respiratory system

Abstract

The present invention relates to a respiratory system. Systems and methods for performing respiratory therapy in a respiratory system can regulate the flow of respiratory gases to a patient based on a detected patient respiratory cycle. The respiratory system can include a non-sealing patient interface. The respiratory system can be configured to deliver high flow therapy. The system can synchronize the flow rate with the detected patient respiratory cycle. The magnitude of the flow rate variation can be based in part on a user-selected value. The regulation of the flow rate can be accomplished by using a positive feedback system to control the motor speed. The regulation of the flow rate can also be limited by the controller, thereby preventing the flow rate from crossing minimum and / or maximum thresholds.

Description

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of application No. 2020800152900, filed February 21, 2020, entitled “Adjustable Exhalation Relief in Respiratory Therapy,” which claims priority to provisional application US 62 / 809099, filed February 22, 2019, the entire contents of which are incorporated herein by reference.) TECHNICAL FIELD

[0002] The present disclosure relates to methods and systems for flow therapy using a flow therapy device to deliver gas to a patient. This application claims priority to provisional application US 62 / 809099, filed February 22, 2019, the entire contents of which are incorporated herein by reference. BACKGROUND

[0003] Respiratory assistance devices are used to deliver a flow of gas to a user or patient in various environments, such as a hospital, medical facility, inpatient care, or home environment. Respiratory assistance devices or flow therapy devices can include a humidification device for delivering heated and humidified gas. The device can optionally include a valve for delivering oxygen with the flow of gas. The flow therapy device can allow for adjustment and control of the characteristics of the flow of gas, including flow rate, temperature, gas concentration, humidity, pressure, etc. Sensors, such as heated temperature sensing elements and / or thermistors, are used to measure these properties of the gas. SUMMARY

[0004] The flow of respiratory gas in a flow therapy device can be adjusted based on a detected patient breathing cycle. The flow of gas can be adjusted such that the flow delivered during exhalation is lower than the flow delivered during inhalation. The adjustment can improve the comfort of the patient. The system can synchronize the flow rate with the detected patient breathing cycle. The magnitude of the change in flow rate can be based in part on a value selected by a user. The flow rate can be adjusted by using a positive feedback system to control the motor speed. The adjustment of the flow rate can also be limited by a controller, preventing the flow rate from crossing minimum and / or maximum thresholds that can vary. The motor speed can be adjusted, i.e., positively fed back, which can cause the adjustment of the flow rate.

[0005] The threshold(s) or limit(s) can ensure that the device maintains at least a minimum flow rate to the patient at all times when the patient is exhaling, while also providing an exhalation flow relief. The maintenance threshold can ensure that the flow rate does not exceed clinically relevant or effective values and / or safety limits for respiratory therapy, in particular for high flow therapy. The user of the device, such as a clinician and / or patient, can also adjust the value of the change in flow rate. The user adjustment can allow the user to select a value of flow relief that the patient finds most comfortable.

[0006] In one arrangement, a respiratory system for delivering respiratory therapy to a patient, the system configured to regulate a flow rate of gas delivered to the patient in accordance with a patient inspiration and expiration cycle, the respiratory system can include a flow generator configured to generate a flow rate of gas; a controller in electrical communication with one or more sensors and configured to: determine the patient inspiration and expiration cycle based on information received from the one or more sensors; and regulate the flow rate of gas based in part on the patient inspiration and expiration cycle, wherein the regulation is attenuated by a parameter determined based in part on a maximum and / or minimum flow rate measured by the one or more sensors during the patient inspiration and expiration cycle.

[0007] In one arrangement, the flow generator can include a motor.

[0008] In one arrangement, the flow rate is regulated by outputting a motor control signal.

[0009] In one arrangement, the motor can include a brushless direct current motor.

[0010] In one arrangement, the patient inspiration and expiration cycle can be determined based on a first input and a second input received by the controller, the first input and the second input relating to a gas flow characteristic or a performance of a component of the system.

[0011] In one arrangement, the first input can correspond to a flow rate from the one or more sensors.

[0012] In one arrangement, the second input can correspond to a pressure of the gas flow from the one or more sensors. In one arrangement, the second input can correspond to a speed of the motor.

[0013] In one arrangement, the speed of the motor can be determined based at least in part on one or more motor parameters.

[0014] In one arrangement, the maximum and / or minimum flow rate measured by the one or more sensors can be an unregulated response to the patient inspiration and expiration.

[0015] In one arrangement, the regulation can be further attenuated by comparing the maximum and / or minimum flow rate measured by the one or more sensors to a maximum and / or minimum threshold.

[0016] In one arrangement, the maximum and / or minimum flow rate measured by the one or more sensors can be gradually limited by a negative feedback term.

[0017] In one arrangement, the parameter can include the negative feedback term, which can gradually increase in response to the measured maximum and / or minimum flow rate until the measured maximum and / or minimum flow rate no longer exceeds the maximum and / or minimum threshold.

[0018] In one configuration, the maximum and / or minimum threshold can be set by a user.

[0019] In one configuration, the system includes a user interface configured to receive user input to adjust the maximum and / or minimum threshold.

[0020] In one configuration, the maximum and / or minimum threshold can be a clinically relevant limit for respiratory therapy.

[0021] In one configuration, the minimum threshold can be between 0-5 lpm. In one configuration, the minimum threshold can be between 5-10 lpm. In one configuration, the minimum threshold can be between 10-15 lpm. In one configuration, the minimum threshold can be between 15-20 lpm. In one configuration, the minimum threshold can be between 20-25 lpm. In one configuration, the minimum threshold can be between 25-30 lpm. In one configuration, the minimum threshold can be between 30-35 lpm. In one configuration, the minimum threshold can be between 35-40 lpm. In one configuration, the minimum threshold can be between 40-45 lpm. In one configuration, the minimum threshold can be between 45-50 lpm. In one configuration, the minimum threshold can be between 50-55 lpm. In one configuration, the minimum threshold can be between 55-60 lpm.

[0022] In one configuration, the maximum threshold can be between 20-25 lpm. In one configuration, the maximum threshold can be between 25-30 lpm. In one configuration, the maximum threshold can be between 30-35 lpm. In one configuration, the maximum threshold can be between 35-40 lpm. In one configuration, the maximum threshold can be between 40-45 lpm. In one configuration, the maximum threshold can be between 45-50 lpm. In one configuration, the maximum threshold can be between 50-55 lpm. In one configuration, the maximum threshold can be between 55-60 lpm. In one configuration, the maximum threshold can be between 60-65 lpm. In one configuration, the maximum threshold can be between 65-70 lpm. In one configuration, the maximum threshold can be between 70-75 lpm. In one configuration, the maximum threshold can be between 75-80 lpm. In one configuration, the maximum threshold can be between 80-85 lpm. In one configuration, the maximum threshold can be between 85-90 lpm. In one configuration, the maximum threshold can be between 90-95 lpm. In one configuration, the maximum threshold can be between 95-100 lpm.

[0023] In one configuration, the maximum and / or minimum threshold can be a safety limit for respiratory therapy.

[0024] In one configuration, the maximum and / or minimum threshold can depend on a selected flow rate.

[0025] In one configuration, the maximum and / or minimum threshold can be a predetermined percentage or value above and below a selected flow rate.

[0026] In one configuration, the maximum and / or minimum threshold can depend on a selected flow rate and a selected breath synchronization setting.

[0027] In one configuration, the system can include a user interface configured to receive user input to adjust the breath synchronization setting.

[0028] In one configuration, the breath synchronization setting can include a range of numbers. In one configuration, the breath synchronization setting can include a plurality of categories, the plurality of categories including at least a low setting and a high setting.

[0029] In one configuration, the maximum and / or minimum threshold can be a predetermined percentage or value above and below a selected flow rate, the percentage or value varying based on a selected breath synchronization setting.

[0030] In one configuration, the adjustment can be performed repeatedly.

[0031] In one configuration, the adjustment can include an increase in flow rate when the patient is inhaling.

[0032] In one configuration, the adjustment can include a decrease in flow rate when the patient is exhaling.

[0033] In one configuration, the one or more sensors can include an ultrasonic transducer assembly.

[0034] In one configuration, the one or more sensors can include a heated temperature sensing element.

[0035] In one configuration, the system can be a high flow respiratory system.

[0036] In one configuration, the system can include a non-sealing patient interface.

[0037] In one configuration, the non-sealing patient interface can include a non-sealing nasal cannula.

[0038] In one arrangement, a respiratory system for delivering respiratory therapy to a patient, the system configured to regulate a flow rate of gas delivered to the patient in accordance with a patient inspiration and expiration cycle, the respiratory system can include a flow generator configured to generate a flow rate of gas; and a controller in electrical communication with one or more sensors and configured to: determine the patient inspiration and expiration cycle based on information received from the one or more sensors; and regulate the flow rate based in part on the patient inspiration and expiration cycle, wherein the regulation can be attenuated by comparing a maximum and / or minimum flow rate measured by the one or more sensors to a maximum and / or minimum threshold.

[0039] In one arrangement, the flow generator can include a motor.

[0040] In one arrangement, the flow rate is regulated by outputting a motor control signal.

[0041] In one arrangement, the motor can include a brushless direct current motor.

[0042] In one arrangement, the patient inspiration and expiration cycle can be determined based on a first input and a second input received by the controller, the first input and the second input relating to a gas flow characteristic or a performance of a component of the system.

[0043] In one arrangement, the first input can correspond to a flow rate from the one or more sensors.

[0044] In one arrangement, the second input can correspond to a pressure of the gas flow from the one or more sensors. In one arrangement, the second input can correspond to a speed of the motor.

[0045] In one arrangement, the speed of the motor can be determined based at least in part on one or more motor parameters.

[0046] In one arrangement, the maximum and / or minimum threshold can be set by a user.

[0047] In one arrangement, the system includes a user interface configured to receive user input to adjust the maximum and / or minimum threshold.

[0048] In one arrangement, the maximum and / or minimum threshold can be a clinically relevant limit of the respiratory therapy.

[0049] In one configuration, the minimum threshold can be between 0-5 lpm. In one configuration, the minimum threshold can be between 5-10 lpm. In one configuration, the minimum threshold can be between 10-15 lpm. In one configuration, the minimum threshold can be between 15-20 lpm. In one configuration, the minimum threshold can be between 20-25 lpm. In one configuration, the minimum threshold can be between 25-30 lpm. In one configuration, the minimum threshold can be between 30-35 lpm. In one configuration, the minimum threshold can be between 35-40 lpm. In one configuration, the minimum threshold can be between 40-45 lpm. In one configuration, the minimum threshold can be between 45-50 lpm. In one configuration, the minimum threshold can be between 50-55 lpm. In one configuration, the minimum threshold can be between 55-60 lpm.

[0050] In one configuration, the maximum threshold can be between 20-25 lpm. In one configuration, the maximum threshold can be between 25-30 lpm. In one configuration, the maximum threshold can be between 30-35 lpm. In one configuration, the maximum threshold can be between 35-40 lpm. In one configuration, the maximum threshold can be between 40-45 lpm. In one configuration, the maximum threshold can be between 45-50 lpm. In one configuration, the maximum threshold can be between 50-55 lpm. In one configuration, the maximum threshold can be between 55-60 lpm. In one configuration, the maximum threshold can be between 60-65 lpm. In one configuration, the maximum threshold can be between 65-70 lpm. In one configuration, the maximum threshold can be between 70-75 lpm. In one configuration, the maximum threshold can be between 75-80 lpm. In one configuration, the maximum threshold can be between 80-85 lpm. In one configuration, the maximum threshold can be between 85-90 lpm. In one configuration, the maximum threshold can be between 90-95 lpm. In one configuration, the maximum threshold can be between 95-100 lpm.

[0051] In one configuration, the maximum and / or minimum threshold can be a safety limit for respiratory therapy.

[0052] In one configuration, the maximum and / or minimum threshold can depend on a selected flow rate.

[0053] In one configuration, the maximum and / or minimum threshold can be a predetermined percentage or value above and below a selected flow rate.

[0054] In one configuration, the maximum and / or minimum threshold can depend on a selected flow rate and a selected respiratory synchronization setting.

[0055] In one configuration, the system can include a user interface configured to receive user input to adjust the breath synchronization setting.

[0056] In one configuration, the breath synchronization setting can include a series of numbers. In one configuration, the breath synchronization setting can include a plurality of categories, the plurality of categories including at least a low setting and a high setting.

[0057] In one configuration, the maximum and / or minimum threshold can be a predetermined percentage or value above and below the selected flow rate, the percentage or value varying based on the selected breath synchronization setting.

[0058] In one configuration, the adjusting can be performed repeatedly.

[0059] In one configuration, each adjustment can be limited by a parameter determined based in part on the maximum and / or minimum flow rate measured by the one or more sensors.

[0060] In one configuration, the maximum and / or minimum flow rate measured by the one or more sensors can be an unrestricted response to patient inhalation and exhalation.

[0061] In one configuration, the maximum and / or minimum flow rate measured by the one or more sensors can be gradually limited by a negative feedback term.

[0062] In one configuration, the parameter can include the negative feedback term, the negative feedback term can gradually increase in response to the measured maximum and / or minimum flow rate until the measured maximum and / or minimum flow rate no longer exceeds the maximum and / or minimum threshold.

[0063] In one configuration, the adjusting can include an increase in flow rate when the patient is inhaling.

[0064] In one configuration, the adjusting can include a decrease in flow rate when the patient is exhaling.

[0065] In one configuration, the one or more sensors can include an ultrasonic transducer assembly.

[0066] In one configuration, the one or more sensors can include a heated temperature sensing element.

[0067] In one configuration, the system can be a high flow respiratory system.

[0068] In one configuration, the system can include a non-sealing patient interface.

[0069] In one configuration, the non-sealing patient interface can include a non-sealing nasal cannula.

[0070] In one arrangement, a method of regulating a flow rate of gas delivered to a patient using a respiratory system in accordance with inspiration and expiration of the patient, the respiratory system including a flow generator configured to generate the flow rate of gas, the method can include using a controller of the respiratory system: determining a cycle of inspiration and expiration of the patient based on information received from one or more sensors of the respiratory system; and regulating the flow rate based in part on the cycle of inspiration and expiration, wherein the regulation can be attenuated by a parameter determined based in part on a maximum and / or minimum flow rate measured by the one or more sensors during the cycle of inspiration and expiration.

[0071] In one arrangement, the flow generator can include a motor.

[0072] In one arrangement, the flow rate is regulated by outputting a motor control signal.

[0073] In one arrangement, the motor can include a brushless direct current motor.

[0074] In one arrangement, the determining can determine the cycle of inspiration and expiration of the patient based on a first input and a second input received by the controller, the first input and the second input relating to a gas flow characteristic or a performance of a component of the system.

[0075] In one arrangement, the first input can correspond to a flow rate from the one or more sensors.

[0076] In one arrangement, the second input can correspond to a pressure of the gas flow from the one or more sensors. In one arrangement, the second input can correspond to a speed of the motor.

[0077] In one arrangement, the method can further include determining a speed of the motor based at least in part on one or more motor parameters.

[0078] In one arrangement, the maximum and / or minimum flow rate measured by the one or more sensors can be an unregulated response to inspiration and expiration of the patient.

[0079] In one arrangement, the regulation can be further attenuated by comparing the maximum and / or minimum flow rate measured by the one or more sensors to a maximum and / or minimum threshold.

[0080] In one arrangement, the maximum and / or minimum flow rate measured by the one or more sensors can be gradually limited by a negative feedback term.

[0081] In one arrangement, the parameter can include the negative feedback term, which can gradually increase in response to the measured maximum and / or minimum flow rate until the measured maximum and / or minimum flow rate no longer exceeds the maximum and / or minimum threshold.

[0082] In one configuration, the maximum and / or minimum threshold can be set by a user.

[0083] In one configuration, the system includes a user interface configured to receive user input to adjust the maximum and / or minimum threshold.

[0084] In one configuration, the maximum and / or minimum threshold can be a clinically relevant limit for respiratory therapy.

[0085] In one configuration, the minimum threshold can be between 0-5 lpm. In one configuration, the minimum threshold can be between 5-10 lpm. In one configuration, the minimum threshold can be between 10-15 lpm. In one configuration, the minimum threshold can be between 15-20 lpm. In one configuration, the minimum threshold can be between 20-25 lpm. In one configuration, the minimum threshold can be between 25-30 lpm. In one configuration, the minimum threshold can be between 30-35 lpm. In one configuration, the minimum threshold can be between 35-40 lpm. In one configuration, the minimum threshold can be between 40-45 lpm. In one configuration, the minimum threshold can be between 45-50 lpm. In one configuration, the minimum threshold can be between 50-55 lpm. In one configuration, the minimum threshold can be between 55-60 lpm.

[0086] In one configuration, the maximum threshold can be between 20-25 lpm. In one configuration, the maximum threshold can be between 25-30 lpm. In one configuration, the maximum threshold can be between 30-35 lpm. In one configuration, the maximum threshold can be between 35-40 lpm. In one configuration, the maximum threshold can be between 40-45 lpm. In one configuration, the maximum threshold can be between 45-50 lpm. In one configuration, the maximum threshold can be between 50-55 lpm. In one configuration, the maximum threshold can be between 55-60 lpm. In one configuration, the maximum threshold can be between 60-65 lpm. In one configuration, the maximum threshold can be between 65-70 lpm. In one configuration, the maximum threshold can be between 70-75 lpm. In one configuration, the maximum threshold can be between 75-80 lpm. In one configuration, the maximum threshold can be between 80-85 lpm. In one configuration, the maximum threshold can be between 85-90 lpm. In one configuration, the maximum threshold can be between 90-95 lpm. In one configuration, the maximum threshold can be between 95-100 lpm.

[0087] In one configuration, the maximum and / or minimum threshold can be a safety limit for respiratory therapy.

[0088] In one configuration, the maximum and / or minimum threshold can depend on the selected flow rate.

[0089] In one configuration, the maximum and / or minimum threshold can be a predetermined percentage or value above and below the selected flow rate.

[0090] In one configuration, the maximum and / or minimum threshold can depend on the selected flow rate and a selected breath synchronization setting.

[0091] In one configuration, the system can include a user interface configured to receive user input to adjust the breath synchronization setting.

[0092] In one configuration, the breath synchronization setting can include a range of numbers. In one configuration, the breath synchronization setting can include a plurality of categories including at least a low setting and a high setting.

[0093] In one configuration, the maximum and / or minimum threshold can be a predetermined percentage or value above and below the selected flow rate, the percentage or value varying based on the selected breath synchronization setting.

[0094] In one configuration, the adjustment can be performed repeatedly.

[0095] In one configuration, the adjustment can include an increase in flow rate when the patient is inhaling.

[0096] In one configuration, the adjustment can include a decrease in flow rate when the patient is exhaling.

[0097] In one configuration, the one or more sensors can include an ultrasonic transducer assembly.

[0098] In one configuration, the one or more sensors can include a heated temperature sensing element.

[0099] In one configuration, the system can be a high flow respiratory system.

[0100] In one configuration, the system can include a non-sealing patient interface.

[0101] In one configuration, the non-sealing patient interface can include a non-sealing nasal cannula.

[0102] In one arrangement, a method of regulating a flow rate of gas delivered to a patient according to patient inhalation and exhalation using a respiratory system including a flow generator configured to generate a flow rate of gas, the method can include using a controller of the respiratory system: determining a cycle of patient inhalation and exhalation based on information received from the one or more sensors; and regulating the flow rate based at least in part on the cycle of patient inhalation and exhalation, wherein the regulation can be attenuated by comparing a maximum and / or minimum flow rate measured by the one or more sensors to a maximum and / or minimum threshold.

[0103] In one arrangement, the flow generator can include a motor.

[0104] In one arrangement, the flow rate is regulated by outputting a motor control signal.

[0105] In one arrangement, the motor can include a brushless direct current motor.

[0106] In one arrangement, the determining can determine the cycle of patient inhalation and exhalation based on a first input and a second input received by the controller, the first input and the second input relating to a gas flow characteristic or a performance of a component of the system.

[0107] In one arrangement, the first input can correspond to a flow rate from the one or more sensors.

[0108] In one arrangement, the second input can correspond to a pressure of the gas flow from the one or more sensors. In one arrangement, the second input can correspond to a speed of the motor.

[0109] In one arrangement, the method can further include determining a speed of the motor based at least in part on one or more motor parameters.

[0110] In one arrangement, the maximum and / or minimum threshold can be set by a user.

[0111] In one arrangement, the system includes a user interface configured to receive user input to regulate the maximum and / or minimum threshold.

[0112] In one arrangement, the maximum and / or minimum threshold can be a clinically relevant limit of respiratory therapy.

[0113] In one configuration, the minimum threshold can be between 0-5 lpm. In one configuration, the minimum threshold can be between 5-10 lpm. In one configuration, the minimum threshold can be between 10-15 lpm. In one configuration, the minimum threshold can be between 15-20 lpm. In one configuration, the minimum threshold can be between 20-25 lpm. In one configuration, the minimum threshold can be between 25-30 lpm. In one configuration, the minimum threshold can be between 30-35 lpm. In one configuration, the minimum threshold can be between 35-40 lpm. In one configuration, the minimum threshold can be between 40-45 lpm. In one configuration, the minimum threshold can be between 45-50 lpm. In one configuration, the minimum threshold can be between 50-55 lpm. In one configuration, the minimum threshold can be between 55-60 lpm.

[0114] In one configuration, the maximum threshold can be between 20-25 lpm. In one configuration, the maximum threshold can be between 25-30 lpm. In one configuration, the maximum threshold can be between 30-35 lpm. In one configuration, the maximum threshold can be between 35-40 lpm. In one configuration, the maximum threshold can be between 40-45 lpm. In one configuration, the maximum threshold can be between 45-50 lpm. In one configuration, the maximum threshold can be between 50-55 lpm. In one configuration, the maximum threshold can be between 55-60 lpm. In one configuration, the maximum threshold can be between 60-65 lpm. In one configuration, the maximum threshold can be between 65-70 lpm. In one configuration, the maximum threshold can be between 70-75 lpm. In one configuration, the maximum threshold can be between 75-80 lpm. In one configuration, the maximum threshold can be between 80-85 lpm. In one configuration, the maximum threshold can be between 85-90 lpm. In one configuration, the maximum threshold can be between 90-95 lpm. In one configuration, the maximum threshold can be between 95-100 lpm.

[0115] In one configuration, the maximum and / or minimum threshold can be a safety limit for respiratory therapy.

[0116] In one configuration, the maximum and / or minimum threshold can depend on a selected flow rate.

[0117] In one configuration, the maximum and / or minimum threshold can be a predetermined percentage or value above and below a selected flow rate.

[0118] In one configuration, the maximum and / or minimum threshold can depend on a selected flow rate and a selected respiratory synchronization setting.

[0119] In one configuration, the system can include a user interface configured to receive user input to adjust the breath synchronization setting.

[0120] In one configuration, the breath synchronization setting can include a range of numbers. In one configuration, the breath synchronization setting can include a plurality of categories, the plurality of categories including at least a low setting and a high setting.

[0121] In one configuration, the maximum and / or minimum threshold can be a predetermined percentage or value above and below the selected flow rate, the percentage or value varying based on the selected breath synchronization setting.

[0122] In one configuration, the adjusting can be performed repeatedly.

[0123] In one configuration, each adjustment can be limited by a parameter determined based in part on the maximum and / or minimum flow rate measured by the one or more sensors.

[0124] In one configuration, the maximum and / or minimum flow rate measured by the one or more sensors can be an unrestricted response to patient inhalation and exhalation.

[0125] In one configuration, the maximum and / or minimum flow rate measured by the one or more sensors can be gradually limited by a negative feedback term.

[0126] In one configuration, the parameter can include the negative feedback term, the negative feedback term can gradually increase in response to the measured maximum and / or minimum flow rate until the measured maximum and / or minimum flow rate no longer exceeds the maximum and / or minimum threshold.

[0127] In one configuration, the adjusting can include an increase in flow rate when the patient is inhaling.

[0128] In one configuration, the adjusting can include a decrease in flow rate when the patient is exhaling.

[0129] In one configuration, the one or more sensors can include an ultrasonic transducer assembly.

[0130] In one configuration, the one or more sensors can include a heated temperature sensing element.

[0131] In one configuration, the system can be a high flow respiratory system.

[0132] In one configuration, the system can include a non-sealing patient interface.

[0133] In one configuration, the non-sealing patient interface can include a non-sealing nasal cannula.

[0134] In one arrangement, a respiratory system for delivering respiratory therapy to a patient, the system configured to regulate a flow rate of gas delivered to the patient in accordance with patient inhalation and exhalation, the respiratory system can comprise a flow generator with a motor for generating a flow of gas; and a controller in electrical communication with one or more sensors, and the controller configured to: cause display of an exhalation relief level setting on a user interface of the respiratory system; receive first user input to increase and / or decrease the exhalation relief level; cause display of a maximum and / or minimum flow rate threshold setting on the user interface; receive second user input to increase and / or decrease the maximum and / or minimum flow rate threshold; and regulate the flow rate based on the first user input and the second user input, wherein the first user input can be configured to allow regulation of the flow rate based in part on a cycle of patient inhalation and exhalation, and the second user input can be configured to dampen the regulation based on the first user input by comparing a maximum and / or minimum flow rate measured by the one or more sensors to the maximum and / or minimum threshold.

[0135] In one arrangement, the first user input can be configured to allow regulation of the flow rate based in part on the cycle of patient inhalation and exhalation by turning the exhalation relief on and / or off, and / or adjusting the amplitude of the exhalation relief.

[0136] In one arrangement, the exhalation relief level setting can comprise a plurality of different exhalation relief levels.

[0137] In one arrangement, the plurality of different exhalation relief levels can comprise a plurality of categories, the plurality of categories comprising at least a low exhalation relief level and a high exhalation relief level. In one arrangement, the plurality of different exhalation relief levels can comprise a series of numbers. In one arrangement, the plurality of different exhalation relief levels can comprise a sliding scale.

[0138] In one arrangement, the first user input can be received via a button on the user interface.

[0139] In one arrangement, the patient has access to the exhalation relief level setting.

[0140] In one arrangement, the patient does not have access to the maximum and / or minimum flow rate threshold setting.

[0141] In one arrangement, the clinician or technician has access to the maximum and / or minimum flow rate threshold setting.

[0142] In one arrangement, the system can be a high flow respiratory system.

[0143] In one arrangement, the system can comprise a non-sealing patient interface.

[0144] In one configuration, the non-sealing patient interface can include a non-sealing nasal cannula.

[0145] In one configuration, the exhalation relief levels can influence a negative feedback on the adjustment of the flow rate as applied in any of the configurations disclosed herein.

[0146] In one configuration, a respiratory system for delivering respiratory therapy to a patient, the system configured to adjust a flow rate of gas delivered to the patient in accordance with patient inhalation and exhalation, the respiratory system can include a flow generator with a motor for generating a flow of gas; and a controller in electrical communication with one or more sensors, and the controller configured to: cause display of an exhalation relief level setting on a user interface of the respiratory system, the setting comprising a plurality of different exhalation relief levels; receive user input via the user interface to increase and / or decrease the exhalation relief level; and adjust the flow rate based on the user input, wherein the user input can be configured to allow adjustment of the flow rate based in part on a cycle of patient inhalation and exhalation.

[0147] In one configuration, the user input can be configured to allow adjustment of the flow rate based in part on the cycle of patient inhalation and exhalation by opening and / or closing the exhalation relief, and / or adjusting the magnitude of the exhalation relief.

[0148] In one configuration, the plurality of different exhalation relief levels can comprise a plurality of categories, the plurality of categories comprising at least a low exhalation relief level and a high exhalation relief level. In one configuration, the plurality of different exhalation relief levels can comprise a series of numbers. In one configuration, the plurality of different exhalation relief levels can comprise a sliding scale.

[0149] In one configuration, the first user input can be received via a button on the user interface.

[0150] In one configuration, the controller is further configured to dampen the adjustment based on the user input by comparing a maximum and / or minimum flow rate measured by the one or more sensors to a maximum and / or minimum flow rate threshold.

[0151] In one configuration, the system can be a high flow respiratory system.

[0152] In one configuration, the system can include a non-sealing patient interface.

[0153] In one configuration, the non-sealing patient interface can include a non-sealing nasal cannula.

[0154] In one configuration, the exhalation relief levels can influence a negative feedback on the adjustment of the flow rate as applied in any of the configurations disclosed herein.

[0155] In one arrangement, a respiratory system for delivering respiratory therapy to a patient, the system configured to regulate a flow rate of gas delivered to the patient in accordance with patient inhalation and exhalation, the respiratory system can comprise a flow generator with a motor for generating a flow of gas; and a controller in electrical communication with one or more sensors, and the controller configured to: cause display of a maximum and / or minimum flow rate threshold setting on the user interface; receive user input to increase and / or decrease the maximum and / or minimum flow rate threshold; and regulate the flow rate based on the user input, wherein the user input can be configured to attenuate regulation of the flow rate based on a cycle of patient inhalation and exhalation by comparing the maximum and / or minimum flow rate measured by the one or more sensors to the maximum and / or minimum threshold.

[0156] In one arrangement, the user input can be received via a button on the user interface.

[0157] In one arrangement, the patient has no access to the maximum and / or minimum flow rate threshold setting.

[0158] In one arrangement, the clinician or technician has access to the maximum and / or minimum flow rate threshold setting.

[0159] In one arrangement, the maximum and / or minimum flow rate threshold can influence a negative feedback term of the regulation of the flow rate as applied in any of the arrangements disclosed herein.

[0160] In one arrangement, the controller can be configured to regulate the flow rate based on a cycle of patient inhalation and exhalation by receiving an exhalation relief level set by the user.

[0161] In one arrangement, the controller can be configured to cause display of a plurality of different exhalation relief levels on the user interface.

[0162] In one arrangement, the plurality of different exhalation relief levels can comprise a plurality of categories, the plurality of categories comprising at least a low exhalation relief level and a high exhalation relief level. In one arrangement, the plurality of different exhalation relief levels can comprise a range of numbers. In one arrangement, the plurality of different exhalation relief levels can comprise a sliding scale.

[0163] In one arrangement, the patient has access to the exhalation relief level setting.

[0164] In one arrangement, the system can be a high flow respiratory system.

[0165] In one arrangement, the system can comprise a non-sealing patient interface.

[0166] In one arrangement, the non-sealing patient interface can comprise a non-sealing nasal cannula. Attached Figure Description

[0167] These and other features, aspects, and advantages of this disclosure are described with reference to the accompanying drawings of certain embodiments, which are intended to illustrate certain embodiments and not to limit the scope of this disclosure.

[0168] FIG. 1A A high-flow respiratory system configured to provide respiratory therapy to a patient is illustrated schematically.

[0169] FIG. 1B This is a front perspective view of an exemplary high-flow therapeutic device with the humidification chamber in the appropriate position.

[0170] FIG. 1C yes FIG. 1B A three-dimensional view of the high-flow-rate treatment equipment.

[0171] FIG. 2A An exemplary block diagram is shown of a control system that interacts with and / or provides control and direction to components of a flow therapy device.

[0172] FIG. 2B An exemplary block diagram is shown of a control system that interacts with and / or provides control and direction to components of a flow therapy device.

[0173] FIG. 2C A block diagram of an exemplary controller is shown.

[0174] FIG. 3A A block diagram of an exemplary motor / sensor module is shown.

[0175] FIG. 3B An exemplary sensing chamber for a flow therapy device is shown.

[0176] FIG. 4 A flowchart illustrating an exemplary process for operating a flow therapy device is provided.

[0177] FIG. 5 A block diagram of an exemplary system for performing respiratory circulation enhancement for a flow therapy device is shown.

[0178] FIG. 6 An exemplary motor speed and flow rate of a flow therapy device during enhanced respiratory circulation are shown.

[0179] FIG. 7A to FIG. 7C An exemplary user interface display or a portion thereof showing the target flow rate and / or expiratory release settings is presented.

[0180] [0178A] FIG. 8 Another flow therapy system is illustrated in diagram form.

[0181] [0178B]FIG. 9 is a schematic diagram of a closed loop control system. DETAILED DESCRIPTION

[0182] While certain examples are described below, those skilled in the art will appreciate that the present disclosure extends beyond the specifically disclosed examples and / or uses and obvious modifications and equivalents thereof. Thus, it is intended that the scope of the present disclosure herein disclosed should not be limited by any of the specific examples described below.

[0183] In FIG. 1A there is provided a schematic representation of a high flow respiratory system 10. The respiratory system 10 can comprise a main device housing 100. The main device housing 100 can contain a flow generator 11, which can be in the form of a motor / impeller arrangement such as a blower, an optional humidifier or humidification chamber 12, a controller 13 and a user interface 14. The user interface 14 can comprise a display and one or more input devices such as one or more buttons, a touchscreen, a combination of a touchscreen and one or more buttons, etc. The controller 13 can comprise one or more hardware and / or software processors and can be configured or programmed to control components of the apparatus including, but not limited to, operating the flow generator 11 to generate a flow of gas for delivery to a patient, operating the humidifier 12 (if present) to humidify and / or heat the flow of gas, receiving user input from the user interface 14 for reconfiguration and / or user-defined operation of the respiratory system 10, and outputting information to the user (e.g. on the display). The user can be a patient, a healthcare professional, or anyone using the system 10.

[0184] With continuing reference FIG. 1A to, a patient breathing conduit 16 can be coupled to a gas flow outlet 21 in the main device housing 100 of the respiratory system 10 and to a patient interface 17. The patient interface can be a non-sealing interface like a nasal cannula with a manifold 19 and nasal prongs 18 for providing high flow therapy. The patient breathing conduit 16 can also be coupled to a sealing interface like a mask, a nasal mask or a nasal pillows mask. The patient interface can also optionally comprise an endotracheal tube, a tracheostomy interface, or other.

[0185] The gas flow can be generated by a flow generator 11 and can be humidified before being delivered to a patient via a patient conduit 16 through a patient interface 17. The controller 13 can control the flow generator 11 to generate a gas flow at a desired flow rate, and / or control one or more valves to control the mixing of air and oxygen or other breathable gas. The controller 13 can control a heating element in the humidification chamber 12, if present, to heat the gas to a desired temperature that achieves a desired level of temperature and / or humidity for delivery to the patient. The patient conduit 16 can have a heating element 16a, such as a heating wire, to heat the gas flow passing to the patient. The heating element 16a can also be controlled by the controller 13.

[0186] The system 10 can use flow rate sensor(s), pressure sensor(s), temperature sensor(s), humidity sensor(s), or other sensors in communication with the controller 13 to monitor characteristics of the gas flow and / or to operate the system 10 in a manner that provides suitable therapy. Ultrasonic transducers and heated temperature sensing elements are examples of sensors that can be used to measure flow rate, among other parameters. Gas flow characteristics can include gas concentration, flow rate, pressure, temperature, humidity, or others. Sensors 3a, 3b, 3c, 20, 25, such as pressure sensors, temperature sensors, humidity sensors, and / or flow rate sensors, can be placed at different locations in the main device housing 100, the patient conduit 16, and / or the patient interface 17. The controller 13 can receive output from the sensors to help it operate the respiratory system 10 in a manner that provides suitable therapy, in order to determine suitable target temperatures, flow rates, and / or pressures for the gas flow. Providing suitable therapy can include meeting the inspiratory needs of the patient.

[0187] The system 10 can include a wireless data transmitter and / or receiver, or transceiver 15, to enable the controller 13 to receive data signals 8 wirelessly from the operating sensors and / or to control different components of the system 10. Additionally or alternatively, the data transmitter and / or receiver 15 can transmit data to a remote server or enable remote control of the system 10. The system 10 can also include a wired connection, e.g., using a cable or wire, to enable the controller 13 to receive data signals 8 from the operating sensors and / or to control different components of the system 10.

[0188] As used herein, "high flow" therapy refers to the administration of gas to a patient's airway at a relatively high flow rate that typically meets or exceeds the patient's peak inspiratory demand. Flow rates used to achieve "high flow" can be any of the flow rates listed below. For example, in some configurations, for an adult patient, "high flow therapy" can refer to the delivery of gas to the patient at a flow rate of greater than or equal to about 10 liters per minute (10 LPM), such as between about 10 LPM and about 100 LPM, or between about 15 LPM and about 95 LPM, or between about 20 LPM and about 90 LPM, or between about 25 LPM and about 85 LPM, or between about 30 LPM and about 80 LPM, or between about 35 LPM and about 75 LPM, or between about 40 LPM and about 70 LPM, or between about 45 LPM and about 65 LPM, or between about 50 LPM and about 60 LPM. In some configurations, for a neonatal, infant, or pediatric patient, "high flow therapy" can refer to the delivery of gas to the patient at a flow rate of greater than 1 LPM, such as between about 1 LPM and about 25 LPM, or between about 2 LPM and about 25 LPM, or between about 2 LPM and about 5 LPM, or between about 5 LPM and about 25 LPM, or between about 5 LPM and about 10 LPM, or between about 10 LPM and about 25 LPM, or between about 10 LPM and about 20 LPM, or between about 10 LPM and 15 LPM, or between about 20 LPM and 25 LPM. High flow therapy devices for adult patients, neonatal, infant, or pediatric patients can deliver gas to the patient at a flow rate of between about 1 LPM and about 100 LPM, or at a flow rate within any of the sub-ranges described above.

[0189] FIG. 1B and FIG. 1C An example high flow therapy device or breathing apparatus of a respiratory system 10 is shown. The apparatus can include a housing 300 that encloses a flow generator. The flow generator can include a motor / sensor module. The motor / sensor module can be non-removable from the main housing 300. The motor / sensor module can also optionally be removable from the main housing 300. The housing 300 can include a humidifier or humidification chamber bay 318 for receiving a removable humidification chamber 310. The removable humidification chamber 310 contains a suitable liquid, such as water, for heating and humidifying gas delivered to a patient. The humidification chamber 310 can be fluidly coupled to the apparatus housing 300 in a linear slide-in motion into the chamber bay 318. A gas outlet port 322 can establish fluid communication between the motor / sensor module and the inlet 306 of the chamber 310.

[0190] Heated and humidified gas can exit from the outlet 308 of the chamber 310 into a humidified gas return tube 340, which can include a removable L-shaped elbow. The removable elbow can further include a patient outlet port 344 for coupling to an inspiratory conduit, such as the inspiratory conduit 16 of the FIG. 1A Humidified gas return tube 340 and patient outlet port 344 can each have a seal, such as an O-ring seal or a T-seal, to provide a sealed gas passageway between the device housing 300, humidification chamber 310, and the inspiratory conduit. The floor portion of the humidification chamber compartment 318 in the housing 300 can include a heater arrangement, such as a heating plate or other suitable heating element, for heating water in the humidification chamber 310 for use in the humidification process.

[0191] As shown in FIG. 1C The device can include an arrangement that enables the flow generator to deliver air, oxygen (or an alternative supplemental gas) or a suitable mixture thereof to the humidification chamber 310 and from there to the patient. Such an arrangement can include an air inlet 356' in the rear wall 322 of the housing 300. The device can include a separate oxygen (or other breathable gas) inlet port 358'. In the illustrated configuration, the oxygen inlet port 358' can be positioned adjacent to a side of the housing 300 at the rear end of the housing 300. The oxygen port 358' can be connected to an oxygen source, such as a tank. The oxygen inlet port 358' can be in fluid communication with a valve. The valve can suitably be a solenoid valve that is capable of controlling the amount of oxygen added to the flow of gas delivered to the humidification chamber 310.

[0192] The housing 300 can include a suitable electronics board, such as a sensing circuit board. The electronics board can house or can be in electrical communication with suitable electrical or electronic components, such as but not limited to microprocessors, capacitors, resistors, diodes, operational amplifiers, comparators, and switches. One or more sensors can be used with the electronics board. The components of the electronics board, such as but not limited to one or more microprocessors, can act as a controller 13 of the device. One or more of the electronics board can be in electrical communication with the electrical components of the system 10, including but not limited to the display unit and user interface 14, the motor, the valve, and the heating plate, to operate the motor to provide a desired flow rate of gas, to humidify and heat the flow of gas to an appropriate level, and to supply an appropriate amount of oxygen (or an appropriate amount of an alternative supplemental gas) to the flow of gas.

[0193] As described above, operating sensors (such as flow, temperature, humidity, and / or pressure sensors) can be placed at different locations within the respiratory device, patient catheter 16, and / or cannula 17. An electronics board can communicate electrically with these sensors. Outputs from the sensors can be received by the controller 13 to assist in operating the respiratory system 10 in a manner that provides optimal therapy, including generally meeting inspiratory needs. One or more sensors (e.g., Hall effect sensors) can be used to measure the motor speed of the flow generator's motor. The motor can include a brushless DC motor from which motor speed can be measured without the use of a separate sensor. For example, during operation of a brushless DC motor, the back electromotive force (back-EMF) can be measured from the unenergized windings of the motor, from which the motor position can be determined, which can then be used to calculate the motor speed. Furthermore, a motor driver can be used to measure the motor current, which can be used in conjunction with the measured motor speed to calculate the motor torque. The motor can also include a low-inertia motor.

[0194] Indoor air can be introduced through the inlet port (e.g.) FIG. 1C Air enters the flow generator through the air inlet port 356'. The flow generator can operate at motor speeds greater than 1,000 RPM and less than 30,000 RPM, greater than 2,000 RPM and less than 21,000 RPM, or any of the above values. Operation of the flow generator can mix gases entering the flow generator, such as gases entering the motor / sensor chamber through the inlet port. Using a flow generator as a mixer can reduce pressure drops that may occur in systems with separate mixers (such as static mixers including baffles), as mixing requires energy.

[0195] Control system

[0196] FIG. 2A and FIG. 2B A block diagram 200 illustrates an exemplary control system 220 that can detect patient condition and control the operation of a flow therapy device including a gas source. The control system 220 can manage the flow rate of gas as it is delivered to the patient through the flow therapy device. For example, the control system 220 can increase or decrease the flow rate by controlling the output of the motor speed of the flow generator or blower 230, or (e.g., in an auxiliary gas port) the output of valve 232. As discussed below, the control system 220 can automatically determine a setpoint or personalized flow rate for a specific patient. The flow rate can be optimized by the control system 220 to improve patient comfort and treatment.

[0197] The control system 220 can generate audio output 238, and / or display / visual output 239. For example, the flow therapy device can include a display and / or a speaker. The display can indicate to the clinician any warnings or alarms generated by the control system 220. The display can also indicate control parameters that the clinician can adjust. For example, the control system 220 can automatically recommend a flow rate for a particular patient. The control system 220 can also determine the respiratory status of the patient, including but not limited to generating the respiratory rate of the patient, and send it to the display.

[0198] The control system 220 can vary the heater control output to control one or more of the heating elements (e.g., to maintain a temperature set point of the gas delivered to the patient). The control system 220 can also vary the operation or duty cycle of the heating elements. The heater control output can include a heater plate control output 234 and a heated breathing tube(s) control output 236.

[0199] The control system 220 can determine the outputs 230-239 based on one or more received inputs 201-216. The inputs 201-216 can correspond to sensor measurements received automatically by the controller (as shown in FIG. 1A 、 FIG. 2B and FIG. 2C ). The control system 220 can receive sensor inputs including, but not limited to: temperature sensor(s) input 201, flow rate sensor(s) input 202, motor speed input 203, pressure sensor(s) input 204, gas fraction sensor(s) input 205, humidity sensor(s) input 206, pulse oximeter (e.g., Sp02) sensor(s) input 207, stored parameter(s) or user parameter 208, duty cycle or pulse width modulation (PWM) input 209, voltage input(s) 210, current input(s) 211, acoustic sensor(s) input 212, power input(s) 213, resistance input(s) 214, C02sensor(s) input 215, and / or spirometer input 216. The control system 220 can receive inputs from a user or store parameter values in memory 274 (as shown in FIG. 2C(As shown in the diagram). The control system 220 can dynamically adjust the flow rate for the patient during treatment. The control system 220 can continuously monitor system parameters and patient parameters. Any other suitable inputs and / or outputs can be used with the control system 220. For example, using the pulse oximeter sensor inputs 207, the control system 220 can implement one or more closed-loop control systems to control the oxygen composition in the gas flow, as described in International Application No. PCT / NZ2018 / 050137, filed October 5, 2018, and published as WO2019 / 070136, the entire contents of which are incorporated herein by reference and included in Appendix A. Using the closed-loop control system(s), the flow therapy device can monitor the patient's oxygen saturation (SpO2) and control the fraction of oxygen (FdO2) delivered to the patient. The flow therapy device can also automatically adjust FdO2 to achieve a target SpO2 value for the patient.

[0200] like FIG. 2B As shown, the control system 220 can receive inputs from multiple components of the flow therapy device, such as a transthoracic asynchronous (TAA) sensor input 252, a respiratory sensor input 254, a work of breathing (WOB) sensor input 256, a CO2 and / or pressure sensor input 258, and user-inputted and / or stored values ​​260. Not necessarily. FIG. 2A All inputs 202-210 shown may exist. FIG. 2B The control system 220 can output heater control output 262, flow control output 264, and display / audio output 266 based on inputs 252-260. Inputs 202 to 210 and outputs 230 to 234 may not all be present. For example, the control system 220 may only receive WOB sensor (e.g., EMG) input 256 and generate flow control measurement value 264. Depending on the configuration, some components corresponding to the inputs may not be included in the flow therapy device. The absence of an input itself can be used by the control system 220 to determine input or system conditions.

[0201] The control system 220 may include programming instructions for detecting input conditions and controlling output conditions. FIG. 2C A block diagram of an exemplary controller 270 is shown. Programming instructions can be stored in the memory 274 of the controller 270. These programming instructions can correspond to the methods, processes, and functions described herein. The control system 276 can be executed by one or more hardware processors 272 of the controller 270. The programming instructions can be implemented using C, C++, JAVA, or any other suitable programming language. The controller may also include circuitry 278 for receiving sensor signals. Some or all of the control system 276 can be implemented in dedicated circuitry 278 (such as an ASIC and FPGA).

[0202] The controller can further include a display 280 for transmitting the status of the patient and the breathing assistance system. The display 280 can also show warnings. The controller can also receive user input via a user interface such as the display 280. The user interface can alternatively or additionally comprise buttons or dials.

[0203] Motor / sensor module

[0204] FIG. 3A A block diagram of a motor / sensor module 2000 is shown, which can be used as part of a flow therapy apparatus. The motor / sensor module includes a flow generator 2001 that entrains room air for delivery to a patient. The flow generator 2001 can be a centrifugal blower.

[0205] Room air enters a room air inlet 2002, which enters the flow generator 2001 through an inlet port 2003. The inlet port 2003 can include a valve 2004 through which pressurized gas can enter the flow generator 2001. The valve 2004 can control the flow of oxygen (or other supplemental gas) into the blower 2001. The valve 2004 can be any type of valve, including a proportional valve or a two-position valve. The inlet port can not include a valve.

[0206] The flow generator 2001 can operate at a motor speed greater than 1,000 RPM and less than 30,000 RPM, greater than 2,000 RPM and less than 25,000 RPM, greater than 3,000 RPM and less than 24,000 RPM, or between any of the values above. Operation of the flow generator 2001 mixes the gas that enters the flow generator 2001 through the inlet port 2003. Using the flow generator 2001 as a mixer can reduce the pressure drop that can occur in systems with a separate mixer, such as a static mixer that includes baffles, because mixing requires energy, and the flow generator imparts energy.

[0207] The mixed air exits the flow generator 2001 through a conduit 2005 and enters a flow path 2006 in a sensing chamber 2007. A circuit board with sensors 2008 is positioned in the sensing chamber 2007 such that the circuit board is immersed in the gas flow. The sensors 2008 on the circuit board are positioned in the gas flow to measure a property of the gas in the flow. After passing through the flow path 2006 in the sensing chamber 2007, the gas exits 2009 to a humidification chamber 310.

[0208] The flow path 2006 has a curved shape. Gas enters at inlet 2103, flows along the curved flow path 2104, and exits on the opposite side of flow path 2105. The inlet and outlet can be positioned in opposite vertical directions, and the gas flow can enter the path vertically upwards, then curve to a horizontal direction, and then curve back to a vertically upwards direction. The flow path may not have sharp turns. The flow path may have curved ends and relatively straight intermediate sections. The flow path may maintain a constant cross-sectional shape throughout its entire length. The flow path may taper slightly inwards from the first end and widen again to the second end, which can accelerate the flow for better accuracy, stability, and reproducibility in measurements. The surface of the flow path may be lined with a surface modifier / lubricant to reduce friction within the flow path. The curved flow path shape can reduce the pressure drop of the gas flow without reducing the sensitivity of the flow measurement by partially aligning the measurement area with the flow path. Many different flow path configurations can be used.

[0209] like FIG. 3B As shown, the mixed air can exit the flow generator and enter flow path 356 in sensor chamber 350, which can be located within the motor / sensor module. A sensing circuit board 352, equipped with sensors (such as an ultrasonic transducer 354 and / or a heated temperature sensing element), can be positioned within sensor chamber 350 such that the sensing circuit board is at least partially immersed in the gas flow. At least some sensors on the sensing circuit board can be positioned in the gas flow to measure the properties of the gas in the flow. After passing through flow path 356 in sensor chamber 350, the gas can exit into a humidification chamber.

[0210] Sensing circuit board 352 may include sensors such as acoustic transmitters and / or receivers, humidity sensors, temperature sensors, thermistors, etc. At least two different types of sensors can be used to measure gas flow rate. The first type of sensor may include a heated temperature sensing element (or thermistor) that determines the flow rate by monitoring heat transfer between the gas flow and the heated temperature sensing element. As the gas flows around and passes over the heated temperature sensing element, the heated temperature sensing element can operate at a constant target temperature within the flow. The sensor can measure the amount of power required to maintain the heated temperature sensing element at the target temperature. The target temperature can be configured to be higher than the temperature of the gas flow, such that more power is required at a higher flow rate to maintain the heated temperature sensing element at the target temperature.

[0211] The second type of sensor can include acoustic (such as ultrasonic transducer) sensor components. Acoustic sensors including acoustic emitters and / or receivers can be used to measure the time of flight of acoustic signals to determine gas velocity and / or composition, which can be used in a flow therapy device. In one ultrasonic sensing (including ultrasonic transducers that can act as emitters and / or receivers) topology, a driver causes a first sensor (such as an ultrasonic transducer) to generate an ultrasonic pulse in a first direction. A second sensor (such as a second ultrasonic transducer) receives the pulse and provides a time of flight measurement of the pulse between the first ultrasonic transducer and the second ultrasonic transducer. Using this time of flight measurement, the speed of sound of the gas flow between the ultrasonic transducers can be calculated by a processor or controller of the flow therapy device. The second sensor can also emit, and the first sensor can receive, a pulse in a second direction opposite the first direction to provide a second measurement of the time of flight, allowing determination of characteristics of the gas flow, such as flow rate or velocity. In another acoustic sensing topology, an acoustic pulse emitted by an acoustic emitter such as an ultrasonic transducer can be received by an acoustic receiver such as a microphone.

[0212] More accurate flow measurements can be determined in combination with readings from both the first type of sensor and the second type of sensor. For example, a previously determined flow rate and one or more outputs from one 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 type of sensor and the second type of sensor in order to calculate a final flow rate.

[0213] Regulating flow based on respiratory cycle

[0214] Some patients can find it more comfortable to have the operation of the flow therapy device adjusted based on the patient's breathing cycle. For example, the flow rate of air provided by the flow therapy device can be adjusted as the patient inhales and exhales. The flow rate can be increased during the patient's inhalation and decreased during the patient's exhalation. The flow rate can be adjusted (e.g., increased) during the patient's inhalation and not adjusted during the patient's exhalation, or vice versa. Inhalation and exhalation can also be referred to as inspiration and expiration.

[0215] The patient's breathing cycle can be represented as a waveform including alternating inspiration and expiration phases. By determining and monitoring the patient's breathing cycle waveform, the operation of the flow therapy device can be modified based on the patient's breathing cycle. For example, the flow therapy device can be configured to control gas flow using a periodic waveform that can be adjusted based on the patient's measured breathing cycle waveform.

[0216] FIG. 4A flowchart illustrating an exemplary process for regulating the operation of a flow therapy device is provided. At block 402, control signals are used to drive the flow therapy device (e.g., as shown in the diagram). FIG. 1A The flow generator 11 shown is associated with a motor. The motor can be used to generate an airflow to assist the patient's breathing. Control signals may include an initial waveform. The initial waveform may include a default waveform or be based on one or more measurements associated with the patient.

[0217] At box 404, multiple measurements are received at the controller, which can be used to determine the patient's respiratory cycle. These measurements may include flow rate 404a, motor speed 404b, pressure 404c, etc.

[0218] At box 406, the received measurements are used to determine the patient's predicted respiratory cycle. The patient's predicted respiratory cycle can be determined using one or more different techniques, such as by monitoring flow deviation (e.g., deviation from the average or setpoint flow value), flow limitation (e.g., discussed below), system leakage (i.e., a portion of the airflow generated by the blower that does not flow to the patient's lungs), etc.

[0219] Continue to refer to FIG. 4 At box 408, the control signal for the motor is adjusted based on the predicted respiratory cycle. For example, the control signal can be adjusted so that the flow rate increases with the patient's inhalation and decreases with the patient's exhalation.

[0220] The process can then return to box 402, where a regulated control signal is used to drive the blower motor to generate an airflow for the patient.

[0221] This process can also be implemented on respiratory systems with sealed patient interfaces. Pressure sensors can be placed anywhere in the flow path. A non-limiting example of a sealed patient interface is an NIV mask. An NIV mask can seal against the patient's face, resulting in virtually no system leakage. This allows the pressure of the gas delivered to the patient to be measured near or at the patient end. For example, the pressure sensor can be positioned inside the NIV mask or outside the patient's nostrils. The pressure sensor can also be positioned where the NIV mask is connected to the patient's breathing tube (e.g., FIG. 1A The patient's breathing tube 16 is shown in the manifold.

[0222] FIG. 5 Demonstrated for use in FIG. 4 A block diagram of an exemplary system for adjusting the control signal of the motor at box 408. FIG. 5 As shown, patient 502 is connected to flow therapy device 504, for example... FIG. 1Aa flow therapy device 10. The device can include a flow generator with a motor 506 that can be used to provide a flow of air to a patient 502.

[0223] During operation of the flow therapy device 504, a plurality of measurements can be acquired and transmitted to a control signal feedback module 510 in order to adjust the control signal of the motor 506 based on the breathing cycle of the patient 502. For example, parameters of the motor 506 can be used to measure the motor speed and / or the system pressure as described above. One or more flow rate sensors 508 can be used to monitor the flow rate of the air flow. The flow rate sensors 508 can include two or more different types of sensors, such as a heated temperature sensing element and an ultrasonic transducer assembly. In addition, one or more additional sensors, such as a pressure sensor, can be used to measure one or more additional measurements (e.g., pressure).

[0224] The plurality of measurements (e.g., motor speed, flow rate, etc.) can be used to determine the breathing cycle of the patient at a breathing cycle detection module 512. The determined breathing cycle can be in the form of an alternating waveform (e.g., a substantially sinusoidal waveform). Both measurements regarding the motor 506 and measurements of the flow rate sensor 508 can be fed into the breathing cycle detection module 512.

[0225] Once the breathing cycle of the patient has been determined, the breathing cycle can be used to adjust the control signal of the motor 506. For example, the calculated breathing cycle waveform from the breathing cycle detection module 512 can be subjected to positive feedback 514.

[0226] The positive feedback 514 can work with the patient during the patient's breathing cycle by decreasing the motor speed when the patient is exhaling, and / or increasing the motor speed when the patient is inhaling. The positive feedback can be implemented during inhalation but not during exhalation, or the positive feedback can be implemented during exhalation but not during inhalation. For example, a patient who is trying to reduce his or her work while breathing using "pursed-lip breathing" when exhaling can benefit from positive feedback that increases the flow rate during inhalation but not from positive feedback that decreases the flow rate during exhalation. By not implementing positive feedback during exhalation, the exhalation pressure and exhalation time can be increased, which can be beneficial to some patients. One or more scaling parameters can be used to increase or decrease the amplitude of the control signal that controls the motor 506 speed based on the determined amplitude of the patient's inhalation / exhalation. For example, the positive feedback of the blower motor control signal can be represented as:

[0227]

[0228] where ω corresponds to the motor speed, R corresponds to the patient limitation, and corresponding to its average and baseline values, and k p corresponding to a positive feedback parameter.

[0229] As described above, flow limitation can also be used to determine the patient’s breathing cycle. Generally, the respiratory system as a whole can have some flow resistance (also referred to as a “limitation” or R), which can be used to indicate the relationship between the change in pressure p of the system and the flow of the system. The limitation R can vary as the patient inhales and exhales. The greater the R value indicates the greater the limitation (e.g., when the patient exhales).

[0230] With continued reference to FIG. 5 The measurements from the flow rate sensor 508 can also be fed into a minimum and / or maximum detection module 520 for measured flow rate. The minimum and / or maximum measured flow rate can be used to determine a negative feedback term 516, which can then be combined 518 with the positive feedback 514 to generate the control signal for the motor 506.

[0231] The negative feedback can limit the positive feedback applied to the control signal to certain bounds, thereby dampening changes in the control signal as the patient inhales or exhales. The negative feedback can include minimum and / or maximum threshold flow rate values. The minimum flow rate value can ensure that the device maintains a flow rate above the threshold, regardless of how difficult the patient is breathing. This can ensure the effectiveness and / or safety of the high flow therapy. The maximum flow rate value can limit the amount of flow rate adjustment based on the patient’s breathing cycle, even as the amplitude of the patient’s inhalation or exhalation increases.

[0232] The positive feedback 514 can include a breath synchronization setting on a display of the device, which can be adjusted by a user or care provider. The positive feedback breath synchronization setting can allow the user or care provider to adjust the settings of the machine to further improve comfort and / or effectiveness by manually adjusting the amount of positive feedback. These settings can include, for example, any number of selectable values, such as 2-10, 2-5, 2, 3, 4, 5, or others. The selectable values can be labeled by a number. Alternatively, the selectable values can be labeled into different categories, such as a high setting, a medium setting, and / or a low setting. Alternatively, the settings can allow the user to go higher (e.g., by pressing a “+” button, etc.) or lower (e.g., by pressing a “-” button, etc.) on the breath synchronization value.

[0233] Breath synchronization can be introduced gradually, for example, by increasing the amplitude of the positive feedback while keeping the average target flow rate the same during the amplitude increase. Gradual introduction can occur when breath synchronization is first turned on, and / or when the user increases the exhalation relief level (i.e., increases the positive feedback level). Gradual introduction can cause the positive feedback to slowly increase from zero or its previous level to its new value over a predetermined duration (e.g., about 30 seconds, about 1 minute, about 2 minutes, about 3 minutes, about 4 minutes, or about 5 minutes). This can cause the motor speed to oscillate, and in turn, the flow rate to oscillate, such that the amplitude slowly increases. Gradual introduction can reduce potential patient discomfort during the initial phase of breath synchronization, in which the flow rate changes cannot be perfectly synchronized with the patient's breath. During the gradual introduction, the flow rate can start to cross the flow rate threshold. At this point, the negative feedback term can also start to gradually increase, thereby eliminating or substantially eliminating further increases in the positive feedback term, in order to maintain the flow rate within the maximum and / or minimum threshold.

[0234] In FIG. 6 an example of the effect of the positive feedback on the motor speed is shown. As shown in the top graph of FIG. 6 , the motor speed 602 varies over several breath cycles. The motor speed can include a nominal motor speed and the positive feedback, the maximum and minimum values of which are enveloped by the positive feedback term 604. The amount of positive feedback 604 is limited, which is initially set high enough such that no limit occurs. Accordingly, the initially sensed maximum and minimum flow rates are un-limited responses to the patient's breath, and are gradually limited by the negative feedback. As shown in FIG. 5 , the process for determining the flow rate does not know in advance the degree of adjustment of the motor speed in order to remain within the limit or threshold. Thus, the negative feedback gradually limits the positive feedback, for example, the negative feedback can gradually increase until the measured or sensed maximum and / or minimum flow rate no longer exceeds the limit or threshold.

[0235] The minimum and / or maximum threshold flow rate can be a fixed value, that is, regardless of the selected flow rate or the selected breath synchronization value. Alternatively or additionally, the minimum and / or maximum threshold flow rate can be set by the user. This can ensure that the device always delivers the minimum flow rate and / or never exceeds the maximum flow rate, regardless of the selected flow rate or the selected breath synchronization value. Allowing the user to set the threshold(s) can also allow the flow therapy device to deliver gas at a flow rate that is comfortable for a particular patient. The maximum and / or minimum threshold can be set independently of the breath synchronization settings. For example, a clinician can be allowed to set the maximum and / or minimum threshold to ensure the effectiveness and / or safety of the high flow therapy, while the patient can be allowed to set the breath synchronization value based on what the patient finds most comfortable.

[0236] Alternatively or additionally, the minimum and / or maximum flow rates can be determined based on a user-defined target flow rate. For example, the maximum and / or minimum flow rates can be a certain percentage higher or lower than the selected flow rate. Alternatively or additionally, the maximum and / or minimum flow rates can be a certain value higher or lower than the selected flow rate.

[0237] Alternatively or additionally, the minimum and / or maximum flow rate can be based on both the selected flow rate and the selected respiratory synchrony value. For example, the maximum and / or minimum flow rate can be a percentage higher and lower than the selected flow rate. This percentage value can then vary based on the selected respiratory synchrony value. Alternatively, the maximum and / or minimum flow rate can be a value higher and lower than the selected flow rate. This value can then vary based on the selected respiratory synchrony value.

[0238] FIG. 6 The bottom graphic shows the flow rate 606 sensed by the device's (multiple) flow rate sensors, as well as the minimum flow rate 608 and maximum flow rate 610 set by the user. Flow rate 606 is based on... FIG. 6 The top graph and the patient's positive feedback are caused by changes in motor speed. To maintain the flow rate within these limits 608, 610, the device's controller measures the minimum and maximum flow rates within each breath and then repeatedly adjusts the feedback loop to drive the flow within the limits, for example, by following... FIG. 5 The process shown is as follows.

[0239] Exemplary user interface or portions thereof

[0240] like FIG. 7A and FIG. 7B As shown, it could be FIG. 1A The user interface 700 of the user interface 14 can display settings that allow users, such as patients or clinicians, to adjust the expiratory release (“ER”) level 702. The expiratory release level corresponds to the aforementioned positive feedback item or respiratory synchronization setting. FIG. 7A and FIG. 7B As shown, the user can select four different expiratory release levels, which can include, for example... FIG. 7A The absence of expiratory release (i.e., no positive feedback) and the first or lowest expiratory release level are indicated by all three ER loops being empty at 704. FIG. 7B Two of the three ER coils 704 represent the second expiratory release level, and the third or highest expiratory release level (that is, the highest or maximum positive feedback term). The user can adjust the expiratory release level, for example, via button 703 or other forms of user input to increase or decrease the level.

[0241] like FIG. 7A and FIG. 7BThe ER level 702 shown illustrates an exemplary expiratory release setting. As mentioned above, the user interface can display other forms of expiratory release settings, such as numerical values, sliding scales, or others. Expiratory release settings can include different numbers of levels, which can be discrete or continuous. FIG. 7C As shown, when the expiratory release settings menu is collapsed, the user interface 700 can also display the previously selected expiratory release level 708 (e.g., below the target flow rate value) on the screen. The previously selected expiratory release level 708 can also optionally be displayed only if the user has already set the expiratory release volume to a value greater than 0.

[0242] like FIG. 7A to FIG. 7C As shown, the user interface 700 may optionally allow adjustment of the set flow rate 705 via, for example, a button 706 or other form of user input for increasing or decreasing the set flow rate 705. The user interface 700 may also display a maximum flow rate threshold 710 and a minimum flow rate threshold 712, allowing the user to adjust the set flow rate 705 between the maximum and minimum flow rate thresholds. In the configuration, the maximum and minimum flow rate thresholds may be set by the user (e.g., a clinician) on a separate menu. The separate menu may be designed for use by clinicians, technicians, and / or engineers. The separate menu may also be designed to be inaccessible to patients or other general users.

[0243] Flow therapy system

[0244] Additional reference FIG. 8 It shows something similar to FIG. 1A System 10 of the system. Except for environment entry port 27. FIG. 8 The system additionally includes an oxygen inlet port 28 for connecting to an oxygen source (such as a hospital oxygen supply or oxygen cylinder). FIG. 8 The system also includes a temperature sensor 29 located at or near the end of the intake tube. According to this disclosure, FIG. 8 System 10 is also suitable for controlling the flow rate of breathable gases.

[0245] Operational sensors 3a, 3b, 3c, such as flow sensors, temperature sensors, humidity sensors, and / or pressure sensors, can be placed at various locations in the flow therapy system 10. Additional sensors (e.g., sensors 20, 25) can be placed in various locations on the patient conduit 16 and / or cannula 17 (e.g., a temperature sensor 29 can be present at or near the end of the inspiratory tube). The output from the sensors can be received by the controller 13 to assist the controller in operating the flow therapy system 10 in a manner that provides suitable therapy. In some configurations, providing suitable therapy includes meeting the peak inspiratory demand of the patient. The system 10 can have a transmitter and / or receiver 15 to enable the controller 13 to receive signals 8 from the sensors and / or to control different components of the flow therapy system 10, including but not limited to the flow generator 11, the humidifier 12, and the heating wire 16a, or accessories or peripherals associated with the flow therapy system 10. Additionally or alternatively, the transmitter and / or receiver 15 can deliver data to a remote server or enable remote control of the system 10.

[0246] After the oxygen and ambient air have been mixed, the oxygen can be measured by placing one or more gas composition sensors, such as an ultrasonic transducer system, also known as an ultrasonic sensor system. The measurement can be made within the device, the delivery conduit, the patient interface, or at any other suitable location.

[0247] The oxygen concentration can also be measured by using flow rate sensors on at least two of the ambient air inlet conduit, the oxygen inlet conduit, and the final delivery conduit to determine the flow rate of at least two of the gases. By determining the flow rate of two inlet gases or one inlet gas and one total flow rate along with the assumed or measured oxygen concentration of the inlet gases (ambient air is about 20.9% and oxygen is about 100%), the oxygen concentration of the final gas composition can be calculated. Alternatively, flow rate sensors can be placed at all three of the ambient air inlet conduit, the oxygen inlet conduit, and the final delivery conduit to allow for redundancy and to test that each sensor is working correctly by checking for consistency of the readings. Other methods of measuring the oxygen concentration delivered by the flow therapy device 10 can also be used.

[0248] The flow therapy system 10 can include a patient sensor 26, such as a pulse oximeter or a patient monitoring system, to measure one or more physiological parameters of the patient, such as the patient's blood oxygen saturation (Sp02), heart rate, respiratory rate, perfusion index, and to provide a measure of signal quality. The sensor 26 can communicate with the controller 13 through a wired connection or through communication over a wireless transmitter on the sensor 26. The sensor 26 can be a disposable adhesive sensor designed to be connected to the patient's finger. The sensor 26 can be a non-disposable sensor. Sensors designed for different age groups and to be connected to different locations on the patient are available and can be used with the flow therapy system 10. The pulse oximeter will attach to the user, typically at their finger, although other locations, such as the earlobe, are an option. The pulse oximeter will connect to the processor in the device and will constantly provide a signal indicative of the patient's blood oxygen saturation. The patient sensor 26 can be a hot-pluggable device that can be attached or interchanged during operation of the flow therapy system 10. For example, the patient sensor 26 can connect to the flow therapy system 10 using a USB interface or using a wireless communication protocol, such as near field communication, WiFi, or Bluetooth®. When the patient sensor 26 is disconnected during operation, the flow therapy system 10 can continue to operate in its previous state of operation for a defined period of time. After the defined period of time, the flow therapy system 10 can trigger an alarm, transition from an automatic mode to a manual mode, and / or exit the control mode (e.g., automatic mode or manual mode) altogether. The patient sensor 26 can be a bedside monitoring system or other patient monitoring system that communicates with the flow therapy system 10 through a physical or wireless interface. ) connect to the flow therapy system 10. When the patient sensor 26 is disconnected during operation, the flow therapy system 10 can continue to operate in its previous state of operation for a defined period of time. After the defined period of time, the flow therapy system 10 can trigger an alarm, transition from an automatic mode to a manual mode, and / or exit the control mode (e.g., automatic mode or manual mode) altogether. The patient sensor 26 can be a bedside monitoring system or other patient monitoring system that communicates with the flow therapy system 10 through a physical or wireless interface.

[0249] Control system

[0250] Referring again to FIG. 8 , the controller 13 can be programmed with or configured to execute a closed loop control system for controlling operation of the flow therapy system 10. The closed loop control system can be configured to ensure that the patient's Sp02 reaches a target level and consistently remains at or near that level.

[0251] The controller 13 can receive input(s) from the user that can be used by the controller 13 to perform a closed loop control system. The target Sp02 value can be a single value or a range of values. The value(s) can be preset, selected by a clinician, or determined based on a patient type, where the patient type can refer to a current ailment and / or information about the patient such as age, weight, height, gender, and other patient characteristics. Similarly, the target Sp02 can be two values, each selected in any of the ways described above. The two values would represent a range of acceptable values for the Sp02 of the patient. The controller can target one value within the range. The target value can be the middle of the range or any other value within the range, which can be preset or selected by the user. Alternatively, the range can be automatically set based on the target value for Sp02. The controller can be configured to have one or more set responses when the Sp02 value of the patient moves outside of the range. The responses can include sounding an alarm, changing to manual control of Fd02, changing Fd02 to a particular value, and / or other responses. The controller can have one or more ranges, where one or more different responses occur when the controller moves outside of each range.

[0252] The graphical user interface of the flow therapy system 10 can be configured to prompt the user to input a patient type, and the Sp02 limits can be determined based on the user’s selection. Additionally, the user interface can include a customization option where the user can define the limits.

[0253] Generally, the Sp02 will be controlled between about 80% and about 100%, or between about 80% and about 90%, or between about 88% and about 92%, or between about 90% and about 99%, or between about 92% and about 96%. The Sp02 can be controlled between any two suitable values from any two of the ranges described above. The target Sp02 can be between about 80% and about 100%, or between about 80% and about 90%, or between about 88% and about 92%, or between about 90% and about 99%, or between about 92% and about 96%, or about 94%, or 94%, or about 90%, or 90%, or about 85%, or 85%. The Sp02 target can be any value between any two suitable values from any two of the ranges described above. For a defined range, the Sp02 target can correspond to the middle of the Sp02.

[0254] Fd02may be configured to be controlled within a range. As previously discussed, as long as the flow rate meets or exceeds the patient's peak inspiratory demand, the measured oxygen concentration in the system (Fd02) will be essentially the same as the oxygen concentration the patient is breathing (Fi02), so these terms can be considered equivalent. Each range limit can be preset, user selected, or determined based on patient type, where patient type can refer to current ailment and / or information about the patient such as age, weight, height, sex, and / or other patient characteristics. Alternatively, a single value for Fd02may be selected, and the range can be determined based at least in part on the value. For example, the range can be a set amount above and below the selected Fd02. The selected Fd02may be used as a starting point for the controller. If the controller attempts to move Fd02outside the range, the system can have one or more responses. These responses can include sounding an alarm, preventing Fd02from moving outside the range, switching to manual control of Fd02, and / or switching to a particular Fd02. The device can have one or more ranges, where one or more different responses occur when the device reaches the limit of each range.

[0255] Fd02may be controlled between about 21% and about 100%, or between about 21% and about 90%, or between about 21% and about 80%, or between about 21% and about 70%, or between about 21% and about 60%, or between about 21% and about 50%, or between about 25% and about 45%. Fd02may be controlled between any two suitable values from any two of the ranges described. The Fd02target can be between any two suitable values from any two of the ranges described. If the range is based on a single value, the upper and lower limits can be determined by adding / subtracting a fixed amount from the selected value. The amount added or subtracted can be about 1%, or about 5%, or 10%, or about 15%, or about 20%, or about 30%, or about 50%, or about 100%. The amount added / subtracted can vary relative to the selected value. For example, the upper limit can be 20% higher than the selected value, so for the range of control, a selected value of 50% Fd02would have an upper limit of 60%. The percentage used for the range can be about 1%, or about 5%, or 10%, or about 15%, or about 20%, or about 30%, or about 50%, or about 100%. The method used to calculate the lower and upper limits will not necessarily need to be the same. If a single value is used, the value can be between about 21% and about 100%, or between about 25% and about 90%, or between about 25% and about 80%, or between about 25% and about 70%, or between about 25% and about 60%, or between about 25% and about 50%, or between about 25% and about 45%.

[0256] Closed loop control

[0257] Referring toFIG. 9 A schematic diagram of a closed loop control system 1000 is shown. The closed loop control system can utilize two control loops. The first control loop can be implemented by an Sp02 controller. The Sp02 controller can determine a target Fd02 based in part on a target Sp02 and / or a measured Sp02. As discussed above, the target Sp02 value can be a single value or a range of acceptable values. The value(s) can be preset, selected by a clinician, or automatically determined based on patient characteristics. In general, the target Sp02 value is received or determined prior to or at the beginning of a therapy session, although the target Sp02 value can be received at any time during the therapy session. During the therapy session, the Sp02 controller can also receive as inputs measured Fd02 reading(s) from the gas composition sensor and measured Sp02 reading(s) and signal quality reading(s) from the patient sensor. In some configurations, the Sp02 controller can receive a target Fd02 as an input, in which case the output of the Sp02 controller can be provided directly back to the Sp02 controller as an input. Based at least in part on these inputs, the Sp02 controller can output a target Fd02 to the second control loop.

[0258] The second control loop can be implemented by an Fd02 controller. The Fd02 controller can receive inputs of measured Fd02 and target Fd02. The Fd02 controller can then output an oxygen inlet valve control signal to control the operation of the oxygen valve based on the difference between these measured Fd02 and target Fd02 values. When the flow therapy system 10 is operating in an automatic mode, the Fd02 controller can receive the target Fd02 value output from the first control loop. The Fd02 controller can also receive additional parameters, such as a flow rate value, gas properties, and / or measured Fd02. The gas properties can include the temperature of the gas at the 02 inlet and / or the oxygen content of the supply. The gas supply connected to the oxygen inlet valve can be an oxygen enriched gas flow, where the oxygen content of the supply can be less than pure oxygen (i.e., 100%). For example, the oxygen supply can be an oxygen enriched gas flow with an oxygen content less than 100% and greater than 21%.

[0259] The Fd02controller can determine from at least some of these inputs the oxygen flow rate needed to achieve the target Fd02. The Fd02controller can use the flow rate input in order to alter the valve control signal. If the flow rate changes, the Fd02controller can automatically calculate the new required oxygen flow rate needed to maintain the target Fd02 at the new flow rate without having to wait for feedback from the gas concentration sensors, such as measured Fd02values. The Fd02controller can then output an altered valve control signal to control the valve based on the new flow rate. In some configurations, the control signal of the Fd02controller can set the current of the oxygen valve in order to control the operation of the oxygen valve. Additionally or alternatively, the Fd02controller can detect changes in the measured Fd02and alter the position of the valve accordingly. During the manual mode, the second control loop can operate independently without receiving the target Fd02from the first control loop. Instead, the target Fd02may be received from a user input or a default value.

[0260] During the treatment period, the Sp02controller and the Fd02controller can continue to automatically control the operation of the flow therapy system until the end of the treatment period or an event triggers a change from the automatic mode to the manual mode.

[0261] Terminology

[0262] While the disclosure has been described in the context of certain embodiments and examples, it is understood that the disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses and obvious modifications and equivalents thereof. Moreover, although the best mode has been disclosed for carrying out the disclosure, a wide variety of modifications thereto can be made that will be apparent to those skilled in the art. For example, other features of the disclosed embodiments can be combined in different combinations than the combinations explicitly disclosed. It is therefore intended that the disclosure not be limited to the particular disclosed embodiments described above. Rather, the scope of the disclosure is to be determined entirely by the following claims, which are to be interpreted in light of the teachings recited herein. It is further intended that the features of the disclosed embodiments can be used in any combination or sub-combination with the features of other disclosed embodiments. For example, features described above in connection with one embodiment can be used in combination with or substituted for features of a different embodiment, and the combination still falls within the scope of the disclosure. It is understood that the various features and aspects of the disclosed embodiments can be combined or substituted for one another, to form variations of the disclosed embodiments. Therefore, it is intended that the disclosure not be limited to the particular disclosed embodiments described above. Accordingly, unless otherwise indicated, each embodiment of the disclosure can include one or more features of each other embodiment of the disclosure described herein, in addition to its own necessary features.

[0263] Features, materials, characteristics, or groups described in conjunction with a particular aspect, embodiment, or example are not to be interpreted as being unsuitable for, nor requiring, combination with any of the other aspects, embodiments, or examples described in this section or elsewhere in this specification, unless so incompatible. All features disclosed in this specification, including any accompanying claims, abstract, and drawings, and / or any method or process disclosed can be combined in any combination, provided such a combination does not inherently contradict any of the features or steps of such a combination. The present disclosure is not limited to the details of any foregoing embodiments. The scope of this disclosure extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), or to any novel step of any method or process so disclosed.

[0264] Furthermore, certain features described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation can also be implemented separately or in any suitable sub-combination. Moreover, although some features can be described above as acting in concert, in some cases one or more features of a claimed combination can be removed and the combination can be claimed as a sub-combination or variation of a sub-combination.

[0265] Furthermore, although certain operations can be depicted in the drawings or described herein in a particular order, such operations need not be performed in the particular order shown or in sequential order, or that all operations be performed, to achieve desirable results. Other operations that are not depicted or described are within the scope of the example methods and processes. For example, one or more additional operations can be performed before, after, simultaneously, or between any of the described operations. Further, these operations can be rearranged or reordered in other implementations. Those skilled in the art will appreciate that the actual steps taken in the processes shown and / or disclosed can differ from one or more of the steps shown in the drawings. Depending on the embodiment, certain of the steps described above can be removed, others can be added, and the sequence of steps can be altered. Moreover, features and attributes of the specific embodiments disclosed above can be combined in different ways to form additional implementations, all of which fall within the scope of the present disclosure. Also, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products.

[0266] For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. It is to be understood that not necessarily all such advantages can be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure can be practiced without some or all of the advantages to be

[0267] Conditional language used herein, such as, among others, "can," "could," "might," "may," "e.g.," "for instance," "e.g.," "for example," and the like, unless specifically stated otherwise, is understood as simply permitting that there are other instances when the alternative, modification or other embodiment can not be used. Thus, the conditional language is not generally intended to imply that features, elements and / or steps are in any way required, or that one or more embodiments necessarily include logic for deciding, with or without other input or prompting, whether these features, elements and / or steps are included or are to be performed, or whether they are used or not.

[0268] Connective language, such as the phrase "at least one of X, Y, and Z," is generally understood as meaning that the item, term, etc. can be one, some, or all of the elements listed. Thus, such connective language is generally not intended to mean that certain embodiments require at least one of X, at least one of Y, and at least one of Z.

[0269] Degree language such as "about," "approximately," "generally," and "substantially" as used herein with respect to a given value, quantity, or characteristic is intended to convey that the value, quantity, or characteristic is within a degree of accuracy, or within a range of values, that is acceptable for the given purpose. For example, the terms "about," "approximately," "generally," and "substantially" can refer to an amount that is within less than 10% of the stated amount, within less than 5% of the stated amount, within less than 1% of the stated amount, within less than 0.1% of the stated amount, or within less than 0.01% of the stated amount. As another example, in certain embodiments, the terms "approximately parallel" and "substantially parallel" refer to an amount that deviates from being perfectly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degrees, or other value, amount, or characteristic.

[0270] Any of the methods disclosed herein need not be performed in the order recited. The methods disclosed herein include some actions performed by a practitioner; however, the methods can also include any third-party instructions for those actions, whether explicit or implicit. For example, an action such as "controlling motor speed" includes "instructing control of motor speed."

[0271] All of the methods and tasks described herein can be performed by a computer system and are entirely automated. In some cases, the computer system can include multiple different computers or computing devices (e.g., physical servers, workstations, storage arrays, cloud computing resources, etc.) that communicate and interoperate over a network to perform the described functions. Each such computing device typically includes a processor (or multiple processors) that executes program instructions or modules stored in memory or other non-transitory computer readable storage media or devices (e.g., solid state storage devices, disk drives, etc.). Different functions described herein can be embodied in such program instructions, and / or can be implemented in specialized circuitry (e.g., ASICs or FPGAs) of the computer system. When the computer system includes multiple computing devices, these devices can be co-located but need not be. The results of the disclosed methods and tasks can be stored persistently, by transforming physical storage chips and / or disks, for example, into different states. In some embodiments, the computer system can be a cloud-based computing system whose processing resources are shared by multiple different business entities or other users.

[0272] The scope of the disclosure is not intended to be limited to the particular disclosure of the preferred implementation in this section or elsewhere in the specification, and can be defined by the claims as they can be presented in this section or elsewhere in the specification or in the future. The language of the claims will be construed broadly based on the language employed in the claims and will not be limited to examples described in the specification or described during prosecution of the application, which examples are to be construed as non-exclusive.

Claims

1. A high-flow respiratory system for delivering high-flow respiratory therapy to a patient, the system being configured to adjust the flow rate of gas delivered to the patient according to the patient's inhalation and exhalation, the system comprising: A flow generator, which includes a motor, is used to generate a gas flow. as well as The controller is in electrical communication with one or more sensors and is configured to: The user interface of the respiratory system displays the expiratory release level settings, which include several different expiratory release levels; Before treatment begins, user input is received via this user interface to increase or decrease the expiratory release level; Before treatment begins, the availability of user input to reduce the expiratory release level is determined based on a comparison with a minimum flow rate threshold selected to ensure the effectiveness and safety of high-flow treatment. The minimum flow rate threshold includes a percentage higher or lower than the selected flow rate. The patient's inhalation and exhalation cycles are determined based on information received from the one or more sensors; The flow rate is adjusted based on the user input, wherein the user input is configured to allow adjustment of the flow rate in part based on the cycle of the patient's exhalation; as well as The modulation is reduced by comparing the minimum flow rate threshold with the minimum flow rate measured by the one or more sensors during the high-flow-rate respiratory therapy.

2. The system as claimed in claim 1, wherein, The user input is configured to allow the flow rate to be adjusted, in part, based on the patient’s inspiratory and expiratory cycles, by turning the expiratory release on or off, or by adjusting the magnitude of the expiratory release.

3. The system as described in claim 1 or 2, wherein, The multiple different expiratory release levels include multiple categories, which include at least low expiratory release levels and high expiratory release levels.

4. The system as described in claim 1 or 2, wherein, These multiple different expiratory release levels include a series of numbers.

5. The system as described in claim 1 or 2, wherein, These multiple different expiratory release levels include a sliding scale.

6. The system as claimed in claim 1 or 2, wherein, The user input is received via one or more buttons on the user interface.

7. The system of claim 1 or 2, comprising a non-sealed patient interface.

8. The system of claim 7, wherein, The unsealed patient interface includes an unsealed nasal cannula.

9. The system as claimed in claim 1 or 2, wherein, These expiratory release levels affect the negative feedback of this regulation of the flow rate.

10. The system as claimed in claim 1 or 2, wherein, The controller is further configured to display a minimum flow rate threshold setting on the user interface and to receive a second user input to increase and / or decrease the minimum flow rate threshold.

11. The system as claimed in claim 1 or 2, wherein, The controller is further configured to reduce the regulation based on the user input, by means of parameters determined in part based on the minimum flow rate measured by the one or more sensors during the patient's inhalation and exhalation cycles.

12. The system as claimed in claim 1 or 2, wherein, The flow rate is adjusted by outputting a motor control signal.

13. The system as claimed in claim 1 or 2, wherein, This adjustment includes reducing the flow rate when the patient is exhaling.

14. The system as claimed in claim 1 or 2, wherein, The patient's inhalation and exhalation cycles are determined based on a first input and a second input received by the controller, the first input and the second input being related to gas flow characteristics or the performance of components of the system.

15. The system of claim 14, wherein, The first input corresponds to the flow rate from the one or more sensors.

16. The system of claim 14, wherein, The second input corresponds to the pressure of the gas flow from the one or more sensors, or the speed of the motor in the flow generator.

17. The system as claimed in claim 1 or 2, wherein, This adjustment is performed repeatedly.

18. The system as claimed in claim 1 or 2, wherein, The one or more sensors include an ultrasonic transducer assembly or a heated temperature sensing element.

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