Respiratory support devices and / or their components and / or their use

Abstract

A device is disclosed that is configured to operate in at least one therapeutic mode and at least one non-therapeutic mode, and after operating in the at least one non-therapeutic mode for a predetermined period of time, the device is configured to transfer data to a device and / or receive a software package from a device and / or receive treatment parameters from a device and / or update device parameters.

Description

[Technical field]

[0001] The present disclosure relates to various respiratory assistance devices and / or components thereof and / or uses thereof. [Background technology]

[0002] Respiratory support devices are used to deliver a gas flow to a patient in a variety of environments, such as hospitals, medical facilities, home care, or home environments. The respiratory support device (e.g., flow therapy device and / or pressure therapy device) may include an oxygen inlet that allows the respiratory device to deliver supplemental oxygen along with the gas flow. The respiratory support device may also (or alternatively) include an ambient air inlet and an airflow generator (e.g., including a blower) that provides gas to the patient. The respiratory support device may also (or alternatively) include a humidification device that allows the respiratory device to deliver heated and humidified gas. The respiratory support device may allow the characteristics of the gas flow to be adjusted and controlled. These characteristics may include, for example, flow rate, temperature, gas concentration (such as supplemental oxygen concentration), humidity, and pressure, among others.

[0003] Patients with various health conditions and illnesses may benefit from respiratory assistance (e.g., respiratory therapy). In at least one form, respiratory therapy may be oxygen therapy. For example, patients with chronic obstructive pulmonary disease (COPD), pneumonia, asthma, tracheal dysplasia, heart failure, cystic fibrosis, sleep apnea, lung disease, respiratory trauma, acute distress, and / or other conditions or illnesses may benefit from respiratory therapy. Similarly, patients receiving pre- and post-operative oxygen therapy may also benefit from respiratory therapy. By way of further example, patients with obstructive sleep apnea (OSA) may also benefit from respiratory therapy (e.g., CPAP and / or bilevel therapy). Summary of the Invention [Means for solving the problem]

[0004] In a first aspect of the present disclosure, there is provided a respiratory assistance apparatus comprising: an airflow generator configured to generate a gas flow; a humidifier gaseously connected to the airflow generator and configured to humidify the gas flow; Including, The apparatus is configured to be connected to a conduit that transports a gas flow; the device is configured to operate in at least one therapeutic mode and at least one non-therapeutic mode, and during operation in the at least one therapeutic mode, the device is configured to provide therapy to a user; the device is configured to collect and store data, the data including therapy data and / or device data collected during operation in at least one therapy mode; After operating in at least one non-therapeutic mode for a predetermined period of time, the device: a) Transferring data to a device; or b) receive a software package on or from a device; or c) receiving a device or treatment parameters from the device; or d) updating the parameters of the device, or e) Perform any combination of a) to e). It is configured as follows.

[0005] When the device is operating in at least one therapy mode, therapy may be provided to the user.

[0006] At least one treatment mode is a) Continuous positive airway pressure (CPAP) mode, b) Bubble Continuous Positive Airway Pressure (BCPAP) mode; c) Nasal high flow (NHF) mode, d) Bi-level mode; e) Any combination of a) to d) may include.

[0007] The device may include a controller configured to operate the device according to any of the treatment modes a)-d) above.

[0008] The device (and optionally a controller of the device) may be configured to control the airflow generator and / or the humidifier according to at least one treatment mode.

[0009] Each treatment mode may have one or more associated treatment parameters.

[0010] The relevant therapeutic parameters include one or more of the following: a therapeutic flow rate of gas, a therapeutic pressure support level, a therapeutic temperature of the gas, a therapeutic humidity of the gas, a therapeutic temperature at the end of the breathing conduit.

[0011] Each therapy mode may have associated software executed by the device and configured to control the device to provide a particular therapy.

[0012] When the device is operating in at least one non-therapy mode, no therapy may be provided to the user.

[0013] The device may be configured to automatically operate in at least one non-therapeutic mode after completion of at least one therapeutic mode.

[0014] The device may be configured to enter at least one non-therapeutic mode after receiving an end therapy command (optionally via input from the user interface and / or by detecting that the patient interface has been removed from the user).

[0015] The end of treatment command is a) via input from a user interface; b) by detecting that the patient interface has been removed from the user; c) by detecting that the patient interface has been removed from the user for a predetermined period of time; d) Any combination of a) to c) can be generated.

[0016] When the device is operating in at least one non-therapeutic mode, the airflow generator may be activated to generate a gas flow.

[0017] A user may also select a treatment mode via the user interface. The controller may receive user input, i.e., a selection of a treatment mode by the user, via the user interface and operate the device accordingly to provide treatment according to the selected treatment mode.

[0018] When the device is operating in at least one non-therapeutic mode, the airflow generator directs the gas flow to a flow rate of gas flow provided during a therapeutic mode that is less than a therapeutic flow rate; A predetermined flow rate, and / or Given Motor Speed It may be provided in.

[0019] In some given configurations, a predetermined flow rate can be provided by controlling a predetermined motor speed, which may be, for example, by a look-up table or formula that defines the relationship between flow rate and motor speed. In non-treatment modes, this approach makes it easier to control the airflow generator since no patient is connected and resistance to flow is known (i.e., during disinfection mode) or assumed to be constant (i.e., drying and / or disinfection modes).

[0020] When the device is operating in at least one non-therapeutic mode, the humidifier (optionally a heater plate of the humidifier) ​​may be activated, and optionally the humidifier may be configured to humidify the gas flow.

[0021] When the device is operating in at least one non-therapeutic mode, a heater in the conduit may be activated and configured to heat the gas flow within the conduit.

[0022] The at least one non-treatment mode may include a drying mode configured to dry the conduit.

[0023] When the device is operating in a dry mode, the heater in the conduit may be controlled while the airflow generator provides gas at a predetermined flow rate.

[0024] When the device is operating in the dry mode, the humidifier heater may be controlled to a predetermined value (optionally, the predetermined value is a predetermined power, which may be less than about 5% or less than about 10% of the maximum power provided to the heater plate) or the heater plate may be deactivated during the dry mode.

[0025] The heater in the conduit may be controlled to a predetermined temperature at the end of the conduit, or to a predetermined duty cycle, or to a predetermined voltage, or to a predetermined current, or to a predetermined power.

[0026] The predetermined duty cycle may be 100%.

[0027] The predetermined temperature may be greater than 45 degrees Celsius.

[0028] The drying mode may be configured to operate for about 20 minutes to about 120 minutes, or for about 90 minutes.

[0029] The drying mode may include controlling the airflow generator to provide a predetermined airflow generator output, which may be a motor speed of between about 1000 RPM and about 3000 RPM, or less than about 2000 RPM.

[0030] The drying mode can include controlling the airflow generator to provide a predetermined flow rate, which can be between about 5 liters / minute and about 20 liters / minute.

[0031] The dry mode may be configured to evaporate any condensation remaining within the device and / or the patient breathing conduit and / or the patient interface.

[0032] The non-therapy mode may be a warm-up mode.

[0033] The device may operate in a warm-up mode when the device is powered on.

[0034] The warm-up mode may include controlling a heater in the conduit to control the temperature at the end of the conduit to a desired temperature.

[0035] The desired temperature at the end of the conduit may be based on one or more treatment parameters of the device.

[0036] The one or more treatment parameters include: a) treatment chamber outlet temperature; b) Therapeutic dew point temperature (at the chamber outlet or conduit end) c) treatment humidity (at the chamber outlet or conduit end); and / or d) treatment temperature at the end of the conduit; e) Any combination of a) to e) It could be.

[0037] The desired temperature at the end of the conduit may be a predetermined temperature.

[0038] The temperature at the end of the conduit may be within about 2 degrees Celsius to about 5 degrees Celsius, or about 2.5 degrees Celsius of the desired patient end temperature, optionally about 2 degrees Celsius to about 5 degrees Celsius, or about 2.5 degrees Celsius below the predetermined temperature or treatment parameter.

[0039] The warm-up mode may include controlling the heater of the humidifier to a predetermined temperature, or to a predetermined duty cycle, or to a predetermined voltage, or to a predetermined current, or to a predetermined power.

[0040] The warm-up mode may include deactivating the airflow generator.

[0041] The conduit may be configured to deliver gas to the patient through the patient interface.

[0042] The non-therapeutic mode can be a germicidal mode.

[0043] In the sterilization mode, the device may be configured to be connected to a sterilization conduit.

[0044] In the sterilization mode, the heater in the sterilization conduit may be controlled so that the gas flow in the sterilization conduit reaches a predetermined temperature.

[0045] The predetermined temperature can be between about 50 degrees Celsius and about 100 degrees Celsius, or between about 60 degrees Celsius and about 90 degrees Celsius.

[0046] The sterilization conduit may include a temperature sensor.

[0047] The sterilization mode can include controlling the airflow generator to provide a predetermined flow rate, the predetermined flow rate being between about 10 liters / minute and about 20 liters / minute.

[0048] The non-therapeutic mode may be a standby mode.

[0049] The standby mode may include operating the airflow generator at a predetermined flow rate or a predetermined motor speed.

[0050] The predetermined flow rate can be less than the therapeutic flow rate being provided to the patient.

[0051] The predetermined motor speed can be between about 1000 RPM and about 3000 RPM, or less than about 2000 RPM.

[0052] The treatment data may include data regarding the user and / or the treatment provided to the user.

[0053] The treatment data is a) User's oxygen saturation (SpO2) b) The user's breathing rate c) Humidity (dew point) of the gas provided to the user d) The flow rate of gas provided to the user. e) The user's tidal volume f) User's minute ventilation g) Any combination of a) to f) may include.

[0054] The treatment data is a) Device usage data b) Answers to one or more questions provided to the user c) Treatment Report (optionally, the treatment report relates to past treatment session reports and / or currently completed treatment sessions) d) Results of the interview e) Any combination of a) to d) may include.

[0055] The device may include one or more sensors configured to determine treatment data.

[0056] When the device is operating in at least one non-therapeutic mode, the user is asked one or more questions and provides answers to those questions via at least one user interface, and the questions and / or the answers to the questions form part of the therapeutic data.

[0057] The device may be configured to receive sensor output from one or more sensors, and the treatment data may be based on the sensor output from the one or more sensors.

[0058] The one or more sensors may be disposed within the housing of the device.

[0059] The sensor or sensors may be located remotely from the device.

[0060] The treatment data can be from at least one treatment mode.

[0061] The treatment data may include data from at least one previous treatment mode.

[0062] The therapy data may include data from at least one therapy mode that has not previously been transferred to the device.

[0063] The device data may relate to one or more characteristics of the device and / or the device's surrounding environment.

[0064] The data may be transferred to the device even if the device is not operating in at least one therapy mode.

[0065] The data may be transferred to the device after a predetermined time has elapsed since the last data transfer to the device (optionally, the predetermined time is 24 hours).

[0066] The equipment is a) Server b) Local Devices c) Remote Device d) Any combination of a) to c) It could be.

[0067] The predetermined time period can be from about 5 minutes to about 25 minutes.

[0068] The predetermined time may be greater than 5 minutes.

[0069] The predetermined amount of time may be less than the total amount of time the device is configured to operate in a non-therapeutic mode.

[0070] The predetermined time may be a percentage of the total time the device is configured to operate in a non-therapeutic mode.

[0071] The apparatus may include a controller configured to control operation of the apparatus.

[0072] If the user attempts to power off the device while data is being transferred to the appliance, the user may be presented with a visual and / or audio indicator.

[0073] The user may be presented with a visual and / or audio indicator while the data is being uploaded to the device.

[0074] To prevent the device from being turned off immediately after the device has finished a therapeutic mode, the device must be turned off after operating in at least one non-therapeutic mode for a predetermined period of time. a) Transferring data to a device, or b) receiving a software package on or from a device; or c) receiving a device or treatment parameters from the device; or d) updating the parameters of the device, or e) Perform any combination of a) to e). It can be configured as follows.

[0075] After operating in at least one non-therapeutic mode for a predetermined period of time, the device may be configured to activate the network interface and establish a connection with a device to transfer data to the device and / or receive software packages and / or treatment parameters from or to the device.

[0076] The software package is a) Firmware updates, b) Software Updates may include one or more of:

[0077] After receiving the software package, the device may apply the software package to the device.

[0078] Updating the parameters of the device may include performing a sensor recalibration.

[0079] After receiving treatment parameters from a device or devices, the device may apply updates to the device's treatment parameters.

[0080] The device may receive software packages and / or treatment parameters only if they are updates to the current software package and / or current treatment parameters.

[0081] The apparatus may have a gas inlet and a gas outlet, and the conduit may be configured to be connected to the gas outlet.

[0082] The apparatus may include one or more sensors (optionally temperature sensors) positioned in the gas flow.

[0083] The apparatus may include one or more sensors (optionally temperature sensors) disposed in the gas outlet.

[0084] The device may include a housing, the airflow generator and / or the humidifier being disposed within the housing.

[0085] After operating in a non-therapeutic mode for a predetermined period of time, the device is configured to update device parameters and then transfer this data to the equipment.

[0086] After operating in a non-therapeutic mode for a predetermined period of time, the device is configured to transfer data to a device and thereafter receive a software package from or about the device, and thereafter update parameters of the device.

[0087] After operating in a non-therapeutic mode for a predetermined period of time, the device is configured to update device parameters, then transfer data to a device, then receive a software package from the device, and then update device parameters based on the device or the software package received from the device.

[0088] The device is configured to receive treatment parameters from or to a device after transferring data to the device.

[0089] The device may be configured to receive treatment parameters from a device or devices after receiving a software package from the device or devices.

[0090] The device may be configured to receive treatment parameters from a device or devices prior to updating device parameters.

[0091] The device may include at least one display (optionally as part of the display module).

[0092] When operating in non-therapeutic mode, the device may display non-therapeutic information on the display.

[0093] The information may be one or more of the following: type of non-therapeutic mode, an indication that the non-therapeutic mode is active, time remaining in the non-therapeutic mode, and a warning not to use the device.

[0094] The updated parameters of the device may be sensor calibration parameters (and optionally sensor calibration parameters) of one or more sensors.

[0095] Sensor calibration parameters may relate to the relationship between the output of one or more sensors and the property that the sensor is configured to measure.

[0096] The one or more sensors include may include a flow sensor configured to measure a flow rate of the gas flow, optionally the flow sensor including an ultrasonic sensor; and / or An oxygen concentration sensor configured to measure an oxygen concentration of the gas may be included, and optionally the oxygen concentration sensor may include an ultrasonic sensor.

[0097] If auxiliary gas is not provided as part of the gas flow, the device may be configured to determine an output of an oxygen concentration sensor indicative of the oxygen concentration of the gas flow, and the device is configured to determine oxygen concentration sensor calibration parameters based on the output of the oxygen concentration sensor and the estimated ambient oxygen concentration.

[0098] The estimated ambient oxygen concentration can be about 19% to about 23%, about 20.9%, or about 21%, or about 22%.

[0099] When an auxiliary gas is provided as the gas flow, the device is configured to determine an output of an oxygen concentration sensor indicative of an oxygen concentration of the gas flow, and the device is configured to determine an oxygen concentration sensor calibration parameter based on the output of the oxygen concentration sensor and the predetermined oxygen concentration.

[0100] In another aspect of the present disclosure, a respiratory assistance apparatus is provided, comprising: a gas inlet and a gas outlet; A housing and an airflow generator disposed within the housing, the airflow generator configured to generate a gas flow; a humidifier disposed within the housing, in fluid communication with the airflow generator and configured to humidify a gas flow from the airflow generator, the humidifier including a heater configured to heat a fluid in a humidification chamber of the humidifier; a conduit connected to the gas outlet and configured to transport a gas flow, the conduit including a heater configured to heat the gas flow in the conduit; one or more sensors disposed within the housing; a controller including at least one processor and a memory, the controller configured to control at least the flow generator, the humidifier, and the heater of the conduit, and configured to receive sensor output from the one or more sensors and store data based on the sensor output from the one or more sensors; Including, the controller is configured to operate the device in at least a therapeutic mode and a non-therapeutic mode, in which in the therapeutic mode the device is configured to provide therapy to a user in accordance with one or more therapeutic parameters, and in which in the non-therapeutic mode at least one of the airflow generator, the heater of the humidifier, and / or the heater of the conduit are activated and no gas flow is provided to the user; After operating in the non-therapeutic mode for a predetermined period of time, the controller a) Transferring data to a device; or b) receive a software package on or from a device; or c) receiving a device or treatment parameters from the device; or d) updating the parameters of the device, or e) Perform any combination of a) to d) It is configured as follows.

[0101] In another aspect of the present disclosure, a respiratory assistance apparatus is provided, comprising: a gas inlet and a gas outlet; A housing and an airflow generator disposed within the housing, the airflow generator configured to generate a gas flow; a humidifier disposed within the housing, in fluid communication with the airflow generator and configured to humidify a gas flow from the airflow generator, the humidifier including a heater configured to heat a fluid in a humidification chamber of the humidifier; a conduit connected to the gas outlet and configured to transport a gas flow, the conduit including a heater configured to heat the gas flow in the conduit; one or more sensors disposed within the housing; a controller including at least one processor and a memory, the controller configured to control at least the flow generator, the humidifier, and the heater of the conduit, and configured to receive sensor output from the one or more sensors and store data based on the sensor output from the one or more sensors; Including, The controller is configured to operate the device in at least a therapy mode and a desiccation mode, where in the therapy mode the device is configured to provide therapy to a user in accordance with one or more therapy parameters, and in the desiccation mode the heater of the humidifier is deactivated and the heater of the conduit is activated while the airflow generator provides gas at a predetermined flow rate and / or at a predetermined motor speed of the airflow generator motor; After operating in Dry mode for at least 10 minutes, the controller a) Transferring data to a device; or b) receive a software package on or from a device; or c) receiving a device or treatment parameters from the device; or d) updating the parameters of the device, or e) Perform any combination of a) to d) It is configured as follows.

[0102] After operating in at least one non-therapeutic mode for a predetermined period of time, the device may be configured to activate the network interface and establish a connection with the appliance.

[0103] The device may further include one or more remote sensors located remotely from the device.

[0104] The controller may be configured to receive sensor output from the one or more remote sensors, and the controller is configured to store data based on the sensor output from the one or more remote sensors.

[0105] After receiving a software package from or on a device, the apparatus may be configured to apply the software package.

[0106] The software may check the version of the software package and update the device's software package if it is an older version.

[0107] The device may transmit a confirmation message to the appliance upon successful installation of the software package and / or transmit an error report if the software package was not successfully installed.

[0108] After receiving a device or treatment parameters from the device (as a prescribed update), the device may be configured to update the device's treatment parameters based on the received treatment parameters.

[0109] Receiving the software package and receiving the treatment parameters may be initiated by a fetch operation by the device.

[0110] The device may be configured to query the equipment as to whether any updated software packages and / or updated treatment parameters are available, and if updated software packages and / or updated treatment parameters are available, the device is configured to receive the software packages and / or treatment parameters.

[0111] In a respiratory assistance device, a gas inlet and a gas outlet; A housing and an airflow generator disposed within the housing, the airflow generator configured to generate a gas flow; a humidifier disposed within the housing, in fluid communication with the airflow generator and configured to humidify a gas flow from the airflow generator, the humidifier including a heater configured to heat a fluid in a humidification chamber of the humidifier; a conduit connected to the gas outlet and configured to transport a gas flow, the conduit including a heater configured to heat the gas flow in the conduit; one or more sensors disposed within the housing; a controller including at least one processor and a memory, the controller configured to control at least the flow generator, the humidifier, and the heater of the conduit, and configured to receive sensor output from the one or more sensors and store data based on the sensor output from the one or more sensors; Including, The controller is configured to operate the device in at least a therapy mode and a warm-up mode, in which in the therapy mode the device is configured to provide therapy to the user according to one or more therapy parameters, and in the warm-up mode the humidifier heater and the breathing conduit heater are activated and the flow generator is deactivated; After 10 minutes of operation in warm-up mode, the controller a) Transferring data to a device; or b) receive a software package on or from a device; or c) receiving a device or treatment parameters from the device; or d) updating the parameters of the device, or e) Perform any combination of a) to d) It is configured as follows.

[0112] In a respiratory assistance device, an airflow generator configured to generate a gas flow; a humidifier gaseously connected to the airflow generator and configured to humidify the gas flow; Including, The apparatus is configured to be connected to a conduit that transports a gas flow; the device is configured to operate in at least one therapeutic mode and at least one non-therapeutic mode, and during operation in the at least one therapeutic mode, the device is configured to provide therapy to the user; the device is configured to collect and store data, the data including therapy data and / or device data collected during operation in at least one therapy mode; the device is configured to send a notification to the apparatus that a therapy parameter update or software package is available; the device is configured to download updated treatment parameters and / or updated software packages from the device; After operating in at least one non-therapeutic mode for a predetermined period of time, the device is configured to apply updated treatment parameters and / or an updated software package.

[0113] When the device is operating on battery power, the device may refrain from performing an action after a predetermined time in non-therapeutic mode, or may prompt the user to confirm the action before performing it.

[0114] When the device is operating on battery power, the user may be able to manually prompt the device to perform an action (optionally after a predetermined time in non-therapy mode).

[0115] When the device is reconnected to an external power source, the device may prompt the user to take an action (optionally after a predetermined time in non-therapy mode).

[0116] When the device enters the charging state, the device may be configured to perform an action immediately or after a predetermined time in the charging state (optionally after a predetermined time in a non-therapy mode).

[0117] The predetermined time may be the predetermined time for operation in a non-therapeutic mode as described above, or greater than about 2 minutes, or greater than about 5 minutes.

[0118] In some embodiments, the charging state may be entered when the device is powered on.

[0119] Once a service operation is completed (e.g. a general service of the device or replacement of a component of the device), the device may be configured to perform an action immediately, or to perform an action a predetermined time after the service operation is completed.

[0120] In some embodiments, after the service activity is completed, the device may prompt the user (in this case a service technician) (as described above) to perform an action.

[0121] With respect to the operation being performed after a service operation, this operation may serve as a connectivity test to ensure that the communications module is in an operational state.

[0122] When the device enters a mobile state (e.g., traveling by airplane or traveling away from the user's usual location), the device may refrain from performing an action after a predetermined time in non-therapy mode, or may prompt the user to confirm the action before performing it.

[0123] Once the device is no longer in motion, the device may prompt the user to perform an action.

[0124] When the device is in a mobile state, the user may be able to manually prompt the device to perform an action.

[0125] In the mobile state, the device may deactivate the communications module (or a portion of the communications module).

[0126] In mobile situations, the device may also run on batteries.

[0127] In another aspect of the present disclosure, a respiratory assistance apparatus is provided, comprising: an airflow generator configured to generate a gas flow; a humidifier pneumatically connected to the airflow generator and configured to humidify the gas flow; Including, the device is configured to operate in at least one therapeutic mode and at least one non-therapeutic mode, and during operation in the at least one therapeutic mode, the device is configured to provide therapy to a user; When the device is operating in at least one non-therapeutic mode, the device is configured to update at least one parameter of the device.

[0128] The device may be configured to update parameters of the device after the device has operated in at least one non-therapeutic mode for a predetermined period of time.

[0129] The device may be configured to update device parameters after the non-therapeutic mode is completed.

[0130] The updated parameters of the device may be sensor calibration parameters (and optionally sensor calibration parameters) of at least one sensor.

[0131] The apparatus may be configured to update sensor calibration parameters of at least one sensor at least once, and optionally multiple times.

[0132] The apparatus may be configured to update sensor calibration parameters for the at least one sensor and, after a predetermined time, to update the sensor calibration parameters for the at least one sensor again.

[0133] The sensor calibration parameters may relate to a relationship between the output of at least one sensor and a property that the sensor is configured to measure.

[0134] The sensor calibration parameters may be stored in the device's memory.

[0135] The sensor calibration parameters may be used by the device to determine a characteristic that the sensor is configured to measure based on an output of at least one sensor.

[0136] The sensor calibration parameters may be used by the device in a therapeutic mode.

[0137] The sensor calibration parameters are: Calibration coefficient, Calibration curve, Sensor internal parameters may include one or more of:

[0138] The device may be configured to update the control scheme based on the sensor calibration parameters.

[0139] The apparatus may be configured to update the sensor calibration parameters based on the output of the at least one sensor and the other sensor.

[0140] The at least one sensor and the other sensor may be configured to measure the same characteristic.

[0141] At least one of the sensors may include a first pressure sensor and the other sensor may include a second pressure sensor, and the device is configured to update sensor calibration parameters of the first pressure sensor based on an output of the second pressure sensor.

[0142] The first pressure sensor may be an ambient pressure sensor and the second pressure sensor is a pressure sensor disposed within the flow path of the device.

[0143] In a non-therapeutic mode, no gas flow may be provided from the airflow generator so that the ambient pressure is the same as the pressure of the gas in the flow path.

[0144] At least one of the sensors may include a first temperature sensor and the other sensor may include a second temperature sensor, and the device is configured to update sensor calibration parameters of the first temperature sensor based on an output of the second temperature sensor.

[0145] The first temperature sensor may be an air temperature sensor and the second temperature sensor is a patient end temperature sensor located near a patient end of a conduit configured to be connected to the device.

[0146] The first temperature sensor may be co-located with the second temperature sensor.

[0147] In a non-therapeutic mode, the device is configured to not provide power to the humidifier heater and / or the conduit heater for a predetermined period of time, so that the air temperature is the same as the temperature of the gas in the flow path.

[0148] At least one sensor A sensor module (optionally disposed between the airflow generator and the humidifier) Airflow Generator Upstream location of airflow generator Downstream location of the airflow generator humidifier Upstream location of the humidifier Downstream location of the humidifier a conduit configured to be connected to the gas outlet of the humidifier and to transport the gas flow to a user (optionally at a user end of the conduit near a patient interface); Patient Interface Ambient Sensor A measurement chamber (optionally as part of the sensor module) Humidification chamber inlet Humidification chamber outlet is placed in one or more of the

[0149] The apparatus can include at least one valve configured to be connected to a source of auxiliary gas, the valve configured to control auxiliary gas flow.

[0150] The auxiliary gas may be oxygen.

[0151] The auxiliary gas flow may be blended with ambient air, and the blended auxiliary gas and ambient air are provided to the airflow generator.

[0152] The auxiliary gas flow may be configured to be added to the gas flow generated by the airflow generator.

[0153] The device may be configured to operate the valve to control the auxiliary gas concentration of the gas flow provided to the user to a therapeutic oxygen concentration.

[0154] The device may include at least one patient oxygen saturation sensor, and the device is configured to operate a valve to control an auxiliary gas concentration in the gas flow provided to the user based on an output of the at least one patient oxygen saturation sensor to reach a therapeutic patient oxygen concentration.

[0155] When the device updates the device's parameters, the device may be configured to operate a valve to block auxiliary gas flow.

[0156] If the device is configured to operate the valve to block auxiliary gas flow, the concentration of the auxiliary gas in the gas flow may be assumed to be the concentration of the auxiliary gas in the ambient air.

[0157] The apparatus may include an alternate supply inlet, the alternate supply inlet configured to be connected to a source of auxiliary gas.

[0158] The auxiliary gas flow from the alternative supply may be configured to be blended with the ambient air, and the blended auxiliary gas and ambient air are provided to the airflow generator.

[0159] A supplemental gas flow from an alternative supply port may be configured to be added to the gas flow generated by the airflow generator.

[0160] Before the device updates the device's parameters, the device may be configured to prompt the user (optionally via the user interface) to disconnect the source of auxiliary gas from the alternate supply.

[0161] At least one sensor may be an oxygen concentration sensor, and optionally, the oxygen concentration sensor includes an ultrasonic sensor.

[0162] If auxiliary gas is not provided as part of the gas flow, the device may be configured to determine an output of an oxygen concentration sensor indicative of the oxygen concentration of the gas flow, and the device is configured to determine oxygen concentration sensor calibration parameters based on the output of the oxygen concentration sensor and the estimated ambient oxygen concentration.

[0163] The estimated ambient oxygen concentration may be about 19% to about 23%, about 20.9%, or about 21%, or about 22%.

[0164] When an auxiliary gas is provided as a gas flow, the device may be configured to determine an output of an oxygen concentration sensor indicative of an oxygen concentration of the gas flow, the device may be configured to determine an output of an oxygen concentration sensor indicative of an oxygen concentration of the gas flow, and the device is configured to determine oxygen concentration sensor calibration parameters based on the output of the oxygen concentration sensor and the predetermined oxygen concentration.

[0165] The predetermined oxygen concentration may be 100%.

[0166] Ambient air may not be provided as part of the gas flow.

[0167] The predetermined oxygen concentration may be input by a user.

[0168] The user may be prompted to connect an auxiliary source to the device and indicate the oxygen concentration of the auxiliary source.

[0169] The device may be configured to operate the airflow generator at a predetermined flow rate or at a predetermined motor speed.

[0170] The device may be configured to operate the airflow generator at a predetermined flow rate or a predetermined motor speed after the device has determined the oxygen concentration sensor calibration parameters.

[0171] The at least one sensor may be a flow sensor configured to measure a flow rate of the gas flow.

[0172] During the non-therapeutic mode, the device may be configured to cause the airflow generator to stop generating gas flow and to determine an output of the flow sensor indicative of a flow rate of the gas, and the device may be configured to determine flow sensor calibration parameters based on the output of the flow sensor and a predetermined zero flow rate.

[0173] The predetermined zero flow rate may be 0 LPM.

[0174] During the non-therapeutic mode, the device may be configured to determine an output of the flow sensor indicative of a flow rate of the gas while the airflow generator is generating a gas flow, and the device is configured to determine flow sensor calibration parameters to be applied to the output of the flow sensor based on the output of the flow sensor and a predetermined flow rate.

[0175] The predetermined flow rate may be greater than 0 LPM, or about 10 LPM, or about 20 LPM, or about 30 LPM, or about 40 LPM, or about 50 LPM, or about 60 LPM, or about 70 LPM.

[0176] When the auxiliary gas is provided as a gas flow, the apparatus may be configured to determine an output of a humidity sensor indicative of the humidity of the gas flow of gas, and the apparatus is configured to determine a humidity sensor calibration parameter based on the output of the humidity sensor and the predetermined humidity.

[0177] The predetermined humidity may be 0% relative humidity or 0 absolute humidity.

[0178] The controller may be configured to determine humidity sensor calibration parameters based on the output of other humidity sensors.

[0179] The humidity sensor and / or other humidity sensors may include: Ambient Humidity Sensor Gas Flow Humidity Sensor may include.

[0180] The at least one non-treatment mode may include a drying mode configured to dry the conduit.

[0181] When the device is operating in a dry mode, the heater in the conduit may be controlled while the airflow generator provides gas at a predetermined flow rate.

[0182] When the device is operating in the dry mode, the humidifier heater may be controlled to a predetermined value (optionally, the predetermined value is a predetermined power, which is less than about 5% or less than about 10% of the maximum power provided to the heater plate) or the heater plate may be deactivated during the dry mode.

[0183] The heater in the conduit may be controlled to a predetermined temperature at the end of the conduit, or to a predetermined duty cycle, or to a predetermined voltage, or to a predetermined current, or to a predetermined power.

[0184] The predetermined duty cycle may be 100%.

[0185] The predetermined temperature may be greater than 45 degrees Celsius.

[0186] The drying mode may be configured to operate for about 20 minutes to about 120 minutes, or for about 90 minutes.

[0187] The drying mode may include controlling the airflow generator to provide a predetermined airflow generator output, the airflow generator output being a motor speed of between about 1000 RPM and about 3000 RPM, or less than about 2000 RPM.

[0188] The drying mode can include controlling the airflow generator to provide a predetermined flow rate, the predetermined flow rate being between about 5 liters / minute and about 20 liters / minute.

[0189] The dry mode may be configured to evaporate any condensation remaining within the device and / or the patient breathing conduit and / or the patient interface.

[0190] The non-therapy mode may be a warm-up mode.

[0191] The non-therapeutic mode may be a standby mode.

[0192] When the device is operating in at least one therapy mode, therapy may be provided to the user.

[0193] At least one treatment mode is a) Continuous positive airway pressure (CPAP) mode, b) Bubble Continuous Positive Airway Pressure (BCPAP) mode; c) Nasal high flow (NHF) mode, d) Bi-level mode; e) Any combination of a) to d) may include.

[0194] When the device is operating in at least one non-therapy mode, no therapy may be provided to the user.

[0195] The device may be configured to automatically operate in at least one non-therapeutic mode after at least one therapeutic mode is completed.

[0196] The apparatus includes: At the end of non-treatment mode At the start of non-treatment mode The method may be configured to update in one or more of:

[0197] The device may include a controller configured to control the airflow generator and / or humidifier in at least one therapeutic mode and at least one non-therapeutic mode, and during operation in the at least one therapeutic mode, the device is configured to provide therapy to a user.

[0198] The controller may be configured to update at least one parameter of the device.

[0199] After the device updates its parameters, the device may be configured to transfer the data to the appliance.

[0200] The data may include updated parameters of the device.

[0201] The device may include at least one display (optionally as part of the display module).

[0202] The display may display information regarding the sensor calibration process.

[0203] A report may be generated based on the information about the sensor calibration process.

[0204] The information may include one or more of the sensor error and whether the sensor is within or outside the error range, calibration success or failure, and / or a solution for the sensor failure.

[0205] In another aspect of the present disclosure, there is provided an airflow generator configured to generate a gas flow, comprising: a humidifier pneumatically connected to the airflow generator and configured to humidify the gas flow; The apparatus is configured to be connected to a conduit that transports a gas flow; The device is configured to operate in at least a therapy mode and a desiccation mode, in which in the therapy mode the device is configured to provide therapy to a user in accordance with one or more therapy parameters, and in the desiccation mode the heater of the humidifier is deactivated and the heater of the conduit is deactivated while the airflow generator provides gas at a predetermined flow rate and / or a predetermined motor speed; At least while operating in the dry mode (and optionally after a predetermined time) the apparatus: Transfer data to a device and then Update at least one sensor calibration parameter of at least one sensor (and optionally at least two sensors) of the device. It is configured as follows.

[0206] It is to be understood that any of the above statements may be combined with any one or more of the other statements.

[0207] Reference to a numerical range disclosed herein (e.g., 1-10) includes reference 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), as well as any range of significant numbers within that range (e.g., 2-8, 1.5-5.5, and 3.1-4.7), and thus all subranges of all ranges explicitly disclosed herein are intended to be expressly disclosed hereby. These are merely examples of what is specifically intended, and all possible combinations of numerical values ​​between the lowest and highest values ​​specified shall be considered to be expressly set forth herein as well.

[0208] It should be understood that alternative embodiments or configurations may include any of the components, elements, or any combination of two or more of the components, elements illustrated, described, or referred to herein.

[0209] Some embodiments of the present disclosure may also be broadly described as consisting of or including the parts, elements, and features referred to or indicated in the specification of this specification, individually or collectively, and any combination of any two or more of said parts, elements, or features, and where a specific integer having a known equivalent to one of ordinary skill in the art to which this disclosure pertains is recited herein, such known equivalent is deemed to be included herein as if it were individually set forth.

[0210] The term "comprising" as used herein means "including." In interpreting each description containing the term "comprising," there may be other features present than those preceding the term. The related terms (comprise, comprises) are to be interpreted in the same manner.

[0211] The term request, when used with respect to a controller, may refer to the controller sending a signal to a component instructing the component to perform one or more actions.

[0212] As used herein, the term "s" following a noun is meant to include the plural and / or the singular form of that noun.

[0213] As used herein, the term "and / or" means "and" or "or," or both, where the context allows.

[0214] This disclosure discloses the above and also contemplates configurations, of which only examples are provided below.

[0215] When a list is presented, it is to be understood that the disclosure also includes any and all combinations of the items in that list.

[0216] Specific embodiments and improvements thereon will become apparent to those skilled in the art from the detailed description herein when considered in conjunction with the drawings, such as those set forth below. [Brief description of the drawings]

[0217] [Figure 1] 1 illustrates diagrammatically a respiratory assistance device; [Diagram 2] 1 shows a sensing circuit board that may be used in a respiratory assistance device. [Diagram 3] FIG. 1 is a first bottom perspective view of the main housing of the respiratory assistance device showing a recess within the housing for the motor and / or sensor module subassembly. [Figure 3A] FIG. 11 is a second bottom perspective view of the main housing of the respiratory assistance device showing a recess for the motor and / or sensor module sub-assembly. [Figure 4] FIG. 1 is a perspective view of a respiratory assistance device. [Diagram 5]FIG. 2 is a perspective view of the motor and / or sensor subassembly, underside of the main housing, and fixed elbow of the respiratory assistance device. [Figure 6] FIG. 13 is an exploded perspective view of the components of the motor and / or sensor subassembly, with arrows illustrating generally the gas flow path through the subassembly. [Figure 7] FIG. 13 is a bottom view of the cover and sensing PCB of the motor and / or sensor subassembly showing the location of the sensors. [Figure 8] FIG. 2 is a schematic gas flow diagram for the filter module and the valve module, with solid arrows indicating flow. [Figure 8A] 1 is a schematic diagram of a system including the device and a breathing conduit. [Figure 9] 1 shows a user interface for presenting a questionnaire on a respiratory assistance device. [Figure 10] 1 shows a user interface for presenting a questionnaire on a respiratory assistance device. [Figure 11] 1 shows a user interface for presenting a questionnaire on a respiratory assistance device. [Figure 12] 1 shows a user interface for presenting a questionnaire on a respiratory assistance device. [Figure 13] 1 shows a user interface for presenting a questionnaire on a respiratory assistance device. [Figure 14] 1 shows a user interface for presenting a questionnaire on a respiratory assistance device. [Figure 15] 1 shows a user interface for presenting a questionnaire on a respiratory assistance device. [Figure 16] 1 shows a user interface for presenting a questionnaire on a respiratory assistance device. [Figure 17] 1 shows a user interface for presenting a questionnaire on a respiratory assistance device. [Figure 18] 1 shows a user interface for presenting a questionnaire on a respiratory assistance device. [Figure 19A] FIG. 1 shows a flow diagram of the device operating in therapeutic and non-therapeutic modes. [Figure 19B] FIG. 1 shows a flow diagram of the device operating in therapeutic and non-therapeutic modes. [Figure 19C] FIG. 1 shows a flow diagram of the device operating in therapeutic and non-therapeutic modes. [Figure 20A] FIG. 1 shows a flow diagram of the device operating in therapeutic and non-therapeutic modes. [Figure 20B] FIG. 1 shows a flow diagram of the device operating in therapeutic and non-therapeutic modes. [Figure 21] FIG. 1 is a perspective view of a respiratory assistance device including a sterile conduit; [Figure 22] 1 shows the layout of data including treatment data and device data. [Figure 23] 1 shows a flow diagram of an apparatus for performing the operations. [Figure 24] FIG. 1 is a flow diagram illustrating a system for providing respiratory assistance or providing respiratory therapy to a patient. [Diagram 25] FIG. 1 shows a flow diagram of the apparatus operating in NHF mode and dry mode. [Figure 25A] FIG. 1 shows a flow diagram of the device operating in non-treatment and desiccation modes. [Figure 26] FIG. 1 shows a flow diagram of the device operating in NHF mode and warm-up mode. [Figure 27] 1 shows a flow diagram of the device operating in a non-therapeutic mode and updating device parameters. [Figure 28] FIG. 13 is a flow diagram of the device operating in a non-therapeutic mode and updating the sensor calibration parameters of the device. [Figure 29] 1 shows a flow diagram of an apparatus for updating parameters of the apparatus. [Diagram 30] 1 shows a flow diagram of an apparatus for updating parameters of the apparatus. [Diagram 31] 1 shows a flow diagram of an apparatus for updating parameters of the apparatus. [Diagram 32] 1 illustrates an example flow diagram for determining sensor calibration parameters. [Diagram 33] 1 illustrates an example flow diagram for determining oxygen concentration sensor calibration parameters. [Diagram 34] 1 illustrates an example flow diagram for determining flow sensor calibration parameters. [Diagram 35] 1 illustrates an example flow diagram for determining humidity sensor calibration parameters. [Diagram 36] 13 shows a flow diagram of an example of a device transitioning to a non-therapeutic mode after completion of a therapeutic mode. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0218] The respiratory assistance device 10 provides therapy to the user based on one or more therapy modes. A therapy mode relates, for example, to a particular type of therapy (NHF, CPAP, NIV, etc.). A therapy mode also includes one or more therapy parameters of the device specific to the type of therapy provided. For example, in a therapy mode providing nasal high-flow therapy, the therapy parameters may include a desired flow rate and a desired dew point. Other types of high-flow therapy are also envisioned, for example tracheal high-flow via a non-sealing tracheal interface.

[0219] The respiratory support device may provide multiple different therapies with associated therapy modes. For example, the respiratory support device may provide continuous positive airway pressure therapy, Bubble Continuous Positive Airway Pressure (BCPAP) therapy, high-flow therapy, e.g., nasal high-flow (NHF) therapy, bi-level pressure therapy (e.g., NIV therapy). A user may select the appropriate operating mode. The user will use an appropriate patient interface to enable delivery of the selected therapy, e.g., a non-occlusive interface for high-flow therapy. Alternatively, the respiratory support device may be configured to provide only one type of therapy.

[0220] During operation of the device 10, the device 10 may be configured to operate in one or more non-therapeutic modes. While the device is operating in a non-therapeutic mode, no therapy is provided to the user. A non-therapeutic mode may refer to a mode of the device 10 that involves moving into or out of a therapeutic mode (e.g., preparing the device for a therapeutic mode or moving the device from a therapeutic mode to storage or powered off). In a non-therapeutic mode, a patient interface is generally not attached to the patient.

[0221] The treatment mode may be performed during a treatment session.

[0222] Exemplary non-treatment modes may include a warm-up mode, a drying mode, a standby mode, and a disinfection mode.

[0223] The non-treatment mode may be performed as a non-treatment process for a predetermined time (eg, drying mode) and / or until a desired sensor output is reached (eg, temperature requirement for a period of time in disinfection mode).

[0224] During operation, the device may perform one or more operations, such as: During its operation, the device may collect various data (eg, usage data or other treatment compliance data, or data regarding parameters of the treatment) and transfer the data to some equipment. The device may receive software packages (eg, firmware or software updates) from or to a device. The device may receive treatment parameters (eg, an updated prescription) from a device or devices. The device may receive updated parameters for the device (eg, to recalibrate one or more components of the equipment).

[0225] The device may be a device located locally with the device (eg, in the same home or hospital, ie, a tablet or computer) or remotely (eg, a server).

[0226] The device may perform the above-mentioned operations during treatment, however, in this case the equipment may not be provided with the most up-to-date information (if the treatment session is not completed) or some operations, such as firmware updates or updating system parameters, may not be safe during treatment.

[0227] Performing an action during treatment may pose safety and / or health risks to the patient (i.e., interruption of treatment). Additionally, if the action may affect treatment parameters (e.g., receiving and applying treatment parameters), the treatment parameters may be updated during the course of a treatment session, which may pose safety and / or health risks.

[0228] If the operation is performed at the completion of the therapeutic mode, there is a risk that the user may completely power off the device after the treatment, prematurely while the device is operating in a non-therapeutic mode. If the device is powered off during operation, there is a risk of data corruption or incomplete transfer of data or errors in the application of the software package. Furthermore, some operations may not be possible while the device is not powered on.

[0229] For example, an error in the application of a software package may result in the performance of the device being impaired or certain of its functions not working, creating an unacceptable health risk to the patient.

[0230] In systems where treatment data may be uploaded at the end of treatment or after some time has passed after treatment, the user may turn off the device before operating, or the device may have to wait for a very long time to ensure that the user does not turn off the device (which may create the problems mentioned above).

[0231] Additionally, a user may have to physically power on a device to perform an action (e.g., to receive and apply a software package). Having to physically power on a device to be able to perform an action may be an inconvenience to the user, and the action may not occur (e.g., the software package may not be applied) unless the user physically commands the device to perform the action.

[0232] The present disclosure provides for a predetermined period of time to operate in a non-therapeutic mode before commencing any of the operations, thereby reducing the likelihood that a user will completely power off the device and reducing the risk that the device will be powered off mid-operation.

[0233] This also ensures that the risk of the action interrupting or disrupting important routines of the device and / or interrupting or disrupting therapy is reduced.

[0234] The present disclosure may provide a safe opportunity for the device to initiate any of the actions when it is safe for the device and / or the patient to perform that action.

[0235] A safe opportunity for a device may be when there is a low risk to the device's hardware and / or software / firmware integrity, for example when there is a low risk of a firmware or software update being interrupted.

[0236] A safe opportunity for the patient may be when the patient is not connected to the device for therapy or using the device while it is applying any changes, testing sensors, etc.

[0237] Furthermore, after a period of operation in non-therapeutic mode, there is a reduced risk of an alarm sounding or having to perform a critical routine that would interfere with the operation that needs to be performed. By starting operation directly after treatment (as the user may not yet be disconnected from the interface and still be connected to the device if the user needs to continue to be monitored for safety), there may be a higher risk of an alarm sounding or having to perform a critical routine.

[0238] Additionally, a user may occasionally change their mind about starting a therapy session and therefore may turn the device on for a short period of time before turning it off If the device attempts to perform an action when it is turned on, this may be interrupted by the user turning the device off.

[0239] The present disclosure also provides an architecture in which all data transfers to and from device 10 are initiated and controlled by device 10. This may provide security benefits since device 10 does not need to monitor connections from devices, but rather performs actions in response to device queries.

[0240] The respiratory aid apparatus 10 is shown in Figure 1. The respiratory aid apparatus 10 may include a housing 100 that houses one or more of an airflow generator 11, in some embodiments in the form of a motor / impeller mechanism (e.g. a blower), a humidifier 12 pneumatically connected to the airflow generator 11, a controller 13, and a user interface 14 (e.g. including a display and, for example, button(s), touch screen or other input device(s)).

[0241] The humidifier 12 may humidify and / or heat the gas flow to an appropriate level. The controller 13 may be configured to control the humidifier 12 (e.g., by controlling at least a heater of the humidifier).

[0242] The humidifier 12 may include a humidification chamber 300. The humidification chamber 300 may be configured to be removable from the humidifier (e.g., for replacement, cleaning, and / or refilling). Alternatively, the humidification chamber 300 may be non-removable from the humidifier.

[0243] The humidifier 12 may include a humidifier heater 310, for example as a heater plate (see FIG. 4 ). The humidifier heater provides heat to the humidification chamber 300. The liquid in the humidification chamber 300 may be water or other liquid and / or may include a mixture of one or more liquids (e.g., a mixture of water and a medicinal agent).

[0244] The controller 13 may be configured or programmed to control the operation of the respiratory assistance apparatus 10. For example, the controller 13 may control components of the respiratory assistance apparatus 10, including, but not limited to, operating the airflow generator 11 to generate a flow of gas (gas flow) to be delivered to the patient, operating the humidifier 12 (if present) to humidify and / or heat the generated gas flow, controlling oxygen flow to the airflow generator blower, receiving user input from the user interface 14 for reconfiguration and / or user-defined operation of the respiratory assistance apparatus 10, and outputting information to the user (e.g., on a display).

[0245] The controller 13 may include one or more computer processors and associated non-transitory memory or storage media for storing processor-executable instructions or code that, when executed by the one or more processors, cause the respiratory assistance device to perform the steps and processes described herein.

[0246] It should be understood that when device 10 is described herein as performing an operation, it may be that controller 13 controls one or more components of device 10 to perform that operation.

[0247] It is to be understood that the methods described herein may be performed by a controller (or other processor).

[0248] The term therapeutic support device may be used interchangeably with respiratory assistance device, or respiratory therapy device, or flow therapy device.

[0249] The term respiratory assistance system may be used interchangeably with respiratory assistance system, or respiratory therapy system, or flow therapy system.

[0250] The term current flow rate may refer to a measurement of flow rate made currently (e.g., at the current time step). It should be understood that the term current flow rate is not limited to the most recent flow rate determined, but can also include a recently performed flow rate determination (e.g., from a past time step or a recent flow rate determination) and / or a filtered flow rate determination made based on a series of past measurements (which may sometimes include signal filtering and / or processing).

[0251] The methods described herein may be embodied as software stored on the controller (or associated memory) and executed by the controller (and / or associated processor), or as software modules as part of the control software.

[0252] With respect to receiving treatment, the user is the patient, but with respect to interacting with the device (e.g., interacting with the user interface), the user may be one or more of a patient, a medical professional (e.g., a clinician), or any other person interested in using the device.

[0253] As used herein, "gas flow" may refer to any gas flow that may be provided by a respiratory assistance device, such as an ambient air flow, a flow comprising substantially 100% oxygen, a flow comprising any combination of ambient air and oxygen, and / or the like.

[0254] The respiratory conduit 16 is connected at one end to a gas outlet 21 within the housing 100 of the respiratory assistance apparatus 10. At the other end, the respiratory conduit 16 is connected to a patient interface 17, such as a non-sealing nasal cannula comprising a manifold 19 and nasal prongs 18. Additionally or alternatively, the respiratory conduit 16 may be connected to a face mask, a nasal mask, a nasal pillow mask, an endotracheal tube, a tracheostomy interface, and / or the like.

[0255] In some configurations, the interface 17 may be a sealed interface, for example when the device is providing CPAP therapy.

[0256] A breathable conduit may be provided between the breathing conduit 16 and the patient interface 17 .

[0257] In some embodiments, a different type of conduit may be connected to the gas outlet 21, for example a sterilizing conduit in sterilizing mode.

[0258] The gas flow generated by the respiratory assistance apparatus 10 may be humidified and delivered to the patient via the respiratory conduit 16 and the patient interface 17.

[0259] The respiratory conduit 16 may include a heater 16a for heating the gas flow passing therethrough to the patient. The heater 16a may be under control of the controller 13. In at least one configuration, the heater 16a is a heater wire. The respiratory conduit 16 and / or the patient interface 17 may be considered part of a respiratory support therapy system. The respiratory support system 1 may include the respiratory support apparatus 10, the respiratory conduit 16, and the patient interface 17.

[0260] The controller 13 can control the airflow generator 11 to generate a gas flow at a desired rate (e.g., a therapeutic flow rate). The controller 13 can also control the supplemental oxygen inlet to enable delivery of supplemental oxygen.

[0261] The controller 13 may also control a humidifier heater in the humidifier 12 and / or a heater 16a in the breathing conduit 16 to heat the gas to a desired temperature for a desired therapeutic level and / or comfort level for the patient.

[0262] The controller 13 is provided with or can identify suitable target temperatures for the gas flow and may control the humidifier heater of the humidifier 12 and / or the breathing conduit heater 16a based on the suitable target temperature(s) for the gas flow.

[0263] The heater 16a in the respiratory conduit 16 may be controlled by the controller 13 to reach a desired temperature. The desired temperature may be, or may be based on, one or more temperature setpoints and / or one or more humidity setpoints (e.g., therapeutic humidity).

[0264] The humidifier heater of the humidifier 12 may be controlled by the controller 13 to reach a desired temperature. The desired temperature may be, or may be based on, one or more temperature setpoints and / or one or more humidity setpoints. The desired temperature may be a treatment parameter.

[0265] The controller 13 may control the heater 16a in the respiratory conduit 16 and / or the humidifier heater of the humidifier 12 to a desired temperature by closed loop control based on the output of one or more sensors.

[0266] The one or more temperature set points may be related to one or more parameters of the device for treatment (e.g., gas dew point or temperature) or may be provided within the memory of the device (e.g., a predetermined temperature).

[0267] One or more treatment parameters in a high flow therapy treatment mode, such as a nasal high flow mode (NHF mode), include: The therapeutic flow rate of gas delivered to the user Therapeutic humidity level (e.g., relative or absolute humidity, or dew point) Therapeutic oxygen concentration provided to the user Therapeutic concentration of auxiliary gas provided to the user The therapeutic temperature of the gas provided to the user (for example) It may include any combination of the above.

[0268] In BCPAP mode, one or more therapy parameters are The therapeutic flow rate of gas delivered to the user Therapeutic humidity level (e.g., relative or absolute humidity, or dew point) Therapeutic oxygen concentration provided to the user Therapeutic concentration of auxiliary gas provided to the user The therapeutic temperature of the gas provided to the user It may include any combination of the above.

[0269] In the CPAP mode, one or more therapy parameters are Therapeutic humidity level (e.g., relative or absolute humidity, or dew point) Therapeutic oxygen concentration provided to the user The therapeutic temperature of the gas provided to the user Therapeutic concentration of auxiliary gas provided to the user The therapeutic level of pressure support (e.g., CPAP pressure) provided to the user Therapeutic PEEP pressure delivered to the user It may include any combination of the above.

[0270] In bilevel mode, one or more treatment parameters are: Therapeutic humidity level (e.g., relative or absolute humidity, or dew point) Therapeutic oxygen concentration provided to the user The therapeutic temperature of the gas provided to the user Therapeutic concentration of auxiliary gas provided to the user The therapeutic IPAP / EPAP pressure delivered to the user (inhalation positive airway pressure / exhalation positive airway pressure) It may include any combination of the above.

[0271] The treatment temperature may include the treatment temperature at the chamber outlet and / or the treatment temperature at the end of the breathing conduit.

[0272] The therapeutic humidity may be at the chamber outlet or at the end of the breathing conduit.

[0273] Therapeutic humidity levels can be a dew point of about 37 degrees Celsius or an absolute humidity of greater than about 38 mg H2O or greater than about 44 mg H2O.

[0274] This humidity level can cause condensation during use, and it is important that the respiratory conduit 16 be dried prior to reuse of the conduit. This is particularly necessary in a home care environment where the tube is reused (e.g., every 7-14 days). In hospitals, the tube is often replaced with each new patient, although the same patient may reuse the same tube. To reduce the risk of infection and pathogen growth, the respiratory conduit is dried to remove moisture, including liquids (e.g., by implementing a dry mode, as described in more detail below).

[0275] Given the high flow and corresponding humidity provided during NHF mode, this may increase the amount of condensation formation, which may further increase the importance of Dry mode, which will be described in more detail below.

[0276] A user may input one or more treatment types associated with the treatment mode via the user interface.

[0277] A user may input one or more treatment parameters via the user interface.

[0278] The desired temperature may be at the end of the respiratory conduit 16, at the patient interface, at the gas outlet, at the humidity chamber outlet, at any sensor in the device, and / or any combination thereof.

[0279] The one or more temperature set points are The desired dew point (i.e., the temperature that indicates the desired humidity) Desired dew point Predetermined temperature Desired temperature may include one or more of:

[0280] In some embodiments, the controller 13 may control the heater 16 a of the respiratory conduit 16 based on the desired temperature of the gas at the patient interface and / or the desired temperature at the end of the respiratory conduit 16 .

[0281] The device may be powered by an external power source (eg, a wired connection to a power grid).

[0282] In some embodiments, the device may be powered by at least one battery. The battery may be located in the device housing and / or externally attached to the device housing. In some embodiments, the battery is removable. Alternatively, the battery is non-removable.

[0283] 4, the oxygen inlet port 28 includes a valve 1003 through which pressurized gas may enter the respiratory therapy device 10. The valve may control the flow of oxygen to the respiratory therapy device 10. The valve may be any type of valve, including a proportional valve or a binary valve.

[0284] The oxygen source can be an oxygen cylinder or a hospital oxygen supply. Medical oxygen is typically 95% to 100% pure. Less pure oxygen sources can also be used. Examples of valve modules and filters are disclosed in U.S. Provisional Patent Application No. 62 / 409,543, entitled "Valve Modules and Filter," filed October 18, 2016, and U.S. Provisional Patent Application No. 62 / 488,841, entitled "Valve Modules and Filter," filed April 23, 2017, both of which are incorporated by reference in their entireties.

[0285] The respiratory assistance apparatus 10 is able to measure and control the oxygen content of the gas being delivered to the patient and therefore the oxygen content of the gas inhaled by the patient.

[0286] The respiratory assistance device 10 may provide high-flow therapy, where a high flow rate of delivered gas meets or exceeds the patient's peak inspiratory demand.

[0287] Operational sensors 3a, 3b, 3c, such as flow, temperature, humidity and / or pressure sensors, may be located at various locations within the respiratory assistance apparatus 10. Additional sensors (e.g. sensors 20, 25) may be located at various locations in the respiratory conduit 16 and / or patient interface 17 (e.g. there may be a temperature sensor 29 at or near the end of the inspiratory tube).

[0288] The respiratory therapy device 10 may have a communications module 15 that enables the controller 13 to receive signals 8 from sensors and / or control various components of the respiratory assistance device 10, including, but not limited to, the airflow generator 11, the humidifier 12, the heater 16a, a humidifier heater, or accessories or peripherals associated with the respiratory assistance device 10. Additionally or alternatively, the communications module 15 may deliver data to a remote server or allow for remote control of the respiratory therapy device 10 or respiratory therapy system 1.

[0289] The communication module may include a transmitter, a receiver, and / or a transceiver.

[0290] The communication module 15 may function as a network interface.

[0291] The communications module 15 may use one or more communications protocols known in the art, such as Wi-Fi, Bluetooth, Zigbee, cellular (3G, 4G, or 5G, etc.).

[0292] The communications module may include multiple separate transmitters, receivers, and / or transceivers for each communications protocol or group of communications protocols.

[0293] Communications module 15 may be configured to transmit data and receive data from one or more devices (eg, servers), as described in more detail below.

[0294] In some embodiments, one or more leak or occlusion events or alarms (described in more detail below) may be sent to one or more servers and / or devices (e.g., computers, phones, or tablets) and additional information related to the events or alarms (e.g., time, duration, or severity) may additionally be sent to the servers and / or devices.

[0295] As previously mentioned, the respiratory assistance device 10 can measure and control the oxygen content of the gas being delivered to the patient. The oxygen can be measured by placing one or more gas composition sensors (such as an ultrasound transducer system) after the oxygen has mixed with the ambient air. Measurements can occur within the respiratory therapy device 10, the patient breathing conduit 16, the patient interface 17, or any other suitable location.

[0296] The oxygen concentration measured within the device may be equivalent to the administered concentration (FdO2) and may be substantially the same as the oxygen concentration breathed by the patient, i.e., the inspired oxygen concentration (FiO2), and therefore these terms may be considered equivalent.

[0297] The oxygen concentration may also be measured using flow sensors in at least two of the ambient air inlet conduit, the oxygen outlet conduit, and the patient breathing conduit to identify the flow rates of at least two gases. By identifying both inlet gases or one inlet gas and one total flow rate, the oxygen concentration of the final gas composition can be calculated, taking into account the assumed or measured oxygen concentration of the inlet gases (ambient air is about 20.9%, oxygen is about 100%) as well. Alternatively, flow sensors can be installed in all three of the ambient air inlet conduit, the oxygen inlet conduit, and the breathing conduit to provide redundancy and to allow testing that each sensor is working correctly by checking the consistency of the readings. Other methods of measuring the oxygen concentration delivered by the respiratory assistance device 10 may also be used.

[0298] The respiratory assistance device 10 can include a patient sensor 26, such as a pulse oximeter or patient monitor system, to measure one or more physiological parameters of the patient, such as the patient's blood oxygen level (e.g., blood oxygen saturation (SpO2)), heart rate, respiratory rate, perfusion index, and provide an indication of signal quality. The sensor 26 can communicate with the controller 13 through a wired connection or by communication through a wireless transmitter on the sensor 26. The sensor 26 can be a disposable adhesive sensor designed to be connected to the patient's finger. The sensor 26 can be a non-disposable sensor (i.e., a reusable sensor). Sensors for different age groups and designed to be connected to various parts of the patient are available and can be used with the respiratory assistance system 1. The pulse oximeter can be attached to the patient's body, typically to a finger, although other locations such as the earlobe can be selected. The pulse oximeter can be connected to a processor of the respiratory therapy device 10 and can provide a constant signal indicative of the patient's blood oxygen level. The patient sensors 26 may be hot-swappable devices that can be installed or replaced during operation of the respiratory assistance apparatus 10. For example, the patient sensors 26 may connect to the respiratory assistance apparatus 10 using a USB interface or using a wireless communication protocol (e.g., Bluetooth®).

[0299] If the patient sensor 26 is disconnected during operation, the respiratory assistance apparatus 10 may continue to operate in its previous operating state for a predetermined period of time. After the prescribed period of time has elapsed, the respiratory assistance apparatus 10 may trigger an alarm, switch from automatic to manual mode, and / or exit a control mode (e.g., automatic or manual mode) entirely. The patient sensor 26 may be a bedside monitoring system or other patient monitoring system that communicates with the respiratory assistance apparatus 10 through a physical or wireless interface.

[0300] The respiratory assistance device 10 may include or be in the form of a high flow therapy device.

[0301] High flow therapy as discussed herein is intended to have its typical and ordinary meaning as understood by those skilled in the art, which generally refers to a respiratory support device that delivers a target flow of humidified breathing gas through an intentionally non-occlusive patient interface at a rate that generally matches or exceeds the patient's inspiratory flow rate. Exemplary patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults often range from about 15 liters per minute to about 60 liters per minute or more. Typical flow rates for pediatric patients (e.g., neonates, infants, toddlers) often range from about 1 liter per minute per kilogram of patient weight to about 3 liters per minute per kilogram of patient weight or more, but are not limited to these. High flow therapy may also optionally include a gas mixture composition that includes a dose of supplemental oxygen and / or a therapeutic agent. High-flow therapy is often referred to as high-flow nasal airway (NHF), humidified high-flow nasal cannula (HHFNC), high-flow nasal oxygen (HFNO), high-flow therapy (HFT), or high-flow tracheal airway (THF), among other common names.

[0302] For example, in some configurations, for an adult patient, "high flow therapy" can refer to delivering gas to the patient at a flow rate greater than or equal to about 10 liters per minute (10 LPM), such as from about 10 LPM to about 100 LPM, or from about 15 LPM to about 95 LPM, or from about 20 LPM to about 90 LPM, or from about 25 LPM to about 85 LPM, or from about 30 LPM to about 80 LPM, or from about 35 LPM to about 75 LPM, or from about 40 LPM to about 70 LPM, or from about 45 LPM to about 65 LPM, or from about 50 LPM to about 60 LPM. In some configurations, for neonatal, infant, or toddler patients, "high flow therapy" may refer to delivery of gas to the patient at a flow rate of greater than 1 LPM, such as from about 1 LPM to about 25 LPM, or from about 2 LPM to about 25 LPM, or from about 2 LPM to about 5 LPM, or from about 5 LPM to about 25 LPM, or from about 5 LPM to about 10 LPM, or from about 10 LPM to about 25 LPM, or from about 10 LPM to about 20 LPM, or from about 10 LPM to 15 LPM, or from about 20 LPM to 25 LPM. High flow therapy devices for adult, neonatal, infant, or toddler patients, in some configurations, deliver gas to the patient at a flow rate of from about 1 LPM to about 100 LPM, or any of the subranges described above. The delivered gas may include a portion of oxygen. In some configurations, the percentage of oxygen in the delivered gas can be from about 20% to about 100%, or from about 30% to about 100%, or from about 40% to about 100%, or from about 50% to about 100%, or from about 60% to about 100%, or from about 70% to about 100%, or from about 80% to about 100%, or from about 90% to about 100%, or about 100%, or 100%.

[0303] High-flow therapy can be effective in meeting or exceeding a patient's inspiratory flow and increasing a patient's oxygenation and / or reducing the effort of breathing.

[0304] High flow therapy may be delivered to the patient's nostrils and / or through the mouth or tracheostomy interface.

[0305] High-flow therapy can create a nasopharyngeal lavage effect, where the anatomical dead space of the upper airway is washed away by the high flow of incoming gas. This can reduce rebreathing of nitrogen and carbon dioxide while creating a reservoir of fresh gas that can be used with every breath. Meeting inspiratory demand and cleaning the airway is even more important in controlling the patient's FdO2. High-flow therapy can be delivered with a non-occlusive patient interface, such as a nasal cannula. High-flow therapy can reduce the patient's respiratory rate. High-flow therapy can provide expiratory resistance to the patient.

[0306] High flow therapy may be used to treat patients with obstructive pulmonary diseases such as COPD, bronchiectasis, dyspnea, cystic fibrosis, emphysema and / or patients with respiratory distress or hypercapnia.

[0307] The term "non-sealing patient interface" (i.e., a patient interface that is not sealed), as used herein, may refer to an interface that provides an air connection between the patient's airway and a gas flow source (e.g., from the airflow generator 11) that does not completely occlude the patient's airway. An unsealed air connection may include less than about 95% occlusion of the patient's airway. An unsealed air connection may include less than about 90% occlusion of the patient's airway. An unsealed air connection may include between about 40% and about 80% occlusion of the patient's airway. The airway may include one or both nostrils and / or the mouth of the patient. In the case of a nasal cannula, the airway is through the nares.

[0308] CPAP therapy may involve providing gas to a user at continuous positive pressure (and, optionally, one or more treatment parameters as described in detail above).

[0309] BCPAP may involve providing gas to a user at a therapeutic flow rate (and, optionally, one or more therapeutic parameters, as described in detail above).

[0310] Bi-level therapy may involve providing gas to a user at a therapeutic flow rate (and, optionally, one or more therapeutic parameters as described in detail above).

[0311] The closed interface may be used when the device provides CPAP, bilevel, or BCPAP therapy.

[0312] The airflow generator 11 may be or may include a blower module, which may include at least one blower 11' configured to generate said gas flow.

[0313] The airflow generator 11 may include an ambient air inlet port 27, through which ambient room air may be drawn into the blower. The respiratory assistance apparatus 10 may also include an oxygen inlet port 28, which leads to a valve through which pressurized gas may enter the airflow generator 11. The valve may control the flow of oxygen to the airflow generator 11. The valve may be any type of valve, including a proportional valve or a binary valve.

[0314] The blower 11' can operate at a motor speed of greater than about 1,000 RPM, less than about 8,000 RPM, greater than about 2,000 RPM, less than about 10,000 RPM, or any of these values ​​between. The blower 11' can mix gases entering the blower 11' through inlet ports (e.g., ambient air inlet port 27 and / or oxygen inlet port 28). Using the blower 11' as a mixer can reduce pressure drop compared to a system with a separate mixer, such as a static mixer including a baffle.

[0315] It will be appreciated that other auxiliary gases may be provided instead of oxygen, for example the oxygen inlet port 28 may be an auxiliary gas inlet port and a valve may be configured to control the auxiliary gas flow.

[0316] The respiratory aid apparatus may further include a gas composition sensor, which may be a sensor as described below (e.g. an ultrasonic transducer arrangement).

[0317] The respiratory assistance apparatus 10 includes a flow sensor that may be configured to measure the flow of breathable gas to the patient.

[0318] The controller 13 may include one or more processors. The processors may be configured with computer-readable instructions.

[0319] The controller 13 may include at least one memory device, which may be configured to store the computer-readable instructions.

[0320] The memory element may be a non-transitory computer-readable medium.

[0321] The controller 13 may be a microprocessor or an ASIC, an FPGA, or a combination of ICs or microprocessors, or any other suitable components and / or architecture.

[0322] The respiratory assistance device may include at least one display module configured to display the alarm output.

[0323] The respiratory assistance device may include at least one audio module configured to emit an audio alarm.

[0324] In some embodiments, the at least one audio module may include a speaker.

[0325] The display module may include at least one display (eg, a liquid crystal display (LCD), or a light emitting diode (LED) display, although it should be understood that either display technology may be used).

[0326] The display module may be configured to receive input to the system (eg, as a touch screen) and thus may be at least a part of the user interface 14, or the display portion.

[0327] The display module may be configured as an input / output (I / O) module, for example, configured to receive input from a user and provide output to the user (e.g., as part of user interface 14 or on a display).

[0328] The display module may be in communication with the controller 13. In some embodiments, the display module may provide information (e.g., set points) to the controller 13. In some embodiments, the display module may receive information (e.g., alarms, sensor outputs, and / or other calculated variables) from the controller 13.

[0329] 2, there is shown a sensing circuit board 2200 that can be implemented in the respiratory assistance apparatus 10. The sensing circuit board 2200 can be positioned in the sensor chamber such that the sensing circuit board 2200 is at least partially submerged in the gas flow. The gas flow can exit the blower 11' through a conduit and enter a flow path in the sensor chamber. At least some of the sensors on the sensing circuit board 2200 can be positioned in the gas flow (shown in the direction of arrow 2203) to measure gas properties in the flow. After passing through the flow path in the sensor chamber, the gas can exit the humidifier 12 as described above.

[0330] The sensing circuit board 2200 can be a sensing printed circuit board (PCB). Alternatively, the circuitry on the board 2200 can be implemented by electrically wiring electronic components rather than being printed on a circuit board. At least a portion of the sensing circuit board 2200 can be mounted outside the gas flow. The gas flow can be generated by the airflow generator 11 described above. The sensing circuit board 2200 can include an ultrasonic transducer 2204. The sensing circuit board 2200 can include one or more thermistors 2205. The thermistor 2205 can be configured to measure the temperature of the gas flow. The sensing circuit board 2200 can include a thermistor flow sensor 2206. The sensing circuit board 2200 can include other types of sensors, such as humidity sensors (including dedicated humidity sensors used with another temperature sensor and combined humidity and temperature sensors), sensors that measure air pressure, sensors that measure differential pressure, and / or sensors that measure gauge pressure. The thermistor flow sensor 2206 may include a hot wire anemometer, such as a platinum wire, and / or a thermistor, such as a negative temperature coefficient (NTC) or positive temperature coefficient (PTC) thermistor. Other non-limiting examples of heated temperature sensing elements include glass or epoxy encapsulated or unencapsulated thermistors. The thermistor flow sensor 2206 may be configured to measure the flow rate of gas by receiving a constant power supply or by being held at a constant temperature or a constant temperature difference between the sensor and the gas flow.

[0331] Locating one or more of the thermistor 2205 and / or thermistor flow sensor 2206 downstream of the blower and mixer combination means that the sensor readings are not affected by heat provided to the gas flow by the blower. Furthermore, by immersing at least a portion of the sensing circuit board and sensor in the flow path, the accuracy of the measurement can be increased. Compared to a non-immersed sensor, a sensor immersed in the flow is more likely to be subjected to the same conditions, such as temperature and pressure, as the gas flows. Thus, such an immersed sensor may provide a better representation of the characteristics of the gas flow.

[0332] The sensing circuit board 2200 may include an ultrasonic transducer, transceiver, or other sensor that measures a property of the gas flow, such as the gas composition or concentration of one or more gases in the gas stream. As will be appreciated, any suitable transducer, transceiver, or sensor may be attached to the sensing circuit board 2200. In this configuration, the gas composition sensor is an ultrasonic transducer that utilizes ultrasonic or acoustic waves to determine the gas concentration.

[0333] The ultrasonic transducer may be an ultrasonic transducer pair disposed axially opposite each other in the sensor chamber in the direction of flow, and may be configured to determine the flow rate using time-of-flight measurements.

[0334] Some examples of flow therapy devices are disclosed in International Application No. PCT / NZ2016 / 050193, filed December 2, 2016, entitled "Flow Path Sensing for Flow Therapy Apparatus," and International Application No. PCT / IB2016 / 053761, filed June 24, 2016, entitled "Breathing Assistance Apparatus," both of which are incorporated by reference in their entireties.

[0335] The device 10 may include an elbow 325 configured to be connected to the breathing conduit 16 (eg, to provide a gas outlet 21). The elbow 326 may include one or more sensors.

[0336] The configuration of the respiratory assistance apparatus 10 is shown in Figures 3 to 7. For example, as shown in Figure 4, the respiratory assistance apparatus includes a housing 100. The housing 100 has a housing upper body portion 102 and a housing lower body portion 202.

[0337] As shown in Figures 3 and 3A, the lower body 202 has a motor recess 250 for receiving a removable or non-removable motor and / or sensor module 400 as shown in Figures 13-15 and described in more detail below. Adjacent to its rear edge, the bottom wall 230 has a recess opening 251 for receiving a removable or non-removable motor / sensor module 400 as shown in Figures 5 and 6 and described in more detail below.

[0338] 5-7 show in more detail the motor and / or sensor module or subassembly 400. As previously mentioned, the lower body 202 includes a recess 250 for receiving the motor and sensor module 400. The airflow generator may include the motor and / or sensor module or subassembly 400.

[0339] 5-7, the motor and / or sensor module 400 includes a laminated arrangement of three main components: a base 403 of the subassembly 400 (on which the motor 402 is positioned), an outlet gas flow passage and sensing layer 420 positioned above the base 403, and a cover layer 440. The base 403, the sensing layer 420, and the cover layer 440 may be assembled to form a subassembly housing having a shape complementary to that of the recess 250 such that the subassembly 400 can be received within the recess 250. The base 403 is configured to close the recess opening 251 when the subassembly 400 is positioned within the recess 250. The subassembly 400 may be held in place within the recess in any suitable manner, such as by fasteners, clips, or a quick release mechanism, or may be permanently secured in place.

[0340] The sensing layer includes a gas flow passage that includes one or more sensors, the gas flow passage being positioned to deliver gas to an exit port of the housing.

[0341] Motor 402 has a body 408 that defines an impeller chamber that houses an impeller. Motor 402 may be any suitable gas blower motor, such as a motor and impeller assembly of the type described in published PCT application WO2013 / 009193, the contents of which are incorporated herein by reference in their entirety.

[0342] The gas outlet 406 is in fluid communication with a gas inlet of the outlet gas flow path and with a sensing layer 420 that is stacked above the motor. The layer 420 includes a body 422 that includes a number of mounting legs 425 that can be inserted into a number of mounting slots (not shown) in the base 403 to secure the body 422 to the base 403. In one configuration, the body 422 defines a gas flow path that couples the gas outlet 406 to the gas inlet of the gas flow path and the sensing layer 420.

[0343] The body 422 defines a lower portion 426 of the sensing and gas flow passages. The cover layer 440 has a body 442 that defines an upper portion 446 of the sensing and gas flow passages, the shapes of the upper and lower portions 426, 446 substantially corresponding to one another.

[0344] 6 and 7, the gas flow path includes a straight, elongated gas flow path portion 428, 448. The inlet is in fluid communication with a gas flow path tangential inlet portion 430, 450, which is located at or adjacent to the inlet end of the straight, elongated gas flow path portion 428, 448. Recesses 433, 453 and 434, 454 may be provided at each end of the straight, elongated gas flow path portion.

[0345] The gas flow outlet port 452 extends longitudinally through the body 442 of the cover layer 440 and is positioned at or adjacent to the opposite end of the straight elongated portions 428, 448 of the gas flow passages. The gas outlet port 452 is in fluid communication with an upper portion of the motor recess 250, which is in fluid communication with the gas flow passage. Again, the configuration of the walls 252 and ceiling 262 of the recess 250 allows gas to escape from the motor / sensor module 400, and the gas will vent to the atmosphere, rather than entering the portion of the housing 100 that contains most of the electronics and controls. The recess 250 may include a spacer(s), such as a protrusion extending downwardly from the ceiling 262 as shown in FIG. 15, that maintains a suitable spacing for gas flow from the gas outlet port 452 and the recess ceiling 262.

[0346] 7, it can be seen that at least a portion of the gas flow path through and exiting the motor and / or sensing module 400 has a serpentine or undulating configuration. For example, the direction in which gas flow travels through the elongated portions 428, 448 is generally opposite the direction in which gas flow travels from the gas exit port 452 to the entrance of the gas flow path through the elbow 324. The serpentine or undulating configuration may increase the amount of time gas remains in the gas flow path, thus improving sensing.

[0347] As shown in Figures 6 and 7, the cover layer 440 includes a sensing printed circuit board (PCB) 456. The cover layer 440 may also include one or more temperature sensors, such as thermistors, within the gas flow path elongated portions 428, 448. One sensor may measure the gas temperature and the other may function as a redundant temperature sensor. Alternatively, one of the thermistors may be used as a reference flow sensor (e.g., by use as a constant temperature thermistor) and the measured temperature may be used to determine the gas flow rate through the gas flow path portions 428, 448. The one or more temperature sensors may be located on the gas flow facing portion of the sensing PCB 456. The sensing PCB 456 may additionally include other sensors, including but not limited to pressure sensors, humidity sensors, and dew point sensors.

[0348] One or more electronics boards 272 are in electrical communication with or coupled to the sensors to process information received from the sensors and to operate the device 10 based on the information received from the sensors.

[0349] In an alternative configuration, the motor / impeller unit may be provided at a location remote from the apparatus 10. In that configuration, the module received within the recess 250 may include only the gas flow path and various sensors to deliver gas to the fixed elbow 324 and thereby to the humidification chamber 300. In an alternative configuration, the module received within the recess 250 may include only the motor and gas flow path and no sensors.

[0350] In other alternative configurations, the motor and / or sensor module 400 may not be removable from the recess 250, but instead may be permanently mounted therein.

[0351] Some configurations provide the advantage of isolating electrical / electronic components from gases in the gas flow.

[0352] The flow path is compact and has fewer bends / sharp bends, thereby reducing flow separation and providing less resistance to the flow.

[0353] The motor and flow path arrangement provides another layer of isolation from the wall arrangement.

[0354] Having a modular motor and / or sensor module allows various portions of the module to be removed as needed for cleaning and / or servicing and / or replacement of components.

[0355] In some embodiments, there are no leak paths within the motor and / or sensor module.

[0356] The motor and / or sensor module may be potential leak locations, but a leak in that area would allow oxygen to escape into the atmosphere or into the liquid chamber.

[0357] 8, the device 10 may include a valve module 4001 that controls oxygen and / or other gases (e.g., other supplemental gases) entering the gas flow path of the device 10, allowing the device 10 to adjust the percentage of oxygen (or other supplemental gases) entrained in the airflow. The valve module is formed as a modular unit for ease of manufacture, assembly, servicing, or replacement, e.g., in the event of an outage, routine maintenance, or future upgrades / improvements.

[0358] The valve module 4001 may be configured to operate to control the oxygen concentration (or other auxiliary gas concentration) of the gas provided to the user at a therapeutic oxygen concentration.

[0359] The valve module 4001 may include one or more filters located a) upstream of the valve, b) downstream of the valve, or c) both upstream and downstream of the valve.

[0360] The apparatus 10 may include a filter module 1001, which may include a filter.

[0361] The filter module 1001 and valve module 4001 described herein may provide a variable gas flow path for the device. For example, the valve module may control oxygen flow into the gas flow path of the device through the valve module and filter module. Alternatively, the valve module may be bypassed by connecting an alternate oxygen source directly to the filter module through the alternate supply inlet. This may be practical if the user wishes to manually adjust the oxygen supply (i.e., via a wall-mounted supply rotameter).

[0362] It will be appreciated that the apparatus may be provided with another auxiliary gas other than oxygen.

[0363] It should be understood that the filter modules and valve modules described herein may be used separately in an apparatus to deliver a gas flow, or alternatively, the filter and valve modules may be used together as a filter and valve assembly for enhanced functionality.

[0364] In the illustrated configuration, the device 10 supplies oxygen to via valve module 4001 (for automatic oxygen regulation by the device) or An alternative gas inlet is provided at the top of the filter (allowing for attachment of a manually adjustable oxygen source - e.g. a wall mounted source regulated by a regulator) The payment is received by at least one of the following:

[0365] The apparatus 10 may include a manifold. The manifold may be disposed on the housing. The manifold may provide one or more of a supplemental gas inlet (e.g., an oxygen inlet), an alternative gas inlet, and / or an air inlet.

[0366] The manifold may provide oxygen, alternative gas, and / or ambient air to the valve module 4001, the filter module 1001, and / or the blower 11' of the airflow generator 11.

[0367] An oxygen inlet or alternative gas supply inlet may be provided on one side of the manifold.

[0368] The manifold may allow excess oxygen to be flooded into the ambient environment and / or may allow oxygen to be flooded into the ambient environment when the blower is off but oxygen continues to be supplied, preventing O2 buildup within the enclosure.

[0369] Figure 8A shows a schematic diagram of the device 1. Figure 8A shows the various locations of sensors 40, 41, 42, 43, 44, 45, 46, 47 and 48 of the system, which will be described in more detail below.

[0370] A gas flow path may be provided from one or more inlets through the filter module 1001, via the generator 11, the humidifier 12, and the breathing conduit 16 to the patient interface.

[0371] As mentioned above, the device 10 may receive air (e.g., ambient air via the ambient air inlet port 27). The air inlet may include at least one air inlet sensor. The at least one air inlet sensor 41 may include a temperature sensor and / or a humidity sensor (e.g., an absolute humidity sensor and / or a relative humidity sensor).

[0372] As discussed above, the device 10 may receive an auxiliary gas (e.g., oxygen via the oxygen inlet port 28). The auxiliary gas inlet may include at least one auxiliary gas inlet sensor 42. The valve module 4001 may be configured to operate to control the flow of the auxiliary gas (e.g., oxygen), as discussed above.

[0373] The at least one auxiliary gas inlet sensor 42 may be part of or separate from the valve module 4001. In FIG. 8A, the at least one auxiliary gas inlet sensor 42 is shown as part of the valve module 4001 and located downstream of the valve 30. In some configurations, the sensor oxygen inlet sensor 42 may be provided separately from the valve module 4001, either upstream or downstream of the valve module 4001.

[0374] The at least one auxiliary gas inlet sensor 42 may include at least one pressure sensor configured to measure the pressure of the auxiliary gas supply.

[0375] As previously mentioned, the apparatus 10 may receive a supplemental gas through an alternate supply inlet.

[0376] The device 1 may include one or more additional sensors 40. The additional sensors may be located within the device (e.g., within the housing) and / or exposed to the surrounding environment. The additional sensors may include a pressure sensor (e.g., an air pressure sensor). In some embodiments, the one or more additional sensors 40 are located at or near the valve module 4001.

[0377] As previously mentioned, the filter module 1001 receives gas from the auxiliary gas inlet and / or the alternate supply inlet, and air from the air inlet.

[0378] As shown in Figure 8A, the airflow generator 11 is pneumatically connected to the filter module. The airflow generator 11 includes a blower 11' (described in more detail elsewhere herein). The airflow generator 11 may include a motor and / or sensor module 400, as described in more detail above.

[0379] The airflow generator 11 may include at least one blower sensor 43 configured to measure a characteristic of the blower. The at least one blower sensor 43 may be configured to measure a characteristic of a blower motor. The at least one blower sensor 43 may include a motor speed sensor.

[0380] At least one blower sensor 43 may measure an electrical characteristic of the blower (eg, the blower's motor).

[0381] The at least one blower sensor 43 may be located as part of the blower or may be located remotely from the blower, such as on a control board (e.g., if the at least one blower sensor 43 measures an electrical characteristic of the blower).

[0382] The airflow generator may also include at least one sensor 44 positioned downstream of the blower 11′ (e.g., as shown in FIG. 8A ). In some configurations, the at least one sensor 44 is provided upstream of the blower. The at least one sensor 44 may be provided as part of the sensor module 400 (as described in more detail above). The at least one sensor 44 may include one or more of at least one temperature sensor, at least one flow sensor (e.g., one or more ultrasonic transducers as described above), at least one pressure sensor (e.g., an absolute pressure sensor and / or a differential pressure sensor configured to measure the pressure in the gas flow path with respect to the surroundings), at least one humidity sensor.

[0383] The aforementioned sensor 3 a may be a blower sensor 43 and / or a sensor 44 .

[0384] As shown in Figure 8A, the device 10 may also include at least one non return valve (NRV) 31 at the humidifier inlet, which may be, for example, a fixed elbow 324 as previously described.

[0385] The humidifier 12, described in more detail above, is pneumatically connected to the airflow generator (e.g., via at least a fixed elbow 324). The humidifier heater may include at least one humidifier heater sensor 45. The at least one humidifier heater sensor 35 may be a temperature sensor and / or a humidifier heater power sensor configured to measure power provided to the humidifier heater. The humidifier heater power sensor may be located remote from the heater (e.g., on a control board).

[0386] 8A, the device 10 may also include at least one humidifier outlet sensor 46 disposed in the humidifier outlet. The humidifier outlet may be the elbow 325. The humidifier outlet sensor 46 may be one or more temperature sensors.

[0387] The aforementioned sensor 3b may be the humidifier heater sensor 45 and / or the humidifier outlet sensor 46. Similarly, the sensor 3c may be the humidifier outlet sensor 46.

[0388] As previously discussed, the respiratory conduit 16 includes a respiratory conduit 16 heater 16a. The respiratory conduit 16 may include at least one respiratory conduit sensor 48 (e.g., sensor 29, previously discussed). The at least one respiratory conduit sensor 48 may be located at the patient end of the conduit 16. The at least one respiratory conduit sensor 48 may be a temperature sensor.

[0389] A power sensor 47 may also be provided to the heater 16a of the respiratory conduit 16 to measure the power provided to the heater 16a of the respiratory conduit 16. The power sensor 47 may be located remote from the respiratory conduit 16 (e.g. on a control board).

[0390] The various configurations described are merely example configurations, and any one or more features of any of these configurations may be used in combination with any one or more features of any of the other configurations.

[0391] As another example, while the recess for the motor and / or sensor subassembly is described as being on the underside of the housing, it could alternatively be on the back, side, front, or top of the housing. The air and / or oxygen inlets could also be located in different locations as needed.

[0392] As another example, rather than the humidification chamber 300 and chamber bay being configured such that the humidification chamber 300 is inserted into and removed from the chamber bay from the front of the housing, the configuration may be such that the humidification chamber 300 is inserted into and removed from the chamber bay from the side, back, or top of the housing.

[0393] As another example, although the filter module is described as being inserted into the housing from above and the valve module is described as being inserted into the housing from below, either or both of these components may be inserted into any suitable portion of the housing, such as the upper portion, lower portion, side portion, front portion, or rear portion.

[0394] The filter module and valve module are described in the context of a respiratory assistance device capable of delivering heated and humidified gases to a patient or user.

[0395] The filter module and / or valve module may alternatively be used in devices that do not require a humidifier, and therefore do not require the humidification chamber 300. For example, it will be appreciated that the configuration that isolates the motor and gas flow path from the electrical and electronic components is commonly utilized in other types of gas delivery devices.

[0396] The device may be powered on (i.e., turned on) by connecting the device to a power source (i.e., a battery or electrical connection) and / or by one or more inputs on the device (e.g., a power switch and / or an input at a user interface).

[0397] The device may be powered down (i.e., put into a powered off state) by disconnecting the device from its power source (i.e., a battery or electrical connection) and / or by one or more inputs on the device (e.g., a power switch and / or an input on a user interface).

[0398] The device 10 may present a prompt including one or more questions when the device is in a non-therapeutic mode. In some embodiments, the non-therapeutic mode in which the prompt is presented may be a warm-up mode and / or a drying mode (described in more detail below).

[0399] The device 10 may present one or more queries to the user.

[0400] The interview may include one or more including one or more user directed questions regarding one or more health parameters.

[0401] Each question includes a number of user input elements through which user input is received in response to that user-directed question.

[0402] The device 10 may present a questionnaire, which may be as disclosed in International Publication No. 2021 / 090184 (PCT Application No. PCT / IB2020 / 060335), which is incorporated by reference into this specification.

[0403] The device 10 may present a questionnaire at the start of a non-treatment mode.

[0404] The device 10 performs an interview, When the device starts up, or At the start of a non-treatment mode, or when the user is prompted to enter one or more therapy parameters of the respiratory support device (optionally via a therapy control screen); or when the user begins to input one or more therapy parameters of the respiratory support device (optionally via a therapy control screen); or When the user starts a therapy (optionally via the Therapy Control screen), or When manually activated by the user, Or any combination of the above It can be presented.

[0405] 9 to 18 show a user interface for presenting a medical interview on a respiratory assistance device, in which multiple questions and multiple possible answers are displayed.

[0406] The questions may relate to one or more health parameters of a patient.

[0407] 9 illustrates a start-up screen having a graph user touch element, a power user touch element, and a menu user touch element. For example, the start-up screen may be the first screen a patient sees when the patient turns on the respiratory support device as described herein. The graph user touch element may allow for the display of data graphs of various treatment parameters or patient health parameters as selected, whether displayed on the same page or on a different page of the user interface, as described herein. The power user touch element may be used to power on or off (e.g., as described above) or restart the respiratory support device as selected, as described herein.

[0408] Figure 10 shows the introduction screen after the start-up screen. The introduction screen displays a "Hello" message (or other introductory or welcoming message).

[0409] FIG. 11 shows an overall mood screen that presents questions (eg, patient health information, consultation requests) asking about the patient's overall mood at a particular time of day.

[0410] FIG. 12 illustrates a sore throat screen posing a similar question to FIG. 15. However, unlike the question and potential answers of FIG. 15, the question and potential answers of FIG. 12 relate to a patient's sore throat parameters. The question of FIG. 12 includes multiple possible answers and an associated icon for each. The icons are color-coded with respect to the patient's condition associated with the answer, and show a facial expression with respect to the patient's condition associated with the answer (described in more detail below).

[0411] Figure 13 shows a respiration screen presenting similar questions to Figures 11 and 12. However, unlike the questions and potential answers of Figures 11 and 12, the questions and potential answers of Figure 13 relate to the patient's respiration parameters.

[0412] FIG. 14 shows a cough screen presenting the same questions as in FIGS. 11-13.

[0413] FIG. 15 shows a sputum color screen presenting the same questions as in FIGS. 11-14.

[0414] FIG. 16 shows an antibiotic usage screen presenting similar questions as in FIGS. 11-15.

[0415] FIG. 17 shows a steroid use screen presenting similar questions to FIGS. 11-16.

[0416] FIG. 18 shows an inhaler use screen presenting similar questions to those in FIGS.

[0417] A health provider may establish one or more patient baselines regarding questions and / or health parameters.

[0418] The baseline may be displayed to the user when the corresponding question (or a question regarding a health parameter) is displayed. The baseline may be displayed by a graphical element (e.g., the folded corners in Figs. 12, 15, 16, 17) or through highlighting.

[0419] In some embodiments, the questionnaire (and / or one or more questions and answers) may be presented when the device enters a non-therapeutic mode of operation (e.g., when the device enters a drying mode). This may allow the user to complete the questionnaire before a predetermined period of operation in the non-therapeutic mode has elapsed. Thus, the questionnaire (and / or one or more answers to the questions) may be transferable to the device when the operation is to be performed (as described in more detail below).

[0420] In some embodiments, the questionnaire (and / or one or more questions and answers) may be presented in a first non-therapeutic mode (e.g., a warm-up mode) and transferred to the device (described in more detail below) in a second non-therapeutic mode (e.g., a drying mode).

[0421] The data relating to the interview (and / or one or more questions and answers) may be packaged in one package, or there may be separate packages for the treatment data and the question and answer data.

[0422] The questionnaire (and / or one or more questions and answers) may be collected in the first non-therapeutic mode and then stored in the device's memory (e.g., after a predetermined time, as described in more detail below) before being transferred during operation in the second non-therapeutic mode.

[0423] The device may operate in a first non-treatment mode prior to a treatment session (eg, a warm-up mode) and in a second non-treatment mode after a treatment session (eg, a dry-down mode after a treatment session).

[0424] In some embodiments, during non-therapy mode, a Therapy Summary screen is displayed, which may include aspects of Therapy Data (described in more detail below).

[0425] As previously mentioned, the device may be configured to operate in at least one therapeutic mode and at least one non-therapeutic mode.

[0426] When operating in a non-therapeutic mode, the device may display non-therapeutic information on the display.

[0427] The information may include one or more of the following: a type of non-therapeutic mode, an indication that the non-therapeutic mode is active, time remaining in the non-therapeutic mode, and a warning not to use the device.

[0428] In the therapy mode, the device is configured to provide therapy to the user.

[0429] The treatment mode is a) Continuous positive airway pressure (CPAP) mode b) Bubble Continuous Positive Airway Pressure (BCPAP) mode c) Nasal High Flow (NHF) mode d) Bilevel pressure mode (e.g., NIV mode) in which pressure is controlled between IPAP and EPAP. e) Any combination of a) to d) may include.

[0430] Each treatment mode may have one or more associated treatment parameters of the device (as described in more detail above), such as therapeutic flow rate of gas, therapeutic pressure support level, therapeutic temperature of gas, therapeutic humidity of gas, therapeutic temperature at the end of the breathing conduit, etc.

[0431] Each treatment mode may have associated software configured to be executed by the device 10 (eg, by the controller 13) to control the device to provide a particular treatment.

[0432] Generally, one mode of therapy is provided at a time (ie, CPAP and NHF cannot be delivered simultaneously).

[0433] In each treatment mode, the user may be provided with a different interface or different options of inputs for the device.

[0434] In each treatment mode, the device may include a different control scheme (eg, a pressure control scheme for CPAP mode and a flow control scheme for NHF mode).

[0435] In each therapy mode, the device may have one or more alarm conditions. The one or more alarms may be activated when an alarm condition is met. The alarm conditions may be based on the particular therapy mode (i.e., the specific therapy being provided) and / or one or more fault conditions that may occur during therapy.

[0436] The device may also be configured to operate in one or more non-therapeutic modes, in which no therapy is provided to the user.

[0437] The non-treatment modes may include a drying mode, a warm-up mode, a standby mode, and / or a disinfection mode.

[0438] In some embodiments, the airflow generator is activated to generate a gas flow when the device is operating in at least one non-therapeutic mode, hi some embodiments, the airflow generator is controlled to achieve a predetermined motor speed and / or a predetermined flow rate when the device is operating in at least one non-therapeutic mode.

[0439] In some configurations, the predetermined flow rate may be provided by controlling the motor speed of the airflow generator. This may be done, for example, by a look-up table or equation that defines the relationship between flow rate and motor speed. In non-treatment modes, this may make it easier to control the airflow generator, since no patient is connected and resistance to flow may be known (i.e., during sterilization mode) or may be assumed to be constant (i.e., during drying and / or disinfection modes).

[0440] In some configurations, to control the airflow generator (e.g., to provide a predetermined flow rate and / or a predetermined motor speed), the device may use feedback control based on one or more sensors, e.g., to control the motor speed, a motor speed sensor may be used, or a current / voltage sensing unit that monitors the current or voltage to the motor. To control the flow rate, a flow sensor may be used (e.g., an ultrasonic sensor and / or a thermistor as described elsewhere herein).

[0441] In some embodiments, the flow generator is configured to provide a gas flow rate that is less than a therapeutic flow rate when the device is operating in at least one non-therapeutic mode.

[0442] In some embodiments, when the device is operating in at least one non-therapeutic mode, the airflow generator is configured to provide a flow rate that is less than about 50%, or less than about 25%, or less than about 10% of the therapeutic flow rate.

[0443] In some embodiments, the humidifier (and optionally the heater of the humidifier) ​​is activated when the device is operating in at least one non-therapeutic mode. In some embodiments, the humidifier is configured to humidify the gas flow when the device is operating in at least one non-therapeutic mode.

[0444] In some embodiments, when the device is operating in at least one non-therapeutic mode, the humidifier is configured to humidify the gas flow to less than therapeutic humidity.

[0445] In some embodiments, when the device is operating in at least one non-therapeutic mode, the humidifier is configured to humidify the gas flow to less than about 50%, or less than about 25%, or less than about 10% of therapeutic humidity (e.g., absolute or relative humidity, and / or dew point).

[0446] In some embodiments, when the device is operating in at least one non-therapeutic mode, a heater in the conduit is activated and configured to heat the gas flow in the respiratory conduit.

[0447] In some embodiments, when the device is operating in at least one non-therapeutic mode, the heater in the conduit is configured to heat the gas flow to a conduit end temperature that is less than the conduit treatment end temperature.

[0448] In some embodiments, when the device is operating in at least one non-therapeutic mode, the heater in the conduit is configured to heat the gas flow to less than about 50%, or less than about 25%, or less than about 10% of the therapeutic temperature (e.g., the therapeutic temperature at the end of the conduit or the therapeutic humidity as a dew point).

[0449] As shown in Figure 19A, the device may be configured to switch between operating in a therapeutic mode 910 and a non-therapeutic mode 911. Switching between operating in a therapeutic mode 910 and a non-therapeutic mode 911 may be based on one or more triggers, such as, for example, an indication that a therapy session is complete 913, as shown in Figure 20A.

[0450] 19B, the device's operation in a non-therapeutic mode 911 may serve as a transition from the device's operation in a therapeutic mode 910 to a state 912 where the device is powered off. The transition from the device's operation in a therapeutic mode 910 to a state 912 where the device is powered off may be important because powering off the device directly from a therapeutic mode may cause damage to one or more components of the device or system. In this case, the non-therapeutic mode may be, for example, a dry mode configured to dry out the breathing conduit of the device so that it can be safely powered off.

[0451] As shown in Figure 20A, the device may transition from operating in a therapeutic mode 910 to operating in a non-therapeutic mode 911 when a treatment session is completed. In some embodiments, the device may be configured to automatically operate in at least one non-therapeutic mode after completion of at least one therapeutic mode. Alternatively, upon completion of treatment, the user may be presented with a prompt on the user interface to transition to operating in a non-therapeutic mode.

[0452] The device may transition to the second, non-therapeutic mode in response to a trigger, which may be the passage of time or a manual input (e.g., input via a user interface).

[0453] The device may determine that a therapy session is complete when the user enters an end therapy command.

[0454] The end of therapy command may be generated by a user-mediated input on a user interface.

[0455] An end therapy command may be generated upon detection of the patient interface being removed from the user.

[0456] The end of therapy command may be generated upon detection of the patient interface remaining removed from the user for a predetermined period of time.

[0457] Detecting that the therapeutic interface has been removed from the user can be performed according to the method(s) described in PCT Publication No. WO 2020 / 178746, the entirety of which is incorporated herein by reference.

[0458] Detecting that the patient interface has been removed from the user may be based on estimation of flow conductance / change in flow conductance, or any other suitable method.

[0459] An end therapy command may be generated upon detection of the patient interface 17 being disconnected from the respiratory conduit 16 (optionally for a predetermined period of time).

[0460] Detecting that the patient interface has been removed may be based on detecting that the user's breathing has stopped (optionally for a predetermined period of time).

[0461] The user may be asked to confirm the end therapy command (eg, via a user interface).

[0462] Detecting that the user has stopped breathing may include: a) the output of a patient interface sensor located within the patient interface b) A flow sensor located within the device c) a pressure sensor located within the device Any combination of a) to c) The method may be based on one or more of:

[0463] Detecting that the patient interface has been removed may be based on a change in the conductance of the flow path (optionally over a predetermined period of time).

[0464] As shown in Figure 20A, the device is powered off when the non-therapeutic mode is completed. The non-therapeutic mode may be completed based on time and / or one or a parameter of the device (e.g., a sensor) reaching a desired value.

[0465] The device may be powered off (i.e., from a power on state to a power off state) after the device has operated in one or more non-therapeutic modes.

[0466] The device may be powered off automatically upon completion of the therapeutic mode or by input from the user, hi some embodiments, the user may not be able to power off the device until the non-therapeutic mode is completed.

[0467] In some embodiments, for example, as shown in FIG. 19C, device operation in a non-therapeutic mode 911 can serve as a transitional period from device power-on to device operation in a therapeutic mode 910. The transition from device power-on to device operation in a therapeutic mode is also important because the device may not be able to immediately operate in a therapeutic mode to provide sufficient therapy to the user (e.g., may not be able to provide gas at therapeutic parameters). In this case, the non-therapeutic mode can be, for example, a warm-up mode configured to warm up the device before it begins operating in a therapeutic mode.

[0468] As shown in Figure 20B, the device may transition from operating in a non-therapeutic mode 911 to operating in a therapeutic mode 910 upon completion of the non-therapeutic mode (as described in more detail above). In some embodiments, the device may be configured to automatically operate in at least one therapeutic mode before operating in at least one therapeutic mode. Alternatively, upon completion of the non-therapeutic mode, the user may be presented with a prompt indicating that the device is ready for therapy, and the user may enter an input into the user interface to transition to operating in a therapeutic mode.

[0469] The device may operate in one or more non-therapeutic modes after the device is powered on (i.e., from a powered off state to a powered on state).

[0470] As previously mentioned, the non-therapeutic mode may be a dry mode in which the device may operate to dry out the respiratory conduit.

[0471] The dry mode reduces the risk of pathogen growth in the humid post-treatment environment and can extend the safe service life of the respiratory conduit. The dry mode is performed for at least 30 minutes, and preferably for at least 90 minutes to minimize the risk of pathogen (i.e., microbial) growth within the conduit (i.e., tubing).

[0472] Dry mode can be particularly important in NHF systems, where the high flow and corresponding humidity provided to the user can result in large amounts of condensation during use.

[0473] The drying mode may be the drying process described in PCT Publication No. WO 2006 / 126900, which is incorporated herein by reference.

[0474] Operation of the device in the dry mode is important after the device has finished operating in the treatment mode, as the dry mode allows any condensation present in the breathing conduit to be removed after treatment.

[0475] The device may operate in a drying mode after operation in a treatment mode, which is then completed (eg, as shown in Figures 19B and 20A and described in more detail above).

[0476] In some configurations, ozone gas may be provided to the gas flow path during the drying mode.

[0477] While the device is operating in the dry mode, the heater in the breathing conduit is controlled while the flow generator provides gas at a predetermined flow rate.

[0478] When the device is operating in dry mode, the humidifier heater is deactivated.

[0479] When the device is operating in dry mode the heater in the breathing conduit is controlled to a predetermined temperature at the end of the breathing conduit, or to a predetermined duty cycle, or to a predetermined voltage, or to a predetermined current, or to a predetermined power.

[0480] The predetermined duty cycle may be 100%.

[0481] The predetermined temperature is greater than 45 degrees Celsius.

[0482] The drying mode may be configured to operate for about 20 minutes to about 120 minutes, or for about 90 minutes.

[0483] If the user attempts to power off the device before the drying mode is complete, the device may display a message to the user that the drying mode is not yet complete and / or may not allow the user to power off the device or may not allow the user to power off the device without further confirmation.

[0484] The drying mode includes controlling the airflow generator to provide a predetermined airflow generator output, the airflow generator output being a motor speed of between about 1000 RPM and about 3000 RPM, or less than about 2000 RPM.

[0485] The drying mode includes controlling the airflow generator to provide a predetermined flow rate, the predetermined flow rate being between about 5 liters / minute and about 20 liters / minute.

[0486] The dry mode is configured to evaporate any condensation remaining within the device and / or breathing conduit and / or patient interface.

[0487] In some embodiments, when the device is operating in dry mode, the device presents a message informing the user not to wear the patient interface 17.

[0488] As previously mentioned, the non-therapy mode may be a warm-up mode in which the device may operate to prepare the device for the therapy mode.

[0489] Operating the device in a warm-up mode prior to a therapy mode can be important to ensure that when therapy is initiated, the device will provide a gas flow at the therapy parameters for that therapy mode. Having the device turn on the humidifier heater and / or breathing conduit heater prior to a therapy mode helps the device provide a gas flow at the therapy parameters for that therapy mode when the device begins operation in that therapy mode.

[0490] In some embodiments, during the warm-up mode, the heater of the humidifier is activated.

[0491] In some embodiments, during the warm-up mode the humidifier heater and / or the breathing conduit heater are activated.

[0492] In some configurations, during warm-up mode the humidifier heater and / or breathing conduit heater are operated at 100% power, eg, 100% duty cycle.

[0493] The device may operate in a warm-up mode when the device is powered on (ie, from a power off state to a power on state).

[0494] The warm-up mode may include controlling a heater in the breathing conduit to control the temperature at the end of the conduit to a desired temperature.

[0495] The desired temperature at the end of the conduit may be based on one or more treatment parameters of the device.

[0496] The desired temperature at the end of the breathing conduit may be a predetermined temperature.

[0497] The temperature at the end of the respiratory conduit is within about 2 degrees Celsius to about 5 degrees Celsius, or about 2.5 degrees Celsius of the desired temperature at the end of the conduit, and optionally about 2 degrees Celsius to about 5 degrees Celsius, or about 2.5 degrees Celsius below a predetermined temperature or treatment parameter.

[0498] The temperature at the end of the breathing conduit may be greater than about 25 degrees Celsius, or between about 25 degrees Celsius and about 28 degrees Celsius.

[0499] The warm-up mode may include controlling the heater of the humidifier to a predetermined temperature, or to a predetermined duty cycle, or to a predetermined voltage, or to a predetermined current, or to a predetermined power.

[0500] In some configurations, the rate of temperature rise (eg, to a therapeutic temperature at the end of the breathing conduit) may be controlled.

[0501] The warm-up mode may include deactivating the airflow generator. Alternatively, the warm-up mode includes operating the airflow generator at a predetermined flow rate or a predetermined airflow generator output. In some embodiments, the predetermined flow rate is lower than the therapeutic flow provided to the patient. In some embodiments, the predetermined airflow generator output is a motor speed of about 1000 RPM to about 3000 RPM, or less than about 2000 RPM.

[0502] In some configurations, the warm-up mode may include increasing the airflow generator output for a predetermined time. The increase may be to a therapeutic parameter. In some configurations, the airflow generator output may be increased from a first level to a second level. For example, in the warm-up mode, the device may increase the flow rate provided by the airflow generator from zero flow (or a low flow) to a therapeutic flow rate over a period of time. The predetermined period of time may be the length of the warm-up mode.

[0503] In some configurations, the rate of increase in flow rate, for example to a therapeutic flow rate, can be controlled.

[0504] The condition for exiting the warm-up mode may be when the device reaches one or more treatment parameters (or within a particular margin of one or more treatment parameters) and / or other desired temperature and / or after a predetermined elapsed time.

[0505] If the user attempts to start a therapy session before the warm-up mode is complete, the device may display a message to the user that the warm-up mode is not complete and / or may not allow the device to operate in therapy mode without further confirmation.

[0506] As previously mentioned, the non-therapeutic mode may be a sterilization mode in which the device may be operated to sterilize the device.

[0507] The sterilization mode may be based on the method for sterilizing respiratory assistance devices disclosed in PCT Publication No. WO 2007 / 069922, which is incorporated herein by reference.

[0508] In the sterilization mode, it may be possible to sterilize a portion of the gas flow path (e.g., elbows 325, 235). This may allow the device to be safely reused without having to replace components of the device between uses and patients. Sterilization may also prevent cross-contamination if the device is used between multiple patients and may allow for full reuse of the device. The sterilization mode may be used in both home and hospital environments.

[0509] When the device is operating in a sterilization mode, the device may be connected to a sterilization conduit, which may include a heater to heat gas passing through the sterilization conduit.

[0510] During sterilization mode, the sterilization conduit 124 may be connected to the gas outlet 21 of the device and to the airflow generator outlet (or humidification chamber inlet) as shown in FIG. 21, so that gas flows from the airflow generator through the sterilization conduit, through elbow 325 and optionally filter 123 or a valve attached to elbow 325, to atmosphere.

[0511] In the sterilization mode, the heater of the sterilization conduit 124 may be controlled so that the gas flow in the sterilization conduit 124 reaches a predetermined temperature. The predetermined temperature may be between about 50 degrees Celsius and about 100 degrees Celsius, or between about 60 degrees Celsius and about 90 degrees Celsius.

[0512] The predetermined temperature may be a temperature measured by another sensor in the system, such as a sensor in the elbow 325 or the sensor module 400. Additionally or alternatively, the predetermined temperature may be a temperature measured by a temperature sensor in the sterilization conduit.

[0513] The sterilization mode may include controlling the airflow generator to provide a predetermined motor speed. The motor speed may be about 1000 RPM to about 6000 RPM, or about 2000 RPM to about 5000 RPM, or preferably about 2000 RPM to about 3000 RPM. In some embodiments, the predetermined motor speed is 2000 RPM.

[0514] Alternatively, the sterilization mode may include controlling the airflow generator to provide a predetermined flow rate, the predetermined flow rate being between about 10 liters / minute and about 20 liters / minute.

[0515] The device may operate in a sterilization mode when it is detected that a sterile conduit is connected to the device.

[0516] Detection of the sterilization tube may be by identifying the heater wire resistance (or, for example, heater wire resistance range) inherent to and / or within the sterilization conduit, by an identification means, such as a thermistor or RFID tag or other identification element.

[0517] As previously mentioned, the non-therapeutic mode may be a standby mode.

[0518] A standby mode may allow the device to enter a mode that keeps the device ready to operate in a therapy mode if necessary.

[0519] The device may operate in standby mode when a user enters an input via the user interface. In some embodiments, the device may operate in standby mode after it is detected that the patient interface has been removed from the user. In some embodiments, the end therapy command may be generated by detecting that the patient interface has been removed from the patient for a predetermined amount of time (which may be less than the predetermined amount of time required for the device to operate in dry mode as described in more detail above).

[0520] Detecting that the patient interface has been removed may be performed as described in more detail above.

[0521] The standby mode may include operating the airflow generator at a predetermined flow rate or a predetermined motor speed.

[0522] The predetermined flow rate is lower than the therapeutic flow rate.

[0523] The predetermined motor speed is between about 1000 RPM and about 3000 RPM, or less than about 2000 RPM.

[0524] The device may operate in the drying mode after a predetermined period of time during which the device has been operating in the standby mode.

[0525] The device is configured to collect and store the data. The device may collect data at any time. In some embodiments, the device may be configured to collect data while the device is operating in a standby mode, i.e., a non-therapeutic mode.

[0526] 22, the data 920 may include therapy data 921 collected during operation in at least one therapy mode. The data may additionally or alternatively include device data.

[0527] Treatment data 921 includes data about the user and / or treatment provided to the user.

[0528] The therapy data 921 may include data regarding one or more separate therapy sessions.

[0529] In some embodiments, the treatment data includes data from at least a previous treatment mode.

[0530] Treatment Data 921 is a) User's oxygen saturation (SpO2) b) The user's breathing rate c) Humidity (dew point) of the gas provided to the user d) The flow rate of gas provided to the user. e) Patient end temperature f) The user's tidal volume g) User's minute ventilation h) Device usage data i) Answers to one or more questions provided to the user j) Treatment Report (optionally, the treatment report relates to past treatment session reports and / or the just completed treatment session) k) information about at least one medical interview, as explained in more detail above; L) At least one medical history question m) At least one medical questionnaire response n) One or more patient baselines o) Any combination of a) to n) may include.

[0531] In some embodiments, during the non-therapeutic mode, the user is presented with one or more questions, the user provides answers to the questions via at least one user interface, and the questions and / or answers to the questions become part of the treatment data, it being understood that the questions and answers may be related to the questionnaire or separate from the questionnaire.

[0532] The treatment data may be collected by one or more sensors, as described in more detail elsewhere herein.

[0533] The device may receive sensor output from one or more sensors, and the treatment data may be based on the sensor output from the one or more sensors.

[0534] One or more sensors may be located within the housing of the device, such as, for example, motion sensors 3a, 3b, 3c shown in Figure 1. Alternative sensor locations are shown in Figure 8A and described below.

[0535] One or more sensors may be located remotely from the device (ie, external to the housing), such as patient sensor 26 shown in FIG.

[0536] As shown in FIG. 22, the device data may include data regarding one or more characteristics of the device and / or the device's surrounding environment.

[0537] The device data may include a unique identification of the device.

[0538] The device data may include a sensor calibration profile (containing information about the calibration of one or more sensors of the device).

[0539] The device data may include software and / or firmware versions of the device's software or firmware.

[0540] The device data may include the total usage time of the device, or the usage time of one or more components of the device (eg, a conduit or a blower).

[0541] The device data may include the identity of one or more components of the device (eg, the hardware version of the airflow generator or sensor).

[0542] As shown in FIG. 23, after operating in at least one non-therapeutic mode for a period of time, the device may perform the following operations 924: a) Transferring data to a device; or b) receive a software package on or from a device; or c) receiving a device or treatment parameters from the device (optionally as a prescription); or d) updating the parameters of the device, or e) Any combination of a) to d) The device is configured to perform one of the following:

[0543] The operations 924 may be performed simultaneously or sequentially.

[0544] It is to be understood that multiple operations 924 are disclosed, and that any one of the operations can be performed independently, as well as in any combination of the operations 924 in any order.

[0545] The operations 924 may be performed according to priority: each operation may have a respective priority, and the device may perform these operations in order from the highest priority operation to the lowest priority operation.

[0546] Transferring data to a device may be the highest priority task, followed by updating device parameters (e.g., performing sensor calibration), then receiving a software package from or to a device, then receiving treatment parameters (optionally as a prescription) from or to a device.

[0547] Prioritizing operations can be important, for example, when a device is running from battery power because the device may shut down when the battery runs out. By performing operations in priority order, the likelihood that they will be completed while the equipment is still powered is increased.

[0548] In some configurations, when the device is operating from battery power, the device may prioritize providing power to components necessary to perform an operation (e.g., the communications module when transmitting or receiving, or the sensor and associated circuitry when performing sensor calibration. In some configurations, these operations may be performed before other processes as part of a non-therapeutic mode.

[0549] During drying and disinfection modes, the airflow generators and heater wires are activated, power utilization is increased, and therefore priority for power delivery may be given to components required to perform the operation and / or the operation may be performed before other processes as part of a non-treatment mode.

[0550] In some configurations, the device is configured to update device parameters and then transfer this data to an appliance. This scheme means that sensor calibration information is included in the data transfer. This may allow for earlier alerting of a fault in the device (e.g., via an appliance such as a phone) and / or recording of the fault in the device and / or in the patient and device management functions (e.g., to notify a service technician).

[0551] In some configurations, the device is configured to transfer data to an appliance and then receive a software package from or to the appliance, which then updates parameters of the device.

[0552] In some configurations, the device is configured to update device parameters, then transfer data to an appliance, then receive a software package from the appliance, and then update device parameters based on the software package received from the appliance.

[0553] The device may be configured to receive treatment parameters from a device or devices after receiving a software package from the device. By updating the treatment parameters after receiving the software package, the software integrity of the device is ensured before applying new prescription settings.

[0554] The device may be configured to receive treatment parameters from a device or devices after transferring data to the device. This means that updated treatment parameters (e.g., as prescription updates) can be applied during non-therapeutic modes based on data transferred from the device. Based on data transferred from the device to the device, the device and / or a clinician with access to the patient and device management functionality can make decisions regarding prescription updates. Furthermore, some of the non-therapeutic modes last for a predefined time, so that there is enough time for the clinician to review and approve changes to the treatment prescription and have them incorporated into the device.

[0555] The device may be configured to receive treatment parameters from a device or devices and then update the device parameters.

[0556] The device may be configured to transfer data to the device before the device receives treatment parameters from or to the device.

[0557] The software package may be an updated software package (compared to the device's current software package).

[0558] In some embodiments, the device may be configured to query the device whether an updated software package is available based on the device's current software package version, and optionally, the device communicates the current software package version or a timestamp of the current software package to the device.

[0559] The device may check the software package version and update the software package on the device if it is an older version.

[0560] The device may send a confirmation message to the appliance if the software package is successfully installed, and / or send an error report if the software installation is unsuccessful.

[0561] The treatment parameters may be updated treatment parameters (compared to the device's current treatment parameters).

[0562] In some embodiments, the device is configured to query the device whether updated treatment parameters are available based on the device's current treatment parameters. Optionally, the device communicates the current treatment parameters and / or the current treatment parameter version and / or a timestamp of the current treatment parameters to the device.

[0563] The device may be configured to request the software package and / or treatment parameters from the device, which may then enable the device to begin receiving the software package and / or treatment parameters or may provide a location (e.g., another device) from which the device can receive the software package and / or treatment parameters.

[0564] It should be understood that receiving the software package and / or treatment parameters may be initiated by a fetch action, i.e., the device requests information from the device, which is distinct from a push action, where the device pushes a notification to the device that there is an updated software package and treatment parameters. Alternatively, receiving the software package and receiving the treatment parameters may be initiated by a push action from the device.

[0565] 23 shows that when the device is operating in a non-therapeutic mode, the device checks and determines 923 whether the device has been operating in a non-therapeutic mode for a predetermined time. If the device has been operating in a non-therapeutic mode for the specified time 923, the device performs one of the actions 924 (as described above).

[0566] The equipment is a) The server (which can be a local or remote server) b) Local Devices c) Remote Device d) Any combination of a) to c) It could be.

[0567] In some configurations, the device may be, for example, a phone (e.g., a smartphone), a computer (e.g., a desktop or laptop) and / or a tablet and / or a wearable device, such as a smart watch, having computing and wireless communication capabilities.

[0568] The device may be part of a content delivery network or a distributed platform of other devices (eg, a cloud computing platform).

[0569] The devices and equipment may be part of a patient and device management platform.

[0570] The patient and device management platform may be a server or a network of servers, or a cloud computing system or other suitable architecture for operating the patient and device management platform. The patient and device management platform (i.e., including at least one remote server as an appliance) further includes memory for storing received data and various software applications or services executed to perform various functions. The patient and device management platform may then communicate information or instructions to the device 10, depending at least in part on the received data. For example, the nature of the received data may trigger the remote server (or a software application executing on the remote server) to communicate an alert, alarm, or notification to the device 10.

[0571] The patient and device management platform may further store the received data for access by authorized parties, such as a clinician or patient, or other authorized parties. The patient and device management platform may further be configured to generate a report in response to a request from an authorized party. The report may include answers to the questionnaire and / or other patient respiratory parameters, such as respiratory rate or SpO2, and / or parameters, such as flow rate, humidity level (e.g., as a treatment report as described above).

[0572] Different types of data may be provided with different devices made available to different parties (e.g., equipment data may be provided to a service technician and treatment data may be provided to medical personnel).

[0573] FIG. 24 shows an architecture diagram illustrating a system for providing respiratory assistance or providing respiratory therapy to a patient. The data (answers and / or dashboards and / or plots) can then be provided to an external storage device such as a USB, the patient and device management platform, a mobile device (e.g., smartphone, laptop, tablet, wearable), and an insurance company or device provider. If the data is provided to a USB, the data can later be downloaded to a computer, which can then provide the data to the patient and device management platform or the insurance company. In some embodiments, the mobile device or the patient and device management platform can allow data to be returned to the respiratory assistance device (e.g., information to the patient about changes in physiological condition or pathology of the patient).

[0574] It should be understood that the devices referred to in each of the above may be the same or different devices, for example, the device 10 may transfer data to the same or different device from which it received the software package.

[0575] The device may be part of the patient and device management platform, or the device may be any device or combination of devices that is a component of the patient and device management platform.

[0576] In some embodiments, operation 924 is performed only when the device transitions from a therapeutic mode to a non-therapeutic mode.

[0577] In some embodiments, operation 924 occurs only in a non-therapy mode after a therapy session is completed.

[0578] The therapy data transferred to the device may include data from at least one therapy mode that has not previously been transferred to the device.

[0579] Data may be transferred to the device even if the device does not operate in at least one therapy mode.

[0580] The data may be transferred to the device after a predetermined time has elapsed since the last transfer of data to the device (optionally, the predetermined time is 24 hours).

[0581] The predetermined time period can be from about 5 minutes to about 25 minutes.

[0582] In some embodiments, the predetermined period of time is greater than 5 minutes.

[0583] In some embodiments, the predetermined time is less than the total time the device is configured to operate in the non-treatment mode, for example, if the drying mode is configured to operate for a predetermined length of time - i.e., 90 minutes (e.g., as a drying process), the predetermined time will be less than 90 minutes.

[0584] In some embodiments, the predetermined time is a percentage of the total time the device is configured to operate in the non-therapeutic mode. In some embodiments, the percentage of the total time the device is configured to operate in the non-therapeutic mode is less than about 50%, less than about 40%, or less than about 30%. For example, if the drying mode is configured to operate for a predetermined length of time - i.e., 90 minutes (e.g., as a drying process), the predetermined time may be, for example, 50%, 45 minutes.

[0585] For example, as shown in FIG. 25, after operating in a nasal high flow (NHF) mode 950, the device may operate in a dry mode when the treatment session is completed 913 (e.g., by a user indicating completion of the treatment session). In the dry mode, the humidifier heater is deactivated and the conduit heater is activated while the airflow generator provides gas at a predetermined flow rate. During operation in the dry mode, the user may power off the device before the dry mode is complete. If the user attempts to turn off the device before completion of the dry mode, the device may display a message alerting the user that the dry mode is incomplete.

[0586] After the device has operated 953 in the dry mode for a predetermined time (in this case, 10 minutes), the device may perform one or more actions 924. For example, the device may transfer data (including treatment data and device data) to a device (e.g., a server), receive a software package from a device (e.g., from the same or a different server), and receive a treatment parameter package from a device (e.g., from the same or a different server).

[0587] While the device is performing operation 924, the device may display a message warning the user not to power off the device.

[0588] For example, as shown in Figure 26, the device may operate in a warm-up mode when powered on 951. In the warm-up mode, the humidifier heater and the breathing conduit heater are activated, while the flow generator is deactivated.

[0589] The device 10 may operate in the NHF mode once the warm-up mode is complete (e.g., when a user indicates the beginning of a therapy session) 950. If the warm-up mode has not reached its exit condition (e.g., a desired temperature and / or a predetermined elapsed time), the device may display a message to the user that the warm-up mode is not complete.

[0590] After the device has operated in warm-up mode for a predetermined time (in this case, 10 minutes), the device may perform one or more operations 924. For example, the device may transfer data (including therapy data and device data) to a device (e.g., a server), receive a software package from a device (e.g., from the same or a different server), and receive a therapy parameter package from a device (e.g., from the same or a different server).

[0591] If the user attempts to power off the device while data is being transferred to the appliance, the user may be presented with a visual and / or audio indicator.

[0592] In some embodiments, the user is presented with a visual and / or audio indicator while the data is being uploaded to the device.

[0593] The visual indicator may be presented on a display module.

[0594] The visual indicator may be, for example, a picture of a modem icon and / or a message.

[0595] The device may be prevented from being turned off while an operation is taking place, however the potential inconvenience to the user in this case is limited, as the user would not want to turn the device off before the end of a non-therapeutic process.

[0596] In the non-therapeutic mode, the device may display a visual indicator on the display to warn the user not to use the device while in the non-therapeutic mode.

[0597] By operating the device in a non-therapeutic mode for a predetermined period of time, operation 924 is ensured that operation 924 is not performed if the device is turned off immediately after it exits the therapeutic mode, which may result in operation 924 not being able to be completed.

[0598] To facilitate the transfer of data and / or to receive software packages and / or treatment parameters from the device, the device is configured to operate a network interface (described in more detail above) and establish a connection with a device to transfer data to and / or receive software packages and / or treatment parameters from a device or devices.

[0599] The software package may include a firmware update (e.g., for controlling one or more hardware functions of the device). Additionally or alternatively, the software package may include a software update (e.g., for updating an algorithm or routine within the device, such as a control algorithm).

[0600] In some embodiments, after receiving the software package, the device applies the software package to the device.

[0601] The ability to receive updates in this manner ensures timely roll-out of updates that may improve device performance.

[0602] A predetermined time delay after entering non-treatment mode may be important for applying the software package to the device, because if the device is turned off during the installation of the software package, the software may not be applied or may only be partially applied, which may adversely affect the functionality of the device. For example, if the software package is applied at the end of a treatment session, the user may turn off the device after treatment. Furthermore, if the software package is only applied when selected by the user (to reduce the risk of the device being turned off), the user may not apply the important software package due to inconvenience. As another example, if the software package is applied during treatment, there is a risk that insufficient treatment will be provided for a period of time.

[0603] Updating the device parameters may include updating device calibration parameters. Updating the device parameters may include performing a sensor recalibration (e.g., as described in more detail below).

[0604] The device may receive one or more updated parameters for the device from an appliance and apply these updated parameters to the device. The updated parameters for the device may include, for example, a specific time since operation in a non-therapeutic mode for an operation to occur, or sensor calibration settings. The updated parameters may be received as part of a software package.

[0605] In some embodiments, after receiving treatment parameters from a device or devices, the device applies updates (e.g., as prescription updates) to the device's parameters. The treatment parameters may be specific to a particular treatment mode. The updates to the treatment parameters may also update only a small portion of the device's treatment parameters, and not necessarily all of the device's treatment parameters.

[0606] For example, updates to the treatment parameters may include, for example, a change in the oxygen concentration of the gas provided to the user and / or a change in the humidity level provided to the user.

[0607] Additionally, because operation 924 is only performed in non-therapeutic mode, data transmission and reception is reduced, which means that data communication charges can be reduced compared to if the device was constantly transmitting and receiving data.

[0608] The device 10 may transmit a signal to the equipment every predetermined amount of time (e.g., at a predetermined time interval) if the device has not been operating in a therapy mode. In some embodiments, the predetermined amount of time is 24 hours. In this case, device data may also be transmitted at the same time.

[0609] If the signal transmission is unsuccessful (e.g., due to a poor connection), the device will retry the transmission after a certain time, up to a certain number of attempts, until 24 hours have elapsed. If unsuccessful after the certain number of attempts, the device will wait until the next 24-hour window and start the process again.

[0610] The device may send a notification to the device that an update to the therapy parameters or software package is available, in which case the device may download the update from the device but wait a predetermined amount of time in non-therapy mode before applying the update.

[0611] When the device is operating via, e.g., battery-powered (e.g., as described above), the device may not perform an action or prompt the user to confirm the action before performing an action after a predetermined time in a non-operational mode, which may conserve battery charge or allow the user more control over the device's power usage.

[0612] In some embodiments, when the device is operating via battery power, a user may be able to manually prompt the device (optionally via an input into a user interface) to perform an action.

[0613] In some embodiments, when the device is operating via battery power, the user may be able to manually prompt the device to perform an action after operating in a non-therapeutic mode for a predetermined period of time.

[0614] In some embodiments, when the device is reconnected to external power, the device may prompt the user to perform an action (e.g., when there is data to transfer or when it is time for the device to check for updated software packages).

[0615] In some embodiments, when the device is reconnected to an external power source, the device may prompt the user to perform an action after operating in a non-therapeutic mode for a predetermined period of time.

[0616] When the device enters the battery charging state (e.g., when connected to an external power source), the device may be configured to perform an action immediately or after a predetermined time has elapsed in the battery charging state (optionally after operating for a predetermined time in a non-therapeutic mode).

[0617] The predetermined time period may be the predetermined time period previously described for operation in the non-therapeutic mode, or greater than about 2 minutes, or greater than about 5 minutes.

[0618] In some embodiments, the battery charging state may be entered when the device is not powered on.

[0619] Upon completion of a service operation (e.g. a general service of the device, or replacement of a component of the device), the device may be configured to perform an action immediately, or to perform an action a predetermined time after the service operation is completed.

[0620] In some embodiments, after the service task is completed, the device may prompt the user (in this case the service technician) to perform an action (as described above).

[0621] With respect to the operation being performed after a service operation, the operation may serve as a connectivity test to ensure that the communication module is functional.

[0622] When the device is in a mobile state (e.g., traveling by air or moving away from the user's usual location), the device may not take any action after a predefined time in non-therapeutic mode, or may prompt the user to confirm the action before performing it, which may limit data transmission costs or conserve battery charge.

[0623] In some embodiments, when the device is no longer in a mobile state, the device may prompt the user to perform an action (e.g., when there is data to transfer or when it is time for the device to check for updated software packages).

[0624] When the device is in a mobile state, the user may be able to manually prompt the device (optionally via an input to a user interface) to perform an action.

[0625] In the mobile state, the device may deactivate the communication module (or a portion of the communication module) in accordance with regulations regarding aircraft travel. In some embodiments, in the mobile state, the device may also operate on batteries.

[0626] As previously mentioned, the device is configured to operate in at least one therapeutic mode and at least one non-therapeutic mode.

[0627] As shown in Fig. 27, when the device is operating in at least one non-therapeutic mode 911, the device is configured to update 960 device parameters. In the non-therapeutic mode, a safe opportunity is provided for the device to update device parameters (e.g., as described in more detail above). The updated parameters may be used during the therapeutic mode 910, for example, sensor calibration parameters 961 updated in the non-therapeutic mode 911 may be used in the therapeutic mode 910 (e.g., as shown in Fig. 28).

[0628] As shown in FIG. 29, the device is configured to update 960 parameters of the device after the device has operated 970 in at least one non-therapeutic mode for a predetermined period of time.

[0629] In some embodiments, the device may be configured to update 960 device parameters after the device has been operating in a non-therapeutic mode for about 10 minutes.

[0630] In some configurations, the device may be configured to update 960 device parameters approximately 5 minutes before the device terminates operation in a non-therapeutic mode.

[0631] Alternatively or additionally, as shown in FIG. 30, the device is configured to update 960 device parameters upon exit of the non-therapeutic mode 971.

[0632] In some configurations, for example, as part of step 924 of Figure 25, the device may be configured to update device parameters prior to transferring the data to the appliance. The transferred data may include, for example, updated device parameters.

[0633] As shown in FIG. 25A, after operation in therapy mode 950, for example when a therapy session is completed 913 (e.g., after an end therapy command, as described in more detail above), the device may operate in dry mode. In dry mode, the humidifier heater is deactivated and the conduit heater is activated while the airflow generator provides gas at a predetermined flow rate. During operation in dry mode, the user may power off the device before the dry mode is complete. If the user attempts to turn off the device before the dry mode is complete, the device may display a message alerting the user that the dry mode is incomplete.

[0634] After the device has operated in dry mode for a predetermined time 953 (in this case 10 minutes), the device may update at least one parameter of the device 960. The parameters may include one or more sensor calibration parameters as described in more detail elsewhere. After the one or more sensor calibration parameters have been updated, the device proceeds to step 924'' where the device transfers data to the equipment. The data may include one or more sensor calibration parameters. The data may include other data, as already described in more detail, such as treatment data and / or device data. In some configurations, the device may perform one or more operations 924 after one or more sensor calibration parameters have been updated (e.g., as described in more detail elsewhere and shown in, e.g., FIG. 31).

[0635] While the device is performing operation 924, the device may display a message warning the user not to power off the device.

[0636] As shown in Figure 31, the device may be configured to update 960 device parameters upon exiting 972 the non-therapeutic mode and then perform other operations as described in more detail above. In some configurations, the device may provide a prompt to the user via a user interface to confirm updating the device parameters.

[0637] By updating device parameters during some non-therapeutic modes (e.g., drying mode and / or warm-up mode and / or cool-down mode and / or disinfection mode), the device may be able to make effective use of the time the device is in a non-therapeutic mode. This means that device parameters may be updated while the device is performing some non-therapeutic modes that occur during normal operation of the device. This may mean that the device does not need to stop performing some non-therapeutic modes to update device parameters.

[0638] Additionally, as previously mentioned, the device does not need to update device parameters while in a therapy mode, as updating device parameters while in a therapy mode may increase risk to the patient as the update may mean that delivery of therapy needs to be stopped or therapy will not be provided with the required therapy parameters.

[0639] Having a separate mode in which the device updates parameters can be more inconvenient for the user as it must be actively selected by the user and this may make the user unwilling to update the device. This can lead to the device not being updated frequently, which can impair therapy. Having the device not operate when parameters are not updated can be a risk, for example, if the user needs therapy but must wait for the device to update parameters before use.

[0640] In some configurations, the updated parameters of the device may include sensor calibration parameters for at least one sensor.

[0641] The accuracy of the sensors may degrade over time or may be compromised by damage or misuse. If the sensors are not properly calibrated, the device may not be able to provide proper therapy. If the sensors are not properly calibrated, the device's control system may not be able to control the device's functions.

[0642] For example, if the flow sensor (ie, ultrasonic flow sensor) is not properly calibrated, the device may not accurately deliver flow-based therapy (eg, high-flow therapy).

[0643] As another example, if the pressure sensor is not properly calibrated, the device may not accurately deliver pressure-based therapy (eg, CPAP, BCPAP, and / or bi-level therapy).

[0644] As another example, if the oximetry sensor (i.e., ultrasonic oximetry sensor) is not properly calibrated, the device may not be able to accurately control the amount of oxygen provided to the user, which may mean that the user is not provided with therapeutic oxygen levels and may end up with under- or over-oxygenated, which may lead to negative health consequences.

[0645] Updating the sensor calibration parameters may ensure safe and proper functioning of the device.

[0646] In some configurations, the at least one sensor may be any sensor in the device. For example, the at least one sensor may be any sensor described elsewhere herein. In some configurations, the at least one sensor may be associated with the device. For example, the at least one sensor may be connected to the device.

[0647] At least one sensor Pressure Sensors Temperature Sensor Humidity sensor Oxygen concentration sensor Flow Sensor It can be any one of the following:

[0648] The pressure sensor may be an absolute pressure sensor or a differential pressure sensor.

[0649] The at least one sensor may be part of a sensor module (as described in more detail above). In some configurations, the sensor assembly may include at least one, or multiple, sensors (e.g., temperature and humidity sensors).

[0650] The sensor may be configured to measure a property (eg, a property of a gas), for example a pressure sensor may be configured to measure the pressure of a gas.

[0651] For example, as described in more detail above with respect to FIG. 8A , the at least one sensor may be located on one or more of the following: A sensor module (optionally, the sensor module may be located as part of the flow generator and / or between the blower and the humidifier) ​​- e.g., sensor 44 Airflow generators - e.g. sensors 3a, 44 and / or 43 A location upstream of the airflow generator - e.g. sensors 41 and / or 42 A location downstream of the airflow generator—e.g., sensors 44, 46, and / or 48 Humidifier - e.g. sensors 45 and / or 46 A location upstream of the humidifier - e.g., sensors 41, 42, and / or 44 A location downstream of the humidifier - e.g., sensors 46 and / or 48 A conduit connected to the gas outlet of the humidifier and configured to transport the gas flow to a user (optionally at a user end of the conduit proximate the patient interface) - e.g., a sensor 48 Patient Interface Ambient sensors - e.g. sensor 40 A measuring chamber (optionally as part of a sensor module) - e.g., a sensor 44 Humidification inlet and / or humidification chamber inlet Humidification outlet and / or humidification chamber outlet - e.g. sensor 46 Control board - e.g. sensors 43, 44 and / or 47

[0652] For example, motion sensors 3a, 3b, 3c, and 29 may be included in device 1 as shown in Figure 1, and / or sensors 40, 41, 42, 43, 44, 45, 46, 47, and 48 may be included as shown in Figure 8A. The motion sensors may be in any of the locations as previously described, or any of the sensors may be as previously described.

[0653] The sensor calibration parameters may relate to a relationship between the output of at least one sensor and a property that the sensor is configured to measure. Calibration coefficients Calibration curve Internal parameters of the sensor may include one or more of:

[0654] For example, a calibration coefficient or curve may be a coefficient or curve used as part of an equation to specify the relationship between the output of a sensor and the property that the sensor is configured to measure.

[0655] The correction curve or coefficient may be, for example, an offset applied to the sensor output.

[0656] In some configurations, the sensor calibration parameters may be the particular formula used (eg, based on a selection from multiple formulas).

[0657] In some configurations, internal parameters of the sensor may be updated, and the internal parameters may be used in the sensor providing an output.

[0658] The device may be configured to update the sensor calibration parameters of at least one sensor at least once, and optionally multiple times. For example, the device may update the sensor calibration parameters of at least one sensor and then update the sensor calibration parameters of the at least one sensor again after a predetermined time. For example, during a non-therapeutic mode, the sensor calibration parameters may be updated multiple times.

[0659] The apparatus may be configured to update the sensor calibration parameters based on the output of at least one sensor and another sensor, the output of one sensor may be compared to the output of another sensor, and the sensor calibration parameters may be determined based on the comparison.

[0660] The sensor calibration parameters may be used by the device to determine a characteristic that the at least one sensor is configured to measure based on an output of the at least one sensor. Additionally, the device may be configured to update a control scheme based on the sensor calibration parameters. For example, a different humidity control scheme may be used to control the humidity output of the device (e.g., a humidifier of the device) based on the sensor calibration parameters.

[0661] The sensor calibration parameters may be stored in the device's memory.

[0662] The sensor calibration parameters may be used by the device in a therapeutic mode.

[0663] The device may be configured to update the sensor calibration parameters if the sensor error is outside of a tolerance. The tolerance may be based on the specific type and / or location of the sensor. For example, an oxygen concentration sensor (described in more detail below) has a tolerance of + / - 3%.

[0664] The tolerances may include specification tolerances and / or therapeutic tolerances. Specification tolerances may be based on the particular specifications of the sensor, and being outside of the specification tolerances may indicate a sensor failure (i.e., a miscalibration of the sensor). The acceptable therapeutic tolerances may be the tolerances associated with what the sensor may be acceptable for use in delivering therapy.

[0665] Treatment tolerances may be based on specific sensor locations and sensor types Treatment tolerances may be based on the device control system and use of sensors in the controls.

[0666] If it does not stay within the specification tolerances, the device may return a fault and prevent use of the device, ie, sensor miscalibration.

[0667] If it does not stay within therapeutic tolerance, the device may update the sensor calibration parameters for that sensor.

[0668] If the sensor error is within the tolerance range (i.e., the sensor calibration was successful), the device may not update the sensor calibration parameters for that sensor and may continue to use the current sensor calibration parameters. If the sensor error is outside the tolerance range, the device may update the sensor calibration parameters for that sensor, which may also be classified as a successful sensor calibration.

[0669] Sensor errors may be identified, for example, by comparing the outputs of sensors within the device (e.g., a first sensor and a second sensor, as described in more detail below) and / or by performing certain tests, as described in more detail below.

[0670] In situations where the error is based on a comparison of the outputs of the sensors, one of the sensors is assumed to be correct and the error is identified from this sensor. The particular sensor assumed to be correct may depend, for example, on the type of sensor, the location of the sensor, and the sensor error, as well as the status of the device. The device may perform one or more checks on the particular sensor assumed to be correct before assuming it is correct. For example, if the sensor assumed to be correct is a temperature sensor and the temperature is outside an acceptable range, the device may not assume that the sensor is correct.

[0671] If the device detects that the sensor is out of tolerance and / or the sensor calibration parameters have changed by more than a threshold, the device may perform any combination of the following: a) Activating an alarm on the device (e.g. an audio and / or visual alarm) b) sending the alarm condition to a device (eg, a device described elsewhere herein, which may be, for example, the user's device or a clinician's device); c) Prevent operation of the device (in some configurations the device may be allowed to operate after a user acknowledges the alarm, in some configurations a service technician may need to repair and / or service the device before it is allowed to operate). d) generating a report, the report including information regarding the sensor calibration process (e.g., including errors and whether the sensor was within tolerance or out of tolerance, success or failure of the calibration, and / or a solution to a sensor failure). The report may be transferred to the instrument or, optionally, may be part of the data transferred to the instrument. In some configurations, the report is displayed on the device display and / or the instrument display. e) Displaying information regarding the sensor calibration process via the device display and / or the equipment display (e.g., including errors and whether the sensor is within or out of tolerance, success or failure of the calibration, and / or a solution to the sensor failure).

[0672] Below are some examples of updating sensor calibration parameters for at least one sensor. It should be understood that any combination of the following examples may be combined.

[0673] The sensor calibration parameters may be updated for at least one of the sensors. The sensor calibration parameters may be updated simultaneously or sequentially.

[0674] Multiple tests may be performed on each sensor to update the sensor calibration parameters associated with that sensor, for example, for a flow sensor, a zero flow calibration may be performed along with a predetermined flow calibration (as described in more detail below).

[0675] In some configurations, the at least one sensor includes a first sensor and the other sensor includes a second sensor. The apparatus 1 may be configured to update a sensor calibration parameter for the first sensor based on an output of the second sensor. The sensor calibration parameter may be based on a comparison between an output of the first sensor based on an output of the second sensor. For example, as shown in FIG. 32, in step 991, the apparatus 1 determines an output of the first sensor, in step 992, the apparatus 1 determines an output of the second sensor, and in step 990, the apparatus 1 determines a sensor calibration parameter based on the output of the first sensor and the output of the second sensor. It should be understood that steps 991 and 992 can be performed in parallel.

[0676] The first sensor may be an ambient sensor and the second sensor may be a sensor disposed within the flow path of the device.

[0677] In a non-therapeutic mode, the controller may control the airflow generator such that no gas is provided by the airflow generator and gas conditions in the flow path are the same as ambient conditions.

[0678] In some configurations, the first sensor may be co-located with the second sensor (eg, as an ambient sensor or located within the gas flow path).

[0679] Specific examples relating to a pressure sensor, a temperature sensor, a flow sensor, and a humidity sensor are outlined below, with it being understood that in the following examples the first and second sensors may be interchanged.

[0680] In some configurations, the at least one sensor includes a first pressure sensor and the other sensor includes a second pressure sensor. The apparatus 1 may be configured to update a sensor calibration parameter for the first pressure sensor based on an output of the second pressure sensor. The sensor calibration parameter may be based on a comparison of an output of the first pressure sensor and an output of the second pressure sensor.

[0681] The first pressure sensor may be an ambient pressure sensor and the second pressure sensor is a pressure sensor disposed within the flow path of the device.

[0682] In some configurations, the pressure sensors may be sensors 40, 41, 42, 44, 46, and / or 48.

[0683] In some configurations, when the device is calibrating the auxiliary gas inlet sensor 42, the device may prompt the user to ensure that no gas supply is connected to the auxiliary gas inlet and that the ambient pressure is the same as the pressure at the auxiliary gas inlet.

[0684] The apparatus may determine whether gas supply to one or both of the auxiliary gas inlet and / or the alternative gas inlet is detected. The method of detecting the gas supply may be as disclosed in PCT Publication WO 2021 / 048744, the entirety of which is incorporated herein by reference.

[0685] The presence of a gas supply connected to the auxiliary gas inlet may be detected by pulsing the valve (e.g., opening it fully for a short period of time and then closing it) and observing the subsequent variation in gas composition (via an oxygen concentration sensor). During this procedure, the blower may provide flow at a predetermined rate.

[0686] In a non-therapeutic mode, the controller may control the airflow generator so that no gas flow is provided from the airflow generator and the ambient pressure is the same as the pressure of the gas in the flow path (i.e., the gas flow path is at the same pressure as the ambient).

[0687] In some configurations, the first pressure sensor may be co-located with the second pressure sensor (eg, as an ambient sensor or located within the gas flow path).

[0688] In some configurations, during a non-therapeutic mode, the device may control the airflow generator to provide no gas flow (i.e., control the airflow generator to a zero flow rate). For example, if the non-therapeutic mode is a dry mode (where the airflow generator is controlled to provide a predetermined flow rate and / or motor speed), the device may control the airflow generator to a zero flow rate (e.g., by turning off the blower) and update at least one sensor calibration parameter based on a comparison between the output of the first pressure sensor based on the output of the second pressure sensor. The device may update the sensor calibration parameter multiple times during the dry mode.

[0689] A flow rate of 0 can be zero flow rate or so close to zero that the flow rate of the gas is insignificant.

[0690] In some configurations, the pressure sensor may be a differential pressure sensor configured to measure the pressure difference between the ambient environment and the gas flow path, in which case the sensor calibration parameters may be identified based on the output of the pressure sensor when no gas flow is provided (as described above), whereby the ambient pressure is the same as the pressure of the gas in the flow path, and the output of the differential pressure sensor should be zero.

[0691] The tolerance of the pressure sensor may be about + / - 2 cmH2O to about + / - 3 cmH2O, or about + / - 5 cmH2O to about + / - 15 cmH2O, or about + / - 10 cmH2O. The error may be the difference between the output of the first pressure sensor and the second pressure sensor.

[0692] In some configurations, the at least one sensor includes a first temperature sensor and the other sensor includes a second temperature sensor. The apparatus is configured to update a sensor calibration parameter of the first temperature sensor based on an output of the second temperature sensor. The sensor calibration parameter may be based on a comparison of an output of the first temperature sensor and an output of the second temperature sensor.

[0693] The first temperature sensor may be an air temperature sensor (e.g., additional sensor 40) and the second temperature sensor may be a patient-end temperature sensor located at or near a patient-end of a conduit configured to be connected to the device. In some configurations, the first temperature sensor may be a patient-end temperature sensor located at or near a patient-end of a conduit configured to be connected to the device and the second temperature sensor may be an air temperature sensor.

[0694] The first temperature sensor may be co-located with the second temperature sensor (eg, as an ambient sensor or located within the gas flow path).

[0695] The tolerance of the temperature sensors may be about + / - 0° C. to about 3° C., or about 0.5° C. to about 1° C., or about + / - 3° C. The error may be the difference between the output of the first temperature sensor and the second temperature sensor.

[0696] In some configurations, the temperature sensors may be sensors 40, 41, 42, 44, 46, and / or 48.

[0697] In some configurations, the at least one sensor includes a first flow sensor and the other sensor includes a second flow sensor. The apparatus 1 may be configured to update a sensor calibration parameter for the first flow sensor based on an output of the second flow sensor. The sensor calibration parameter may be based on a comparison of an output of the first flow sensor and an output of the second flow sensor.

[0698] The first flow sensor can be a hot wire anemometer (e.g., a heated thermistor) type and the second flow sensor can be an ultrasonic sensor (as described in more detail elsewhere). In some configurations, the first flow sensor can be an ultrasonic sensor and the second flow sensor can be a hot wire anemometer (e.g., a heated thermistor) type sensor.

[0699] The tolerance between the first flow sensor and the second flow sensor may be about + / -0.5 LPM to about + / -5 LPM, or about + / -1 LPM to about + / -4 LPM, or about + / -3 LPM, or about + / -2.5 LPM.

[0700] The error may be the difference between the outputs of the first flow sensor and the second flow sensor.

[0701] In some configurations, the flow sensor may be sensor 44 (eg, thermistor 2206 and ultrasonic transducer 2204).

[0702] In a non-therapeutic mode, the device may be configured to not provide power to the heater of the humidifier and / or the heater wire of the conduit for a predetermined period of time, thereby allowing the air temperature to equalize with the temperature of the gas in the flow path. This may occur toward the end of the non-therapeutic mode (e.g., for a predetermined period of time before the end of the non-therapeutic mode) and / or after other sensor calibration parameters have been determined as described elsewhere.

[0703] The apparatus may include at least one valve, which may be or be part of a valve module, as described in more detail above.

[0704] The at least one valve may be configured to be connected to a source of auxiliary gas, which may be, for example, oxygen.

[0705] At least one valve may control the auxiliary gas flow. In some configurations, the at least one valve may control the auxiliary gas flow to reach an auxiliary gas concentration. For example, the at least one valve may control the auxiliary gas concentration (of the gas flow provided to the user) to reach a therapeutic patient oxygen concentration. In some configurations, the device may further include at least one patient oxygen saturation sensor, and the operation of the at least one valve to control the auxiliary gas concentration to reach a therapeutic patient oxygen saturation may be based on an output of the at least one patient oxygen saturation sensor. As another example, the device may be configured to operate the valve to control the auxiliary gas concentration such that the gas flow can be provided to the user at a therapeutic oxygen concentration.

[0706] The auxiliary gas flow may be configured to be blended with ambient air, and the blended auxiliary gas and ambient air may be provided to an airflow generator.

[0707] In some configurations, the auxiliary gas flow may be configured to be added to the gas flow generated by the airflow generator.

[0708] In some configurations, when the apparatus is updating the parameters, the at least one valve may be operated to block auxiliary gas flow, but the concentration of auxiliary gas in the gas flow may be assumed to be the concentration of auxiliary gas in the ambient air when the at least one valve is so operated. In some configurations, before the apparatus updates the parameters of the apparatus, the apparatus may be configured to prompt the user (optionally via a user interface) to disconnect the auxiliary gas source from the alternative supply inlet.

[0709] The alternative supply inlet may be configured to be connected to a source of auxiliary gas. The auxiliary gas flow from the alternative supply inlet may be configured to be blended with ambient air, and the blended auxiliary gas and ambient air may be provided to the airflow generator. The auxiliary gas flow from the alternative supply inlet may be configured to be added to the gas flow generated by the airflow generator.

[0710] At least one sensor may be an oximetry sensor, which may include, for example, an ultrasonic sensor, which may be an ultrasonic transducer as described in more detail above.

[0711] The apparatus may be configured to determine an output of the oxygen concentration sensor when no auxiliary gas is provided as part of the gas flow and / or when auxiliary gas is provided as part of the gas flow. The output of the oxygen concentration sensor may be indicative of the oxygen concentration of the gas flow.

[0712] The device may be configured to identify oxygen concentration sensor calibration parameters.

[0713] The apparatus may be configured so that auxiliary gas is not provided as part of the gas flow. Configuring the apparatus 1 so that auxiliary gas is not provided as part of the gas flow may be by controlling at least one valve to not provide auxiliary gas and / or by prompting a user to take action to prevent auxiliary gas from being provided (e.g., by turning off the auxiliary gas source).

[0714] In some configurations (e.g., if it is determined that no auxiliary gas is provided as part of the gas flow), oxygen concentration sensor calibration parameters are determined based on the output of the oxygen concentration sensor and / or an estimated ambient oxygen concentration. The estimated ambient oxygen concentration may be, for example, about 19% to about 23%, or about 20.9%, or about 21%, or about 22%.

[0715] For example, as shown in Figure 33, in step 911 the device is operating in a non-therapeutic mode and in step 995 the device 1 determines whether auxiliary gas is being provided as part of the gas flow. If auxiliary gas is being provided, the device continues to operate in the non-therapeutic mode, if auxiliary gas is not being provided the device proceeds to step 993 and determines the output of the oximetry sensor. In step 996 the device 1 determines oximetry sensor calibration parameters based on the output of the oximetry sensor.

[0716] The oxygen concentration sensor parameters may additionally be determined based on an estimated ambient oxygen concentration, which may be measured by other sensors, estimated, or input by a user via a user interface, for example.

[0717] In some configurations (e.g., when an auxiliary gas is provided as part of the gas flow and / or when ambient air is not provided as part of the gas flow), the oxygen concentration sensor calibration parameters may be determined based on the output of the oxygen concentration sensor and / or a predetermined oxygen concentration. The predetermined oxygen concentration may be, for example, 100%. In some configurations, the predetermined oxygen concentration may be input by a user.

[0718] In some configurations, the device may be configured such that ambient air cannot be provided as part of the gas flow. Configuring the device 1 such that ambient air is not provided as part of the gas flow may be by controlling at least one valve to provide only auxiliary gas and / or by prompting a user to take an action to prevent ambient air from being provided.

[0719] In some configurations, the user may be prompted to connect a supplemental source to the device and indicate the oxygen concentration of the supplemental source.

[0720] After determining the oximetry sensor calibration parameters, the device may be configured to operate the airflow generator at a predetermined flow rate and / or at a predetermined motor speed. In some configurations, the device may be configured to operate the airflow generator at a predetermined flow rate and / or at a predetermined motor speed after the device determines the oximetry sensor calibration parameters. This may be useful to flush all oxygen from the system before the system enters a therapy mode.

[0721] The at least one sensor may be a flow sensor. The flow sensor may be configured to measure a flow rate of the gas flow.

[0722] During the non-therapeutic mode, the device may be configured to cause the airflow generator to cease generating gas flow and determine an output of the flow sensor, which may be indicative of the flow rate of the gas.

[0723] 34, the device may be configured to control the airflow generator to a zero flow rate in step 984, and then determine flow sensor calibration parameters in step 986 based on the output of the flow sensor (determined in step 985) and / or the determined zero flow rate. The flow sensor calibration parameters may be applied to the output of the flow sensor. The determined zero flow rate may be, for example, 0 LPM.

[0724] During a non-therapeutic mode, the device may be configured to determine an output of the flow sensor while the airflow generator is generating a gas flow. The output may be indicative of a flow rate of the gas. The device may be configured to determine flow sensor calibration parameters based on the output of the flow sensor and / or a predetermined flow rate. The parameters may be applied to the output of the flow sensor. The predetermined flow rate may be greater than 0 LPM, or about 10 LPM, or about 20 LPM, or about 30 LPM, or about 40 LPM, or about 50 LPM, or about 60 LPM, or about 70 LPM.

[0725] The predetermined flow rate may be based on the motor speed (e.g., from a motor speed sensor as discussed above). The relationship between motor speed and flow rate may be based on a formula and / or a look-up table, where a motor speed corresponds to an associated flow rate.

[0726] The device may be configured to determine flow sensor calibration parameters based on the flow sensor output and / or motor speed. For example, as discussed above, the flow sensor output is expected to be known from the motor speed. For example, it may be known that at a particular motor speed (and optionally without a patient connected), a particular flow should be expected. If the flow sensor measures outside of a predetermined tolerance, the flow sensor calibration parameters may be updated.

[0727] The tolerance of the flow sensor may be from about + / - 0.1 LPM to about + / - 3 LPM, or from about + / - 0.5 LPM to about + / - 1 LPM.

[0728] The tolerance for zero flow may be the difference between zero flow and the output of the flow sensor when no flow is provided.

[0729] The tolerance for a given flow rate may be the difference between the given flow rate and the output of the flow sensor at the given flow rate.

[0730] Identifying flow sensor calibration parameters during non-therapeutic modes can be advantageous because a non-therapeutic flow rate may be provided (e.g., one that is not appropriate or prescribed for the patient, e.g., lower or higher than a typical therapeutic flow rate.

[0731] Furthermore, during non-treatment modes, the patient is not connected, so the characteristics of the system are consistent (e.g., flow conductance between the airflow generator and the end of the conduit or sterilization conduit), and therefore the relationship between flow rate and motor speed and / or between measured flow rate and motor speed may be more reliable.

[0732] Moreover, in certain non-therapeutic modes, such as sterilization modes, where the patient interface is disconnected and a specific tube with known properties (e.g., flow conductance) is connected in a loop to the device inlet / outlet, the comparison becomes even more reliable. Furthermore, differences in interface types may not need to be taken into account.

[0733] The apparatus may be configured to determine an output of the humidity sensor. The output may be indicative of a humidity of the gas flow. In some configurations, the apparatus may be configured to determine an output of the humidity sensor (indicative of a humidity of the gas flow) when an auxiliary gas is provided as the gas flow. In some configurations, the apparatus may be configured to determine an output of the humidity sensor (indicative of a humidity of the gas flow) when there is no ambient air in the gas flow.

[0734] 35, in some configurations, the device is configured to determine humidity sensor calibration parameters based on the output of the humidity sensor and / or a predetermined humidity in step 987. The predetermined humidity may be, for example, 0% relative humidity, or 0 absolute humidity. In some configurations, the controller may be configured to determine humidity sensor calibration parameters based on the output of other humidity sensors.

[0735] The humidity sensor and / or other humidity sensors may include an ambient humidity sensor or a gas flow humidity sensor.

[0736] In some configurations, the at least one sensor may include a first humidity sensor and a second humidity sensor. The apparatus 1 may be configured to update a sensor calibration parameter for the first humidity sensor based on an output of the second humidity sensor. The sensor calibration parameter may be based on a comparison between an output of the first humidity sensor based on an output of the second humidity sensor.

[0737] The first humidity sensor may be an ambient humidity sensor and the second humidity sensor is disposed in the flow path of the device.

[0738] In a non-therapeutic mode, the controller may control the airflow generator so that no gas flow is provided from the airflow generator, thereby causing the ambient humidity to be the same as the pressure of the gas in the flow path (i.e., the gas flow path has the same humidity as the surroundings).

[0739] In some configurations, the first humidity sensor may be co-located with the second humidity sensor (eg, as an ambient sensor or located within the gas flow path).

[0740] The tolerance of the humidity sensor may be about + / - 0% to about + / - 5%, or about + / - 0% to about + / - 2%, or about + / - 2%. The percentage may be the percentage of water vapor in the environment being sampled.

[0741] The tolerance may be the difference between the output of the first humidity sensor and the output of the second humidity sensor.

[0742] The device may be configured such that no therapy is provided to the user during operation in at least one non-therapeutic mode. The at least one non-therapeutic mode may include: a drying mode configured to dry the conduit, and / or Warm-up mode, and / or Standby mode may include at least one of:

[0743] The device may be configured to provide therapy to a user during operation in at least one therapy mode, the at least one therapy mode comprising: Continuous Positive Airway Pressure (CPAP) mode, and / or Bubble Continuous Positive Airway Pressure (BCPAP) mode, and / or Nasal High Flow (NHF) mode, and / or Bi-level (e.g., NIV) mode may include at least one of:

[0744] As shown in FIG. 36, in some configurations, the device is configured to automatically operate 911 in at least one non-therapeutic mode after completion 914 of at least one therapeutic mode.

[0745] The device may be configured to update device parameters upon exiting a non-therapeutic mode and / or upon entering a non-therapeutic mode.

Claims

1. A respiratory assistance device comprising: an airflow generator configured to generate a gas flow; a humidifier gaseously connected to the airflow generator and configured to humidify the gas flow; configured to be connected to a conduit that transports the gas flow; configured to operate in at least one therapeutic mode and at least one non-therapeutic mode, wherein when operating in the at least one therapeutic mode, therapy is provided to a user, and when operating in the at least one non-therapeutic mode, therapy is not provided to the user; configured to collect and store data, the data including therapy data and / or device data collected during operation in the at least one therapy mode; after operating in said at least one non-therapeutic mode for a predetermined period of time; a) transferring said data to a device; or b) receiving a software package from or on a device; or c) receiving a device or treatment parameters from said device; or d) updating the parameters of the respiratory assistance device; or e) Perform any combination of a) to d).

1. A respiratory assistance apparatus configured as follows.

2. The at least one treatment mode includes: a) Continuous Positive Airway Pressure (CPAP) mode; b) Bubble Continuous Positive Airway Pressure (BCPAP) mode; c) Nasal High Flow (NHF) mode; d) Bi-level mode; e) any combination of a) to d) 2. The respiratory assistance apparatus of claim 1, comprising:

3. 2. The respiratory assistance apparatus of claim 1, wherein the respiratory assistance apparatus is configured to automatically operate in the at least one non-therapeutic mode following completion of the at least one therapeutic mode.

4. configured to enter the at least one non-therapeutic mode after receiving an end therapy command; The treatment end command is a) via input from a user interface; b) by detecting that a patient interface has been removed from said user; c) by detecting that the patient interface has been removed from the user for a predetermined period of time; d) Any combination of a) to c) A respiratory assistance device as claimed in claim 1 .

5. When the respiratory assistance apparatus is operating in the at least one non-therapeutic mode, the airflow generator is activated to generate the gas flow, the airflow generator directs the gas flow in a manner that: a sub-therapeutic flow rate of the gas flow provided during a therapeutic mode; and / or Predetermined flow rate 2. A respiratory assistance apparatus as claimed in claim 1,

6. the at least one non-treatment mode includes a drying mode configured to dry the conduit and evaporate condensation remaining within the respiratory assistance apparatus and / or a patient respiratory conduit and / or a patient interface; When the respiratory assistance apparatus is operating in the dry mode: a heater in the conduit is controlled while the flow generator provides gas at a predetermined flow rate; and / or the heater of the humidifier is controlled to a predetermined value (optionally, the predetermined value is a predetermined power, the predetermined power being less than about 5% or less than about 10% of the maximum power provided to a heater plate) or the heater plate is deactivated during the drying mode; and / or 2. A respiratory assistance device as described in claim 1, wherein the heater of the conduit is controlled to a predetermined temperature at the end of the conduit (preferably the predetermined temperature is greater than 45 degrees Celsius) or to a predetermined duty cycle (preferably the predetermined duty cycle is 100%) or to a predetermined voltage or to a predetermined current or to a predetermined power.

7. 7. A respiratory assistance apparatus as claimed in claim 6, wherein the dry mode is configured to operate for between about 20 minutes and about 120 minutes, or for about 90 minutes.

8. the drying mode includes controlling the airflow generator to provide a predetermined airflow generator output, the airflow generator output being a motor speed of about 1000 RPM to about 3000 RPM, or less than about 2000 RPM; and / or 7. A respiratory assistance apparatus as claimed in claim 6, wherein the dry mode further comprises controlling the airflow generator to provide a predetermined flow rate, the predetermined flow rate being between about 5 litres / minute and about 20 litres / minute.

9. 2. The respiratory assistance apparatus of claim 1, wherein the non-therapeutic mode is a warm-up mode, and the respiratory assistance apparatus operates in the warm-up mode when powered on.

10. the warm-up mode includes controlling a heater in the conduit to control a temperature at the end of the conduit to a desired temperature; the desired temperature at the end of the conduit is based on one or more treatment parameters of the respiratory assistance device and / or is a predetermined temperature; The one or more treatment parameters include: a) treatment chamber outlet temperature; b) the treatment dew point temperature (at the chamber outlet or at the end of the conduit); c) treatment humidity (at the chamber outlet or at the end of the conduit); and / or d) the treatment temperature at the end of the conduit; e) any combination of a) to d) 10. The respiratory assistance device of claim 9 .

11. 10. A respiratory assistance device as described in claim 9, wherein the warm-up mode includes deactivating the airflow generator and / or controlling the humidifier heater to a predetermined temperature, or to a predetermined duty cycle, or to a predetermined voltage, or to a predetermined current, or to a predetermined power.

12. the treatment data includes data about the user and / or data about a treatment provided to the user; The treatment data includes: a) the user's oxygen saturation (SpO2); b) the user's breathing rate; c) the humidity (dew point) of the gas provided to said user; d) the flow rate of the gas provided to the user; e) the user's tidal volume; f) the user's minute ventilation; g) usage data of said respiratory assistance device; h) answers to one or more questions provided to the user; i) a treatment report (preferably said treatment report relates to past treatment session reports and / or currently completed treatment sessions); j) As a result of the interview, k) any combination of a) to j) 2. The respiratory assistance apparatus of claim 1, comprising:

13. one or more sensors configured to determine the treatment data; when the respiratory assistance device is operating in the at least one non-therapeutic mode, the user is asked one or more questions and provides answers to these questions via at least one user interface, the questions and / or the answers to the questions forming part of the therapeutic data; 2. The respiratory assistance apparatus of claim 1, wherein the respiratory assistance apparatus is configured to receive sensor output from the one or more sensors, and the therapy data is based on the sensor output from the one or more sensors.

14. 2. A respiratory assistance device as claimed in claim 1, wherein the therapy data includes data from at least one previous therapy mode and / or from at least one therapy mode not previously transferred to the device.

15. 2. The respiratory assistance apparatus of claim 1, wherein the data is transferred to the device even when the respiratory assistance apparatus is not operating in at least one therapy mode.

16. The data is transferred to the device after a predetermined time has elapsed since the last data transfer to the device (preferably, the predetermined time is 24 hours or about 5 minutes to about 25 minutes); The device comprises: a) a server; b) a local device; c) a remote device; d) any combination of a) to c) 2. The respiratory assistance device of claim 1 .

17. providing a visual and / or audio indicator to the user if the user attempts to power off the respiratory assistance apparatus while the data is being transferred to the device; 10. A respiratory assistance apparatus as claimed in claim 1, wherein the user is presented with a visual and / or audio indicator whilst the data is being uploaded to the device.

18. The respiratory assistance device of claim 1 , further comprising: applying the software package to the respiratory assistance device after receiving the software package; and applying updates to the therapeutic parameters of the respiratory assistance device after receiving the therapeutic parameters from a device or devices.

19. 2. A respiratory assistance device as claimed in claim 1, wherein the software package and / or the therapy parameters are received only if they are updates to a current software package and / or current therapy parameters.

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