CN117597168A - Respiratory assistance equipment and/or its components and/or its use - Google Patents

Abstract

A device is disclosed that is configured to operate in at least one treatment mode and at least one non-treatment mode. After operating in the at least one non-therapy mode for a predetermined time, the device is configured to: transmit data to a device, and/or receive a software package from a device or the device, and/or receive a software package from a device or the device Receive treatment parameters, and/or update parameters of the device.

Description

Respiratory assistance equipment and/or its components and/or its use

Technical field

The present disclosure relates to various respiratory assistance devices and/or components thereof and/or uses thereof.

Background technique

Respiratory assist devices are used to deliver a flow of gas to patients in a variety of settings, such as hospitals, medical facilities, residential care, or home settings. Respiratory assistance devices (eg, flow therapy devices and/or pressure therapy devices) may include an oxygen inlet that enables the respiratory device to deliver supplemental oxygen along with the gas flow. The breathing assistance device may also (or alternatively) include an ambient air inlet and a flow generator (eg including a blower) for providing gas to the patient. The respiratory assistance device may also (or alternatively) include a humidification device that enables the respiratory device to deliver heated and humidified gas. Breathing assist devices may allow the characteristics of the gas flow to be regulated and controlled. These characteristics may include, for example, flow rate, temperature, gas concentration (such as supplemental oxygen concentration), humidity, and pressure.

Patients with a variety of health conditions and diseases can benefit from breathing assistance, such as respiratory therapy. In at least one form, the respiratory treatment may be oxygen therapy. For example, have chronic obstructive pulmonary disease (COPD), pneumonia, asthma, bronchopulmonary dysplasia, heart failure, cystic fibrosis, sleep apnea, lung disease, respiratory trauma, acute respiratory distress and/or other conditions or People with the disease can benefit from respiratory treatments. Similarly, patients who receive pre- and post-operative oxygen may benefit from respiratory therapy. As a further example, patients with obstructive sleep apnea (OSA) may also benefit from respiratory treatments such as CPAP and/or bi-level therapy.

Contents of the invention

In a first aspect of the present disclosure, a respiratory assistance device is provided, the respiratory assistance device comprising:

a flow generator configured to generate a flow of gas;

a humidifier configured to be pneumatically connected to the flow generator and to humidify the gas flow,

wherein the device is configured to be connected to a conduit conveying the flow of gas,

wherein the device is configured to operate in at least one treatment mode and at least one non-therapeutic mode, wherein when operating in the at least one treatment mode, the device is configured to provide treatment to the user,

wherein the device is configured to collect and store data including treatment data and/or device data collected during operation in the at least one treatment mode,

Wherein, after operating in the at least one non-therapy mode for a predetermined time, the device is configured to:

a) transmit that data to the device, or

b) receive a software package from a device or the device, or

c) receive treatment parameters from a device or the device, or

d) Update the parameters of the device, or

e) Any combination of a) to e).

Treatment can be provided to the user when the device is operating in at least one treatment mode.

The at least one treatment mode may include:

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).

The device may include a controller configured to operate the device according to any of the treatment modes a) to d) listed above.

The device (and optionally the device's controller) may be configured to control the flow generator and/or humidifier according to at least one treatment mode.

Each treatment mode may have one or more associated treatment parameters.

Wherein, the associated treatment parameters include one or more of the following: treatment flow rate of gas, treatment pressure support level, treatment temperature of gas, treatment humidity of gas, treatment temperature at the end of the breathing tube.

Each treatment mode may have associated software configured to be executed by the device to control the device to provide a specific treatment.

No therapy is provided to the user when the device is operating in at least one non-therapeutic mode.

The device may be configured to automatically operate in at least one non-therapy mode upon completion of at least one therapy mode.

The device may be configured to enter at least one non-therapy mode upon receipt of an end-of-therapy command (optionally generated via input from the user interface and/or by detecting that the patient interface has been removed from the user).

The end of treatment command can be generated as follows:

a) via input from the 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 amount of time,

d) Any combination of a) to c).

The flow generator can be activated and generate a flow of gas when the device is operating in the at least one non-therapy mode.

The user may also select a treatment mode via the user interface. The controller may receive user input, ie, user selection of a treatment mode, via the user interface and operate the device accordingly to provide treatment in accordance with the selected treatment mode.

When the device is operating in the at least one non-therapy mode, the flow generator can provide the gas flow in the following manner:

A flow rate that is less than the treatment flow rate of the gas flow provided during the treatment mode, and/or,

scheduled traffic, and/or,

Predetermined motor speed.

In some configurations, it is assumed that a predetermined flow rate can be provided by controlling a predetermined motor speed. This can be achieved, for example, by a lookup table or formula that defines the relationship between flow rate and motor speed. In non-therapeutic mode, this approach may allow easier control of the flow generator since no patient is connected and the flow resistance may be known (i.e., in sterile mode), or assumed to be constant (i.e. , in drying mode and/or disinfecting mode).

When the device is operating in at least one non-therapeutic mode, the humidifier (optionally the humidifier's heated plate) may be activated, and optionally the humidifier may be configured to humidify the gas flow.

When the device is operating in at least one non-therapy mode, the heater of the catheter may be activated and may be configured to heat the flow of gas in the catheter.

The at least one non-treatment mode may include a drying mode configured to dry the catheter.

When the device is operated in dry mode, the heater of the conduit can be controlled while the flow generator provides gas at a predetermined flow rate.

When the device is operated in the drying mode, the heater of the humidifier can be controlled to a predetermined value (optionally, the predetermined value is a predetermined power, and the predetermined power can be less than about 5% of the maximum power provided to the heating plate or less than approximately 10%), or the heating plate can be deactivated during drying mode.

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

The predetermined duty cycle may be 100%.

The predetermined temperature may be higher than 45 degrees Celsius.

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

The drying mode may include controlling the flow generator to provide a predetermined flow generator output, wherein the flow generator output may be a motor speed of about 1000 RPM to about 3000 RPM or less than about 2000 RPM.

The drying mode may include controlling the flow generator to provide a predetermined flow rate, where the predetermined flow rate may be from about 5 liters/minute to about 20 liters/minute.

Drying mode may be configured to evaporate remaining condensate in the device and/or patient breathing tube and/or patient interface.

The non-treatment mode may be a warming mode.

When the device is turned on, the device can operate in warming mode.

The warming mode may include controlling the heater of the conduit to control the temperature at the end of the conduit to a desired temperature.

The desired temperature at the tip of the catheter may be based on one or more treatment parameters of the device.

The one or more treatment parameters may be:

a) Treatment chamber outlet temperature,

b) the therapeutic dew point temperature (at the chamber outlet or the end of the conduit),

c) treatment humidity (at the chamber outlet or end of the conduit), and/or

d) the therapeutic temperature at the end of the catheter,

e) Any combination of a) to e).

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

The catheter tip temperature may be within about 2 degrees Celsius to about 5 degrees Celsius or about 2.5 degrees Celsius of the desired patient end temperature, and optionally about 2 degrees Celsius to about 5 degrees Celsius or about 2.5 degrees Celsius below the predetermined temperature or treatment parameters.

The warming mode may include controlling the heater of the humidifier to a predetermined temperature, a predetermined duty cycle, a predetermined voltage, a predetermined current, or a predetermined power.

Warming mode may include deactivating the flow generator.

The catheter may be configured to deliver these gases to the patient via the patient interface.

The non-treatment mode may be a disinfection mode.

In disinfection mode, the device can be configured to connect to a disinfection conduit.

In the sterilization mode, the heater of the sterilization conduit may be controlled such that the gas flow in the sterilization conduit reaches a predetermined temperature.

The predetermined temperature may be about 50 degrees Celsius to about 100 degrees Celsius or about 60 degrees Celsius to about 90 degrees Celsius.

The sterile catheter may include a temperature sensor.

The disinfection mode may include controlling the flow generator to provide a predetermined flow rate, wherein the predetermined flow rate is about 10 liters/minute to about 20 liters/minute.

The non-therapy mode may be a standby mode.

Standby mode may include operating the flow generator at a predetermined flow rate or predetermined motor speed.

The predetermined flow rate may be lower than the treatment flow rate provided to the patient.

The predetermined motor speed may be from about 1000 RPM to about 3000 RPM or less than about 2000 RPM.

Treatment data may include data related to the user and/or treatment provided to the user.

This treatment data can include:

a) The user’s oxygen saturation (SpO2),

b) the user’s breathing rate,

c) the humidity (dew point) of the gas supplied to that user,

d) the flow rate of gas supplied to the user,

e) The user’s tidal volume,

f) Minute ventilation of the user,

g) Any combination of a) to f).

This treatment data can include:

a) Usage data of the device,

b) Answers to one or more questions provided to the user,

c) Treatment report (optionally, the treatment report relates to previous treatment session reports and/or the currently completed treatment session),

d) Results of health inquiries,

e) Any combination of a) to d).

The device may include one or more sensors configured to determine the treatment data.

One or more questions are presented to the user while the device is operating in the at least one non-therapy mode, and the user provides answers to the questions via at least one user interface, and wherein the questions and/or responses to the questions Answers to the questions form part of the treatment data.

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

The one or more sensors may be located within the housing of the device.

The one or more sensors may be located remotely from the device.

The treatment data can be from the at least one treatment mode.

The treatment data may include at least data from historical treatment patterns.

The treatment data may include data from at least one treatment mode that has not been previously transmitted to the device.

The device data may relate to one or more properties of the device and/or the device's surroundings.

This data may be transmitted to the device even if the device is not operating in at least one treatment mode.

The data may be transmitted to the device after a predetermined period of time has elapsed since the last transmission of data to the device (optionally, the predetermined period of time is 24 hours).

The device can be:

a) Server

b)Local device

c)Remote device

d) Any combination of a) to c).

The predetermined time may be from about 5 minutes to about 25 minutes.

The predetermined time can be greater than 5 minutes.

The predetermined time may be less than the total length of time the device is configured to operate in the non-therapy mode.

The predetermined time may be a proportion of the total length of time the device is configured to operate in the non-therapy mode.

The device may include a controller configured to control operation of the device.

If the user attempts to turn off the device while the data is being transferred to the device, the user may be presented with a visual indication and/or an audible indication.

When the data is uploaded to the device, visual and/or auditory instructions may be presented to the user.

To ensure that the device does not shut down immediately after exiting this therapy mode, the device can be configured to:

a) transmit that data to the device, or

b) receive a software package from a device or the device, or

c) receive treatment parameters from a device or the device, or

d) Update the parameters of the device, or

e) Any combination of a) to e).

These operations are performed after operating in the at least one non-therapy mode for the predetermined time.

After operating in the at least one non-therapy mode for a predetermined time, the device may be configured to activate a network interface and establish a connection with the device to transmit data to the device, and/or receive software from a device or the device package and/or treatment parameters.

The package can include one or more of the following:

a) Firmware update,

b)Software updates.

After receiving the software package, the device can apply the software package to the device.

Updating the device's parameters may include sensor recalibration.

After receiving these treatment parameters from a device or the device, the device may apply treatment parameters that update the device.

The device may receive the software package and/or the treatment parameters only if the software package and/or the treatment parameters are updates to the current software package and/or the current treatment parameters.

The device may have a gas inlet and a gas outlet, and the conduit may be configured to connect to the gas outlet.

The device may include one or more sensors (optionally temperature sensors) located in the gas flow.

The device may include one or more sensors (optionally temperature sensors) located in the gas outlet.

The device may include a housing and the flow generator and/or humidifier are located in the housing.

After operating in the non-therapy mode for a predetermined time, the device is configured to update parameters of the device and then transmit the data to the device.

After operating in the non-therapy mode for a predetermined time, the device is configured to: transmit data to the device, then receive a software package from the device or devices, and then update parameters of the device.

After operating in the non-therapy mode for a predetermined time, the device is configured to: update parameters of the device, then transmit data to the device, then receive a software package from a device or the device, and then based on the data received from a device or the device. The device receives software packages that update the device's parameters.

The device may be configured to receive treatment parameters from a device or devices after transmitting data to the device.

The device may be configured to receive treatment parameters from the device or devices upon receipt of the software package from the device or devices.

The device may be configured to receive treatment parameters from a device or devices before updating parameters of the device.

The device may include at least one display (optionally as part of a display module).

When operating in a non-therapy mode, the device may display non-therapy related information on the display.

This information can be one or more of the following: type of non-therapeutic mode, indication that the non-therapeutic mode is active, time remaining in the non-therapeutic mode, warning not to use the device.

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

The sensor calibration parameters may relate to the relationship between the output of the one or more sensors and the characteristics that the sensor is configured to measure.

The one or more sensors may include:

a flow sensor configured to measure the flow rate of the gas flow, optionally the flow sensor includes an ultrasonic sensor, and/or

An oxygen concentration sensor configured to measure the oxygen concentration of these gases, optionally, the oxygen concentration sensor includes an ultrasonic sensor.

When no supplemental gas is provided as part of the gas flow, the apparatus may be configured to determine an output of the oxygen concentration sensor indicative of an oxygen concentration of the gas flow, wherein based on the output of the oxygen concentration sensor and the estimated ambient concentration of oxygen , the device is configured to determine oxygen concentration sensor calibration parameters.

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

When supplemental gas is provided as the gas flow, the device may be configured to determine an output of the oxygen concentration sensor indicative of an oxygen concentration of the gas flow, wherein based on the output of the oxygen concentration sensor and the predetermined oxygen concentration, the device is Configured to determine oxygen concentration sensor calibration parameters.

In another aspect of the present disclosure, a respiratory assistance device is provided, the respiratory assistance device comprising:

gas inlet and gas outlet,

case,

a flow generator located within the housing, the flow generator configured to generate a flow of gas,

A humidifier located within the housing, the humidifier in fluid communication with the flow generator and configured to humidify the gas flow from the flow generator, the humidifier including a humidification chamber configured to humidify the humidifier A heater that heats the fluid in the

a conduit configured to be connected to the gas outlet and deliver the gas flow, the conduit including a heater configured to heat the gas flow in the conduit,

one or more sensors located within the housing,

a controller, the controller including at least a processor and a memory, the controller being configured to control at least the flow generator, the humidifier, and the heater of the conduit, wherein the controller is configured to receive input from the one or more sensor outputs of the sensors and storing data based on the sensor outputs from the one or more sensors,

wherein the controller is configured to operate the device in at least a treatment mode and a non-treatment mode, wherein in the treatment mode the device is configured to provide treatment to the user according to one or more treatment parameters, and in the non-treatment mode in therapy mode, at least one of the flow generator, the humidifier heater, and/or the catheter heater is activated and no gas flow is provided to the user,

Wherein, after operating in the non-therapy mode for a predetermined time, the controller is configured to:

a) transmit that data to the device, or

b) receive a software package from a device or the device, or

c) receive treatment parameters from a device or the device, or

d) Update the parameters of the device, or

e) Any combination of a) to d).

In another aspect of the present disclosure, a respiratory assistance device is provided, the respiratory assistance device comprising:

gas inlet and gas outlet,

case,

a flow generator located within the housing, the flow generator configured to generate a flow of gas,

A humidifier located within the housing, the humidifier in fluid communication with the flow generator and configured to humidify the gas flow from the flow generator, the humidifier including a humidification chamber configured to humidify the humidifier A heater that heats the fluid in the

a conduit configured to be connected to the gas outlet and deliver the gas flow, the conduit including a heater configured to heat the gas flow in the conduit,

one or more sensors located within the housing,

a controller, the controller including at least a processor and a memory, the controller being configured to control at least the flow generator, the humidifier, and the heater of the conduit, wherein the controller is configured to receive input from the one or more sensor outputs of the sensors and storing data based on the sensor outputs from the one or more sensors,

wherein the controller is configured to operate the device in at least a treatment mode and a drying mode, wherein in the treatment mode the device is configured to provide treatment to the user according to one or more treatment parameters, and in the drying mode , the heater of the humidifier is deactivated and the heater of the conduit is activated while the flow generator provides gas at a predetermined flow rate and/or a predetermined motor speed of the motor of the flow generator,

Wherein, after operating in this drying mode for at least 10 minutes, the controller is configured to:

a) transmit that data to the device, or

b) receive a software package from a device or the device, or

c) receive treatment parameters from a device or the device, or

d) Update the parameters of the device, or

e) Any combination of a) to d).

After operating in the at least one non-therapy mode for a predetermined time, the device may be configured to activate the network interface and establish a connection with the device.

The device may further include one or more remote sensors positioned remotely from the device.

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

After receiving the software package from a device or the device, the device may be configured to apply the software package.

The device can check the package version and update the package on the device if the package is an older version.

Once the software package is successfully installed, the device may transmit a confirmation message to the device and/or an error report if the software package is not successfully installed.

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

Receiving software packages and receiving treatment parameters can be initiated through the Get operation of the device.

The device may be configured to query the device if any updated software package and/or updated treatment parameters are available, and if an updated software package and/or updated treatment parameters are available, the device is configured to receive the software package and/or treatment parameters.

A breathing assistance device consisting of:

gas inlet and gas outlet,

case,

a flow generator located within the housing, the flow generator configured to generate a flow of gas,

A humidifier located within the housing, the humidifier in fluid communication with the flow generator and configured to humidify the gas flow from the flow generator, the humidifier including a humidification chamber configured to humidify the humidifier A heater that heats the fluid in the

a conduit configured to be connected to the gas outlet and deliver the gas flow, the conduit including a heater configured to heat the gas flow in the conduit,

one or more sensors located within the housing,

a controller, the controller including at least a processor and a memory, the controller being configured to control at least the flow generator, the humidifier, and the heater of the conduit, wherein the controller is configured to receive input from the one or more sensor outputs of the sensors and storing data based on the sensor outputs from the one or more sensors,

wherein the controller is configured to operate the device in at least a treatment mode and a warming mode, wherein in the treatment mode the device is configured to provide treatment to the user according to one or more treatment parameters, and in the warming mode , the humidifier heater and the breathing tube heater are activated, and the flow generator is deactivated,

Among them, after operating in this heating mode for 10 minutes, the controller is configured as:

a) transmit that data to the device, or

b) receive a software package from a device or the device, or

c) receive treatment parameters from a device or the device, or

d) Update the parameters of the device, or

e) Any combination of a) to d).

A breathing assistance device consisting of:

a flow generator configured to generate a flow of gas;

a humidifier configured to be pneumatically connected to the flow generator and to humidify the gas flow,

wherein the device is configured to be connected to a conduit conveying the flow of gas,

wherein the device is configured to operate in at least one treatment mode and at least one non-therapeutic mode, wherein when operating in the at least one treatment mode, the device is configured to provide treatment to the user,

wherein the device is configured to collect and store data including treatment data and/or device data collected during operation in the at least one treatment mode,

wherein the device is configured to send notifications to the device of updates to treatment parameters or that a software package is available,

wherein the device is configured to download updated treatment parameters and/or updated software packages from the device,

Wherein, after operating in the at least one non-treatment mode for a predetermined time, the device is configured to apply updated treatment parameters and/or updated software packages.

When the device is operated via a battery as a power source, the device may take no action after a predetermined time in the non-therapy mode, or may prompt the user to confirm the action before taking the action.

When the device is operated via a battery as a power source, the user may be able to manually prompt the device (optionally after a predetermined time in non-therapy mode) to take action.

When the device is reconnected to external power, the device can prompt the user (optionally after a predetermined time in non-therapy mode) to perform an action.

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

The predetermined time may be the predetermined time described above with respect to operating in the non-therapy mode, or greater than about 2 minutes or greater than about 5 minutes.

In some embodiments, the charging state may be entered when the device is not turned on.

When the maintenance task is completed (eg, general maintenance of the equipment, or replacement of equipment parts), the equipment can be configured to perform actions immediately or perform actions at a predetermined time after the maintenance task is completed.

In some embodiments, after the repair task is completed, the device may prompt the user (in this case the service technician) to take action (as described above).

In the case where an action is performed after a maintenance task, the action can serve as a connectivity test to ensure that the communication module is operational.

When the device enters travel mode (such as air travel or travel away from the user's normal location), after a predetermined time in non-therapy mode, the device may take no action or may prompt the user to confirm an action before taking it.

The device can prompt the user to perform actions when the device exits travel status.

Users may be able to manually prompt the device to take action while the device is in travel mode.

In the travel state, the device may deactivate the communication module (or part of the communication module).

In travel mode, the device can also be operated by battery.

In another aspect of the present disclosure, a respiratory assistance device is provided, the respiratory assistance device comprising:

a flow generator configured to generate a flow of gas;

a humidifier configured to be pneumatically connected to the flow generator and to humidify the gas flow,

wherein the device is configured to operate in at least one treatment mode and at least one non-therapeutic mode, wherein when operating in the at least one treatment mode, the device is configured to provide treatment to the user,

Wherein, the device is configured to update at least one parameter of the device when the device is operating in the at least one non-therapy mode.

The device may be configured to update parameters of the device after the device has been operated in at least one non-therapy mode for a predetermined time.

The device may be configured to update the parameters of the device after the non-therapy mode has been completed.

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

The device may be configured to update sensor calibration parameters of the at least one sensor at least once, and optionally multiple times.

The device may be configured to update a sensor calibration parameter of the at least one sensor and update the sensor calibration parameter of the at least one sensor again after a predetermined time.

Sensor calibration parameters may relate to a relationship between an output of the at least one sensor and a characteristic that the sensor is configured to measure.

Sensor calibration parameters can be stored in the device's memory.

The device may use the sensor calibration parameters to determine characteristics that the sensor is configured to measure based on the output of the at least one sensor.

Sensor calibration parameters can be used by the device in therapy mode.

Sensor calibration parameters can include one or more of the following:

Calibration coefficient,

calibration curve,

The internal parameters of the sensor.

The device can be configured to update the control scheme based on sensor calibration parameters.

The device may be configured to update sensor calibration parameters based on outputs of the at least one sensor and additional sensors.

The at least one sensor and the additional sensor may be configured to measure the same characteristic.

The at least one sensor may comprise a first pressure sensor and the additional sensor comprises a second pressure sensor, and the apparatus is configured to update a sensor calibration parameter of the first pressure sensor based on the output of the second pressure sensor.

The first pressure sensor may be an ambient pressure sensor and the second pressure sensor is a pressure sensor located in the flow path of the device.

In non-therapy mode, the flow generator may not provide gas flow such that the ambient pressure is the same as the gas pressure in the flow path.

At least one sensor may include a first temperature sensor and the additional sensor may include a second temperature sensor, and wherein the device is configured to update a sensor calibration parameter of the first temperature sensor based on an output of the second temperature sensor.

The first temperature sensor may be an ambient temperature sensor and the second temperature sensor is a patient-end temperature sensor located adjacent the patient end of the catheter configured to be connected to the device.

The first temperature sensor may be located at the same location as the second temperature sensor.

In the non-therapeutic mode, the device is configured to provide no power to the humidifier's heater and/or the conduit's heater for a predetermined period of time such that the ambient temperature is the same as the temperature of the gas in the flow path.

The at least one sensor is located in one or more of the following:

sensor module (optionally, the sensor module is located between the flow generator and the humidifier),

traffic generator,

The location upstream of the flow generator,

location downstream of the flow generator,

humidifier,

The location upstream of the humidifier,

The location downstream of the humidifier,

A conduit configured to connect to the gas outlet of the humidifier and deliver a flow of gas to a user (optionally at the user end of the conduit proximate the patient interface)

patient interface,

environmental sensors,

Measuring chamber (optionally as part of the sensor module),

humidification chamber entrance,

Humidification chamber outlet.

The apparatus may include at least one valve configured to be connected to a source of supplemental gas, the valve being configured to control the flow of the supplemental gas.

The supplementary gas can be oxygen.

The make-up gas flow may be configured to be combined with ambient air, and the combined make-up gas and ambient air are provided to the flow generator.

The supplemental gas flow may be configured to be added to the gas flow produced by the flow generator.

The device may be configured to operate the valve to control the supplemental gas concentration of the gas flow provided to the user to be at a therapeutic oxygen concentration.

The device may include at least one patient oxygen saturation sensor, and wherein the device is configured to operate the valve to control a supplemental gas concentration of the gas flow provided to the user based on an output of the at least one patient oxygen saturation sensor to achieve Treat the patient's oxygen saturation.

The device may be configured to operate the valve to prevent the flow of makeup gas while the device is updating parameters of the device.

When the device is configured to operate the valve to block the flow of makeup gas, it may be assumed that the concentration of makeup gas in the gas flow is the concentration of makeup gas in the ambient air.

The device may include an alternative supply inlet configured to be connected to a source of supplemental gas.

The make-up gas flow from the alternative supply inlet may be configured to be combined with ambient air, and the combined make-up gas and ambient air are provided to the flow generator.

A supplemental gas flow from an alternative supply inlet may be configured to be added to the gas flow produced by the flow generator.

The device may be configured (optionally via a user interface) to prompt the user (optionally via a user interface) to disconnect the source of supplemental gas from the alternative supply inlet before the device updates the device's parameters.

The at least one sensor may be an oxygen concentration sensor, optionally including an ultrasonic sensor.

When no supplemental gas is provided as part of the gas flow, the apparatus may be configured to determine an output of the oxygen concentration sensor indicative of an oxygen concentration of the gas flow, wherein based on the output of the oxygen concentration sensor and the estimated ambient concentration of oxygen , the device is configured to determine oxygen concentration sensor calibration parameters.

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

When supplemental gas is provided as the gas flow, the device may be configured to determine an output of the oxygen concentration sensor indicative of an oxygen concentration of the gas flow, wherein based on the output of the oxygen concentration sensor and the predetermined oxygen concentration, the device is Configured to determine oxygen concentration sensor calibration parameters.

The predetermined oxygen concentration may be 100%.

Ambient air cannot be provided as part of the gas flow.

The predetermined oxygen concentration can be entered by the user.

The user can be prompted to connect a supplemental source to the device and indicate the oxygen concentration of the supplemental source.

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

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

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

During the non-therapy mode, the device may be configured to cause the flow generator to cease generating gas flow and determine an output of the flow sensor indicative of gas flow, wherein based on the output of the flow sensor and the predetermined no flow, the device is configured to Determine flow sensor calibration parameters.

The scheduled no traffic can be 0LPM.

During the non-therapy mode, the device may be configured to determine an output of the flow sensor indicative of the gas flow while the flow generator is producing the gas flow, wherein based on the output of the flow sensor and the predetermined flow rate, the device is configured to determine whether Flow sensor calibration parameters applied to the output of the flow sensor.

The predetermined flow rate may be above 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.

When supplemental gas is provided as the gas stream, the device may be configured to determine an output of a humidity sensor indicative of a humidity of the gas stream, wherein based on the output of the humidity sensor and the predetermined humidity, the device is configured to determine a humidity sensor calibration parameter.

The predetermined humidity may be 0% relative humidity, or no absolute humidity.

The controller may be configured to determine the humidity sensor calibration parameters based on the output of another humidity sensor.

The humidity sensor and/or another humidity sensor may include:

ambient humidity sensor

Gas flow humidity sensor.

The at least one non-treatment mode may include a drying mode configured to dry the catheter.

When the device is operated in dry mode, the heater of the conduit can be controlled while the flow generator provides gas at a predetermined flow rate.

When the device is operating in the drying mode, the heater of the humidifier can be controlled to a predetermined value (optionally, the predetermined value is a predetermined power, and the predetermined power is less than about 5% of the maximum power provided to the heating plate or less than about 10%), or the heating plate is deactivated during this drying mode.

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

The predetermined duty cycle may be 100%.

The predetermined temperature may be higher than 45 degrees Celsius.

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

The dry mode may include controlling the flow generator to provide a predetermined flow generator output, wherein the flow generator output is a motor speed of about 1000 RPM to about 3000 RPM or less than about 2000 RPM.

The drying mode may include controlling the flow generator to provide a predetermined flow rate, wherein the predetermined flow rate is about 5 liters/minute to about 20 liters/minute.

Drying mode may be configured to evaporate remaining condensate in the device and/or patient breathing tube and/or patient interface.

The non-treatment mode may be a warming mode.

The non-therapy mode may be a standby mode.

Treatment can be provided to the user when the device is operating in at least one treatment mode.

The at least one treatment mode may include:

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).

No therapy is provided to the user when the device is operating in at least one non-therapeutic mode.

The device may be configured to automatically operate in at least one non-therapy mode upon completion of at least one therapy mode.

The device can be configured to update the device's parameters under one or more of the following conditions:

end of non-therapeutic mode,

Beginning of non-therapeutic mode.

The device may include a controller, wherein the controller is configured to control the flow generator and/or humidifier in at least one therapy mode and at least one non-therapy mode, wherein when operating in the at least one therapy mode , the device is configured to provide treatment to the user.

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

After the device has updated the device's parameters, the device may be configured to transmit the data to the device.

The data may include updated parameters of the device.

The device may include at least one display (optionally as part of a display module).

The display can show information related to the sensor calibration process.

Reports can be generated based on information related to the sensor calibration process.

The information may include one or more of the following: sensor errors and whether the sensor is within or outside tolerance, success or failure of calibration, and/or solutions to sensor failures.

In another aspect of the present disclosure, a flow generator configured to generate a flow of gas is provided.

a humidifier configured to be pneumatically connected to the flow generator and to humidify the gas flow,

wherein the device is configured to be connected to a conduit conveying the flow of gas,

wherein the device is configured to operate in at least a treatment mode and a drying mode, wherein in the treatment mode the device is configured to provide treatment to the user according to one or more treatment parameters, and in the drying mode the the humidifier heater is deactivated and the conduit heater is activated while the flow generator provides gas at a predetermined flow rate and/or a predetermined motor speed,

Wherein, when operating in at least dry mode (and optionally after a predetermined time), the device is configured to:

transfer data to the device, and then,

At least one sensor calibration parameter of at least one sensor (and optionally at least two sensors) of the device is updated.

It should be understood that any of the above statements may be combined with any one or more other statements.

Reference to a numerical range disclosed herein (e.g., 1 to 10) is intended to also include reference to all rational numbers within this range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10), as well as any rational number range within this range (e.g., 2 to 8, 1.5 to 5.5, and 3.1 to 4.7), and therefore, the entirety of all ranges expressly disclosed herein is hereby expressly disclosed subrange. These are merely examples of what is specifically intended to be disclosed, and all possible combinations of numerical values between the lowest and highest values enumerated should be considered to be expressly stated in a similar manner in this application.

It is to be understood that alternative embodiments or configurations may include any and all combinations of two or more of the parts, elements or features shown, described or referred to in this specification.

Some embodiments of the present disclosure may also be construed broadly to include the parts, elements, and features that are individually or collectively referred to or specified in the specification of this application, and any two or more of said parts, elements, or features. or all combined or included therein, and, where reference is made herein to a specific integer having equivalents known in the art to which this disclosure relates, such known equivalents are deemed to be incorporated herein as well as if individually set forth. Out the same.

The term "comprising" used in this specification means 'including'. When interpreting each statement in this specification containing the term 'comprising', there may also be features other than the feature or features that follow the term. Related terms such as 'comprise' and 'comprises' will be interpreted in the same way.

The term request when used in the context of a controller may refer to a signal sent by the controller to a component instructing the component to perform one or more actions.

As used herein, the term '(pluralities)' following a noun refers to the plural and/or singular form of that noun.

As used herein, the term "and/or" means "and" or "or" or both where the context permits.

This disclosure discloses the foregoing and also contemplates a variety of structures, examples of which are given below.

It should be understood that when a list is presented, this disclosure includes any combination of the items in the list.

Description of drawings

Specific embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description herein, with reference to the following drawings, in which:

Figure 1 shows a breathing assistance device in diagrammatic form.

Figure 2 shows a sensing circuit board that can be used in respiratory assistance equipment.

Figure 3 is a first bottom perspective view of the main housing of the respiratory assistance device showing recesses inside the housing for the motor and/or sensor module sub-assembly.

3A is a second bottom perspective view of the main housing of the respiratory assistance device showing recesses for the motor and/or sensor module subassembly.

Figure 4 is a perspective view of the breathing assistance device.

Figure 5 is a perspective view of the motor and/or sensor subassembly, the underside of the main housing, and the retaining elbow of the respiratory assistance device.

Figure 6 is an exploded perspective view of components of the motor and/or sensor subassembly, schematically showing gas flow paths through the subassembly by arrows.

Figure 7 is an underside view of the cover and sensing PCB of the motor and/or sensor subassembly showing the location of the sensors.

Figure 8 is a schematic gas flow path diagram of a filter module and a valve module, with solid arrows indicating flow.

Figure 8A is a schematic diagram of a system including a device and a breathing tube.

Figures 9-18 illustrate a user interface presenting health queries on a respiratory assistance device.

Figures 19A-20B illustrate flowcharts of operation of the device in treatment mode and non-treatment mode.

Figure 21 is a perspective view of a respiratory assistance device with a sterile catheter.

Figure 22 shows a data layout including treatment data and device data.

Figure 23 shows a flowchart of actions taken by the device.

Figure 24 is a flow diagram illustrating a system for providing respiratory assistance or providing respiratory therapy to a patient.

Figure 25 shows a flow chart for operation of the device in NHF mode and drying mode.

Figure 25A shows a flow chart for operation of the device in non-treatment mode and drying mode.

Figure 26 shows a flow chart for operation of the device in NHF mode and warming mode.

Figure 27 shows a flow diagram for operating the device in non-therapy mode and updating device parameters.

Figure 28 illustrates a flow diagram for operating the device in a non-therapy mode and updating sensor calibration parameters of the device.

Figures 29 to 31 show a flow chart for a device to update device parameters.

Figure 32 shows a flowchart of an example of determining sensor calibration parameters.

Figure 33 shows a flowchart of an example of determining oxygen concentration sensor calibration parameters.

Figure 34 shows a flowchart of an example of determining flow sensor calibration parameters.

Figure 35 shows a flowchart of an example of determining humidity sensor calibration parameters.

Figure 36 shows a flowchart of an example of the device moving to a non-therapy mode after completion of the therapy mode.

Detailed ways

Breathing assistance device 10 provides therapy to the user based on one or more therapy modes. For example, treatment modes are associated with specific types of treatment (NHF, CPAP, NIV, etc.). A treatment mode also includes one or more treatment parameters specific to the device for the type of treatment being provided. For example, in a treatment mode that provides nasal high flow therapy, treatment parameters may include a desired flow rate and a desired dew point. Other types of high-flow therapy are also considered, such as tracheal high-flow via an unsealed tracheal interface.

Breathing assistance devices can provide a variety of different treatments based on associated treatment modes. For example, respiratory assistance devices may provide continuous positive airway pressure therapy, bubble continuous positive airway pressure (BCPAP) therapy, high flow therapy (eg, nasal high flow (NHF) therapy), bilevel pressure therapy (eg, NIV therapy). The user can select the appropriate operating mode. The user will use an appropriate patient interface to enable the delivery of the selected treatment, such as an unsealed interface to enable the delivery of high flow treatments. Alternatively, the respiratory device may be configured to provide only a single type of treatment.

During operation of device 10, device 10 may be configured to operate in one or more non-therapeutic modes. When the device is operating in non-therapy mode, no therapy is provided to the user. Non-therapy modes may refer to modes of the device 10 associated with transitions into or out of therapy mode (eg, preparing the device for therapy mode, or transitioning the device from therapy mode to storage or shutdown). In non-therapy mode, there is typically no patient interface engaged with the patient.

Treatment modes can be operated during treatment periods.

Example non-treatment modes may include warming mode, drying mode, standby mode, and disinfection mode.

The non-treatment mode may operate as a non-treatment process for a predetermined time (eg, drying mode), and/or until a desired sensor output is achieved (eg, temperature requirements for a period of time in disinfection mode).

During operation, the device can take one or more actions, such as:

The device can collect various data while operating (such as usage data or other treatment compliance data, or data related to treatment parameters) and transmit these data to the device.

The device may receive software packages (such as firmware or software updates) from a device or the device.

The device may receive treatment parameters (eg, updated prescriptions) from a device or device.

The device may receive updated parameters for the device (eg, to recalibrate one or more components of the device).

The device may be a device that is local to the device (eg, within the same home or hospital - ie, a tablet or computer), or a device that is remotely located (eg, a server).

The device can take the above actions during treatment, however in this case the latest information is not provided to the device (if the treatment period has not been completed), or some actions are taken during treatment (such as firmware update or update of system parameters) ) may not be safe.

Taking actions during treatment may result in safety risks and/or health risks for the patient (i.e., interruption of treatment). Further, if the action is one that may affect the treatment parameters (eg, receiving and applying treatment parameters), the treatment parameters may be updated in the middle of the treatment period, which may pose safety risks and/or health risks.

If action is taken when treatment mode is complete, there is a risk that the user may completely turn off the device early after treatment, while the device is operating in non-therapy mode. If the device is switched off during action, there is a risk of data corruption or incomplete data transfer, or errors when applying the software package. Furthermore, when the device is not turned on, some actions may not be possible.

For example, errors when applying a software package may cause device performance to suffer or certain features to not work. This poses unacceptable health risks to patients.

In systems where treatment data can be uploaded at the end of treatment or after a period of time has elapsed after treatment, the user may turn off the device before the action occurs, or the device may have to wait a long time to ensure that the user does not turn off the device (which may lead to the problems described above ).

Further, the user may be required to specifically turn on the device to take action (such as receiving and applying software packages). Having to specifically turn on the device to take an action may inconvenience the user, and if the user does not specifically instruct the device to take an action, no action may be taken (e.g., a software package may not be applied).

This disclosure introduces a predetermined period of time operating in a non-therapeutic mode before initiating any action. This reduces the likelihood that the user will turn off the device completely and reduces the risk of the device being turned off during action.

This also ensures that there is a reduced risk of movements interrupting or interfering with important equipment routines and/or interrupting or interfering with therapy.

This disclosure may provide a safe opportunity for the device to initiate any action when it is safe for the device and/or the patient to take the action.

The security opportunity for a device may be when the risk to the integrity of the device's hardware and/or software/firmware is low. For example, when the risk of a firmware or software update being interrupted is low.

For patients, safety opportunities may be when the patient is not connected to or using the device for treatment while the device is applying any changes, testing sensors, etc.

Further, after operating in non-therapeutic mode for a period of time, the risk of alarms being raised or the need to run import routines that interfere with actions that need to be run is reduced. Starting actions immediately after treatment (where the user may still require safety monitoring as they may not have removed their interface and are still connected to the device) may increase the risk of alarms being raised or the need to run an import routine.

Further, because users may occasionally change their minds about starting a treatment session, they may turn the device on briefly and then turn it off. If the device attempts to take an action while the device is on, this may be interrupted by the user turning off the device.

The present disclosure also allows for an architecture in which all data transfers to and from device 10 are initiated by and controlled by device 10 . This may provide security benefits because the device 10 does not need to monitor connections from the device and take action in response to interrogation of the device.

Figure 1 shows a breathing assistance device 10. Respiratory assistance device 10 may include a housing 100 containing one or more of: a flow generator 11 (eg, a blower) in some embodiments in the form of a motor/impeller arrangement, a pneumatic Connected to the flow generator 11 are the humidifier 12, the controller 13, and the user interface 14 (comprising, for example, a display and input device(s) such as button(s), touch screen, etc.).

Humidifier 12 may humidify the gas flow and/or heat the gas flow to an appropriate level. Controller 13 may be configured to control humidifier 12 (eg, by controlling at least a humidifier heater).

Humidifier 12 may include humidification chamber 300 . Humidification chamber 300 may be configured to be removed from the humidifier (eg, for replacement, cleaning, and/or refilling). Alternatively, the humidification chamber 300 may be non-removable from the humidifier.

Humidifier 12 may include humidifier heater 310, for example as a heating plate (see Figure 4). The humidifier heater provides heat to the humidification chamber 300. The liquid in humidification chamber 300 may be water or another liquid, and/or may include a mixture of one or more liquids (eg, a mixture of water and medication).

Controller 13 may be configured or programmed to control the operation of respiratory assistance device 10 . For example, controller 13 may control components of respiratory assistance device 10 including, but not limited to: operating flow generator 11 to generate a flow of gas for delivery to the patient (gas flow); operating humidifier 12 (if present) to humidify and/or heat the generated gas flow; control the flow of oxygen into the flow generator blower; receive user input from the user interface 14 to perform reconfiguration and/or user-defined operations on the respiratory assistance device 10; and provide user input to the user. Output information (e.g. on a monitor).

Controller 13 may include one or more computer processors and associated non-transitory memory or storage media that stores processor-executable instructions or code. When executed by one or more processors, these instructions cause the respiratory therapy device to implement the steps and processes described herein.

It should be understood that when the description describes device 10 taking an action, controller 13 may be controlling one or more components of device 10 to take an action.

It should be understood that the methods described herein may be performed by a controller (or another processor).

The term breathing assistance apparatus may be used interchangeably with respiratory assistance apparatus, or respiratory therapy device, or flow therapy device.

The term breathing assistance system may be used interchangeably with respiratory assistance system, or respiratory therapy system, or flow therapy system.

The term current flow may refer to a flow measurement that has been made currently (eg at the current time step). It should be understood that the term current flow is not limited to the most recent flow determination and may include flow determinations made recently (e.g., based on previous time steps or recent flow determinations), and/or filtered based on a series of past measurements. Traffic determination (which may optionally include signal filtering and/or processing).

The methods described herein may be embodied as software or software modules, as control software (e.g., computer readable) stored in a controller (or associated memory) and executed by the controller (and/or associated processor) part of the instruction).

In the case of receiving treatment, the user is the patient, whereas in the case of interacting with the device (e.g., with a user interface), the user may be a patient, a healthcare professional (e.g., a clinician), or a person interested in using the device one or more of any other persons.

As used herein, "gas flow" may refer to any gas flow that may be provided by a breathing assistance device, such as a flow of ambient air, a flow that includes substantially 100% oxygen, a flow that includes some combination of ambient air and oxygen wait.

The breathing conduit 16 is coupled at one end to a gas outlet 21 in the housing 100 of the breathing assistance device 10 . The breathing tube 16 is coupled at the other end to a patient interface 17 , such as a non-sealed nasal cannula having a manifold 19 and a nasal prong 18 . Additionally or alternatively, breathing tube 16 may be coupled to a face mask, nasal mask, nasal pillow mask, endotracheal tube, tracheostomy interface, or the like.

In some configurations, such as when the device provides CPAP therapy, interface 17 may be a sealed interface.

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

In some embodiments, different conduit types may be connected to the gas outlet 21, such as a sterilization conduit in sterilization mode.

The flow of gas produced by the breathing assistance device 10 may be humidified and delivered to the patient via the breathing conduit 16 and patient interface 17 .

The breathing tube 16 may have a heater 16a to heat the flow of gas to the patient. Heater 16a may be controlled by controller 13. In at least one configuration, heater 16a is a heating wire. Breathing conduit 16 and/or patient interface 17 may be considered part of a respiratory assistance therapy system. The breathing assistance system 1 may include a breathing assistance device 10 , a breathing tube 16 and a patient interface 17 .

Controller 13 may control flow generator 11 to generate a flow of gas at a desired flow rate (eg, treatment flow). Controller 13 may also control the supplemental oxygen inlet to allow delivery of supplemental oxygen.

The controller 13 may also control the humidifier heater in the humidifier 12 and/or the heater 16a in the breathing tube 16 to heat the gas to a desired temperature to achieve a desired level of therapy and/or comfort for the patient.

The controller 13 may be set with a suitable target temperature for the gas flow or may determine a suitable target temperature for the gas flow. The controller 13 may control the humidifier heater of the humidifier 12 and/or the breathing tube heater 16a based on one or more suitable target temperatures of the gas flow.

The heater 16a in the breathing tube 16 can be controlled by the controller 13 to achieve a desired temperature. The desired temperature may be or be based on one or more temperature set points and/or one or more humidity set points (eg, therapeutic humidity).

The humidifier heater of humidifier 12 can be controlled by controller 13 to achieve a desired temperature. The desired temperature may be or be based on one or more temperature set points and/or one or more humidity set points. The desired temperature may be a treatment parameter.

Controller 13 may control heater 16a in breathing tube 16 and/or the humidifier heater of humidifier 12 to a desired temperature through closed loop control based on the output of one or more sensors.

The one or more temperature set points may be related to one or more treatment parameters of the device used for treatment (eg, dew point or temperature of the gas) or may be provided in the memory of the device (eg, a predetermined temperature).

One or more treatment parameters in a high-flow treatment mode, such as nasal high-flow mode (NHF mode), may include any combination of:

the therapeutic flow rate of gas provided to the user,

treatment humidity levels (such as relative or absolute humidity, or dew point),

The therapeutic oxygen concentration provided to the user,

The therapeutic concentration of assist gas provided to the user,

The therapeutic temperature of the gas provided to the user (for example).

One or more treatment parameters in BCPAP mode may include any combination of the following:

the therapeutic flow rate of gas provided to the user,

treatment humidity levels (such as relative or absolute humidity, or dew point),

The therapeutic oxygen concentration provided to the user,

The therapeutic concentration of assist gas provided to the user,

the therapeutic temperature of the gas provided to the user,

One or more treatment parameters in CPAP mode may include any combination of the following:

treatment humidity levels (such as relative or absolute humidity, or dew point),

The therapeutic oxygen concentration provided to the user,

the therapeutic temperature of the gas provided to the user,

The therapeutic concentration of assist gas provided to the user,

The therapeutic level of pressure support provided to the user (e.g., CPAP pressure),

Therapeutic PEEP pressure provided to the user.

One or more treatment parameters in bilevel mode can include any combination of the following:

treatment humidity levels (such as relative or absolute humidity, or dew point),

The therapeutic oxygen concentration provided to the user,

the therapeutic temperature of the gas provided to the user,

The therapeutic concentration of assist gas provided to the user,

Therapeutic IPAP/EPAP pressure (inspiratory positive airway pressure/expiratory positive airway pressure) provided to the user.

The treatment temperature may include a treatment temperature at the chamber outlet and/or a treatment temperature at the tip of the breathing tube.

Therapeutic humidity can be at the chamber outlet or at the end of the breathing tube.

The therapeutic humidity level may be a dew point of about 37 degrees Celsius, or an absolute humidity above about 38 mg _H2O or about 44 mg _H2O .

This level of humidity can cause condensation during use, and it is important to dry the breathing tube 16 before reusing the tube. This is particularly needed in home care settings where tubes are reused (e.g. 7-14 days). In hospitals, tubes are frequently changed for new patients, but the same tube may be reused for the same patient. To reduce the risk of infection and the risk of pathogen growth, the breathing tube is dried to remove moisture, including liquid (eg by operating the drying mode, as described in more detail below).

Given the high flow rates provided during NHF mode and the corresponding humidity, this may increase the amount of condensate formed, which may further increase the importance of the drying mode, as described in more detail below.

The user may input one or more treatment types associated with the treatment mode via the user interface.

The user may input one or more treatment parameters via the user interface.

The desired temperature may be at the end of the breathing tube 16, at the patient interface, at the gas outlet, at the humidification chamber outlet, at any sensor of the device, and/or any combination thereof.

One or more temperature set points can include one or more of the following:

Desired dew point (e.g. temperature indicating desired humidity),

predetermined dew point,

predetermined temperature,

desired temperature.

In some embodiments, controller 13 may control heater 16a of breathing tube 16 based on a desired temperature of the gas at the patient interface and/or a desired temperature at the tip of breathing tube 16.

The device may be powered by an external power source (e.g. via a wired connection to the power grid).

In some embodiments, the device may be powered by at least one battery. The battery may be located in the housing of the device and/or attached externally to the housing of the device. In some embodiments, the battery is removable. Alternatively, the battery is not removable.

For example, as shown in FIG. 4 , the oxygen inlet port 28 includes a valve 1003 through which pressurized gas can enter the respiratory therapy device 10 . The valve may control the flow of oxygen into the respiratory therapy device 10. The valve can be any type of valve, including proportional or two-position valves.

The oxygen source can be an oxygen tank or a hospital oxygen supply. The purity of medical-grade oxygen is typically between 95% and 100%. Lower purity oxygen sources may also be used. Examples of valve modules and filters are provided in U.S. Provisional Application No. 62/409,543 entitled "Valve Modules and Filter" filed on October 18, 2016 and in U.S. Patent Application No. 62/409,543 filed on April 23, 2017. Disclosed in U.S. Provisional Application No. 62/488,841 for "Valve Modules and Filters," which is incorporated herein by reference in its entirety.

The breathing assistance device 10 can measure and control the oxygen content of the gas delivered to the patient, and therefore the oxygen content of the gas breathed in by the patient.

Breathing assist device 10 can provide high flow therapy in which a high flow rate of delivered gas meets or exceeds the patient's peak inspiratory needs.

Operating sensors 3a, 3b, 3c, such as flow sensors, temperature sensors, humidity sensors and/or pressure sensors, may be placed in various locations in the breathing assistance device 10. Additional sensors (eg, sensors 20, 25) may be placed at various locations on the breathing tube 16 and/or patient interface 17 (eg, a temperature sensor 29 may be present at or near the end of the suction tube).

Respiratory therapy device 10 may have a communication module 15 to enable controller 13 to receive signals 8 from sensors and/or control various components of respiratory assistance device 10, including but not limited to flow generator 11, humidifier 12, heater 16a, humidification heater, or accessories or peripherals associated with the breathing assistance device 10. Additionally or alternatively, the communication module 15 may transmit data to a remote server or enable remote control of the respiratory therapy device 10 or the respiratory therapy system 1 .

Communication modules may include transmitters, receivers, and/or transceivers.

The communication module 15 can be used as a network interface.

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

A communications module may include multiple individual transmitters, receivers, and/or transceivers for each or group of communications protocol(s).

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

In some embodiments, one or more leak or blockage events or alerts (as described in greater detail below) may be transmitted to one or more servers and/or devices (eg, computers, phones, or tablets). Additional information associated with the event or alarm (eg, time, duration, or severity) may be additionally transmitted to the server and/or device.

As described above, respiratory assistance device 10 can measure and control the oxygen content of the gas delivered to the patient. After the oxygen and ambient air have been mixed, the oxygen can be measured by placing one or more gas composition sensors, such as an ultrasonic transducer system. Measurements may be taken within respiratory therapy device 10, patient breathing tube 16, patient interface 17, or at any other suitable location.

The oxygen concentration measured in the device may be equivalent to the delivered fraction of oxygen (FdO2) and may be substantially the same as the oxygen concentration of the patient's breath, the fraction of inspired oxygen (FiO2), and therefore these terms may be considered equivalent.

The oxygen concentration may also be measured by using flow sensors on at least two of the ambient air inlet conduit, the oxygen inlet conduit, and the patient breathing conduit to determine the flow rates of the at least two gases. The final gas can be calculated by determining the flow rates of two inlet gases or one inlet gas and a total flow rate along with the assumed or measured oxygen concentration of the inlet gas (approximately 20.9% for ambient air and approximately 100% for oxygen) Oxygen concentration of the composition. Alternatively, flow sensors can be placed on all three of the ambient air inlet conduits, oxygen inlet conduits, and breathing conduits to allow for redundancy and to test that each sensor is working correctly by checking for consistency in readings. Other methods of measuring oxygen concentration delivered by respiratory assistance device 10 may also be used.

The respiratory assistance device 10 may include a patient sensor 26 (such as a pulse oximeter or patient monitoring system) to measure one or more physiological parameters of the patient (such as the patient's blood oxygen concentration (eg, the patient's blood oxygen saturation (SpO2))) , heart rate, respiratory rate, perfusion index) and provide a measure of signal quality. Sensor 26 may communicate with controller 13 through a wired connection or through communication via a wireless transmitter on sensor 26 . Sensor 26 may be a disposable adhesive sensor designed to attach to the patient's finger. Sensor 26 may be a non-disposable sensor (ie, a reusable sensor). Sensors designed for different age groups and to be attached to different locations on the patient's body are available and can be used with the breathing assistance system 1 . A pulse oximeter can be attached to the patient (typically at their finger), but other locations, such as the earlobe, are also an option. A pulse oximeter may be connected to a processor in respiratory therapy device 10 and may continuously provide a signal indicative of the patient's blood oxygen saturation. Patient sensor 26 may be a hot-swappable device that may be attached or interchanged during operation of respiratory assistance device 10 . For example, patient sensor 26 may use a USB interface or use a wireless communication protocol such as ) is connected to the breathing assistance device 10.

When the patient sensor 26 is disconnected during operation, the respiratory assist device 10 may continue to operate in its previous operating state for a defined period of time. After a defined period of time, breathing assistance device 10 may trigger an alarm, transition from automatic mode to manual mode, and/or exit control mode entirely (eg, automatic mode or manual mode). Patient sensor 26 may be a bedside monitoring system or other patient monitoring system that communicates with respiratory assistance device 10 through a physical or wireless interface.

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

High flow therapy as discussed herein is intended to be given its typical ordinary meaning as understood by those skilled in the art, which generally refers to respiratory assist devices that are generally intended to be used via an intentionally unsealed patient interface. A flow rate that meets or exceeds the patient's inspiratory flow rate to deliver a target flow rate of humidified respiratory gas. Typical patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults often range, but are not limited to, from about fifteen liters/minute to about sixty liters/minute or more. Typical flow rates for pediatric patients (eg, neonates, infants, and children) often range, but are not limited to, from about one liter/minute/kg of patient weight to about three liters/minute/kg of patient weight or more. High flow therapy may also optionally include gas mixture components including supplemental oxygen and/or administration of therapeutic drugs. High-flow therapy is often referred to as nasal high flow (NHF), humidified high-flow nasal cannula (HHFNC), high-flow nasal oxygen therapy (HFNO), high-flow therapy (HFT), or transtracheal high flow (THF), among other common names.

For example, in some configurations, for an adult patient, 'high flow therapy' may 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 between about 10 LPM and about 100 LPM, or between about 15 LPM and Between about 95LPM, or between about 20LPM and about 90LPM, or between about 25LPM and about 85LPM, or between about 30LPM and about 80LPM, or between about 35LPM and about 75LPM, or between about 40LPM and about 70LPM, Or between about 45LPM and about 65LPM, or between about 50LPM and about 60LPM. In some configurations, for a neonatal, infant, or pediatric patient, "high flow therapy" may refer to delivering gas to the patient at a flow rate of greater than 1 LPM, such as between about 1 LPM and about 25 LPM, or between about 2 LPM and about 25 LPM, or Between about 2LPM and about 5LPM, or between about 5LPM and about 25LPM, or between about 5LPM and about 10LPM, or between about 10LPM and about 25LPM, or between about 10LPM and about 20LPM, or between about 10LPM and 15LPM time, or between about 20LPM and 25LPM. In some configurations, a high flow therapy device for an adult patient, neonatal, infant, or pediatric patient may deliver the patient at a flow rate between about 1 LPM and about 100 LPM, or at a flow rate in any of the subranges outlined above. Transport gas. The delivered gas may include a certain percentage of oxygen. In some configurations, the percentage of oxygen in the delivered gas can be between about 20% and about 100%, or between about 30% and about 100%, or between about 40% and about 100%, or about Between 50% and about 100%, or between about 60% and about 100%, or between about 70% and about 100%, or between about 80% and about 100%, or about 90% and about 100% between, or about 100%, or 100%.

High-flow therapy may be effective in meeting or exceeding the patient's inspiratory flow, enhancing the patient's oxygenation, and/or reducing the work of breathing.

High flow therapy may be administered into the patient's nostrils and/or orally, or via a tracheostomy interface.

High-flow therapy can produce a flushing effect in the nasopharynx, such that the anatomical dead space of the upper airway is flushed by the incoming high gas flow. This creates a reserve of fresh gas available for each breath while reducing rebreathing of nitrogen and carbon dioxide. Additionally, meeting the inspiratory needs and flushing the airway is important when trying to control a patient's FdO2. High-flow therapy can be delivered using a non-sealed patient interface (eg, nasal cannula). High-flow therapy may decrease the patient's breathing rate. High-flow therapy can provide patients with expiratory resistance.

High flow therapy may be used to treat patients with obstructive pulmonary disease (eg, COPD, bronchiectasis, dyspnea, cystic fibrosis, emphysema) and/or patients with respiratory distress or hypercapnia.

As used herein, the term "unsealed patient interface" (i.e., an unsealed patient interface) may refer to a gas flow source (such as from flow generator 11) in a patient's airway that does not completely occlude the patient's airway. Provides an interface for pneumatic links between. Unsealed pneumatic links may include less than approximately 95% obstruction of the patient's airway. Unsealed pneumatic links may include less than approximately 90% obstruction of the patient's airway. An unsealed pneumatic link may include an obstruction of between about 40% and about 80% of the patient's airway. The airway may include one or both nostrils of the patient and/or the patient's mouth. With a nasal intubation, the airway passes through the nostril.

CPAP therapy may include providing gas to the user at continuous positive pressure (and optionally, one or more therapy parameters, as described in greater detail above).

BCPAP treatment may include providing gas to the user at a treatment flow rate (and optionally, one or more treatment parameters, as described in greater detail above).

Bi-level treatment may include providing gas to the user at a treatment flow rate (and optionally, one or more treatment parameters, as described in greater detail above).

Sealed interfaces may be used when the device is delivering CPAP, bi-level or BCPAP therapy.

The flow generator 11 may be or include a blower module. The blower module may comprise at least one blower 11' configured to generate said gas flow.

The flow generator 11 may include an ambient air inlet port 27 through which ambient room air may be introduced into the blower. The respiratory assistance device 10 may also include an oxygen inlet port 28 leading to a valve through which pressurized gas may pass into the flow generator 11 . The valve can control the flow of oxygen into the flow generator 11. The valve can be any type of valve, including proportional or two-position valves.

Blower 11' may operate at a motor speed greater than about 1,000 RPM and less than about 8,000 RPM, greater than about 2,000 RPM and less than about 10,000 RPM, or between any of the foregoing values. Blower 11' may mix gases entering blower 11' through inlet ports (eg, ambient air inlet port 27 and/or oxygen inlet port 28). Using the blower 11' as a mixer can reduce the pressure drop relative to a system with a separate mixer, such as a static mixer including baffles.

It will be appreciated that another supplemental gas may be provided in place of the oxygen, for example the oxygen inlet port 28 may be a supplemental gas inlet port and the valve may be configured to control the flow of the supplemental gas.

The respiratory assistance device may further include a gas composition sensor. The gas composition sensor may be a sensor as described below (eg an ultrasonic transducer configuration).

The respiratory assistance device 10 includes a flow sensor. The flow sensor may be configured to measure the flow of breathable gas flow to the patient.

Controller 13 may include one or more processors. The processor can be configured with computer readable instructions.

Controller 13 may include at least one memory element. The memory element may be configured to store the computer-readable instructions.

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

The controller 13 may be a microprocessor or ASIC, an FPGA, or a combination of ICs or microprocessors, or other suitable components and/or architectures.

The respiratory assistance device may include at least one display module configured to display an alarm output.

The breathing assistance device may include at least one sound module configured to emit an audible alarm.

In some embodiments, the at least one sound module may include a speaker.

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

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

Display modules can be configured as input/output (I/O) modules. For example, the display module may be configured to receive input from the user and provide output to the user (eg, as part of user interface 14 or to display part of the user interface).

The display module can communicate with the controller 13. In some embodiments, the display module may provide information (eg, setting values) to controller 13 . In some embodiments, the display module may receive information (eg, alarms, sensor outputs, and/or other calculated variables) from the controller 13 .

Referring additionally to FIG. 2 , a sensing circuit board 2200 that may be implemented in respiratory assistance device 10 is shown. The sensing circuit board 2200 may be positioned in the sensor chamber such that the sensing circuit board 2200 is at least partially immersed in the gas flow. The gas flow may exit the blower 11' through a conduit and enter a flow path in the sensor chamber. At least some of the sensors on sensing circuit board 2200 may be positioned within the gas flow (the direction of which is indicated by arrow 2203) to measure gas properties within the flow. After passing through the flow path in the sensor chamber, the gas can exit to the humidifier 12 described above.

The sensing circuit board 2200 may be a printed sensing circuit board (PCB). Alternatively, the circuit on board 2200 may be constructed using wires connecting electronic components rather than printing the circuit on a circuit board. At least a portion of the sensing circuit board 2200 may be mounted outside of the gas flow. The gas flow may be generated by the flow generator 11 described above. Sensing circuit board 2200 may include ultrasound transducer 2204. Sensing circuit board 2200 may include one or more thermistors 2205. Thermistor 2205 may be configured to measure the temperature of the gas flow. Sensing circuit board 2200 may include a thermistor flow sensor 2206. The sensing circuit board 2200 may include other types of sensors, such as humidity sensors (including humidity-only sensors to be used with separate temperature sensors, as well as combined humidity sensors and temperature sensors), sensors for measuring atmospheric pressure, sensors for Sensors for measuring differential pressure, and/or sensors for measuring gauge pressure. Thermistor flow sensor 2206 may include a hot wire flow meter, such as a platinum wire and/or a thermistor (such as a negative temperature coefficient (NTC) thermistor, or a positive temperature coefficient (PTC) thermistor). Other non-limiting examples of heated temperature sensing elements include glass or epoxy encapsulated thermistors, or unencapsulated thermistors. The thermistor flow sensor 2206 may be configured to measure the flow of gas by being supplied with constant power or by being maintained at a constant temperature or maintaining a constant temperature difference between the sensor and the gas flow.

Positioning one or more of the thermistor 2205 and/or thermistor flow sensor 2206 downstream of the combined blower and mixer means that the sensor readings will depend on the heat supplied by the blower to the gas flow. Furthermore, immersing at least a portion of the sensing circuit board and sensor in the flow path can increase the accuracy of the measurement results. Relative to sensors that are not immersed, sensors immersed in the flow are more likely to be exposed to the same conditions, such as temperature and pressure, as the gas flows. Therefore, these immersed sensors can provide a better representation of gas flow characteristics.

Sensing circuit board 2200 may include ultrasonic transducers, transceivers, or other sensors to measure properties of the gas flow, such as the gas composition or concentration of one or more gases within the gas flow. As should be understood, any suitable transducer, transceiver, or sensor may be mounted to sensing circuit board 2200. In this configuration, the gas composition sensor is an ultrasonic transducer that uses ultrasonic or sound waves to determine gas concentration.

The ultrasonic transducers may be pairs of ultrasonic transducers arranged axially opposite each other in the direction of flow in the sensor chamber. The ultrasonic transducer pair can be configured to use time-of-flight measurements to determine flow.

Some examples of flow therapy devices are International Application No. PCT/NZ2016/050193 entitled "Flow Path Sensing for Flow Therapy Apparatus" filed on December 2, 2016 and June 2016 Disclosure is made in International Application No. PCT/IB2016/053761, entitled "Breathing Assistance Apparatus [Breathing Assistance Equipment]", filed on November 24, 2016, which applications are incorporated herein by reference in their entirety.

Device 10 may include an elbow 325 configured to connect to breathing conduit 16 (and, for example, provide a gas outlet 21). Elbow 326 may include one or more sensors.

Figures 3 to 7 illustrate the configuration of the breathing assistance device 10. For example, as shown in FIG. 4 , a respiratory assistance device includes a housing 100 . The housing 100 has an upper housing 102 and a lower housing 202 .

As shown in FIGS. 3 and 3A , the lower housing 202 has a motor recess 250 for receiving a removable or non-removable motor and/or sensor module 400 , which is shown in FIGS. 13 to 15 is shown in and will be described in further detail below. A recessed opening 251 is provided in the bottom wall 230 near its rear edge for receiving a removable or non-removable motor/sensor module 400, which is shown in Figures 5 and 6 and will be. This is described in further detail below.

Figures 5-7 illustrate the motor and/or sensor module or subassembly 400 in greater detail. As discussed above, the lower housing 202 includes a recess 250 for receiving the motor and/or sensor module 400 . The flow generator may include motor and/or sensor modules or subassemblies 400 .

In the form shown in FIGS. 5-7 , the motor and/or sensor module 400 includes a stacked arrangement of three main components: a base 403 of the subassembly 400 on which the motor 402 is positioned; The outlet gas flow path and sensing layer 420, and the covering layer 440. The base 403 , sensing layer 420 and cover layer 440 are assembled to form a subassembly housing having a shape complementary to the shape of the recess 250 such that the subassembly 400 can be received in the recess 250 . Base 403 is configured to close recess opening 251 when subassembly 400 is positioned in recess 250 . Subassembly 400 may be maintained in place in the recess in any suitable manner, such as with fasteners, clips, or quick release arrangements, or may be secured in a non-removable manner.

The sensing layer includes a gas flow path with one or more sensors arranged to deliver gas to the outlet port of the housing.

Motor 402 has a body 408 that defines an impeller chamber containing an impeller. Motor 402 may be any suitable gas blower motor, and may be, for example, a motor and impeller assembly of the type described in published PCT specification WO2013/009193. The contents of this specification are incorporated herein by reference in their entirety.

The gas outlet 406 is in fluid communication with the gas inlet of the outlet gas flow path and sensing layer 420 that are stacked on top of the motor. This layer 420 includes a body 422 that includes a plurality of mounting legs 425 that can be inserted into a plurality of mounting slots (not shown) in the base 403 to secure the body 422 to the base 403 . In one configuration, body 422 defines a gas flow path coupling gas outlet 406 with the gas flow path and the gas inlet of sensing layer 420 .

Body 422 defines a lower portion 426 of the sensing and gas flow path. Cover 440 has a body 442 that defines an upper portion 446 of the sensing and gas flow path, wherein upper portion 426 and lower portion 446 are shaped to substantially correspond to each other.

As shown in Figures 6 and 7, the gas flow path includes linear elongated gas flow portions 428, 448. The inlets are in fluid communication with tangential inlet portions 430, 450 of the gas flow path located at or adjacent the inlet ends of the rectilinear elongated portions 428, 448 of the gas flow path. Recesses 433, 453 and 434, 454 may be provided at opposite ends of the linear elongated portion of the gas flow path.

The gas outflow outlet ports 452 extend vertically through the body 442 of the cover 440 and are located at or adjacent opposite outlet ends of the rectilinear elongated portions 428, 448 of the gas flow path. The gas outlet port 452 is in fluid communication with an upper portion of the motor recess 250, which in turn is in fluid communication with the gas flow channel. Also, due to the configuration of the walls 252 and roof 262 of the recess 250, if any gas leaks from the motor/sensor module 400, the gas will be vented to the atmosphere rather than entering the portion of the housing 100 that contains the bulk of the electronics and control equipment. . Recess 250 may include spacer(s), such as tabs projecting downwardly from top plate 262 as shown in FIG. 15 , to maintain appropriate spacing for gas flow from gas outlet port 452 and the top plate of recess 262 .

As can be seen in Figure 7, at least a portion of the gas flow path through and out of the motor and/or sensing module 400 has a tortuous or serpentine configuration. For example, the direction of gas flow travel through the elongated portions 428 , 448 is generally opposite to the direction of gas flow travel from the gas outlet port 452 to the entrance of the gas flow channel through the elbow 324 . A tortuous or serpentine configuration can increase the residence time of gas in the gas flow path and therefore improve sensing.

As shown in FIGS. 6 and 7 , cover layer 440 includes a sensing printed circuit board (PCB) 456 . The overlay 440 may also include one or more temperature sensors, such as thermistors, that sit in the elongated portions 428, 448 of the gas flow path. One sensor will measure the gas temperature and the other sensor can be used as a redundant temperature sensor. Alternatively, one of the thermistors may be used as a reference flow sensor (e.g., by acting as a thermostatic thermistor) and the measured temperature may be used to determine gas flow through portions 428, 448 of the gas flow path . One or more temperature sensors may be located on a portion of the sensing PCB 456 facing the gas flow. Additionally, the sensing PCB 456 may include other sensors including, but not limited to, pressure sensors, humidity sensors, and dew point sensors.

One or both electronic circuit boards 272 will be in electrical communication or coupling with these sensors to process information received from the sensors and to operate the device 10 based on the information received from the sensors.

In alternative configurations, the motor/impeller unit may be located remotely from the device 10 . In this configuration, the module housed in recess 250 may simply include a gas flow path and various sensors to deliver gas to stationary elbow 324 and thereby to humidification chamber 300 . In an alternative configuration, the module received in recess 250 may include only the motor and gas flow path, but not the sensor.

In another alternative configuration, the motor and/or sensor module 400 may not be removable from the recess 250 but may be permanently installed therein.

Some configurations may provide the benefit of isolating electrical/electronic components from the gas in the gas flow.

The flow path is compact and has reduced turns/sharps, which reduces flow separation and lowers flow resistance.

The arrangement of the motor and flow paths provides another layer of isolation due to the wall arrangement.

Having modular motor and/or sensor modules enables disassembly of various parts of the module in the event that cleaning and/or repair and/or replacement of parts is required.

In some embodiments, there are no leakage paths in the motor and/or sensor modules.

While the motor and/or sensor module may be a potential leak point, a leak in this area will cause oxygen to be vented to the atmosphere or vented into the liquid chamber.

For example, as shown in Figure 8, device 10 may include a valve module 4001 that controls the flow of oxygen and/or other gases (eg, another supplemental gas) into the gas flow path of device 10 and enables device 10 to Adjust the proportion of oxygen (or another supplemental gas) entrained in the air flow. The valve modules are formed as modular units to facilitate manufacturing, assembly, repair or replacement. For example, in the event of a malfunction, routine maintenance, or future upgrades/improvements.

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

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.

Device 10 may include a filter module 1001, which may include a filter.

The filter module 1001 and valve module 4001 described herein can provide varying gas flow paths to a device. For example, the valve module may control the flow of oxygen into the gas flow path of the device via the valve module and filter module. Alternatively, the alternative oxygen source may be connected directly to the filter module via the alternative supply inlet, thereby bypassing the valve module. This may be practical where the user may wish to adjust the oxygen supply manually (ie via a wall supply rotameter).

It will be appreciated that the device may be supplied with supplemental gases other than oxygen.

It will be appreciated that the filter modules and valve modules described herein may be used separately in equipment for conveying gas streams. Alternatively, the filter and valve modules may be used together as a filter and valve assembly for improved functionality.

In the configuration shown, device 10 receives oxygen in at least one of the following ways:

via valve module 4001 (for automatic oxygen regulation of the device), or

Via an alternative gas inlet provided on the top of the filter (allowing attachment of a manually adjustable oxygen supply - such as a wall supply regulated by a regulator).

Device 10 may include a manifold. The manifold can be located on the housing. The manifold may provide one or more of the following: a supplemental gas inlet (eg, oxygen inlet), an alternative gas inlet, and/or an air inlet.

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 flow generator 11.

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

The manifold may allow excess oxygen to escape into the surrounding environment, and/or the manifold may allow oxygen to escape into the surrounding environment if the blower is turned off and oxygen is continuously supplied. This prevents O2 from accumulating in the housing.

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

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

As described above, device 10 may receive air (eg, ambient air via 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 (eg, an absolute humidity sensor and/or a relative humidity sensor).

As described above, device 10 may receive supplemental gas (eg, oxygen via oxygen inlet port 28). The makeup gas inlet may include at least one makeup gas inlet sensor 42 . The valve module 4001 as described above may be configured to operate to control the flow of supplemental gas (eg, oxygen).

At least one makeup gas inlet sensor 42 may be part of the valve module 4001 or be independent. In FIG. 8A , at least one makeup gas inlet sensor 42 is shown as part of valve module 4001 and located upstream of valve 30 . In some configurations, sensor oxygen inlet sensor 42 may be provided separately from valve module 4001 and located upstream or downstream of valve module 4001 .

The at least one makeup gas inlet sensor 42 may include at least a pressure sensor. The pressure sensor may be configured to measure the pressure of the supplemental gas supply.

As mentioned above, device 10 may receive supplemental gas via an alternative supply inlet.

The device 1 may include one or more additional sensors 40 . Additional sensors may be located within the device (eg, within a housing) and/or exposed to the surrounding environment. Additional sensors may include pressure sensors (eg, ambient pressure sensors). In some embodiments, one or more additional sensors 40 are located at or near valve module 4001.

As described above, the filter module 1001 receives gas from the makeup gas inlet and/or the makeup gas from the alternative supply inlet, and air from the air inlet.

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

The flow generator 11 may include at least one blower sensor 43 configured to measure characteristics of the blower. At least one blower sensor 43 may be configured to measure characteristics of the blower motor. At least one blower sensor 43 may include a motor speed sensor.

At least one blower sensor 43 may measure electrical characteristics of a blower (eg, a blower motor).

The at least one blower sensor 43 may be positioned as part of the blower, or remotely located from the blower, such as on a control panel (eg, when the at least one blower sensor 43 measures the electrical characteristics of the blower).

The flow generator may also include at least one sensor 44 located downstream of the blower 11' (eg, as shown in Figure 8A). In some configurations, at least one sensor 44 is positioned upstream of the blower. At least one sensor 44 may be provided as part of sensor module 400 (as described in greater detail above). At least one sensor 44 may include one or more of the following: 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 relative to the environment), at least one humidity sensor.

The sensor 3a as described above may be the blower sensor 43 and/or the sensor 44.

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

The humidifier 12 described in greater detail above is pneumatically connected to the flow generator (eg, at least via fixed elbow 324 ). The humidifier heater may include at least one humidifier heater sensor 45 . 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 remotely from the heater (eg, on a control panel).

As shown in Figure 8A, device 10 may also include at least one humidifier outlet sensor 46 located in the humidifier outlet. The humidifier outlet may be an elbow 325. Humidifier outlet sensor 46 may be one or more temperature sensors.

Sensor 3b as described above may be a humidifier heater sensor 45 and/or a humidifier outlet sensor 46. Similarly, sensor 3c may be a humidifier outlet sensor 46.

As mentioned above, the breathing tube 16 includes the heater 16a of the breathing tube 16. Breathing tube 16 may include at least one breathing tube sensor 48 (eg, sensor 29 as described above). At least one breathing tube sensor 48 may be located at the patient end of tube 16 . At least one breathing tube sensor 48 may be a temperature sensor.

A breathing tube 16 heater 16a power sensor 47 may also be provided to measure the power provided to the breathing tube heater 16a. The power sensor 47 may be positioned remotely from the breathing tube 16 (eg, on a control panel).

The various configurations described are exemplary configurations only. Any feature or features from any configuration may be used in combination with any feature or features from any other configuration.

As another example, although the motor and/or sensor subassembly recess is described as being located in the bottom side of the housing, the recess may alternatively be located in the rear, side, front, or top of the housing. The air and/or oxygen inlets can also be positioned differently depending on the requirements.

As another example, instead of configuring the humidification chamber 300 and chamber compartments such that the humidification chamber 300 is inserted into and removed from the chamber compartment from the front of the housing, the configuration may In order to allow the humidification chamber 300 to be inserted into and removed from the chamber compartment from the side, rear or top of the housing.

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

The filter module and valve module are described with reference to a respiratory assistance device that can deliver heated and humidified gas to a patient or user.

Alternatively, the filter module and/or valve module may be used with equipment that does not require a humidifier and therefore does not require humidification chamber 300. For example, it will be appreciated that arrangements that isolate the motor and gas flow path from electrical and electronic components have broad application in other types of gas delivery devices.

A device can be turned on (i.e., to a powered-on state) by connecting the device to a power source (i.e., a battery or electrical connection) and/or through one or more inputs to the device (e.g., a power switch and/or inputs on a user interface) .

A device may be shut down (i.e., to a power source) by disconnecting the device from a power source (i.e., a battery or electrical connection) and/or through one or more inputs to the device (e.g., a power switch and/or inputs on a user interface) state).

When device 10 is in a non-therapy mode, the device may present a health query including one or more queries. In some embodiments, the non-treatment mode in which health inquiries are presented may be a warming mode and/or a drying mode (as described in more detail below).

Device 10 may present one or more health queries to the user.

A health query may include one or more user queries related to one or more health parameters.

Each query includes a plurality of user input elements via which user input is received as an answer to the user query.

The device 10 may perform health inquiries as disclosed in WO 2021/090184 (PCT Application No. PCT/IB2020/060335), which is hereby incorporated by reference.

Device 10 may present health inquiries at the beginning of the non-therapy mode.

Device 10 may present health queries at the following times:

when the device is turned on, or

At the beginning of non-therapy mode, or

When the user is prompted to enter one or more therapy parameters for the breathing assistance device (optionally via the therapy control screen), or

When the user initiates input of one or more therapy parameters for the breathing assistance device (optionally via the therapy control screen), or

Once the user starts treatment (optionally via the treatment control screen), or

When manually activated by the user,

or any combination of the above.

Figures 9-18 illustrate a user interface presenting health queries on a respiratory assistance device. Multiple questions and multiple potential responses are displayed.

Multiple questions may relate to one or more health parameters of the patient.

Figure 9 shows a startup screen having graphical user touch elements, advanced user touch elements, and menu user touch elements. For example, the startup screen may be the first screen the patient sees when activating the breathing assistance device, as described herein. Graphical user touch elements may, when selected, be capable of rendering data graphics of various treatment parameters or patient health parameters as described herein, whether such presentation occurs on the same page of the user interface or on a different page. The advanced user touch element may be used to turn the respiratory assistance device on or off (eg, as described above) when selected, or restart the breathing assistance device as described herein.

Figure 10 shows the introduction screen following the startup screen. The introduction screen displays a greeting message (or some other introduction or welcome message).

Figure 11 illustrates a general feeling screen presenting a query (eg, request for user health information, health query) asking about a patient's general feeling at a particular time of day.

Figure 12, similar to Figure 15, shows a sore throat screen presenting a query. However, unlike the query and potential answers of Figure 15, the query and potential answers of Figure 12 are related to the patient's sore throat parameters. The query of Figure 12 includes multiple possible answers, each answer having an associated icon. These icons are color-coded relative to the patient condition associated with the answer and have faces with expressions related to the patient condition associated with the answer (as described in more detail below).

Figure 13 is similar to Figures 11 and 12 and shows a breathing screen presenting a query. However, unlike the queries and potential answers of Figures 11 and 12, the query and potential answers of Figure 13 are related to the patient's breathing parameters.

Figure 14 is similar to Figures 11-13 and shows a cough screen presenting a query.

Figure 15 is similar to Figures 11 to 14 and shows a sputum color screen presenting a query.

Figure 16 is similar to Figures 11-15 and shows an antibiotic usage screen presenting a query.

Figure 17 is similar to Figures 11-16 and shows a steroid usage screen presenting a query.

Figure 18 is similar to Figures 11-17 and shows an inhaler usage screen presenting a query.

The healthcare provider may set one or more patient benchmarks related to problems and/or health parameters.

When the corresponding question (or question related to a health parameter) is displayed, the baseline may be displayed to the user. The datum may be indicated by a graphical element (such as a folded corner in Figures 12, 15, 16, 17) or by highlighting.

In some embodiments, the health query (and/or one or more questions and answers) may be presented when the device enters a non-therapy mode of operation (eg, when the device enters drying mode). This may allow the user to complete the health inquiry before a predetermined time of operation in non-therapy mode has elapsed. Thus, when an action is taken (as described in more detail below), the answers to the health query (and/or one or more answers to the questions) may be used for transmission to the device.

In some embodiments, the health query (and/or one or more questions and answers) may be presented in a first non-therapeutic mode (eg, warming mode) and in a second non-therapeutic mode (eg, drying mode) transmitted to the device (as discussed in more detail below).

Data related to the health query (and/or one or more questions and responses) may be packaged into a single package, or there may be separate packages for treatment data and questionnaire response data.

The health query (and/or one or more questions and answers) may be stored in the memory of the device after being collected in the first non-therapy mode and then transmitted during operation in the second non-therapy mode (e.g., after a predetermined time, as described in more detail below).

The device may operate in a first non-therapeutic mode (eg, warming mode) before the treatment period and in a second non-therapeutic mode (eg, drying mode after the treatment period) after the treatment period.

In some embodiments, the treatment summary screen is displayed during non-treatment mode. The treatment summary screen may include aspects of treatment data (described in more detail below).

As noted above, the device may be configured to operate in at least one treatment mode and at least one non-treatment mode.

When operating in a non-therapy mode, the device may display non-therapy related information on the display.

This information can be one or more of the following: type of non-therapeutic mode, indication that the non-therapeutic mode is active, time remaining in the non-therapeutic mode, warning not to use the device.

In treatment mode, the device is configured to provide treatment to the user.

Treatment modalities may include:

a) Continuous positive airway pressure (CPAP) mode,

b) Bubble continuous positive airway pressure (BCPAP) mode,

c) Nasal high flow (NHF) mode,

d) Bi-level pressure mode (e.g. NIV mode), where the pressure is controlled between IPAP and EPAP,

e) Any combination of a) to d).

Each treatment mode may have one or more associated treatment parameters of the device (as described in greater detail above), such as the treatment flow rate of the gas, the treatment pressure support level, the treatment temperature of the gas, the treatment humidity of the gas, the breathing tube's Therapeutic temperature at the end, etc.

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

Typically, only one type of treatment mode is offered at a time (i.e., CPAP and NHF cannot be offered at the same time).

In each treatment mode, the user may be presented with a different user interface, or different options for device input.

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).

The device can have one or more alarm conditions during each treatment mode. If an alarm condition is met, one or more alarms can be raised. Alert conditions may be based on a specific treatment mode (ie, the specific treatment being provided) and/or one or more fault conditions that may occur during treatment.

The device is also configured to operate in one or more non-therapeutic modes. In non-therapy mode, no therapy is provided to the user.

Non-treatment modes may include drying mode, warming mode, standby mode, and/or disinfecting mode.

In some embodiments, the flow generator is activated and generates a flow of gas when the device is operating in at least one non-therapy mode. In some embodiments, the flow generator is controlled to a predetermined motor speed and/or to achieve a predetermined flow rate when the device is operating in at least one non-therapy mode.

In some configurations, a predetermined flow rate can be provided by controlling the motor speed of the flow generator. This can be achieved, for example, by a lookup table or formula that defines the relationship between flow rate and motor speed. In non-therapeutic mode, this approach may allow easier control of the flow generator since no patient is connected and the flow resistance may be known (i.e., in sterile mode), or assumed to be constant (i.e. , in drying mode and/or disinfecting mode).

In some configurations, to control the flow 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, the motor speed may be used Sensor or current/voltage sensing unit that monitors the current or voltage of the motor. To control flow, flow sensors (eg ultrasonic sensors and/or thermistors described elsewhere in the specification) may be used.

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

In some embodiments, the flow generator is configured to provide less than about 50%, or less than about 25%, or less than about 10% of the treatment flow when the device is operating in at least one non-therapy mode.

In some embodiments, the humidifier (and optionally the humidifier's heater) is activated when the device is operating in at least one non-therapy mode. In some embodiments, the humidifier is configured to humidify the gas flow when the device is operating in at least one non-therapy mode.

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

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

In some embodiments, when the device is operating in at least one non-therapy mode, the catheter's heater is activated and configured to heat the gas flow in the breathing catheter.

In some embodiments, when the device is operating in at least one non-therapy mode, the heater of the catheter is configured to heat the gas flow to a catheter tip temperature that is lower than the treatment catheter tip temperature.

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

As shown in Figure 19A, the device may be configured to change between operating in a therapy mode 910 and operating in a non-therapy mode 911. Changes between operations in treatment mode 910 and operations in non-treatment mode 911 may be based on, for example, one or more triggers indicating completion of a treatment session 913, as shown in Figure 20A.

In some embodiments, for example, as shown in Figure 19B, device operation in non-therapy mode 911 may serve as a transition from device operation in therapy mode 910 to device shutdown 912. The transition from operating in therapy mode 910 to device shutdown 912 may be important because shutting down the device directly from therapy mode may result in damage to one or more components of the device or system. In this case, the non-therapy mode may be, for example, a drying mode configured to dry the breathing tube of the device so that it can be safely closed.

As shown in Figure 20A, when the treatment period ends, the device may transition from operating in a treatment mode 910 to operating in a non-treatment mode 911. In some embodiments, the device may be configured to automatically operate in at least one non-therapy mode upon completion of at least one therapy mode. Alternatively, upon completion of treatment, a prompt may be presented to the user on the user interface to transition to a non-treatment mode of operation.

The device may transition to the second non-therapy mode in response to the trigger. The trigger may be elapsed time or may be manual input (eg, via a user interface).

When the user enters a treatment end command, the device may determine that the treatment session is complete.

The treatment end command may be generated via user input on the user interface.

End of treatment commands may be generated by detecting that the patient interface has been removed from the user.

The treatment end command may be generated by detecting that the patient interface has been removed from the user for a predetermined amount of time.

Detection that the patient interface has been removed from the user may be performed according to the method(s) described in PCT Publication No. WO 2020/178746, which is hereby incorporated by reference in its entirety.

Detecting that the patient interface has been removed from the user may be based on an estimate of flow conductance/conductance change or any other suitable method.

The treatment end command may be generated by detecting that patient interface 17 has been disconnected from breathing tube 16 (optionally for a predetermined amount of time).

Detection that the patient interface has been removed may be detected based on detecting that the user's breathing has stopped, optionally for a period of time.

The user may be required to confirm the treatment end command (eg, via a user interface).

Detecting that the user has stopped breathing can be based on one or more of the following:

a) the output of the patient interface sensor located in the patient interface,

b) Flow sensors located in the equipment,

c) a pressure sensor located in the device,

Any combination of a) to c).

It may be detected that the patient interface has been removed based on a change in conductance of the flow path, optionally for a predetermined period of time.

As shown in Figure 20A, when the non-therapy mode has been completed, the device will shut down. The non-treatment mode may be accomplished based on time and/or one or more parameters of the device (eg, sensor) reaching a desired value.

The device may operate in more than one non-therapeutic mode before the device is turned off (i.e., from the on state to the off state).

The device can be turned off automatically when the treatment mode is completed, or by user input. In some embodiments, the user may not be able to turn off the device until the non-therapy mode is completed.

In some embodiments, for example as shown in Figure 19C, device operation in a non-therapy mode 911 may serve as a transition from device on to device operation in a therapy mode 910. The transition from turning on the device to operating in therapy mode may also be important, as the device may not immediately operate in therapy mode and provide adequate therapy to the user (e.g., unable to deliver gas at therapy parameters). In this case, the non-therapy mode may be, for example, a warming mode configured to warm the device before the device begins operating in the therapy mode.

As shown in Figure 20B, when the non-therapy mode is completed, the device may transition from operating in the non-therapy mode 911 to operating in the therapy mode 910 (as discussed in greater detail above). In some embodiments, the device may be configured to automatically operate in at least one treatment mode and then in at least one treatment mode. Alternatively, upon completion of the non-treatment mode, the user may be presented with a prompt indicating that the device is ready for treatment, and the user may enter input on the user interface to transition to operation of the treatment mode.

After the device is turned on (i.e., from an off state to an on state), the device may operate in more than one non-therapy mode.

As discussed above, the non-treatment mode may be a drying mode. The device can be operated in drying mode to dry the breathing tube.

Dry mode reduces the risk of pathogen growth in a moist post-treatment environment and can extend the safe life of the breathing tube. Drying mode is operated for at least 30 minutes, but preferably at least 90 minutes, in order to minimize the risk of growth of pathogens (ie microorganisms) in the catheter (ie tube).

Drying mode may be particularly important in NHF systems as large amounts of condensation can form during use due to the high flow rates and corresponding humidity supplied to the user.

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

After the device has finished operating in treatment mode, it is important to operate the device in drying mode. Drying mode allows any condensation in the breathing tube to be removed after treatment.

After operating in the treatment mode, the device may be operated in the drying mode and the treatment mode is completed (eg, as shown in Figures 19B and 20A and as described in greater detail above).

In some configurations, when in the drying mode, ozone gas may be provided to the gas flow path.

When the device is operating in dry mode, the breathing tube's heater is controlled while the flow generator provides gas at a predetermined flow rate.

When the device is operated in drying mode, the humidifier's heater is deactivated.

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

The predetermined duty cycle may be 100%.

The predetermined temperature is higher than 45 degrees Celsius.

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

If the user attempts to turn off the device before drying mode is complete, the device may display a message to the user that drying mode has not been completed and/or prevent the user from turning off the device or turn off the device without further confirmation.

The drying mode includes controlling the flow generator to provide a predetermined flow generator output, wherein the flow generator output is a motor speed of about 1000 RPM to about 3000 RPM or less than about 2000 RPM.

The drying mode includes controlling the flow generator to provide a predetermined flow rate, wherein the predetermined flow rate is about 5 liters/minute to about 20 liters/minute.

Drying mode is configured to evaporate remaining condensate in the device and/or breathing tube and/or patient interface.

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

As discussed above, the non-therapy mode may be a warming mode. The device may be operated in a warming mode to prepare the device for treatment mode.

Operating the device in warming mode prior to treatment mode may be important to ensure that when treatment begins the device provides gas flow at the treatment parameters of the treatment mode. Having the device activate the humidifier heater and/or the breathing tube heater prior to the therapy mode helps the device provide gas flow at the therapy parameters of the therapy mode when the device begins operating in the therapy mode.

In some embodiments, in the warming mode, the humidifier's heater is activated.

In some embodiments, in the warming mode, the heater of the humidifier and/or the heater of the breathing tube is activated.

In some configurations, in the warming mode, the humidifier's heater and/or the breathing tube's heater is activated at 100% power (eg, 100% duty cycle).

When the device is turned on (i.e., from the off state to the on state), the device can operate in the warming mode.

The warming mode may include controlling the heater of the breathing tube to control the temperature at the end of the tube to a desired temperature.

The desired temperature at the tip of the catheter may be based on one or more treatment parameters of the device.

The desired temperature at the end of the breathing tube may be a predetermined temperature.

The respiratory catheter tip temperature is within about 2 degrees Celsius to about 5 degrees Celsius or about 2.5 degrees Celsius of the desired catheter tip temperature, and optionally about 2 degrees Celsius to about 5 degrees Celsius or about 2.5 degrees Celsius below the predetermined temperature or treatment parameter.

The breathing tube tip temperature can be above about 25 degrees Celsius, or between about 25 degrees Celsius and about 28 degrees Celsius.

The heating mode includes controlling the heater of the humidifier to a predetermined temperature, a predetermined duty cycle, a predetermined voltage, a predetermined current, or a predetermined power.

In some configurations, the rate of temperature increase may be controlled (eg, to a treatment endpoint of increase to breathing tube temperature).

Warming mode may include deactivating the flow generator. Alternatively, the ramp mode includes operating the flow generator at a predetermined flow rate or a predetermined flow generator output. In some embodiments, the predetermined flow rate is lower than the treatment flow rate provided to the patient. In some embodiments, the predetermined flow generator output is a motor speed of about 1000 RPM to about 3000 RPM or less than about 2000 RPM.

In some configurations, increasing the flow generator output for a predetermined time may be included in the ramp mode. The increase may be an increase in a treatment parameter. In some configurations, the flow generator output can increase from a first level to a second level. For example, in ramp mode, the device can increase the flow rate provided by the flow generator from zero flow (or low flow) to the therapeutic flow rate over a period of time. The predetermined time may be the length of the warming mode.

In some configurations, the rate of increase in flow (eg, to treatment flow) can be controlled.

The end condition of the warming mode may be when the device reaches one or more treatment parameters (or is within a specific range of one or more treatment parameters) and/or other desired temperatures, and/or after a predetermined elapsed time.

If the user attempts to start a treatment session before the warming mode is completed, the device may display a message to the user that the warming mode has not been completed and/or prevent the device from operating in the treatment mode without further confirmation.

As discussed above, the non-treatment mode may be a disinfection mode. The device can be operated in disinfection mode to disinfect the device.

The disinfection mode may be based on the method of disinfecting respiratory assistance equipment as disclosed in PCT Publication No. WO 2007/069922, which is incorporated herein by reference.

The disinfection mode may allow for disinfection of a portion of the gas flow path (eg, elbows 325, 235). This could allow for safe reuse of the device without having to replace parts of the device between uses and between patients. Sterilization also prevents cross-contamination when equipment is used by multiple patients and allows for safe reuse of equipment. Disinfection mode can be utilized in both home and hospital environments.

The device can be connected to a sterilization conduit when the device is operating in sterilization mode. The sterile conduit may include a heater for heating gas passing through the sterile conduit.

During the sterilization mode, the sterilization conduit 124 can be connected to the gas outlet 21 of the device and the flow generator outlet (or humidification chamber inlet) as shown in Figure 21, such that gas flows from the flow generator through the sterilization conduit and through the elbow 325 and a filter 123 or valve optionally attached to elbow 325 to atmosphere.

In the sterilization mode, the heater of the sterilization conduit 124 may be controlled such that the gas flow in the sterilization conduit 124 reaches a predetermined temperature. The predetermined temperature may be about 50 degrees Celsius to about 100 degrees Celsius or about 60 degrees Celsius to about 90 degrees Celsius.

The predetermined temperature may be a temperature measured by another sensor in the system (eg, a sensor in elbow 325 or sensor module 400). Additionally or alternatively, the predetermined temperature may be a temperature measured by a temperature sensor of the sterile catheter.

The disinfection mode may include controlling the flow generator to provide a predetermined motor speed. The motor speed may be from about 1000 RPM to about 6000 RPM, or from about 2000 RPM to about 5000 RPM, or preferably from about 2000 RPM to about 3000 RPM. In some embodiments, the predetermined motor speed is 2000 RPM.

Alternatively, the disinfection mode may include controlling the flow generator to provide a predetermined flow rate, wherein the predetermined flow rate is from about 10 liters/minute to about 20 liters/minute.

When a sterile conduit is detected connected to the device, the device may be operating in sterile mode.

Detection of the sterilization tube can be performed by identifying the specific heating wire resistance (or, for example, a heating wire resistance range) of the sterilization tube and/or by an identifier in the tube (such as a thermistor or resistor or an RFID tag or other identification element) .

As discussed above, the non-therapy mode may be a standby mode.

Standby mode may allow the device to enter a mode that keeps the device ready for operation in treatment mode when needed.

The device may operate in standby mode while a user enters input via the user interface. In some embodiments, the device may operate in standby mode after detecting that the patient interface has been removed from the user. In some embodiments, the treatment end command may be generated by detecting that the patient interface has been removed from the user for a predetermined amount of time (the predetermined amount of time may be less than the predetermined time required for the device to operate in dry mode, as described in more detail above describe).

Detection that the patient interface has been removed may be performed as described in greater detail above.

Standby mode may include operating the flow generator at a predetermined flow rate or predetermined motor speed.

The scheduled flow rate is lower than the treatment flow rate.

The intended motor speed is from about 1000 RPM to about 3000 RPM or less than about 2000 RPM.

The device may be operated in drying mode after a predetermined time has elapsed while the device is already operating in standby mode.

The device is configured to collect and store data. Devices can collect data at any time. In some embodiments, the device may be configured to collect data while the device is operating in a therapy mode or a non-therapy mode.

As shown in Figure 22, data 920 may include treatment data 921 collected during operation in at least one treatment mode. The data may additionally or alternatively include device data.

Treatment data 921 includes data related to the user and/or treatment provided to the user.

Treatment data 921 may include data related to one or more individual treatment sessions.

In some embodiments, treatment data includes at least data from historical treatment patterns.

Treatment data 921 may include:

a) The user’s oxygen saturation (SpO2),

b) the user’s breathing rate,

c) the humidity (dew point) of the gas supplied to that user,

d) the flow rate of gas supplied to the user,

e) Patient end temperature,

f) The user’s tidal volume,

g) Minute ventilation of the user,

h) Usage data of the device,

i) Answers to one or more questions provided to the user,

j) Treatment report (optionally, the treatment report relates to previous treatment session reports and/or the currently completed treatment session),

k) information related to at least one health query, as described in more detail above,

l) at least one health inquiry question,

m)Answer to at least one health inquiry,

n) one or more patient benchmarks,

o) Any combination of a) to n).

In some embodiments, the user is presented with one or more questions in a non-therapy mode and the user provides answers to the questions via at least one user interface, and wherein the questions and/or the answers to the questions form a treatment part of the data. It should be understood that questions and answers may relate to the health inquiry or may be separate from the health inquiry.

Treatment data may be collected by one or more sensors, as described in greater detail elsewhere in the specification.

The device may receive sensor output from the one or more sensors and the treatment data is based on the sensor output from the one or more sensors.

The one or more sensors may be located within the housing of the device, for example the operating sensors 3a, 3b, 3c as shown in Figure 1 . Additional sensor locations are shown in Figure 8A, as discussed below.

As shown in Figure 1, the one or more sensors (eg, patient sensor 26) may be located remotely from the device (ie, outside the housing).

As shown in Figure 22, device data may include data related to one or more properties of the device and/or the device's surrounding environment.

Device data may include the device's unique identifier.

The device data may include a sensor calibration profile (containing information related to the calibration of one or more sensors of the device).

Device data may include software and/or firmware versions of the device's software or firmware.

Equipment data may include the total usage time of the equipment, or the usage time of one or more components of the equipment, such as ducts or blowers.

Device data may include identification of one or more components of the device (eg, hardware version of a flow generator or sensor).

As shown in Figure 23, after operating in at least one non-therapy mode for a predetermined time, the device is configured to take one of the following actions 924:

a) transmit that data to the device, or

b) receive a software package from a device or the device, or

c) receive treatment parameters from a device or device (optionally as a prescription), or

d) Update the parameters of the device, or

e) Any combination of a) to d).

Action 924 may occur simultaneously or sequentially.

Multiple actions 924 are disclosed, and it should be understood that any single action may be taken independently, in addition to any combination of actions 924 in any order.

Actions 924 may be performed in priority order. Each action may have an associated priority, and the device may perform the actions in order from the highest priority action to the lowest priority action.

Transmitting data to a device can be the highest priority task, followed by updating parameters of the device (for example, performing sensor calibration), then receiving a software package from a device or devices, then receiving therapy from a device or devices Parameters (optionally as prescriptions).

For example, when a device operates from battery power, prioritization of actions may be important because the device shuts down when the battery is depleted. Actions taken in priority order increase the chance of completion while the device is still powered.

In some configurations, when the device operates from battery power, the device may prioritize providing power to components necessary to take action (e.g., a communications module when transmitting or receiving, or a sensor and associated circuitry when performing sensor calibration) . In some configurations, these actions may be taken prior to other procedures as part of a non-therapeutic mode.

In drying mode and disinfection mode, with the flow generator and heating wire activated, the power consumption is increased so that the components necessary to take action can be prioritized in the power delivery and/or can be used as a non-treatment mode. These actions are taken as part of other processes.

In some configurations, the device is configured to update parameters of the device and then transmit the data to the device. This approach means that sensor calibration information is included in the transmission of data. This may enable faster fault alarming (eg via a device such as a telephone) and/or fault logging of the device and/or patient and equipment management (eg to notify a service technician).

In some configurations, the device is configured to transmit data to a device, then receive a software package from a device or the device, and then update parameters of the device.

In some configurations, the device is configured to: update parameters of the device, then transmit data to the device, then receive a software package from a device or devices, and then based on a software package received from a device or devices Update the parameters of this device.

The device may be configured to receive treatment parameters from the device or devices upon receipt of the software package from the device or devices. Updating treatment parameters after receiving the software package ensures the integrity of the device software before applying new prescription settings.

The device may be configured to receive treatment parameters from a device or devices after transmitting data to the device. This means that updated treatment parameters can be applied during non-treatment mode (eg as prescription updates) based on data transmitted from the device. Based on the data transmitted from the device to the device, the device and/or a clinician with access to patient and device management can make decisions regarding prescription updates. Further, because some non-therapeutic modes last for a predetermined amount of time, the clinician has sufficient time to review and approve changes to the therapy prescription and push them to the device.

The device may be configured to receive treatment parameters from a device or devices before updating parameters of the device.

The device may be configured to transmit data to a device before the device receives treatment parameters from or to the device.

The package can be a newer package (compared to the device's current package).

In some embodiments, the device is configured to query the device whether any newer software packages are available based on the device's current software package version. Optionally, the device communicates the current package version or a timestamp of the current package to the device.

The device can check the package version and update the package on the device if the package is an older version.

Once the software package is successfully installed, the device may transmit a confirmation message to the device and/or an error report if the software package is not successfully installed.

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

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 a version of the current treatment parameters and/or a timestamp of the current treatment parameters to the device.

The device may be configured to request software packages and/or treatment parameters from the device. The device may then allow the device to begin receiving the software package and/or treatment parameters, or may provide a location (eg, another device) from which the device may receive the software package and/or treatment parameters.

It should be understood that receiving the software package and receiving the treatment parameters may be initiated by a get operation, i.e., the device requests information from the device, as opposed to a push operation, in which the device pushes the updated software package and treatment parameters to the device. notify. Alternatively, receiving the software package and receiving the treatment parameters may be initiated by a push operation of the device.

Figure 23 illustrates that when the device is operating in the non-therapy mode, the device checks to determine whether the device has been operating in the non-therapy mode for a predetermined time 923. If the device has been operating in the non-therapy mode for a predetermined time 923, the device performs one of the actions in 924 (described above).

The device can be:

a) Server (local or remote server)

b)Local device

c)Remote device

d) Any combination of a) to c).

In some configurations, the device may be, for example, a phone (e.g., a smartphone), a computer (e.g., a desktop or laptop computer), and/or a tablet computer and/or a wearable device (e.g., with computing and wireless communications capable smartwatch).

The device may be part of a content distribution network or other distributed device platform, such as a cloud computing platform.

The devices and devices may be part of a patient and device management platform.

The patient and device management platform may be a single 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 (ie, including at least one remote server as a device) further includes memory for storing received data and various software applications or services executed to perform a plurality of functions. The patient and device management platform may then, for example, communicate information or instructions to device 10 based at least in part on the received data. For example, the nature of the data received may trigger a remote server (or a software application running on the remote server) to communicate a warning, alert, or notification to the device 10 .

The patient and device management platform may further store the received data for access by an authorized party, such as a clinician or patient or another authorized party. The patient and device management platform may be further configured to generate reports in response to requests from authorized parties. Reports may include responses to health inquiries and/or other patient respiratory parameters (eg, respiratory rate or SpO2) and/or parameters (eg, flow, humidity levels) (eg, as a treatment report as described above).

Different types of data can be provided to different devices or made available to various parties. For example, device data can be provided to a service technician, while treatment data can be provided to a medical practitioner.

Figure 24 shows an architectural diagram illustrating a system for providing respiratory assistance or providing respiratory therapy to a patient. This data (answers and/or dashboards and/or plots) can then be provided to external storage devices such as USB, patient and device management platforms, mobile devices (e.g., smartphones, laptops, tablets, wearable device) and insurance provider or equipment provider. If the data is provided to the USB, the data can later be downloaded to a computer, which can then feed the data to a patient and device management platform or insurance provider. In some embodiments, the mobile device or patient and device management platform may be able to provide data back to the respiratory assistance device (eg, provide information to the patient regarding the patient's physiological condition or pathological changes).

It should be understood that the means for each of the above may be the same or different means. For example, device 10 may transmit data to the same or a different device than the device from which the software package was received.

It will be appreciated that 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 part of the patient and device management platform.

In some embodiments, action 924 occurs only when the device transitions from treatment mode to non-treatment mode.

In some embodiments, action 924 occurs only in the non-therapy mode after completion of the therapy session.

Treatment data transmitted to the device may include data from at least one treatment mode that has not been previously transmitted to the device.

This data may be transmitted to the device even if the device is not operating in at least one treatment mode.

The data may be transmitted to the device after a predetermined period of time has elapsed since the last transmission of data to the device (optionally, the predetermined period of time is 24 hours).

The predetermined time may be from about 5 minutes to about 25 minutes.

In some embodiments, the predetermined time is greater than 5 minutes.

In some embodiments, the predetermined time is less than the total length of time the device is configured to operate in the non-therapy mode. For example, if the drying mode is configured to operate for a predetermined amount of time—ie, 90 minutes (eg, as a drying process), the predetermined time will be less than 90 minutes.

In some embodiments, the predetermined time is a proportion of the total length of time the device is configured to operate in the non-therapy mode. In some embodiments, the device is configured to operate in the non-therapy mode for a proportion of less than about 50%, or less than 40%, or less than about 30% of the total length of time. For example, if the drying mode is configured to operate for a predetermined amount of time, ie, 90 minutes (eg as a drying process), the predetermined time would be, for example, a 50% ratio - 45 minutes.

For example, as shown in Figure 25, after operating 950 in nasal high flow (NHF) mode and after completion of the treatment session 913 (eg, indicating by the user that the treatment session has been completed), the device may operate in a drying mode. In dry mode, the humidifier's heater is deactivated and the conduit's heater is activated while the flow generator provides gas at a predetermined flow rate. When operating in drying mode, the user may turn off the device before drying mode is complete. If the user attempts to turn off the device before the drying mode is completed, the device may display a message warning the user that the drying mode is not completed.

After the device has operated in drying mode for a predetermined time 953 (10 minutes in this case), the device may take one or more actions 924. For example, the device may transmit data (including treatment data and device data) to the device (e.g., a server), receive software packages from the device (e.g., from the same or a different server), and receive software packages from the device (e.g., from the same or a different server). ) receives the treatment parameter package.

When the device takes action 924, the device can display a message warning the user not to turn off the device.

For example, as shown in Figure 26, the device may operate in a warming mode 951 after being turned on. In warming mode, the humidifier heater and the breathing tube heater are activated, while the flow generator is deactivated.

If the warming mode is completed (eg, if the user indicates the start of a treatment session), the device 10 may operate in NHF mode 950. If the warming mode does not meet its end conditions (eg, desired temperature and/or predetermined elapsed time), the device may display a message to the user that the warming mode is not completed.

After the device has operated in warm mode for a predetermined time (10 minutes in this case), the device may take one or more actions 924. For example, the device may transmit data (including treatment data and device data) to the device (e.g., a server), receive software packages from the device (e.g., from the same or a different server), and receive software packages from the device (e.g., from the same or a different server). ) receives the treatment parameter package.

If the user attempts to turn off the device while data is being transferred to the device, the user may be presented with a visual indication and/or an audible indication.

In some embodiments, visual and/or audible indications are presented to the user when data is uploaded to the device.

Visual indications can be presented on the display module.

The visual indication may be, for example, a picture of a modem icon and/or a message.

You can prevent the device from shutting down when an action is taken. In this case, however, the potential inconvenience to users is limited, as they are unlikely to want to turn off the device before the non-treatment session is complete.

In non-therapy mode, the device may display a visual indication on the display to warn the user not to use the device during non-therapy mode.

The device operating in non-therapy mode for a predetermined time ensures that action 924 is not taken if the device is turned off immediately after exiting therapy mode, as this could jeopardize completion of action 924 .

To facilitate data transmission and/or receipt of software packages and/or treatment parameters from the device, the device is configured to activate a network interface (as described in more detail above) and establish a connection with the device for the purpose of transmitting data to the device and /or receive software packages and/or treatment parameters from a device or the device.

Software packages may include firmware updates (eg, for controlling one or more hardware functions of the device). Additionally or alternatively, the software package may include software updates (eg for updating algorithms or routines in the device, eg a control algorithm).

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

The ability to receive updates in this manner ensures that updates are rolled out in a timely manner, which can improve device performance.

A predetermined time delay after entering non-therapeutic mode may be important for the software package to be applied to the device, as may the device being turned off during installation of the software package, which may result in the software package not being applied or being partially applied, which may affect the functionality of the device . For example, if the software package is applied as soon as the treatment period is over, the user can turn off the device after treatment. Further, if the software package is only applied when selected by the user (to mitigate the risk of device shutdown), the user may not apply important software packages due to inconvenience. In another example, if a software package is applied during treatment, there is a risk of inadequate treatment being provided for a period of time.

Updating parameters of the device may include updating calibration parameters of the device. Updating the parameters of the device may include performing sensor recalibration (eg, as described in greater detail below).

The device may receive one or more updated parameters for the device from the device and apply the updated parameters to the device. Updated parameters of the device may include, for example, a predetermined time after operating in a non-therapy mode when an action is taken, or sensor calibration settings. Updated parameters can be received as part of the software package.

In some embodiments, the device application updates the device's treatment parameters (eg, as a prescription update) after receiving the treatment parameters from a device or the device. Treatment parameters can be specific to a particular treatment mode. Updates to treatment parameters may also update only a subset of the device's treatment parameters, rather than necessarily updating all of the device's treatment parameters.

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

Additionally, because action 924 occurs only in non-therapy mode, the transmission and reception of data is reduced, which means that data costs can be reduced compared to the case where the device continuously transmits and receives data.

If the device 10 is not operating in a therapy mode, the device may transmit signals to the device every predetermined amount of time (eg, at predetermined time intervals). In some embodiments, the predetermined amount of time is 24 hours. In this case, device data can also be transferred simultaneously.

If the transmission of this signal is unsuccessful (for example, due to a connection failure), the device will retry transmission after a certain period of time and until a certain number of attempts have been reached after 24 hours have passed. If unsuccessful after said certain number of attempts, the device will wait for another 24-hour window before starting the process again.

The device may send notifications of updates to treatment parameters or that software packages are available to the device. In this case, the device may download updates from the device but wait in non-therapy mode until a predetermined time has elapsed before applying the updates.

When the device operates via a battery (eg, powered by a battery) (eg, as described above), the device may not take an action after a predetermined time in the non-therapy mode, or may prompt the user to confirm the action before taking the action. This can preserve the battery's charge or allow the user to have more control over the device's power usage.

In some embodiments, the user may be able to manually prompt the device to take action (optionally via input on the user interface) when the device is operating via battery power.

In some embodiments, when the device is operating via battery power, the user may be able to manually prompt the device to take action after operating in a non-therapy mode for a predetermined time.

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

In some embodiments, when the device is reconnected to external power, the device may prompt the user to perform an action after operating in the non-therapy mode for a predetermined time.

The device may be configured to perform actions immediately when the device enters the battery charge state (e.g., when connected to an external power source) or to operate in a non-therapy mode for a predetermined time after being in the battery charge state (e.g., when connected to an external power source). After) perform the action.

The predetermined time may be the predetermined time described above with respect to operating in the non-therapy mode, or greater than about 2 minutes or greater than about 5 minutes.

In some embodiments, the battery charging state may be entered when the device is not turned on.

When the maintenance task is completed (eg, general maintenance of the equipment, or replacement of equipment parts), the equipment can be configured to perform actions immediately or perform actions at a predetermined time after the maintenance task is completed.

In some embodiments, after the repair task is completed, the device may prompt the user (in this case the service technician) to take action (as described above).

In the case where an action is performed after a maintenance task, the action can serve as a connectivity test to ensure that the communication module is operational.

When the device enters travel mode (such as air travel or travel away from the user's normal location), after a predetermined time in non-therapy mode, the device may take no action or may prompt the user to confirm an action before taking it. This may limit data transfer costs or reverse battery charging.

In some embodiments, the device may prompt the user to perform an action when the device exits the travel state (eg, if there is data to transfer, or it is time for the device to check for updated software packages).

When the device is in travel mode, the user may be able to manually prompt the device to take action (optionally via input on the user interface).

In the travel state, the device may deactivate the communication module (or part of the communication module) in accordance with regulations related to aircraft travel. In some embodiments, the device may also operate via batteries in travel mode.

As described above, the device is configured to operate in at least one treatment mode and at least one non-treatment mode.

As shown in Figure 27, when the device is operating 911 in at least one non-therapy mode, the device is configured to update parameters of the device 960. The non-therapy mode may provide the device with a safe opportunity (eg, as described in greater detail above) to update the device's parameters. The updated parameters may be used during treatment mode 910, for example, sensor calibration parameters 961 updated in non-therapy mode 911 may be used during treatment mode 910 (eg, as shown in Figure 28).

As shown in Figure 29, the device is configured to update parameters 960 of the device after the device has been operating in at least one non-therapy mode 970 for a predetermined time.

In some configurations, the device may be configured to update the device's parameters 960 after the device has been operating in a non-therapy mode for approximately 10 minutes.

In some configurations, the device may be configured to update the device's parameters 960 approximately 5 minutes before the end of operation of the device in the non-therapy mode.

Alternatively or additionally, as shown in Figure 30, the device is configured to update parameters 960 of the device at the end of the non-therapy mode 971.

In some configurations, for example, as part of step 924 in Figure 25, the device may be configured to update parameters of the device before transmitting data to the device. The transmitted data may include, for example, updated parameters of the device.

As shown in Figure 25A, after operating in treatment mode 950, for example, when the treatment session is completed 913 (eg, following an end of treatment command as described in greater detail above), the device may operate in a drying mode. In dry mode, the humidifier's heater is deactivated and the conduit's heater is activated while the flow generator provides gas at a predetermined flow rate. When operating in drying mode, the user may turn off the device before drying mode is complete. If the user attempts to turn off the device before the drying mode is completed, the device may display a message warning the user that the drying mode is not completed.

After the device has been operating in dry mode for a predetermined time 953 (10 minutes in this case), the device may update at least one parameter of the device 960 . This parameter may include one or more sensor calibration parameters, as described in more detail elsewhere. After updating the one or more sensor calibration parameters, the device may proceed to step 924" in which the device transmits data to the device. The data may include the one or more sensor calibration parameters. The data may Include other data as described in greater detail above, e.g., treatment data and/or device data. In some configurations, after updating one or more sensor calibration parameters, the device may take one or more actions 924 (e.g., As described in more detail elsewhere and, for example, as shown in Figure 31).

When the device takes action 924, the device can display a message warning the user not to turn off the device.

As shown in Figure 31, the device may be configured to update the device's parameters 960 when the non-therapy mode ends 972, and subsequently take further actions, as described in greater detail above. In some configurations, the device may provide a prompt to the user via the user interface to confirm updating parameters of the device.

Updating the parameters of the device during some non-treatment modes (eg, drying mode and/or warming mode and/or cooling mode and/or disinfecting mode) may allow the device to efficiently utilize the time the device is in the non-treatment mode. This means that the parameters of the device can be updated while the device is adopting some non-therapeutic mode that occurs during normal operation of the device. This could mean that the device's parameters can be updated without the device having to stop taking some non-therapeutic mode.

Further, as mentioned above, the device does not need to update the parameters of the device during treatment mode. Updating the device's parameters during treatment mode may increase patient risk, as the update may mean that treatment needs to stop being delivered or that the required treatment parameters are not provided.

A separate mode with device update parameters may be inconvenient for users as it must be actively selected by the user, and this may prevent users from updating their devices. This can result in devices being updated infrequently, potentially compromising treatment. Preventing device operation when parameters have not been updated can be risky, for example, when a user requires treatment but must wait for the device to update parameters before use.

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

Sensor accuracy may degrade over time or be compromised by damage or improper use. If the sensor is not calibrated, the device may not provide adequate treatment. If the sensor is not calibrated, the device's control system may not be able to control the device's functionality.

For example, if the flow sensor (i.e., ultrasonic flow sensor) is not calibrated, the device may not accurately deliver flow-based therapy (e.g., high-flow therapy).

As a further example, if the pressure sensor is not calibrated, the device may not accurately provide pressure-based therapy (eg, CPAP, BCPAP, and/or bi-level therapy).

As a further example, if the oxygen concentration sensor (i.e., the ultrasonic oxygen concentration sensor) is not calibrated, the device may not be able to accurately control the amount of oxygen provided to the user. This may mean that therapeutic oxygen concentrations are not provided to the user, and the user may be hypoxic or hyperoxic, which may lead to negative health outcomes.

Updating sensor calibration parameters ensures the safety and proper operation of your equipment.

In some configurations, the at least one sensor can be any sensor in the device. For example, the at least one sensor may be any sensor described elsewhere in the specification. In some configurations, the at least one sensor can be associated with the device. For example, the at least one sensor may be connected to the device.

The at least one sensor may be any of the following:

·Pressure Sensor,

·Temperature Sensor,

·Humidity Sensor,

·Oxygen concentration sensor,

·Flow Sensors.

The pressure sensor can be an absolute pressure sensor or a differential pressure sensor.

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 more sensors (eg, temperature and humidity sensors).

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.

As described in greater detail above, for example with respect to Figure 8A, the at least one sensor may be located in one or more of the following:

· Sensor module (optionally, the sensor module can be positioned as part of the flow generator and/or between the blower and humidifier) - e.g. sensor 44,

· Flow generator – e.g. sensors 3a, 44 and/or 43,

· Location upstream of the flow generator – e.g. sensors 41 and/or 42,

· Location downstream of the flow generator - e.g. sensors 44, 46 and/or 48,

· Humidifier - e.g. sensors 45 and/or 46,

· Location upstream of the humidifier - e.g. sensors 41, 42 and/or 44,

· Location downstream of the humidifier - e.g. sensors 46 and/or 48,

A conduit configured to connect to the gas outlet of the humidifier and deliver the gas flow to the user (optionally at the user end of the conduit proximate the patient interface) - e.g., sensor 48,

·Patient interface,

· Environmental sensors - e.g. sensor 40,

·Measurement chamber (optionally as part of the sensor module) - e.g. 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.

For example, operating sensors 3a, 3b, 3c and 29 are included in the device 1 as shown in Figure 1, and/or sensors 40, 41, 42, 43, 44, 45, 46, 47 as shown in Figure 8A and 48 in. The operating sensor may be located anywhere as described above, or any sensor as described above.

Sensor calibration parameters may relate to a relationship between an output of the at least one sensor and a characteristic that the sensor is configured to measure. Sensor calibration parameters can include one or more of the following:

·Calibration coefficient,

·Calibration curve,

·Internal parameters of the sensor.

For example, a calibration coefficient or curve may be a coefficient or curve used as part of a formula that determines the relationship between a sensor's output and a characteristic that the sensor is configured to measure.

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

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

In some configurations, the sensor's internal parameters can be updated. Sensors can use internal parameters to provide output.

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

The device may be configured to update sensor calibration parameters based on outputs of the at least one sensor and additional sensors. The output of one sensor can be compared to the output of another sensor and sensor calibration parameters determined based on the comparison.

The device may use the sensor calibration parameters to determine a characteristic that the at least one sensor is configured to measure based on the output of the at least one sensor. Additionally, the device can be configured to update the control scheme based on sensor calibration parameters. For example, different humidity control schemes may be used to control the humidity output of a device (eg, a humidifier of the device) based on sensor calibration parameters.

Sensor calibration parameters can be stored in the device's memory.

Sensor calibration parameters can be used by the device in therapy mode.

The device may be configured to update the sensor calibration parameters when the sensor's error is outside the allowed tolerance. Allowable tolerances may be based on the specific type and/or location of the sensor. For example, an oxygen concentration sensor (as described in more detail below) may have an acceptable tolerance of +/-3%.

Allowable tolerances may include allowable specification tolerances and/or allowable treatment tolerances. The allowable specification tolerance may be based on the specific specifications of the sensor, and being outside the allowable specification tolerance may indicate that the sensor is faulty (ie, the sensor has failed to calibrate). The allowable treatment tolerance may be a tolerance associated with the sensor's ability to be used acceptably in providing treatment.

Allowable treatment tolerances can be based on specific sensor locations and sensor types. Allowable treatment tolerances can be based on the device control system and the use of sensors in the control.

If the permissible specification tolerances are not met, the device can return a fault and prevent use of the device, i.e., the sensor calibration fails.

If the allowable treatment tolerance is not met, the device can update the sensor's sensor calibration parameters.

If the error of the sensor is within the allowable tolerance (ie, the sensor calibration is successful), the device may not update the sensor calibration parameters of the sensor and continue to use the current sensor calibration parameters. If the sensor's error is outside the allowed tolerance, the device can update the sensor's sensor calibration parameters, which can also be classified as a successful sensor calibration.

Sensor errors may be determined, for example, by comparison between outputs of sensors in the device (eg, a first sensor and a second sensor as described below) and/or by performing specific tests as described in more detail below.

It should be understood that where the error is based on a comparison between the outputs of sensors, it is assumed that one of the sensors is correct and the error is determined based on that sensor. The specific sensor that is assumed to be correct will depend on, for example, sensor type, sensor location, sensor error, and the environment of the device. The device can perform one or more checks on a specific sensor that is assumed to be correct before assuming it to be correct. For example, if the correct sensor is assumed to be a temperature sensor, and the temperature is outside the acceptable range, the device may not assume that the sensor is correct.

If the device detects that the sensor is outside the allowable tolerance and/or if the sensor calibration parameters change beyond a threshold, the device may take any combination of the following:

a) Sound an alarm on the device (e.g. audible alarm and/or visual alarm)

b) transmit the alarm condition to a device (e.g. a device as described elsewhere in the description, which device may be a user device or a clinician device, for example)

c) Prevent operation of the device (in some configurations, the device may be allowed to operate after the user acknowledges the alarm, in some configurations, a service technician may be required to repair and/or service the device before allowing the device to operate)

d) Generate a report containing information related to the sensor calibration process (e.g., including errors and whether the sensor is within or outside tolerance, success or failure of calibration and/or resolution of sensor failure). The report can be transmitted to the device and optionally be part of the data transmitted to the device. In some configurations, the report may be displayed on a display of the device and/or a display of the device.

e) display via the display of the device and/or the display of the device information related to the sensor calibration process (e.g. including errors and whether the sensor is within or outside tolerance, success or failure of calibration and/or sensor malfunction s solution).

Various examples of updating sensor calibration parameters of at least one sensor are described below. It should be understood that any combination of the following examples may be combined.

Sensor calibration parameters may be updated for at least one sensor. Sensor calibration parameters can be updated simultaneously or sequentially.

Each sensor can be tested multiple times to update the sensor calibration parameters associated with that sensor. For example, for a flow sensor, a no-flow calibration can be performed in conjunction with a predetermined flow calibration (as described in more detail below).

In some configurations, at least one sensor includes a first sensor and the additional sensors include a second sensor. The device 1 may be configured to update sensor calibration parameters associated with the first sensor based on the output of the second sensor. The sensor calibration parameters may be based on a comparison between the output of the first sensor and the output of the second sensor. For example, as shown in Figure 32, at step 991, device 1 determines the output of a first sensor, at step 992, device 1 determines the output of a second sensor, and at step 990, device 1 based on the output of the first sensor and the output of the second sensor determine sensor calibration parameters. It should be understood that steps 991 and 992 can be performed in parallel.

The first sensor may be an environmental sensor and the second sensor may be a sensor located in the flow path of the device.

In the non-therapy mode, the controller can control the flow generator such that the flow generator does not provide a flow of gas, so the conditions of the gas in the flow path are the same as the ambient conditions.

In some configurations, the first sensor may be located in the same location as the second sensor (eg, as an environmental sensor, or in the flow path of the gas).

Specific examples related to pressure sensors, temperature sensors, flow sensors, and humidity sensors are outlined below. It should be understood that in the following examples, the first sensor and the second sensor may be interchanged.

In some configurations, at least one sensor includes a first pressure sensor and the additional sensors include a second pressure sensor. The device 1 may be configured to update sensor calibration parameters associated with the first pressure sensor based on the output of the second pressure sensor. The sensor calibration parameters may be based on a comparison between the output of the first pressure sensor and the output of the second pressure sensor.

The first pressure sensor may be an ambient pressure sensor and the second pressure sensor is a pressure sensor located in the flow path of the device.

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

In some configurations, when the device calibrates the makeup gas inlet sensor 42, the device may prompt the user to confirm that no gas supply is connected to the makeup gas inlet such that the ambient pressure is the same as the pressure at the makeup gas inlet.

The device may determine whether gas supply to one or both of the supplemental gas inlet and/or the alternative gas inlet is detected. The method of detecting the gas supply may be as disclosed in PCT Publication No. WO 2021/048744, which is hereby incorporated by reference in its entirety.

The presence of a gas supply connected to the supplemental gas inlet can be detected by pulsating the valve (e.g., momentarily opening it fully and then closing it) and observing subsequent fluctuations in gas composition (via an oxygen concentration sensor). During this procedure, the blower can provide flow at a predetermined flow rate.

In the non-therapy mode, the controller may control the flow generator such that the flow generator does not provide a flow of gas and therefore the ambient pressure is the same as the gas pressure in the flow path (i.e., the pressure of the gas flow path is the same as the pressure of the environment).

In some configurations, the first pressure sensor may be located in the same location as the second pressure sensor (eg, as an environmental sensor, or in the flow path of the gas).

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

No flow may be zero flow or very close to zero flow such that the flow of gas is insignificant.

In some configurations, the pressure sensor may be a differential pressure sensor configured to measure the pressure difference between the surrounding environment and the gas flow path. In this case, when no gas flow is provided (as mentioned above) the sensor calibration parameters can be determined based on the output of the pressure sensor such that the ambient pressure is the same as the gas pressure in the flow path and the output of the differential pressure sensor should be zero .

The pressure sensor may have an allowable tolerance of about +/- _2cmH2O to about +/- _3cmH2O , or about +/- _5cmH2O to about +/- _15cmH2O , or about +/- _10cmH2O . The error may be the difference between the output of the first pressure sensor and the second pressure sensor.

In some configurations, at least one sensor includes a first temperature sensor and the additional sensor includes a second temperature sensor. The device is configured to update a sensor calibration parameter of the first temperature sensor based on the output of the second temperature sensor. The sensor calibration parameters may be based on a comparison between the output of the first temperature sensor and the output of the second temperature sensor.

The first temperature sensor may be an ambient temperature sensor (eg, additional sensor 40), and the second temperature sensor may be a patient-side temperature sensor located in or near the patient-end of a catheter configured to connect to the device. In some configurations, the first temperature sensor may be a patient-end temperature sensor located in or near the patient end of a conduit configured to be connected to the device, and the second temperature sensor may be an ambient temperature sensor.

The first temperature sensor may be located at the same location as the second temperature sensor (eg, as an environmental sensor, or in the flow path of the gas).

The temperature sensor may have an allowable tolerance of 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 outputs of the first temperature sensor and the second temperature sensor.

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

In some configurations, at least one sensor includes a first flow sensor and the additional sensors include a second flow sensor. The device 1 may be configured to update sensor calibration parameters associated with the first flow sensor based on the output of the second flow sensor. The sensor calibration parameters may be based on a comparison between the output of the first flow sensor and the output of the second flow sensor.

The first flow sensor may be of the hot wire anemometer (eg, heated thermistor) type, and the second flow sensor may be an ultrasonic sensor (as described in more detail elsewhere). In some configurations, the first flow sensor may be an ultrasonic sensor and the second flow sensor may be a hot wire anemometer (eg, heated thermistor) type sensor.

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

The error may be the difference between the output of the first flow sensor and the second flow sensor.

In some configurations, the flow sensor may be sensor 44 (and, for example, thermistor 2206 and ultrasonic transducer 2204).

In the non-therapy mode, the device may be configured not to provide power to the humidifier's heater and/or the conduit's heating filament for a predetermined period of time such that the ambient temperature is the same as the temperature of the gas in the flow path. This may be done toward the end of the non-therapy mode (eg, a predetermined time before the end of the non-therapy mode) and/or after other sensor calibration parameters have been determined as described elsewhere.

The device may include at least one valve. The at least one valve may be a valve module or part thereof as described in more detail above.

The at least one valve may be configured to be connected to a source of supplemental gas; the supplemental gas may be, for example, oxygen.

The at least one valve can control the flow of makeup gas. In some configurations, the at least one valve can control the flow of the makeup gas to achieve the makeup gas concentration. For example, the at least one valve may control the supplemental gas concentration (of the gas flow provided to the user) to achieve therapeutic patient oxygen saturation. In some configurations, the device may further include at least one patient oxygen saturation sensor, and operation of the at least one valve for controlling the supplemental gas concentration to achieve a therapeutic patient oxygen saturation may be based on the at least one patient oxygen saturation sensor. output. By further example, the device may be configured to operate the valve to control the supplemental gas concentration such that the flow of gas may be provided to the user at a therapeutic oxygen concentration.

The make-up gas flow may be configured to be combined with ambient air. Combined make-up gas and ambient air can be provided to the flow generator.

In some configurations, the supplemental gas flow may be configured to be added to the gas flow produced by the flow generator.

In some configurations, when the device updates parameters, the at least one valve may be operated to prevent the flow of makeup gas: when the at least one valve is so operated, it may be assumed that the concentration of makeup gas in the gas flow is that in ambient air Make-up gas concentration. In some configurations, the device may be configured to prompt the user (optionally via a user interface) to disconnect the source of the supplemental gas from the alternative supply inlet before the device updates the device's parameters.

An alternative supply inlet may be configured to be connected to a source of supplemental gas. The make-up gas flow from the alternative supply inlet may be configured to be combined with ambient air, and the combined make-up gas and ambient air may be provided to the flow generator. A supplemental gas flow from an alternative supply inlet may be configured to be added to the gas flow produced by the flow generator.

The at least one sensor may be an oxygen concentration sensor. The oxygen concentration sensor may include, for example, an ultrasonic sensor. The ultrasonic sensor may be an ultrasonic transducer as described in greater detail above.

The apparatus may be configured to determine the output of the oxygen concentration sensor when supplemental gas is not provided as part of the gas flow and/or when supplemental gas is provided as part of the gas flow. The output of the oxygen concentration sensor can indicate the oxygen concentration in the gas stream.

The device may be configured to determine oxygen concentration sensor calibration parameters.

The device may be configured such that make-up gas is not provided as part of the gas flow. The device 1 may be configured such that supplementation is not provided as part of the gas flow by controlling at least one valve to not provide supplemental gas and/or by prompting the user to take action to prevent the provision of supplemental gas (eg, by disconnecting the supplemental gas source).

In some configurations, the oxygen concentration sensor calibration parameters are determined based on the output of the oxygen concentration sensor and/or the estimated oxygen ambient concentration (eg, when it is confirmed that supplemental gas is not provided as part of the gas flow). The estimated oxygen ambient concentration may be, for example, about 19% to about 23%, or about 20.9%, or about 21%, or about 22%.

For example, as shown in Figure 33, at step 911, the device is operating in a non-therapy mode, and at step 995, device 1 determines whether to provide supplemental gas as part of the gas flow. If supplemental gas is provided, the device continues to operate in the non-therapy mode, and if supplemental gas is not provided, the device continues to determine the output of the oxygen concentration sensor at step 993. At step 996, device 1 determines oxygen concentration sensor calibration parameters based on the output of the oxygen concentration sensor.

The oxygen concentration sensor parameter may additionally be determined based on an estimated oxygen ambient concentration, which may, for example, be measured by another sensor, estimated, or input by a user via a user interface.

In some configurations, (e.g., when supplemental 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 based on the output of the oxygen concentration sensor and/or a predetermined Determine the oxygen concentration. The predetermined oxygen concentration may be, for example, 100%. In some configurations, a predetermined oxygen concentration may be entered by the user.

In some configurations, the device may be configured such that ambient air may not be provided as part of the gas flow. The device 1 may be configured such that ambient air may not be provided as part of the gas flow, by controlling at least one valve to provide only supplementary gas and/or by prompting the user to take action to prevent ambient air from being provided.

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

After determining the oxygen concentration sensor calibration parameters, the device may be configured to operate the flow generator at a predetermined flow rate and/or a predetermined motor speed. In some configurations, the device may be configured to operate the flow generator at a predetermined flow rate and/or a predetermined motor speed after the device has determined the oxygen concentration sensor calibration parameters. This may help clear any oxygen from the system before it enters therapy mode.

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

During the non-therapy mode, the device may be configured to cause the flow generator to cease generating a flow of gas and determine the output of the flow sensor: the output may be indicative of the flow of gas.

As shown in Figure 34, the device may be configured to determine flow at step 986 based on the output of the flow sensor (determined at step 985) and/or a predetermined no flow after controlling the flow generator to no flow at step 984. Sensor calibration parameters. Flow sensor calibration parameters can be applied to the output of the flow sensor. The predetermined no flow may be OLPM, for example.

During the non-therapy mode, the device may be configured to determine the output of the flow sensor while the flow generator is producing a flow of gas. This output can indicate the flow of gas. The device may be configured to determine flow sensor calibration parameters based on the output of the flow sensor and/or the predetermined flow rate. This parameter can be applied to the output of the flow sensor. The predetermined flow rate may be above 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.

The predetermined flow rate may be based on motor speed (eg, from a motor speed sensor as described above). The relationship between motor speed and flow rate may be based on a formula and/or lookup table such that the motor speed corresponds to the associated flow rate.

The device may be configured to determine flow sensor calibration parameters based on the output of the flow sensor and/or the motor speed. For example, as mentioned above, a motor speed is expected to produce a known output from a flow sensor. For example, it can be known that at a specific motor speed (and optionally without a patient connected) a specific flow rate should be expected. If the flow sensor measurement is outside a predetermined tolerance, the flow sensor calibration parameters may be updated.

The flow sensor may have an allowable tolerance of about +/-0.1 LPM to about +/-3 LPM, or about +/-0.5 LPM to about +/-1 LPM.

The allowable tolerance relative to no flow may be the difference between no flow and the output of the flow sensor when no flow is provided.

The allowable tolerance relative to the predetermined flow rate may be the difference between the predetermined flow rate and the output of the flow sensor at the predetermined flow rate.

Determining flow sensor calibration parameters during non-therapeutic mode may be beneficial because non-therapeutic flow rates may be provided (eg, those that are inappropriate for the patient or non-compliant, eg, which may be lower or higher than typical therapy flows).

Further, during non-therapy mode, the patient will not be connected, so the characteristics of the system will be consistent (eg, flow conductance between the flow generator and the tip of the catheter or sterile catheter). Therefore, the relationship between flow rate and motor speed and/or the relationship between measured flow rate and motor speed may be more reliable.

Further, this comparison is even more reliable in certain non-therapeutic modes (such as sterile mode) where the patient interface is disconnected and specific tubes with known properties (such as flow conductance) are connected in the loop to the device inlet/outlet . Further, different interface types may not need to be considered.

The device may be configured to determine the output of the humidity sensor. This output can indicate the humidity of the gas stream. In some configurations, when supplemental gas is provided as the gas stream, the device may be configured to determine the output of the humidity sensor (indicative of the humidity of the gas stream). In some configurations, the device may be configured to determine the output of the humidity sensor (indicative of the humidity of the gas flow) when there is no ambient air in the gas flow.

As shown in Figure 35, in some configurations, the device is configured to determine the humidity sensor calibration parameters at step 987 based on the output of the humidity sensor and/or the predetermined humidity. The predetermined humidity may be, for example, 0% relative humidity, or no absolute humidity. In some configurations, the controller may be configured to determine the humidity sensor calibration parameters based on the output of another humidity sensor.

The humidity sensor and/or another humidity sensor may include an ambient humidity sensor or a gas flow humidity sensor.

In some configurations, the at least one sensor includes a first humidity sensor and a second humidity sensor. The device 1 may be configured to update sensor calibration parameters associated with the first humidity sensor based on the output of the second humidity sensor. The sensor calibration parameters may be based on a comparison between the output of the first humidity sensor and the output of the second humidity sensor.

The first humidity sensor may be an ambient humidity sensor and the second humidity sensor is a humidity sensor located in the flow path of the device.

In the non-therapy mode, the controller may control the flow generator such that the flow generator does not provide a flow of gas and therefore the ambient humidity is the same as the pressure of the gas in the flow path (i.e., the humidity of the gas flow path is the same as the humidity of the environment).

In some configurations, the first humidity sensor may be located in the same location as the second humidity sensor (eg, as an environmental sensor, or in the flow path of the gas).

The humidity sensor may have an acceptable tolerance of 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 sampled environment.

The allowable tolerance may be the difference between the output of the first humidity sensor and the output of the second humidity sensor.

The device may be configured such that no treatment is provided to the user when it is operated in at least one non-treatment mode. The at least one non-therapeutic mode may include at least one of the following:

a drying mode configured to dry the conduit, and/or

warming mode, and/or

Standby mode.

The device may be configured such that when it is operated in at least one treatment mode, treatment is provided to the user. The at least one treatment mode may include at least one of the following:

Continuous positive airway pressure (CPAP) mode, and/or

Bubble continuous positive airway pressure (BCPAP) mode, and/or

Nasal high flow (NHF) mode, and/or

Bilevel (e.g., NIV) mode.

As shown in Figure 36, in some configurations, the device is configured to automatically operate 911 in the at least one non-therapy mode after completion 914 of the at least one therapy mode.

The device may be configured to update parameters of the device at the end of the non-therapy mode and/or at the beginning of the non-therapy mode.

Claims (79)

1. A breathing assistance device, including: a flow generator configured to generate a flow of gas; a humidifier configured to be pneumatically connected to the flow generator and to humidify the gas flow, wherein said device is configured to be connected to a conduit conveying said flow of gas, wherein the device is configured to operate in at least one treatment mode and at least one non-therapeutic mode, wherein when operating in the at least one treatment mode, the device is configured to provide treatment to the user, wherein said device is configured to collect and store data including treatment data and/or device data collected during operation in said at least one treatment mode, Wherein, after operating in the at least one non-therapy mode for a predetermined time, the device is configured to: a) transmit said data to the device, or b) receive a software package from a device or said device, or c) receive treatment parameters from a device or said device, or d) update the parameters of said equipment, or e) Any combination of a) to d). 2. The breathing assistance device of claim 1, wherein therapy is provided to the user when the device is operating in the at least one therapy mode. 3. The breathing assistance device of claim 1 or claim 2, wherein 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). 4. The breathing assistance device of any one of claims 1 to 3, wherein no therapy is provided to the user when the device is operating in the at least one non-therapy mode. 5. The breathing assistance device of any one of claims 1 to 4, wherein the device is configured to automatically operate in the at least one non-therapy mode upon completion of the at least one therapy mode. 6. The respiratory assistance device of any one of claims 1 to 5, wherein the device is configured to enter the at least one non-therapy mode upon receipt of an end-of-therapy command, which may Optionally generated via the user interface and/or by detecting that the patient interface has been removed from the user. 7. The breathing assistance device of claim 6, wherein the treatment end command is generated as follows: a) via input from the 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 amount of time, d) Any combination of a) to c). 8. The respiratory assistance device of any one of claims 1 to 7, wherein the flow generator is activated and generates the gas when the device is operated in the at least one non-therapy mode. flow. 9. The respiratory assistance device of any one of claims 1 to 8, wherein when the device is operating in the at least one non-therapeutic mode, the flow generator provides the gas in the following manner: flow: A flow rate that is less than the treatment flow rate of the gas flow provided during the treatment mode, and/or, Book traffic. 10. The respiratory assistance device of any one of claims 1 to 9, wherein when the device is operated in the at least one non-therapy mode, the humidifier, optionally the humidifier The heating plate is activated and optionally the humidifier is configured to humidify the gas stream. 11. The respiratory assistance device of any one of claims 1 to 10, wherein when the device is operated in the at least one non-therapy mode, the heater of the catheter is activated and configured to The gas flow in the conduit is heated. 12. The respiratory assistance device of any one of claims 1 to 11, wherein the at least one non-therapy mode includes a drying mode configured to dry the conduit. 13. The respiratory assistance device of claim 12, wherein when the device is operated in the drying mode, the heater of the conduit is controlled while the flow generator provides gas at a predetermined flow rate. 14. The respiratory assistance device of claim 12 or claim 13, wherein the heater of the humidifier is controlled to a predetermined value when the device is operated in the drying mode, or in the drying mode. The heating plate is deactivated during the mode, optionally the predetermined value is a predetermined power and the predetermined power is less than about 5% or less than about 10% of the maximum power provided to the heating plate. 15. The respiratory assistance device of claim 13, wherein the heater of the conduit is controlled to a predetermined temperature at the end of the conduit, or to a predetermined duty cycle, or a predetermined voltage, or a predetermined Current, or predetermined power. 16. The breathing assistance device of claim 15, wherein the predetermined duty cycle is 100%. 17. The respiratory assistance device of claim 16, wherein the predetermined temperature is greater than 45 degrees Celsius. 18. The respiratory assistance device of any one of claims 12 to 17, wherein the drying mode is configured to operate for about 20 minutes to about 120 minutes, or about 90 minutes. 19. The respiratory assistance device of any one of claims 12 to 18, wherein the drying mode includes controlling the flow generator to provide a predetermined flow generator output, wherein the flow generator output is A motor speed of about 1000 RPM to about 3000 RPM or less than about 2000 RPM. 20. The respiratory assistance device of any one of claims 12 to 18, wherein the drying mode includes controlling the flow generator to provide a predetermined flow rate, wherein the predetermined flow rate is from about 5 liters/minute to About 20 liters/minute. 21. The breathing assistance device of any one of claims 12 to 20, wherein the drying mode is configured to evaporate remaining condensate in the device and/or patient breathing conduit and/or patient interface. 22. The breathing assistance device of any one of claims 1 to 21, wherein the non-therapy mode is a warming mode. 23. The breathing assistance device of claim 22, wherein when the device is on, the device operates in the warming mode. 24. The respiratory assistance device of claim 22 or 23, wherein the warming mode includes controlling a heater of the conduit to control the temperature at the end of the conduit to a desired temperature. 25. The respiratory assistance device of claim 24, wherein the desired temperature at the tip of the catheter is based on one or more treatment parameters of the device. 26. The respiratory assistance device of claim 25, wherein the one or more treatment parameters are: a) Treatment chamber outlet temperature, b) the therapeutic dew point temperature at the chamber outlet or the end of the conduit, c) therapeutic humidity at the chamber outlet or end of the conduit, and/or d) the therapeutic temperature at the end of said catheter, e) Any combination of a) to d). 27. A respiratory assistance device as claimed in any one of claims 24 to 26, wherein the desired temperature at the end of the conduit is a predetermined temperature. 28. The respiratory assistance device of claim 26 or 27, wherein the catheter tip temperature is within about 2 degrees Celsius to about 5 degrees Celsius or about 2.5 degrees Celsius of a desired patient end temperature, and optionally is greater than the predetermined temperature. The temperature or the treatment parameter is about 2 degrees Celsius to about 5 degrees Celsius or about 2.5 degrees Celsius lower. 29. The respiratory assistance device according to any one of claims 22 to 28, wherein the heating mode includes controlling the heater of the humidifier to a predetermined temperature, or a predetermined duty cycle, or a predetermined voltage, or Predetermined current, or predetermined power. 30. The respiratory assistance device of any one of claims 22 to 29, wherein the warming mode includes deactivating the flow generator. 31. The breathing assistance device of any one of claims 1 to 30, wherein the conduit is configured to deliver the gas to the patient via a patient interface. 32. The respiratory assistance device of any one of claims 1 to 31, wherein the non-therapeutic mode is a disinfecting mode. 33. The respiratory assistance device of claim 32, wherein in the sterilization mode the device is configured to be connected to a sterile conduit. 34. The respiratory assistance device of claim 33, wherein in the sterilization mode, the heater of the sterilization conduit is controlled such that the gas flow in the sterilization conduit reaches a predetermined temperature. 35. The respiratory assistance device of claim 34, wherein the predetermined temperature is about 50 degrees Celsius to about 100 degrees Celsius or about 60 degrees Celsius to about 90 degrees Celsius. 36. A respiratory assistance device as claimed in claim 34 or claim 35, wherein the sterile conduit includes a temperature sensor. 37. The respiratory assistance device of any one of claims 32 to 36, wherein the sterilization mode includes controlling the flow generator to provide a predetermined flow rate, wherein the predetermined flow rate is from about 10 liters/minute to About 20 liters/minute. 38. The breathing assistance device of any one of claims 1 to 37, wherein the non-therapy mode is a standby mode. 39. The respiratory assistance device of claim 38, wherein the standby mode includes operating the flow generator at a predetermined flow rate or a predetermined motor speed. 40. The respiratory assistance device of claim 39, wherein the predetermined flow rate is lower than the therapeutic flow rate provided to the patient. 41. The respiratory assistance device of claim 39, wherein the predetermined motor speed is from about 1000 RPM to about 3000 RPM or less than about 2000 RPM. 42. The respiratory assistance device of any one of claims 1 to 41, wherein the treatment data includes data relating to the user and/or treatment provided to the user. 43. The respiratory assistance device of claim 42, wherein the treatment data includes: a) The user’s oxygen saturation SpO2, b) the breathing rate of said user, c) the humidity (dew point) of the gas supplied to said user, d) the flow rate of gas provided to said user, e) the tidal volume of said user, f) minute ventilation of said user, g) Any combination of a) to f). 44. The respiratory assistance device of claim 42 or claim 43, wherein the treatment data includes: a) Usage data of said equipment, b) Answers to one or more questions provided to the user, c) treatment reports, optionally relating to previous treatment session reports and/or the currently completed treatment session, d) Results of health inquiries, e) Any combination of a) to d). 45. The respiratory assistance device of any one of claims 1 to 44, wherein the device includes one or more sensors configured to determine the treatment data. 46. The breathing assistance device of any one of claims 1 to 45, wherein one or more questions are presented to the user when the device is operating in the at least one non-therapy mode, and The user provides answers to the questions via at least one user interface, and wherein the questions and/or the answers to the questions form part of the treatment data. 47. The respiratory assistance device of claim 46, wherein the device is configured to receive sensor output from the one or more sensors, wherein the treatment data is based on sensor output from the one or more sensors. . 48. The breathing assistance device of any one of claims 1 to 47, wherein the one or more sensors are located within a housing of the device. 49. The breathing assistance device of any one of claims 1 to 49, wherein the one or more sensors are located remotely from the device. 50. The respiratory assistance device of any one of claims 1 to 49, wherein the treatment data is from the at least one treatment mode. 51. The respiratory assistance device of any one of claims 1 to 50, wherein the treatment data includes at least data from historical treatment patterns. 52. The respiratory assistance device of any one of claims 1 to 51, wherein the treatment data includes data from at least one treatment mode that has not been previously transmitted to the device. 53. The respiratory assistance device of any one of claims 1 to 52, wherein the device data relates to one or more properties of the device and/or the surrounding environment of the device. 54. The respiratory assistance device of any one of claims 1 to 53, wherein the data is transmitted to the device even if the device is not operating in at least one treatment mode. 55. The respiratory assistance device of any one of claims 1 to 54, wherein the data is transmitted to the device after a predetermined period of time has elapsed since the last data transmission to the device, optionally , the predetermined time period is 24 hours. 56. The respiratory assistance device of any one of claims 1 to 55, wherein the device is: a) Server b)Local device c)Remote device d) Any combination of a) to c). 57. The respiratory assistance device of any one of claims 1 to 56, wherein the predetermined time is from about 5 minutes to about 25 minutes. 58. The respiratory assistance device of any one of claims 1 to 57, wherein the predetermined time is greater than 5 minutes. 59. The respiratory assistance device of any one of claims 1 to 58, wherein the predetermined time is less than the total length of time the device is configured to operate in the non-therapy mode. 60. The respiratory assistance device of any one of claims 1 to 59, wherein the predetermined time is a proportion of the total length of time the device is configured to operate in the non-therapy mode. 61. The respiratory assistance device of any one of claims 1 to 60, wherein the device includes a controller configured to control operation of the device. 62. The breathing assistance device of any one of claims 1 to 61, wherein a visual is presented to the user when the user attempts to turn off the device while the data is being transferred to the device. instructions and/or audible instructions. 63. A breathing assistance device as claimed in any one of claims 1 to 62, wherein visual and/or auditory indications are presented to the user when the data is uploaded to the device. 64. The respiratory assistance device of any one of claims 1 to 63, wherein, to ensure that the device does not shut down immediately after the device exits the treatment mode, the device is configured to: a) transmit said data to the device, or b) receive a software package from a device or said device, or c) receive treatment parameters from a device or said device, or d) update the parameters of said equipment, or e) any combination of a) to d), These operations are performed after operating in the at least one non-therapy mode for the predetermined time. 65. The respiratory assistance device of any one of claims 1 to 64, wherein after operating in the at least one non-therapy mode for a predetermined time, the device is configured to activate a network interface and establish communication with the Connection of devices to transmit data to said device and/or to receive software packages and/or treatment parameters from a device or said device. 66. The breathing assistance device of any one of claims 1 to 65, wherein the software package includes one or more of the following: a) Firmware update, b)Software updates. 67. The breathing assistance device of any one of claims 1 to 66, wherein upon receiving the software package, the device applies the software package to the device. 68. The respiratory assistance device of any one of claims 1 to 67, wherein updating parameters of the device includes performing sensor recalibration. 69. The respiratory assistance device of any one of claims 1 to 68, wherein the device application updates the device's treatment parameters after receiving the treatment parameters from a device or devices. 70. The breathing assistance device of any one of claims 1 to 68, wherein the software package and/or the treatment parameters are updated only when the software package and/or the treatment parameters are updates to the current software package and/or the current treatment parameters. The device receives the software package and/or the treatment parameters. 71. A breathing assistance device, comprising: gas inlet and gas outlet, case, a flow generator located within the housing, the flow generator configured to generate a flow of gas, A humidifier located within the housing, the humidifier being in fluid communication with the flow generator and configured to humidify the gas flow from the flow generator, the humidifier including a humidifier configured to humidify the gas flow from the flow generator. A heater that heats the fluid in the humidification chamber of a humidifier, a conduit configured to connect to the gas outlet and deliver the gas flow, the conduit including a heater configured to heat the gas flow in the conduit, one or more sensors located within said housing, a controller, the controller including at least a processor and a memory, the controller being configured to control at least the flow generator, the humidifier, and the heater of the conduit, wherein the controller is configured to receiving sensor output from the one or more sensors and storing data based on the sensor output from the one or more sensors, wherein the controller is configured to operate the device in at least a therapy mode and a non-therapy mode, wherein in the therapy mode the device is configured to provide therapy to the user based on one or more therapy parameters, and in said non-therapy mode, at least one of said flow generator, said humidifier heater and/or said catheter heater is activated and no flow of gas is provided to said user, Wherein, after operating in the non-therapy mode for a predetermined time, the controller is configured to: a) transmit said data to the device, or b) receive a software package from a device or said device, or c) receive treatment parameters from a device or said device, or d) update the parameters of said equipment, or e) Any combination of a) to d). 72. A breathing assistance device, comprising: gas inlet and gas outlet, case, a flow generator located within the housing, the flow generator configured to generate a flow of gas, A humidifier located within the housing, the humidifier being in fluid communication with the flow generator and configured to humidify the gas flow from the flow generator, the humidifier including a humidifier configured to humidify the gas flow from the flow generator. A heater that heats the fluid in the humidification chamber of a humidifier, a conduit configured to connect to the gas outlet and deliver the gas flow, the conduit including a heater configured to heat the gas flow in the conduit, one or more sensors located within said housing, a controller, the controller including at least a processor and a memory, the controller being configured to control at least the flow generator, the humidifier, and the heater of the conduit, wherein the controller is configured to receiving sensor output from the one or more sensors and storing data based on the sensor output from the one or more sensors, wherein the controller is configured to operate the device in at least a treatment mode and a drying mode, wherein in the treatment mode the device is configured to provide treatment to the user based on one or more treatment parameters, and In the drying mode, the heater of the humidifier is deactivated and the heater of the conduit is activated while the flow generator provides gas at a predetermined flow rate and/or a predetermined motor speed, Wherein, after operating in the drying mode for 10 minutes, the controller is configured to: a) transmit said data to the device, or b) receive a software package from a device or said device, or c) receive treatment parameters from a device or said device, or d) update the parameters of said equipment, or e) Any combination of a) to d). 73. The respiratory assistance device of any one of claims 1 to 72, wherein the updated parameters of the device are sensor calibration parameters of one or more sensors, and optionally sensor calibration parameters. 74. The respiratory assistance device of claim 73, wherein the sensor calibration parameter relates to a relationship between the output of the at least one sensor and a characteristic that the sensor is configured to measure. 75. The breathing assistance device of any one of claims 72 to 74, wherein the one or more sensors comprise: a flow sensor configured to measure the flow rate of the gas flow, optionally the flow sensor includes an ultrasonic sensor, and/or and an oxygen concentration sensor configured to measure the oxygen concentration of the gas. Optionally, the oxygen concentration sensor includes an ultrasonic sensor. 76. The respiratory assistance device of claim 75, wherein the device is configured to determine the oxygen concentration sensor indicative of an oxygen concentration of the gas flow when supplemental gas is not provided as part of the gas flow. an output, wherein the device is configured to determine an oxygen concentration sensor calibration parameter based on the output of the oxygen concentration sensor and the estimated oxygen ambient concentration. 77. The respiratory assistance device of claim 76, wherein the estimated oxygen ambient concentration is from about 19% to about 23%, about 20.9%, or about 21%, or about 22%. 78. The respiratory assistance device of any one of claims 75 to 77, wherein when supplemental gas is provided as the gas flow, the device is configured to determine the oxygen concentration indicative of the gas flow. An output of an oxygen concentration sensor, wherein the device is configured to determine an oxygen concentration sensor calibration parameter based on the output of the oxygen concentration sensor and a predetermined oxygen concentration. 79. A breathing assistance device, comprising: a flow generator configured to generate a flow of gas; a humidifier configured to be pneumatically connected to the flow generator and to humidify the gas flow, wherein the device is configured to operate in at least one treatment mode and at least one non-therapeutic mode, wherein when operating in the at least one treatment mode, the device is configured to provide treatment to the user, Wherein, the device is configured to update at least one parameter of the device when the device is operating in the at least one non-therapy mode.