them for display on one or more remote devices or systems, as discussed above, as shown at step 2220. In one configuration, the respiratory device may be configured with additional optional steps that enable the user or clinician to acknowledge, confirm, or reject the suggested treatment parameter setting change depending on whether they want the controller to apply the suggested setting change. For example, the user or clinician may acknowledge or reject the suggested setting change via user interaction with the respiratory device and / or the remote device or system's user interface.

[0561] In the configuration, the controller can be configured to process WOB data (e.g., WOB index data and / or WOB trend data) and then generate notifications, warnings, or alarms suggesting treatment parameter setting adjustments based on comparisons of the WOB data with one or more thresholds. The controller can suggest changes to any one or more treatment settings or device settings, such as, but not limited to, flow rate settings and gas flow oxygen concentration settings (e.g., FiO2 and / or FdO2 settings, which, for example, control the oxygen concentration in the gas flow provided to the patient). Treatment parameter setting adjustment suggestions can include, for example, indications depending on the required response or remedial changes taking into account the comparison of the WOB data with the one or more thresholds, such as 'increase flow rate' or 'decrease flow rate' or 'increase oxygen concentration' or 'decrease oxygen concentration'. As discussed above, the suggested treatment setting adjustments can be presented or displayed on the respiratory device and / or transmitted to a remote device or system for processing and / or display.

[0562] Fifth example application – Disconnecting alarms or notifications

[0563] In another example, the controller may be configured to process any one of the one or more calculated WOB indicators described above to detect the disconnection of any part of the flow path (e.g., the patient breathing circuit and / or the patient interface) and / or the disconnection or disengagement of the patient from the patient interface (e.g., nasal cannula).

[0564] For example, in one configuration, if The WOB indicator (and by extension, WOB indicator or A disconnection may have occurred if WOB metrics (such as WOB indicators) reach zero or exceed a predetermined threshold (e.g., approach zero) for a sufficient period of time (i.e., no patient breathing is detected). If such a disconnection is detected based on WOB data, any appropriate response can be initiated or triggered. For example, the controller can trigger the presentation of audio and / or visual alarms and / or display notifications (e.g., text and / or animations) on a screen to suggest corrective actions. Alternatively or additionally, alarms (visual, auditory, and / or tactile) can be triggered on remote devices or systems, such as, but not limited to, mobile phones, tablets, laptops, pagers, or other suitable devices (further examples of which have been previously described).

[0565] refer to Figure 27A and Figure 27B The diagram shows some examples of possible GUI screen disconnection warning notifications that can be displayed on the screen of a respiratory device or remote device.

[0566] Figure 27A A first example GUI 2300 is shown, in which WOB data has triggered a disconnection warning notification screen, which includes information indicating that a potential disconnection event has been detected and prompts the user or clinician to check the patient circuit (e.g., breathing tube and / or patient interface) connections along the air circuit and / or check for patient detachment from the patient interface.

[0567] Figure 27B A second example GUI 2310 is shown, in which WOB data has triggered a disconnection warning notification screen. This disconnection warning notification screen includes a first GUI element 2312, which includes text information indicating that a potential disconnection event has been detected and prompts the user or clinician to check the patient's circuitry (like...). Figure 27A (Same as in the example). Additionally, a second GUI element 2314, including animations or other visuals, may be displayed next to or simultaneously with the first GUI element. This second GUI element may prompt the user to check the patient's breathing circuit or otherwise visually warn them of potential disconnection events.

[0568] Sixth Example Application – Configurable Alarm Settings

[0569] In another example, the controller of the breathing device may be configured with one or more configurable alarms or trigger thresholds, which can be used to compare the generated WOB data with the one or more configurable alarms or trigger thresholds, and then actions can be taken based on those comparisons.

[0570] For example, any WOB metric or data can be compared to one or more thresholds associated with one or more corresponding notifications, warnings, and / or alarm events. For instance, a controller can be configured with one or more specific notifications, warnings, or alarm events that are triggered if the WOB data meets or conforms to a threshold requirement or threshold rule. The threshold rule or requirement for each notification, warning, and / or alarm event can be based on a single threshold, a threshold range, an upper threshold and a lower threshold, or a threshold function based on one or more parameters and / or conditions (e.g., triggering an alarm / alarm / notification if the WOB data exceeds the upper limit for a specific time period, or if the WOB data exceeds the upper limit more than x times within a specific time period). Whether a notification, warning, and / or alarm event is triggered can depend on whether the WOB data or metric conforms to the threshold rule or function and the associated threshold limits.

[0571] In some configurations, or for certain notification, warning, or alarm events, one or more threshold limits or threshold function parameters can be pre-programmed or pre-configured. In other configurations, or for certain notification, warning, or alarm events, one or more threshold limits or threshold function parameters may be configurable by the user or clinician. In such configurations, the threshold limits or threshold function parameters may be configurable and / or adjustable via a user interface (e.g., a GUI) presented on the respiratory device's display.

[0572] refer to Figure 28A and Figure 28B This shows some examples of possible GUI screens that can be operated to adjust threshold parameters for specific notification, warning, and / or alarm events.

[0573] Figure 28AA first example GUI 2400 is shown, presenting a screen for configuring or adjusting a parameter warning threshold. In this example GUI 2400, a first GUI element 2402 provides notification or information about the parameter warning or notification threshold being adjusted. For example, the parameter warning or notification or alarm may be selected from, but is not limited to, examples of 'High WOB', 'Low WOB', and / or 'Possibly Disconnected'. In this example GUI 2400, a second GUI element 2404 is also provided, which may be a user-interactive or operable GUI element or interface that enables adjustment of the one or more thresholds associated with the parameter warning. In this example, the GUI may be presented on a touchscreen user interface, and the user can interact with the GUI element to configure the threshold via touch input or interactivity. The user-interactive GUI element for adjusting the one or more configurable thresholds may include any suitable form of adjuster, including but not limited to: a dual-state trigger element for increasing or decreasing the threshold limit, a dial or slider scaling element for adjusting the threshold, a selectable discrete threshold element for selecting from a series of discrete threshold levels, and a numerical or categorical input field for inputting the desired threshold.

[0574] exist Figure 28A In the example shown, the threshold is adjusted via a user-interactive GUI 2404 with positive ('+') and negative ('-') GUI elements or buttons. These GUI elements or buttons can be interacted with to incrementally increase and decrease the warning parameter threshold, respectively. In this example, the upper slider element 2406 can represent the upper limit parameter threshold, and the lower slider element 2408 can represent the lower limit parameter threshold. In one configuration, a user can tap, select, or touch either the upper slider element 2406 or the lower slider element 2408, and then move the selected slider element to adjust the selected threshold by interacting with the positive ('+') and negative ('-') GUI elements or buttons. Additionally or alternatively, the user can directly interact with the upper slider element 2406 and / or the lower slider element 2408 by sliding and / or dragging the slider element along the slider bar / range to adjust the corresponding upper limit parameter threshold and / or lower limit parameter threshold.

[0575] Figure 28B The second example GUI 2400a shown is... Figure 28A The same as shown and described, except that it includes a different user-interactive GUI 2404a, which includes qualitative adjustments to the threshold limit via operating 'higher' and 'lower' GUI elements to increase and decrease the limit respectively. Like for... Figure 28AAs in the described example, a user can select either the upper slider element 2406a and / or the lower slider element 2408a, and then interact with the 'higher' or 'lower' GUI element to adjust the selected parameter threshold, or the user can directly interact with either slider element 2406a, 2408a to adjust the associated parameter threshold by sliding and / or dragging the slider element along the slider bar / range.

[0576] In other example configurations, you will see that... Figure 28A and Figure 28B The GUI can alternatively feature a single interactive slider on the slider scale to adjust a single upper limit parameter warning threshold or a lower limit parameter warning threshold.

[0577] In one example configuration, the WOB metric or data can serve as a background parameter used to set or as input to guide the setting of one or more general respiratory device alarm thresholds (e.g., respiratory rate alarm, minute ventilation alarm, tidal volume alarm, and / or so on). In other example configurations, WOB alarms can be configured based on the WOB metric or data, and WOB alarms can serve as alternative alarms for other parameters (such as, but not limited to, respiratory rate, minute ventilation, tidal volume, and / or so on). For example, in some configurations, the WOB metric can be closely correlated with some of these other parameters. For instance, if a patient's respiratory rate or minute ventilation increases, the WOB metric should generally increase accordingly. Similarly, if a patient's respiratory rate or minute ventilation decreases, the WOB metric will generally decrease as well. This can be advantageous in some configurations because detecting certain respiratory parameters in an unsealed respiratory system (e.g., a high-flow nasal system) can be quite difficult. In some cases, the described WOB indicators can be calculated more reliably, but they still depend on the underlying (multiple) patient respiratory parameters, thus making them usable as alternative or proxy indicators that can be used to trigger alarms for one or more respiratory parameters, as explained further later.

[0578] In one example configuration, after the respiratory device is activated and running a respiratory therapy period for the patient, initial WOB metrics or data can be calculated or verified. The respiratory device can then display or visualize the WOB metrics or data or another relevant parameter (e.g., minute ventilation) on its display and provide recommendations for upper or lower threshold limits based at least in part on the WOB metrics or data.

[0579] In one example, it can be provided based on... An alert triggered by comparing WOB metrics or data to a related threshold. WOB indicator alarms can be considered as alternatives to patient minute ventilation alarms (actual patient minute ventilation compared to device or nasal minute ventilation measurements as previously described) or respiratory rate alarms. In some configurations, such alarm thresholds can be advantageous, i.e., the alarm threshold is based on... The WOB index serves as a substitute for alarms regarding patient minute ventilation or respiratory rate. Estimation of WOB metrics may potentially be more accurate and / or more informative about changes in a patient's respiration.

[0580] In one example, used as an alarm The WOB metric can be analogous to a minute ventilation alarm. In this example, WOB parameters are proportional to and closely related to the patient's minute ventilation (MV) (and) ,in (This refers to the tidal volume). Therefore, the device can be configured such that... Certain alarm thresholds for the WOB metric value act as alarm systems for high or low MV. In this case, a larger... The WOB indicator value corresponds to a higher MV, and vice versa.

[0581] In another example, because It is proportional to and closely related to MV, so WOB indicator alarms can be configured to act as respiratory rate (RR) alarms. For example, because Therefore, it can be said that if tidal volume is assumed to be relatively constant during respiratory therapy, then Therefore, reduce (Quantity) may indicate an increased RR, and vice versa. As patients breathe more briefly and more frequently, their RR will increase, while MV (with) (Proportional) will decrease.

[0582] In other examples, the previously discussed WOB metric examples can be monitored against a threshold (e.g., , and / or Any one or more of the following can be used as alternative alarms for patient minute ventilation or respiratory rate. For example, any one or more of the WOB indicator examples can be compared to one or more thresholds configured or calibrated for patient minute ventilation alarms and / or respiratory rate alarms. In some such configurations, the WOB indicator can be compared to a threshold without any temporal aspect (e.g., if the WOB indicator crosses the threshold at any point, an alarm will be triggered). In other such configurations, the WOB indicator can be compared to a threshold with one or more associated additional triggering conditions (e.g., time or trend or other conditions). For example, alarm thresholds can be configured such that they only trigger if the WOB indicator is above or below the threshold for a predetermined or configurable period of time, or if the WOB indicator crosses the threshold a certain number of times within a predetermined or configurable period of time, or under other such conditions.

[0583] In some configurations, for WOB metric alerts, the upper bound or threshold limit can (at least partially) correspond to an undesirably high WOB that requires a change in treatment parameters. Similarly, the lower bound or threshold limit can (at least partially) correspond to an undesirably low WOB, but can also be used as a disconnect alert trigger as previously described. Thus, one or more WOB metrics or data can be compared to one or more thresholds, and these metrics or data can trigger different alerts, warnings, or notifications depending on whether the WOB metric is above or below these thresholds (depending on the threshold function or criterion).

[0584] In one example configuration, a clinician may choose to accept default or respiratory device-recommended notification, warning, and / or alarm thresholds, ignore them entirely, use them in conjunction with their own preferred thresholds or other warning triggers (e.g., SpO2 alarms), or adjust the default or recommended thresholds before accepting them. In this example, the clinician may perform these alarm threshold settings adjustments or threshold configurations or confirmations via the respiratory device's user interface (e.g., a GUI) or remotely via the user interface of another electronic device or system that communicates data with the respiratory device.

[0585] In some configurations, WOB indicator alerts, warnings, or notifications can be configured with multiple or more upper limits or threshold caps and lower limits or threshold saturations. For example, alerts, warnings, or notifications can be configured with cascading or nested thresholds or threshold ranges, or inner and outer threshold ranges, or multiple or a series of progressive or gradually increasing thresholds, wherein the nature of the alert, warning, or notification triggered associated with each corresponding threshold depends on the nature, position, priority, or extreme of that threshold on the overall threshold scale. In one example configuration, for instance, a first upper limit or threshold cap might simply trigger a notification or suggestion to adjust treatment parameters, while a second, higher upper limit or threshold cap might trigger a high-priority warning because the value of this higher upper limit or threshold cap could correspond to a WOB indicator value indicating severe hyperventilation or other serious medical events.

[0586] In one example configuration, the default or recommended upper or lower threshold limits of the respiratory device can be recalibrated or dynamically changed for each treatment period, after a certain time period has elapsed, or after several treatment periods have passed. In other words, the threshold recommendation can be changed daily, weekly, monthly, or at any other suitable time period (which can also be configurable). In one example, the recalibration of the recommended threshold can be based at least in part on changes in one or more calculated WOB metrics or data and / or WOB trend data. For example, the controller can be configured such that a sustained downward trend in one or more WOB metrics or data over one or more treatment periods may cause the recommended upper or lower threshold limits to narrow (i.e., tolerate a narrower acceptable range), shift downward, shift upward, or otherwise change according to any combination thereof.

[0587] In some example scenarios, upper or lower threshold limits or default values ​​can be set or configured across a group of respiratory devices based on hospital, health system, or clinician protocols. In one configuration, the default thresholds can be pre-programmed during manufacturing or configured remotely (e.g., via a cloud-based or server-based patient and / or device management system or platform).

[0588] In one configuration, the upper limit or threshold upper limit / lower limit or threshold lower limit default value can be stored in the respiratory device memory or in the memory of a remote device or system used to configure the respiratory device.

[0589] In some example configurations, warnings, notifications, and / or alarms can be configured to selectively appear on different devices or systems based on thresholds that are crossed. For example, as mentioned, a first upper limit or threshold cap can trigger a notification to adjust treatment parameters and can be displayed only on the respiratory device's display. A second upper limit or threshold cap corresponding to a more stringent threshold can trigger an alarm or notification to be displayed on more than one device or system in addition to the respiratory device, such as, for example, on one or more remote devices.

[0590] In the preceding text, although upper and lower limits or thresholds have been discussed together, in some configurations they can be configured individually or selectively. For example, a clinician or user may selectively configure the lower limit or threshold for disconnect alarms, but may not adjust higher limits or thresholds associated with other alarms or notifications (e.g., high WOB).

[0591] 3. Terms and Definitions

[0592] Unless the context otherwise implies, the phrases 'computer-readable medium' or 'machine-readable medium' as used in this specification and claims should be understood to include a single medium or multiple media. Examples of multiple media include centralized or distributed databases and / or associated caches. These multiple media store one or more sets of computer-executable instructions. The phrases 'computer-readable medium' or 'machine-readable medium' should also be understood to include sets of instructions capable of storing, encoding, or carrying instructions executable by a processor of a computing device and causing the processor to perform any one or more of the methods described herein. Computer-readable media can also store, encode, or carry data structures used by or associated with these sets of instructions. The phrases 'computer-readable medium' and 'machine-readable medium' include, but are not limited to, portable to fixed storage devices, solid-state storage, optical media or optical storage devices, magnetic media, and / or various other media capable of storing, containing, or carrying instructions and / or data. 'Computer-readable medium' or 'machine-readable medium' may be non-transitory.

[0593] As used in this specification and claims, the term 'comprise' means 'consisting of at least part of' or 'including but not limited to', such that it shall be interpreted in an inclusive sense rather than an exclusive or exhaustive sense. When interpreting each expression of the term 'comprise' in this specification and claims, features other than the feature or features that begin with that term may also exist. Related terms (e.g., 'comprise' and 'comprises') shall be interpreted in the same manner.

[0594] The intention is that references to the numerical ranges disclosed herein (e.g., 1 to 10) are also combined with 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, and 10) and any ranges of rational numbers within that range (e.g., 2 to 8, 1.5 to 5.5, and 3.1 to 4.7), and therefore, all subranges of the entire range explicitly disclosed herein are hereby explicitly disclosed. These are merely examples of the specific intentions of the disclosure, and all possible combinations of values ​​between the enumerated minimum and maximum values ​​will be considered as expressly stated in a similar manner in this application.

[0595] The term 'and / or' means 'and' or 'or', or both.

[0596] Using '(s)' after a noun indicates the plural and / or singular form of that noun.

[0597] Unless otherwise expressly stated, or otherwise understood in the context in which they are used, conditional language (e.g., “can,” “may,” “perhaps,” or “may”) is generally intended to convey that certain embodiments include certain features, elements, and / or steps, while other embodiments do not. Therefore, such conditional language is not generally intended to imply that features, elements, and / or steps are required by any means in one or more embodiments, or that one or more embodiments necessarily include logic for determining whether such features, elements, and / or steps are included in or will be implemented in any particular embodiment, with or without user input or prompting.

[0598] The degree language used herein (e.g., the terms “approximately,” “about,” “generally,” and “substantially” as used herein) refers to a value, quantity, or characteristic that is close to the stated value, quantity, or characteristic, and still performs the desired function or achieves the desired result. For example, the terms “approximately,” “about,” “generally,” and “substantially” can refer to a quantity that is less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated quantity.

[0599] References have been made to patent specifications, other external documents, or other sources of information in this specification, generally for the purpose of providing background for discussing the features of the invention. Unless expressly stated otherwise, references to such external documents shall not be construed as an admission that such documents or sources of information in any jurisdiction are prior art or form part of common general knowledge in the art.

[0600] In the foregoing description, specific details have been set forth to provide a thorough understanding of the embodiments. However, those skilled in the art will understand that the embodiments can be practiced without these specific details. For example, software modules, functions, circuits, etc., may be shown as block diagrams to avoid obscuring the embodiments with unnecessarily detailed information. In other instances, well-known modules, structures, and techniques may not have been shown in detail to avoid obscuring the embodiments.

[0601] Furthermore, it should be noted that embodiments can be described as processes, depicted as flowcharts, flow diagrams, structure diagrams, or block diagrams. While flowcharts can describe operations as a sequential process, many operations can be executed in parallel or concurrently. Additionally, the order of operations can be rearranged. A process terminates when its operations are completed. A process can correspond to a method, function, procedure, subroutine, subroutine, etc., in a computer program. When a process corresponds to a function, its termination corresponds to the function returning to the calling function or the main function.

[0602] The aspects of the systems and methods described above can be operable on any type of general-purpose computer system or computing device, including but not limited to desktop computers, laptop computers, notebook computers, tablet computers, smart TVs, game consoles, or mobile devices. The term "mobile device" includes, but is not limited to, wireless devices, mobile phones, smartphones, mobile communication devices, user communication devices, personal digital assistants, mobile handheld computers, laptop computers, wearable electronic devices (e.g., smartwatches and head-mounted devices), e-book readers and reading devices capable of reading electronic content, and / or other types of mobile devices typically carried by an individual and / or having some form of communication capability (e.g., wireless, infrared, short-range radio, cellular, etc.).

[0603] The aspects of the systems and methods described above may be operable or implemented on any type of dedicated or special computer or any machine or computer or server or electronic device (with microprocessor, processor, microcontroller, programmable controller, etc.), or cloud-based platform or other network (whether local or remote) of processor and / or server, or any combination of such devices.

[0604] Furthermore, embodiments can be implemented using hardware, software, firmware, middleware, microcode, or any combination thereof. When implemented in software, firmware, middleware, or microcode, program code or code segments used to perform the necessary tasks can be stored in a machine-readable medium (e.g., storage medium or other storage device). The processor can perform the necessary tasks. Code segments can represent procedures, functions, subroutines, programs, routines, subroutines, modules, software packages, classes, or any combination of instructions, data structures, or program statements. Code segments can be linked to another code segment or hardware circuit by passing and / or receiving information, data, arguments, parameters, or memory contents. Information, arguments, parameters, data, etc., can be passed, forwarded, or transmitted via any suitable means, including memory sharing, messaging, token passing, network transmission, etc.

[0605] In the above description, storage medium may refer to 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.

[0606] The various exemplary logic blocks, modules, circuits, elements, and / or components described in conjunction with the examples disclosed herein can be implemented or performed using any of the following: 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. 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 devices, such as a combination of a DSP and a microprocessor, several microprocessors, one or more microprocessors combined with a DSP core, or any other such configuration.

[0607] The methods or algorithms described in conjunction with the examples disclosed herein can be embodied directly in hardware, in a processor-executable software module, or a combination of both, as processing units, programming instructions, or other indications, and can be contained in a single device or distributed across multiple devices. The software module can reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, removable disk, CD-ROM, or any other form of storage medium known in the art. The storage medium can be coupled to the processor, enabling the processor to read information from and write information to the storage medium. Alternatively, the storage medium can be integrated with the processor.

[0608] Without departing from the scope of this disclosure, one or more of the components and functions shown in the accompanying drawings may be rearranged and / or combined into a single component or embodied in several components. Additional elements or components may also be added without departing from the scope of this disclosure. Additionally, the features described herein may be implemented in software, hardware, as a business approach, and / or combinations thereof.

[0609] In various aspects, embodiments of this disclosure may be embodied in computer-implemented processes, machines (e.g., electronic devices or general-purpose computers or other means providing a platform thereon on which computer programs can be executed), processes performed by such machines, or articles of art. Such articles of art may include computer program products or digital information products (wherein a computer-readable storage medium contains computer program instructions or computer-readable data stored thereon), as well as processes and machines for producing and using these articles of art.

[0610] While this disclosure has been described in the context of certain embodiments and examples, those skilled in the art will understand that this disclosure extends beyond the specific disclosed embodiments to other alternative embodiments and / or uses, as well as obvious modifications and their equivalents. Furthermore, while several variations of the embodiments of this disclosure have been shown and described in detail, other modifications within the scope of this disclosure will be readily apparent to those skilled in the art. It is also contemplated that various combinations or sub-combinations of specific features and aspects of the embodiments may be made, and such combinations or sub-combinations remain within the scope of this disclosure. For example, a feature described above in conjunction with one embodiment may be used with different embodiments described herein, and such combination remains within the scope of this disclosure. It should be understood that various features and aspects of the disclosed embodiments may be combined or substituted with each other to form variations of the embodiments of this disclosure. Therefore, it is intended that the scope of this disclosure should not be limited to the specific embodiments described above. Thus, unless otherwise stated or unless obviously incompatible, each embodiment of this disclosure may include one or more features as described herein from each other embodiment of the invention disclosed herein, in addition to its essential features described herein.

[0611] This disclosure may also be broadly interpreted to include any or all of the parts, elements, and features individually or collectively referred to or indicated in this disclosure, as well as any combination of two or more of the said parts, elements, or features, and where a specific integer having a known equivalent in the field covered by this disclosure is mentioned herein, such known equivalent is considered to be incorporated herein as if individually stated.

[0612] Features, materials, characteristics, or groups described in connection with a particular aspect, embodiment, or example shall be understood to be applicable to any other aspect, embodiment, or example described elsewhere in this section or in this specification, unless incompatible therewith. All features disclosed in this specification (including any appended claims, abstract, and drawings), and / or all steps of any method or process so disclosed, may be combined in any combination, except that at least some of such features and / or steps are mutually exclusive combinations. The scope of protection is not limited to the details of any of the foregoing embodiments. The scope of protection extends to any novel feature or any novel combination of features disclosed in this specification (including any appended claims, abstract, and drawings), or to any novel step or any novel combination of steps in any method or process so disclosed.

[0613] Furthermore, certain features described in the context of individual embodiments in this disclosure may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented individually or in any suitable sub-combination in multiple embodiments. Moreover, although features may be described above as functioning in certain combinations, in some cases, one or more features from a claimed combination may be removed from that combination, and that combination may be claimed as a sub-combination or a variation thereof.

[0614] Furthermore, while operations may be depicted in a specific order in the accompanying drawings or described in the specification, such operations do not necessarily need to be performed in the specific order shown or in sequential order, or all operations need not be performed, to achieve the desired result. Other operations not depicted or described may be incorporated into the example methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the described operations. Further, operations may be rearranged or reordered in other embodiments. Those skilled in the art will understand that in some embodiments, the actual steps taken in the illustrated and / or disclosed processes may differ from those shown in the figures. Depending on the embodiment, some steps described above may be removed, and other steps may be added. In addition, features and properties of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which are within the scope of this disclosure. Moreover, the separation of various system components in the embodiments described above should not be construed as requiring such separation in all embodiments, and it should be understood that the described components and systems may generally be integrated together in a single product or packaged into multiple products.

[0615] For the purposes of this disclosure, certain aspects, advantages, and novel features have been described herein. Not all such advantages may be achieved according to any particular embodiment. Therefore, for example, those skilled in the art will recognize that this disclosure may be embodied or implemented in a manner that achieves one or a set of advantages as taught herein, but not necessarily other advantages as may be taught or suggested herein.

[0616] The scope of this disclosure is not intended to be limited to the specific disclosures of embodiments herein or elsewhere in this specification, and may be defined by the claims as presented elsewhere in this section or elsewhere in this specification, or as to be presented in the future. The language of the claims will be interpreted broadly based on the language used in the claims, and not limited to the examples described in this specification or during the examination of this application, which will be construed as non-exclusive.

Claims

1. A respiratory device configured to provide a gas flow to a user for respiratory therapy, the respiratory device comprising: A flow generator is configured to generate the gas flow for the user; One or more sensors are configured to generate flow parameter data that indicates or represents the gas flow; as well as Controller, wherein the controller is configured to: - Receive the flow parameter data; - The nasal pressure change value, which indicates the user's average nasal pressure, is determined at least in part based on the received flow parameter data; - The work of breathing (WOB) index is determined at least in part based on the determined changes in nasal pressure; and - Initiate one or more actions based at least in part on the determined work of breathing (WOB) index.

2. The breathing device 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, and wherein the breathing device includes one or more flow rate sensors configured to sense and generate the flow rate data, and wherein the one or more flow rate sensors are in electrical communication with the controller.

3. The breathing device according to claim 2, wherein, The one or more flow rate sensors are positioned within or in the flow path of the gas flow, and / or The one or more flow rate sensors are located at or near the outlet of the blower of the flow generator.

4. The breathing device according to claim 2, wherein, The controller is further configured to process the flow rate data to remove noise and / or signal components associated with the flow generator.

5. The breathing device according to claim 4, wherein, The controller is configured to remove noise that affects the flow rate data related to the motor.

6. The breathing device according to claim 4, wherein, The controller is configured to receive data about the motor speed and discard the gas flow rate data if the motor speed is below a preset threshold.

7. The breathing device according to claim 4, wherein, The controller is configured to discard the flow rate data if it determines that the flow rate data parameter of the gas flow is of insufficient quality.

8. The breathing device according to claim 7, wherein, If the flow rate data includes large transient peaks, the flow rate data is determined to be of insufficient quality.

9. The breathing device according to any one of claims 1 to 8, 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, and The breathing device further includes one or more pressure sensors configured to sense and generate the pressure data, and wherein the one or more pressure sensors are in electrical communication with the controller.

10. The breathing device according to claim 9, wherein, The one or more pressure sensors are positioned within or in the flow path of the gas flow, and / or The one or more pressure sensors are located at or near the outlet of the blower of the flow generator.

11. The breathing device according to claim 9, wherein, The controller is further configured to determine an initial nasal pressure estimate that indicates or represents an estimate of the user's nasal pressure, based at least in part on the pressure data.

12. The breathing device according to any one of claims 1 to 8, wherein, The controller is further configured to determine a flow path conductivity estimate, which indicates or represents an estimate of the conductivity of the flow path for the gas flow between the flow generator and the patient interface.

13. The breathing device according to claim 12, wherein, The controller is configured to determine the flow path conductivity estimate based at least in part on an initial nasal pressure estimate that indicates or represents an estimate of the user's nasal pressure.

14. The breathing device according to claim 12, wherein, The controller is configured to determine the flow path conductivity estimate based at least in part on flow rate data that indicates or represents the flow rate of the gas flow provided by the flow generator.

15. The breathing device according to claim 12, wherein, The controller is configured to determine the flow path conductivity estimate based at least in part on pressure data that indicates or represents the pressure of the gas flow at the outlet of the blower of the flow generator.

16. The breathing device according to claim 12, wherein, The controller is configured to determine the flow path conductivity estimate based at least in part on flow rate data that indicates or represents the flow rate of the gas flow provided by the flow generator and pressure data that indicates or represents the pressure of the gas flow at the outlet of the blower of the flow generator.

17. The breathing device according to claim 12, wherein, The controller is configured to determine the nasal pressure change value based at least in part on the flow path conductivity estimate.

18. The breathing device according to claim 12, wherein, The controller is configured to determine the nasal pressure change value based at least in part on flow rate data that indicates or represents the flow rate of the gas flow provided by the flow generator.

19. The breathing device according to claim 12, wherein, The controller is configured to determine the nasal pressure change value based at least in part on minute ventilation data that indicates or represents the average gas volume provided per minute by the flow generator.

20. The breathing device according to claim 19, wherein, The controller is configured to determine minute ventilation data by fitting multiple splines to flow parameter data of the gas flow, wherein the multiple splines are fitted using a least squares criterion, and the minute ventilation data is determined by integrating along the multiple splines.

21. The breathing device according to claim 19, wherein, The controller is configured to determine the minute ventilation data by integrating the absolute value of the first term of a line fitted to the flow parameter data of the gas flow.

22. The breathing device according to claim 19, wherein, The controller is configured to determine the device's per-minute ventilation data by dividing the integral of the absolute value of a line of data fitted to the flow parameter data of the gas flow by a time range.

23. The breathing device according to claim 19, wherein, The controller is configured to determine the device's per-minute ventilation data by averaging the absolute values ​​of a line fitted to the flow parameter data of the gas flow across a series of time points within a time range.

24. The breathing device according to any one of claims 1 to 8, wherein, The nasal pressure change value was determined at a frequency selected within the range of 1 Hz to 20 Hz.

25. The breathing device according to any one of claims 1 to 8, wherein, The nasal pressure variation was continuously determined as a rolling average.

26. The breathing device according to any one of claims 1 to 8, wherein, The breathing device further includes a display screen, and preferably wherein the display screen displays a graphical user interface, and / or preferably wherein the display screen is in electrical communication with the controller, and wherein the controller is configured to display a graphical indicator representing a determined breathing work index on the display screen.

27. The breathing device according to claim 26, wherein, The graphical indicators indicate or represent whether the determined work of breathing index is increasing or decreasing.

28. The breathing device according to any one of claims 1 to 8, wherein, The controller is configured to trigger or generate warnings, alarms, and / or notifications based at least in part on a determined work of breathing index and one or more thresholds.

29. The breathing device according to claim 28, wherein, The warnings, alarms, and / or notifications are triggered or generated at least in part based on the determination that the work of breathing index has increased above a threshold, and / or The warnings, alarms, and / or notifications are triggered or generated at least in part based on the determination that the work of breathing index has decreased below a threshold.

30. The breathing device according to claim 28, wherein, The controller is configured to send or transmit data representing the warning, alarm, and / or notification to a remote device or system that is in data communication with the device.

31. The breathing device according to claim 28, wherein, The controller is configured to generate or provide suggested thresholds and / or parameters associated with one or more thresholds, based at least in part on the work of breathing index.

32. The breathing device according to any one of claims 1 to 8, wherein, The breathing device further includes a housing, and wherein the housing includes or integrates the following: -The flow generator; - A humidifier is configured to heat and humidify the gas stream; - A sensing block or sensor module, including one or more sensors configured to generate flow parameter data indicating or representing the gas flow; and -The controller, and The sensing block or sensor module includes a flow rate sensor and a pressure sensor.

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