Respiratory support control using respiratory rate

Abstract

A method for controlling a flow rate of gas delivered to a patient is disclosed, the method including: delivering a flow of gas to a patient via a patient interface at an operating flow rate; at intervals, receiving or determining a patient parameter indicative of the patient's respiratory rate based on data from one or more sensors; determining a patient's respiratory rate status based on at least the patient parameter and patient parameters received or determined at one or more previous intervals; determining whether to adjust or maintain the operating flow rate based on the patient's respiratory rate status; adjusting the operating flow rate incrementally based on the decision to adjust the operating flow rate; and maintaining the operating flow rate at a current operating flow rate based on the decision to maintain the operating flow rate.

Description

[Technical Field]

[0001] The present disclosure relates to methods and systems for providing respiratory flow therapy to a patient. In particular, the present disclosure relates to controlling operating parameters during use of a non-enclosed breathing apparatus (i.e., an open breathing apparatus) by a patient based on the patient's measured respiratory rate. [Background technology]

[0002] Respiratory assistance apparatus are used to provide a flow of gas to a user or patient in a variety of settings, such as hospitals, medical facilities, residential care, or home environments. Respiratory assistance apparatus or respiratory therapy apparatus (collectively, "respiratory apparatus" or "respiratory device") may use a humidification device to provide supplemental oxygen or other gases along with the gas flow, and / or provide heated and humidified gas. The respiratory apparatus may regulate and control the overall characteristics of the gas flow, including flow rate and gas concentration. Summary of the Invention [Means for solving the problem]

[0003] In a first aspect, the present disclosure broadly comprises a method for controlling a flow rate of gas delivered to a patient, the method comprising: delivering a flow of gas to the patient through a patient interface at an operating flow rate; and, at intervals, receiving or determining a patient parameter indicative of a patient's respiratory rate based on data from one or more sensors; determining a respiratory rate status of the patient based on at least the patient parameters and the patient parameters received or determined at one or more previous intervals; determining whether to adjust or maintain the operating flow rate based on the state of the patient's respiratory rate; adjusting the operating flow rate incrementally based on the determination to adjust the operating flow rate; and maintaining the operating flow rate at a current operating flow rate based on the determination to maintain the operating flow rate.

[0004] In one configuration, the method further includes delivering a flow of gas to the patient through the patient interface at an initial operating flow rate, the initial operating flow rate being determined based on one or more patient characteristics.

[0005] In one configuration, the intervals are spaced apart by variable periods, the variable periods being based on the state of at least the patient's respiratory rate.

[0006] In one configuration, the one or more sensors include one or more sensors configured to be attached to or positioned near the patient to measure a patient parameter indicative of the patient's respiratory rate.

[0007] In one configuration, the step of receiving or determining a patient parameter indicative of the patient's respiration rate includes receiving data from the one or more sensors indicative of a time-averaged respiration rate over a measurement period.

[0008] In one configuration, the at least one sensor stores a plurality of instantaneous measurements over the measurement period and calculates a time-averaged respiration rate.

[0009] In one configuration, the step of determining the state of the patient's respiratory rate includes comparing the patient parameters received or determined in a current interval with the patient parameters received or determined in one or more previous intervals.

[0010] In one configuration, the state of the patient's respiratory rate is related to a degree or amount of change between the patient parameters received or determined in the current interval and the patient parameters received or determined in one or more previous intervals based on the comparison.

[0011] In one configuration, the status of the patient's respiratory rate indicates that the patient's respiratory rate is increasing, decreasing, or substantially stable based on the comparison.

[0012] In one configuration, the step of determining whether to adjust the operating flow rate includes determining to adjust the operating flow rate based on the state of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

[0013] In one configuration, the step of determining whether to adjust or maintain the operating flow rate includes determining to maintain the operating flow rate based on a state of the patient's respiratory rate indicating that the patient's respiratory rate is substantially stable.

[0014] In one configuration, the step of determining whether to adjust or maintain the operating flow rate further comprises comparing the state of the patient's respiratory rate to one or more thresholds.

[0015] In one configuration, the step of incrementally adjusting the operating flow rate includes incrementally increasing the operating flow rate based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

[0016] In one configuration, the increment is a variable increment, the variable increment being based on the state of at least the patient's respiratory rate.

[0017] In one configuration, the step of maintaining the operating flow rate includes maintaining the operating flow rate at a previous incremental operating flow rate.

[0018] In one configuration, the method is performed continuously over the course of a treatment session.

[0019] In one configuration, the gas is delivered to the patient in conditions suitable to provide high flow therapy.

[0020] In one configuration, the method further includes delivering a flow of gas to the patient via a patient interface at an operating oxygen concentration level.

[0021] In one configuration, the method further includes performing, during the interval, the steps of determining whether to adjust or maintain the operating oxygen concentration level based on the state of the patient's respiratory rate; incrementally adjusting the operating oxygen concentration level based on the decision to adjust the operating oxygen concentration level; and maintaining the operating oxygen concentration level at a current operating oxygen concentration level based on the decision to maintain the operating oxygen concentration level.

[0022] In a second aspect, the present disclosure broadly includes a method for controlling operating parameters of gas delivered to a patient, the method including: delivering a flow of gas to the patient via a patient interface at an operating flow rate and an operating oxygen concentration level; at intervals, receiving or determining a patient parameter indicative of the patient's respiratory rate based on data from one or more sensors; determining a state 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 state of the patient's respiratory rate; incrementally adjusting the operating flow rate based on the decision to adjust the operating flow rate; maintaining the operating flow rate based on the decision to maintain the operating flow rate; incrementally adjusting the operating oxygen concentration level based on the decision to adjust the operating oxygen concentration level; and maintaining the operating oxygen concentration level at a current operating oxygen concentration level based on the decision to maintain the operating oxygen concentration level.

[0023] In a third aspect, the present disclosure broadly includes a method for controlling operating parameters 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; and at intervals, receiving or determining a patient parameter indicative of the patient's respiratory rate based on data from one or more sensors; determining a state 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 state of the patient's respiratory rate; incrementally adjusting the operating flow rate based on the decision to adjust the operating flow rate; maintaining the operating flow rate at a current operating flow rate based on the decision to maintain the operating flow rate; determining whether to adjust or maintain the operating oxygen concentration level based on the state of the patient's respiratory rate; incrementally adjusting the operating oxygen concentration level based on the decision to adjust the operating oxygen concentration level; and maintaining the operating oxygen concentration level at a current operating oxygen concentration level based on the decision to maintain the operating oxygen concentration level.

[0024] The method of the second or third aspect may further have any one or more of the following aspects or features defined in the following paragraphs.

[0025] In one configuration, the method further includes delivering a flow of gas to the patient through the patient interface at an initial operating flow rate, the initial operating flow rate being determined based on one or more patient characteristics.

[0026] In one configuration, the method further includes delivering a flow of gas to the patient via a patient interface at an initial operating oxygen concentration level, the initial operating oxygen concentration level being determined based on one or more patient characteristics.

[0027] In one configuration, the intervals are spaced apart by variable periods, the variable periods being based on the state of at least the patient's respiratory rate.

[0028] In one configuration, the one or more sensors include one or more sensors configured to be attached to or positioned near the patient to measure a patient parameter indicative of the patient's respiratory rate.

[0029] In one configuration, the step of receiving or determining a patient parameter indicative of the patient's respiration rate includes receiving data from the one or more sensors indicative of a time-averaged respiration rate over a measurement period.

[0030] In one configuration, the at least one sensor stores a plurality of instantaneous measurements over the measurement period and calculates a time-averaged respiration rate.

[0031] In one configuration, the step of determining the state of the patient's respiratory rate includes comparing the patient parameters received or determined in a current interval with the patient parameters received or determined in one or more previous intervals.

[0032] In one configuration, the state of the patient's respiratory rate is related to a degree or amount of change between the patient parameters received or determined in the current interval and the patient parameters received or determined in one or more previous intervals based on the comparison.

[0033] In one configuration, the status of the patient's respiratory rate indicates that the patient's respiratory rate is increasing, decreasing, or substantially stable based on the comparison.

[0034] In one configuration, the step of determining whether to adjust the operating flow rate includes determining to adjust the operating flow rate based on the state of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

[0035] In one configuration, the step of determining whether to adjust or maintain the operating flow rate includes determining to maintain the operating flow rate based on a state of the patient's respiratory rate indicating that the patient's respiratory rate is substantially stable.

[0036] In one configuration, determining whether to adjust or maintain the operating flow rate and / or the operating oxygen concentration level further comprises comparing the state of the patient's breathing to one or more thresholds.

[0037] In one configuration, the step of incrementally adjusting the operating flow rate includes incrementally increasing the operating flow rate based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

[0038] In one configuration, the increment is a variable increment, the variable increment being based on the state of at least the patient's respiratory rate.

[0039] In one configuration, the step of maintaining the operating flow rate includes maintaining the operating flow rate at a previous incremental operating flow rate.

[0040] In one configuration, the method is performed continuously over the course of a treatment session.

[0041] In one configuration, the gas is delivered to the patient in conditions suitable to provide high flow therapy.

[0042] In a fourth aspect, the present disclosure broadly includes a method for controlling a flow rate of gas delivered to a patient, comprising: delivering gas to the patient via a patient interface at an operating flow rate; progressively applying, at intervals, a plurality of flow rate values ​​as the operating flow rate; receiving or determining, at each of the plurality of flow rate values, a patient parameter indicative of a patient's respiratory rate based on data received from one or more sensors; determining a state 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; maintaining the operating flow rate based on the state of the patient's respiratory rate indicating that the patient's respiratory rate is stable; continuing to receive or determine the patient parameter and performing an iterative process of determining the state of the patient's respiratory rate at further intervals; and adjusting the operating flow rate at the further intervals based on the state of the patient's respiratory rate indicating that the patient's respiratory rate is no longer stable, until the state of the patient's respiratory rate indicates that the patient's respiratory rate is stable.

[0043] In one configuration, 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 at a predetermined time period after adjusting the operating flow rate.

[0044] In one configuration, 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.

[0045] In one configuration, 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 out of range or outside a threshold.

[0046] In one configuration, the method further includes delivering a flow of gas to the patient through the patient interface at an initial operating flow rate, the initial flow rate being determined based on one or more patient characteristics.

[0047] In one configuration, the intervals are spaced apart by variable periods, the variable periods being based on the state of at least the patient's respiratory rate.

[0048] In one configuration, the one or more sensors include one or more sensors configured to be attached to or positioned near the patient to measure a patient parameter indicative of the patient's respiratory rate.

[0049] In one configuration, the step of receiving or determining a patient parameter indicative of the patient's respiration rate includes receiving data from the one or more sensors indicative of a time-averaged respiration rate over a measurement period.

[0050] In one configuration, the at least one sensor stores a plurality of instantaneous measurements over the measurement period and calculates a time-averaged respiration rate.

[0051] In one configuration, the step of determining the state of the patient's respiratory rate includes comparing the patient parameters received or determined in a current interval with the patient parameters received or determined in one or more previous intervals.

[0052] In one configuration, the state of the patient's respiratory rate is related to a degree or amount of change between the patient parameters received or determined in the current interval and the patient parameters received or determined in one or more previous intervals based on the comparison.

[0053] In one configuration, the state of the patient's respiratory rate indicates that the patient's respiratory rate is increasing, decreasing, or stable based on the comparison.

[0054] In one configuration, the step of determining whether the patient's respiratory rate is unstable includes the state of the patient's respiratory rate indicating that the patient's respiratory rate is increasing or decreasing.

[0055] In one configuration, the step of progressively applying a plurality of flow rate values ​​as the operating flow rate includes increasing the operating flow rate by an increment at each interval.

[0056] In one configuration, the increment is a variable increment, the variable increment being based on the state of at least the patient's respiratory rate.

[0057] In one configuration, the step of maintaining the operating flow rate includes maintaining the operating flow rate at a previous incremental operating flow rate.

[0058] In one configuration, the method is performed continuously over the course of a treatment session.

[0059] In one configuration, the gas is delivered to the patient in conditions suitable to provide high flow therapy.

[0060] In one configuration, the method further includes delivering a flow of gas to the patient via a patient interface at an operating oxygen concentration level.

[0061] In one configuration, the method further includes performing, during the interval, the steps of determining whether to adjust or maintain the operating oxygen concentration level based on the patient parameter indicative of at least the patient's respiratory rate; incrementally adjusting the operating oxygen concentration level based on the decision to adjust the operating oxygen concentration level; and maintaining the operating oxygen concentration level at a current operating oxygen concentration level based on the decision to maintain the operating oxygen concentration level.

[0062] In a fifth aspect, the present disclosure broadly includes a respiratory therapy system configured to provide a gas flow to a patient for respiratory therapy, the respiratory therapy system including a patient interface configured to deliver a gas flow to the patient; a flow generator configured to generate the gas flow to the patient at an operating flow rate; one or more sensors configured to measure a patient parameter indicative of the patient's respiratory rate; and a controller configured to control operation of the flow generator, the controller performing the following steps: receiving or determining, at intervals, a patient parameter indicative of the patient's respiratory rate based on data from the one or more sensors; determining a state 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 state of the patient's respiratory rate; adjusting the operating flow rate incrementally based on the determination to adjust the operating flow rate; and maintaining the operating flow rate at a current operating flow rate based on the determination to maintain the operating flow rate.

[0063] In a sixth aspect, the present disclosure broadly includes a respiratory apparatus configured to provide a gas flow to a patient for respiratory therapy, the respiratory apparatus including a flow generator configured to generate the gas flow to the patient at an operating flow rate, and a controller configured to control operation of the flow generator, the controller performing the following steps: receiving or determining, at intervals, a patient parameter indicative of a patient's respiratory rate based on data from one or more sensors; determining a state of the patient's respiratory rate based on at least the patient parameter and the patient parameters received or determined at one or more previous intervals; determining whether to adjust or maintain the operating flow rate based on the state of the patient's respiratory rate; adjusting the operating flow rate incrementally based on the decision to adjust the operating flow rate; and maintaining the operating flow rate at a current operating flow rate based on the decision to maintain the operating flow rate.

[0064] In a seventh aspect, the present disclosure broadly includes a respiratory therapy system configured to provide a flow of gas to a patient for respiratory therapy, said respiratory therapy system including a patient interface configured to deliver a flow of gas to said patient; a flow generator configured to generate said flow of gas to said patient at an operating flow rate; one or more sensors configured to measure a patient parameter indicative of a respiratory rate of said patient; and a controller configured to control operation of said flow generator, said controller receiving or determining, at intervals, a patient parameter indicative of a respiratory rate of said patient based on data from one or more sensors; and determining, at least said patient parameter indicative of a respiratory rate of said patient based on data from one or more previous intervals. The method includes the steps of determining a respiratory rate status of the patient based on the received or determined patient parameters, determining whether to adjust or maintain the operating flow rate and the operating oxygen concentration level based on the respiratory rate status of the patient, incrementally adjusting the operating flow rate based on the decision to adjust the operating flow rate, maintaining the operating flow rate based on the decision to maintain the operating flow rate, incrementally adjusting the operating oxygen concentration level based on the decision to adjust the operating oxygen concentration level, and maintaining the operating oxygen concentration level at a current operating oxygen concentration level based on the decision to maintain the operating oxygen concentration level.

[0065] In an eighth aspect, the present disclosure broadly includes a respiratory apparatus configured to provide a gas flow to a patient for respiratory therapy, the respiratory apparatus including a flow generator configured to generate the gas flow to the patient at an operating flow rate; and a controller configured to control operation of the flow generator, the controller performing the following steps: receiving or determining, at intervals, a patient parameter indicative of a patient's respiratory rate based on data from one or more sensors; determining a state 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 state of the patient's respiratory rate; incrementally adjusting the operating flow rate based on the determination to adjust the operating flow rate; maintaining the operating flow rate based on the determination to maintain the operating flow rate; incrementally adjusting the operating oxygen concentration level based on the determination to adjust the operating oxygen concentration level; and maintaining the operating oxygen concentration level at a current operating oxygen concentration level based on the determination to maintain the operating oxygen concentration level.

[0066] In a ninth aspect, the present disclosure broadly includes a respiratory therapy system configured to provide a flow of gas to a patient for respiratory therapy, the respiratory therapy system including a patient interface configured to deliver a flow of gas to the patient; a flow generator configured to generate the flow of gas to 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 configured to control operation of the flow generator, the controller including steps of: receiving or determining, at intervals, a patient parameter indicative of a respiratory rate of the patient based on data from the one or more sensors; and determining a respiratory rate of the patient based on at least the patient parameter and the patient parameter received or determined at one or more previous intervals. determining a respiratory rate state of the patient; determining whether to adjust or maintain the operating flow rate based on the respiratory rate state of the patient; incrementally adjusting the operating flow rate based on the decision to adjust the operating flow rate; maintaining the operating flow rate at a current operating flow rate based on the decision to maintain the operating flow rate; determining whether to adjust or maintain the operating oxygen concentration level based on the respiratory rate state of the patient; incrementally adjusting the operating oxygen concentration level based on the decision to adjust the operating oxygen concentration level; and maintaining the operating oxygen concentration level at a current operating oxygen concentration level based on the decision to maintain the operating oxygen concentration level.

[0067] In a tenth aspect, the present disclosure broadly includes a respiratory apparatus configured to provide a flow of gas to a patient for respiratory therapy, said respiratory apparatus including a flow generator configured to generate said flow of gas to said patient at an operating flow rate, and a controller configured to control operation of said flow generator, said controller comprising the steps of: receiving or determining, at intervals, patient parameters indicative of a patient's respiratory rate based on data from one or more sensors; determining a state of said patient's respiratory rate based on at least said patient parameters and said patient parameters received or determined at one or more previous intervals; and determining a state of said patient's respiratory rate based on said state of said patient's respiratory rate. determining whether to adjust or maintain the operating flow rate; incrementally adjusting the operating flow rate based on the decision to adjust the operating flow rate; maintaining the operating flow rate at a current operating flow rate based on the decision to maintain the operating flow rate; determining whether to adjust or maintain the operating oxygen concentration level based on the state of the patient's respiratory rate; incrementally adjusting the operating oxygen concentration level based on the decision to adjust the operating oxygen concentration level; and maintaining the operating oxygen concentration level at a current operating oxygen concentration level based on the decision to maintain the operating oxygen concentration level.

[0068] In an eleventh aspect, the present disclosure broadly includes a respiratory therapy system configured to provide a gas flow to a patient for respiratory therapy, the respiratory therapy system including a patient interface configured to deliver a gas flow to the patient; a flow generator configured to generate the gas flow to 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 configured to control operation of the flow generator, the controller including the steps of: progressively applying a plurality of flow rate values ​​as the operating flow rate at intervals; and receiving or determining, at each of the plurality of flow rate values, a patient parameter indicative of a respiratory rate of the patient based on data received from one or more sensors. determining a state of the patient's respiratory rate based on at least the patient parameters and the patient parameters received or determined at one or more previous intervals; maintaining the operating flow rate based on the state of the patient's respiratory rate indicating that the patient's respiratory rate is stable; continuing to receive or determine the patient parameters and performing an iterative process of determining the state of the patient's respiratory rate at further intervals; and adjusting the operating flow rate at the further intervals based on the state of the patient's respiratory rate indicating that the patient's respiratory rate is no longer stable until the state of the patient's respiratory rate indicates that the patient's respiratory rate is stable.

[0069] In a twelfth aspect, the present disclosure broadly includes a respiratory apparatus configured to provide a gas flow to a patient for respiratory therapy, the respiratory apparatus including a flow generator configured to generate the gas flow to the patient at an operating flow rate, and a controller configured to control operation of the flow generator, the controller performing the following steps: progressively applying a plurality of flow rate values ​​as the operating flow rate at intervals; at each of the plurality of flow rate values, receiving or determining a patient parameter indicative of a patient's respiratory rate based on data received from one or more sensors; determining a state 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; maintaining the operating flow rate based on the state of the patient's respiratory rate indicating that the patient's respiratory rate is stable; continuing to receive or determine the patient parameter and performing an iterative process of determining the state of the patient's respiratory rate at further intervals; and adjusting the operating flow rate at the further intervals based on the state of the patient's respiratory rate indicating that the patient's respiratory rate is no longer stable, until the state of the patient's respiratory rate indicates that the patient's respiratory rate is stable.

[0070] The respiratory therapy system of any of the fifth, seventh, ninth, or eleventh aspects, or the respiratory apparatus of the sixth, eighth, tenth, or twelfth aspects, may further have one or more of any of the following aspects or features defined in the following paragraphs:

[0071] In one configuration, the flow generator is further configured to deliver a flow of gas to the patient through the patient interface at an initial operating flow rate, the initial operating flow rate being determined based on one or more patient characteristics.

[0072] In one configuration, the intervals are spaced apart by variable periods, the variable periods being based on the state of at least the patient's respiratory rate.

[0073] In one configuration, the one or more sensors include one or more sensors configured to be attached to or positioned near the patient to measure a patient parameter indicative of the patient's respiratory rate.

[0074] In one configuration, the step of receiving or determining a patient parameter indicative of the patient's respiration rate includes receiving data from the one or more sensors indicative of a time-averaged respiration rate over a measurement period.

[0075] In one configuration, the at least one sensor stores a plurality of instantaneous measurements over the measurement period and calculates a time-averaged respiration rate.

[0076] In one configuration, the step of determining the state of the patient's respiratory rate includes comparing the patient parameters received or determined in a current interval with the patient parameters received or determined in one or more previous intervals.

[0077] In one configuration, the state of the patient's respiratory rate is related to a degree or amount of change between the patient parameters received or determined in the current interval and the patient parameters received or determined in one or more previous intervals based on the comparison.

[0078] In one configuration, the status of the patient's respiratory rate indicates that the patient's respiratory rate is increasing, decreasing, or substantially stable based on the comparison.

[0079] In one configuration, the step of determining whether to adjust the operating flow rate includes determining to adjust the operating flow rate based on the state of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

[0080] In one configuration, the step of determining whether to adjust or maintain the operating flow rate includes determining to maintain the operating flow rate based on a state of the patient's respiratory rate indicating that the patient's respiratory rate is substantially stable.

[0081] In one configuration, the step of determining whether to adjust or maintain the operating flow rate further comprises comparing the state of the patient's respiratory rate to one or more thresholds.

[0082] In one configuration, the step of incrementally adjusting the operating flow rate includes incrementally increasing the operating flow rate based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

[0083] In one configuration, the increment is a variable increment, the variable increment being based on the state of at least the patient's respiratory rate.

[0084] In one configuration, the step of maintaining the operating flow rate includes maintaining the operating flow rate at a previous incremental operating flow rate.

[0085] In one configuration, the steps are performed continuously at the intervals over the course of a treatment session.

[0086] In one configuration, the gas is delivered to the patient in conditions suitable to provide high flow therapy.

[0087] In one configuration, the controller is further configured to deliver a flow of gas to the patient via the patient interface at an operating oxygen concentration level.

[0088] In one configuration, 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, the initial operating oxygen concentration level being determined based on one or more patient characteristics.

[0089] In one configuration, the controller is further configured to perform the following steps during the interval: determining whether to adjust or maintain the operating oxygen concentration level based on the patient's respiratory rate status; incrementally adjusting the operating oxygen concentration level based on the decision to adjust the operating oxygen concentration level; and maintaining the operating oxygen concentration level at a current operating oxygen concentration level based on the decision to maintain the operating oxygen concentration level.

[0090] In some configurations, the system or apparatus further includes a humidifier configured to humidify the gas flow.

[0091] In a thirteenth aspect, the present disclosure broadly includes a respiratory therapy system configured to provide a gas flow to a patient for respiratory therapy, the respiratory therapy system including a patient interface configured to supply a gas flow to the patient, a flow generator configured to generate the gas flow to the patient at an operating flow rate, one or more sensors configured to measure a patient parameter indicative of the patient's respiratory rate based on data received from the one or more sensors, and a controller configured to receive or determine a patient parameter indicative of the patient's respiratory rate, and control the operating flow rate of the flow generator based on the received or determined patient parameter indicative of the patient's respiratory rate.

[0092] The respiratory therapy system of the thirteenth aspect may have any one or more of the aspects or features defined in connection with the fifth aspect, the seventh aspect, the ninth aspect, or the eleventh aspect.

[0093] In a fourteenth aspect, the present disclosure broadly includes a method for controlling a flow rate of gas delivered to a patient, the method comprising: delivering gas to the patient at an operating flow rate via a patient interface; at intervals, receiving or determining a patient parameter indicative of a patient's respiratory rate based on data from one or more patient-contacting sensors; determining whether to adjust or maintain the operating flow rate based on comparing the patient parameter indicative of at least the patient's respiratory rate to one or more thresholds; adjusting the operating flow rate incrementally based on a decision to adjust the operating flow rate; and maintaining the operating flow rate at a current operating flow rate based on a decision to maintain the operating flow rate.

[0094] The method of the fourteenth aspect may have any one or more of the aspects or features defined in relation to the first, second, third or fourth aspect.

[0095] In a fifteenth aspect, the present disclosure broadly includes a respiratory therapy system configured to provide a gas flow to a patient for respiratory therapy, the respiratory therapy system including a patient interface configured to supply a gas flow to the patient at an operating flow rate; a flow generator configured to generate the gas flow to the patient at the operating flow rate; one or more patient-contacting sensors configured to measure a patient parameter indicative of the patient's respiratory rate; and a controller, the controller configured to perform the following steps: receiving or determining a patient parameter indicative of the patient's respiratory rate based on data from the one or more patient-contacting sensors; determining whether to adjust or maintain the operating flow rate based on comparing the patient parameter indicative of at least the patient's respiratory rate with one or more thresholds; adjusting the operating flow rate incrementally based on a decision to adjust the operating flow rate; and maintaining the operating flow rate at a current operating flow rate based on a decision to maintain the operating flow rate.

[0096] The respiratory therapy system of the fifteenth aspect may have any one or more of the aspects or features defined in connection with the fifth aspect, the seventh aspect, the ninth aspect, the eleventh aspect, or the thirteenth aspect.

[0097] In a sixteenth aspect, the present disclosure broadly includes a method for controlling a flow rate of gas delivered to a patient, the method comprising: delivering gas to the patient via a patient interface at an operating flow rate; 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 operating flow rate based on comparing the patient parameter indicative of at least the patient's respiratory rate to one or more thresholds; adjusting the operating flow rate incrementally based on the decision to adjust the operating flow rate; and maintaining the operating flow rate at a current operating flow rate based on the decision to maintain the operating flow rate.

[0098] The method of the sixteenth aspect may have any one or more of the aspects or features defined in relation to the first aspect, second aspect, third aspect, fourth aspect or fourteenth aspect.

[0099] In one configuration, the method further includes receiving or determining a patient parameter indicative of the patient's SpO2 based on data from one or more sensors.

[0100] In one configuration, the step of determining whether to adjust or maintain the operating flow rate is further based on comparing the patient parameter indicative of the patient's SpO2 to one or more thresholds.

[0101] In one configuration, the method further includes receiving or determining a therapy parameter indicative of an FiO2 provided or to be provided to the patient.

[0102] In one configuration, the therapy parameter indicative of the FiO2 provided or to be provided to the patient is based at least in part on the patient parameter indicative of the patient's SpO2.

[0103] In one configuration, the step of determining whether to adjust or maintain the operating flow rate is further based on comparing the patient therapy indicative of the FiO2 provided or to be provided to the patient to one or more thresholds.

[0104] In one configuration, the one or more thresholds include one or more parameter thresholds, each related to a patient or treatment parameter. In one configuration, each parameter threshold is set by a user. In one configuration, the parameter threshold relates to a maximum allowable respiratory rate.

[0105] In certain configurations, the one or more thresholds further include a time-based threshold. In certain configurations, the time-based threshold is set by a user. In certain configurations, the time-based threshold relates to a minimum amount of time that the patient parameter exceeds the patient parameter threshold.

[0106] In one configuration, the increment in the operating flow rate to be adjusted is an increase in the operating flow rate, hi one configuration, the increment is an absolute or fixed amount.

[0107] In some configurations, the increment is a percentage or fraction of the operating flow rate. In some configurations, the increment of the operating flow rate is set by a user.

[0108] In some configurations, adjusting the operating flow rate in increments comprises changing the operating flow rate in step changes. In some configurations, adjusting the operating flow rate in increments comprises ramping the operating flow rate.

[0109] In one configuration, when adjusting the operating flow rate by the increment, the method further includes displaying a prompt or alert to a user indicating that the operating flow rate has been adjusted.

[0110] In one configuration, the method further includes presenting an audible alarm to the user indicating that the operating flow rate has been adjusted.

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

[0112] In a seventeenth aspect, the present disclosure broadly includes a respiratory therapy system configured to provide a gas flow to a patient for respiratory therapy, the respiratory therapy system including a patient interface configured to supply a gas flow to the patient; a flow generator configured to generate the gas flow to the patient at an operating flow rate; one or more sensors configured to measure a patient parameter indicative of the patient's respiratory rate; and a controller configured to control operation of the flow generator, the controller performing 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; deciding whether to adjust or maintain the operating flow rate based on comparing at least the patient parameter indicative of the patient's respiratory rate with one or more thresholds; adjusting the operating flow rate incrementally based on a decision to adjust the operating flow rate; and maintaining the operating flow rate at a current operating flow rate based on a decision to maintain the operating flow rate.

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

[0114] In another aspect, the present disclosure relates to electronically implemented methods comprising software code or coded instructions executable or implemented by a computer, processor, or controller to perform any one or more of the methods or aspects described above.

[0115] In another aspect, the present disclosure broadly includes non-transitory computer-readable media having stored thereon computer-executable instructions that, when executed on a processing device(s), cause the processing device(s) to implement or perform any one or more of the methods or aspects described above.

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

[0117] [Figure 1] 1 illustrates a schematic representation of a respiratory system configured to provide respiratory therapy to a patient. [Figure 2] FIG. 1 is a front view of an example of a breathing apparatus with the humidification chamber in place and the handle / lever raised. [Figure 3] FIG. 3 is a top view corresponding to FIG. 2. [Figure 4] FIG. 3 is a right side view corresponding to FIG. 2. [Figure 5] FIG. 3 is a left side view corresponding to FIG. 2. [Figure 6] FIG. 3 is a rear view corresponding to FIG. 2. [Figure 7] FIG. 3 is a front left perspective view corresponding to FIG. 2. [Figure 8] FIG. 3 is a front right perspective view corresponding to FIG. 2. [Figure 9] FIG. 3 is a bottom view corresponding to FIG. 2. [Figure 10] 1 shows an example of an arrangement of air and oxygen inlet ports for a breathing apparatus. [Figure 11]10A and 10B show alternative configurations for the air and oxygen inlet arrangements for the breathing apparatus. [Figure 12] FIG. 12 is a cross-sectional view showing further details of the air and oxygen inlet arrangement of FIG. 11. [Figure 13] FIG. 12 is another cross-sectional view showing further details of the air and oxygen inlet arrangement of FIG. 11. [Figure 14] FIG. 12 is a longitudinal section showing further details of the air and oxygen inlet arrangement of FIG. 11; [Figure 15] FIG. 1 is an exploded perspective view of the upper and lower chassis components of the main housing of the respiratory apparatus. [Figure 16] FIG. 1 is a front left perspective view of the lower chassis of the main housing showing the housing for receiving the motor / sensor module subassembly. [Figure 17] FIG. 1 is a first bottom perspective view of the main housing of the respiratory apparatus showing a recess within the housing for the motor / sensor module subassembly. [Figure 18] FIG. 10 is a second bottom perspective view of the main housing of the respiratory apparatus showing the recess for the motor / sensor module subassembly. [Figure 19A] FIG. 1 is a block diagram of a control system that interacts with and / or provides control and direction to components of the respiratory system. [Figure 19B] FIG. 1 illustrates a block diagram of an exemplary controller. [Figure 20] FIG. 1 shows a block diagram of a motor and sensor module. [Figure 21] 1 illustrates a sensing chamber in an example motor and sensor module. [Figure 22] 1 illustrates a schematic representation of a respiratory system configured to provide respiratory therapy to a patient. [Figure 23] 1 shows a block diagram of a control system that interacts with and / or provides control and direction to components of the respiratory system. [Figure 24] 1 illustrates a flow diagram of one embodiment of an operating flow rate determination process. [Figure 25]1 illustrates a flow diagram of one embodiment of an operating flow rate and operating oxygen concentration level determination process. [Figure 26] FIG. 1 shows a graph illustrating an example of respiratory rate versus flow rate. [Figure 27] FIG. 1 shows a graph illustrating an example of respiratory rate versus flow rate. [Figure 28] FIG. 1 shows a graph illustrating an example of respiratory rate versus flow rate. [Figure 29] FIG. 1 shows a graph illustrating an example of respiratory rate versus flow rate. [Figure 30] 1 illustrates a flow diagram of one embodiment of an operating oxygen concentration level determination process. DETAILED DESCRIPTION OF THE INVENTION

[0118] While specific examples are described below, those skilled in the art will recognize that the disclosure extends beyond the specifically disclosed examples and / or applications, and obvious modifications and equivalents thereof, and therefore it is not intended that the scope of the disclosure disclosed herein should be limited by the specific examples described below.

[0119] Respiratory support systems, including humidifiers, may be used to deliver heated and humidified respiratory gas to a patient through a conduit and a patient interface. Respiratory support systems can provide a number of therapies to patients requiring respiratory assistance. One type of therapy involves providing high-flow therapy. In high-flow therapy, the respiratory support system delivers a relatively high flow rate of gas through a nasal interface, which may not be sealed. The gas flow rate can be in the range of 5 L / min to 120 L / min. In some embodiments, the gas flow rate can be in the range of 10 L / min to 120 L / min. In some embodiments, the gas flow rate can be in the range of 20 L / min to 120 L / min. In some embodiments, the gas flow rate is in the range of 30 L / min to 50 L / min. In some embodiments, the gas flow rate can be as high as 60 L / min. In some embodiments, the flow rate is greater than 60 L / min but less than 120 L / min. In other embodiments, the flow rate is greater than 120 L / min. The respiratory support system can adjust the gas flow rate during therapy via a control system. High flow therapy and methods for varying flow in respiratory support systems are described in International Publication No. WO 2015 / 033288, entitled "Improvements to Flow Therapy," which is incorporated herein by reference in its entirety.

[0120] The flow rate in high-flow therapy is a function of the patient's condition and can change during treatment. Clinicians or patients may be unable to determine the flow rate at which the respiratory support system will provide optimal therapy and comfort. Healthcare providers often do not know the appropriate flow rate for a particular patient and may set the flow rate too low or too high compared to the clinically optimal flow rate. Healthcare providers also often do not know how to measure the effectiveness of treatment or how long to wait to determine its effectiveness.

[0121] Thus, the present disclosure provides methods and systems for controlling device operating parameters, specifically flow rate and / or oxygen concentration level, for a given patient. The methods can be implemented by a device control system. The respiratory assistance devices and systems described below include control systems implemented with a controller for controlling the device operating parameters. The control system can automatically control the operating flow rate and / or oxygen concentration level of gas delivered to the patient over the course of treatment and based on changes in the patient's condition. Thus, the control system can advantageously improve the effectiveness of high-flow therapy and reduce the likelihood that the patient will require more invasive treatment, such as invasive mechanical ventilation. Control methods for flow rate and / or oxygen concentration level in high-flow therapy can help reduce the amount of time the patient spends during treatment with a flow rate that is too high or too low for their immediate respiratory support needs.

[0122] Flow rate is believed to affect numerous physiological and clinical parameters, such as work of breathing, end-tidal CO2, respiratory rate, thoracic-abdominal phase, and other clinically relevant parameters. The control system and method described above can automatically control active high flow respiratory therapy flow rate based on patient parameters indicative of at least the patient's respiratory rate.

[0123] 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, respiratory rate can be used to assist in controlling operating parameters related to the delivery of high-flow therapy. Respiratory rate can provide a means of identifying optimal or acceptable operating parameters and treatment settings when a patient is receiving high-flow therapy.

[0124] Controlling operating parameters based on physiological parameters typically involves monitoring how physiological parameters, such as respiratory rate, change or respond to determine optimal operating parameters for high-flow therapy. When a clinician or other practitioner manually changes operating parameters in response to measured physiological parameters, it can take a significant amount of time to reach optimal operating parameters. Because of the long titration times required, given that clinicians often lack the time, it is unlikely that the operating parameters will be set to optimal or acceptable conditions.

[0125] Some physiological parameters in use take impractically long time to change in response to changes in therapy or a worsening patient condition. One example is the widely used physiological parameter SpO2. Typically, when a patient's condition worsens, the body first stabilizes the SpO2 level by increasing minute ventilation, delivering more oxygen to the lungs. As a result, SpO2 values ​​are only affected after a significant delay or when the patient's condition has deteriorated significantly. This makes it impractical to use such physiological parameters to control treatment parameters that require minimal response delay.

[0126] 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 measured patient condition. Such a system should be able to titrate parameters up or down to optimal or other acceptable values ​​as the patient uses the therapy. Patient condition should be measured using physiological parameters that provide an early indication of changes in the patient's condition and that can be measured accurately and continuously.

[0127] The control system can automatically control the operating parameters of the respiratory therapy device to provide optimal respiratory therapy to the patient and help reduce the respiratory rate, thereby allowing the patient to feel more relaxed and reducing the work of breathing, i.e., the physical strain of breathing hard. The control system can also help identify the success or failure of treatment more quickly. For example, it may be advantageous to know early on that high-flow therapy is not effective for a particular patient rather than finding out later. The control system may compare the patient's physiological parameters as a function of flow rate to predetermined parameters expected to determine the effectiveness of the treatment.

[0128] Controlling the operating parameters of a respiratory therapy device can provide optimal respiratory therapy, helping to alleviate a patient's respiratory discomfort and reduce the patient's work of breathing, or the effort required to breathe. As described below, a patient's respiratory rate is an indicator of the patient's work of breathing. In particular, a higher respiratory rate may 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.

[0129] The control system described above may generate an indication of an operating parameter, such as flow rate or oxygen concentration level, for display to a physician. Based on the sensitivity of clinical and physiological parameters (such as measured respiratory rate) to the operating parameter, the control system may send an alert to the clinician if the therapy is not effective for a particular patient. The present disclosure may detect when a respiratory therapy is not effective and indicate this to the clinician. The clinician can then make a decision to escalate the patient to another therapy (e.g., bilevel pressure therapy or invasive ventilation).

[0130] 1. Overview of the respiratory support system The methods and processes for controlling the flow rate of gas delivered to a patient are described in the context of an example respiratory device 10 configured or operable to provide nasal high-flow therapy via a non-sealing patient interface. This is intended as a non-limiting example. It will be understood that the methods and processes may be applied to other respiratory devices and / or other modes of operation and / or modes of therapy provided by such devices.

[0131] A schematic diagram of a breathing apparatus 10 is shown in FIG.

[0132] The respiratory apparatus 10 (or "breathing system") comprises a flow source 50 for supplying a high flow gas 31, such as air, oxygen, air mixed with oxygen, or a mixture of air and / or oxygen with one or more other gases. Alternatively, the respiratory aid apparatus may have connections for coupling to the flow source. Thus, the flow source may be considered to form part of the apparatus or to be separate from the apparatus, depending on the context. Alternatively, parts of the flow source may be considered to form part of the apparatus or to be separate from the apparatus. In short, depending on the configuration (some components may be optional), the system may comprise: ·Flow source, a humidifier for humidifying the gas stream; Conduits (such as dry lines or heated breathing tubes), Patient interface, -Backflow prevention valves, and A combination of components selected from the filters may include:

[0133] The device or system will now be described in more detail.

[0134] The flow source can be an in-wall supply of oxygen, a tank of oxygen 50A, a tank of other gas, and / or a high-flow device with a flow generator 50B. FIG. 1 shows the flow source 50 with a flow generator 50B, with 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 regulator and / or other gas flow control 50D, but this is just one option. The flow generator 50B can control the flow rate delivered to the patient 56 using one or more valves, or optionally, the flow generator 50B can include a blower. The flow source can be one or a combination of the flow generator 50B, O2 source 50A, and air source 50C, as previously described. While the flow source 50 is shown as part of the device 10, an external oxygen tank or an in-wall flow source can be considered a separate component, in which case the device would have connection ports for connecting to such a flow source. The flow source provides a (preferably high) flow rate of gas that can be delivered to the patient via the supply conduit 16 and the patient interface 51 .

[0135] The patient interface 51 may be a non-sealing (non-sealing) interface (e.g., when used in high-flow therapy), such as a non-sealing nasal cannula or a non-sealing tracheostomy interface. In some embodiments, the patient interface 51 is a non-sealing patient interface, for example, to help prevent barotrauma (e.g., tissue damage in the lungs or other organs of the respiratory system due to pressure differences relative to the atmosphere). The patient interface may be a non-sealing nasal cannula with a manifold and nasal prongs, and / or a tracheostomy interface, or other suitable type of patient interface. The flow source may provide a base gas flow rate, for example, between 0.5 L / min and 120 L / min, or any range within that range, or a range with higher or lower limits. The ranges and nature of the flow rates are described in more detail below.

[0136] A humidifier 52 may optionally be provided between the flow source 50 and the patient to provide humidification of the delivered gas. One or more sensors 53A, 53B, 53C, 53D, such as a flow sensor, an oxygen fraction sensor, a pressure sensor, a humidity sensor, a temperature sensor, or other sensors, may be located throughout the system and / or directly on or near the patient 56.

[0137] In some configurations, the respiratory system 10 can include a sensor 14 for measuring the oxygen fraction of the air inhaled by the patient. In some embodiments, the sensor 14 can be positioned on the patient interface 51 to measure or otherwise determine the percentage of oxygen in close proximity to / near the patient's mouth and / or nose. In some configurations, the output from the sensor 14 is sent to a controller 19 to help control and thereby modify the operation of the respiratory system 10. The controller 19 is coupled to the flow source 50, the humidifier 52, and the sensor 14. In some configurations, the controller 19 controls these and other portions of the respiratory system 10 described herein. In some examples, the controller can operate the flow source 50 to provide a supply flow of gas at a desired rate high enough to meet or exceed the inspiratory demand of the user (i.e., the patient). The flow rate is provided so that ambient gases are not entrained when the user (i.e., the patient) breathes. In some configurations, the sensor 14 may provide a measurement of the oxygen fraction in the patient's mouth and / or nose to a user, who may input that information into the respiratory system 10 / controller 19 .

[0138] An optional anti-reflux valve 23 may be provided in the breathing conduit 16. Filter(s) may be provided at the air inlet 50C and / or at the inlet to the flow generator 50B to filter the incoming gas before it is pressurized into high flow gas 31 by the flow generator 50B.

[0139] The respiratory support device 10 can be an integrated or discrete component-based arrangement, as generally shown in the dotted box 100 of FIG. 1 . In some configurations, the device or system can have a modular arrangement of components. Furthermore, the device or system may be comprised of some, but not all, of the components shown. Also, the conduits and patient interface need not be part of the system, but can be considered separate. Also, the conduits and patient interface need not be part of the system, but can be considered separate. "Respiratory support device" and "respiratory system" are used herein to broadly include anything that delivers a flow of gas to a patient. Some such devices and systems may include a detection system that can be used to determine whether the flow of gas is meeting inspiratory demand.

[0140] The respiratory apparatus 10 may include a main housing 100. The main housing 100 may include a flow generator 50B, which may be in the form of a motor / impeller arrangement, an optional humidifier or humidification chamber 52, a controller 19, and an input / output I / O user interface 54. The user interface 54 may include a display and input device(s), such as a button(s), a touchscreen (e.g., an LCD screen), or a combination of a touchscreen and button(s). The 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 the flow generator 50B to generate a gas flow for delivery to the patient, operating the humidifier or humidification chamber 52 (if present) to humidify and / or warm the gas flow, receiving user input from the user interface 54 for reconfiguration and / or user-defined operation of the respiratory apparatus 10, and outputting information (e.g., on a display) to a user, whether the user is a patient, a medical professional, or others.

[0141] 1, the patient breathing conduit 16 is coupled to a gas outlet (gas outlet or patient outlet) 21 in the main housing 100 of the respiratory apparatus 10 and may be coupled to a patient interface 17, such as a non-sealing interface, such as a nasal cannula having a manifold and nasal prongs. The patient breathing conduit 16 may also be a tracheostomy interface or other non-sealing interface.

[0142] The gas flow can be generated and humidified by a flow generator 50B before being delivered to the patient via the patient respiratory conduit 16 through the patient interface 51. The controller 19 can control the flow generator 50B to generate a gas flow at a desired flow rate and / or control one or more valves to control the mixture of air with oxygen or other breathable gases. The controller 19 can control a heating element in or associated with the humidification chamber 52 to warm the gas to a desired temperature to achieve a desired level of temperature and / or humidity for delivery to the patient. The patient respiratory conduit 16 can include a heating element, such as a heater wire, to warm the gas flow passing to the patient. The heating element can also be under the control of the controller 19.

[0143] The humidifier 52 of the present device is configured to combine or mix humidity into the gas stream. Various humidifier 52 configurations may be employed. In one configuration, the humidifier 52 may comprise a removable humidification chamber. For example, the humidification chamber may be partially or entirely removed or detached from the flow path and / or the device. By way of example, the humidification chamber may be removed for, for example, refilling, cleaning, replacement, and / or repair. In one configuration, the humidification chamber may be received and held in or within a humidification compartment or bay of the device, or may be coupled on or within the housing of the device.

[0144] The humidification chamber of the humidifier 52 may include a gas inlet and a gas outlet that allow connection to the gas flow path of the device, for example, a gas flow from the flow generator 50B is admitted to the humidification chamber through its gas inlet, warmed and / or humidified, and then discharged from the chamber through its gas outlet.

[0145] The humidification chamber typically contains a liquid, such as water. During operation, the liquid within the humidification chamber is controllably heated by one or more heaters or warming elements associated with the chamber to generate water vapor or steam, increasing the humidity of the gas flowing through the chamber.

[0146] In some configurations, the humidifier is a pass-through humidifier. In other configurations, the humidifier may be a non-pass-through humidifier.

[0147] In one configuration, the humidifier may include a heater plate associated with or provided within a humidification bay, e.g., in which the chamber rests for heating. The chamber may include a heat transfer surface, e.g., a metal insert, plate, or the like, provided on the base or other surface of the chamber that interfaces or engages with the heater plate of the humidifier.

[0148] In other configurations, the humidification chamber may include an internal heater or heater element inside or within the chamber, which may be integrally mounted or provided within the chamber, or may be removable from the chamber.

[0149] The humidification chamber may have any suitable shape and / or size. The location, number, size, and / or shape of the gas inlet and gas outlet of the chamber may be varied as needed. In one configuration, the humidification chamber may have a base surface, one or more sidewalls extending upward from the base surface, and a top or top surface. In one configuration, the gas inlet and gas outlet may be located on the same side of the chamber. In other configurations, the gas inlet and gas outlet may be located on different surfaces of the chamber, such as on opposing sides or locations.

[0150] In some configurations, the gas inlet and gas outlet may have parallel flow axes. In some configurations, the gas inlet and gas outlet may be positioned at the same height above the chamber.

[0151] The device 10 may use ultrasound transducer(s), flow sensor(s), such as a thermistor flow sensor, pressure sensor(s), temperature sensor(s), humidity sensor(s), or other sensors in communication with the controller 19 to monitor characteristics of the gas flow and / or operate the system 10 in a manner to provide appropriate therapy. The characteristics of the gas flow may include gas concentration, flow rate, pressure, temperature, humidity, or other characteristics. The sensors 53A, 53B, 53C, 53D, 14, such as pressure sensors, temperature sensors, humidity sensors, and / or flow sensors, may be located at various locations within the main device housing 100, the patient conduit 16, and / or the patient interface 51. The controller 19 may receive output from the sensors to assist in operating the respiratory apparatus 10 in a manner to provide 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, 53C are located within the device housing, sensor 53D is located within the patient conduit 16, and sensor 14 is located within the patient interface 51.

[0152] The device 10 may include one or more communication modules that enable data communication or connection with one or more external devices or servers via a data link or communication link or data network, whether wired, wireless, or a combination thereof. For example, in one configuration, the device 10 may include a wireless data transmitter and / or receiver, or transceiver 15, to enable the controller 19 to wirelessly receive data signals from operational sensors and / or control various components of the system 10. The transceiver 15, or data transmission and / or reception module, may have an antenna 15a, as shown. In one embodiment, the transceiver may include a Wi-Fi modem. Additionally or alternatively, the data transmitter and / or receiver 15 may deliver data to a remote patient management system (i.e., a remote server) or enable remote control of the system 10. The system 10 may include a wired connection, e.g., using a cable or wire, to enable the controller 19 to receive data signals from operational 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 module, a 4G module, or a 5G module. Module 15 may be or consist of 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 may consist of a single server, multiple servers, or multiple computing devices implemented in a cloud computing network. Communication may be bidirectional between the device and the patient management system (e.g., server) or other remote system. Device 10 may also include other wireless communication modules, such as a Bluetooth module and / or a Wi-Fi module.The Bluetooth and / or WiFi modules enable the device to transmit information wirelessly to other devices, such as smartphones or tablets, or to operate over a LAN (Local Area Network) or Wireless LAN (WLAN). The device may additionally or alternatively include a Near Field Communication (NFC) module to enable data transfer and / or data communication.

[0153] For example, the measured patient data and / or device data (e.g., respiratory rate, duration of use) may be communicated to a remote patient management system (i.e., a remote server). The remote patient management system may be a single server, a network of servers, a cloud computing system, or other suitable architecture for operating the remote patient management system. The remote patient management system (i.e., the remote server) may further include memory for storing received data and various software applications or services running to perform functions. For example, the remote patient management system (i.e., the remote server) may communicate information or instructions to the system 10 depending at least in part on the received data. For example, the nature of the received data may trigger the remote server (or a software application running on the remote server) to communicate an alert, alarm, or notification to the system 10. The remote patient management system may further store the received data so that it can be accessed by an authorized party, such as a clinician, a patient, or other authorized party. The remote patient management system may further be configured to generate a report upon request from the authorized party, and the measured patient data and / or device data may be included in the generated report. The report may also include other patient respiratory parameters (eg, respiratory rate or SpO2) and / or device parameters (eg, flow rate, humidity level).

[0154] The respiratory device 10 may include a high-flow therapy device. High-flow therapy, as described herein, is intended to be given its typical and ordinary meaning as understood by those skilled in the art and generally refers to a respiratory system that delivers a target flow rate of humidified respiratory gas through an intentionally unsealed patient interface at a rate that meets or exceeds the user's inspiratory flow rate. Typical patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults are often, but are not limited to, about 15 liters per minute to about 60 liters per minute or more. Typical flow rates for pediatric patients (e.g., neonates, infants, children) are often, but are not limited to, about 1 liter per minute per kg of body weight to about 3 liters per minute per kg of body weight or more.

[0155] High flow therapy may also optionally include the administration of mixed gas compositions containing supplemental oxygen and / or therapeutic medications.

[0156] High flow therapy is often referred to by colloquial terms such as high nasal flow (NHF), humidified high flow nasal cannula (HHFNC), high flow nasal oxygen (HFNO), high flow therapy (HFT), high flow for tracheostomy patients (THF), etc. For example, in some configurations, "high flow therapy" for an adult patient refers to delivering gas to the patient at a flow rate of about 10 liters per minute (10 LPM) or greater, such as about 10 LPM to about 100 LPM, or about 15 LPM to about 95 LPM, or about 20 LPM to about 90 LPM, or about 25 LPM to about 85 LPM, or about 30 LPM to about 80 LPM, or about 35 LPM to about 75 LPM, or about 40 LPM to about 70 LPM, or about 45 LPM to about 65 LPM, or about 50 LPM to about 60 LPM. In some configurations, "high flow therapy" for neonates, infants, or children refers to delivering gas to a patient at a flow rate of about 1 LPM or greater, such as about 1 LPM to about 25 LPM, or about 2 LPM to about 25 LPM, or about 2 LPM to about 5 LPM, or about 5 LPM to about 25 LPM, or about 5 LPM to about 10 LPM, or about 10 LPM to about 25 LPM, or about 10 LPM to about 20 LPM, or about 10 LPM to about 15 LPM, or about 20 LPM to about 25 LPM. High flow therapy devices intended for adult, neonatal, infant, or pediatric patients may deliver gas to a patient at a flow rate of about 1 LPM to about 100 LPM, or any of the subranges above.

[0157] High-flow therapy is effective in meeting or exceeding a patient's inspiratory demand, enhancing patient oxygenation and / or reducing the patient's work of breathing. Furthermore, high-flow therapy can induce a flushing effect in the nasopharynx, such that the anatomical dead space in the upper airway is flushed by the incoming high-volume gas flow. This flushing effect creates a reservoir of fresh gas with each breath while minimizing rebreathing of gases such as carbon dioxide and nitrogen. High-flow therapy can also increase the patient's exhalation time by increasing the pressure during expiration, thereby decreasing the patient's respiratory rate.

[0158] A patient interface for use with high-flow therapy may be a non-sealing interface to prevent barotrauma, which may include tissue damage to the patient's lungs or other organs of the respiratory system due to pressure differences relative to the atmosphere. The patient interface may be a nasal cannula with a manifold and nasal prongs, and / or a non-sealing tracheostomy interface, or other suitable type of patient interface.

[0159] 2-18 illustrate an example of a respiratory apparatus 10 having a main housing 100. The main housing 100 has a main housing upper chassis 102 and a main housing lower chassis 202. The main housing upper chassis 102 has a peripheral wall arrangement 106 (see FIG. 15). The peripheral wall arrangement defines a humidifier or humidification chamber bay 108 for receiving a removable humidification chamber 300. The removable humidification chamber 300 contains a suitable liquid, such as water, for humidifying gases that can be delivered to a patient.

[0160] In the illustrated form, the perimeter wall arrangement 106 of the main housing upper chassis 102 may include a substantially vertical left outer wall 110 facing in the front-to-rear direction of the main housing 100, a substantially vertical left inner wall 112 facing in the front-to-rear direction of the main housing 100, and an interconnecting wall 114 extending between and interconnecting the upper ends of the left inner and outer walls 110, 112. The main housing upper chassis 102 may further include a substantially vertical right outer wall 116 facing in the front-to-rear direction of the main housing 100, a substantially vertical right inner wall 118 facing in the front-to-rear direction of the main housing 100, and an interconnecting wall 120 extending between and interconnecting the upper ends of the right inner and outer walls 116, 118. The interconnecting walls 114, 120 are angled toward each outer edge of the main housing 100, but may alternatively be substantially horizontal or angled inward.

[0161] The main housing upper chassis 102 may further include a substantially vertical rear outer wall 122. The top of the main housing upper chassis 102 may include a forwardly sloping surface 124. The surface 124 may include a recess 126 for receiving the display and user interface module 54. The display may be configured to display the characteristics of the detected gas(es) in real time. The system may display the patient detection status of the patient interface. If no patient is detected, the controller may disable or stop the output of the respiratory value(s) and / or other display parameters. Optionally, the controller may also output a message indicating that no patient is detected in block 2708. An example of a message is a "--" icon. An interconnecting wall 128 may extend between and interconnect the upper end of the rear outer wall 122 and the rear end of the surface 124.

[0162] 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 shelf. A substantially vertical wall portion 134 may extend downwardly from the front end of the wall portion 132 and terminate in a substantially horizontal floor portion 136 of the humidification chamber bay 108. The left interior wall 112, the right interior wall 118, the wall portion 134, and the floor portion 136 may collectively define the humidification chamber bay 108. The floor portion 136 of the humidification chamber bay 108 may have a recess 138 for receiving a heater arrangement, such as a heater plate 140 or other suitable heating element(s), for heating liquid in the humidification chamber 300 for use during the humidification process.

[0163] The main housing lower chassis 202 can be attached to the upper chassis 102 either by suitable fasteners or by integrated attachment features such as, for example, clips. The main housing lower chassis 202 can include a substantially vertical left outer wall 210 oriented in the fore-aft direction of the main housing 100 and continuous with the left outer wall 110 of the upper chassis 102, and a substantially vertical right outer wall 216 oriented in the fore-aft direction of the main housing 100 and continuous with the right outer wall 116 of the upper chassis 102. The main housing lower chassis 202 can further include a substantially vertical rear outer wall 222 continuous with the rear outer wall 122 of the upper chassis 102.

[0164] The lower housing chassis 202 may have a lip 242 that is contiguous with the lip 142 of the upper housing chassis 102 and forms part of a recess for receiving the handle portion 506 of the lever 500. The lower lip 242 may include a forwardly directed protrusion 243 that serves as a retainer for the handle portion 506 of the lever 500. Instead of the lever 500, the system may also include a spring-loaded guard for retaining the humidification chamber 300 in the humidification chamber bay 108.

[0165] The underside of the lower housing chassis 202 may include a bottom wall 230. Each interconnecting wall 214, 220, 228 may extend between and interconnect the substantially vertical walls 210, 216, 222 and the bottom wall 230. The bottom wall 230 may include a grille 232 having a plurality of openings to allow liquid to drain in the event of leakage (e.g., spillage) from the humidification chamber 300. The bottom wall 230 may further include an elongated slot 234 oriented in the front-to-rear direction. The slot 234 may further allow liquid to drain in the event of leakage from the humidification chamber 300 without entering the electronics housing. In the illustrated configuration, the slot 234 may be wider and longer than the opening in the grille 232 to maximize liquid drainage.

[0166] As shown in FIGS. 17-18 , the lower chassis 202 can have a motor recess 250 for receiving a motor and sensor module. The motor and sensor module can be non-removable from the main housing 100. Alternatively, the motor and sensor module can be removable from the main housing 100, as shown in FIGS. 17-18 . A recess opening 251 can be provided in the bottom wall 230 adjacent its rear edge to receive the motor / sensor module. A continuous, gas-impermeable, uninterrupted perimeter wall 252 can be integrally formed with the bottom wall 230 of the lower chassis 202 and extend upwardly from the perimeter of the opening 251. A rear portion 254 of the perimeter wall 252 has a first height, and a front portion 256 of the perimeter wall 252 has a second height greater than the first height. The rear portion 254 of the perimeter wall 252 terminates in a substantially horizontal step 258, which terminates in an upper, auxiliary rear portion 260 of the perimeter wall 252. The forward portion 256 and the upper auxiliary rear portion 260 of the peripheral wall 252 terminate at a ceiling 262. All of the walls and ceiling 262 are continuous and gas-impermeable, with no discontinuities other than the gas flow paths. Thus, the entire motor recess 250 can be gas-impermeable and uninterrupted except for the gas flow paths.

[0167] The motor and sensor module can be insertable into recess 250 and attached to lower chassis 202. When the motor and sensor module is inserted into lower chassis 202, gas flow tube 264 extends through downward extension tube 133 and can be sealed by a soft seal.

[0168] The humidification chamber 300 can be fluidly coupled to the device 10 in a linear slide-on motion from a position at the front of the housing 100 toward the rear of the housing 100, rearwardly sliding the humidification chamber 300 into the chamber bay 108. The gas outlet port 322 can be in fluid communication with the motor.

[0169] 8, the gas inlet port 340 (humidified gas return) may include a removable L-shaped elbow. The removable elbow may further include a patient outlet port 344 for coupling to the patient conduit 16 to supply 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-seal, to provide a sealed gas passage between the device 10, the humidification chamber 300, and the patient conduit 16.

[0170] The humidification chamber gas inlet port 306 is complementary to the gas outlet port 322, and the humidification chamber gas outlet port 308 is complementary to the gas inlet port 340. The axes of these ports may be parallel to one another to allow the humidification chamber 300 to be inserted into the chamber bay 108 in a linear motion.

[0171] The respiratory device may have air and oxygen (or alternative supplemental gas) inlets in fluid communication with the motor so that the motor can deliver air, oxygen (or alternative supplemental gas), or a mixture thereof to the humidification chamber 300 and, ultimately, to the patient. As shown in FIG. 10 , the device may have a combined air / oxygen (or alternative supplemental gas) inlet arrangement 350. This arrangement may include a combined air / oxygen port 352 into the housing 100, a filter 354, and a cover 356 with a hinge 358. A gas conduit may optionally extend laterally or in another suitable direction and be in fluid communication with an oxygen (or alternative supplemental gas) source. The port 352 may be fluidly coupled to the motor 402. For example, the port 352 may be coupled to the motor / sensor module 400 via a gas flow path between the port 352 and an inlet opening or port in the motor / sensor module 400, which leads to the motor.

[0172] The device may have the arrangement shown in FIGS. 11-14, in which a blower can supply air, oxygen (or alternative auxiliary gases), or a suitable mixture thereof to the humidification chamber 300 and, in turn, to the patient. This arrangement may include an air inlet 356' in the rear wall 222 of the lower chassis 202 of the housing 100. The air inlet 356' comprises a rigid plate having an appropriate grill arrangement of openings and / or slots. Sound-deadening foam may be provided adjacent the interior surface of the plate. An air filter box 354' is positioned within the main housing 100 adjacent to the air inlet 356' and may include an air outlet port 360 for supplying filtered air to the motor via the air inlet port 404 of the motor / sensor module 400. The air filter box 354' may include a filter configured to remove particulates (e.g., dust) and / or pathogens (e.g., viruses or bacteria) from the gas flow. A soft seal, such as an O-ring seal, may be provided between the air outlet port 360 and the air inlet port 404 to seal the components. The device may include a separate oxygen inlet port 358' located adjacent one side of the housing 100 at its rear end for receiving oxygen from an oxygen source, such as a tank or a piped oxygen source. The oxygen inlet port 358' is in fluid communication with a valve 362. The valve 362 may preferably be a solenoid valve that allows for control of the amount of oxygen added to the gas stream supplied to the humidification chamber 300. The oxygen port 358' and valve 362 may be used in conjunction with other supplemental gases to control the addition of other supplemental gases to the gas stream. The other supplemental gases may include any one or more of a number of gases useful in gas therapy, including, but not limited to, heliox and nitric oxide.

[0173] As shown in FIGS. 13-16, the lower housing chassis 202 can include a suitable electronic board, such as a sensing circuit board. The electronic board can be positioned adjacent to each of the outer sidewalls 210, 216 of the lower housing chassis 202. The electronic board can include or be in electrical communication with suitable electrical or electronic components, such as a microprocessor, capacitors, resistors, diodes, operational amplifiers, comparators, switches, etc. Sensors can also be used in conjunction with the electronic board. Components of the electronic board, such as, but not limited to, one or more microprocessors, can function as the controller 19 of the device.

[0174] One or more of the electronic boards can be in electrical communication with the electrical components of the device 10, including the display unit and user interface 54, the motor, the valves 362, and the heater plate 140, to operate the motor to provide the desired flow rate of gas, to operate the humidification chamber 300 to humidify and warm the gas stream to an appropriate level, and to provide an appropriate amount of oxygen (or amount of alternative supplemental gas) to the gas stream.

[0175] The electronic board may be in electrical communication with a connector arrangement 274 that protrudes from the rear wall 122 of the upper housing chassis 102. The connector arrangement 274 may be coupled to an alarm, a pulse oximetry port, and / or other suitable accessories. The electronic board may also be in electrical communication with an electrical connector 276 that may also be provided on the rear wall 122 of the upper housing chassis 102 for providing mains or battery power to the device components.

[0176] Operating sensors such as the sensors shown in FIG. 1 can be located at various locations on the respiratory apparatus, the patient breathing conduit 16, and / or the cannula 51. An electronics board can be in electrical communication with these sensors. Output from the sensors can be received by the controller 19 to assist the controller 19 in operating the respiratory apparatus 10 in a manner that provides optimal therapy, such as by 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 demand and / or to provide other benefits of high-flow therapy as described herein. In the illustrated embodiment, the sensors are located on an electronics board located within the housing. The sensors are encapsulated within the housing.

[0177] As mentioned above, electronic boards and other electrical and electronic components can be pneumatically isolated from the gas flow path for improved safety. The sealing also prevents water ingress.

[0178] 1.1 Control System FIG. 19A shows a block diagram 900 of an exemplary control system 920 (which can be the controller 19 of FIG. 1) that can detect a patient's condition and control the operation of the respiratory system, including the gas source. The control system 920 can manage the flow rate of gas through the respiratory system as the gas is delivered to the patient. For example, the control system 920 can increase or decrease the flow rate by controlling the motor speed output of a blower (also referred to hereinafter as a "blower motor") 930 or the output of a valve 932 in a blender. The control system 920 can automatically determine a set point or personalized value for the flow rate for a particular patient, as described below. The flow rate can be optimized by the control system 920 to improve patient comfort and treatment.

[0179] 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 speaker. The display may indicate to the physician any warnings or alarms generated by the control system 920. The display may also display control parameters that are adjustable by the physician. For example, the control system 920 may automatically recommend a flow rate for a particular patient. The control system 920 may also determine the patient's respiratory status, including, but not limited to, generating the patient's respiratory rate, and transmit that to a display, as described in more detail below.

[0180] The control system 920 can vary heater control outputs to control one or more heating elements (e.g., to maintain a temperature set point of the gas delivered to the patient). The control system 920 can also vary the operation or duty cycle of the heating elements. The heater control outputs can include heater plate control output(s) 934 and heated breathing tube control output(s) 936.

[0181] The control system 920 can determine outputs 930-939 based on one or more received inputs 901-916. The inputs 901-916 can correspond to sensor measurements automatically received by the controller 600 (see FIG. 19B). The control system 920 can receive sensor inputs, including, but not limited to, temperature sensor(s) input 901, flow sensor(s) input 902, motor speed input 903, pressure sensor(s) input 904, gas(es) fraction sensor(s) input 905, humidity sensor(s) input 906, pulse oximeter (e.g., SpO2) sensor(s) input 907, stored or user parameter(s) 908, duty cycle or pulse width modulation (PWM) input 909, voltage(s) input 910, current(s) input 911, acoustic sensor(s) input 912, power(s) input 913, resistance(s) input 914, CO2 sensor(s) input 915, and / or spirometer input 916. The control system 920 can receive input from a user or parameter values ​​stored in memory 624 (shown in FIG. 19B ). The control system 920 can dynamically adjust the patient flow rate over the course of treatment. The control system 920 can continuously sense system and patient parameters. Those skilled in the art will understand, based on the disclosure herein, that any other suitable inputs and / or outputs can be used with the control system 920.

[0182] 1.2 Controller FIG. 19B shows a block diagram of one embodiment of a controller 600 (which may be controller 19 of FIG. 1). The control system 600 may include programming instructions for detecting input conditions and controlling output conditions. The programming instructions may be stored in memory 624 of the controller 600. The programming instructions may correspond to methods, processes, and functions described herein. The programming instructions may be executed by one or more hardware processors 622 of the controller 600. The programming instructions may be implemented in C, C++, JAVA, or other suitable programming language. Some or all of the programming instructions may be implemented in application-specific circuitry 628, such as an ASIC or FPGA.

[0183] The controller 600 may also include circuitry 628 for receiving sensor signals. The controller 600 may further include a display 630 for transmitting 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 detected gas(es) in real time or otherwise. The controller 600 may also receive user input via a user interface, such as the display 630. The user interface may include button(s) and / or dial(s). The user interface may include a touch screen.

[0184] 1.3 Motor / Sensor Module Any of the features of the respiratory system described herein can be combined with any of the sensor modules described herein, including, but not limited to, a humidification chamber, a flow generator, a user interface, a controller, and a patient respiratory conduit configured to couple a gas outlet of the respiratory system to a patient interface.

[0185] Figure 20 shows a block diagram of a motor / sensor module 2000 that can be received by the recess 250 of the respiratory apparatus (shown in Figures 17 and 18). The motor and sensor module can include a blower 2001 that entrains room air for delivery to the patient. The blower 2001 can be a centrifugal blower.

[0186] One or more sensors (e.g., Hall effect sensors) may be used to measure the motor speed of the blower motor. The blower motor may be configured as a brushless DC motor, in which case the motor speed can be measured without using a separate sensor. For example, during operation of a brushless DC motor, back-EMF can be measured from the motor's unpowered windings, from which the motor position can be determined and the motor rotation speed can also be calculated. Additionally, a motor driver may be used to measure the motor current, and the motor torque can be calculated along with the measured motor speed. The blower motor may be configured as a low-inertia motor.

[0187] Room air can enter room air inlet 2002 and enter 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 to blower 2001. Valve 2004 can be any type of valve, including a proportional valve or a binary valve. In some embodiments, the inlet port does not include a valve.

[0188] Blower 2001 can operate at a motor speed greater than 1,000 RPM but less than 30,000 RPM, greater than 2,000 RPM but less than 21,000 RPM, or any of the aforementioned values. Operation of blower 2001 mixes the gas entering blower 2001 through inlet port 2003. Because mixing requires energy, using blower 2001 as a mixer can reduce pressure losses that occur in systems with separate mixers, such as static mixers configured with baffles.

[0189] The mixed air can exit blower 2001 through conduit 2005 and enter flow path 2006 in sensor chamber 2007. A sensor circuit board with sensors 2008 can be positioned in sensor chamber 2007 such that the sensor 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 in the gas flow to measure gas properties within the gas flow. After passing through flow path 2006 in sensor chamber 2007, the gas can exit 2009 to a humidification chamber.

[0190] Locating the sensor 2008 downstream of the blower and mixer 2001 combination can improve measurement accuracy, such as measuring gas fraction concentrations, including oxygen concentration, compared to systems that place the sensor upstream of the blower and / or mixer. This placement can result in a more repeatable flow profile. Furthermore, placing the sensor downstream of the blower and mixer combination avoids pressure losses that would otherwise occur. This is because sensing before the blower stage requires a separate mixer, such as a static mixer with a baffle, between the inlet and the sensing system. The mixer can create a pressure drop across the mixer. Locating the sensing after the blower allows the blower to become the mixer, and furthermore, static mixers reduce pressure, while blowers increase pressure. Additionally, immersing at least a portion of the sensing circuit board and sensor 2008 in the flow path can improve the sensor's measurement accuracy because immersion in the flow increases the likelihood that conditions, such as temperature and pressure, will be similar to those of the gas flow, providing a better representation of the gas flow characteristics.

[0191] Referring to FIG. 21 , gas exiting the blower can enter a flow path 402 within a sensor chamber 400, which can be located within a motor / sensor module and can be sensor chamber 2007 of FIG. 20 . The flow path 402 can have a curved shape. The flow path 402 can be configured to have a curved shape without sharp turns. The flow path 402 can have curved ends and straight sections between the curved ends. The curved flow path shape can reduce pressure loss in the gas flow without reducing the sensitivity of the flow measurement by partially aligning the measurement area with the flow path to form the measurement portion of the flow path.

[0192] A sensing circuit board 404 equipped with sensors such as acoustic transmitters and / or receivers, humidity sensors, temperature sensors, thermistors, etc., can be positioned within the sensor chamber 400 such that the sensing circuit board 404 is at least partially immersed in the flow path 402. Immersing the sensing circuit board and sensors at least partially in the flow path can improve measurement accuracy because sensors immersed in the flow path are more likely to experience conditions such as temperature and pressure that are similar to those of the gas flow, and can better represent the characteristics of the gas flow. After passing through the flow path 402 in the sensor chamber 400, the gas can exit to the humidification chamber.

[0193] Gas flow can be measured using at least two types of sensors. The first type of sensor can consist of a thermistor and can determine the flow rate by monitoring the heat transfer between the gas flow and the thermistor. A thermistor-based flow sensor can operate the thermistor at a constant target temperature within the flow as the gas flows around and past the thermistor. The sensor can measure the amount of power required to maintain the thermistor at the target temperature. The target temperature can be set higher than the temperature of the gas flow, with higher flow rates requiring more power to maintain the thermistor at the target temperature.

[0194] The thermistor flow sensor can also maintain multiple (e.g., two, three, or more) constant thermistor temperatures to prevent the difference between the target temperature and the gas flow temperature from being too small or too large. Multiple different target temperatures allow the thermistor flow sensor to be accurate over a large gas temperature range. For example, the thermistor circuit can be configured to switch between two different target temperatures, ensuring that the gas flow temperature always falls within a certain range (e.g., not too close or too far) of one of the two target temperatures. The thermistor circuit can be configured to operate at a first target temperature of about 50°C to about 70°C, or about 66°C. The first target temperature can be associated with a desired flow temperature range of about 0°C to about 60°C, or about 0°C to about 40°C. The thermistor circuit can be configured to operate at a second target temperature of about 90°C to about 110°C, or about 100°C. The second target temperature can be associated with a desired flow temperature range of about 20°C to about 100°C, or about 30°C to about 70°C.

[0195] The controller can be configured to adjust the thermistor circuit to change between at least first and second target temperature modes by connecting or bypassing a resistor in the thermistor circuit. The thermistor circuit can be arranged in a Wheatstone bridge configuration consisting of a first voltage divider arm and a second voltage divider arm. The thermistor can be located in one of the voltage divider arms. Details of the thermistor flow sensor are described in International Publication No. WO 2018 / 052320, filed September 3, 2017, the entire contents of which are incorporated herein by reference.

[0196] A second type of sensor can be an acoustic sensor assembly. Acoustic sensors, including an acoustic transmitter and / or receiver, can be used to measure the time-of-flight of acoustic signals to determine gas velocity and / or composition, which can be used in flow therapy devices. In one ultrasonic sensing (including an ultrasonic transmitter and / or receiver) topology, a driver transmits an ultrasonic pulse in a first direction to a first sensor, such as an ultrasonic transducer. A second sensor, such as a second ultrasonic transducer, receives the pulse and performs a time-of-flight measurement of the pulse between the first and second ultrasonic transducers. Using this time-of-flight measurement, the speed of sound in the gas flow between the ultrasonic transducers can be calculated by a processor or controller of the respiratory system. A second sensor can transmit a pulse in a second direction opposite the first direction, and the first sensor can receive the time-of-flight pulse to provide a second time-of-flight measurement, allowing characteristics of the gas flow, such as flow rate and velocity, to be determined. In another acoustic sensing topology, acoustic pulses transmitted by an acoustic transmitter, such as an ultrasonic transducer, can be received by an acoustic receiver, such as a microphone. Details of the acoustic flow sensor are described in International Publication No. WO 2017 / 095241, filed December 2, 2016, which is incorporated herein by reference in its entirety.

[0197] One or more flow sensors, or sensor assemblies including the flow sensors or sensors, may be located at various locations within the respiratory apparatus and / or along the gas flow path. In one configuration, the flow sensor(s) or sensor assembly may be installed or located after the flow generator 50B, i.e., the sensor is configured or arranged to sense or measure the gas flow rate in the flow path after the flow generator 50B. In this configuration, the flow signal or data generated by the flow sensor or sensors may represent the flow generator output flow signal or data, i.e., the flow rate of the gas flow output from the flow generator 50B.

[0198] In one configuration, the flow sensor or sensor assembly may be located within the main device housing 100 before or after the humidifier 52 (if present). For example, the flow sensor may be located or configured within the main device housing 100 to sense the gas flow rate in the flow path between the flow generator 50B and the humidifier 52, or at a location in the flow path after the humidifier. In another configuration, the flow sensor or sensor or sensor assembly may be located in or along the respiratory conduit 16 and / or the patient interface 51. In this configuration, the sensor or sensor assembly is configured to sense or measure the gas flow rate in the flow path defined or formed by the respiratory conduit 16 and / or the patient interface 51, i.e., the flow path following the gas outlet 21 of the main device housing 100. In other configurations, the device may be configured with any combination of the configurations or locations of one or more flow sensors or sensor assemblies described above. For example, the device may be configured with any combination of one or more flow sensors or sensor assemblies present 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.

[0199] In some configurations, readings from both the first and second types of sensors can be combined to determine a more accurate flow measurement. For example, a previously determined flow rate and one or more outputs from either type of sensor can be used to determine a predicted current flow rate. The predicted current flow rate can then be updated using one or more outputs from the other of the first and second types of sensors to calculate a final flow rate.

[0200] 2. Example of operating parameter control FIG. 22 is a schematic diagram of an exemplary respiratory support system 2200 similar to the respiratory support system 10 shown in FIG. 1. The respiratory support 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 a patient P. The patient interface may be referred to as a high-flow therapy interface. The gas source 2202 may be referred to as a high-flow therapy device. The respiratory support system 2200 shown in FIG. 22 may be configured with any of the elements of the respiratory support system 10 of FIG. 1. The patient interface 2216 in this example is a non-sealing nasal cannula. The respiratory rate sensor 2215 may be configured with one or more sensors. The one or more respiratory rate sensors 2215 may be one or more sensors configured to be worn on or positioned near the patient P, each configured to measure a patient parameter indicative of the patient's respiratory rate. In one example, one or more of the wearable sensors may be a body-worn respiratory rate sensor. In one example, the one or more sensors may be a body-worn respiration rate sensor.

[0201] The gas source 2202 may include a flow generator or flow source 2224 capable of generating a flow of breathable gas that is supplied to the humidification device 2224. In one embodiment, the flow source 2224 is a blower. However, the flow source 2224 is not limited to a blower and may include a flow meter, a mixer, a flow mode from a ventilator, or any other flow generator. Other flow sources known to those skilled in the art may also be used with any of the embodiments of the present disclosure, as described further below.

[0202] The gas source 2202 can include a controller 2226 that can control the operation of the flow source 2224. For example, the controller 2226 can execute or implement a control system, described in more detail below, to control the operation of the flow source and associated operating parameters of the gas. The control system can, for example, determine the amount of power supplied to the blower in some embodiments that use a blower as the flow source. The speed of the blower or motor can depend on the amount of power.

[0203] 22, the gas source may include a first inlet 2222 and a second inlet 2223. The first inlet 2222 may be configured to supply ambient air to the flow generator 2224, and the second inlet 2223 may be connected to a dry gas source, such as a gas cartridge or tank, and configured to supply the gas to the flow generator 2224. The second inlet 2223 may draw or supply enriched oxygen to the flow generator 2224. The amount of gas supplied 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 supplied or drawn in by the first inlet 2222 to oxygen supplied or drawn in by the second inlet 2223. The oxygen concentration level may be controlled by controlling the first valve and / or the second valve. As an example, the oxygen concentration level may be controlled by controlling only the second valve.

[0204] 2.1 Control System 23 shows a block diagram of an example of a control system 2320 that can detect a patient's condition and control the operation of a respiratory assistance system 10, 2200, including a gas source 124, 2202. In one embodiment, the control system 2320 controls the operating flow rate 2332 of gas delivered to the patient through the respiratory assistance system 10, 2200.

[0205] The control system 2320 can increase or decrease the flow rate by controlling the blower motor speed and / or the blender valve. The control system 2320 can automatically control the operating flow rate for a particular patient based on parameters indicative of the patient's respiratory rate, as described below. The flow rate can be optimized by the control system 2320 to improve patient comfort and therapy.

[0206] Additionally or alternatively, the control system 2320 can increase or decrease the oxygen concentration level by controlling the first and second valves to supply gas from the first and second inlets, 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, as described below. The oxygen concentration level can be optimized by the control system 2320 to improve patient comfort and therapy.

[0207] 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 further include a speaker. The display may display warnings and alarms generated by the control system 2320 to the physician. The display may also display control parameters adjustable by the physician. For example, the control system 2320 may automatically display the flow rate for a particular patient. The control system 2320 may also generate a patient recovery status and transmit it to the display.

[0208] In some embodiments, the control system 2320 can modify the temperature set point 2330 of one of the heating elements, such as a chamber heater, to control the output conditions of the gas delivered to the patient. The control system 2320 can also modify the operation or duty cycle of the heaters described above.

[0209] As described below, the control system 2320 can determine outputs 2330-2334 based on one or more received inputs 2302-2306. The inputs 2302, 2304 can correspond to sensor measurements received automatically by the controller 19, 600, or 2226.

[0210] The control system 2320 receives sensor inputs corresponding to the patient sensor inputs 2302. The patient sensor inputs are obtained from one or more wearable sensors attached to the patient and configured to measure or display a patient parameter, which may be SpO2 or respiratory rate, as described below.

[0211] The control system may receive input from device sensors 2304. For example, such device sensors may consist of one or more of the pressure sensor(s), flow sensor(s), temperature sensor(s), oxygen concentration sensor(s), or ambient sensor(s) in the respiratory assistance system 10, 2200 described above.

[0212] The control system 2320 may receive input from a user 2306 or values ​​stored in memory. For example, a user may input values ​​defining one or more initial values ​​for the operating parameters and / or one or more ranges for the operating parameters. In some embodiments, the initial operating flow rate and / or initial operating oxygen concentration level may be manually set by a clinician. In some embodiments, the range of the operating flow rate and / or 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 operating oxygen concentration level may be pre-set or stored in memory.

[0213] In yet another example, the initial value and / or range of the operating flow rate and / or operating oxygen concentration level may be automatically determined based on one or more additional parameters. The one or more additional parameters may be input by a user and / or stored in memory. The one or more additional parameters may correspond to a patient condition and / or a system condition. The additional parameters may include patient characteristics such as age, weight, sex, height, sleep state (wakefulness or sleep state), respiratory symptoms (e.g., presence or absence of cough and / or sputum production), etc. System parameters may include time of day, type of therapy selected, etc. The control system 2320 can utilize these additional parameters in determining the initial value and / or range of the operating flow rate and / or operating oxygen concentration level.

[0214] The control system 2320 can dynamically adjust the operating flow rate 2332 during the patient's therapy. The control system 2320 can dynamically adjust the operating oxygen concentration level 2336 during the patient's treatment. The control system 2320 can continuously sense system and patient parameters.

[0215] 2.1.1 Controller The control system 2320 may include programming instructions for detecting input conditions and controlling output conditions. These programming instructions may be stored in memory of the controller 19, 600, or 2226. In some embodiments, these programming instructions correspond to the methods, processes, and functions described herein. The control system 2320 is executed by one or more hardware processors of the controller 19, 600, or 2226. The programming instructions may be implemented in C, C++, JAVA, or other suitable programming language. In some embodiments, all or part of the control system 2320 may be implemented in application-specific circuitry such as an ASIC or FPGA.

[0216] As shown in FIG. 23 , the control system 2320 can receive inputs from multiple components of the respiratory assistance system 100. Not all of the inputs 2302-2306 shown in FIG. 23 may be present. Inputs 2302-2306 and outputs 2330-2336 may not be present in all embodiments. For example, the control system 2320 may only receive patient sensor input(s) 2302 and generate flow control output(s) 2332. Depending on the configuration, some components corresponding to the inputs may not be included in the respiratory assistance system 10, 2200. The absence of a particular input may itself be used by the control system 2320 to determine the input or system state.

[0217] 2.2 Breathing rate Respiratory rate can be an important indicator in assessing a patient's condition. Abnormal respiratory rate has been shown to be a predictor of a patient's respiratory disease and status, and in some cases may be a precursor to critical events such as cardiac arrest and transfer to advanced medical care. Therefore, respiratory rate can be an indicator of a patient's worsening or improving condition. Respiratory rate can also be related to the work of breathing.

[0218] Changes in a patient's respiratory status can quickly manifest as changes in respiratory rate. As a patient's condition worsens, minute ventilation may increase. For example, as the efficiency of pulmonary gas exchange decreases with worsening conditions, a higher minute ventilation may be required to maintain normal blood oxygen levels. This increase in minute ventilation is achieved by a combination of faster breathing and higher tidal volumes. Furthermore, the body tends to prioritize faster breathing over higher tidal volumes. Therefore, respiratory rate responds relatively quickly to changes in a patient's condition compared to other measurable patient parameters, such as SpO2.

[0219] Respiratory rate can be influenced by other factors, for example, increased physical activity can increase respiratory rate, but patients receiving respiratory treatments such as high-flow therapy are typically at rest and immobile, minimizing other potential factors in respiratory rate change.

[0220] 2.2.1 Respiration rate sensor Respiratory rate is typically measured manually by counting breaths over a period of time, which introduces a high degree of error and does not allow for continuous monitoring of the patient. Manual measurement is therefore not suitable for this application.

[0221] In the present systems and methods, to control the flow rate of gas delivered to the patient, a patient parameter indicative of the patient's respiratory rate is received or determined based on data obtained from one or more sensors. These sensors (e.g., sensor 2215 shown in FIG. 22) may be one or more sensors configured to be worn on or positioned proximate to the patient to measure the patient parameter indicative of the patient's respiratory rate. In certain examples, the one or more sensors may be body-worn respiratory rate sensors. In these examples, the sensors may be worn on the patient's clothing. In some examples, the one or more sensors are wearable respiratory rate sensors configured to be worn on the body and / or clothing by the patient; for example, the wearable sensor may be in contact with or proximate to the patient.

[0222] In one embodiment, one or more body-contacting sensors may measure diaphragm movement to determine respiration rate. In one embodiment, optical transmission and / or reflective sensors may measure respiration rate by measuring venous and / or arterial blood pulsation. For example, a pulse oximeter may be used to measure respiration rate. In one embodiment, an acoustic sensor attached to or adjacent to the patient may measure respiration rate acoustically or by measuring tracheal vibrations. In one embodiment, a CO2 sensor placed near the patient's mouth and / or nose, for example, attached to a cannula, may measure respiration rate by detecting the cyclic increase in CO2 concentration as the patient exhales.

[0223] In some examples, the one or more wearable respiratory rate sensors may be mechanical sensors. In some examples, the mechanical sensor(s) may be piezoelectric sensor(s). The piezoelectric sensor may be comprised of one or more piezoelectric elements. The piezoelectric elements may be worn near the patient's chest or diaphragm. Movement of the patient's chest as they breathe causes the piezoelectric elements to move, generating a voltage signal in response to the movement. In some examples, the voltage values ​​are transmitted to a respiratory therapy device and processed. The respiratory therapy device determines the patient's respiratory rate based on the voltage values. In other examples, the piezoelectric sensor(s) may include a processor that processes the voltage values ​​to determine the respiratory rate. The determined respiratory rate is then transmitted to the respiratory therapy device.

[0224] In some examples, one or more sensors may not be wearable sensors. In these examples, one or more sensors may not directly contact the patient. Such sensors may be referred to as non-patient-contact sensors. As an example, a piezoelectric sensor placed under the patient's mattress may determine the patient's respiratory rate by detecting movement associated with the patient's breathing. 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 another example, a radar-based sensor configured to measure the patient's respiratory rate may be used. Such radar-based sensors may measure or detect the patient's displacement patterns, which may be used to characterize various cardiopulmonary functions, including respiratory rate.

[0225] Other examples are envisaged for measuring parameters indicative of a patient's respiratory rate, which can be measured through a wearable sensor, such as a smart watch.

[0226] Alternatively, or additionally, instead of measuring patient parameters with sensors attached to or located near the patient, analysis of the flow and pressure delivered by the NHF therapy device can be used to determine the respiratory rate. For example, the controller may 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 may be located in the flow path of the respiratory system. During the delivery of therapy, the patient's breathing may cause changes or fluctuations in the gases 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. The 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.

[0227] One or more of the sensors and methods described above for measuring or determining respiratory rate may be utilized in the present systems and methods. These methods of measuring a patient's respiratory rate are generally non-invasive and unobtrusive, which may result in good patient compliance with the monitoring equipment. They can provide continuous and accurate measurements of respiratory rate.

[0228] In some embodiments, the one or more sensors may be dedicated, body-contacting respiration rate sensors using any of the methods described above. Dedicated, body-contacting respiration rate sensors may accurately and non-invasively measure a patient's respiration rate. For example, some patients may be somewhat active during treatment, moving and sitting. In such cases, a wearable sensor attached to the patient's body or clothing may be more convenient.

[0229] In another example, a non-contact sensor may be utilized if the patient is not active, for example, if the patient is lying in bed during treatment, as there is less movement. In such cases, a non-contact fixed sensor, such as a piezoelectric sensor under the mattress, can be used.

[0230] The one or more sensors may communicate directly with the controller of the high-flow therapy device via a wireless transmitter mounted on the sensor using an appropriate wireless communication protocol (e.g., near-field communication, Wi-Fi, or Bluetooth). Alternatively, the one or more sensors may communicate via a wired connection. The one or more sensors may connect to an intermediate connector, such as a cloud-based connector. The cloud-based connector may then connect to the controller of the high-flow therapy device. Alternatively, the cloud-based connector may provide respiratory rate data to a clinician, who then makes setting adjustments to the high-flow therapy device.

[0231] The one or more sensors may be configured to acquire data measuring or indicative of the patient's instantaneous respiratory rate. The one or more sensors may be configured to measure or provide data measuring or indicative of the instantaneous respiratory rate over a specific time interval. The time interval may be a fixed time interval. In some examples, the fixed time interval is a preset time interval. In such examples, the preset time interval may range from about 1 minute to about 8 hours. The preset time interval may be, for example, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 3 hours, 4 hours, 5 hours, or 6 hours. In other examples, the time interval is a variable time interval. The variable time interval may be set based on the patient's respiratory rate, and / or the patient's respiratory rate status, and / or readings of one or more devices and / or patient sensors, and / or the duration of the therapy session.

[0232] Alternatively, or additionally, one or more sensors may measure or provide data regarding a patient parameter indicative of a time-averaged measurement of the patient's respiratory rate. The time-averaged measurement may be used to achieve a steady-state measurement of the respiratory rate. The steady-state measurement of the respiratory rate may ignore transient measurements. The time-averaged measurement may 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 may range from about 5 seconds to about 30 minutes. The preset measurement period may, for example, range from about 10 seconds to about 15 minutes. The preset measurement period may range from about 30 seconds to about 5 minutes. The preset measurement period may, for example, be 30 seconds, or 1 minute, or 2 minutes, or 5 minutes, or 10 minutes, or 15 minutes, or 30 minutes. In other examples, the measurement period is a variable measurement period. The variable measurement period may be set based on the patient's respiratory rate, and / or the patient's respiratory rate status, and / or one or more device and / or patient sensor readings, and / or the duration of the therapy session.

[0233] In some examples, one or more sensors may measure and store multiple instantaneous measurements indicative of the patient's respiratory rate during a measurement period. In such embodiments, the sensors may calculate a time-averaged measurement based on the multiple instantaneous measurements. The sensors may transmit the calculated time-averaged measurement to a controller of the respiratory therapy device, as described above.

[0234] Alternatively, the sensor may transmit instantaneous measurements to the controller of the respiratory therapy device during the measurement period. In such an example, the controller of the respiratory therapy device calculates a time-averaged measurement. The controller of the respiratory therapy device may use the time-averaged measurement to determine the patient's respiratory rate, as described below.

[0235] Alternatively, the sensor may transmit real-time measurements during the measurement period to an intermediate controller, such as a remote server. In such an embodiment, the intermediate controller may store the real-time measurements and calculate time-averaged measurements. The intermediate controller may use the time-averaged measurements to determine the patient's respiratory rate status or may transmit the time-averaged measurements to a controller of the respiratory therapy device.

[0236] In some examples, the respiration rate measurement may include a moving average, where the current measurement at any point in time represents the time-averaged respiration rate over the most recent measurement period. This moving average may be calculated by the sensor, the intermediate connector, and / or the therapy controller.

[0237] In some examples, the one or more sensors may consist of multiple sensors. The multiple sensors may be used simultaneously to read the respiration rate. For example, the multiple sensors may include a combination of two or more of one or more wearable sensors, and / or under-mattress sensors, and / or flow and / or pressure sensors within the device. In examples where such multiple sensors are used, each sensor may transmit measurements to the controller in the format described above. The controller may calculate an average respiration rate across the multiple sensors based on measurements received from two or more of the available sensors. In some examples, the controller uses all measurements from the multiple sensors to provide a more accurate measurement of the patient's respiration rate.

[0238] In some embodiments, multiple sensors may provide failure redundancy. For example, if one of the sensors fails or becomes dislodged from the patient, one or more other sensors may still be able to collect respiration rate information. In some embodiments, multiple sensors may be used for single-fault tolerance. In such an example, the controller may use measurements from the multiple sensors to detect sensor failure. In this case, the sensor providing an abnormal measurement is not considered when determining the patient's average respiration rate.

[0239] 2.2.2 Respiratory rate versus flow rate An example of the measurements collected is shown in graphical form in Figure 26. The control system 220 can control the operating rate of the gas flow delivered to the patient through the patient interface. Controlling the operating rate affects the patient's measured respiratory rate, as shown in graph 2600 of Figure 26 and as described below.

[0240] When respiratory therapy is provided to a patient using respiratory therapy system 10, 2200, the patient's respiratory response may vary at different flow rates. This is illustrated in graph 2600 of FIG. 26. High-flow therapy may reduce the patient's respiratory rate compared to unassisted breathing. This may be due to increased expiratory resistance resulting in longer expiratory time, improved dead space clearance of exhaled gases, and reduced rebreathing.

[0241] Current understanding of the art is that a reduction in a patient's respiratory rate, particularly one that occurs more rapidly as flow rates increase, is due to improved flushing of the airways, improved CO2 removal, and increased fresh gas (oxygen) reaching the lungs, which increases the efficiency of gas exchange and reduces the number of breaths required.

[0242] Further increases in flow rate may cause a decrease in the patient's respiratory rate, see Figure 28. As shown, this decrease may be shallow. As flow rate (and therefore pressure level) increases, expiratory resistance increases, allowing the lungs to expand further. This increases the lung surface area (alveoli) and improves the efficiency of O2 and carbon dioxide (CO2) exchange. Therefore, as flow rate increases further, the patient's respiratory rate gradually decreases.

[0243] When respiratory therapy is not delivering a flow of gas to a patient, the flow of gas delivered to the patient is 0 liters per minute. At this 0 liters per minute flow rate, the patient has a constant measured respiratory rate, R0, 2604. The patient's respiratory rate may be measured in breaths per minute (bpm). Test results indicate that over a range of flow rates, the flow rate versus respiratory rate curve 2602 exhibits a shape substantially similar to that shown in FIG. 26.

[0244] The first portion of this curve 2602 follows an inverse S-shaped curve (or inverse sigmoid curve). However, past a certain point, indicated at 2606, further increases in flow tend to further decrease the respiratory rate. Around this point 2606, the flow F M The minimum respiratory rate R Mis achieved. At even higher flow rates, the respiratory rate may begin to increase. This is due to the increased effort required to exhale at higher flow rates. In other patients, the respiratory rate may remain fairly constant (i.e., at a minimum) as flow rates increase. In other patients, the respiratory rate may continue to decrease after reaching the RM, but may fall below a threshold, as described below. In still other patients, the respiratory rate may alternate between increasing and decreasing after reaching the RM. This is explained in relation to Figures 28 and 29, described below.

[0245] In some adult patients, the flow rate at which the respiratory rate reaches a minimum, F M may be approximately 45 l / min. This may vary from patient to patient, and even for the same patient at different times, e.g. when healthy and when experiencing respiratory distress. Therefore, it cannot be assumed that the minimum flow rate is the same for all patients.

[0246] Examples of alternative measurements are shown in graphical form in Figures 28 and 29. As in Figure 26, a patient's respiratory response may vary with flow rate. This is shown in graph 2800 of Figures 28 and 29. Over a range of flow rates, the flow versus respiratory rate curve 2802 largely follows a shape similar to that shown.

[0247] The alternative curve 2802 shown in Figures 28 and 29, similar to the curve shown in Figure 26, starts at a low flow rate and exhibits a steep negative slope between about 25 and 30 l / min. The curve 2802 then tapers off to a "minimum" point, as shown at 2806. As shown in Figure 28, at approximately point 2806, the flow rate F M Minimum respiratory rate R M As shown, after the minimum point indicated at 2806, further increases in flow may cause the patient's respiratory rate to rise or fall, resulting in a further decrease or increase.

[0248] In another example, the set of measurements may show a curve that does not have a gradual slope section in the low flow region, as shown in Figures 26-29. In such an alternative example, the curve may show a steeper negative slope at low flow rates, which may suggest that increasing flow has the effect of decreasing the patient's respiratory rate even at low flow rates.

[0249] 29, at least a first respiratory rate R1 of the patient may be determined at a first flow rate F1. At least a second respiratory rate R2 of the patient is determined at a second flow rate F2. The slope, or rate of change, of the patient's respiratory rate between these two flow rates is calculated. In one example, a difference ΔR between at least the first respiratory rate R1 and the second respiratory rate R2 is determined. As described below, a minimum point 2806 may be established based on ΔR, or the negative slope between two or more respiratory rate readings at corresponding flow rates, exceeding a certain threshold.

[0250] As shown, after minimum point 2806, further increases in flow rate may cause the patient's respiratory rate to rise or fall, resulting in further decreases or increases. After minimum point 2806, further increases and decreases in the patient's respiratory rate may be determined to have a slope or difference ΔR below a certain threshold. A negative slope after minimum point 2806 does not define a minimum flow rate because it is below this threshold. While this curve will vary from patient to patient based on various parameters and conditions, a minimum typically occurs after a sharp initial decrease in respiratory rate. If the slope or difference ΔR exceeds a certain threshold at any point after the first minimum, e.g., point 2806, a new minimum may be established.

[0251] 2.2.3 Respiratory rate range A respiratory rate that falls within the desired range may indicate that the patient is healthy and stable. In FIG. 26, this range is represented by R T+ and R T- This range may be between about 12 and 20 breaths per minute, 12 and 18 breaths per minute, or 12 and 16 breaths per minute in some embodiments. This range is typically defined by a clinician or physician.

[0252] This range may vary based on the type of patient, the type of respiratory disease, and other conditions. For example, the range may differ based on whether the patient is being treated in a hospital or at home. In the home setting, it may be desirable to provide earlier warning that the patient's condition is deteriorating or cannot be stabilized with high-flow therapy. Therefore, the range used at home may be narrower than the range used in a hospital.

[0253] A healthy patient is likely to have a resting respiratory rate within the desired range. However, a patient experiencing respiratory distress is likely to have an elevated respiratory rate. In the example of Figure 26, the patient's respiratory rate, R0, at a flow rate of 0 l / min is above the upper threshold, R T+ The desired amount is R in Figure 26. T+ and R T- This is shown by the shaded area between

[0254] 2.3 Flow control method 24 shows a flow chart of an example of a method 2400 for controlling the amount of gas delivered to a patient based on the patient's measured volume. The process or method 2400 can be performed by any of the systems described herein. The process or method 2400 may be performed by the control system 2220, for example.

[0255] In some embodiments, the process or method 2400 may be performed continuously or sequentially over a treatment session. In some examples, a treatment session may be a single treatment session defined from the start of therapy at a certain flow rate until the end of therapy at a certain flow rate or higher. In some embodiments, the flow rate defining the start and end of treatment may be a flow rate of 0 liters / minute or higher.

[0256] The control system 2320 can adjust the operating flow rate of the gas supplied or provided by the respiratory therapy device 2202. The control system 2320 follows the below-described iterative process or method 2400 of titration to find a substantially optimal operating flow rate using feedback from one or more sensors. The substantially optimal operating flow rate may be a flow rate at or near a minimum for the patient's respiratory rate. Furthermore, in some examples, the substantially optimal operating flow rate may be a flow rate within which the patient's respiratory rate falls.

[0257] The control system 2320 may, for example, increase the blower motor speed when a blower is used as the flow source 2224 to increase the flow of gas through the respiratory assistance system 10, 2200. The control system 2320 may measure one or more patient conditions in response to changes in one or more system parameters. The control system 2320 may measure the patient's respiratory flow in response to changes in the operating flow rate.

[0258] a.Initial operating flow rate The process 2400 can begin at block 2402 with the respiratory therapy device 2202 beginning to deliver a gas flow. The gas flow is provided at least at an operating flow rate. In some embodiments, the operating flow rate is sufficient to provide high-flow therapy to the patient during use, such as within a range of flow rates, as described above. The control system 2320 can set the initial operating flow rate. The control system can also set other operating parameters of the device 2202. The operating parameters of the respiratory therapy device 2202 can control the characteristics of the gas flow delivered or provided by the respiratory therapy device 2202.

[0259] As described above, the initial operating flow rate may be manually set by a clinician. In some embodiments, the range of operating flow rates may also be manually set by a clinician. Alternatively, the initial value and / or range of operating flow rates may be preset and stored in memory. The initial value and / or acceptable range of operating flow rates may be determined based on one or more additional parameters. The additional parameters may include patient characteristics such as age, weight, height, gender, sleep state (awake or asleep), respiratory symptoms (e.g., presence or absence of cough and / or sputum), and / or system parameters such as time of day, type of selected therapy, etc. The control system 2320 can utilize these additional parameters in determining the initial value and / or range of operating flow rates and / or operating oxygen concentration levels.

[0260] In some embodiments, once treatment is initiated, an optional step (not shown) may initially increase the operating flow rate. In such an example, once the operating flow rate has been incremented in this step, process 2400 then begins an iterative control loop comprised of steps 2404-2414.

[0261] b. Spacing Once treatment is initiated and gas flow is delivered from the respiratory therapy device at the operating flow rate, process 2400 begins a recursive control loop that includes steps 2404-2414. The recursive control loop is performed at intervals and includes performing steps 2404-2414 at the intervals.

[0262] In some embodiments, the intervals are defined by the control system 2320 waiting a time interval before performing each of steps 2404-2410 / 2412. For example, the control system 220 may wait a time interval before proceeding to perform steps 2404-2410 / 2412. This step is indicated by block 2414 of process 2400. Step 2414 of waiting an interval may be performed before step 2404 and after steps 2410 or 2412 are performed, such that there is a delay between performing each iteration of the control loop 2400. It will be appreciated that steps 2404-2410 / 2412 may be performed at substantially the same time interval.

[0263] In some embodiments, the time interval may be a fixed time interval. The fixed time interval may be the same for each iteration of the control loop. In some embodiments, the fixed time interval is a preset time interval. For example, the preset time interval may be less than 10 minutes or greater than 10 minutes. In such examples, the preset time interval may range from about 1 minute to about 8 hours. The preset time interval may be, for example, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, or 2 hours.

[0264] In other examples, the time interval is a variable time interval. The variable time interval may be, or may be optional, different between each interval of each iteration of the control loop. The variable time interval may be calculated or determined. In some examples, the variable time interval may be based on the patient's respiratory rate, and / or the patient's respiratory rate status, and / or one or more devices, and / or patient sensor readings, and / or the amount of time of the therapy session. In some examples, the variable period is calculated or determined by the control system 2320 for each interval.

[0265] In further examples, the time period is set to a first value if the patient's respiratory rate condition is within a first range and is set to at least a second value if the patient's respiratory rate condition is within a second range. For example, if the control system 2320 determines that the patient's respiratory rate is decreasing at a steady rate above a threshold between intervals, the time period may be set to a first value. If the control system 2320 determines that the patient's respiratory rate is decreasing at a steady rate below a threshold between intervals, the time period may be set to a second value. The first value may be less than the second value. In other embodiments, the first value may be greater than the second value. Additional thresholds and corresponding values ​​are envisioned.

[0266] c. Measuring or determining respiratory rate 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 described above.

[0267] As described above, the control system 2320 may determine the patient's respiratory rate at block 2404 based on one or more sensor-received measurements. In one example, the sensor measurements are plethysmography signals. Other measurements for determining the respiratory rate are described above. In some examples, the patient's respiratory rate may be entered via a user interface and received by the control system 2320. The control system 2320 may store the received or determined respiratory rate in memory.

[0268] In some examples, the control system 2320 may evaluate the quality of the received data or the determined respiratory rate. In such an example, the control system 2320 may determine that an additional measurement of the respiratory rate is necessary based on the received data or the determined respiratory rate being inadequate. For example, the control system 2320 may determine whether the last measured respiratory rate meets or exceeds a boundary condition. If the control system 2320 determines that an additional measurement is necessary, the control system 2320 may perform step 2404 again until an adequate measurement is obtained. Alternatively, if the control system 2320 determines that an additional measurement is not necessary, the control system 2320 may determine the patient's respiratory rate status in block 2406, as described below.

[0269] The control system 2320 may store in memory the measured patient parameters indicative of the patient's respiratory rate for each interval or measurement period. The control system 2320 may also store in memory additional patient and / or system parameters and associate them with the measured patient parameters for each interval. Thus, the control system 2320 may store the patient's condition and the respiratory assistance system 10, 2200 in association with the measured parameters.

[0270] d. Determining respiratory rate status At block 2406, the control system 2320 determines the patient's respiratory rate status. The control system 2320 determines the patient's respiratory rate status based on at least the patient parameters received or determined in step 2404. The control system 2320 may also determine the patient's respiratory rate status based on one or more patient parameters received or determined at one or more previous intervals.

[0271] In some examples, the patient's respiratory rate status is determined based on comparing the received or determined patient parameter indicative of the patient's respiratory rate in a current interval with patient parameters indicative of the patient's respiratory rate received or determined in at least one or more previous intervals.

[0272] In some examples, the patient's respiratory rate status is based on at least comparing the received or determined patient parameter indicative of the patient's respiratory rate to a patient parameter indicative of the patient's respiratory rate received or determined in the immediately preceding interval.

[0273] In an example such as that described above, the comparison may indicate a change in a patient parameter indicative of the patient's respiratory rate between two or more intervals.

[0274] In some examples, the patient's respiratory rate status may be determined based on an assessment of the trend of the patient's respiratory rate over time. The trend may be based on at least the measured patient parameter indicative of the patient's respiratory rate measured in a current interval and one or more patient parameters indicative of the patient's respiratory rate measured in one or more previous intervals. The trend may indicate a change in the patient parameter indicative of the patient's respiratory rate between two or more intervals.

[0275] In some examples, determining the patient's respiratory rate status may include calculating, by the control system 2320, a rate of change of the patient's respiratory rate over time. The patient's respiratory rate status 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 a patient parameter indicative of the patient's respiratory rate received or determined in a current interval and one or more patient parameters indicative of the patient's respiratory rate received or determined in one or more previous intervals. The control system 2320 may determine a derivative of the function using one or more patient parameters indicative of the patient's respiratory rate in the function.

[0276] In some examples, the patient's respiratory rate status may be the patient's respiratory rate status. The patient's respiratory rate status may be grouped into categories, for example. In some examples, the categories may be such as "stable" or "decreasing" or "increasing."

[0277] The patient's respiratory rate status may be grouped into categories based, for example, on a comparison of a patient parameter indicative of the patient's respiratory rate at different intervals and / or a calculated rate of change of the patient's respiratory rate.

[0278] For example, if the control system determines, based on the above-described comparison, determination, or calculation between the received or determined patient parameters indicative of the patient's respiratory rate in the current interval and parameters indicative of the patient's respiratory rate received or determined in at least one or more previous intervals, that the patient's respiratory rate is decreasing between intervals, the patient's respiratory rate status may be displayed as "decreasing."

[0279] Additionally, if the comparison or determination or calculation determines that the patient's respiratory rate has increased between intervals, the patient's respiratory rate status may be displayed as "increased."

[0280] Additionally, if the comparison or determination or calculation indicates that the patient's respiratory rate remains substantially the same between intervals, the patient's respiratory rate status may be indicated as "stable." Control system 2320 may indicate that the patient's respiratory rate status is "stable" if the comparison or determination or calculation indicates that the change in the patient's respiratory rate is below a threshold.

[0281] In some examples, the threshold may be quantified as a percentage difference or change between the received or determined patient parameter indicative of the patient's respiratory rate in the current interval and a patient parameter indicative of the patient's respiratory rate received or determined in at least one or more previous intervals. In such examples, the threshold may be a percentage difference or change greater than 2.5%. In a further example, the threshold may be a percentage difference or change greater than 5%. In a further example, the threshold may be a percentage difference or change greater than 7.5%. In a further example, the threshold may be a percentage difference or change greater than 10%. In a further example, the threshold may be a percentage difference or change greater than 12.5%. In a further example, the threshold may be a percentage difference or change greater than 15%. In a further example, the threshold may be a percentage difference or change greater than 20%. In a further example, the threshold may be a percentage difference or change greater than 25%.

[0282] In some examples, the threshold may be quantified as a percentage difference or change between the received or determined patient parameter indicative of the patient's respiratory rate in a current interval and a patient parameter indicative of the patient's respiratory rate received or determined in at least one or more previous intervals. In such examples, the threshold may be a difference or change of greater than 0.1 breaths per minute (bpm). In further examples, the threshold may be a difference or change of greater than 0.5 bpm. In further examples, the threshold may be a difference or change of greater than 1 bpm. In further examples, the threshold may be a difference or change of greater than 1.5 bpm. In further examples, the threshold may be a difference or change of greater than 2 bpm. In further examples, the threshold may be a difference or change of greater than 2.5 bpm. In further examples, the threshold may be a difference or change of greater than 4 bpm. In further examples, the threshold may be a difference or change of greater than 5 bpm.

[0283] In some embodiments, the thresholds are automatically determined based on one or more parameters. The one or more parameters are entered by a user and / or stored in memory. The one or more parameters can correspond to a patient condition and / or a system condition. The parameters may include patient characteristics such as age, weight, sex, height, sleep state (awake or asleep), respiratory symptoms (e.g., presence or absence of cough and / or sputum production), etc. System parameters may include time of day, type of therapy selected, etc. The control system can use these parameters in determining the thresholds.

[0284] The control system 2320 can dynamically adjust the operating flow rate 2332 during the patient's therapy. The control system 2320 can dynamically adjust the operating oxygen concentration level 2336 during the patient's treatment. The control system 2320 can continuously sense system and patient parameters.

[0285] 29, one or more patient parameters indicative of a patient's respiratory rate, denoted R1, are received or determined for at least a first interval associated with a flow rate, F1. At least a second interval occurring after the first interval, one or more patient parameters indicative of a patient's respiratory rate, denoted R2, a flow rate, F2, are received or determined for the second interval.

[0286] The patient's respiratory rate status may be determined based on at least R1 and R2. In some embodiments, the slope, or rate of change, of the patient's respiratory rate between at least two flow rates, F1 and F2, may be calculated. In one embodiment, a difference, ΔR, between at least a first respiratory rate, R1, and a second respiratory rate, R2, may be determined. As described above, the patient's respiratory rate status may be based on ΔR, or the negative slope and interval between two or more respiratory rate readings for corresponding flow rates. Additionally, the patient's respiratory rate status may be based on ΔR compared to a threshold value. The threshold value may be as described above.

[0287] In some embodiments, the control system can determine whether the patient's respiratory rate has reached a minimum respiratory rate. For example, as shown in Figures 26 and 28, the control system can determine whether the patient's minimum respiratory rate, R M is the flow rate F M In such an example, the patient's respiratory rate status may be classified as "stable" when it is determined that the patient's respiratory rate has reached a minimum respiratory rate based on the methodology described above.

[0288] Additionally or alternatively, the patient's respiratory rate status may be classified by the degree of change based on a comparison, determination, or calculation performed between data from different intervals. In such an example, the patient's respiratory rate status may indicate the degree or amount of change in each interval. For example, the patient's respiratory rate status may indicate that the patient's respiratory rate is decreasing, and the degree or amount of change in the current interval is a certain amount (e.g., quantified in breaths per minute (bpm)) compared to the previous interval. For example, this may be relative to a threshold value that can be quantified as an amount or percentage of difference or change, as described above.

[0289] The determination of the patient's respiratory rate status may take into account the status determined in one or more previous intervals. In this manner, the control system 2320 can track the patient's respiratory rate status over or between multiple intervals.

[0290] In some examples, the determination of the patient's respiratory rate status may take into account the determined state of the patient's respiratory rate since the start of therapy delivery, e.g., from the delivery of therapy at an initial operating flow rate. The control system may decide to adjust or increase the operating flow rate until the control system determines that the patient's respiratory rate status indicates that the patient's respiratory rate is decreasing, and then makes a decision to maintain the flow rate. That is, the control system adjusts the operating flow rate from the initial operating flow rate until the patient's respiratory rate or patient's respiratory rate status changes above or outside a threshold. After that point, the control system continues to adjust the flow rate until the control system determines that the patient's respiratory rate or patient's respiratory status is below, within, or a different threshold. At that point, the control system maintains the operating flow rate.

[0291] For example, with reference to the graphs shown in Figures 26-29, the patient's respiratory rate remains relatively stable at low flow rates, and the curves show a steep negative slope between approximately 25 and 30 L / min. The curve then becomes shallower and reaches a "minimum" point. M And the minimum flow rate R M In this example, the control system adjusts the operating flow rate from the initial operating flow rate through the lower flow rate values ​​at which the patient's respiratory rate is substantially stable until the patient's respiratory rate or patient's respiratory condition changes above or outside the threshold corresponding to the steep negative slope of the curve. After that point, the control system continues to adjust the flow rate until the control system determines that the patient's respiratory rate or patient's respiratory condition is below, within, or a different threshold. This is referred to as the flow rate F. M The minimum respiratory rate R M This is considered to be the point where the curve shallows to a "minimum" point indicated by . At that point, the control system maintains the operating flow. The control system then continues to assess the patient's respiratory rate status and decides to adjust the operating flow if the patient's respiratory rate status indicates that an adjustment should be made, for example, if the patient's rate of change is outside a threshold.

[0292] In some embodiments, at each interval of determining the patient's respiratory rate status in steps 2404 and 2406, the controller determines or receives patient parameter indicators indicative of the patient's current operating flow rate, a flow rate above the operating flow rate, and a flow rate below the operating flow rate. The controller may then determine the patient's respiratory rate status using a patient parameter indicative of the patient's respiratory rate at the current operating flow rate (i.e., current respiratory rate), a patient parameter indicative of the patient's respiratory rate at incremental flow rates above the operating flow rate (i.e., high-flow respiratory rate), and a patient parameter indicative of the patient's respiratory rate at incremental flow rates below the operating flow rate (i.e., low-flow respiratory rate).

[0293] In these examples, step 2404 of method 2400 includes the controller determining or receiving, in any order, a patient parameter indicative of the patient's respiratory rate at the current operating flow rate, increasing the operating flow rate incrementally above the current operating flow rate, determining or receiving a patient parameter indicative of the patient's respiratory rate at the increased operating flow rate, decreasing the flow rate incrementally below the current operating flow rate, and determining or receiving a patient parameter indicative of the patient's respiratory flow rate at the decreased operating flow rate. In some embodiments, additional patient parameters are determined or received at one or more increments above and / or below the operating flow rate.

[0294] In some embodiments, determining or receiving a patient parameter indicative of the patient's respiratory rate at one or each of the current, reduced, and / or increased operating flow rates includes waiting a time interval for the patient to respond to the change in flow rate before determining or receiving the patient parameter. The time interval and flow rate increment may be as described above.

[0295] In these examples, step 2406 of method 2400 includes determining the patient's respiratory rate status based on evaluation of a patient parameter indicative of the patient's respiratory rate measured at the current operating flow rate (i.e., current respiratory rate), one or more increments above the operating flow rate (i.e., high-flow operating flow rate(s)), and one or more increments below the operating flow rate (i.e., low-flow operating flow rate(s)).

[0296] The controller is configured to evaluate the respiratory rate(s) at the higher flow rates using the method(s) described above in connection with step 2406 to determine whether the respiratory rate(s) at the higher flow rates indicate whether the patient's respiratory rate is stable or increasing. The controller is configured to evaluate the respiratory rate(s) at the lower flow rates using the method(s) described above in connection with step 2406 to determine whether the respiratory rate(s) at the lower flow rates indicate whether the patient's respiratory rate is stable or increasing.

[0297] Thus, the controller may be configured to assess the patient's respiratory rate status at the operating flow rate, at one or more increments above the operating flow rate, and at one or more increments below the operating flow rate. Based on this assessment, the controller may determine that the patient's operating flow rate is stable, increasing, or decreasing; and similarly, at one or more increments above the operating flow rate, the operating flow rate is stable, increasing, or decreasing; or at one or more increments below the operating flow rate, the operating flow rate is stable, increasing, or decreasing.

[0298] The controller can determine in a situation where the operating flow rate is stable or increasing by one or more increments, and if the operating flow rate is increasing by one or more increments, that the current operating flow rate is the optimal operating flow rate and there is no need to change the operating flow rate in step 2408.

[0299] The controller may determine that the operating flow rate is lower than the optimal operating flow rate in situations where the operating flow rate is decreasing by one or more increments above. The controller may also determine that the operating flow rate is lower than the optimal operating flow rate when the operating flow rate is increasing by one or more increments above. In such situations, the controller may determine in step 2408 that the operating flow rate should be increased by an increment.

[0300] Additionally, if the operating flow rate stabilizes at one or more increments, the controller may determine that the operating flow rate is higher than optimal. The controller may determine that the operating flow rate is lower than the optimal operating flow rate in situations where the operating flow rate is decreasing at one or more increments. The controller may also determine that the operating flow rate is lower than the optimal operating flow rate in situations where the operating flow rate is increasing at one or more increments. In such situations, the controller may determine that the operating flow rate should be decreased by an increment.

[0301] If the patient's respiratory rate at one or more increments above the operating flow rate and one or more increments below the operating flow rate does not allow a definitive determination of whether the operating flow rate is the optimal operating flow rate, the controller may perform a second calibration using a second increment. In some embodiments, the second increment may be larger than the first increment. The second increment may provide a greater change in the patient's respiratory rate to aid in determining the optimal operating flow rate. The method described above may be repeated using the second increment.

[0302] Furthermore, if the patient's respiratory rate conditions at one or more increments above the operating flow rate and one or more increments below the operating flow rate do not provide a conclusive determination of whether the operating flow rate is the optimal operating flow rate, the controller may restart the initial flow rate to determine the optimal operating flow rate and perform the entire method 2400 again.

[0303] In some examples, step 2406 may include determining the patient's respiratory rate status at the maintained operating flow rate at each defined time interval. Step 2406 may further include determining the patient's respiratory rate status at a first flow rate higher than the maintained operating flow rate. Step 2406 may further include determining the patient's respiratory rate status at a second flow rate lower than the maintained operating flow rate.

[0304] In these examples, step 2408 may include adjusting or maintaining the operating flow rate in response to a comparison of the patient's respiratory rate condition at the maintained operating flow rate, the patient's respiratory rate condition at the first flow rate, and the patient's respiratory rate condition at the second flow rate. The conditions determined at the maintained operating flow rate, the first flow rate, and the second flow rate may be compared relative to one another.

[0305] In some further examples, step 2406 may include determining, at each defined time interval, the patient's respiratory rate status at a fourth flow rate lower than the maintained operating flow rate. The fourth flow rate may be lower than the second flow rate. Step 2406 may further include determining the patient's respiratory rate status at a third flow rate higher than the maintained operating flow rate. The third flow rate may be higher than the first flow rate.

[0306] In these further examples, step 2408 may include adjusting or maintaining the operating flow rate in response to a comparison of the patient's respiratory rate condition at the maintained operating flow rate, the patient's respiratory rate condition at the third flow rate, and the patient's respiratory rate condition at the fourth flow rate. The conditions determined at the maintained operating flow rate, the third flow rate, and the fourth flow rate may be compared relative to one another.

[0307] e. Deciding whether to adjust or maintain the operating flow rate In block 2408, the control system 2320 may determine whether to adjust or maintain the operating flow rate based on the determined state of the patient's respiratory rate.

[0308] The control system 2320 can use the determined patient respiratory rate status to determine whether to adjust or maintain the operating flow rate. If the patient respiratory rate status indicates that the patient respiratory rate is decreasing, the control system 2320 in step 2408 can determine to increase the operating flow rate. Similarly, if the patient respiratory rate status indicates that the patient respiratory rate is substantially stable, the control system 2320 in step 2408 can determine to maintain the operating flow rate.

[0309] In some examples, if the patient's respiratory rate status indicates that the patient's respiratory rate is increasing, then in step 2408 the control system 2320 may decide to decrease the operating flow rate.

[0310] In some embodiments, the control system 2320 in step 2408 uses the patient's respiratory rate and the status of one or more previous operating flow rate adjustments to determine whether to increase or decrease the operating flow rate. For example, if the operating flow rate was increased in a 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 whether to increase or decrease the operating flow rate.

[0311] Conversely, if the operating flow rate was decreased in the previous interval and the patient's respiratory rate status indicates that the patient's respiratory rate is decreasing, the control system 2320 in step 2408 may decide to decrease the operating flow rate. Additionally, if the operating flow rate was decreased in the previous interval and the patient's respiratory rate status indicates that the patient's respiratory rate is increasing, the control system 2320 in step 2408 may decide to increase the operating flow rate.

[0312] In some examples, in block 2408, the control system 2320 may determine to maintain the operating flow rate based on a patient respiratory rate condition indicating that the patient's respiratory rate is substantially the same between intervals. The intervals may be the current interval and one or more previous intervals, as described above. In such examples, the control system 2320 may determine that the patient's respiratory rate is substantially the same between intervals based on the comparison in step 2406 indicating that the patient parameter indicative of the patient's respiratory rate at the current interval is within a defined range or threshold of one or more previous intervals. In some examples, in block 2408, the control system 2320 may determine to maintain the operating flow rate based on the patient's respiratory rate status indicating that the patient's respiratory rate is substantially stable or classified as “stable.” The patient's respiratory rate status is determined in step 2406.

[0313] In some examples, based on determining in block 2408 that the operating flow rate is to be maintained for the first time, the control system 2320 may maintain the operating flow rate by adjusting the operating flow rate back to the operating flow rate of the previous interval. In such an example, the operating flow rate may be incrementally increased back to the rate at which the patient's minimum respiratory rate was achieved. In this manner, the minimum respiratory rate R is maintained, as shown in FIG. M is the flow rate F M In some examples, the decision to maintain the operating flow rate may be the first time in a treatment session. In other examples, it may be the first time in a series of treatment sessions.

[0314] In these examples, if the patient's respiratory rate remains substantially constant between the two operating flow rates, it may be preferable to use the lower of the two flow rates. That is, if there is a minimum respiratory rate between the flow rates (e.g., if the curve has a minimum flat portion), it may be preferable to use the minimum operating flow rate that achieves that minimum respiratory rate.

[0315] In other instances, the operating flow may not be increased even if increasing the final operating flow results in a slight increase in the patient's respiratory rate. Because the patient's respiratory rate increases slower with increasing flow than with decreasing flow from the minimum, it may be desirable to set the flow above the minimum for increased stability.

[0316] incremental If the control system 2320 determines that the operating flow rate needs to be adjusted, it may proceed to step 2410 and adjust the operating flow rate in increments. In some embodiments, the increments may be fixed time increments. The fixed time increments may be the same increments for each iteration of the control loop. In some embodiments, the fixed time increments are predetermined time increments.

[0317] In other embodiments, the increments are variable time increments. The variable time increments may be based on the patient's respiratory rate, and / or the patient's respiratory rate status, and / or multiple devices, and / or patient sensor readings, and / or the amount of time of the therapy session. In step 2408, the control system may also determine the size of the variable increments for adjusting the operating flow rate.

[0318] In yet another example, the increment, whether fixed or variable, may be automatically determined based on one or more additional parameters. The one or more additional parameters may be input by a user and / or stored in memory. The one or more additional parameters may correspond to patient and / or system conditions. The additional parameters may include patient characteristics such as age, weight, sex, height, sleep state (awake or asleep), respiratory symptoms (e.g., presence or absence of cough and / or sputum production), etc. System parameters may include time of day, type of therapy selected, etc. The control system 2320 can use these additional parameters in determining the increment.

[0319] The increment may be from about 0.1 L / min to about 20 L / min, optionally from about 0.5 L / min to about 15 L / min, optionally from about 1 L / min to about 10 L / min, optionally from about 2 L / min to about 8 L / min, optionally from about 3 L / min to about 6 L / min, and preferably about 5 L / min.

[0320] In some embodiments, process 2400 may use larger flow rate increments at the beginning of a treatment session because minimum respiratory rates are less likely to be achieved at lower flow rates. For example, 10 L / min increments may be used until the system reaches 30 L / min. At that point, 5 L / min increments may be used. Alternatively, a healthcare professional may set the initial operating flow rate to a higher flow rate to make the titration process faster. If the flow rate increases in initial increments above the initial flow rate, the titration process should begin decreasing the flow rate in increments to find the minimum.

[0321] In another example, the increment may be proportional to the difference between the respiratory rate received or determined in the current interval and an upper threshold RT+, as described below. For example, if the patient's respiratory rate is much higher than the upper threshold, a larger increment is used so that the respiratory rate approaches the desired threshold at a faster rate. The smaller this difference, the smaller the increment in flow rate.

[0322] Threshold In some examples, in block 2408, the control system 2320 may also compare the received or determined patient respiratory rate and / or patient respiratory state to one or more thresholds.

[0323] In one example, the one or more thresholds may be upper and lower thresholds. The one or more thresholds may prevent the patient's respiratory rate from falling outside a predetermined range. A respiratory rate that is within a desired range may indicate a healthy and / or stable patient.

[0324] In Figure 26, this range is R T+ and R T- In this example, the upper threshold is R T+ and the lower threshold is R T-This range may be between approximately 12-20 breaths per minute, 12-18 breaths per minute, or 12-16 breaths per minute in some embodiments. This range is typically defined by a clinician or physician and may be entered into the respiratory therapy device and received by control system 220. In some embodiments, control system 220 may determine the range based on one or more patient and / or system conditions.

[0325] This range may vary based on the type of patient, the type of respiratory disease, and other conditions. For example, the range may differ based on whether the patient is being treated in a hospital or at home. In the home setting, it may be desirable to provide earlier warning that the patient's condition is deteriorating or cannot be stabilized with high-flow therapy. Therefore, the range used at home may be narrower than the range used in a hospital.

[0326] In some embodiments, at block 2408, the control system 2320 can receive additional parameters corresponding to the patient's condition and / or the system's status. The additional parameters may include patient characteristics such as age, sex, weight, height, sleep state (awake or asleep), respiratory symptoms (such as the presence or absence of cough and / or sputum production), etc. System parameters may include the time of day, the type of therapy selected, etc. The control system 2320 can use these additional parameters in determining one or more thresholds.

[0327] In some embodiments, the patient curve is determined by the minimum respiratory rate R M is the lower threshold R T- In this case, the respiratory rate may be lower than R T- When the respiratory rate falls below R T- This reduces the operating flow rate by one increment so that the patient's respiratory rate is equal to or greater than the lower threshold R T- Do not fall below this.

[0328] In some embodiments, a high-flow therapy device may reach its maximum operating flow rate before a minimum respiratory rate is found. That is, the patient's minimum respiratory rate occurs at a flow rate above the maximum operating flow rate achievable by the high-flow device. In some devices, the maximum operating flow rate is 70-80 l / min. If the flow rate reaches this maximum without achieving the minimum respiratory rate, an alarm may sound, informing the patient that an alternative therapy, such as CPAP, noninvasive ventilation, or invasive ventilation, may be initiated. Alternatively, the high-flow therapy device may provide a different type of therapy, such as nasal high flow, CPAP, or NIV. In this case, the high-flow device may switch to a different type of therapy once the maximum flow rate is reached at the high-flow therapy setting.

[0329] In other examples, the control system 2320 may not attempt to achieve a minimum flow rate. Instead, the control system may achieve a minimum flow rate that is within a desired range. For example, with reference to FIG. 26, the control system may select the F that provides the lowest flow rate that provides a respiratory rate within a threshold. T+ The flow rate may be increased incrementally until it reaches an upper threshold R T+ At this point, the control system will stop increasing the flow rate.

[0330] In other examples, it may be desirable to keep the respiratory rate somewhere between an upper and lower threshold. In this embodiment, control system 2320 titrates by performing steps 2404-2410 / 2412 for the patient's respiratory rate anywhere in the desired range. In these examples, control system 2320 may perform steps 2404-2412 as long as the patient's respiratory rate is within the desired range by comparing the patient's respiratory rate to a threshold. In these examples, control system 2320 determines the patient's respiratory rate status when the patient's respiratory rate is "stable" or at a minimum, e.g., R M When the patient's respiratory rate is increased to an upper threshold R T+ and the lower threshold R T- When the pressure is within the range of 100 psi, the operating flow rate may be maintained.

[0331] Additionally or alternatively, the control system 2320 may set boundary or threshold conditions for the operating flow rate and not select a flow rate below a minimum flow rate. The control system 2320 may also limit the maximum flow rate to a clinician-set limit or a maximum flow rate stored in the controller. This limit may be based on a flow rate that may cause patient discomfort, such as 120 L / min for adults or 3 L / min / kg for neonates or children. Increasing the flow rate also increases noise and pressure. Therefore, based on the data collected by the control system 2320, block 2408 may compare the operating flow rate for the current interval to boundary or threshold conditions for the flow rate.

[0332] f. Adjustment of operating flow rate At block 2410, the control system 2320 may adjust the operating flow rate based on the adjustment of the operating flow rate determined at block 2408. The control system 2320 may adjust the operating flow rate in the increment determined at block 2408.

[0333] As discussed above, in step 2408, if the patient's respiratory rate status indicates that the patient's respiratory rate is decreasing, the control system 2320 may determine to increase the operating flow rate. In step 2410, the control system 2320 increases the operating flow rate by an incremental amount.

[0334] In some examples, if the patient's respiratory rate status indicates that the patient's respiratory rate is increasing, then in step 2408 the control system 2320 may decide to decrease the operating flow rate.

[0335] Increasing the operating flow rate may include adjusting the operating flow rate from a first value to a second, higher value, the difference between the first value and the second value being the increment.

[0336] Adjusting the operating flow rate includes adjusting the flow generator motor speed. For example, this may be accomplished by outputting one or more flow control outputs 2332, as described above. In such an example, increasing the operating flow rate by an increment includes adjusting the blower motor speed from a first value to a second, higher value. The adjustment of the motor speed may be proportional to the adjustment of the operating flow rate.

[0337] In some embodiments, the control system 2320 may adjust the operating flow rate within a range. The range may be defined by a maximum allowable flow rate and / or a minimum allowable flow rate. The control system 2320 may be configured to stop further increases in the operating flow rate if it determines that an increase in the determined operating flow rate would exceed the maximum allowable flow rate.

[0338] g. Maintaining operating flow rate At block 2412, control system 2320 may maintain the operating flow rate based on the control system's decision to maintain the operating flow rate at block 2408. As described above, at step 2408, if the patient's respiratory rate status indicates that the patient's respiratory rate is substantially stable or otherwise minimal, control system 2320 may determine to maintain the operating flow rate. At step 2412, control system 2320 implements the maintenance of the operating flow rate, as described above.

[0339] f. Wait for an interval In block 2414, after the control system 2320 adjusts the operating flow rate in step 2410 or maintains the operating flow rate in step 2412, the process 2400 waits a time interval before again performing each of steps 2404-2410 / 2412, as described above.

[0340] For example, the control system 2320 may wait a time interval before proceeding to perform steps 2404-2410 / 2412. This step is indicated by block 2414 of the process 2400. In this manner, there is a delay between performing each iteration of the control loop 2400. It will be appreciated that steps 2404-2410 / 2412 may be performed at substantially equal time intervals.

[0341] g. Additional / Alternative Embodiments In some alternative embodiments, the control system may be configured to first perform steps 2402 and 2404. The control system may then be configured to display a patient parameter indicative of the patient's respiratory therapy user via a display on the respiratory therapy device or via a display on an external device in operative communication with the respiratory therapy device and forming part of the respiratory therapy system. In some embodiments, the display of the patient parameter indicative of the patient's respiratory rate may also be accompanied by a display of the operating flow rate.

[0342] Additionally, user input may be received by the control system. The display may be configured to allow a user interface, such as a touch screen, to provide user input. In some examples, user input may be provided by one or more buttons, knobs, or dials on the respiratory therapy device. The user input may be configured to allow a user to manually adjust the operating flow rate. The adjustment of the operating flow rate is performed by the user based on a displayed indication of the patient's respiratory rate (or other patient parameter).

[0343] In some further embodiments, method 2400 may further include sending a prompt to the user based on the determination in step 2408. In these examples, if step 2408 determines to adjust the operating flow rate, the user receives a prompt via the display that the operating flow rate is being adjusted. The new operating flow rate, and in some embodiments, the previous operating flow rate, are presented to the user via the display. In this manner, the user is informed that the adjustment of the operating flow rate has changed.

[0344] In other examples, if a decision is made to adjust the operating flow rate in step 2408, the user is prompted that the controller has determined that the operating flow rate should be adjusted. In such an example, the user is prompted to confirm whether to proceed with adjusting the operating flow rate. The user may provide input in response to the prompt, for example, via a display. If confirming input from the user is received, the controller proceeds to step 2410 and adjusts the operating flow rate by an incremental amount. If confirming input is not received, or is not received in time, the controller may proceed to step 2412 to maintain the current operating flow rate.

[0345] In some examples, the decision to adjust the operating flow rate and / or the proposed new operating flow rate determined by the controller may be presented as a suggestion to the user rather than being automatically implemented by the controller. The controller may be configured to present one or more prompts to the user and allow user input related to the proposed new operating flow rate. The user input may also be configured to provide confirmation of the proposed operating flow rate and to allow adjustment of the proposed operating flow rate prior to confirmation.

[0346] In some additional examples, the controller may be configured to save the operating flow rate to memory at the end of a session. At the end of each treatment session, the controller saves the most recent operating flow rate to memory. At the start of the next treatment session, in step 2402, the saved operating flow rate is used as the initial operating flow rate for the treatment session.

[0347] 2.4 Alternative flow control methods In an alternative example of a flow control method, step 2408 of method 2400 is modified from the example described above. In this alternative example, step 2408, which determines whether to adjust or maintain the operating flow rate, is based on comparing at least a parameter indicative of the patient's respiratory rate to one or more thresholds, as described below. 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 embodiment are as described above.

[0348] 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 treatment parameter. The one or more thresholds may be associated with the patient's respiratory rate and / or one or more additional patient or treatment parameters. The one or more thresholds may be associated with corresponding parameters. The one or more thresholds may comprise an upper threshold and / or a lower threshold for each parameter. For example, a respiratory rate threshold may comprise an upper respiratory rate and a lower respiratory rate. The respiratory rate threshold may be, for example, between a lower threshold of about 5 breaths per minute and an upper threshold of about 35 breaths per minute, optionally between an upper threshold of about 8 breaths per minute and an upper threshold of about 25 breaths per minute, optionally between an upper threshold of about 11 breaths per minute and an upper threshold of about 21 breaths per minute, optionally between an upper threshold of about 12 breaths per minute and an upper limit of about 20 breaths per minute, optionally between an upper limit of about 12 breaths per minute and an upper limit of about 18 breaths per minute, and preferably between a lower limit of about 12 breaths per minute and an upper limit of about 16 breaths per minute. This range is typically defined by a clinician or physician.

[0349] The one or more thresholds may further include one or more time-based thresholds. The time-based thresholds may relate to a minimum amount of time that a parameter or parameters remain above each corresponding parameter threshold or thresholds. The time-based thresholds may be a period of time. For example, the time-based thresholds may be greater than or equal to 5 minutes and less than or equal to 60 minutes, more preferably greater than or equal to 10 minutes and less than or equal to 45 minutes, and even more preferably less than or equal to 15 minutes.

[0350] Any of the one or more thresholds, including one or more parameter thresholds and / or 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 the thresholds may alternatively be predefined or preset and stored in memory in operational association with the controller.

[0351] In these examples, step 2408 includes evaluating the patient parameters received or determined from step 2404 against one or more thresholds. The method may proceed to step 2410 to adjust the operating flow rate based on the parameter(s) meeting or exceeding one or more thresholds. If the parameters do not meet or exceed one or more thresholds, the method proceeds to step 2412 to maintain the operating flow rate.

[0352] In some embodiments, once the parameter(s) are set, the user can confirm and begin providing therapy using the device. Method 2400 is performed as described above, omitting step 2406. In step 2408, if a parameter such as the patient's respiratory rate is greater than a threshold value (e.g., a respiratory rate threshold), in some time threshold embodiments, the method may proceed to step 2410 to incrementally adjust the operating flow rate.

[0353] In any described example relating to step 2410 of method 2400, the increment for adjusting the operating flow rate may be an absolute value (i.e., a value in liters per minute (L / min)). The absolute value may be set by a user; for example, a 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, and preferably between about 5 L / min. Optionally, it may be between about 5 l / min and about 10 l / min, optionally it may be between about 10 l / min and about 15 l / min, optionally it may be between about 10 l / min and about 20 l / min, optionally it may be a value between about 20 l / min and about 30 l / min. Alternatively, the absolute value may be preset during manufacture of the respiratory device or during initial setup of the case and stored in the memory of the device.

[0354] Alternatively, the increment for adjusting the operating flow rate may be determined as a percentage or fraction of the operating flow rate or initial operating flow rate. This percentage or fraction may be set by the user, for example, the user may set a percentage or fraction between 0 and 30% of the operating flow rate. Alternatively, the percentage or fraction may be preset during manufacture of the respiratory device or during initial case setup and stored in the device's memory.

[0355] In these examples, the increment of the operating flow rate adjusted in step 2410 may be an increase in the operating flow rate. In some embodiments, the increment for the adjustment may be a decrease in the operating flow rate.

[0356] In some embodiments, incrementally adjusting the operating flow rate 2410 comprises changing the operating flow rate by a step change relative to the incrementally set operating flow rate. In embodiments, incrementally adjusting the operating flow rate 2410 includes ramping the operating flow rate to the incremental operating flow rate over a period of time.

[0357] In some examples, when the operating flow rate is adjusted incrementally, method 2400 further includes displaying a prompt or alert to the user indicating that the operating flow rate has been adjusted. The prompt or alert indicating that the operating flow rate has been adjusted may be presented via a display. The display may be configured to display a symbol or text to the user indicating that the operating flow rate has been adjusted. In this manner, the user may be alerted, for example, to indicate that a patient parameter has exceeded one or more thresholds and an adjusted (e.g., increased) operating flow rate is being provided.

[0358] Additionally or alternatively, the method may include presenting an audible alarm to the user indicating that the operating flow rate has been adjusted. The audible alarm may be provided simultaneously with a prompt or alert displayed on the display. In these examples, the controller may be configured to wait an interval (e.g., 5, 10, 15, or other minutes, as described above). If the parameter (e.g., respiratory rate) has not fallen below the threshold after the interval, the controller may be configured to present an alert and / or alarm.

[0359] In some embodiments, once the operating flow rate has been adjusted incrementally, the method no longer includes a decision as to whether to adjust or maintain the operating flow rate. The controller may cease performing steps 2404-2414 at this point. The device may be "locked" at the adjusted (e.g., increased) operating flow rate. Further adjustments to the operating flow rate after adjustment may require manual adjustment via the user interface. This is because, in some embodiments, threshold-based adjustments to the operating flow rate may be made by the controller only if the patient exhibits a high respiratory rate. Therefore, this may be considered a clinically significant situation, and user intervention may be required to further adjust the operating flow rate, particularly to decrease it from an increased level. In other embodiments, the method may include performing steps 2404-2414 as described above without preventing further adjustments to the operating flow rate.

[0360] 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, determining whether to adjust or maintain the operating flow rate, is further based on comparing the patient parameter indicative of the patient's SpO2 to one or more thresholds. The one or more thresholds in this example may relate to 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 to trigger an adjustment of the operating flow rate in step 2404 based on a comparison of the SpO2 to one or more thresholds. For example, if the measured SpO2 falls below a threshold for a certain period of time (e.g., five minutes), the method determines that an adjustment (i.e., an increase) of the operating flow rate is necessary. Using the patient's SpO2 can be an alternative to using the patient's respiratory rate or can be used in combination with the patient's respiratory rate. When used in combination with the patient's respiratory rate, the SpO2 may have one or more specific thresholds, and the respiratory rate may have one or more specific thresholds.

[0361] Additionally, the controller may receive or determine therapy parameters indicative of the FiO2 provided or to be provided to the patient. The therapy parameters indicative of the FiO2 provided or to be provided to the patient may be based at least in part on patient parameters indicative of the patient's SpO2. The indication of the patient's FiO2 may be a useful indicator when the FiO2 is automatically adjusted by the therapy device based on a signal related to the patient's SpO2, as described below. In these examples, step 2408, determining whether to adjust or maintain the operating flow rate, is further based on comparing the patient therapy indicative of the FiO2 provided or to be provided to the patient. In this example, if the controller of the system increases the FiO2 above a certain threshold (for a minimum time), this may be a surrogate indicator of a decrease in SpO2. In this manner, the controller can use the increase in FiO2 as an indication to adjust the operating flow rate. Using an FiO2 measurement may be an alternative to using the patient's respiratory rate, or may be used in combination with the patient's respiratory rate. When used in combination with the patient's respiratory rate, the FiO2 has one or more specific thresholds, and the respiratory rate has one or more specific thresholds.

[0362] 2.5 How to control oxygen concentration levels In some embodiments, in addition to the flow control methods described above, the control system can automatically control the operating oxygen concentration level of the gas delivered to the patient over the course of treatment and based on changes in the patient's condition.

[0363] In such an embodiment, the control system 2320 can increase or decrease the oxygen concentration level (i.e., FiO2) by controlling one or more of the first and second valves to supply gas through the first and second inlets, 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 oxygen concentration level can be optimized by the control system 2320 to improve patient comfort and therapy.

[0364] Details of an exemplary method for automatically controlling the O2 level provided to a patient by adjusting the O2 fraction (FiO2) provided to the patient to maintain the patient's measured SpO2 level within a target SpO2 range are described in International Publication No. WO 2019 / 070136, filed October 5, 2018, the entire contents of which are incorporated herein by reference.

[0365] a. Effect of oxygen concentration level on respiratory rate vs. airflow relationship An example of the collected measurements is shown in graphical form in Figure 27. 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. Controlling the operating flow rate and operating oxygen concentration level affects the patient's measured respiratory rate, as shown by graph 2700 in Figure 27 and described below.

[0366] In this example, when respiratory therapy is not delivering gas to the patient, the flow rate of gas delivered to the patient is 0 liters / minute. At a flow rate of 0 liters / minute, the patient's respiratory rate, R0, is 2704. The patient's respiratory rate may be measured in breaths per minute (bpm). Testing has shown that over a range of flow rates, the flow rate versus respiratory rate curves 2702, 2710 follow a shape substantially similar to that shown in FIG. 27.

[0367] The first portion of this curve 2702, 2710 follows an inverse S-shaped curve (or inverse sigmoid curve). However, past a certain point indicated by 2706, 2708, further increases in flow cease, allowing the respiratory rate to decrease further. Substantially at this point 2706, 2708, the flow F M The minimum respiratory rate R M At higher flow rates, the respiratory rate begins to rise due to the increased effort required to exhale at higher flow rates.

[0368] Curve 2702 shows a first flow rate versus respiratory rate curve. Curve 2710 shows a second flow rate versus respiratory rate curve. Increasing the fraction of inspired oxygen (FiO2) in the gas stream delivered to the patient allows more oxygen to be available per breath. As a result, the patient obtains the same amount of oxygen from a smaller volume of inspired gas, resulting in a decrease in minute ventilation. The respiratory rate may decrease because the body tends to prefer slow breathing over shallow breathing. Thus, curve 2710 shows curve 2702 after the operating oxygen concentration level has been increased.

[0369] As shown, increasing the operating oxygen concentration level, i.e., FiO2, has the effect of shifting the flow versus respiratory rate curve downward, as shown by the difference from curve 2702 to curve 2710. Curve 2710 is sometimes referred to as the oxygen concentration increase curve 2710. This shift is proportional to the increase in operating oxygen concentration level, i.e., FiO2.

[0370] At lower operating flow rates, it may be difficult to achieve a high percentage operating oxygen concentration level or FiO2 because the total flow delivered is a low percentage of the inspired gas. For this reason, the oxygen concentration increase curve 2710 is not plotted at low flow rates.

[0371] This curve movement with increasing operating oxygen concentration level can be used in situations where increasing the operating flow rate alone is not enough to reduce the respiratory rate to within the desired range. In such situations, curve 2702 shown in Figure 27 may result. As shown, even after full titration to reach FM, the patient's respiratory rate RM remains above Rmax.

[0372] In some cases, an already compromised patient with a suboptimal SpO2 level may begin receiving high-flow therapy. In these cases, it is important to quickly restore SpO2 to an optimal level. In these cases, the controller can use closed-loop SpO2 control in conjunction with the closed-loop respiratory rate control method described above.

[0373] b. Overview of SpO2 control In some examples, at the initiation of high-flow therapy, the controller can be configured to receive one or more SpO2 measurements, e.g., from one or more sensors. The controller may be configured to compare the one or more received SpO2 measurements to one or more thresholds. In these examples, if the SpO2 level falls below the threshold, the concentration of oxygen (FiO2) delivered to the patient can be adjusted in an attempt to restore the SpO2 to a stable level, e.g., as described in WO 2019 / 070136.

[0374] In such examples, as disclosed above (e.g., in connection with method 2400), the respiration rate-based adjustment of operating flow occurs after or simultaneously with this SpO2 control. In these examples, the SpO2 controller or control loop adjusts the FiO2, and the respiration rate controller or control loop adjusts the operating flow, and the respiration rate controller or control loop adjusts the operating flow, so that the two closed-loop control methods can operate simultaneously and independently. However, in these examples, the respiration rate-based FiO2 control described herein does not operate simultaneously with the SpO2-based FiO2 of the control method of this example.

[0375] In one example, upon initiation of therapy delivery, SpO2-based FiO2 control can operate until SpO2 reaches a stable level. This involves comparing SpO2 readings received from one or more sensors to one or more thresholds. For example, a stable SpO2 level can be defined as an SpO2 measurement above a threshold. Once SpO2 reaches a stable level for a minimum time threshold, such as 10-30 minutes, more preferably 15 minutes, SpO2 control can be disabled by the controller, and respiratory rate-based control of operating flow, as described in connection with FIG. 24 above, and optionally respiratory rate-based control of FiO2, as described in connection with FIG. 25 below, can be enabled.

[0376] In some embodiments, at the start of therapy, SpO2-based control of FiO2 and respiratory rate-based control of operating flow may operate simultaneously. Once SpO2 reaches a stable level as described above (e.g., above a threshold for a period of time), SpO2-based control of FiO2 may be disabled and respiratory rate-based control of FiO2 may be enabled, as described in connection with method 2500 below.

[0377] c. Oxygen concentration control method Figure 25 is a flow chart of an embodiment 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. Process or method 2500 is comprised of the steps of process or method 2400 as shown and described in connection with Figure 24. As will be appreciated, 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.

[0378] As shown, at each interval, the control system 2320 may further adjust or maintain the operating flow rate and oxygen concentration level of the gas supplied or provided by the respiratory therapy device 100, 2202. Using feedback from one or more sensors, the control system 2320 follows an iterative process or method 2500 of titration, described below, to find a substantially optimal operating flow rate and oxygen concentration level.

[0379] The iterative process or method 2500 can be performed continuously or continuously over or during a therapy session.

[0380] A substantially optimal operating flow rate and oxygen concentration level is one where the patient's respiratory rate is at or near a minimum and within a range.

[0381] The control system 2320 may increase the blower motor speed if a blower is used as the flow source 50, 2224 to increase the operating flow rate of gas through the respiratory assistance system 10, 2200.

[0382] The control system 2320 can also increase the oxygen concentration level by controlling one or both of the first and second valves to supply gas through the first and second inlets 2222, 2223, respectively.

[0383] The control system 2320 can automatically control the operating flow rate and / or operating oxygen concentration level for a particular patient based on parameters indicative of the patient's respiratory rate. The operating flow rate and operating oxygen concentration level can be optimized by the control system 2320 to improve patient comfort and therapy.

[0384] The control system 2320 can measure one or more patient conditions in response to changes in the operating flow rate and / or oxygen concentration level. The control system 2320 can measure the patient's respiratory rate in response to changes in the operating flow rate and / or oxygen concentration level.

[0385] 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 perform the oxygen control steps 2516 and 2518 / 2520. In other embodiments, the oxygen control steps 2516 and 2518 / 2520 may occur before the flow control steps 2508 and 2510 / 2512.

[0386] As shown in FIG. 25, if the control system 2320 determines to adjust the operating flow rate in block 2508 and adjusts the operating flow rate in block 2510, the method proceeds to step 2514 to wait for an increment, similar to the method described in connection with FIG. 24.

[0387] Alternatively, if the control system 2320 determines to maintain the operating flow rate at block 2508, then the operating flow rate is maintained at block 2512, and the method then proceeds to step 2516 and performs oxygen control steps 2516 and 2518 / 2520, and then proceeds to step 2514 and waits for an increment.

[0388] In these examples, control of the operating flow rate is repeated until the operating flow rate is maintained. Once maintained, oxygen concentration control can be used to maintain the operating flow rate at a stable or minimum level and increase the oxygen concentration, i.e., FiO2, until the patient's respiratory rate is within a desired range. In such embodiments, control of the operating flow rate can reduce the patient's respiratory rate to a stable level, but it may still fall outside the desired range. Therefore, the oxygen concentration can be controlled to further reduce the patient's respiratory rate and bring it within the desired range. If the patient's respiratory rate can be minimized, stabilized, and within the desired range using flow rate alone, adjustment of the oxygen concentration may not be necessary.

[0389] In an alternative example, the control system 2320 determines to adjust the operating flow rate in block 2508, adjusts the operating flow rate in block 2510, then the method proceeds to step 2516 and performs oxygen control steps 2516 and 2518 / 2520, and then proceeds to step 2514 and waits for an increment. In such an example, the control system 2320 performs control of the operating oxygen concentration level and operating flow rate at the same intervals regardless of the patient's respiratory rate status.

[0390] The respiration rate determination blocks or steps 2504 and 2506, the flow rate control blocks or steps 2508 and 2510 / 2512, and the oxygen control steps 2516 and 2518 / 2520 may all be performed at the same interval. In other embodiments, one or more of these blocks or steps may be performed at different intervals. For example, in one interval, the control system 2320 may perform the flow rate determination blocks or steps 2504 and 2506, and the flow rate control blocks or steps 2508 and 2510 / 2512. In the next interval, the control system 2320 may perform the respiration rate determination blocks or steps 2504 and 2506, and the oxygen control steps 2516 and 2518 / 2520. This alternating cycle may continue in the future.

[0391] Oxygen control steps 2516 and 2518 / 2520 will now be described. Block 2516 includes determining whether to adjust or maintain the operating oxygen concentration level. This determination may be based on a measured patient parameter indicative of the patient's respiratory rate during the current interval. In some examples, the determination may be based on the patient's respiratory rate status determined during the current interval, as described above. In some examples, the determination whether to adjust or maintain the operating oxygen concentration level may be further based on comparing the patient parameter indicative of the patient's respiratory rate to one or more thresholds. In other examples, the determination whether to adjust or maintain the operating oxygen concentration level may be further based on comparing the patient's respiratory rate status determined during the current interval to one or more thresholds.

[0392] Control system 2320 then proceeds to either block 2518 or 2520 based on the determination at block 2516. Block 2518 includes incrementally adjusting the operating oxygen concentration level based on determining 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 determining that the operating oxygen concentration level is to be maintained.

[0393] d. Decide whether to adjust or maintain the operating oxygen concentration level 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 indicative of the patient's respiratory rate for the current interval. In such examples, this may include determining whether to adjust or maintain the operating oxygen concentration level, and may further be based on comparing the patient parameter indicative of the patient's operating oxygen concentration level to one or more thresholds.

[0394] The control system 2320 may compare the received or determined patient parameter indicative of the patient's respiratory rate to one or more respiratory rate targets. The target respiratory rate(s) may define a respiratory rate threshold. In some embodiments, the target(s) are comprised of an upper threshold and a lower threshold. For example, as shown in FIG. 27, the upper threshold is designated Rmax and the lower threshold is designated Rmin. In some embodiments, the target(s) may further comprise a midpoint of the threshold or other value of the threshold. In such embodiments, the defined range is between the upper range threshold and the lower range threshold.

[0395] If the received or determined patient parameter indicating the patient's respiratory rate indicates that the patient's respiratory rate is greater than the upper threshold, the control system 2320 in step 2516 may decide to increase the operating oxygen concentration level.

[0396] Similarly, if the received or determined patient parameter indicating the patient's respiratory rate indicates that the patient's respiratory rate is below a lower threshold and above a lower threshold, the control system 2320 in step 2516 may decide to maintain the operating oxygen concentration level.

[0397] 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 threshold, the control system 2320 in step 2516 may decide to decrease the operating oxygen concentration level.

[0398] Additionally or alternatively, the control system 2320 may set boundary conditions for the operating oxygen concentration level and not select a concentration level that exceeds the maximum rate. The control system 2320 may also limit the oxygen concentration level to a minimum level, which may be set by a clinician or stored in the controller. Thus, based on data collected by the control system 2320, the control system 2320 may compare the operating oxygen concentration level for the current interval to the boundary conditions in block 2516.

[0399] In some examples, if the operating oxygen concentration level reaches the maximum allowable concentration level and the patient's respiratory rate still does not meet the target value(s) or is within the upper and lower threshold ranges, an alarm may sound. Additionally, the control system 2320 may prevent the oxygen concentration level from being adjusted and instead maintain it.

[0400] In some examples, once the patient's respiratory rate condition is deemed stable or minimal, for example, as shown in step 2506, FIG. 27, the patient's respiratory rate may be within the desired range or within upper and lower thresholds, but may exceed the target rate, such as between Rmax and Rmin, or above RT. In such an example, because the patient's respiratory rate is within the upper and lower thresholds, the control system 2320 may determine that supplemental oxygen is not necessary and to maintain the operating oxygen concentration level. There is no need to adjust or increase the operating oxygen concentration, or FiO2.

[0401] If control system 2320 determines that the operating oxygen concentration level needs to be adjusted, it may proceed to step 2518 and adjust the operating oxygen concentration level in increments. In some embodiments, the increments may be fixed time increments. In other embodiments, the increments are variable time increments. It will be appreciated that the increments for adjusting the operating oxygen concentration level may be determined in the same manner as the increments for the operating flow rate in blocks or steps 2408 / 2508.

[0402] The increment can be from about 0.1% to about 20%, optionally from about 0.5% to about 15%, optionally from about 1% to about 10%, optionally from about 2% to about 8%, optionally from about 3% to about 6%, and preferably about 5%.

[0403] e. Adjustment of operating oxygen concentration In block 2518, control system 2320 may adjust the operating oxygen concentration level based on the control system adjusting the operating oxygen concentration level determined in block 2516. Control system 2320 may adjust the operating oxygen concentration level in the increment determined in block 2516.

[0404] 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 being the increment.

[0405] Adjusting the operating oxygen concentration level may comprise adjusting the first and / or second valves of the flow generator. For example, this may be accomplished by outputting one or more oxygen control outputs 2336, as described above. In such an embodiment, incrementally increasing the operating oxygen concentration level includes adjusting the second valve to increase the amount of oxygen drawn or delivered to the blower. The valve adjustment may be proportional to the adjustment of the operating oxygen concentration level.

[0406] f. Maintaining operating oxygen concentration In block 2520, control system 2320 may maintain the operating oxygen concentration level based on the control system's decision to maintain the operating oxygen concentration level in block 2516. As described above, in step 2516, control system 2320 may determine to maintain the operating oxygen concentration level if the patient's respiratory rate is within the upper and lower thresholds. In step 2520, control system 2320 maintains the operating oxygen concentration level as described above.

[0407] At block 2514, the control system 2320 adjusts the operating oxygen concentration level at step 2518 or maintains the operating oxygen concentration level at step 2520, and the process 2500 then waits a time interval before again performing step 2504 and the remainder of the process 2500, as described above.

[0408] Although processes 2400 and 2500 are described separately, control system 2320 can implement either or both of these processes simultaneously to control flow rate and / or oxygen concentration levels. Thus, control system 2320 can use a combination of the steps of processes 2400 and 2500 to control flow rate and / or oxygen concentration levels to provide optimal therapy to the patient.

[0409] 2.6 Oxygen concentration control 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 control only the oxygen concentration level.

[0410] Figure 30 shows a flowchart of an example method 3000 for controlling the oxygen concentration level of gas delivered to a patient based on the patient's measured respiratory rate. Process or method 3000 is comprised of many of the steps of process or method 2500 as shown and described in connection with Figure 25. It will 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.

[0411] As shown, at each interval, the control system 2320 may further adjust or maintain the operating flow rate and oxygen concentration level of the gas supplied or provided by the respiratory therapy device 100, 2202. The control system 2320 follows an iterative process or method 3000 of titration to find a substantially optimal oxygen concentration level using feedback from one or more sensors. The substantially optimal oxygen concentration level may be a level at which the patient's respiratory rate is at or near a minimum and / or within a range.

[0412] The process or method 3000 may be performed continuously or continuously during or for the duration of a treatment session.

[0413] In this embodiment, the operating flow rate is set by the clinician or user and is not iteratively controlled by the control system 2320 as described above in connection with Figures 24 and 25. The control system 2320 can control the blower motor speed, if a blower is used as the flow source 50, 2224, to set the flow rate of gas through the respiratory assistance system 10, 2200. The clinician or user of the respiratory device can manually change the operating flow rate during treatment, but it is not automatically titrated.

[0414] The oxygen concentration level may be iteratively titrated to keep the patient's respiratory rate within a desired range, as described in connection with steps or blocks 2502, 2504, 2506, 2516, 2518, 2520, and 2514 of Figure 25. The control system 2320 may increase the oxygen concentration level by controlling one or both of the first and second valves to supply gas through the first and second inlets 2222, 2223, respectively.

[0415] 2.7 Warning The control system 220 can also generate alarms or warnings based on measured physiological patient parameters. For example, if the respiratory rate exceeds or falls below an acceptable limit, the control system 220 can generate a display alarm. Alternatively, the control system can generate alarms or warnings based on the relative insensitivity of the measured parameter value to changes in flow rate. For example, insensitivity of a patient parameter, such as respiratory rate, to flow rate may indicate that therapy may be ineffective. In some embodiments, the control system 220 can change the flow rate and determine that the patient parameter, such as respiratory rate, is not significantly affected by the change in flow rate. Based on the lack of correlation, the control system 220 can determine that therapy may not be optimal for the patient.

[0416] 2.8 Purpose Respiratory support system 100 and high-flow therapy can be used to support patients in emergency rooms, intensive care units (ICUs), operating rooms (ORs), other hospital settings, or at home. In particular, respiratory support system 100 can be used to support patients during anesthesia, pre-oxygenation, and post-operative care. Using high-flow therapy is advantageous in some embodiments because the patient is still able to communicate and the mouth is not covered by a mask. When tracheal intubation or endoscopy is required, the mouth may be blocked, preventing invasive tracheal intubation. Therefore, high-flow therapy with the nasal cannula configuration of respiratory support system 100 can be used in such situations to provide respiratory support. Control system 220 can determine the patient's respiratory rate or other physiological parameters in such cases and automatically determine the flow rate setpoint. When a patient uses respiratory support system 100 at home, the control system 220 can be used to initially adjust the flow rate setpoint. The patient can also measure and input their own respiratory rate using the controller.

[0417] Terms and Definitions The phrase "computer-readable medium" or "machine-readable medium" as used in this specification and claims should be interpreted to include a single medium or multiple media unless the context suggests otherwise. 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 phrase "computer-readable medium" or "machine-readable medium" should be interpreted to include any medium capable of storing, encoding, or carrying instructions that are executed by a processor of a computing device to cause the processor to perform any one or more of the methods described herein. The computer-readable medium is used by these sets of instructions. It may also store, encode, or carry data structures associated with these sets of instructions. The phrases "computer-readable medium" and "machine-readable medium" include, but are not limited to, portable to non-removable storage devices, solid-state memory, optical or optical storage media, magnetic media, and / or various other media that can store, contain, or carry instruction(s) and / or data. A "computer-readable medium" or "machine-readable medium" may be non-transitory.

[0418] The term "comprising" as used in this specification and claims means "consisting at least in part of" or "including, but not limited to," to be interpreted in an inclusive sense, as opposed to an exclusive or exhaustive sense. When interpreting each statement in this specification and claims containing the term "comprising," there may be features other than those of the term preceded by the term. Related phrases such as "comprise" and "comprises" should be interpreted in a similar manner.

[0419] Reference to a range of numerical values ​​disclosed herein (e.g., 1 to 10) is intended to encompass all rational numbers within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10), as well as any range of rational numbers within that range (e.g., 2 to 8, 1.5 to 5.5, and 3.1 to 4.7). Accordingly, all subranges of every range explicitly disclosed herein are hereby expressly disclosed. These are merely examples of what is specifically intended, and all possible combinations of numerical values ​​between the lowest and highest values ​​recited are considered to be equally expressly intended in this patent application.

[0420] The term "and / or" means "and" or "or," or both.

[0421] The use of "(s)" following a noun refers to the plural and / or singular form of that noun.

[0422] Conditional expressions such as "can," "could," "might," or "may," unless otherwise specified or understood otherwise within the context of use, are generally intended to convey that certain features, elements, and / or steps are included in particular examples and not included in other examples. Thus, such conditional expressions generally do not imply that the features, elements, and / or steps are in any way required. Nor do they necessarily imply that one or more examples include logic for determining whether those features, elements, and / or steps are included in or should be performed in a particular example, with or without input or prompting from the user.

[0423] As used herein, terms indicating degree, such as "approximately," "about," "generally," "substantially," and the like, refer to a value, amount, or characteristic that approximates a stated value, amount, or characteristic that performs a desired function or achieves a desired result. For example, the terms "approximately," "about," "generally," and "substantially" can indicate an amount within ranges of less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated amount.

[0424] Any reference herein to patent specifications, other external documents, or other sources of information is generally for the purpose of providing a context for discussing features of the present invention, and unless otherwise specified, the reference to such external documents shall not be construed as an admission that such documents or such sources are prior art or form part of the general knowledge in the art in any jurisdiction.

[0425] In the above description, specific details are provided to provide a thorough understanding of the embodiments. However, those skilled in the art will understand that the embodiments may be practiced without such specific details. For example, software modules, functions, circuits, etc. may be shown in block diagrams to avoid obscuring the embodiments in unnecessary detail. In other instances, well-known modules, structures, and techniques may not be shown in detail to avoid obscuring the embodiments.

[0426] It should also be noted that the embodiments may be described as a process that is depicted as a flowchart, a flow diagram, a structure diagram, or a block diagram. While a flowchart may describe operations as a sequential process, many of the operations may be performed in parallel or concurrently. Additionally, the order of operations may be rearranged. A process terminates when the operations contained in the process are completed. A process may correspond to a method, a function, a procedure, a subroutine, a subprogram, etc. in a computer program. When a process corresponds to a function, its termination corresponds to the function's return to the calling function or the main function.

[0427] 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, laptop, notebook, tablet, smart TV, game console, or mobile device. The term "mobile device" includes, but is not limited to, wireless devices, mobile phones, smartphones, mobile communication devices, user communication devices, personal digital assistants, mobile handheld computers, laptop computers, wearable electronic devices such as smart watches and head-mounted devices, e-book readers, reading devices capable of reading electronic content, and / or other types of mobile devices (e.g., radio, infrared, short-range radio, cellular, etc.) that are typically carried by an individual and / or have some communication capability.

[0428] Aspects of the systems and methods described above can be operated or implemented on any machine or computer or server or electronic device having any type of special purpose computer, or specialized computer, or microprocessor, microcontroller, programmable controller, etc., or cloud-based platform, or other network of processors and / or servers, whether local or remote, or any combination of such devices.

[0429] Furthermore, embodiments may be implemented by hardware, software, firmware, middleware, microcode, or any combination thereof. When implemented in software, firmware, middleware, or microcode, the program code or code segments to perform the necessary tasks may be stored in a machine-readable medium such as a storage medium or other storage(s). A processor may perform the necessary tasks. A code segment may represent a procedure, a function, a subprogram, a program, a routine, a subroutine, a module, a software package, a class, or any combination of instructions, data structures, or program statements. A code segment may be coupled to another code segment or a hardware circuit by passing information, data, arguments, parameters, or memory contents. Information, arguments, parameters, data, etc. may be passed, forwarded, or transmitted via any suitable means including memory sharing, message passing, token passing, network transmission, etc.

[0430] In the above description, a storage medium may represent 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.

[0431] The various illustrative logic blocks, modules, circuits, elements, and / or components described in connection with the embodiments disclosed herein may be implemented or embodied as 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, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general-purpose processor may be a microprocessor, but may alternatively be any conventional processor, controller, microcontroller, circuit, and / or state machine. A processor may also be implemented as a combination of computing components, such as a DSP and a microprocessor, multiple microprocessors, a combination of one or more microprocessors and a DSP core, or other configuration.

[0432] The methods or algorithms described in connection with the embodiments disclosed herein may be embodied directly in hardware, in a software module executable by a processor, or in the form of a process unit, programming instructions, or other instructions, whether contained in a single device or distributed across multiple devices. A software module may reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, a hard disk, a removable disk, a CD-ROM, or any other form of storage medium known in the art. The storage medium may be coupled to the processor such that the processor can read information from, and write information to, the storage medium. Alternatively, the storage medium may be integral to the processor.

[0433] One or more of the illustrated components and functions may be retrofitted and / or combined into a single component or embodied in multiple components without departing from the scope of the disclosure. Also, additional elements or components may be added without departing from the scope of the disclosure. Furthermore, features described herein may be implemented in software, hardware, business methods, and / or combinations thereof.

[0434] In its various aspects, embodiments of the present disclosure may be embodied in computer-implemented processes, machines (such as electronic devices, or general-purpose computers, or other devices that provide a platform on which a computer program can run), processes performed by such machines, or articles of manufacture. Such articles may include computer program products or digital information products having stored thereon a computer-readable storage medium containing computer program instructions or computer-readable data, as well as processes and machines for making and using these articles of manufacture.

[0435] While the present disclosure has been described in the context of specific embodiments and examples, those skilled in the art will recognize that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as obvious modifications and equivalents thereof. Moreover, while several variations of the embodiments of the present disclosure have been shown and described in detail, other variations that are within the scope of the present disclosure will be readily apparent to those skilled in the art. It is also contemplated that various combinations or subcombinations of specific features and aspects of the embodiments may still fall within the scope of the present disclosure. For example, features described above in connection with one embodiment can be used with different embodiments described herein, and the combination will still fall within the scope of the present disclosure. It should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another to form various aspects of the embodiments of the present disclosure. Therefore, it is not intended that the scope of the disclosure herein be limited by the specific embodiments described above. Thus, unless otherwise specified or clearly incompatible, each embodiment of the present disclosure may include, in addition to its essential features described herein, one or more features described herein from each of the other embodiments of the invention disclosed herein.

[0436] The present disclosure may also be broadly described as consisting of the parts, elements, and features referred to or shown in the disclosure, individually or collectively, and any and all combinations of any two or more of said parts, elements, or features; and where specific integers that have known equivalents in the art to which the present disclosure pertains are referred to herein, such known equivalents are deemed to be incorporated herein as if individually defined.

[0437] It is understood that features, materials, properties, or groups described in connection with a particular aspect, embodiment, or example are also applicable to other aspects, embodiments, or examples described in this section or elsewhere in this specification, except where incompatible therewith. All features disclosed in this specification (including the accompanying claims, abstract, and drawings), and / or all steps of any method or process so disclosed, may be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. Protection is not limited to the details of the foregoing embodiments. Protection extends to any novel or novel combination of features disclosed in this specification (including the accompanying claims, abstract, and drawings), or any novel or novel combination of steps of any method or process so disclosed.

[0438] Furthermore, certain features that are described in this disclosure in the context of separate embodiments or examples can also be implemented in combination in a single embodiment or example. Conversely, various features that are described in the context of a single embodiment or example can also be implemented in multiple embodiments or examples separately or in any suitable subcombination. Furthermore, while features are described above as acting in a particular combination, in some cases, one or more features can be extracted from a claimed combination and that combination can be claimed as a subcombination or a variation of that subcombination.

[0439] Furthermore, while operations may be depicted in the figures or described in the specification in a particular order, such operations need not be performed in the particular order shown or sequentially to achieve desirable results, and not all operations need be performed. Other operations not depicted or described may be incorporated into example methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between described operations. Furthermore, in other embodiments, operations may be rearranged or reordered. Those skilled in the art will appreciate that in some embodiments, the steps actually taken in the illustrated and / or disclosed processes may differ from those depicted in the figures. In some embodiments, some of the steps described may be omitted, or other steps may be added. Furthermore, features and attributes of specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which are within the scope of the present disclosure. Additionally, the separation of various system components in the above-described embodiments should not be construed as requiring such separation in all embodiments, and it should be understood that the described components and system components may generally be integrated together in a single product or packaged in multiple products.

[0440] For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not all such advantages may necessarily be achieved in accordance with any particular embodiment. Thus, for example, one skilled in the art will recognize that the present disclosure may be embodied or implemented in a manner that achieves one advantage or advantages as taught herein, without necessarily achieving other advantages that may be taught or suggested herein.

[0441] The scope of the present disclosure is not intended to be limited by the specific disclosure of embodiments in this section or elsewhere herein, but may be defined by the claims presented in this section or elsewhere herein, or by claims presented in the future. 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 practice of this application, which examples are to be construed as non-exclusive.

Claims

1. 1. A method for controlling the flow rate of gas delivered to a patient, comprising: delivering gas to the patient via a patient interface at an operating flow rate; At intervals, receiving or determining a patient parameter indicative of the patient's respiratory rate based on data from one or more sensors; determining a respiratory rate status of the patient based on at least the patient parameters and the patient parameters received or determined at one or more previous intervals; determining whether to adjust or maintain the operating flow rate based on the state of the patient's respiratory rate; adjusting the operating flow rate incrementally based on the determination to adjust the operating flow rate; maintaining the operating flow rate at a current operating flow rate based on a determination to maintain the operating flow rate; A method comprising:

2. 10. The method of claim 1, further comprising delivering a flow of gas to the patient through the patient interface at an initial operating flow rate, the initial operating flow rate being determined based on one or more patient characteristics.

3. 3. The method of claim 1 or 2, wherein the intervals are spaced apart by variable periods, the variable periods being based on the state of at least the patient's respiratory rate.

4. 10. The method of any one of the preceding claims, wherein the one or more sensors comprise one or more sensors configured to be attached to or placed near the patient to measure a patient parameter indicative of the patient's respiratory rate.

5. 10. The method of any one of the preceding claims, wherein the step of receiving or determining a patient parameter indicative of the patient's respiratory rate comprises receiving data from the one or more sensors indicative of a time-averaged respiratory rate over a measurement period.

6. 6. The method of claim 5, wherein the at least one sensor stores a plurality of instantaneous measurements over the measurement period and calculates a time-averaged respiration rate.

7. 10. The method of any one of the preceding claims, wherein the step of determining the state of the patient's respiratory rate comprises comparing the patient parameters received or determined in a current interval with the patient parameters received or determined in one or more previous intervals.

8. 8. The method of claim 7, wherein the state of the patient's respiratory rate is related to a degree or amount of change between the patient parameters received or determined in the current interval and the patient parameters received or determined in one or more previous intervals based on the comparison.

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

10. 10. The method of claim 9, wherein the step of determining whether to adjust the operating flow rate comprises determining to adjust the operating flow rate based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

11. 11. The method of claim 9 or claim 10, wherein the step of determining whether to adjust or maintain the operating flow rate comprises determining to maintain the operating flow rate based on a state of the patient's respiratory rate indicating that the patient's respiratory rate is substantially stable.

12. 10. The method of any one of the preceding claims, wherein the step of determining whether to adjust or maintain the operating flow rate further comprises comparing the state of the patient's respiratory rate to one or more thresholds.

13. 11. The method of claim 10, wherein the step of incrementally adjusting the operating flow rate comprises incrementally increasing the operating flow rate based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

14. 14. The method of claim 13, wherein the increment is a variable increment, and the variable increment is based on the state of at least the patient's respiratory rate.

15. The method of claim 11 , wherein the step of maintaining the operating flow rate comprises maintaining the operating flow rate at a previous increment of the operating flow rate.

16. 10. The method of any one of the preceding claims, wherein the method is performed continuously over a treatment session.

17. 10. A method according to any one of the preceding claims, wherein the gas is delivered to the patient in conditions suitable to provide high flow therapy.

18. 10. The method of any one of the preceding claims, further comprising supplying a flow of gas to the patient via a patient interface at an operating oxygen concentration level.

19. The method further comprises, in the interval: determining whether to adjust or maintain the operating oxygen concentration level based on the state of the patient's respiratory rate; adjusting the operating oxygen concentration level incrementally based on the determination to adjust the operating oxygen concentration level; 20. The method of claim 18, further comprising: maintaining the operating oxygen concentration level at a current operating oxygen concentration level based on the determination to maintain the operating oxygen concentration level.

20. 1. A method for controlling operating parameters of gas delivered to a patient, comprising: delivering a flow of gas to the patient via a patient interface at an operating flow rate and an operating oxygen concentration level; At intervals, receiving or determining a patient parameter indicative of the patient's respiratory rate based on data from one or more sensors; determining a respiratory rate status of the patient based on at least the patient parameters and the patient parameters 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 state of the patient's respiratory rate; incrementally adjusting the operating flow rate based on the determination to adjust the operating flow rate; maintaining the operating flow rate based on a determination to maintain the operating flow rate; adjusting the operating oxygen concentration level incrementally based on the determination to adjust the operating oxygen concentration level; maintaining the operating oxygen concentration level at a current operating oxygen concentration level based on a determination to maintain the operating oxygen concentration level; A method comprising:

21. 1. A method for controlling operating parameters of gas delivered to a patient, comprising: delivering a flow of gas to the patient via a patient interface at an operating flow rate and an operating oxygen concentration level; At intervals, receiving or determining a patient parameter indicative of the patient's respiratory rate based on data from one or more sensors; determining a respiratory rate status of the patient based on at least the patient parameters and the patient parameters received or determined at one or more previous intervals; determining whether to adjust or maintain the operating flow rate based on the state of the patient's respiratory rate; incrementally adjusting the operating flow rate based on the determination to adjust the operating flow rate; maintaining the operating flow rate at a current operating flow rate based on the determination to maintain the operating flow rate; determining whether to adjust or maintain the operating oxygen concentration level based on the state of the patient's respiratory rate; adjusting the operating oxygen concentration level incrementally based on the determination to adjust the operating oxygen concentration level; maintaining the operating oxygen concentration level at a current operating oxygen concentration level based on a determination to maintain the operating oxygen concentration level; A method comprising:

22. 22. The method of claim 20 or 21, further comprising delivering a flow of gas to the patient through a patient interface at an initial operating flow rate, the initial operating flow rate being determined based on one or more patient characteristics.

23. 23. The method of any one of claims 20-22, further comprising delivering a flow of gas to the patient via a patient interface at an initial operating oxygen concentration level, the initial operating oxygen concentration level being determined based on one or more patient characteristics.

24. 24. The method of any one of claims 20 to 23, wherein said intervals are spaced apart by variable periods, said variable periods being based on said state of at least said patient's respiratory rate.

25. 25. The method of any one of claims 20-24, wherein the one or more sensors comprise one or more sensors configured to be attached to or placed near the patient to measure a patient parameter indicative of the patient's respiratory rate.

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

27. 27. The method of claim 26, wherein the at least one sensor stores a plurality of instantaneous measurements over the measurement period and calculates a time-averaged respiration rate.

28. 28. The method of any one of claims 20 to 27, wherein the step of determining the state of the patient's respiratory rate comprises comparing the patient parameters received or determined in a current interval with the patient parameters received or determined in one or more previous intervals.

29. 29. The method of claim 28, wherein the state of the patient's respiratory rate is related to a degree or amount of change between the patient parameters received or determined in the current interval and the patient parameters received or determined in one or more previous intervals based on the comparison.

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

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

32. 32. The method of claim 30 or claim 31, wherein the step of determining whether to adjust or maintain the operating flow rate comprises determining to maintain the operating flow rate based on a state of the patient's respiratory rate indicating that the patient's respiratory rate is substantially stable.

33. 33. The method of any one of claims 20-32, wherein determining whether to adjust or maintain the operating flow rate and / or the operating oxygen concentration level further comprises comparing the state of the patient's breathing to one or more thresholds.

34. 32. The method of claim 31 , wherein the step of incrementally adjusting the operating flow rate comprises incrementally increasing the operating flow rate based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

35. 35. The method of claim 34, wherein the increment is a variable increment, and the variable increment is based on the state of at least the patient's respiratory rate.

36. 33. The method of claim 32, wherein the step of maintaining the operating flow rate comprises maintaining the operating flow rate at a previous increment of the operating flow rate.

37. 37. The method of any one of claims 20 to 36, wherein the method is performed continuously over a treatment session.

38. A method according to any one of claims 20 to 37, wherein the gas is delivered to the patient in conditions suitable to provide high flow therapy.

39. 1. A method for controlling the flow rate of gas delivered to a patient, comprising: delivering gas to the patient via a patient interface at an operating flow rate; At intervals, progressively applying a plurality of flow rate values ​​as the operating flow rate; receiving or determining, at each of the plurality of flow rates, a patient parameter indicative of the patient's respiratory rate based on data received from one or more sensors; determining a respiratory rate status of the patient based on at least the patient parameters and the patient parameters received or determined at one or more previous intervals; maintaining the operating flow rate based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is stable; continuing to receive or determine the patient parameters and performing an iterative process of determining the status of the patient's respiratory rate at further intervals; adjusting the operating flow rate for the further interval based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is no longer stable until the condition of the patient's respiratory rate indicates that the patient's respiratory rate is stable; A method comprising:

40. 40. The method of claim 39, wherein 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 time period after adjusting the operating flow rate.

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

42. 42. The method of any one of claims 39-41, wherein the condition of the patient's respiratory rate indicates that the patient's respiratory rate is no longer stable comprises determining that the condition of the patient's respiratory rate is out of range or outside a threshold.

43. 43. The method of any one of claims 39 to 42, further comprising delivering a flow of gas to the patient through a patient interface at an initial operating flow rate, the initial flow rate being determined based on one or more patient characteristics.

44. 44. The method of any one of claims 39 to 43, wherein said intervals are spaced apart by variable periods, said variable periods being based on said state of at least said patient's respiratory rate.

45. 45. The method of any one of claims 39 to 44, wherein the one or more sensors comprise one or more sensors configured to be attached to or placed near the patient to measure a patient parameter indicative of the patient's respiratory rate.

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

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

48. 48. The method of any one of claims 39 to 47, wherein the step of determining the state of the patient's respiratory rate comprises comparing the patient parameters received or determined in a current interval with the patient parameters received or determined in one or more previous intervals.

49. 49. The method of claim 48, wherein the state of the patient's respiratory rate is related to a degree or amount of change between the patient parameters received or determined in the current interval and the patient parameters received or determined in one or more previous intervals based on the comparison.

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

51. 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. A method according to any one of claims 39 to 51, wherein the step of progressively applying a plurality of flow rate values ​​as the operating flow rate comprises increasing the operating flow rate by an increment at each interval.

53. 53. The method of claim 52, wherein the increment is a variable increment, and the variable increment is based on the state of at least the patient's respiratory rate.

54. A method according to any one of claims 39 to 53, wherein the step of maintaining the operating flow rate comprises maintaining the operating flow rate at a previous incremental operating flow rate.

55. 55. The method of any one of claims 39 to 54, wherein the method is performed continuously over a treatment session.

56. 56. A method according to any one of claims 39 to 55, wherein the gas is delivered to the patient in conditions suitable to provide high flow therapy.

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

58. In said interval, determining whether to adjust or maintain the operating oxygen concentration level based on the patient parameter indicative of at least the patient's respiratory rate; adjusting the operating oxygen concentration level incrementally based on the determination to adjust the operating oxygen concentration level; 58. The method of claim 57, further comprising: based on the determination to maintain the operating oxygen concentration level, maintaining the operating oxygen concentration level at a current operating oxygen concentration level.

59. 1. A respiratory therapy system configured to provide a flow of gas to a patient for respiratory therapy, comprising: a patient interface configured to deliver a flow of gas to the patient; a flow generator configured to generate the flow of gas to the patient at an operating flow rate; one or more sensors configured to measure a patient parameter indicative of the patient's respiratory rate; a controller configured to control operation of the flow generator, the controller at intervals: receiving or determining a patient parameter indicative of the patient's respiratory rate based on data from one or more sensors; determining a respiratory rate status of the patient based on at least the patient parameters and the patient parameters received or determined at one or more previous intervals; determining whether to adjust or maintain the operating flow rate based on the state of the patient's respiratory rate; adjusting the operating flow rate incrementally based on the determination to adjust the operating flow rate; maintaining the operating flow rate at a current operating flow rate based on the determination to maintain the operating flow rate. Respiratory therapy systems.

60. 1. A respiratory apparatus configured to provide a flow of gas to a patient for respiratory therapy, comprising: a flow generator configured to generate the flow of gas to the patient at an operating flow rate; a controller configured to control operation of the flow generator, the controller at intervals: receiving or determining a patient parameter indicative of the patient's respiratory rate based on data from one or more sensors; determining a respiratory rate status of the patient based on at least the patient parameters and the patient parameters received or determined at one or more previous intervals; determining whether to adjust or maintain the operating flow rate based on the state of the patient's respiratory rate; adjusting the operating flow rate incrementally based on the determination to adjust the operating flow rate; maintaining the operating flow rate at a current operating flow rate based on the determination to maintain the operating flow rate. breathing apparatus.

61. 1. A respiratory therapy system configured to provide a flow of gas to a patient for respiratory therapy, comprising: a patient interface configured to deliver a flow of gas to the patient; a flow generator configured to generate the flow of gas to the patient at an operating flow rate; one or more sensors configured to measure a patient parameter indicative of the patient's respiratory rate; a controller configured to control operation of the flow generator, the controller at intervals: receiving or determining a patient parameter indicative of the patient's respiratory rate based on data from one or more sensors; determining a respiratory rate status of the patient based on at least the patient parameters and the patient parameters 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 state of the patient's respiratory rate; incrementally adjusting the operating flow rate based on the determination to adjust the operating flow rate; maintaining the operating flow rate based on a determination to maintain the operating flow rate; adjusting the operating oxygen concentration level incrementally based on the determination to adjust the operating oxygen concentration level; maintaining the operating oxygen concentration level at a current operating oxygen concentration level based on the determination to maintain the operating oxygen concentration level. Respiratory therapy systems.

62. 1. A respiratory apparatus configured to provide a flow of gas to a patient for respiratory therapy, comprising: a flow generator configured to generate the flow of gas to the patient at an operating flow rate; a controller configured to control operation of the flow generator, the controller at intervals: receiving or determining a patient parameter indicative of the patient's respiratory rate based on data from one or more sensors; determining a respiratory rate status of the patient based on at least the patient parameters and the patient parameters 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 state of the patient's respiratory rate; incrementally adjusting the operating flow rate based on the determination to adjust the operating flow rate; maintaining the operating flow rate based on a determination to maintain the operating flow rate; adjusting the operating oxygen concentration level incrementally based on the determination to adjust the operating oxygen concentration level; maintaining the operating oxygen concentration level at a current operating oxygen concentration level based on the determination to maintain the operating oxygen concentration level. breathing apparatus.

63. 1. A respiratory therapy system configured to provide a flow of gas to a patient for respiratory therapy, comprising: a patient interface configured to deliver a flow of gas to the patient; a flow generator configured to generate the flow of gas to the patient at an operating flow rate; one or more sensors configured to measure a patient parameter indicative of the patient's respiratory rate; a controller configured to control operation of the flow generator, the controller at intervals: receiving or determining a patient parameter indicative of the patient's respiratory rate based on data from one or more sensors; determining a respiratory rate status of the patient based on at least the patient parameters and the patient parameters received or determined at one or more previous intervals; determining whether to adjust or maintain the operating flow rate based on the state of the patient's respiratory rate; incrementally adjusting the operating flow rate based on the determination to adjust the operating flow rate; maintaining the operating flow rate at a current operating flow rate based on the determination to maintain the operating flow rate; determining whether to adjust or maintain the operating oxygen concentration level based on the state of the patient's respiratory rate; adjusting the operating oxygen concentration level incrementally based on the determination to adjust the operating oxygen concentration level; maintaining the operating oxygen concentration level at a current operating oxygen concentration level based on the determination to maintain the operating oxygen concentration level. Respiratory therapy systems.

64. 1. A respiratory apparatus configured to provide a flow of gas to a patient for respiratory therapy, comprising: a flow generator configured to generate the flow of gas to the patient at an operating flow rate; a controller configured to control operation of the flow generator, the controller at intervals: receiving or determining a patient parameter indicative of the patient's respiratory rate based on data from one or more sensors; determining a respiratory rate status of the patient based on at least the patient parameters and the patient parameters received or determined at one or more previous intervals; determining whether to adjust or maintain the operating flow rate based on the state of the patient's respiratory rate; incrementally adjusting the operating flow rate based on the determination to adjust the operating flow rate; maintaining the operating flow rate at a current operating flow rate based on the determination to maintain the operating flow rate; determining whether to adjust or maintain the operating oxygen concentration level based on the state of the patient's respiratory rate; adjusting the operating oxygen concentration level incrementally based on the determination to adjust the operating oxygen concentration level; maintaining the operating oxygen concentration level at a current operating oxygen concentration level based on the determination to maintain the operating oxygen concentration level. breathing apparatus.

65. 1. A respiratory therapy system configured to provide a flow of gas to a patient for respiratory therapy, comprising: a patient interface configured to deliver a flow of gas to the patient; a flow generator configured to generate the flow of gas to the patient at an operating flow rate; one or more sensors configured to measure a patient parameter indicative of the patient's respiratory rate; a controller configured to control operation of the flow generator, the controller at intervals: progressively applying a plurality of flow rate values ​​as the operating flow rate; receiving or determining, at each of the plurality of flow rates, a patient parameter indicative of the patient's respiratory rate based on data received from one or more sensors; determining a respiratory rate status of the patient based on at least the patient parameters and the patient parameters received or determined at one or more previous intervals; maintaining the operating flow rate based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is stable; continuing to receive or determine the patient parameters and performing an iterative process of determining the status of the patient's respiratory rate at further intervals; adjusting the operating flow rate for the further interval based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is no longer stable, until the condition of the patient's respiratory rate indicates that the patient's respiratory rate is stable. Respiratory therapy systems.

66. 1. A respiratory apparatus configured to provide a flow of gas to a patient for respiratory therapy, comprising: a flow generator configured to generate the flow of gas to the patient at an operating flow rate; a controller configured to control operation of the flow generator, the controller at intervals: progressively applying a plurality of flow rate values ​​as the operating flow rate; receiving or determining, at each of the plurality of flow rates, a patient parameter indicative of the patient's respiratory rate based on data received from one or more sensors; determining a respiratory rate status of the patient based on at least the patient parameters and the patient parameters received or determined at one or more previous intervals; maintaining the operating flow rate based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is stable; continuing to receive or determine the patient parameters and performing an iterative process of determining the status of the patient's respiratory rate at further intervals; adjusting the operating flow rate for the further interval based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is no longer stable, until the condition of the patient's respiratory rate indicates that the patient's respiratory rate is stable. breathing apparatus.

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

68. 68. A respiratory therapy system or breathing apparatus according to any one of claims 59 to 67, wherein said intervals are spaced apart by variable periods, said variable periods being based on said state of at least said patient's respiratory rate.

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

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

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

72. 72. A respiratory therapy system or breathing apparatus according to any one of claims 59 to 71, wherein the step of determining the state of the patient's respiratory rate comprises comparing the patient parameters received or determined in a current interval with the patient parameters received or determined in one or more previous intervals.

73. 73. A respiratory therapy system or breathing apparatus as described in claim 72, wherein the status of the patient's respiratory rate relates to a degree or amount of change between the patient parameters received or determined in the current interval and the patient parameters received or determined in one or more previous intervals based on the comparison.

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

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

76. 76. The respiratory therapy system or breathing apparatus of claim 74 or claim 75, wherein the step of determining whether to adjust or maintain the operating flow rate includes determining to maintain the operating flow rate based on a state of the patient's respiratory rate indicating that the patient's respiratory rate is substantially stable.

77. 77. A respiratory therapy system or breathing apparatus according to any one of claims 59 to 76, wherein the step of determining whether to adjust or maintain the operating flow rate further comprises comparing the state of the patient's respiratory rate to one or more thresholds.

78. 76. The respiratory therapy system or breathing apparatus of claim 75, wherein the step of incrementally adjusting the operating flow rate comprises incrementally increasing the operating flow rate based on the condition of the patient's respiratory rate indicating that the patient's respiratory rate is decreasing.

79. 79. The respiratory therapy system or breathing apparatus of claim 78, wherein the increments are variable increments, and the variable increments are based on the state of at least the patient's respiratory rate.

80. 77. The respiratory therapy system or breathing apparatus of claim 76, wherein the step of maintaining the operating flow rate includes maintaining the operating flow rate at the previous increment of the operating flow rate.

81. 81. A respiratory therapy system or breathing apparatus according to any one of claims 59 to 80, wherein said steps are performed continuously at said intervals over a treatment session.

82. 82. A respiratory therapy system or breathing apparatus according to any one of claims 59 to 81, wherein the gas is delivered to the patient in conditions suitable to provide high flow therapy.

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

84. 84. The respiratory therapy system or breathing 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, the initial operating oxygen concentration level being determined based on one or more patient characteristics.

85. The controller, during the interval: determining whether to adjust or maintain the operating oxygen concentration level based on the state of the patient's respiratory rate; adjusting the operating oxygen concentration level incrementally based on the determination to adjust the operating oxygen concentration level; 85. The respiratory therapy system or breathing apparatus of any one of claims 59 to 84, further configured to: maintain the operating oxygen concentration level at a current operating oxygen concentration level based on a determination to maintain the operating oxygen concentration level.

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

87. A respiratory therapy system or respiratory device as described in any one of claims 59 to 86, wherein the system or device further includes a non-transitory computer readable medium accessible to or in data communication with the controller, preferably the non-transitory computer readable medium including a non-volatile memory having computer executable instructions stored thereon, the computer executable instructions, when executed on the controller or processing device(s), causing the controller or processing device(s) to implement or perform one or more steps or methods or aspects described in any one of claims 59 to 86.

88. 1. A respiratory therapy system configured to provide a flow of gas to a patient for respiratory therapy, 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 to the patient at an operating flow rate; one or more sensors configured to measure a patient parameter indicative of the patient's respiratory rate; a controller, the controller comprising: receiving or determining a patient parameter indicative of a respiratory rate of the patient based on data received from the one or more sensors; configured to control the operating flow rate of the flow generator based on the received or determined patient parameter indicative of the patient's respiratory rate. Respiratory therapy systems.

89. 1. A method for controlling the flow rate of gas delivered to a patient, comprising: delivering gas to the patient via a patient interface at an operating flow rate; At intervals, receiving or determining a patient parameter indicative of the patient's respiratory rate based on data from one or more patient-contacting sensors; determining whether to adjust or maintain the operating flow rate based on comparing the patient parameter indicative of at least the patient's respiratory rate to one or more thresholds; adjusting the operating flow rate incrementally based on the determination to adjust the operating flow rate; maintaining the operating flow rate at a current operating flow rate based on a determination to maintain the operating flow rate; A method comprising:

90. 1. A respiratory therapy system configured to provide a flow of gas to a patient for respiratory therapy, 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 to the patient at an operating flow rate; one or more patient-contacting sensors configured to measure a patient parameter indicative of the patient's respiratory rate; a controller, the controller comprising: receiving or determining a patient parameter indicative of a patient's respiratory rate based on data from the one or more patient-contact sensors; determining whether to adjust or maintain the operating flow rate based on comparing the patient parameter indicative of at least the patient's respiratory rate to one or more thresholds; adjusting the operating flow rate incrementally based on the determination to adjust the operating flow rate; maintaining the operating flow rate at a current operating flow rate based on the determination to maintain the operating flow rate. Respiratory therapy systems.

91. 1. A method for controlling the flow rate of gas delivered to a patient, comprising: delivering gas to the patient via a patient interface at an operating flow rate; 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 operating flow rate based on comparing the patient parameter indicative of at least the patient's respiratory rate to one or more thresholds; adjusting the operating flow rate incrementally based on the determination to adjust the operating flow rate; maintaining the operating flow rate at a current operating flow rate based on a determination to maintain the operating flow rate; A method comprising:

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

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

94. 94. The method of claim 92 or claim 93, wherein the method further comprises receiving or determining a therapy parameter indicative of the FiO2 provided or to be provided to the patient.

95. 94. The method of claim 93, wherein the therapy parameter indicative of an FiO2 provided or to be provided to the patient is based at least in part on the patient parameter indicative of an SpO2 of the patient.

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

97. 97. The method of any one of claims 91 to 96, wherein the one or more thresholds comprise one or more parameter thresholds, each of the one or more parameter thresholds relating to a patient or treatment parameter.

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

99. 98. The method of claim 97, wherein the parameter threshold relates to a maximum allowable respiratory rate.

100. 100. The method of any one of claims 97 to 99, wherein the one or more thresholds further comprise a time-based threshold.

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

102. 102. The method of claim 101, wherein the time-based threshold relates to a minimum amount of time that the patient parameter exceeds the patient parameter threshold.

103. A method according to any one of claims 91 to 102, wherein the increment in the operating flow rate to be adjusted is an increase in the operating flow rate.

104. 104. The method of claim 103, wherein the increment is an absolute or fixed amount.

105. 104. The method of claim 103, wherein the increment is a percentage or fraction of the operating flow rate.

106. A method according to any one of claims 103 to 105, wherein the increment in the operating flow rate is set by a user.

107. A method according to any one of claims 91 to 106, wherein adjusting the operating flow rate in increments comprises changing the operating flow rate in step changes.

108. The method of any one of claims 91 to 106, wherein adjusting the operating flow rate in increments comprises ramping the operating flow rate.

109. 109. The method of any one of claims 91 to 108, wherein if adjusting the operating flow rate by the increment, the method further comprises displaying a prompt or alert to a user indicating that the operating flow rate has been adjusted.

110. 110. The method of claim 109, further comprising presenting an audible alarm to the user indicating that the operating flow rate has been adjusted.

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

112. 1. A respiratory therapy system configured to provide a flow of gas to a patient for respiratory therapy, comprising: a patient interface configured to deliver a flow of gas to the patient; a flow generator configured to generate the flow of gas to the patient at an operating flow rate; one or more sensors configured to measure a patient parameter indicative of the patient's respiratory rate; a controller configured to control operation of the flow generator, the controller 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 operating flow rate based on comparing the patient parameter indicative of at least the patient's respiratory rate to one or more thresholds; adjusting the operating flow rate incrementally based on the determination to adjust the operating flow rate; maintaining the operating flow rate at a current operating flow rate based on the determination to maintain the operating flow rate. Respiratory therapy systems.

Images