Estimation of respiratory parameters in the respiratory system

Abstract

A method is provided for estimating a patient's out-of-therapy respiratory parameters during therapy. The method includes the steps of: providing a gas flow at multiple flow rates via a flow generator, wherein the flow rates include at least an operating flow rate and one or more intermediate flow rates; receiving flow parameter data from one or more sensors indicating or representing one or more characteristics of the gas flow provided by the flow generator at each of the multiple flow rates; estimating or determining the patient's respiratory parameters at each of the multiple flow rates based at least on the received data; and estimating the patient's out-of-therapy respiratory parameters based at least on the estimated or determined respiratory parameters at each of the multiple flow rates.

Description

[Technical Field]

[0001] This disclosure relates to a respiratory device that provides a gas flow, a method for controlling a respiratory device that provides a gas flow to a user, and a respiratory system that provides a gas flow to a user. More specifically, this disclosure relates to estimating out-of-therapy respiratory parameters while a patient is using a respiratory system. [Background technology]

[0002] Respiratory apparatuses are used to provide a gas flow to a user or patient in a variety of settings, such as hospitals, medical facilities, home care, or home environments. Respiratory support devices or respiratory therapy devices (collectively, “respiratory apparatus” or “respiratory device”) may use humidifiers to provide supplemental oxygen or other gases along with the gas flow, and / or provide heated and humidified gases. Respiratory apparatuses may allow for the adjustment and control of the overall gas flow characteristics, including flow rate, temperature, gas concentration, humidity, and pressure. Sensors, such as flow sensors and / or pressure sensors, are used to measure the gas flow characteristics. [Overview of the Initiative] [Means for solving the problem]

[0003] In a first aspect, the disclosure broadly includes a method for estimating a patient's out-of-therapy respiratory parameters during therapy, the method comprising: providing a gas flow at a plurality of flow rates through a flow generator, wherein the flow rates include at least a working flow rate and one or more intermediate flow rates; receiving flow parameter data from one or more sensors indicating or representing one or more characteristics of the gas flow provided by the flow generator at each of the plurality of flow rates; estimating or determining a patient's respiratory parameters at each of the plurality of flow rates, at least in part on the received flow parameter data; and estimating a patient's out-of-therapy respiratory parameters, at least in part on the estimated or determined respiratory parameters at each of the plurality of flow rates.

[0004] In one configuration, the flow parameter data includes flow data that indicates or represents the flow rate of the gas flow provided by the flow generator.

[0005] In one configuration, the flow parameter data includes pressure data that indicates or represents the pressure of the gas flow provided by the flow generator.

[0006] In one configuration, the step of estimating or determining the patient's respiratory parameters at each of multiple flow rates includes evaluating the flow parameter data.

[0007] In one configuration, the patient's respiratory parameter is the patient's respiratory rate. In another configuration, the patient's respiratory parameter is the patient's inspiratory-expiratory time ratio.

[0008] In one configuration, the step of estimating or determining the patient's respiratory rate at each of several flow rates includes: performing frequency analysis of flow parameter data at intermediate flow rates; identifying multiple maximums of the signal obtained from the frequency analysis; and outputting the frequency corresponding to the frequency component with the largest magnitude among the multiple maximums as the estimated respiratory rate of the patient.

[0009] In one configuration, the operating flow rate includes the therapeutic flow rate. In one configuration, one or more intermediate flow rates include one or more sub-therapeutic flow rates, and one or more sub-therapeutic flow rates are lower than the operating flow rate.

[0010] In one configuration, the step of providing a gas flow at a plurality of flow rates includes adjusting the flow rate to different intermediate flow rates at one or more time intervals.

[0011] In one configuration, the step of estimating or determining the patient's respiratory parameters is performed at each time interval.

[0012] In one configuration, the intermediate flow rate is reduced at each time interval.

[0013] In one configuration, the intermediate flow rate may include a minimum flow rate.

[0014] In one configuration, adjusting the flow rate to different intermediate flow rates includes gradually increasing the flow rate from the current flow rate to a different intermediate flow rate.

[0015] In one configuration, the flow rate is maintained at each of the one or more intermediate flow rates for a minimum or predetermined period before performing the step of estimating or determining the patient's respiratory parameters at each flow rate.

[0016] In one configuration, the minimum or predetermined period is inversely proportional to the estimated respiratory parameters of the patient. The minimum or predetermined period is at least long enough to allow the residual effect of the previous flow rate on the patient's respiratory parameters to decay.

[0017] In one configuration, the method further includes a step of returning to the operating flow rate after the step of estimating the patient's extra-therapy respiratory parameters. Returning to the operating flow rate includes first increasing the flow rate to one or more intermediate flow rates. The operating flow rate may increase to one or more intermediate flow rates at stepped intervals before returning to the operating flow rate.

[0018] In one configuration, the method further includes the steps of receiving flow parameter data at the operating flow rate and estimating or determining the patient's respiratory parameters at the operating flow rate based on at least the flow parameter data.

[0019] In one configuration, the step of estimating the patient's out-of-therapy respiratory parameters is based on the estimated or determined respiratory parameters at at least one or more intermediate flows and at the operating flow.

[0020] In one configuration, the flow parameter data includes oxygen concentration data that indicates or represents the oxygen concentration of the gas flow provided by the flow generator.

[0021] In one configuration, estimating the patient's out-of-therapy respiratory parameters is further based on flow rate data received at least for each of multiple flow rates.

[0022] In one configuration, estimating the patient's out-of-therapy respiratory parameters is further based on oxygen concentration data received at each of several intermediate flow rates.

[0023] In one configuration, the step of estimating the patient's out-of-therapy respiratory parameters is performed by the model, which uses respiratory parameters estimated or determined at least for each of several flow rates as input. In another configuration, the model further uses flow parameter data as input. In yet another configuration, the model further uses flow parameter data received at the operating flow rate and flow data received at one or more intermediate flow rates as input.

[0024] In one configuration, the model is a linear model and includes coefficients that define the relationship between the input estimated or determined respiratory parameters and the flow parameter data at each flow rate. In another configuration, the model further includes parameters that relate the estimated or determined respiratory parameters and the flow parameter data at each flow rate. The parameters of the model are: - The mean values ​​of the patient's estimated or determined respiratory parameters at each of multiple flow rates, - The difference between the operating flow rate and the minimum flow rate, - The difference between the patient's respiratory parameter at the operating flow rate and the mean value of the patient's estimated or determined respiratory parameter at each of one or more intermediate flow rates, wherein the difference is divided by the difference between the operating flow rate and one or more intermediate flow rates. - The difference between the oxygen concentration data of the gas flow at one or more intermediate flow rates and the ambient reading of the oxygen concentration level, This may include at least one or more of the following.

[0025] In one configuration, if the flow generator does not provide flow, the model is configured to output values ​​corresponding to estimates of the patient's respiratory parameters. In another configuration, the model is configured to output values ​​related to the expected changes in the patient's respiratory parameters based on changes in flow rate.

[0026] In one configuration, the output value relates to the expected change in the patient's respiratory parameters, as the flow rate increases from zero to a predetermined operating flow rate for therapeutic flow.

[0027] In one configuration, the model includes a fitted linear equation, which takes as input the estimated values ​​of the patient's respiratory parameters at each flow rate, and the measured values ​​of the flow rates. In one configuration, the fitted linear equation is in the form of a series of linear terms. The fitted linear equation can extrapolate the patient's respiratory parameters based on the input of estimated or determined respiratory parameters at each of several intermediate flow rates.

[0028] In one configuration, the fitted linear equation is configured to output extrapolated respiratory parameters for a patient, based on inputs of at least estimated or determined respiratory parameters determined for each of several flow rates. The extrapolated respiratory parameters for a patient are approximations of the patient's respiratory parameters at flow rates below at least the lowest intermediate flow rate.

[0029] In one configuration, the patient's out-of-therapy respiratory parameters are estimated while the respiratory therapy system is supplying air to the patient's airways. Alternatively, the patient's out-of-therapy respiratory parameters may be estimated while the respiratory therapy system is providing gas flow to the patient's airways.

[0030] In one configuration, the method further includes the step of determining the difference between the patient's estimated or determined respiratory parameters at the operating flow rate and the patient's estimated out-of-therapy respiratory parameters.

[0031] In one configuration, the determination of the difference between the patient's estimated or determined respiratory parameters at operating flow rate and the patient's estimated out-of-therapy respiratory parameters is further based on one or more mean values ​​of the patient's out-of-therapy respiratory parameters determined over multiple therapy sessions and / or multiple flow reduction and respiratory parameter estimation cycles over one therapy session.

[0032] In one configuration, the method further includes the step of determining the state of the patient's respiratory parameters based on flow parameter data.

[0033] In one configuration, the method further includes the step of controlling a flow generator to provide a gas flow at multiple intermediate flow rates based on the patient's respiratory parameter state, which indicates that the patient's respiratory parameters are substantially stable.

[0034] In one configuration, the step of determining the state of a patient's respiratory parameters includes determining an index or estimate of the patient's respiratory parameters based on flow parameter data received at multiple intervals while at working flow rate, and comparing the index or estimate of the patient's respiratory parameters at each interval with at least an index or estimate of the patient's respiratory parameters at one or more previous intervals.

[0035] In one configuration, the patient's respiratory parameter status is related, based on comparison, to the degree or amount of change between the index or estimate of the patient's respiratory parameter determined in the current interval and the index or estimate of the patient's respiratory parameter determined in one or more previous intervals.

[0036] In one configuration, the method further includes sending or transmitting data representing the patient's estimated out-of-therapy respiratory parameters to an external device via a data communication protocol.

[0037] In one configuration, the method further includes the step of adjusting one or more parameters of the flow generator, or related to the flow generator, based at least in part on the patient's estimated out-of-therapy respiratory parameters.

[0038] In one configuration, the method further includes the step of generating or providing proposed thresholds and / or parameters associated with one or more thresholds, at least in part, based on the patient's estimated out-of-therapy respiratory parameters.

[0039] In one configuration, the method further includes a step of generating warnings, alarms, and / or notifications that include data indicating proposed adjustments to one or more therapeutic settings, at least in part, based on the patient's estimated extratherapeutic respiratory parameters and one or more thresholds. Therapeutic settings may include flow settings and / or FiO2 settings.

[0040] In one configuration, this method is configured for use in an open-seal respiratory therapy system. This method is configured for use in the delivery of high-flow nasal therapy.

[0041] In one configuration, the output value relates to the expected change in the patient's respiratory parameters, as the flow rate increases from zero to a predetermined operating flow rate for therapeutic flow.

[0042] In one configuration, the fitted linear equation takes the form of a series of linear terms.

[0043] In a second aspect, the Disclosure broadly includes a respiratory device configured to provide a gas flow to a patient, the respiratory device comprising: a flow generator configured to generate a gas flow for the patient at a plurality of flow rates; one or more sensors, each configured to generate flow parameter data indicating or representing one or more characteristics of the gas flow; and a controller, the controller configured to control the flow generator to provide a gas flow at a plurality of flow rates, wherein the plurality of flow rates include at least an operating flow rate and one or more intermediate flow rates; to receive flow parameter data from one or more sensors at each of the plurality of flow rates; to estimate or determine the patient's respiratory parameters at each of the plurality of flow rates, at least in part on the received flow parameter data; and to estimate the patient's out-of-therapy respiratory parameters at least in part on the estimated or determined respiratory parameters at each of the plurality of flow rates.

[0044] In one configuration, the flow parameter data includes flow data that indicates or represents the flow rate of the gas flow provided by the flow generator.

[0045] In one configuration, the flow parameter data includes pressure data that indicates or represents the pressure of the gas flow at the outlet of the flow generator's blower.

[0046] In one configuration, the controller is configured to estimate or determine the patient's respiratory parameters at each of several flow rates by evaluating flow parameter data.

[0047] In one configuration, the patient's respiratory parameter is the patient's respiratory rate. In another configuration, the patient's respiratory parameter is the patient's inspiratory-expiratory time ratio.

[0048] In one configuration, the controller is configured to estimate or determine the patient's respiratory rate at each of several flow rates by performing frequency analysis of flow parameter data at an intermediate flow rate, identifying multiple maximum values ​​in the signal obtained from the frequency analysis, and outputting the frequency corresponding to the frequency component with the largest magnitude among the multiple maximum values ​​as the estimated respiratory rate of the patient.

[0049] In one configuration, the operating flow rate includes the therapeutic flow rate. In one configuration, one or more intermediate flow rates include one or more sub-therapeutic flow rates, and one or more sub-therapeutic flow rates are lower than the operating flow rate.

[0050] In one configuration, the controller is configured to control the flow generator to provide a gas flow at multiple flow rates by adjusting the flow rate to different intermediate flow rates at one or more time intervals.

[0051] In one configuration, the controller is configured to estimate or determine the patient's respiratory parameters at each time interval.

[0052] In one configuration, the intermediate flow rate in each time interval is reduced in each time interval. In one configuration, the intermediate flow rate may include the minimum flow rate. In one configuration, adjusting the flow rate to a different intermediate flow rate involves gradually increasing the flow rate from the current flow rate to a different intermediate flow rate.

[0053] In one configuration, the controller is configured to minimize or maintain the flow rate for a predetermined period at each of one or more intermediate flow rates before estimating or determining the patient's respiratory parameters at each flow rate.

[0054] In one configuration, the duration is inversely proportional to the patient's estimated respiratory parameters.

[0055] In one configuration, the predetermined period is at least long enough to allow the residual effect of the previous flow rate on the patient's respiratory parameters to decay.

[0056] In one configuration, the controller is further configured to control the flow generator to return to the working flow rate after estimating the patient's out-of-therapy respiratory parameters.

[0057] In one configuration, returning to the operating flow rate first involves increasing the operating flow rate to one or more intermediate flow rates. The operating flow rate may be increased to one or more intermediate flow rates at gradual intervals before returning to the operating flow rate.

[0058] In one configuration, the controller is further configured to receive flow parameter data at the operating flow rate and to estimate or determine the patient's respiratory parameters at the operating flow rate, based at least on the flow parameter data.

[0059] In one configuration, the controller is configured to estimate the patient's out-of-therapy respiratory parameters based on the estimated or determined respiratory parameters at each of at least one or more intermediate flow rates and the operating flow rate.

[0060] In one configuration, the flow parameter data includes oxygen concentration data that indicates or represents the oxygen concentration of the gas flow provided by the flow generator.

[0061] In one configuration, the controller is configured to estimate the patient's out-of-therapy respiratory parameters based on flow rate data received for at least one of several flow rates.

[0062] In one configuration, the controller is configured to estimate the patient's out-of-therapy respiratory parameters based on oxygen concentration data received at each of several intermediate flow rates.

[0063] In one configuration, the controller is configured to use a model to estimate the patient's out-of-therapy respiratory parameters, and the model uses respiratory parameters estimated or determined for each of several flow rates as input. In another configuration, the model uses flow parameter data as input.

[0064] In one configuration, the model uses flow parameter data received at the operating flow rate and flow data received at one or more intermediate flow rates as input.

[0065] In one configuration, the model is a linear model and includes coefficients that define the relationship between the input estimated or determined respiratory parameters and the flow parameter data at each flow rate. In another configuration, the model further includes parameters that relate the estimated or determined respiratory parameters and the flow parameter data at each flow rate. The parameters of the model are: - The mean values ​​of the patient's estimated or determined respiratory parameters at each of multiple flow rates, - The difference between the operating flow rate and the minimum flow rate, - The difference between the patient's respiratory parameter at the operating flow rate and the mean value of the patient's estimated or determined respiratory parameter at each of one or more intermediate flow rates, wherein the difference is divided by the difference between the operating flow rate and one or more intermediate flow rates. - The difference between the oxygen concentration data of the gas flow at one or more intermediate flow rates and the ambient reading of the oxygen concentration level, This may include at least one or more of the following.

[0066] In one configuration, if the respiratory therapy device does not provide flow, the model is configured to output values ​​corresponding to estimates of the patient's respiratory parameters.

[0067] In one configuration, the model is configured to output values ​​related to the expected changes in the patient's respiratory parameters based on changes in flow rate.

[0068] In one configuration, the output value relates to the expected change in the patient's respiratory parameters, as the flow rate increases from zero to a predetermined operating flow rate for therapeutic flow.

[0069] In one configuration, the model includes a fitted linear equation, which takes the estimated patient respiratory parameters at each flow rate and the measured flow rate as inputs.

[0070] In one configuration, the fitted linear equation takes the form of a series of linear terms.

[0071] In one configuration, the fitted linear equation extrapolates the patient's respiratory parameters based on the input of estimated or determined respiratory parameters at each of several intermediate flow rates.

[0072] In one configuration, the fitted linear equation is configured to output extrapolated respiratory parameters for a patient, based on inputs of at least estimated or determined respiratory parameters determined for each of several flow rates.

[0073] In one configuration, the extrapolated respiratory parameters of the patient are approximations of the patient's respiratory parameters at flows at least below the minimum intermediate flow rate.

[0074] In one configuration, the patient's out-of-therapy respiratory parameters are estimated while the respiratory device provides gas flow to the patient's airways.

[0075] In one configuration, the patient's out-of-therapy respiratory parameters are estimated while the patient is using a respiratory device for therapeutic purposes.

[0076] In one configuration, the controller is further configured to determine the difference between the patient's estimated or determined respiratory parameters at the operating flow rate and the patient's estimated out-of-therapy respiratory parameters.

[0077] In one configuration, the determination of the difference between the patient's estimated or determined respiratory parameters at operating flow rate and the patient's estimated out-of-therapy respiratory parameters is further based on one or more mean values ​​of the patient's out-of-therapy respiratory parameters determined over multiple therapy sessions and / or multiple flow reduction and respiratory parameter estimation cycles over one therapy session.

[0078] In one configuration, the controller is further configured to determine the patient's respiratory parameter status based on flow parameter data.

[0079] In one configuration, the controller is further configured to control the flow generator to provide gas flow at multiple intermediate flow rates based on the patient's respiratory parameter state, which indicates that the patient's respiratory parameters are substantially stable.

[0080] In one configuration, the controller is configured to determine the state of the patient's respiratory parameters by determining an index or estimate of the patient's respiratory parameters based on flow parameter data received at multiple intervals while the operating flow rate is active, and by comparing the index or estimate of the patient's respiratory parameters at each interval with at least an index or estimate of the patient's respiratory parameters at one or more previous intervals.

[0081] In one configuration, the patient's respiratory parameter status is related, based on comparison, to the degree of change between the index or estimate of the patient's respiratory parameter determined in the current interval and the index or estimate of the patient's respiratory parameter determined in one or more previous intervals.

[0082] In one configuration, the controller is further configured to transmit data representing the patient's estimated out-of-therapy respiratory parameters to a device or system with which it is communicating data.

[0083] In one configuration, the controller is further configured to adjust one or more parameters of the respiratory device based at least partially on the patient's estimated extra-therapeutic respiratory parameters.

[0084] In one configuration, the controller is further configured to generate proposed thresholds and / or parameters related to one or more thresholds, at least partially based on the patient's estimated out-of-therapy respiratory parameters.

[0085] In one configuration, the controller is further configured to generate warnings, alarms, and / or notifications that include data indicating suggested adjustments to one or more therapeutic settings, at least partially based on the patient's estimated extratherapeutic respiratory parameters and one or more thresholds. Therapeutic settings may include flow rate settings and / or FiO2 settings.

[0086] In one configuration, the respiratory device is configured for use in an open-seal respiratory therapy system. The respiratory device may be configured for use in the delivery of high-flow nasal therapy.

[0087] In one configuration, the output value relates to the expected change in the patient's respiratory parameters, as the flow rate increases from zero to a predetermined operating flow rate for therapeutic flow.

[0088] In one configuration, the fitted linear equation takes the form of a series of linear terms.

[0089] In a third aspect, the Disclosure broadly includes a respiratory therapy system configured to provide a gas flow to a user, the respiratory therapy system comprising: a flow generator configured to generate a gas flow for a user at multiple flow rates; one or more sensors, each configured to generate flow parameter data indicating or representing one or more characteristics of the gas flow; a respiratory conduit operably coupled to the flow generator and configured to deliver the gas flow from the flow generator to the user; a patient interface operably coupled to the respiratory conduit; and a controller configured to control the flow generator to provide a gas flow at multiple flow rates, wherein the multiple flow rates include at least an operating flow rate and one or more intermediate flow rates; to receive flow parameter data from one or more sensors at each of the multiple flow rates; to estimate or determine the patient's respiratory parameters at each of the multiple flow rates based at least on the flow parameter data; and to estimate the patient's out-of-therapy respiratory parameters based at least on the estimated or determined respiratory parameters at each of the multiple flow rates.

[0090] In one configuration, the flow parameter data includes flow data that indicates or represents the flow rate of the gas flow provided by the flow generator.

[0091] In one configuration, the flow parameter data includes pressure data that indicates or represents the pressure of the gas flow at the outlet of the flow generator's blower.

[0092] In one configuration, the controller is configured to estimate or determine the patient's respiratory parameters at each of several flow rates by evaluating flow parameter data.

[0093] In one configuration, the patient's respiratory parameter is the patient's respiratory rate. In another configuration, the patient's respiratory parameter is the patient's inspiratory-expiratory time ratio.

[0094] In one configuration, the controller is configured to estimate or determine the patient's respiratory rate at each of several flow rates by performing frequency analysis of flow parameter data at an intermediate flow rate, identifying multiple maximum values ​​in the signal obtained from the frequency analysis, and outputting the frequency corresponding to the frequency component with the largest magnitude among the multiple maximum values ​​as the estimated respiratory rate of the patient.

[0095] In one configuration, the operating flow rate includes the therapeutic flow rate. In one configuration, one or more intermediate flow rates include one or more sub-therapeutic flow rates, and one or more sub-therapeutic flow rates are lower than the operating flow rate.

[0096] In one configuration, the controller is configured to control the flow generator to provide a gas flow at multiple flow rates by adjusting the flow rate to different intermediate flow rates at one or more time intervals.

[0097] In one configuration, the controller is configured to estimate or determine the patient's respiratory parameters at each time interval.

[0098] In one configuration, the intermediate flow rate in each time interval is reduced in each time interval. In one configuration, the intermediate flow rate may include the minimum flow rate. In one configuration, adjusting the flow rate to a different intermediate flow rate involves gradually increasing the flow rate from the current flow rate to a different intermediate flow rate.

[0099] In one configuration, the controller is configured to maintain a flow rate for a predetermined period at each of one or more intermediate flow rates before estimating or determining the patient's respiratory parameters at each flow rate.

[0100] In one configuration, the duration is inversely proportional to the patient's estimated respiratory parameters.

[0101] In one configuration, the predetermined period is at least long enough to allow the residual effect of the previous flow rate on the patient's respiratory parameters to decay.

[0102] In one configuration, the controller is further configured to control the flow generator to return to the working flow rate after estimating the patient's out-of-therapy respiratory parameters.

[0103] In one configuration, returning to the operating flow rate first involves increasing the operating flow rate to one or more intermediate flow rates. The operating flow rate may be increased to one or more intermediate flow rates at gradual intervals before returning to the operating flow rate.

[0104] In one configuration, the controller is further configured to receive flow parameter data at the operating flow rate and to estimate or determine the patient's respiratory parameters at the operating flow rate, based at least on the flow parameter data.

[0105] In one configuration, the controller is configured to estimate the patient's out-of-therapy respiratory parameters based on the estimated or determined respiratory parameters at each of at least one or more intermediate flow rates and the operating flow rate.

[0106] In one configuration, the flow parameter data includes oxygen concentration data that indicates or represents the oxygen concentration of the gas flow provided by the flow generator.

[0107] In one configuration, the controller is configured to estimate the patient's out-of-therapy respiratory parameters based on flow rate data received for at least one of several flow rates.

[0108] In one configuration, the controller is configured to estimate the patient's out-of-therapy respiratory parameters based on oxygen concentration data received at each of several intermediate flow rates.

[0109] In one configuration, the controller is configured to use a model to estimate the patient's out-of-therapy respiratory parameters, and the model uses respiratory parameters estimated or determined for each of several flow rates as input. In another configuration, the model uses flow parameter data as input.

[0110] In one configuration, the model uses flow parameter data received at the operating flow rate and flow data received at one or more intermediate flow rates as input.

[0111] In one configuration, the model is a linear model and includes coefficients that define the relationship between the input estimated or determined respiratory parameters and the flow parameter data at each flow rate. In another configuration, the model further includes parameters that relate the estimated or determined respiratory parameters and the flow parameter data at each flow rate. The parameters of the model are: - The mean values ​​of the patient's estimated or determined respiratory parameters at each of multiple flow rates, - The difference between the operating flow rate and the minimum flow rate, - The difference between the patient's respiratory parameter at the operating flow rate and the mean value of the patient's estimated or determined respiratory parameter at each of one or more intermediate flow rates, wherein the difference is divided by the difference between the operating flow rate and one or more intermediate flow rates. - The difference between the oxygen concentration data of the gas flow at one or more intermediate flow rates and the ambient reading of the oxygen concentration level, This may include at least one or more of the following.

[0112] In one configuration, if the respiratory therapy device does not provide flow, the model is configured to output values ​​corresponding to estimates of the patient's respiratory parameters.

[0113] In one configuration, the model is configured to output values ​​related to the expected changes in the patient's respiratory parameters based on changes in flow rate.

[0114] In one configuration, the output value relates to the expected change in the patient's respiratory parameters, as the flow rate increases from zero to a predetermined operating flow rate for therapeutic flow.

[0115] In one configuration, the model includes a fitted linear equation, which takes the estimated patient respiratory parameters at each flow rate and the measured flow rate as inputs.

[0116] In one configuration, the fitted linear equation takes the form of a series of linear terms.

[0117] In one configuration, the fitted linear equation extrapolates the patient's respiratory parameters based on the input of estimated or determined respiratory parameters at each of several intermediate flow rates.

[0118] In one configuration, the fitted linear equation is configured to output extrapolated respiratory parameters for a patient, based on inputs of at least estimated or determined respiratory parameters determined for each of several flow rates.

[0119] In one configuration, the extrapolated respiratory parameters of the patient are approximations of the patient's respiratory parameters at flows at least below the minimum intermediate flow rate.

[0120] In one configuration, the patient's out-of-therapy respiratory parameters are estimated while the respiratory device provides gas flow to the patient's airways.

[0121] In one configuration, the patient's out-of-therapy respiratory parameters are estimated while the patient is using a respiratory device for therapeutic purposes.

[0122] In one configuration, the controller is further configured to determine the difference between the patient's estimated or determined respiratory parameters at the operating flow rate and the patient's estimated out-of-therapy respiratory parameters.

[0123] In one configuration, the determination of the difference between the patient's estimated or determined respiratory parameters at operating flow rate and the patient's estimated out-of-therapy respiratory parameters is further based on one or more mean values ​​of the patient's out-of-therapy respiratory parameters determined over multiple therapy sessions and / or multiple flow reduction and respiratory parameter estimation cycles over one therapy session.

[0124] In one configuration, the controller is further configured to determine the patient's respiratory parameter status based on flow parameter data.

[0125] In one configuration, the controller is further configured to control the flow generator to provide gas flow at multiple intermediate flow rates based on the patient's respiratory parameter state, which indicates that the patient's respiratory parameters are substantially stable.

[0126] In one configuration, the controller is configured to determine the state of the patient's respiratory parameters by determining an index or estimate of the patient's respiratory parameters based on flow parameter data received at multiple intervals while the operating flow rate is active, and by comparing the index or estimate of the patient's respiratory parameters at each interval with at least an index or estimate of the patient's respiratory parameters at one or more previous intervals.

[0127] In one configuration, the patient's respiratory parameter status is related, based on comparison, to the degree of change between the index or estimate of the patient's respiratory parameter determined in the current interval and the index or estimate of the patient's respiratory parameter determined in one or more previous intervals.

[0128] In one configuration, the controller is further configured to transmit data representing the patient's estimated out-of-therapy respiratory parameters to a device or system with which it is communicating data.

[0129] In one configuration, the controller is further configured to adjust one or more parameters of the respiratory device based at least partially on the patient's estimated extra-therapeutic respiratory parameters.

[0130] In one configuration, the controller is further configured to generate proposed thresholds and / or parameters related to one or more thresholds, at least partially based on the patient's estimated out-of-therapy respiratory parameters.

[0131] In one configuration, the controller is further configured to generate warnings, alarms, and / or notifications that include data indicating suggested adjustments to one or more therapeutic settings, at least partially based on the patient's estimated extratherapeutic respiratory parameters and one or more thresholds. Therapeutic settings may include flow rate settings and / or FiO2 settings.

[0132] In one configuration, the patient interface is an open-seal patient interface. The respiratory therapy system may be an open-seal respiratory therapy system. The respiratory therapy system may be configured for use in the delivery of nasal high-flow therapy.

[0133] In one configuration, the output value relates to the expected change in the patient's respiratory parameters, as the flow rate increases from zero to a predetermined operating flow rate for therapeutic flow.

[0134] In one configuration, the fitted linear equation takes the form of a series of linear terms.

[0135] In a fourth aspect, the Disclosure broadly includes a method for estimating out-of-therapy respiratory parameters of a patient using a respiratory device configured to provide a gas flow to a user, the device comprising: a flow generator configured to generate a gas flow for a user at at least an operating flow rate; one or more sensors, each configured to generate flow parameter data indicating or representing one or more characteristics of the gas flow; and a controller, the Method comprising: being performed or implemented by the controller and controlling the flow generator to provide a gas flow at a plurality of intermediate flow rates; receiving flow parameter data at each of the plurality of intermediate flow rates; estimating or determining the patient's respiratory parameters at each of the plurality of intermediate flow rates based at least in part on the flow parameter data; and estimating the patient's out-of-therapy respiratory parameters at least in part on the respiratory parameters estimated or determined at each of the plurality of intermediate flow rates.

[0136] In a fifth aspect, the Disclosure broadly includes a respiratory therapy system, the respiratory therapy system including a respiratory therapy device comprising a flow generator configured to provide a gas flow at at least an operating flow rate, one or more sensors configured to generate data indicating or representing one or more characteristics of the gas flow, and a controller; and a remote computing device communicating with the controller of the respiratory therapy device, the remote computing device being configured to determine or receive an index of a patient's out-of-therapy respiratory parameters, the index of the patient's out-of-therapy respiratory parameters being at least in part based on data indicating or representing one or more characteristics of the gas flow.

[0137] In a sixth aspect, the disclosure broadly includes respiratory therapy devices configured to provide a gas flow to a user, comprising: a flow generator configured to provide a gas flow at at least an operating flow rate; one or more sensors each configured to generate data indicating or representing one or more characteristics of the gas flow; and a controller configured to adjust the operating flow rate to a plurality of intermediate flow rates, measure or estimate a patient's respiratory parameters at least in part on data indicating or representing one or more characteristics of the gas flow at each flow rate, and determine or estimate off-therapy respiratory parameters at least in part on a plurality of measured or estimated respiratory parameters of the patient.

[0138] In a seventh aspect, the Disclosure includes a respiratory therapy device configured to provide a gas flow to a user, comprising: a flow generator configured to provide a gas flow at at least an operating flow rate; one or more sensors, each configured to generate data indicating or representing one or more characteristics of the gas flow; and a controller, configured to determine or receive an index of a patient's out-of-therapy respiratory parameter, wherein the index of the out-of-therapy respiratory parameter is determined at least in part on data indicating or representing one or more characteristics of the gas flow; and to adjust the operating flow rate based on the index of the out-of-therapy respiratory parameter.

[0139] In the eighth aspect, the disclosure broadly includes a method for estimating out-of-therapy respiratory parameters of a patient undergoing treatment, the method comprising: providing a gas flow at an operating flow rate via a flow generator; receiving data indicating or representing one or more characteristics of the gas flow provided by the flow generator; estimating or determining the patient's respiratory parameters at the operating flow rate based at least on the received data; adjusting the operating flow rate to an intermediate flow rate at one or more intervals and estimating or determining the patient's respiratory parameters at least on the received data; and estimating the patient's out-of-therapy respiratory parameters using a model based at least on the respiratory parameters estimated or determined at each interval and the respiratory parameters estimated or determined at the operating flow rate.

[0140] In the ninth aspect, the disclosure broadly includes a method for estimating a patient's extra-therapeutic respiratory parameters during therapy, the method being: The method includes: providing a gas flow at multiple flow rates via a flow generator; receiving data indicating or representing one or more characteristics of the gas flow provided by the flow generator at each of the multiple flow rates; estimating or determining the patient's respiratory parameters at each of the multiple flow rates based at least on the received data; estimating the patient's out-of-therapy respiratory parameters using a model based at least on the estimated or determined respiratory parameters at each of the multiple flow rates; and determining the difference between at least the estimated or determined respiratory rates / parameters at each of the multiple flow rates.

[0141] In a tenth embodiment, the Disclosure provides instructions for implementing one or more of the methods or embodiments described above. Executable by a computer, processor, or controller, or including executable software code or coded instructions, Regarding methods that are implemented electronically.

[0142] In the eleventh embodiment, the present disclosure, when executed on a processing device(s), A processing device (or multiple devices) stores computer executable instructions on it that cause it to perform or execute one or more of the methods or embodiments described above. This broadly includes non-temporary computer-readable media.

[0143] The fourth, fifth, sixth, seventh, eighth, ninth, tenth, and eleventh embodiments may include one or more of the features of the first, second, or third embodiments described above.

[0144] In a twelfth aspect, the Disclosure broadly includes a respiratory therapy device configured to provide a gas flow to a user, the respiratory therapy device comprising: a flow generator configured to provide a gas flow in accordance with one or more therapeutic parameters, wherein one or more therapeutic parameters include at least an operating flow rate; one or more sensors configured to generate data indicating or representing one or more characteristics of the gas flow; a display for showing information to a user; and a controller configured to receive data indicating or representing one or more characteristics of the gas flow from one or more sensors; determine or receive an index of a patient's out-of-therapy respiratory parameter, wherein the index of the out-of-therapy respiratory parameter is determined at least in part on data indicating or representing one or more characteristics of the gas flow; and cause the display to show one or more graphical displays, each graphical display being based on an index of a patient's out-of-therapy respiratory parameter.

[0145] In one configuration, the graphic display is configured to show the user indicators of extra-therapeutic respiratory parameters.

[0146] In one configuration, the graphical display screen is configured to display one or more out-of-therapy respiratory parameters based at least in part on an index of out-of-therapy respiratory parameters over time.

[0147] In one configuration, the graphic display is configured to show notifications, warnings, or suggestions based on indicators of extratherapeutic respiratory parameters.

[0148] In one configuration, the graphic display is configured to show suggestions for changing the therapeutic settings of the respiratory therapy device based on indicators of extra-therapeutic respiratory parameters.

[0149] In a thirteenth aspect, the Disclosure broadly includes a respiratory therapy device configured to provide a gas flow to a user, the respiratory therapy device including a flow generator configured to provide a gas flow in accordance with one or more therapeutic parameters, wherein the one or more therapeutic parameters include at least an operating flow rate; one or more sensors, each configured to generate data indicating or representing one or more characteristics of the gas flow; and a controller, configured to receive data indicating or representing one or more characteristics of the gas flow from one or more sensors; determine or receive an index of a patient's out-of-therapy respiratory parameter, wherein the index of the out-of-therapy respiratory parameter is determined at least in part on data indicating or representing one or more characteristics of the gas flow; and adjust one or more of the therapeutic parameters based on the index of the patient's out-of-therapy respiratory parameter.

[0150] In one configuration, the controller determines an index of a patient's out-of-therapy respiratory parameters by controlling a flow generator to provide a gas flow at multiple flow rates, wherein the multiple flow rates include at least a working flow rate and one or more intermediate flow rates; estimates or determines the patient's respiratory parameters at each of the multiple flow rates, at least in part, based on the received flow parameter data; and estimates the patient's out-of-therapy respiratory parameters at least in part, based on the estimated or determined respiratory parameters at each of the multiple flow rates.

[0151] In one configuration, one or more of the therapeutic parameters include flow rate settings and / or FiO2 settings.

[0152] The twelfth and thirteenth embodiments may include one or more of the features of the first, second, or third embodiments described above.

[0153] These and other features, aspects, and advantages of the Disclosure will be described with reference to drawings of specific embodiments, which are intended to schematically illustrate specific embodiments and are not intended to limit the Disclosure. [Brief explanation of the drawing]

[0154] [Figure 1] A schematic diagram of a respiratory system configured to provide respiratory therapy to a patient is shown. [Figure 2] A block diagram of a control system that interacts with and / or provides control and instructions to the components of the respiratory system is shown. [Figure 3] A block diagram of an exemplary controller is shown. [Figure 4] An exemplary block diagram for determining respiratory rate from gas flow parameters is shown. [Figure 5] An illustrative flowchart shows how to use the output from the algorithm to determine the respiratory rate estimate. [Figure 6] A schematic flowchart illustrating an example of the respiratory parameter determination process is shown. [Figure 7] An exemplary flowchart for estimating out-of-therapy respiratory parameters using flow parameter data is shown. [Figure 8] An exemplary flowchart for estimating out-of-therapy respiratory parameters using flow parameter data is shown. [Figure 9] An illustrative flowchart is shown for estimating the number of out-of-therapy inhalations using flow parameter data. [Figure 10] An illustrative flowchart is shown for estimating the number of out-of-therapy inhalations using flow parameter data. [Modes for carrying out the invention]

[0155] While specific embodiments are described below, those skilled in the art will understand that this disclosure extends beyond the specifically disclosed embodiments and / or uses, as well as their obvious modifications and equivalents. Therefore, the scope of this disclosure disclosed herein is not intended to be limited by the specific embodiments described below.

[0156] 1. Overview of an exemplary respiratory device Examples of methods and processes for estimating extra-therapeutic respiratory parameters are described in the context of an exemplary respiratory device or respiratory support device (these terms are used interchangeably) 100 configured or operable to provide nasal high-flow therapy via an open-seal patient interface. This is intended as a non-limiting embodiment. It will be understood that the methods and processes described herein may be applicable to other respiratory devices, and / or other modes of operation, and / or modes of treatment performed by such devices.

[0157] Figure 1 shows a schematic diagram of an exemplary respiratory system 10. The respiratory system 10 includes a respiratory apparatus (shown overall in a dashed box 60) having a flow generator 50B and a controller 19. The respiratory apparatus 60 may further include a humidifier 52. The respiratory apparatus 60 may include an integrated flow generator 50B and humidifier 52 (for example, the flow generator 50B and humidifier 52 may be located within the same housing of the respiratory apparatus 60), or the humidifier 52 may be in a separate housing. A delivery conduit 16 and a patient interface 51 may be provided as part of the respiratory system 10 to fluidly couple to the respiratory apparatus 60.

[0158] Controller 19 may include one or more control systems, for example, the control system 920 in Figure 2, which is described further below, and / or have a configuration similar to the controller 600 in Figure 3, which is described further below. Controller 19 may have controller functions as described further below in the context of the control system 920 in Figure 2 or the controller 600 in Figure 3.

[0159] The respiratory system 10 consists of a flow source 50 for supplying a high-flow gas 31 such as air, oxygen, air mixed with oxygen, or a mixture of air and / or oxygen with one or more other gases. The respiratory support device 60 may have a connection for connecting to the flow source. Thus, depending on the context, the flow source may be considered to form part of the device 60 or to be considered separate from the device 60, and conversely, a part of the flow source may be considered to form part of the device 60 or to be considered separate from the device 60. In short, depending on the configuration (some components may be optional), the system 10 is, ·Flow source, • Humidifiers that use a gas flow to humidify • Conduit (e.g., dryline or heated breathing tube), • Patient interface, • Backflow prevention valve, and Filter It can include combinations of components selected from.

[0160] The system 10, including the device 60, will be described in more detail.

[0161] The flow source can be a high-flow device comprising an in-wall oxygen supply unit, an oxygen tank 50A, a tank for other gases, and / or a flow generator 50B. Figure 1 shows a flow source 50 with a flow generator 50B, which optionally has an air inlet 50C and an optional connection to an oxygen (O2) source (such as a tank or O2 generator) 50A via a shut-off valve and / or regulator and / or other gas flow control 50D, but this is only one option. The flow generator 50B can control the flow rate delivered to the user or patient 56 using one or more valves, or optionally, the flow generator 50B can include a blower. The flow source 50 can be one or a combination of the flow generator 50B, O2 source 50A, and air source 50C described above. Although the flow source 50 is shown as part of the device 60, in the case of an external oxygen tank or an in-wall outflow source, it can be considered a separate component, in which case the device 60 has a connection port for connecting to such a flow source. The flow source 50 supplies gas at a (preferably high) flow rate that can be delivered to the patient 56 via the delivery conduit 16 and the patient interface 51.

[0162] The patient interface 51 may be an unsealed interface, such as an unsealed nasal cannula (for example, when used in high-flow therapy). In some embodiments, the patient interface 51 is an unsealed patient interface that helps prevent, for example, barotrauma (e.g., tissue damage to the lungs or other organs of the respiratory system due to the pressure difference relative to the atmosphere). The patient interface 51 may be a nasal cannula with a manifold and nasal prongs, or another suitable type of unsealed patient interface. The flow source 50 may provide a base gas flow rate, for example, between 0.5 L / min and 375 L / min, or any range within that range, or a range with a higher or lower limit. Details of the flow rate range and properties will be described later.

[0163] A humidifier 52 may optionally be installed between the flow source 50 and the patient 56 to humidify the supplied gas. One or more sensors 53A, 53B, 53C, 53D, such as a flow sensor, oxygen fraction sensor, pressure sensor, humidity sensor, temperature sensor, or other sensor, may be placed in the entire system 10 and / or directly on or near the patient 56. Alternatively or additionally, sensors capable of deriving such parameters may be used. Further or alternatively, sensors 53A-53D may be one or more physiological sensors for sensing patient physiological parameters such as heart rate, oxygen saturation, partial pressure of oxygen in the blood, respiratory rate, and partial pressure of carbon dioxide (CO2) in the blood. Alternatively or additionally, sensors capable of deriving such parameters may be used. Other patient sensors include an EEG sensor, a body band for detecting respiration, and other suitable sensors. In some configurations, the humidifier 52 may be optional, or may be preferred in light of the advantages that the humidified gas contributes to maintaining airway condition and providing comfort to the patient. One or more of the sensors 53A to 53D are either part of the device 60 or outside the device 60, with the device 60 having inputs for any external sensors. The sensors (e.g., 53A to 53D) can be coupled to the controller 19, or their outputs can be transmitted to the controller 19.

[0164] In some configurations, the breathing system 10 may include a sensor 14 for measuring the oxygen fraction of the air inhaled by the patient 56. In some embodiments, the sensor 14 may be located on the patient interface 51 to measure or otherwise determine the percentage of oxygen in close proximity to the patient's mouth and / or nose. In some configurations, the output from the sensor 14 is sent to a controller 19 to assist in the control of the breathing apparatus 60 and, accordingly, modify its operation. The controller 19 is coupled to the flow source 50, the humidifier 52, and the sensor 14. In some configurations, the controller 19 controls these and other embodiments of the breathing apparatus 60 and breathing system 10 described herein. In some examples, the controller 19 may operate the flow source 50 to provide a supply flow rate of gas 31 at a desired flow rate high enough to meet or exceed the user's (i.e., patient's) inspiratory demand. The provided flow rate is sufficient so that ambient gas is not entrained when the user (i.e., patient) 56 breathes. In some configurations, the sensor 14 can communicate to the user the measured oxygen fraction in the patient's mouth and / or nose, and the user can input this information into the respiratory device 60 / controller 19.

[0165] An optional backflow prevention valve 23 may be provided in the breathing conduit 16. Filters may be provided at the air inlet 50C and / or the inlet to the flow generator 50B to filter the incoming gas before it is pressurized into a high-flow gas 31 by the flow generator 50B.

[0166] The respiratory support system 10 can be an integrated or component-based configuration. In some configurations, the system 10 and / or the device 60 can be a modular configuration of components. Furthermore, the system 10 and / or the device 60 may consist of some of the illustrated components, not all of which are necessarily required. The conduit 16 and the patient interface 51 are separate from the respiratory device 60. The respiratory support device is broadly understood herein to include anything that supplies a flow rate of gas to a patient. The respiratory support device can be part of the respiratory system. Some such devices and systems may include a detection system that can be used to determine whether the gas flow rate is meeting the inspiratory demand.

[0167] The respiratory device 60 may include a main unit housing (not shown). The housing may include a flow generator 50B, which may be in the form of a motor / impeller arrangement, an optional humidifier or humidification chamber 52, a controller 19, and an input / output I / O user interface 54. The user interface 54 may include a display and input device(s), such as buttons, a touchscreen (e.g., an LCD touchscreen), or a combination of a touchscreen and buttons(s). The controller 19 may include one or more hardware processors and / or software processors, which may be configured or programmed to control components of the respiratory device 60, the control of which includes, but is not limited to, operating the flow generator 50B to generate a gas flow 31 for delivery to the patient 56, operating the humidifier or humidification chamber 52 (if present) to humidify and / or warm the gas flow 31, receiving user input from the user interface 54 for reconfiguration and / or user-defined operation of the respiratory device 60, and outputting information to the user (e.g., on a display). Users include patients, healthcare professionals, and others.

[0168] In one configuration, the user interface 54 of the respiratory device 60 may include a removable display screen or touchscreen.

[0169] Continuing to refer to Figure 1, the patient breathing conduit 16 is connected to a gas outlet (gas outlet or patient outlet) 21 in the main unit housing of the respiratory device 60 and can be connected to a patient interface 51 such as an unsealed interface like a nasal cannula with a manifold and nasal prongs. The patient breathing conduit 16 can also be a tracheostomy interface or other unsealed interface.

[0170] The gas flow 31 can be generated and humidified by a flow generator 50B before being supplied to the patient 56 via the patient breathing conduit 16 through the patient interface 51. The controller 19 can control the flow generator 50B to produce a gas flow 31 of a desired flow rate and / or control one or more valves to control the mixing of air with oxygen or other breathable gases. The controller 19 can heat the gas to a desired temperature to achieve a desired level of temperature and / or humidity for delivery to the patient 56 by controlling a heating element in or associated with the humidification chamber 52. The patient breathing conduit 16 may have a heating element, such as a heater wire, to heat the gas flow 31 passing through the patient 56. The heating element may also be under the control of the controller 19.

[0171] The humidifier 52 of the device 60 is configured to combine humidity with the gas flow 31 or to mix humidity with the gas flow 31. Various configurations of the humidifier 52 may be employed. In one configuration, the humidifier 52 may consist of a removable humidification chamber. For example, the humidification chamber may be partially or entirely removed or disconnected from the flow path and / or device 60. As an example, the humidification chamber may be removed for, for example, refilling, cleaning, replacement and / or repair. In one configuration, the humidification chamber may be received and held in or inside a humidification compartment or bay of the device 60, or it may be coupled on or inside the housing of the device 60.

[0172] The humidification chamber of the humidifier 52 may include a gas inlet and a gas outlet that allow connection to the gas flow path of the device 60. For example, the gas flow 31 from the flow generator 50B is received into the humidification chamber through its gas inlet, heated and / or humidified, and then discharged from the chamber through its gas outlet.

[0173] A humidifying chamber contains or receives a certain amount of liquid, typically water. During operation, the liquid in the humidifying chamber is controlled by one or more heaters or heating elements attached to the chamber, generating water vapor or steam, which increases the humidity of the gas flowing through the chamber.

[0174] In one configuration, the humidifier 52 is a through-type humidifier. In another configuration, the humidifier 52 may be a non-through-type humidifier.

[0175] In one configuration, the humidifier 52 may include a heater plate associated with, or provided within, a humidification bay on which a chamber is placed for heating. The chamber may include a heat transfer surface, such as a metal insert, plate, or similar, provided on the base or other surface of the chamber that joins or engages with the heater plate of the humidifier 52.

[0176] In other configurations, the humidification chamber may be equipped with an internal heater or heater element inside or within the chamber. The internal heater or heater element may be integrally mounted within the chamber, provided within the chamber, or removable from the chamber.

[0177] The humidification chamber may have any suitable shape and / or size. The location, number, size, and / or shape of the chamber's gas inlet and gas outlet may be modified as needed. In one configuration, the humidification chamber may have a base surface, one or more side walls extending upward from the base surface, and a top or apex surface. In one configuration, the gas inlet and gas outlet may be located on the same side of the chamber. In other configurations, the gas inlet and gas outlet may be located on different surfaces of the chamber, such as opposing sides or positions.

[0178] In some configurations, the gas inlet and gas outlet may have parallel flow axes. In some configurations, the gas inlet and gas outlet may be positioned at the same height on the chamber.

[0179] The system 10, including the device 60, can operate the device 60 in a manner that monitors the characteristics of the gas flow 31 and / or provides appropriate treatment by using ultrasonic transducers, flow sensors such as thermistor flow sensors, pressure sensors, temperature sensors, humidity sensors, or other sensors in communication with the controller 19. The characteristics of the gas flow may include gas concentration, flow rate, pressure, temperature, humidity, or other characteristics. Sensors 53A, 53B, 53C, 53D, 14, such as pressure sensors, temperature sensors, humidity sensors, and / or flow sensors, can be placed in various locations within the main unit housing, patient conduit 16, and / or patient interface 51. The controller 19 can receive outputs from sensors 53A, 53B, 53C, 53D, 14 to assist in operating the respiratory device 60 in a manner that provides appropriate treatment, such as determining appropriate target temperature, flow rate, and / or pressure of the gas flow. Providing appropriate treatment may include meeting or exceeding the patient's inspiratory demand. In the illustrated embodiment, sensors 53A, 53B, and 53C are located within the housing of the device 60, sensor 53D is located within the patient conduit 16, and sensor 14 is located within the patient interface 51.

[0180] The breathing system 10 may include a sensor configuration or sensor module. The sensor configuration or module may include multiple sensor types. The breathing system 10 may include one or more of a flow (or flow rate) sensor, a pressure sensor, a temperature sensor, a humidity sensor, and an oxygen (O2) sensor. The O2 sensor may be an ultrasonic sensor. The ultrasonic sensor may be positioned along the flow and can therefore be used as a flow sensor in addition to the O2 sensor. One non-limiting example of a flow sensor is a thermistor flow sensor described in International Publication No. 2018 / 052320, filed on 3 September 2017, which is incorporated herein by reference in its entirety. Another non-limiting example of a flow sensor is an acoustic flow sensor described in International Publication No. 2017 / 095241, filed on 2 December 2016, which is incorporated herein by reference in its entirety.

[0181] In some configurations, the gas flow rate can be measured using at least two types of sensors. For example, the first type of sensor may include a thermistor flow sensor, and the second type of sensor may include an acoustic flow sensor. Readings from both the first and second type of sensors can be combined to determine a more accurate flow rate measurement. For example, the previously determined flow rate and one or more outputs from either type of sensor can be used to determine the predicted current flow rate. The predicted current flow rate can then be updated using one or more outputs from the other of the first and second type of sensors to calculate the final flow rate.

[0182] The device 60 may include one or more communication modules that enable data communication or connection with one or more external devices or servers via a data link or communication link or data network, whether wired, wireless, or a combination thereof. For example in one configuration, the device 60 may include a wireless data transmitter and / or receiver, or transceiver 15, to enable the controller 19 to receive data signals wirelessly from an operation sensor and / or to control various components of the device 60. The transceiver 15 or data transmitter and / or receiver module may have an antenna 15a as shown. In one embodiment, the transceiver 15 may include a Wi-Fi modem. Additionally or alternatively, the data transmitter and / or receiver 15 may deliver data to a remote patient management system (i.e., a remote server) or enable remote control of the device 60. The device 60 may include a wired connection, for example using a cable or wire, to enable the controller 19 to receive data signals from an operation sensor and / or to control various components of the device 60. The device 60 may include one or more wireless communication modules. For example, device 60 may include a cellular communication module, such as a 3G module, a 4G module, or a 5G module. Module 15 may be a modem that enables device 60 to communicate with a remote patient management system (not shown) using a suitable communication network, or may include such a modem. The remote management system may consist of a single server, multiple servers, or multiple computing devices implemented in a cloud computing network. The communication may be bidirectional between device 60 and the patient management system (e.g., a server) or other remote system. Device 60 may also include other wireless communication modules, such as a Bluetooth® module and / or a Wi-Fi module.Bluetooth and / or Wi-Fi modules enable the device 60 to wirelessly transmit information to other devices, such as smartphones and tablets, or to operate via a LAN (Local Area Network) or Wi-Fi (WLAN). The device 60 may additionally or alternatively include a Near Field Communication (NFC) module to enable data transfer and / or data communication.

[0183] For example, data representing a determined or calculated work of breathing (WOB) indicator may be communicated to a remote patient management system (i.e., a remote server). The remote patient management system may be a single server, a network of servers, a cloud computing system, or other suitable architecture for operating the remote patient management system. The remote patient management system (i.e., the remote server) further includes memory for storing received data and various software applications or services to perform multiple functions. The remote patient management system (i.e., the remote server) may then, as part of system 10, communicate information or commands to device 60, at least in part, depending on the received data. For example, depending on the nature of the received data, it may trigger the remote server (or a software application running on the remote server) to transmit a warning, alarm, or notification to device 60. The remote patient management system may further store the received data so that it can be accessed by an authorized party, such as a clinician, patient, or other authorized party. The remote patient management system may further be configured to generate reports upon request from an authorized party, and the work of breathing data may be included in the generated reports. The report may also include other data or patient respiratory parameters, such as respiratory rate or SpO2, and / or device parameters, such as flow rate and humidity level.

[0184] The respiratory apparatus 60 may include a high-flow therapy device. High-flow therapy as described herein is intended to be given a typical and ordinary meaning as understood by those skilled in the art, and generally refers to a respiratory system having a high-flow therapy device that delivers a target flow rate of humidified respiratory gas through a patient interface that is not intentionally sealed, at a flow rate that meets or exceeds the user's inspiratory flow rate. Typical patient interfaces include, but are not limited to, a nasal interface or a tracheal patient interface. Typical flow rates for adults are often in the range of approximately 15 liters per minute (15 liters / min) to approximately 60 liters per minute (60 liters / min) or more, but are not limited to these. Typical flow rates for children (neonatal, infant, child, etc.) are often approximately 1 liter per minute per kg of body weight to approximately 3 liters per minute per kg of body weight or more, but are not limited to these.

[0185] High-flow therapy may optionally include the administration of mixed gas compositions containing supplemental oxygen and / or therapeutic drugs.

[0186] High-flow therapy is often referred to by various names such as nasal high-flow (NHF), humidified high-flow nasal cannula (HHFNC), high-flow nasal oxygen (HFNO), high-flow therapy (HFT), and high-flow (THF) for tracheostomy patients. For example, in some configurations, "high-flow therapy" for adult patients refers to supplying gas to the patient at a flow rate of approximately 10 L / min (10 LPM) or more, such as approximately 10 LPM to 100 LPM, or approximately 15 LPM to 95 LPM, or approximately 20 LPM to 90 LPM, or approximately 25 LPM to 85 LPM, or approximately 30 LPM to 80 LPM, or approximately 35 LPM to 75 LPM, or approximately 40 LPM to 70 LPM, or approximately 45 LPM to 65 LPM, or approximately 50 LPM to 60 LPM. In some configurations, for neonatal, infant, or pediatric patients, “high-flow therapy” may refer to the delivery of gas to the patient at a flow rate exceeding 1 LPM, such as approximately 1 LPM to approximately 25 LPM, or approximately 2 LPM to approximately 25 LPM, or approximately 2 LPM to approximately 5 LPM, or approximately 5 LPM to approximately 25 LPM, or approximately 5 LPM to approximately 10 LPM, or approximately 10 LPM to approximately 25 LPM, or approximately 10 LPM to approximately 20 LPM, or approximately 10 LPM to 15 LPM, or approximately 20 LPM to 25 LPM. High-flow therapy devices for adult patients, neonatal, infant, or pediatric patients may deliver gas to the patient at a flow rate of approximately 1 LPM to approximately 100 LPM, or any of the sub-ranges described above.

[0187] High-flow therapy is effective in meeting or exceeding a patient's inspiratory demand, promoting oxygenation, and / or reducing the work of breathing. Furthermore, high-flow therapy can produce a flushing effect in the nasopharynx, as it flushes the anatomical dead space of the upper airway with a high volume of gas flow. This flushing effect creates a reservoir of fresh gas with each breath, minimizing rebreathing of carbon dioxide and nitrogen. High-flow therapy can also lengthen the patient's expiratory time due to the pressure during exhalation, which reduces the patient's respiratory rate.

[0188] The flow rate may be set by the clinician to achieve flushing of the patient's upper airway and / or to meet or exceed the patient's inspiratory demand and / or to provide at least some of the benefits of high-flow therapy (HFT) described herein. The flow rate may further be set to improve oxygenation, slow the patient's respiratory rate, and otherwise reduce the patient's respiratory effort.

[0189] The patient interface for use in high-flow therapy may be an open interface to prevent barotrauma, which may include tissue damage to the patient's lungs or other organs of the respiratory system due to the pressure difference relative to the atmosphere. The patient interface may be a nasal cannula with a manifold and nasal prongs, and / or an open tracheostomy interface, or another suitable type of open patient interface.

[0190] The respiratory apparatus or device 60 may have air and oxygen (or alternative auxiliary gas) inlets that are in fluid communication with the motor of the respiratory apparatus 60, enabling the motor to deliver air, oxygen (or alternative auxiliary gas), or a mixture thereof to a humidifying chamber and thereby to the patient.

[0191] The respiratory device 60 may include a connector configuration having one or more connectors, such as USB or other suitable connectors, for connecting an alarm, pulse oximetry port, and / or other suitable accessories.

[0192] The respiratory apparatus 60 may include an electrical connector that can supply main electricity or battery power to the respiratory apparatus 60. The respiratory apparatus 60 may further include a battery or internal power supply that can supply power to the apparatus 60 for a set period of time if the main electricity or battery power is cut off.

[0193] 1.1 Control System Figure 2 shows a block diagram 900 of an exemplary control system 920 (which may also be the controller 19 in Figure 1) that can detect the patient's condition and control the operation of the respiratory system, including the gas source. The control system 920 can manage the flow rate of gas flowing through the respiratory system when gas is supplied 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 the "blower motor") 930 or the output of the valve 932 in the blender. The control system 920 can automatically determine a set value or a personalized value for the flow rate for a particular patient, as will be described later. The flow rate can be optimized by the control system 920 to improve patient comfort and treatment.

[0194] The control system 920 may also generate audio and / or display / visual outputs 938, 939. For example, the flow therapy device may include a display and / or audio output device (e.g., a speaker). The display may show the physician any warnings or alarms generated by the control system 920. The display may also show control parameters that can be adjusted by the physician. 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 and transmit it to the display, including but not limited to generating the patient's respiratory rate, which will be described in more detail below.

[0195] The control system 920 can modify the heater control output to control one or more heating elements (for example, to maintain a temperature setpoint for the gas supplied to the patient). The control system 920 can also modify the operation or duty cycle of the heating elements. The heater control output may include heater plate control outputs 934 and heated breathing tube control outputs 936.

[0196] The control system 920 can determine outputs 930 to 939 based on one or more received inputs 901 to 916. Inputs 901 to 916 can correspond to sensor measurements automatically received by the controller 600 (see Figure 3). The control system 920 can receive sensor inputs including, but is not limited to, temperature sensor input 901, flow sensor input 902, motor speed input 903, pressure sensor input 904, gas fraction sensor input 905, humidity sensor input 906, pulse oximeter (e.g., SpO2) sensor input 907, saved or user parameters 908, duty cycle or pulse width modulation (PWM) input 909, voltage input 910, current input 911, acoustic sensor input 912, power input 913, resistance input 914, CO2 sensor input 915, and / or spirometer input 916. The control system 920 can receive inputs from the user or parameter values ​​stored in memory 624 (shown in Figure 3). The control system 920 can dynamically adjust the patient's flow rate over the course of treatment. The control system 920 can continuously detect system parameters and patient parameters. Those skilled in the art will understand, based on the disclosure herein, that any other suitable inputs and / or outputs can be used with the control system 920.

[0197] 1.2 Controller Figure 3 shows a block diagram of one embodiment of the controller 600 (which may be, for example, the controller 19 in Figure 1). The control system 600 may include programming instructions for detecting input conditions and controlling output conditions. The programming instructions may be stored in the memory 624 of the controller 600. The programming instructions may correspond to the methods, processes, and functions described herein. The programming instructions may be executed by one or more hardware processors 622 of the controller 600. The programming instructions may be implemented in C, C++, Java®, or other suitable programming language. Some or all of the programming instructions may be implemented in application-specific circuits 628 such as ASICs or FPGAs.

[0198] The controller 600 may also include a circuit 628 for receiving sensor signals. The controller 600 may further include a display 630 for transmitting the status of the patient and the respiratory support system. The display 630 may also display warnings and / or other alerts. The display 630 may be configured to display the characteristics of the detected gas(s) in real time or otherwise. The controller 600 may also receive user input through a user interface such as the display 630. The user interface may include buttons and / or dials. The user interface may include a touchscreen.

[0199] 2. Example of an out-of-therapy respiratory parameter estimation process A method and process for estimating extra-therapeutic respiratory parameters will be described in the context of the exemplary respiratory device 100 described above, which is configured or operable to provide nasal high-flow therapy via an open patient interface. As previously described, this method and process may also be applied to other respiratory devices, and / or other operating modes, and / or therapeutic modes performed by such devices.

[0200] 2.1 Overview of the Out-of-Therapy Respiratory Parameter Estimation Process Patient respiratory parameters, such as respiratory rate, can provide information about whether a patient's condition is worsening or improving. This is because respiratory parameters can indicate a patient's health status or respiratory health status. Generally speaking, patients with chronic respiratory conditions, or respiratory system disorders due to infection, disease, injury, etc., will exhibit abnormal respiratory parameters, such as a high / high respiratory rate. For example, in cases of chronic obstructive pulmonary disease (COPD), bronchiectasis, or emphysema, a common symptom of a worsening condition is an increased respiratory rate, which may indicate oxygenation difficulties or other underlying problems. An increased or rising respiratory rate over a period of several days may be, for example, a sign of an impending worsening in these conditions or the onset of a respiratory infection. Furthermore, in patients who have recently been treated for an acute respiratory condition and are still recovering, changes in respiratory parameters (e.g., increased respiratory rate) can be an early sign of a worsening of the patient's condition that requires attention.

[0201] Respiratory parameters can also provide information about when a patient has stabilized after receiving or being provided with respiratory therapy. Therefore, monitoring or determining a patient's respiratory parameters can help in controlling the operating parameters associated with the provision of respiratory therapy by a respiratory device. An example of respiratory therapy provided by a respiratory device is high-flow therapy (HFT). Respiratory parameters can also provide a means of identifying the operating parameters or therapy settings that are optimal or otherwise acceptable when a patient is receiving respiratory therapy. For example, operating parameters or therapy settings may relate to the flow rate provided by the respiratory device and / or the oxygen content / concentration (FdO2 (percentage of oxygen delivered) or FiO2) of the gas flow provided to the patient and / or the pressure provided by the respiratory device, among other operating parameters or therapy settings.

[0202] As used herein and in the claims, the term “respiratory parameters” should be interpreted to include physiological parameters related to a patient’s respiration or respiration unless the context otherwise suggests. For example, breathing or respiration will be understood to encompass the inspiratory and expiratory / inspiratory and expiratory phase cycles. Respiratory parameters may relate to the timing and / or volume of a patient’s breathing or respiration. Thus, respiratory parameters may relate to respiratory timing parameters or respiratory volume parameters. Respiratory parameters may be measurable by one or more sensors, or separately, may be determined or estimated based on the output of one or more sensors. Examples of respiratory parameters include respiratory rate, inspiratory and / or expiratory time, or the inspiratory-to-expiratory ratio (I:E ratio).

[0203] While a patient is receiving respiratory therapy, one or more of the patient's respiratory parameters, such as respiratory rate, may change significantly and subsequently fail to provide an accurate indicator of the patient's condition. While a reduction or improvement of dyspnea is a desirable outcome of respiratory therapy, the purpose of this disclosure is to monitor occlusive or out-of-therapy respiratory parameters in patients after chronic or acute care (e.g., at home) to assess whether there are changes in the patient's respiratory parameters, which, as described above, can be used as an early sign of deterioration in the patient's condition. Changes in one or more of a patient's respiratory parameters (such as respiratory rate) are typical responses to respiratory therapy, particularly high-flow therapy. High-flow therapy generally has the effect of reducing the patient's work of breathing and / or respiratory rate. The reduction in the patient's work of breathing and / or respiratory rate may be a result of the increased respiratory (end-expiratory) pressure provided by high-flow therapy and / or dead space clearance that typically occurs due to the high flow rate provided by high-flow therapy, as described above. The provision of supplemental oxygen, which may also be included in high-flow therapy, may also contribute to the reduction in the patient's work of breathing and / or respiratory rate.

[0204] Therefore, measuring or estimating one or more of a patient's respiratory parameters while the patient is not receiving treatment and is inactive, which may also be called “out-of-therapy respiratory parameters,” can also be useful in predicting the possibility or potential for deterioration or worsening of the patient’s condition. Changes in one or more of a patient’s out-of-therapy respiratory parameters may indicate the onset of a respiratory disease or infection, or a worsening of a pre-existing chronic respiratory condition. A decrease or at least stabilization of a patient’s out-of-therapy respiratory parameters over time can be a good indicator of the patient’s tolerance to therapy and suggests that the configuration of the therapy device settings is appropriate.

[0205] As stated above, the purpose of this disclosure is, for example, to monitor the refractory or out-of-therapy respiratory parameters of patients receiving chronic or acute care in a home setting. However, the methods, apparatus, and systems of this disclosure may be equally useful in a hospital setting. When used in a hospital setting, this disclosure may contribute, for example, to identifying whether a patient can be safely removed from a respiratory therapy device or whether the provided flow rate settings can be safely reduced.

[0206] As used herein and in the claims, the term “out-of-therapy respiratory parameters” refers to measurable, or separately estimated or approximated, respiratory parameters of a patient at rest or in a resting state, not undergoing physical exercise, and not receiving respiratory therapy. In some cases, out-of-therapy respiratory parameters may be, but not always, parameters measured, estimated, or approximated while the patient is asleep.

[0207] This disclosure relates to the estimation of one or more out-of-therapy respiratory parameters of a patient while air (or a mixture of gases including additional oxygen) is being supplied to the user's airway using a respiratory therapy system. Thus, the estimation of out-of-therapy respiratory parameters in this disclosure relates to the estimation of respiratory parameters that are typically measured when the flow generator is not generating flow while air is being supplied to the patient using a respiratory therapy system, and they are at rest or resting and not under physical movement.

[0208] Typically, measuring a patient's out-of-therapy respiratory parameters relies on the use of external sensing devices and / or measurement procedures that occur when the patient is not receiving respiratory therapy. These external sensing devices and / or measurement procedures generally contribute to the overall inconvenience for the patient because they require additional steps on top of using respiratory therapy devices. They may require these procedures to be performed once a day, or even multiple times a day, which may be perceived as inconvenient and therefore ignored. In addition, or as an alternative, patients may be required to wear components of monitoring devices (such as chest bands and / or pulse oximeters) that may be uncomfortable or easily forgotten to put on. If not worn, they cannot measure out-of-therapy respiratory parameters. In any case, the inconvenience or visual sufficiency associated with each approach may result in unwelcome consequences that could prevent patients from following respiratory therapy prescriptions, including respiratory therapy devices.

[0209] Accordingly, this disclosure is intended to provide means for seamlessly enabling the measurement of a patient's out-of-therapy respiratory parameters or the estimation of one or more surrogate out-of-therapy respiratory parameters while using a respiratory therapy device. Thus, this disclosure enables the estimation of one or more of a patient's out-of-therapy respiratory parameters without requiring any specific or additional actions or procedures to be performed, or without requiring the use of external sensors by the patient.

[0210] The estimation of one or more out-of-therapy respiratory parameters of a patient provided by this disclosure may contribute to improved compliance with respiratory therapy / multiple therapies by facilitating better monitoring and means of adjusting therapy prescriptions to suit different patients. Estimating a patient's out-of-therapy respiratory parameter(s) may also contribute to monitoring the effects of respiratory therapy on the patient and may be used to determine if there is a change in the patient's respiratory status. Furthermore, as described, estimating a patient's out-of-therapy respiratory parameters while the patient is using a respiratory therapy device may improve patient compliance because it does not require performing additional actions or using additional sensors to measure the patient's out-of-therapy respiratory parameter(s).

[0211] The methods, apparatus, and systems of this disclosure do not require additional sensors to estimate a patient's out-of-therapy respiratory parameters. The methods, apparatus, and systems of this disclosure use sensors of a respiratory therapy device together with a controller, the controller being located in the respiratory therapy device or elsewhere within the respiratory therapy system. Additionally, this disclosure may lead to increased data coverage and / or reliability of measuring or estimating a patient's out-of-therapy respiratory parameters because, for example, it does not need to ensure that external sensors are properly (or not at all) attached by the patient. It can also provide a comparison of similar forms of out-of-therapy respiratory parameters taken from a patient while the patient is receiving therapy or under similar conditions, as will be further described.

[0212] This disclosure also enables the determination or estimation of a patient's extra-therapeutic respiratory parameters(s) concurrently with the delivery of therapy. A patient's respiratory parameters, such as respiratory rate, can vary significantly throughout the day. For example, a patient's respiratory rate can be greatly affected by conscious breathing. As is understood, when a patient is sleeping or in another resting state, their breathing is usually more regular and consistent. It can also slow down. When a patient is awake, their breathing can fluctuate dramatically, for example, due to any kind of exertion, exercise, or change in emotional state.

[0213] Therefore, the ability to estimate a patient's extra-therapeutic respiratory parameters simultaneously with the delivery of respiratory therapy can enable comparison with less confounding factors such as time of day and patient activity level. This can lead to improved reliability of inferences made from the estimated respiratory parameters used.

[0214] A patient's respiratory rate is an important metric that can indicate a patient's respiratory effort. A respiratory rate higher than normal may indicate an adverse respiratory condition, such as a respiratory disease. Typically, when a patient is receiving respiratory therapy, such as nasal high-flow therapy, their respiratory rates may be within an acceptable range due to the therapy being provided. For example, by using this disclosure to estimate and monitor a patient's out-of-therapy respiratory rate, a clinician may be able to establish an indicator of the patient's health. A patient's out-of-therapy respiratory rate may be collated over a long period, such as days, weeks, or months, to determine an indicator of the patient's health or respiratory status. Trends in out-of-therapy respiratory rate over time can also be used to provide an indicator of the patient's health or respiratory status. For example, a decrease in out-of-therapy respiratory rate may indicate that the respiratory therapy being provided is effective for a particular patient.

[0215] This disclosure provides a method for reliably estimating one or more out-of-therapy respiratory parameters of a patient while the patient is receiving high-flow therapy delivered by a respiratory device, using sensor data available from a respiratory device and / or algorithms implemented in the respiratory device, as well as an apparatus and system for implementing the method. The estimated out-of-therapy respiratory parameters may be used to enhance clinical decision-making, patient outcomes, and / or respiratory device operation in order to deliver improved high-flow therapy.

[0216] This disclosure relates to methods and / or algorithms for estimating one or more extratherapeutic respiratory parameters based at least in part on sensed flow parameter data indicating or representing gas flow in a respiratory device in use by a patient or user, as well as corresponding devices and systems for implementing them. As an example, a method for estimating three different extratherapeutic respiratory parameters is described below.

[0217] In an exemplary configuration, various respiratory parameters are determined or calculated at least in part based on flow parameter data indicating or representing the gas flow in the respiratory device's flow path. In an exemplary configuration, the flow parameter data includes flow data indicating or representing the flow rate of the gas flow provided by the respiratory device during respiratory therapy. In one example, the flow data may be a flow signal generated by one or more flow sensors installed or positioned in the respiratory device's flow path. One or more flow sensors may be installed in the flow path downstream of the respiratory device's flow generator. Fluctuations in the flow signal around a typical human respiratory frequency are observed when a patient is using the respiratory device during respiratory therapy. The flow signal may contain noise, and in an exemplary configuration, signal preprocessing may be applied to the raw flow signal generated by the flow sensor(s) to substantially filter out or at least minimize the effects of the noise. By analyzing the fluctuations in the preprocessed flow signal, various respiratory parameters of a patient can be determined or estimated while the patient is receiving respiratory therapy with the respiratory device.

[0218] In some exemplary configurations, the flow parameter data used to determine or estimate the respiratory parameters may additionally or alternatively include pressure data indicating or representing the gas flow provided by the flow generator (e.g., the pressure at the blower outlet in the breathing apparatus). The flow parameter data may further include motor speed data indicating or representing the speed at which the flow generator's blower is operating.

[0219] As described below, this disclosure relates to controlled adjustment of the operating flow rate for one or more intermediate flow rates, measurement or estimation of one or more respiratory parameters at the intermediate flow rates, and one or more models / algorithms for determining the patient's out-of-therapy respiratory parameters based on the measured or estimated respiratory parameters at the intermediate flow rates, all of which minimize interruption to the respiratory therapy being delivered.

[0220] Respiratory parameters intended by this disclosure as relating to a patient and for which out-of-therapy values ​​can be estimated include respiratory rate (RR) and inspiratory-to-expiratory time ratio (I:E ratio). Exemplary configurations for these respiratory parameters are outlined, but it will be understood that out-of-therapy values ​​for other respiratory parameters can also be estimated by the methods outlined below. Furthermore, it will be understood that additional respiratory parameters, which are derivatives of any of the above-mentioned respiratory parameters, can also be estimated. These differential respiratory parameters can be determined or estimated using the above-mentioned respiratory parameters. For example, differential respiratory parameters may include inspiratory time, or expiratory time, or total respiratory time. These differential respiratory parameters can be determined based on the estimated out-of-therapy respiratory rate or I:E ratio.

[0221] Respiratory parameters that are intended to have out-of-therapy values ​​estimated using this method(s) can be measured or determined at intermediate or sub-therapeutic flow rates and then used to predict or extrapolate out-of-therapy values.

[0222] To ensure understanding, these exemplary configurations involve several general steps for estimating out-of-therapy values ​​for all exemplary respiratory parameters, which are outlined below.

[0223] Methods and / or algorithms for estimating out-of-therapy respiratory parameters may be run or implemented on any suitable controller or processor. In exemplary configurations, methods and / or algorithms for estimating out-of-therapy respiratory parameters may be run or implemented on the main controller or primary controller of the respiratory device. As described above, the main controller of the respiratory device communicates electrically or data-wise with at least flow and / or pressure sensors located within the main housing of the respiratory device, the respiratory conduit, and / or the patient interface. In some exemplary configurations, a pressure sensing line may supply pressure samples from the patient interface to one or more pressure sensors located within the main housing of the respiratory device.

[0224] 2.2 Examples of determining respiratory parameters Here, we briefly describe an exemplary method or algorithm for determining or estimating two exemplary respiratory parameters using a respiratory therapy device.

[0225] 2.2.1 Determination of the first exemplary respiratory parameter, i.e., respiratory rate Here, we describe a first exemplary method or algorithm for determining or estimating a first exemplary respiratory parameter, which represents the patient's respiratory rate.

[0226] Respiratory rate can be an important indicator for assessing a patient's condition. Abnormal respiratory rates can be predictors of respiratory disease or respiratory status, and in some cases, may foreshadow serious events such as cardiac arrest and the need for advanced medical intervention. Therefore, respiratory rate can be an indicator of deterioration or improvement in a patient's condition. Respiratory rate can also be related to a patient's work of breathing.

[0227] Changes in a patient's respiratory status can manifest rapidly as changes in respiratory rate. As a patient's condition worsens, their respiratory rate may increase. For example, the efficiency of gas exchange in the lungs can decrease as respiratory status deteriorates (e.g., as a COPD-associated lung infection progresses), simultaneously lowering blood oxygen levels. When a patient attempts to increase minute ventilation to maintain normal blood oxygen levels, this triggers a sustained increase in respiratory rate. Thus, respiratory rate responds relatively quickly to changes in a patient's condition compared to other measurable patient parameters such as peripheral oxygen saturation (SpO2), which can typically be measured by an external pulse oximeter.

[0228] A patient's respiratory rate can be affected by other factors; for example, increased physical activity can increase respiratory rate. However, patients receiving respiratory therapy, such as high-flow therapy, are usually at rest and not moving, so other potential factors influencing respiratory rate changes are minimized.

[0229] Further details of the method for determining or estimating a patient's respiratory rate are described in International Publication No. 2019 / 102384, filed on 22 November 2018, which is incorporated herein by reference in its entirety.

[0230] Figure 4 shows an exemplary process for determining or estimating a patient's respiratory rate. A sensor output 2202 from a sensor configured to measure gas flow parameters can be fed to a signal processing algorithm 2204. The sensor can be located within the gas flow path, at least partially within the gas flow path, or outside the gas flow path. The gas flow parameters can vary with the patient's respiration. The gas flow parameters can be flow rate, pressure, oxygen or carbon dioxide data (e.g., concentration of gas in the gas flow), or others. A controller or processor(s) can execute the signal processing algorithm 2204 to process the signal output 2202 and measure the gas flow parameters. The gas flow parameter signal 2206 can be fed to a signal analysis algorithm 2008.

[0231] The Signal Analysis Algorithm 2008 may include a frequency analysis algorithm for discrete time series. The frequency analysis algorithm may include a Discrete Fourier Transform (DFT) step. The Discrete Fourier Transform takes discrete time series data and transforms it into a set of complex numbers containing frequency, magnitude, and phase information. The basic form of the DFT is as follows:

[0232]

number

[0233] The time between data points limits the resolution of frequencies within the range. To ensure reliable detection of frequencies within the dataset, the sampling frequency must be at least twice the frequency of interest, i.e., the Nyquist frequency. This frequency should be at least the same pitch as any frequency components that may need to be detected and analyzed. The process described herein may require measuring the patient's respiration at at least 60 breaths per minute, or at a pitch of approximately 1 Hz, which requires a sampling rate of at least 2 Hz, or a sampling period of 500 ms per sample. The sampling rate can also be higher than twice the maximum detectable frequency measured to provide a buffer.

[0234] However, a higher sampling rate results in more data points to process, which will be more computationally demanding. The sampling rate can also be limited by the rate at which the sensor can deliver data. For example, when using flow rate as a gas flow parameter, a thermistor sensor can provide data points at a rate of every 14 ms or at a frequency of 71.4 Hz.

[0235] To balance the need for reliable detection of the patient's respiratory rate with the need to prevent excessively high sampling rates, the sampling rate of the signal analysis algorithm 2208 can be approximately 14 ms (71.4 Hz) to approximately 500 ms (2 Hz), or approximately 20 ms (50 Hz) to approximately 400 ms (2.5 Hz), or approximately 25 ms (40 Hz) to approximately 333 ms (3 Hz), or approximately 40 ms (25 Hz) to approximately 250 ms (4 Hz), or approximately 50 ms (20 Hz) to approximately 200 ms (5 Hz), or approximately 100 ms (10 Hz).

[0236] The dominant frequency determined by the signal analysis algorithm 2208 from the output series can be the respiratory rate. The dominant frequency may be the frequency with the greatest magnitude. Since the patient's respiratory activity often contributes most significantly to the variation of the gas flow parameter compared to other factors that may affect the gas flow parameter, it can be assumed that the dominant frequency corresponds to the patient's respiratory rate. An exception to this is that, as mentioned above, in configurations that use the absolute value of the gas flow parameter instead of the variation from the mean or target value, the frequency component appearing at 0 Hz is ignored. The large magnitude at 0 Hz represents the mean value of the gas flow parameter, not the respiratory rate.

[0237] During frequency analysis using the signal analysis algorithm 2208, the magnitudes of various frequency components are calculated from the data, each representing the intensity of each frequency component in the data. The dominant frequency, or the frequency component with the greatest magnitude, as determined by algorithm 2208, is considered to be the respiratory frequency 2210.

[0238] As shown in Figure 5, in some configurations that implement the frequency analysis algorithm, in each iteration of the algorithm, the controller can receive the magnitude output from the algorithm in step 2302. In step 2304, the controller can identify the local maximums of the magnitude output by the frequency analysis algorithm. A local maximum is defined as the magnitude of a frequency component that is greater than the magnitude of an adjacent frequency and is sufficiently far from any larger local maximum. The controller can identify two or more of the largest local maximums in each iteration of the algorithm (e.g., two, three, four, five, six, or more).

[0239] Following the identification of local maxima, the controller may apply a filter to each of the magnitudes of two or more local maxima. In order to apply a filter, in determination step 2306, the controller identifies whether the frequency of any one of the local maxima is close to the frequency of one of two or more local maxima from the previous iteration. Each of the last local maxima is individually compared to each of the previous local maxima to determine if there is a match. If one of the local maxima is close to one of the previous local maxima (e.g., substantially the same as one of the previous local maxima, or within a predetermined distance from one of the previous local maxima), in step 2308, the filter uses the previous filtered magnitude value of the previous local maxima and the magnitude of the last local maxima when determining the filtered frequency of the last local maxima. A last local maxima close to a previous local maxima may indicate that the last local maxima is caused by the same waveform as the previous local maxima. If one of the local maximums is not close to any of the previous local maximums, the controller starts the filtered magnitude of the new local maximum with zero (i.e., assumes a zero value for the filtered magnitude of the previous local maximums), and in step 2310, applies the filter to the last local maximum to obtain the filtered magnitude of the local maximum. When one of the local maximums is not close to any of the previous local maximums, the last local maximum is assumed to be caused by a new waveform.

[0240] Once the filtered magnitudes for all the last maximums have been determined, in step 2312, the controller selects the highest of the 2 to 5 filtered magnitudes. The frequency associated with the highest filtered magnitude value is assumed to best represent the patient's respiratory rate. The filtering described above allows the method to ignore short-term high-amplitude signals because short-term high-amplitude signals are less likely to correspond to the patient's respiration and are instead likely to be caused by transient actions such as coughing.

[0241] In step 2314, the controller can apply another filter over time to the selected frequency (above) to generate the patient's filtered respiratory rate. In each iteration of the algorithm, the filtered respiratory rate is updated using the last selected frequency. The filter in step 2314 can also be weighted by the magnitude of the frequency component selected from the frequency analysis algorithm so that the respiratory rate estimate is updated more quickly when the respiratory signal is stronger.

[0242] 2.2.2 Determination of a second exemplary respiratory parameter, namely the I:E ratio Here, we describe a second exemplary method or algorithm for determining or estimating a second exemplary respiratory parameter. The second exemplary respiratory parameter is the ratio of the inspiratory portion of a patient's respiration to the total respiratory time or the expiratory portion of a patient's respiration, commonly referred to as the "I:E ratio".

[0243] Further details of the method for determining or estimating a patient's I:E ratio are described in International Publication No. 2022 / 167982, filed on February 4, 2022, which is incorporated herein by reference in its entirety.

[0244] Referring to Figure 6, an exemplary process 700 for determining or estimating a patient's I:E ratio is shown. The algorithm 700 operates or is performed while the respiratory device 10 is in operation, i.e., when high-flow therapy (or other forms of respiratory therapy) is being delivered to the patient.

[0245] In step 701, the algorithm 700 receives or reads flow parameter data, such as the raw flow signal or flow data, which represents or indicates the flow rate of the gas flow or gas stream delivered to the patient, from, for example, one or more flow sensors of the respiratory device. In this example, the algorithm operates continuously as new flow data arrives and processes the arriving data as follows:

[0246] In step 702, the raw flow data is preprocessed, for example, by filtering or other processing, to remove unwanted signal components, such as those related to the flow generator motor. The output of the preprocessing is a signal representing or indicating the patient's respiratory data (with some residual noise components). In one configuration, the preprocessed signal may be in the form of flow parameter variation data. The flow parameter variation data may include multiple data points. Each data point may be a measure of the variation or deviation of the flow parameter from a mean or target value, so that the flow parameter variation data captures the behavior of the flow parameter that may be attributable to the patient's respiration. Optionally, this preprocessing step 702 may include a preliminary step to evaluate the quality of the incoming raw flow data before further preprocessing. For example, high-quality raw flow data may be further preprocessed into flow parameter variation data and sent to the next step, while low-quality data may be discarded.

[0247] In step 703, the preprocessed flow parameter variation data is processed to determine or calculate the ratio of the inhalation time and / or exhalation time to the total respiration time. The respiration parameter ratio can optionally be calculated as a moving average by continuously summing and averaging the preprocessed flow parameter variation data points. This ratio can be summed and stored. The stored moving average of the respiration parameter ratio can be presented on a display (e.g., the graphical user interface of the device).

[0248] The respiration parameter value (m + ) can be generated to represent or indicate whether the patient is currently breathing or exhaling. The respiration parameter value (m + ) can be a boolean or truth value that changes according to the patient's respiratory state, i.e., whether breathing or exhaling. In this exemplary configuration, the respiration parameter value (m + ) is a boolean value representing or indicating whether the patient is currently breathing. For example, in this configuration, the controller is configured to assign a "1" value when the patient is breathing, i.e., (m + ) is 1 for the patient's inhalation, and to assign "0" when the patient is exhaling, i.e., (m + ) is 0 for the patient's exhalation. The determination of whether the patient is breathing or exhaling can be made based on a fit function or line analysis of the flow parameter variation data, or directly from the flow parameter variation data, depending on the configuration. The controller can determine whether the patient is breathing or exhaling at a given point in the data by comparing the corresponding data points of the fit function or line to a threshold (which can be zero, i.e., if the data point on the line is above zero, the patient is breathing, if below zero, the patient is exhaling, or another value). The data processing applied to determine the respiration parameter value, and the related criteria or thresholds (if any) will be described in more detail later.

[0249] The algorithm uses the respiratory parameter value (m) calculated from the previous step. + Calculate the moving, motion, or filtered mean of the patient's respiratory or expiratory cycle inspiratory time (T). i ) vs. total respiratory time (T tot ) Current respiratory parameter ratio (T i / T tot ) represents or indicates. Optionally, in some configurations, this step may include or have one or more additional processes or processing steps. As will be further described, such optional additional steps may include, for example, noise correction and / or noise cleaning and / or noise filtering processes, and / or determination or processing of signal or data quality.

[0250] In step 704, algorithm 700 may optionally receive data indicating the current respiratory rate, or calculate respiratory rate data representing the current respiratory rate based on preprocessed data from step 702. The determination of the respiratory rate in step 704 may be performed before, simultaneously with, or after step 703. The respiratory rate data may be received from other sources or sensors, or alternatively, calculated from flow parameter data or flow parameter variability data.

[0251] The algorithm is T i / T tot Based on the respiratory parameter ratios and respiratory rate data representing the respiratory rate, one or more additional respiratory parameters or ratios can be calculated. Such additional respiratory parameters or ratios may include, for example, the inspiratory time (T). i ), exhalation time (T e ), total respiratory time (T tot ), the ratio of inspiratory time to expiratory time (I:E ratio, T i / T e ), the ratio of exhalation time to inhalation time (T e / T i ), and / or the ratio of expiratory time to total respiratory time (T e / T tot ) may include.

[0252] As you can understand, as new flow data is received and processed by the algorithm, the algorithm continuously updates the calculated respiratory parameters, so that the parameters and / or ratios are updated in real time (or near real time) while the respiratory device is operating and delivering high-flow therapy.

[0253] In step 705, the algorithm 700 may optionally determine one or more additional respiratory parameters and / or ratios based on the respiratory parameter ratios calculated from step 703 and the respiratory rate data from step 704.

[0254] As new flow data is reached, the algorithm continues to run and update the additional respiratory parameters being calculated, so that the parameters and / or ratios are updated in real time while the respiratory device is operating and delivering high-flow therapy.

[0255] In step 706, the algorithm 700 may perform one or more actions and / or functions based on the primary respiratory parameter ratio calculated or updated from step 703 and / or additional respiratory parameters from step 705. For example, respiratory parameter data generated by the algorithm during the operation of the respiratory device may be continuously supplied to other control functions of the device for the purposes of analysis, monitoring, display, alarm, storage, and / or notification.

[0256] 2.3 Example of an out-of-therapy respiratory parameter estimation process Referring to FIGS. 7-10, examples of various methods for determining or estimating a patient's ex-therapy breathing parameters are described below, although it will be understood that alternative methods may be used. The methods and processes for estimating a patient's ex-therapy breathing parameters are described in the context of the exemplary breathing apparatus 100 described above, which is configured or operable to provide nasal high flow therapy via a non-occlusive patient interface. As previously explained, the methods and processes may also be applied to other breathing apparatuses, and / or other operating modes, and / or treatment modes performed by such apparatuses.

[0257] The exemplary processes 2400, 2500 described may be performed once over a therapy session, or a sleep session occurring during at least a segment of a therapy session. In other examples, they may be performed more than once over a therapy session, or a sleep session occurring during a therapy session.

[0258] In FIGS. 7 and 8, an example of a method 2400 for estimating a patient's ex-therapy breathing parameters using a breathing apparatus is shown. In these examples, the breathing apparatus is configured to provide a gas flow to a user and includes at least a flow generator, one or more sensors, and a controller. The flow generator is configured to generate a gas flow for the user at a plurality of flow rates, the plurality of flow rates including at least an operating flow rate and one or more intermediate flow rates. Each of the one or more sensors is configured to generate flow parameter data indicative of or representing one or more characteristics of the gas flow.

[0259] Next, the exemplary process shown in FIG. 7 will be described. Method 2400 may be executed or performed by the controller of the exemplary breathing apparatus 100 described above. In step 2402, the controller performs the step of controlling the flow generator to generate a gas flow or provide it to the user or patient at an operating flow rate. The operating flow rate may be a treatment flow rate. The treatment flow rate may be suitable for providing high flow therapy to the patient.

[0260] In step 2404, the flow generator is controlled to provide a gas flow at an intermediate flow rate. In step 2406, the controller is configured to receive flow parameter data while a gas flow at an intermediate flow rate is being provided to the patient. The flow parameter data can be received from one or more sensors. In step 2408, the controller is configured to estimate or determine a patient's respiratory parameters while a gas flow at an intermediate flow rate is being provided to the patient, based at least on the received flow parameter data. In step 2410, the controller determines whether to further adjust the flow rate to a different / separate intermediate flow rate. For example, the controller may determine that a further adjustment of the flow rate to a lower intermediate flow rate or a higher intermediate flow rate is needed. If the controller determines that a further intermediate flow rate is needed, the process returns to step 2404 and provides a gas flow at the further intermediate flow rate before repeating steps 2406 - 2410. If the controller determines that a further intermediate flow rate is not needed, the process proceeds to step 2412 and estimates the patient's ex-therapy respiratory parameters based at least on the estimated or determined respiratory parameters at each of the intermediate flow rates.

[0261] In step 2402, the controller performs the step of generating a gas flow or providing it to a user or patient at an operating flow rate. The operating flow rate can be a therapeutic flow rate. The operating flow rate can be suitable for providing high-flow respiratory therapy to a patient. The operating flow rate may be configured or prescribed by a clinician.

[0262] In step 2404, the flow generator is controlled to provide a gas flow at an intermediate flow rate. In some embodiments, one or more of the intermediate flow rates can include a sub-therapeutic flow rate. In such examples, one or more of the intermediate flow rates may be lower than the operating flow rate.

[0263] In some embodiments, one or more intermediate flows may be therapeutic flows or therapeutically effective flows, and one or more intermediate flows may be lower or slightly lower than the working flow but still high enough to provide at least some of the benefits of high-flow therapy. In such embodiments, the intermediate flows may be less than the working flow. One or more intermediate flows that are still therapeutic or therapeutically effective also affect respiratory parameters compared to the working flow. For example, a patient's respiratory rate may increase closer to the out-of-therapy level at one or more intermediate flows compared to the respiratory rate at the working flow.

[0264] In some examples, process 2400 may perform steps 2404-2410 two or more times so that the flow is provided at multiple intermediate flow rates. Thus, step 2402 may include adjusting the operating flow rate to multiple distinct intermediate flow rates at one or more further intervals.

[0265] In these examples, step 2408, which estimates or determines the patient's respiratory parameters based on at least the received data, occurs at each intermediate flow rate and is based on the flow parameter data received at the intermediate flow rates in step 2406.

[0266] In some examples, the intermediate flow rate in each progression interval is lower than the intermediate flow rate in the previous interval. Therefore, the flow rate can be reduced to a lower intermediate flow rate in each interval. The controller may gradually reduce the flow rate through several intermediate flow rates lower than the previous intermediate flow rate, and perform steps 2406-2408 at each reduced intermediate flow rate. Alternatively, the intermediate flow rates may vary, for example, so that multiple intermediate flow rates alternate between two or more flow rates (which are nevertheless lower than the operating flow rate).

[0267] The controller may store a minimum or lower limit flow rate. In some examples, the minimum flow rate may be a fixed value so as to apply to all patients who may be using a respiratory therapy device. In other examples, the minimum flow rate is a variable value that may change based on different therapy sessions and / or different patients. In these examples, the minimum flow rate may depend on, or be based on, at least the therapy session or the patient's operating flow rate or prescribed therapeutic flow rate. The minimum flow rate is not low enough to pose a risk to patients requiring respiratory support, or at least not so low that the reduced flow rate is noticeable to the patient (especially patients who are sleeping or at rest).

[0268] In step 2410, the controller may compare the current intermediate flow rate to the minimum flow rate. The controller may determine whether the minimum flow rate has been reached. If the minimum flow rate has been reached, the controller may increase the flow rate back to the working flow rate. The controller may gradually increase the flow rate back to the working flow rate. Gradual increase may include increasing the flow rate progressively to higher intermediate flow rates, each corresponding to one or more of the intermediate flow rates previously used in the process. In other examples, the controller may increase the flow rate back to the working flow rate in a ramping style, which may include increasing the flow rate back to the working flow rate linearly (e.g., in a straight line) or non-linearly (e.g., using a curve, exponential curve, or logarithmic curve) rather than performing an incremental increase. In some examples, the controller may take steps to gradually increase the flow rate back to the working flow rate, either more quickly or more slowly.

[0269] In other examples, the intermediate flow rate may be greater or less than the previous intermediate flow rate. As will be discussed later, the controller may gradually reduce the flow rate through several intermediate flow rates lower than the previous intermediate flow rate, performing steps 2406-2408 at each reducing intermediate flow rate. The controller may then determine that a minimum flow rate has been reached, and thereafter may gradually increase the flow rate through several intermediate flow rates greater than the previous intermediate flow rate, performing steps 2406-2408 at each intermediate flow rate. Gradually increasing the intermediate flow rate may involve increasing the flow rate to progressively higher intermediate flow rates that correspond to one or more intermediate flow rates previously used in the process, or to flow rates that are distinct intermediate flow rates from those previously used in the process.

[0270] In some examples, the flow rate gradually ramps from the operating flow rate to each intermediate flow rate. Furthermore, the flow rate may gradually ramp from each intermediate flow rate to the next intermediate flow rate. In other examples, the flow rate is stepwise between the operating flow rate and the intermediate flow rates.

[0271] In some cases, the flow rate is maintained at a minimum or predetermined duration at one or more intermediate flow rates before steps 2406 and 2408 are performed. This allows the patient's respiratory parameter(s) to stabilize at that intermediate flow rate, which can lead to a more accurate determination or estimation of the respiratory parameter(s). The period before steps 2406–2408 are performed can be at least long enough to allow the residual effect of the therapy at the previous flow rate on the patient's respiratory parameter to decay.

[0272] Therefore, the step of estimating or determining the patient's respiratory parameters at each of several intermediate flow rates may be performed at some point after the flow rate has been changed to an intermediate flow rate. In some examples, the period may be predetermined or predetermined. The period may be constant throughout the entire process 2400. In other examples, the period may be variable between intervals. In such examples, the period may be related to the received flow parameter data. The period may be proportional to or have a fixed ratio with the patient's flow parameter data or estimated respiratory parameters. Alternatively, the period may be inversely proportional to at least the patient's estimated respiratory parameters.

[0273] For example, if a patient's respiratory rate is relatively high, more respiratory cycles will be captured in a given period. However, if a patient's respiratory rate is relatively low, fewer cycles will be captured in that same period. If the objective is to capture a fixed number of respiratory cycles, the time taken at each flow rate may be shortened or increased depending on the patient's measured / estimated respiratory rate.

[0274] Since higher respiratory rates generally mean shorter expiratory periods, and vice versa, a similar logic can be applied to exemplary configurations where the patient's respiratory parameters are their I:E ratio, resulting in a patient's I:E ratio being higher when their respiratory rates are higher, and vice versa. However, the I:E ratio can vary considerably at a given respiratory rate depending on various factors (including changes in the patient's state and physiological function, whether they are awake, their stage of sleep (if sleeping), and transient respiration). Therefore, in such exemplary configurations, the controller may be configured to identify specific heterogeneous I:E ratios (e.g., with significantly longer expiratory-to-inspiratory periods, and thus longer respiratory cycles overall) and, based on this, extend or shorten such periods with flow as appropriate.

[0275] In step 2406, the controller is configured to receive flow parameter data while the patient is being supplied with a gas flow at an intermediate flow rate. The flow parameter data may include flow data indicating or representing the flow rate of the gas flow supplied by the flow generator. As described above, the exemplary respiratory therapy device 100 may include one or more flow sensors configured to sense and generate flow data. One or more flow sensors may be placed or located in or within the gas flow path. More specifically, one or more flow sensors may be placed or located at or near the outlet of the blower of the flow generator. One or more flow sensors may communicate electrically with the controller.

[0276] Additionally or alternatively, flow parameter data may include pressure data indicating or representing the pressure of the gas flow at the blower outlet of the flow generator. As described above, the exemplary respiratory therapy device 100 may include one or more pressure sensors configured to sense and generate pressure data. One or more pressure sensors may be placed or located in or within the gas flow path. More specifically, one or more pressure sensors may be placed or located at or near the blower outlet of the flow generator. One or more pressure sensors may communicate electrically with a controller.

[0277] In step 2408, the controller is configured to estimate or determine the patient's respiratory parameters at intermediate flow rates based on at least the received flow parameter data. The step of estimating or determining the patient's respiratory parameters at each of several intermediate flow rates may include evaluating or processing the received flow parameter data. For example, this step may include evaluating or processing the flow data and / or pressure data received at the intermediate flow rates to determine the patient's respiratory parameters at those intermediate flow rates.

[0278] As mentioned above, in some cases, a patient's respiratory parameter may be the patient's respiratory rate. Additionally or alternatively, a patient's respiratory parameter may be the patient's inspiratory-expiratory time ratio.

[0279] It will be understood that any one or more of these exemplary respiratory parameters can be determined or estimated using the methods described above.

[0280] In step 2410, the controller determines whether to continue with further intermediate flow rates. As described above, the controller may gradually reduce the flow rate through several intermediate flow rates lower than the previous intermediate flow rate, performing steps 2406–2408 at each reducing intermediate flow rate. Next, in step 2410, the controller may determine whether to continue with an even lower flow rate. This determination may be based on comparing the current intermediate flow rate to one or more thresholds or values. Thresholds or values ​​may define a range and / or minimum flow rate offered to the patient. The range or minimum may be predefined. The range or minimum may be set by the clinician. In other examples, the range or minimum may be determined by the controller based on the patient's estimated or determined respiratory parameter(s). The range or minimum may define or be associated with a minimum flow rate.

[0281] In step 2410, the controller may evaluate the current intermediate flow rate against a range or minimum. If the intermediate flow rate is within the range and / or has not yet reached the minimum, the process then returns to step 2404 to provide a gas flow at a further intermediate flow rate before repeating steps 2406-2410.

[0282] If the current intermediate flow rate is close to or outside the range, or close to or outside the minimum, the controller may then determine in step 2410 that no further intermediate flow rate is needed. Based on this determination, the controller may decide to proceed to step 2412 instead of returning to step 2404.

[0283] If the controller determines that a further intermediate flow rate is required, the process returns to step 2404 and provides a gas flow at the further intermediate flow rate before re-executing steps 2406 - 2410.

[0284] If the controller determines that a further intermediate flow rate is not required, the process executes step 2412 and estimates the patient's ex-therapy respiratory parameters based at least on the estimated or determined respiratory parameters at each of one or more intermediate flow rates.

[0285] As will be appreciated, in all examples of the present disclosure, the patient's ex-therapy respiratory parameter(s) are estimated while the respiratory therapy system is supplying air to the user's airway. In some examples, one or more of the patient's ex-therapy respiratory parameter(s) are estimated while the patient is using the respiratory therapy system for treatment purposes.

[0286] In some examples, in one configuration, the method further includes receiving flow parameter data at an operating flow rate and estimating or determining the patient's respiratory parameters at the operating flow rate based at least on the flow parameter data received at the operating flow rate.

[0287] In such examples, step 2412 of process 2400 for estimating the patient's ex-therapy respiratory parameters may be based at least on the estimated or determined respiratory parameters at each of the plurality of intermediate flow rates and at the operating flow rate.

[0288] In some examples, flow parameter data may include oxygen concentration data indicating or representing the concentration of oxygen in the gas flow provided by the flow generator. For example, flow parameter data may include data indicating or representing the fraction of delivered oxygen (FdO2), which is the oxygen fraction of the delivered gas flow output by the respiratory therapy device 100. The exemplary respiratory therapy device 100 may include one or more oxygen concentration sensors configured to sense and generate oxygen concentration data. One or more oxygen concentration sensors may be placed or positioned in or within the flow path of the gas flow.

[0289] Step 2412, which estimates the patient's extra-therapeutic respiratory parameters (multiple), may be performed using a model. The model may be part of a function or algorithm. The model may be based on, or receive as input, the estimated or determined respiratory parameters (multiple) at each of several intermediate flow rates. The model may further be based on, or receive as input, the estimated or determined respiratory parameters (multiple) at the operating flow rate.

[0290] The respiratory therapy device may further include a non-temporary computer-readable medium accessible to or communicating with the controller. The non-temporary computer-readable medium may include non-volatile memory. Models(s) may be stored in non-volatile memory. In some examples, for example, using more complex models that may require considerable processing power, such models(s) may be stored on a remote device or server, and the respiratory device can simply outsource processing to these other processors by sending various inputs to the remote device or server that performs the processing.

[0291] In some examples, the model is a linear model or multiple linear models. The model(s) may be one or more generalized linear models and may include one or more equations. The generalized linear model(s) may include appropriate coefficients for determining or estimating specific out-of-therapy values ​​of respiratory parameters, such that different terms of the model(s) and / or equation(s) may be appropriately weighted for a particular respiratory parameter, as will be described in relation to further examples such as those relating to out-of-therapy respiratory rate. The model(s) may be used to estimate one or more out-of-therapy respiratory parameters.

[0292] The model may further be based on, or receive as input, flow parameter data and estimated or determined respiratory parameters (multiple) at each of the intermediate flow rates. The model may further be based on, or receive as input, flow parameter data and estimated or determined respiratory parameters (multiple) received at the operating flow rate, as well as flow parameter data and estimated or determined respiratory parameters (multiple) received at each of the intermediate flow rates.

[0293] In such examples, flow parameter data may include oxygen concentration data. The model(s) may be based on, or may receive as input, oxygen concentration data received at each of the intermediate flow rates. The model(s) may further be based on, or may receive as input, oxygen concentration data received at the operating flow rate.

[0294] A model may include one or more coefficients. In the example, the coefficients define, represent, or model the relationship between the estimated or determined respiratory parameter(s) and the received flow parameter data at each flow rate.

[0295] In some cases, one or more of the coefficients may be pre-determined or pre-set. One or more of the coefficients may be based on collected patient data. In some cases, one or more of the coefficients may be generated using a supervised machine learning algorithm with collected patient data. Patient data may be collected from a wide range of patients. The patient data should allow the coefficient(s) to be relatively universally applicable across a general patient population. However, different coefficients are intended to be generated and used for different patient populations, for example, based on patients identified as having a particular respiratory and / or disease state. For example, specific models may exist for different types or groups of patients. In such cases, the coefficients may differ between models based on the classified type or group of patients. Examples of different patient groups or types include, for example, patients with COPD stages I-IV, bronchiectasis, acute heart failure, ARDS, pulmonary edema, and pneumonia, to provide some examples.

[0296] The coefficients may be generated using supervised machine learning algorithms (or more) with collected patient data, and measured or determined respiratory parameter and flow rate data from at least one patient population may be fed into the supervised machine learning algorithms (or more). The machine learning process (or more) may include inputting data related to respiratory parameter (or more) and corresponding flow rate parameter data measured or determined from one or more patients. The machine learning process (or more) may include inputting data related to respiratory parameter (or more) and corresponding flow rate parameter data measured or determined from multiple patient populations. Each patient population may correspond to a different group associated with a particular disease and / or disease state, as described above.

[0297] In some examples, the model(s) and / or the coefficients(s) that make up the model(s) may be generated by one or more machine learning algorithms. The machine learning algorithms may be run or performed to train a suitable model for use in estimating the out-of-therapy respiratory parameters(s). The model(s) may be used to determine the coefficients that provide weighting for different items within the model. The generated model(s) may be implemented on a respiratory therapy device, thereby configuring the device's controller to estimate the patient's out-of-therapy respiratory parameters using the generated model(s) described above. The respiratory therapy device's controller may be programmed with the pre-generated model(s), and the relevant parameters / variables may be used as inputs to the model(s) to process them.

[0298] Machine learning algorithms may require significant processing resources and are therefore not suitable for running on the controller of a respiratory therapy device, which may have limited computing resources due to being an embedded system. Therefore, machine learning algorithms that may be used to generate coefficients may run on a processor or server that is remote from the respiratory therapy device. However, in some cases, if resources are available on the respiratory therapy device controller, machine learning algorithms may run on the respiratory therapy device controller.

[0299] Models can describe nonlinear relationships between variables and outputs. These models may include support vector machines (SVMs), tree-based models (e.g., decision trees, but not limited to them), random forests or the XGBoost (eXtreme Gradient Boosting) algorithm, and / or artificial neural networks. Models may also include, among other things, generalized linear models, linear or logistic regressions, and linear discriminant analysis models. Models may also include autoregressive integrated moving average models (ARIMA). Input features may include raw or preprocessed, normalized, and / or combined data before being fed into these models (e.g., using dimensionality reduction methods such as principal component analysis or multi-component analysis).

[0300] Similar to coefficients, models for estimating a patient's out-of-therapy respiratory parameters may include one or more variables. These variables may include, or be based on, estimated or determined respiratory parameters and / or flow parameter data at each flow rate.

[0301] In the example, the variables used in the model may include at least one or more of the following: - The mean values ​​of the patient's estimated or determined respiratory parameters at each of several intermediate flow rates. For example, after running the function several times, a set of data is collected that relates changes in the patient's respiratory parameters to changes in flow rates, e.g., changes in the patient's respiratory parameters as the flow rate changes, based on the mean values ​​of the patient's estimated or determined respiratory parameters at each of several intermediate flow rates. The model can then use this collected data to extrapolate the out-of-therapy respiratory parameters at 0 L / min. The effects of flow (and optionally, supplemental oxygen) and changes in flow on other respiratory parameters, such as the patient's respiratory rate, can be modeled in a similar manner. - The difference between the operating flow rate and the minimum flow rate. This minimum flow rate can be zero, or a non-zero value that does not result in (or results in very minimal) reduction of respiratory parameters (i.e., has little or no therapeutic effect). This minimum flow rate can be a fixed "target" that depends on the baseline / operating flow rate. The respiratory therapy device does not actually need to reduce to this flow rate. - The difference between the patient's respiratory parameter at the operating flow rate and the average value of the patient's estimated or determined respiratory parameter at each of several intermediate flow rates, wherein this difference is divided by the difference between the operating flow rate and one or more intermediate flow rates. - The difference between oxygen concentration data for a gas flow at one or more intermediate flow rates (i.e., the percentage of oxygen delivered FdO2 or the percentage of oxygen inhaled FiO2) and the ambient oxygen concentration level reading.

[0302] In one example, a model(s) may be used at each intermediate flow point. The model(s) may generate multiple values ​​related to changes in the patient's respiratory parameters(s) considering the change in flow rate, and these multiple values ​​may be used together to project or calculate the trajectory of the patient's respiratory parameters as they change with further reduction in flow rate. The model(s) may use a set of patient measurements and / or temporal relationship data between sets of measurements to estimate the patient's out-of-therapy respiratory parameters. In other words, in some examples, the data input to the model(s) may include data indicating that a series of data points are from consecutive points in time; for example, each input may be a vector or matrix containing multiple data points across different consecutive points in time.

[0303] In another example, the model(s) may run at one intermediate flow point and use changes in the patient's respiratory parameter(s) to estimate the patient's out-of-therapy respiratory parameter(s) by considering changes in the flow value.

[0304] The model(s) are configured to output values ​​corresponding to estimates of one or more out-of-therapy respiratory parameters of a patient. In other words, the estimation of one or more respiratory parameters of a patient is performed when the respiratory therapy device is not providing airflow.

[0305] In some examples, the model(s) are configured to output changes in the patient's respiratory parameters(s) in response to changes in flow rate. If the change in flow rate corresponds to a decrease to zero flow rate (i.e., no treatment), this can then be used to determine the out-of-therapy respiratory parameters.

[0306] In some examples, the model(s) may be configured to output values ​​related to the change in flow rate that represent the expected change in a patient's respiratory parameters. The model(s) may provide an output that quantifies the expected change in respiratory parameters(s) as the flow rate changes from the working flow rate to a sub-therapeutic flow rate(s), where the sub-therapeutic flow rate is an intermediate flow rate low enough to be considered to result in a reduced therapeutic effect. This relationship may allow extrapolation of respiratory parameters(s) at intermediate flow rates to below the minimum flow rate without the need to drastically reduce the flow rate, such as when the patient is sleeping or at rest, or when therapy is interrupted.

[0307] In some cases, the controller may further identify whether the measured or determined patient-specific data accurately match the model(s). This may occur across several therapy sessions. For example, estimated or determined patient parameters(s) and / or changes in estimated or determined patient parameters in response to changes in flow rate may be compared to the predicted or estimated respiratory parameters output by the model. If there is a consistent mismatch, the algorithm may perform recalibration of coefficients or identify a better set of coefficients for the patient. For example, the controller may not have knowledge of the patient's updated disease status if the patient has progressed from COPD stage I to II following a worsening of the condition. Nevertheless, the controller (or an external / remote computing device receiving data from the respiratory therapy device) may determine whether the patient's response to changes in flow better matches a different model. For example, it may determine that the patient's condition better corresponds to a patient in COPD stage II rather than stage I, and therefore switch to a model associated with stage II patients.

[0308] In some cases, estimated or determined respiratory parameters at intermediate flow rates can be extrapolated using a model to estimate out-of-therapy respiratory parameters. Extrapolation can be performed using the same model as described above, or another appropriate technique.

[0309] In some examples, the model includes a fitted linear equation or a fitted linear model. The fitted linear equation or fitted linear model is run using data that includes estimates of the patient's respiratory parameters at each intermediate flow rate and measurements of the intermediate flow rates mentioned above. The model may extrapolate the estimated or determined respiratory parameters(s) at intermediate flow rates based on time-series data. Standard techniques such as quadratic interpolation or the application of ARIMA (Autoregressive Moving Average) models can be used.

[0310] In some cases, estimates of extra-therapeutic respiratory parameters may be determined via inference using a combination of multiple values ​​(e.g., mean or weighted mean) of the estimated or determined respiratory parameters at intermediate flow rates calculated during process 2400.

[0311] The model may include a fitted equation that can be used to extrapolate the patient's respiratory parameters to an extratherapeutic value based on at least the estimated or determined respiratory parameters at each of several intermediate flow rates. The fitted equation is configured to provide the patient's extrapolated respiratory parameters based on at least the estimated or determined respiratory parameters at each of several intermediate flow rates.

[0312] The model can be run several times; for example, respiratory parameters at the working flow rate are determined or estimated, and then the flow rate can be ramped to one or more intermediate flow rates, with respiratory parameters determined or estimated at each intermediate flow rate, which can be extrapolated to a good estimate of out-of-therapy respiratory rate. By making several estimates or determinations of the patient's respiratory parameters at different flow rates and determining several values ​​that represent the change in respiratory parameters compared to the change in flow rate from the model, the trajectory of respiratory parameters as they approach the out-of-therapy flow rate can be determined.

[0313] In some cases, process 2400 may proceed to adjust the flow rate provided to sub-therapeutic flow rates below the minimum flow rate after stepping through several intermediate flow rates. In situations where the device's predetermined operating flow rate is already relatively low (e.g., 35 L / min or less compared to the upper limit of 60 L / min or 70 L / min of flow rates typically used in high-flow therapy), the controller may proceed to adjust the flow rate provided to these sub-therapeutic flow rates. It is possible to adjust to sub-therapeutic flow rates without disturbing the patient, as the flow rate may still be at the lower limit of a typical high-flow therapy flow rate. Reducing the flow rate provided to the patient from 60 L / min to 10 L / min is a significant reduction and is likely to be noticeable to the patient, probably enough to wake or warn the patient. By comparison, a reduction from 30 L / min to 25 L / min is a smaller change that may not wake or warn the patient. The changes between intermediate flow rates required to observe changes in the patient's respiratory parameters in this disclosure may be fairly small and could be of any degree from 1 L / min to 10 L / min (including those). In the example, a 10% reduction in flow rate between different flow rates (i.e., a decrease in flow rate from, for example, a therapeutic flow rate of 30 L / min to a reduced flow rate of 27 L / min) may be sufficient to have a noticeable effect on the received readings while avoiding confusion for the patient.

[0314] In these examples, values ​​close to or substantially corresponding to the patient's extra-therapeutic respiratory parameters (or multiple parameters) can be measured or determined as described above, rather than being modeled or extrapolated. In these examples, the patient's extra-therapeutic respiratory parameters can be measured or determined using the methods described in relation to step 2408 of process 2400.

[0315] The advantage of this approach is that less extrapolation may be required compared to previous approaches that use models or extrapolate data. This approach may involve reducing the flow rate to lower sub-therapeutic levels (but not down to zero or non-therapeutic levels) so that less extrapolation of data is required. The data collected at these lower sub-therapeutic flow rates may be closer to the data collected when no therapy is provided, and therefore, estimation of out-of-therapy respiratory parameters may be performed at lower flow values ​​compared to previous approaches. For example, respiratory parameters measured at 20 L / min are typically closer to those measured at 0 L / min (or close to it) than if the parameters were measured at 40 L / min, so respiratory parameters estimated at lower sub-therapeutic flow rates (20 L / min) are closer to those measured at zero flow rate.

[0316] In some cases, time-series data of a patient's estimated or determined respiratory parameters(s) at sub-therapeutic flow rates below the minimum flow rate, and the patient's estimated or determined respiratory parameters(s) at multiple intermediate flow rates, can be input into an equation or model and used to estimate the patient's respiratory parameters(s) when the flow rate tends to be zero, i.e., out-of-therapy respiratory parameters(s). In some cases, the model may be a fitted model as described above, which extrapolates the values.

[0317] In some examples, the model may include a fitted equation that can be used to extrapolate the patient's respiratory parameters to an out-of-therapy value, based at least on the estimated or determined respiratory parameters at each of several intermediate flow rates. The fitted equation may be configured to provide the patient's extrapolated respiratory parameters, based at least on the estimated or determined respiratory parameters at each of several intermediate flow rates. The patient's extrapolated respiratory parameters may be approximations of the patient's respiratory parameters at flow rates at least below the lowest intermediate flow rate.

[0318] In some of these examples, the period spent at sub-therapeutic flow rates before receiving flow parameter data (step 2406) and then estimating or determining the patient's respiratory parameters (multiple) below the minimum flow rate (step 2408) should be long enough to mitigate any residual effects of the previously provided flow rate on the patient's respiratory parameters (multiple). Additionally or alternatively, the period spent before receiving flow parameter data (step 2406) and then estimating or determining the patient's respiratory parameters (multiple) (step 2408) may be inversely proportional to the previously estimated respiratory parameters (multiple), as described above, to ensure that a sufficient number of respiratory cycles are included in the data for processing.

[0319] Other additional features Next, we will describe the exemplary process shown in Figure 8. The exemplary process shown in Figure 8 corresponds to the process shown in Figure 7, but with additional steps that may be performed. Steps 2402, 2404, 2406, 2408, 2410, and 2412 are common to both the example shown in Figure 7 and Figure 8, and it will be understood that they are performed as described above in relation to Figure 7. Steps 2403, 2405, 2407, and 2409 are simply additional steps to the example shown in Figure 8. These additional steps will be described here.

[0320] In step 2403, the controller is configured to receive flow parameter data at the operating flow rate. As can be understood, the features of step 2403 correspond to the features of step 2406 described above. The difference is that the flow parameter data in step 2403 is received at the operating flow rate.

[0321] In some examples, the controller is configured to receive flow parameter data in step 2403 after a minimum period has elapsed since the start of the therapy session. The predetermined period may be long enough to allow the patient's respiration to stabilize sufficiently.

[0322] In step 2405, the controller may be configured to assess whether one or more respiratory stability criteria are met. This step may include determining the patient's respiratory parameter status based on the flow parameter data received in step 2403.

[0323] In most configurations, it is best that the patient has stable respiratory parameters before performing the steps of the described process. If the patient's respiration is unstable, then fluctuations in the estimated or determined respiratory parameters during the process of adjusting to an intermediate flow rate may be misrepresented as changes in the flow rate.

[0324] Additionally, a stable respiratory rate can be used to determine whether the patient is asleep or nearing sleep. Performing the flow reduction and measurement process of this implementation while the patient is asleep may be preferable, as the patient is less likely to alter those respiratory parameters (in response to variables other than the therapy device flow rate). The described process can be performed as intended if the patient is not asleep but their respiration is sufficiently stable.

[0325] Therefore, in step 2405, the controller may be configured to evaluate whether one or more respiratory stability criteria are met. If the controller determines that the respiratory stability criteria are met, the method 2400 then proceeds to step 2404, controlling the flow generator to provide a gas flow at multiple intermediate flow rates.

[0326] The controller may determine that the respiratory stability criteria are met based on the patient's respiratory parameter status, which indicates that the patient's respiratory parameters are substantially stable.

[0327] In some examples, the step of determining the status of a patient's respiratory parameters may include determining an index or estimate of the patient's respiratory parameters. The index or estimate of the patient's respiratory parameters may be based on flow parameter data received at one or more intervals while at working flow. The step of determining the status of a patient's respiratory parameters may additionally or alternatively include determining an index or estimate of the patient's respiratory parameters using data received from one or more sensors configured to measure patient parameters. Data from the sensor(s) may be received at one or more intervals while at working flow. For example, the sensors may include one or more of a connected pulse oximeter, heart rate sensor, and / or external respiratory rate sensor. The sensor(s) may be connected to the respiratory therapy device controller via a wired or wireless connection.

[0328] The indicator or estimate of the patient's respiratory parameters at each interval can be compared with at least the indicator or estimate of the patient's respiratory parameters at one or more previous intervals.

[0329] In such cases, the patient's respiratory rate status is related, based on comparison, to the degree or amount of change between the indicator or estimate of the patient's respiratory parameter determined in the current interval and the indicator or estimate of the patient's respiratory parameter determined in one or more previous intervals.

[0330] Based on the above comparison, the controller may determine, for example, that the patient's respiratory rate status indicates that the patient's respiratory rate is increasing, decreasing, or substantially stable.

[0331] Based on the controller's determination that the patient's respiratory parameters (e.g., respiratory rate) indicate that the patient's respiratory parameters are substantially stable, the controller may determine that the respiratory stability criteria are met, and the process may proceed to step 2404.

[0332] In some examples, step 2405, which determines the state of the patient's respiratory parameters, further includes comparing the state of the patient's respiratory parameters to one or more thresholds.

[0333] In a further example, determining the state of a patient's respiratory parameters may involve evaluating a specific patient's respiratory stability criteria. Evaluating a patient's respiratory stability criteria may involve comparing the measured or determined patient's respiratory parameters or respiratory stability parameters to one or more thresholds. The measured or determined patient's respiratory parameters or respiratory stability parameters may be measures of the variability of one or more of the patient's respiratory parameters (such as respiratory rate). The measure of variability for each respiratory parameter may be the ratio of the standard deviation of the respiratory parameter to the mean value of the respiratory parameter over two or more measured intervals.

[0334] In some cases, the measure of variability of a respiratory parameter or each respiratory parameter may be a coefficient of variability. In some cases, the measure of variability of respiratory rate may be the ratio of the standard deviation of the signal envelope of a respiratory parameter to the mean value of the signal envelope of a respiratory parameter.

[0335] Wait for the interval In step 2407, the controller 2400 adjusts the flow rate to an intermediate flow rate and then proceeds to wait for a certain interval or period. In this step, the controller may maintain the flow rate at each of one or more intermediate flow rates for a minimum period before steps 2406 and 2408 are performed. This allows the patient's respiratory parameter(s) to stabilize at that intermediate flow rate, which can lead to a more accurate determination or estimation of the respiratory parameter(s). The period before steps 2406-2408 are performed may be at least long enough to allow the residual effect of the previous flow rate on the patient's respiratory parameter to decay.

[0336] Therefore, step 2406, which estimates or determines the patient's respiratory parameters at each of several intermediate flow rates, may be performed at some point after the flow rate has been changed to an intermediate flow rate. In some examples, the period may be pre-set or pre-determined. The period may be constant throughout process 2400. In other examples, the period may be variable between intervals. In such examples, the period may be related to the received flow parameter data. The period may be proportional to or have a fixed ratio with the patient's flow parameter data or estimated respiratory parameters. Alternatively, the period may be inversely proportional to at least the patient's estimated respiratory parameters.

[0337] For example, if a patient's respiratory rate is relatively high, more respiratory cycles will be captured in a given period. However, if a patient's respiratory rate is relatively low, fewer cycles will be captured in that same period. If the objective is to capture a fixed number of respiratory cycles, the time taken at each flow rate may be shortened or increased depending on the patient's measured / estimated respiratory rate.

[0338] A similar logic can also be applied to exemplary configurations where the patient's respiratory parameters are their I:E ratio. Providing high-flow therapy can result in an extended expiratory phase of the respiratory cycle, with higher flow rates extending the duration of the expiratory phase. Thus, the I:E ratio decreases as the flow rate increases. Respiratory rate may also decrease in parallel. Conversely, as the flow rate decreases, the expiratory phase decreases (while respiratory rate may also increase in parallel), and as a result, the I:E ratio increases in this scenario. A patient's I:E ratio may be higher if their respiratory rate is higher, and vice versa, but this is not always the case. An increasing I:E ratio means increasing towards 1:1 (indicating severe hyperventilation), while a decreasing I:E ratio means decreasing towards 1:2-1:3 (healthy levels).

[0339] Return to operating flow rate After step 2412 is performed and the controller determines an estimated value for the patient's extratherapeutic respiratory parameter(s), method 2400 may further include restoring the flow rate to the working flow rate. The controller may restore the flow rate to the working flow rate in step 2409. The working flow rate may be considered the initial flow rate.

[0340] In some examples, step 2409 may be performed by increasing the working flow rate to one or more increasing intermediate flow rates. The controller may gradually increase the flow rate to an intermediate flow rate greater than the previous intermediate flow rate. The gradual increase may correspond to one or more of the intermediate flow rates previously used in the process, or to one or more new or different intermediate flow rates. In other examples, the controller may increase the flow rate back to the working flow rate in a ramping manner (e.g., with linear or nonlinear water retention as described above), or may increase the flow rate stepwise back to the working flow rate more quickly or more slowly.

[0341] In other examples, the intermediate flow rate may be greater or less than the previous intermediate flow rate. As will be described later, the controller may gradually reduce the flow rate through several intermediate flow rates that are lower than the previous intermediate flow rate, and perform steps 2406-2408 at each intermediate flow rate being reduced.

[0342] As mentioned above, the controller may store the minimum flow rate. In step 2410, the controller may determine that the minimum flow rate has been reached, and thereafter, in step 2409, the controller may gradually increase the flow rate toward the working flow rate. The increase in flow rate toward the working flow rate in step 2409 may pass through several intermediate flow rates that are larger than the previous intermediate flow rate. In some examples, the controller may also perform steps 2406-2408 at each increasing intermediate flow rate. The increasing intermediate flow rates may correspond to one or more intermediate flow rates previously used in the process, or they may be separate or new intermediate flow rates.

[0343] In some examples, step 2412 is performed and the controller determines the estimated values ​​of the patient's out-of-therapy respiratory parameters(s) using one of the methods described above. After this, the estimated values ​​of the patient's out-of-therapy respiratory parameters(s) may be output by the controller or used by the controller.

[0344] 2.4 Example of an out-of-therapy respiratory rate estimation process As shown in Figures 9 and 10, a method 2600 for estimating the out-of-therapy respiratory rate of a patient using a respiratory device is presented. The steps of the described method 2600 are similar to those of the previously described method 2400, but they relate to an example where the patient's out-of-therapy respiratory rate is estimated and the out-of-therapy respiratory rate is a specific type of out-of-therapy respiratory parameter.

[0345] It will be understood that the steps described with respect to steps 2402, 2403, 2404, 2405, 2406, 2407, 2408, 2409, 2410, and 2412 of Method 2400 in Figures 7 and 8 correspond to steps 2602, 2603, 2604, 2605, 2606, 2607, 2608, 2609, 2610, and 2612 of Method 2600 shown in Figures 9 and 10. It will be understood that the steps of Method 2600 differ from the steps of Step 2400 in that they are particularly related to determining the patient's out-of-therapy respiratory rate.

[0346] Here, we will explain the method 2600 shown in Figures 9 and 10 for estimating the patient's out-of-therapy respiratory rate.

[0347] In step 2602, the controller performs the step of generating a gas flow or providing it to the user or patient at an operating flow rate. The operating flow rate may be a therapeutic flow rate. The therapeutic flow rate may be suitable for providing high-flow therapy to the patient.

[0348] In step 2604, the flow generator is controlled to provide a gas flow at an intermediate flow rate. In step 2406, the controller is configured to receive flow parameter data while the gas flow is being provided to the patient at an intermediate flow rate. The flow parameter data may be received from one or more sensors.

[0349] In step 2608, the controller is configured to estimate or determine the patient's respiratory rate while the patient is being supplied with a gas flow at an intermediate flow rate, based at least on the received flow parameter data.

[0350] In step 2610, the controller determines whether to further adjust the flow rate to another intermediate flow rate. For example, the controller may determine that further adjustment of the flow rate to a lower or higher intermediate flow rate is necessary. If the controller determines that further intermediate flow rates are needed, the process returns to step 2604 and provides the gas flow at the further intermediate flow rate before repeating steps 2606-2610.

[0351] If the controller determines that no further intermediate flow is needed, the process performs step 2612 to estimate the patient's out-of-therapy respiratory rate, based at least on the estimated or determined respiratory rate at each intermediate flow.

[0352] Here, we will discuss the subtle differences between methods 2612 and 2412, which are particularly relevant to the estimated out-of-therapy respiratory rate of the patient.

[0353] Similar to step 2412 described above, step 2612, which estimates the patient's out-of-therapy respiratory rate, may be performed for each of several intermediate flow rates based on or receiving the respiratory rate estimated or determined from step 2608.

[0354] A patient's out-of-therapy respiratory rate can be determined using a model. The model may be part of a function or algorithm. The model may be based on, or receive as input, estimated or determined respiratory rates at each of several intermediate flow rates. The model may further be based on, or receive as input, estimated or determined respiratory rates at the working flow rate.

[0355] In some examples, the model is one or more linear models. The model(s) may be one or more generalized linear models and may contain one or more equations. The generalized linear model(s) may contain appropriate coefficients for determining or estimating specific out-of-therapy values ​​of respiratory rate.

[0356] The model(s) may further be based on, or receive as input, flow parameter data and estimated or determined respiratory rates at each of several intermediate flow rates. The model may further be based on, or receive as input, flow parameter data and estimated or determined respiratory rates received at the operating flow rate, as well as flow parameter data and estimated or determined respiratory rates received at each of several intermediate flow rates.

[0357] Patient's out-of-therapy respiratory rate (RR) 療法外 A model(s) for estimating ) may include one or more variables. The variables may include, or be based on, estimated or determined respiratory parameters(s) and / or flow parameter data at each flow rate.

[0358] For example, a model for estimating a patient's out-of-therapy respiratory rate is an intermediate flow rate (Q 中間 The estimated or determined respiratory rate (RR) of the patient is calculated when the patient is in each of the following states. 中間 Each of the following can be taken into consideration.

[0359] Additionally, the parameters used in the model may include at least one or more of the following: - Mean value of patient's determined or estimated respiratory rate at operating flow rate (μ) RR動作 ) - The average value of the patient's estimated or determined respiratory rate at each of several intermediate flow rates (μ RR中間 ) - Operating flow rate (Q 動作 ) and minimum flow rate (Q 最小 ) is the difference, and the difference is (Q 動作 -Q 最小 ) - Estimated or determined respiratory rate (RR) of the patient at the operating flow rate 動作 ) and the estimated or determined respiratory rate (RR) of the patient at each of the multiple intermediate flow rates. 中間 This is the difference between the average value of ) and the operating flow rate, and the difference is divided by the difference between the operating flow rate and one or more intermediate flow rates, i.e.,

number

[0360] The linear model also includes a set of coefficients (α) that can weight each of the above items in the model by their effect on the estimate of the change in flow rate. n The coefficients can consist of the following: The coefficients can define the relationship between the estimated or determined respiratory parameter(s) and the received flow parameter data at each flow rate, as described above.

[0361] For example, a model for estimating a patient's out-of-therapy respiratory rate may take the following form:

number

[0362] In a further example, a model for estimating a patient's out-of-therapy respiratory rate uses the difference (FiO) between oxygen concentration data from gas flow at one or more intermediate flow rates and ambient readings of oxygen concentration levels. 2送達 -FiO 2周囲 ) may additionally include parameters related to ). In such examples, a model for estimating a patient's out-of-therapy respiratory rate may take the following form:

number

[0363] In further examples, a model for estimating a patient's out-of-therapy respiratory rate is ΔRR / ΔQ, i.e., the estimated change in respiratory rate due to a change in flow rate, or more specifically, Q 動作 and Q 中間 The model can output the change in respiratory rate between [the specified point] and [the specified point], and can take the following forms.

number

[0364] While the above example illustrates the implementation of a generalized linear model, it is important to note that the same features can be used to train more complex models such as tree-based models, support vector machines, and artificial neural networks. Data inputs may be preprocessed and / or combined through dimensionality reduction algorithms (e.g., principal component analysis) and / or combined with additional metadata (e.g., demographic data, patient status data, etc.).

[0365] Finally, the model architecture may or may not consider the temporal relationships between different measurements of a given patient (e.g., it may or may not implement a time series model).

[0366] 2.5 Other embodiments a) Determination of the difference (ΔRP) between in-therapy respiratory parameters and out-of-therapy respiratory parameters. In some examples, the Method 2400 / 2600 may further include a step of determining the difference (ΔRP) between the patient's estimated or determined respiratory parameter at the operating flow rate and the patient's estimated out-of-therapy respiratory parameter.

[0367] The difference (ΔRP) between a patient's estimated or determined respiratory parameters at operating flow and the patient's estimated out-of-therapy respiratory parameters can be used as an indicator of therapeutic efficacy. It can also be used as an indicator of compliance or adherence. For example, a small difference may suggest insufficient therapeutic relief, which can be a predictor of whether the patient will follow or is unlikely to follow the therapeutic prescription.

[0368] In some cases, the difference (ΔRP) between the patient's estimated or determined respiratory parameter at operating flow rate and the patient's estimated out-of-therapy respiratory parameter may be provided or output as a numerical value. For example, the difference may be provided or output as a value related to the difference in respiratory rate per minute between the determined or estimated intra-therapeutic respiratory parameter and the out-of-therapy respiratory parameter.

[0369] Alternatively or additionally, the difference ΔRP may be provided or output as a percentage difference. For example, the difference may be provided or output as a percentage change in the patient's respiratory parameter between the measured in-therapy value and the estimated out-of-therapy value.

[0370] The determination of the difference ΔRP between the patient's estimated or determined respiratory parameters at operating flow and the patient's estimated out-of-therapy respiratory parameters is further based on one or more mean values ​​of the patient's out-of-therapy respiratory parameters determined over multiple therapy sessions and / or multiple flow cycles over a single therapy session.

[0371] In some configurations, the controller may perform multiple flow reduction and estimation cycles (i.e., Method 2400 / 2600) over the course of one or more therapy sessions. Data from multiple cycles may be processed separately or combined for further processing and / or use (e.g., averaged). By performing multiple cycles and calculating the average, the controller can successfully apply more subtle flow reductions to estimate a patient's out-of-therapy respiratory parameters(s). Performing more subtle flow reductions with a minimum number of cycles may have less apparent effects on the patient's respiratory parameters(s), which may reduce the accuracy of the out-of-therapy parameter estimates(s). This can be mitigated by performing multiple cycles with more subtle flow reductions. In the case of flow reductions of this disclosure, it will be understood that multiple cycles may be beneficial to the accuracy of estimation or determination.

[0372] The difference ΔRP, whether expressed as a numerical value or a percentage, can provide a good indicator of therapeutic effectiveness. It can also be useful as an indicator of therapy adherence, especially when followed up over long periods (weeks, months, or years). This is because it is an objective descriptor of perceived therapeutic relief. It is an objective descriptor of perceived therapeutic relief because it can show how effective the therapy is on the patient's respiratory parameters, in other words, how well the therapy is received by the patient. When followed up over time, ΔRP can show improvement in the patient's respiratory parameter(s) over long periods (improvement may mean a reduction or increase in the difference, depending on which parameter was observed), which can indicate adherence to the therapy prescription as well as the effectiveness of the therapy.

[0373] The output from the ΔRP determination process can be used for a variety of clinician information applications. These may include recording the ΔRP for each session and transmitting the records to a clinician device or server, presenting clinicians with alerts associated with the ΔRP, and / or displaying the ΔRP as part of an adherence monitoring program.

[0374] b) Perform the above steps multiple times throughout a therapy session. In the example, method 2400 (and 2600) can be repeated multiple times. Ideally, this is done when the patient's respiratory parameters or their coefficient of variation (as previously stated with respect to stability criteria) begin to increase, for example, while a continuous operating flow rate is provided, as long as respiration remains stable. Collecting multiple out-of-therapy estimates and averaging them may be advantageous as it can help flatten any discrepancies and reduce the impact of any spurious estimates that may occur (for example, due to excessively noisy sensor readings).

[0375] If multiple out-of-therapy respiratory parameter estimates are calculated across one or more therapy sessions, the controller can use a vector (e.g., length N) or multiple out-of-therapy respiratory parameter estimates (RP) subt ) and the average value (multiple values) of respiratory parameters estimated or determined by the operating flow rate (multiple values) (μ RPベースライン Another suitable data structure (e.g., a matrix, list, etc.) can be used to store both ) and ).

[0376] Next, the method may include calculating an estimate of the mean change in respiratory parameters, which is the change in respiratory parameters from baseline (e.g., at the operating flow rate) as the flow rate is reduced to a sub-therapeutic level.

number

[0377] Because the absolute values ​​of a patient's determined respiratory parameters depend on a range of physiological factors, including the underlying respiratory state the patient may have, directly monitoring the numerical values ​​of the respiratory parameters themselves (or performing other functions based on them) may not always be useful. Studying percentage deviations provides a more relative indicator of a patient's responsiveness to high-flow therapy, specific therapy parameter configurations, and / or their adherence to therapy programs.

[0378] c) Consideration of the effect of supplemental O2 on extra-therapeutic RR estimates In some examples, flow parameter data may include oxygen concentration data indicating or representing the oxygen concentration in the gas flow provided by the flow generator. The device may include one or more oxygen concentration sensors configured to sense and generate oxygen concentration data. One or more oxygen concentration sensors may be placed or positioned in or within the gas flow path. Additionally, the device may include one or more oxygen concentration sensors configured to sense and generate oxygen concentration data relating to the oxygen concentration of the ambient air around the device, which may be taken in by the device before the addition of auxiliary O2.

[0379] In such cases, the step of estimating the patient's out-of-therapy respiratory parameters may further be based on oxygen concentration data received at each of several intermediate flow rates and / or oxygen concentration data related to the ambient air oxygen concentration.

[0380] In addition to flow rate, the presence of supplemental oxygen in the respiratory gas mixture delivered to the patient can affect measured or estimated patient respiratory parameters (e.g., respiratory rate). In some cases, as the flow rate decreases to intermediate flow rates, etc., the measured oxygen concentration value (the percentage of oxygen in the gas stream delivered to the patient, e.g., the percentage of inspired oxygen - FiO2) may increase. If the delivered oxygen concentration is greater than the ambient oxygen concentration (typically 20.9–21.0%), the out-of-therapy respiratory estimate should take this into account. Therefore, the step of estimating the patient's out-of-therapy respiratory parameters can be extended by including a parameter with a weighting factor to account for the effect of additional O2, measured by one or more oxygen concentration sensors at working flow rates and / or intermediate flow rates. The parameter is (FiO2). 2送達 -FiO 2増加 ) may be equal to, but other suitable terms can be adopted to describe the difference (or their effect) between the O2 percentage of the delivered gas and the ambient O2. The parameters (including weighting coefficients) may accurately account for the effect of FiO2 above ambient on the patient's respiratory parameter(s).

[0381] e) Extra-therapeutic respiratory parameters (multiple parameters) estimated by remote computing devices. In some examples, the controller of a respiratory therapy device may communicate data with one or more remote computing devices and / or servers. In these examples, the remote computing devices may perform some or all of the processing steps of Method 2400 or 2600 (i.e., steps 2403, 2405, 2406, 2408, 2412 and steps 2603, 2605, 2606, 2608, 2612). For example, a remote computing device(s) / server(s) may be configured to perform any one or more of the following steps: receiving flow parameter data for each of a plurality of intermediate flow rates from the device controller, and / or estimating or determining the patient's respiratory parameters for each of the plurality of intermediate flow rates based at least on the received flow parameter data, and / or receiving the estimated or determined respiratory parameters of the patient for each of the plurality of intermediate flow rates from the device controller, and / or determining or receiving an index of the patient's out-of-therapy respiratory parameters based at least on the received or estimated or determined respiratory parameters for each of the plurality of intermediate flow rates.

[0382] 2.6 Application of Out-of-Therapy Respiratory Parameter Estimation Decision values ​​or estimates of out-of-therapy respiratory parameters (multiple) taken during one or more therapy sessions may be stored. These decision values ​​or estimates may be stored in the controller's memory and / or in the memory of an external device or server. The decision values ​​or estimates may be from a series of therapy sessions. Stored decision values ​​or estimates of out-of-therapy respiratory parameters may enable time-based tracking (and / or other analysis) of trends. Stored decision values ​​or estimates of out-of-therapy respiratory parameters may be processed to enable trend tracking and / or other analysis. Stored decision values ​​or estimates of out-of-therapy respiratory parameters may be processed by the respiratory therapy device's controller and / or by the controller of an external device or server. Processed decision values ​​or estimates of out-of-therapy respiratory parameters may further be stored as trend data.

[0383] The extratherapeutic respiratory parameters(s), data, or trend data disclosed herein may be generated and used by respiratory devices in one or more different applications or functions, examples of which are discussed further below.

[0384] As described, in some configurations, out-of-therapy respiratory parameters(s) are generated and used by one or more uses or functions during a respiratory therapy session in which a patient using a respiratory device is receiving. In some configurations, the uses or functions may utilize and / or process the out-of-therapy respiratory parameter data generated and stored during the respiratory therapy session for post-treatment processing and / or storage, such as by sending or transmitting the out-of-therapy respiratory parameter data and / or associated therapeutic data to a remote or cloud computing system, e.g., a patient and / or device management platform.

[0385] The following provides further details on various applications and / or functions that may utilize and / or process the extra-therapeutic respiratory parameters generated by the above-mentioned and / or the model(s) described above. In some of the examples described below, one or more extra-therapeutic respiratory parameters or data may be used for any one or more of the following actions:

[0386] Record extra-therapeutic respiratory parameters (multiple) and / or ΔRP for each session, transmit the recordings to an external (e.g., clinician) device or server, present alerts associated with ΔRP to the clinician, and / or display ΔRP as part of an adherence monitoring program.

[0387] The values ​​may be processed and used to suggest adjustments to the patient's therapeutic prescription, which may be presented to the patient's clinician. For example, extra-therapeutic respiratory parameters and / or ΔRP may be analyzed to make recommendations to increase or decrease one or more therapeutic settings or parameters of the respiratory apparatus, for example, the therapeutic parameters may be one or more of the flow rate, pressure level, and / or FiO2 of the provided gas flow.

[0388] The data can be used to titrate the therapeutic settings or parameters of a respiratory device over time, based on extratherapeutic respiratory parameters and / or ΔRP. For example, the flow rate or pressure level of a respiratory device can be titrated to an optimal level for therapeutic efficacy based on extratherapeutic respiratory parameters and / or ΔRP generated over one or more therapeutic sessions and / or one or more flow adjustment cycles over each or all of one or more therapeutic sessions.

[0389] Out-of-therapy respiratory parameter data and / or out-of-therapy respiratory parameter trend data are transmitted for display on a respiratory device or related device, for example, on the device's display screen, or on a related device or a device that communicates data with the device.

[0390] Triggering or generating alarms, notifications, or suggestions (visual, auditory, and / or tactile) on a respiratory device or associated device that communicates data with the device, and / or triggering or generating one or more warnings, alarms, and / or notifications at least in part based on determined out-of-therapy respiratory parameter data and one or more thresholds. The alarms, notifications, and / or warnings may be audible, visual, and / or tactile.

[0391] Based at least partially on out-of-therapy respiratory parameter data and / or more thresholds, trigger or generate one or more warnings, alarms, and / or notifications containing data indicating suggested adjustments or changes to therapeutic settings and / or device settings.

[0392] Any one or more of the exemplary uses and / or functions described above or below may be used in combination by a respiratory apparatus.

[0393] A first exemplary use is the display of out-of-therapy respiratory parameter data. In this example, out-of-therapy respiratory parameter data generated by the respiratory device may be displayed on the respiratory device's display screen (e.g., a graphical user interface, GUI) or transmitted for display on an associated remote device or system that communicates with the device. As described above, raw or absolute out-of-therapy respiratory parameters may be displayed, and / or the patient's out-of-therapy respiratory parameter ratio may also be displayed. Additionally or alternatively, one or more out-of-therapy respiratory parameter trend or trend data (e.g., “out-of-therapy respiratory parameter is increasing,” “out-of-therapy respiratory parameter is decreasing,” “out-of-therapy respiratory parameter is stable”) associated with the out-of-therapy respiratory parameter data may be displayed alone or concurrently with the out-of-therapy respiratory parameter indicator data. Furthermore, other information regarding the out-of-therapy respiratory parameter(s) may also be calculated and displayed. For example, the controller may be configured to compare the estimated or determined out-of-therapy respiratory parameter(s) with typical or “healthy” out-of-therapy respiratory parameters (such as mean or typical healthy patient parameters). The controller may be configured to calculate the percentage or ratio of the current out-of-therapy respiratory parameter to the typical or “healthy” out-of-therapy parameter. Percentages or ratios may be displayed on the screen.

[0394] Typical or "healthy" out-of-therapy respiratory parameters may be a predefined configuration or benchmark of out-of-therapy respiratory parameters based on experimental data. In other examples, typical or "healthy" out-of-therapy respiratory parameters may be selected from a given set of values. Typical or "healthy" out-of-therapy respiratory parameters may be selected based on the therapy setting (e.g., operating flow rate) and / or other inputs such as the patient's age, sex, height, weight, disease type, and / or condition.

[0395] A second exemplary use is the display of notices and / or suggestions. In this example, out-of-therapy respiratory parameter data and / or related notifications and / or suggestions, generated or triggered based on respiratory work (WOB) data, may be displayed to the user, patient, and / or clinician or clinical staff (e.g., respiratory therapist, nurse, etc.). The out-of-therapy respiratory parameter data, notifications, and / or suggestions may be displayed on the respiratory device's display screen (e.g., GUI) and / or transmitted for display on a remote device or system that communicates data with the device.

[0396] In one configuration, the respiratory device display may be configured to display or present one or more determined out-of-therapy respiratory parameters based on any of those disclosed above. The determined out-of-therapy respiratory parameters may be displayed in real time as they are determined. The display of out-of-therapy respiratory parameters may also prompt the user to check whether the respiratory device (e.g., flow rate, pressure level, and / or FiO2 settings) improves the patient's out-of-therapy respiratory parameters in real time (e.g., resulting in lower, lower, or decreasing out-of-therapy respiratory rates). This configuration may allow the user or clinician to fine-tune the respiratory device's therapeutic settings for the patient with the aim of reducing the patient's out-of-therapy respiratory parameters.

[0397] In other configurations, one or more audible and / or visual alerts, warnings, notifications, prompts, or similar may be presented or displayed on the display screen / GUI simultaneously with out-of-therapy respiratory parameters or data. Audible warnings, alarms, and / or notifications may be provided via the device's audio output device. For example, if a patient's out-of-therapy respiratory parameters are increasing with a new flow setting, an appropriate warning may be presented or delivered.

[0398] As described above, the notification data or information provided on the out-of-therapy respiratory parameter notification, warning, and / or suggestion display screen may be provided or presented in any appropriate visual format or combination of visual formats, including, but not limited to, numerical data, text information, graphic format or format, continuous trend lines, data plotted or graphed over time, icons, animations, and / or color-coded information. Additionally or alternatively, the notification data may be provided, for example, audibly and / or with audible cues or voice commands.

[0399] Any of the above notification data (e.g., warnings, notices, suggestions, etc.) triggered in response to calculated or determined out-of-therapy respiratory parameter data may, additionally or alternatively, be transmitted for display or presentation on a detachable device or system that is directly or indirectly communicating data with the respiratory device. Additionally or alternatively, out-of-therapy respiratory parameter data generated by the respiratory device may trigger the presentation of such notification data on a remote device or system, for example, the remote device or system may trigger the display or presentation of notification data in response to receiving and processing out-of-therapy respiratory parameter data from the respiratory device. For example, the remote device or system may include, but is not limited to, a mobile phone, smartphone, tablet, laptop, pager, personal computer, wearable device, or any other suitable electronic device, as it may have a visual (e.g., display screen), audible and / or haptic user interface.

[0400] In some configurations, out-of-therapy respiratory parameter data and / or associated triggered notification data may be transmitted by the respiratory device to a remote device or system for presentation. In some configurations, out-of-therapy respiratory parameter data and / or associated triggered notification data may be transmitted to a remote cloud or server-based patient and / or device management system that processes the incoming data and then relays the out-of-therapy respiratory parameters and / or notification data to one or more other electronic devices or systems (e.g., clinician electronic devices or systems). In some configurations, the patient and / or device management system may be configured to receive out-of-therapy respiratory parameter data from the respiratory device, process the out-of-therapy respiratory parameter data, and have notification data presented (e.g., pushed, triggered, or generated) on one or more remote electronic devices or systems (e.g., clinician electronic devices or systems).

[0401] A third exemplary application is a proposal for adjusting therapeutic parameter settings in response to estimated extra-therapeutic respiratory parameters. In some examples, a respiratory device controller may generate suggestions regarding therapeutic parameters or setting adjustments, or may automatically adjust therapeutic parameters or settings based on calculated out-of-therapy respiratory parameters. In such examples, the controller may be configured to process and analyze estimated out-of-therapy respiratory parameters and generate recommendations for therapeutic parameters or setting adjustments based at least partially on, or in response to, the out-of-therapy respiratory parameters. Additionally or alternatively, the controller may be configured to automatically adjust one or more therapeutic parameters or settings based at least partially on estimated out-of-therapy respiratory parameters. Thus, out-of-therapy respiratory parameter data can be used for titration over time of optimal therapeutic settings and / or parameters, such as flow rate settings. In one example, the controller may select and / or adjust the provided operating flow rate of a flow generator to maximize the patient's ΔRR (difference between in-therapy and out-of-therapy respiratory rates) based on estimated ΔRR. In another example, the controller may select and / or adjust the provided operating flow rate of a flow generator to minimize the patient's respiratory rate based on the patient's estimated out-of-therapy respiratory rate.

[0402] The titration of therapy settings and / or parameters may be based on further processing of out-of-therapy respiratory parameter data against one or more thresholds or similar. The controller may be configured to compare out-of-therapy respiratory parameter data against one or more thresholds. If it is determined that the out-of-therapy respiratory parameters are outside one or more configurable thresholds or separately show a negative trend, then one or more therapy settings or parameter changes may be proposed or triggered. Then, as described above, the controller may be configured to display or present those proposed therapy parameter changes on the respiratory device's display screen and / or transmit them for display on one or more remote devices or systems.

[0403] Terms and Definitions As used herein and in the claims, the terms “computer-readable medium” or “machine-readable medium” should be interpreted to include one or more mediums unless the context suggests otherwise. Examples of multiple mediums include centralized or distributed databases and / or associated caches. These multiple mediums store one or more sets of computer-executable instructions. The terms “computer-readable medium” or “machine-readable medium” should be interpreted to include any medium that can store information. Furthermore, “computer-readable medium” or “machine-readable medium” includes any medium that can store, encode, or carry instructions executed by the processor of a computing device, causing the processor to perform one or more of the methods described herein. Computer-readable mediums are used by these instruction sets. They can also store, encode, or carry data structures associated with these instruction sets. The terms “computer-readable media” and “machine-readable media” include, but are not limited to, portable to stationary storage devices, solid-state memory, optical media or optical storage devices, magnetic media, and / or a variety of other media that can store, contain, or carry instructions and / or data. “Computer-readable media” or “machine-readable media” may be non-transient.

[0404] As used herein and in the claims, the phrases “comprising” are to be interpreted in an inclusive sense, as opposed to an exclusive or exhaustive sense, meaning “consisting of at least a portion of” or “consisting of, but not limited to.” When interpreting each statement containing the phrase “comprising” in this specification and in the claims, there may be other characteristics besides the term preceded by that phrase. Related phrases such as “comprise” and “comprises” should be interpreted similarly.

[0405] References to numerical ranges disclosed herein (e.g., 1 to 10) are intended to encompass all rational numbers within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10), as well as any range of rational numbers within that range (e.g., 2 to 8, 1.5 to 5.5, and 3.1 to 4.7). Accordingly, all subranges of all ranges expressly disclosed herein are hereby expressly disclosed. These are merely examples of what is specifically intended, and all possible combinations of numerical values ​​between the listed minimum and maximum values ​​are deemed to be similarly expressly disclosed in this patent application.

[0406] The term "and / or" means "and" or "or," or both.

[0407] The use of "(plural)" following a noun indicates the plural and / or singular form of that noun.

[0408] Conditional expressions such as "can," "could," "might," or "may" are generally intended to indicate that certain features, elements, and / or steps are included in certain examples, and not included in others, unless otherwise specified or understood in the context in which they are used. Therefore, such conditional expressions generally do not mean that the features, elements, and / or steps are mandatory in any way. Nor do they necessarily mean that one or more examples contain logic for determining whether these features, elements, and / or steps are included in or should be implemented in a particular example, with or without user input or prompting.

[0409] As used herein, terms indicating degree, such as “approximately,” “about,” “generally,” and “substantially,” represent values, quantities, or characteristics close to the stated value, quantity, or characteristic that perform the desired function or achieve the desired result. For example, the terms “approximately,” “about,” “generally,” and “substantially” may indicate quantities within the ranges of less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated quantity.

[0410] Where references are made herein to patent specifications, other external documents, or other sources of information, these are generally intended to provide a context for discussing the features of the present invention. Unless otherwise specified, references to such external documents shall not be construed in any jurisdiction as an admission that such documents or sources of information constitute prior art or form part of the general knowledge in the art.

[0411] In the above description, specific details have been provided to ensure a thorough understanding of the embodiments. However, those skilled in the art will understand that the embodiments can be implemented even without such specific descriptions. For example, software modules, functions, circuits, etc., may be shown in block diagrams to avoid obscuring the embodiments with unnecessary details. In other embodiments, well-known modules, structures, and techniques may not be shown in detail to avoid obscuring the embodiments.

[0412] Furthermore, it should be noted that embodiments may be described as processes depicted as flowcharts, flow diagrams, structural diagrams, or block diagrams. While flowcharts can describe operations as sequential processes, many operations can be performed in parallel or concurrently. Moreover, the order of operations may be rearranged. A process terminates when the operations it contains are completed. A process can correspond to a method, function, procedure, subroutine, subprogram, etc., in a computer program. If a process corresponds to a function, its termination corresponds to the function's return to the calling function or main function.

[0413] The embodiments of the systems and methods described above can operate on any general-purpose computer system or computing device, including but not limited to desktops, laptops, notebooks, tablets, smart TVs, game consoles, or mobile devices. The term "mobile device" includes, but is not limited to, wireless devices, mobile phones, smartphones, mobile communication devices, user communication devices, personal digital assistants, mobile handheld computers, laptop computers, wearable electronic devices such as smartwatches and head-mounted devices, e-book readers, reading devices capable of reading electronic content, and / or other types of mobile devices that are typically carried by an individual and / or have some communication capabilities (e.g., wireless, infrared, short-range wireless, mobile phones, etc.).

[0414] The embodiments of the systems and methods described above are operable or implementable on any machine, computer, server, or electronic device having any type of purpose-specific computer or special computer, or a microprocessor, microcontroller, programmable controller, etc., or a cloud-based platform, or other network of processors and / or servers, whether local or remote, or any combination of such devices.

[0415] Furthermore, embodiments can be implemented by hardware, software, firmware, middleware, microcode, or any combination thereof. When implemented by software, firmware, middleware, or microcode, program code or code segments for performing the required tasks may be stored on a machine-readable medium such as a storage medium or other storage device. A processor may perform the required tasks. Code segments can represent procedures, functions, subprograms, programs, routines, subroutines, modules, software packages, classes, or any combination of instructions, data structures, and program statements. Code segments may also be coupled to other code segments or hardware circuits by passing information, data, arguments, parameters, or memory contents. Information, arguments, parameters, data, etc., may be passed, transferred, or transmitted via any suitable means, including memory sharing, message passing, token passing, and network transmission.

[0416] In the above description, a storage medium may refer to one or more devices for storing data. These devices include read-only memory (ROM), random access memory (RAM), magnetic disk storage media, optical storage media, flash memory devices, and / or other machine or computer-readable media for storing information.

[0417] The various exemplary logic blocks, modules, circuits, elements, and / or components described in connection with the embodiments disclosed herein may be implemented or carried out by general-purpose processors, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs) or other programmable logic components, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. The general-purpose processor may be a microprocessor, but may also be any conventional processor, controller, microcontroller, circuit, and / or state machine. The processor may also be implemented as a combination of computing components, such as a DSP and a microprocessor, multiple microprocessors, a combination of one or more microprocessors and a DSP core, or other configurations.

[0418] The methods or algorithms described in connection with the embodiments disclosed herein may be directly embodied in hardware, processor-executable software modules, or a combination of both, in the form of process units, programming instructions, or other instructions, which may be contained in a single device or distributed across multiple devices. The software modules may reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disks, removable disks, CD-ROMs, or any other form of storage medium known in the art. The storage medium may be coupled to the processor so that the processor can read information from or write information to the storage medium. Alternatively, the storage medium may be integrated with the processor.

[0419] One or more illustrated components and functions can be retrofitted to and / or combined with a single component, or embodied in multiple components, without departing from the scope of this disclosure. Additional elements or components can also be added without departing from the scope of this disclosure. Furthermore, the features described herein can be implemented in software, hardware, business methods, and / or combinations thereof.

[0420] In various embodiments, embodiments of the present disclosure can be embodied in computer-implemented processes, machines (such as electronic devices, or general-purpose computers, or other devices that provide a platform capable of executing computer programs), processes performed by such machines, or manufactured articles. Such articles include computer program products or digital information products in which a computer-readable storage medium contains computer program instructions or computer-readable data stored therein, as well as processes and machines that produce and use such manufactured articles.

[0421] While this disclosure has been described in the context of specific embodiments and examples, it will be understood by those skilled in the art that this disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as obvious modifications and equivalents thereof. Furthermore, while some variations of the embodiments of this disclosure have been shown and described in detail, other modifications that fall within the scope of this disclosure will be readily apparent to those skilled in the art. Moreover, various combinations or subcombinations of specific features and aspects of the embodiments are intended to remain within the scope of this disclosure. For example, features described above in relation to one embodiment can be used with different embodiments described herein, and such combinations remain within the scope of this disclosure. It should be understood that various features and aspects of the disclosed embodiments may be combined with or substituted for each other to form various aspects of the embodiments of this disclosure. Accordingly, the scope of the disclosure herein is not intended to be limited by the specific embodiments described above. Accordingly, unless otherwise stated or unless obviously incompatible, each embodiment of this disclosure may include, in addition to its essential features described herein, one or more features described herein from other embodiments of the invention disclosed herein.

[0422] Furthermore, it can be said more broadly that this disclosure consists of, individually or collectively, parts, elements, and features referred to or shown herein, as well as any or all combinations of any two or more such parts, elements, or features, and where any particular integer having known equivalents in the art to which this disclosure relates is referred herein, such known equivalents shall be deemed incorporated herein as if they were individually defined.

[0423] Features, materials, properties, or groups described in connection with a particular aspect, embodiment, or example are understood to be applicable to other aspects, embodiments, or examples described in this section or elsewhere in this specification, unless otherwise incompatible. All features disclosed herein (including the appended claims, abstract, and drawings) and / or all steps of any method or process disclosed herein may be combined in any combination, except for any combination in which at least some of such features and / or steps are mutually exclusive. The protection is not limited to the details of the embodiments described herein. The protection extends to novel or novel combinations of features disclosed herein (including the appended claims, abstract, and drawings), or novel or novel combinations of steps of any method or process disclosed herein.

[0424] Furthermore, certain features described in this disclosure in the context of separate embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented separately or in any suitable subcombination in multiple embodiments. Furthermore, although features have been described above as acting in specific combinations, in some cases, one or more features may be extracted from a claimed combination and claimed as a subcombination or variation of a subcombination.

[0425] Furthermore, while operations may be depicted in drawings or described in the specification in a specific order, such operations do not need to be performed in the specific order or sequentially shown to achieve the desired result, and not all operations need to be performed. Other operations not depicted or described may be incorporated into the methods and processes of the embodiments. For example, one or more additional operations may be performed before, after, simultaneously with, or in between the described operations. Furthermore, in other embodiments, operations may be rearranged or changed in order. Those skilled in the art will understand that in some embodiments, the steps actually taken in the illustrated and / or disclosed processes may differ from those shown in the drawings. In some embodiments, some of the steps described above may be omitted, or other steps may be added. Furthermore, additional embodiments may be formed by combining features and attributes of the particular embodiments disclosed above in different ways, all of which are included within the scope of this disclosure. Also, the separation of various system components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the described components and system components can generally be integrated together in a single product or packaged in multiple products.

[0426] For the purposes of this disclosure, specific embodiments, advantages, and novel features are described herein. Such advantages are not necessarily achieved according to a particular embodiment. Therefore, for example, a person skilled in the art will recognize that this disclosure may be embodied or implemented in a manner that achieves one or more advantages as taught herein, without necessarily achieving other advantages that may be taught or suggested herein.

[0427] The scope of this disclosure is not intended to be limited by any specific disclosure of embodiments in this section or elsewhere in this specification, but may be defined by claims presented in this section or elsewhere in this specification, or by claims to be presented in the future. The language of the claims should be interpreted broadly based on the language adopted in the claims, and should not be limited to the embodiments described herein or during the practice of this application, and these embodiments should be interpreted as non-exclusive.

Claims

1. A method for estimating a patient's extra-therapeutic respiratory parameters during therapy, wherein the method is: A step of providing a gas flow at multiple flow rates via a flow generator, wherein the flow rates include at least an operating flow rate and one or more intermediate flow rates. The steps include receiving flow parameter data from one or more sensors that indicate or represent one or more characteristics of the gas flow provided by the flow generator at each of the plurality of flow rates, A step of estimating or determining the patient's respiratory parameters at each of the plurality of flow rates, based at least partially on the received flow parameter data; The method includes the step of estimating the patient's out-of-therapy respiratory parameters based at least in part on the estimated or determined respiratory parameters at each of the plurality of flow rates.

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

3. The method according to claim 1 or 2, wherein the flow parameter data includes pressure data indicating or representing the pressure of the gas flow provided by the flow generator.

4. The method according to any one of claims 1 to 3, wherein the step of estimating or determining the respiratory parameters of the patient at each of the plurality of flow rates includes evaluating the flow rate parameter data.

5. The method according to any one of claims 1 to 4, wherein the respiratory parameter of the patient is the respiratory rate of the patient.

6. The method according to any one of claims 1 to 4, wherein the respiratory parameter of the patient is the inspiratory-expiratory time ratio of the patient.

7. The step of estimating or determining the respiratory rate of the patient at each of the plurality of flow rates is: The frequency analysis of the flow rate parameter data is performed at the aforementioned intermediate flow rate, Identifying multiple maximum values ​​of the signal obtained from the frequency analysis, The method according to claim 5, further comprising outputting the frequency corresponding to the frequency component having the largest magnitude among the plurality of maximum values ​​as the estimated respiratory rate of the patient.

8. The method according to any one of claims 1 to 7, wherein the operating flow rate includes a therapeutic flow rate.

9. The method according to claim 8, wherein the one or more intermediate flow rates include one or more sub-therapeutic flow rates, and the one or more sub-therapeutic flow rates are lower than the operating flow rate.

10. The method according to any one of claims 1 to 9, wherein the step of providing the gas flow at multiple flow rates includes adjusting the flow rates to different intermediate flow rates at one or more time intervals.

11. The method according to claim 10, wherein the step of estimating or determining the respiratory parameters of the patient is performed at each time interval.

12. The method according to claim 10 or 11, wherein the intermediate flow rate is reduced at each time interval.

13. The method according to any one of claims 1 to 12, wherein the intermediate flow rate may include a minimum flow rate.

14. The method according to any one of claims 10 to 13, wherein adjusting the flow rate to a different intermediate flow rate includes gradually increasing the flow rate from the current flow rate to the different intermediate flow rate.

15. The method according to any one of claims 1 to 14, wherein the flow rate is maintained at a minimum or predetermined period at each of the one or more intermediate flow rates before performing the step of estimating or determining the respiratory parameters of the patient at each flow rate.

16. The method according to claim 15, wherein the minimum or predetermined period is inversely proportional to the estimated respiratory parameters of the patient.

17. The method according to claim 15 or 16, wherein the minimum or predetermined period is at least long enough to allow the residual effect of the previous flow rate on the patient's respiratory parameters to decay.

18. The method according to any one of claims 1 to 17, further comprising the step of returning to the operating flow rate after the step of estimating the patient's out-of-therapy respiratory parameters.

19. The method according to claim 18, wherein returning to the operating flow rate first includes increasing the flow rate to one or more intermediate flow rates.

20. The method according to claim 19, wherein the flow rate is increased to one or more intermediate flow rates at stepwise intervals before returning to the operating flow rate.

21. The above method further, The steps include receiving flow parameter data at the aforementioned operating flow rate, The method according to any one of claims 1 to 20, comprising the step of estimating or determining the patient's respiratory parameters at the operating flow rate based on at least the flow rate parameter data.

22. The method according to claim 21, wherein the step of estimating the patient's out-of-therapy respiratory parameters is based on the estimated or determined respiratory parameters at at least one or more intermediate flow rates and the operating flow rate.

23. The method according to any one of claims 1 to 22, wherein the flow parameter data includes oxygen concentration data indicating or representing the oxygen concentration of the gas flow provided by the flow generator.

24. The method according to any one of claims 1 to 23, further comprising estimating the patient's out-of-therapy respiratory parameters based on flow rate data received at least for each of the plurality of flow rates.

25. The method according to claim 24, further estimating the patient's out-of-therapy respiratory parameters based on the oxygen concentration data received at each of the plurality of intermediate flow rates.

26. The method according to any one of claims 1 to 25, wherein the step of estimating the out-of-therapy respiratory parameters of the patient is performed by a model, the model using at least the estimated or determined respiratory parameters for each of the plurality of flow rates as input.

27. The method according to claim 26, wherein the model further uses the flow rate parameter data as input.

28. The method according to claim 27, wherein the model further uses the flow parameter data received at the operating flow rate and the flow rate data received at one or more intermediate flow rates as inputs.

29. The method according to any one of claims 26 to 28, wherein the model is a linear model and includes coefficients that define the relationship between the input estimated or determined respiratory parameter and the flow parameter data at each flow rate.

30. The method according to any one of claims 26 to 29, wherein the model further includes the estimated or determined respiratory parameter and the flow parameter data at each flow rate as related parameters.

31. The parameters of the aforementioned model are: - The average value of the estimated or determined respiratory parameters of the patient at each of the plurality of flow rates, - The difference between the operating flow rate and the minimum flow rate, - The difference between the patient's respiratory parameter at the operating flow rate and the average value of the patient's estimated or determined respiratory parameter at each of the one or more intermediate flow rates, wherein the difference is divided by the difference between the operating flow rate and the one or more intermediate flow rates. - The difference between the oxygen concentration data of the gas flow at one or more intermediate flow rates and the ambient reading of the oxygen concentration level, The method according to claim 30, comprising at least one or more of the following.

32. The method according to any one of claims 26 to 31, wherein if the flow generator does not provide flow, the model is configured to output a value corresponding to an estimate of the patient's respiratory parameters.

33. The method according to any one of claims 26 to 32, wherein the model is configured to output values ​​related to the expected changes in the patient's respiratory parameters based on changes in flow rate.

34. The method according to any one of claims 26 to 28, wherein the model includes a fitted linear equation, the fitted linear equation takes as input the estimated values ​​of the patient's respiratory parameters at each flow rate and the measured values ​​of the flow rates.

35. The method according to claim 34, wherein the fitted linear equation extrapolates the respiratory parameters of the patient based on the input of the estimated or determined respiratory parameters at each of the plurality of intermediate flow rates.

36. The method according to claim 34 or 35, wherein the fitted linear equation is configured to output an extrapolated respiratory parameter of the patient based on the input of at least the estimated or determined respiratory parameter determined for each of the plurality of flow rates.

37. The method according to claim 36, wherein the extrapolated respiratory parameter of the patient is an approximation of the patient's respiratory parameter at a flow rate of at least less than the minimum intermediate flow rate.

38. The method according to claim 33, wherein the output value relates to the expected change in the patient's respiratory parameter to an increase in flow rate from zero to a predetermined operating flow rate for therapeutic flow rate.

39. The method according to any one of claims 1 to 38, wherein the patient’s extra-therapeutic respiratory parameters are estimated while the respiratory therapy system provides a gas flow to the patient’s airway.

40. The method according to any one of claims 1 to 39, further comprising the step of determining the difference between the patient's estimated or determined respiratory parameter at the operating flow rate and the patient's estimated out-of-therapy respiratory parameter.

41. The method according to claim 40, wherein the determination of the difference between the patient's estimated or determined respiratory parameter at the operating flow rate and the patient's estimated out-of-therapy respiratory parameter is further based on one or more mean values ​​of the patient's out-of-therapy respiratory parameter determined over multiple therapy sessions and / or multiple flow rate reduction and respiratory parameter estimation cycles over one therapy session.

42. The method according to any one of claims 1 to 41, further comprising the step of determining the state of the patient's respiratory parameters based on the flow parameter data.

43. The method according to any one of claims 1 to 42, further comprising the step of controlling the flow generator to provide the gas flow at the plurality of intermediate flow rates based on the state of the patient's respiratory parameters indicating that the patient's respiratory parameters are substantially stable.

44. The step of determining the state of the patient’s respiratory parameters is: Based on flow parameter data received at multiple intervals while the operating flow rate is maintained, an index or estimate of the patient's respiratory parameter is determined. The method according to claim 43, comprising comparing the index or estimate of the respiratory parameter of the patient at each interval with at least the index or estimate of the respiratory parameter of the patient at one or more previous intervals.

45. The method according to claim 43 or 44, wherein the state of the patient's respiratory parameter relates to the degree or amount of change between the index or estimate of the patient's respiratory parameter determined at the current interval and the index or estimate of the patient's respiratory parameter determined at one or more previous intervals, based on the comparison.

46. The method according to any one of claims 1 to 45, further comprising the step of sending or transmitting data representing the estimated out-of-therapy respiratory parameters of the patient to an external device via a data communication protocol.

47. The method according to any one of claims 1 to 46, further comprising the step of adjusting one or more parameters of the flow generator or related to the flow generator based at least in part on the estimated out-of-therapy respiratory parameters of the patient.

48. The method according to any one of claims 1 to 47, further comprising the step of generating or providing proposed thresholds and / or parameters related to the one or more thresholds, at least in part, based on the estimated out-of-therapy respiratory parameters of the patient.

49. The method according to claim 48, further comprising the step of generating a warning, alarm, and / or notification including data indicating a proposed adjustment to one or more therapeutic settings, at least in part based on the estimated extratherapeutic respiratory parameters and one or more thresholds of the patient.

50. The aforementioned therapy settings include flow rate settings and / or FiO ２ The method according to claim 49, including the setting.

51. The method according to any one of claims 1 to 50, configured for use in an open-seal respiratory therapy system.

52. The method according to any one of claims 1 to 51, configured for use in the delivery of transnasal high-flow therapy.

53. A respiratory device configured to provide a gas flow to a patient, A flow generator configured to generate the gas flow for the patient at multiple flow rates, One or more sensors, each configured to generate flow parameter data that shows or represents one or more characteristics of the gas flow, A controller, wherein the controller Controlling the flow generator to provide a gas flow at the aforementioned plurality of flow rates, wherein the plurality of flow rates include at least an operating flow rate and one or more intermediate flow rates. The process involves receiving flow parameter data from one or more sensors for each of the aforementioned plurality of flow rates, Estimating or determining the patient's respiratory parameters at each of the plurality of flow rates based at least partially on the received flow parameter data, A respiratory device comprising a controller configured to estimate the patient's out-of-therapy respiratory parameters based at least in part on the estimated or determined respiratory parameters determined for each of the plurality of flow rates.

54. The breathing apparatus according to claim 53, wherein the flow parameter data includes flow data indicating or representing the flow rate of the gas flow provided by the flow generator.

55. The breathing apparatus according to claim 53 or 54, wherein the flow parameter data includes pressure data indicating or representing the pressure of the gas flow at the outlet of the blower of the flow generator.

56. The respiratory device according to any one of claims 53 to 55, wherein the controller is configured to estimate or determine the patient's respiratory parameters at each of the plurality of flow rates by evaluating the flow rate parameter data.

57. The respiratory device according to any one of claims 53 to 56, wherein the respiratory parameter of the patient is the respiratory rate of the patient.

58. The respiratory device according to any one of claims 53 to 56, wherein the respiratory parameter of the patient is the inspiratory-expiratory time ratio of the patient.

59. The controller determines the patient's respiratory rate at each of the multiple flow rates. The frequency analysis of the flow rate parameter data is performed at the aforementioned intermediate flow rate, Identifying multiple maximum values ​​of the signal obtained from the frequency analysis, The method according to claim 5, further comprising outputting the frequency corresponding to the frequency component having the largest magnitude among the plurality of maximum values ​​as the estimated respiratory rate of the patient.

60. The respiratory device according to any one of claims 53 to 59, wherein the operating flow rate includes a therapeutic flow rate.

61. The respiratory device according to claim 60, wherein the one or more intermediate flow rates include one or more sub-therapeutic flow rates, and the one or more sub-therapeutic flow rates are lower than the operating flow rate.

62. The breathing apparatus according to any one of claims 53 to 61, wherein the controller is configured to control the flow generator to provide the gas flow at multiple flow rates by adjusting the flow rate to different intermediate flow rates at one or more time intervals.

63. The respiratory device according to claim 62, wherein the controller is configured to estimate or determine the respiratory parameters of the patient at each time interval.

64. The breathing apparatus according to claim 62 or 63, wherein the intermediate flow rate at each time interval is reduced at each time interval.

65. The breathing apparatus according to any one of claims 53 to 64, wherein the intermediate flow rate may include the minimum flow rate.

66. The breathing apparatus according to any one of claims 62 to 65, wherein adjusting the flow rate to a different intermediate flow rate includes gradually increasing the flow rate from the current flow rate to the different intermediate flow rate.

67. The respiratory apparatus according to any one of claims 53 to 66, wherein the controller is configured to maintain the flow rate at each of the one or more intermediate flow rates at a minimum or for a predetermined period of time before estimating or determining the patient's respiratory parameters at each flow rate.

68. The respiratory device according to claim 67, wherein the predetermined period is inversely proportional to the estimated respiratory parameters of the patient.

69. The respiratory apparatus according to claim 67 or 68, wherein the predetermined period is at least long enough to allow the residual effect of the previous flow rate on the patient's respiratory parameters to decay.

70. The respiratory apparatus according to any one of claims 53 to 69, wherein the controller is further configured to control the flow generator to return to the operating flow rate after estimating the patient's out-of-therapy respiratory parameters.

71. The breathing apparatus according to claim 70, wherein returning to the operating flow rate first includes increasing the operating flow rate to one or more intermediate flow rates.

72. The breathing apparatus according to claim 71, wherein the operating flow rate is increased to one or more intermediate flow rates at stepwise intervals before returning to the operating flow rate.

73. The controller further, Receiving flow parameter data at the aforementioned operating flow rate, A respiratory device according to any one of claims 53 to 72, configured to estimate or determine the patient's respiratory parameters at the operating flow rate based on at least the flow rate parameter data.

74. The respiratory device according to claim 73, wherein the controller is configured to estimate the patient's out-of-therapy respiratory parameters based on the estimated or determined respiratory parameters at at least one or more intermediate flow rates and the operating flow rate.

75. The breathing apparatus according to any one of claims 53 to 74, wherein the flow parameter data includes oxygen concentration data indicating or representing the oxygen concentration of the gas flow provided by the flow generator.

76. The respiratory device according to any one of claims 53 to 75, wherein the controller is configured to estimate the patient's out-of-therapy respiratory parameters based on the flow rate data received at least for each of the plurality of flow rates.

77. The respiratory device according to claim 76, wherein the controller is further configured to estimate the patient's out-of-therapy respiratory parameters based on the oxygen concentration data received at each of the plurality of intermediate flow rates.

78. The respiratory device according to any one of claims 53 to 77, wherein the controller is configured to estimate the patient's out-of-therapy respiratory parameters using a model, and the model uses at least the estimated or determined respiratory parameters for each of the plurality of flow rates as input.

79. The respiratory apparatus according to claim 78, wherein the model further uses the flow parameter data as input.

80. The respiratory apparatus according to claim 79, wherein the model further uses the flow parameter data received at the operating flow rate and the flow data received at one or more intermediate flow rates as inputs.

81. The respiratory apparatus according to any one of claims 78 to 80, wherein the model is a linear model and includes coefficients that define the relationship between the input estimated or determined respiratory parameter and the flow parameter data at each flow rate.

82. The respiratory apparatus according to any one of claims 78 to 81, wherein the model further includes the estimated or determined respiratory parameters and the flow parameter data at each flow rate as related parameters.

83. The parameters of the aforementioned model are: - The average value of the estimated or determined respiratory parameters of the patient at each of the plurality of flow rates, - The difference between the operating flow rate and the minimum flow rate, - The difference between the patient's respiratory parameter at the operating flow rate and the average value of the patient's estimated or determined respiratory parameter at each of the one or more intermediate flow rates, wherein the difference is divided by the difference between the operating flow rate and the one or more intermediate flow rates. - The difference between the oxygen concentration data of the gas flow at one or more intermediate flow rates and the ambient reading of the oxygen concentration level, The method according to claim 30, comprising at least one or more of the following.

84. The respiratory device according to any one of claims 78 to 83, wherein if the respiratory therapy device does not provide flow, the model is configured to output a value corresponding to an estimate of the patient's respiratory parameters.

85. The respiratory device according to any one of claims 78 to 84, wherein the model is configured to output a value related to the expected change in the patient's respiratory parameters based on a change in flow rate.

86. The respiratory apparatus according to any one of claims 78 to 80, wherein the model includes a fitted linear equation, the fitted linear equation uses the estimated values ​​of the patient's respiratory parameters at each flow rate and the measured values ​​of the flow rates as inputs.

87. The respiratory device according to claim 86, wherein the fitted linear equation extrapolates the respiratory parameters of the patient based on the input of the estimated or determined respiratory parameters at each of the plurality of intermediate flow rates.

88. The respiratory device according to claim 86 or 87, wherein the fitted linear equation is configured to output extrapolated respiratory parameters of the patient based on inputs of at least the estimated or determined respiratory parameters determined for each of the plurality of flow rates.

89. The respiratory device according to claim 88, wherein the extrapolated respiratory parameters of the patient are approximations of the patient's respiratory parameters at a flow rate of at least less than the minimum intermediate flow rate.

90. The respiratory device according to claim 85, wherein the output value relates to the expected change in the patient's respiratory parameter to an increase in flow rate from zero to a predetermined operating flow rate for therapeutic flow rate.

91. The respiratory device according to any one of claims 53 to 90, wherein the patient's out-of-therapy respiratory parameters are estimated while the patient uses the respiratory device for therapeutic purposes.

92. The respiratory device according to any one of claims 53 to 91, wherein the controller is further configured to determine the difference between the patient's estimated or determined respiratory parameter at the operating flow rate and the patient's estimated out-of-therapy respiratory parameter.

93. The respiratory device according to claim 92, wherein the determination of the difference between the patient's estimated or determined respiratory parameter at the operating flow rate and the patient's estimated out-of-therapy respiratory parameter is further based on one or more mean values ​​of the patient's out-of-therapy respiratory parameter determined over multiple therapy sessions and / or multiple flow rate reduction and respiratory parameter estimation cycles over one therapy session.

94. The respiratory device according to any one of claims 53 to 93, wherein the controller is further configured to determine the state of the patient's respiratory parameters based on the flow rate parameter data.

95. The respiratory apparatus according to any one of claims 53 to 94, wherein the controller is further configured to control the flow generator to provide the gas flow at the plurality of intermediate flow rates based on the state of the patient's respiratory parameters indicating that the patient's respiratory parameters are substantially stable.

96. The aforementioned controller, Based on flow parameter data received at multiple intervals while the operating flow rate is maintained, an index or estimate of the patient's respiratory parameter is determined. The method according to claim 43, comprising comparing the index or estimate of the respiratory parameter of the patient at each interval with at least the index or estimate of the respiratory parameter of the patient at one or more previous intervals.

97. The respiratory device according to claim 95 or 96, wherein the state of the patient's respiratory parameters relates to the degree of change between the index or estimate of the patient's respiratory parameters determined at the current interval and the index or estimate of the patient's respiratory parameters determined at one or more previous intervals, based on the comparison.

98. The respiratory apparatus according to any one of claims 53 to 97, wherein the controller is further configured to transmit data representing the estimated out-of-therapy respiratory parameters of the patient to a device or system communicating with the apparatus.

99. The respiratory device according to any one of claims 53 to 98, wherein the controller is further configured to adjust one or more parameters of the respiratory device based at least in part on the estimated extratherapeutic respiratory parameters of the patient.

100. The respiratory device according to any one of claims 53 to 99, wherein the controller is further configured to generate proposed thresholds and / or parameters related to the one or more thresholds, at least in part, based on the estimated extratherapeutic respiratory parameters of the patient.

101. The respiratory device according to claim 100, wherein the controller is further configured to generate warnings, alarms, and / or notifications including data indicating proposed adjustments to one or more therapeutic settings based at least partially on the patient's estimated extratherapeutic respiratory parameters and one or more thresholds.

102. The aforementioned therapy settings include flow rate settings and / or FiO ２ The breathing apparatus according to claim 101, including settings.

103. The respiratory device according to any one of claims 53 to 102, configured for use in an open respiratory therapy system.

104. The respiratory device according to any one of claims 53 to 103, configured for use in the delivery of nasal high-flow therapy.

105. The aforementioned non-closed respiratory therapy system is A breathing conduit is operably coupled to the flow generator and configured to transport the gas flow from the flow generator to the user, A patient interface operably coupled to the aforementioned respiratory conduit, The respiratory apparatus according to claim 103, comprising the respiratory apparatus according to any one of claims 53 to 102.

106. The method according to claim 34, or the breathing apparatus according to claim 86, wherein the fitted linear equation is in the form of a series of linear terms.

107. A respiratory therapy device configured to provide a gas flow to a user, A flow generator configured to provide a gas flow according to one or more therapeutic parameters, wherein the one or more therapeutic parameters include at least an operating flow rate, One or more sensors, each configured to generate flow parameter data that shows or represents one or more characteristics of the gas flow, A controller, wherein the controller Receiving the flow parameter data from one or more of the sensors, Determining or receiving an index of the patient's out-of-therapy respiratory parameters, wherein the index of the out-of-therapy respiratory parameters is determined or received based at least in part on the flow parameter data. A respiratory therapy device comprising a controller configured to adjust one or more of the therapeutic parameters based on the indicators of the patient's extra-therapeutic respiratory parameters.

108. The aforementioned controller, Controlling the flow generator to provide a gas flow at the aforementioned plurality of flow rates, wherein the plurality of flow rates include at least an operating flow rate and one or more intermediate flow rates. Estimating or determining the patient's respiratory parameters at each of the plurality of flow rates based at least partially on the received flow parameter data, The respiratory therapy device according to claim 107, configured to determine an index of the patient's out-of-therapy respiratory parameters by estimating the patient's out-of-therapy respiratory parameters based at least in part on the estimated or determined respiratory parameters determined for each of the plurality of flow rates.

109. The breathing apparatus according to claim 109, wherein the flow parameter data includes flow data indicating or representing the flow rate of the gas flow provided by the flow generator.

110. The respiratory device according to claim 109 or 110, wherein the respiratory parameter of the patient is the respiratory rate of the patient.

111. The respiratory device according to claim 109 or 110, wherein the respiratory parameter of the patient is the inspiratory-expiratory time ratio of the patient.

112. The respiratory device according to any one of claims 109 to 112, wherein the operating flow rate includes a therapeutic flow rate.

113. The respiratory device according to claim 113, wherein the one or more intermediate flow rates include one or more sub-therapeutic flow rates, and the one or more sub-therapeutic flow rates are lower than the operating flow rate.

114. The controller further, Receiving flow parameter data at the aforementioned operating flow rate, A respiratory device according to any one of claims 53 to 72, configured to estimate or determine the patient's respiratory parameters at the operating flow rate based on at least the flow rate parameter data.

115. The respiratory device according to claim 115, wherein the controller is configured to estimate the patient's out-of-therapy respiratory parameters based on the estimated or determined respiratory parameters at at least one or more intermediate flow rates and the operating flow rate.

116. The respiratory device according to any one of claims 109 to 116, wherein the controller is configured to estimate the patient's out-of-therapy respiratory parameters based on the flow rate data received at least for each of the plurality of flow rates.

117. The respiratory device according to any one of claims 109 to 117, wherein the patient's out-of-therapy respiratory parameters are estimated while the patient uses the respiratory device for therapeutic purposes.

118. One or more of the aforementioned therapeutic parameters are flow rate setting and / or FiO ２ A breathing apparatus according to any one of claims 107 to 118, including settings.

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