Nasal minute ventilation and peak inspiratory flow in a respiratory flow therapy system

Abstract

A system and method for determining nasal minute ventilation and peak inspiratory flow in an unsealed respiratory treatment system. The device can receive respiratory device gas flow parameter data indicative of a patient's respiration. The controller can process the gas flow parameter data to remove noise. The controller can determine device minute ventilation and convert device minute ventilation to nasal minute ventilation. The controller can monitor and / or display data related to at least one of nasal minute ventilation, rate of change of nasal minute ventilation, and trend of nasal minute ventilation. The respiratory device can activate an alarm or notification when at least one of nasal minute ventilation, rate of change of nasal minute ventilation, and trend of nasal minute ventilation exceeds or falls below a threshold value.

Description

[Technical field]

[0001] The present disclosure relates to methods and systems for providing respiratory flow therapy to a patient. In particular, the present disclosure relates to estimating one or more respiratory parameters in an unsealed respiratory flow therapy system (i.e., in an open respiratory therapy system using an unsealed patient interface). [Background technology]

[0002] Respiratory support apparatus are used in a variety of environments, such as hospitals, medical facilities, home care, or home environments, to deliver a gas flow to a user or patient. Respiratory support or respiratory treatment apparatus (collectively "respiratory apparatus" or "respiratory device") may be used to deliver supplemental oxygen or other gases with a gas flow, and / or a humidifier to deliver heated and humidified gas. Respiratory apparatus may be able to regulate and control characteristics of the gas flow, including flow rate, temperature, gas concentration, humidity, pressure, etc. Sensors, such as flow and / or pressure sensors, are used to measure the characteristics of the gas flow. Summary of the Invention [Means for solving the problem]

[0003] Respiratory devices can monitor and determine various parameters (i.e., known as respiratory parameters) associated with a patient's use of the device. The parameter data (i.e., respiratory parameters) can inform a clinician about the patient's health, use of the respiratory device, and / or improving the patient's respiratory function. The data can assist in determining the effectiveness of high-flow therapy provided to the patient. The data can also be used to improve the functionality of the respiratory device itself.

[0004] Inhalation and exhalation by a patient using a respiratory device can affect gas flow within the device because when the patient inhales through a patient interface, such as a mask or nasal cannula, the resistance to gas flow within the patient interface decreases, and when the patient exhales, the resistance to gas flow within the patient interface increases. Some parameters, such as respiratory rate, are determined by monitoring the changes in the flow parameter signal due to inhalation and exhalation.

[0005] In a sealed system, this inhalation and exhalation is relatively easy to measure due to the use of a sealed interface. However, in a non-sealed system (i.e., an open system using a non-sealed interface), such as a nasal high flow system using a non-sealed patient interface, the patient's inhalation and exhalation are more difficult to determine due to the open (i.e., non-sealed) nature of the system. It may be easy to mistake irregularities in the signal, particularly the time domain signal, as a respiratory trigger event. Parameters determined from such an analysis may be misleading when the respiratory device may detect a breath in the signal when there is no breathing (e.g., due to the patient being unplugged, not breathing through the nose, and / or other reasons).

[0006] The present disclosure relates to better understanding patient breathing, and in particular to determining patient breathing parameters in unsealed high flow systems. This can be accomplished by performing an analysis of gas flow parameters to estimate breathing parameters (i.e., respiratory parameters). The estimated breathing parameters (i.e., respiratory parameters) can include nasal minute ventilation (i.e., patient minute ventilation) and / or the patient's peak inspiratory flow. These breathing parameters (i.e., respiratory parameters) can be used to visually present trend data (e.g., plots of time series over time). The trend data can be used to provide alerts, prompts, and / or notifications to a user or clinician to adjust treatment parameters (e.g., flow rate) to improve treatment outcomes.

[0007] In one configuration, a respiratory device is configured to deliver respiratory therapy to a patient using an unsealed respiratory interface (i.e., an unsealed patient interface), the device is configured to provide information related to the patient's breathing, the device includes a controller, the controller is configured to receive data of a parameter indicative of the patient's breathing of the gas flow of the respiratory device while the device is being used with the unsealed user interface, determine a parameter indicative of the device's minute ventilation or device minute ventilation, and indicate the minute ventilation (i.e., the user's minute ventilation) to a user. The indication of the patient-provided minute ventilation (i.e., the patient's minute ventilation) indicates the amount of respiratory gas provided to the user per minute. The minute ventilation is the nasal minute ventilation (i.e., the patient's minute ventilation) when an unsealed nasal interface, such as a nasal cannula, is used.

[0008] In one configuration, the controller is further configured to process the gas flow parameter data to remove noise. In one configuration, the controller is configured to remove noise associated with the effect of the motor on the gas flow parameter. In one configuration, the controller is configured to receive data on the motor speed, and the gas flow parameter is discarded if the motor speed is below a preset threshold. In one configuration, the controller is configured to discard the gas flow parameter if the controller determines that the gas flow parameter is of poor quality. In one configuration, the gas flow parameter is of poor quality because it includes a large transient peak.

[0009] In one configuration, determining the minute ventilation of the device includes utilizing a mathematical function to the gas flow parameter. The function may include fitting one or more curves. In one example, the minute ventilation of the device includes fitting a plurality of splines to the gas flow parameter data, the plurality of splines being fitted using a least squares criterion, and the minute ventilation of the device is determined by integrating along the plurality of splines. The function is used to average the measured data and determine the best fit. In one configuration, determining the minute ventilation of the device includes integrating the absolute value of the first term of a line fitted to the gas flow parameter data. In one configuration, determining the minute ventilation of the device includes integrating the absolute value of the line fitted to the gas flow parameter data divided by a time range. In one configuration, determining the minute ventilation of the device includes averaging the absolute value of the line fitted to the gas flow parameter data over a range of time points within the time range.

[0010] In one configuration, the device minute ventilation is converted to nasal minute ventilation (i.e., patient minute ventilation) to indicate the amount of gas delivered to the user per minute. In one configuration, the device minute ventilation is converted to nasal minute ventilation (i.e., patient minute ventilation) using a scalar calibration constant. In one configuration, the scalar calibration constant is determined by inputting patient interface parameters related to the nasal cannula or current flow rate. In one configuration, the scalar calibration constant is determined by inputting at least one of the cannula type, the patient's size, and the nostril diameter, and / or the amount of nasal obstruction of the user. In one configuration, the scalar calibration constant is calculated by temporarily placing a sealed face mask on the patient's face while the patient wears an unsealed nasal cannula to measure at least one flow parameter of the respiratory device.

[0011] In some configurations, the controller is further configured to monitor at least one of nasal minute ventilation, rate of change of nasal minute ventilation, and trend of nasal minute ventilation. In some examples, these parameters are patient parameters.

[0012] In some configurations, the respiratory device further includes a display, the display configured to display data related to the nasal minute ventilation. In some configurations, the respiratory device further includes a display, the display configured to display data related to the rate of change of the nasal minute ventilation. In some configurations, the respiratory device further includes a display, the display configured to display data related to the trend of the nasal minute ventilation. The nasal minute ventilation value (i.e., number) may be displayed on the display of the device. The respiratory device may also include one or more wireless communication modules, for example a cellular communication module and / or a WIFI module and / or a short-range communication module such as Bluetooth. The determined nasal minute ventilation may be transmitted by the respiratory device via the communication module to a remote server at regular intervals (e.g., after a treatment session or at regular intervals during treatment). The server may store or process the nasal minute ventilation. The server may be configured to include the nasal minute ventilation information in an appropriate treatment report for a particular patient. The server is configured to communicate with multiple therapy devices and receive nasal minute ventilation data for multiple patients and manage this data to generate reports and the like.

[0013] In some configurations, the respiratory device is configured to activate an alarm or notification when nasal minute ventilation exceeds or falls below a preset threshold. In some configurations, the respiratory device is configured to activate an alarm or notification when the rate of change of nasal minute ventilation exceeds or falls below a preset threshold. In some configurations, the respiratory device is configured to activate an alarm or notification when the trend of nasal minute ventilation exceeds or falls below a preset threshold.

[0014] In one configuration, the respiratory device includes a patient interface, the patient interface including a nasal cannula.

[0015] In one configuration, the respiratory device is configured to deliver nasal high flow therapy.

[0016] In one configuration, the respiratory device further includes a humidifier configured to humidify the gas flow to the patient.

[0017] In one configuration, a respiratory device is configured to deliver respiratory therapy to a patient using an unsealed respiratory interface, the device is configured to provide information related to the patient's respiration, the device includes a controller configured to receive data for a parameter of a gas flow of the respiratory device indicative of the patient's respiration, process the data for the gas flow parameter to remove noise, determine whether the gas flow parameter is of sufficient quality, determine a minute ventilation of the device, and convert the minute ventilation of the device to a nasal minute ventilation using a scalar calibration constant.

[0018] In one configuration, the controller is configured to remove noise associated with the effect of the motor on the gas flow parameter. In one configuration, the controller is configured to receive data on the motor speed, and the gas flow parameter is discarded if the motor speed is below a preset threshold. In one configuration, the gas flow parameter is of poor quality because it includes large transient peaks.

[0019] In one configuration, determining the minute ventilation of the device includes fitting a plurality of splines to the gas flow parameter data, the plurality of splines being fitted using a least squares criterion, and the minute ventilation of the device is determined by integrating along the plurality of splines. In one configuration, determining the minute ventilation of the device includes integrating the absolute value of a first term of a line fitted to the gas flow parameter data. In one configuration, determining the minute ventilation of the device includes integrating the absolute value of a line fitted to the gas flow parameter data divided by a time range. In one configuration, determining the minute ventilation of the device includes averaging the absolute value of a line fitted to the gas flow parameter data over a range of time points in the time range.

[0020] In one configuration, the controller is configured to calculate a normalized device minute ventilation based on the device minute ventilation. In one configuration, the controller is configured to calculate a noise correction factor correlated to the normalized device minute ventilation. In one configuration, the controller is configured to calculate a corrected device minute ventilation by correlating the normalized device minute ventilation and the noise correction factor with the device minute ventilation.

[0021] In one configuration, the scalar calibration constant is determined by inputting a patient interface parameter related to the nasal cannula or current flow rate. In one configuration, the scalar calibration constant is determined by inputting at least one of the cannula type, the patient size, and the nostril diameter. In one configuration, the scalar calibration constant is calculated by temporarily placing a sealed face mask over the patient's face while the patient is wearing a nasal cannula to measure at least one flow parameter of the respiratory device.

[0022] In one configuration, the controller is further configured to monitor at least one of nasal minute ventilation, rate of change of nasal minute ventilation, and trend of nasal minute ventilation, which parameters may be transmitted to a remote server via the communications module.

[0023] In some configurations, the respiratory device further includes a display configured to display data related to nasal minute ventilation. In some configurations, the respiratory device further includes a display configured to display data related to rate of change of nasal minute ventilation. In some configurations, the respiratory device further includes a display configured to display data related to trends in nasal minute ventilation.

[0024] In some configurations, the respiratory device is configured to activate an alarm or notification when nasal minute ventilation exceeds or falls below a preset threshold. In some configurations, the respiratory device is configured to activate an alarm or notification when the rate of change of nasal minute ventilation exceeds or falls below a preset threshold. In some configurations, the respiratory device is configured to activate an alarm or notification when the trend of nasal minute ventilation exceeds or falls below a preset threshold.

[0025] In one configuration, the respiratory device includes a patient interface, the patient interface including a nasal cannula.

[0026] In one configuration, the respiratory device is configured to deliver nasal high flow therapy.

[0027] In one configuration, the respiratory device includes a humidifier configured to humidify the gas flow to the patient.

[0028] In one configuration, a respiratory device is configured to deliver respiratory therapy to a patient using an unsealed respiratory interface, the device is configured to provide information related to the patient's respiration, the device includes a controller, the controller is configured to receive data for a parameter of a gas flow of the respiratory device indicative of the patient's respiration, and to determine a maximum inspiratory flow for the patient.

[0029] In one configuration, the controller is further configured to determine the minute ventilation of the device.

[0030] In one configuration, the patient's maximum inspiratory flow is based on the minute ventilation of the device.

[0031] In one configuration, the controller is further configured to process the gas flow parameter data to remove noise. In one configuration, the controller is configured to remove noise associated with the effect of the motor on the gas flow parameter. In one configuration, the controller is configured to receive data on the motor speed, and the gas flow parameter is discarded if the motor speed is below a preset threshold. In one configuration, the controller is configured to discard the gas flow parameter if the controller determines that the gas flow parameter is of poor quality. In one configuration, the gas flow parameter is of poor quality because it includes a large transient peak.

[0032] In one configuration, determining the minute ventilation of the device includes fitting a plurality of splines to the gas flow parameter data, the plurality of splines being fitted using a least squares criterion, and the minute ventilation of the device is determined by integrating along the plurality of splines. In one configuration, determining the minute ventilation of the device includes integrating the absolute value of a first term of a line fitted to the gas flow parameter data. In one configuration, determining the minute ventilation of the device includes integrating the absolute value of a line fitted to the gas flow parameter data divided by a time range. In one configuration, determining the minute ventilation of the device includes averaging the absolute value of a line fitted to the gas flow parameter data over a range of time points within the time range.

[0033] In one configuration, the controller is configured to calculate a normalized device minute ventilation based on the device minute ventilation. In one configuration, the controller is configured to calculate a normalized device minute ventilation based on the device minute ventilation. In one configuration, the controller is configured to calculate a corrected device minute ventilation by correlating the normalized device minute ventilation and a noise correction factor with the device minute ventilation.

[0034] In some configurations, the controller is further configured to convert the minute ventilation of the device to a nasal minute ventilation. In some configurations, the minute ventilation of the device is converted to a nasal minute ventilation using a scalar calibration constant. In some configurations, the scalar calibration constant is determined by inputting a patient interface parameter associated with the nasal cannula or current flow rate. In some configurations, the scalar calibration constant is determined by inputting at least one of the cannula type, the patient size, and the nostril diameter. In some configurations, the scalar calibration constant is calculated by temporarily placing a sealed face mask on the patient's face while the patient is wearing the nasal cannula to measure at least one flow parameter of the respiratory device. In some configurations, the patient's peak inspiratory flow is determined by converting the nasal minute ventilation by applying the calibration constant. In some configurations, the calibration constant is 3. In some configurations, the calibration constant is 4. In some configurations, the calibration constant is 5. In some configurations, the calibration constant is 6. In some configurations, the calibration constant is between 3 and 6.

[0035] In one configuration, the controller is further configured to monitor at least the peak inspiratory flow or a rate of change of the peak inspiratory flow.

[0036] In one configuration, the respiratory device further includes a display, the display configured to display data related to the peak inspiratory flow. In one configuration, the respiratory device further includes a display, the display configured to display data related to the rate of change of the peak inspiratory flow. In one configuration, the respiratory device is configured to activate an alarm or notification when the peak inspiratory flow exceeds or falls below a preset threshold.

[0037] In one configuration, the respiratory device is configured to activate an alarm or notification when the rate of change of peak inspiratory flow exceeds or falls below a preset threshold.

[0038] In one configuration, the respiratory device includes a patient interface, the patient interface including a nasal cannula.

[0039] In one configuration, the respiratory device is configured to deliver nasal high flow therapy.

[0040] In one configuration, the respiratory device further includes a humidifier configured to humidify the gas flow to the patient.

[0041] In one configuration, a respiratory device is configured to deliver respiratory therapy to a patient using an unsealed respiratory interface, the device is configured to provide information related to the patient's breathing, the device includes a controller, the controller is configured to receive a flow rate of a gas flow of the respiratory device while the device is in use with the unsealed user interface, and to determine a respiratory parameter based on the received gas flow rate, the respiratory parameter being indicative of the patient's ventilation.

[0042] In one configuration, the controller is configured to display the respiratory parameters on a graphical user interface.

[0043] In one configuration, the controller is configured to determine the minute ventilation of the device based on the gas flow, and the controller is configured to determine the patient ventilation based on the minute ventilation of the device.

[0044] In one configuration, the controller is further configured to manipulate the flow rate of the gas stream to eliminate noise.

[0045] In one configuration, the controller is configured to remove noise associated with the effect of the motor on the parameters of the gas flow.

[0046] In one configuration, the controller is configured to receive data on the motor speed, and the parameters of the gas flow are discarded if the motor speed falls below a preset threshold. In one configuration, the controller is configured to discard the gas flow rate if the controller determines that the gas flow rate is of insufficient quality. In one configuration, the gas flow rate is of insufficient quality because it includes a large transient peak. In one configuration, the controller is configured to determine a minute ventilation of the device according to any one of the configurations above, and the nasal minute ventilation may be calculated as defined in any of the configurations above. In one configuration, a respiratory device is configured to deliver respiratory therapy to a patient using an unsealed respiratory interface, the device is configured to provide information related to the patient's breathing, the device includes a controller, the controller is configured to receive a gas flow rate of the respiratory device while the device is being used with the unsealed user interface, and to determine a patient's maximum inspiratory flow based on the received gas flow rate, the patient's maximum inspiratory flow being indicative of the patient's ventilation.

[0047] In one configuration, the controller is configured to display the patient's peak inspiratory flow on a graphical user interface. In one configuration, the controller is configured to determine the patient's peak inspiratory flow based on the device's minute ventilation. In one configuration, the device's minute ventilation is based on the gas stream flow rate, the gas stream flow rate being preprocessed according to any of the above configurations. In one configuration, the device's minute ventilation is calculated according to any of the above configurations. In one configuration, the controller is further configured to convert the device's minute ventilation to nasal minute ventilation according to any of the above configurations.

[0048] In one configuration, the controller is configured to monitor at least the peak inspiratory flow or the rate of change of the peak inspiratory flow. In one configuration, the respiratory device further includes a display, the display configured to display data related to at least one of the peak inspiratory flow or the rate of change of the peak inspiratory flow. In one configuration, the breath is configured to activate an alarm or notification when the peak inspiratory flow exceeds or falls below a preset threshold. In one configuration, the breath is configured to activate an alarm or notification when the rate of change of the peak inspiratory flow exceeds or falls below a preset threshold.

[0049] In one configuration, the controller is configured to determine a tidal volume and activate an alarm or notification when the tidal volume falls below a preset threshold. In one configuration, the controller is configured to normalize the corrected device minute ventilation using the device flow. In one configuration, the respiratory device further includes a display configured to display data related to the corrected device minute ventilation. In one configuration, the respiratory device further includes a display configured to display data related to a rate of change of the corrected device minute ventilation. In one configuration, the respiratory device further includes a display configured to display data related to a trend of the corrected device minute ventilation. In one configuration, the respiratory device is configured to activate an alarm or notification when the corrected device minute ventilation exceeds or falls below a preset threshold. In one configuration, the respiratory device is configured to activate an alarm or notification when the rate of change of the corrected device minute ventilation exceeds or falls below a preset threshold. In one configuration, the respiratory device is configured to activate an alarm or notification when the trend of the corrected device minute ventilation exceeds or falls below a preset threshold.

[0050] These and other features, aspects, and advantages of the present disclosure will be described with reference to the drawings of specific embodiments, which are illustrative of specific embodiments and are not intended to limit the disclosure. [Brief description of the drawings]

[0051] [Figure 1A] 1 illustrates generally a respiratory system configured to provide respiratory therapy to a patient. [Figure 1B] 2 illustrates generally another embodiment of a respiratory system configured to provide respiratory therapy to a patient. [Diagram 2] A front view of an embodiment of a respiratory device is shown with the humidification chamber in place and the handle / lever raised. [Diagram 3] FIG. 3 shows a plan view of the embodiment of the respiratory device of FIG. 2. [Figure 4] FIG. 3 shows a right side view of the embodiment of the respiratory device of FIG. [Diagram 5] FIG. 3 shows a left side view of the embodiment of the respiratory device of FIG. 2. [Figure 6] FIG. 3 shows a rear view of the embodiment of the respiratory device of FIG. 2. [Figure 7] FIG. 3 shows a front left perspective view of the embodiment of the respiratory device of FIG. [Figure 8] FIG. 3 shows a front right perspective view of the embodiment of the respiratory device of FIG. [Figure 9] FIG. 3 shows a bottom view of the embodiment of the respiratory device of FIG. 2. [Figure 10] 1 shows an embodiment of an air and oxygen inlet arrangement for a breathing device. [Figure 11] 13 shows another embodiment of the air and oxygen inlet arrangement of the breathing device. [Figure 12] FIG. 12 shows a cross-sectional view showing further details of the air and oxygen inlet arrangement of FIG. [Figure 13] FIG. 12 shows another cross-sectional view showing further details of the air and oxygen inlet arrangement of FIG. [Figure 14] FIG. 12 shows a longitudinal section view showing further details of the air and oxygen inlet arrangement of FIG. [Figure 15] FIG. 1 shows an exploded view of the upper and lower chassis components of the main housing of the respiratory device. [Figure 16] FIG. 1 illustrates a front left side perspective view of the lower chassis of the main housing, showing the housing for receiving the motor and / or sensor module subassembly. [Figure 17] FIG. 2 shows a first rear perspective view of the main housing of the respiratory device, showing recesses inside the housing for the motor and / or sensor module subassembly. [Figure 18] FIG. 13 shows a second rear perspective view of the main housing of the respiratory device, showing recesses for the motor and / or sensor module subassembly. [Figure 19A] FIG. 1 shows a block diagram of a control system that interacts with and / or controls and directs components of the respiratory system. [Figure 19B] 1 illustrates a block diagram of an exemplary controller. [Figure 20] FIG. 2 shows a block diagram of the motor and sensor module. [Figure 21] 1 illustrates a sensing chamber of an exemplary motor and sensor module. [Figure 22A] 1 illustrates an embodiment of a flow chart for a method of estimating nasal minute ventilation. [Figure 22B] 1 illustrates another embodiment of a flow chart for a method for estimating nasal minute ventilation. [Figure 22C] 1 illustrates another embodiment of a flow chart for a method for estimating nasal minute ventilation. [Figure 22D] 1 illustrates another embodiment of a flow chart for a method for estimating nasal minute ventilation. [Diagram 23] 13 shows another embodiment of a flow chart for a method of estimating minute ventilation of a device. [Figure 24] 1 illustrates an embodiment of a flow chart for a method of estimating peak inspiratory flow. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0052] Although specific examples are described below, those skilled in the art will recognize that the disclosure extends beyond the specifically disclosed examples and / or uses obvious modifications and equivalents thereof, and therefore it is not intended that the scope of the disclosure disclosed herein should be limited to any specific examples described below.

[0053] Overview of an Exemplary Respiratory System A schematic diagram of the respiratory system 10 is provided in FIG. 1A. The respiratory system 10 may include a main device housing 100. The main device housing 100 may contain a flow generator 11, which may be in the form of a motor / impeller arrangement, an optional humidifier or humidification chamber 12, a controller 13, and a user interface 14. The user interface 14 may include a display and input devices such as buttons, a touch screen, a combination of a touch screen and buttons, or the like. The controller 13 may include one or more hardware and / or software processors and may be configured or programmed to control components of the device, including, but not limited to, operating the flow generator 11 to generate a gas flow for delivery to a patient, operating the humidifier 12 (if present) to humidify and / or heat the gas flow, receiving user input from the user interface 14 for reconfiguration and / or user-defined operation of the respiratory system 10, and outputting information to a user (e.g., on a display). The user may be a patient, a medical professional, or others.

[0054] Continuing to refer to FIG. 1A, the patient respiratory conduit 16 may be coupled to a gas outlet 21 within the main device housing 100 of the respiratory system 10 and may be coupled to a patient interface 17, such as a non-sealing interface such as a nasal cannula with a manifold 19 and nasal prongs 18.

[0055] The gas flow may be generated by a flow generator 11 and may be humidified before being delivered to the patient through the patient interface 17 via the patient conduit 16. The controller 13 may control the flow generator 11 to generate a gas flow at a desired flow rate, and / or one or more valves to control the mixture of air and oxygen or other breathable gas. The controller 13 may control a heating element in the humidification chamber 12, if present, to heat the gas to a desired temperature to achieve a desired level of temperature and / or humidity for delivery to the patient. The patient conduit 16 may have a heating element 16a, such as a heater wire, to heat the gas flow passing to the patient. The heating element 16a may also be under the control of the controller 13.

[0056] The system 10 may use ultrasonic transducers, flow sensors such as thermistor flow sensors, pressure sensors, temperature sensors, humidity sensors, or other sensors in communication with the controller 13 to monitor characteristics of the gas flow and / or operate the system 10 in a manner to provide appropriate therapy. The gas flow characteristics may include gas concentration, flow rate, pressure, temperature, humidity, or others. The sensors 3a, 3b, 3c, 20, 25, such as pressure, temperature, humidity, and / or flow sensors, may be located at various locations within the main device housing 100, the patient conduit 16, and / or the patient interface 17. The controller 13 may receive outputs from the sensors to assist in determining appropriate target temperatures, flow rates, and / or pressures of the gas flow and in operating the respiratory system 10 in a manner to provide appropriate therapy. Providing appropriate therapy may include meeting or exceeding the patient's inhalation demand to reduce entrainment of ambient air at the patient interface.

[0057] The system 10 may include a wireless data transmitter and / or receiver, or transceiver 15, by which the controller 13 may wirelessly receive data signals 8 from the actuation sensors and / or control various components of the system 10. Additionally or alternatively, the data transmitter and / or receiver 15 may transmit data to a remote patient management system (i.e., a remote server) or allow remote control of the system 10. The system 10 may include a wired connection, for example using a cable or wire, by which the controller 13 may receive data signals 8 from the actuation sensors and / or control various components of the system 10. The system may also include one or more wireless communication modules by which the system may communicate with one or more other devices (e.g., a mobile phone or a remote computing system). The system 10 may include a mobile communication module, for example a 3G, 4G, or 5G module. The system 10 may also include a Bluetooth module and a Wifi module. The system 10 may further include additional wireless communication modules. The wireless communication modules may allow bidirectional communication from the respiratory system to the remote patient management system (i.e., a remote server). For example, the measured nasal minute ventilation data (i.e., the patient's minute ventilation) may be communicated to a remote server (i.e., a remote patient management system). The remote patient management system may be a single server or a network of servers, or a cloud computing system, or other suitable architecture for operating the remote patient management system. The remote patient management system (i.e., the remote server) further includes a memory for storing the received data, and various software applications or services executed to perform a number of functions. For example, the remote patient management system (i.e., the remote server) may then communicate information or instructions to the system 10 depending at least in part on the received data. For example, the nature of the received data may trigger the remote server (or a software application running on the remote server) to communicate an alert, alarm, or notification to the system 10.The remote patient management system may further store the received data for access by an authorized party, such as a clinician or a patient or another authorized party.

[0058] FIG. 1B illustrates another configuration of the respiratory system 20. A schematic diagram of an exemplary respiratory system 20 is provided in FIG. 1B. The respiratory system 20 (i.e., "respiratory support device") includes a flow source 50 for providing a high flow rate gas 31, such as air, oxygen, air mixed with oxygen, or a mixture of air and / or oxygen with one or more other gases. In some embodiments, the respiratory system 20 can have a connection for coupling to the flow source 50. In some examples, the flow source 50 can form part of the respiratory system 20 or can be separate from the respiratory system 20. In some embodiments, a portion of the flow source 50 can form part of the respiratory system 20 and a portion of the flow source 50 can be formed outside the respiratory system 20. In some examples, the respiratory system 20 can include a combination of components. For example, the respiratory system 20 can be selected from a flow source, a humidifier for humidifying the gas flow, an intake tube, a conduit (e.g., a dry line or a heated breathing tube), a patient interface, a check valve, a filter, and other combinations.

[0059] In some embodiments, the flow source 50 can include an in-wall supply of oxygen, a tank of oxygen 50A, a tank of other gases with a flow generator 50B, and / or a high flow device. FIG. 1B shows the flow source 50 with a flow generator 50B. In some embodiments, the flow source 60 includes an inlet 50C and an O 2 In some embodiments, the inlet 50C and the O 2 The source 50A is connected through a gas flow control 50D. The gas flow control 50D can be, for example, a shutoff valve, a regulator, or the like. In some examples, the flow generator 50B can control the flow delivered to the patient 56 using one or more valves. In some embodiments, the flow generator 50B can include a blower. In some examples, the flow source 50 includes a flow generator 50B, O 21B, the flow source 50 can be a part of the device 20. In some embodiments, when the flow source 50 includes an external oxygen tank or an internal wall source, the flow source 50 can be considered to be a separate component, in which case the breathing system 20 has a connection port for connecting to the flow source 50. In some examples, the flow source 50 provides a gas flow that can be delivered to the patient via the delivery conduit 26 and the patient interface 51. As discussed in more detail below, the flow source 50 can provide a high flow rate of gas to the patient.

[0060] The respiratory system 20 can include a patient interface 51. In some embodiments, the patient interface 51 can be a non-sealed (i.e., non-sealing) interface, such as a non-sealing nasal cannula. A non-sealed interface can be used, for example, during high-flow therapy. In some configurations, the patient interface 51 is a non-sealing patient interface that can be used to help prevent barotrauma (e.g., tissue damage to the lungs or other organs of the respiratory system due to pressure differences relative to the surroundings) while high-flow therapy is being provided to the patient. High-flow therapy (i.e., providing a high flow of heated and humidified gas through a sealed interface) can cause damage to the patient's lungs and / or airways due to high pressure created in the lungs through the sealed interface. In some configurations, the flow source 50 can provide a base gas flow rate, for example, between 0.5 liters / min and 375 liters / min, or any range within that range, or even higher or lower limits. Details of the ranges and nature of the flow rates are provided in more detail below.

[0061] 1B, the respiratory system 20 can include a humidifier 52. In some examples, the humidifier 52 can be provided between the flow source 50 and the patient to optionally provide humidification to the delivered gas. In some configurations, the humidifier may be optional or may be preferred due to the benefit of humidified gas in helping to maintain airway conditions.

[0062] In some configurations, the respiratory system 20 can include one or more of the sensors 53A, 53B, 53C, 53D that can be placed through the system and / or on, on, or near the patient 56. In some examples, the sensors 53A, 53B, 53C, 53D are sensors for detecting parameters of the respiratory system 20, such as flow, oxygen fraction, pressure, humidity, temperature, etc. In some configurations, the sensors 53A, 53B, 53C, 53D are sensors for deriving parameters of the respiratory system 20, such as flow, oxygen fraction, pressure, humidity, temperature, etc. In some examples, the sensors 53A, 53B, 53C, 53D can be one or more physiological sensors for sensing patient physiological parameters, such as heart rate, oxygen saturation, partial pressure of oxygen in the blood, respiration rate, partial pressure of carbon dioxide in the blood, etc. In some examples, the respiratory system 20 can include other patient sensors, such as EEG sensors, a waist band for detecting respiration, and other suitable sensors. In some configurations, one or more of the sensors 53A, 53B, 53C, 53D may form part of or be external to the respiratory system 20, the respiratory system 20 having an input for any external sensor. The sensors may be coupled to or may transmit their output to the controller 29.

[0063] In some configurations, the respiratory system 20 may include a sensor 24 for measuring the oxygen fraction of the air inhaled by the patient. In some examples, the sensor 24 may be placed on a patient interface 51 to measure or otherwise determine the oxygen fraction in close proximity to the patient's mouth and / or nose. In some configurations, the output from the sensor 24 is sent to a controller 29 to assist in controlling the respiratory system 20 and alter operation accordingly. The controller 29 is coupled to the flow source 50, the humidifier 52, and the sensor 24. In some configurations, the controller 29 controls these and other aspects of the respiratory system 20 as described herein. In some examples, the controller may operate the flow source 50 to deliver a gas flow at a desired flow rate high enough to meet or exceed the inhalation demand of the user (i.e., the patient). The flow rate is provided to be sufficient to avoid contamination with ambient gases as the user (i.e., the patient) inhales. In some configurations, the sensor 24 may deliver a measurement of the oxygen fraction in the patient's mouth and / or nose to a user, who may input the information into the respiratory system 20 / controller 29.

[0064] In some configurations, the breathing system 20 may include a breathing conduit 26. In some examples, the breathing conduit 26 may include a check valve. In some configurations, one or more filters may be provided at the air inlet 50C and / or at the inlet to the flow generator 50B to filter the incoming gas before it is pressurized and enters the high flow gas 31 into the flow generator 50B.

[0065] In some configurations, the respiratory system 20 can be an integrated or separate component-based arrangement. In some examples, the respiratory system 20 can be a modular arrangement of components. The respiratory system 20 may include some or all of the components shown in FIG. 1B. For example, the conduit 26 and the patient interface 51 can be separate from the respiratory system 20. Although the device / system shown in FIG. 1B has been referred to as a respiratory support device or a respiratory system, this should not be considered limiting. Respiratory support devices and respiratory systems will be considered broadly herein to include anything that provides a gas flow to a patient. In some configurations, the respiratory support devices and respiratory systems can include a detection system that can be used to determine whether the gas flow meets the inhalation demand.

[0066] In some configurations, the respiratory system 20 may include a main device housing. Although this is not shown in FIG. 1B, the main device housing may be similar to the main device housing 100 shown in FIG. 1A. In some configurations, the main device housing may contain the flow generator 50B, the controller 29, and the input / output I / O user interface 54. In some configurations, the flow generator 50b may include a motor / impeller arrangement. In some examples, the main device housing may also contain the humidifier 52. In some examples, the user interface 54 may include a display and input devices, such as buttons, a touch screen (e.g., an LCD screen), and a combination of a touch screen and buttons, or the like.

[0067] In some configurations, the controller 29 may include one or more hardware and / or software processors and may be configured or programmed to control components of the system. For example, in some configurations, the controller 29 may be configured to operate the flow generator 50 to generate a gas flow for delivery to the patient, operate the humidifier 52 to humidify and / or heat the gas flow, receive user input from a user interface 54 for reconfiguration and / or user-defined operation of the respiratory assistance apparatus 20, and output information to a user (e.g., on a display). The user may be a patient, a medical professional, or otherwise.

[0068] 1B, the patient breathing conduit 26 may be coupled to a gas outlet (gas outlet or patient outlet port) within the main device housing of the respiratory system 20 and may be coupled to a patient interface 24, such as a non-sealed interface, such as a nasal cannula with a manifold and nasal prongs. In some configurations, the patient breathing conduit 26 may also be a tracheostomy interface or other non-sealed interface.

[0069] In some configurations, the gas flow may be generated by the flow generator 50B, humidified, and then delivered to the patient 56 through the patient interface 51 via the patient respiratory conduit 26. In some examples, the controller 29 may control the flow generator 50B to generate a gas flow at a desired flow rate, and / or one or more valves may control the mixture of air and oxygen or other breathable gas. The controller 29 may control a heating element in or associated with the humidification chamber to heat the gas to a desired temperature. In some configurations, the humidification chamber may help achieve a desired level of temperature and / or humidity of the gas for delivery to the patient 56. In some examples, the patient respiratory conduit 26 may include a heating element, such as a heater wire, to heat the gas flow passing to the patient 56. An example of a heater wire is not depicted in FIG. 1B, but can be seen in heater wire 16a in FIG. 1A. In some configurations, the heating element may also be under the control of the controller 29.

[0070] In some examples, the humidifier 52 of the breathing system 20 is configured to combine or introduce humidity into the gas flow. The humidifier 52 of the breathing system 20 can be utilized using a variety of configurations. In some configurations, the humidifier 52 can include a removable humidification chamber. For example, the humidification chamber can be partially or completely removed or disconnected from the flow path and / or the breathing system 20. The humidification chamber can be removed, for example, for refilling, cleaning, replacement, and / or repair. In some configurations, the humidification chamber can be received by or maintained within a bay of a humidification component or device, or can alternatively be coupled on or within a housing of the device.

[0071] In some configurations, the humidification chamber of the humidifier 52 may include a gas inlet and a gas outlet so that it can be connected into the gas flow path of the breathing system 20. In some examples, the gas flow from the flow generator 50B is received into the humidification chamber through its gas inlet and, after being heated and / or humidified, exits the chamber through its gas outlet. The humidification chamber may contain a certain amount of liquid, specifically water or the like. In some configurations, the liquid in the humidification chamber is controllably heated by one or more heaters or heating elements associated with the chamber to generate water vapor or steam to increase the humidity of the gas flowing through the chamber. In some examples, the humidifier is a pass-over humidifier. In some configurations, the humidifier may be a non-pass-over humidifier. In some examples, the humidifier 52 may include a heating plate. The heating plate may be associated with or within the humidification bay, for example, where the chamber sits for heating. In some configurations, the chamber may be provided with a heat transfer surface (e.g., a metal insert, plate, or the like in a base or other surface of the chamber) that interfaces with or engages with a heating plate of the humidifier. In some examples, the humidification chamber may include an internal heater or heating element inside or within the chamber. In some configurations, the internal heater or heating element may be integrally mounted or provided inside the chamber, or may be removable from the chamber.

[0072] In some configurations, the humidification chamber may be of any suitable shape and / or size. In some examples, the location, number, size and / or shape of the gas inlet and gas outlet of the chamber may vary. In some configurations, the humidification chamber may have a base surface, one or more sidewalls extending upward from the base surface, and a top surface or top surface. In some configurations, the gas inlet and gas outlet may be located on the same side of the chamber. In some examples, the gas inlet and gas outlet may be on different sides of the chamber, such as on both sides or locations, or other different locations. In some configurations, the gas inlet and gas outlet may have parallel flow axes. In some examples, the gas inlet and gas outlet may be located at the same height above the chamber.

[0073] As discussed above, the system 20 may use ultrasonic transducers, flow sensors such as thermistor flow sensors, pressure sensors, temperature sensors, humidity sensors, or other sensors in communication with the controller 29 to monitor characteristics of the gas flow and / or operate the system 20 in a manner to provide appropriate therapy. The gas flow characteristics may include gas concentration, flow rate, pressure, temperature, humidity, or others. The sensors 53A, 53B, 53C, 53D, 24, such as pressure, temperature, humidity, and / or flow sensors, may be located at various locations within the main device housing, the patient conduit 26, and / or the patient interface 51. The controller 29 may receive outputs from the sensors to determine appropriate target temperatures, flow rates, and / or pressures of the gas flow to assist in operating the respiratory support apparatus 20 in a manner to provide appropriate therapy. Providing appropriate therapy may include meeting the inhalation demand of the patient. In the configuration shown, sensors 53A, 53B, and 53C are positioned within the housing of the device, sensor 53D within the patient conduit 26, and sensor 24 within the patient interface 51.

[0074] In some configurations, the respiratory system 20 may include one or more communication modules so that data can be communicated or connected to one or more external devices or servers via a data or communication link or data network, whether wired, wireless, or a combination thereof. In some configurations, the respiratory system 20 may include a wireless data transmitter and / or receiver, or transceiver 25 so that the controller 29 can wirelessly receive data signals from the actuation sensors and / or control various components of the respiratory system 20. In some examples, the transceiver 15 or data transmitter and / or receiver module may have an antenna. In some configurations, the transceiver may include a Wi-Fi modem. In some examples, the data transmitter and / or receiver 25 may deliver data to a remote server or allow remote control of the respiratory system 20. The respiratory system 20 may include a wired connection, for example using a cable or wire, so that the controller 29 can receive data signals from the actuation sensors and / or control various components of the respiratory system 20. The respiratory system 20 may include one or more wireless communication modules. For example, the device may include a cellular communication module, such as a 3G, 4G or 5G module. Module 25 may be or include a modem that allows the device to communicate with a remote server using a suitable communication network. The communication may be two-way communication between the device and a server or other remote system. The remote system may receive patient data, such as respiratory rate, nasal minute ventilation (i.e., patient ventilation), measured SpO 2 , as well as, for example, flow rate, humidity, oxygen concentration (i.e., FiO 2The respiratory system 20 may be a remote patient management system that stores treatment parameters using a Bluetooth® (Bluetooth Profiler) and a wireless LAN (Wireless LAN). Treatment parameters and patient data may be received for each treatment session, and this data may be stored and used to generate one or more reports. The one or more reports may be accessible to an authorized party, such as a clinician or an insurance provider or a patient. The one or more reports may also be transmitted to an authorized party. The respiratory system 20 may also include other wireless communication modules, such as a Bluetooth module and / or a Wi-Fi module. The Bluetooth and / or WiFi module may enable the respiratory system 20 to wirelessly transmit information to another device, such as a smartphone or tablet, or operate via a local area network (LAN) or wireless LAN (WLAN). The respiratory system 20 may include a Near Field Communication (NFC) module to enable data transfer and / or data communication.

[0075] Respiratory system 10 and / or respiratory system 20 may include a high flow therapy device. As discussed herein, high flow therapy is intended to be given its typical ordinary meaning as understood by those skilled in the art to generally refer to a respiratory system that delivers a target flow of humidified respiratory gas through an intentionally unsealed patient interface with a flow rate generally intended to meet or exceed the inspiratory flow of the user. Exemplary patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults are often in the range of, but are not limited to, about 15 liters per minute to about 60 liters per minute or more. Typical flow rates for pediatric users (such as neonates, infants, and children) are often in the range of, but are not limited to, about 1 liter per minute per kilogram of the user's body weight to about 3 liters per minute per kilogram of the user's body weight or more. High flow therapy may also include a gas mixture component, optionally including administration of supplemental oxygen and / or therapeutic medication. High flow therapy is often referred to as nasal high flow (NHF), humidified high flow nasal cannula (HHFNC), high flow nasal oxygen (HFNO), high flow therapy (HFT), or tracheal high flow (THF), among other common names. For example, in some configurations, "high flow therapy" for an adult patient may refer to delivering gas to the patient at a flow rate of about 10 liters per minute (10 LPM) or greater, such as about 10 LPM to about 100 LPM, or about 15 LPM to about 95 LPM, or about 20 LPM to about 90 LPM, or about 25 LPM to about 85 LPM, or about 30 LPM to about 80 LPM, or about 35 LPM to about 75 LPM, or about 40 LPM to about 70 LPM, or about 45 LPM to about 65 LPM, or about 50 LPM to about 60 LPM, etc.In some configurations, "high flow therapy" for neonates, infants, or children may refer to delivering gas to a patient at a flow rate of greater than 1 LPM, such as from about 1 LPM to about 25 LPM, or from about 2 LPM to about 25 LPM, or from about 2 LPM to about 5 LPM, or from about 5 LPM to about 25 LPM, or from about 5 LPM to about 10 LPM, or from about 10 LPM to about 25 LPM, or from about 10 LPM to about 20 LPM, or from about 10 LPM to about 15 LPM, or from about 20 LPM to about 25 LPM, etc. High flow therapy devices for adult, neonatal, infant, or child patients may deliver gas to a patient at a flow rate of from about 1 LPM to about 100 LPM, or any subrange of flow rates outlined above.

[0076] High flow therapy can be effective in meeting or exceeding the inspiratory demand of a patient, increasing the patient's oxygenation, and / or reducing the work of breathing. Additionally, high flow therapy can create a washout effect in the nasopharynx such that the anatomical dead space of the upper airway is washed away by the high incoming gas flow. The washout effect can create a reservoir of fresh gas available with every breath, while minimizing rebreathing of carbon dioxide, nitrogen, etc.

[0077] A patient interface for use in high flow therapy can be a non-sealing interface to prevent barotrauma, which can include tissue damage to the lungs or other organs of the patient's respiratory system due to pressure differences with the atmosphere. The patient interface can be a nasal cannula with a manifold and nasal prongs, or a non-sealing airway interface.

[0078] 2-17B show an exemplary respiratory device of the respiratory system 10 having a main housing 100. The main housing 100 has a main housing upper chassis 102 and a main housing lower chassis 202. The main housing upper chassis 102 has a peripheral wall arrangement 106 (see FIG. 15). The peripheral wall arrangement defines a humidifier or humidification chamber bay 108 for receiving a removable humidification chamber 300. The removable humidification chamber 300 contains a suitable liquid, such as water, for humidifying gases that can be delivered to a patient.

[0079] In the form shown, the perimeter wall arrangement 106 of the main housing top chassis 102 can include a substantially vertical left outer wall 110 oriented in the fore-aft direction of the main housing 100, a substantially vertical left inner wall 112 oriented in the fore-aft direction of the main housing 100, and an interconnecting wall 114 extending between an upper end of the left inner wall 112 and an upper end of the left outer wall 110 and interconnecting the upper end of the left inner wall 112 and the upper end of the left outer wall 110. The main housing top chassis 102 can further include a substantially vertical right outer wall 116 oriented in the fore-aft direction of the main housing 100, a substantially vertical right inner wall 118 oriented in the fore-aft direction of the main housing 100, and an interconnecting wall 120 extending between an upper end of the right inner wall 118 and an upper end of the right outer wall 116 and interconnecting the upper end of the right inner wall 118 and the upper end of the right outer wall 116. The interconnecting walls 114, 120 are angled toward the respective outer edges of the main housing 100, but may alternatively be substantially horizontal or angled inwardly.

[0080] The main housing upper chassis 102 may further include a substantially vertical rear outer wall 122. The top of the main housing upper chassis 102 may include a forwardly sloping surface 124. The surface 124 may have a recess 126 for receiving the display and user interface module 14. The display may be configured to display the sensed gas characteristics in real time. The system may display the patient detection status of the patient interface. If no patient is detected, the controller may not output or may stop outputting the respiration value and / or other parameters for display. The controller may also optionally output a message to display that no patient is detected in block 2708. An example of the message may be an icon. An interconnecting wall 128 may extend between an upper end of the rear outer wall 122 and a rear edge of the surface 124 and interconnect the upper end of the rear outer wall 122 and the rear edge of the surface 124.

[0081] A substantially vertical wall 130 may extend downwardly from a front end of the face 124. A substantially horizontal wall 132 may extend forwardly from a lower end of the wall 130 to form a ledge. A substantially vertical wall 134 may extend downwardly from a front end of the wall 132 and terminate at a substantially horizontal floor 136 of the humidification chamber bay 108. The left interior wall 112, the right interior wall 118, the wall 134, and the floor 136 may together define the humidification chamber bay 108. The floor 136 of the humidification chamber bay 108 may have a recess 138 to receive a heater arrangement, such as a heating plate 140 or other suitable heating element, to heat liquid within the humidification chamber 300 for use during the humidification process.

[0082] The main housing lower chassis 202 may be attached to the upper chassis 102 by either suitable fasteners, such as clips, or integral mounting features. The main housing lower chassis 202 may include a substantially vertical left outer wall 210 oriented in the fore-aft direction of the main housing 100 and continuous with the left outer wall 110 of the upper chassis 102, as well as a substantially vertical right outer wall 216 oriented in the fore-aft direction of the main housing 100 and continuous with the right outer wall 116 of the upper chassis 102. The main housing lower chassis 202 may further include a substantially vertical rear outer wall 222 continuous with the rear outer wall 122 of the upper chassis 102.

[0083] The lower housing chassis 202 may have a lip 242 that is continuous with the lip 142 of the upper housing chassis 102 and also forms part of a recess for receiving the handle portion 506 of the lever 500. The lower lip 242 may include a forward facing protrusion 243 that acts as a retainer for the handle portion 506 of the lever 500. In place of the lever 500, the system may have a spring loaded guard to retain the humidification chamber 300 in the humidification chamber bay 108.

[0084] The underside of the lower housing chassis 202 may include a bottom wall 230. Each of the interconnecting walls 214, 220, 228 may extend between the substantially vertical walls 210, 216, 222 and the bottom wall 230 and interconnect the walls 210, 216, 222 and the bottom wall 230. The bottom wall 230 may include a grille 232 including a plurality of holes through which liquid may drain if it leaks from the humidification chamber 300 (e.g., from an outlet). The bottom wall 230 may additionally include an elongated front-to-back oriented groove 234. The groove 234 may additionally drain liquid if it leaks from the humidification chamber 300 without the liquid entering the electronic housing. In the illustrated configuration, the groove 234 may be wide and elongated with respect to the holes of the grille 232 to maximize liquid drainage.

[0085] As shown in FIGS. 17-18, the lower chassis 202 can have a motor recess 250 for receiving a motor and sensor module. The motor and sensor module may not be removable from the main housing 100. The motor and sensor module can be removable from the main housing 100 as shown in FIGS. 17-18. A recessed opening 251 can be provided in the bottom wall 230 adjacent its rear edge for receiving the motor / sensor module. A continuous, gas impermeable, uninterrupted peripheral wall 252 can be integrally formed with the bottom wall 230 of the lower chassis 202 and extend upwardly from a perimeter of the opening 251. A trailing portion 254 of the peripheral wall 252 has a first height and a forward portion 256 of the peripheral wall 252 has a second height, which is higher than the first height. The trailing portion 254 of the peripheral wall 252 terminates in a substantially horizontal step 258 which in turn terminates in an upper auxiliary trailing portion 260 of the peripheral wall 252. The forward portion 256 and upper auxiliary aft portion 260 of the peripheral wall 252 terminate at a ceiling 262. All of the walls and the ceiling 262 can be a continuous, uninterrupted, gas-tight, non-gas flow path. Thus, the entire motor recess 250 can be a continuous, uninterrupted, gas-tight, non-gas flow path.

[0086] The motor and sensor module can be inserted into the recess 250 and attached to the lower chassis 202. When the motor and sensor module is inserted into the lower chassis 202, the gas flow path tube 264 can extend through the downward extension tube 133 and be sealed by a soft seal.

[0087] The humidification chamber 300 may be fluidly coupled to the device 10 for linear sliding motion from a location at the front of the housing 100 toward the rear of the housing 100 toward the rear of the humidification chamber 300 entering the chamber bay 108. The gas outlet port 322 may be in fluid communication with a motor. Humidification is advantageous as it hydrates the airways, improves comfort, and maintains physiological stability in compromised airways.

[0088] 8, the gas inlet port 340 (humidified gas return) may include a removable L-shaped elbow. The removable elbow may further include a patient outlet port 344 for coupling to the patient conduit 16 to deliver gas to the patient interface. Each of the gas outlet port 322, the gas inlet port 340, and the patient outlet port 344 may have a soft seal, such as an O-ring seal or a T-seal, to provide a sealed gas passage between the device 10, the humidification chamber 300, and the patient conduit 16.

[0089] The humidification chamber gas inlet port 306 may be complementary to a gas outlet port 322, and the humidification chamber gas outlet port 308 may be complementary to a gas inlet port 340. The axes of the ports may be parallel to one another to allow the humidification chamber 300 to be inserted into the chamber bay 108 with linear motion.

[0090] The respiratory device may have air and oxygen (or alternative auxiliary gas) inlets in fluid communication with the motor so that the motor can deliver air, oxygen (or alternative auxiliary gas), or a mixture thereof to the humidification chamber 300 and thereby to the patient. As shown in FIG. 10, the device may have a combined air / oxygen (or alternative auxiliary gas) inlet arrangement 350. This arrangement may include a combined air / oxygen port 352 in the housing 100, a filter 354, and a cover 356 with a hinge 358. A gas tube may optionally extend laterally or in another suitable direction and be in fluid communication with an oxygen (or alternative auxiliary gas) source. The port 352 may be fluidly coupled with the motor 402. For example, the port 352 may be coupled with the motor / sensor module 400 via a gas flow path between the port 352 and an inlet hole or a port in the motor and the sensor module 400, which would then lead to the motor.

[0091] The device may have the arrangement shown in Figs. 11-14 for the motor to be able to deliver air, oxygen (or alternative auxiliary gas), or a suitable mixture thereof to the humidification chamber 300 and thereby to the patient. This arrangement may include an air inlet 356' in the rear wall 222 of the lower chassis 202 of the housing 100. The air inlet 356' comprises a rigid plate with a suitable grill arrangement of holes and / or grooves. Sound deadening foam may be provided adjacent the plate on the inner side of the plate. An air filter box 354' may be positioned adjacent the air inlet 356' inside the main housing 100 and may include an air outlet port 360 for delivering filtered air to the motor via the air inlet port 404 in the motor / sensor module 400. The air filter box 354' may include a filter configured to remove particulates (e.g. dust) and / or pathogens (e.g. viruses or bacteria) from the gas flow. A soft seal, such as an O-ring seal, may be provided between the air outlet port 360 and the air inlet port 404 to seal between the components. The device may include a separate oxygen inlet port 358' positioned adjacent one side of the housing 100 at its rear end, which receives oxygen from an oxygen source, such as a tank or piped oxygen source. The oxygen inlet port 358' is in fluid communication with a valve 362. The valve 362 may suitably be a solenoid valve that may control the amount of oxygen added to the gas stream delivered to the humidification chamber 300. The oxygen port 358' and valve 362 may be used in conjunction with other supplemental gases to control the addition of other supplemental gases to the gas stream. The other supplemental gases may include any one or more of a number of gases useful in gas therapy, including, but not limited to, heliox and nitric oxide.

[0092] As shown in Figures 13-16, the lower housing chassis 202 can include a suitable electronic board, such as a sensing circuit board. The electronic board can be positioned adjacent to each of the outer side walls 210, 216 of the lower housing chassis 202. The electronic board can contain or be in electrical communication with suitable electrical or electronic components, such as, but not limited to, microprocessors, capacitors, resistors, diodes, operational amplifiers, comparators, and switches. Sensors can be used in conjunction with the electronic board. Components of the electronic board (such as, but not limited to, one or more microprocessors) can act as the controller 13 of the device.

[0093] One or both of the electronic boards may be in electrical communication with the electrical components of the device 10, including the display unit and user interface 14, the motor, the valve 362, and the heating plate 140, to operate the motor to provide the desired gas flow rate, to operate the humidification chamber 300 to humidify and heat the gas flow to an appropriate level, and to supply an appropriate amount of oxygen (or an amount of alternative auxiliary gas) to the gas stream.

[0094] The electronic board may be in electrical communication with a connector arrangement 274 that protrudes from the rear wall 122 of the upper housing chassis 102. The connector arrangement 274 may be coupled to an alarm, a pulse oximetry port, and / or other suitable accessories. The electronic board may also be in electrical communication with an electrical connector 276, which may also be provided on the rear wall 122 of the upper housing chassis 102 for providing mains or battery power to the components of the device.

[0095] As mentioned above, operational sensors such as flow, temperature, humidity, and / or pressure sensors may be located at various locations within the respiratory device as shown in Figure 1A, the patient breathing conduit 16, and / or the cannula 17. The electronics board may be in electrical communication with those sensors. Output from the sensors may be received by the controller 13 to assist the controller 13 to operate the respiratory system 10 in a manner that provides optimal therapy, including meeting inspiratory demand.

[0096] As outlined above, electronic boards and other electrical and electronic components can be pneumatically isolated from the gas flow paths for improved safety. Sealing also prevents water ingress.

[0097] Control System FIG. 19A shows a block diagram 900 of an exemplary control system 920 (which may be the controller 13 of FIG. 1A) that can detect a patient's condition and control the operation of the breathing system, including the gas source. The control system 920 can manage the flow rate of gas through the breathing system as the gas is delivered to the patient. For example, the control system 920 can increase or decrease the flow rate by controlling the output of the motor speed of the blower (hereinafter also referred to as "blower motor") 930 or the output of the valve 932 in the agitator. The control system 920 can automatically determine a set value or a personalized value of the flow rate for a particular patient as discussed below. The flow rate can be optimized by the control system 920 to improve patient comfort and treatment.

[0098] The control system 920 may also generate audio and / or display / visual outputs 938, 939. For example, the flow therapy device may include a display and / or a speaker. The display may indicate to the physician any warnings or alerts generated by the control system 920. The display may also indicate control parameters that the physician may adjust. For example, the control system 920 may automatically recommend a flow rate for a particular patient. The control system 920 may also determine the patient's respiratory status, including, but not limited to, generating the patient's respiratory rate, and transmit that to a display, as described in more detail below.

[0099] The control system 920 can vary the heater control output to control one or more of the heating elements (e.g., to maintain a temperature set point of the gas delivered to the patient). The control system 920 can also vary the activation or duty cycle of the heating elements. The heater control outputs can include a heater plate control output 934 and a heated breathing tube control output 936.

[0100] The control system 920 can determine outputs 930-939 based on one or more received inputs 901-916. The inputs 901-916 can correspond to sensor measurements automatically received by the controller 600 (shown in FIG. 19B). The control system 920 can receive, from, but not limited to, a temperature sensor input 901, a flow sensor input 902, a motor speed input 903, a pressure sensor input 904, a gas fraction sensor input 905, a humidity sensor input 906, a pulse oximeter (e.g., SpC) sensor input 907, stored or user parameters 908, a duty cycle or pulse width modulation (PWM) input 909, a voltage input 910, a current input 911, an auditory sensor input 912, a power input 913, a resistance input 914, and optionally a CO 2Sensor inputs may be received, including a sensor input 915 and / or optionally a lung capacity input 916. A pulse oximeter may also be optional. The control system 920 may receive inputs from a user or parameter values ​​stored in memory 624 (shown in FIG. 19B). The control system 920 may dynamically adjust the flow rate for the patient over the course of the patient's treatment. The control system 920 may continuously sense system and patient parameters. Those of skill in the art will recognize based on the disclosure herein that any other suitable inputs and / or outputs may be used with the control system 920.

[0101] controller FIG. 19B shows a block diagram of a controller 600 (which can be the controller 13 of FIG. 1A or the controller of FIG. 1B). The controller 600 can include programming instructions for detecting input conditions and controlling output conditions. The programming instructions can be stored in a memory 624 of the controller 600. The programming instructions can correspond to the methods, processes and functions described herein. The programming instructions can be executed by one or more hardware processors 622 of the controller 600. The programming instructions can be implemented in C, C++, JAVA, or any other suitable programming language. Some or all of the portions of the programming instructions can be implemented in application specific integrated circuits 628, such as ASICs and FPGAs.

[0102] The controller 600 may also include circuitry 628 for receiving sensor signals. The controller 600 may further include a display 630 for communicating the status of the patient and the respiratory assistance system. The display 630 may also show warnings and / or other alerts. The display 630 may be configured to display the sensed gas characteristics in real time or otherwise. The controller 600 may also receive user input via a user interface, such as the display 630. The user interface may include buttons and / or dials. The user interface may include a touch screen.

[0103] Motor and Sensor Module Any feature of the respiratory system described herein, including, but not limited to, the humidification chamber, the flow generator, the user interface, the controller, and a patient respiratory conduit configured to connect a gas outlet of the respiratory system to a patient interface, may be combined with any sensor module described herein.

[0104] Figure 20 shows a block diagram of a motor and sensor module 2000 that may be received by the recess 250 in the respiratory device (shown in Figures 17 and 18). The motor and sensor module may include a blower 2001 that entrains room air and delivers it to the patient. The blower 2001 may be a centrifugal blower.

[0105] One or more sensors (e.g., Hall effect sensors) may be used to measure the motor speed of the blower motor. The blower motor may include a brushless DC motor, and the motor speed may be measured from the brushless DC motor without the use of a separate sensor. For example, during operation of the brushless DC motor, the back EMF may be measured from the unenergized windings of the motor, from which the motor position may be determined, which may then be used to calculate the motor speed. In addition, the motor driver may be used to measure the motor current, which may be used along with the measured motor speed to calculate the motor torque. The blower motor may also include a low inertia motor. Room air may enter the room air inlet 2002, which enters the blower 2001 through the inlet port 2003. The inlet port 2003 may include a valve 2004, and compressed gas may enter the blower 2001 through the valve 2004. The valve 2004 may control the flow of oxygen into the blower 2001. The valve 2004 can be any type of valve, including a proportional valve or a binary valve. In some configurations, the inlet port does not include a valve.

[0106] Blower 2001 can operate at a motor speed of greater than 1,000 RPM and less than 30,000 RPM, greater than 2,000 RPM and less than 21,000 RPM, or any of the preceding values ​​in between. Operation of blower 2001 mixes gases entering blower 2001 through inlet port 2003. Using blower 2001 as a mixer can reduce pressure drop that would otherwise occur in a system with a separate mixer, such as a static mixer including baffles, because mixing requires energy.

[0107] The mixed air can exit the blower 2001 through a conduit 2005 and enter a flow path 2006 in a sensor chamber 2007. A sensing circuit board with a sensor 2008 can be positioned in the sensor chamber 2007 such that the sensing circuit board is at least partially immersed in the gas flow. At least a portion of the sensor 2008 on the sensing circuit board can be positioned in the gas flow to measure gas characteristics in the flow. After passing through the flow path 2006 in the sensor chamber 2007, the gas can exit 2009 and enter a humidification chamber.

[0108] Positioning the sensor 2008 downstream of the combined blower and mixer 2001 can increase the accuracy of measurements, such as measurements of gas fraction concentrations, including oxygen concentration, on systems where the sensor is positioned upstream of the blower and / or mixer. Such positioning can provide a repeatable flow profile. Furthermore, positioning the sensor downstream of the combined blower and mixer avoids the pressure drop that would otherwise occur if sensing were to occur before the blower, since a separate mixer, such as a static mixer with baffles, would be required between the inlet and the sensing system. The mixer can introduce a pressure drop across the mixer. Positioning the sensing after the blower can make the blower a mixer, while a static mixer would reduce pressure as opposed to a blower increasing pressure. Immersing at least a portion of the sensing circuit board and sensor 2008 in the flow path can also increase the accuracy of the measurement, as a sensor immersed in the flow means is more likely to be subjected to the same conditions as the gas flow, such as temperature and pressure, and therefore provide a better indication of the gas flow characteristics.

[0109] With reference to FIG. 21, gas exiting the blower can enter a flow path 402 in a sensor chamber 400, which can be located in the motor and sensor module and can be the sensor chamber 2007 of FIG. 20. The flow path 402 can have a curved shape. The flow path 402 can be configured to have a curved shape without sharp turns. The flow path 402 can have curved ends with straight sections between the curved ends. The curved flow path shape can reduce the pressure drop of the gas flow without reducing the sensitivity of the flow measurement by coinciding a portion of the measurement area with the flow path to form a measurement section of the flow path, as described below with reference to FIGS. 23A-23B.

[0110] A sensing circuit board 404 with sensors such as auditory transmitters and / or receivers, humidity sensors, temperature sensors, thermistors, and the like can be positioned within the sensor chamber 400 such that the sensing circuit board 404 is at least partially immersed within the flow path 402. Immersing the sensing circuit board and sensors at least partially within the flow path can increase the accuracy of the measurement as sensors immersed in the flow path are more likely to experience the same conditions, e.g., temperature and pressure, as the gas flow and therefore provide a better indication of the characteristics of the gas flow. After passing through the flow path 402 within the sensor chamber 400, the gas can exit to a humidification chamber.

[0111] The gas flow rate may be measured using at least two different types of sensors. A first type of sensor may include a thermistor that can determine the flow rate by monitoring heat transfer between the gas flow and the thermistor. A thermistor flow sensor may operate a thermistor at a constant target temperature in the flow as the gas flows past around the thermistor. The sensor may measure the amount of power required to maintain the thermistor at the target temperature. The target temperature may be configured to be higher than the temperature of the gas flow, so that more power is required to maintain the thermistor at the target temperature at higher flow rates.

[0112] The thermistor flow sensor can also maintain multiple (e.g., two, three, or more) constant temperatures on the thermistor to avoid too small or too large a difference between the target temperature and the gas stream temperature. Multiple different target temperatures allow the thermistor flow sensor to be accurate over a large temperature range of the gas. For example, the thermistor circuit can be configured to be able to switch between two different target temperatures so that the temperature of the gas stream always falls within a certain range relative to one of the two target temperatures (e.g., not too close, but not too far). The thermistor circuit can be configured to operate at a first target temperature of about 50°C to about 70°C, or about 66°C. The first target temperature can be associated with a desired flow temperature range of about 0°C to about 60°C, or about 0°C to about 40°C. The thermistor circuit can be configured to operate at a second target temperature of about 90°C to about 110°C, or about 100°C. The second target temperature can relate to a desired flow temperature range of about 20°C to about 100°C, or about 30°C to about 70°C.

[0113] The controller can be configured to adjust the thermistor circuit to change between at least a first target temperature mode and a second target temperature mode by connecting or bypassing a resistor in the thermistor circuit. The thermistor circuit can be arranged in a Wheatstone bridge configuration including a first voltage driver arm and a second voltage driver arm. The thermistor can be located on one of the voltage driver arms. More details of the thermistor flow sensor are described in International Patent Application No. PCT / NZ2017 / 050119, filed September 3, 2017, the entirety of which is incorporated herein by reference.

[0114] A second type of sensor can include an auditory sensor assembly. An auditory sensor including an auditory transmitter and / or receiver can be used to measure the time of flight of an auditory signal to determine gas velocity and / or composition that can be used within a flow therapy device. In one ultrasonic sensing (including an ultrasonic transmitter and / or receiver) topology, a driver causes a first sensor, such as an ultrasonic transducer, to generate an ultrasonic pulse in a first direction. A second sensor, such as a second ultrasonic transducer, receives the pulse and provides a measurement of the time of flight of the pulse between the first ultrasonic transducer and the second ultrasonic transducer. Using this measurement of the time of flight, the speed of sound of the gas flow between the ultrasonic transducers can be calculated by a processor or controller of the respiratory system. The second sensor can transmit a pulse in a second direction opposite the first direction to provide a second measurement of the time of flight, which the first sensor can receive and determine a characteristic of the gas flow, such as flow rate or velocity. In another auditory sensing topology, an auditory pulse transmitted by an auditory transmitter, such as an ultrasonic transducer, can be received by an auditory receiver, such as a microphone. More details of the acoustic flow sensor are described in International Patent Application No. PCT / NZ2016 / 050193, filed December 2, 2016, the entirety of which is incorporated herein by reference.

[0115] Readings from both the first and second types of sensors can be combined to determine a more accurate flow measurement. For example, a previously determined flow rate and one or more outputs from one of the types of sensors can be used to determine a predicted current flow rate. The predicted current flow rate can then be updated using one or more outputs from the other of the first and second types of sensors to calculate a final flow rate.

[0116] Data Preprocessing As discussed above, flow data in an unsealed system, such as a nasal high flow system, can be difficult to determine. The open nature of the system results in a very low signal to noise ratio. Any measured flow data can contain various irregularities and noise that can obscure the flow data and must be considered to accurately determine the desired measurements. Flow data is important because it can provide information about the unsealed system and the patient's respiratory flow.

[0117] The flow signal may be sent through a pre-processing step to remove noise and other irregularities from any acquired flow data. Pre-processing allows the controller to remove certain distortions from the flow parameters so that the flow parameter signals used to determine the device output and / or patient respiratory parameters (e.g., nasal minute ventilation and / or peak inspiratory flow) may better reflect the effect on the patient's breathing of the gas flow parameters used to treat the patient. More details on pre-processing of flow signals are described in International Patent Application No. PCT / IB2020 / 051816, filed March 4, 2020, which is incorporated herein by reference in its entirety.

[0118] When a patient is attached to the respiratory system and breathing through the patient interface, the fluctuations in the preprocessed flow rate or other flow parameter data acquired in the orifice system are composed of random uncorrelated noise originating from various sources and correlated respiratory signals. Preprocessing of the data can begin with the controller receiving the flow parameter data (e.g., unprocessed data). The controller can then perform preprocessing steps, for example, by determining whether the flow parameter data is good or suitable for use. If the data is not suitable for use, the controller can discard the data.

[0119] In determining suitability of the data, the controller may receive second flow parameter data of a different type than the first flow parameter data. The second flow parameter data is assumed to have a correlation to the first parameter. The second flow parameter data may include, for example, motor speed, pressure, and / or oxygen flow or concentration, or any other parameter that may have or provide an indication of an effect of gas flow other than the effect of the patient's breathing on the gas flow. The controller may be configured to determine whether the second flow parameter data is useful as a correlation parameter to the first flow parameter data. For example, the second flow parameter data may be a useful correlation metric if the second flow parameter data meets a threshold level. If the second flow parameter data does not meet the threshold level, the second flow parameter data is assumed not to correlate to the first flow parameter data. As a result, the second flow parameter data may be ignored or truncated (i.e., deleted or not utilized by the controller). If there is insufficient second flow parameter data, the controller may determine that it has insufficient data to use the first flow parameter data and may discard the first parameter data. If the second flow parameter data meets a minimum threshold level, the controller can determine that the first parameter data is suitable for use.

[0120] As an example, the second flow parameter data may represent a motor speed. To identify a patient's breath in the first flow parameter data, the motor needs to operate at a sufficient speed. If the motor speed is too low, the effect or correlation of the motor speed on the flow data (such as flow rate) may not be accurately predicted. Thus, after the controller receives the motor speed data, the controller may compare the motor speed to a minimum motor speed threshold. If the motor speed is below the threshold, the controller may consider the first flow parameter data to be inappropriate and may discard some or all of the first flow parameter data. However, if the motor speed exceeds the threshold, the controller may calculate a recent change in the motor speed. Changes in the motor speed may cause changes in the first flow parameter data, which may make it more difficult to identify a patient's breath from the first flow parameter data. While the effect of the motor speed may be removed to some extent from the first flow parameter data, if the change in the motor speed is larger, the data may be too unreliable to identify a patient's breath. Thus, the controller may apply a travel filter to the relative change in the motor speed to generate a first value representing a recent relative change in the motor speed. The controller may then compare the first value to a first threshold. If the first value exceeds the first threshold, the controller may consider the flow parameter data unsuitable and the flow data point may be discarded. If the first value is below the first threshold, the controller may consider the flow parameter data suitable for use.

[0121] As another example, the second flow parameter data may represent a concentration of the auxiliary gas from the auxiliary gas source. The first flow parameter data (e.g., flow rate) may be affected by the flow rate or concentration of the auxiliary gas from the auxiliary gas source. The controller may receive oxygen flow rate data or oxygen concentration data. The controller may calculate a recent change in the oxygen flow rate or oxygen concentration. If the oxygen flow rate or concentration changes, the resulting change in the total flow may make it more difficult to identify the patient's breath in the flow signal or other flow parameter signal. The controller may then apply a travel filter to the change in the oxygen concentration or oxygen flow rate of the gas to generate a second value representing a recent change in the oxygen concentration or flow rate. The controller may compare the second value to a second threshold. If the second value exceeds the second threshold, the controller may determine that the first flow parameter data is not suitable and may discard the first flow parameter data point. However, if the second flow parameter data is below the threshold, the controller may consider the flow parameter data to be suitable.

[0122] As noted above, the first flow parameter data (or any other flow parameter data) may also be modified to remove the effect of the motor (or other factors such as oxygen concentration or flow rate) if the controller deems the data appropriate. Modifying the first flow parameter data may involve removing the assumed effect of other variables from the first flow parameter data (such as motor speed). This assumed effect is only valid if the gas flow parameter data meets certain criteria. As noted above, if these criteria are not met, the data may be discarded.

[0123] The process can modify the first flow parameter data to remove the effect of the motor speed. The effect of the motor can be estimated using the motor speed and the flow conductance. The controller can measure the instantaneous flow conductance. The flow conductance can be calculated as provided below.

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[0124] In the equations provided above, C is the flow conductance, filt() is the filter function, Q is the flow parameter data, and ω motor is the motor speed. In some configurations, the filter function is a low pass filter. In some examples, the flow parameter data is a flow signal generated by a device flow sensor. The flow conductance is approximately constant over time and therefore can be estimated using a low pass filter. The controller measures the instantaneous flow conductance at each iteration using the current motor speed and the measured flow rate. The controller can filter the instantaneous flow conductance to determine a filtered flow conductance.

[0125] The controller can compare the instantaneous flow conductance to the filtered flow conductance to see if the difference is significant. If the difference is significant, then some physical system is likely to have changed, such as when a cannula is attached or detached. The instantaneous flow conductance can be compared to the filtered flow conductance by taking the difference between the two variables and comparing to a minimum or maximum threshold. If the difference is above or below the threshold, then the difference is deemed significant and the controller can reset the filtered flow conductance. The controller can also change the filter coefficients of the filter function in the calculation of the filtered flow conductance based on the difference between the instantaneous flow conductance and the filtered flow conductance. This allows the filtered flow conductance to be changed more quickly when the variation in flow conductance is high, such as when a cannula is first attached.

[0126] If the difference between the instantaneous flow conductance and the filtered flow conductance does not exceed a threshold, the difference is deemed insignificant and the controller can estimate the effect of the motor on flow. The controller can use the filtered flow conductance and the motor speed to output an effect value. The value can be subtracted or otherwise removed from the flow data to arrive at preprocessed flow data. The preprocessed flow data can be more indicative of the patient's respiratory flow (but the preprocessed flow data can still contain signal noise).

[0127] The controller may also track recent changes in flow conductance. The changes may be tracked by adding the difference between the last two instantaneous flow conductances to a running total, which is then damped over time. The damped running total is filtered to obtain a filtered recent change in flow conductance. The filtered recent change in flow conductance may be used in further parts of the frequency analysis algorithm along with the pre-processed flow data.

[0128] Nasal minute ventilation and peak inspiratory flow As discussed above, while inhalation and exhalation are relatively easy to measure in a sealed system, respiratory parameters are much more difficult to measure in an unsealed system. In an unsealed system, such as a high-flow nasal system, the open nature of the system (due to the use of an unsealed patient interface) makes it significantly more difficult to determine the patient's inhalation and exhalation, as the desired signal is often weak and obscured by noise.

[0129] The present disclosure provides a reliable method for estimating important patient respiratory parameters in an unsealed system (e.g., an unsealed nasal cannula used in a high-flow system). A controller estimates nasal minute ventilation (MV n ) and estimate the maximum inspiratory flow.

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[0130] Nasal minute ventilation (MV n ) and / or peak inspiratory flow

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[0131] Estimated nasal minute ventilation (MV n ) and / or maximum inspiratory flow

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[0132] Nasal minute ventilation The controller measures the nasal minute ventilation (MV n The method may include a step configured to calculate an estimate of the minute ventilation (MV device ) represents the minute ventilation of the device and is a measurement of the average volume of air pushed into and out of the device per minute. Due to the high leakiness of the nasal cannula interface in unsealed systems, it can be very difficult to accurately determine a patient's true minute ventilation. This is especially true while high-flow therapy is being delivered. Nasal Minute Ventilation (MV n An estimate of nasal minute ventilation (MV) can therefore be calculated by using manual inputs characterizing the cannula fit (e.g., cannula size, model dimensions) and the known constant flow rate of gas through the cannula. n ) is the minute ventilation (MV device ) to the nasal minute ventilation (MV n ) signal or measurement, a calibration constant (K n ) to the device's minute ventilation (MV device ) for nasal minute ventilation (MV n ), device minute ventilation (MV device ), and maximum inspiratory flow

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[0133] Figures 22A, 22B, 22C, and 22D show four flow charts for a method of estimating nasal minute ventilation. Figure 22A shows a simplified method of estimating nasal minute ventilation 1000. Figures 22B, 22C, and 22D show a more detailed method of estimating nasal minute ventilation 1100. As discussed below, nasal minute ventilation (MV n To determine the minute ventilation (MV device ) must first be calculated.

[0134] As shown in FIG. 22A, the process includes measuring nasal minute ventilation (MV) to monitor and determine the effect of treatment parameters. n ) and nasal minute ventilation (MV n ) to use the device's minute ventilation (MV device). The method for estimating nasal minute ventilation 1000 begins with acquiring raw flow data at step 1002. The raw flow data may be obtained from a flow sensor, such as an ultrasonic flow sensor. The method for estimating nasal minute ventilation 1000 may include pre-processing the raw flow data to remove unwanted signal components at step 1004. Removal of the unwanted signal components is described in more detail above. The unwanted signal components may be present from a flow generator motor. In some configurations, the unwanted signal components may originate from other sources (e.g., noise), and the unwanted signal components may originate primarily from the flow generator motor. For example, the pre-processed flow data may be a flow signal that includes a component associated with the patient's respiratory activity. For example, the component associated with the patient's respiratory activity may be included in the flow signal as a change in the magnitude of the flow (e.g., as a fluctuation). Once pre-processed, the flow data may be representative of the patient's respiratory data. The method 1000 may include, assuming the data is of sufficient quality, determining whether the pre-processed data is representative of the minute ventilation (MV device ), step 1006, where the device can be run through a minute ventilation algorithm to calculate minute ventilation (MV device ) is obtained, step 1008 of method 1000 optionally calculates the minute ventilation (MV device ) to the nasal minute ventilation (MV n ) can be converted into nasal minute ventilation (MV n ) is calculated using a scalar calibration constant to calculate the device's minute ventilation (MV device As discussed in more detail below, the scalar calibration constant can be determined by using manually input parameters for the nasal cannula and the current flow rate. Once the nasal minute ventilation (MV nOnce an estimate of nasal minute ventilation (MV) has been calculated, method 1000 may monitor the patient's nasal minute ventilation, rate of change of nasal minute ventilation, and / or trend of nasal minute ventilation at step 1010. Information about the patient's nasal minute ventilation, rate of change of nasal minute ventilation, and / or trend of nasal minute ventilation may be used to provide information to a user and / or medical personnel at step 1012. Nasal minute ventilation (MV n ) may be in the form of displayed data, alerts, and / or notifications, which, as discussed above, may allow the user and / or medical personnel to adjust treatment parameters to improve treatment outcomes.

[0135] FIG. 22B shows a more detailed flow chart of a method for estimating nasal minute ventilation 1100. Similar to method 1000, method 1100 begins with acquiring raw flow data at step 1102. The raw flow data may be obtained from a flow sensor, such as an ultrasonic flow sensor. Method 1100 may include pre-processing the raw flow data to remove unwanted signal components at step 1104. Removal of unwanted signal components is described in more detail above. Unwanted signal components may be present from a flow generator motor. Once pre-processed, the flow data may be representative of the patient's respiratory data. The processed flow data may then be analyzed at step 1106 to determine if the quality of the data is sufficiently good. If not, the flow data is discarded and method 1100 returns to step 1102 to wait to receive raw flow data.

[0136] However, if the data is determined to be of sufficient quality, the data is processed and the method 1100 uses the processed data to calculate the minute ventilation (MV device ), the data can be considered to be of sufficient quality if it does not contain large transient peaks (possibly due to interface adjustments). device) measures the average volume of air pushed into and out of the device per minute. As shown in step 1112, the minute ventilation (MV device The process for calculating t can be performed by first fitting a spline to the flow data using a least squares criterion. The flow data may be, for example, the nearest pre-filtered flow data points. In some configurations, the least squares criterion first estimates the pre-processed flow data (e.g., the respiratory signal) and then integrates along the spline to estimate ventilation.

[0137] The method 1100 may include measuring the minute ventilation (MV device ) is calculated using a spline. In some examples, the use of a spline can be more beneficial than alternative methods (e.g., a series of filters configured to generate a statistical measure of the data) because it can perform better (i.e., fit / interpolate the data more accurately) over a wide range of sampling frequencies. This is described in more detail below. The method 1000 includes calculating the minute ventilation (MV device The instantaneous estimate of the device's minute ventilation (MV device ) is estimated from the gas flow parameter data.

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[0138] Device Minute Volume (MV device The estimate of the gas flow parameter (MV ) represents the average of the absolute value of the curve fitted to the data of the gas flow parameters (i.e., calculated without using splines to interpolate the data). Any of the above estimates can be used as inputs to method 1100, but each has advantages and disadvantages depending on random errors in the sensor data and the patient's respiratory rate. Method 1100 calculates the minute ventilation (MV ) of the device, which represents the integral of the absolute value of the first term of the line fitted to the signal. device ) estimate, which is the most robust and least sensitive to random error, but also the most sensitive to respiratory rate.

[0139] Once the method 1100 has determined the minute ventilation (MV device ) estimate, the device's minute ventilation (MV device ) is optionally calculated in step 1118 as nasal minute ventilation (MV n ) can be converted to an estimate of the device's minute ventilation (MV device ) is an optional scalar calibration constant (K n ) to measure nasal minute ventilation (MV n ) can be converted into a calibration constant (K n) may optionally be calculated at least in part using manually entered patient interface parameters in step 1108, and then a scalar calibration value may be determined in step 1110. The manually entered patient interface parameters may be related to the nasal cannula and the current flow rate. These parameters may include, but are not limited to, the cannula type, the patient size, the nostril occlusion (or an estimate thereof), and the nostril diameter. These parameters may estimate the aforementioned cannula type, the patient size, and the nostril diameter. Alternatively, these parameters may be determined automatically by the device, for example, by using an automatic peripheral component detection system or by receiving flow data from a flow sensor. The calibration constant (K n ) may be calculated through a calibration step or process in which a full seal face mask with an outlet flow sensor is temporarily placed over the patient's nasal cannula. The full seal face mask may be used to capture various flow parameters and may be input into a calibration constant determination function, algorithm, or method. Alternatively, the calibration constant may be derived from an estimate of flow conductance calculated within the controller.

[0140] Nasal minute ventilation (MV n Once an estimate of nasal minute ventilation (MV) has been calculated, method 1100 may monitor the patient's nasal minute ventilation, rate of change in nasal minute ventilation, and / or trend in nasal minute ventilation at step 1120. Information about the patient's nasal minute ventilation, rate of change in nasal minute ventilation, and / or trend in nasal minute ventilation may be used to provide information to a user and / or medical personnel at step 1122. As discussed above, nasal minute ventilation (MV) may be calculated based on the patient's nasal minute ventilation (MV). n The information related to the nasal minute ventilation (MV) can be in the form of displayed data, alarms, and / or notifications. n ) itself, nasal minute ventilation (MV n ) or nasal minute ventilation (MV nBy monitoring either the long-term trends of nasal minute ventilation (MVn), the device controller may be configured to present audio, visual, or audio-visual alarms or notifications to the user and / or healthcare provider. These alarms may include prompts to adjust therapy parameters, such as flow rate. The alarms may be configured to be triggered based on suggested or manually entered thresholds. As discussed above, this may allow the user and / or healthcare provider to adjust therapy parameters to improve therapy outcomes. Trends in nasal minute ventilation (MVn) may also be displayed on the device screen as a plot, chart, or graph. Based on the trend data presented, notifications and / or alarms may be triggered based thereon.

[0141] FIG. 22C shows another more detailed flow chart of a method for estimating nasal minute ventilation 1200. Similar to methods 1000 and 1100, method 1200 begins with acquiring raw flow data at step 1202. The raw flow data may be obtained from a flow sensor, such as an ultrasonic flow sensor. In some configurations, at step 1204, the raw flow data is first analyzed to determine whether the quality of the data is sufficiently good. If it is determined that the raw flow data is of sufficient quality, the data may be pre-processed to remove unwanted signal components. If the raw flow data is of insufficient quality, the flow data is discarded and method 1200 returns to step 1202 to wait to receive additional raw flow data. In some examples, method 1200 may include pre-processing the raw flow data to remove unwanted signal components at step 1206. Removal of unwanted signal components is described in more detail above. Unwanted signal components may be present from a flow generator motor. Once pre-processed, the flow data may be representative of the patient's respiratory data. In some configurations, once the flow data has been pre-processed, the data may proceed to step 1212 where method 1200 fits a curve to the flow data. The data may be deemed to be of sufficient quality if it does not contain large transient peaks (possibly due to interface adjustments). The minute ventilation (MV device ) measures the average volume of air pushed into and out of the device per minute. The process for fitting a curve to the flow data can be performed by first fitting a spline to the flow data using a least squares criterion. In some configurations, the fitted line can be represented (approximately) by:

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[0142] In the equations provided above, m is the fit parameter that corresponds to the mean of the flow data, s is the slope (i.e., gradient), and t * is the linear range of the normalized time parameter. In some configurations, t* is the linear range of the normalized time parameter, where the “oldest” time point in the flow data is equal to −1 and the “most recent” time point in the flow data is equal to 1.

[0143] In some configurations, other methods of function approximation may also be used. The flow data may be, for example, the most recent pre-filtered flow data points. In some examples, least squares methods may be used to approximate the pre-processed flow data (e.g., respiratory signal), and then integrate along a spline to estimate ventilation. In some configurations, the controller may perform various line and / or curve fitting methods to fit one or more functions to selected portions of the change in flow parameter data. This may include, for example, regression analysis, interpolation, extrapolation, linear least squares, non-linear least squares, total least squares, simple linear regression, robust simple linear regression, polynomial regression, orthogonal regression, Deming regression, linear piecewise linear regression, regressive dilution, and / or other non-limiting examples of techniques. In some configurations, one or more functions including at least the above may generate a curve. In some configurations, the curve may be a straight line. The lines or curves described herein may include multiple curves, vertices, and / or other features. The lines described herein may be straight, sloping, and / or horizontal. In some cases, the straight line described herein may be a best fit line.

[0144] The method 1200 may include measuring the minute ventilation (MV device The method 1000 may include step 1214, in which an instantaneous estimate of the device's minute ventilation (MV device The instantaneous estimate of the device's minute ventilation (MV device ) is estimated from the gas flow parameter data.

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[0145] Device Minute Volume (MV device The estimate of the gas flow parameter (MV ) represents the average of the absolute value of the curve fitted to the data of the gas flow parameters (i.e., calculated without using splines to interpolate the data). Any of the above estimates can be used as inputs to method 1200, but each has advantages and disadvantages depending on random errors in the sensor data and the patient's respiratory rate. Method 1200 calculates the device's minute ventilation (MV ), which represents the integral of the absolute value of the first term of the line fitted to the signal. device) can be used, which is the most tolerant and least sensitive to random errors, while also being the most sensitive to respiratory rate. In some implementations, method 1200 can skip step 1212 and the preprocessed flow data can proceed directly to step 1214, where method 1200 can directly calculate the average of selected preprocessed flow data points.

[0146] Once the method 1200 has determined the minute ventilation (MV device ) estimate, the device's minute ventilation (MV device ) is optionally calculated in step 1218 as nasal minute ventilation (MV n ) can be converted to an estimate of the device's minute ventilation (MV device ) is the nasal minute ventilation (MV n ), before being converted into an estimate of the instantaneous device minute ventilation (MV device ) can be applied to average the nasal minute ventilation (MV). In some configurations, each estimate or series of estimates captured over multiple iterations of the previously described steps can be averaged or "smoothed" using a filter (e.g., an exponential filter). In some examples, this step occurs after the initial estimate, but before any additional processing steps (i.e., nasal minute ventilation (MV n In some configurations, the device's minute ventilation (MV device ) is the scalar calibration constant (K n ) to calculate nasal minute ventilation (MV n ) can be converted into a calibration constant (K n) may optionally be calculated at least in part using manually entered patient interface parameters in step 1208, and then a scalar calibration value may be determined in step 1210. The manually entered patient interface parameters may be related to the nasal cannula and the current flow rate. These parameters may include, but are not limited to, the cannula type, the patient size, the nostril occlusion (or an estimate thereof), and the nostril diameter. These parameters may estimate the aforementioned cannula type, the patient size, and the nostril diameter. Alternatively, these parameters may be determined automatically by the device, for example, by using an automatic peripheral component detection system or by receiving flow data from a flow sensor. The calibration constant (K n ) may be calculated through a calibration step or process in which a full seal face mask with an outlet flow sensor is temporarily placed over the patient's nasal cannula. A full seal face mask may be used to capture various flow parameters and input into a calibration constant determination function, algorithm, or method. Alternatively, the calibration constant may be derived from an estimate of flow conductance calculated in the controller. The flow conductance may be calculated in the controller based on a determined flow rate of gas and a determined pressure of the flow rate. Alternatively, several flow conductance values ​​may be stored in a look-up table, with the controller configured to select a flow conductance from the look-up table.

[0147] Nasal minute ventilation (MV n Once an estimate of nasal minute ventilation (MV) has been calculated, method 1200 may monitor the patient's nasal minute ventilation, rate of change of nasal minute ventilation, and / or trend in nasal minute ventilation at step 1220. Information about the patient's nasal minute ventilation, rate of change of nasal minute ventilation, and / or trend in nasal minute ventilation may be used to provide information to a user and / or medical personnel at step 1222. As discussed above, nasal minute ventilation (MV) may be calculated based on the patient's nasal minute ventilation (MV). n The information related to the nasal minute ventilation (MV) can be in the form of displayed data, alarms, and / or notifications.n ) itself, nasal minute ventilation (MV n ) or nasal minute ventilation (MV n By monitoring either the long-term trends of nasal minute ventilation (MVn), the device controller may be configured to present audio, visual, or audio-visual alarms or notifications to the user and / or healthcare provider. These alarms may include prompts to adjust therapy parameters, such as flow rate. The alarms may be configured to be triggered based on suggested or manually entered thresholds. As discussed above, this may allow the user and / or healthcare provider to adjust therapy parameters to improve therapy outcomes. Trends in nasal minute ventilation (MVn) may also be displayed on the device screen as a plot, chart, or graph. Based on the trend data presented, notifications and / or alarms may be triggered based thereon.

[0148] In some configurations, the device's minute ventilation (MV device An estimate of nasal minute ventilation (MV) is determined, filtered, and then calculated by taking the integral of the absolute value of the first term of a line fitted to the flow signal (e.g., a zero-order spline). n ), in some cases the device's minute ventilation (MV device ) is estimated for each of the data points using all three methods discussed above. As previously mentioned, the three methods include: (1) the device minute ventilation (MV device ) is estimated from the gas flow parameter data.

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[0149] FIG. 22D shows the minute ventilation (MV device 13 shows another flowchart of a method of estimating nasal minute ventilation 1300, which is estimated for each of the data points using all three approaches discussed above. Similar to methods 1000, 1100, 1200, method 1300 begins with acquiring raw flow data at step 1302. The raw flow data may be obtained from a flow sensor, such as an ultrasonic flow sensor. In some configurations, at step 1304, the raw flow data is first analyzed to determine whether the quality of the data is sufficiently good. If it is determined that the raw flow data is of sufficient quality, the data may be pre-processed to remove unwanted signal components. If the raw flow data is of insufficient quality, the flow data is discarded and method 1300 returns to step 1302 to wait to receive additional raw flow data. In some examples, method 1300 may include pre-processing the raw flow data to remove unwanted signal components at step 1306. Removal of unwanted signal components is described in more detail above. Unwanted signal components may be present from a flow generator motor. Once pre-processed, the flow data may be representative of the patient's respiratory data. In some configurations, once the flow data is pre-processed, the data may proceed to step 1312 where method 1300 fits a curve to the flow data. The data may be deemed to be of sufficient quality if it does not contain large transient peaks (possibly due to interface adjustments). The minute ventilation (MV device) measures the average volume of air pushed into and out of the device per minute. The process for fitting a curve to the flow data can be performed by first fitting a spline to the flow data using a least squares criterion. In some configurations, the fitted line can be represented (approximately) by:

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[0150] In the equations provided above, m is the fit parameter that corresponds to the mean of the flow data, s is the slope (i.e., gradient), and t * is the linear range of the normalized time parameter. In some configurations, t * is the linear range of the normalized time parameter, where the “oldest” time point in the flow data is equal to −1 and the “most recent” time point in the flow data is equal to 1.

[0151] In some configurations, other methods of function approximation may also be used. The flow data may be, for example, the most recent pre-filtered flow data points. In some examples, least squares methods may be used to approximate the pre-processed flow data (e.g., respiratory signal), and then integrate along a spline to estimate ventilation. In some configurations, the controller may perform various line and / or curve fitting methods to fit one or more functions to selected portions of the change in flow parameter data. This may include, for example, regression analysis, interpolation, extrapolation, linear least squares, non-linear least squares, total least squares, simple linear regression, robust simple linear regression, polynomial regression, orthogonal regression, Deming regression, linear piecewise linear regression, regressive dilution, and / or other non-limiting examples of techniques. In some configurations, one or more functions including at least the above may generate a curve. In some configurations, the curve may be a straight line. The lines or curves described herein may include multiple curves, vertices, and / or other features. The lines described herein may be straight, sloping, and / or horizontal. In some cases, the straight line described herein may be a best fit line.

[0152] The method 1300 may include measuring the minute ventilation (MV device The method 1300 may include step 1314, in which three instantaneous estimates of the device's minute ventilation (MV device In some configurations, one of the three estimates may be based on data for the parameter of the gas flow.

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[0153] In some configurations, the method 1300 may skip step 1312 and the preprocessed flow data may proceed directly to step 1314, where the method 1300 may directly calculate the average of the selected preprocessed flow data points.

[0154] Once the method 1300 has determined the minute ventilation (MV device ), the filter calculates the instantaneous device minute ventilation (MV device ) to average the device's minute ventilation (MV device ) can be applied. In some configurations, each estimate or series of estimates captured over multiple iterations of the previously described steps can be averaged or "smoothed" using a filter (e.g., an exponential filter). In some examples, this step occurs after the initial estimate, but before any additional processing steps (i.e., nasal minute ventilation (MV n It is possible that this occurs before ), which converts the .times. ...

[0155] The method 1300 includes three measurements (i.e., the first MV device Estimate of the second MV device Estimates of and the third MV device There are three unknown values ​​or signal components that can construct and / or contribute to the estimated device minute ventilation signal, the estimated MV (an estimate of the MV), and the estimated device minute ventilation signal. These unknown values ​​and signal components can include, for example, noise, respiratory rate (e.g., patient-induced changes in flow rate), and the underlying device minute ventilation signal. Thus, there is a set of three analytical expressions or equations that can be solved simultaneously to derive expressions for noise, respiratory rate, and device minute ventilation. In some configurations, solving three analytical expressions or equations simultaneously can be very computationally expensive and thus demands processing hardware in embedded device applications such as medical devices. In some configurations, in method 1300, the algorithm of method 1300 calculates the three MV according to the number of data points used for each of the estimates. deviceTo normalize the estimate of MV, first proceed to step 1318. In some examples, the method 1300 can include step 1320, where a noise correction factor can be calculated, the noise correction factor being related to the signal-to-noise ratio. The calculation of the noise correction factor in step 1320 can be similar to any calculation disclosed in applicant's International Patent Application No. PCT / IB2020 / 051816, filed March 4, 2020, entitled "Patient Attachment Detection in a Respiratory Flow Treatment System," the entirety of which is incorporated herein by reference. In some configurations, the normalized MV device A noise correction factor associated with one or more of the estimates of may be calculated.

[0156] In some configurations, the method 1300 includes an algorithm that calculates the normalized minute ventilation estimate and a noise correction factor to calculate the minute ventilation of the device (MV device ) to one of the estimated values ​​of the device's minute ventilation (MV). In some configurations, the fitted function may include terms derived at least in part from several numerical values. In some configurations, this corrected curve may include a step 1322 that uses a predefined fitted curve that relates the device's minute ventilation (MV device ) can be estimated. This is the device's minimum noise and dependence on respiratory rate for minute ventilation (MV device ) can be provided.

[0157] In some configurations, the method 1300 may include measuring the minute ventilation (MV device ) is the nasal minute ventilation (MV n ) in some configurations. In some examples, this step may include step 1324, where the estimated value or series of estimated values ​​captured over multiple iterations of the previously described steps may be averaged or "smoothed" using a filter (e.g., an exponential filter). In some examples, this step may occur after the initial estimate, but before any additional processing steps (i.e., nasal minute ventilation (MV nIn some configurations, the device's minute ventilation (MV device ) is the scalar calibration constant (K n ) to calculate nasal minute ventilation (MV n ) can be converted into a calibration constant (K n ) may optionally be calculated at least in part using manually entered patient interface parameters in step 1308, and then a scalar calibration value may be determined in step 1310. The manually entered patient interface parameters may be related to the nasal cannula and the current flow rate. These parameters may include, but are not limited to, the cannula type, the patient size, the nostril occlusion (or an estimate thereof), and the nostril diameter. These parameters may estimate the aforementioned cannula type, the patient size, and the nostril diameter. Alternatively, these parameters may be determined automatically by the device, for example, by using an automatic peripheral component detection system or by receiving flow data from a flow sensor. The calibration constant (K n ) may be calculated through a calibration step or process in which a full seal face mask with an outlet flow sensor is temporarily placed over the patient's nasal cannula. The full seal face mask may be used to capture various flow parameters and input into a calibration constant determination function, algorithm, or method. Alternatively, the calibration constant may be derived from an estimate of flow conductance calculated within the controller. Flow conductance may be determined as previously described.

[0158] Nasal minute ventilation (MV n Once an estimate of nasal minute ventilation (MV) has been calculated, method 1300 may monitor the patient's nasal minute ventilation, rate of change in nasal minute ventilation, and / or trend in nasal minute ventilation at step 1326. Information about the patient's nasal minute ventilation, rate of change in nasal minute ventilation, and / or trend in nasal minute ventilation may be used to provide information to a user and / or medical personnel at step 1328. As discussed above, nasal minute ventilation (MV) may be calculated based on the patient's nasal minute ventilation (MV).n The information related to the nasal minute ventilation (MV) can be in the form of displayed data, alarms, and / or notifications. n ) itself, nasal minute ventilation (MV n ) or nasal minute ventilation (MV n By monitoring either the long-term trends of nasal minute ventilation (MVn), the device controller may be configured to present audio, visual, or audio-visual alarms or notifications to the user and / or healthcare provider. These alarms may include prompts to adjust therapy parameters, such as flow rate. The alarms may be configured to be triggered based on suggested or manually entered thresholds. As discussed above, this may allow the user and / or healthcare provider to adjust therapy parameters to improve therapy outcomes. Trends in nasal minute ventilation (MVn) may also be displayed on the device screen as a plot, chart, or graph. Based on the trend data presented, notifications and / or alarms may be triggered based thereon.

[0159] FIG. 23 shows a flow chart of a method for estimating normalized device minute ventilation 1400. Unlike the method shown in FIGS. 22B-22D, instead of calculating nasal minute ventilation, the respiratory device takes the corrected device minute ventilation and normalizes it using the device flow rate. In some configurations, this can provide an estimate of device minute ventilation that does not change flow and is independent of device flow rate. In some examples, the estimated device minute ventilation is also independent of nasal cannula fit and can provide a generic representation of the patient's minute ventilation without first converting the estimated device minute ventilation to nasal minute ventilation.

[0160] Method 1400 begins with obtaining raw flow data at step 1402. The raw flow data may be obtained from a flow sensor, such as an ultrasonic flow sensor. In some configurations, at step 1404, the raw flow data is first analyzed to determine whether the quality of the data is sufficiently good. If it is determined that the raw flow data is of sufficient quality, the data may be pre-processed to remove unwanted signal components. If the raw flow data is of insufficient quality, the flow data is discarded and method 1400 returns to step 1402 to wait to receive additional raw flow data. In some examples, method 1400 may include pre-processing the raw flow data to remove unwanted signal components at step 1406. Removal of unwanted signal components is described in more detail above. Unwanted signal components may be present from a flow generator motor.

[0161] In some configurations, once the flow data has been pre-processed, the data may proceed to step 1408 where method 1400 fits a curve to the flow data. The data may be deemed to be of sufficient quality if it does not contain large transient peaks (possibly due to adjustments to the interface). The minute ventilation (MV device ) measures the average volume of air pushed into and out of the device per minute. The process for fitting a curve to the flow data can be performed by first fitting a spline to the flow data using a least squares criterion. In some configurations, the fitted line can be represented (approximately) by:

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[0162] In the equations provided above, m is the fit parameter that corresponds to the mean of the flow data, s is the slope (i.e., gradient), and t * is the linear range of the normalized time parameter. In some configurations, t *is the linear range of the normalized time parameter, where the “oldest” time point in the flow data is equal to −1 and the “most recent” time point in the flow data is equal to 1.

[0163] In some configurations, other methods of function approximation may also be used. The flow data may be, for example, the most recent pre-filtered flow data points. In some examples, least squares methods may be used to approximate the pre-processed flow data (e.g., respiratory signal), and then integrate along a spline to estimate ventilation. In some configurations, the controller may perform various line and / or curve fitting methods to fit one or more functions to selected portions of the change in flow parameter data. This may include, for example, regression analysis, interpolation, extrapolation, linear least squares, non-linear least squares, total least squares, simple linear regression, robust simple linear regression, polynomial regression, orthogonal regression, Deming regression, linear piecewise linear regression, regressive dilution, and / or other non-limiting examples of techniques. In some configurations, one or more functions including at least the above may generate a curve. In some configurations, the curve may be a straight line. The lines or curves described herein may include multiple curves, vertices, and / or other features. The lines described herein may be straight, sloping, and / or horizontal. In some cases, the straight line described herein may be a best fit line.

[0164] The method 1400 may include measuring the minute ventilation (MV device The method 1400 may include step 1410, in which three instantaneous estimates of the device's minute ventilation (MV device In some configurations, one of the three estimates may be based on data for the parameter of the gas flow.

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[0165] In some configurations, the method 1400 may skip step 1408 and the preprocessed flow data may proceed directly to step 1410 where the method 1300 may directly calculate the average of the selected preprocessed flow data points.

[0166] Once the method 1400 has determined the minute ventilation (MV device ), the filter calculates the instantaneous device minute ventilation (MV device ) to average the device's minute ventilation (MV device ) can be applied. In some configurations, each estimate or series of estimates captured over multiple iterations of the previously described steps can be averaged or "smoothed" using a filter (e.g., an exponential filter). In some examples, this step occurs after the initial estimate, but before any additional processing steps (i.e., nasal minute ventilation (MV n It is possible that this occurs before ), which converts the .times. ...

[0167] The method 1400 includes three measurements (i.e., the first MV device Estimate of the second MV device Estimates of and the third MV deviceThere are three unknown values ​​or signal components that can construct and / or contribute to the estimated device minute ventilation signal, the estimated MV (an estimate of the MV), and the estimated device minute ventilation signal. These unknown values ​​and signal components can include, for example, noise, respiratory rate (e.g., patient-induced changes in flow rate), and the underlying device minute ventilation signal. Thus, there is a set of three analytical expressions or equations that can be solved simultaneously to derive expressions for noise, respiratory rate, and device minute ventilation. In some configurations, solving three analytical expressions or equations simultaneously can be very computationally expensive and thus demands processing hardware in embedded device applications such as medical devices. In some configurations, in method 1400, the algorithm of method 1400 calculates the three MV according to the number of data points used for each of the estimates. device To normalize the estimate of MV, first proceed to step 1414. In some examples, the method 1400 can include step 1416, where a noise correction factor can be calculated, the noise correction factor being related to the signal-to-noise ratio. The calculation of the noise correction factor in step 1416 can be similar to any calculation disclosed in applicant's International Patent Application No. PCT / IB2020 / 051816, filed March 4, 2020, entitled "Patient Attachment Detection in a Respiratory Flow Treatment System," the entirety of which is incorporated herein by reference. In some configurations, the normalized MV device A noise correction factor associated with one or more of the estimates of may be calculated.

[0168] In some configurations, the method 1400 includes an algorithm that calculates the normalized minute ventilation estimate and a noise correction factor to calculate the minute ventilation of the device (MV device ) to one of the estimated values ​​of the device's minute ventilation (MV). In some configurations, the fitted function may include terms derived at least in part from several numerical values. In some configurations, this corrected curve may include a predefined fitted curve that relates the device's minute ventilation (MV device) can be estimated. This is the device's minimum noise and dependence on respiratory rate for minute ventilation (MV device ) can be provided.

[0169] In some configurations, the method 1400 may include calculating a corrected device minute ventilation (MV device ) is normalized using the device flow rate. In some examples, the same data previously used in the previous step (i.e., good pre-processed flow rate data) may be used to normalize the corrected device minute ventilation (MV device ), the flow remains constant and provides an estimate of device minute ventilation that is independent of device flow. As mentioned previously, the corrected device minute ventilation (MV device ) is able to be independent of nasal cannula fit and provides a generic indication of a patient's minute ventilation (without further conversion to nasal minute ventilation).

[0170] Once normalized, the device minute ventilation (MV device Once an estimate of nasal minute ventilation (MV) has been calculated, method 1400 may monitor the patient's nasal minute ventilation, rate of change in nasal minute ventilation, and / or trend in nasal minute ventilation at step 1422. Information about the patient's nasal minute ventilation, rate of change in nasal minute ventilation, and / or trend in nasal minute ventilation may be used to provide information to a user and / or healthcare provider at step 1424. As discussed above, normalized device minute ventilation (MV) may be calculated using a nasal minute ventilation (MV) metric. device The information related to the normalized device minute ventilation (MV) can be in the form of displayed data, alarms, and / or notifications. device ) itself, the normalized device minute ventilation (MV device ) or normalized device minute ventilation (MV deviceBy monitoring either the long-term trends of the MV, the device controller may be configured to present an audio, visual, or audio-visual alarm or notification to the user and / or healthcare provider. These alarms may include prompts to adjust therapy parameters, such as flow rate. The alarms may be configured to be triggered based on suggested or manually entered thresholds. As discussed above, this may allow the user and / or healthcare provider to adjust therapy parameters to improve therapy outcomes. Normalized Device Minute Ventilation (MV device ) trends can also be displayed on the device screen as a plot, chart, or graph. Based on the trend data shown, notifications and / or alerts can be triggered based on them. In some instances, the patient's nasal minute ventilation can be monitored indirectly by monitoring the normalized device minute ventilation.

[0171] The user and / or healthcare professional may wish to measure nasal minute ventilation (MV) as opposed to its average or instantaneous value. n The rate of change of the calibration constant (K n Determination of nasal minute ventilation (MV) can be difficult and potentially inaccurate and unreliable. n ) directly may be of limited benefit due to issues with accuracy and / or reliability of the immediate value. In some configurations, nasal minute ventilation (MV n The accuracy and / or reliability of the immediate value of K n However, the accuracy and / or reliability of the nasal minute ventilation (MV n ) values ​​may have significant error, whereas nasal minute ventilation (MV n ) trend accurately or reliably represents the patient's respiratory effort over time. For example, the nasal minute ventilation (MV n A trend towards a decrease or increase in nasal minute ventilation (MV) can indicate efficacy of treatment or deterioration of the patient's health. n Due to the subjectivity of nasal minute ventilation (MV nChanges or trends in nasal minute ventilation (MV) may be more useful to users and medical personnel as opposed to the instantaneous value itself. n ) is the nasal minute ventilation (MV n ) readings can be subjective because they may vary with each patient's individual height, mass, and other results. There is significant variability between patients, and clinicians may not be able to accurately measure a single nasal minute ventilation (MV n It can be difficult to draw any strong conclusions based on nasal minute ventilation (MV) values ​​alone. n If the nasal minute ventilation (MV) increases over time, this can indicate to the user and / or medical personnel that the treatment parameters are effective in strengthening the patient's lungs over time. n ) decreases over time, this can indicate to the user or medical professional that the patient's lung function is deteriorating. For example, nasal minute ventilation (MV n A decrease in nasal minute ventilation (MV) can indicate worsening asthma symptoms, increased scar tissue, decreased energy for the patient, increased bacterial or viral infections, and increased fluid in the lungs. n ) trend information can be particularly useful when the nasal high flow system is used in the home setting. Trend information can help the user identify deterioration in the patient without requiring know-how to interpret individual data points and values.

[0172] If the respiratory rate RR is known, the patient's tidal volume (V T ) is an estimate of nasal minute ventilation (MV n ) may be calculated as follows:

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[0173] Maximum Inspiratory Flow The controller determines the maximum intake flow.

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[0174] Maximum Inspiratory Flow

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[0175] FIG. 24 shows a flow chart of a method for estimating peak inspiratory flow 1500. Method 1500 begins with acquiring raw flow data at step 1502. The raw flow data may be obtained from a flow sensor, such as an ultrasonic flow sensor. Method 1500 may include pre-processing the raw flow data to remove unwanted signal components at step 1504. Removal of unwanted signal components is described in more detail above (e.g., step 1004 of method 1000, step 1104 of method 1100, step 1206 of method 1200, and step 1306 of method 1300). Unwanted signal components may be present from a flow generator motor. Once pre-processed, the flow data may represent respiratory data for the patient. Method 1500 proceeds to derive a peak inspiratory flow (MV), assuming the pre-processed data is of sufficient quality, based on the minute ventilation (MV) of the device. device ), step 1506, where the device can be run through a minute ventilation algorithm to calculate the minute ventilation (MV device ) is obtained, the method 1500 optionally calculates the minute ventilation (MV device ) to the nasal minute ventilation (MV n ), as described in more detail above, into nasal minute ventilation (MVn ) is calculated using a scalar calibration constant to calculate the device's minute ventilation (MV device ) can be estimated by converting and / or transforming the nasal cannula and the current flow rate. As previously discussed, the scalar calibration constant can be determined by using manual input parameters for the nasal cannula and the current flow rate. In some configurations, the nasal minute ventilation (MV n ) is obtained, the maximum inspiratory flow

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[0176] Maximum Inspiratory Flow

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[0177] Maximum Inspiratory Flow

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[0178] Often, users and / or healthcare professionals will adjust the fraction of inspired oxygen (FiO) instead of adjusting the flow rate. 2 The oxygen concentration is adjusted at the supply with the aim of increasing the fraction of inspired oxygen (FiO) at the time of supply. While this can have the desired effect, it may be more advantageous to increase the flow rate instead. 2) is the fraction of inspired oxygen (FiO) that the patient actually receives due to interface leaks in an unsealed system. 2 By instead increasing the device flow rate, this does not necessarily correspond to the fraction of inspired oxygen received (FiO 2 ) is the desired fraction of inspired oxygen (FiO 2 ), in some configurations, by understanding whether the device output meets the patient's maximum inspiratory demand, the flow rate can be adjusted accordingly.

[0179] The device controller determines the maximum intake flow.

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[0180] Maximum Inspiratory Flow

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[0181] In some configurations, the respiratory treatment device may be controlled based on one of the determined patient parameters, for example to reach a set flow rate that matches or slightly exceeds the patient's maximum inspiratory flow rate. The patient's maximum inspiratory flow rate may be estimated and compared to the set flow rate. The controller may increase the flow rate if the estimated maximum inspiratory flow rate exceeds the set flow rate. If the flow rate significantly exceeds the patient's estimated maximum inspiratory flow rate, the controller may reduce the flow rate. Similarly, the controller may control the blower to provide a flow rate and the user's estimated nasal minute ventilation according to a set threshold. The clinician may be able to manually set the nasal minute ventilation threshold. The controller may then estimate the current nasal minute ventilation over a period of time and if it finds it to be below the threshold, the flow rate may be adjusted (increased). The magnitude of the adjustment may be based at least in part on the difference between the set threshold and the estimated nasal minute ventilation value.

[0182] Terminology Unless the context clearly requires otherwise, throughout this specification and claims, the words "comprise," "comprising," and the like, are to be construed in an inclusive sense, i.e., "including but not limited to," as opposed to an exclusive or exhaustive sense.

[0183] Although the present disclosure has been described with respect to specific embodiments and examples, those skilled in the art will understand that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses modifications and equivalents thereof that are obvious. In addition, while several variations of the embodiments of the present disclosure have been shown and described in detail, other modifications that are within the scope of the present disclosure will be readily apparent to those skilled in the art. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the present disclosure. For example, the features described above in relation to one embodiment may be used with different embodiments described herein, and the combinations will still fall within the scope of the present disclosure. It should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for each other to form different modes of embodiments of the present disclosure. Thus, it is intended that the scope of the disclosure herein should not be limited by the specific embodiments described above. Accordingly, unless otherwise specified or clearly contradictory, each embodiment of the present invention may include, in addition to its basic features described herein, one or more features as described herein from the embodiments of the present invention disclosed herein with each other.

[0184] It is to be understood that a feature, material, property, or group described in connection with a particular aspect, embodiment, or example may be applied to any other aspect, embodiment, or example described in this section or anywhere herein, unless inconsistent therewith. All features disclosed herein (including any accompanying claims, summary, and drawings), and / or all steps of any method or process so disclosed, may be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. Protection is not limited to the details of any of the foregoing embodiments. Protection extends to any novel, or any novel combination, of features disclosed herein (including any accompanying claims, summary, and drawings), or any novel, or any novel combination of steps of any method or process so disclosed.

[0185] Moreover, certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, while features may be described above as working in a particular combination, one or more features from a claimed combination can, in some cases, be deleted from the combination, and the combination may be claimed as a subcombination or a variation of the subcombination.

[0186] Moreover, while operations may be depicted in the figures or described herein in a particular order, such operations need not be performed in the specific order or sequential order shown, or all operations need not be performed, to achieve a desired result. Other operations not depicted or described may be incorporated into the example methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any described operations. Furthermore, operations may be rearranged or resequenced in other implementations. Those skilled in the art will recognize that in some embodiments, the actual steps performed in the illustrated and / or disclosed processes may differ from the steps shown in the figures. Depending on the embodiment, certain steps described above may be removed and others may be added. Furthermore, the features and attributes of certain embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. Also, the separation of the various system components of the above implementations should not be understood as requiring such separation in all implementations, and it should be understood that the components and systems described may generally be integrated together in a single product or multiple product packages.

[0187] For purposes of this disclosure, certain aspects, advantages, and novel features have been described herein. Not necessarily all such advantages may be achieved by any particular embodiment. Thus, for example, one skilled in the art will recognize that the present disclosure may be embodied or carried out in a manner that achieves one advantage or group of advantages as taught herein, without necessarily achieving other advantages as may be taught or suggested herein.

[0188] Predicate language such as "can," "could," "might," or "may" used, unless expressly stated otherwise or understood differently within the context in which it is used, is generally intended to convey that certain embodiments include certain features, elements, and / or steps, while other embodiments do not. Thus, such predicate language is generally not intended to suggest that features, elements, and / or steps are in any way required for one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without other user input or prompts, whether those features, elements, and / or steps are included in or should be performed in any particular embodiment.

[0189] Language of degree as used herein, such as the terms "approximately," "about," "generally," and "substantially," as used herein, refers to a value, amount, or characteristic that is close to a stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," "generally," and "substantially" may refer to an amount that is less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated amount.

[0190] EXEMPLARY AND / OR PREFERRED FEATURES 1. A respiratory device configured to deliver respiratory therapy to a patient using an unsealed respiratory interface, the device comprising: A controller, the controller comprising: receiving data of a parameter of a gas flow of the respiratory device indicative of a patient's respiration while the device is in use with an unsealed user interface; determining a device minute ventilation or a parameter indicative of the device minute ventilation; A respiratory device configured to indicate a minute ventilation of a user. 2. A respiratory device as described in paragraph 1, wherein the controller is further configured to process data of the gas flow parameters to remove noise. 3. A respiratory device as described in paragraph 2, wherein the controller is configured to remove noise associated with the effect of the motor on parameters of the gas flow. 4. A respiratory device as described in paragraph 3, wherein the controller is configured to receive data on the motor speed, and the gas flow parameters are discarded if the motor speed falls below a preset threshold. 5. A respiratory device as described in any one of paragraphs 1 to 3, wherein the controller is configured to discard the gas flow parameters if the controller determines that the gas flow parameters are of insufficient quality. 6. A respiratory device as described in paragraph 5, wherein the gas flow parameters are of poor quality as they include large transient peaks. 7. A respiratory device described in any one of paragraphs 1 to 6, wherein determining the minute ventilation of the device includes fitting a plurality of splines to data of the gas flow parameters, the plurality of splines being fitted using a least squares criterion, and the minute ventilation of the device being determined by integrating along the plurality of splines. 8. A respiratory device described in any one of paragraphs 1 to 6, wherein determining the minute ventilation of the device includes determining the integral of the absolute value of the first term of a straight line fitted to the data of the gas flow parameters. 9. A respiratory device described in any one of paragraphs 1 to 6, wherein determining the minute ventilation of the device includes determining the integral of the absolute value of a straight line fitted to the gas flow parameter data divided by a time range. 10. A respiratory device as described in any one of paragraphs 1 to 6, wherein determining the minute ventilation of the device includes averaging the absolute value of a straight line fitted to data of the gas flow parameter over a range of time points within the time range. 11. A respiratory device according to any one of paragraphs 1 to 10, wherein the controller is configured to calculate a normalized device minute ventilation based on the device minute ventilation. 12. A respiratory device as described in paragraph 11, wherein the controller is configured to calculate a noise correction factor correlated to a normalized minute ventilation of the device. 13. A respiratory device as described in paragraph 12, wherein the controller is configured to calculate a corrected device minute ventilation by correlating the normalized device minute ventilation and a noise correction factor with the device minute ventilation. 14. A respiratory device according to any one of paragraphs 1 to 13, wherein the minute ventilation of the device is converted to nasal minute ventilation. 15. A respiratory device according to paragraph 14, wherein the minute ventilation of the device is converted to nasal minute ventilation using a scalar calibration constant. 16. A respiratory device as described in paragraph 15, wherein the scalar calibration constant is determined by entering a nasal cannula or a patient interface parameter related to the current flow rate. 17. A respiratory device as described in paragraph 15, wherein the scalar calibration constant is determined by inputting at least one of the type of cannula, the patient's size, and the nostril diameter, and / or the amount of nasal obstruction of the user. 18. A respiratory device as described in paragraph 15, wherein the scalar calibration constant is calculated by temporarily placing a sealed face mask on the patient's face while the patient is wearing an unsealed nasal cannula to measure at least one flow parameter of the respiratory device. 19. A respiratory device according to any one of paragraphs 1 to 18, wherein the controller is further configured to monitor at least one of nasal minute ventilation, rate of change of nasal minute ventilation, and trend of nasal minute ventilation. 20. A respiratory device according to any one of paragraphs 1 to 19, wherein the respiratory device further comprises a display, the display being configured to display data relating to nasal minute ventilation. 21. A respiratory device according to any one of paragraphs 1 to 19, wherein the respiratory device further comprises a display, the display being configured to display data relating to the rate of change of nasal minute ventilation. 22. A respiratory device according to any one of paragraphs 1 to 19, wherein the respiratory device further comprises a display, the display being configured to display data relating to trends in nasal minute ventilation. 23. A respiratory device as described in any one of paragraphs 1 to 22, wherein the respiratory device is configured to activate an alarm or notification when nasal minute ventilation exceeds or falls below a preset threshold. 24. A respiratory device as described in any one of paragraphs 1 to 22, wherein the respiratory device is configured to activate an alarm or notification when the rate of nasal minute ventilation exceeds or falls below a preset threshold. 25. A respiratory device as described in any one of paragraphs 1 to 22, wherein the respiratory device is configured to activate an alarm or notification when the trend of nasal minute ventilation exceeds or falls below a preset threshold. 26. A respiratory device according to any one of paragraphs 1 to 25, wherein the respiratory device includes a patient interface, the patient interface including a nasal cannula. 27. A respiratory device described in any one of paragraphs 1 to 26, wherein the respiratory device is configured to deliver nasal high-flow therapy. 28. A respiratory device according to any one of paragraphs 1 to 27, further comprising a humidifier configured to humidify the gas flow to the patient. 29. A respiratory device configured to deliver respiratory therapy to a patient using an unsealed respiratory interface, the device being configured to provide information related to the patient's breathing, the device comprising: A controller, the controller comprising: receiving parameter data of a gas flow of a respiratory device indicative of a patient's respiration; processing the gas flow parameter data to remove noise; Determining whether the parameters of the gas stream are of sufficient quality; Determine the minute ventilation of the device, A respiratory device configured to convert the device's minute ventilation to nasal minute ventilation using a scalar calibration constant. 30. A respiratory device as described in paragraph 29, wherein the controller is configured to remove noise associated with the influence of the motor on the parameters of the gas flow. 31. A respiratory device as described in paragraph 30, wherein the controller is configured to receive data on the motor speed, and the gas flow parameter is discarded if the motor speed falls below a preset threshold. 32. A respiratory device as described in paragraph 31, wherein the gas flow parameters are of poor quality as they include large transient peaks. 33. A respiratory device described in any one of paragraphs 29 to 32, wherein determining the minute ventilation of the device includes fitting a plurality of splines to data of the gas flow parameters, the plurality of splines being fitted using a least squares criterion, and the minute ventilation of the device being determined by integrating along the plurality of splines. 34. A respiratory device described in any one of paragraphs 29 to 32, wherein determining the minute ventilation of the device includes determining the integral of the absolute value of the first term of a straight line fitted to the gas flow parameter data. 35. A respiratory device described in any one of paragraphs 29 to 32, wherein determining the minute ventilation of the device comprises the integral of the absolute value of a straight line fitted to the gas flow parameter data divided by a time range. 36. A respiratory device described in any one of paragraphs 29 to 32, wherein determining the minute ventilation of the device includes averaging the absolute value of a straight line fitted to data of the gas flow parameter over a range of time points within the time range. 37. A respiratory device according to any one of paragraphs 29 to 36, wherein the controller is configured to calculate a normalized device minute ventilation based on the device minute ventilation. 38. A respiratory device as described in paragraph 37, wherein the controller is configured to calculate a noise correction factor correlated to normalized minute ventilation of the device. 39. A respiratory device as described in paragraph 38, wherein the controller is configured to calculate a corrected device minute ventilation by correlating the normalized device minute ventilation and a noise correction factor with the device minute ventilation. 40. A respiratory device as described in paragraph 39, wherein the scalar calibration constant is determined by entering a nasal cannula or a patient interface parameter related to the current flow rate. 41. A respiratory device as described in paragraph 39, wherein the scalar calibration constant is determined by inputting at least one of the cannula type, the patient's size, and the nostril diameter. 42. A respiratory device as described in paragraph 39, wherein the scalar calibration constant is calculated by temporarily placing a sealed face mask on the patient's face while the patient is wearing a nasal cannula to measure at least one flow parameter of the respiratory device. 43. A respiratory device according to any one of paragraphs 29 to 42, wherein the controller is further configured to monitor at least one of nasal minute ventilation, rate of change of nasal minute ventilation, and trend of nasal minute ventilation. 44. A respiratory device according to any one of paragraphs 29 to 43, wherein the respiratory device further comprises a display, the display being configured to display data relating to nasal minute ventilation. 45. A respiratory device according to any one of paragraphs 29 to 43, wherein the respiratory device further comprises a display, the display being configured to display data relating to the rate of change of nasal minute ventilation. 46. ​​A respiratory device according to any one of paragraphs 29 to 43, wherein the respiratory device further comprises a display, the display being configured to display data relating to trends in nasal minute ventilation. 47. A respiratory device according to any one of paragraphs 26 to 46, wherein the respiratory device is configured to activate an alarm or notification when nasal minute ventilation exceeds or falls below a preset threshold. 48. A respiratory device described in any one of paragraphs 29 to 46, wherein the respiratory device is configured to activate an alarm or notification when the rate of change of nasal minute ventilation exceeds or falls below a preset threshold. 49. A respiratory device according to any one of paragraphs 29 to 46, wherein the respiratory device is configured to activate an alarm or notification when the trend of nasal minute ventilation exceeds or falls below a pre-set threshold. 50. A respiratory device according to any one of paragraphs 29 to 49, wherein the respiratory device includes a patient interface, the patient interface including a nasal cannula. 51. A respiratory device described in any one of paragraphs 29 to 50, wherein the respiratory device is configured to deliver nasal high-flow therapy. 52. A respiratory device according to any one of paragraphs 29 to 51, further comprising a humidifier configured to humidify the gas flow to the patient. 53. A respiratory device configured to deliver respiratory therapy to a patient using an unsealed respiratory interface, the device being configured to provide information related to the patient's breathing, the device comprising: A controller, the controller comprising: receiving parameter data of a gas flow of a respiratory device indicative of a patient's respiration; A respiratory device configured to determine a maximum inspiratory flow for a patient. 54. A respiratory device as described in paragraph 53, wherein the controller is configured to determine the minute ventilation of the device. 55. A respiratory device as described in paragraph 54, wherein the patient's maximum inspiratory flow is based on the minute ventilation of the device. 56. A respiratory device described in any one of paragraphs 53 to 55, wherein the controller is further configured to process data of the gas flow parameters to remove noise. 57. A respiratory device as described in paragraph 56, wherein the controller is configured to remove noise associated with the effect of the motor on the parameters of the gas flow. 58. A respiratory device as described in paragraph 57, wherein the controller is configured to receive data on the motor speed, and the gas flow parameters are discarded if the motor speed falls below a preset threshold. 59. A respiratory device described in any one of paragraphs 53 to 58, wherein the controller is configured to discard the gas flow parameters if the controller determines that the gas flow parameters are of insufficient quality. 60. A respiratory device as described in paragraph 59, wherein the gas flow parameters are of poor quality as they include large transient peaks. 61. A respiratory device described in any one of paragraphs 54 to 60, wherein determining the minute ventilation of the device includes fitting a plurality of splines to data of the gas flow parameters, the plurality of splines being fitted using a least squares criterion, and the minute ventilation of the device being determined by integrating along the plurality of splines. 62. A respiratory device described in any one of paragraphs 54 to 61, wherein determining the minute ventilation of the device includes determining the integral of the absolute value of the first term of a straight line fitted to the data of the gas flow parameters. 63. A respiratory device described in any one of paragraphs 54 to 62, wherein determining the minute ventilation of the device comprises the integral of the absolute value of a straight line fitted to the gas flow parameter data divided by a time range. 64. A respiratory device described in any one of paragraphs 54 to 63, wherein determining the minute ventilation of the device comprises averaging the absolute value of a straight line fitted to data of the gas flow parameter over a range of time points within the time range. 65. A respiratory device described in any one of paragraphs 53 to 64, wherein the controller is configured to calculate a normalized device minute ventilation based on the device minute ventilation. 66. A respiratory device as described in paragraph 65, wherein the controller is configured to calculate a noise correction factor correlated to normalized minute ventilation of the device. 67. A respiratory device as described in paragraph 66, wherein the controller is configured to calculate a corrected device minute ventilation by correlating the normalized device minute ventilation and a noise correction factor with the device minute ventilation. 68. A respiratory device according to any one of paragraphs 54 to 67, wherein the controller is further configured to convert the minute ventilation of the device to nasal minute ventilation. 69. A respiratory device according to paragraph 68, wherein the minute ventilation of the device is converted to nasal minute ventilation using a scalar calibration constant. 70. A respiratory device as described in paragraph 69, wherein the scalar calibration constant is determined by inputting a nasal cannula or a patient interface parameter related to the current flow rate. 71. A respiratory device as described in paragraph 70, wherein the scalar calibration constant is determined by inputting at least one of the cannula type, the patient's size, and the nostril diameter. 72. A respiratory device as described in paragraph 71, wherein the scalar calibration constant is calculated by temporarily placing a sealed face mask on the patient's face while the patient is wearing an unsealed nasal cannula to measure at least one flow parameter of the respiratory device. 73. A respiratory device described in any one of paragraphs 68 to 72, wherein the patient's maximum inspiratory flow is determined by converting nasal minute ventilation by applying a calibration constant. 74. A respiratory device as described in paragraph 73, wherein the calibration constant is 3. 75. A respiratory device as described in paragraph 73, wherein the calibration constant is 4. 76. A respiratory device as described in paragraph 73, wherein the calibration constant is 5. 77. A respiratory device as described in paragraph 73, wherein the calibration constant is 6. 78. A respiratory device as described in paragraph 73, wherein the calibration constant is between 3 and 6. 79. A respiratory device according to any one of paragraphs 53 to 78, wherein the controller is further configured to monitor at least the maximum inspiratory flow or the rate of change of the maximum inspiratory flow. 80. The breathing method of any one of paragraphs 53 to 79, wherein the breathing device further includes a display, the display configured to display data relating to the maximum inspiratory flow. 81. A respiratory device as described in any one of paragraphs 53 to 80, wherein the respiratory device further comprises a display, the display being configured to display data relating to the rate of change of peak inspiratory flow. 82. A respiratory device described in any one of paragraphs 53 to 81, wherein the respiratory device is configured to activate an alarm or notification when the maximum inspiratory flow exceeds or falls below a preset threshold. 83. A respiratory device described in any one of paragraphs 53 to 82, wherein the respiratory device is configured to initiate an alarm or notification when the rate of change of peak inspiratory flow exceeds or falls below a preset threshold. 84. A respiratory device according to any one of paragraphs 53 to 83, wherein the respiratory device includes a patient interface, the patient interface including a nasal cannula. 85. A respiratory device described in any one of paragraphs 53 to 84, wherein the respiratory device is configured to deliver nasal high-flow therapy. 86. A respiratory device according to any one of paragraphs 54 to 85, further comprising a humidifier configured to humidify the gas flow to the patient. 87. A respiratory device configured to deliver respiratory therapy to a patient using an unsealed respiratory interface, the device being configured to provide information related to the patient's breathing, the device comprising: A controller, the controller comprising: receiving a flow rate of the gas flow of the respiratory device while the device is in use with an unsealed user interface; The respiratory device is configured to determine a respiratory parameter based on the received flow rate of gas, the respiratory parameter being indicative of a minute ventilation of the patient. 88. A respiratory device as described in paragraph 87, wherein the controller is configured to display the respiratory parameters on a graphical user interface. 89. A respiratory device described in any one of paragraphs 87 or 88, wherein the controller is configured to determine the minute ventilation of the device based on the gas flow, and the controller is configured to determine the minute ventilation of the patient based on the minute ventilation of the device. 90. A respiratory device according to any one of paragraphs 87 to 89, wherein the controller is further configured to process the flow rate of the gas flow to eliminate noise. 91. A respiratory device as described in paragraph 90, wherein the controller is configured to remove noise associated with the effect of the motor on parameters of the gas flow. 92. A respiratory device as described in paragraph 91, wherein the controller is configured to receive data on the motor speed, and the gas flow parameter is discarded if the motor speed falls below a preset threshold. 93. A respiratory device as described in any one of paragraphs 87 to 92, wherein the controller is configured to discard a flow rate of the gas flow if the controller determines that the flow rate of the gas flow is of insufficient quality. 94. A respiratory device as described in paragraph 93, wherein the flow rate of the gas flow is of poor quality as it includes large transient peaks. 95. A respiratory device as described in any one of paragraphs 87 to 94, wherein the controller is configured to determine the minute ventilation of the device as described in any one of paragraphs 7 to 10, and the patient's minute ventilation may be calculated as defined in any one or more of the above paragraphs. 96. A respiratory device configured to deliver respiratory therapy to a patient using an unsealed respiratory interface, the device being configured to provide information related to the patient's breathing, the device comprising: A controller, the controller comprising: receiving a flow rate of the gas flow of the respiratory device while the device is in use with an unsealed user interface; The respiratory device is configured to determine a maximum inspiratory flow for the patient based on the flow rate of the received gas. 97. A respiratory device as described in paragraph 96, wherein the controller is configured to display the patient's maximum inspiratory flow on a graphical user interface. 98. A respiratory device as described in any one of paragraphs 96 or 97, wherein the controller is configured to determine the patient's maximum inspiratory flow based on the minute ventilation of the device. 99. A respiratory device described in any one of paragraphs 96 to 98, wherein the minute ventilation of the device is based on the flow rate of the gas stream, the flow rate of the gas stream being pre-treated according to any one of paragraphs 56 to 60. 100. A respiratory device as described in any one of paragraphs 96 to 99, wherein the minute ventilation of the device is calculated according to any one of paragraphs 61 to 64. 101. A respiratory device as described in any one of paragraphs 96 to 100, wherein the controller is configured to convert the minute ventilation of the device to nasal minute ventilation in accordance with any one of paragraphs 68 to 78. 102. A respiratory device according to any one of paragraphs 96 to 101, wherein the controller is configured to monitor at least the maximum inspiratory flow or the rate of change of the maximum inspiratory flow. 103. A respiratory device as described in any one of paragraphs 96 to 102, wherein the respiratory device further includes a display, the display configured to display data relating to at least one of the maximum inspiratory flow or the rate of change of the maximum inspiratory flow. 104. A respiratory device as described in any one of paragraphs 96 to 103, wherein the respiratory device is configured to initiate an alarm or notification when the maximum inspiratory flow exceeds or falls below a preset threshold. 105. A respiratory device described in any one of paragraphs 96 to 104, wherein the respiratory device is configured to initiate an alarm or notification when the rate of change of peak inspiratory flow exceeds or falls below a preset threshold. 106. A respiratory device described in any one of paragraphs 1 to 28, wherein the controller is configured to determine a tidal volume and to initiate an alarm or notification when the tidal volume falls below a preset threshold. 107. A respiratory device described in any one of paragraphs 29 to 52, wherein the controller is configured to determine a tidal volume and to initiate an alarm or notification when the tidal volume falls below a preset threshold. 108. A respiratory device described in any one of paragraphs 53 to 86, wherein the controller is configured to determine a tidal volume and to initiate an alarm or notification when the tidal volume falls below a preset threshold. 109. A respiratory device described in any one of paragraphs 87 to 95, wherein the controller is configured to determine a tidal volume and to initiate an alarm or notification when the tidal volume falls below a preset threshold. 110. A respiratory device described in any one of paragraphs 96 to 105, wherein the controller is configured to determine a tidal volume and to initiate an alarm or notification when the tidal volume falls below a preset threshold. 111. A respiratory device described in any one of paragraphs 1 to 28, wherein the controller is configured to use the device flow rate to normalize the corrected device minute ventilation. 112. A respiratory device according to any one of paragraphs 111, further comprising a display configured to display data relating to at least one of the corrected device minute ventilation, the rate of change of the corrected device minute ventilation, and the trend of the corrected device minute ventilation. 113. A respiratory device described in any one of paragraphs 111 or 112, wherein the respiratory device is configured to activate an alarm or notification when at least one of the following occurs: the corrected device minute ventilation exceeds or falls below a preset threshold, the rate of change of the corrected device minute ventilation exceeds or falls below a preset threshold, and the trend of the corrected device minute ventilation exceeds or falls below a preset threshold. 114. A respiratory device described in any one of paragraphs 29 to 52, wherein the controller is configured to use the device flow rate to normalize the corrected device minute ventilation. 115. A respiratory device as described in any one of paragraphs 114, wherein the respiratory device further comprises a display configured to display data relating to at least one of the corrected device minute ventilation, the rate of change of the corrected device minute ventilation, and the trend of the corrected device minute ventilation. 116. A respiratory device described in any one of paragraphs 114 or 115, wherein the respiratory device is configured to activate an alarm or notification when at least one of the following occurs: the corrected device minute ventilation exceeds or falls below a preset threshold, the rate of change of the corrected device minute ventilation exceeds or falls below a preset threshold, and the trend of the corrected device minute ventilation exceeds or falls below a preset threshold. 117. A respiratory device described in any one of paragraphs 53 to 86, wherein the controller is configured to use the device flow rate to normalize the corrected device minute ventilation. 118. The respiratory device of paragraph 117, further comprising a display configured to display data relating to at least one of the corrected device minute ventilation, the rate of change of the corrected device minute ventilation, and the trend of the corrected device minute ventilation. 119. A respiratory device described in any one of paragraphs 117 or 118, wherein the respiratory device is configured to activate an alarm or notification when at least one of the following occurs: the corrected device minute ventilation exceeds or falls below a preset threshold, the rate of change of the corrected device minute ventilation exceeds or falls below a preset threshold, and the trend of the corrected device minute ventilation exceeds or falls below a preset threshold. 120. A respiratory device described in any one of paragraphs 87 to 95, wherein the controller is configured to use the device flow rate to normalize the corrected device minute ventilation. 121. A respiratory device according to any one of paragraphs 120, further comprising a display configured to display data relating to at least one of the corrected device minute ventilation, the rate of change of the corrected device minute ventilation, and the trend of the corrected device minute ventilation. 122. A respiratory device described in any one of paragraphs 120 or 121, wherein the respiratory device is configured to activate an alarm or notification when at least one of the following occurs: the corrected device minute ventilation exceeds or falls below a preset threshold, the rate of change of the corrected device minute ventilation exceeds or falls below a preset threshold, and the trend of the corrected device minute ventilation exceeds or falls below a preset threshold. 123. A respiratory device described in any one of paragraphs 96 to 105, wherein the controller is configured to use the device flow rate to normalize the corrected device minute ventilation. 124. A respiratory device as described in any one of paragraphs 123, further comprising a display configured to display data relating to at least one of the corrected device minute ventilation, the rate of change of the corrected device minute ventilation, and the trend of the corrected device minute ventilation. 125. A respiratory device described in any one of paragraphs 123 or 124, wherein the respiratory device is configured to activate an alarm or notification when at least one of the following occurs: the corrected device minute ventilation exceeds or falls below a preset threshold, the rate of change of the corrected device minute ventilation exceeds or falls below a preset threshold, and the trend of the corrected device minute ventilation exceeds or falls below a preset threshold. 126. A respiratory device configured to deliver respiratory therapy to a patient using an unsealed respiratory interface, comprising: A blower and A humidifier and a housing that holds a blower and a humidifier, the blower and humidifier being at least partially held within the housing; a gas inlet formed in the housing; a gas flow path extending from the gas inlet through the blower and the humidifier, The humidifier is in fluid communication with the blower; The blower has a gas flow path in fluid communication with the gas inlet. one or more flow sensors disposed in the gas flow path, the one or more flow sensors configured to measure gas flow data; a controller disposed within the housing, the controller in electrical communication with the blower, the humidifier, and the one or more flow sensors, the controller configured to control operation of the blower and the humidifier; The controller is a controller configured to receive flow data from the one or more flow sensors, the controller configured to filter the flow data to remove noise and process the received flow data to determine minute ventilation to the user; a controller configured to provide the determined minute ventilation to a display; and a display in electrical communication with the display, the minute ventilation to the user being presented on the display. 127. A respiratory device as described in paragraph 126, wherein the controller is configured to perform the functions described in any one or more of paragraphs 1 to 125. 128. A breathing system for managing a user, comprising: A breathing device according to any one of paragraphs 1 to 127; 1. A respiratory system comprising: a remote patient management system in wireless communication with a respiratory device, the remote patient management system configured to receive a user's minute ventilation, store the received minute ventilation, and associate the stored minute ventilation with a particular user.

Claims

1. 1. A respiratory device configured to deliver respiratory therapy to a patient using an unsealed respiratory interface, the device comprising: a controller, the controller comprising: receiving data of a parameter of a gas flow of the respiratory device indicative of the patient's respiration while the device is in use with an unsealed user interface; determining a device minute ventilation or a parameter indicative of the device minute ventilation; A respiratory device configured to indicate a minute ventilation of a user.

2. 10. The respiratory device of claim 1, wherein the controller is further configured to process the data of the parameter of the gas flow to remove noise.

3. 3. The respiratory device of claim 2, wherein the controller is configured to filter noise associated with a motor's effect on the parameter of the gas flow.

4. 4. The respiratory device of claim 3, wherein the controller is configured to receive data on a motor speed, and the parameter of the gas flow is discarded if the motor speed falls below a preset threshold.

5. A respiratory device according to any one of claims 1 to 3 dependent on claim 2, wherein the controller is configured to discard the parameters of the gas flow if the controller determines that the parameters of the gas flow are of insufficient quality.

6. 6. A respiratory device as claimed in claim 5, wherein the parameters of the gas flow are of poor quality as they include large transient peaks.

7. 7. A respiratory device according to any one of claims 1 to 6, wherein determining the minute ventilation of the device comprises fitting a plurality of splines to the data for the parameters of the gas flow, the plurality of splines being fitted using a least squares criterion, and the minute ventilation of the device being determined by integrating along the plurality of splines.

8. 7. A respiratory device according to any one of claims 1 to 6, wherein determining the minute ventilation of the device comprises determining the integral of the absolute value of a first term of a straight line fitted to the data for the parameter of the gas flow.

9. 7. A respiratory device according to any one of claims 1 to 6, wherein determining the minute ventilation of the device comprises determining the integral of the absolute value of a straight line fitted to the data for the parameter of the gas flow divided by a time range.

10. 7. A respiratory device according to any one of claims 1 to 6, wherein determining the minute ventilation of the device comprises averaging the absolute value of a straight line fitted to the data of the parameter of the gas flow over a range of time points within a time range.

11. A respiratory device according to any preceding claim, wherein the controller is configured to calculate a normalised device minute ventilation based on the device minute ventilation.

12. 12. The respiratory device of claim 11, wherein the controller is configured to calculate a noise correction factor correlated to the normalized device minute ventilation.

13. 13. The respiratory device of claim 12, wherein the controller is configured to calculate a corrected device minute ventilation by correlating the normalized device minute ventilation and the noise correction factor with the device minute ventilation.

14. A respiratory device according to any one of claims 1 to 13, wherein the minute ventilation of the device is converted to nasal minute ventilation.

15. 15. The respiratory device of claim 14, wherein the minute ventilation of the device is converted to nasal minute ventilation using a scalar calibration constant.

16. 16. A respiratory device according to any one of claims 1 to 15, wherein the controller is further configured to monitor at least one of the nasal minute ventilation, rate of change of nasal minute ventilation, and trend of nasal minute ventilation.

17. A respiratory device according to any preceding claim, further comprising a display configured to display data relating to the nasal minute ventilation.

18. A respiratory device according to any one of claims 1 to 16, further comprising a display, the display configured to display data relating to the rate of change of nasal minute ventilation.

19. A respiratory device according to any preceding claim, further comprising a display, the display configured to display data relating to trends in nasal minute ventilation.

20. A respiratory device according to any one of claims 1 to 19, wherein the respiratory device is configured to activate an alarm or notification when the nasal minute ventilation exceeds or falls below a preset threshold.

21. 20. A respiratory device according to any one of claims 1 to 19, wherein the respiratory device is configured to activate an alarm or notification when the rate of change of the nasal minute ventilation exceeds or falls below a pre-set threshold.

22. A respiratory device according to any one of claims 1 to 19, wherein the respiratory device is configured to activate an alarm or notification when the trend in the nasal minute ventilation exceeds or falls below a pre-set threshold.

23. A respiratory device according to any preceding claim, wherein the respiratory device includes a patient interface, the patient interface including a nasal cannula.

24. A respiratory device according to any preceding claim, wherein the respiratory device is configured to deliver nasal high flow therapy.

25. 25. A respiratory device according to any preceding claim, further comprising a humidifier configured to humidify the gas flow to the patient.

26. A respiratory device according to any one of claims 1 to 25, wherein the controller is configured to use the device flow rate to normalise a corrected device minute ventilation and generate a normalised device minute ventilation.

27. 27. The respiratory device of claim 26, further comprising a display configured to display data relating to at least one of the normalized device minute ventilation, the rate of change of the normalized device minute ventilation, and the trend of the normalized device minute ventilation.

28. 28. The respiratory device of claim 26 or 27, wherein the respiratory device is configured to activate an alarm or notification when at least one of the following occurs: the normalized device minute ventilation exceeds or falls below a preset threshold; the rate of change of the normalized device minute ventilation exceeds or falls below a preset threshold; and the trend of the normalized device minute ventilation exceeds or falls below a preset threshold.

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