Respiratory support control using respiratory frequency

Abstract

A method for controlling a flow rate of gas delivered to a patient, the method comprising: delivering a flow of gas to the patient via a patient interface at a working flow rate; and performing the following steps at the interval: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data from the one or more sensors; determining a condition of a respiratory rate of the patient based at least on the patient parameter and the patient parameter received or determined at one or more previous intervals; determining whether to adjust or maintain the workflow based on the condition of the respiratory rate of the patient; and based on a determination that the workflow is to be adjusted, incrementally adjusting the workflow, and based on a determination that the workflow is to be maintained, maintaining the workflow at the current workflow.

Description

Technical Field

[0001] The present disclosure relates to methods and systems for providing respiratory flow therapy to a patient. Specifically, the present disclosure relates to controlling operating parameters during use of an unsealed respiratory device (ie, an open respiratory device) by a patient based on the patient's measured respiratory rate. Background Art

[0002] In various settings, such as hospitals, medical facilities, home care, or home environments, respiratory assistance devices are used to deliver a flow of gas to a user or patient. Respiratory assistance devices or respiratory therapy devices (collectively referred to as "respiratory devices" or "respiratory apparatus") can be used to deliver supplemental oxygen or other gases with the flow of gas, and / or humidification devices can be used to deliver heated and humidified gas. Respiratory devices can allow for adjustment and control of gas flow characteristics, including flow rate and gas concentration. Summary of the Invention

[0003] In a first aspect, the present disclosure generally includes a method for controlling the flow of gas delivered to a patient, the method comprising: delivering a flow of gas to the patient via a patient interface at an operating flow rate; and performing the following steps at intervals:

[0004] Receive or determine a patient parameter indicating the patient's respiratory rate based on data from one or more sensors; determine a condition of the patient's respiratory rate based at least on the patient parameter and the patient parameter received or determined at one or more previous intervals; determine whether to adjust or maintain the workload based on the condition of the patient's respiratory rate; and based on determining that the workload is to be adjusted, adjust the workload by increments; and based on determining that the workload is to be maintained, maintain the workload at a current workload.

[0005] In one configuration, the method further includes delivering the flow of gas to the patient via the patient interface at an initial operating flow rate, wherein the initial operating flow rate is determined based on one or more patient characteristics.

[0006] In configurations, the intervals are spaced apart from one another by variable time periods based at least on the condition of the patient's respiratory rate.

[0007] In a configuration, the one or more sensors include one or more sensors configured to be attached to or located proximate to a patient to measure a patient parameter indicative of a respiratory rate of the patient.

[0008] In an arrangement, the step of receiving or determining a patient parameter indicative of a respiratory rate of the patient comprises receiving data indicative of a time-averaged respiratory rate over a measurement period from the one or more sensors.

[0009] In a configuration, the at least one sensor stores a plurality of instantaneous measurements during the measurement period and calculates a time-averaged respiratory rate.

[0010] In configurations, wherein the step of determining the condition of the patient's respiratory rate includes comparing the patient parameter received or determined at a current interval with the patient parameter received or determined at one or more previous intervals.

[0011] In configurations, based on the comparison, the condition of the patient's respiratory rate is related to a degree or amount of change between the patient parameter received or determined at the current interval and the patient parameter received or determined at one or more previous intervals.

[0012] In configurations, based on the comparison, the condition of the patient's respiratory rate indicates that the patient's respiratory rate is increasing or decreasing or is substantially stable.

[0013] In one configuration, the step of determining whether to adjust the workload includes determining to adjust the workload based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

[0014] In one configuration, the step of determining whether to adjust or maintain the workload includes determining to maintain the workload based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is substantially stable.

[0015] In an arrangement, the step of determining whether to adjust or maintain the workload further comprises comparing the condition of the patient's respiratory rate to one or more thresholds.

[0016] In configurations, the step of incrementally adjusting the workload includes increasing the workload based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

[0017] In an arrangement, the increment is a variable increment based at least on the condition of the patient's respiratory rate.

[0018] In one configuration, the step of maintaining the workload includes maintaining the workload at a workload having a previous increment.

[0019] In one configuration, the method is performed continuously within a therapy session.

[0020] In the configuration, the gas is delivered to the patient under conditions suitable for providing high flow therapy.

[0021] In one configuration, the method further comprises delivering the flow of gas to the patient via the patient interface at the working oxygen concentration level.

[0022] In a configuration, the method further includes: performing the steps of, at the interval, determining whether to adjust or maintain the operating oxygen concentration level based on the condition of the patient's respiratory rate, and adjusting the operating oxygen concentration level by increments based on a determination that the operating oxygen concentration level is to be adjusted, and maintaining the operating oxygen concentration level at a current operating oxygen concentration level based on a determination that the operating oxygen concentration level is to be maintained.

[0023] In a second aspect, the present disclosure generally includes a method for controlling an operating parameter of gas delivered to a patient, the method comprising: delivering a flow of gas to the patient via a patient interface at an operating flow rate and an operating oxygen concentration level; performing the following steps at an interval: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data from one or more sensors; determining a condition of the patient's respiratory rate based on at least the patient parameter and the patient parameter received or determined at one or more previous intervals; determining whether to adjust or maintain the operating flow rate and the operating oxygen concentration level based on the condition of the patient's respiratory rate; incrementally adjusting the operating flow rate based on a determination that the operating flow rate is to be adjusted, and maintaining the operating flow rate at a current operating flow rate based on a determination that the operating flow rate is to be maintained; and incrementally adjusting the operating oxygen concentration level based on a determination that the operating oxygen concentration level is to be adjusted, and maintaining the operating oxygen concentration level at a current operating oxygen concentration level based on a determination that the operating oxygen concentration level is to be maintained.

[0024] In a third aspect, the present disclosure generally includes a method for controlling an operating parameter of gas delivered to a patient, the method comprising: delivering a flow of gas to the patient via a patient interface at an operating flow rate and an operating oxygen concentration level; performing the following steps at an interval: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data from one or more sensors; determining a condition of the patient's respiratory rate based on at least the patient parameter and the patient parameter received or determined at one or more previous intervals; determining whether to adjust or maintain the operating flow rate based on the condition of the patient's respiratory rate; adjusting the operating flow rate by increments based on a determination that the operating flow rate is to be adjusted, and maintaining the operating flow rate at a current operating flow rate based on a determination that the operating flow rate is to be maintained; and determining whether to adjust or maintain the operating oxygen concentration level based on the condition of the patient's respiratory rate, wherein the operating oxygen concentration level is adjusted by increments based on a determination that the operating oxygen concentration level is to be adjusted, and the operating oxygen concentration level is maintained at the current operating oxygen concentration level based on a determination that the operating oxygen concentration level is to be maintained.

[0025] The method according to the second aspect or the third aspect may further have any one or more of the following aspects or features defined in the following paragraphs.

[0026] In a configuration, the method further comprises: delivering the flow of gas to the patient via the patient interface at an initial operating flow rate, wherein the initial operating flow rate is determined based on one or more patient characteristics.

[0027] In one configuration, the method further includes delivering the flow of gas to the patient via the patient interface at an initial operating oxygen concentration level, wherein the initial operating oxygen concentration level is determined based on one or more patient characteristics.

[0028] In configurations, the intervals are spaced apart from one another by variable time periods based at least on the condition of the patient's respiratory rate.

[0029] In a configuration, the one or more sensors include one or more sensors configured to be attached to or located proximate to a patient to measure a patient parameter indicative of a respiratory rate of the patient.

[0030] In an arrangement, the step of receiving or determining a patient parameter indicative of a respiratory rate of the patient comprises receiving data indicative of a time-averaged respiratory rate over a measurement period from the one or more sensors.

[0031] In an arrangement, the at least one sensor stores a plurality of instantaneous measurements during the measurement period and calculates a time-averaged respiratory rate.

[0032] In configurations, the step of determining the condition of the patient's respiratory rate includes comparing the patient parameter received or determined at a current interval with the patient parameter received or determined at one or more previous intervals.

[0033] In configurations, based on the comparison, the condition of the patient's respiratory rate is related to a degree or amount of change between the patient parameter received or determined at the current interval and the patient parameter received or determined at one or more previous intervals.

[0034] In configurations, based on the comparison, the condition of the patient's respiratory rate indicates that the patient's respiratory rate is increasing or decreasing or is substantially stable.

[0035] In one configuration, the step of determining whether to adjust the workload includes determining to adjust the workload based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

[0036] In a configuration, the step of determining whether to adjust or maintain the workload includes determining to maintain the workload based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is substantially stable.

[0037] In an arrangement, the step of determining whether to adjust or maintain the operating flow rate and / or the operating oxygen concentration level further comprises comparing the condition of the patient's respiratory rate to one or more threshold values.

[0038] In configurations, the step of incrementally adjusting the workload includes increasing the workload based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

[0039] In an arrangement, the increment is a variable increment based at least on the condition of the patient's respiratory rate.

[0040] In one configuration, the step of maintaining the workload includes maintaining the workload at a workload having a previous increment.

[0041] In one configuration, the method is performed continuously within a therapy session.

[0042] In a configuration, wherein the gas is delivered to the patient under conditions suitable for providing high flow therapy.

[0043] In a fourth aspect, the present disclosure generally includes a method for controlling the flow of gas delivered to a patient, the method comprising: delivering a flow of gas to the patient via a patient interface at a working flow; progressively applying a plurality of flow values ​​as the working flow at intervals; at each of the plurality of flow values, receiving or determining a patient parameter indicating the patient's respiratory rate based on data received from one or more sensors, and determining a condition of the patient's respiratory rate based at least on the patient parameter and the patient parameter received or determined at one or more previous intervals; based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is stable, maintaining the working flow, and performing an iterative process of continuing to receive or determine the patient parameters and determining the condition of the patient's respiratory rate at further intervals, wherein based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is no longer stable, adjusting the working flow at the further intervals until the condition of the patient's respiratory rate indicates that the patient's respiratory rate is stable.

[0044] In configurations, the step of receiving or determining a patient parameter indicative of the patient's respiratory rate based on data received from one or more sensors occurs a predetermined period of time after adjusting the workload.

[0045] In configurations, the condition of the patient's respiratory rate indicating that the patient's respiratory rate is stable includes determining that the condition of the patient's respiratory rate is within a range or threshold.

[0046] In configurations, the condition of the patient's respiratory rate indicating that the patient's respiratory rate is no longer stable includes determining that the condition of the patient's respiratory rate is outside of a range or threshold.

[0047] In one configuration, the method further includes delivering the flow of gas to the patient via the patient interface at an initial operating flow rate, wherein the initial flow rate is determined based on one or more patient characteristics.

[0048] In configurations, the intervals are spaced apart from one another by variable time periods based at least on the condition of the patient's respiratory rate.

[0049] In a configuration, the one or more sensors include one or more sensors configured to be attached to or located proximate to a patient to measure a patient parameter indicative of a respiratory rate of the patient.

[0050] In an arrangement, wherein the step of receiving or determining a patient parameter indicative of a respiratory rate of the patient comprises receiving data indicative of a time-averaged respiratory rate over a measurement period from the one or more sensors.

[0051] In an arrangement, the at least one sensor stores a plurality of instantaneous measurements during the measurement period and calculates a time-averaged respiratory rate.

[0052] In configurations, the step of determining the condition of the patient's respiratory rate includes comparing the patient parameter received or determined at a current interval with the patient parameter received or determined at one or more previous intervals.

[0053] In configurations, based on the comparison, the condition of the patient's respiratory rate is related to a degree or amount of change between the patient parameter received or determined at the current interval and the patient parameter received or determined at one or more previous intervals.

[0054] In configurations, based on the comparison, the condition of the patient's respiratory rate indicates that the patient's respiratory rate is increasing or decreasing or is stable.

[0055] In an arrangement, the step of determining whether the patient's respiratory rate is unstable includes the condition of the patient's respiratory rate indicating that the patient's respiratory rate is increasing or decreasing.

[0056] In one configuration, the step of gradually applying a plurality of flow values ​​as the operating flow includes increasing the operating flow by increments at each interval.

[0057] In an arrangement, the increment is a variable increment based at least on the condition of the patient's respiratory rate.

[0058] In the configuration, the step of maintaining the work flow includes: maintaining the work flow at a work flow having a previous increment.

[0059] In one configuration, the method is performed continuously within a therapy session.

[0060] In the configuration, the gas is delivered to the patient under conditions suitable for providing high flow therapy.

[0061] In one configuration, the method further comprises delivering the flow of gas to the patient via the patient interface at the working oxygen concentration level.

[0062] In a configuration, the method further includes performing the steps of: determining, at the interval, based at least on the patient parameter indicative of a respiratory rate of the patient, whether to adjust or maintain the operating oxygen concentration level; and adjusting the operating oxygen concentration level by increments based on a determination that the operating oxygen concentration level is to be adjusted, and maintaining the operating oxygen concentration level at a current operating oxygen concentration level based on a determination that the operating oxygen concentration level is to be maintained.

[0063] In a fifth aspect, the present disclosure generally includes a respiratory therapy system configured to provide a gas flow to a user for respiratory therapy, the respiratory therapy system comprising: a patient interface configured to deliver a gas flow to a patient; a flow generator configured to generate the gas flow for the user at a working flow rate; one or more sensors configured to measure a patient parameter indicating the patient's respiratory rate; and a controller, wherein the controller is configured to control the operation of the flow generator and to perform the following steps at intervals: receiving or determining a patient parameter indicating the patient's respiratory rate based on data from the one or more sensors; determining a condition of the patient's respiratory rate based on at least the patient parameter and the patient parameter received or determined at one or more previous intervals; determining whether to adjust or maintain the working flow rate based on the condition of the patient's respiratory rate; and adjusting the working flow rate by increments based on a determination that the working flow rate is to be adjusted; and maintaining the working flow rate at a current working flow rate based on a determination that the working flow rate is to be maintained.

[0064] In a sixth aspect, the present disclosure generally includes a respiratory device configured to provide a gas flow to a user for respiratory therapy, the respiratory device comprising: a flow generator configured to generate the gas flow for the user at a working flow rate; and a controller, wherein the controller is configured to control the operation of the flow generator and to perform the following steps at intervals: receiving or determining a patient parameter indicating the patient's respiratory rate based on data from one or more sensors; determining a condition of the patient's respiratory rate based on at least the patient parameter and the patient parameter received or determined at one or more previous intervals; determining whether to adjust or maintain the working flow rate based on the condition of the patient's respiratory rate; and adjusting the working flow rate by increments based on a determination that the working flow rate is to be adjusted; and maintaining the working flow rate at a current working flow rate based on a determination that the working flow rate is to be maintained.

[0065] In a seventh aspect, the present disclosure generally includes a respiratory therapy system configured to provide a flow of gas to a user for respiratory therapy, the respiratory therapy system comprising: a patient interface configured to deliver the flow of gas to the patient; a flow generator configured to generate the flow of gas for the user at an operating flow rate; one or more sensors configured to measure a patient parameter indicative of a respiratory rate of the patient; and a controller, wherein the controller is configured to control operation of the flow generator and, at intervals, perform the following steps: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data from the one or more sensors; and determining a condition of the patient's respiratory rate based at least on the patient parameter and the patient parameter received or determined at one or more previous intervals; determining whether to adjust or maintain the workload flow rate and the workload oxygen concentration level based on the condition of the patient's respiratory rate; incrementally adjusting the workload flow rate based on a determination that the workload flow rate is to be adjusted, and maintaining the workload flow rate at a current workload flow rate based on a determination that the workload flow rate is to be maintained; and incrementally adjusting the workload oxygen concentration level based on a determination that the workload oxygen concentration level is to be adjusted, and maintaining the workload oxygen concentration level at a current workload oxygen concentration level based on a determination that the workload oxygen concentration level is to be maintained.

[0066] In an eighth aspect, the present disclosure generally includes a respiratory apparatus configured to provide a flow of gas to a user for respiratory therapy, the respiratory apparatus comprising: a flow generator configured to generate the flow of gas for the user at a working flow rate; and a controller, wherein the controller is configured to control operation of the flow generator and, at intervals, perform the following steps: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data from one or more sensors; determining a condition of the patient's respiratory rate based on at least the patient parameter and the patient parameter received or determined at one or more previous intervals; determining whether to adjust or maintain the working flow rate and working oxygen concentration level based on the condition of the patient's respiratory rate; adjusting the working flow rate by increments based on a determination that the working flow rate is to be adjusted, and maintaining the working flow rate at a current working flow rate based on a determination that the working flow rate is to be maintained; and adjusting the working oxygen concentration level by increments based on a determination that the working oxygen concentration level is to be adjusted, and maintaining the working oxygen concentration level at a current working oxygen concentration level based on a determination that the working oxygen concentration level is to be maintained.

[0067] In a ninth aspect, the present disclosure generally includes a respiratory therapy system configured to provide a flow of gas to a user for respiratory therapy, the respiratory therapy system comprising: a patient interface configured to deliver the flow of gas to the patient; a flow generator configured to generate the flow of gas for the user at an operating flow rate; one or more sensors configured to measure a patient parameter indicative of a respiratory rate of the patient; and a controller, wherein the controller is configured to control operation of the flow generator and, at intervals, perform the following steps: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data from the one or more sensors; determining a patient parameter indicative of a respiratory rate of the patient based at least on the patient parameter and at one or more determining a condition of the patient's respiratory rate based on the patient parameters received or determined at a plurality of previous intervals; determining whether to adjust or maintain the workload flow rate based on the condition of the patient's respiratory rate; adjusting the workload flow rate by increments based on the determination that the workload flow rate is to be adjusted, and maintaining the workload flow rate at a current workload flow rate based on the determination that the workload flow rate is to be maintained; and determining whether to adjust or maintain the workload oxygen concentration level based on the condition of the patient's respiratory rate, wherein the workload oxygen concentration level is adjusted by increments based on the determination that the workload oxygen concentration level is to be adjusted, and the workload oxygen concentration level is maintained at the current workload oxygen concentration level based on the determination that the workload oxygen concentration level is to be maintained.

[0068] In a tenth aspect, the present disclosure generally comprises a respiratory apparatus configured to provide a flow of gas to a user for respiratory therapy, the respiratory apparatus comprising: a flow generator configured to generate the flow of gas for the user at a working flow rate; and a controller, wherein the controller is configured to control operation of the flow generator and, at an interval, perform the following steps: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data from one or more sensors; determining a condition of the patient's respiratory rate based on at least the patient parameter and the patient parameter received or determined at one or more previous intervals; determining whether to adjust or maintain the working flow rate based on the condition of the patient's respiratory rate; adjusting the working flow rate by increments based on a determination that the working flow rate is to be adjusted, and maintaining the working flow rate at a current working flow rate based on a determination that the working flow rate is to be maintained; and determining whether to adjust or maintain a working oxygen concentration level based on the condition of the patient's respiratory rate, wherein the working oxygen concentration level is adjusted by increments based on a determination that the working oxygen concentration level is to be adjusted, and the working oxygen concentration level is maintained at a current working oxygen concentration level based on a determination that the working oxygen concentration level is to be maintained.

[0069] In an eleventh aspect, the present disclosure generally includes a respiratory therapy system configured to provide a flow of gas to a user for respiratory therapy, the respiratory therapy system comprising: a patient interface configured to deliver a flow of gas to the patient; a flow generator configured to generate the flow of gas for the user at a working flow rate; one or more sensors configured to measure a patient parameter indicative of a respiratory rate of the patient; and a controller, wherein the controller is configured to control operation of the flow generator and to perform the following steps at intervals: gradually applying a plurality of flow values ​​as the working flow rate; at each flow value in the plurality of flow values, applying a plurality of flow values ​​based on a flow rate received from the one or more sensors; The method comprises the steps of: receiving or determining a patient parameter indicating a respiratory rate of the patient based on the received data, and determining a condition of the respiratory rate of the patient based at least on the patient parameter and the patient parameter received or determined at one or more previous intervals; maintaining the workload based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is stable, and performing an iterative process of continuing to receive or determine the patient parameter and determining the condition of the patient's respiratory rate at further intervals, wherein based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is no longer stable, adjusting the workload at the further intervals until the condition of the patient's respiratory rate indicates that the patient's respiratory rate is stable.

[0070] In a twelfth aspect, the present disclosure generally includes a respiratory device configured to provide a gas flow to a user for respiratory therapy, the respiratory device comprising: a flow generator configured to generate the gas flow for the user at a working flow rate; and a controller, wherein the controller is configured to control the operation of the flow generator and to perform the following steps at intervals: progressively applying a plurality of flow values ​​as the working flow rate; at each of the plurality of flow values, receiving or determining a patient parameter indicating the patient's respiratory frequency based on data received from one or more sensors, and determining a condition of the patient's respiratory frequency based at least on the patient parameter and the patient parameter received or determined at one or more previous intervals; based on the condition of the patient's respiratory frequency indicating that the patient's respiratory frequency is stable, maintaining the working flow rate, and performing an iterative process of continuing to receive or determine the patient parameter and determining the condition of the patient's respiratory frequency at further intervals, wherein based on the condition of the patient's respiratory frequency indicating that the patient's respiratory frequency is no longer stable, adjusting the working flow rate at the further intervals until the condition of the patient's respiratory frequency indicates that the patient's respiratory frequency is stable.

[0071] The respiratory therapy system according to any one of the fifth, seventh, ninth or eleventh aspects, or the respiratory apparatus according to the sixth, eighth, tenth or twelfth aspects, may further comprise any one or more of the following aspects or features defined in the following paragraphs.

[0072] In a configuration, wherein the flow generator is further configured to deliver the flow of gas to the patient via the patient interface at an initial operating flow rate, and wherein the initial operating flow rate is determined based on one or more patient characteristics.

[0073] In configurations, the intervals are spaced apart from one another by variable time periods based at least on the condition of the patient's respiratory rate.

[0074] In a configuration, the one or more sensors include one or more sensors configured to be attached to or located proximate to a patient to measure a patient parameter indicative of a respiratory rate of the patient.

[0075] In an arrangement, the step of receiving or determining a patient parameter indicative of a respiratory rate of the patient comprises receiving data indicative of a time-averaged respiratory rate over a measurement period from the one or more sensors.

[0076] In an arrangement, the at least one sensor stores a plurality of instantaneous measurements during the measurement period and calculates a time-averaged respiratory rate.

[0077] In configurations, the step of determining the condition of the patient's respiratory rate includes comparing the patient parameter received or determined at a current interval with the patient parameter received or determined at one or more previous intervals.

[0078] In a configuration, wherein based on the comparison, the condition of the patient's respiratory rate is related to a degree or amount of change between the patient parameter received or determined at the current interval and the patient parameter received or determined at one or more previous intervals.

[0079] In configurations, based on the comparison, the condition of the patient's respiratory rate indicates that the patient's respiratory rate is increasing or decreasing or is substantially stable.

[0080] In one configuration, the step of determining whether to adjust the workload includes determining to adjust the workload based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

[0081] In one configuration, the step of determining whether to adjust or maintain the workload includes determining to maintain the workload based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is substantially stable.

[0082] In an arrangement, the step of determining whether to adjust or maintain the workload further comprises comparing the condition of the patient's respiratory rate to one or more thresholds.

[0083] In configurations, the step of incrementally adjusting the workload includes increasing the workload based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

[0084] In an arrangement, the increment is a variable increment based at least on the condition of the patient's respiratory rate.

[0085] In the configuration, the step of maintaining the work flow includes: maintaining the work flow at a work flow having a previous increment.

[0086] In a configuration, these steps are performed continuously at the intervals within a therapy session.

[0087] In the configuration, the gas is delivered to the patient under conditions suitable for providing high flow therapy.

[0088] In one configuration, the controller is further configured to deliver a flow of gas to the patient via the patient interface at the working oxygen concentration level.

[0089] In one configuration, the controller is further configured to deliver the flow of gas to the patient via the patient interface at an initial operating oxygen concentration level, wherein the initial operating oxygen concentration level is determined based on one or more patient characteristics.

[0090] In a configuration, the controller is further configured to perform the following steps at the interval: determine whether to adjust or maintain the operating oxygen concentration level based on the condition of the patient's respiratory rate, and based on a determination that the operating oxygen concentration level is to be adjusted, adjust the operating oxygen concentration level by increments, and based on a determination that the operating oxygen concentration level is to be maintained, maintain the operating oxygen concentration level at a current operating oxygen concentration level.

[0091] In one configuration, the system or apparatus further comprises a humidifier configured to humidify the gas flow.

[0092] In a thirteenth aspect, the present disclosure generally includes a respiratory therapy system configured to provide a gas flow to a user for respiratory therapy, the respiratory therapy system comprising: a patient interface configured to deliver a gas flow to the patient; a flow generator configured to generate the gas flow for the user at a working flow rate; one or more sensors configured to measure a patient parameter indicative of the patient's respiratory rate; and a controller, wherein the controller is configured to: receive or determine a patient parameter indicative of the patient's respiratory rate based on data received from the one or more sensors; and control the working flow rate of the flow generator based on the received or determined patient parameter indicative of the patient's respiratory rate.

[0093] The respiratory therapy system according to the thirteenth aspect may have any one or more of the aspects or features defined in combination with the fifth, seventh, ninth or eleventh aspects.

[0094] In a fourteenth aspect, the present disclosure generally includes a method for controlling the flow of gas delivered to a patient, the method comprising: delivering a flow of gas to the patient at a working flow rate via a patient interface; and performing the following steps at intervals: receiving or determining a patient parameter indicative of the patient's respiratory rate based on data from one or more non-patient contact sensors; determining whether to adjust or maintain the working flow rate based on at least comparing the patient parameter indicative of the patient's respiratory rate with one or more thresholds; and adjusting the working flow rate by increments based on a determination that the working flow rate is to be adjusted; and maintaining the working flow rate at the current working flow rate based on a determination that the working flow rate is to be maintained.

[0095] The method according to the fourteenth aspect may have any one or more aspects or features defined in combination with the first aspect, the second aspect, the third aspect or the fourth aspect.

[0096] In a fifteenth aspect, the present disclosure generally includes a respiratory therapy system configured to provide a gas flow to a patient for respiratory therapy, the respiratory therapy system comprising: a patient interface configured to deliver a gas flow to the patient at a working flow rate; a flow generator configured to generate the gas flow for the patient at a working flow rate; one or more non-patient contact sensors configured to measure a patient parameter indicating a respiratory rate of the patient; and a controller, wherein the controller is configured to: receive or determine a patient parameter indicating the respiratory rate of the patient based on data from the one or more non-patient contact sensors; determine whether to adjust or maintain the working flow rate based on at least comparing the patient parameter indicating the respiratory rate of the patient with one or more thresholds; and based on a determination that the working flow rate is to be adjusted, adjust the working flow rate by increments; and based on a determination that the working flow rate is to be maintained, maintain the working flow rate at a current working flow rate.

[0097] The respiratory therapy system according to the fifteenth aspect may have any one or more of the aspects or features defined in combination with the fifth, seventh, ninth, eleventh or thirteenth aspects.

[0098] In a sixteenth aspect, the present disclosure generally includes a method for controlling the flow of gas delivered to a patient, the method comprising: delivering a flow of gas to the patient at a working flow rate via a patient interface; and performing the following steps at intervals: receiving or determining a patient parameter indicative of the patient's respiratory rate based on data from one or more sensors; determining whether to adjust or maintain the working flow rate based on at least comparing the patient parameter indicative of the patient's respiratory rate with one or more thresholds; and adjusting the working flow rate by increments based on a determination that the working flow rate is to be adjusted; and maintaining the working flow rate at a current working flow rate based on a determination that the working flow rate is to be maintained.

[0099] The method according to the sixteenth aspect may have any one or more aspects or features defined in combination with the first aspect, the second aspect, the third aspect, the fourth aspect or the fourteenth aspect.

[0100] In one configuration, the method further includes receiving or determining a patient parameter indicative of SpO2 of the patient based on data from the one or more sensors.

[0101] In configurations, the step of determining whether to adjust or maintain the operating flow is further based on comparing the patient parameter indicative of the patient's SpO2 to one or more thresholds.

[0102] In a configuration, wherein the method further comprises: receiving or determining a therapy parameter indicative of FiO2 being provided or to be provided to the patient.

[0103] In configurations, the therapy parameter indicative of FiO2 being provided or to be provided to the patient is based at least in part on the patient parameter indicative of SpO2 of the patient.

[0104] In configurations, the step of determining whether to adjust or maintain the operating flow is further based on comparing the patient therapy indicative of the FiO2 being provided or to be provided to the patient to one or more thresholds.

[0105] In one configuration, the one or more thresholds include one or more parameter thresholds, each of the one or more parameter thresholds being related to a patient parameter or a therapy parameter. In one configuration, the or each parameter threshold is set by a user. In one configuration, the parameter threshold is related to a maximum acceptable respiratory rate.

[0106] In one embodiment, the one or more threshold values ​​further include a time-based threshold value. In one embodiment, the time-based threshold value is set by a user. In one embodiment, the time-based threshold value is related to a minimum amount of time that the patient parameter is above the patient parameter threshold value.

[0107] In a configuration, the increment of the workload to be adjusted is an increase in the workload. In a configuration, the increment is an absolute amount or a fixed amount. In a configuration, the increment is a percentage or a fraction of the workload. In a configuration, the increment of the workload is set by a user.

[0108] In one configuration, adjusting the workload by increments includes changing the workload by a step change. In one configuration, adjusting the workload by increments includes gradually adjusting the workload.

[0109] In a configuration, when the workload is adjusted by the increment, the method further comprises: displaying a prompt or reminder to the user indicating that the workload has been adjusted.

[0110] In an arrangement, the method further comprises presenting an audible alarm to the user indicating that the workload has been adjusted.

[0111] In an arrangement, once the workload flow rate has been adjusted by the increment, the method no longer includes determining whether to adjust or maintain the workload flow rate.

[0112] In a seventeenth aspect, the present disclosure generally includes a respiratory therapy system configured to provide a gas flow to a patient for respiratory therapy, the respiratory therapy system comprising: a patient interface configured to deliver the gas flow to the patient; a flow generator configured to generate the gas flow for the patient at a working flow rate; one or more sensors configured to measure a patient parameter indicative of the patient's respiratory rate; and a controller, wherein the controller is configured to control the operation of the flow generator and to perform the following steps at intervals: receiving or determining a patient parameter indicative of the patient's respiratory rate based on data from the one or more sensors; determining whether to adjust or maintain the working flow rate based on at least comparing the patient parameter indicative of the patient's respiratory rate with one or more thresholds; and adjusting the working flow rate in increments based on a determination that the working flow rate is to be adjusted; and maintaining the working flow rate at a current working flow rate based on a determination that the working flow rate is to be maintained.

[0113] The respiratory therapy system according to the seventeenth aspect may have any one or more of the aspects or features defined in combination with the sixteenth, fifth, seventh, ninth, eleventh or thirteenth aspects.

[0114] In another aspect, the present disclosure relates to an electronically implemented method comprising software code or coded instructions that can be executed or implemented by a computer, processor, or controller to implement any one or more of the methods or aspects described above.

[0115] In another aspect, the present disclosure generally includes a non-transitory computer-readable medium having computer-executable instructions stored thereon that, when executed on one or more processing devices, cause the one or more processing devices to perform or execute any one or more of the methods or aspects described above. BRIEF DESCRIPTION OF THE DRAWINGS

[0116] These and other features, aspects, and advantages of the present disclosure are described with reference to the accompanying drawings of certain embodiments, which are intended to schematically illustrate certain embodiments and not to limit the present disclosure.

[0117] Figure 1 A respiratory system configured to provide respiratory therapy to a patient is schematically illustrated.

[0118] Figure 2 is a front view of an example breathing apparatus with the humidification chamber in place and the handle / joystick raised.

[0119] Figure 3 is with Figure 2Corresponding top view.

[0120] Figure 4 is with Figure 2 Corresponding right side view.

[0121] Figure 5 is with Figure 2 Corresponding left side view.

[0122] Figure 6 is with Figure 2 Corresponding rear view.

[0123] Figure 7 is with Figure 2 Corresponding left front perspective view.

[0124] Figure 8 is with Figure 2 Corresponding right front perspective view.

[0125] Figure 9 is with Figure 2 Corresponding bottom view.

[0126] Figure 10 Example configurations of air and oxygen inlet arrangements for a breathing apparatus are shown.

[0127] Figure 11 Another example configuration of an air and oxygen inlet arrangement for a breathing apparatus is shown.

[0128] Figure 12 It shows Figure 11 Cross-sectional views of further details of the air and oxygen inlet arrangements.

[0129] Figure 13 It shows Figure 11 Another cross-sectional view of further details of the air and oxygen inlet arrangements.

[0130] Figure 14 It shows Figure 11 A longitudinal section view showing further details of the air and oxygen inlet arrangements.

[0131] Figure 15 Exploded view of the upper and lower chassis components of the breathing apparatus main housing.

[0132] Figure 16 is a left front perspective view of the lower chassis of the main housing showing the housing for housing the motor / sensor module subassembly.

[0133] Figure 17 is a first underside perspective view of the main housing of the breathing apparatus showing the recess within the housing for the motor / sensor module subassembly.

[0134] Figure 18 is a second underside perspective view of the main housing of the breathing apparatus showing the recess for the motor / sensor module subassembly.

[0135] Figure 19A A block diagram of a control system that interacts with and / or provides control and direction to components of a respiratory system is illustrated.

[0136] Figure 19B A block diagram of an example controller is illustrated.

[0137] Figure 20 Illustrated is a block diagram of the motor and sensor modules.

[0138] Figure 21 The sensing chamber of an example motor and sensor module is illustrated.

[0139] Figure 22 A respiratory system configured to provide respiratory therapy to a patient is schematically illustrated.

[0140] Figure 23 A block diagram of a control system that interacts with and / or provides control and direction to components of a respiratory system is illustrated.

[0141] Figure 24 A flow chart illustrating an embodiment of a workload determination process is shown.

[0142] Figure 25 A flow chart illustrating an embodiment of a process for determining an operating flow rate and an operating oxygen concentration level is shown.

[0143] Figure 26 A graphical representation of an example respiratory rate versus flow relationship is shown.

[0144] Figure 27 A graphical representation of an example respiratory rate versus flow relationship is shown.

[0145] Figure 28 A graphical representation of an example respiratory rate versus flow relationship is shown.

[0146] Figure 29 A graphical representation of an example respiratory rate versus flow relationship is shown.

[0147] Figure 30 A flow chart illustrating an embodiment of an operating oxygen concentration level determination process is shown. DETAILED DESCRIPTION

[0148] Although certain examples are described below, it will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed examples and / or uses and obvious modifications and equivalents thereof. Therefore, the scope of the present disclosure disclosed herein is intended not to be limited by any specific examples described below.

[0149] A respiratory support system that includes a humidification device can be used to deliver heated and humidified respiratory gases to a patient via a catheter and a patient interface. The respiratory support system can provide a variety of therapies for patients requiring respiratory support. One of these therapies includes high-flow therapy. In high-flow therapy, the respiratory support system delivers a relatively high flow of gas through a nasal interface, which can be unsealed. The gas flow can range from 5 L / min to 120 L / min. In some examples, the gas flow can range from 10 L / min to 120 L / min. In some examples, the gas flow can range from 20 L / min to 120 L / min. In some examples, the gas flow ranges from 30 L / min to 50 L / min. In some examples, the gas flow can be as high as 60 L / min. In some examples, the flow is greater than 60 L / min but less than 120 L / min. In other examples, the flow is 120 L / min or higher. The respiratory support system can adjust the gas flow during treatment via a control system. A discussion of high flow therapy and how flow can be varied in respiratory assistance systems can be found in PCT Publication No. WO 2015 / 033288, entitled “Improvements to Flow Therapy,” which is incorporated herein by reference in its entirety.

[0150] The flow rate during high-flow therapy can vary based on the patient's condition and can change during treatment. Clinicians or patients may not be able to determine the flow rate that the respiratory assistance system should use to provide optimal therapy and comfort. Caregivers often do not know the appropriate flow rate for a specific patient and often set the flow rate too low or too high for the clinically optimal flow rate. Caregivers also often do not know how to measure the effectiveness of therapy or how long they should wait to determine effectiveness.

[0151] Accordingly, the present disclosure provides methods and systems for controlling the operating parameters (specifically, flow rate and / or oxygen concentration level) of a device for a given patient. These methods can be performed by a control system of the device. The respiratory assistance device and system discussed below include a control system implemented using a controller, which is used to control the operating parameters of the device. The control system can automatically control the operating flow rate and / or oxygen concentration level of the gas delivered to the patient during the therapy time based on changes in the patient's condition. Therefore, the control system can advantageously improve the efficacy of the high flow therapy and reduce the probability that the patient will require more invasive treatments (such as invasive mechanical ventilation). The flow rate and / or oxygen concentration level control method for high flow respiratory therapy can help patients reduce the length of time that the flow rate is set too high or too low for immediate respiratory support requirements during therapy.

[0152] Flow rate can affect a variety of physiological and clinical parameters, including work of breathing, end-tidal CO2, respiratory rate, thoracic and abdominal phase, and other clinically relevant parameters. The described control system and method can automatically control the working flow of high-flow respiratory therapy based on at least a patient parameter indicative of the patient's respiratory rate.

[0153] Physiological parameters such as respiratory rate can provide information about whether a patient's condition is worsening or improving. Physiological parameters such as respiratory rate can also provide information about when a patient has stabilized after receiving high-flow therapy. Thus, using respiratory rate can help control operating parameters associated with providing high-flow respiratory therapy. When a patient is receiving high-flow therapy, respiratory rate can provide a means of identifying optimal or other acceptable operating parameters or therapy settings.

[0154] Controlling operating parameters based on physiological parameters typically involves monitoring how physiological parameters (such as respiratory rate) change or react to determine optimal operating parameters for high-flow therapy. If a clinician or other personnel manually changes the operating parameters in response to measured physiological parameters, the process of achieving optimal operating parameters can be very time-consuming. Because this process requires a long titration period, which clinicians do not have the time to perform, it is unlikely that the operating parameters will be set to optimal or otherwise acceptable conditions.

[0155] Some of the physiological parameters used may also take an unrealistically long time to change in response to therapy changes or worsening patient conditions. One example is SpO2, which is widely used as a physiological parameter. Typically, when a patient's condition worsens, the body initially tries to keep SpO2 stable by increasing minute ventilation and delivering more oxygen to the lungs. Therefore, SpO2 may only be affected after significant delays and / or after significant worsening of the patient's condition. In such cases, using these physiological parameters for therapy parameter control (which requires minimal response delay) is impractical.

[0156] Therefore, there is a need for a control system and method that can automatically control the operating parameters of a respiratory therapy device based on a measured patient condition. Such a system should be able to optimize the parameters to optimal or other acceptable values ​​while the patient is receiving the therapy. Patient condition should be measured using physiological parameters that provide early indications of changes in the patient's condition and that can be measured accurately and continuously.

[0157] The control system's automatic control of the operating parameters of the respiratory therapy device can help deliver optimal respiratory therapy to the patient and can help reduce their respiratory rate, thereby allowing the patient to relax more and reducing their work of breathing, or in other words, reducing the physical burden of exerting themselves to breathe. The control system can also help more quickly identify the success or failure of therapy. For example, it may be beneficial to know early on that high-flow therapy is not working for a particular patient. The control system can compare the patient's physiological parameters with expected, predetermined parameters based on the flow rate to determine the effectiveness of the therapy.

[0158] Providing optimal respiratory therapy by controlling the operating parameters of a respiratory therapy device can help reduce a patient's respiratory distress and reduce the patient's work of breathing (i.e., the effort required for the patient to breathe). As will be discussed, a patient's respiratory rate can provide an indication of their work of breathing. Specifically, a higher respiratory rate can indicate a higher work of breathing. The present disclosure relates to controlling a respiratory device based on respiratory rate to reduce the work of breathing.

[0159] The control system discussed can generate an indication of an operating parameter (such as flow or oxygen concentration level) for display to a physician. If, based on the sensitivity or insensitivity of clinical parameters and physiological parameters (such as measured respiratory rate) to the operating parameter, the therapy is not effective for a particular patient, the control system can issue a warning to the clinician. The present disclosure can detect whether respiratory therapy is ineffective and indicate this detection result to the clinician. The clinician can then decide to upgrade the patient to a different therapy, such as bi-level pressure therapy or invasive ventilation.

[0160] 1. Overview of respiratory assistance system

[0161] Methods and processes for controlling the flow of gas delivered to a patient will be described in conjunction with an example respiratory device 10 that is configured or operable to provide nasal high-flow therapy via an unsealed patient interface. This example is intended as a non-limiting example. It should be understood that these methods and processes can be applied to other respiratory devices and / or other modes of operation and / or therapy modes provided by such devices.

[0162] Figure 1 A schematic diagram of an example breathing apparatus 10 is provided.

[0163] The respiratory apparatus 10 (or "breathing system") includes a flow source 50 for providing a high flow rate of gas 31, such as air, oxygen, air mixed with oxygen, or a mixture of air and / or oxygen and one or more other gases. Alternatively, the respiratory assistance apparatus may have a connection coupled to the flow source. Thus, depending on the context, the flow source may be considered to constitute part of the apparatus or to be separate from the apparatus; or even that part of the flow source constitutes part of the apparatus and part of the flow source is external to the apparatus. In summary, depending on the configuration (some components may be optional), the system may include a combination of components selected from the following:

[0164] · Source of flow;

[0165] A humidifier for humidifying the gas flow;

[0166] Tubing (e.g. dry line or heated breathing tube);

[0167] Patient interface;

[0168] Check valve;

[0169] Filters.

[0170] The device or system will be described in more detail.

[0171] The flow source may be a wall oxygen supply, an oxygen tank 50A, other gas tanks, and / or a high flow device with a flow generator 50B. Figure 1 A flow source 50 is shown having a flow generator 50B having an optional air inlet 50C and an optional connection to an O2 source (such as a tank or O2 generator) 50A via a shutoff valve and / or a regulator and / or other gas flow control 50D, but this is merely an option. The flow generator 50B can use one or more valves to control the flow delivered to the patient 56, or alternatively, the flow generator 50B can include a blower. The flow source can be one of the flow generator 50B, O2 source 50A, air source 50C as described, or a combination thereof. The flow source 50 is shown as part of the device 10, although in the case of an external oxygen tank or a wall-mounted source, the flow source can be considered a separate component, in which case the device has a connection port to connect to such a flow source. The flow source provides a (preferably high flow) gas flow that can be delivered to the patient via the delivery conduit 16 and the patient interface 51.

[0172] The patient interface 51 can be an unsealed (non-sealed) interface (for example, when used for high-flow therapy), such as a non-sealed nasal cannula or a non-sealed tracheostomy interface. In some embodiments, the patient interface 51 is a non-sealed patient interface, which, for example, helps to prevent barotrauma (for example, tissue damage to the lungs or other organs of the respiratory system due to pressure differences relative to the atmosphere). The patient interface can be: a non-sealed nasal cannula with a manifold and a nasal prong; and / or a tracheostomy interface; or any other suitable type of patient interface. The flow source can provide a base gas flow rate of, for example, between 0.5 liters / minute and 120 liters / minute, or any range within this range, or a range with higher or lower limits. The details of the range and nature of the flow rate will be described later.

[0173] A humidifier 52 may optionally be positioned between the flow source 50 and the patient to humidify the delivered gas. One or more sensors 53A, 53B, 53C, 53D (such as flow sensors, oxygen fraction sensors, pressure sensors, humidity sensors, temperature sensors, or other sensors) may be positioned throughout the system and / or at, on, or near the patient 56.

[0174] In some configurations, breathing system 10 may include sensor 14 for measuring the oxygen fraction of air inhaled by a patient. In some examples, sensor 14 may be placed on patient interface 51 to measure or otherwise determine the oxygen fraction near (located / near / adjacent to) the patient's mouth and / or nose. In some configurations, output from sensor 14 is sent to controller 19 to assist in controlling breathing system 10 and altering its operation accordingly. Controller 19 is coupled to flow source 50, humidifier 52, and sensor 14. In some configurations, controller 19 controls these and other aspects of breathing system 10, as described herein. In some examples, the controller may operate flow source 50 to provide a delivered gas flow rate at a desired flow rate high enough to meet or exceed the user's (i.e., patient's) inhalation demand. The provided flow rate is sufficient to prevent entrainment of ambient gas during the user's (i.e., patient's) inhalation. In some configurations, sensor 14 may communicate the oxygen fraction measurement at the patient's mouth and / or nose to the user, who may input this information into breathing system 10 / controller 19.

[0175] An optional check valve 23 may be provided in the breathing conduit 16. One or more filters may be provided at the air inlet 50C and / or the inlet of the flow generator 50B to filter the incoming gas before the flow generator 50B pressurizes the incoming gas into the high flow gas 31 .

[0176] The breathing assistance device 10 may be an integrated or separate component-based arrangement, typically such as Figure 1100. In some configurations, the device or system may be a modular arrangement of components. Furthermore, the device or system may include only some of the components shown, not all of which are required. Additionally, the catheter and patient interface are not necessarily part of the system and may be considered separate. Hereinafter, the system will be referred to as a respiratory assistance device or a respiratory system, but this should not be considered limiting. Respiratory assistance devices and respiratory systems are generally considered herein to include anything that provides a flow of gas to a patient. Some such devices and systems include a detection system that can be used to determine whether the flow of gas meets the inhalation requirement.

[0177] Respiratory device 10 may include a main device housing 100. Main device housing 100 may contain: 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. User interface 54 may include a display and input devices, such as buttons, a touch screen (e.g., an LCD screen), or a combination of a touch screen and buttons. Controller 19 may include one or more hardware and / or software processors and may be configured or programmed to control components of the system, including, but not limited to, operating flow generator 50B to generate a flow of gas delivered to the patient, operating humidifier or humidification chamber 52 (if present) to humidify and / or heat the flow of gas, receiving user input from user interface 54 to reconfigure respiratory device 10 and / or perform user-defined operations, and outputting information to the user (e.g., on a display). The user may be a patient, a medical professional, or another person.

[0178] Continue to refer Figure 1 The patient breathing conduit 16 can be coupled to a gas flow outlet (gas outlet or patient outlet port) 21 in the main device housing 100 of the respiratory apparatus 10 and to a patient interface 17, such as a non-sealing interface, such as a nasal cannula with a manifold and nasal prongs. The patient breathing conduit 16 can also be a tracheostomy interface or other unsealed interface.

[0179] The gas flow may be generated by a flow generator 50B and may be humidified before being delivered to the patient via the patient breathing conduit 16 through the patient interface 51. The controller 19 may control the flow generator 50B to generate a gas flow of a desired flow rate and / or control one or more valves to control the mixing of air and oxygen or other breathable gas. If present, the controller 19 may control a heating element in or associated with the humidification chamber 52 to heat the gas to a desired temperature, achieving a desired temperature and / or humidity level for delivery to the patient. The patient breathing conduit 16 may have a heating element (such as a heater wire) to heat the gas flow to the patient. The heating element may also be under the control of the controller 19.

[0180] The humidifier 52 of the device is configured to combine humidity with the gas flow or introduce humidity into the gas flow. Various humidifier 52 configurations can be adopted. In one configuration, the humidifier 52 may include a removable humidification chamber. For example, the humidification chamber can be partially or completely removed or disconnected from the flow path and / or the device. By way of example, the humidification chamber can be removed to, for example, refill, clean, replace and / or repair. In one configuration, the humidification chamber can be accommodated and maintained by a humidification compartment or bracket of the device, or can be accommodated and maintained in the humidification compartment or bracket, or can be coupled on or in the housing of the device.

[0181] The humidification chamber of the humidifier 52 may include a gas inlet and a gas outlet so as to be connected to the gas flow path of the device. For example, after heating and / or humidification, the gas flow from the flow generator 50B is admitted into the humidification chamber via its gas inlet and leaves the humidification chamber via its gas outlet.

[0182] The humidification chamber contains a quantity of liquid, typically water or the like. In operation, the liquid in the humidification chamber is controllably heated by one or more heaters or heating elements associated with the humidification chamber to generate water vapor or steam to increase the humidity of the gas flowing through the humidification chamber.

[0183] In one configuration, the humidifier is a flow-through humidifier. In another configuration, the humidifier can be a non-flow-through humidifier.

[0184] In one configuration, the humidifier may include a heater plate, for example, associated with or located within a humidifying tray, with the humidifying chamber seated on the heater plate for heating. The humidifying chamber may be provided with a heat transfer surface (e.g., a metal insert, plate, or the like) on a base surface or other surface of the humidifying chamber that interfaces or engages with the heater plate of the humidifier.

[0185] In another configuration, the humidification chamber may include an internal heater or heater element located within or within the cab. The internal heater or heater element may be integrally mounted or provided within the humidification chamber, or may be removable from the humidification chamber.

[0186] The humidifying chamber can be of any suitable shape and / or size. The position, number, size and / or shape of the gas inlet and gas outlet of the humidifier can be varied as needed. In one configuration, the humidifying chamber can have a base surface, one or more side walls extending upward from the base surface, and an upper surface or top surface. In one configuration, the gas inlet and gas outlet can be located on the same side of the humidifying chamber. In another configuration, the gas inlet and gas outlet can be located on different surfaces of the humidifying chamber, such as opposite sides or relative positions, or other different positions.

[0187] In some configurations, the gas inlet and the gas outlet can have parallel flow axes.In some configurations, the gas inlet and the gas outlet can be located at the same height of the humidification chamber.

[0188] Device 10 can communicate with controller 19 using ultrasonic transducers, flow sensors (such as thermistor flow sensors), pressure sensors, temperature sensors, humidity sensors, or other sensors to monitor gas flow characteristics and / or operate system 10 in a manner that provides appropriate therapy. Gas flow characteristics may include gas concentration, flow rate, pressure, temperature, or humidity, among others. Sensors 53A, 53B, 53C, 53D, and 14 (such as pressure sensors, temperature sensors, humidity sensors, and / or flow sensors) can be placed at various locations within main device housing 100, patient conduit 16, and / or patient interface 51. Controller 19 can receive output from these sensors to assist it in operating respiratory device 10 in a manner that provides appropriate therapy, such as determining an appropriate target temperature, flow rate, and / or pressure for the gas flow. Providing appropriate therapy may include meeting or exceeding the patient's inspiratory demand. In the illustrated embodiment, sensors 53A, 53B, and 53C are located within the device housing, sensor 53D is located within patient conduit 16, and sensor 14 is located within patient interface 51.

[0189] The device 10 may include one or more communication modules to enable data communication or connection with one or more external devices or servers via a data link or communication link or data network (whether wired, wireless, or a combination of the two). In one configuration, for example, the device 10 may include a wireless data transmitter and / or receiver or transceiver 15 to enable the controller 19 to wirelessly receive data signals from the operating sensors and / or control various components of the system 10. The transceiver 15 or data transmitter and / or receiver module may have an antenna 15a, as shown. In one example, the transceiver may include a Wi-Fi modem. Additionally or alternatively, the data transmitter and / or receiver 15 may transmit data to a remote patient management system (i.e., a remote server) or enable remote control of the system 10. The system 10 may include a wired connection, such as using a cable or wire, to enable the controller 19 to receive data signals from the operating sensors and / or control various components of the device 10. The device 10 may include one or more wireless communication modules. For example, the device may include a cellular communication module, such as a 3G, 4G, or 5G module. Module 15 can be or can include a modem that enables the device to communicate with a remote patient management system (not shown) using an appropriate communication network. The remote management system can include a single server or multiple servers or multiple computing devices implemented in a cloud computing network. The communication can be a two-way communication between the device and the patient management system (e.g., a server) or other remote system. The device 10 can also include other wireless communication modules, such as a Bluetooth module and / or a Wi-Fi module. The Bluetooth module and / or the WiFi module allow the device to send information to another device (such as a smartphone or tablet computer) wirelessly, or to operate via a LAN (local area network) or a wireless LAN (WLAN). The device can additionally or alternatively include a near field communication (NFC) module to allow data transmission and / or data communication.

[0190] For example, the measured patient data and / or device data (e.g., respiratory rate, usage time) can be transmitted to a remote patient management system (i.e., a remote server). The remote patient management system can be a single server, a network of servers, a cloud computing system, or other suitable architecture for operating a remote patient management system. The remote patient management system (i.e., a remote server) also includes a memory for storing the received data and various software applications or services that are executed to perform various functions. The remote patient management system (i.e., a remote server) can then, for example, transmit information or instructions to system 10 based at least in part on the received data. For example, the nature of the received data can trigger the remote server (or a software application running on the remote server) to transmit an alert, alarm, or notification to system 10. The remote patient management system can also store the received data for access by authorized parties (such as clinicians, patients, or another authorized party). The remote patient management system can be further configured to generate reports in response to requests from authorized parties, and the measured patient and / or device data can be included in the generated reports. These reports can also include other patient respiratory parameters, such as respiratory rate or SpO2, and / or device parameters, such as flow rate and humidity level.

[0191] The respiratory apparatus 10 may include a high flow therapy apparatus. As will be understood by those skilled in the art, high flow therapy as discussed herein is intended to have its typical ordinary meaning, which generally refers to a respiratory system delivering a targeted flow of humidified breathing gas via an intentionally unsealed patient interface, wherein the flow rate is generally intended to meet or exceed the user's inspiratory flow rate. Typical patient interfaces include, but are not limited to, a nasal patient interface or a tracheostomy patient interface. Typical flow rates for adults are generally, but are not limited to, about 15 liters per minute to about 60 liters per minute or more. Typical flow rates for pediatric users (such as neonates, infants, and children) are generally, but are not limited to, about 1 liter per minute per kilogram of user body weight to about 3 liters per minute per kilogram of user body weight or more.

[0192] High flow therapy may also optionally include gas mixture components including supplemental oxygen and / or therapeutic drug administration.

[0193] High flow therapy is often referred to as nasal high flow (NHF), humidified high flow nasal cannula (HHFNC), high flow nasal oxygen (HFNO), high flow therapy (HFT) or tracheostomy high flow (THF) among other common names. For example, in some configurations, for an adult patient, "high flow therapy" can refer to delivering gas to the patient at a flow rate greater than or equal to about 10 liters per minute (10 LPM), such as between about 10 LPM and about 100 LPM, or between about 15 LPM and about 95 LPM, or between about 20 LPM and about 90 LPM, or between about 25 LPM and about 85 LPM, or between about 30 LPM and about 80 LPM, or between about 35 LPM and about 75 LPM, or between about 40 LPM and about 70 LPM, or between about 45 LPM and about 65 LPM, or between about 50 LPM and about 60 LPM. In some configurations, for a neonatal, infant, or pediatric patient, "high flow therapy" may refer to delivering gas to the patient at a flow rate greater than 1 LPM, such as between about 1 LPM and about 25 LPM, or between about 2 LPM and about 25 LPM, or between about 2 LPM and about 5 LPM, or between about 5 LPM and about 25 LPM, or between about 5 LPM and about 10 LPM, or between about 10 LPM and about 25 LPM, or between about 10 LPM and about 20 LPM, or between about 10 LPM and 15 LPM, or between about 20 LPM and 25 LPM. A high flow therapy device for an adult, neonatal, infant, or pediatric patient may deliver gas to the patient at a flow rate between about 1 LPM and about 100 LPM, or within any of the subranges outlined above.

[0194] High-flow therapy can effectively meet or exceed a patient's inspiratory needs, increasing oxygenation and / or reducing the work of breathing. Additionally, high-flow therapy can produce a flushing effect in the nasopharynx, flushing the anatomical dead space of the upper airway with the high-flow incoming gas stream. This flushing effect can produce a large amount of fresh gas with each breath while minimizing the rebreathing of carbon dioxide, nitrogen, and other gases. Due to the pressure during exhalation, high-flow therapy can also increase the patient's expiratory time. This, in turn, can reduce the patient's respiratory rate.

[0195] The patient interface used for high flow therapy can be a non-sealing interface to prevent barotrauma, which can include tissue damage to the lungs or other organs of the patient's respiratory system due to differences in air pressure relative to the atmosphere. The patient interface can be: a nasal cannula with a manifold and nasal prongs; and / or a non-sealing tracheostomy interface; or any other suitable type of patient interface.

[0196] Figures 2 to 18An example breathing apparatus of a breathing device 10 having a main housing 100 is shown. The main housing 100 has a main housing upper chassis 102 and a main housing lower chassis 202. The main housing upper chassis 102 has a peripheral wall arrangement 106 (see FIG. Figure 15 ). The peripheral wall arrangement defines a humidifier or chamber carrier 108 for housing a removable humidification chamber 300. The removable humidification chamber 300 contains a suitable liquid, such as water for humidifying gases that can be delivered to a patient.

[0197] In the illustrated form, the peripheral wall arrangement 106 of the main housing upper chassis 102 may include a substantially vertical left side outer wall 110 oriented in a front-to-rear direction of the main housing 100, a substantially vertical left side inner wall 112 oriented in a front-to-rear direction of the main housing 100, and an interconnecting wall 114 extending between and interconnecting the upper ends of the left side inner wall 112 and the left side outer wall 110. The main housing upper chassis 102 may also include a substantially vertical right side outer wall 116 oriented in a front-to-rear direction of the main housing 100, a substantially vertical right side inner wall 118 oriented in a front-to-rear direction of the main housing 100, and an interconnecting wall 120 extending between and interconnecting the upper ends of the right side inner wall 118 and the right side outer wall 116. The interconnecting walls 114, 120 are angled toward the respective outer edges of the main housing 100, but may alternatively be substantially horizontal or angled inward.

[0198] The main housing upper chassis 102 may also include a substantially vertical rear outer wall 122. The upper portion of the main housing upper chassis 102 may include a surface 124 that is angled forward. The surface 124 may have a recess 126 for accommodating a display and a user interface module 54. The display may be configured to display the characteristics of the sensed gas in real time. The system may display the patient detection status of the patient interface. If no patient is detected, the controller may not output or may stop outputting the respiratory rate value and / or other parameters for display. The controller may also optionally output a message to indicate that no patient was detected at box 2708. An example of such a message may be a "--" icon. The interconnecting wall 128 may extend and interconnect between the upper end of the rear outer wall 122 and the rear edge of the surface 124.

[0199] A substantially vertical wall portion 130 may extend downwardly from the front end of the surface 124. A substantially horizontal wall portion 132 may extend forwardly from the lower end of the wall portion 130 to form a flange. A substantially vertical wall portion 134 may extend downwardly from the front end of the wall portion 132 and terminate at a substantially horizontal floor portion 136 of the humidification chamber bracket 108. The left inner wall 112, the right inner wall 118, the wall portion 134, and the floor portion 136 may collectively define the humidification chamber bracket 108. The floor portion 136 of the humidification chamber bracket 108 may have a recess 138 to accommodate a heater arrangement, such as a heater plate 140 or other suitable heating element, for heating liquid in the humidification chamber 300 for use in the humidification process.

[0200] The main housing lower chassis 202 may be attachable to the upper chassis 102, for example, by suitable fasteners or integrated attachment features, such as clips. The main housing lower chassis 202 may include a substantially vertical left side outer wall 210 oriented in a front-to-rear direction of the main housing 100 and contiguous with the left side outer wall 110 of the upper chassis 102, and a substantially vertical right side outer wall 216 oriented in a front-to-rear direction of the main housing 100 and contiguous with the right side outer wall 116 of the upper chassis 102. The main housing lower chassis 202 may also include a substantially vertical rear outer wall 222 contiguous with the rear outer wall 122 of the upper chassis 102.

[0201] The lower housing chassis 202 may have a lip 242 that abuts the lip 142 of the upper housing chassis 102 and also forms part of a recess for receiving the handle portion 506 of the joystick 500. The lower lip 242 may include a forwardly directed protrusion 243 that serves as a retainer for the handle portion 506 of the joystick 500. The system may have a spring-loaded guard instead of the joystick 500 for retaining the humidification chamber 300 in the chamber bracket 108.

[0202] The underside of the lower housing chassis 202 may include a bottom wall 230. Respective interconnecting walls 214, 220, 228 may extend and interconnect between the substantially vertical walls 210, 216, 222 and the bottom wall 230. The bottom wall 230 may include a grille 232 comprising a plurality of apertures to allow liquid to drain in the event of a leak (e.g., overflow) from the humidification chamber 300. The bottom wall 230 may additionally include an elongated slot 234 oriented forward and backward. The slot 234 may additionally allow liquid to drain in the event of a leak from the humidification chamber 300 without allowing the liquid to enter the electronics housing. In the illustrated configuration, the slot 234 may be wide and elongated relative to the apertures of the grille 232 to maximize liquid drainage.

[0203] like Figures 17 and 18 As shown, the lower chassis 202 may have a motor recess 250 for accommodating a motor and sensor module. The motor and sensor module may not be removable from the main housing 100. Figures 17 and 18 As illustrated, the motor and sensor module may be removable from the main housing 100. A recess 251 may be provided in the bottom wall 230 adjacent the rear edge of the bottom wall for accommodating the motor / sensor module. A continuous, airtight, unbroken peripheral wall 252 may be integrally formed with the bottom wall 230 of the lower chassis 202 and extend upward from the periphery of the recess 251. A rearward portion 254 of the peripheral wall 252 has a first height, and a forward portion 256 of the peripheral wall 252 has a second height greater than the first height. The rearward portion 254 of the peripheral wall 252 terminates in a substantially horizontal step 258, which in turn terminates in an upper auxiliary rearward portion 260 of the peripheral wall 252. The forward portion 256 and the upper auxiliary rearward portion 260 of the peripheral wall 252 terminate in a ceiling 262. With the exception of the gas flow channel, all walls and the ceiling 262 may be continuous, airtight, and unbroken. Therefore, the entire motor recess 250 except for the gas flow channel may be airtight and unbroken.

[0204] The motor and sensor module may be insertable into the recess 250 and attachable to the lower chassis 202. When the motor and sensor module is inserted into the lower chassis 202, the gas flow channel tube 264 may extend through the downward extension tube 133 and be sealed by the soft seal.

[0205] Humidification chamber 300 may be fluidly coupled to apparatus 10 in a linear sliding motion in a rearward direction of humidification chamber 300, entering chamber bracket 108 from the front of housing 100 in a direction toward the rear of housing 100. Gas outlet port 322 may be in fluid communication with the motor.

[0206] like Figure 8 As shown, the gas inlet port 340 (humidified gas circuit) may include a removable L-shaped elbow. The removable elbow may also include a patient outlet port 344 for coupling to the patient conduit 16 to deliver gas to the patient interface. The gas outlet port 322, the gas inlet port 340, and the patient outlet port 344 may each have a soft seal, such as an O-ring seal or a T-ring seal, to provide a sealed gas passage between the device 10, the humidification chamber 300, and the patient conduit 16.

[0207] Humidification chamber gas inlet port 306 may be complementary to gas outlet port 322, and humidification chamber gas outlet 308 may be complementary to gas inlet port 340. The axes of these ports may be parallel to each other to enable humidification chamber 300 to be inserted into humidification chamber holder 108 in a linear motion.

[0208] The breathing apparatus may have air and oxygen (or alternative auxiliary gas) inlets in fluid communication with the motor, such that the motor can deliver air, oxygen (or alternative auxiliary gas), or a mixture thereof to the humidification chamber 300 and thereby to the patient. Figure 10 As shown, the device may have a combined air / oxygen (or alternatively auxiliary gas) inlet arrangement 350. The arrangement may include a combined air / oxygen port 352 entering the housing 100, a filter 354, and a cover 356 with a hinge 358. The gas tube may also optionally extend laterally or in another appropriate direction and be in fluid communication with the oxygen (or alternatively auxiliary gas) source. The port 352 may be fluidically coupled to the motor 402. For example, the port 352 may be coupled to the motor and sensor module 400 via a gas flow channel. The gas flow channel is located between the port 352 and the inlet hole or port in the motor and sensor module 400, and then leads to the motor.

[0209] The device may have Figures 11 to 14 The arrangement shown is such that the blower can deliver air, oxygen (or alternatively auxiliary gas) or a suitable mixture thereof to the humidification chamber 300 and thereby deliver it to the patient. The arrangement may include an air inlet 356' in the rear wall 222 of the lower chassis 202 of the housing 100. The air inlet 356' comprises a rigid plate having a grid arrangement of suitable holes and / or slots. Soundproofing foam may be provided adjacent to the plate on the inner side of the plate. An air filter box 354' may be located adjacent to the air inlet 356' in the main housing 100 and include an air outlet port 360 to deliver filtered air to the motor via the air inlet port 404 in the motor / sensor module 400. The air filter box 354' may include a filter configured to remove particles (e.g., dust) and / or pathogens (e.g., viruses or bacteria) from the gas stream. A soft seal (such as an O-ring seal) may be provided between the air outlet port 360 and the air inlet port 404 to seal between the components. The device may include a separate oxygen inlet port 358', which is located at the rear end of the housing 100, adjacent to one side of the housing, for receiving oxygen from an oxygen source (such as a tank or pipeline oxygen source). The oxygen inlet port 358' is in fluid communication with a valve 362. The valve 362 can suitably be a solenoid valve that enables control of the amount of oxygen added to the gas flow delivered to the humidification chamber 300. The oxygen port 358' and the valve 362 can be used together with other auxiliary gases to control the addition of other auxiliary gases to the gas flow. Other auxiliary gases may include any one or more of a variety of gases useful for gas therapy, including but not limited to helium oxygen and nitric oxide.

[0210] like Figures 13 to 16As shown, the lower housing chassis 202 may include a suitable electronics board, such as a sensing circuit board. The electronics board may be positioned adjacent to the respective outer sidewalls 210, 216 of the lower housing chassis 202. The electronics board may contain or be electrically connected to suitable electrical or electronic components, such as, but not limited to, a microprocessor, a capacitor, a resistor, a diode, an operational amplifier, a comparator, and a switch. Sensors may be used in conjunction with the electronics board. Components of the electronics board, such as, but not limited to, one or more microprocessors, may serve as the controller 19 of the device.

[0211] One or more of the electronics boards may be in electrical communication with electrical components of the apparatus 10, including the display unit and user interface 54, the motor, the valve 362, and the heater board 140, for operating the motor to provide the desired gas flow, operating the humidification chamber 300 to humidify and heat the gas flow to an appropriate level, and supplying an appropriate amount of oxygen (or an appropriate amount of an alternative auxiliary gas) to the gas flow.

[0212] The electronics board can be in electrical communication with a connector arrangement 274 that protrudes from the rear wall 122 of the upper housing chassis 102. The connector arrangement 274 can be coupled to an alarm, a pulse oximetry port, and / or other suitable accessories. The electronics board can also be in electrical communication with an electrical connector 276 that can also be provided in the rear wall 122 of the upper housing chassis 102 to provide mains or battery power to the components of the device.

[0213] As mentioned above, operational sensors (such as flow sensors, temperature sensors, humidity sensors and / or pressure sensors) may be placed at various locations in the respiratory device, the patient's respiratory conduit 16 and / or the cannula 51, such as Figure 1 As shown. The electronics board can be in electrical communication with these sensors. Outputs from these sensors can be received by the controller 19 to assist the controller 19 in operating the respiratory apparatus 10 in a manner to provide optimal therapy, such as controlling a set flow rate. The set flow rate can be selected to provide flushing of the patient's upper airway and / or to meet or exceed the patient's inspiratory needs and / or to provide other advantages of high flow therapy described herein. In the illustrated embodiment, the sensors are located on the electronics board, which is located within the housing. The sensors are enclosed within the housing.

[0214] As outlined above, the electronics board and other electrical and electronic components can be pneumatically isolated from the gas flow path to increase safety. The seal also prevents water ingress.

[0215] 1.1 Control System

[0216] Figure 19A An example control system 920 (which may be Figure 1900 of a controller 19 in a respiratory system (controller 19 in FIG), the example control system is capable of detecting a patient condition and controlling operation of a respiratory system including a gas source. The control system 920 can manage the flow of the gas as it flows through the respiratory system and is delivered to the patient. For example, the control system 920 can increase or decrease the flow by controlling the motor speed output of a blower (hereinafter also referred to as a "blower motor") 930 or the output of a valve 932 in a mixer. As discussed below, the control system 920 can automatically determine a set value or personalized value for the flow rate for a specific patient. The control system 920 can optimize the flow rate to improve patient comfort and therapy.

[0217] The control system 920 may also generate audio and / or display / visual outputs 938, 939. For example, the flow therapy device may include a display and / or a speaker. The display may indicate to the physician any warnings or alarms generated by the control system 920. The display may also indicate control parameters that may 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 state, including, but not limited to, generating the patient's respiratory rate, and sending it to the display, as described in greater detail below.

[0218] The control system 920 can vary the heater control outputs to control one or more of the heating elements (e.g., to maintain a temperature set point for the gas being delivered to the patient). The control system 920 can also vary the operation or duty cycle of the heating elements. The heater control outputs can include a heater plate control output 934 and a heated breathing tube control output 936.

[0219] The control system 920 may determine outputs 930 to 939 based on one or more received inputs 901 to 916. The inputs 901 to 916 may be combined with the inputs 901 to 916 generated by the controller 600 (e.g., Figure 19B The control system 920 may receive sensor inputs including, but 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, stored parameters 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 may receive input from a user or memory 624 (e.g., Figure 19BThe control system 920 can dynamically adjust the flow rate for the patient during the patient's therapy time. The control system 920 can continuously monitor system parameters and patient parameters. A person of ordinary skill in the art will understand based on the present disclosure that any other suitable inputs and / or outputs can be used with the control system 920.

[0220] 1.2 Controller

[0221] Figure 19B The controller 600 (which may be Figure 1 Controller 600 may include programming instructions for detecting input conditions and controlling output conditions. These programming instructions may be stored in memory 624 of controller 600. These programming instructions may correspond to the methods, processes, and functions described herein. These programming instructions may be executed by one or more hardware processors 622 of controller 600. These programming instructions may be implemented in C, C++, JAVA, or any other suitable programming language. Some or all of the various portions of these programming instructions may be implemented in application-specific circuitry 628, such as an ASIC or FPGA.

[0222] The controller 600 may also include circuitry 628 for receiving sensor signals. The controller 600 may also include a display 630 for displaying the status of the patient and the respiratory assistance system. The display 630 may also display warnings and / or other alerts. The display 630 may be configured to display the characteristics of the sensed gas in real time or in other ways. The controller 600 may also receive user input via a user interface (such as the display 630). The user interface may include buttons and / or a dial. The user interface may include a touch screen.

[0223] 1.3 Motor and sensor module

[0224] Any features of the respiratory systems described herein, including but not limited to a humidification chamber, a flow generator, a user interface, a controller, and a patient breathing conduit configured to couple the gas flow outlet of the respiratory system to a patient interface, may be combined with any of the sensor modules described herein.

[0225] Figure 20 A block diagram of a motor and sensor module 2000 is illustrated, which may be provided by a recess 250 in a respiratory device (e.g., Figure 17 and Figure 18 The motor and sensor module may include a blower 2001 that entrains room air for delivery to the patient. The blower 2001 may be a centrifugal blower.

[0226] One or more sensors (e.g., Hall effect sensors) can be used to measure the motor speed of the blower motor. The blower motor can include a brushless DC motor from which the motor speed can be measured without the use of a separate sensor. For example, during operation of the brushless DC motor, back EMF can be measured from the non-powered windings of the motor, from which the motor position can be determined, which in turn can be used to calculate the motor speed. Additionally, a motor driver can be used to measure the motor current, which can be used together with the measured motor speed to calculate the motor torque. The blower motor can include a low inertia motor.

[0227] Room air can enter room air inlet 2002, which enters blower 2001 through inlet port 2003. Inlet port 2003 can include valve 2004, through which pressurized gas can enter blower 2001. Valve 2004 can control the flow of oxygen into blower 2001. Valve 2004 can be any type of valve, including a proportional valve or a two-way valve. In some embodiments, the inlet port does not include a valve.

[0228] The blower 2001 can be operated at a motor speed greater than 1,000 RPM and less than 30,000 RPM, greater than 2,000 RPM and less than 21,000 RPM, or any value in between. The operation of the blower 2001 mixes the gas entering the blower 2001 through the inlet port 2003. Because mixing requires energy, using the blower 2001 as a mixer can reduce the pressure drop that would otherwise occur in a system with a separate mixer (such as a static mixer including baffles).

[0229] The mixed air can exit blower 2001 through conduit 2005 and enter flow path 2006 in sensor chamber 2007. A sensing circuit board with sensors 2008 can be positioned in sensing chamber 2007, such that the sensing circuit board is at least partially immersed in the gas flow. At least some of the sensors 2008 on the sensing circuit board can be positioned within the gas flow to measure gas properties within the gas flow. After passing through flow path 2006 in sensor chamber 2007, the gas can be exhausted 2009 to a humidification chamber.

[0230] Positioning sensor 2008 downstream of the combined blower and mixer 2001 can improve the accuracy of measurements (such as measuring gas fraction concentrations, including oxygen concentration, by positioning the sensor upstream of the blower and / or mixer). This positioning can provide a repeatable flow profile. Furthermore, positioning the sensor downstream of the combined blower and mixer avoids the pressure drop that would otherwise occur if sensing occurred before the blower, requiring a separate mixer (such as a baffled static mixer) between the inlet and the sensing system. A mixer can introduce a pressure drop within the mixer. Positioning the sensor after the blower allows the blower to act as a mixer, while a static mixer reduces pressure, whereas a blower increases pressure. Furthermore, immersing at least a portion of the sensing circuit board and sensor 2008 in the flow path can improve measurement accuracy because immersing the sensor in the flow path means it is more likely to experience the same conditions as the gas flow (such as temperature and pressure), thereby better representing the gas flow characteristics.

[0231] refer to Figure 21 , the gas leaving the blower may enter a flow path 402 in a sensor chamber 400, which may be located within the motor and sensor module and may be Figure 20 Sensor chamber 2007 of FIG. Flow path 402 may have a curved shape. Flow path 402 may be configured to have a curved shape without sharp turns. Flow path 402 may have curved ends with straighter sections between the curved ends. The curved flow path shape can reduce pressure drops in the gas flow without reducing the sensitivity of the flow measurement by aligning the measurement area with the flow path to form a measurement portion of the flow path.

[0232] A sensing circuit board 404 having sensors (such as acoustic transmitters and / or receivers, humidity sensors, temperature sensors, and thermistors) can be positioned in the sensor chamber 400 such that the sensing circuit board 404 is at least partially immersed in the flow path 402. Immersing at least a portion of the sensing circuit board and sensors in the flow path can improve measurement accuracy because the sensors immersed in the flow are more likely to be subject to the same conditions (such as temperature and pressure) as the gas flow, thereby providing a better representation of the gas flow characteristics. After passing through the flow path 402 in the sensor chamber 400, the gas can be exhausted to the humidification chamber.

[0233] Gas flow can be measured using at least two different types of sensors. The first type of sensor can include a thermistor, which can determine flow rate by monitoring heat transfer between the gas flow and the thermistor. A thermistor flow sensor can operate the thermistor at a constant target temperature within the flow as gas flows around and past the thermistor. The sensor can measure the power required to maintain the thermistor at the target temperature. The target temperature can be configured to be higher than the temperature of the gas flow, so that more power is required to maintain the thermistor at the target temperature at higher flow rates.

[0234] The thermistor flow sensor can also maintain multiple (e.g., two, three, or more) constant temperatures on the thermistor to avoid the difference between the target temperature and the gas flow temperature being too small or too large. Multiple different target temperatures allow the thermistor flow sensor to remain accurate over a wide range of gas temperatures. For example, the thermistor circuit can be configured to switch between two different target temperatures so that the gas flow temperature always falls within a certain range (e.g., not too close but not too far) relative to one of the two target temperatures. The thermistor circuit can be configured to operate at a first target temperature of approximately 50°C to approximately 70°C or approximately 66°C. This first target temperature can be associated with a desired flow temperature range of approximately 0°C to approximately 60°C or approximately 0°C to approximately 40°C. The thermistor circuit can be configured to operate at a second target temperature of approximately 90°C to approximately 110°C or approximately 100°C. The second target temperature can be associated with a desired flow temperature range of approximately 20°C to approximately 100°C or approximately 30°C to approximately 70°C.

[0235] The controller can be configured to adjust the thermistor circuit to at least vary between a first target temperature mode and a second target temperature mode by connecting or bypassing a resistor within the thermistor circuit. The thermistor circuit can be arranged in a Wheatstone bridge configuration comprising a first voltage divider arm and a second voltage divider arm. The thermistor can be located in one of the voltage divider arms. Further details of the thermistor flow sensor are described in PCT Publication No. WO2018 / 052320, filed on September 3, 2017, which is incorporated herein by reference in its entirety.

[0236] A second type of sensor may include an acoustic sensor assembly. Acoustic sensors, including an acoustic transmitter and / or receiver, can be used to measure the time of flight of an acoustic signal to determine gas velocity and / or composition, which can be used in flow therapy devices. In one ultrasonic sensing topology (including an ultrasonic transmitter and / or receiver), a driver causes a first sensor (such as an ultrasonic transducer) to generate an ultrasonic pulse in a first direction. A second sensor (such as a second ultrasonic transducer) receives the pulse and provides a measurement of the time of flight of the pulse between the first and second ultrasonic transducers. This time-of-flight measurement can be used by a processor or controller of the respiratory system to calculate the speed of sound of the gas flow between the ultrasonic transducers. The second sensor can transmit the pulse, and the first sensor can receive the pulse in a second direction opposite the first direction to provide a second time-of-flight measurement, thereby enabling determination of gas flow characteristics, such as flow rate or velocity. In another acoustic sensing topology, an acoustic receiver (such as a microphone) can receive the acoustic pulse transmitted by the acoustic transmitter (such as an ultrasonic transducer). More details of the acoustic flow sensor are described in PCT Application Publication No. WO 2017 / 095241, filed on December 2, 2016, which is incorporated herein by reference in its entirety.

[0237] One or more flow sensors, or sensor assemblies including one or more flow sensors, can be located at various locations in the respiratory device and / or along the gas flow path. In one configuration, one or more flow sensors or sensing assemblies can be located or arranged after the flow generator 50B, i.e., the sensors are configured or arranged to sense or measure the flow of gas in the flow path after the flow generator 50B. In this configuration, the flow signal or flow data generated by the flow sensor can represent the flow generator output flow signal or data (i.e., the flow rate of the gas flow output from the flow generator 50B).

[0238] In one exemplary configuration, one or more flow sensors or sensor assemblies may be located in the main device housing 100 before or after the humidifier 52 (if present). For example, the flow sensor may be arranged or configured in the main device housing 100 to sense the flow of gas at a position in the flow path between the flow generator 50B and the humidifier 52 or at a position in the flow path after the humidifier. In another exemplary configuration, one or more flow sensors or sensor assemblies may be located in or along the respiratory conduit 16 and / or patient interface 51. In this configuration, the sensor or sensor assembly is configured to sense or measure the flow of gas in the flow path, which includes or is constituted by the respiratory conduit 16 and / or patient interface 51, i.e., the flow path after the gas flow outlet 21 of the main device housing 100. In another exemplary configuration, the device may include any combination of the one or more flow sensors or sensor assembly configurations or positions mentioned. For example, the apparatus may include one or more flow sensors or any combination of sensor assemblies at any one or more locations along the gas flow path (whether in the main device housing 100, the breathing conduit 16, and / or the patient interface 51).

[0239] In some configurations, readings from both the first and second sensor types can be combined to determine a more accurate flow measurement. For example, a previously determined flow rate and one or more outputs from one of these sensor types can be used to determine a predicted current flow rate. This predicted current flow rate can then be updated using one or more outputs from the other of the first and second sensor types to calculate a final flow rate.

[0240] 2. Working parameter control example

[0241] Figure 22 Shown with Figure 1 Schematic diagram of an example respiratory assistance system 2200 similar to respiratory assistance system 10 is shown. Respiratory assistance system 2200 includes a gas source 2202, a respiratory rate sensor 2215, and a patient interface 2216. The patient interface provides high-flow therapy to patient P. The patient interface may be referred to as a high-flow therapy interface. Gas source 2202 may be referred to as a high-flow therapy device. Figure 22 The respiratory assistance system 2200 shown may include Figure 1Any element of the elements of the respiratory assistance system 10 in the embodiment. The patient interface 2216 in this example is an unsealed nasal cannula. The respiratory rate sensor 2215 may include one or more sensors. The one or more respiratory rate sensors 2215 may be one or more sensors configured to be attached to or located near the patient P. Each of the one or more sensors 2215 is configured to measure a patient parameter indicative of the respiratory rate of the patient. In an example, one or more of the wearable sensors may be a body-mounted respiratory rate sensor.

[0242] Gas source 2202 may include a flow generator or source 2224 that can generate a flow of breathing gas to be provided to humidification device 2224. In the example, flow source 2224 is a blower. However, flow source 2224 is not limited to a blower and may include a flow meter, a mixer, a flow pattern from a ventilator, or any other flow generating device. Other flow sources known to those skilled in the art may also be used with any of the examples of the present disclosure discussed further below.

[0243] Gas source 2202 may include a controller 2226 that controls the operation of flow source 2224. For example, controller 2226 may execute or implement a control system, described in greater detail below, to control the operation of the flow source and related operating parameters of the gas. For example, in some examples using a blower as the flow source, the control system may control the amount of power delivered to the blower. The fan or motor speed may be dependent on the amount of power.

[0244] In an example, the flow source 2224 may include a fan and a motor. Figure 22 As shown, the gas source may include a first inlet 2222 and a second inlet 2223. The first inlet 2222 may be configured to provide ambient air to the flow generator 2224, and the second inlet 2223 may be configured to be connected to a dry gas source (e.g., a gas tank or storage tank) and provide the gas to the flow generator 2224. The second inlet 2223 may draw or provide concentrated oxygen into the flow generator 2224. The amount of gas provided or drawn by the first inlet 2222 and / or the second inlet 2223 may be controlled by one or more valves (not shown). For example, the first inlet 2222 may be controlled by a first valve, and the second inlet 2223 may be controlled by a second valve. The one or more valves may be controlled by a controller 2226. The oxygen concentration level, which may also be referred to as the oxygen concentration in the gas, may be defined by the ratio of ambient air provided or drawn by the first inlet 2222 to the oxygen provided or drawn by the second inlet 2223. The oxygen concentration level may be controlled by controlling the first valve and / or the second valve. In an example, the oxygen concentration level may be controlled by controlling only the second valve.

[0245] 2.1 Control System

[0246] Figure 23 A block diagram illustrating an example of a control system 2320 that can detect a patient condition and control the operation of a respiratory assistance system 10, 2200 (including a gas source 124, 2202) is shown. In the example, the control system 2320 controls an operating flow rate 2332 of gas flowing through the respiratory assistance system 10, 2200 as it is delivered to the patient.

[0247] The control system 2320 can increase or decrease the flow rate by controlling the motor speed of the blower and / or the valve in the mixer. The control system 2320 can automatically control the working flow rate for a specific patient based on a parameter indicating the patient's respiratory rate, as discussed below. The control system 2320 can optimize the flow rate to improve patient comfort and therapy.

[0248] Additionally or alternatively, the control system 2320 can also increase or decrease the oxygen concentration level by controlling the first valve and the second valve to provide gas from the first inlet and the second inlet, respectively. The control system 2320 can automatically control the operating oxygen concentration level for a particular patient based on a parameter indicative of the patient's respiratory rate, as discussed below. The control system 2320 can optimize the oxygen concentration level to improve patient comfort and therapy.

[0249] The control system 2320 may also generate audio and / or visual output 2334. For example, the respiratory assistance system 100 may include a display, which may also include a speaker. The display may indicate to the physician any warnings or alarms generated by the control system 2320. The display may also indicate control parameters that may be adjusted by the physician. For example, the control system 2320 may automatically display the workload for a particular patient. The control system 2320 may also generate a patient's recovery status and send it to the display.

[0250] In some examples, the control system 2320 can change the temperature set point 2330 of one of the heating elements (such as a humidification chamber heater) to control the output conditions of the gas delivered to the patient. The control system 2320 can also change the operation or duty cycle of the heater described above.

[0251] As will be described, the control system 2320 may determine outputs 2330 to 2334 based on one or more received inputs 2302 to 2306. The inputs 2302, 2304 may correspond to sensor measurements received automatically by the controller 19, 600, or 2226.

[0252] The control system 2320 receives sensor input corresponding to the patient sensor input 2302. The patient sensor input may be from one or more wearable sensors configured to be attached to the patient to measure or provide an indication of a patient parameter. As will be discussed, the patient parameter may be SpO2 or respiratory rate.

[0253] The control system may also receive sensor inputs from device sensors 2304. For example, such device sensors may include one or more of the pressure sensors, flow sensors, temperature sensors, oxygen concentration sensors, or environmental sensors described above in the breathing assistance system 10, 2200.

[0254] The control system 2320 may also receive input from the user 2306 or values ​​stored in memory. For example, the user may input one or more initial values ​​for one or more of the operating parameters and / or values ​​defining ranges for one or more of the operating parameters. In an example, the initial operating flow rate and / or the initial operating oxygen concentration level may be manually set by a clinician. In an example, the range of the operating flow rate and / or the operating oxygen concentration level may also be manually set by a clinician. Alternatively, the initial values ​​and / or ranges of the operating flow rate and / or the operating oxygen concentration level may be pre-set or stored in memory.

[0255] In another example, the initial value and / or range of the working flow rate and / or working oxygen concentration level can be automatically determined based on one or more additional parameters. The one or more additional parameters can be input by the user and / or stored in the memory. The one or more additional parameters can correspond to the patient's condition and / or the system condition. The additional parameters can include patient characteristics such as age, weight, gender, height, sleep state (awake or asleep) and respiratory symptoms (e.g., presence of cough and / or sputum production). System parameters can include the time of day and the type of therapy selected. The control system 2320 can use these additional parameters to determine the initial value and / or range of the working flow rate and / or working oxygen concentration level.

[0256] The control system 2320 can dynamically adjust the operating flow rate 2332 for the patient during the patient therapy time. The control system 2320 can also dynamically adjust the operating oxygen concentration level 2336 for the patient during the patient therapy time. The control system 2320 can continuously monitor system parameters and patient parameters.

[0257] 2.1.1 Controller

[0258] The control system 2320 may include programming instructions for detecting input conditions and controlling output conditions. These programming instructions may be stored in a memory of the controller 19, 600, or 2226. In some examples, these programming instructions correspond to the methods, processes, and functions described herein. The control system 2320 may be executed by one or more hardware processors of the controller 19, 600, or 2226. These programming instructions may be implemented in C, C++, JAVA, or any other suitable programming language. In some examples, some or all of the various components of the control system 2320 may be implemented in application-specific circuits (such as ASICs and FPGAs).

[0259] like Figure 23 As illustrated, the control system 2320 may receive input from various components of the respiratory assistance system 100. Figure 23 All of the inputs 2302 to 2306 are shown as being present. In all examples, the inputs 2302 to 2306 and the outputs 2330 to 2336 may not necessarily be present. For example, the control system 2320 may only receive the patient sensor input 2302 and generate the flow control output 2332. Depending on the configuration, some of the components corresponding to these inputs may not be included in the respiratory assistance system 10, 2200. The control system 2320 may use the absence of an input itself to determine an input or system condition.

[0260] 2.2 Respiratory rate

[0261] Respiratory rate can be an important indicator of a patient's condition. Abnormal respiratory rate has been shown to predict a patient's respiratory status and / or respiratory disease, and in some cases, other serious events such as cardiac arrest and the need for escalation to a higher level of care. Therefore, respiratory rate can provide an indication of whether a patient's condition is worsening or improving. Respiratory rate can also be correlated with the work of breathing.

[0262] Changes in a patient's respiratory condition can quickly manifest as changes in respiratory rate. As a patient's condition worsens, their minute ventilation may increase. For example, as the condition worsens, the efficiency of gas exchange within the lungs may decrease, requiring a higher minute ventilation to maintain normal blood oxygen levels. This increase in minute ventilation is achieved through some combination of faster breathing and larger tidal volumes. Additionally, the body tends to breathe faster with larger tidal volumes. In this way, respiratory rate responds relatively quickly to changes in a patient's condition when compared to other measurable patient parameters (such as SpO2).

[0263] Respiratory rate can be affected by other factors; for example, increased physical activity may increase respiratory rate. However, patients receiving respiratory therapy (such as high-flow therapy) are typically resting, minimizing other potential causes of respiratory rate changes.

[0264] 2.2.1 Respiratory Rate Sensor

[0265] Respiratory rate is typically measured manually by counting breaths over a set time. This results in a high probability of error and prevents continuous patient monitoring. Therefore, manual measurement is not suitable for this purpose.

[0266] The present system and method for controlling the flow of gas delivered to a patient includes receiving or determining a patient parameter indicative of the patient's respiratory rate based on data from one or more sensors. The one or more sensors (such as Figure 22 Sensors 2215 (shown) may be one or more sensors configured to be attached to or positioned near a patient to measure a patient parameter indicative of the patient's respiratory rate. In examples, one or more of the sensors may be body-mounted respiratory rate sensors. In these examples, the sensors may be attached to the patient's clothing. In some examples, one or more of the sensors may be wearable respiratory rate sensors configured to be worn by the patient on their body and / or clothing, such as where the wearable respiratory rate sensor is in contact with or in proximity to the patient.

[0267] In one example, one or more body contact sensors can measure the movement of the diaphragm to determine the respiratory rate. In one example, translucent and / or reflective sensors can measure the respiratory rate by measuring the pulsations in the venous and / or arterial blood. For example, a pulse oximeter can be used to find the respiratory rate. In one example, an acoustic sensor can be placed on or near the patient to measure the respiratory rate by ultrasound or by vibrations in the trachea. In one example, a CO2 sensor located near the patient's mouth and / or nose (e.g., attached to a cannula) can determine the respiratory rate by the periodic increase in CO2 concentration when the patient exhales.

[0268] In some examples, one or more of the wearable respiratory rate sensors can be mechanical sensors. In some examples, the mechanical sensor can be a piezoelectric sensor. The piezoelectric sensor can include one or more piezoelectric elements. These piezoelectric elements can be mounted near the patient's chest or diaphragm. Movement of the patient's chest during breathing causes the piezoelectric element to move and generate a voltage based on the movement signal. In some examples, the voltage value can be sent to a respiratory therapy device for processing. The respiratory therapy device can determine the patient's respiratory rate based on the voltage value. In other examples, the piezoelectric sensor can include a processor that processes the voltage value and determines the respiratory rate. The determined respiratory rate can then be sent to the respiratory therapy device.

[0269] In one example, one or more of the sensors may not be wearable sensors. In one example, one or more of the sensors may not be in direct contact with the patient. Such sensors may be referred to as non-patient contact sensors. In one such example, a piezoelectric sensor may be placed under the patient's mattress and detect movement as the patient breathes to determine respiratory rate. In another example, an acoustic-based sensor may be used that utilizes one or more microphones to detect sound waves associated with the patient's respiratory function. In other examples, a radar-based sensor configured to measure the patient's respiratory rate may be used. The radar-based sensor may measure or detect a patient's displacement pattern, which may be used to characterize various cardiopulmonary functions, including respiratory rate.

[0270] Other examples are also envisioned, such as measuring a parameter indicative of a patient's breathing rate via a wearable sensor, such as a smartwatch.

[0271] For sensors attached to the patient or located near the patient to measure patient parameters, analysis of the flow and pressure delivered by the NHF therapy device can be used alternatively or additionally to determine the respiratory rate. For example, the controller can use signals from one or more pressure sensors and / or one or more flow sensors of the device. The one or more pressure sensors and / or one or more flow sensors can be located in the flow path of the respiratory system. During the provision of therapy, the patient's breathing may cause changes or fluctuations in the gas in the flow path of the respiratory system. These changes or fluctuations can be measured or determined based on signals from the one or more pressure sensors and / or one or more flow sensors of the device. These changes or fluctuations can then be evaluated (e.g., by Fourier transform or other waveform analysis) to determine or estimate the patient's respiratory rate.

[0272] In the present systems and methods, any one or more of the sensors and methods mentioned above can be used to measure or determine respiratory rate. These methods of measuring a patient's respiratory rate are generally non-invasive and non-intrusive, thus providing good patient compliance with monitoring equipment. These methods can continuously and accurately measure respiratory rate.

[0273] In some examples, one or more of the sensors can be dedicated body-contact respiratory rate sensors, such as those using any of the methods described above. Dedicated body-contact respiratory rate sensors can accurately and non-invasively measure the patient's respiratory rate. For example, some patients may be somewhat active during therapy (such as when they move or sit down). In these cases, a wearable sensor attached to the patient's body or clothing may be more convenient.

[0274] In other examples, the patient may be less active and a contactless sensor may be utilized. For example, the patient may be reclining in bed while receiving therapy, so they don't move much. In such examples, a contactless fixed sensor, such as a piezoelectric sensor under the mattress, may be used.

[0275] The one or more sensors may use any suitable wireless communication protocol (such as, for example, near field communication, Wi-Fi, or ), communicating directly with the controller of the high-flow therapy device via a wireless transmitter on the sensor. Alternatively, one or more of the sensors can communicate via a wired connection. One or more of the sensors can also be connected to an intermediate connector, such as a cloud-based connector. The cloud-based connector can then connect to the controller of the high-flow therapy device. Alternatively, the cloud-based connector can provide respiratory rate data to a clinician, who can then make setting adjustments to the high-flow therapy device.

[0276] The one or more sensors may be configured to measure or provide data indicative of the patient's instantaneous respiratory rate. The one or more sensors may be configured to measure or provide data indicative of the patient's instantaneous respiratory rate at specific time intervals. The time interval may be a fixed time interval. In some examples, the fixed time interval is a pre-set time interval. In such examples, the pre-set time interval may be between about 1 minute and about 8 hours. The pre-set time interval may, for example, be 5 minutes, or 10 minutes, or 15 minutes, or 30 minutes, or 45 minutes, or 1 hour, or 1 hour and 30 minutes, or 2 hours, or 3 hours, or 4 hours, or 5 hours, or 6 hours. In another example, the time interval is a variable time interval. The variable time interval may be based on the patient's respiratory rate and / or the patient's respiratory rate condition, and / or readings of one or more devices and / or patient sensors, and / or the amount of time in a therapy session.

[0277] Alternatively or additionally, the one or more sensors may be capable of measuring or providing data related to a patient parameter indicative of a time-averaged measurement of the patient's respiratory rate. This time-averaged measurement can be used to achieve a steady-state reading of the respiratory rate. The steady-state reading of the respiratory rate can ignore any transient measurements. The time-averaged measurement can be calculated over a measurement period. In one example, the measurement period is a fixed measurement period. In some examples, the fixed measurement period is a preset measurement period. In such examples, the preset measurement period can be between approximately 5 seconds and approximately 30 minutes. The preset measurement period can be between approximately 10 seconds and approximately 15 minutes. The preset measurement period can be between approximately 30 seconds and approximately 5 minutes. The preset measurement period can be, for example, 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, or 30 minutes. In another example, the measurement period is a variable measurement period. The variable measurement period can be based on the patient's respiratory rate and / or the patient's respiratory rate condition, and / or readings from one or more devices and / or patient sensors, and / or the amount of time in a therapy session.

[0278] In some examples, one or more of the sensors can measure and store multiple instantaneous measurements indicating the patient's respiratory rate during a measurement period. In such embodiments, the sensor can calculate a time-averaged measurement based on the multiple instantaneous measurements. The sensor can then send the calculated time-averaged measurement to a controller of the respiratory therapy device, as discussed above.

[0279] Alternatively, the sensor can send instantaneous measurements to the controller of the respiratory therapy device during a measurement period. In such an example, the controller of the respiratory therapy device then calculates a time-averaged measurement. The controller of the respiratory therapy device can then use the time-averaged measurement to determine the status of the patient's respiratory rate, as will be discussed.

[0280] Alternatively, during a measurement period, the sensor can send instantaneous measurements to an intermediate controller (such as a remote server). In such embodiments, the intermediate controller can store the instantaneous measurements and calculate a time-averaged measurement. The intermediate controller can then use the time-averaged measurement to determine the status of the patient's respiratory rate or send the time-averaged measurement to a controller of the respiratory therapy device.

[0281] In some examples, the respiratory rate reading may include a rolling average, such that the current reading at any point in time includes the time-averaged respiratory rate over the most recent measurement period. The rolling average may be calculated by the sensor, the intermediate connector, and / or the therapy controller.

[0282] In some examples, the one or more sensors may include multiple sensors. The multiple sensors may be used simultaneously to provide respiratory rate readings. For example, the multiple sensors may include a combination of two or more of the following: one or more wearable sensors, and / or under-mattress sensors, and / or flow sensors and / or pressure sensors in the device. In such examples utilizing multiple sensors, each sensor may send a measurement to the controller in a form as described above. The controller may then determine an average respiratory rate of the multiple sensors based on the measurements received from two or more of the available sensors. In some examples, the controller uses the measurements from all of the multiple sensors to provide a more accurate measurement of the patient's respiratory rate.

[0283] In some examples, the multiple sensors can provide redundancy in the event of a failure. For example, if one of the sensors stops functioning or is somehow separated from the patient, respiratory rate information can still be collected by another sensor or sensors. In some examples, the multiple sensors can be used for single-point failure tolerance. In such examples, the controller can use measurements from the multiple sensors to detect a sensor failure, such that the sensor providing the abnormal reading is not considered when determining the patient's average respiratory rate.

[0284] 2.2.2 Respiratory rate and flow

[0285] Figure 26 An example set of collected measurements is illustrated in a graphical format. The control system 220 can control the operating flow rate of the gas flow delivered to the patient via the patient interface. Control of the operating flow rate in turn affects the patient's measured respiratory rate, as determined by Figure 26 As shown in Figure 2600 and discussed below.

[0286] When providing respiratory therapy to a patient using the respiratory therapy system 10, 2200, the patient's respiratory response may vary with different flow rates, as determined by Figure 26 As shown in Figure 2600, high flow therapy can reduce the patient's respiratory rate relative to unassisted ventilation. This may be due to increased resistance to exhalation, resulting in longer exhalation time, improved dead space clearance of exhaled gas, and reduced rebreathing.

[0287] It is currently understood in the art that a reduction in a patient's respiratory rate, particularly one that occurs more rapidly with an increase in flow, is caused by improved flushing of the airways, improving CO2 clearance and allowing more fresh gas (oxygen) to enter the lungs. This increases the efficiency of gas exchange and reduces the number of breaths required.

[0288] As flow continues to increase, the patient's respiratory rate may decrease, e.g. Figure 28 As shown in the figure, this decrease can be gradual. As the flow rate (and pressure level) increases, there may be greater resistance to exhalation, which leads to further expansion of the lungs, resulting in a larger lung (alveolar) surface area and more efficient O2 and CO2 exchange. Therefore, as the flow rate increases further, the patient's respiratory rate slowly decreases.

[0289] When respiratory therapy is not providing any gas flow to the patient, the flow rate of gas delivered to the patient is 0 l / min. At this flow rate of 0 l / min, the patient will have a certain respiratory rate R0, 2604. The patient's respiratory rate can be measured in breaths per minute (bpm). Tests have shown that within a certain flow rate range, the flow rate vs. respiratory rate curve 2602 essentially follows the same Figure 26 Shapes similar to those shown.

[0290] The first portion of the curve 2602 follows an inverse sigmoid curve (or reverse S-shaped curve). However, after a certain point, as shown by 2606, further increases in flow stop reducing the respiratory rate further. Essentially at this point 2606, at flow F M The lowest respiratory rate R M At even higher flows, the respiratory rate may begin to rise. This may be due to the increased effort required to exhale at high flows. In other patients, the patient's respiratory rate may remain essentially constant (i.e., at a minimum value) at higher flows. In other patients, the patient's respiratory rate may continue to decrease after reaching Rm, but may be below a threshold, as discussed below. In still other patients, the patient's respiratory rate may increase and decrease after reaching Rm, as will be discussed below in conjunction with Figure 28 and Figure 29 discussed.

[0291] For some adult patients, the flow rate F at which the respiratory rate reaches its lowest value M It may be around 45 l / min. This may vary between different patients. It may also be different for the same patient at different times, such as when the patient is healthy versus when they are in respiratory distress. Therefore, it cannot be assumed that the minimum flow rate is the same for all patients.

[0292] Figure 28 and Figure 29 An alternative example set of collected measurement results is illustrated in a graphical format. Figure 26 As shown, the patient's respiratory response can vary with different flow rates, as shown by Figure 28 and Figure 29 2800. Within a certain flow range, the flow rate versus respiratory rate curve 2802 generally follows a shape similar to that shown.

[0293] Figure 28 and Figure 29 The alternative curve 2802 is shown with Figure 26 The curve shown similarly starts at a lower flow rate with a steeper negative gradient between about 25 l / min and 30 l / min. The curve 2802 then flattens out to a "bottom" point as shown by 2806. Figure 28 As shown, basically at point 2806, at flow rate F M Reach the minimum respiratory rate R M As shown, after the nadir, as indicated by 2806, further increases in flow may cause the patient's respiratory rate to rise and fall, causing it to further decrease and / or increase.

[0294] In an alternative example, a set of measurements may show a curve without a flat gradient segment at low flow rates, e.g. Figures 26 to 29 In an alternative example of this type, the curve may have a steeper negative gradient at lower flow rates. This can indicate that even at lower flow rates, increased flow has the effect of reducing the patient's respiratory rate.

[0295] like Figure 29 As shown, at least a first respiratory rate R1 of the patient can be determined at a first flow rate F1. At least a second respiratory rate R2 of the patient can be determined at a second flow rate F2, and a gradient or rate of change of the patient's respiratory rate can be calculated between the two flow rates. In one example, a difference ΔR between at least the first respiratory rate R1 and the second respiratory rate R2 can be determined. As will be discussed, a nadir 2806 can be established based on ΔR, or a negative gradient between two or more respiratory rate readings at corresponding flow rates being greater than a threshold.

[0296] As shown, after the nadir, as shown by 2806, further increases in flow may cause the patient's respiratory rate to rise and fall, causing it to further decrease and / or increase. After the nadir shown by 2806, further increases and decreases in the patient's respiratory rate may be determined to have a gradient or difference ΔR below a certain threshold. Subsequent negative gradients after the nadir 2806 may be below the threshold, thus not defining a minimum flow. This curve will vary between patients based on various parameters and conditions, but the nadir will typically occur after the first sharp decrease in respiratory rate. If a point after the first determined nadir, such as shown by 2806, is determined to have a gradient or difference ΔR above the certain threshold, a new nadir may be established.

[0297] 2.2.3 Respiratory rate range

[0298] A respiratory rate within the desired range may indicate a healthy and / or stable patient condition. Figure 26The range is shown as R T+ to R T- In some examples, the range can be between approximately 12 breaths per minute (BPM) to 20 BPM, 12 BPM to 18 BPM, or 12 BPM to 16 BPM. This range is typically defined by a clinician or doctor.

[0299] This range may vary depending on the patient type, respiratory condition, and other circumstances. For example, the range may differ depending on whether the patient is being treated in the hospital or at home. At home, a patient may need advance warning that their condition is worsening or cannot be stabilized with high-flow therapy. Therefore, the range used at home may be narrower than that used in the hospital.

[0300] A healthy patient's resting respiratory rate may be within the expected range. However, a patient with respiratory distress may have an elevated respiratory rate. Figure 26 In the example shown, the patient's respiratory rate R0 at a flow rate of 0 l / min is higher than the upper threshold R T+ The required range is determined by Figure 26 The shaded area in R T+ to R T- between.

[0301] 2.3 Flow Control Method

[0302] Figure 24 A flow chart illustrating an example of a method 2400 for controlling the flow of gas delivered to a patient based on the patient's measured respiratory rate. The process or method 2400 can be implemented by any of the systems described herein. The process or method 2400 can be implemented, for example, by the control system 2220.

[0303] The process or method 2400 can be performed continuously or continually within a therapy session. In some examples, the therapy session can be a single therapy session defined as starting with therapy provided at a certain flow rate and ending with therapy provided at a flow rate at or above a certain flow rate. In some examples, the flow rate defining the start and end of therapy can be any flow rate at or above 0 l / min.

[0304] Control system 2320 can adjust the operating flow rate of gas delivered or provided by respiratory therapy device 2202. Control system 2320 follows an iterative titration process or method 2400, discussed below, to find a substantially optimal operating flow rate using feedback from one or more sensors. The substantially optimal operating flow rate can be the flow rate at which the patient's respiratory rate is at or near a minimum. Additionally, in some examples, the substantially optimal operating flow rate can be the flow rate at which the patient's respiratory rate is within a range.

[0305] When a blower is used as the flow source 2224, the control system 2320 can, for example, increase the blower's motor speed to increase the operating flow of gas through the respiratory assistance system 10, 2200. The control system 2320 can measure one or more patient conditions in response to changes in one or more system parameters. The control system 2320 can measure the patient's respiratory rate in response to changes in the operating flow.

[0306] a. Initial workload

[0307] Process 2400 may begin at block 2402, where respiratory therapy device 2202 begins delivering a flow of gas. The flow of gas is provided at least at an operating flow rate. In some examples, the operating flow rate is sufficient to provide high-flow therapy to the patient during use, such as within the flow ranges discussed above. Control system 2320 may set the initial operating flow rate. The control system may also set other operating parameters of respiratory therapy device 2202. The operating parameters of respiratory therapy device 2202 may control the characteristics of the flow of gas delivered or provided by respiratory therapy device 2202.

[0308] As described above, the initial operating flow rate can be manually set by a clinician. In an example, the range of the operating flow rate can also be manually set by a clinician. Alternatively, the initial value and / or range of the operating flow rate can be pre-set or stored in a memory. The initial value and / or range of the operating flow rate can alternatively be determined based on one or more additional parameters. Additional parameters may include patient characteristics, such as age, weight, height, sex, sleep state (awake or asleep) and respiratory symptoms (e.g., presence of cough and / or sputum production), etc., and / or system parameters, including time of day and selected therapy type, etc. The control system 2320 can use these additional parameters to determine the initial value and / or range of the operating flow rate.

[0309] In some examples, once therapy begins, in an optional step (not shown), the operating flow rate can initially be increased incrementally. In such examples, once the operating flow rate is increased incrementally in this step, process 2400 then continues to begin an iterative control loop including steps 2404 to 2414.

[0310] b. Interval

[0311] Once therapy has begun and the respiratory therapy device is providing gas flow at the operating flow rate, process 2400 proceeds to begin an iterative control loop comprising steps 2404 through 2414. The iterative control loop is executed at intervals and comprises executing steps 2404 through 2414 at the intervals.

[0312] In some examples, the control system 2320 waits for a time interval before executing each of steps 2404 through 2410 / 2412, thereby defining the interval. For example, the control system 220 may wait for a time interval before continuing to execute steps 2404 through 2410 / 2412. This step is illustrated by block 2414 of process 2400. The step 2414 of waiting for the interval may be executed before step 2404 and after steps 2410 or 2412, such that there is a delay between each iteration of the control loop 2400. It should be understood that steps 2404 through 2410 / 2412 may be executed within substantially the same time interval.

[0313] In some examples, the time interval may be a fixed time interval. The fixed time interval may be the same interval for each iteration of the control loop. In some examples, the fixed time interval is a pre-set time interval. For example, the pre-set time period may be less than 10 minutes or greater than or equal to 10 minutes. In such examples, the pre-set time interval may be between about 1 minute and about 8 hours. The pre-set time interval may be, for example, 5 minutes, or 10 minutes, or 15 minutes, or 30 minutes, or 45 minutes, or 1 hour, or 1 hour and 30 minutes, or 2 hours.

[0314] In other examples, the time interval is a variable time interval. The variable time interval can be different for each iteration of the control loop, or a different variable time interval can be selected. The variable time interval can be based on a calculation or determination. In some examples, the variable time interval can be based on the patient's respiratory rate and / or the patient's respiratory rate status, and / or readings from one or more devices and / or patient sensors, and / or the amount of time in a therapy session. In some examples, the variable time interval is calculated or determined by the control system 2320 at each interval.

[0315] In another example, when the patient's respiratory rate condition is within a first range, the time period is set to a first value, and when the patient's respiratory rate condition is within a second range, the time period is set to at least a second value. For example, if the control system 2320 determines that the patient's respiratory rate decreases at a rate above a threshold between intervals, the time period can be set to the first value. If the control system 2320 determines that the patient's respiratory rate decreases at a rate below a threshold between intervals, the time period can be set to the second value. The first value can be less than the second value. In other embodiments, the first value can be greater than the second value. Additional thresholds and corresponding values ​​are contemplated.

[0316] c. Measure or determine respiratory rate

[0317] At block 2404, the control system 2320 receives or determines a patient parameter indicative of the patient's respiratory rate. The patient parameter indicative of the patient's respiratory rate may be based on data from one or more sensors, as discussed above.

[0318] As discussed above, the control system 2320 can determine the patient's respiratory rate based on one or more sensor measurements received at block 2404. In an example, the sensor measurement is a plethysmographic signal. Other measurements used to determine respiratory rate are discussed above. In some examples, the patient's respiratory rate can be input via a user interface and received by the control system 2320. The control system 2320 can store the received or determined respiratory rate in a memory.

[0319] In some examples, the control system 2320 can evaluate the quality of the received data or the determined respiratory rate. In such examples, the control system 2320 can determine that additional measurements of the respiratory rate are needed based on the received data or the determined respiratory rate being inadequate. For example, the control system 2320 can determine whether the last measured respiratory rate met or exceeded a boundary condition. If the control system 2320 determines that additional measurements are needed, the control system 2320 can perform step 2404 again until an appropriate reading is obtained. Alternatively, if the control system 2320 determines that additional measurements are not needed, the control system 2320 can then proceed to determine the status of the patient's respiratory rate at block 2406, as will be discussed.

[0320] The control system 2320 can store the measured patient parameters indicating the patient's respiratory rate in memory for each interval or measurement cycle. The control system 2320 can also store additional patient and / or system parameters in memory and associate them with the measured patient parameters for each interval. Accordingly, the control system 2320 can store the status of the patient and the respiratory assistance system 10, 2200 in conjunction with the measured parameters.

[0321] d. Determine the respiratory rate

[0322] At block 2406, the control system 2320 determines the status of the patient's respiratory rate. The control system 2320 determines the status of the patient's respiratory rate based on at least the patient parameters received or determined at step 2404. The control system 2320 may also determine the status of the patient's respiratory rate based on one or more patient parameters received or determined at one or more previous intervals.

[0323] In some examples, the condition of the patient's respiratory rate is determined based on comparing the received or determined patient parameter indicative of the patient's respiratory rate at the current interval with a patient parameter indicative of the patient's respiratory rate received or determined at at least one or more previous intervals.

[0324] In some examples, the condition of the patient's breathing rate is based at least on comparing the received or determined patient parameter indicative of the patient's breathing rate to a patient parameter indicative of the patient's breathing rate received or determined at a most recent previous interval.

[0325] In examples such as above, the comparison may indicate a change in a patient parameter indicative of the patient's breathing rate between two or more intervals.

[0326] In some examples, a condition of the patient's respiratory rate can be determined based on evaluating a trend in the patient's respiratory rate over time. The trend can be based on at least the measured patient parameter indicating the patient's respiratory rate acquired at a current interval and one or more patient parameters indicating the patient's respiratory rate measured at one or more previous intervals. The trend can indicate a change in the patient parameter indicating the patient's respiratory rate between two or more intervals.

[0327] In some examples, determining the condition of the patient's respiratory rate may include calculating, by the control system 2320, a rate of change of the patient's respiratory rate over time. The condition of the patient's respiratory rate may be determined based on evaluating a rate of change of a patient parameter indicative of the patient's respiratory rate. The rate of change of the patient parameter indicative of the patient's respiratory rate may be determined based on a calculation using the patient parameter indicative of the patient's respiratory rate received or determined at the current interval and one or more patient parameters indicative of the patient's respiratory rate received or determined at one or more previous intervals. The control system 2320 may use the one or more patient parameters indicative of the patient's respiratory rate in a function to determine a derivative of the function.

[0328] In some examples, the condition of the patient's respiratory rate can be a state of the patient's respiratory rate. The state of the patient's respiratory rate can, for example, be categorized into a certain category. In some examples, the category can be, for example, "stable," "decreasing," or "increasing." For example, the state of the patient's respiratory rate can be categorized into a certain category based on a comparison of patient parameters indicating the patient's respiratory rate at different intervals and / or a calculated rate of change of the patient's respiratory rate.

[0329] For example, if the control system determines that the patient's respiratory rate has decreased between intervals based on a comparison or determination or calculation between the received or determined patient parameters indicative of the patient's respiratory rate at the current interval discussed above and the patient parameters indicative of the patient's respiratory rate received or determined at at least one or more previous intervals, the condition of the patient's respiratory rate may be indicated as "decreased."

[0330] Additionally, if the comparison or determination or calculation indicates that the patient's respiratory rate increased between the intervals, the condition of the patient's respiratory rate may be indicated as "elevated."

[0331] Additionally, if the comparison or determination or calculation indicates that the patient's respiratory rate remains substantially constant between intervals, the condition of the patient's respiratory rate can be indicated as "stable." If the comparison or determination or calculation indicates that the change in the patient's respiratory rate is below a threshold, the control system 2320 can indicate that the condition of the patient's respiratory rate is "stable."

[0332] In some examples, the threshold value may be quantified as a percentage of the difference or change between the patient parameter indicative of the patient's respiratory rate received or determined at the current interval and the patient parameter indicative of the patient's respiratory rate received or determined at at least one or more previous intervals. In such examples, the threshold value may be a percentage of difference or change greater than 2.5%. In other examples, the threshold value may be a percentage of difference or change greater than 5%. In other examples, the threshold value may be a percentage of difference or change greater than 7.5%. In other examples, the threshold value may be a percentage of difference or change greater than 10%. In other examples, the threshold value may be a percentage of difference or change greater than 12.5%. In other examples, the threshold value may be a percentage of difference or change greater than 15%. In other examples, the threshold value may be a percentage of difference or change greater than 20%. In other examples, the threshold value may be a percentage of difference or change greater than 25%.

[0333] In some examples, the threshold value can be quantified as the difference or amount of change between the patient parameter indicative of the patient's respiratory rate received or determined at the current interval and the patient parameter indicative of the patient's respiratory rate received or determined at least at one or more previous intervals. In such examples, the threshold value can be a difference or amount of change greater than 0.1 breaths per minute (bpm). In another example, the threshold value can be a difference or amount of change greater than 0.5 bpm. In another example, the threshold value can be a difference or amount of change greater than 1 bpm. In another example, the threshold value can be a difference or amount of change greater than 1.5 bpm. In another example, the threshold value can be a difference or amount of change greater than 2 bpm. In another example, the threshold value can be a difference or amount of change greater than 2.5 bpm. In another example, the threshold value can be a difference or amount of change greater than 4 bpm. In another example, the threshold value can be a difference or amount of change greater than 5 bpm.

[0334] In some examples, the threshold value can be automatically determined based on one or more parameters. The one or more parameters can be input by the user and / or stored in memory. The one or more parameters can correspond to the patient's condition and / or the system condition. The parameters can include patient characteristics such as age, weight, gender, height, sleep state (awake or asleep) and respiratory symptoms (e.g., presence of cough and / or sputum production). System parameters can include the time of day and the type of therapy selected. The control system can use these parameters to determine the threshold value.

[0335] The control system 2320 can dynamically adjust the operating flow rate 2332 for the patient during the patient therapy time. The control system 2320 can also dynamically adjust the operating oxygen concentration level 2336 for the patient during the patient therapy time. The control system 2320 can continuously monitor system parameters and patient parameters.

[0336] like Figure 29 As shown, at at least a first interval associated with flow F1, one or more patient parameters indicative of the patient's respiratory rate (indicated by R1) are received or determined. At at least a second interval occurring after the first interval (the second interval being associated with flow F2), one or more patient parameters indicative of the patient's respiratory rate (indicated by R2) are received or determined.

[0337] The patient's respiratory rate status can be determined based on at least R1 and R2. In an example, a gradient or rate of change of the patient's respiratory rate between at least the two flow rates F1 and F2 can be calculated. In one example, a difference ΔR between at least the first respiratory rate R1 and the second respiratory rate R2 can be determined. As discussed, the patient's respiratory rate status can be based on ΔR or a negative gradient between two or more readings of respiratory rate at corresponding flow rates and intervals. Additionally, the patient's respiratory rate status can be based on ΔR compared to a threshold. The threshold can be a threshold such as that discussed above.

[0338] In some examples, the control system can determine whether the patient's respiratory rate has reached a minimum respiratory rate. Figure 26 and Figure 28 As shown, the patient's minimum respiratory rate R M Can be in flow F M In such an example, based on the methodology discussed above, when it is determined that the patient's respiratory rate has reached the minimum respiratory rate, the condition of the patient's respiratory rate may be classified as "stable."

[0339] Additionally or alternatively, the status of the patient's respiratory rate can be categorized by degree of change based on a comparison or determination or calculation between data from different intervals. In such examples, the status of the patient's respiratory rate can indicate the degree of change or amount of change at each interval. For example, the status of the patient's respiratory rate can indicate that the patient's respiratory rate is decreasing, and the degree of change or amount of change at the current interval compared to the previous interval is a certain amount (e.g., quantified as breaths per minute (bpm)). For example, this can be associated with a threshold value, which can be quantified as an amount or percentage of difference or change, as discussed above.

[0340] The conditions determined at one or more previous intervals may be considered when determining the condition of the patient's respiratory rate. Thus, the control system 2320 may track the condition of the patient's respiratory rate in or between multiple intervals.

[0341] In some examples, determining the condition of the patient's respiratory rate can take into account the condition of the patient's respiratory rate determined since the start of providing therapy. For example, this information can come from providing therapy at an initial working flow rate. The control system can determine to adjust or increase the working flow rate until the control system determines that the condition of the patient's respiratory rate indicates that the patient's respiratory rate is decreasing, and then the control system determines to maintain the flow rate thereafter. In other words, the control system adjusts the working flow rate from the initial working flow rate until the patient's respiratory rate or the condition of the patient's respiratory rate becomes above a threshold or outside a threshold. After this, the control system continues to adjust the flow rate until the control system determines that the patient's respiratory rate or the condition of the patient's respiratory rate is below the threshold or other threshold or within the threshold or other threshold. At this point, the control system maintains the working flow rate.

[0342] For example, regarding Figures 26 to 29 As shown in the graph, the patient's respiratory rate is relatively stable at lower flows, with a steeper negative gradient between about 25 l / min and 30 l / min. The curve then flattens to a "lowest" point. M Reach the minimum respiratory rate R M In this example, the control system adjusts the operating flow from the initial operating flow throughout the lower flow values ​​at which the patient's respiratory rate is substantially stable until the patient's respiratory rate or the condition of the patient's respiratory rate becomes above or outside a threshold value, which corresponds to the steeper negative gradient of the curve. Thereafter, the control system continues to adjust the flow until the control system determines that the patient's respiratory rate or the condition of the patient's respiratory rate is below or within the threshold value or other threshold value. This will be considered the point at which the curve flattens to a "lowest" point, as indicated by the flow rate F M Minimum respiratory rate R MAt this point, the control system maintains the operating flow. The control system then continues to determine the status of the patient's respiratory rate and, if the status of the patient's respiratory rate indicates that the operating flow should be adjusted (e.g., if the rate of change of the patient's respiratory rate is outside a threshold), determines to adjust the operating flow.

[0343] In some examples, steps 2404 and 2406 for determining the condition of the patient's respiratory rate may include: at each interval, the controller determining or receiving a patient parameter indicating the patient's respiratory rate at a current operating flow rate, at a flow rate that is one increment higher than the operating flow rate, and at a flow rate that is one increment lower than the operating flow rate. The controller may then use the patient parameter indicating the patient's respiratory rate at the current operating flow rate (i.e., the current respiratory rate), the patient parameter indicating the patient's respiratory rate at a flow rate that is one increment higher than the operating flow rate (i.e., the higher respiratory rate), and the patient parameter indicating the patient's respiratory rate at a flow rate that is one increment lower than the operating flow rate (i.e., the lower respiratory rate) to determine the condition of the patient's respiratory rate.

[0344] In these examples, step 2404 of method 2400 includes: the controller determining or receiving, in any order, a patient parameter indicating the patient's respiratory rate at the current operating flow; increasing the operating flow by an increment above the current operating flow and determining or receiving a patient parameter indicating the patient's respiratory rate at the increased operating flow; decreasing the flow by an increment below the current operating flow and determining or receiving a patient parameter indicating the patient's respiratory rate at the decreased operating flow. In some examples, additional patient parameters are determined or received at one or more additional increments above and / or below the operating flow.

[0345] In some examples, determining or receiving a patient parameter indicating the patient's respiratory rate at one or each of the current workload, the reduced workload, and / or the increased workload includes waiting for a time interval for the patient to respond to the flow change before determining or receiving the patient parameter. The time interval and the flow increment can be as discussed above.

[0346] In these examples, step 2406 of method 2400 includes determining a condition of the patient's respiratory rate based on an evaluation of a patient parameter indicating the patient's respiratory rate obtained at a current operating flow (i.e., a current respiratory rate), the patient's respiratory rate obtained at a flow rate that is one or more increments above the operating flow (i.e., a higher flow respiratory rate), and the patient's respiratory rate obtained at a flow rate that is one or more increments below the operating flow (i.e., a lower flow respiratory rate).

[0347] The controller is configured to evaluate the higher flow respiratory rate and determine whether the higher flow respiratory rate indicates that the patient's respiratory rate is stable or increasing using the method described above in connection with step 2406. The controller similarly evaluates the lower flow respiratory rate and determines whether the lower flow respiratory rate indicates that the patient's respiratory rate is stable or increasing using the method described above in connection with step 2406.

[0348] Thus, the controller can be configured to assess the status of the patient's respiratory rate at the operating flow, at one or more increments above the operating flow, and at one or more increments below the operating flow. Based on this assessment, the controller can determine that at the operating flow, the patient's respiratory rate is stable, increasing, or decreasing; and similarly, at a flow rate one or more increments above the operating flow, the patient's respiratory rate is stable, increasing, or decreasing; and at a flow rate one or more increments below the operating flow, the patient's respiratory rate is stable, increasing, or decreasing.

[0349] At step 2408, the controller may determine that the current operating flow is the optimal operating flow and that the operating flow does not need to be changed in the following situations: the patient's respiratory rate is stable or increasing at a flow rate that is one or more increments above the operating flow; and the patient's respiratory rate is increasing at a flow rate that is one or more increments below the operating flow.

[0350] The controller may determine that the workload is below the optimal workload if: the patient's respiratory rate is decreasing at a flow rate that is one or more increments above the workload; or if the patient's respiratory rate is increasing at a flow rate that is one or more increments below the workload. In these cases, the controller may determine that the workload should be increased incrementally at step 2408.

[0351] The controller can determine that the operating flow is above the optimal operating flow if the patient's respiratory rate is stable at flows that are one or more increments above the operating flow, and at flows that are one or more increments below the operating flow. In these cases, the controller can determine that the operating flow should be decreased by the increment.

[0352] If the patient's respiratory rate does not provide a definitive determination of whether the workload is optimal at one or more increments above and one or more increments below the workload, the controller can perform a second calibration using a second increment. In some examples, the second increment can be larger than the first increment. The second increment can provide a larger change in the patient's respiratory rate, which can help determine the optimal workload. The method described above can be repeated using the second increment.

[0353] Additionally, if the patient's respiratory rate condition at one or more increments above the workload and one or more increments below the workload does not provide a definitive determination of whether the workload is the optimal workload, the controller may re-execute the entire method 2400 starting from the initial flow to determine the optimal workload.

[0354] In some examples, step 2406 may include determining the patient's respiratory rate at the maintained operating flow rate at each defined time interval. Step 2406 may also include determining the patient's respiratory rate at a first flow rate that is higher than the maintained operating flow rate. Step 2406 may additionally include determining the patient's respiratory rate at a second flow rate that is lower than the maintained operating flow rate.

[0355] In these examples, step 2408 can include adjusting or maintaining the operating flow rate based on a comparison of: a condition of the patient's respiratory rate at the maintained operating flow rate; a condition of the patient's respiratory rate at the first flow rate; and a condition of the patient's respiratory rate at the second flow rate. The conditions determined at the maintained operating flow rate, at the first flow rate, and at the second flow rate can be compared relative to each other.

[0356] In some further examples, step 2406 may include determining, at each defined time interval, a respiratory rate of the patient at a fourth flow rate that is lower than the maintained operating flow rate. The fourth flow rate may be lower than the second flow rate. Step 2406 may also include determining a respiratory rate of the patient at a third flow rate that is higher than the maintained operating flow rate. The third flow rate may be higher than the first flow rate.

[0357] In these further examples, step 2408 can include adjusting or maintaining the operating flow rate based on a comparison of: a condition of the patient's respiratory rate at the maintained operating flow rate; a condition of the patient's respiratory rate at a third flow rate; and a condition of the patient's respiratory rate at a fourth flow rate. The conditions determined at the maintained operating flow rate, at the third flow rate, and at the fourth flow rate can be compared relative to each other.

[0358] e. Determine whether to adjust or maintain workload flow

[0359] Then, at box 2408, the control system 2320 can determine whether to adjust or maintain the working flow based on the determined condition of the patient's respiratory rate.

[0360] The control system 2320 can use the determined condition of the patient's respiratory rate to determine whether to adjust or maintain the workload. If the condition of the patient's respiratory rate indicates that the patient's respiratory rate is decreasing, the control system 2320 can determine to increase the workload at step 2408. Similarly, if the condition of the patient's respiratory rate indicates that the patient's respiratory rate is substantially stable, the control system 2320 can determine to maintain the workload at step 2408.

[0361] In some examples, if the condition of the patient's respiratory rate indicates that the patient's respiratory rate is increasing, then at step 2408, control system 2320 may determine to decrease the workload.

[0362] In some examples, the control system 2320 uses the patient's respiratory rate status and one or more previous adjustments to the workload to determine whether to increase or decrease the workload at step 2408. For example, if the workload was increased in the previous interval and the patient's respiratory rate status for the current interval indicates that the patient's respiratory rate is decreasing, the control system 2320 may determine to increase the workload.

[0363] Conversely, if the workload was decreased during the previous interval and the condition of the patient's respiratory rate indicates that the patient's respiratory rate is decreasing, the control system 2320 may determine to decrease the workload at step 2408. Furthermore, if the workload was decreased during the previous interval and the condition of the patient's respiratory rate indicates that the patient's respiratory rate is increasing, the control system 2320 may determine to increase the workload at step 2408.

[0364] In some examples, at block 2408, the control system 2320 can determine that the workload is to be maintained based on a condition of the patient's respiratory rate indicating that the patient's respiratory rate is substantially the same between intervals. The intervals can be the current interval and one or more previous intervals, as discussed above. In such examples, the control system 2320 can determine that the patient's respiratory rate is substantially the same between intervals based on the comparison at step 2406 indicating that the patient parameter (which indicates the patient's respiratory rate at the current interval) is within a defined range or threshold for one or more previous intervals.

[0365] In some examples, at block 2408, control system 2320 may determine that the workload is to be maintained based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is substantially stable between intervals or otherwise categorized as "stable." At step 2406, the condition of the patient's respiratory rate is determined.

[0366] In some examples, at block 2408, based on the first determination to maintain the workload, the control system 2320 can maintain the workload by adjusting the workload back to the workload of the previous interval. In such examples, the workload can be incrementally set back to the flow rate at which the patient's lowest respiratory rate is achieved. In this way, the workload can be adjusted back to the workload of the previous interval. M Reach the minimum respiratory rate R M ,like Figure 26 In some examples, the first determination to maintain the workload may be the first in a therapy session. In other examples, it may be the first in multiple therapy sessions.

[0367] In these examples, when the patient's respiratory rate remains substantially constant between intervals, the lower of the two operating flow rates is preferably used. In other words, if there is a lowest respiratory rate among the multiple flow rates (e.g., the curve has a flat portion at the lowest value), the lowest operating flow rate at which the lowest respiratory rate is achieved is preferably used.

[0368] In other examples, even if the resulting increase in the operating flow slightly increases the patient's respiratory rate, the operating flow may not be set back incrementally. Because the patient's respiratory rate rises more slowly when the flow is increased than when it is reduced from the lowest flow, it may be preferable to set the flow above the minimum value to increase stability.

[0369] Increment

[0370] If the control system 2320 determines that the operating flow rate should be adjusted, it can proceed to step 2410 and adjust the operating flow rate by an increment. In some examples, the increment can be a fixed time increment. The fixed time increment can be the same increment for each iteration of the control loop. In some examples, the fixed time increment is a pre-set time increment.

[0371] In another example, the increment is a variable time increment. The variable increment can be based on the patient's respiratory rate and / or the patient's respiratory rate status, and / or readings of one or more device and / or patient sensors, and / or the amount of time in the therapy session. At step 2408, the control system can also determine the size of the variable increment used to adjust the workload.

[0372] In another example, the increment (whether fixed or variable) can be automatically determined based on one or more additional parameters. The one or more additional parameters can be input by the user and / or stored in memory. The one or more additional parameters can correspond to the patient's condition and / or the system condition. The additional parameters may include patient characteristics such as age, weight, height, gender, sleep state (awake or asleep) and respiratory symptoms (e.g., presence of cough and / or sputum production). System parameters may include the time of day and the type of therapy selected. The control system 2320 may use these additional parameters to determine the increment.

[0373] The increment may be between about 0.1 l / min and about 20 l / min, optionally between about 0.5 l / min and about 15 l / min, optionally between about 1 l / min and about 10 l / min, optionally between about 2 l / min and about 8 l / min, optionally between about 3 l / min and about 6 l / min, and preferably about 5 l / min.

[0374] In some examples, process 2400 may use larger flow increments at the beginning of a therapy session. This is because it is less likely to achieve a minimum respiratory rate at low flow rates. For example, the system may use increments of 10 L / min until the system reaches 30 L / min. Once 30 L / min is reached, increments of 5 L / min may be used. Alternatively, the healthcare practitioner may set the initial working flow rate to a higher flow rate to make the titration process faster. If the first increment above the initial flow rate results in an increase in respiratory rate, the titration process should begin by decreasing the flow incrementally to find the minimum value.

[0375] In another example, the increment can be proportional to the difference between the respiratory rate received or determined for the current interval and the upper threshold RT+, as discussed below. For example, if the patient's respiratory rate is much higher than the upper threshold, a larger increment is used to bring the respiratory rate closer to the desired range at a faster rate. As the difference becomes smaller, the increment of flow used also becomes smaller.

[0376] Threshold

[0377] In some examples, at block 2408 , the control system 2320 may also compare the received or determined patient's respiratory rate and / or the condition of the patient's respiratory rate to one or more thresholds.

[0378] In one example, the one or more thresholds may be an upper threshold and a lower threshold. The one or more thresholds may be such that the patient's respiratory rate does not fall outside a predetermined range. A respiratory rate within the desired range may indicate a healthy and / or stable patient condition.

[0379] exist Figure 26 The range is shown as R T+ to R T- In this example, the upper threshold is R T+ , the lower threshold is R T- In some examples, the range can be between approximately 12 breaths per minute (BPM) to 20 BPM, 12 BPM to 18 BPM, or 12 BPM to 16 BPM. This range is typically defined by a clinician or physician. The range can be input to the respiratory therapy device and received by control system 220. In some examples, control system 220 can determine the range based on one or more patient conditions and / or system conditions.

[0380] This range may vary depending on the patient type, respiratory condition, and other circumstances. For example, the range may differ depending on whether the patient is being treated in the hospital or at home. At home, a patient may need advance warning that their condition is worsening or cannot be stabilized with high-flow therapy. Therefore, the range used at home may be narrower than that used in the hospital.

[0381] In some embodiments, at block 2408, the control system 2320 may receive additional parameters corresponding to the patient's condition and / or system status. The additional parameters may include patient characteristics such as age, sex, height, weight, sleep state (awake or asleep), and respiratory symptoms (e.g., presence of cough and / or sputum production). System parameters may include the time of day and the type of therapy selected. The control system 2320 may use these additional parameters to determine one or more thresholds.

[0382] In some examples, the patient's profile may be such that the minimum respiratory rate R M Below the lower limit R T- In this case, once the respiratory rate drops below R T- , the control system can set the working flow back in increments so that the respiratory rate reaches or exceeds R T- This ensures that the patient's respiratory rate does not remain below the lower threshold R T- .

[0383] In some examples, the high flow therapy device may reach its maximum operating flow before finding the minimum respiratory rate. In other words, the patient's minimum respiratory rate occurs at a flow rate that is higher than the maximum operating flow rate that the high flow device can achieve. For some devices, the maximum operating flow rate may be 70 l / min to 80 l / min. If the operating flow reaches this maximum value without achieving the minimum respiratory rate, an alarm may sound to advise the patient to receive other therapies, such as CPAP, non-invasive ventilation, or invasive ventilation. Alternatively, the high flow therapy device may be able to deliver different kinds of therapies, such as nasal high flow, CPAP, and NIV. In this case, when the maximum flow is reached with the high flow therapy setting, the high flow device can switch to other types of therapies.

[0384] In another example, the control system 2320 may not seek to achieve a minimum respiratory rate. Instead, the control system may achieve the lowest flow rate when the respiratory rate is within the desired range. For example, referring to Figure 26 , the control system can gradually increase the flow until it reaches F T+ , that is, the minimum flow rate that provides a respiratory rate within the threshold. This respiratory rate may be close to the upper threshold R T+ At this point, the control system stops increasing the working flow.

[0385] In another example, it may be desirable to maintain the respiratory rate between an upper threshold and a lower threshold. In this embodiment, the control system 2320 will titrate the patient's respiratory rate to a position within the desired range by executing steps 2404 to 2410 / 2412. In these examples, the control system 2320 may execute steps 2404 to 2412 by comparing the patient's respiratory rate to the threshold values ​​as long as the patient's respiratory rate is within the desired range. In these examples, when the patient's respiratory rate condition indicates that the patient's respiratory rate is "stable" or at a minimum value (such as R M ), and the patient's respiratory rate is additionally at the upper threshold R T+ and the lower threshold R T- When the system is running, the control system 2320 can maintain the working flow.

[0386] Additionally or alternatively, the control system 2320 can set boundary conditions or threshold conditions for the operating flow rate and not select a flow rate below a minimum flow rate. The control system 2320 can also limit the flow rate to a maximum flow rate, which can be set by the clinician or stored in the controller. The limit can be based on a flow rate at which the patient may begin to feel uncomfortable, such as 120 L / min for adults and 3 L / min / kg for neonatal patients and children. Higher flows can also increase noise and pressure. Accordingly, based on the data collected by the control system 2320, the control system can compare the operating flow rate at the current interval with the boundary conditions or threshold conditions of the flow rate at box 2408.

[0387] f. Adjust the workflow

[0388] At block 2410, the control system 2320 may adjust the workload flow rate based on the control system's determination at block 2408 that the workload flow rate should be adjusted. The control system 2320 may adjust the workload flow rate by the increment determined at block 2408.

[0389] As discussed above, at step 2408, if the condition of the patient's respiratory rate indicates that the patient's respiratory rate is decreasing, the control system 2320 can determine to increase the workload. At step 2410, the control system 2320 proceeds to increase the workload by an increment.

[0390] In some examples, if the condition of the patient's respiratory rate indicates that the patient's respiratory rate is increasing, then at step 2408, control system 2320 may determine to decrease the workload.

[0391] Increasing the workload may include adjusting the workload from a first value to a higher second value, wherein the difference between the first value and the second value is the increment.

[0392] Adjusting the operating flow rate includes adjusting the motor speed of the flow generator. For example, this can be achieved by outputting one or more flow control outputs 2332, as discussed above. In such an example, increasing the operating flow rate by an increment includes adjusting the motor speed of the blower from a first value to a second, higher value. The adjustment in motor speed can be proportional to the adjustment in operating flow rate.

[0393] In some examples, control system 2320 can adjust the operating flow rate within a range. The range can be defined by a maximum allowable flow rate and / or a minimum allowable flow rate. Control system 2320 can be configured to stop further increasing the operating flow rate if it determines that the determined increase in the operating flow rate will exceed the maximum allowable flow rate.

[0394] g. Maintain workflow

[0395] At block 2412, the control system 2320 may maintain the operating flow rate based on the control system's determination at block 2408 that the operating flow rate should be maintained. As discussed above, at step 2408, if the patient's respiratory rate condition indicates that the patient's respiratory rate is substantially stable or at a minimum value, the control system 2320 may determine that the operating flow rate should be maintained. At step 2412, the control system 2320 proceeds to maintain the operating flow rate, as discussed above.

[0396] f. Waiting interval

[0397] At box 2414, as previously discussed, after the control system 2320 adjusts the working flow at step 2410 or maintains the working flow at step 2412, the process 2400 then proceeds to a waiting time interval and then executes each of steps 2404 to 2410 / 2412 again.

[0398] For example, the control system 2320 may wait for a time interval before continuing to execute steps 2404 through 2410 / 2412. This step is illustrated by block 2414 of the process 2400. Thus, there is a delay between each iteration of the control loop 2400. It should be understood that steps 2404 through 2410 / 2412 may be executed within substantially the same time interval.

[0399] g. Additional / Optional Implementation

[0400] In some alternative examples, the control system can be configured to initially perform steps 2402 and 2404. The control system can then be configured to display a patient parameter indicative of the patient's respiratory rate to a user via a display of the respiratory therapy device, or a display of an external device in operative communication with the respiratory therapy device and forming part of a respiratory therapy system. In some examples, in addition to displaying the patient parameter indicative of the patient's respiratory rate, an indication of the workload can also be shown.

[0401] Additionally, user input can be received by the control system. The display can be configured to allow a user interface, such as via a touch screen, to provide user input. In some examples, the user input can be provided by one or more buttons, knobs, or dials of the respiratory therapy device. The user input is configured to allow the user to manually adjust the workload. The adjustment of the workload performed by the user is based on the displayed indication of the patient's respiratory rate (or other patient parameter).

[0402] In some further examples, method 2400 may further include prompting a user based on the decision at step 2408. In these examples, once step 2408 determines that the workload is to be adjusted, the user is prompted via a display that the workload is being adjusted. Additionally, the user may be presented with a new workload, and in some examples, a previous workload, via the display. Thus, the user is informed of changes to the workload.

[0403] In other examples, once step 2408 determines that the workload should be adjusted, the controller prompts the user that the controller has determined that the workload should be adjusted. In such examples, the user is prompted to confirm whether to continue adjusting the workload. The user can respond to this prompt, for example, by providing input via a display. Once a confirmation input is received from the user, the controller proceeds to step 2410 to adjust the workload in increments. If no confirmation input is received or if no confirmation input is received within a time period, the controller can proceed to step 2412 to maintain the current workload.

[0404] In some examples, the determination that the workload should be adjusted and / or the proposed new workload determined by the controller can be presented to the user as a suggestion rather than automatically implemented by the controller. The controller can be configured to present one or more prompts to the user regarding the proposed new workload and allow user input. Similarly, the user input can be configured to provide confirmation of the proposed workload and / or allow the proposed workload to be adjusted before confirmation.

[0405] In some additional examples, the controller can be configured to store the workload at the end of the therapy session in a memory. At the end of each therapy session, the controller can store the latest workload in the memory. When the next therapy session starts, at step 2402, the stored workload can be used as the initial workload for the therapy session.

[0406] 2.4 Alternative Examples of Flow Control Methods

[0407] In an alternative example flow control method, step 2408 of method 2400 is modified from the example described above. In this alternative example, step 2408 of determining whether to adjust or maintain the operating flow is based on comparing at least the patient parameter indicating the patient's respiratory rate to one or more thresholds, as will be described. In these examples, step 2406 may not be performed, and the method may proceed directly from step 2404 to step 2408. The other steps of method 2400 in this alternative example are as described above.

[0408] In this example, the user may be prompted to set one or more thresholds. The one or more thresholds may be one or more parameter thresholds. Each of the one or more parameter thresholds is associated with a patient or therapy parameter. The one or more thresholds may be associated with the patient's respiratory rate and / or one or more additional patient or therapy parameters. One or more of these thresholds may be associated with the corresponding parameter. The one or more thresholds may include an upper threshold and / or a lower threshold for each parameter. For example, the respiratory rate threshold may include an upper respiratory rate limit and a lower respiratory rate limit. The respiratory rate threshold may, for example, be between a lower limit of approximately 5 breaths per minute and an upper limit of approximately 35 breaths per minute, alternatively between approximately 8 breaths per minute and approximately 25 breaths per minute, alternatively between approximately 11 breaths per minute and approximately 21 breaths per minute, alternatively between approximately 12 breaths per minute and approximately 20 breaths per minute, alternatively between an upper limit of approximately 12 breaths per minute and approximately 18 breaths per minute, and preferably between a lower limit of approximately 12 breaths per minute and an upper limit of approximately 16 breaths per minute. This range is typically defined by a clinician or physician.

[0409] The one or more threshold values ​​may also include one or more time-based threshold values. The time-based threshold value may be associated with a minimum amount of time that one or more parameters are above each or more corresponding parameter threshold values. The time-based threshold value may be a time period. For example, the time-based threshold value may be between 5 minutes and 60 minutes, or more preferably between 10 minutes and 45 minutes, or more preferably 15 minutes.

[0410] Any of the one or more thresholds, including the one or more parameter thresholds, and / or the one or more time-based thresholds, may be set by a user. The thresholds may be set by a user using a user interface. Any one or more of these thresholds may alternatively be predefined or preconfigured and stored in a memory operatively connected to the controller.

[0411] In these examples, step 2408 includes evaluating the patient parameters received or determined from step 2404 according to the one or more thresholds. The method can proceed to step 2410 to adjust the workload based on the one or more parameters reaching or exceeding the one or more thresholds. If the parameters do not reach or exceed the one or more thresholds, the method proceeds to step 2412 to maintain the workload.

[0412] In some examples, once the user sets the parameters, they can confirm the parameters and begin using the device to provide therapy. Method 2400 will be performed as described above, skipping step 2406. At step 2408, when a parameter (such as the patient's respiratory rate) is greater than a threshold (e.g., a respiratory rate threshold), in some examples, for a time threshold, the method will proceed to step 2410 to adjust the workload by increments.

[0413] In any of the examples described in connection with step 2410 of the method 2400 , the increment used to adjust the operating flow rate can be an absolute value (ie, a value in liters per minute (L / min)). The absolute value may be user-configurable, for example, the user may set the increment to a value between about 0.1 l / min and about 30 l / min, optionally between about 0.1 l / min and about 15 l / min, optionally between about 0.1 l / min and about 10 l / min, optionally between about 0.1 l / min and about 5 l / min, optionally between about 1 l / min and about 10 l / min, optionally between about 2 l / min and about 8 l / min, optionally between about 3 l / min and about 6 l / min, preferably about 5 l / min, optionally between about 5 l / min and about 10 l / min, optionally between about 10 l / min and about 15 l / min, optionally between about 10 l / min and about 20 l / min, optionally between about 20 l / min and about 30 l / min. Alternatively, the absolute value may be pre-configured at the time of manufacture of the breathing apparatus or, in this case, at initial setup, and stored in the device's memory.

[0414] Alternatively, the increment for adjusting the workload can be determined as a percentage or fraction of the workload or initial workload. This percentage or fraction can be set by the user, for example, the user can set the percentage or fraction between 0% and 30% of the workload. Alternatively, this percentage or fraction can be pre-configured at the time of manufacture of the respiratory device or at initial setup, and stored in the device's memory.

[0415] In these examples, the increment of the workload to be adjusted at step 2410 may be an increase in the workload. In some examples, the increment of adjustment may be a decrease in the workload.

[0416] In some examples, the step 2410 of incrementally adjusting the workload includes changing the workload to the incremental workload in steps. In other examples, the step 2410 of incrementally adjusting the workload includes gradually adjusting the workload to the incremental workload over a period of time.

[0417] In some examples, when the workload is adjusted by the increment, method 2400 further includes: displaying a prompt or reminder to the user indicating that the workload has been adjusted. The prompt or reminder indicating that the workload has been adjusted can be presented via a display. The display can be configured to show a symbol or text to indicate to the user that the workload has been adjusted. Thus, the user is alerted that a parameter (e.g., a patient parameter) has exceeded one or more thresholds and that an adjusted (e.g., increased) workload is being achieved.

[0418] Additionally or alternatively, the method may include presenting an audible alarm to the user indicating that the workload has been adjusted. The audible alarm may be provided along with a prompt or reminder presented on the display. In these examples, the controller may be configured to wait for an interval (e.g., 5 minutes, 10 minutes, 15 minutes, or other values ​​as described above). If the parameter (e.g., respiratory rate) does not fall below a threshold after the interval, the controller may be configured to present the reminder and / or alarm.

[0419] In some examples, once the workflow has been adjusted by the increment, the method no longer includes determining whether to adjust or maintain the workflow. At this point, the controller can stop executing steps 2404 to 2414. The device can be "locked" at the adjusted (e.g., increased) workflow. To further adjust the workflow after the workflow has been adjusted, the user may need to make manual adjustments via the user interface. This is because, in some examples, the controller can adjust the workflow based on a threshold only when the patient exhibits a higher respiratory rate. Therefore, since this may be considered a clinically serious situation, user intervention may be required to further adjust the workflow, specifically to reduce it from an already elevated level. In other examples, the method may include executing steps 2404 to 2414 as described above, without preventing further adjustment of the workflow.

[0420] In some examples, the controller may receive or determine a patient parameter indicative of the patient's SpO2 based on data from one or more sensors. In these examples, step 2408 of determining whether to adjust or maintain the workload is further based on comparing the patient parameter indicative of the patient's SpO2 with one or more thresholds. The one or more thresholds in this example may be associated with a range or lower limit of the patient's SpO2. The controller may use the patient's SpO2 measured by one or more external sensors at step 2404 to trigger an adjustment to the workload based on a comparison of SpO2 with one or more thresholds. For example, if the measured SpO2 falls below a threshold within a time period (e.g., 5 minutes), the method determines that the workload needs to be adjusted (i.e., increased). Using the patient's SpO2 can be an alternative to using the patient's respiratory rate, or can be used in conjunction with the patient's respiratory rate. When used in conjunction with the patient's respiratory rate, SpO2 can have one or more specific thresholds, and the respiratory rate can have one or more specific thresholds.

[0421] Additionally, the controller may receive or determine a therapy parameter indicating the FiO2 being provided or to be provided to the patient. The therapy parameter indicating the FiO2 being provided or to be provided to the patient may be based at least in part on the patient parameter indicating the patient's SpO2. The indication of the patient's FiO2 may be a useful indicator when the therapy device automatically adjusts the FiO2 based on a signal related to the patient's SpO2, as described below. In these examples, step 2408 of determining whether to adjust or maintain the operating flow is further based on comparing the patient therapy indicating the FiO2 being provided or to be provided to the patient to one or more thresholds. In this example, if (within a minimum time period) the controller in the system increases the FiO2 above a certain threshold, this may be a surrogate indicator of low SpO2. Therefore, the controller may use the increase in FiO2 as an indication to adjust the operating flow. Using the FiO2 reading may be an alternative to using the patient's respiratory rate, or may be used in conjunction with the patient's respiratory rate. When used in conjunction with a patient's respiratory rate, FiO2 may have one or more specific thresholds, and respiratory rate may have one or more specific thresholds.

[0422] 2.5 Oxygen concentration level control method

[0423] In some examples, the control system may automatically control the operating oxygen concentration level of the gas delivered to the patient over the therapy time based on changes in the patient's condition, in addition to the flow control methods described above.

[0424] In such an example, the control system 2320 can increase or decrease the oxygen concentration level (i.e., FiO2) by controlling one or more of the first valve and the second valve to provide gas from the first inlet and the second inlet, respectively. The control system 2320 can automatically control the operating oxygen concentration level for a particular patient based on parameters indicative of the patient's respiratory rate and / or the patient's SpO2. The control system 2320 can optimize the oxygen concentration level to improve patient comfort and therapy.

[0425] PCT application publication No. WO2019 / 070136A1, filed on October 5, 2018, describes details of example methods that automatically control the level of O2 provided to a patient by adjusting the fraction of O2 provided to the patient (FiO2) so as to maintain the patient's measured SpO2 level within a target SpO2 range, and the entire text of this PCT application publication is incorporated herein by reference.

[0426] a. Effect of oxygen concentration levels on the relationship between respiratory rate and flow

[0427] Figure 27 An example set of collected measurements is illustrated in a graphical format. The control system 2320 can control the operating flow rate and operating oxygen concentration level of the gas flow delivered to the patient via the patient interface. Control of the operating flow rate and operating oxygen concentration level in turn affects the patient's measured respiratory rate, as determined by Figure 27 As shown in Figure 2700 and discussed below.

[0428] In this example, when respiratory therapy is not providing any gas flow to the patient, the flow rate of gas delivered to the patient is 0 l / min. At this flow rate of 0 l / min, the patient will have a certain respiratory rate R0, 2704. The patient's respiratory rate can be measured in breaths per minute (bpm). Tests have shown that within a certain flow rate range, the flow rate and respiratory rate curves 2702, 2710 generally follow the same flow rate. Figure 27 The shape shown is similar to the shape.

[0429] The first portion of the curve 2702, 2710 follows an inverse sigmoid curve (or reverse S-shaped curve). However, after a certain point, as shown by 2706, 2708, further increases in flow stop further reducing the respiratory rate. Essentially at this point 2706, 2708, at a flow rate F M The lowest respiratory rate R M At even higher flows, respiratory rate begins to rise. This is probably due to the increased effort required to exhale at higher flows.

[0430] Curve 2702 shows a first flow rate versus respiratory rate curve. Curve 2710 shows a second flow rate versus respiratory rate curve. When the fraction of inspired oxygen (FiO2) in the gas flow provided to the patient increases, more oxygen is available with each breath. This results in a decrease in minute ventilation because the patient receives the same amount of oxygen from a lower volume of inspired gas. Because the body prefers slower breathing rather than shallower breathing, the respiratory rate may decrease. Thus, curve 2710 shows curve 2702 after the working oxygen concentration level has been increased.

[0431] As shown, increasing the operating oxygen concentration level or FiO2 can have the effect of shifting the flow rate versus respiratory rate curve downward. This is illustrated by the difference between curve 2702 and curve 2710. Curve 2710 can be referred to as increasing oxygen concentration curve 2710. This shift can be proportional to the increase in the operating oxygen concentration level or FiO2.

[0432] At lower operating flows, it may be difficult to achieve a high percentage of operating oxygen concentration levels or FiO2 because a low proportion of the total flow delivered is inspired gas. Therefore, the increasing oxygen concentration curve 2710 is not plotted at low flows.

[0433] This curve shift by increasing the working oxygen concentration level can be used in situations where the respiratory rate cannot be reduced to a desired range by increasing the working flow alone. In such cases, the curve 2702 shown in the figure can be used with Figure 27 The curves shown are similar. As shown, even after full titration to FM, the patient's respiratory rate, RM, remains above Rmax.

[0434] In some cases, high-flow therapy may be initiated when the patient's condition is already deteriorating (at which point SpO2 may be suboptimal). In such cases, it is important to quickly restore SpO2 to optimal levels. Therefore, the controller may use closed-loop SpO2 control in conjunction with the closed-loop respiratory rate control method described above.

[0435] b.SpO2 Control Overview

[0436] In some examples, at the start of high flow therapy, the controller can be configured to receive one or more SpO2 readings, for example, from one or more sensors. The controller can be configured to compare the received one or more SpO2 readings with one or more thresholds. In these examples, if the SpO2 level is below the threshold, the oxygen concentration (FiO2) provided to the patient can be adjusted to attempt to restore SpO2 to a stable level, as described in PCT Application Publication No. WO2019 / 070136A1.

[0437] In such examples, respiratory rate-based workload adjustment, as disclosed above (e.g., with respect to method 2400), can be performed after or simultaneously with SpO2 control. In these examples, because the SpO2 controller or control loop adjusts FiO2 and the respiratory rate controller or control loop adjusts workload, the two closed-loop control methods can operate simultaneously and independently. However, in these examples, the respiratory rate-based FiO2 control described herein does not operate simultaneously with the SpO2-based FiO2 of the present example control method.

[0438] In one example, upon initiation of therapy, SpO2-based FiO2 control may be run until SpO2 has reached a stable level. This may include comparing SpO2 readings received from one or more sensors to one or more thresholds. For example, a stable SpO2 level may be defined as an SpO2 reading above a threshold. Once SpO2 is at a stable level for a minimum period of time (such as a time threshold, e.g., 10 to 30 minutes, or more preferably 15 minutes), the controller may deactivate SpO2 control and may enable respiratory rate-based work flow control (as described above in conjunction with Figure 24 described) and optionally FiO2 control based on respiratory rate (as described below in conjunction with Figure 25 described).

[0439] In some examples, at the start of therapy, SpO2-based FiO2 control and respiratory rate-based operating flow control can operate simultaneously. Once SpO2 reaches a stable level such as described above (e.g., above a threshold for a time threshold), SpO2-based FiO2 control can be disabled and respiratory rate-based FiO2 control can be enabled, as described below in conjunction with method 2500.

[0440] c. Oxygen concentration control method

[0441] Figure 25 A flow chart illustrating an example of a method 2500 for controlling the flow rate and oxygen concentration level of gas delivered to a patient based on the patient's measured respiratory rate is shown. The process or method 2500 includes, for example, Figure 24 2400. It will be appreciated that blocks or steps 2502, 2504, 2506, 2508, 2510, 2512, and 2514 correspond to blocks or steps 2402, 2404, 2406, 2408, 2410, 2412, and 2414, respectively.

[0442] As shown, at each interval, the control system 2320 may additionally adjust or maintain the operating flow rate and oxygen concentration level of the gas delivered or provided by the respiratory therapy device 100, 2202. The control system 2320 follows an iterative process or method 2500 of titration, discussed below, to find a substantially optimal operating flow rate and oxygen concentration level using feedback from one or more sensors.

[0443] The process or method 2500 may be performed continuously or continually within a therapy session or throughout a therapy session.

[0444] Substantially optimal operating flow and oxygen concentration levels may be such that the patient's respiratory rate is at or near a minimum value and the patient's respiratory rate is within range.

[0445] When a blower is used as the flow source 50 , 2224 , the control system 2320 may increase the motor speed of the blower to increase the working flow rate of gas through the breathing assistance system 10 , 2200 .

[0446] The control system 2320 may also increase the oxygen concentration level by controlling one or both of the first valve and the second valve to supply gas from the first inlet 2222 and the second inlet 2223 , respectively.

[0447] The control system 2320 can automatically control the operating flow rate and / or operating oxygen concentration level for a particular patient based on a parameter indicating the patient's respiratory rate. The control system 2320 can optimize the operating flow rate and operating oxygen concentration level to improve patient comfort and therapy.

[0448] The control system 2320 may measure one or more patient conditions in response to changes in the workload and / or oxygen concentration level. The control system 2320 may measure the patient's respiratory rate in response to changes in the workload and / or oxygen concentration level.

[0449] After the respiratory rate determination blocks or steps 2504 and 2506 and the flow control blocks or steps 2508 and 2510 / 2512, the control system 2320 may then perform the oxygen control steps 2516 and 2518 / 2520. In other examples, the oxygen control steps 2516 and 2518 / 2520 may occur before the flow control steps 2508 and 2510 / 2512.

[0450] like Figure 25 As shown, if the control system 2320 determines to adjust the working flow at box 2508, and then adjusts the working flow at box 2510, then in combination with Figure 24 Similar to the method described, the method proceeds to step 2514 to wait for the increment.

[0451] Alternatively, if the control system 2320 determines to maintain the operating flow at box 2508, it proceeds to maintain the operating flow at box 2512, and then the method proceeds to step 2516 to perform oxygen control steps 2516 and 2518 / 2520, and then proceeds to step 2514 to wait for the increment.

[0452] In these examples, the operating flow rate control is performed iteratively until the operating flow rate is maintained. Once the operating flow rate is maintained, the oxygen concentration control can be used to maintain the operating flow rate at a stable or minimum level and increase the concentration of oxygen or FiO2 until the patient's respiratory rate is within the desired range. In these embodiments, controlling the operating flow rate allows the patient's respiratory rate to drop to a stable level, which may still be outside the preferred range. Therefore, the oxygen concentration can be controlled so that the patient's respiratory rate can be further reduced to within the preferred range. If the patient's respiratory rate can be minimized and can be brought to a stable level and within the desired range using only the flow rate, then the oxygen concentration may not need to be adjusted.

[0453] In another example, if the control system 2320 determines to adjust the operating flow rate at block 2508, the operating flow rate is adjusted at block 2510, and the method then proceeds to step 2516 to perform oxygen control steps 2516 and 2518 / 2520, and then proceeds to step 2514 to wait for an increment. In these examples, the control system 2320 performs control of the operating oxygen concentration level and the operating flow rate within the same interval regardless of the patient's respiratory rate status.

[0454] Respiratory rate determination blocks or steps 2504 and 2506, flow control blocks or steps 2508 and 2510 / 2512, and oxygen control steps 2516 and 2518 / 2520 may all be performed within the same interval. In other examples, one or more of these blocks or steps may be performed within different intervals. For example, within one interval, the control system 2320 may perform respiratory rate determination blocks or steps 2504 and 2506, and flow control blocks or steps 2508 and 2510 / 2512. Within the next interval, the control system 2320 may perform respiratory rate determination blocks or steps 2504 and 2506, and oxygen control steps 2516 and 2518 / 2520. This alternating process may be repeated within subsequent intervals. Oxygen control steps 2516 and 2518 / 2520 will now be discussed. Block 2516 includes determining whether to adjust or maintain the operating oxygen concentration level. This determination may be based on a measured patient parameter indicating the patient's respiratory rate at the current interval. In some examples, this determination can be based on the condition of the patient's respiratory rate determined at the current interval, as discussed above. In some examples, determining whether to adjust or maintain the operating oxygen concentration level can also be based on comparing a patient parameter indicative of the patient's respiratory rate received or determined at the current interval to one or more threshold values. In other examples, determining whether to adjust or maintain the operating oxygen concentration level can also be based on comparing the condition of the patient's respiratory rate determined at the current interval to one or more threshold values.

[0455] Then, based on the determination at block 2516, the control system 2320 proceeds to block 2518 or 2520. Block 2518 then includes adjusting the operating oxygen concentration level by an increment based on the determination that the operating oxygen concentration level is to be adjusted. Block 2520 includes maintaining the operating oxygen concentration level at the current operating oxygen concentration level based on the determination that the operating oxygen concentration level is to be maintained.

[0456] d. Determine whether to adjust or maintain the working oxygen concentration level

[0457] In block 2516, the control system 2320 may determine whether to adjust or maintain the operating oxygen concentration level. This determination may be based on a measured patient parameter indicating the patient's respiratory rate at the current interval. In such an example, this may include: determining whether to adjust or maintain the operating oxygen concentration level may also be based on comparing a patient parameter indicating the patient's respiratory rate received or determined at the current interval to one or more threshold values.

[0458] The control system 2320 can compare the received or determined patient parameters indicative of the patient's respiratory rate to one or more target respiratory rates. The target respiratory rate can define a respiratory rate threshold. In an example, the target can include an upper range threshold and a lower range threshold. For example, Figure 27 As shown, the upper range threshold is shown by Rmax, and the lower range threshold is shown by Rmin. In some examples, the target can also include the midpoint of the range, or any other value of the range. The range defined in such examples is between the upper range threshold and the lower range threshold.

[0459] If the received or determined patient parameter indicative of the patient's respiratory rate indicates that the patient's respiratory rate is greater than the upper range threshold, then at step 2516, the control system 2320 may determine that the operating oxygen concentration level is to be increased.

[0460] Similarly, if the received or determined patient parameter indicative of the patient's respiratory rate indicates that the patient's respiratory rate is below the lower range threshold and above the upper range threshold, then at step 2516, the control system 2320 may determine that the operating oxygen concentration level is to be maintained.

[0461] In some examples, if the received or determined patient parameter indicative of the patient's respiratory rate indicates that the patient's respiratory rate is below a lower range threshold, then at step 2516, the control system 2320 may determine to decrease the operating oxygen concentration level.

[0462] Additionally or alternatively, the control system 2320 can set boundary conditions for the operating oxygen concentration level and not select a concentration level above a maximum level. The control system 2320 can also limit the oxygen concentration level to a minimum level that can be set by a clinician or stored in the controller. Accordingly, based on data collected by the control system 2320, the operating oxygen concentration level at the current interval can be compared to the boundary conditions at block 2516.

[0463] For example, if the operating oxygen concentration level reaches the maximum acceptable concentration level and the patient's respiratory rate is still not at the target or within the upper and lower range thresholds, an alarm may sound. Additionally, the control system 2320 may prevent adjustment of the oxygen concentration level and may instead maintain the oxygen concentration level.

[0464] In some examples, once the patient's respiratory rate condition is deemed stable or at a minimum value, such as at step 2506, the patient's respiratory rate may be within a desired range or within an upper and lower threshold, but still above a target level, such as between Rmax and Rmin, and above RT, as shown. Figure 27In such an example, because the patient's respiratory rate is within the upper and lower thresholds, the control system 2320 can determine that the operating oxygen concentration level should be maintained because supplemental oxygen is not required. No adjustment or increase in the operating oxygen concentration or FiO2 is required.

[0465] If the control system 2320 determines that the operating oxygen concentration level should be adjusted, it can proceed to step 2518 and adjust the operating oxygen concentration level by increments. In some examples, the increments can be fixed time increments. In another example, the increments can be variable time increments. It should be understood that the increments used to adjust the operating oxygen concentration level can be determined in the same manner as the increments for the operating flow rate at block or step 2408 / 2508.

[0466] The increase may be between about 0.1% and about 20%, optionally between about 0.5% and about 15%, optionally between about 1% and about 10%, optionally between about 2% and about 8%, optionally between about 3% and about 6%, and preferably about 5%.

[0467] e. Adjust working oxygen concentration

[0468] At block 2518, the control system 2320 may adjust the operating oxygen concentration level based on the control system's determination at block 2516 that the operating oxygen concentration level is to be adjusted. The control system 2320 may adjust the operating oxygen concentration level by the increment determined at block 2516.

[0469] Adjusting the operating oxygen concentration level may include adjusting the operating oxygen concentration level from a first value to a second, higher value. The difference between the first value and the second value is the increment.

[0470] Adjustment of the operating oxygen concentration level can include adjusting a first valve and / or a second valve of the flow generator. For example, this can be accomplished by outputting one or more oxygen control outputs 2336, as discussed above. In such an example, incrementally increasing the operating oxygen concentration level includes adjusting the second valve to increase the amount of oxygen being drawn or provided to the blower. The valve adjustment can be proportional to the adjustment of the operating oxygen concentration level.

[0471] f. Maintain working oxygen concentration

[0472] At block 2520, the control system 2320 may maintain the operating oxygen concentration level based on the control system's determination to maintain the operating oxygen concentration level at block 2516. As discussed above, at step 2516, if the patient's respiratory rate is within the upper and lower thresholds, the control system 2320 may determine to maintain the operating oxygen concentration level. At step 2520, the control system 2320 proceeds to maintain the operating oxygen concentration level, as discussed above.

[0473] At box 2514, after the control system 2320 adjusts the operating oxygen concentration level at step 2518 or maintains the operating oxygen concentration level at step 2520, the process 2500 proceeds to a waiting time interval and then performs step 2504 and the remainder of the process 2500 as previously discussed.

[0474] Although processes 2400 and 2500 are described separately, control system 2320 can perform one or both of these processes simultaneously to control flow rate and / or oxygen concentration level. Accordingly, control system 2320 can use a combination of steps from processes 2400 and 2500 to control flow rate and / or oxygen concentration level to provide optimal therapy to the patient.

[0475] 2.6 Control of oxygen concentration

[0476] In some alternative examples, the operating flow rate may be set by a clinician and not controlled by the control system 2320. In such examples, the control system 2320 may only control the oxygen concentration level.

[0477] Figure 30 A flow chart illustrating an example of a method 3000 for controlling the oxygen concentration level of gas delivered to a patient based on the patient's measured respiratory rate. The process or method 3000 includes, for example, Figure 25 Many of the steps of the process or method 2500 are shown and described. It should be understood that blocks or steps 3002, 3004, 3006, 3016, 3018, 3020, and 3014 correspond to blocks or steps 2502, 2504, 2506, 2516, 2518, 2520, and 2514, respectively.

[0478] As shown, at each interval, the control system 2320 can additionally adjust or maintain the operating flow rate and oxygen concentration level of the gas delivered or provided by the respiratory therapy device 100, 2202. The control system 2320 follows an iterative process or titration method 3000 to find a substantially optimal oxygen concentration level using feedback from one or more sensors. The substantially optimal oxygen concentration level can be, for example, such that the patient's respiratory rate is at or near a minimum value and / or the patient's respiratory rate is within a range.

[0479] The process or method 3000 may be performed continuously or continually within a therapy session or throughout a therapy session.

[0480] In this example, the workload can be set by the clinician or user rather than being controlled in an iterative manner by the control system 2320, as previously described in conjunction with Figure 24 and Figure 25 When a blower is used as the flow source 50, 2224, the control system 2320 can control the blower's motor speed to set the operating flow of gas through the respiratory assistance system 10, 2200. The clinician or user of the respiratory device can manually change the operating flow during therapy, but it will not be titrated automatically.

[0481] The working oxygen concentration level can be combined with Figure 25 The patient's respiratory rate is iteratively titrated to keep the patient's respiratory rate within a desired range as described in steps or blocks 2502, 2504, 2506, 2516, 2518, 2520, and 2514. The control system 2320 can increase the oxygen concentration level by controlling one or both of the first and second valves to provide gas from the first inlet 2222 and the second inlet 2223, respectively.

[0482] 2.7 Warning

[0483] The control system 220 can also generate alarms or warnings based on the measured physiological parameters of the patient. For example, if the respiratory rate exceeds or drops below an acceptable limit, the control system 220 can generate an alarm for display. Alternatively, the control system can generate an alarm or warning based on the relative insensitivity of the measured parameters to changes in flow. For example, if a patient parameter (such as respiratory rate) is not sensitive to flow, this may indicate that the therapy is unlikely to be effective. In one embodiment, the control system 220 can change the flow and determine that the patient parameter (such as respiratory rate) is not significantly affected by the change in flow. Based on the lack of correlation, the control system 220 can determine that the therapy may not be optimal for the patient.

[0484] 2.8 Application

[0485] The high-flow therapy respiratory assistance system 100 can be used to support patients in the emergency room, intensive care unit (ICU), operating room (OR), other hospital areas, or at home. Specifically, the respiratory assistance system 100 can be used to support patients under anesthesia, pre-oxygenation, and post-surgery. In some embodiments, using high-flow therapy may have advantages because the patient can still communicate and the mouth is not covered by a mask. Any time a patient requires intubation or an endoscopy, the mouth may be blocked and cannot be used to provide invasive air support. Accordingly, in these situations, high-flow therapy and the nasal cannula configuration of the respiratory assistance system 100 can be used to provide respiratory support. In these situations, the control system 220 can determine the patient's respiratory rate or other physiological parameters and automatically determine the flow setting. When the patient uses the respiratory assistance system 100 at home, the control system 220 can be used to adjust the flow setting during the initial phase. The patient can also measure their respiratory rate and input it using the controller.

[0486] Terms and Definitions

[0487] Unless the context indicates otherwise, the phrases "computer-readable medium" or "machine-readable medium" as used in this specification and claims shall be deemed to include a single medium or multiple media. Examples of multiple media include centralized or distributed databases and / or associated caches. These multiple media store one or more sets of computer-executable instructions. The phrases "computer-readable medium" or "machine-readable medium" shall also be deemed to include any medium capable of storing, encoding, or carrying an instruction set for execution by a processor of a computing device and causing the processor to perform any one or more of the methods described herein. The computer-readable medium may also be capable of storing, encoding, or carrying data structures used by or associated with these instruction sets. The phrases "computer-readable medium" and "machine-readable medium" include, but are not limited to, portable fixed storage devices, solid-state memories, optical media or optical storage devices, magnetic media, and / or various other media capable of storing, containing, or carrying instructions and / or data. "Computer-readable medium" or "machine-readable medium" may be non-transitory.

[0488] The term "comprising" as used in this specification and claims means "including at least in part" or "including, but not limited to," so that it is to be understood as inclusive rather than exclusive or exhaustive. When interpreting a statement in this specification and claims containing the term "comprising," features other than the one or those following the term may also be present. Related terms such as "comprising" and "including" are to be interpreted in the same manner.

[0489] Reference to a numerical range disclosed herein (e.g., 1 to 10) is intended to also include reference to all rational numbers within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10), as well as any range of rational numbers within that range (e.g., 2 to 8, 1.5 to 5.5, and 3.1 to 4.7), and thus all subranges of all ranges explicitly disclosed by the text are hereby explicitly disclosed. These are merely examples of what is specifically intended, and in this application, all possible combinations of numerical values ​​between the lowest value and the highest value should be considered to be expressly stated in a similar manner.

[0490] The term "and / or" means "and" or "or", or both.

[0491] The word "(s)" after a noun refers to the plural and / or singular form of the noun.

[0492] Unless specifically stated otherwise or understood otherwise in the context of use, conditional language (such as "may," "can," "might," or "could") is generally intended to convey that some embodiments include certain features, elements, and / or steps that other embodiments do not. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are in any way required for one or more embodiments, or that one or more embodiments must include logic for deciding, with or without user input or prompting, whether such features, elements, and / or steps are included or to be performed in any particular embodiment.

[0493] As used herein, language of degree, such as the terms "substantially," "approximately," "about," "generally," and "substantially," as used herein, refers to a value, amount, or characteristic that is close to a stated value, amount, or characteristic and still performs a desired function or achieves a desired result. For example, the terms "substantially," "about," "generally," and "substantially" may refer to an amount that is less than 10% of the stated amount, less than 5% of the stated amount, less than 1% of the stated amount, less than 0.1% of the stated amount, and less than 0.01% of the stated amount.

[0494] Where patent specifications, other external documents or other sources of information are cited in this specification, this is generally for the purpose of providing a context for discussing features of the invention. Unless specifically stated otherwise, the reference to such external documents is not to be construed as an admission that, in any jurisdiction, such documents or such sources of information are prior art or form part of the common general knowledge in the art.

[0495] In the above description, specific details are provided to provide a thorough understanding of the embodiments. However, those skilled in the art will appreciate that the embodiments may be practiced without these specific details. For example, software modules, functions, circuits, etc. may be illustrated using block diagrams to avoid obscuring the embodiments with unnecessary detail. In other instances, well-known modules, structures, and techniques may not be shown in detail to avoid obscuring the embodiments.

[0496] Additionally, it should be noted that these embodiments may be described as a process, which may be depicted as a flow chart, flow diagram, structure diagram, or block diagram. Although a flow chart may describe operations as a sequential process, many of the operations may be performed in parallel or concurrently. Furthermore, the order of the operations may be rearranged. A process terminates after its operations are completed. A process may correspond to a method, function, process, subroutine, subprogram, etc. in a computer program. When a process corresponds to a function, its termination corresponds to the function returning to the calling function or main function.

[0497] Aspects of the systems and methods described above can operate on any type of general-purpose computer system or computing device, including but not limited to a desktop computer, a laptop computer, a notebook computer, a tablet computer, a smart television, a game console, or a mobile device. The term "mobile device" includes but is not limited to a wireless device, a mobile phone, a smart phone, a mobile communication device, a user communication device, a personal digital assistant, a mobile handheld computer, a laptop computer, a wearable electronic device such as a smart watch and a head-mounted device, an e-book reader and a reading device capable of reading electronic content typically carried by an individual, and / or other types of mobile devices having some type of communication capability (e.g., wireless, infrared, short-range radio, cellular, etc.).

[0498] Aspects of the systems and methods described above may be operated or implemented on any type of dedicated or specialized computer, or any machine or computer or server or electronic device having a microprocessor, processor, microcontroller or programmable controller, or the like, or a cloud-based platform or other network of processors and / or servers (whether local or remote), or any combination of such devices.

[0499] In addition, embodiment can be realized by hardware, software, firmware, middleware, microcode or their any combination.When realizing in software, firmware, middleware or microcode, program code or code segment for performing necessary tasks can be stored in machine-readable medium, such as in storage medium or other storage device.Processor can perform necessary tasks.Code segment can represent any combination of process, function, subroutine, program, routine, subroutine, module, software package, class, or instruction, data structure or program statement.Code segment can be coupled to another code segment or hardware circuit by transmitting and / or receiving information, data, parameter, parameter or memory content.Information, parameter, parameter, data etc. can be transmitted, forwarded or transmitted via any suitable means (comprising memory sharing, message passing, token passing, network transmission etc.).

[0500] In the above description, storage media may refer to one or more devices for storing data, including read-only memory (ROM), random access memory (RAM), magnetic disk storage media, optical storage media, flash memory devices and / or other machine or computer-readable media for storing information.

[0501] The various illustrative logical blocks, modules, circuits, elements, and / or components described in conjunction with the examples disclosed herein may be implemented or performed using a general-purpose processor, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA) or other programmable logic component, a discrete gate or transistor logic component, a discrete hardware component, or any combination thereof designed to perform the functions described herein. A general-purpose processor may be a microprocessor, but in an alternative embodiment, the processor may be any conventional processor, controller, microcontroller, circuit, and / or state machine. A processor may also be implemented as a combination of computing components, for example, a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0502] The methods or algorithms described in conjunction with the examples disclosed herein may be embodied directly in hardware, in software modules that can be executed by a processor, or in a combination of the two, in the form of processing units, programming instructions, or other instructions, and may be contained in a single device or distributed across multiple devices. The software modules may be located in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, removable disk, CD-ROM, or any other form of storage medium known in the art. The storage medium may be coupled to the processor so that the processor can read information from the storage medium and write information to the storage medium. In an alternative, the storage medium may be integral with the processor.

[0503] Without departing from the scope of this disclosure, one or more of the components and functions illustrated in the figures may be rearranged and / or combined into a single component or embodied as multiple components. Additional elements or components may also be added without departing from the scope of this disclosure. Additionally, the features described herein may be implemented in software, hardware, as a business method, and / or a combination thereof.

[0504] In its various aspects, embodiments of the present disclosure may be embodied in computer-implemented processes, machines (such as electronic devices, general-purpose computers, or other devices that provide a platform on which computer programs can be executed), processes performed by these machines, or articles of manufacture. Such articles may include computer program products or digital information products (in which a computer-readable storage medium contains computer program instructions or computer-readable data stored thereon), as well as processes and machines for creating and using these articles of manufacture.

[0505] Although the present disclosure has been described in the context of certain embodiments and examples, it will be understood by those skilled in the art that the present disclosure extends from the specifically disclosed embodiments to other alternative embodiments and / or uses and their obvious modifications and equivalents. In addition, although several variations of the embodiments of the present disclosure have been shown and described in detail, it will be readily apparent to those skilled in the art that other variations are within the scope of the present disclosure. It is also contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be made, and that these combinations and sub-combinations still fall within the scope of the present disclosure. For example, the features described above in conjunction with one embodiment may be used with different embodiments described herein, and the combination still falls within the scope of the present disclosure. It will be understood that the various features and aspects of the disclosed embodiments may be combined or substituted with each other to form different modes of embodiments of the present disclosure. Therefore, the scope of the present disclosure is intended not to be limited by the specific embodiments described above. Accordingly, unless otherwise stated, or unless expressly incompatible, each embodiment of the present disclosure may include, in addition to its basic features described herein, one or more features described herein of each other embodiment of the present invention as disclosed herein.

[0506] The present disclosure can generally be said to also include individual or group portions, elements, and features mentioned or indicated in the present disclosure, as well as any or all combinations of any two or more of said portions, elements, or features, and where specific integers mentioned herein have known equivalents in the art to which the present disclosure relates, such known equivalents are deemed to be incorporated herein as if individually set forth.

[0507] Unless incompatible, features, materials, characteristics or groups described in conjunction with a particular aspect, embodiment or example are to be understood to be applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification. All features disclosed in this specification (including any accompanying claims, abstract and drawings), and / or all steps of any method or process disclosed, may be combined in any combination, except combinations where at least some of such features and / or steps are mutually exclusive. Protection is not limited to the details of any foregoing embodiments. Protection extends to any novel feature or any novel combination of features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel method or any novel combination of methods or processes so disclosed.

[0508] Furthermore, certain features described in this disclosure in the context of separate implementations or examples may also be implemented in combination with a single implementation or example. Conversely, various features described in the context of a single implementation or example may also be implemented in multiple implementations or examples, either individually or in any suitable subcombination. Furthermore, while features may be described above as functioning in certain combinations, in some cases one or more features from a claimed combination may be deleted from the combination, and a combination may be claimed as a subcombination or a variation of a subcombination.

[0509] In addition, although operations are depicted in a particular order in the drawings or described in a particular order in the specification, it is not necessary to perform such operations in the particular order or sequence shown in order to achieve the desired results, nor is it necessary to perform all operations. Other operations not depicted or described may be incorporated into the example methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the described operations. In addition, these operations may be rearranged or reordered in other specific implementations. Those skilled in the art will understand that in some embodiments, the actual steps taken in the illustrated and / or disclosed processes may differ from the steps shown in the figures. Depending on the embodiment, some of the steps described above may be removed, or other steps may be added. In addition, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. In addition, the separation of various system components in the specific implementations described above should not be understood as requiring such separation in all specific implementations, and it should be understood that the described components and systems may generally be integrated together in a single product or packaged in multiple products.

[0510] For the purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not all such advantages may be achieved according to any particular embodiment. Thus, for example, those skilled in the art will recognize that the present disclosure may be embodied or implemented in a manner that achieves one advantage or group of advantages taught herein without necessarily achieving other advantages taught or suggested herein.

[0511] It is intended that the scope of the present disclosure be limited not by the specific disclosure of the embodiments in this section or elsewhere in this specification, but by the claims in this section or elsewhere in this specification or as presented in the future. The claim language is to be interpreted broadly based on the language employed in the claims and not limited to the examples described in this specification or during the prosecution of this application, which examples are to be construed as non-exclusive.

Claims

1. A method for controlling the flow of gas delivered to a patient, the method comprising: delivering a flow of gas to the patient via a patient interface at an operating flow rate; as well as Perform the following steps at the interval: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data from one or more sensors; determining a condition of the patient's respiratory rate based at least on the patient parameter and the patient parameter received or determined at one or more previous intervals; determining whether to adjust or maintain the working flow based on the condition of the patient's respiratory rate; as well as Based on determining that the workload is to be adjusted, the workload is adjusted in increments, and based on determining that the workload is to be maintained, the workload is maintained at a current workload.

2. The method according to claim 1, wherein The method further includes delivering a flow of gas to the patient via a patient interface at an initial operating flow rate, wherein the initial operating flow rate is determined based on one or more patient characteristics.

3. The method according to claim 1 or 2, wherein: The intervals are spaced apart from one another by variable time periods based at least on the condition of the patient's breathing rate.

4. A method according to any preceding claim, wherein: The one or more sensors include one or more sensors configured to be attached to or located near the patient to measure a patient parameter indicative of a breathing rate of the patient.

5. A method according to any preceding claim, wherein: The step of receiving or determining a patient parameter indicative of a breathing rate of the patient comprises receiving data indicative of a time-averaged breathing rate over a measurement period from the one or more sensors.

6. The method according to claim 5, wherein: The at least one sensor stores a plurality of instantaneous measurements during the measurement period and calculates a time-averaged respiratory frequency.

7. A method according to any preceding claim, wherein: The step of determining the condition of the patient's respiratory rate includes comparing the patient parameter received or determined at a current interval with the patient parameter received or determined at one or more previous intervals.

8. The method according to claim 7, wherein: Based on the comparison, the condition of the patient's respiratory rate is related to a degree or amount of change between the patient parameter received or determined at the current interval and the patient parameter received or determined at one or more previous intervals.

9. The method according to claim 8, wherein Based on the comparison, the condition of the patient's respiratory rate indicates that the patient's respiratory rate is increasing or decreasing or is substantially stable.

10. The method according to claim 9, wherein: The step of determining whether to adjust the workload includes determining to adjust the workload based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

11. The method according to claim 9 or 10, wherein: The step of determining whether to adjust or maintain the workload includes determining to maintain the workload based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is substantially stable.

12. A method according to any preceding claim, wherein: The step of determining whether to adjust or maintain the workload further includes comparing the condition of the patient's respiratory rate to one or more thresholds.

13. The method according to claim 10, wherein: The step of incrementally adjusting the workload includes increasing the workload based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

14. The method according to claim 13, wherein The increment is a variable increment based at least on the condition of the patient's breathing rate.

15. The method according to claim 11, wherein The step of maintaining the working flow includes maintaining the working flow at a working flow having a previous increment.

16. A method according to any preceding claim, wherein: The method is performed continuously within a therapy session.

17. A method according to any preceding claim, wherein: The gas is delivered to the patient under conditions suitable for providing high flow therapy.

18. A method according to any preceding claim, wherein: The method also includes delivering a flow of gas to the patient via a patient interface at an operating oxygen concentration level.

19. The method according to claim 18, wherein The method further comprises performing the following steps at the interval: determining whether to adjust or maintain the operating oxygen concentration level based on the condition of the patient's respiratory rate; and Based on a determination that the operating oxygen concentration level is to be adjusted, the operating oxygen concentration level is adjusted by an increment, and based on a determination that the operating oxygen concentration level is to be maintained, the operating oxygen concentration level is maintained at a current operating oxygen concentration level.

20. A method for controlling an operating parameter of a gas delivered to a patient, the method comprising: delivering a flow of gas to the patient via a patient interface at an operating flow rate and an operating oxygen concentration level; Perform the following steps at the interval: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data from one or more sensors; determining a condition of the patient's respiratory rate based at least on the patient parameter and the patient parameter received or determined at one or more previous intervals; determining whether to adjust or maintain the operating flow rate and the operating oxygen concentration level based on the condition of the patient's respiratory rate; Based on determining that the workload is to be adjusted, adjusting the workload by an increment, and based on determining that the workload is to be maintained, maintaining the workload at a current workload; as well as Based on a determination that the operating oxygen concentration level is to be adjusted, the operating oxygen concentration level is adjusted by an increment, and based on a determination that the operating oxygen concentration level is to be maintained, the operating oxygen concentration level is maintained at a current operating oxygen concentration level.

21. A method for controlling an operating parameter of a gas delivered to a patient, the method comprising: delivering a flow of gas to the patient via a patient interface at an operating flow rate and an operating oxygen concentration level; Perform the following steps at the interval: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data from one or more sensors; determining a condition of the patient's respiratory rate based at least on the patient parameter and the patient parameter received or determined at one or more previous intervals; determining whether to adjust or maintain the working flow based on the condition of the patient's respiratory rate; Based on determining that the workload flow rate is to be adjusted, adjusting the workload flow rate by increments, and Based on determining that the workload is to be maintained, maintaining the workload at a current workload; and determining whether to adjust or maintain the operating oxygen concentration level based on the condition of the patient's respiratory rate, wherein based on a determination that the operating oxygen concentration level is to be adjusted, the operating oxygen concentration level is adjusted by increments, and based on a determination that the operating oxygen concentration level is to be maintained, the operating oxygen concentration level is maintained at a current operating oxygen concentration level.

22. The method according to claim 20 or 21, wherein The method further includes delivering a flow of gas to the patient via a patient interface at an initial operating flow rate, wherein the initial operating flow rate is determined based on one or more patient characteristics.

23. The method according to any one of claims 20 to 22, wherein The method also includes delivering a flow of gas to the patient via a patient interface at an initial operating oxygen concentration level, wherein the initial operating oxygen concentration level is determined based on one or more patient characteristics.

24. The method according to any one of claims 20 to 23, wherein The intervals are spaced apart from one another by variable time periods based at least on the condition of the patient's breathing rate.

25. The method according to any one of claims 20 to 24, wherein The one or more sensors include one or more sensors configured to be attached to or located near the patient to measure a patient parameter indicative of a breathing rate of the patient.

26. The method according to any one of claims 20 to 25, wherein The step of receiving or determining a patient parameter indicative of a breathing rate of the patient comprises receiving data indicative of a time-averaged breathing rate over a measurement period from the one or more sensors.

27. The method according to claim 26, wherein The at least one sensor stores a plurality of instantaneous measurements during the measurement period and calculates a time-averaged respiratory frequency.

28. The method according to any one of claims 20 to 27, wherein The step of determining the condition of the patient's respiratory rate includes comparing the patient parameter received or determined at a current interval with the patient parameter received or determined at one or more previous intervals.

29. The method according to claim 28, wherein Based on the comparison, the condition of the patient's respiratory rate is related to a degree or amount of change between the patient parameter received or determined at the current interval and the patient parameter received or determined at one or more previous intervals.

30. The method according to claim 29, wherein Based on the comparison, the condition of the patient's respiratory rate indicates that the patient's respiratory rate is increasing or decreasing or is substantially stable.

31. The method according to claim 30, wherein The step of determining whether to adjust the workload includes determining to adjust the workload based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

32. The method according to claim 30 or 31, wherein The step of determining whether to adjust or maintain the workload includes determining to maintain the workload based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is substantially stable.

33. The method according to any one of claims 20 to 32, wherein The step of determining whether to adjust or maintain the operating flow rate and / or the operating oxygen concentration level further comprises comparing the condition of the patient's respiratory rate to one or more threshold values.

34. The method according to claim 31, wherein The step of incrementally adjusting the workload includes increasing the workload incrementally based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

35. The method according to claim 34, wherein The increment is a variable increment based at least on the condition of the patient's breathing rate.

36. The method of claim 32, wherein: The step of maintaining the working flow includes maintaining the working flow at a working flow having a previous increment.

37. The method according to any one of claims 20 to 36, wherein The method is performed continuously within a therapy session.

38. The method according to any one of claims 20 to 37, wherein The gas is delivered to the patient under conditions suitable for providing high flow therapy.

39. A method for controlling the flow of gas delivered to a patient, the method comprising: delivering a flow of gas to the patient via a patient interface at an operating flow rate; gradually applying a plurality of flow values ​​at intervals as the working flow; receiving or determining, at each flow value of the plurality of flow values, a patient parameter indicative of a respiratory rate of the patient based on data received from one or more sensors, and determining a condition of the respiratory rate of the patient based at least on the patient parameter and the patient parameter received or determined at one or more previous intervals; Based on the condition of the patient's respiratory frequency indicating that the patient's respiratory frequency is stable, the workload is maintained, and an iterative process is performed to continue receiving or determining the patient parameters and determining the condition of the patient's respiratory frequency at further intervals, wherein based on the condition of the patient's respiratory frequency indicating that the patient's respiratory frequency is no longer stable, the workload is adjusted at the further intervals until the condition of the patient's respiratory frequency indicates that the patient's respiratory frequency is stable.

40. The method of claim 39, wherein The step of receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data received from one or more sensors occurs a predetermined time period after adjusting the workload.

41. The method according to claim 39 or 40, wherein The condition of the patient's respiratory rate indicating that the patient's respiratory rate is stable includes determining that the condition of the patient's respiratory rate is within a range or a threshold.

42. The method according to any one of claims 39 to 41, wherein The condition of the patient's respiratory rate indicating that the patient's respiratory rate is no longer stable includes determining that the condition of the patient's respiratory rate is outside of a range or threshold.

43. The method according to any one of claims 39 to 42, wherein The method further includes delivering a flow of gas to the patient via a patient interface at an initial operating flow rate, wherein the initial flow rate is determined based on one or more patient characteristics.

44. The method according to any one of claims 39 to 43, wherein The intervals are spaced apart from one another by variable time periods based at least on the condition of the patient's breathing rate.

45. The method according to any one of claims 39 to 44, wherein The one or more sensors include one or more sensors configured to be attached to or located near the patient to measure a patient parameter indicative of a breathing rate of the patient.

46. ​​A method according to any one of claims 39 to 45, wherein The step of receiving or determining a patient parameter indicative of a breathing rate of the patient comprises receiving data indicative of a time-averaged breathing rate over a measurement period from the one or more sensors.

47. The method of claim 46, wherein The at least one sensor stores a plurality of instantaneous measurements during the measurement period and calculates a time-averaged respiratory frequency.

48. The method according to any one of claims 39 to 47, wherein The step of determining the condition of the patient's respiratory rate includes comparing the patient parameter received or determined at a current interval with the patient parameter received or determined at one or more previous intervals.

49. The method according to claim 48, wherein Based on the comparison, the condition of the patient's respiratory rate is related to a degree or amount of change between the patient parameter received or determined at the current interval and the patient parameter received or determined at one or more previous intervals.

50. The method of claim 49, wherein Based on the comparison, the condition of the patient's respiratory rate indicates that the patient's respiratory rate is increasing or decreasing or is stable.

51. The method of claim 50, wherein: The step of determining whether the patient's respiratory rate is unstable includes the condition of the patient's respiratory rate indicating that the patient's respiratory rate is increasing or decreasing.

52. The method according to any one of claims 39 to 51, wherein The step of gradually applying a plurality of flow values ​​as the operating flow includes increasing the operating flow by increments at each interval.

53. The method of claim 52, wherein: The increment is a variable increment based at least on the condition of the patient's breathing rate.

54. The method according to any one of claims 39 to 53, wherein The step of maintaining the working flow includes maintaining the working flow at a working flow having a previous increment.

55. The method according to any one of claims 39 to 54, wherein The method is performed continuously within a therapy session.

56. The method according to any one of claims 39 to 55, wherein The gas is delivered to the patient under conditions suitable for providing high flow therapy.

57. The method according to any one of claims 39 to 56, wherein The method also includes delivering a flow of gas to the patient via a patient interface at an operating oxygen concentration level.

58. The method of claim 57, wherein The method further comprises performing the following steps at the interval: determining whether to adjust or maintain the operating oxygen concentration level based at least on the patient parameter indicative of a respiratory rate of the patient; and Based on a determination that the operating oxygen concentration level is to be adjusted, the operating oxygen concentration level is adjusted by an increment, and based on a determination that the operating oxygen concentration level is to be maintained, the operating oxygen concentration level is maintained at a current operating oxygen concentration level.

59. A respiratory therapy system configured to provide a flow of gas to a patient for respiratory therapy, the respiratory therapy system comprising: a patient interface configured to deliver a flow of gas to the patient; a flow generator configured to generate the flow of gas for the patient at an operating flow rate; one or more sensors configured to measure a patient parameter indicative of a respiratory rate of the patient; and A controller, wherein the controller is configured to control the operation of the flow generator and perform the following steps at intervals: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data from one or more sensors; determining a condition of the patient's respiratory rate based at least on the patient parameter and the patient parameter received or determined at one or more previous intervals; determining whether to adjust or maintain the working flow based on the condition of the patient's respiratory rate; as well as Based on determining that the workload is to be adjusted, the workload is adjusted in increments, and based on determining that the workload is to be maintained, the workload is maintained at a current workload.

60. A respiratory apparatus configured to provide a flow of gas to a patient for respiratory therapy, the respiratory apparatus comprising: a flow generator configured to generate the flow of gas for the patient at an operating flow rate; and A controller, wherein the controller is configured to control the operation of the flow generator and perform the following steps at intervals: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data from one or more sensors; determining a condition of the patient's respiratory rate based at least on the patient parameter and the patient parameter received or determined at one or more previous intervals; determining whether to adjust or maintain the working flow based on the condition of the patient's respiratory rate; as well as Based on determining that the workload is to be adjusted, the workload is adjusted in increments, and based on determining that the workload is to be maintained, the workload is maintained at a current workload.

61. A respiratory therapy system configured to provide a flow of gas to a patient for respiratory therapy, the respiratory therapy system comprising: a patient interface configured to deliver a flow of gas to the patient; a flow generator configured to generate the flow of gas for the patient at an operating flow rate; one or more sensors configured to measure a patient parameter indicative of a respiratory rate of the patient; and A controller, wherein the controller is configured to control the operation of the flow generator and perform the following steps at intervals: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data from one or more sensors; determining a condition of the patient's respiratory rate based at least on the patient parameter and the patient parameter received or determined at one or more previous intervals; determining whether to adjust or maintain the operating flow rate and the operating oxygen concentration level based on the condition of the patient's respiratory rate; Based on determining that the workload is to be adjusted, adjusting the workload by an increment, and based on determining that the workload is to be maintained, maintaining the workload at a current workload; as well as Based on a determination that the operating oxygen concentration level is to be adjusted, the operating oxygen concentration level is adjusted by an increment, and based on a determination that the operating oxygen concentration level is to be maintained, the operating oxygen concentration level is maintained at a current operating oxygen concentration level.

62. A respiratory apparatus configured to provide a flow of gas to a patient for respiratory therapy, the respiratory apparatus comprising: a flow generator configured to generate the flow of gas for the patient at an operating flow rate; and A controller, wherein the controller is configured to control the operation of the flow generator and perform the following steps at intervals: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data from one or more sensors; determining a condition of the patient's respiratory rate based at least on the patient parameter and the patient parameter received or determined at one or more previous intervals; determining whether to adjust or maintain the operating flow rate and the operating oxygen concentration level based on the condition of the patient's respiratory rate; Based on determining that the workload is to be adjusted, adjusting the workload by an increment, and based on determining that the workload is to be maintained, maintaining the workload at a current workload; as well as Based on a determination that the operating oxygen concentration level is to be adjusted, the operating oxygen concentration level is adjusted by an increment, and based on a determination that the operating oxygen concentration level is to be maintained, the operating oxygen concentration level is maintained at a current operating oxygen concentration level.

63. A respiratory therapy system configured to provide a flow of gas to a patient for respiratory therapy, the respiratory therapy system comprising: a patient interface configured to deliver a flow of gas to the patient; a flow generator configured to generate the flow of gas for the patient at an operating flow rate; one or more sensors configured to measure a patient parameter indicative of a respiratory rate of the patient; and A controller, wherein the controller is configured to control the operation of the flow generator and perform the following steps at intervals: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data from one or more sensors; determining a condition of the patient's respiratory rate based at least on the patient parameter and the patient parameter received or determined at one or more previous intervals; determining whether to adjust or maintain the working flow based on the condition of the patient's respiratory rate; Based on determining that the workload flow rate is to be adjusted, adjusting the workload flow rate by increments, and Based on determining that the workload is to be maintained, maintaining the workload at a current workload; and determining whether to adjust or maintain the operating oxygen concentration level based on the condition of the patient's respiratory rate, wherein based on a determination that the operating oxygen concentration level is to be adjusted, the operating oxygen concentration level is adjusted by increments, and based on a determination that the operating oxygen concentration level is to be maintained, the operating oxygen concentration level is maintained at a current operating oxygen concentration level.

64. A respiratory apparatus configured to provide a flow of gas to a patient for respiratory therapy, the respiratory apparatus comprising: a flow generator configured to generate the flow of gas for the patient at an operating flow rate; and A controller, wherein the controller is configured to control the operation of the flow generator and perform the following steps at intervals: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data from one or more sensors; determining a condition of the patient's respiratory rate based at least on the patient parameter and the patient parameter received or determined at one or more previous intervals; determining whether to adjust or maintain the working flow based on the condition of the patient's respiratory rate; Based on determining that the workload flow rate is to be adjusted, adjusting the workload flow rate by increments, and Based on determining that the workload is to be maintained, maintaining the workload at a current workload; and determining whether to adjust or maintain the operating oxygen concentration level based on the condition of the patient's respiratory rate, wherein based on a determination that the operating oxygen concentration level is to be adjusted, the operating oxygen concentration level is adjusted by increments, and based on a determination that the operating oxygen concentration level is to be maintained, the operating oxygen concentration level is maintained at a current operating oxygen concentration level.

65. A respiratory therapy system configured to provide a flow of gas to a patient for respiratory therapy, the respiratory therapy system comprising: a patient interface configured to deliver a flow of gas to the patient; a flow generator configured to generate the flow of gas for the patient at an operating flow rate; one or more sensors configured to measure a patient parameter indicative of a respiratory rate of the patient; and A controller, wherein the controller is configured to control the operation of the flow generator and perform the following steps at intervals: gradually applying a plurality of flow values ​​as the working flow; receiving or determining, at each flow value of the plurality of flow values, a patient parameter indicative of a respiratory rate of the patient based on data received from one or more sensors, and determining a condition of the respiratory rate of the patient based at least on the patient parameter and the patient parameter received or determined at one or more previous intervals; Based on the condition of the patient's respiratory frequency indicating that the patient's respiratory frequency is stable, the workload is maintained, and an iterative process is performed to continue receiving or determining the patient parameters and determining the condition of the patient's respiratory frequency at further intervals, wherein based on the condition of the patient's respiratory frequency indicating that the patient's respiratory frequency is no longer stable, the workload is adjusted at the further intervals until the condition of the patient's respiratory frequency indicates that the patient's respiratory frequency is stable.

66. A respiratory apparatus configured to provide a flow of gas to a patient for respiratory therapy, the respiratory apparatus comprising: a flow generator configured to generate the flow of gas for the patient at an operating flow rate; and A controller, wherein the controller is configured to control the operation of the flow generator and perform the following steps at intervals: gradually applying a plurality of flow values ​​as the working flow; receiving or determining, at each flow value of the plurality of flow values, a patient parameter indicative of a respiratory rate of the patient based on data received from one or more sensors, and determining a condition of the respiratory rate of the patient based at least on the patient parameter and the patient parameter received or determined at one or more previous intervals; Based on the condition of the patient's respiratory frequency indicating that the patient's respiratory frequency is stable, the workload is maintained, and an iterative process is performed to continue receiving or determining the patient parameters and determining the condition of the patient's respiratory frequency at further intervals, wherein based on the condition of the patient's respiratory frequency indicating that the patient's respiratory frequency is no longer stable, the workload is adjusted at the further intervals until the condition of the patient's respiratory frequency indicates that the patient's respiratory frequency is stable.

67. The respiratory therapy system of any one of claims 59, 61, 63, or 65, or the respiratory apparatus of any one of claims 60, 62, 64, or 66, wherein: The flow generator is further configured to deliver a flow of gas to the patient via a patient interface at an initial operating flow rate, and wherein the initial operating flow rate is determined based on one or more patient characteristics.

68. A respiratory therapy system or apparatus according to any one of claims 59 to 67, wherein: The intervals are spaced apart from one another by variable time periods based at least on the condition of the patient's breathing rate.

69. A respiratory therapy system or apparatus according to any one of claims 59 to 68, wherein: The one or more sensors include one or more sensors configured to be attached to or located near the patient to measure a patient parameter indicative of a breathing rate of the patient.

70. The respiratory therapy system or apparatus of any one of claims 59 to 69, wherein: The step of receiving or determining a patient parameter indicative of a breathing rate of the patient comprises receiving data indicative of a time-averaged breathing rate over a measurement period from the one or more sensors.

71. The respiratory therapy system or apparatus of claim 70, wherein: The at least one sensor stores a plurality of instantaneous measurements during the measurement period and calculates a time-averaged respiratory frequency.

72. A respiratory therapy system or apparatus according to any one of claims 59 to 71, wherein: The step of determining the condition of the patient's respiratory rate includes comparing the patient parameter received or determined at a current interval with the patient parameter received or determined at one or more previous intervals.

73. The respiratory therapy system or apparatus of claim 72, wherein: Based on the comparison, the condition of the patient's respiratory rate is related to a degree or amount of change between the patient parameter received or determined at the current interval and the patient parameter received or determined at one or more previous intervals.

74. The respiratory therapy system or apparatus of claim 73, wherein: Based on the comparison, the condition of the patient's respiratory rate indicates that the patient's respiratory rate is increasing or decreasing or is substantially stable.

75. The respiratory therapy system or apparatus of claim 74, wherein: The step of determining whether to adjust the workload includes determining to adjust the workload based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

76. A respiratory therapy system or apparatus according to claim 74 or 75, wherein: The step of determining whether to adjust or maintain the workload includes determining to maintain the workload based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is substantially stable.

77. A respiratory therapy system or apparatus according to any one of claims 59 to 76, wherein: The step of determining whether to adjust or maintain the workload further includes comparing the condition of the patient's respiratory rate to one or more thresholds.

78. The respiratory therapy system or apparatus of claim 75, wherein: The step of incrementally adjusting the workload includes increasing the workload incrementally based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

79. The respiratory therapy system or apparatus of claim 78, wherein: The increment is a variable increment based at least on the condition of the patient's breathing rate.

80. The respiratory therapy system or apparatus of claim 76, wherein: The step of maintaining the working flow includes maintaining the working flow at a working flow having a previous increment.

81. The respiratory therapy system or apparatus of any one of claims 59 to 80, wherein: The steps are performed continuously at the intervals within a therapy session.

82. The respiratory therapy system or apparatus of any one of claims 59 to 81, wherein: The gas is delivered to the patient under conditions suitable for providing high flow therapy.

83. The respiratory therapy system or apparatus of any one of claims 59 to 82, wherein: The controller is further configured to deliver a flow of gas to the patient via a patient interface at an operating oxygen concentration level.

84. The respiratory therapy system or apparatus of claim 83, wherein: The controller is further configured to deliver a flow of gas to the patient via a patient interface at an initial operating oxygen concentration level, wherein the initial operating oxygen concentration level is determined based on one or more patient characteristics.

85. A respiratory therapy system or apparatus according to any one of claims 59 to 84, wherein: The controller is further configured to perform the following steps at the interval: determining whether to adjust or maintain the operating oxygen concentration level based on the condition of the patient's respiratory rate; and Based on a determination that the operating oxygen concentration level is to be adjusted, the operating oxygen concentration level is adjusted by an increment, and based on a determination that the operating oxygen concentration level is to be maintained, the operating oxygen concentration level is maintained at a current operating oxygen concentration level.

86. The respiratory therapy system or apparatus of any one of claims 59 to 85, further comprising a humidifier configured to humidify the flow of gas.

87. A respiratory therapy system or apparatus according to any one of claims 59 to 86, wherein: The system or apparatus further comprises a non-transitory computer-readable medium capable of being accessed by or communicating data with the controller, and preferably, wherein the non-transitory computer-readable medium comprises a non-volatile memory having computer-executable instructions stored thereon, the computer-executable instructions, when executed on the controller or one or more processing devices, causing the controller or one or more processing devices to perform or execute any one or more of the steps or methods or aspects described in any one of claims 59 to 86.

88. A respiratory therapy system configured to provide a flow of gas to a patient for respiratory therapy, the respiratory therapy system comprising: a patient interface configured to deliver a flow of gas to the patient at an operating flow rate; a flow generator configured to generate the flow of gas for the patient at an operating flow rate; one or more sensors configured to measure a patient parameter indicative of a respiratory rate of the patient; and A controller, wherein the controller is configured to: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data received from the one or more sensors; as well as The operating flow rate of the flow generator is controlled based on a received or determined patient parameter indicative of a respiratory rate of the patient.

89. A method for controlling the flow of gas delivered to a patient, the method comprising: delivering a flow of gas to the patient via a patient interface at an operating flow rate; as well as Perform the following steps at the interval: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data from one or more non-patient contact sensors; determining whether to adjust or maintain the workload based on comparing at least the patient parameter indicative of a respiratory rate of the patient to one or more thresholds; as well as Based on determining that the workload is to be adjusted, the workload is adjusted in increments, and based on determining that the workload is to be maintained, the workload is maintained at a current workload.

90. A respiratory therapy system configured to provide a flow of gas to a patient for respiratory therapy, the respiratory therapy system comprising: a patient interface configured to deliver a flow of gas to the patient at an operating flow rate; a flow generator configured to generate the flow of gas for the patient at an operating flow rate; one or more non-patient-contacting sensors configured to measure a patient parameter indicative of a respiratory rate of the patient; and A controller, wherein the controller is configured to: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data from the one or more non-patient contact sensors; determining whether to adjust or maintain the workload based on comparing at least the patient parameter indicative of a respiratory rate of the patient to one or more thresholds; as well as Based on determining that the workload is to be adjusted, the workload is adjusted in increments, and based on determining that the workload is to be maintained, the workload is maintained at a current workload.

91. A method for controlling the flow of gas delivered to a patient, the method comprising: delivering a flow of gas to the patient via a patient interface at an operating flow rate; as well as Perform the following steps at the interval: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data from one or more sensors; determining whether to adjust or maintain the workload based on comparing at least the patient parameter indicative of a respiratory rate of the patient to one or more thresholds; as well as Based on determining that the workload is to be adjusted, the workload is adjusted in increments, and based on determining that the workload is to be maintained, the workload is maintained at a current workload.

92. The method of claim 91, wherein The method also includes receiving or determining a patient parameter indicative of SpO2 of the patient based on data from one or more sensors.

93. The method of claim 92, wherein: The step of determining whether to adjust or maintain the operating flow is further based on comparing the patient parameter indicative of the patient's SpO2 to one or more thresholds.

94. The method according to claim 92 or 93, wherein The method also includes receiving or determining a therapy parameter indicative of the FiO2 being provided or to be provided to the patient.

95. The method of claim 94, wherein The therapy parameter indicative of the FiO2 being provided or to be provided to the patient is based at least in part on the patient parameter indicative of the patient's SpO2.

96. The method of claim 95, wherein The step of determining whether to adjust or maintain the operating flow is further based on comparing the patient therapy indicative of the FiO2 being provided or to be provided to the patient to one or more thresholds.

97. The method according to any one of claims 91 to 96, wherein The one or more thresholds include one or more parameter thresholds, each of the one or more parameter thresholds being related to a patient parameter or a therapy parameter.

98. The method of claim 97, wherein The or each parameter threshold is set by a user.

99. The method of claim 97, wherein The parameter threshold is related to the maximum acceptable respiratory rate.

100. The method according to claims 97 to 99, wherein The one or more thresholds also include a time-based threshold.

101. The method according to claim 100, wherein The time-based threshold is set by the user.

102. The method according to claim 101, wherein The time-based threshold is related to a minimum amount of time that the patient parameter is above the patient parameter threshold.

103. The method according to any one of claims 91 to 102, wherein The increment of the workload to be adjusted is an increase in the workload.

104. The method according to claim 103, wherein The increment is an absolute amount or a fixed amount.

105. The method of claim 103, wherein: The increment is a percentage or a fraction of the workload.

106. The method according to any one of claims 103 to 105, wherein The increment of the workload is set by a user.

107. The method according to any one of claims 91 to 106, wherein Adjusting the workload by increments includes changing the workload by a step change.

108. The method according to any one of claims 91 to 106, wherein Adjusting the workload in increments includes gradually adjusting the workload.

109. The method according to any one of claims 91 to 108, wherein When the workload is adjusted by the increment, the method further includes: displaying a prompt or reminder to the user indicating that the workload has been adjusted.

110. The method of claim 109, wherein The method also includes presenting an audible alert to the user indicating that the workload has been adjusted.

111. The method according to any one of claims 91 to 110, wherein Once the workload flow rate has been adjusted by the increment, the method no longer includes determining whether to adjust or maintain the workload flow rate.

112. A respiratory therapy system configured to provide a flow of gas to a patient for respiratory therapy, the respiratory therapy system comprising: a patient interface configured to deliver a flow of gas to the patient; a flow generator configured to generate the flow of gas for the patient at an operating flow rate; one or more sensors configured to measure a patient parameter indicative of a respiratory rate of the patient; and A controller, wherein the controller is configured to control the operation of the flow generator and perform the following steps at intervals: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data from one or more sensors; determining whether to adjust or maintain the workload based on comparing at least the patient parameter indicative of a respiratory rate of the patient to one or more thresholds; as well as Based on determining that the workload is to be adjusted, the workload is adjusted in increments, and based on determining that the workload is to be maintained, the workload is maintained at a current workload.

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