A respiratory system for facilitating respiratory physiotherapy

Abstract

A breathing assistance apparatus that is configured to provide a flow of gases to a user. The apparatus has a flow generator that is operable to generate the flow of gases for the user, and a humidifier that is operable to humidify the flow of gases in accordance with humidity settings. A controller is provided that controls the breathing assistance apparatus. The controller can selectively operate the breathing assistance apparatus in a therapy mode in which the controller controls the flow of gases to provide a respiratory therapy in a therapy session for the user, and an exercise mode in which the controller controls the flow of gases in accordance with an exercise session of one or more breathing exercises being performed by the user against the flow of gases.

Description

[0001] A RESPIRATORY SYSTEM FOR FACILITATING RESPIRATORY PHYSIOTHERAPY

[0002] FIELD OF THE DISCLOSURE

[0003] The present disclosure relates to a respiratory system for facilitating respiratory physiotherapy as part of a therapy programme. The respiratory physiotherapy may comprise facilitation of breathing exercises. The respiratory system may comprise a breathing assistance apparatus and a mouthpiece attachment. The respiratory system may capture data for measuring user performance and / or compliance with the therapy programme or components of it, such as the breathing exercises.

[0004] BACKGROUND

[0005] Breathing assistance apparatuses are used in various environments such as hospital, medical facility, residential care, or home environments to deliver a flow of gases to users or patients. A breathing assistance or respiratory therapy apparatus may be used to deliver supplementary oxygen or other gases with a flow of gases, and / or a humidification apparatus to deliver heated and humidified gases. A breathing assistance apparatus may allow adjustment and control over characteristics of the gases flow, including flow rate, temperature, gases concentration, humidity, pressure, etc. Sensors, such as flow sensors and / or pressure sensors are used to measure characteristics of the gases flow.

[0006] SUMMARY

[0007] In a first aspect, this disclosure broadly relates to an apparatus that is configured to provide a flow of gases to a user, comprising: a flow generator that is operable to generate the flow of gases for the user; a humidifier that is operable to humidify the flow of gases in accordance with humidity settings; and a controller that is configured to control the apparatus in accordance with an exercise mode in which the controller controls the flow of gases in accordance with an exercise session of one or more breathing exercises being performed by the user against the flow of gases, and wherein the controller is configured to control the humidity settings of the humidifier in accordance with a humidity control protocol that is associated with the exercise mode.

[0008] In a configuration, the humidity control protocol is at least partly based on one or more environmental data representing environmental conditions associated with the environment within which the apparatus is operating.

[0009] In a configuration, the environmental data is provided by one or more sensors of the apparatus and / or external data sources that are in data communication with the apparatus.

[0010] In a configuration, the environmental data comprises any one or more of the following parameters: ambient temperature, ambient humidity, temperature of gases drawn into a gases inlet of the apparatus for the flow generator, humidity of the gases drawn into a gases inlet of the apparatus for the flow generator, and local weather data.

[0011] In a configuration, the humidity control protocol is at least partly based on the humidity settings applied by the controller in a preceding therapy session in therapy mode, or a current humidity of the flow of gases generated or remaining from a preceding therapy session. In a configuration, the humidity control protocol comprises transitioning from a first humidity associated with the preceding therapy session to a second humidity associated with the exercise session.

[0012] In a configuration, the first humidity is a target humidity setting of the preceding therapy session or a current sensed humidity level of the flow of gases prior to commencement of the exercise session.

[0013] In a configuration, the second humidity is a target humidity setting associated with the exercise session.

[0014] In a configuration, the humidity control protocol comprises a gradual or ramped transition from the first humidity to the second humidity.

[0015] In a configuration, the gradual or ramped transition applied is in accordance with a configurable rate of change.

[0016] In a configuration, the gradual or ramped transition applied is in accordance with a configurable ramping period that defines the time period to transition from the first humidity to the second humidity.

[0017] In a configuration, the humidity control protocol comprises a sharp or instantaneous transition from the first humidity to the second humidity.

[0018] In a configuration, the first humidity is higher than the second humidity such the humidity control protocol is configured to reduce the humidity of the flow of gases for the exercise session relative to the humidity associated with the preceding therapy session.

[0019] In a configuration, the first humidity is lower than the second humidity such that the humidity control protocol is configured to increase the humidity of the flow of gases for the exercise session relative to the humidity associated with the preceding therapy session. In a configuration, the humidity control protocol is configured to maintain a constant target humidity setting for the entire exercise session.

[0020] In a configuration, the humidity control protocol is configured to change a target humidity setting during the exercise session.

[0021] In a configuration, the humidity control protocol is configured to change the target humidity setting based at least partly on the type of breathing exercise being performed by the user during the exercise session.

[0022] In a configuration, a change or changes in the target humidity setting are synchronised to a change or changes in the type of breathing exercise being performed by the user during the exercise session.

[0023] In a configuration, the humidity control protocol is configured to change the target humidity setting in a manner that is asynchronous or independent to a change or changes in the type of breathing exercise being performed by the user during the exercise session.

[0024] In a configuration, a series of one or more different types of breathing exercises are performed during an exercise session and each type of breathing exercise has a respective preconfigured humidity setting.

[0025] In a configuration, the humidity control protocol is configured to apply or change a target humidity setting so as to correspond to the preconfigured humidity setting for the type of breathing exercise being performed.

[0026] In a configuration, the preconfigured humidity setting for a type of breathing exercise is dependent or at least partly based on the associated pressure and / or flow rate of the flow of gases provided for that type of breathing exercise.

[0027] In a configuration, the preconfigured humidity setting is lower for a breathing exercise with a low pressure or flow rate relative to a breathing exercise with a higher pressure or flow rate. In a configuration, the humidity control protocol is configured to apply a target humidity setting based at least partly on the flow rate of the flow of gases provided for the breathing exercise.

[0028] In a configuration, the humidity control protocol is configured to apply a humidity setting of above approximately 31 °C dew point for a flow rate above approximately 151pm, or above approximately 201pm, or above approximately 251pm.

[0029] In a configuration, the humidity control protocol is configured to apply a humidity setting of above approximately 25°C dew point for a flow rate above approximately 151pm, or above approximately 201pm, or above approximately 251pm.

[0030] In a configuration, the humidity control protocol is configured to apply a humidity setting of below approximately 31 °C dew point for a flow rate below approximately 151pm, or below approximately 201pm, or below approximately 251pm.

[0031] In a configuration, the humidity control protocol is configured to apply a humidity setting of below approximately 25°C dew point for a flow rate below approximately 151pm, or below approximately 201pm, or below approximately 251pm.

[0032] In a configuration, the humidity control protocol is configured to change a target humidity setting during the exercise session in accordance with a humidity plan stored in the controller or memory accessible to the controller.

[0033] In a configuration, the humidity plan defines a target humidity setting that is independent of the length of the exercise session and / or type of breathing exercises being performed in the exercise session.

[0034] In a configuration, the humidity plan defines an oscillating target humidity setting.

[0035] In a configuration, the oscillating target humidity setting oscillates between a lower humidity setting and an upper humidity setting. In a configuration, the humidity plan defines an application of the target humidity setting or oscillating target humidity setting for a predetermined time period.

[0036] In a configuration, the humidity plan defines an application of the target humidity setting or oscillating target humidity setting until any one or more of the following triggers occurs: receiving manual user input by user to apparatus requesting a drop in humidity, detecting a specified number mouthpiece or respiratory patient interface disconnections, detected predefined user actions, determining delivery of a completed total humidity dosage, detecting a metric or combination of metrics satisfying a respective maximum or minimum threshold, the metrics comprising any one or more of the following: number of breathing exercises completed, time completed for breathing exercises, amount of humidity delivered, and number of breaths undertaken.

[0037] In a configuration, the humidity control protocol is configured to reduce the target humidity setting or oscillating target humidity setting applied following one of the triggers occurring.

[0038] In a configuration, the humidity control protocol is configured to reduce the target humidity setting or oscillating target humidity setting temporarily for a predetermined time period and / or until a preconfigured trigger is detected, and then resumes application of the prior target humidity setting or oscillating target humidity setting.

[0039] In a configuration, the oscillating target humidity setting comprises an oscillating humidity profile selected or created from any one or more the following oscillating profiles: sinusoidal profile, sawtooth profile, square wave profile, and triangle profile. In a configuration, the controller is configured to implement the oscillating target humidity setting of the humidity plan by controlling a power output waveform of a heater plate of the humidifier to oscillate according to an oscillating power profile selected or created from any one or more of the following oscillating profiles: sinusoidal profile, sawtooth profile, square wave profile, and triangle profile.

[0040] In a configuration, the oscillating humidity profile and / or oscillating power profile comprises any sequence, combination, and / or superimposition of oscillating profiles.

[0041] In a configuration, the breathing exercises of the exercise session comprise any one or more of:

[0042] ACBTs, maximal voluntary ventilation breathing, huffing, slow and deep inhalation, inspiratory breath hold forced expiration, and / or pursed lip breathing.

[0043] In a configuration, the breathing exercises of the exercise session comprise any one or more of: breathing against an oscillating positive expiratory pressure (OPEP), breathing against intrapulmonary percussive ventilation (IPV), breathing against a continuous positive airway pressure (CPAP) with oscillations, and / or breathing against a Bilevel pressure (Bilevel) with oscillations.

[0044] In a configuration, the apparatus further comprises a mouthpiece attachment that is fluidly connected or connectable to a gases outlet of the apparatus, either directly or via a breathing conduit, to receive the flow of gases, and wherein the mouthpiece attachment enables a user to perform the breathing exercises against the flow of gases. In a configuration, the breathing exercises of the exercise session comprise any one or more of:

[0045] ACBTs, maximal voluntary ventilation breathing, huffing, slow and deep inhalation, pursed lip breathing, inspiratory breath hold, forced expiration, breathing against an oscillating positive expiratory pressure (OPEP), breathing against intrapulmonary percussive ventilation (IPV), breathing against a continuous positive airway pressure (CPAP) with oscillations, and / or breathing against a Bilevel pressure (Bilevel) with oscillations.

[0046] In a configuration, the controller is configured to prompt the user to perform, after and / or before one or more of the breathing exercises, one or more of the following: normal breathing, and tidal breathing.

[0047] In a configuration, the controller is configured to control the pressure and / or flow rate of the flow of gases during the exercise mode as the user performs the breathing exercises.

[0048] In a configuration, the controller is configured to control the pressure and / or flow rate of the flow of gases during the exercise mode to control a pneumatic resistance provided to the user as the user performs breathing exercises against the flow of gases.

[0049] In a configuration, the controller is configured to prevent any negative pressure in the flow of gases during the breathing exercises. In a configuration, the breathing exercises comprise mucus clearance therapy (MCT) exercises.

[0050] In a configuration, the MCT exercises comprise the controller providing a flow of gases having a pressure or flow rate that comprises an oscillatory component.

[0051] In a configuration, the MCT exercises comprise any one or more of: breathing against an oscillating positive expiratory pressure (OPEP), breathing against intrapulmonary percussive ventilation (IPV), breathing against a continuous positive airway pressure (CPAP) with oscillations, and / or breathing against a Bilevel pressure (Bilevel) with oscillations.

[0052] In a configuration, the breathing exercises comprise MCT exercises and other different exercises, and wherein the humidity control protocol is configured to maintain a higher target humidity setting for MCT exercises relative to the other exercises.

[0053] In a configuration, the higher target humidity setting is at least approximately 31 °C dew point, or at least 37° dew point, or at least 44°C dew point.

[0054] In a configuration, the humidity control protocol is configured to select or derive a target humidity setting for the exercise session based at least partly on or as a function of one or more therapy settings associated with a preceding therapy session in therapy mode.

[0055] In a configuration, the therapy settings include any one or more of the following: pressure setting, flow rate setting, and / or humidity setting.

[0056] In a configuration, the controller is further configured to selectively control the apparatus in accordance with a therapy mode in which the controller controls the flow of gases to provide respiratory therapy in a therapy session for the user.

[0057] In a configuration, the apparatus is a breathing assistance apparatus. In a configuration, the controller is configured to control the apparatus, in either therapy mode or exercise mode, to deliver the flow of gases in accordance with a Positive Airway Pressure (PAP) mode in which the flow of gases is provided according to a PAP therapy with a pressure setting or settings having an oscillatory component and humidity settings in accordance with the humidity control protocol.

[0058] In a configuration, the controller is configured to control the apparatus to deliver the flow of gases with pressure settings according to a Non-invasive ventilation (NIV) therapy with an oscillatory component, and humidity settings according to at least approximately 31 °C dew point, or at least approximately 37°C dew point.

[0059] In a configuration, the exercise mode comprises providing a flow of gases in accordance with flow rate and / or pressure settings that have an oscillatory component.

[0060] In a configuration, the controller operates or switches the apparatus to operate in accordance with the exercise mode without input from the user.

[0061] In a second aspect, this disclosure broadly relates to a breathing assistance apparatus that is configured to provide a flow of gases to a user, comprising: a flow generator that is operable to generate the flow of gases for the user; a humidifier that is operable to humidify the flow of gases in accordance with humidity settings; a controller that is operable to control the breathing assistance apparatus, the controller being configured to selectively operate the breathing assistance apparatus in: a therapy mode in which the controller controls the flow of gases to provide a respiratory therapy in a therapy session for the user; and an exercise mode in which the controller controls the flow of gases in accordance with an exercise session of one or more breathing exercises being performed by the user against the flow of gases, and wherein the controller is configured, in a single use session, to initiate the therapy mode for one or more therapy sessions of respiratory therapy and initiate the exercise mode for one or more exercise sessions of breathing exercises at least partly according to a therapy schedule.

[0062] In a configuration, the controller initiates the therapy mode and exercise mode in a sequence that corresponds to the therapy schedule.

[0063] In a configuration, the controller is configured to initiate and / or switch between the therapy mode and the exercise mode according to the therapy schedule and based on user input to the apparatus.

[0064] In a configuration, the controller is configured to generate prompts to the user to initiate and / or switch between the therapy mode and the exercise mode according to the therapy schedule.

[0065] In a configuration, the controller is configured to initiate and / or switch between the therapy mode and the exercise mode based on confirmatory user input in response to the prompts.

[0066] In a configuration, the controller is configured to automatically initiate the therapy mode and the exercise mode in a sequence that corresponds to the therapy schedule.

[0067] In a configuration, the therapy schedule is stored in a memory of the apparatus or accessible to the apparatus.

[0068] In a configuration, the therapy schedule is at least partly configurable via a user interface of the apparatus or remotely from an external device in data communication with the apparatus.

[0069] In a configuration, the controller is configured to generate the therapy schedule at least partly based on prescription data received via a user interface of the apparatus or remotely from an external device that is in data communication with the apparatus. In a configuration, the controller is configured to generate the therapy schedule at least partly based on user input received via a user interface of the apparatus or remotely from an external device that is in data communication with the apparatus.

[0070] In a configuration, the controller is configured to receive the therapy schedule into a memory of the apparatus from an external device that is in data communication with the apparatus.

[0071] In a configuration, the therapy schedule is at least partly automatically configured for the user based on user-specific data.

[0072] In a configuration, the user-specific data comprises any one or more of the following: usage data relating to the user’s prior therapy sessions and / or exercise sessions, sensor data captured by sensors of the apparatus during the user’s prior therapy sessions and / or exercise sessions, and / or survey feedback data representing the user’s feedback relating to prior therapy sessions and / or exercise sessions, and / or survey feedback data representing the user’s feedback relating to their perceived health status.

[0073] In a configuration, the therapy schedule is at least partly preconfigured by the controller prior to the commencement of the use session based on one or more data parameters received by or accessible to the apparatus.

[0074] In a configuration, the therapy schedule is at least partly dynamically configured by the controller during the use session based on one or more data parameters received by or accessible to the apparatus.

[0075] In a configuration, the therapy schedule is at least partly dynamically configured by the controller according to one or more rules that are triggered based on evaluation of the one or more data parameters, and wherein a triggered rule causes the controller to switch from a therapy mode to exercise mode, or vice versa. In a configuration, one or more of the rules are triggered based on evaluation of one or more of the data parameters against one or more thresholds.

[0076] In a configuration, the data parameters comprise any one or more of: time of day, length of session or use session, frequency of use, and / or physiological parameters of the user.

[0077] In a configuration, the controller is configured to implement a therapy schedule that comprises: initiating the therapy mode for a therapy session and subsequently initiating the exercise mode for an exercise session following the therapy session.

[0078] In a configuration, the controller is configured to implement a therapy schedule that comprises: initiating the exercise mode for an exercise session and subsequently initiating the therapy mode for a therapy session following the exercise session.

[0079] In a configuration, the controller is configured to implement a therapy schedule that comprises: initiating the therapy mode for a therapy session both before and after initiating the exercise mode for an exercise session, such that a therapy session is provided both before and after an exercise session.

[0080] In a configuration, the controller is configured to implement a therapy schedule that comprises: initiating the therapy mode for a therapy session; and subsequently initiating one or more repeated cycles comprising: pausing the therapy session in therapy mode, initiating an exercise session in exercise mode, and re-initiating the paused therapy session in therapy mode.

[0081] In a configuration, the controller is configured to implement a therapy schedule that comprises: alternating between the therapy mode for a therapy session and the exercise mode for an exercise session to provide a series or multiple alternating therapy sessions and exercise sessions. In a configuration, each therapy session in the series provides the same type of respiratory therapy.

[0082] In a configuration, at least one therapy session in the series provides a different type of respiratory therapy relative to other therapy sessions in the series.

[0083] In a configuration, the series comprises a first therapy session comprising a pressure- controlled respiratory therapy, and a subsequent second therapy session comprising a flow-controlled respiratory therapy, or vice versa.

[0084] In a configuration, each exercise session in the series provides the same type of breathing exercises.

[0085] In a configuration, at least one exercise session in the series provides different breathing exercises relative to other exercise sessions in the series.

[0086] In a configuration, the series comprises a first exercise session comprising mucus clearance therapy (MCT) exercises, and a subsequent second exercise session comprising other different exercises, or vice versa.

[0087] In a configuration, the controller is configured to implement a therapy schedule that comprises: initiating the therapy mode for a therapy session that comprises a pressure- controlled or flow-controlled respiratory therapy; and subsequently initiating the exercise mode for an exercise session, and wherein the exercise session comprises continuing the pressure-controlled or flow-controlled respiratory therapy with an oscillatory component applied to the flow of gases so as to provide mucus clearance therapy (MCT) exercises.

[0088] In a configuration, the apparatus further comprises: a breathing conduit for delivery of the flow of gases; and a respiratory patient interface and / or a mouthpiece attachment that is fluidly connected or connectable to a user-end of the breathing conduit to receive the flow of gases. In a configuration, the controller in exercise mode is configured to control the flow of gases to control a pneumatic resistance provided at the mouthpiece attachment or respiratory patient interface while the user performs one or more breathing exercises with the mouthpiece attachment or respiratory patient interface.

[0089] In a configuration, the respiratory patient interface is connected to the breathing conduit during the therapy mode.

[0090] In a configuration, the mouthpiece attachment is connected to the breathing conduit during the exercise mode.

[0091] In a configuration, the respiratory patient interface is connected to the breathing conduit during both the therapy mode and exercise mode such that the user performs the therapy sessions and exercise sessions of the therapy schedule with the same respiratory patient interface.

[0092] In a configuration, the controller is configured to generate a prompt instructing the user on which interface to connect to the breathing conduit depending on the mode of operation of the apparatus and / or breathing exercise being performed, the interface comprising the respiratory patient interface or the mouthpiece attachment.

[0093] In a configuration, the respiratory therapy or therapies provided in therapy mode comprises any one or more of: high flow therapy, nasal high flow (NHF) therapy,

[0094] Positive Airway Pressure (PAP) therapy,

[0095] Continuous Positive Airway Pressure (CPAP) therapy,

[0096] Non-invasive ventilation (NIV) therapy, oscillation therapy, and / or

[0097] Bilevel pressure therapy. In a configuration, the breathing exercises provided in exercise mode comprise any one or more of:

[0098] ACBTs, maximal voluntary ventilation breathing, huffing, slow and deep inhalation, pursed lip breathing, inspiratory breath hold, forced expiration, breathing against a fixed positive expiratory pressure (PEP), breathing against an oscillating positive expiratory pressure (OPEP), breathing against intrapulmonary percussive ventilation (IPV), breathing against a continuous positive airway pressure (CPAP) with oscillations, and / or breathing against a Bilevel pressure (Bilevel) with oscillations.

[0099] In a configuration, the breathing exercises provided in exercise mode comprise mucus clearance therapy (MCT) exercises.

[0100] In a configuration, the MCT exercises comprise the controller providing a flow of gases having a pressure or flow rate that comprises an oscillatory component.

[0101] In a configuration, the MCT exercises comprise any one or more of: breathing against an oscillating positive expiratory pressure (OPEP), breathing against intrapulmonary percussive ventilation (IPV), breathing against a continuous positive airway pressure (CPAP) with oscillations, and / or breathing against a Bilevel pressure (Bilevel) with oscillations.

[0102] In a configuration, the breathing exercises provided in exercise mode comprise MCT exercises and other exercises, wherein the other exercises comprise any one or more of: normal breathing,

[0103] ACBTs, tidal breathing, maximal voluntary ventilation breathing, huffing, slow and deep inhalation, inspiratory breath hold, forced expiration, and / or pursed lip breathing.

[0104] In a configuration, the respiratory therapy provided in therapy mode comprises nasal high flow (NHF) therapy, and the breathing exercises provided in therapy mode comprise mucus clearance therapy (MCT) exercises and / or other exercises; and wherein the controller is configured to implement a therapy schedule that comprises: initiating a therapy session of NHF therapy in therapy mode before and / or after initiating an exercise session of MCT exercises and / or other exercises in exercise mode.

[0105] In a configuration, the respiratory therapy provided in therapy mode comprises non- inventive ventilation (NIV) therapy, and the breathing exercises provided in therapy mode comprise mucus clearance therapy (MCT) exercises and / or other exercises; and wherein the controller is configured to implement a therapy schedule that comprises: initiating a therapy session of NIV therapy in therapy mode before and / or after initiating an exercise session of MCT exercises and / or other exercises in exercise mode.

[0106] In a configuration, the respiratory therapy provided in therapy mode comprises non- inventive ventilation (NIV) therapy or nasal high flow (NHF) therapy, and the breathing exercises provided in therapy mode comprise mucus clearance therapy (MCT) exercises and / or other exercises; and wherein the controller is configured to implement a therapy schedule that comprises: initiating a therapy session of one of either NIV therapy or NHF therapy in therapy mode before initiating an exercise session of MCT exercises and / or other exercises in exercise mode; and initiating a therapy session of the other of either NIV therapy or NHF therapy in therapy mode after the exercise session.

[0107] In a configuration, the controller operates the humidifier to humidify the flow of gases in either or both of the therapy mode and exercise mode.

[0108] In a configuration, the controller is configured to apply humidity settings to the humidifier that are at least partly based on the type of respiratory therapy and / or breathing exercises being provided by the apparatus.

[0109] In a configuration, the therapy mode is configured to deliver a flow of gases according to an oscillatory therapy.

[0110] In a configuration, the controller is further operable any one or more of the following additional modes: rest mode and cough mode.

[0111] In a configuration, the controller is further operable in a pre-conditioning mode.

[0112] In a configuration, the therapy schedule corresponds to a therapy programme.

[0113] In a configuration, the therapy programme comprises a sequence of stages, each stage having an assigned mode of operation.

[0114] In a configuration, the controller is configured to operate the breathing assistance apparatus in the assigned mode operation for each stage in the therapy programme.

[0115] In a configuration, the therapy programme comprises a preconfigured sequence of stages, each stage with an assigned mode of operation.

[0116] In a configuration, the therapy programme comprises a sequence of stages, each stage having an assigned mode of operation selected from at least one or more of the following modes: therapy mode, exercise mode, cough mode, and rest mode. In a configuration, the controller is configured to operate the breathing assistance apparatus in a pre-conditioning mode prior to initiating the therapy programme.

[0117] In a configuration, the therapy programme comprises a sequence of stages, each stage having an assigned mode of operation selected from at least one or more of the following modes: therapy mode, exercise mode, cough mode, rest mode, and pre-conditioning mode.

[0118] In a configuration, the controller is configured to transition the breathing assistance apparatus between the assigned modes of operation of the stages of the therapy programme automatically.

[0119] In a configuration, the controller is configured to transition the breathing assistance apparatus between the assigned modes of operation of the stages of the therapy programme at least partly based on user input or interaction with the breathing assistance apparatus.

[0120] In a configuration, the user input or interaction is received by the controller via a user interface of the breathing assistance apparatus.

[0121] In a configuration, the therapy programme comprises a sequence of any permutation of stages comprising assigned modes of operation selected from at least one or more of the following modes: therapy mode, exercise mode, cough mode, rest mode, and preconditioning mode.

[0122] In a configuration, the therapy comprises one or more individual stages or one or more groups of stages that are repeated one or more times.

[0123] In another aspect, this disclosure broadly relates to a breathing assistance apparatus that is configured to provide a flow of gases to a user, comprising: a flow generator that is operable to generate the flow of gases for the user; a humidifier that is operable to humidify the flow of gases in accordance with humidity settings; a controller that is operable to control the breathing assistance apparatus, the controller being configured to selectively operate the breathing assistance apparatus in: a therapy mode in which the controller controls the flow of gases to provide a respiratory therapy in a therapy session for the user; and an exercise mode in which the controller facilitates an exercise session of one or more breathing exercises being performed by the user, and wherein the controller is configured, in a single use session, to initiate the therapy mode for one or more therapy sessions of respiratory therapy and initiate the exercise mode for one or more exercise sessions of breathing exercises at least partly according to a therapy schedule.

[0124] In a third aspect, this disclosure broadly comprises a breathing assistance apparatus that is configured to provide a flow of gases to a user, comprising: a flow generator that is operable to generate the flow of gases for the user; a humidifier that is operable to humidify the flow of gases; a controller that is operable to control the breathing assistance apparatus, the controller being configured to selectively operate the breathing assistance apparatus in: a therapy mode in which the controller controls the flow of gases according to therapy settings to provide a respiratory therapy in a therapy session for the user; a pre-conditioning mode in which the controller controls the flow of gases according to pre-conditioning settings to pre-condition the user for an exercise session in exercise mode; and an exercise mode in which the controller controls the flow of gases in accordance with an exercise session of one or more breathing exercises being performed by the user against the flow of gases, and wherein the controller is configured to transition from a current therapy session in therapy mode to an exercise session in exercise mode by: initiating a pre-conditioning mode prior to the commencement of the exercise session. In a configuration, the pre-conditioning mode is configured to immediately modify one or more of the therapy settings to the pre-conditioning settings.

[0125] In a configuration, the pre-conditioning mode is configured to gradually transition one or more of the therapy settings to the pre-conditioning settings.

[0126] In a configuration, the pre-conditioning mode is configured to gradually transition one or more of the therapy settings to the pre-conditioning settings over a transition period.

[0127] In a configuration, the controller is configured to operate the pre-conditioning mode for a pre-conditioning period.

[0128] In a configuration, the pre-conditioning period is preconfigured.

[0129] In a configuration, the pre-conditioning period is configurable or selectable via user input to the apparatus either directly or indirectly via an external device in data communication with the apparatus.

[0130] In a configuration, the controller is configured to initiate the transition from therapy mode to exercise mode during a therapy session based at least partly on transition data, and wherein initiating the transition comprises initiating the pre-conditioning mode.

[0131] In a configuration, the transition data comprises data indicative of a transition time at which the apparatus will transition to the exercise mode from the current therapy mode.

[0132] In a configuration, the controller receives the data indicative of the transition time either prior to the therapy session or during the therapy session.

[0133] In a configuration, the controller is configured to operate the pre-conditioning mode for a pre-conditioning period prior to the transition time.

[0134] In a configuration, the transition data comprises user input data received during the current therapy session that represents a desired transition to exercise mode. In a configuration, the user input data further comprises a selected pre-conditioning period, and wherein the controller is configured to operate the pre-conditioning mode for the selected pre-conditioning period, prior to initiating the exercise mode for an exercise session.

[0135] In a configuration, the transition data comprises one or more trigger conditions, and wherein the controller initiates the pre-conditioning mode based at least partly on whether at least one of the trigger conditions is satisfied.

[0136] In a configuration, the one or more trigger conditions comprise evaluating whether one or more user physiological parameters satisfy one or more thresholds.

[0137] In a configuration, the controller is configured to initiate the exercise mode for an exercise session immediately following the completion of a pre-conditioning period in the preconditioning mode.

[0138] In a configuration, the controller is configured to initiate the exercise mode for an exercise session after a predetermined or configurable preparation period has elapsed following the completion of the pre-conditioning period in the pre-conditioning mode.

[0139] In a configuration, the controller is operable to terminate the preparation period to commence the exercise session in exercise mode in response to user input received by the apparatus or automatically based on data sensed or determined by the apparatus.

[0140] In a configuration, the controller is configured to initiate the exercise mode for an exercise session in response to user input following the completion of the pre-conditioning period in the pre-conditioning mode.

[0141] In a configuration, the user input is a response to a query by the apparatus as to whether the user is prepared to commence the exercise session in the exercise mode. In a configuration, the controller is configured to initiate the exercise mode for an exercise session in response to one or more trigger conditions being satisfied following the completion of the pre-conditioning period in the pre-conditioning mode.

[0142] In a configuration, the one or more trigger conditions comprise evaluating whether one or more user physiological parameters satisfy one or more thresholds.

[0143] In a configuration, the one or more trigger conditions comprises determining or confirming via user input and / or sensor data whether the user has undertaken preparatory actions prompted by the apparatus.

[0144] In a configuration, the controller is operable to transition from the current therapy session in therapy mode directly to the exercise session in exercise mode without initiating the pre-conditioning mode, in response to user input to skip the pre-conditioning mode.

[0145] In a configuration, the pre-conditioning settings are preconfigured based at least partly on factory default settings and / or user-defined default settings.

[0146] In a configuration, the pre-conditioning settings are configured based on received user input or configuration data received from an external device that is in data communication with the apparatus.

[0147] In a configuration, the pre-conditioning settings are based at least partly on or a function of the therapy settings of the current therapy session.

[0148] In a configuration, the pre-conditioning settings are derived as a function or scaled version of the therapy settings within preconfigured upper and lower limits.

[0149] In a configuration, the pre-conditioning settings are based at least partly on the settings to be applied during the exercise session in exercise mode.

[0150] In a configuration, the pre-conditioning settings for the flow of gases comprise settings relating to any one or more of the following settings: flow rate, humidity, pressure, FiO2, and / or FdO2. In a configuration, the apparatus further comprises a controllable supplementary oxygen supply that is blended with atmospheric air to form the flow of gases, and wherein the pre-conditioning settings comprise higher FiO2 and / or FdO2 settings relative to the corresponding settings intended for the exercise session in exercise mode and / or the current therapy settings, so as to pre-oxygenate the user prior to the exercise session.

[0151] In a configuration, the controller is configured to turn off or substantially reduce the supplementary oxygen supply during the exercise session in exercise mode, relative to the pre-conditioning settings.

[0152] In a configuration, the pre-conditioning settings comprise a higher humidity setting relative to the corresponding setting intended for the exercise session in exercise mode and / or the current therapy setting.

[0153] In a configuration, the pre-conditioning settings comprise a higher flow rate setting relative to the corresponding setting intended for the exercise session in exercise mode and / or the current therapy setting.

[0154] In a configuration, the pre-conditioning settings comprise a higher pressure setting relative to the corresponding setting intended for the exercise session in exercise mode and / or the current therapy setting.

[0155] In a configuration, the current therapy session in therapy mode is configured with therapy settings that provide a first type of respiratory therapy, and wherein the pre-conditioning settings are configured to provide a different second type of respiratory therapy.

[0156] In a configuration, the current therapy session in therapy mode is configured with therapy settings that provide a pressure-controlled respiratory therapy, and wherein the preconditioning settings are configured to provide a flow-controlled respiratory therapy.

[0157] In a configuration, the pressure-controlled therapy is CPAP, Bilevel or NIV therapy, and the flow-controlled therapy is nasal high flow (NHF) therapy. In a configuration, the apparatus further comprises a breathing conduit connected to a gases outlet of the apparatus and a respiratory patient interface connected to an end of the breathing conduit for delivering the flow of gases to the user, and wherein the controller is configured to prompt the user to connect a different type of respiratory patient interface for the pre-conditioning mode relative to the type of respiratory patient interface connected during therapy mode.

[0158] In a configuration, the controller is configured to prompt the user to switch from a sealed respiratory patient interface to a non-sealed respiratory patient interface for the preconditioning mode, or vice versa.

[0159] In a configuration, the current therapy session in therapy mode is configured to provide a nasal high flow (NHF) therapy according to therapy settings that comprise a flow rate setting and a humidity setting, and wherein the pre-conditioning settings modify the flow rate setting and the humidity setting.

[0160] In a configuration, the current therapy session in therapy mode is configured to provide NIV therapy according to therapy settings that comprise an inspiratory pressure setting (IPAP), an expiratory pressure setting (EPAP), and rate of change of pressure setting, and wherein the pre-conditioning settings modify at least one or more of the IPAP, EPAP, and / or rate of change of pressure settings.

[0161] In a configuration, the respiratory therapy or therapies provided in therapy mode comprises any one or more of: high flow therapy, nasal high flow (NHF) therapy,

[0162] Positive Airway Pressure (PAP) therapy,

[0163] Continuous Positive Airway Pressure (CPAP) therapy,

[0164] Non-invasive ventilation (NIV) therapy, oscillation therapy, and / or

[0165] Bilevel pressure therapy. In a configuration, the breathing exercises provided in exercise mode comprise any one or more of:

[0166] ACBTs, maximal voluntary ventilation breathing, huffing, slow and deep inhalation, pursed lip breathing, inspiratory breath hold, forced expiration, breathing against a fixed positive expiratory pressure (PEP), breathing against an oscillating positive expiratory pressure (OPEP), breathing against intrapulmonary percussive ventilation (IPV), breathing against a continuous positive airway pressure (CPAP) with oscillations, and / or breathing against a Bilevel pressure (Bilevel) with oscillations.

[0167] In a configuration, the breathing exercises provided in exercise mode comprise mucus clearance therapy (MCT) exercises.

[0168] In a configuration, the MCT exercises comprise the controller providing a flow of gases having a pressure or flow rate that comprises an oscillatory component.

[0169] In a configuration, the MCT exercises comprise any one or more of: breathing against an oscillating positive expiratory pressure (OPEP), breathing against intrapulmonary percussive ventilation (IPV), breathing against a continuous positive airway pressure (CPAP) with oscillations, and / or breathing against a Bilevel pressure (Bilevel) with oscillations. In a configuration, the breathing exercises provided in exercise mode comprises MCT exercises and other exercises, wherein the other exercises comprise any one or more of:

[0170] ACBTs, maximal voluntary ventilation breathing, huffing, slow and deep inhalation, forced expiration, inspiratory breath hold, and / or pursed lip breathing.

[0171] In a configuration, the controller is configured to transition from a current therapy session to an exercise session by initiating the pre-conditioning mode during the current therapy session and prior to the commencement of the exercise session.

[0172] In a configuration, initiating pre-conditioning mode comprises modifying one or more of the therapy settings of the current therapy session to the pre-conditioning settings.

[0173] In a configuration, the pre-conditioning settings of the pre-conditioning mode are independent of the therapy settings of the current therapy session in therapy mode.

[0174] In a configuration, the therapy mode is configured to deliver a flow of gases according to an oscillatory therapy.

[0175] In a configuration, the controller is further operable any one or more of the following additional modes: rest mode and cough mode.

[0176] In a configuration, the controller is configured to deliver a sequence of stages as a therapy programme.

[0177] In a configuration, the therapy programme comprises a sequence of stages, each stage having an assigned mode of operation. In a configuration, the controller is configured to operate the breathing assistance apparatus in the assigned mode operation for each stage in the therapy programme.

[0178] In a configuration, the therapy programme comprises a preconfigured sequence of stages, each stage with an assigned mode of operation.

[0179] In a configuration, the therapy programme comprises a sequence of stages, each stage having an assigned mode of operation selected from at least one or more of the following modes: therapy mode, exercise mode, cough mode, and rest mode.

[0180] In a configuration, the controller is configured to operate the breathing assistance apparatus in the pre-conditioning mode prior to initiating the therapy programme.

[0181] In a configuration, the therapy programme comprises a sequence of stages, each stage having an assigned mode of operation selected from at least one or more of the following modes: therapy mode, exercise mode, cough mode, rest mode, and pre-conditioning mode.

[0182] In a configuration, the controller is configured to transition the breathing assistance apparatus between the assigned modes of operation of the stages of the therapy programme automatically.

[0183] In a configuration, the controller is configured to transition the breathing assistance apparatus between the assigned modes of operation of the stages of the therapy programme at least partly based on user input or interaction with the breathing assistance apparatus.

[0184] In a configuration, the user input or interaction is received by the controller via a user interface of the breathing assistance apparatus.

[0185] In a configuration, the therapy programme comprises a sequence of any permutation of stages comprising assigned modes of operation selected from at least one or more of the following modes: therapy mode, exercise mode, cough mode, rest mode, and preconditioning mode.

[0186] In a configuration, the therapy comprises one or more individual stages or one or more groups of stages that are repeated one or more times.

[0187] In another aspect, this disclosure broadly comprises a breathing assistance apparatus that is configured to provide a flow of gases to a user, comprising: a flow generator that is operable to generate the flow of gases for the user; a humidifier that is operable to humidify the flow of gases; a controller that is operable to control the breathing assistance apparatus, the controller being configured to selectively operate the breathing assistance apparatus in: a therapy mode in which the controller controls the flow of gases according to therapy settings to provide a respiratory therapy in a therapy session for the user; a pre-conditioning mode in which the controller controls the flow of gases according to pre-conditioning settings to pre-condition the user for an exercise session in exercise mode; and an exercise mode in which the controller facilitates an exercise session of one or more breathing exercises being performed by the user, and wherein the controller is configured to transition from a current therapy session in therapy mode to an exercise session in exercise mode by: initiating a pre-conditioning mode prior to the commencement of the exercise session.

[0188] In another aspect, the disclose broadly comprises a breathing assistance apparatus that is configured to provide a flow of gases to a user, comprising: a flow generator that is operable to generate the flow of gases for the user; a humidifier that is operable to humidify the flow of gases; a controller that is operable to control the breathing assistance apparatus, the controller being configured to selectively operate the breathing assistance apparatus following a therapy programme that comprises a sequence of modes of operation, the modes of operation comprising at least one of: a therapy mode; an exercise mode; a cough mode; and a rest mode, and wherein the controller is further configured to selectively operate the breathing assistance apparatus in a pre-conditioning mode.

[0189] In a configuration, the therapy mode is an oscillation therapy mode that is configured to deliver the flow of gases according to an oscillation therapy.

[0190] In a configuration, the controller is configured to operate the breathing assistance apparatus in the pre-conditioning mode prior to commencing delivery of the therapy programme.

[0191] In a configuration, the controller is configured to operate the breathing assistance apparatus in the pre-conditioning mode for a time period before commencing delivery of the therapy programme.

[0192] In a configuration, the time period of the pre-conditioning mode is predetermined.

[0193] In a configuration, the therapy programme is configured on the breathing assistance apparatus prior to commencement of the therapy programme.

[0194] In a configuration, the therapy programme is configured on the breathing assistance apparatus according to a prescription.

[0195] In a configuration, the sequence of modes of the therapy programme comprises at least one exercise mode. In a configuration, the sequence of modes of the therapy programme comprises at least one oscillation therapy mode.

[0196] In a configuration, the sequence of modes of the therapy programme comprises a final mode in the sequence that is an exercise mode or cough mode.

[0197] In a configuration, the sequence of modes of the therapy programme comprises a rest mode after an exercise mode or an oscillation therapy mode.

[0198] In a configuration, the controller is configured to transition from at least one first mode in the sequence of modes of the therapy programme to a second mode in the sequence of modes of the therapy programme automatically.

[0199] In a configuration, the controller transitions from the at least one first mode to the second mode automatically without requiring any input from the user.

[0200] In a configuration, the controller is configured to transition from at least one first mode in the sequence of modes of the therapy programme to a second mode in the sequence of modes of the therapy programme based at least partly on user input or interaction with the breathing assistance apparatus.

[0201] In a configuration, the user input or interaction is received by the controller via a user interface of the breathing assistance apparatus.

[0202] In a configuration, the user input or interaction is received via actuation of a physical or graphical button of the user interface of the breathing assistance apparatus.

[0203] In a configuration, the controller is configured to provide guidance on a user interface of the breathing assistance apparatus during the pre-conditioning mode and / or therapy programme.

[0204] In a configuration, the guidance is provided in any one or more of the following formats: visual, audio, and / or haptic. In a configuration, parameters and / or settings of each mode of operation in the sequence of modes of the therapy programme are configurable via a user interface of the breathing assistance apparatus.

[0205] In another aspect, this disclosure broadly comprises a breathing assistance apparatus that is configured to provide a flow of gases to a user, comprising: a flow generator that is operable to generate the flow of gases for the user; a humidifier that is operable to humidify the flow of gases; a controller that is operable to control the breathing assistance apparatus, the controller being configured to selectively operate the breathing assistance apparatus following a therapy programme that comprises a sequence of modes of operation, the modes of operation comprising at least one of: a therapy mode; an exercise mode; a cough mode; a rest mode; and a pre-conditioning mode.

[0206] In another aspect, this disclosure broadly comprises a method of providing respiratory therapy, the method comprising: providing a respiratory therapy device; administering, using the respiratory therapy device, a respiratory therapy; and administering, using the respiratory therapy device, respiratory exercises.

[0207] In a configuration, providing a respiratory therapy device comprises providing a respiratory therapy device comprising a humidifier.

[0208] In a configuration, the respiratory therapy device is one or more of a high flow therapy device, a nasal high flow therapy device, a continuous positive airway pressure (CPAP) therapy device, a positive airway pressure (PAP) therapy device, a non-invasive ventilation (NIV) therapy device or a bilevel pressure therapy device.

[0209] In a configuration, the respiratory exercises comprise one or more of

[0210] ACBTs, maximal voluntary ventilation breathing, huffing, slow and deep inhalation, or pursed lip breathing.

[0211] In a configuration, the respiratory exercises comprise one or more of: breathing against an oscillating positive expiratory pressure (OPEP), breathing against intrapulmonary percussive ventilation (IPV), breathing against a continuous positive airway pressure (CPAP) with oscillations, and / or breathing against a Bilevel pressure (Bilevel) with oscillations.

[0212] In a configuration, the method further comprising selecting a pressure and / or flow rate for the respiratory exercises.

[0213] In a configuration, the method further comprising adjusting the pressure and / or flow rate during the respiratory exercises.

[0214] In a configuration, the method further comprising automatically varying the pressure and / or flow rate during the respiratory exercises.

[0215] In a configuration, the method further comprising providing instructions or a prompt for attaching a first patient interface configured for administering respiratory therapy and / or providing instructions for attaching a second patient interface device configured for administering respiratory exercises. In a configuration, the method further comprising providing instructions or a prompt to perform a specified breathing exercise via the respiratory therapy device.

[0216] In a configuration, the method further comprising providing instructions or a prompt to perform a second different specified breathing exercise via the respiratory therapy device.

[0217] In a configuration, the instructions or the prompt are provided on a graphical user interface (GUI).

[0218] In a configuration, the GUI further provides a graphic indicative of a type of breathing exercise.

[0219] In another aspect, this disclosure broadly comprises a method of providing breathing exercises to a user, the method comprising: providing a respiratory therapy device; providing a respiratory therapy user interface; providing a respiratory exercise user interface; causing a user to breathe into the respiratory therapy device using the respiratory exercise user interface, the respiratory exercise user interface pneumatically connected to the respiratory therapy device and the respiratory therapy device providing a flow of gases; and providing, by the respiratory therapy device, a flow of gases to the respiratory exercise user interface.

[0220] In a configuration, providing a respiratory therapy device comprises providing a respiratory therapy device comprising a humidifier and the flow of gases comprises humidified gases.

[0221] In a configuration, the causing a user to breathe into a respiratory exercise device comprises providing a visual or auditory prompt on a display of the respiratory therapy device. In a configuration, the causing a user to breathe into a respiratory exercise user interface comprises providing a visual or auditory prompt on a user’s communication device.

[0222] In a configuration, the display further provides a graphic or animation of a respiratory exercise to perform.

[0223] In a configuration, the respiratory therapy device provides a positive pressure to the respiratory exercise device

[0224] In a configuration, the positive pressure is one or more of an oscillating positive pressure, a PEP, OPEP, IPV, CPAP or Bilevel oscillations.

[0225] In a configuration, the respiratory therapy device detects breath cycles during respiratory exercises.

[0226] In a configuration, respiratory therapy device provides a high flow of gases during respiratory exercises.

[0227] In a configuration, the respiratory therapy device provides a flow of gases sufficient to provide a pneumatic resistance of 70 L / min.

[0228] In a configuration, the collecting data from sensors in the respiratory therapy device indicative of the respiratory exercises of the user.

[0229] In a configuration, the respiratory therapy device collects data indicative of respiratory exercise performed by a user.

[0230] In a configuration, the respiratory therapy device provides an indication that a user has complied with exercise instructions. In a configuration, the respiratory therapy device applies filtering or statistical analysis to the collected data to determine a combined or aggregated average or collated set of data.

[0231] In a configuration, the method further comprising causing a user to perform a plurality of breathing exercises, spaced apart by an interval.

[0232] In a configuration, the method further comprising causing a user to perform a plurality of different breathing exercises.

[0233] In a configuration, the method further comprising prompting the user to perform a series of different respiratory modes comprising one or more of a pre-conditioning mode, a respiratory therapy mode, a respiratory exercise mode, a cough mode or a rest mode.

[0234] In another aspect, this disclosure broadly comprises a method of causing a user to perform respiratory exercises, the method comprising: sending, from one or more servers to a device associated with a user, instructions or prompts to perform various steps of one or more breathing exercises; receiving at the one or more servers confirmation, from the device associated with the user, indicating a user has complied with the instructions or prompts.

[0235] In a configuration, the respiratory therapy device comprises a humidifier and is configured to provide respiratory therapy.

[0236] In a configuration, the user device is one of a respiratory therapy device or a user communication device.

[0237] In a configuration, the confirmation is determined based on data obtained from sensors in the user respiratory therapy device.

[0238] In a configuration, the data obtained from the sensors is filtered or processed to remove noise. In a configuration, the confirmation comprises compliance data.

[0239] In a configuration, the method further comprising receiving performance data of the one or more breathing exercises.

[0240] In a configuration, the method further comprising receiving subjective feedback data responsive to at least one questionnaire.

[0241] In a configuration, the method further comprising sending, by the one or more servicers, a prompt to a care provider to follow up with user in response to one or more of compliance data, performance data of the one or more breathing exercises, or subjective feedback data falling outside of acceptable data.

[0242] In a configuration, the method further comprising amending, by a care provider or the one or more servers, a physiotherapy plan based on one or more of compliance data, performance data of the one or more breathing exercises, or subjective feedback data.

[0243] In another aspect, this disclosure broadly comprises a method of providing breathing exercises to a user using a breathing machine including a flow generator and a humidifier, the method comprising: providing, by the breathing machine, a pre-conditioning mode which provides a flow of humidified respiratory gases to a user; after providing the pre-conditioning mode, providing a sequence of physiotherapy modes comprising one or more of a rest mode, an exercise mode, a respiratory therapy mode, or a cough mode.

[0244] In a configuration, the method further comprising providing instructions to a user to operate the breathing machine. In a configuration, providing instructions comprises providing instructions on a user interface of the breathing machine.

[0245] In a configuration, providing instructions comprises providing instructions on a user device.

[0246] In a configuration, the method further comprising providing a graphic illustrating the instructions.

[0247] In a configuration, providing the sequence of physiotherapy modes further comprises providing instructions to a user to configure or reconfigure the breathing machine with a user interface associated with at least one of the sequence of physiotherapy modes.

[0248] In a configuration, the breathing machine comprises a humidification chamber configured to humidify respiratory gases.

[0249] In a configuration, the pre-conditioning mode provides humidified respiratory gases to the patient.

[0250] In a configuration, the pre-conditioning mode is followed by a cough mode where a patient is instructed to cough.

[0251] In a configuration, the pre-conditioning mode is followed by a respiratory exercise mode where a patient is instructed o breath into a respiratory exercise user interface.

[0252] In a configuration, the pre-conditioning mode is followed by a respiratory therapy mode comprising one or more of high flow therapy, a nasal high flow therapy, a continuous positive airway pressure (CPAP) therapy, a positive airway pressure (PAP) therapy, a non-invasive ventilation (NIV) therapy or a bilevel pressure therapy. In a configuration, the method further comprising a transition time between different modes.

[0253] In a configuration, the method further comprising basing breathing machine settings during the pre-conditioning mode at least partly on settings to be applied during a subsequent respiratory exercise mode.

[0254] In a configuration, the method further comprising one or more additional pre-conditioning modes in between one or more other modes.

[0255] In a configuration, a flow rate is provided during the respiratory exercise mode.

[0256] In a configuration, an oscillating flow rate is provided during the respiratory exercise mode.

[0257] In a configuration, the method further comprising syncing respiratory exercises to a respiratory cycle during the respiratory exercise mode.

[0258] In a configuration, a predetermined pressure is provided during the respiratory exercise mode.

[0259] In a configuration, the sequence of physiotherapy modes is customizable by a user.

[0260] In another aspect, this disclosure broadly comprises a method of providing breathing exercises to a user using a breathing machine including a flow generator and a humidifier, the method comprising: providing, by the breathing machine, a first mode of operation, the first mode of operation comprising at least one of a pre-conditioning mode, a rest mode, an exercise mode or a cough mode; and causing the respiratory therapy device to transition from first mode of operation to a second mode of operation, the second mode of operation comprising at least one of the pre-conditioning mode, the rest mode, the exercise mode or the cough mode.

[0261] In a configuration, the method further comprising providing instructions to a user to operate the breathing machine.

[0262] In a configuration, providing instructions comprises providing instructions on a user interface of the breathing machine.

[0263] In a configuration, providing instructions comprises providing instructions on a user device.

[0264] In a configuration, the method further comprising providing a graphic illustrating the instructions.

[0265] In a configuration, the method further providing a sequence of physiotherapy modes and further comprising providing instructions to a user to configure or reconfigure the breathing machine with a user interface associated with at least one of the physiotherapy modes.

[0266] In a configuration, the breathing machine comprises a humidification chamber configured to humidify respiratory gases.

[0267] In a configuration, the pre-conditioning mode provides humidified respiratory gases to the patient.

[0268] In a configuration, a pre-conditioning mode is followed by a cough mode where a patient is instructed to cough. In a configuration, a pre-conditioning mode is followed by a respiratory exercise mode where a patient is instructed o breath into a respiratory exercise user interface.

[0269] In a configuration, a pre-conditioning mode is followed by a respiratory therapy mode comprising one or more of high flow therapy, a nasal high flow therapy, a continuous positive airway pressure (CPAP) therapy, a positive airway pressure (PAP) therapy, a non-invasive ventilation (NIV) therapy or a bilevel pressure therapy.

[0270] In a configuration, the method further comprising a transition time between different modes.

[0271] In a configuration, the method further comprising basing breathing machine settings during a pre-conditioning mode at least partly on settings to be applied during a subsequent respiratory exercise mode.

[0272] In a configuration, the method further comprising one or more additional pre-conditioning modes in between one or more other modes.

[0273] In a configuration, a flow rate is provided during the respiratory exercise mode.

[0274] In a configuration, an oscillating flow rate is provided during the respiratory exercise mode.

[0275] In a configuration, the method further comprising syncing respiratory exercises to a respiratory cycle during the respiratory exercise mode.

[0276] In a configuration, a predetermined pressure is provided during the respiratory exercise mode.

[0277] In a configuration, the sequence of physiotherapy modes is customizable by a user. In another aspect, this disclosure broadly comprises a respiratory exercise device comprising: a first end configured to connect to a gases conduit of a respiratory therapy device; and a second end comprising a mouthpiece configured to be blown into by a user for respiratory exercises.

[0278] In a configuration, the respiratory therapy device is configured to initiate respiratory exercise upon detecting that the respiratory exercise device is connected to the respiratory therapy device.

[0279] Any of the above aspects of the disclosure may further comprise any one or more of the following features or aspects:

[0280] In one configuration, the mouthpiece attachment may be an auxiliary component or attachment that can be connected to the gases outlet of a breathing assistance apparatus or to the end of a breathing circuit conduit of or connected to a breathing assistance apparatus, such that the mouthpiece attachment receives a flow of gases from the breathing assistance apparatus. In a further configuration, the breathing assistance apparatus may be configured to operate with two or more conduits - including at least a first conduit configured for delivering therapy (such as nasal high flow therapy) to which a nasal cannula may be removably connected, and a second conduit comprising an integrated mouthpiece attachment.

[0281] In a configuration, the breathing assistance apparatus further comprises a humidifier, optionally situated along the flow path of the apparatus between the flow generator and mouthpiece attachment.

[0282] In a configuration, the flow generator comprises a blower and / or turbine.

[0283] In a configuration, controlling the pneumatic resistance comprises providing a positive flow of gases at a constant pressure or a constant flow rate. In a configuration, the breathing assistance apparatus further comprises one or more sensors for detecting one or more characteristics of the flow of gases and generating representative sensor data.

[0284] In a configuration, the one or more sensors comprise one or more of: a flow rate sensor; and / or a pressure sensor; wherein the one or more sensors are positioned between the flow generator and an outlet of the breathing assistance apparatus.

[0285] In a configuration, the one or more sensors are provided in a housing of the breathing assistance apparatus along with the flow generator and controller.

[0286] In a configuration, the flow rate sensor is provided in the form of an ultrasonic-type sensor and / or a heated bead flow sensor.

[0287] In a configuration, the controller is configured to receive the sensor data from the one or more sensors; and determine, based at least partly on the sensor data, one or more parameters of the flow of gases while the user performs any one or more steps of the breathing exercise.

[0288] In a configuration, controlling the pneumatic resistance provided at the mouthpiece attachment while the user performs one or more steps of the breathing exercise comprises providing a flow of gases with a flow rate that is sufficient to prevent back-flow of the user’s breath into an outlet of the breathing assistance apparatus.

[0289] In a configuration, the flow rate of the flow of gases is sufficient to prevent back-flow, but insufficient to impede a user’s performance of the one or more steps of the breathing exercise.

[0290] In a configuration, controlling the pneumatic resistance provided at the mouthpiece attachment while the user performs one or more steps of the breathing exercise comprises any one of: maintaining a fixed value of positive flow rate of the flow of gases along the flow path; maintaining a fixed value of zero flow rate of the flow of gases along the flow path; varying the flow rate of the flow of gases along the flow path to counteract the flow caused by a user’s breath; maintaining a fixed value of pressure at the mouthpiece attachment; maintaining a first value of pressure during an expiratory phase of a breathing exercise, and maintaining a second value of pressure during an inspiratory phase of a breathing exercise.

[0291] In a configuration, controlling the pneumatic resistance at the mouthpiece attachment as the user breathes against a fixed positive expiratory pressure (PEP) comprises providing a flow rate of the flow of gases sufficient to induce a pre-defined constant PEP at the mouthpiece attachment.

[0292] In a configuration, controlling the pneumatic resistance at the mouthpiece attachment as the user breathes against an oscillating positive expiratory pressure (OPEP) comprises providing a flow rate of the flow of gases sufficient to induce an oscillating PEP at the mouthpiece attachment.

[0293] In a configuration, providing a flow rate of the flow of gases sufficient to induce an oscillating PEP at the mouthpiece attachment comprises varying the flow rate of the flow of gases between a first threshold that provides a pre-defined upper PEP value, and a second threshold that provides a pre-defined lower PEP value.

[0294] In a configuration, the breathing assistance apparatus further comprises a flutter valve.

[0295] In a configuration, the controller is in communication with a display screen.

[0296] In a configuration, the controller is further configured to cause the display screen to display one or more text-based and / or graphical instruction steps for the user to perform the one or more steps of the breathing exercise. In a configuration, the controller is further configured to cause the display screen to display in text and / or graphical form encouragement feedback related to the breathing exercise step being performed by the user.

[0297] In a configuration, the display screen is touch-sensitive and configured to receive inputs from the user.

[0298] In a configuration, the display screen is configured to provide one or more touch-sensitive graphical elements that, when interacted with by the user, enable adjustment of one or more parameters of the flow of gases being provided during a breathing exercise step.

[0299] In a configuration, the adjustments are confined to boundaries configured by a medical professional managing the patient.

[0300] In a configuration, the display screen is configured to receive user input to enable user adjustment of one or more characteristics of the flow of gases being provided during one or more steps of the breathing exercise, and wherein the adjustments are confined to boundaries configured by a medical professional managing the user.

[0301] In a configuration, the breathing assistance apparatus further comprises a wireless communications module that is in electrical communication with the controller.

[0302] In a configuration, the controller is further configured to communicate data via the wireless communications module to a remote device or server for storage and / or processing.

[0303] In a configuration, the remote device is one or more of a smartphone, tablet, laptop, smart watch, wearable device, smart glasses, actigraphy device or other suitable peripheral with the prerequisite communication and processing capabilities. In a configuration, the data communicated comprises data relating to one or more characteristics of the flow of gases as detected by one or more sensors of the apparatus.

[0304] In a configuration, the data communicated comprises data relating to one or more parameters of the flow of gases captured during the user’ s performance of the one or more steps of the breathing exercise.

[0305] In a configuration, the data communicated comprises determined user breathing parameter data including one or more of the user’s respiratory rate, minute ventilation, and / or tidal volume.

[0306] In a configuration, the data communicated comprises performance data relating to the user’s performance of a breathing exercise programme, breathing exercise and / or specific steps of the breathing exercise.

[0307] In a configuration, the data communicated comprises compliance data relating to the user’s compliance to a breathing exercise programme.

[0308] In a configuration, the data communicated comprises subjective feedback data generated by the user.

[0309] In a configuration, the subjective feedback data comprises at least one response to at least one questionnaire.

[0310] In a configuration, the data is transmitted to the remote device or server is in the form of a report or report data.

[0311] In a configuration, the controller is further configured to prompt a user to perform the one or more steps of the breathing exercise. In a configuration, prompting a user to perform the one or more steps of the breathing exercise comprises providing the prompt via the breathing assistance apparatus.

[0312] In a configuration, prompting a user to perform the one or more steps of the breathing exercise comprises generating an audio prompt by the breathing assistance apparatus.

[0313] In a configuration, prompting a user to perform the one or more steps of the breathing exercise comprises generating a visual prompt on a display or interface of the breathing assistance apparatus.

[0314] In a configuration, prompting a user to perform the one or more steps of the breathing exercise comprises providing the prompt on an external device that is in data communication with the breathing assistance apparatus.

[0315] In a configuration, the external device is one or more of a smartphone, tablet, laptop, smart watch, wearable device, smart glasses, actigraphy device or other suitable peripheral with the prerequisite communication and processing capabilities.

[0316] In a configuration, controlling the pneumatic resistance provided at the mouthpiece attachment while the user performs the one or more steps of the breathing exercise comprises providing a positive flow of gases at a constant pressure or a constant flow rate.

[0317] In a configuration, the apparatus further comprising one or more sensors for detecting one or more characteristics of the flow of gases and generating representative sensor data. For example, the one or more sensors comprise one or more of: a flow rate sensor; and / or a pressure sensor; wherein the one or more sensors are positioned between the flow generator and an outlet of the breathing assistance apparatus. In a configuration, the controller is configured to: receive the sensor data from the one or more sensors; and determine, based at least partly on the sensor data, one or more parameters of the flow of gases while the user performs any of the one or more steps of the breathing exercise.

[0318] In a configuration, the controller is configured to determine, based at least partly on the sensor data received from the one or more sensors, one or more of the following parameters: a user flow rate signal representing a user-generated flow rate component of the flow of gases generated by the user during their performance of the one or more steps of the breathing exercise; and / or a user pressure signal representing a user-generated pressure component of the flow of gases generated by the user during their performance of the one or more steps of the breathing exercise.

[0319] In a configuration, the controller is further configured to cause the display screen to display a flow and / or breath profile for the user to follow in their performance of the one or more steps of the breathing exercise.

[0320] In a configuration, the display screen is configured to display in text and / or graphical form information relating to one or more parameters of the flow of gases.

[0321] In a configuration, the controller is further configured to cause the display screen to display a current value of the one or more parameters versus one or more pre-defined target values.

[0322] In a configuration, the controller is configured to prompt a user to perform the one or more steps of the breathing exercise according to a periodic interval. The periodic interval may be configurable. The periodic interval may be configurable via a user interface of the breathing assistance apparatus. The periodic interval is configurable via a user interface of a remote device in data communication with the breathing assistance apparatus. The periodic interval may beremotely configurable by a medical professional using an external device that is in data communication with the breathing assistance apparatus.

[0323] In another aspect, this disclosure broadly comprises a non-transitory computer-readable medium having stored thereon computer executable instructions that, when executed on a processing device or devices, cause the processing device or devices to perform any one or more aspects above.

[0324] In another aspect, this disclosure broadly comprises a set of application program interfaces or an application program interface (API) embodied on a computer-readable medium for execution on a processing device in conjunction with an application program that perform any method of any one or more aspects above.

[0325] Any aspect of this disclosure above may further comprise any one or more aspects or features or configurations mentioned in respect of any one or more of the other aspects of this disclosure above.

[0326] BRIEF DESCRIPTION OF THE DRAWINGS

[0327] These and other features, aspects, and advantages of the present disclosure are described with reference to the drawings of certain embodiments, which are intended to schematically illustrate certain embodiments and not to limit the disclosure.

[0328] Figure 1 shows schematically a breathing assistance apparatus configured to provide a respiratory therapy to a patient.

[0329] Figure 2A illustrates a block diagram of a control system interacting with and / or providing control and direction to components of a breathing assistance apparatus.

[0330] Figure 2B illustrates a block diagram of an example controller.

[0331] Figure 3 illustrates a block diagram of a motor and sensor module. Figure 4 illustrates a sensing chamber of an example motor and sensor module.

[0332] Figure 5 shows a schematic diagram of the breathing assistance apparatus of Figure 1 with an embodiment of a mouthpiece attachment connected to the end of the breathing conduit.

[0333] Figure 6 shows a perspective view from a connector end of a mouthpiece attachment in an example embodiment.

[0334] Figure 7 shows a perspective view from a mouthpiece end of the mouthpiece attachment of Figure 6.

[0335] Figure 8 shows a first side elevation view of the mouthpiece attachment of Figure 6.

[0336] Figure 9 shows a second side elevation view of the mouthpiece attachment of Figure 6.

[0337] Figure 10 shows a plan view of the mouthpiece attachment of Figure 6.

[0338] Figure 11 shows an underside view of the mouthpiece attachment of Figure 6.

[0339] Figure 12 shows a first end view of the mouthpiece attachment of Figure 6 from a mouthpiece end.

[0340] Figure 13 shows a second end view of the mouthpiece attachment of Figure 6 from a connector end.

[0341] Figure 14 shows a cross-sectional view of the mouthpiece attachment through lines AA of Figures 12 and 13.

[0342] Figure 15 shows a close-up perspective view of a connector end of the mouthpiece attachment of Figure 6.

[0343] Figure 16 shows a first end perspective view of an example embodiment of a removable mouthpiece for the mouthpiece attachment.

[0344] Figure 17 shows a second end perspective view of the removable mouthpiece of Figure 16.

[0345] Figure 18 shows a plan view of the removable mouthpiece of Figure 16.

[0346] Figure 19 shows a cross-sectional view of the removable mouthpiece through line BB of Figure 18.

[0347] Figure 20 shows a side elevation view of the removable mouthpiece of Figure 16.

[0348] Figure 21 shows a cross-sectional view of the removable mouthpiece through line CC of Figure 20. Figure 22 shows a perspective view of the mouthpiece attachment of Figure 6 assembled with the removable mouthpiece of Figure 16 in an embodiment.

[0349] Figure 23 shows an exploded perspective view of the mouthpiece attachment and removable mouthpiece of Figure 22.

[0350] Figure 24 shows a side view of the mouthpiece attachment with assembled mouthpiece of Figure 22.

[0351] Figure 25 shows a cross-sectional view of the mouthpiece attachment with assembled mouthpiece through line DD of Figure 24.

[0352] Figure 26 shows a plan view of the mouthpiece attachment with assembled mouthpiece of Figure 22.

[0353] Figure 27 shows a cross-sectional view of the mouthpiece attachment with assembled mouthpiece through line EE of Figure 26.

[0354] Figure 28 shows a first perspective view of the mouthpiece attachment with assembled mouthpiece of Figure 22 including clip formations.

[0355] Figure 29 shows a second perspective view of the mouthpiece attachment with assembled mouthpiece and clip formations of Figure 28.

[0356] Figure 30 shows a side elevation view of the mouthpiece attachment with assembled mouthpiece and clip formations of Figure 28.

[0357] Figure 31 is a flow diagram of the process of performing measurements with the mouthpiece attachment and a breathing assistance apparatus in accordance with one example configuration.

[0358] Figure 32 is a flow diagram of prompts instructing a user to perform a set of repeated breathing exercises in accordance with one example configuration.

[0359] Figure 33 is a flow diagram of the process of performing measurements with the mouthpiece attachment and a breathing assistance apparatus in accordance with another example configuration.

[0360] Figure 34 is a graph of example sensed flow rate data for healthy and sick persons performing measurements with the mouthpiece attachment and breathing assistance apparatus. Figure 35 is a flow diagram of a method of performing breathing exercises with the mouthpiece attachment and a breathing assistance apparatus in accordance with one example configuration.

[0361] Figure 36 is a flow diagram of a method of performing breathing exercises with the mouthpiece attachment and a breathing assistance apparatus in accordance with another example configuration.

[0362] Figure 37 is a schematic graph showing how a humidity setting may change when transitioning between a therapy session in therapy mode, pre-conditioning mode, and exercise mode, in an example configuration.

[0363] Figure 38 is a schematic graph showing how a flow rate setting may change when transitioning between a therapy session in therapy mode, pre-conditioning mode, and exercise mode, in an example configuration.

[0364] Figure 39 is a flow diagram of a flow process for transitioning from a therapy mode to an exercise mode in accordance with an example configuration that includes a preconditioning mode.

[0365] Figure 40 is a flow diagram of an example base structure of a therapy programme in accordance with an example configuration.

[0366] Figure 41 is a flow diagram of a first example configuration of a therapy programme in accordance with the base structure.

[0367] Figure 42 is a flow diagram of a second example configuration of a therapy programme in accordance with the base structure.

[0368] Figure 43 is a flow diagram of a third example configuration of a therapy programme in accordance with the base structure.

[0369] Figure 44 is a flow diagram of a fourth example configuration of a therapy programme in accordance with the base structure.

[0370] Figure 45 is a flow diagram of a first user interface workflow example of the user interface in accordance with an example configuration of the manual initiation of an oscillation therapy session.

[0371] Figure 46 is a screenshot of an example graphical user interface (GUI) screen of the user interface representing a manual oscillation therapy overview screen in accordance with an example configuration. Figure 47 is a screenshot of an example GUI screen of the user interface for a pressure setting screen for adjusting the maximum and minimum pressure settings for an oscillation therapy mode in accordance with an example configuration.

[0372] Figure 48 is a screenshot of an example GUI screen of the user interface for an oscillation frequency setting screen for adjusting the oscillation frequency setting for an oscillation therapy mode in accordance with an example configuration.

[0373] Figure 49 is a screenshot of an example GUI pop-up or notification screen of the user interface for confirming and / or recommending pre-conditioning prior to oscillation therapy in accordance with an example configuration.

[0374] Figure 50 is a screenshot of an example GUI screen of the user interface for an oscillation therapy screen that is displayed during an oscillation therapy session in accordance with an example configuration.

[0375] Figure 51 is a screenshot of an example GUI pop-up or notification screen of the user interface for confirming a stop oscillation therapy action in accordance with an example configuration.

[0376] Figure 52 is a flow diagram of a second user interface workflow example of the user interface in accordance with an example of the configuration and commencement of a therapy programme.

[0377] Figure 53 is a screenshot of an example therapy programme overview screen that is displayed during the second user interface workflow example.

[0378] Figure 54 is a screenshot of an example oscillation therapy adjustment screen that is displayed during the second user interface workflow example.

[0379] Figure 55 is a screenshot of an example stage type selection screen that is displayed during the second user interface workflow example.

[0380] Figure 56 is a screenshot of an example rest mode adjustment screen that is displayed during the second user interface workflow example.

[0381] Figure 57 is a screenshot of an example exercise mode screen that is displayed during the second user interface workflow example.

[0382] Figure 58 a screenshot of the example exercise mode screen of Figure 57 after a therapy programme pause has been activated during the second user interface workflow example. Figure 59 is a flow diagram of a third user interface workflow example of the user interface in accordance with an example of the configuration and commencement of a therapy programme.

[0383] DETAILED DESCRIPTION

[0384] Although certain examples are described below, those of skill in the art will appreciate that the 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 disclosure herein disclosed should not be limited by any particular examples described below.

[0385] 1. Overview of breathing assistance apparatus with therapy mode and exercise mode

[0386] This disclosure relates to a breathing assistance apparatus that is selectively operable in a therapy mode to deliver a flow of gases for respiratory therapy in a therapy session, or an exercise mode to deliver a flow of gases for an exercise session of breathing exercises for physiotherapy or physiotherapy exercises. Physiotherapy exercises may also be known as respiratory therapy exercises, chest physiotherapy, or chest physical therapy.

[0387] In a configuration, the flow of gases may be delivered to the user by a breathing conduit connected to a gases outlet of the apparatus, and a respiratory patient interface or mouthpiece attachment connected to a user-side end of the breathing conduit. In a configuration, a respiratory patient interface may be used in both therapy mode and exercise mode. In another configuration, a respiratory patient interface may be used in therapy mode, and the mouthpiece in exercise mode.

[0388] This disclosure relates to various control schemes or methods that are applicable to an apparatus which provides therapy mode and exercise mode including, but not limited to, any one or more of the following: • In a configuration, a controller of the apparatus may be configured to control humidity settings of a humidifier of the apparatus when operating in exercise mode in accordance with a humidity control protocol.

[0389] • In a configuration, a controller of the apparatus may be configured to control automated or semi-automated sequencing of therapy sessions and exercise sessions in a single use session, according to a therapy schedule.

[0390] • In a configuration, a controller of the apparatus may be configured to control the transitioning of the apparatus from a current therapy session in therapy mode to an exercise session in exercise mode, including initiating a pre-conditioning mode prior to the exercise session.

[0391] The mouthpiece attachment (or mouthpiece) is an attachment or auxiliary component for use with a breathing assistance apparatus or respiratory system or exercise system or exercise apparatus. Unless the context specifies otherwise, the terms ‘system’ or ‘apparatus’ may to refer to any one or more of a breathing assistance apparatus, respiratory system, exercise system, exercise apparatus, or any other apparatus or system with a flow generator. Additionally, in the following description, when describing features of a breathing assistance apparatus or respiratory system, such features may also apply in the context of apparatus or systems which are selectively operable in either respiratory therapy mode or exercise mode, and also may apply to dedicated exercise systems or exercise apparatus.

[0392] In a configuration, during the performance of breathing exercises in exercise mode, the controller of the breathing assistance apparatus may control the flow generator to control a flow of gases (e.g., air or air supplemented with one or more other gases such as oxygen) according to a configurable flow rate setting(s) or pressure setting(s) (i.e., the flow of gases may be flow-controlled or pressure-controlled). The flow of gases provides a controllable pneumatic resistance in the flow path against the user’s breathing exercises.

[0393] In one sense, the phrase ‘pneumatic resistance’ as used in this disclosure, unless the context suggests otherwise, can mean the characteristics of the flow of gases provided to the user (e.g., via the respiratory patient interface and / or mouthpiece attachment), and may correspond to or be defined by one or more characteristics of the flow of gases (e.g., flow rate or pressure). For example, the controlled flow rate and / or pressure of the flow of gases may define the nature of the pneumatic resistance. For example, a fixed or variable (e.g., oscillating) pneumatic resistance may correspond to a fixed or variable (e.g., oscillating) pressure characteristic and / or flow rate characteristic in the flow of gases. In this sense, controlling the ‘pneumatic resistance’ provided at the respiratory patient interface and / or mouthpiece attachment may also be considered as controlling one or more characteristics of the flow of gases provided at the respiratory patient interface and / or mouthpiece attachment, as the user performs the breathing exercises.

[0394] In the following description, an example breathing assistance apparatus will be described, which can be used with the mouthpiece attachment. The example breathing assistance apparatus may be configured primarily for high flow therapy or which has a high flow therapy mode (e.g., a nasal high flow therapy mode). However, the mouthpiece attachment can be used with any breathing assistance apparatus, system or device having a flow generator (e.g., comprising a blower, fan, compressor or the like) that is operable to generate a controllable flow of gases for respiratory therapy, or any other apparatus or system comprising a flow generator. The breathing assistance apparatus may be operable or configured to provide a single type of therapy or may be operable or configured to provide multiple different respiratory therapies. For example, the breathing assistance apparatus may be configured to operate in a single therapy mode or may be configured to operate in or provide multiple selectable therapy modes. By way of example, the breathing assistance apparatus may provide any one or more of the following respiratory therapies and / or therapy modes: high flow therapy (e.g., nasal high flow (NHF) therapy), Positive Airway Pressure (PAP) therapy, Continuous Positive Airway Pressure (CPAP) therapy, non-invasive ventilation (NIV) therapy, bi-level PAP therapy, oscillation therapy, or other such flow- or pressure-controlled respiratory therapies.

[0395] The mouthpiece attachment may connect with a breathing assistance apparatus or system comprising an active or passive humidifier in the flow path, or an apparatus or system without a humidifier. When the apparatus is operating in exercise mode, the flow of gases may be provided without added humidity (i.e., any humidifier in the apparatus is switched off or deactivated or disconnected), or may be provided with humidity according to humidity settings.

[0396] 2. Example breathing assistance apparatus and mouthpiece attachment

[0397] The control schemes and methods of the apparatus will be described in the context of an example breathing assistance apparatus 10 and mouthpiece attachment. The apparatus 10 may be operable in a therapy mode to provide one or more respiratory therapies in a therapy session, and an exercise mode to provide one or more breathing exercises in an exercise session. This is intended as a non-limiting example. The control schemes and methods may be operable with a broad range of breathing assistance apparatuses comprising flow generators, and with different types of mouthpiece attachments.

[0398] 2. J Schematic overview of apparatus

[0399] A schematic representation of the example breathing assistance apparatus 10 is provided in Figure 1.

[0400] The breathing assistance apparatus 10 (or ‘respiratory system’) comprises a flow source 50 for providing a high flow gas 31 such as air, oxygen, air blended with oxygen, or a mix of air and / or oxygen and one or more other gases. Alternatively, the breathing assistance apparatus can have a connection for coupling to a flow source. As such, the flow source might be considered to form part of the apparatus or be separate to it, depending on context, or even part of the flow source forms part of the apparatus, and part of the flow source falls outside of the apparatus. In short, depending on the configuration (some components may be optional), the system can include a combination of components selected from the following:

[0401] • a flow source,

[0402] • a humidifier for humidifying the gas-flow, • a conduit (e.g., dry line or heated breathing tube),

[0403] • a patient interface,

[0404] • a non-return valve, and / or

[0405] • a filter

[0406] The apparatus or system will be described in more detail.

[0407] The flow source could be an in-wall supply of oxygen or air, a tank of oxygen 50A or air, a tank of other gas and / or a high flow apparatus with a flow generator 5 OB. Figure 1 shows a flow source 50 with a flow generator 50B, with an optional air inlet 50C and optional connection to an 02 source (such as tank or 02 generator) 50A via a shut off valve and / or regulator and / or other gas flow control 50D, but this is just one option. The flow generator 50B can control flows delivered to the patient 56 using one or more valve, or optionally the flow generator 50B can comprise a blower. The flow source could be one or a combination of a flow generator 50B, 02 source 50A, air source 50C as described. The flow source 50 is shown as part of the apparatus 10, although in the case of an external oxygen tank or in-wall source, it may be considered a separate component, in which case the apparatus has a connection port to connect to such flow source. The flow source provides a (preferably high) flow of gas that can be delivered to a patient via a delivery conduit 16, and patient interface 51.

[0408] The patient interface 51 may be an unsealed (non-sealing) interface (for example when used in high flow therapy and / or when the breathing assistance apparatus is operating in a flow-controlled mode - controlling the flow generator to provide a target flow of gases) such as a non-sealing nasal cannula, or a sealed (sealing) interface (for example when used in CPAP, NIV, Bilevel, and / or when the breathing assistance apparatus is operating in a pressure-controlled mode - controlling the flow generator to provide a target pressure) such as a nasal mask, full face mask, or nasal pillows. In some embodiments, the patient interface 51 is a non-sealing patient interface which would for example help to prevent barotrauma (e.g., tissue damage to the lungs or other organs of the respiratory system due to difference in pressure relative to the atmosphere). In some embodiments, the patient interface 51 is a sealing mask that seals with the patient’s nose and / or mouth. The patient interface may be a nasal cannula with a manifold and nasal prongs, and / or a face mask, and / or a nasal pillows mask, and / or a nasal mask, and / or a tracheostomy interface, or any other suitable type of patient interface. The flow source could provide a base gas flow rate of between, e.g. 0.5 litres / min and 375 litres / min, or any range within that range, or even ranges with higher or lower limits. Details of the ranges and nature of flow rates will be described later.

[0409] A humidifier 52 can optionally be provided between the flow source 50 and the patient to provide humidification of the delivered gas. In a configuration, the humidifier is configured so as to be removed from or isolated within the breathing assistance apparatus during the exercise mode. Additionally or alternatively, when the apparatus is operating in exercise mode, the humidifier of the apparatus is switched off or otherwise deactivated so as to not add humidity to the flow of gases. In another configuration, the humidifier is operable to humidify the flow of gases in accordance with humidity settings in any mode of operation of the apparatus including, but not limited to, therapy mode, exercise mode, and a pre-conditioning mode (described later).

[0410] One or more sensors 53A, 53B, 53C, 53D such as flow, oxygen fraction, pressure, humidity, temperature or other sensors can be placed throughout the system and / or at, on or near the patient 56. Alternatively, or additionally, sensors from which such parameters can be derived could be used. In addition, or alternatively, the sensors 53A-53D can be one or more physiological sensors for sensing patient physiological parameters such as, heart rate, oxygen saturation, partial pressure of oxygen in the blood, respiratory rate, partial pressure of CO2 in the blood, and end tidal CO2. Alternatively, or additionally, sensors from which such parameters can be derived could be used. Other patient sensors could comprise EEG sensors, torso bands to detect breathing, and any other suitable sensors. One or more of the sensors might form part of the apparatus, or be external thereto, with the apparatus having inputs for any external sensors. The sensors can be coupled to or send their output to a controller 19.

[0411] A sensor 14 may be provided for measuring the oxygen fraction of air the patient inspires. This can be placed on the patient interface 51, for example, to measure or otherwise determine the fraction of oxygen proximate (at / near / close to) the patient’s mouth and / or nose. The output from the sensor 14 is sent to a controller 19 to assist control of the breathing assistance apparatus to determine if the peak inspiratory demand is being met, and alter operation accordingly. The controller 19 is coupled to the flow source 50, humidifier 52 and sensor 14. It controls these and other aspects of the apparatus or system to be described below. The controller can operate the flow source to provide the delivered flow of gas at a desired flow rate high enough to meet peak inspiratory demand. In an alternative, the sensor 14 might convey measurements of oxygen fraction at the patient mouth and / or nose to a user, who then inputs the information to the respiratory apparatus / controller. Any disclosure / embodiment hereinafter could be read as having that alternative, where appropriate.

[0412] An optional non-return valve 23 may be provided in the breathing conduit 16 or anywhere else in the gas flow path to prevent exhaled gases flowing back into unwanted areas or portions of the flow path of the apparatus. A filter or filters may be provided at the air inlet 50C and / or inlets to the flow generator 50B to filter the incoming gases before they are pressurized into a high flow gas 31 by to the flow generator 50B.

[0413] The breathing assistance apparatus 10 could be an integrated or a separate componentbased arrangement, generally shown in the dotted box 100 in Figure 1. In some configurations, the apparatus or system could be a modular arrangement of components. Furthermore, the apparatus or system may just comprise some of the components shown, not necessarily all are essential. Also, the conduit and patient interface do not have to be part of the system, and could be considered separate. Hereinafter it will be referred to as a breathing assistance apparatus or respiratory system, but this should not be considered limiting. Breathing assistance apparatus and respiratory system will be broadly considered herein to comprise anything that provides a flow of gas to a patient.

[0414] The breathing assistance apparatus 10 can include a main device housing (not shown). The main device housing can contain the flow generator 50B that can be in the form of a motor / impeller arrangement, an optional humidifier 52, a controller 19, and an input / output I / O user interface 54. The user interface 54 can include a display and input device(s) such as button(s), a touch screen (e.g., an LCD screen), a combination of a touch screen and button(s), or the like. The controller 19 can include one or more hardware and / or software processors and can be configured or programmed to control the components of the system, including but not limited to operating the flow generator 50B to create a flow of gases for delivery to a patient, operating the humidifier 52 to humidify and / or heat the gases flow, receiving user input from the user interface 54 for reconfiguration and / or user-defined operation of the breathing assistance apparatus 10, and outputting information (for example on the display) to the user. The user can be a patient, healthcare professional, or others.

[0415] In one configuration, the user interface 54 of the breathing assistance apparatus 10 may comprise a removable display screen or touch screen.

[0416] In one configuration, the user interface 54 of the breathing assistance apparatus may comprise a graphical user interface (GUI) presented on a display screen or touch screen.

[0417] In one configuration, the user interface of the breathing assistance apparatus may comprise audio hardware and / or software to facilitate user input and / or interaction via voice command or control.

[0418] With continued reference to Figure 1, a patient breathing conduit 16 can be coupled to a gases flow outlet (gases outlet) 21 in the main device housing of the breathing assistance apparatus 10, and be coupled to a patient interface 51, such as a non-sealing interface like a nasal cannula with a manifold and nasal prongs, or a sealing interface like a nasal or face mask. The patient interface 51 can also be a tracheostomy interface.

[0419] The gases flow can be generated by the flow generator 50B, and may be humidified, before being delivered to the patient via the patient breathing conduit 16 through the patient interface 51. The controller 19 can control the flow generator 50B to generate a gases flow of a desired flow rate, and / or one or more valves to control mixing of air and oxygen or other breathable gas. The controller 19 can control a heating element in or associated with the humidification chamber 12, to heat the gases to a desired temperature that achieves a desired level of temperature and / or humidity for delivery to the patient. The patient breathing conduit 16 can have a heating element, such as a heater wire, to heat gases flow passing through to the patient. The heating element can also be under the control of the controller 19.

[0420] The humidifier 52 of the apparatus is configured to combine or introduce humidity with or into the gases flow. Various humidifier 52 configurations may be employed. In one configuration, the humidifier 52 can comprise a humidification chamber that is removable. For example, the humidification chamber may be partially or entirely removed or disconnected from the flow path and / or apparatus. By way of example, the humidification chamber may be removed for refilling, cleaning, replacement and / or repair for example. In one configuration, the humidification chamber may be received and retained by or within a humidification compartment or bay of the apparatus, or may otherwise couple onto or within the housing of the apparatus.

[0421] A skilled person will appreciate that adding humidity to the flow of gases can help to or at least minimise drying out of the user’s airways when receiving the flow of gases. By way of example, the added humidity can mimic the natural humidification of air / gases that takes place when the user breathes normally. The added humidity may help to improve the comfort of the user when receiving the flow of gases. The humidification chamber of the humidifier 52 may comprise a gases inlet and a gases outlet to enable connection into the gases flow path of the apparatus. For example, the flow of gases from the flow generator 50B is received into the humidification chamber via its gases inlet and exits the chamber via its gases outlet, after being heated and / or humidified.

[0422] The humidification chamber contains a volume of liquid, typically water or similar. In operation, the liquid in the humidification chamber is controllably heated by one or more heaters or heating elements associated with the chamber to generate water vapour or steam to increase the humidity of the gases flowing through the chamber.

[0423] In one configuration, the humidifier is a pass-over humidifier. In another configuration, the humidifier may be a non-pass-over humidifier.

[0424] In one configuration, the humidifier 52 may comprise a heater plate, for example, associated with or within a humidification bay that the chamber sits on for heating. The chamber may be provided with a heat transfer surface, e.g., a metal insert, plate or similar, in the base or other surface of the chamber that interfaces or engages with the heater plate of the humidifier 52.

[0425] In another configuration, the humidification chamber may comprise an internal heater or heater elements inside or within the chamber. The internal heater or heater elements may be integrally mounted or provided inside the chamber, or may be removable from the chamber.

[0426] The humidification chamber may be any suitable shape and / or size. The location, number, size, and / or shape of the gases inlet and gases outlet of the chamber may be varied as required. In one configuration, the humidification chamber may have a base surface, one or more side walls extending up from the base surface, and an upper or top surface. In one configuration, the gases inlet and gases outlet may be position on the same side of the chamber. In another configuration, the gases inlet and gases outlet may be on different surfaces of the chamber, such as on opposite sides or locations, or other different locations.

[0427] In some configurations, the gases inlet and gases outlet may have parallel flow axes. In some configurations, the gases inlet and gases outlet may be positioned at the same height on the chamber.

[0428] The system 10 can use ultrasonic transducer(s), flow sensor(s) such as a thermistor flow sensor, pressure sensor(s), temperature sensor(s), humidity sensor(s), or other sensors, in communication with the controller 19, to monitor characteristics of the gases flow and / or operate the system 10 in a manner that provides suitable therapy. The gases flow characteristics can include gases concentration, flow rate, pressure, temperature, humidity, or others. The sensors 53A, 53B, 53C, 53D, 14, such as pressure, temperature, humidity, and / or flow sensors, can be placed in various locations in the main device housing 100, the patient conduit 16, and / or the patient interface 51. The controller 19 can receive output from the sensors to assist it in operating the breathing assistance apparatus 10 in a manner that provides suitable therapy, such as to determine a suitable target temperature, flow rate, and / or pressure of the gases flow. Providing suitable therapy can include meeting a patient’s inspiratory demand. In the illustrated embodiment sensors 53A, 53B, and 53C are positioned in the housing of the apparatus, sensor 53D in the patient conduit 16, and sensor 14 in the patient interface 51.

[0429] The apparatus 10 can include one or more communication modules to enable data communication or connection with one or more external devices or servers over a data or communication link or data network, whether wired, wireless, or a combination thereof. In one configuration for example, the apparatus 10 can include a wireless data transmitter and / or receiver, or a transceiver 15 to enable the controller 19 to receive data signals in a wireless manner from the operation sensors and / or to control the various components of the system 10. The transceiver 15 or data transmitter and / or receiver module may have an antenna 15a as shown. In one example, the transceiver may comprise a Wi-Fi modem. Additionally, or alternatively, the data transmitter and / or receiver 15 can deliver data to a remote server or enable remote control of the system 10. The system 10 can include a wired connection, for example, using cables or wires, to enable the controller 19 to receive data signals 8 from the operation sensors and / or to control the various components of the apparatus 10. The apparatus 10 may comprise one or more wireless communication modules. For example, the apparatus may comprise a cellular communication module such as for example a 3G, 4G or 5G module. The module 15 may be or may comprise a modem that enables the apparatus to communicate with a remote server using an appropriate communication network. The communication may be two-way communication between the apparatus and a server or other remote system. The apparatus 10 may also comprise other wireless communication modules such as for example a Bluetooth module and / or a Wi-Fi module. The Bluetooth and / or WiFi module allow the apparatus to wirelessly send information to another device such as, for example, a smartphone, tablet, laptop, smart watch, wearable device, smart glasses, actigraphy device, or to operate over a LAN (local area network) or Wireless LAN (WLAN). The apparatus may additionally, or alternatively, comprise a Near Field Communication (NFC) module to allow for data transfer and / or data communication.

[0430] The breathing assistance apparatus 10 may be operable in a therapy mode that provides high flow therapy. High flow therapy as discussed herein is intended to be given its typical ordinary meaning, as understood by a person of skill in the art, which generally refers to a respiratory system delivering a targeted flow of humidified respiratory gases via an intentionally unsealed patient interface with flow rates generally intended to meet or exceed inspiratory flow of a user. Typical patient interfaces include, but are not limited to, a nasal or tracheal patient interface. Typical flow rates for adults often range from, but are not limited to, about fifteen litres per minute to about sixty litres per minute or greater. Typical flow rates for pediatric users (such as neonates, infants and children) often range from, but are not limited to, about one litre per minute per kilogram of user weight to about three litres per minute per kilogram of user weight or greater.

[0431] High flow therapy can also optionally include gas mixture compositions including supplemental oxygen and / or administration of therapeutic medicaments. High flow therapy is often referred to as nasal high flow (NHF), humidified high flow nasal cannula (HHFNC), high flow nasal oxygen (HFNO), high flow therapy (HFT), or tracheal high flow (THF), among other common names. For example, in some configurations, for an adult patient ‘high flow therapy’ may refer to the delivery of gases to a patient at a flow rate of greater than or equal to about 10 litres 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 child patient ‘high flow therapy’ may refer to the delivery of gases to a patient at a flow rate of greater than 1 LPM, such as between about

[0432] 1 LPM and about 25 LPM, or between about 2 LPM and about 25 LPM, or between about

[0433] 2 LPM and about 5 LPM, or between about 5 LPM and about 25 LPM, or between about 5 LPM and about 10 LPM, or between about 10 LPM and about 25 LPM, or between about 10 LPM and about 20 LPM, or between about 10 LPM and 15 LPM, or between about 20 LPM and 25 LPM. A high flow therapy apparatus with an adult patient, a neonatal, infant, or child patient, may deliver gases to the patient at a flow rate of between about 1 LPM and about 100 LPM, or at a flow rate in any of the sub-ranges outlined above.

[0434] High flow therapy can be effective in meeting or exceeding the patient's inspiratory demand, increasing oxygenation of the patient and / or reducing the work of breathing. Additionally, high flow therapy may generate a flushing effect in the nasopharynx such that the anatomical dead space of the upper airways is flushed by the high incoming gases flow. The flushing effect can create a reservoir of fresh gas available of each and every breath, while minimizing re-breathing of carbon dioxide, nitrogen, etc. High flow therapy can also increase expiratory time of the patient due to pressure during expiration. This in turn reduces the respiratory rate of the patient. The flow rate may be set by a medical professional to achieve flushing of the patient’s upper airways and / or meet or exceed a patient’s inspiratory demand and / or provide at least some of the advantages of high flow therapy (HFT) described herein.

[0435] The patient interface for use in a high flow therapy can be a non-sealing interface to prevent barotrauma, which can include tissue damage to the lungs or other organs of the patient’s respiratory system due to difference in pressure relative to the atmosphere. The patient interface can be a nasal cannula with a manifold and nasal prongs, and / or an unsealed tracheostomy interface, or any other suitable type of patient interface.

[0436] 2.2 Control System

[0437] Figure 2A illustrates a block diagram 900 of an example control system 920 (which can be the controller 19 in Figure 1) that can detect patient conditions and control operation of the respiratory system including the gases source. The control system 920 can manage a flow rate and / or pressure of the gases flowing through the respiratory system as the gases are delivered to a patient. For example, the control system 920 can increase or decrease the flow rate or pressure by controlling an output of a motor speed of the blower (hereinafter also referred to as a “blower motor”) 930 or an output of a valve 932 in a blender. The control system 920 can automatically determine a set value or a personalized value of the flow rate or pressure for a particular patient as discussed below. The flow rate or pressure can be optimized by the control system 920 to improve patient comfort and therapy.

[0438] The control system 920 can also generate audio and / or display / visual outputs 938, 939. For example, the breathing assistance apparatus can include a display and / or a speaker. The display can indicate to the physicians any warnings or alarms generated by the control system 920. The display can also indicate control parameters that can be adjusted by the physicians. For example, the control system 920 can automatically recommend a flow rate or pressure for a particular patient. The control system 920 can also determine a respiratory state of the patient, including but not limited to generating a respiratory rate of the patient, and send it to the display, which will be described in greater detail below.

[0439] The control system 920 can change heater control outputs to control one or more of the heating elements (for example, to maintain a temperature set point of the gases delivered to the patient). The control system 920 can also change the operation or duty cycle of the heating elements. The heater control outputs can include heater plate control output(s) 934 and heated breathing tube control output(s) 936.

[0440] The control system 920 can determine the outputs 930-939 based on one or more received inputs 901-916. The inputs 901-916 can correspond to sensor measurements received automatically by the controller 600 (shown in FIG. 2B). The control system 920 can receive sensor inputs including but not limited to temperature sensor(s) inputs 901, flow rate sensor(s) inputs 902, motor speed inputs 903, pressure sensor(s) inputs 904, gas(s) fraction sensor(s) inputs 905, humidity sensor(s) inputs 906, pulse oximeter (for example, SpO2) sensor(s) inputs 907, stored or user parameter(s) 908, duty cycle or pulse width modulation (PWM) inputs 909, voltage(s) inputs 910, current(s) inputs 911, acoustic sensor(s) inputs 912, power(s) inputs 913, resistance(s) inputs 914, CO2sensor(s) inputs 915, and / or spirometer inputs 916. The control system 920 can receive inputs from the user or stored parameter values in a memory 624 (shown in FIG. 2B).

[0441] The control system 920 can dynamically adjust flow rate or pressure for a patient over the time of their therapy. The control system 920 can continuously detect system parameters and patient parameters. A person of ordinary skill in the art will appreciate based on the disclosure herein that any other suitable inputs and / or outputs can be used with the control system 920.

[0442] In one configuration, the apparatus can have one or more pressure sensors. One or more pressure sensors may be provided to sense or measure a pressure characteristic of the flow of gases in the flow path of the apparatus and generated respective pressure variables, such as pressure sensor signals or data. The pressure sensors may include any type of suitable pressure sensor including, but not limited to, a gauge pressure sensor and / or an absolute pressure sensor.

[0443] 2.3 Controller

[0444] Figure 2B illustrates a block diagram of an embodiment of a controller 600 (which can be the controller 19 in Figure 1). The controller 600 can include programming instructions for detection of input conditions and control of output conditions. The programming instructions can be stored in the memory 624 of the controller 600. The programming instructions can correspond to the methods, processes and functions described herein. The programming instructions can be executed by one or more hardware processors 622 of the controller 600. The programming instructions can be implemented in C, C++, JAVA, or any other suitable programming languages. Some or all of the portions of the programming instructions can be implemented in application specific circuitry 628 such as ASICs and FPGAs.

[0445] The controller 600 can also include circuits 628 for receiving sensor signals. The controller 600 can further include a display 630 for transmitting status of the patient and the respiratory assistance system. The display 630 can also show warnings and / or other alerts. The display 630 can be configured to display characteristics of sensed gas(es) in real time or otherwise. The controller 600 can also receive user inputs via the user interface such as display 630. The user interface can include button(s) and / or dial(s). The user interface can comprise a touch screen.

[0446] 2.4 Motor and Sensor module

[0447] Figure 3 illustrates a block diagram of the motor and sensor module 2000, which can be received by a recess 250 in the breathing assistance apparatus. The motor and sensor module can include a blower 2001, which entrains room air to deliver to a patient. The blower 2001 can be a centrifugal blower. One or more sensors (for example, Hall-effect sensors) may be used to measure a motor speed of the blower motor. The blower motor may comprise a brushless DC motor, from which motor speed can be measured without the use of separate sensors. For example, during operation of a brushless DC motor, back-EMF can be measured from the nonenergized windings of the motor, from which a motor position can be determined, which can in turn be used to calculate a motor speed. In addition, a motor driver may be used to measure motor current, which can be used with the measured motor speed to calculate a motor torque. The blower motor may comprise a low inertia motor.

[0448] Room air can enter a room air inlet 2002, which enters the blower 2001 through an inlet port 2003. The inlet port 2003 can include a valve 2004 through which a pressurized gas may enter the blower 2001. The valve 2004 can control a flow of oxygen into the blower 2001. The valve 2004 can be any type of valve, including a proportional valve or a binary valve. In some embodiments, the inlet port does not include a valve.

[0449] The blower 2001 can operate at a motor speed of greater than 1,000 RPM and less than 30,000 RPM, greater than 2,000 RPM and less than 21,000 RPM, or between any of the foregoing values. Operation of the blower 2001 mixes the gases entering the blower 2001 through the inlet port 2003.

[0450] The mixed air can exit the blower 2001 through a conduit 2005 and enters the flow path 2006 in the sensor chamber 2007. A sensing circuit board with sensors 2008 can positioned in the sensor chamber 2007 such that the sensing circuit board is at least partially immersed in the gases flow. At least some of the sensors 2008 on the sensing circuit board can be positioned within the gases flow to measure gases properties within the flow. After passing through the flow path 2006 in the sensor chamber 2007, the gases can exit 2009 to the humidification chamber.

[0451] Positioning sensors 2008 downstream of the combined blower and mixer 2001 can increase accuracy of measurements, such as the measurement of gases fraction concentration, including oxygen concentration, over systems that position the sensors upstream of the blower. Such a positioning can give a repeatable flow profile. Further, positioning the sensors downstream of the combined blower and mixer avoids the pressure drop that would otherwise occur, as where sensing occurs prior to the blower, a separate mixer, such as a static mixer with baffles, is required between the inlet and the sensing system. The mixer can introduce a pressure drop across the mixer. Positioning the sensing after the blower can allow the blower to be a mixer. Also, immersing at least part of the sensing circuit board and sensors 2008 in the flow path can increase the accuracy of measurements because the sensors being immersed in the flow means they are more likely to be subject to the same conditions, such as temperature and pressure, as the gases flow and therefore provide a better representation of the gases flow characteristics.

[0452] Referring to Figure 4, the gases exiting the blower can enter a flow path 402 in a sensor chamber 400, which can be positioned within the motor and sensor module and can be the sensor chamber 2007 of Figure 3. The flow path 402 can have a curved shape. The flow path 402 can be configured to have a curved shape with no sharp turns. The flow path 402 can have curved ends with a straighter section between the curved ends. A curved flow path shape can reduce pressure drop in a gases flow without reducing the sensitivity of flow measurements by partially coinciding a measuring region with the flow path to form a measurement portion of the flow path.

[0453] A sensing circuit board 404 with sensors, such as acoustic transmitters and / or receivers, gas flow rate sensor, humidity sensor, temperature sensor, pressure sensor(s), thermistor, and the like, can be positioned in the sensor chamber 400 such that the sensing circuit board 404 is at least partially immersed in the flow path 402. Immersing at least part of the sensing circuit board and sensors in the flow path can increase the accuracy of measurements because the sensors immersed in the flow are more likely to be subject to the same conditions, such as temperature, flow rate, humidity, and pressure, as the gases flow, and therefore provide a better representation of the characteristics of the gases flow. After passing through the flow path 402 in the sensor chamber 400, the gases can exit to the humidification chamber. Alternatively, one or more of the pressure sensor(s) may be provided on one or more separate circuit boards that are positioned or located so as to enable the pressure sensor(s) to measure or sense pressure characteristics associated with the flow of gases and / or ambient pressure.

[0454] The gases flow rate may be measured using at least two different types of sensors. The first type of sensor can comprise a thermistor, which can determine a flow rate by monitoring heat transfer between the gases flow and the thermistor. The second type of sensor can comprise an acoustic sensor assembly. Acoustic sensors including acoustic or ultrasonic transmitters and / or receivers can be used to measure a time of flight of acoustic signals to determine gases velocity and / or composition, which can be used in breathing assistance apparatuses.

[0455] 2.5 Example mouthpiece attachment

[0456] Example embodiments of the mouthpiece attachment will be described in the context of the example breathing assistance apparatus 10 described above.

[0457] In a configuration, the mouthpiece attachment is automatically identified by the breathing assistance apparatus when connected or in close proximity - for example, by an RFID tag, NFC chip, Bluetooth beacon or any other suitable means. Alternatively, the mouthpiece attachment may be identified based on a pressure and / or flow characteristic. For example, in one configuration, a specific flow rate is provided by the flow generator and the pressure is measured to determine the identity of the attached mouthpiece. In a further configuration, the mouthpiece attachment is identified based on a flow and motor speed relationship. For example, the motor speed required to produce a predetermined flow rate identifies the mouthpiece attachment.

[0458] Referring to Figure 5, an example configuration of a system 700 that comprises a breathing assistance apparatus 10 with a mouthpiece 1702 is shown. The breathing assistance apparatus 10 of the system 700 may be operated in an exercise mode with the user performing breathing exercises against the flow of gases via the mouthpiece 1702 attached to the end of the breathing conduit, rather than the nasal cannula 51 or other respiratory patient interface used in therapy mode.

[0459] In this example configuration, the mouthpiece attachment 1702 is a component that can be releasably or removably connected to an end of the patient breathing conduit 16. Once the mouthpiece attachment is connected to the breathing conduit 16, the breathing assistance apparatus 10 may be operated in an exercise mode in which the patient is guided through one or more breathing exercises. Example embodiments of the configuration of the mouthpiece attachment, apparatus, exercise mode, and process of using the mouthpiece attachment with the breathing assistance apparatus will be described in further detail below.

[0460] In one example configuration, the mouthpiece attachment 1702 is configured to connect or otherwise fluidly couple, either directly or indirectly via a breathing conduit, to the flow path of a breathing assistance apparatus 10 comprising a flow generator. In this configuration, the mouthpiece attachment receives a flow of gases generated by the flow generator of the breathing assistance apparatus 10.

[0461] As described above, the breathing assistance apparatus 10 comprises one or more sensors that measure or sense characteristics of the flow of gases. The one or more sensors may generate sensor data that represent one or more characteristics of the flow of gases. The sensor data may be processed or analysed to extract or generate patient breathing information or features from the sensor data. By way of example, patient breathing information may comprise a patient or user flow rate signal and / or a patient or user pressure signal, representing the flow and / or pressure affected by the patient or user during performed breathing exercises.

[0462] In some configurations, measurements may be captured by recording and processing sensor data from the one or more sensors of the apparatus as the user performs one or more breathing exercises with the mouthpiece attachment in exercise mode. Some breathing exercises or techniques (such as normal breathing, maximal breathing and huffing) may not require the use of a mouthpiece attachment during exercise mode, with the user instead engaging with the breathing assistance apparatus via another suitable respiratory patient interface such as a nasal cannula, nasal mask, nasal pillows, or face mask.

[0463] In one configuration, the breathing assistance apparatus 10 can be used or operated in exercise mode for respiratory physiotherapy (i.e., exercise sessions comprising breathing exercises), in addition to being operable in a therapy mode to deliver one or more respiratory therapies. In this example configuration, the mouthpiece attachment 1702 need not necessarily have any sensors or electronics, as the measurement data is obtained from the one or more sensors of the breathing assistance apparatus 10 and / or breathing conduit 16. This configuration enables the mouthpiece attachment 1702 to leverage the existing sensors and sensing capability of the breathing assistance apparatus 10, as will be explained further below. This configuration allows for a lower-cost mouthpiece attachment to be manufactured that is primarily a mechanical component and which can be used with the breathing assistance apparatus 10 to perform measurements using the pre-existing one or more sensors of the breathing assistance apparatus. For example, in this configuration, the mouthpiece attachment does not need onboard sensors or sensing capability, which would add significant cost to the component. Additionally, the mouthpiece attachment is able to leverage the pneumatic resistance provided by the flow of gases generated by the flow generator, rather than requiring additional, potentially complex and costly elements to provide the pneumatic resistance (e.g., valves).

[0464] In the configuration described below, the system 700 employs the mouthpiece attachment 1702 connected to the flow path of the breathing assistance apparatus 10 and leverages the existing flow path sensors of the breathing assistance apparatus to measure or sense one or more characteristics of the flow of gases during an exercise mode as the user performs breathing exercises with the mouthpiece attachment. The sensors may, for example, include sensors for sensing any one or more of the following gas flow characteristics: flow rate, pressure, temperature, humidity, gases concentration or any other characteristic that can be used for identifying patient breathing information or characteristics during breathing exercises. The sensor data obtained from the sensors during the exercise mode can be processed and / or analysed to generate or extract or identify one or more measurements, metrics, features and / or assessments associated with the patient’s breathing. In this embodiment, the sensors are external to the mouthpiece attachment 1702, and are preferably located in the main housing 100 of the breathing assistance apparatus and / or along the patient breathing conduit 16.

[0465] Referring to Figures 6-15, an example configuration of the mouthpiece attachment 1702 will be described in further detail.

[0466] In this configuration, the mouthpiece attachment 1702 comprises a main body 1704 that extends between a first end 1706 and a second end 1708. The first end 1706 of the main body is a connector end, and the second end 1708 is a mouthpiece end.

[0467] In this configuration, the main body 1704 is a component in the form of a conduit, tube or tubular component, or manifold component. The main body has a main lumen or lumens extending between its connector end 1706 and mouthpiece end 1708 to allow a flow of gases to flow or be conveyed along the main body 1704 between its ends. The main lumen or lumens are in the form of a passage or channel or internal space extending between the openings at the connector end 1706 and mouthpiece end 1708.

[0468] In this configuration, the mouthpiece attachment 1702 may be held by the fingers and / or hand of a user, and held to their mouth as they perform breathing exercises into the mouthpiece attachment 1702. In one example, the main body is shaped and / or dimensioned to be suitable for gripping and / or holding by a hand or hands of a user.

[0469] Main body and main lumen

[0470] Referring to Figure 14, in this configuration, the main body 1704 comprises a single main lumen generally indicated at 1710. The main lumen 1710 is a passage or channel extending along the length of the main body 1704 between the open ends 1706, 1708 of the main body. The shape and / or dimensions of the main lumen 1710 may be uniform or non-uniform along the length of the main body 1704. For example, the inner dimensions or diameter of the main lumen 1710 may be uniform or vary along the length of the main body 1704. The main lumen 1710 is generally defined by the surrounding peripheral wall of the main body and / or any internal features within the main body.

[0471] In this configuration, the internal diameter of the main lumen 1710 is substantially uniform along at least a portion of the length of the main body 1704. Referring to Figure 14, a central portion of the main lumen, generally indicated at 1712 between the connector end 1706 and mouthpiece end 1708, has a substantially uniform diameter, as indicated by D6. In this configuration, the internal diameter D7 of the main lumen 1710 widens or is larger in a mouthpiece end region 1713 at or toward the mouthpiece end 1708, relative to internal diameter D6 in the central region 1712 of the main lumen 1710. In this example configuration, the internal diameter D6 of the main lumen in the central region 1712 steps or transitions into the larger diameter D7 in the mouthpiece end region 1713.

[0472] In one example, the internal dimension or diameter D6 in the central region 1712 of the main lumen 1710 may be approximately 22.5mm and the internal dimension or diameter D7 in the mouthpiece end region 1713 may be approximately 25 mm, but it will be appreciated alternative dimensions or diameters may be used, depending on the characteristics of the breathing conduit for connection.

[0473] This configuration can also be described as the central portion 1712 of the main lumen 1710 having a substantially uniform cross-sectional area. In other embodiments, it will be appreciated that the internal profile, cross-sectional area or diameter of the main lumen 1710 may vary in alternative arrangements or configurations, including widening, narrowing, or a combination of these along one or more portions or the entire length of the main body 1704. The variations or transitions in diameter or profile or cross-sectional area of the main lumen 1710 may be gradual or progressive, or sharper or with stepped changes. In this configuration, the difference in the internal diameters, dimensions or cross- sectional areas of the central region 1712 and mouthpiece end region 1713 are defined by the thickness of the peripheral wall of the main body 1704. In this configuration, the outer dimension or diameter of the main body 1704 of the mouthpiece attachment 1712 is substantially uniform along the central 1712 and mouthpiece end regions 1713, as indicated by diameter D8. As such, the thickness of the peripheral wall of the main body 1704 in the central region 1712 is greater than the thickness of the peripheral wall of the main body in the mouthpiece end region 1713, to thereby create the internal diameters D6 and D7 discussed above.

[0474] In this configuration, the main body 1704 is an elongate component. The main body 1704 is substantially hollow and defined by a conduit or conduits, or peripheral wall or walls, that extend between the ends 1706, 1708 of the main body. In this embodiment, the main body 1704 has a substantially circular cross-section along its length as shown in Figures 24, 25, 30 and 31 for example.

[0475] In one configuration, the outer dimensions or diameter of the main body 1704 may be substantially uniform along its length. In alternative configurations, the outer dimensions or diameter of the main body 1704 may vary along its length.

[0476] In this configuration, the main body 1704 comprises a first region 1720 and a second region 1721, as shown in Figure 14. The first region 1720 is cylindrical and defined by outer diameter or dimension indicated at D8. The second region 1721 is cylindrical and defined by outer diameter or dimension indicated at D9. In this example, the first region 1720 extends from the mouthpiece end 1708 and terminates at an intermediate location 1722 toward the connector end 1706, and the second region 1721 extends from the intermediate location 1722 to the connector end 1706. In this example, the first region 1720 includes the mouthpiece end region 1713 and central region 1712 of the main body 1704, and the second region 1721 includes or defines the connector end region. In this configuration, the first region 1720 is larger in dimension or diameter D8 than the dimension or diameter D9 of the second region 1721. For example, in this embodiment, the connector end region indicated at 1721 has a smaller diameter or dimension than the remainder of the main body 1704. In this configuration, the first region 1720 of the main body 1704 is of larger diameter or dimension D8 and steps down or transitions to the second region 1721 of the main body that has a smaller diameter or dimension D9. In this configuration, the cylinder or cylindrical wall defining the first region 1720 steps down or transitions at intermediate location or shoulder 1722 to a cylinder or cylindrical wall defining the second region 1721. In this configuration, the cylinder or cylindrical wall defining the first region 1720 is longer and larger in diameter than the cylinder or cylindrical wall defining the second region 1721. In this configuration, the dimensions and configuration of the connector end region of the second region 1721 may be configured for complementary engagement or connection to the end of a breathing conduit 16 of a breathing assistance apparatus 10, as shown in Figure 5.

[0477] In one example, the outer dimension or diameter D8 of the first region 1720 of the main body 1704 may be approximately 27.5mm and the dimension or diameter D9 of the second region 1721 defining the connector end region may be approximately 20.8mm, but it will be appreciated alternative dimensions or diameters may be used, depending on the characteristics of the breathing conduit for connection and / or other design factors.

[0478] In this configuration, the main body 1704 has a substantially cylindrical form-factor or shape, with an outer surface defined by circular cross-sectional profile or shape along its length. It will be appreciated that the main body 1704 may be provided in alternative shapes or configurations. For example, the cross-sectional profile of the outer surface of the main body may be circular, oval, rectangular, square, arbitrary or any suitable shape or combination of shapes and sizes along the length of the main body.

[0479] In this configuration, the main body 1704 and main lumen 1710 can generally be defined or aligned along or with reference to a central longitudinal axis. The main body and main lumen are straight and extend in a single axis or dimension. In alternative configurations, it will be appreciated that the main body and / or main lumen may have alternative shapes and configurations such as, but not limited to, curvilinear, arcuate, elbow-configuration, or may otherwise have a non-straight profile that does not conform or align to a single longitudinal axis or dimension. It will be appreciated that various shapes and configurations of the main body can be provided with a main lumen that fluidly communicates between the connector end and mouthpiece end of the main body.

[0480] Connector end

[0481] Referring to Figures 5 and 13-15, the connector end 1706 of the mouthpiece attachment 1702 will be described in more detail.

[0482] In this configuration, the connector end 1706 is configured to releasably connect or attach to the end of a breathing conduit 16 or tube of the breathing assistance apparatus 10. As will be appreciated, the breathing conduit 16 of a breathing assistance apparatus is a typically a flexible conduit that attaches or connects at one end to a gases outlet 21 of the breathing assistance apparatus such that it is fluidly connected or in fluid communication with the flow of gases generated by the flow generator 11 of the apparatus. The other end of the breathing conduit 16 typically provides a connector for releasably connecting or coupling to a respiratory patient interface (e.g., nasal cannula, nasal mask, full face mask, tracheostomy interface or similar) to deliver the flow of gases to a patient’s airway when the breathing assistance apparatus is used for respiratory therapy (e.g. high flow therapy, PAP therapy or similar), e.g. in normal therapy mode. In this embodiment, the connector end 1706 of the mouthpiece attachment 1702 is configured or arranged to releasably connect or attach to the connector or end of the breathing conduit such that the mouthpiece attachment is in fluid communication with the flow of gases conveyed along the breathing conduit.

[0483] In this configuration, the connector end 1706 of the mouthpiece attachment 1702 comprises a connecting structure or arrangement generally indicated at 1714 that is configured to provide a releasable fluid connection to the end or connector of a breathing conduit 16. The end or connector of the breathing conduit may comprise a complementary connecting structure or arrangement for engaging and attaching with the connector end 1706 of the mouthpiece attachment 1702 for coupling the two components together in a releasable manner. In this configuration, the connecting structure 1714 may be provided by a pair of opposing resilient clipping protrusions that releasably engage or clip into corresponding formations or indents or catches or complementary end or connector of the breathing conduit 16. It will be appreciated that the connector end 1706 may be configured, arranged or provided with any suitable form of mechanical releasably fastening or coupling to complement the end or a connector of the breathing conduit including, but not limited to, screw threaded, rotational locking or coupling, clip fittings, snap-fit connection, push-fit connection, interference-fit connection, latch connection, or the like.

[0484] In some configurations, the connector end 1706 may be provided with a connecting structure that is compatible with connecting to the end of one or more specific types of breathing conduits, including brand or manufacturer-specific breathing conduits. For example, in one embodiment, the connector end 1706 may be configured to attach or connect to a 20mm breathing tube used with a high flow breathing assistance apparatus. In other configurations, the connector end 1706 may be provided with a generic or universal connecting structure or configuration that is operable or able to couple to the end of various or a broad range of different types of breathing conduits.

[0485] In the configuration shown, the connector end 1706 is configured for releasable connection or coupling with the end or a connector of the breathing conduit 16. This allows the mouthpiece attachment 1702 to be connected to the breathing conduit to facilitate patient breathing exercises in an exercise mode of the apparatus, and then removed following the exercise session, leaving the breathing conduit able to be connected or re-connected to a patient interface for use in a respiratory therapy mode.

[0486] In alternative configurations, the connector end 1706 of the mouthpiece attachment may be configured with a non-releasable permanent connection to the breathing tube 16, such that the components can’t be released from each other without breakage. Alternatively, a semi -permanent connection may be provided between the connector end 1706 of the mouthpiece attachment and the breathing conduit 16, such that tools or similar are required to release the components from each other.

[0487] In further alternative configurations, the mouthpiece attachment 1702 may be provided with an integral breathing conduit extending from the connector end 1706. In such an embodiment, the mouthpiece attachment 1702 is combined with an integral flexible conduit extending from the connector end. The integral flexible conduit may terminate in a connector end which can releasably connect or attach to the gases outlet 21 of the breathing assistance apparatus.

[0488] In another configuration, the mouthpiece attachment 1702 may be configured to releasably connect or attach directly to the gases outlet 16 of the breathing assistance apparatus without an intermediate breathing conduit. In another embodiment, the mouthpiece attachment 1702 may be configured to releasably connect or attach directly to the flow generator outlet or gases outlet port, if the humidifier chamber is removed from the apparatus. In another embodiment, the humidifier or humidifier chamber may be bypassed via a bypass conduit or other bypass configuration. For example, the mouthpiece attachment may attach directly to or indirectly via the breathing conduit to a bypass conduit or port or outlet that bypasses the humidifier or humidifier chamber, such that the mouthpiece attachment is in fluid communication with the flow of gases from the flow generator outlet, and the humidifier is temporarily cut-out or bypassed from the flow path.

[0489] Mouthpiece end

[0490] Referring to Figures 12 and 14, the mouthpiece end 1708 of the mouthpiece attachment 1702 will be described in more detail.

[0491] In this configuration, the mouthpiece end 1708 is a portion that is configured to releasably receive and retain an optional removable mouthpiece, to be explained in further detail later. In this configuration, the mouthpiece end 1708 is an open cylindrical portion at the end of the main body 1704. The mouthpiece end 1708 is non-threaded in this embodiment but could be threaded in other embodiments. However, it will be appreciated that the mouthpiece end 1708 may be any other suitable shape or configuration for receiving and retaining a releasable mouthpiece.

[0492] In alternative configurations, the mouthpiece attachment 1702 may be used directly without a separate removable mouthpiece. In such configurations, the mouthpiece may be integrally formed with the mouthpiece end 1708 or the mouthpiece end 1708 itself may be configured as a mouthpiece or used as a mouthpiece for fluidly communicating with the airway of a user or patient when they seal their mouth around the mouthpiece, in use. It will be appreciated that the shape and configuration of the mouthpiece portion or end of the main body may be cylindrical, oval, elliptical, mouth-shaped or any other suitable shape suitable for a user’s mouth.

[0493] Exhaust vent holes

[0494] In this configuration, the mouthpiece attachment 1702 comprises one or more exhaust openings that are in fluid communication with the main lumen of the mouthpiece attachment 1702. The exhaust opening or openings provide a pathway for the flow of gases and / or exhaled breath from the user or patient to escape to atmosphere or the surrounding environment, during use of the mouthpiece attachment. Without one or more exhaust openings, complete blockage of the flow path may occur in some system configurations when the user places their mouth on the mouthpiece or otherwise creates a seal around the mouthpiece during use. In alternative configurations, the mouthpiece attachment 1702 may not have any exhaust vents or exhaust openings, and the system configuration may allow for this. For example, exhaust vents, exhaust openings, and / or pressure relief valves may be provided in the flow path upstream of the mouthpiece attachment.

[0495] Referring to Figures 6-10 and 14, an example configuration of the exhaust openings will be described in further detail. In the configuration shown, the mouthpiece attachment 1702 is provided with one or more exhaust openings 1716. The one or more exhaust openings 1716 are located between the connector end 706 and mouthpiece end 1708. In this configuration, the one or more exhaust openings 1716 are provided in and / or along the main body 1704 of the mouthpiece attachment 1702.

[0496] In this configuration, the exhaust openings 1716 are in the form of or comprise flush vents. The flush vents are through-holes, openings or apertures extending through the peripheral wall of the main body 1704 of the mouthpiece attachment 1702. The flush vents may be substantially flush with the outer surface (e.g., cylindrical surface) of the main body 1704 of the mouthpiece attachment 1702. Referring to Figure 14, in this configuration, the exhaust openings 1716 extend from the outer surface through to the inner surface of the wall of the main body (i.e., through the entire thickness of the wall) to thereby provide a passage(s) or pathway(s) for gases and / or exhaled breath in the main lumen to escape or exhaust from the device to the surrounding atmosphere or environment. As shown, in this configuration, the exhaust openings are non-protruding or flush relative to the peripheral wall of the main body 1704 and comprise holes or vents formed directly in the wall of the main body. However, in alternative configurations, one or more protruding exhaust vents may project from the surface wall or the main body.

[0497] In this configuration, the shape of the exhaust openings 1716 is circular, but it will be appreciated that any other shape or profile or combination of different shapes or profiles may be used for the exhaust openings or holes in alternative embodiments. If a plurality of exhaust openings 1716 are provided, these may be uniform in shape and / or size, or alternatively they may be a combination of different shapes and / or sizes.

[0498] The total cross-sectional area of the exhaust opening or openings 1716 may be configured to suit the desired exhaust flow requirements. For example, the size or dimension of the exhaust openings 1716 may be configured to suit the exhaust flow requirements, relative to the size and characteristics of the overall mouthpiece attachment 1702. For example, for circular exhaust openings 1716, the diameter of the openings may be customised or configured to suit the required exhaust flow requirements. By way of example only, in this example configuration, each of the exhaust openings 1716 is a circular hole or aperture having a diameter of approximately 5mm. As such, the opening area of each exhaust opening is approximately 19.6mm2. In this example, the inner cross-sectional area of the main lumen is approximately 397.6mm2as defined by the internal diameter D6 of 22.5mm. As such, each exhaust opening 1716 has an opening area that is approximately 5% of the cross-sectional area of the main lumen of the main body of the mouthpiece attachment 1702. Further, in this example, the total exhaust opening area as provided by the three uniform exhaust openings 1716 is approximately 15% of the cross-sectional area of the main lumen of the mouthpiece attachment 1702.

[0499] In the configuration shown, exhaust openings 1716 comprise a linear arrangement, line or line array of uniformly spaced-apart exhaust openings 1716 provided along one side surface or region of the main body 1704 of the mouthpiece attachment 1702. In this example embodiment, the line array of exhaust openings 1716 extends in a direction aligned with the longitudinal axis of the main body 1704. In this example configuration, there are three exhaust openings, but it will be appreciated that the number of exhaust openings 1716 in the array may be varied and that the spacing may be uniform or non- uniform in other configurations. In this example configuration, the line array of exhaust openings 1716 is located closer to the mouthpiece end 1708 of the main body 1704 than the connector end 1706, but alternatively the exhaust openings 1716 may be located centrally or closer to the connector end of the main body in other configurations.

[0500] There may be a single exhaust opening or a plurality of exhaust openings. The number, arrangement or pattern of the one or more exhaust openings may vary in different configurations. In some configurations, the exhaust openings are arranged in an array such as a linear array or non-linear array, or any other pattern or configuration. In some configurations, the exhaust openings may be provided in a line or lines extending along the length of main body 1704 on one or more sides or surface regions. In some configurations, the line or lines of exhaust openings are aligned with the longitudinal axis as shown, or they may extend in other directions. In some configurations, the exhaust openings may be provided circumferentially about the circumference of the main body. For example, the exhaust openings may be provided in the form of one or more an annular vents or annular arrays of spaced-apart exhaust openings about the circumference of the main body 1704. The annular array or arrays of spaced-apart exhaust openings or holes in the wall of the main body may extend about the entire circumference or at least a portion or portions of the circumference of the main body.

[0501] There may be one or a plurality of exhaust openings or arrays of exhaust openings extending along and / or about the surface of the main body 1704, including along or about any one or more regions or sides or surfaces of the main body. In some configurations, the exhaust openings may be provided on opposite or opposing sides, or on multiple sides of the main body 1704.

[0502] The location of the one or more exhaust openings or arrays or exhaust openings along and / or about the main body 1704 may vary. In one configuration, the exhaust opening or openings may be centrally located or located in a middle region of the mouthpiece attachment 1702 or main body 1704. In other configurations, the exhaust opening or openings may be located at or toward either the connector end 1706 or mouthpiece end 1708 of the main body 1704. In yet other configurations, a plurality of exhaust openings may be spaced-apart along the bulk or entire length of the main body 1704, whether on the same or different side surfaces of the main body.

[0503] In general, the properties of the one or more exhaust openings 1716 may be varied in different configurations including, but not limited to, the number, shape, opening area, arrangement, uniformity, circumference, and / or diameter for example.

[0504] In some configurations, the mouthpiece attachment 1702 may comprise a mixture of different types of exhaust openings. Some exhaust openings may be protruding vents as mentioned above and others may be flush vents or exhaust openings of the type described in regard to this example configuration mouthpiece attachment 1702. Some exhaust openings may comprise a single opening, and others may comprise multiple openings, or may comprise an arrangement of openings or ports or holes forming a mesh or honeycomb vent arrangement that is flush with the outer surface of the main body, for example.

[0505] Removable mouthpiece

[0506] As discussed, in some configurations the mouthpiece end 1708 of the main body 1704 may itself be a mouthpiece, or may have an integrated mouthpiece. In this configuration, the mouthpiece attachment 1702 is provided with a releasable or removable mouthpiece that is received or attached to or into the mouthpiece end 1708 of the main body 1704.

[0507] With reference to Figures 16-27, an example of the mouthpiece attachment 1702 with a removable mouthpiece 1730 will be described in further detail. The mouthpiece 1730 may be optional, in the sense that the mouthpiece end 1708 of the main body 1704 of the mouthpiece attachment 1702 can operate as a mouthpiece. However, the removable mouthpiece 1730 may provide certain advantages in some scenarios or circumstances from a usability, manufacturing and / or hygiene viewpoints.

[0508] In this example configuration, the removable mouthpiece 1730 is a hollow conduit component with a mouthpiece portion 1732 for the user’s mouth at one end, and an attachment portion 1734 at the other end for releasably connecting or attaching to the mouthpiece end 1708 of the mouthpiece attachment 1702.

[0509] In this example configuration, the mouthpiece portion or region 1732 of the mouthpiece 1730 comprises an oval or elliptical shape or cross-sectional profile along at least a portion of its length. The mouthpiece portion or region extends between a first end or point indicated at 1736 and a second end or point indicated at 1738. The first end or point 1736 is at an intermediate location along the length of the mouthpiece 1730 and defines the boundary or transition between the mouthpiece portion 1732 and attachment portion 1734. In this example configuration, the mouthpiece portion or region 1732 transitions progressively in shape or cross-section from a circular cross-section at the first end at 1736 to an oval or elliptical shape as it extends toward the open elliptical or oval opening at the second end 1738.

[0510] In this example configuration, the attachment portion or region 1734 of the mouthpiece 1730 is a cylindrical conduit portion. Referring to Figure 18, in this configuration, the outer diameter DIO of the attachment portion 1734 of the mouthpiece 1730 is dimensioned or selected to complement the internal diameter D7 of the mouthpiece end 1708 of the main body (see Figure 14) such that the attachment portion 1734 can be inserted or plugged into the socket or port or opening provided by mouthpiece end 1708, as shown by arrow F in Figure 23. In this configuration, the relative dimensions of the outer diameter DIO or circumference of the attachment portion 1734 of the mouthpiece 1730 and the inner diameter D7 of the mouthpiece end 1708 of the main body 1704 of the mouthpiece attachment 1702 may be configured to provide a push-fit, friction fit or interference fit, so that the removable mouthpiece can be suitably received and retained in the mouthpiece attachment during use. Sufficient hand or pulling force in direction G (see Figure 23) may be applied by a user to remove or pull the removable mouthpiece 1730 from the mouthpiece end 1708 of the mouthpiece attachment, for replacement, cleaning, repair and / or disposal for example.

[0511] Referring to Figures 22-27, the assembly and disassembled mouthpiece attachment 1702 with removable mouthpiece 1730 is shown by way of example. Figure 23 shows an exploded view of the mouthpiece attachment 1702 with the mouthpiece 1730 removed or disconnected from the mouthpiece end 1708. Figures 22 and 24-27 show various perspective, elevation and cross-sectional views of the mouthpiece attachment 1702 with the removable mouthpiece 1730 installed, assembled or inserted into the mouthpiece end 1708 of the main body 1704, ready for use.

[0512] It will be appreciated that any other suitable releasable or removable coupling or connection arrangement or structure for connecting the removable mouthpiece 1730 to the end of the mouthpiece attachment 1702 may be used in alternative configurations including, but not limited to, snap-fit, screw-thread, fastening or clipping systems, or the like.

[0513] Referring to the cross-sectional views in Figures 19 and 21, the removable mouthpiece in this configuration comprises a single main lumen or passage indicated at 1736 extending between its ends. Referring to Figures 25 and 27, the mouthpiece lumen 1736 provides the fluid communication to the main lumen or lumens (e.g., main lumen 1710) of the main body 1704 of the mouthpiece attachment 1702, so that the removable mouthpiece can convey the flow of gases to a user during use.

[0514] In alternative configurations, the mouthpiece may be provided with a plurality or multiple lumens (e.g., channels or passages) extending along its length, e.g., in an array or mesh or honeycomb type arrangement.

[0515] In this example configuration, the removable mouthpiece 1730 is elongate and varies in cross-sectional shape along at least a portion of its length. It will be appreciated that various shapes or cross-sectional profiles may be used to create the mouthpiece 1730. In one example, the shape of the attachment portion 1734 may complement or suit the mouthpiece end 1708 of the mouthpiece attachment 1702 to allow for attachment, and the mouthpiece portion 1732 may be any other suitable shape or profile for a user to seal their mouth around or over. For example, the mouthpiece portion 1732 may be circular, elliptical, oval, mouth-shaped, or any other suitable shape in cross-section.

[0516] The removable mouthpiece 1730 in this configuration is a substantially straight or elongate component defined about a central longitudinal axis. However, it will be appreciated that the mouthpiece may have any suitable shape, including having one or more arcs or bends, and / or may be elbow-like in general shape.

[0517] As discussed, in this configuration the removable mouthpiece 1730 is arranged to be a releasable component of the mouthpiece attachment 1702. However, the mouthpiece 1730 described above may alternatively be integrally formed with or extend from the end of the main body 1704 of the measurement 1702 in other configurations. It will be appreciated that any of the properties and aspects of the removable mouthpiece 1730 described above may equally apply to an integral or permanent mouthpiece portion of the main body 1704.

[0518] Anti-occlusion features

[0519] Referring to Figures 28-30, in some configurations the mouthpiece attachment 1702 may optionally comprise one or more anti-occlusion features, formations, or protrusions 1740 near, about or in the vicinity of the exhaust openings 1716 to assist in preventing the openings from being accidentally or inadvertently blocked or covered during use by a patient. For example, the anti-occlusion features 1740 may assist in preventing a user or patient from accidentally or inadvertently covering or blocking one or more of the flush exhaust openings 1716 with their fingers and / or hand in use.

[0520] In this example configuration, the anti-occlusion features comprise a pair of spaced-apart walls or surfaces 1740 that protrude or extend from the wall of the main body 1704 along each side of the linear arrangement of exhaust openings 1716. The pair of walls protrude above the surface of the main body 1704 and exhaust openings 1716 and are arranged to prevent accidental or inadvertent blocking or covering of the exhaust openings in use.

[0521] In this example configuration, the anti-occlusion protruding walls 1740 are curved or have an arcuate profile and are arranged to collectively form a clip or attachment mechanism that can be used to clip, attach or mount the mouthpiece attachment 1702 to a carry stand or to the breathing assistance apparatus when not in use. For example, the pair of protruding curved walls 1740 oppose each other and form a cylindrical clipping aperture or region above the exhaust openings for clipping or mounting to a complementary sized and shaped cylindrical component of a carry stand or of the breathing assistance apparatus or some other complementary mounting structure or component. The protruding walls may be rigid or semi-rigid, and in some configurations may have some resilient flexibility to enable provide or form a snap-fit clip or clipping arrangement. It will be appreciated that the anti-occlusion features may be any other shape, size or arrangement relative to the exhaust openings that is sufficient to assist in preventing blockage or covering of the exhaust openings during use. There may be one anti-occlusion feature or a plurality or multiple anti-occlusion features. In some configurations, the antiocclusion features may have a dual purpose or function, such as also forming a clip, but in other configurations the anti-occlusion features may have the sole function of preventing blockage of the exhaust openings during use.

[0522] Materials - Mechanical configuration of mouthpiece attachment

[0523] The example mouthpiece attachment 1702 described above may be formed of any suitable materials.

[0524] In one configuration, the main body 1704 may be primarily formed of a rigid or semirigid materials or combination of materials such as, but not limited to, plastic or plastic polymer such as, but not limited to, polycarbonate (PC), polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), polyvinyl chloride (PVC), Acrylonitrile-Butadiene-Styrene (ABS), or carboards, glass, metal, or any other suitable rigid or semi-rigid material.

[0525] The main body 1704 of the mouthpiece attachment 1702 may be made of the same or similar material to the removable mouthpiece 1730, or these components may be formed of different materials. For example, in one configuration, the main body 1704 may be primarily formed of a plastic polymer and the removable mouthpiece may be formed of the same or different plastic polymer. In another configuration, the main body 1704 may be primarily formed of a plastic polymer, and the removable mouthpiece may be formed from cardboard or heavy-duty paper for example.

[0526] The materials used and / or thickness of the materials used to form the mouthpiece attachment 1702 may depend on the circumstances of use. In some configurations, the entire mouthpiece attachment, including the main body 1704 and removable mouthpiece 1730 may be made from lower-cost or lower-grade materials more suited for a disposable item. In other configurations, the main body 1704 may be configured as a multi-time use and / or multi-user component formed of a more durable or longer-lasting material such as plastic, but a lower-cost material may be used for removable mouthpiece, such as cardboard or a thinner or lower-grade or lower-cost plastic, as the mouthpiece may be configured as a one-time or single -user disposable item.

[0527] It will be appreciated that a range of different mouthpiece attachments may be formed from different materials. Some mouthpiece attachments, or particular components thereof, may be formed with higher-grade and / or more durable materials for longer or multi-time use, and other mouthpiece attachments, or at least particular components there of (e.g., the removable mouthpiece) may be formed of lower-cost and / or disposable and / or less durable single-use type materials such as, but not limited to, cardboard or lower-grade or thinner plastics.

[0528] In some configurations, the mouthpiece attachment, or components thereof (e.g., removable mouthpiece) may be configured to be suited to delivery and / or shipping to end users, for use a specified number of times or for a fixed lifespan (e.g., having an expiry or use by date). In such scenarios, the mouthpiece attachment may be formed of materials more suited to a disposable item.

[0529] 2.6 Exercise mode of breathing assistance apparatus

[0530] As part of their therapy programme, a patient may be required to perform a programme of breathing exercises for respiratory physiotherapy. Currently, patients may be provided with a standalone passive mechanical device through which they are required to exhale. Such passive mechanical devices are provided with adjustable or swappable flow restrictor components that can be configured to provide fixed or variable resistance to flow from patient exhalations, which has physiotherapeutic benefits. At least some embodiments of this disclosure provide a simple, low-cost mechanical attachment (e.g., mouthpiece attachment) for use with breathing assistance apparatuses to provide breathing exercises for respiratory physiotherapy. The controller, software and / or firmware of the breathing apparatuses may be configured to provide an exercise mode that can be initiated while the patient performs the breathing exercises with the mouthpiece attachment or other respiratory patient interface connected to the flow of gases generated by the breathing assistance apparatus.

[0531] In the exercise mode, the flow generator of the breathing assistance apparatus 10 is operable to provide a controlled flow of gases to control a pneumatic resistance to a patient’s breathing exercises and / or otherwise provide a flow of gases with desired flow rate and / or pressure characteristics against which the user may perform breathing exercises. Sensors onboard the breathing assistance apparatus 10 can be leveraged to provide a measure of a patient’s performance of the breathing exercises, evaluating a patient’s breathing while the exercises are being performed, and / or evaluating the patient’s compliance to the programme of breathing exercises.

[0532] The breathing assistance apparatus 10 may be capable of one or more modes of operation. In this configuration, the breathing assistance apparatus 10 comprises a therapy mode that may be operable to provide a flow of gases with specific properties (e.g., flow rate and / or pressure and / or humidity and / or oxygen concentration) that is suitable for one or more respiratory therapies such as, but not limited to, nasal high flow (NHF) therapy, CPAP, Bilevel PAP / NIV, oscillation therapy, or other such respiratory therapy. In this configuration, the breathing assistance apparatus 10 further comprises an exercise mode. In one example, the exercise mode may be initiated when the breathing assistance apparatus is used with the mouthpiece attachment 1702 or a respiratory patient interface to undertake breathing exercises in an exercise session.

[0533] As will be explained in further detail later, in the exercise mode, the user may be instructed or prompted to perform various steps of one or more breathing exercises into the mouthpiece of the mouthpiece attachment 1702 while the flow generator of the apparatus is operated to control a pneumatic resistance or other characteristics of the flow of gases provided to the user. The one or more sensors of the breathing assistance apparatus 10 may be used to sense one or more properties or characteristics of the flow of gases during the breathing exercises. The sensor data may then be processed or filtered or otherwise analysed / processed to generate data indicative of performance of the breathing exercises, and / or compliance with a breathing exercise programme.

[0534] In a configuration, the breathing assistance apparatus 10 may be configured to initiate or activate the exercise mode in response to user input to the user interface of the breathing assistance apparatus 10. Additionally, or alternatively, the exercise mode may be initiated remotely by another external device or system that is in data communication with the breathing assistance apparatus 10 over a data network (e.g., a Wi-Fi network). Additionally, or alternatively, the exercise mode may be initiated upon detecting that the mouthpiece attachment 1702 has been connected to the breathing assistance apparatus 10 and / or breathing conduit 16.

[0535] By way of example, the user interface of the apparatus 10 may have an operable button (whether mechanical or touch-sensitive) or a touch-screen interface or button (e.g., GUI) that is operable to initiate the exercise mode. Additionally, or alternatively, the apparatus 10 may be controlled via a user’s smart device in data communication with the apparatus (e.g., over Bluetooth, Wi-Fi, infrared or similar). For example, a smartphone application may be provided to remotely control the apparatus and the smartphone application may provide a GUI button that is operable to initiate the exercise mode on the breathing assistance apparatus 10.

[0536] Remote initiation of the exercise mode may occur by a remote user such as a medical professional providing user input to a remote electronic device or server that is in data communication with the breathing assistance apparatus 10. By way of example, the remote device or server may have a software application that can provide an operable command or a GUI with a GUI element / button that is operable to initiate the exercise mode on the breathing assistance apparatus 10 remotely via a control signal or command data sent over the data network. The remote device or server may have any form of suitable user interface for receiving user input from the medical professional or other user, including one or more mechanical or touch-sensitive buttons or interfaces, and / or an electronic GUI displayed on a display screen.

[0537] It will be appreciated that the breathing assistance apparatus 10 and / or remote device or server or system may receive user input to initiate the exercise mode through other means, including voice or audible control or commands via a voice interface or voice assistant device.

[0538] In a configuration, the exercise mode may be initiated manually. For example, a user may manually select the exercise mode via input to the apparatus. Additionally, or alternatively, a medical professional may initiate the exercise mode via remote control as discussed above. Additionally, or alternatively, the exercise mode may be initiated automatically, either locally by the local controller 19 of the breathing assistance apparatus 10 or remotely by a processor of a remote device, system or server. Automatic initiation of the exercise mode may occur according to a configurable schedule or periodic interval. The configurable schedule or periodic interval may be configured by the user or by a remote medical professional via the respective user interfaces and / or software applications of the breathing assistance apparatus 10 and remote device, system or server.

[0539] In an embodiment, the apparatus and / or remote device, system or server may be configured to prompt or remind the user or remote medical professional to initiate the exercise mode. The prompts or reminders may be visual prompts and / or audio prompts, provided, for example, via the user interfaces of the breathing assistance apparatus 10 and / or any remote device, server or system in data communication with the breathing assistance apparatus 10. By way of example, the visual prompts may be displayed on a display or touch-screen display of the breathing assistance apparatus 10 or remote device and any audible prompts may be provided via an audio output device (e.g., speaker) of the apparatus or remote device. The user or remote medical professional may initiate the exercise mode in response to the prompt or prompts. In some scenarios, the user may be prompted via phone, email, SMS, smartphone application message or notification, or another suitable electronic communication method to prompt them to undertake an exercise session comprising a programme of one or more breathing exercises.

[0540] In some configurations, the prompts may be automatically generated in accordance with a preset or configurable schedule (e.g., a periodic interval). The apparatus may be provided with an initial default schedule or periodic interval during manufacture. The schedule or periodic interval may be configured by the user or remote medical professional via an interface or software application of the apparatus and remote device, server or system. Alternatively, the remote medical professional may be able to trigger the prompts on the apparatus 10 in a manual or ad hoc manner when desired via an interface or software application of the remote device, system or server.

[0541] Referring to Figures 31-33, example methods 750,750A of using the mouthpiece attachment 1702 with a breathing assistance apparatus 10 in exercise mode will be described in further detail. The methods in this example are implemented primarily by computing instructions or software executed on a processor or controller of the breathing assistance apparatus 10 when it enters exercise mode. The principles of the example methods 750,750A may be applied to any of the examples, configurations, or variations of the breathing assistance apparatus and / or mouthpiece attachment described previously.

[0542] It will be appreciated that various steps in the example methods to be described need not necessarily operate in the order described. Some steps may occur in parallel, overlap with other steps, or may be performed in a different order to those shown in the Figures, without impacting on the overall methods. Some steps may not be required or may be altered, depending on the specific configuration and / or operation of the breathing assistance apparatus and / or mouthpiece attachment.

[0543] Initiating patient exercise mode

[0544] In one example configuration, the breathing assistance apparatus 10 may start the exercise mode when the mouthpiece attachment 1702 is connected. By way of example, the breathing assistance apparatus 10 may initiate the exercise mode automatically when a mouthpiece attachment is detected in the flow path, or alternatively when a user selects the exercise mode via input on a user interface (e.g., GUI) of the apparatus.

[0545] In another example configuration, the breathing assistance apparatus 10 may initiate the exercise mode upon start-up.

[0546] In another example configuration, the breathing assistance apparatus 10 may initiate the exercise mode for an exercise session in accordance with a therapy schedule that defines and / or co-ordinates a sequence of one or more therapy sessions in therapy mode and one or more exercise sessions in exercise mode.

[0547] Referring to Figure 31, in this embodiment, the method 750 starts at step 752 by the exercise mode of the breathing assistance apparatus 10 being initiated in response to manual activation by the local user or patient, or remotely by a remote medical professional or similar, or in response to automatic initiation (for example based on a therapy schedule or other criteria being satisfied, as described above). As previously discussed, the user or medical professional may be prompted to initiate the exercise mode in response to a prompt (such as a reminder). Once in the exercise mode, the breathing assistance apparatus 10 may be configured to provide the user with one or more prompts, instructions, and / or other forms of guidance on some or all steps of the method, as will be explained below.

[0548] The prompts, instructions and / or guidance may relate to configuring the breathing assistance apparatus and / or mouthpiece attachment, and / or may relate to the performance of one or more steps of breathing exercises. The prompts, instructions, and / or guidance may be visual, with text and / or graphical imagery, and displayed via a graphical user interface (GUI) on the display of the apparatus. Additionally, or alternatively, the prompts, instructions and / or guidance can be in the form of audible instructions provided via a speaker of the apparatus, for example. In other configurations, any such visual and / or audible prompts, instructions and / or guidance can be provided by a suitable external electronic device in communication with the breathing assistance apparatus, such as a smartphone, tablet, laptop, smart watch, wearable device, smart glasses, actigraphy device, or similar such device. In a configuration, a user may respond to the prompts, instructions and / or guidance with voice- activated commands or responses. Various GUI screen prompts for the steps in the exercise method 750 may be presented to a user, as described below by way of example only. The GUI screen prompts may be provided alone or in combination with audio prompts, guidance and / or instructions over a speaker or audio output device.

[0549] As will be explained further below, in some configurations, the apparatus may present step-by-step instructions, prompts, and / or guidance on how to use the mouthpiece attachment during the exercise mode or during an exercise session. In this context, an ‘exercise session’ is intended to mean operating the breathing assistance apparatus in the exercise mode to carry out breathing exercises or a programme of breathing exercises.

[0550] During the exercise mode the breathing assistance apparatus may determine whether the interface is correctly sealed to the user (for example to the mouth of the user). The breathing assistance apparatus may use a flow-pressure relationship to determine this, where if for a given flow the pressure is below a threshold this may be indicative the interface is not correctly sealed, and if for a given flow the pressure is above a threshold this may be indicative the interface is correctly sealed. Other methods of detecting whether the interface is correctly sealed to the user may be used for example calculating leak and determining when leak exceeds a threshold.

[0551] During the exercise mode the breathing assistance apparatus may check the pressure of the gases delivered to the user, and if they exceed a threshold then control the pressure of the gases to a safe pressure. The safe pressure may for example be a minimum pressure when an oscillating pressure is provided. The pressure may be a pressure measured at the breathing assistance apparatus or in the flow path of the gases or may be an estimated pressure at a location in the flow path (for example at the mouthpiece). By way of example only, the visual and / or audible instructions, prompts and / or guidance may provide information to the user about any one or more of the following:

[0552] • the operating mode of the apparatus (e.g., exercise mode);

[0553] • how to disconnect the patient interface from the apparatus and / or breathing conduit;

[0554] • how to connect or attach the mouthpiece attachment to the gases outlet, breathing conduit or flow path of the apparatus;

[0555] • how to perform the breathing exercise(s);

[0556] • how to perform normal breathing or tidal breathing at the end of the exercise session following the breathing exercises; and / or

[0557] • how to perform maximum inspirations, breath holds, and / or walking around (e.g., to increase breath volume).

[0558] The information above can be provided using any combination of text, numbers, characters, images, icons, graphics, animations, videos and / or audio.

[0559] The GUI display screen prompts may comprise any combination of text, imagery, animations, videos and / or other graphics, to provide the user with information and / or guidance on the instructions or prompts for each step. Prompts may also be audibly presented by a speaker in the apparatus.

[0560] In a configuration, prompts are provided by any suitable external electronic device in communication with the breathing assistance apparatus, such as a smartphone, tablet, laptop, smart watch, wearable device, smart glasses, actigraphy device, or similar such device. The prompts may be provided via a display screen of the external electronic device, and / or via one or more speakers.

[0561] In a configuration, a user may vocally interact with the prompts (such as confirming they have been understood the instructions and followed them). Instructing user to disconnect respiratory patient interface

[0562] After initiation of the exercise mode, the user may be instructed at step 754 to remove any respiratory patient interface 51 (e.g., nasal cannula, face mask or other interface, depending on the therapy type) that might be connected to the breathing conduit 16 of the breathing assistance apparatus or confirm that no respiratory patient interface 51 is connected to the breathing conduit 16. For example, a respiratory patient interface 51 may be connected to the breathing conduit 16 if the breathing assistance apparatus was last used in a therapy mode in a prior therapy session. In other configurations, the user may perform the breathing exercises in exercise mode using the respiratory patient interface from therapy mode (i.e., without using the mouthpiece attachment), depending on the nature of the breathing exercises to be performed.

[0563] Connecting mouthpiece attachment

[0564] The next step 756 in the exercise method 750 comprises the user being prompted to connect the mouthpiece attachment 1702 to the end of the breathing conduit 16 (or other gases outlet along the flow path) of the apparatus 10 in the manner previously described. The user may pre-assemble or install the removable mouthpiece 1730 before or after connecting the mouthpiece attachment 1702 to the end of the breathing conduit 16. The apparatus 10 may for example instruct the user to connect the mouthpiece attachment 1702 to the breathing conduit 16 and may provide information or guidance on how to connect the components, in some configurations.

[0565] Starting flow of gases to create pneumatic resistance

[0566] In the next step 758 in the exercise method 750, the controller is configured to control the flow generator 11 of the breathing assistance apparatus 10 to deliver a desired flow of gases along the flow path to the gases outlet 21. The flow of gases flows through the breathing conduit 16 and into the mouthpiece attachment 1702. The flow of gases into the mouthpiece attachment 1702 provides a controllable pneumatic resistance and / or gases flow with desired flow rate or pressure characteristics for the exercises, as previously described. In one configuration, the exercise mode may be configured to provide the flow of gases at a constant, predetermined or configurable flow rate and / or pressure, so as to provide a substantially constant pneumatic resistance. In another configuration, the flow of gases may also be controlled to zero (i.e., the flow generator 11 ceases providing a flow of gases to the mouthpiece attachment). In another configuration, the flow of gases may be provided with flow rate or pressure characteristics (e.g., fixed, variable, or oscillating) that are suitable for the breathing exercise or exercises being performed.

[0567] In one configuration, the user’s breathing (inhaling and exhaling) into the mouthpiece attachment while the flow of gases is provided causes fluctuations in the characteristics of the flow of gases. The characteristics of the flow of gases may, for example, be the flow rate or pressure characteristics of the flow of gases. Those fluctuations are indicative of the user’s breathing and may be detected and / or identified in the sensor data detected during the exercise mode, as will be explained later.

[0568] The flow of gases may be controlled for a predetermined or configurable time period. The flow of gases may be provided until the user has completed the required breathing exercises for an exercise session or until some other criteria is detected or satisfied. In one example, the user may signal or confirm the end of an exercise session via input into the user interface (e.g., GUI) of the apparatus (e.g., pressing an ‘end session’ button or similar on the GUI). In another example, the exercise session may be considered to have ended if the apparatus does not detect any breathing activity for a predetermined time period, which may infer the apparatus is no longer in use. In another example, the exercise session may end in accordance with a therapy schedule.

[0569] The flow rate setting or pressure setting of the flow of gases, and associated pneumatic resistance, may be varied depending on the patient or patient characteristics such as, but not limited to, their age, sex, height weight, disease stage, and / or other relevant parameters that may affect or represent their respiratory capacity and strength. Additionally, or alternatively, the flow rate setting or pressure setting may vary depending on the particular breathing exercise step being undertaken. For example, the flow rate setting or pressure setting may be varied depending on which breathing exercise is being undertaken (e.g., forced exhalations, breathing against an oscillating pressure, restful breathing, or any other type of breathing). Additionally, or alternatively, the flow rate setting or pressure setting may be universally set based on an industry standard related to the pneumatic resistance required for breathing exercises or each specific breathing exercise, or may be set by a medical professional.

[0570] In some embodiments, the breathing assistance apparatus, during exercise mode, may be configured or operable to control the composition of gases delivered during an exercise session or portion of the exercise session. In some configurations, the flow of gases may be air augmented with a supplemental gas such as oxygen and the oxygen fraction of the flow of gases may be controlled to a particular oxygen concentration setting. In other configurations, the breathing assistance apparatus is controlled to deliver a flow of air (i.e., if supplementary gases such as oxygen are available, they are turned off or their flow rate reduced to zero via a controllable valve for example). It will be appreciated that any suitable composition of one or more gases could be delivered.

[0571] In one configuration, during exercise mode, the breathing assistance apparatus 10 may be configured to deliver a non-humified flow of gases (i.e., the flow of gases is provided at substantially ambient humidity). For example, the humidifier may be switched off or deactivated or disconnected. In another configuration, during exercise mode, the breathing assistance apparatus may be configured to deliver a humidified flow of gases. For example, the humidity settings of the humidifier may be controlled to deliver the flow of gases at the desired humidity level during specific breathing exercises and / or an exercise session.

[0572] Instructing user to perform breathins exercises

[0573] In this configuration, once a flow of gases is being delivered via the mouthpiece attachment 1702, the user can then be prompted to perform one or more breathing exercises with the mouthpiece of the mouthpiece attachment 1702, as indicated at step 760. In one example, the user may be instructed to perform breathing exercises into the mouthpiece attachment against the flow of gases. The breathing exercises may comprise any one or more of the following (discussed in further detail later):

[0574] • normal breathing,

[0575] • ACBTs,

[0576] • tidal breathing,

[0577] • maximal voluntary ventilation breathing,

[0578] • huffing,

[0579] • slow and deep inhalation,

[0580] • pursed lip breathing,

[0581] • inspiratory breath hold,

[0582] • forced expiration,

[0583] • breathing against a fixed positive expiratory pressure (PEP),

[0584] • breathing against an oscillating positive expiratory pressure (OPEP),

[0585] • breathing against intrapulmonary percussive ventilation (IPV),

[0586] • breathing against continuous positive airway pressure (CPAP) with oscillations,

[0587] • breathing against a Bilevel pressure (Bilevel) with oscillations, and / or

[0588] • breathing against any other profile of the flow of gases set by a medical professional .

[0589] In this disclosure, ‘normal breathing’ is intended to mean when the user breathes normally (which will be restfully), i.e., without instructions to breathe deeply or forcefully.

[0590] In this disclosure, ‘tidal breathing’ is intended to mean when the user breathes deeply. This can be considered more 'conscious' or active breathing, involving deep and slow breathing, with relaxed exhalations (i.e., the breathing is not forceful, including the exhalations). The difference between normal breathing and tidal breathing can be subtle. Both are forms of restful or relaxed breathing. However, the key difference is that normal breathing should aim to be done as non-consciously as possible, i.e., without too much ‘thinking’ on the user’s part, whereas tidal breathing in the context of this disclosure is more focused, deep breathing, especially on inhalation.

[0591] In this disclosure, ‘maximal voluntary ventilation breathing’ is intended to mean when the user inhales deeply and exhales forcefully (forced exhalation being an important difference from tidal breathing). For example, the user is essentially trying to exert maximum force with their lungs during maximal breathing.

[0592] Some of the breathing exercise examples above comprise or involve breathing against a flow of gases that is provided in accordance with a specific respiratory therapy (e.g., PEP, OPEP, IPV, CPAP with oscillations, Bilevel with oscillations), and these will be explained in further detail later.

[0593] In examples where oscillations are provided as part of the breathing exercise, the oscillations may for example be generated by the flow generator (i.e. the blower and / or valve as part of the flow generator) or by a valve as part of the breathing assistance system - i.e. connected to a component for example a delivery conduit 16, or patient interface 51, or an expiratory conduit (not shown), or a controllable valve in any other part of the flow path of the breathing assistance apparatus or system.

[0594] In some examples, where a baseline positive pressure is provided and the oscillations occur about that baseline pressure, then the flow generator may provide the baseline pressure and the valve the oscillations.

[0595] As described elsewhere in the specification the oscillations may be flow oscillations or pressure oscillations.

[0596] In one example configuration, the apparatus may prompt the user to exhale for a fixed period, e.g., for a specific time period. The time period may be 1, 2, 3 or more seconds, by way of example only, or some other specified time period depending on the assessment and / or exercise being undertaken. By way of example, the user may be prompted to breathe in, and then exhale as hard as they can into the mouthpiece of the mouthpiece attachment for a specific length of time or until they are out of breath. A countdown timer may be displayed to the user (e.g., via a GUI display of the breathing assistance apparatus) to show how long they need to exhale into the mouthpiece attachment for.

[0597] Collecting, storing and / or analysing sensor data

[0598] As the user or patient performs the breathing exercises, the breathing assistance apparatus, is configured to sense or measure one or more characteristics of the flow of gases via one or more sensors of the breathing assistance apparatus, as indicated at step 762. In particular, the controller of the breathing assistance apparatus, while operating in the exercise mode, receives or retrieves sensor data from one or more sensors while the breathing exercises are carried out by the patient.

[0599] In one example configuration, the controller of the breathing assistance apparatus is configured to sample the flow rate signal of one or more flow rate sensors of the apparatus. As discussed, the apparatus may comprise one or more flow rate sensors or configurations that are arranged to sense the flow rate of the flow of gases and generate a representative flow rate signal or flow rate data. In other embodiments, one or more other characteristics of the flow of gases may be sensed and measured during the breathing exercises including, but not limited to, pressure, temperature, humidity, gas concentration, or any other property that may be useful directly or indirectly for analysing a user’s performance and / or a user’s breathing information.

[0600] Exercise sessions comprising a plurality of breathing exercises

[0601] In some configurations, the apparatus may be configured, while in the exercise mode, to instruct the user to perform repeated or multiple breathing exercises in a session. In one example, the user may be instructed to perform a plurality of breathing exercises, spaced apart by predetermined time interval(s). For example, a plurality or multiple (e.g., two, three or another specified number of) breathing exercises might be performed in a uniformly or non-uniformly spaced-apart manner or according to a preconfigured time interval. In one configuration, sensor data for each breathing exercise is received from the one or more relevant sensors to create multiple sets of measurement data, one set for each breathing exercise.

[0602] In some configurations, the apparatus may be configured to detect the start of a breathing exercise initiated by the patient by processing and / or monitoring the sensor data. For example, the apparatus may be configured to process the flow rate data received while in the exercise mode to identify an offset in the flow rate relative to a threshold or range, or identify a significant deviation that is otherwise indicative of a user commencing a breathing exercise with the mouthpiece attachment 1702. Upon detecting the start of the breathing exercise, the apparatus may trigger the countdown timer and / or other display GUI screen prompts or other instructions to request the user to continue the breathing exercise for a required time period.

[0603] Additionally or alternatively, the breathing exercise detection can be used to count the number of repeated breathing exercises that have been performed by the user in an exercise session. The exercise count can be compared against a minimum number required or other performance or compliance threshold, and can be used to prompt the user to continue doing breathing exercises until a required number have been registered. Each breathing exercise detected within the session can have its own respective set of associated measurement data (e.g., sensor data) gathered from the one or more sensors, for subsequent processing.

[0604] The sets of measurement data from each breathing exercise may then be combined, aggregated or otherwise processed to create an averaged or collated set of data. Alternatively, other statistical analyses may be applied to the measurement data to extract a filtered set of data with reduced noise and / or which is less impacted by anomalies, such as the user making a mistake in following the instructions or performing the exercises incorrectly. In some configurations, the highest quality or best set of measurement data may be selected from the sets of measurement data for subsequent processing, analysis, and / or communication (e.g., transmitted to a medical professional or to the user as feedback). Example of guiding a user to perform a breathing exercise

[0605] Referring to Figures 32, a more detailed explanation of one example of the process of prompting the user to perform breathing exercises at step 760 in the exercise method 750 will be provided.

[0606] In this example configuration, the user is instructed to perform a breathing exercise with the mouthpiece of the mouthpiece attachment 1702 for x seconds, as shown at sub-step 760A.

[0607] The user is then instructed to repeat the breathing exercise for x seconds y times, as shown at sub-step 706B. The variables x (time duration of the exercise or exercise step) and y (number of repetitions of the exercise or exercise steps) may be configured or set as desired. In one example, the apparatus is configured so that the user is prompted to undertake a minimum number of breathing exercises in the exercise session, e.g., at least three or some other suitable number.

[0608] After the user has performed the required number of breathing exercise repetitions (which may be optionally automatically detected by the apparatus as described above or otherwise confirmed by user input), the user is prompted to breathe normally for a specific time period, as shown at sub-step 760C to complete the exercise session. For example, the user may be prompted to undertake normal breathing or alternatively tidal breathing for z minutes (e.g., at least 2 minutes or some other time period). As discussed above, normal breathing is different to tidal breathing, which is typically more deep, focused breathing (although still relaxed, and non-forceful). It will be appreciated that the variable z may be configured as desired. In one embodiment, during the end of the breathing session 760C, sensor data may be recorded and stored. The stored sensor data for the normal breathing or tidal breathing may then be further processed and / or used to extract or calculate one or more normal breathing or tidal breathing measures or parameters for the patient, as explained further below. Optionally, the controller may be configured to prompt the user to perform, after and / or before one or more of the other breathing exercises, one or more of the following: normal breathing, tidal breathing, maximum inspirations, breath holds, and / or walking around (e.g., to increase breath volume).

[0609] Assessing user performance based on sensor data and / or measurement data

[0610] One or more processing algorithms may be applied to the sensor data and / or measurement data from the breathing exercises to extract, identify or analyse one or more features indicative of a user’s performance and / or compliance with the prescribed therapy programme of breathing exercises.

[0611] By way of example, in one configuration the sensed flow rate data of the flow of gases in the flow path of the breathing assistance apparatus is collected and stored during the breathing exercises. This flow rate data may represent measurement data indicative of a user’s performance and / or user’s breathing. The flow rate data (sensed in the breathing assistance apparatus) fluctuates as the user performs a breathing exercise through or into the mouthpiece attachment, which is in fluid communication with the flow path of the breathing assistance apparatus. The fluctuation in the flow rate signal or data enables one or more features indicative of a user’s performance and / or breathing to be identified and extracted from the flow rate signal, via further processing of the set of flow rate data (e.g. sensor data) associated with the breathing exercise.

[0612] Referring to Figure 33, another example exercise method 750A is shown which is a modified version of the exercise method 750 shown in Figure 31. Like reference numerals represent like steps. The modified exercise method 750A includes an optional additional step 764 which relates to any one or more of the following: processing and / or analysing the measurement data (e.g., sensor data) gathered during the breathing exercises to generate user performance results or result data, storing the measurement data and / or results, transmitting the measurement data and / or results, and / or displaying the measurement data and / or results. By way of example, the measurement data (e.g., sensor data) may be stored and processed by the controller of the breathing assistance apparatus, and / or transmitted to an external device or server or system for storage and / or further processing and / or extraction and analysis of user performance and / or breathing parameters or measurements for the user. The sensor data and / or user performance and / or breathing measurements generated, whether represented graphically, numerically or in any other format, may be displayed to the user on the display of the breathing assistance apparatus and / or transmitted to one or more external or remote devices, systems or servers (e.g., as part of a cloud platform), for storage, access, display and / or viewing by a medical professional or other authorised persons.

[0613] In one configuration, the raw sensor data may be processed by the controller of the breathing assistance apparatus to generate the one or more user performance measurements and / or breathing data.

[0614] In another configuration, the raw sensor data may be transmitted to an external or remote electronic device (e.g., smartphone, tablet, laptop, smart watch, wearable device, smart glasses, actigraphy device, PC, remote server, remote system, cloud server platform, or other processing device) for further processing to generate the one or more user performance measurements and / or breathing data. The raw sensor data may be transmitted in real-time during an exercise session or at the end or conclusion of the exercise session.

[0615] In another configuration, the raw sensor data may be partly processed by the controller of the breathing assistance apparatus and partly processed by an external or remote electronic device (e.g., smartphone, tablet, laptop, smart watch, wearable device, smart glasses, actigraphy device, PC, remote server, remote system, cloud server platform, or other processing device).

[0616] In configurations where the raw or partly processed sensor data is processed by an external or remote electronic device (e.g., smartphone, tablet, laptop, smart watch, wearable device, smart glasses, actigraphy device, PC, wearable, remote server, remote system, cloud server platform, or other processing device), the external or remote device or system may transmit the processed data back to the breathing assistance apparatus or another local device for storage and / or display. For example, the breathing assistance apparatus or other local device may store the processed data, and / or perform further actions or processing including displaying the processed data or results on a display screen associated with the breathing assistance apparatus or other local device.

[0617] In one example configuration, the controller of the breathing assistance apparatus may be configured to transmit the sensor data to a user’s electronic device (e.g., a smartphone, tablet, laptop, smart watch, wearable device, smart glasses, actigraphy device, or similar). The user’s electronic device may perform processing of the raw sensor data to generate the user’s performance measurements and / or breathing data, and may then transmit that processed data to a remote server or system for further processing, storage and / or display. In some configurations, the breathing assistance apparatus may only have short-range data communication capability (e.g., Bluetooth, NFC, infrared technologies, or a physical wired connection) with the user’s local electronic device (e.g., smartphone, tablet, laptop, smart watch, wearable device, smart glasses, actigraphy device, or similar). The user’s electronic device may have additional longer-range data communication capabilities (e.g., Wi-Fi, cellular, 4G, 4G LTE, and / or 5G technologies) and may then transmit the raw or processed data to a remote server or system, thereby acting as a relay or transmitter for the breathing assistance apparatus.

[0618] Extracting or generating user performance features and / or breathing data from the sensor data

[0619] Referring to Figure 34, an example of the flow rate data signal and the fluctuations caused by breathing exercises (in this case forced expiratory manoeuvres) into the mouthpiece attachment is shown. In this example, the flow of gases was set to provide pneumatic resistance at a flow rate of 70 L / min. It will be appreciated that other flow rates or ranges of flow rates may be suitable for generating suitable measurement data during use of the mouthpiece attachment with the breathing assistance apparatus in exercise mode. It is further envisaged that the controllable pneumatic resistance can be provided in the form of a fixed or variable (e.g., oscillating) pressure (e.g., for breathing exercises comprising PEP, OPEP, IPV, and / or CPAP with oscillations therapy).

[0620] In this example configuration, the flow rate of approximately 70L / min may provide the advantage of preventing any back flow of the user’s exhaled breath into the apparatus 10. It will be appreciated that other flow rates may be sufficient to provide this benefit in different configurations, and the flow rate selected may be based on balancing one or more factors and / or to suit particular criteria or a particular configuration of the breathing assistance apparatus and / or mouthpiece attachment. For example, in some configurations, the flow rate may be configured to provide sufficient pneumatic resistance for performing the required user performance measurements and / or breathing exercises, and / or to avoid back flow into the apparatus which can result in condensation forming on the sensors within the breathing assistance apparatus and bacterial contamination.

[0621] The flow rate selected for use may additionally or alternatively be a function of or based at least partly on the pneumatic properties of the configuration of the breathing assistance apparatus and / or mouthpiece attachment (e.g., including flow resistances of the flow path and / or output flow path after the flow generator). For example, the flow rate may be configured or selected based at least partly on the pneumatic properties of one or more of the following: the output flow path of the breathing assistance apparatus, the breathing conduit, and / or mouthpiece attachment. For example, in a breathing assistance apparatus with a non-return valve in the flow path, a much lower flow rate (e.g., approximately 10 E / min) may be suitable or sufficient for gathering the required measurement data and / or performing at least some types of breathing exercises when running in an exercise mode with the mouthpiece attachment attached.

[0622] An example of the fluctuation in the sensed flow rate data caused by a healthy person doing a breathing exercise (in this case a forced exhalation) into the mouthpiece attachment is shown at 790, and the fluctuation in the sensed flow rate data for a sick person is shown at 792. As illustrated in Figure 34, the healthy person causes a larger and sharper drop in the sensed flow rate of the flow of gases, compared to the sick person or person with reduced or impaired lung function or performance. In one example configuration, the sensor data (e.g., flow rate or other sensor data) may represent the user performance measurement data and / or breathing data, and / or the sensor data may be processed to extract one or more user performance measurement data values and / or breathing information.

[0623] In one example configuration, the sensor data (e.g., flow rate or other sensor data), the processed user performance measurement data, and / or the breathing data may be graphed or represented graphically for display on a user interface (e.g., GUI display). In such configurations, the graphs may be further processed to identify and / or determine the health status of a user or trends in the user’s condition, e.g., whether the user’s condition is improving or deteriorating.

[0624] Patient physiological parameters

[0625] In an example configuration, if the patient is instructed or prompted to take multiple breaths at the end of an exercise session (e.g., see sub-step 760C above in Figure 32), one or more patient physiological parameters may be estimated or calculated or extracted from the sensor data recorded over the multiple breathing exercises. These parameters may include, for example, any one or more of the following: tidal volume, respiratory rate, minute ventilation, peak inspiratory flow, and peak expiratory flow.

[0626] Further examples of breathing exercise methods

[0627] Referring to Figures 35 and 36, further example exercise methods 1490 and 1500 will be described in further detail. As with earlier described examples, the exercise methods in these examples are implemented primarily by an algorithm or computing-instructions executed by a processor or controller of the breathing assistance apparatus 10 when it enters an exercise mode. The principles of the example methods 1490 and 1500 may be applied to any of the examples, configurations, or variations of the breathing assistance apparatus and / or mouthpiece attachment described above. It will be appreciated that various steps in the example methods 1490 and 1500 to be described need not necessarily operate in the order described. Some steps may occur in parallel or overlap or in a different order, without impacting on the overall process. Some steps may not be required or may be altered, depending on the specific configuration and / or operation of the breathing assistance apparatus, exercise system and / or mouthpiece attachment. Additionally, any of the steps disclosed in relation to methods 1490 and 1500 may be combined with, supplemented by and / or swapped interchangeably with the steps of methods 750 and 750 A described above.

[0628] Referring to Figure 35, the method 1490 starts at step 1491 with a prompt to initiate the breathing exercise session. As above, this prompt may be manually generated by a user or may be provided to a user via the apparatus 10 and / or some other external device (such as a smartphone, tablet, laptop, smart watch, wearable device, smart glasses, actigraphy device, or similar). Alternatively, the exercise mode may be automatically triggered remotely by a supervising medical professional or according to a pre-programmed condition or based on a therapy schedule. The breathing exercise session is then commenced at step 1492, where the controller is configured to control the flow generator 11 of the breathing assistance in order to provide a desired pneumatic resistance or flow of gases to the breathing exercise(s). It is envisaged that the target pneumatic resistance or characteristics of the flow of gases (e.g., flow rate and / or pressure) will depend upon the particular step of the breathing exercise or type of breathing exercise being performed as set out below.

[0629] In one configuration, the breathing exercises may include any one or more of the following types of breathing exercise:

[0630] • normal breathing,

[0631] • ACBTs,

[0632] • tidal breathing,

[0633] • maximal voluntary ventilation breathing, • huffing (i.e., huff coughing — a medical exercise that involves taking a breath in, holding it, and exhaling forcefully but slowly and continuously),

[0634] • slow and deep inhalation,

[0635] • pursed lip breathing,

[0636] • inspiratory breath hold,

[0637] • forced expiration,

[0638] • breathing against a fixed positive expiratory pressure (PEP),

[0639] • breathing against an oscillating positive expiratory pressure (OPEP),

[0640] • breathing against intrapulmonary percussive ventilation (IPV),

[0641] • breathing against continuous positive airway pressure (CPAP) with oscillations, and / or

[0642] • breathing against a Bilevel pressure (Bilevel) with oscillations.

[0643] A breathing exercise session or programme of breathing exercises may comprise any one or more of the above types of breathing exercise. The steps may be performed in any order, with the exact combination, duration and order being ultimately dependent upon patient pathology and / or a prescribed breathing exercise programme.

[0644] The above list of examples is provided to exemplify the types of ‘breathing exercises’ that may be prescribed for the user to perform in a breathing exercise programme or exercise session. Some of the breathing exercises listed above include respiratory therapy components and / or are defined based on a respiratory therapy being provided during the breathing exercise. For example, some of the breathing exercises involve the user breathing against a flow of gases provided in accordance with PEP therapy, OPEP therapy, IPV therapy, CPAP with oscillations therapy, and / or Bilevel with oscillations therapy. A mouthpiece attachment of the type described above may be used with the breathing assistance apparatus in any one or more of the breathing exercises listed or alternatively a respiratory patient interface may be used in some of the breathing exercises. A skilled person will appreciate that OPEP therapy is a form of respiratory therapy intended to help dislodge and mobilise mucus in the patient’s airways by having the patient breathe against an oscillating positive pressure (during exhalation phase only of patient’s breathing cycle).

[0645] The oscillations for the breathing exercises may be provided at a frequency of between about 1 Hz and about 30 Hz. In some examples, the oscillations may be provided at a frequency of about 3 Hz to about 5Hz, or about 2Hz to about 12 Hz.

[0646] In examples, where pressure oscillations are delivered, the oscillations may be provided as oscillating between a maximum pressure and a minimum pressure. The minimum pressure may be about 0 cmH20 to about 40cmH2O. The maximum pressure may be about 4 cmH20 to about 70 cmH20. For example, the oscillations may be provided as oscillating between about 5 cmH20 and about 20 cmH20, or about 5 cmH20 and about 10 cmH20.

[0647] In examples, where baseline pressure is provided, the baseline pressure may be between the oscillating pressures.

[0648] In some examples, the oscillations may be provided at 3 Hz at between about 5 cmH20 and about 20 cmH20, or at about 3 Hz at between about 5 cmH20 and about 10 cmH20, or at about 3 Hz at between about 5 cmH20 and about 10 cmH20.

[0649] The breathing exercise may be provided for about 2 minutes to about 10 minutes, or about 5 minutes to about 20 minutes, or about 3 minutes, or about 4 minutes, or about 5 minutes, or about 6 minutes.

[0650] One or more rest periods may be provided during the breathing exercise where the user is instructed to remove the interface (for example the mouthpiece). During the rest period the apparatus may stop providing oscillations (and optionally stops providing flow and / or pressure completely). During the one or more rest periods a timer may be shown on the user interface indicating to the user how long remains in the rest period.

[0651] In a first example configuration, a breathing exercise comprising OPEP therapy may comprise the breathing assistance apparatus providing a flow of gases with an oscillating positive pressure that is continuous over the user’s breathing cycle(s). The oscillating positive pressure is provided by the flow generator of the apparatus at a suitable expiratory pressure level, which may be lower than a CPAP pressure level so as to not challenge the user’s breathing too much. In this first example configuration, the user may be instructed (e.g., via a visual and / or audible prompt provided by the apparatus) to inhale through their nose while holding the mouthpiece to their mouth or to disengage from the mouthpiece while inhaling, and then to exhale through the mouthpiece against the oscillating positive pressure.

[0652] In a second example configuration, the apparatus may be configured to detect the user’s breathe cycle or phase (e.g., whether they are inhaling or exhaling) when they are using the mouthpiece. Based on the detected breath cycle, the flow generator of the breathing assistance apparatus is controlled to provide the oscillating positive pressure or any pressure during exhalations only. This configuration provides breath-synchronised OPEP therapy. In other example configurations, the oscillating positive expiratory pressure may be synchronised with the exhalation phase of the user’s breath cycle using other techniques and / or user input.

[0653] A skilled person will appreciate that IPV is similar to OPEP therapy, but typically uses lower-frequency oscillations than OPEP, and oscillations in IPV are synchronised with breathing (i.e., the oscillating positive pressure is provided across the entire breathing cycle during both the inhalation and exhalation phases, although it may have different characteristics during each phase, whereas OPEP is only intended to be provided during exhalation phases). By way of example, the frequency of the positive pressure oscillations in IPV may be approximately 2-4Hz, compared with approximately 10Hz for OPEP. For breathing exercises involving either OPEP or IPV therapies, the positive pressure provided comprises a baseline positive pressure and the oscillations occur about that baseline pressure, such that the oscillating positive pressure is always positive (i.e., it is above zero).

[0654] A breathing exercise involving breathing against CPAP with oscillations comprises providing an oscillating pressure about a continuous mean over a patient’ s whole breath cycle (e.g., during inhalation and exhalation). In particular, the oscillating pressure waveform representing the oscillating pressure is always above zero (i.e., a positive pressure). In some cases, the oscillating pressure may have a minimum that is zero or near zero, but is never a negative pressure.

[0655] A breathing exercise involving breathing against Bilevel with oscillations comprises providing an oscillating pressure about constant pressures over a patient’s whole breath cycle, wherein the pressure on inspiration is higher than the pressure on expiration. In particular, the oscillating pressure waveform representing the oscillating pressure is always above zero (i.e., a positive pressure). In some cases, the oscillating pressure may have a minimum that is zero or near zero, but is never a negative pressure.

[0656] In one example configuration, depending on the particular breathing exercise being performed, the controller may operate in a flow-controlled mode to provide a constant positive flow in the flow path sufficient to prevent back-flow into the apparatus, but not so high that the user experiences significant resistance to their normal breathing.

[0657] In another example configuration, depending on the particular breathing exercise being performed, the controller may operate in a flow-controlled mode to provide a pneumatic resistance to a desired level in the flow path of the apparatus, and this level may be higher than a back-flow prevention flow rate.

[0658] In another example configuration, the controller may operate in a pressure-controlled mode while the patient is performing breathing exercises. In one configuration, the controller may control the pressure of the flow of gases during the inhalation phase, exhalation phase, or across the entire breathing cycle according to pressure settings configured for breathing exercises that involve respiratory therapies such as, but not limited to, PEP, OPEP, IPV, CPAP with oscillations, and Bilevel with oscillations. For example, the controller may be configured to ensure a consistent or oscillating positive expiratory pressure (PEP) is provided to the patient while they perform a breathing exercise such as, but not limited to, the breathing exercises listed above that comprise PEP, OPEP, and IPV therapies. In another example, Bilevel pressure with oscillations may be provided, with a higher pressure provided during inspiration (as compared to expiration), partially mimicking cough-assist devices and helping to promote mucus clearance.

[0659] The nature of the controlled pneumatic resistance provided via the flow of gases may at least partly depend on the type of breathing exercise being performed (examples of some of the types of breathing exercises being provided in the list above). The controller of the breathing assistance apparatus controls the flow generator to control one or more characteristics (e.g., flow rate and / or pressure) of the flow of gases to provide the desired characteristics (e.g., pneumatic resistance) in the flow of gases. In some example configurations, the controller may provide the desired pneumatic resistance for a breathing exercise using any one or more of the following control techniques:

[0660] • maintaining a fixed value of positive flow rate of the flow of gases along the flow path;

[0661] • maintaining a fixed value of zero flow rate of the flow of gases along the flow path;

[0662] • varying the flow rate of the flow of gases along the flow path to counteract the flow caused by a user’s breath;

[0663] • maintaining a fixed value of pressure at the mouthpiece attachment;

[0664] • maintaining a first value or first average value of pressure during an expiratory phase of a breathing exercise, and maintaining a second value or second average value of pressure during an inspiratory phase of a breathing exercise. In one example configuration in which the user is performing a breathing exercise against a fixed positive expiratory pressure (PEP), the controller of the apparatus is configured to provide a flow rate of the flow of gases that is sufficient to induce a pre-defined constant PEP at the mouthpiece attachment. In some configurations, the constant PEP is provided only during the exhalation phase of the user’s breathing cycle. Alternatively, if a continuous fixed pressure is provided across the entire breath cycle, the user may inhale through their nose or otherwise detach from the mouthpiece during the inhalation phase, and then exhale through the mouthpiece during the exhalation phase.

[0665] In one example configuration in which the user is performing a breathing exercise against an oscillating positive expiratory pressure (OPEP), the controller of the apparatus is configured to provide a flow rate of the flow of gases that is sufficient to induce an oscillating PEP at the mouthpiece attachment. In one embodiment, providing a flow rate of the flow of gases sufficient to induce an oscillating PEP at the mouthpiece attachment comprises varying or oscillating the flow rate of the flow of gases between a first threshold or value that provides a pre-defined upper PEP value, and a second threshold or value that provides a pre-defined lower PEP value. In some configurations, the oscillating PEP is provided only during the exhalation phase of the user’ s breathing cycle. Alternatively, if a continuous oscillating pressure is provided across the entire breath cycle, the user may inhale through their nose or otherwise detach from the mouthpiece during the inhalation phase, and then exhale through the mouthpiece during the exhalation phase.

[0666] In addition, and depending again on the particular type of breathing exercise being performed, a user may be prompted or otherwise guided to either attach, detach or bypass the mouthpiece attachment from the breathing assistance apparatus. For example, in some scenarios one or more of the breathing exercise steps may be performed without the mouthpiece attachment, and instead via a nasal interface or other respiratory patient interface for example. Once in the exercise mode, at step 1493 the breathing assistance apparatus 10 may be configured to provide the user with one or more instructions on some parts of the first breathing exercise step. As described above, the instructions may be visual with text and / or imagery displayed as part of a graphical user interface (GUI) on a display of the apparatus, and / or audible instructions provided via a speaker of the apparatus, for example.

[0667] In one example configuration, the breathing assistance apparatus may be configured to provide real-time instructions to the user to follow during their performance of one or more steps of the breathing exercise. The real-time instructions may, for example, include the display of a flow and / or breath profile for the user to follow during the performance of the exercise. For example, the flow and / or breath profile may show or define target inhalation and / or exhalation times or timing, and / or target user-generate flow rates and / or pressures for the user to generate during the breathing exercise.

[0668] It is further contemplated that a user could be provided with real-time feedback relating to a breathing exercise. In one example, the feedback may comprise a visual indication of whether the user’s expiratory flow is sufficient and how long to continue exhaling for, in the context of a step or type of breathing exercise. In this example, ‘sufficient’ may mean a threshold amount of flow required to see a beneficial effect from the breathing exercise. The threshold may depend on the patient and their characteristics. The threshold may be configurable by a medical professional as part of the prescribed programme of breathing exercises. The threshold may be loaded into memory of the controller of the apparatus.

[0669] In one example configuration, the display of the apparatus may display real-time feedback relating to the user’s performance of one or more steps of the breathing exercise. This feedback may be displayed in text and / or graphical form. In one configuration, the feedback may comprise information relating to one or more parameters of the flow of gases. For example, the one or more parameters of the flow of gases may be usergenerated flow rate and / or user-generated pressure data or signals extracted or processed from the sensor data recorded during the breathing exercise, or any other userperformance relevant parameter relating to the flow of gases. In one embodiment, the display of the apparatus may be configured to display information representing the one or more parameters of the flow of gases relative to one or more pre-defined target values or thresholds. For example, the apparatus may display (graphically, numerically, and / or textually) the user-generated flow rate and / or user-generated pressure signal relative to one or more target values or thresholds, as they perform the breathing exercise.

[0670] The display may also be configured to allow a user to make some adjustments to breathing exercise parameters themselves, without the involvement of a supervising medical professional. For example, the user may want to slightly adjust (i.e., increase or decrease) the pneumatic resistance (whether flow-controlled or pressure-controlled) provided by the flow generator during a particular breathing exercise or exercise step, or for all breathing exercises or steps, depending on whether they are struggling to perform the exercise or alternatively need a more challenging exercise. In one example configuration, the user-adjustments may be confined by boundaries and / or thresholds configured by a medical professional that is managing the user.

[0671] In one example configuration, the real-time feedback may comprise any one or more of a visualization of the flow of gases induced by the user, a progress through an exercise, a timer, and / or other suitable graphics could be provided, optionally in the form of a ‘progress bar’ or meter. These visualisations may coach or guide a user to perform or complete a breathing exercise and / or exercise session properly in accordance with a prescribed programme.

[0672] In one example configuration, the real-time feedback displayed on the display of the apparatus may comprise encouragement feedback or positive feedback relating to the user’s performance of one or more steps of the breathing exercise. This encouragement feedback may be provided in text and / or graphical form. In one embodiment, the encouragement feedback may comprise positive affirmation or message to the user, to encourage them to complete or continue the breathing exercise. It is also envisaged that instructions for performing breathing exercises and / or real-time feedback discussed above may be provided via a display and / or speaker of any suitable external electronic device, such as a smartphone, tablet, laptop, smart watch, wearable device, smart glasses, actigraphy device, or similar such device. Likewise, user input or interaction (e.g., adjustments to parameters as discussed above) may also be provided through such external electronic devices.

[0673] At step 1494, further instructions are provided on the second breathing exercise step. This continues for all steps of the one or more breathing exercises until step 1495. During each of the steps 1492-1495, one or more of the flow rate and pressure sensors in the breathing assistance apparatus 10 can capture measurement data representative of the user’s performance, as described in detail previously.

[0674] In one example configuration, the measurement data may comprise flow rate data and / or pressure data for the flow of gases that is sensed or captured as the user performs the breathing exercises and / or during particular steps of the breathing exercises, as previously described. This measurement data can be captured during any or all of the types of breathing exercises described above. The measured data may be processed to determine user breathing parameters or metrics such as, but not limited to, respiratory rate, tidal volume, and / or minute ventilation, as the user preforms any one or more of the breathing exercises.

[0675] At step 1496, this measurement data is processed by the controller to determine performance metrics, which may include data indicative of patient-generated characteristics or parameters of the flow of gases during the steps of the breathing exercises. The patient-generated characteristics of the flow of gases may include patientgenerated flows or pressures represented by data such as the user flow rate signal and / or the user pressure signal, as previously described. Additionally, or alternatively, the measurement data and / or any other data generated or extracted from the measurement data discussed above (e.g., including but not limited to patient-generated characteristics or parameters of the flow of gases, user breathing parameters or metrics, etc.) may be transmitted to an external computing device such as a remote server or personal computing device for processing or analysis (e.g., by a medical professional).

[0676] At step 1497, the patient-generated characteristics of the flow of gases (e.g., patientgenerated flows and / or pressures) and / or any other captured or determined parameters may be evaluated. For example, the evaluation may be performed with reference or based at least partly on comparing the data to a pre-defined magnitude and / or time thresholds. In the specific case of user flow rate signals, it may be useful to determine if a target or threshold user flow rate was met and sustained for a sufficient period of time during the breathing exercise and / or specific step or type of the breathing exercise.

[0677] The results or performance data from this evaluation at step 1497, and optionally any of the raw and / or processed data itself can then be transmitted to a supervising medical professional or other medical professional for further analysis and decision making. This may include uploading the results of the evaluation and / or measurement data to a patient’s electronic medical record or another database for storage and review. Electronic transmission of patient respiratory performance evaluation(s) and / or measurement data as described above may facilitate more effective at-home therapy, potentially obviating or at least reducing the need for regular clinic visits.

[0678] In one configuration, the evaluation step may comprise generating a diagnosis of a respiratory disorder of the patient based on raw or processed data generated during the breathing exercise or exercise session. In one example, the method may comprise identifying or extracting a patient-associated feature in the sensor data representative of one or more characteristics of the flow of gases during the breathing exercise. The patient- associated feature may be a user-generated flow rate or user-generated pressure signal. The patient-associated feature may be compared to a threshold or thresholds. Bidirectional electronic data transmission between the user and supervising medical professional via the breathing assistance apparatus (optionally routed via a personal electronic or computing device of the types described above) further facilitates feedback to and from a patient.

[0679] In one example, this bidirectional data transmission can help keep the supervising medical professional up to date with the patient’s health and fitness, and may enable the medical professional to fine-tune or adjust the patient’s breathing exercise programme more frequently. For example, the breathing exercise programme may include any one or more of the following parameters: exercise session frequency (e.g., daily, twice daily, every two days, etc), the breathing exercises to be performed in exercise session(s) and constituent steps of the exercises, the parameters of each breathing exercise or exercise step (e.g., pressure levels, flow rates, pneumatic resistance(s), durations, etc).

[0680] In another example, this bidirectional data transmission allows a medical professional to provide feedback to their patients and / or further instructions about a particular breathing exercise or a new exercise for the programme. In another example, this data transmission allows a user to provide subjective feedback about the breathing exercise programme and / or particular steps or aspects of the breathing exercise or exercises. In one configuration, the user may be prompted to complete an electronic questionnaire that comprises questions relating to the user’s subjective feedback on the breathing exercises and / or their performance. The user’s response data to the questionnaire may be transmitted for remote processing. The questionnaire may be completed at the end of an exercise session or use session with the breathing assistance apparatus, for example.

[0681] Referring to Figure 36, the method 1500 begins at step 1501 with a prompt to initiate the breathing exercise session. As described above in relation to process 1490, the breathing exercise session is started at step 1502 and the user is guided through the performance of a series of n breathing exercise steps at step 1503. At step 1504 flow and / or pressure data is processed to identify features that can indicate whether or not a breathing exercise step has been performed or whether it has been performed adequately. The controller may identify a certain feature (e.g., a magnitude of patient-generated flow rate and / or patientgenerated pressure) that indicates the user has attempted to perform or has completed a breathing exercise step or any steps in a session. Calculating or detecting particular features that can be used to identify if a patient has attempted or completed an exercise or exercise step may be useful if a supervising medical professional is not so interested in closely tracking the patient’s success in performing individual breathing exercises or exercise steps, but rather whether or not the user is engaging in a prescribed breathing exercise programme.

[0682] The data representing identified features and / or exercise performance metrics can then be recorded at step 1505 and communicated to the supervising medical professional at step 1506. The identified features and / or exercise performance metrics can be collated as a record, such as a report, before or after communication to the supervising medical professional. For example, the data may be collated in a report on a patient’s local device (either the breathing assistance apparatus itself or a local personal computing device in communication with the breathing assistance apparatus) before communication, or on a medical professional’s local electronic device, after communication.

[0683] Optionally, at step 1507, instances where a prompt to initiate an exercise session has been generated but no corresponding activity by the user has been detected are flagged and reported to a supervising medical professional. In this scenario, the report can be used to flag non-compliant patients (who may not be engaging with an exercise programme for various reasons). For example, report data may be generated that comprises information (e.g., compliance data) that identifies if a patient is not starting or complying with individual exercise sessions and / or their prescribed exercise programme overall. In some configurations, the report data may be transmitted and / or a notification to the medical professional may be generated if a particular threshold of non-compliance is reached (e.g., if a certain threshold number of exercises sessions are detected as being skipped by the patient). Additionally, or alternatively, during optional step 1507 report data can be generated that comprises information (e.g., performance data) indicative of whether a patient is encountering difficulties or is otherwise unsuccessful in completing one or more breathing exercises and / or exercise steps. This report data relates to patients that are attempting to comply with their exercise programme but are encountering difficulties. This type of report data may also be generated by processing of the measurement data captured during an exercise session. In some configurations, the report data may be transmitted and / or a notification to the medical professional may be generated if a particular threshold of patient difficulty is detected.

[0684] For example, the measurement data may be processed to identify if a patient is having difficulty with the breathing exercises and / or particular steps of the exercises. The identification of difficulty may be based on one or more factors such as, but not limited to, the patient not generating enough flow during an exercise or repeatedly skipping an exercise or exercise step (e.g., by not attempting or even stopping the exercise session early). The report data may comprise data identifying the individual exercises or exercise steps that the patient is having difficulty with. In some configurations, a prioritised notification and / or alert system may be triggered in which the priority associated with the notification and / or alert to the medical professional is based on the number of identified failed or partially failed exercises and / or exercise steps compared to one or more thresholds. For example, a high priority notification and / or alert may be triggered if a high number (e.g., exceeding a high-priority threshold) of failed or partially failed exercises and / or exercise steps is detected, and a low priority notification and / or alert may be triggered if a lower number (e.g., in accordance with a low-priority threshold) of failed or partially failed exercises and / or exercise steps is detected.

[0685] These various reports, report data, and / or associated notifications / alerts described above in optional step 1507 maybe generated and / or transmitted in real time, collated and transmitted at regular, customizable intervals (e.g., as part of a weekly, fortnightly, or monthly report), transmitted based on one or more threshold criteria, and / or on request by the medical professional or even the patient. It is envisaged that the described methods 1490, 1500 may enable improved compliance and adherence monitoring of users to prescribed exercise programmes. A supervising medical professional or physiotherapist is able to assist the patient to perform the breathing exercises correctly and regularly (in accordance with a programme), by assessing the user’s performance of the breathing exercises (or even individual steps of the breathing exercises) as well as their overall compliance to a prescribed exercise programme. For example, if the medical professional receives a report indicating that the patient has not been following an exercise programme, or has been failing to adequately perform one or more steps of said exercise programme, they can follow-up with their patient. The follow-up could either in person or remote. For example, the follow-up may be via the prompts generated and displayed on one or more of the breathing assistance apparatus 10 or other suitable computing or electronic devices associated with the patient. The indicated user performance may also result in the medical professional amending the programme and / or tailoring the guidance provided to the user for the one or more steps of the breathing exercise.

[0686] The described methods 1490, 1500 may further enable remote adjustment of breathing exercise parameters (e.g., flow rates, pressures, phasing of breath exercise steps) provided by the breathing assistance apparatus in response to user feedback and performance metrics. If the breathing exercise programme is not resulting in any noticeable improvements for the user, or if the user is reporting discomfort or otherwise showing signs of difficulty in completing the exercises, then patient adherence may decline. Requiring an appointment with their supervising medical professional merely to calibrate their physiotherapy device could be a barrier to addressing such an issue. Remote bidirectional communication of data and feedback between a user / patient and a supervising medical professional and the remote updating of apparatus settings may eliminate the need for such a visit. Compliance may thus be improved by providing patient-specific feedback before, during and after the breathing exercises are performed.

[0687] Synchronising breathing exercises with the user’s breathing cycle As discussed above, some of the breathing exercises may comprise the user breathing with the mouthpiece attachment or patient interface against a flow of gases provided in accordance with one or more therapies (e.g., PEP, OPEP, IPV, CPAP with oscillations, and / or Bilevel with oscillations). For some such breathing exercises, characteristics of the flow of gases provided by the breathing assistance apparatus may be dependent on or a function of the user’s breathing cycle (e.g., inhalation and exhalation phases). These breathing exercises may require some form of breathing detection or synchronisation (i.e., input or identification of the user’s breathing cycle phase as to whether they are inhaling or exhaling). By way of example, characteristics of the flow of gases or breathing exercise therapy settings that may vary based on the user’s breathing cycle may include, but are not limited to, pressure, flow rate, and / or oscillation characteristics of the positive pressure provided, and the relevant characteristics and / or settings will depend on the nature of the therapy provided during the breathing exercise.

[0688] In one example, a breathing exercise may comprise PEP or OPEP therapy in which the user breathes against a fixed positive expiratory pressure (PEP) or oscillating positive expiratory pressure (OPEP) during exhalation only. For this breathing exercise, a method of detecting when the user is exhaling is required.

[0689] In another example, the breathing exercise may comprise IPV therapy in which the user breathes against a first type of oscillating pressure during inhalation, and a second (optionally different) type of oscillation pressure during exhalation. For this breathing exercise, a method of detecting when the user is inhaling and / or exhaling is required.

[0690] In another example, the breathing exercise may comprise Bilevel with oscillations therapy in which the user breathes against an inspiratory positive airway pressure with oscillations during inhalation, and a lower expiratory positive airway pressure with oscillations during expiration. For this breathing exercise, a method of detecting when the user is inhaling and / or exhaling is required. For breathing exercises that involve therapies requiring breathing detection and / or breath synchronisation, the breathing assistance apparatus may comprise one or more methods or configurations for detecting or identifying the user’s breathing cycle (i.e., inhalation and exhalation phases).

[0691] In one example configuration, the controller of the breathing assistance apparatus may automatically detect the user’s breathing cycle and may automatically synchronise the characteristics of the flow of gases to be provided in accordance with the breathing exercise therapy (e.g., PEP, OPEP, IPV, Bilevel with oscillations therapy etc).

[0692] A skilled person will appreciate that breathing detection algorithms are known that can detect the user’s breathing cycle (e.g., inhalation and exhalation phases) for a breathing assistance apparatus. Some such algorithms are based on processing characteristics of the flow of gases and detecting the user’s real-time breathing from sensor signals that sense characteristics of the flow of gases (e.g., pressure and / or flow rate signals). Other such algorithms may have dedicated breathing detection sensors or receive other data indicative of the user’ s real-time breathing or breath cycle. In one example, the controller may be configured to to detect the entire breathing cycle signal of the user. In another example, the controller may be configured to detect only certain features of the breathing cycle necessary to identify a specific breathing phase of the user. One example feature may be detecting zero-crossings which are indicative of a transition from inspiration to expiration, or vice versa. Another example feature may be detecting positive user flow or negative user flow, which can indicate whether the current phase is expiration or inspiration.

[0693] The controller of the breathing assistance apparatus in this configuration may execute one or more breathing detection algorithms or receive breathing data from an external device or sensor to generate a breathing cycle signal. The controller may then synchronise and / or co-ordinate the characteristics of the flow of gases with the user’s breathing cycle and in accordance with the breathing exercise therapy settings. 3. Control schemes applicable to breathins assistance apparatus with therapy mode and exercise mode

[0694] This disclosure relates to various control schemes or methods that are applicable to an apparatus of the type or types described above or similar apparatus, which provide at least an exercise mode breathing exercises, and optionally also in some configurations a therapy mode for respiratory therapy. All features and / or variants described regarding the apparatus above may be applied or utilised to implement any of the control schemes described below.

[0695] Various example control schemes which may be implemented on such apparatus are described below. It will be appreciated that an apparatus may implement any one or more of the control schemes or features or functionality of the control schemes in any combination. For example, features or functions from one control scheme may also be applied or used in any of the other control schemes, in any suitable combination.

[0696] 3. J First example control scheme - exercise mode operating with humidity control protocol

[0697] Overview

[0698] This first example control scheme may be applied to the breathing assistance apparatus as described above having a therapy mode and an exercise mode. Alternatively, the control scheme may be applied to an apparatus that is a dedicated breathing exercise device or system having an exercise mode, without any therapy mode. A controller of the apparatus may be configured to control humidity settings of a humidifier of the apparatus when operating in exercise mode in accordance with a humidity control protocol.

[0699] Example configurations As described above, the apparatus that is configured to provide a flow of gases to a user, and comprises a flow generator that is operable to generate the flow of gases for the user, and a humidifier that is operable to humidify the flow of gases in accordance with humidity settings. The controller of the apparatus is configured to control the breathing assistance apparatus in accordance with an exercise mode in which the controller controls the flow of gases in accordance with an exercise session of one or more breathing exercises being performed by the user against the flow of gases. During the exercise mode the controller is also configured to control the humidity settings of the humidifier in accordance with a humidity control protocol that is associated with the exercise mode. This provides a humidified flow of gases to the user during at least one or more of the breathing exercises.

[0700] In one configuration, the humidity control protocol is at least partly based on one or more environmental data representing environmental conditions associated with the environment within which the apparatus is operating. For example, the environmental data is provided by one or more sensors of the apparatus and / or external data sources that are in data communication with the apparatus. By way of example, the environmental data comprises any one or more of the following parameters: ambient temperature, ambient humidity, temperature of gases drawn into a gases inlet of the apparatus for the flow generator, humidity of the gases drawn into a gases inlet of the apparatus for the flow generator, and local weather data.

[0701] In one configuration, the humidity control protocol is at least partly based on the humidity settings applied by the controller in a preceding therapy session in therapy mode, or a current humidity of the flow of gases generated or remaining from a preceding therapy session. For example, the humidity control protocol comprises transitioning from a first humidity associated with the preceding therapy session to a second humidity associated with the exercise session.

[0702] In one configuration, the first humidity may be a target humidity setting of the preceding therapy session or a current sensed humidity level of the flow of gases prior to commencement of the exercise session. The second humidity may be a target humidity setting associated with the exercise session.

[0703] In one configuration, the humidity control protocol comprises a gradual or ramped transition from the first humidity to the second humidity. In one example, the gradual or ramped transition applied may be in accordance with a configurable rate of change. In another example, the gradual or ramped transition applied may be in accordance with a configurable ramping period that defines the time period to transition from the first humidity to the second humidity.

[0704] In another configuration, the humidity control protocol comprises a sharp or instantaneous transition from the first humidity to the second humidity.

[0705] In one example, the first humidity is higher than the second humidity such the humidity control protocol is configured to reduce the humidity of the flow of gases for the exercise session relative to the humidity associated with the preceding therapy session. In another example, the first humidity is lower than the second humidity such that the humidity control protocol is configured to increase the humidity of the flow of gases for the exercise session relative to the humidity associated with the preceding therapy session.

[0706] In one configuration, the humidity control protocol is configured to maintain a constant target humidity setting for the entire exercise session.

[0707] In another configuration, the humidity control protocol is configured to change a target humidity setting during the exercise session. In a first example, the humidity control protocol is configured to change the target humidity setting based at least partly on the type of breathing exercise being performed by the user during the exercise session. The change or changes in the target humidity setting may be synchronised to a change or changes in the type of breathing exercise being performed by the user during the exercise session. In a second example, the humidity control protocol is configured to change the target humidity setting in a manner that is asynchronous or independent to a change or changes in the type of breathing exercise being performed by the user during the exercise session.

[0708] In one configuration, a series of one or more different types of breathing exercises may be performed during an exercise session and each type of breathing exercise has a respective preconfigured humidity setting. In one example, the humidity control protocol is configured to apply or change a target humidity setting so as to correspond to the preconfigured humidity setting for the type of breathing exercise being performed.

[0709] In one configuration, the preconfigured humidity setting for a type of breathing exercise is dependent or at least partly based on the associated pressure and / or flow rate of the flow of gases provided for that type of breathing exercise. In some configurations, the preconfigured humidity setting is lower for a breathing exercise with a low pressure or flow rate relative to a breathing exercise with a higher pressure or flow rate.

[0710] In another configuration, the humidity control protocol is configured to apply a target humidity setting based at least partly on the flow rate of the flow of gases provided for the breathing exercise.

[0711] In one example, the humidity control protocol is configured to apply a humidity setting of above approximately 31 °C dew point for a flow rate above approximately 151pm, or above approximately 201pm, or above approximately 251pm. In another example, the humidity control protocol is configured to apply a humidity setting of above approximately 25°C dew point for a flow rate above approximately 151pm, or above approximately 201pm, or above approximately 251pm.

[0712] In one example, the humidity control protocol is configured to apply a humidity setting of below approximately 31 °C dew point for a flow rate below approximately 151pm, or below approximately 201pm, or below approximately 251pm. In another example, the humidity control protocol is configured to apply a humidity setting of below approximately 25°C dew point for a flow rate below approximately 151pm, or below approximately 201pm, or below approximately 251pm. In one configuration, the humidity control protocol is configured to change a target humidity setting during the exercise session in accordance with a humidity plan stored in the controller or memory accessible to the controller.

[0713] In one configuration, the humidity plan may define a target humidity setting that is independent of the length of the exercise session and / or type of breathing exercises being performed in the exercise session.

[0714] In one example, the humidity plan may define an oscillating target humidity setting. For example, the oscillating target humidity setting oscillates between a lower humidity setting and an upper humidity setting.

[0715] In one configuration, the humidity plan may define an application of the target humidity setting or oscillating target humidity setting for a predetermined time period.

[0716] In one configuration, the humidity plan may define an application of the target humidity setting or oscillating target humidity setting until one or more triggers or trigger events occurs. Examples of triggers or trigger events may include, but are not limited to, any one or more of the following: receiving manual user input by user to apparatus requesting a drop in humidity, detecting a specified number of mouthpiece or respiratory patient interface disconnections, detected predefined user actions, determining delivery of a completed total humidity dosage, detecting a metric or combination of metrics satisfying a respective maximum or minimum threshold, the metrics comprising any one or more of the following: o number of breathing exercises completed, o time completed for breathing exercises, o amount of humidity delivered, and o number of breaths undertaken. In one example, the humidity control protocol may be configured to reduce the target humidity setting or oscillating target humidity setting applied following one of the triggers occurring. In another example, the humidity control protocol may be configured to reduce the target humidity setting or oscillating target humidity setting temporarily for a predetermined time period and / or until a preconfigured trigger is detected, and then resumes application of the prior target humidity setting or oscillating target humidity setting.

[0717] In one configuration, the oscillating target humidity setting comprises an oscillating humidity profile selected or created from any one or more the following oscillating profiles: sinusoidal profile, sawtooth profile, square wave profile, and triangle profile. In one example, the controller is configured to implement the oscillating target humidity setting of the humidity plan by controlling a power output waveform of a heater plate of the humidifier to oscillate according to an oscillating power profile selected or created from any one or more of the following oscillating profiles: sinusoidal profile, sawtooth profile, square wave profile, and triangle profile.

[0718] In one example, the oscillating humidity profile and / or oscillating power profile may comprise any sequence, combination, and / or superimposition of oscillating profiles.

[0719] In one configuration, the breathing exercises of the exercise session comprise any one or more of:

[0720] - ACBTs, maximal voluntary ventilation breathing,

[0721] - huffing, slow and deep inhalation, inspiratory breath hold, forced expiration, and / or pursed lip breathing.

[0722] Additionally, or alternatively, the breathing exercises of the exercise session may comprise any one or more of: breathing against a fixed positive expiratory pressure (PEP), breathing against an oscillating positive expiratory pressure (OPEP), breathing against intrapulmonary percussive ventilation (IPV), breathing against a continuous positive airway pressure (CPAP) with oscillations, and / or breathing against a Bilevel pressure (Bilevel) with oscillations.

[0723] As previously described, in some configurations, the apparatus may further comprise a mouthpiece attachment that is fluidly connected or connectable to a gases outlet of the apparatus, either directly or via a breathing conduit, to receive the flow of gases. The mouthpiece attachment enables a user to perform at least some or all of the breathing exercises against the flow of gases. Additionally, or alternatively, the user may perform at least some or all of the exercises via a respiratory patient interface connected to the breathing conduit.

[0724] In another configuration, the breathing exercises of the exercise session may comprise any one or more of:

[0725] - ACBTs, maximal voluntary ventilation breathing,

[0726] - huffing, slow and deep inhalation, pursed lip breathing, inspiratory breath hold, forced expiration, breathing against a fixed positive expiratory pressure (PEP), breathing against an oscillating positive expiratory pressure (OPEP), breathing against intrapulmonary percussive ventilation (IPV), breathing against a continuous positive airway pressure (CPAP) with oscillations, and / or breathing against a Bilevel pressure (Bilevel) with oscillations. Additionally, the controller may be configured to prompt the user to perform, after and / or before one or more of the breathing exercises, one or more of the following: normal breathing, and tidal breathing.

[0727] In one configuration, the controller may be configured to control the pressure and / or flow rate of the flow of gases during the exercise mode as the user performs the breathing exercises. In one example configuration, the controller may be configured to control the pressure and / or flow rate of the flow of gases during the exercise mode to control a pneumatic resistance provided to the user as the user performs breathing exercises against the flow of gases. In some configurations, the controller may be configured to prevent any negative pressure in the flow of gases during the breathing exercises.

[0728] In one configuration, the breathing exercises comprise mucus clearance therapy (MCT) exercises. In one example, the MCT exercises comprise the controller providing a flow of gases having a pressure or flow rate that comprises an oscillatory component. By way of further example, in this configuration, the MCT exercises may comprise any one or more of: breathing against an oscillating positive expiratory pressure (OPEP), breathing against intrapulmonary percussive ventilation (IPV), breathing against a continuous positive airway pressure (CPAP) with oscillations, and / or breathing against a Bilevel pressure (Bilevel) with oscillations.

[0729] In one configuration, the breathing exercises comprise MCT exercises and other different exercises, and wherein the humidity control protocol is configured to maintain a higher target humidity setting for MCT exercises relative to the other exercises. In one example, the higher target humidity setting may be at least approximately 31 °C dew point, or at least 37° dew point, or at least 44°C dew point.

[0730] In one configuration, the humidity control protocol is configured to select or derive a target humidity setting for the exercise session based at least partly on or as a function of one or more therapy settings associated with a preceding therapy session in therapy mode. In one example, the therapy settings may include any one or more of the following: pressure setting, flow rate setting, and / or humidity setting.

[0731] In one configuration, the apparatus may further comprise a therapy mode. For example, the controller may be further configured to selectively control the apparatus in accordance with the therapy mode in which the controller controls the flow of gases to provide respiratory therapy in a therapy session for the user. The controller may selectively operate the apparatus in accordance with therapy mode or exercise mode, and may transition or switch between these modes, if desired. The user may select the mode of operation, or it may be at least partly automatically selected based on one or more inputs and / or sensors. In this configuration, the apparatus may be a breathing assistance apparatus of the type previously described.

[0732] In one configuration, the controller may be configured to control the apparatus, in either therapy mode or exercise mode, to deliver the flow of gases in accordance with a Positive Airway Pressure (PAP) mode in which the flow of gases is provided according to a PAP therapy with a pressure setting or settings having an oscillatory component and humidity settings in accordance with the humidity control protocol. In one configuration, the controller may be configured to control the apparatus to deliver the flow of gases with pressure settings according to a Non-invasive ventilation (NIV) therapy with an oscillatory component, and humidity settings according to at least approximately 31 °C dew point, or at least approximately 37°C dew point.

[0733] In one configuration, the exercise mode may comprise providing a flow of gases in accordance with flow rate and / or pressure settings that have an oscillatory component. The oscillatory component typically comprises a frequency or frequencies that are higher or faster than the user’s breathing rate or frequency.

[0734] In one configuration, the controller may operate or switch the apparatus to operate in accordance with the exercise mode without input from the user. For example, the user may be receiving respiratory therapy in therapy mode, and then the controller may switch to exercise mode by adding or superimposing an oscillatory component onto the pressure and / or flow rate of the flow of gases, for example to provide a MCT therapy in exercise mode.

[0735] Example applications

[0736] Some example applications and uses of the first example control scheme are explained below.

[0737] One of the physiotherapies provided by the apparatus could be breathing exercises improved by providing the user with a humidified gas stream or flow of gases. For example, if the apparatus has been used in therapy mode prior to the breathing exercises, the water in the humidifier (e.g., if the humidifier is a tub / reservoir type) will already be heated to deliver a humidity level in the flow of gases. The controller of the apparatus may be configured to increase or decrease (relative to the existing or prior humidity level of the therapy session) the humidity level delivered to the user when the breathing exercises begin in an exercise session in exercise mode, depending on the required or desired humidity level for the exercises.

[0738] The humidity control provided during the breathing exercises in exercise mode may be adapted based on the environmental conditions that the apparatus is operating in. By way of example, the environmental conditions may include, but are not limited to: ambient temperature, gases inlet humidity (may be same as ambient humidity), gases inlet temperature, and / or local weather. These environmental inputs or data may be provided by sensors or data from external sources that are in data communication with the apparatus.

[0739] In one example application, when breathing exercises for an exercise session in exercise mode are to begin after a period of respiratory therapy in therapy mode, the target humidity for the exercise session may be modified in various ways, as explained below. In one example, when the target humidity for the exercise session is greater than the target humidity of a preceding respiratory therapy, the apparatus may gradually transition to the new target humidity for the exercise session level over a period, or alternatively may increase the humidity level or new target humidity level instantaneously / as fast as possible.

[0740] In another example, when the target humidity of the exercise session is lower than the target humidity of a preceding respiratory therapy, the humidity may be ramped down to gradually reach the target humidity level for the exercise session. Alternatively, the humidity level or new target humidity level could be immediately decreased.

[0741] In either of the above examples, the gradient of the ramp up or down of the humidity level or new target humidity level can be a predetermined rate of change or be set to achieve a desired ramping period (e.g., rate is determined to achieve a fixed period to target humidity).

[0742] In other configurations, the humidity level may be controlled during a sequence of breathing exercises of the exercise session, as explained further below.

[0743] In one example, the humidity level provided may be constant or, alternatively, the humidity provided to the user could change over the course of the breathing exercise session. The change may be synchronized with the breathing exercise, or may alternatively be asynchronous or independent to the breathing exercise.

[0744] In another example, the user could perform one breathing exercise in the exercise session, but more likely will complete a series of exercises to improve different aspects of the respiratory system / breathing function. The humidity requirements for each exercise may be different to get optimum results, and the controller of the apparatus may be configured to apply humidity settings at least partly based on the type of breathing exercise being performed. In another example, the humidity level applied by the controller may be at least partly dependent on the flow rate and / or pressure of the flow of gases provided during the exercise session or particular breathing exercise. For example, for exercises in which the apparatus is providing a relatively low flow / low pressure (e.g., 20L / min or 4cmH2O), the humidity level could be lowered relative to higher flow rates and / or pressures.

[0745] In another example, the user or clinician could program a humidity plan into the controller or memory accessible to the controller, and the controller may control the humidity setting or humidity level of the flow of gases based on the humidity plan for the exercise session. In one configuration, the humidity plan may operate over the course of the breathing exercises irrespective of the length of the exercise session and the exercises being undertaken.

[0746] In one example, the humidity plan may define that the humidity level should oscillate between an upper and lower humidity limit. The period of such an oscillation could be 5, 10, 15 minutes, or some other configurable time period. The configurable time period may be on a time scale of minutes in one configuration, or any other suitable time scale unit in other configurations. Advantageously, if users have comfort issues when the upper level of humidity is provided, the oscillatory pattern or profile of the fluctuating humidity means these patients still receive periods of physiotherapy provided at high levels of humidity, while getting relief from the humidity in the phases where lower humidity is provided.

[0747] In some example configurations, the humidity plan may operate asynchronously of the breathing exercise being performed.

[0748] In some example configurations, the oscillatory humidity level may be achieved by the controller causing the application of an oscillatory power output waveform to the heater plate of the humidifier. The oscillatory power output waveform may comprise any one or more oscillatory waveform profiles including, but not limited to: a sinusoidal, sawtooth, square wave, and triangle profile. 3.2 Second example control scheme - Breathing assistance apparatus operating according to therapy schedule

[0749] Overview

[0750] This second example control scheme may be applied to the breathing assistance apparatus as described above having a therapy mode and an exercise mode. A controller of the apparatus may be configured to control automated or semi-automated sequencing of therapy sessions and exercise sessions in a single use session, according to a therapy schedule.

[0751] In some examples, the therapy mode may be provided for at least 10 minutes, or at least 15 minutes, or at least 30 minutes, or at least 1 hour, or at least 2 hours, or at least 3 hours, or at least 4 hours before the exercise session.

[0752] In some examples, the therapy mode may be provided for about 0.5 hour to about 24 hours of a day, or about 0.5 hour to about 12 hours of a day, or for about 0.5 hour to about 4 hours of a day.

[0753] Example configurations

[0754] As described above, the breathing assistance apparatus is configured to provide a flow of gases to a user, and comprises a flow generator that is operable to generate the flow of gases for the user, and a humidifier that is operable to humidify the flow of gases in accordance with humidity settings. The controller of the apparatus is operable to control the breathing assistance apparatus in a therapy mode in which the controller controls the flow of gases to provide a respiratory therapy in a therapy session for the user, and an exercise mode in which the controller controls the flow of gases in accordance with an exercise session of one or more breathing exercises being performed by the user against the flow of gases. The controller is configured, in a single use session, to initiate the therapy mode for one or more therapy sessions of respiratory therapy and initiate the exercise mode for one or more exercise sessions of breathing exercises at least partly according to a therapy schedule.

[0755] In one configuration, the controller initiates the therapy mode and exercise mode in a sequence that corresponds to the therapy schedule.

[0756] In one configuration, the controller is configured to initiate and / or switch between the therapy mode and the exercise mode according to the therapy schedule and based on user input to the apparatus.

[0757] In one configuration, the controller is configured to generate prompts to the user to initiate and / or switch between the therapy mode and the exercise mode according to the therapy schedule. By way of example, the controller is configured to initiate and / or switch between the therapy mode and the exercise mode based on confirmatory user input in response to the prompts.

[0758] In one configuration, the controller is configured to automatically initiate the therapy mode and the exercise mode in a sequence that corresponds to the therapy schedule.

[0759] In one configuration, the therapy schedule is stored in a memory of the apparatus or accessible to the apparatus.

[0760] In one configuration, the therapy schedule is at least partly configurable via a user interface of the apparatus or remotely from an external device in data communication with the apparatus.

[0761] In one configuration, the controller is configured to generate the therapy schedule at least partly based on prescription data received via a user interface of the apparatus or remotely from an external device that is in data communication with the apparatus.

[0762] In one configuration, the controller is configured to generate the therapy schedule at least partly based on user input received via a user interface of the apparatus or remotely from an external device that is in data communication with the apparatus. In one configuration, the controller is configured to receive the therapy schedule into a memory of the apparatus from an external device that is in data communication with the apparatus.

[0763] In one configuration, the therapy schedule is at least partly automatically configured for the user based on user-specific data. By way of example, the user-specific data may comprise any one or more of the following: usage data relating to the user’s prior therapy sessions and / or exercise sessions, sensor data captured by sensors of the apparatus during the user’s prior therapy sessions and / or exercise sessions, and / or survey feedback data representing the user’s feedback relating to prior therapy sessions and / or exercise sessions, and / or survey feedback data representing the user’s feedback relating to their perceived health status.

[0764] In one configuration, the therapy schedule is at least partly preconfigured by the controller prior to the commencement of the use session based on one or more data parameters received by or accessible to the apparatus.

[0765] In one configuration, the therapy schedule is at least partly dynamically configured by the controller during the use session based on one or more data parameters received by or accessible to the apparatus.

[0766] In one configuration, the therapy schedule is at least partly dynamically configured by the controller according to one or more rules that are triggered based on evaluation of the one or more data parameters, and wherein a triggered rule causes the controller to switch from a therapy mode to exercise mode, or vice versa. In one example, one or more of the rules are triggered based on evaluation of one or more of the data parameters against one or more thresholds. By way of example, the data parameters used in the dynamic configuration of the therapy schedule may comprise any one or more of: time of day, length of session or use session, frequency of use, and / or physiological parameters of the user.

[0767] In one configuration, the controller is configured to implement a therapy schedule that comprises: initiating the therapy mode for a therapy session and subsequently initiating the exercise mode for an exercise session following the therapy session.

[0768] In one configuration, the controller is configured to implement a therapy schedule that comprises: initiating the exercise mode for an exercise session and subsequently initiating the therapy mode for a therapy session following the exercise session.

[0769] In one configuration, the controller is configured to implement a therapy schedule that comprises: initiating the therapy mode for a therapy session both before and after initiating the exercise mode for an exercise session, such that a therapy session is provided both before and after an exercise session.

[0770] In one configuration, the controller is configured to implement a therapy schedule that comprises: initiating the therapy mode for a therapy session; and subsequently initiating one or more repeated cycles comprising: pausing the therapy session in therapy mode, initiating an exercise session in exercise mode, and re-initiating the paused therapy session in therapy mode.

[0771] In one configuration, the controller is configured to implement a therapy schedule that comprises: alternating between the therapy mode for a therapy session and the exercise mode for an exercise session to provide a series or multiple alternating therapy sessions and exercise sessions.

[0772] In one configuration, each therapy session in the series provides the same type of respiratory therapy.

[0773] In another configuration, at least one therapy session in the series provides a different type of respiratory therapy relative to other therapy sessions in the series. By way of example, the series may comprise a first therapy session comprising a pressure-controlled respiratory therapy, and a subsequent second therapy session comprising a flow- controlled respiratory therapy, or vice versa.

[0774] In one configuration, each exercise session in the series provides the same type of breathing exercises.

[0775] In one configuration, at least one exercise session in the series provides different breathing exercises relative to other exercise sessions in the series. By way of example, the series may comprise a first exercise session comprising mucus clearance therapy (MCT) exercises, and a subsequent second exercise session comprising other different exercises, or vice versa.

[0776] In one configuration, the controller is configured to implement a therapy schedule that comprises: initiating the therapy mode for a therapy session that comprises a pressure- controlled or flow-controlled respiratory therapy; and subsequently initiating the exercise mode for an exercise session, and wherein the exercise session comprises continuing the pressure-controlled or flow-controlled respiratory therapy with an oscillatory component applied to the flow of gases so as to provide mucus clearance therapy (MCT) exercises.

[0777] As described above, the apparatus may further comprise a breathing conduit for delivery of the flow of gases, and a respiratory patient interface and / or a mouthpiece attachment that is fluidly connected or connectable to a user-end of the breathing conduit to receive the flow of gases.

[0778] In one configuration, the controller in exercise mode may be configured to control the flow of gases to control a pneumatic resistance provided at the mouthpiece attachment or respiratory patient interface while the user performs one or more breathing exercises with the mouthpiece attachment or respiratory patient interface.

[0779] In one example, the respiratory patient interface is connected to the breathing conduit during the therapy mode, and the mouthpiece attachment is connected to the breathing conduit during the exercise mode. In another example, the respiratory patient interface is connected to the breathing conduit during both the therapy mode and exercise mode such that the user performs the therapy sessions and exercise sessions of the therapy schedule with the same respiratory patient interface.

[0780] In one configuration, the controller is configured to generate a prompt instructing the user on which interface to connect to the breathing conduit depending on the mode of operation of the apparatus and / or breathing exercise being performed, the interface comprising the respiratory patient interface or the mouthpiece attachment.

[0781] In one configuration, the respiratory therapy or therapies provided in therapy mode may comprise any one or more of: high flow therapy, nasal high flow (NHF) therapy,

[0782] Positive Airway Pressure (PAP) therapy,

[0783] Continuous Positive Airway Pressure (CPAP) therapy,

[0784] Non-invasive ventilation (NIV) therapy, oscillation therapy, and / or

[0785] Bilevel pressure therapy.

[0786] In one configuration, the breathing exercises provided in exercise mode may comprise any one or more of:

[0787] - ACBTs, maximal voluntary ventilation breathing,

[0788] - huffing, slow and deep inhalation, pursed lip breathing, inspiratory breath hold, forced expiration, breathing against a fixed positive expiratory pressure (PEP), breathing against an oscillating positive expiratory pressure (OPEP), breathing against intrapulmonary percussive ventilation (IPV), breathing against a continuous positive airway pressure (CPAP) with oscillations, and / or breathing against a Bilevel pressure (Bilevel) with oscillations.

[0789] In one configuration, the breathing exercises provided in exercise mode comprise mucus clearance therapy (MCT) exercises. In one example, the MCT exercises comprise the controller providing a flow of gases having a pressure or flow rate that comprises an oscillatory component. The oscillatory component typically comprises a frequency or frequencies that are higher or faster than the user’s breathing rate or frequency.

[0790] In another example, the MCT exercises comprise any one or more of: breathing against an oscillating positive expiratory pressure (OPEP), breathing against intrapulmonary percussive ventilation (IPV), breathing against a continuous positive airway pressure (CPAP) with oscillations, and / or breathing against a Bilevel pressure (Bilevel) with oscillations.

[0791] In one configuration, the breathing exercises provided in exercise mode comprise MCT exercises and other exercises. By way of example, the other exercises may comprise any one or more of: normal breathing,

[0792] - ACBTs, tidal breathing, maximal voluntary ventilation breathing,

[0793] - huffing, slow and deep inhalation, inspiratory breath hold, forced expiration, and / or pursed lip breathing. In one configuration, the respiratory therapy provided in therapy mode comprise nasal high flow (NHF) therapy, and the breathing exercises provided in exercise mode comprise mucus clearance therapy (MCT) exercises and / or other exercises. In this configuration, the controller is configured to implement a therapy schedule that comprises: initiating a therapy session of NHF therapy in therapy mode before and / or after initiating an exercise session of MCT exercises and / or other exercises in exercise mode.

[0794] In another configuration, the respiratory therapy provided in therapy mode comprises non-inventive ventilation (NIV) therapy, and the breathing exercises provided in exercise mode comprise mucus clearance therapy (MCT) exercises and / or other exercises; and wherein the controller is configured to implement a therapy schedule that comprises: initiating a therapy session of NIV therapy in therapy mode before and / or after initiating an exercise session of MCT exercises and / or other exercises in exercise mode.

[0795] In another configuration, the respiratory therapy provided in therapy mode comprises non-inventive ventilation (NIV) therapy or nasal high flow (NHF) therapy, and the breathing exercises provided in exercise mode comprise mucus clearance therapy (MCT) exercises and / or other exercises; and wherein the controller is configured to implement a therapy schedule that comprises: initiating a therapy session of one of either NIV therapy or NHF therapy in therapy mode before initiating an exercise session of MCT exercises and / or other exercises in exercise mode; and initiating a therapy session of the other of either NIV therapy or NHF therapy in therapy mode after the exercise session.

[0796] In one configuration, the controller operates the humidifier to humidify the flow of gases in either or both of the therapy mode and exercise mode.

[0797] In one configuration, the controller is configured to apply humidity settings to the humidifier that are at least partly based on the type of respiratory therapy and / or breathing exercises being provided by the apparatus.

[0798] Example applications Providing both respiratory therapy (i.e., therapy mode) and physiotherapies (i.e., breathing exercises in exercise mode) in a single apparatus allows combining of therapies and adjusting their delivery for better synergy and optimal treatment of the user. A combination, mixture, sequence or series of therapy sessions in therapy mode and exercise sessions in exercise mode may be implemented by the controller of the apparatus in accordance with a therapy schedule, in a single use session by the user.

[0799] In one configuration, using respiratory therapies (i.e., therapy mode) before, during or after undertaking physiotherapy (i.e., exercise mode) can advantageously compound the benefits of both therapies to improve health outcomes for the user. Example therapy schedule configurations and associated advantage may include, but are not limited to: respiratory therapy (i.e., therapy mode) before physiotherapy (i.e., exercise mode). Respiratory therapies provide oxygenation, humidity and CO2 washout that contributes to mucus clearance and gas exchange in the follow-on exercise session, and / or may support gas exchange and reduce work of breathing for the user. respiratory therapy (i.e., therapy mode) after physiotherapy (i.e., exercise mode). Airways are less obstructed by mucus due to the prior exercise session, and respiratory therapy is better able to target parts of the airways that were not reachable prior - improving gas exchange. The respiratory therapy may also help the user recover from the physical exertion of the exercise session. respiratory therapy (i.e., therapy mode) with intermittent pauses to do physiotherapy (i.e., exercise mode). This configuration provides a combination of the prior advantages.

[0800] In one configuration, the therapy schedule stored or accessible by the apparatus schedules the two different therapy treatments (i.e., respiratory therapy in therapy mode and physiotherapy in exercise mode) based on prescription (e.g., input by clinician), and / or user-preference (i.e., either input by user or automated by the apparatus). In one example configuration, the clinician may define the therapy schedule either on the apparatus via the user interface or remotely via an electronic device in data communication with the apparatus. The clinician may receive feedback data about the user and their performance in prior therapy sessions and / or exercise sessions, as input into the derivation of the user’s prescription.

[0801] In one configuration, the controller of the apparatus is configured to automatically or at least partly automatically initiate, terminate and switch between the therapy mode for therapy sessions and exercise mode, in accordance with the loaded therapy schedule.

[0802] In one configuration, the therapy schedule may be implemented or guided at least partly automatically by the controller of the apparatus, but with the user still having control of initiation, termination and switching between the therapy mode and exercise mode by interacting with the user interface of the apparatus. For example, the apparatus may provide a prompt to the user notifying of their therapy schedule, and prompts for initiating, terminating and / or switching between the therapy sessions and exercise sessions in accordance with the therapy schedule. The user may interact with the prompts to confirm and / or action the prompts.

[0803] In some configurations, certain therapies (whether respiratory therapies and / or breathing exercises) may be optional and therefore not prescribed. In this configuration, the user may still opt in to receive such therapies and may configure the electronic therapy schedule to include one or more such optional therapies. The user may configure the therapy schedule via the user interface of the apparatus and / or remotely via an electronic device in data communication with the apparatus.

[0804] In some configurations, the apparatus may determine the therapy schedule based on apparatus feedback (e.g. usage data, sensor data, survey / questionnaire feedback) for what may best suit the user. In some configurations, data parameters such as, but not limited to, the time of day, length of a session, frequency of a therapy or thresholds on user physiological parameters may be used as input to the derived therapy schedule and / as inputs to any rules / triggers that are part of the therapy schedule. For example, the therapy schedule may be dynamic and may include one or more rules / triggers that when satisfied control the initiation, termination, and / or switching between the therapy mode and exercise mode. The rules and / or triggers may be satisfied based on any one or more data parameters satisfying respective thresholds for example.

[0805] In one example configuration, a therapy schedule may be implemented that causes the user to receive high flow therapy for a first treatment period in therapy mode, then undertake breathing exercises in exercise mode, and then receive high flow therapy in therapy mode for a second treatment period. By way of example, the respiratory therapy could be a pressure-controlled therapy such as Bilevel or CPAP. In one example, this cycle of therapy and exercise sessions may repeat multiple times according to the therapy schedule, throughout the user’s single use session with the apparatus.

[0806] In one example configuration, the therapy schedule may restrict the therapy mode to Bilevel therapy at night and high flow therapy during day. In another example configuration, the therapy schedule may restrict to Bilevel for a minimum period (e.g., 1 hour) as the first respiratory therapy in the schedule, and then move to high flow therapy for a minimum period (e.g. 2 hours) as the second respiratory therapy, as it’s more tolerable.

[0807] In one example configuration, a first respiratory treatment period in the therapy schedule may deliver a first type of respiratory therapy, and a second or later respiratory treatment period may deliver a different second type of respiratory therapy. For example, the first respiratory treatment period could be a flow-controlled therapy and the second respiratory treatment period could be a pressure-controlled therapy, or vice versa. In other example configurations, the therapy schedule may comprise or co-ordinate the therapy sessions and / or exercise sessions in accordance with any one or more of the following schemes:

[0808] High flow therapy (i.e., in therapy mode) being provided for prescribed minimum period (e.g., 4 hours) before switching to physiotherapy (i.e., exercise mode).

[0809] Performing a number (e.g., frequency of use) of breathing exercises or until an increase in the user’s tidal volume to a threshold is reached before switching to respiratory therapy (i.e., therapy mode) for CO2 washout, for example implementing high flow therapy.

[0810] During respiratory therapy (i.e., in therapy mode), pausing intermittently to do physiotherapy in exercise mode (e.g., flow of gases with oscillations (MCT) or other breathing exercises) for a short portion (e.g., 5 min), then returning to the respiratory therapy session in therapy mode.

[0811] During respiratory therapy in therapy mode, superimposing oscillations on the current therapy settings (to convert the therapy session into an exercise session such as MCT). The oscillations may be applied for the whole breath cycle, or alternatively just inhalation or exhalation.

[0812] In one configuration, the first exercise session and second exercise session of the therapy schedule can be two different physiotherapies (i.e., types of MCT and / or breathing exercises). For example, the first exercise session in exercise mode may be MCT, and the second exercise session in exercise mode may comprise the user carrying out other breathing exercises, or vice versa.

[0813] In one configuration, the therapy schedule may include an exercise session comprising MCT that is intermittently paused for other short or micro-sessions of breathing exercises to further induce a cough or coughing.

[0814] 3.3 Third example control scheme - Pre-conditioning mode for transitioning from therap y mode to exercise mode

[0815] Overview The third example control scheme may be applied to the breathing assistance apparatus described above having at least a therapy mode and an exercise mode. A controller of the apparatus may be configured to control the transitioning of the apparatus from a current therapy session in therapy mode to an exercise session in exercise mode, including initiating a pre-conditioning mode prior to the exercise session.

[0816] In some examples, the therapy mode may be provided for at least 10 minutes, or at least 15 minutes, or at least 30 minutes, or at least 1 hour, or at least 2 hours, or at least 3 hours, or at least 4 hours before the exercise session.

[0817] In some examples, the therapy mode may be provided for about 0.5 hour to about 24 hours of a day, or about 0.5 hour to about 12 hours of a day, or for about 0.5 hour to about 4 hours of a day.

[0818] The pre-conditioning mode may be provided f...

Claims

CLAIMS1. A breathing assistance apparatus that is configured to provide a flow of gases to a user, comprising: a flow generator that is operable to generate the flow of gases for the user; a humidifier that is operable to humidify the flow of gases in accordance with humidity settings; a controller that is operable to control the breathing assistance apparatus, the controller being configured to selectively operate the breathing assistance apparatus in: a therapy mode in which the controller controls the flow of gases to provide a respiratory therapy in a therapy session for the user; and an exercise mode in which the controller controls the flow of gases in accordance with an exercise session of one or more breathing exercises being performed by the user against the flow of gases, and wherein the controller is configured, in a single use session, to initiate the therapy mode for one or more therapy sessions of respiratory therapy and initiate the exercise mode for one or more exercise sessions of breathing exercises at least partly according to a therapy schedule.

2. A breathing assistance apparatus according to claim 1 wherein the controller initiates the therapy mode and exercise mode in a sequence that corresponds to the therapy schedule.

3. A breathing assistance apparatus according to claim 1 or claim 2 wherein the controller is configured to generate the therapy schedule at least partly based on prescription data received via a user interface of the apparatus or remotely from an external device that is in data communication with the apparatus.

4. A breathing assistance apparatus according to any one of claims 1-3 wherein the therapy schedule is at least partly automatically configured for the user based on userspecific data.

5. A breathing assistance apparatus according to claim 4 wherein the user- specific data comprises any one or more of the following: usage data relating to the user’s prior therapy sessions and / or exercise sessions, sensor data captured by sensors of the apparatus during the user’s prior therapy sessions and / or exercise sessions, and / or survey feedback data representing the user’s feedback relating to prior therapy sessions and / or exercise sessions, and / or survey feedback data representing the user’s feedback relating to their perceived health status.

6. A breathing assistance apparatus according to any one of claims 1-5 wherein the therapy schedule is at least partly dynamically configured by the controller during the use session based on one or more data parameters received by or accessible to the apparatus.

7. A breathing assistance apparatus according to claim 6 wherein the therapy schedule is at least partly dynamically configured by the controller according to one or more rules that are triggered based on evaluation of the one or more data parameters, and wherein a triggered rule causes the controller to switch from a therapy mode to exercise mode, or vice versa.

8. A breathing assistance apparatus according to any one of claims 6 or claim 7 wherein the data parameters comprise any one or more of: time of day, length of session or use session, frequency of use, and / or physiological parameters of the user.

9. A breathing assistance apparatus according to any one of claims 1-8 wherein the controller is configured to implement a therapy schedule that comprises: initiating the therapy mode for a therapy session and subsequently initiating the exercise mode for an exercise session following the therapy session.

10. A breathing assistance apparatus according to any one of claims 1-8 wherein the controller is configured to implement a therapy schedule that comprises: initiating the therapy mode for a therapy session; and subsequently initiating one or more repeated cycles comprising: pausing the therapy session in therapy mode, initiating an exercise session in exercise mode, and re-initiating the paused therapy session in therapy mode.

11. A breathing assistance apparatus according to any one of claims 1-8 wherein the controller is configured to implement a therapy schedule that comprises: alternating between the therapy mode for a therapy session and the exercise mode for an exercise session to provide a series or multiple alternating therapy sessions and exercise sessions.

12. A breathing assistance apparatus according to claim 11 wherein at least one therapy session in the series provides a different type of respiratory therapy relative to other therapy sessions in the series.

13. A breathing assistance apparatus according to any one of claims 1-8 wherein the controller is configured to implement a therapy schedule that comprises: initiating the therapy mode for a therapy session that comprises a pressure-controlled or flow- controlled respiratory therapy; and subsequently initiating the exercise mode for an exercise session, and wherein the exercise session comprises continuing the pressure- controlled or flow-controlled respiratory therapy with an oscillatory component applied to the flow of gases so as to provide mucus clearance therapy (MCT) exercises.

14. A breathing assistance apparatus according to any one of claims 1-13 wherein the apparatus further comprises: a breathing conduit for delivery of the flow of gases; anda respiratory patient interface and / or a mouthpiece attachment that is fluidly connected or connectable to a user-end of the breathing conduit to receive the flow of gases.

15. A breathing assistance apparatus according to any one of claims 1-14 wherein the breathing exercises provided in exercise mode comprise mucus clearance therapy (MCT) exercises.

16. A breathing assistance apparatus according to claim 15 wherein the MCT exercises comprise the controller providing a flow of gases having a pressure or flow rate that comprises an oscillatory component.

17. A breathing assistance apparatus according to any one of claims 1-14 wherein the respiratory therapy provided in therapy mode comprises nasal high flow (NHF) therapy, and the breathing exercises provided in therapy mode comprise mucus clearance therapy (MCT) exercises and / or other exercises; and wherein the controller is configured to implement a therapy schedule that comprises: initiating a therapy session of NHF therapy in therapy mode before and / or after initiating an exercise session of MCT exercises and / or other exercises in exercise mode.

18. A breathing assistance apparatus according to any one of claims 1-17 wherein the controller operates the humidifier to humidify the flow of gases in either or both of the therapy mode and exercise mode.

19. A breathing assistance apparatus according to claim 18 wherein the controller is configured to apply humidity settings to the humidifier that are at least partly based on the type of respiratory therapy and / or breathing exercises being provided by the apparatus.

20. A breathing assistance apparatus according to any one of claims 1-19 wherein the therapy mode is configured to deliver a flow of gases according to an oscillatory therapy.

21. A breathing assistance apparatus according to any one of claims 1-20 wherein the controller is further operable any one or more of the following additional modes: rest mode and cough mode.

22. A breathing assistance apparatus according to any one of claims 1-21 wherein the controller is further operable in a pre-conditioning mode.

23. A breathing assistance apparatus according to any one of claims 1-22 wherein the therapy schedule corresponds to a therapy programme.

24. A breathing assistance apparatus according to claim 23 wherein the therapy programme comprises a sequence of stages, each stage having an assigned mode of operation.

25. A breathing assistance apparatus according to claim 24 wherein the controller is configured to operate the breathing assistance apparatus in the assigned mode operation for each stage in the therapy programme.

26. A breathing assistance apparatus according to any one of claims 23-25 wherein the therapy programme comprises a preconfigured sequence of stages, each stage with an assigned mode of operation.

27. A breathing assistance apparatus according to any one of claims 23-26 wherein the therapy programme comprises a sequence of stages, each stage having an assigned mode of operation selected from at least one or more of the following modes: therapy mode, exercise mode, cough mode, rest mode, and pre-conditioning mode.

28. A breathing assistance apparatus that is configured to provide a flow of gases to a user, comprising: a flow generator that is operable to generate the flow of gases for the user; a humidifier that is operable to humidify the flow of gases; a controller that is operable to control the breathing assistance apparatus, the controller being configured to selectively operate the breathing assistance apparatus in:a therapy mode in which the controller controls the flow of gases according to therapy settings to provide a respiratory therapy in a therapy session for the user; a pre-conditioning mode in which the controller controls the flow of gases according to pre-conditioning settings to pre-condition the user for an exercise session in exercise mode; and an exercise mode in which the controller controls the flow of gases in accordance with an exercise session of one or more breathing exercises being performed by the user against the flow of gases, and wherein the controller is configured to transition from a current therapy session in therapy mode to an exercise session in exercise mode by: initiating a pre-conditioning mode prior to the commencement of the exercise session.

29. A breathing assistance apparatus according to claim 28 wherein the controller is configured to initiate the transition from therapy mode to exercise mode during a therapy session based at least partly on transition data, and wherein initiating the transition comprises initiating the pre-conditioning mode.

30. A breathing assistance apparatus according to claim 29 wherein the transition data comprises one or more trigger conditions, and wherein the controller initiates the preconditioning mode based at least partly on whether at least one of the trigger conditions is satisfied.

31. A breathing assistance apparatus according to claim 30 wherein the one or more trigger conditions comprise evaluating whether one or more user physiological parameters satisfy one or more thresholds.

32. A breathing assistance apparatus according to any one of claims 28-31 wherein the controller is configured to initiate the exercise mode for an exercise session immediately following the completion of a pre-conditioning period in the pre-conditioning mode.

33. A breathing assistance apparatus according to any one of claims 28-31 wherein the controller is configured to initiate the exercise mode for an exercise session after a predetermined or configurable preparation period has elapsed following the completion of the pre-conditioning period in the pre-conditioning mode.

34. A breathing assistance apparatus according to claim 33 wherein the controller is operable to terminate the preparation period to commence the exercise session in exercise mode in response to user input received by the apparatus or automatically based on data sensed or determined by the apparatus.

35. A breathing assistance apparatus according to any one of claims 28-31 wherein the controller is configured to initiate the exercise mode for an exercise session in response to one or more trigger conditions being satisfied following the completion of the preconditioning period in the pre-conditioning mode.

36. A breathing assistance apparatus according to claim 35 wherein the one or more trigger conditions comprise evaluating whether one or more user physiological parameters satisfy one or more thresholds.

37. A breathing assistance apparatus according to claim 35 or claim 36 wherein the one or more trigger conditions comprises determining or confirming via user input and / or sensor data whether the user has undertaken preparatory actions prompted by the apparatus.

38. A breathing assistance apparatus according to any one of claims 28-37 wherein the controller is operable to transition from the current therapy session in therapy mode directly to the exercise session in exercise mode without initiating the pre-conditioning mode, in response to user input to skip the pre-conditioning mode.

39. A breathing assistance apparatus according to any one of claims 28-38 wherein the pre-conditioning settings are preconfigured based at least partly on factory default settings and / or user-defined default settings.

40. A breathing assistance apparatus according to any one of claims 28-39 wherein the pre-conditioning settings are configured based on received user input or configuration data received from an external device that is in data communication with the apparatus.

41. A breathing assistance apparatus according to any one of claims 28-40 wherein the pre-conditioning settings are based at least partly on or a function of the therapy settings of the current therapy session.

42. A breathing assistance apparatus according to claim 41 wherein the pre-conditioning settings are derived as a function or scaled version of the therapy settings within preconfigured upper and lower limits.

43. A breathing assistance apparatus according to any one of claims 28-42 wherein the pre-conditioning settings are based at least partly on the settings to be applied during the exercise session in exercise mode.

44. A breathing assistance apparatus according to any one of claims 28-43 wherein the pre-conditioning settings for the flow of gases comprise settings relating to any one or more of the following settings: flow rate, humidity, pressure, FiO2, and / or FdO2.

45. A breathing assistance apparatus according to any one of claims 28-44 wherein the apparatus further comprises a controllable supplementary oxygen supply that is blended with atmospheric air to form the flow of gases, and wherein the pre-conditioning settings comprise higher FiO2 and / or FdO2 settings relative to the corresponding settings intended for the exercise session in exercise mode and / or the current therapy settings, so as to pre-oxygenate the user prior to the exercise session.

46. A breathing assistance apparatus according to any one of claims 28-45 wherein the pre-conditioning settings comprise a higher humidity setting relative to the corresponding setting intended for the exercise session in exercise mode and / or the current therapy setting.

47. A breathing assistance apparatus according to any one of claims 28-46 wherein the pre-conditioning settings comprise a higher flow rate setting relative to the corresponding setting intended for the exercise session in exercise mode and / or the current therapy setting.

48. A breathing assistance apparatus according to any one of claims 28-47 wherein the pre-conditioning settings comprise a higher pressure setting relative to the corresponding setting intended for the exercise session in exercise mode and / or the current therapy setting.

49. A breathing assistance apparatus according to any one of claims 28-48 wherein the current therapy session in therapy mode is configured with therapy settings that provide a first type of respiratory therapy, and wherein the pre-conditioning settings are configured to provide a different second type of respiratory therapy.

50. A breathing assistance apparatus according to claim 49 wherein the current therapy session in therapy mode is configured with therapy settings that provide a pressure- controlled respiratory therapy, and wherein the pre-conditioning settings are configured to provide a flow-controlled respiratory therapy.

51. A breathing assistance apparatus according to any one of claims 28-50 wherein the current therapy session in therapy mode is configured to provide a nasal high flow (NHF) therapy according to therapy settings that comprise a flow rate setting and a humidity setting, and wherein the pre-conditioning settings modify the flow rate setting and the humidity setting.

52. A breathing assistance apparatus according to any one of claims 28-50 wherein the current therapy session in therapy mode is configured to provide NIV therapy according to therapy settings that comprise an inspiratory pressure setting (IPAP), an expiratory pressure setting (EPAP), and rate of change of pressure setting, and wherein the preconditioning settings modify at least one or more of the IPAP, EPAP, and / or rate of change of pressure settings.

53. A breathing assistance apparatus according to any one of claims 28-52 wherein the respiratory therapy or therapies provided in therapy mode comprises any one or more of: high flow therapy, nasal high flow (NHF) therapy,Positive Airway Pressure (PAP) therapy,Continuous Positive Airway Pressure (CPAP) therapy,Non-invasive ventilation (NIV) therapy, oscillation therapy, and / orBilevel pressure therapy.

54. A breathing assistance apparatus according to any one of claims 28-53 wherein the breathing exercises provided in exercise mode comprise any one or more of:ACBTs, maximal voluntary ventilation breathing, huffing, slow and deep inhalation, pursed lip breathing, inspiratory breath hold, breathing against a fixed positive expiratory pressure (PEP), breathing against an oscillating positive expiratory pressure (OPEP), breathing against intrapulmonary percussive ventilation (IPV), breathing against a continuous positive airway pressure (CPAP) with oscillations, and / or breathing against a Bilevel pressure (Bilevel) with oscillations.

55. A breathing assistance apparatus according to any one of claims 28-54 wherein the breathing exercises provided in exercise mode comprise mucus clearance therapy (MCT) exercises.

56. A breathing assistance apparatus according to any one of claims 28-55 wherein the pre-conditioning settings of the pre-conditioning mode are independent of the therapy settings of the current therapy session in therapy mode.

57. A breathing assistance apparatus according to any one of claims 28-56 wherein the therapy mode is configured to deliver a flow of gases according to an oscillatory therapy.

58. A breathing assistance apparatus according to any one of claims 28-57 wherein the controller is further operable any one or more of the following additional modes: rest mode and cough mode.

59. A breathing assistance apparatus according to any one of claims 28-58 wherein the controller is configured to deliver a sequence of stages as a therapy programme.

60. A breathing assistance apparatus according to claim 59 wherein the therapy programme comprises a sequence of stages, each stage having an assigned mode of operation.

61. A breathing assistance apparatus according to claim 59 or claim 60 wherein the therapy programme comprises a sequence of stages, each stage having an assigned mode of operation selected from at least one or more of the following modes: therapy mode, exercise mode, cough mode, and rest mode.

62. A breathing assistance apparatus according to claim 61 wherein the controller is configured to operate the breathing assistance apparatus in the pre-conditioning mode prior to initiating the therapy programme.

63. A breathing assistance apparatus according to any one of claims 59-62 wherein the therapy programme comprises a sequence of stages, each stage having an assigned mode of operation selected from at least one or more of the following modes: therapy mode, exercise mode, cough mode, rest mode, and pre-conditioning mode.

64. A breathing assistance apparatus according to any one of claims 59-63 wherein the controller is configured to transition the breathing assistance apparatus between the assigned modes of operation of the stages of the therapy programme automatically.

65. A breathing assistance apparatus according to any one of claims 59-63 wherein the controller is configured to transition the breathing assistance apparatus between the assigned modes of operation of the stages of the therapy programme at least partly based on user input or interaction with the breathing assistance apparatus.

66. A breathing assistance apparatus according to any one of claims 59-65 wherein the therapy comprises one or more individual stages or one or more groups of stages that are repeated one or more times.

67. A breathing assistance apparatus that is configured to provide a flow of gases to a user, comprising: a flow generator that is operable to generate the flow of gases for the user; a humidifier that is operable to humidify the flow of gases; a controller that is operable to control the breathing assistance apparatus, the controller being configured to selectively operate the breathing assistance apparatus following a therapy programme that comprises a sequence of modes of operation, the modes of operation comprising at least one of: a therapy mode; an exercise mode; a cough mode; and a rest mode, and wherein the controller is further configured to selectively operate the breathing assistance apparatus in a pre-conditioning mode.

68. A breathing assistance apparatus according to claim 67 wherein the therapy mode is an oscillation therapy mode that is configured to deliver the flow of gases according to an oscillation therapy.

69. A breathing assistance apparatus according to claim 67 or claim 68 wherein the controller is configured to operate the breathing assistance apparatus in the preconditioning mode prior to commencing delivery of the therapy programme.

70. A breathing assistance apparatus according to any one of claims 67-69 wherein the controller is configured to operate the breathing assistance apparatus in the preconditioning mode for a time period before commencing delivery of the therapy programme.

71. A breathing assistance apparatus according to claim 70 wherein the time period of the pre-conditioning mode is predetermined.

72. A breathing assistance apparatus according to any one of claims 67-71 wherein the therapy programme is configured on the breathing assistance apparatus prior to commencement of the therapy programme.

73. A breathing assistance apparatus according to any one of claims 67-72 wherein the therapy programme is configured on the breathing assistance apparatus according to a prescription.

74. A breathing assistance apparatus according to any one of claims 67-73 wherein the sequence of modes of the therapy programme comprises at least one exercise mode.

75. A breathing assistance apparatus according to any one of claims 67-74 wherein the sequence of modes of the therapy programme comprises at least one oscillation therapy mode.

76. A breathing assistance apparatus according to any one of claims 67-75 wherein the sequence of modes of the therapy programme comprises a final mode in the sequence that is an exercise mode or cough mode.

77. A breathing assistance apparatus according to any one of claims 67-76 wherein the sequence of modes of the therapy programme comprises a rest mode after an exercise mode or an oscillation therapy mode.

78. A breathing assistance apparatus according to any one of claims 67-77 wherein the controller is configured to transition from at least one first mode in the sequence of modes of the therapy programme to a second mode in the sequence of modes of the therapy programme automatically.

79. A breathing assistance apparatus according to any one of claims 67-78 wherein the controller is configured to transition from at least one first mode in the sequence of modes of the therapy programme to a second mode in the sequence of modes of the therapy programme based at least partly on user input or interaction with the breathing assistance apparatus.

80. A breathing assistance apparatus according to any one of claims 67-79 wherein the controller is configured to provide guidance on a user interface of the breathing assistance apparatus during the pre-conditioning mode and / or therapy programme.

81. A breathing assistance apparatus according to any one of claims 67-80 wherein parameters and / or settings of each mode of operation in the sequence of modes of the therapy programme are configurable via a user interface of the breathing assistance apparatus..

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